Access to medical products in the South-East Asia Region, 2021: Review of progress

Access to medical products in the South-East Asia Region 2021 Review of progress 9 789290 228967 Access to medical products in the South-East Asia Region, 2021: Review of progress Access to medical products in the South-East Asia Region, 2021: Review of progress ISBN: 978 92 9022 896 7 © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/ igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Access to medical products in the South-East Asia Region, 2021: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2021. Licence: CC BY-NC- SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in India iiiAccess to medical products in the South-East Asia Region, 2021: Review of progress Contents Foreword by the Regional Director v PART I: Improving access to medical products: where are we now? 1 Status of access indicators in the South-East Asia Region 4 PART 2: Improving access to quality medical products: what interventions are being used? 11 Improving quality, safety and efficacy of medical products 13 Improving affordability of medical products 16 Collaboration on procurement 18 Improving access to medical abortion medicines 18 Improving access to safe blood and blood products 20 Combating antimicrobial resistance 20 Monitoring progress 23 The way forward 26 References 28 PART 3: Country profiles 29 Bangladesh 31 Bhutan 35 Democratic People’s Republic of Korea 39 India 43 Indonesia 47 Maldives 51 Myanmar 55 Nepal 59 Sri Lanka 63 Thailand 67 Timor-Leste 71

vAccess to medical products in the South-East Asia Region, 2021: Review of progress Foreword by the Regional Director The WHO South-East Asia Region is committed to ensuring access for all to safe, effective, affordable and quality medical products, in line with the 2018 Delhi Declaration on Improving Access to Essential Medical Products, and the Region’s Flagship Priority Programme on achieving universal health coverage (UHC). Across the Region, spending on medicines comprises a large proportion of out-of-pocket costs. To reduce those costs, Member States have in recent years begun implementing medical products pricing policies, which play a key role in ensuring that medicines are affordable. Several Member States have improved governance in medicine management, including by strengthening national policies and procurement systems. The finalization of the Initiative for Collaborative Procurement in South-East Asia (iCAPS) procedures, which guides implementation, is an important milestone towards collaborative procurement. The interest in leveraging the Initiative to increase access to essential antidotes, even from countries outside the Region, has been inspiring. To build resilient supply chains, especially during the COVID-19 pandemic, efforts to reduce risks and dependency, and increase domestic production, are ongoing. Such efforts will diversify the supply base and secure sufficient stockpiles of medical products. Partnership with the private sector, alongside ongoing regulatory system strengthening, is necessary for technology transfer and enhanced local production of high-priority medical products. Initiatives such as the COVID-19 Technology Access Pool could be effective in achieving these outcomes by providing a one-stop shop for developers of health products to share their intellectual property, knowledge and data. Monitoring access to medical products remains a complex endeavour that requires gathering of information from multiple sources and ensuring the interoperability of data collection systems. More complete and timely data on access to medicines will better enable countries to identify access disparities between population groups and understand the effects of interventions across their medicine supply and distribution chains. The COVID-19 pandemic has resulted in massive human and economic costs, partly on account of shortages of critical medical products. It has exposed vulnerabilities that impact the global supply chain. This report provides Member States, partners and other stakeholders an opportunity to review progress and identify and leverage new opportunities to improve access to essential medical products for a fairer, healthier Region for all. Dr Poonam Khetrapal Singh Regional Director WHO South-East Asia 1PART I Improving access to medical products: where are we now?

3Access to medical products in the South-East Asia Region, 2021: Review of progress Every disease management strategy requires access to essential medical products for prevention, diagnosis and effective management for treatment, palliative care and rehabilitation. Health-care services rely on access to essential medical products that include medicines, vaccines, medical devices, diagnostics, protective equipment and assistive devices. These products must be of assured quality, safety and efficacy, as well as appropriate, available and affordable. At the Seventy-first session of the WHO Regional Committee in September 2018, intercountry technical consultations following the Decision SEA/RC70(3) that was adopted by the Seventieth session of the Regional Committee led to the adoption of the ministerial “Delhi Declaration on Improving Access to Essential Medical Products in the Region and Beyond”. The Delhi Declaration1 was significant as it included a commitment for access to the entire range of medical products for achieving universal health coverage and the 2030 Agenda for Sustainable Development. In addition, SEA Region Member States actively participated in global consultations that led to the adoption of significant World Health Assembly resolutions on this subject. In Health Assembly resolution WHA72.8 of 2019 on “Improving the transparency of markets for medicines, vaccines and other health products”, the World Health Assembly expanded the scope of “health products” to include “medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies, and other health technologies”. Despite improvements in the availability of essential medical products in the Region, access of essential medicines and other essential medical products continues to pose a challenge. The high level of out-of-pocket (OOP) spending on health care in many SEA Region countries is a matter of concern, and is pushing around 65 million into poverty every year. This is mainly on account of spending on medical products, particularly medicines that account for the major share of OOP payment, in several countries of the Region. The current COVID-19 pandemic resulted in devastating human and economic costs, partly on account of shortages of critical medical supplies including PPEs, essential medicines, diagnostics, vaccines and medical devices. Production capacity was unable to meet the rapid surge in demand. Furthermore, lockdowns, travel and export bans, and suspended transport services had a direct impact on dwindled production, disrupted distribution and also increased cost of not only emergency medical supplies but other critical medicines required for essential health-care services. The pandemic has significantly highlighted the importance of timely access to quality, safe, effective medical products. Accordingly, all SEA Region Member States have supported World Health Assembly resolution WHA 73.1 of 2020 on access to medical products. Member States recognized “the need for all countries to have unhindered, timely access to quality, safe, efficacious and affordable diagnostics, therapeutics, medicines and vaccines, and essential health technologies and their components, as well as equipment”. 4 Access to medical products in the South-East Asia Region, 2021: Review of progress StatuS of acceSS indicatorS in the South-eaSt aSia region This publication provides an update to the 2019 report on access to medicines.2 Proportion of target population covered by vaccines Immunization coverage is an important indicator to monitor access to medical products. Regional immunization coverage with three doses of diphtheria, tetanus and pertussis (DTP3)3 vaccine has been maintained at above 90% since 2012, with DPT coverage ranging between 83% and 99% in 2019. In the last five years, five countries sustained high (>95%) coverage. Fig. 1. Regional Immunization overage with three doses of diphtheria, tetanus and pertussis (DTP3) vaccines, 2009–2019 50% 60% 70% 80% 90% 100% 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Pe rc en ta ge (% ) Bangladesh Bhutan DPR Korea India Indonesia Maldives Myanmar Nepal Sri Lanka Thailand Timor-Leste Regional average Source: WHO_UNICEF coverage estimates: Vaccines monitoring system, 2021 Global Summary (https:// apps.who.int/immunization_monitoring/globalsummary/timeseries/tswucoveragebcg.html) Availability of essential medicines in health facilities The availability and affordability of medicines, as per the standard method for reporting the SDG Target 3. b.3. indicator4 of medicines availability, is not yet regularly monitored globally or in the South-East Asia Region. Hence, the most recent health facility surveys from the Member States were used to provide insight. 5Access to medical products in the South-East Asia Region, 2021: Review of progress Table 1. Recent health facility surveys in the Region which collect information on medicines availability and price Country Year Reference Availability Prices Bangladesh 2020 Bangladesh Health Facility Survey 2017 Final Report. 2019 https://dhsprogram.com/ publications/publication-SPA28-SPA-Final- Reports.cfm- (accessed 25 January 2021). ✓ χ Bangladesh 2019 Evaluating medicine prices, availability and affordability in Bangladesh using World Health Organization and Health Action International methodology. BMC Health Services Research 2019; 19(1):383. https://bmchealthservres.biomedcentral. com/articles/10.1186/s12913-019-4221-z (accessed 25 June 2019). ✓ ✓ Bangladesh 2018 Service Availability and Readiness Assessment (SARA) survey for NCDs and Disability Service Delivery System in Bangladesh. 2018; 1–47 (internal communication). ✓ χ Myanmar 2015 Nationwide Service Availability and Readiness Assessment (SARA) Myanmar 2015 (internal communication). ✓ χ Nepal 2015 Aryal KK, Dangol R, Gartoulla P, Subedi GR. Health services availability and readiness in seven provinces of Nepal: further analysis of the 2015 Nepal Health Facility Survey, DHS Further Analysis Report No. 115. Ministry of Health and Population, Nepal, 2018. https://dhsprogram.com/pubs/pdf/FA115/ FA115.pdf (accessed 18 June 2019). ✓ χ Sri Lanka 2017 Rathish D, Premarathna I, Jayathilake T, Kandegedara C, Punchihewa K, Ananda L, et al. Availability of essential medicines in selected public, primary and secondary health care institutions of a rural Sri Lankan district: A spot survey. BMC Health Services Research.2017;17(1):1–9. http://dx.doi. org/10.1186/s12913-016-1969-2 (accessed 18 June 2019). ✓ χ Sri Lanka 2017 Service availability and readiness assessment 2017 Sri Lanka. 2018;1-314. http://www. searo.who.int/srilanka/sara_sri-lanka_2107_ report.pdf (accessed 18 June 2019). ✓ χ 6 Access to medical products in the South-East Asia Region, 2021: Review of progress Country Year Reference Availability Prices Sri Lanka 2014 Dabare PRL, Wanigatunge CA, Beneragama BH. A national survey on availability, price and affordability of selected essential medicines for noncommunicable diseases in Sri Lanka. BMC Public Health. 2014;14(1):817. http:// bmcpublichealth.biomedcentral.com/artic les/10.1186/1471-2458-14-817 (accessed 25 June 2019). ✓ ✓ Fig. 2 reports the overall availability of a nationally defined basket of essential medicines from recent national surveys in four countries. It ranges from 37% to 82% and is on average higher in private than public facilities, as was reported in the Access to medical products in South-East Asia Region 2019 publication.ii Fig. 2. Average availability (%) of essential medicines in four countries of the WHO South-East Asia Region 37% 57% 51% 82% 63% 69% 48% 73% 0% 20% 40% 60% 80% 100% Bangladesh (n=72) Myanmar (n=103) Nepal (n=40) Sri Lanka (n=65) Public Private n = number of medicines in the basket Source: Service Availability and Readiness Assessments (SARA) survey in Myanmar, 2015, Sri Lanka, 2017; Service Provision Assessments (SPA) surveys Nepal 2015, Health Facility Survey, Bangladesh, 2017. Access to pain medication Improving access to pain relief and palliative care has received increased attention in the Region. In 2014 Member States passed the first WHO global resolution on palliative care. WHO has included an indicator in its Thirteenth General Programme of Work 2019–2023 Impact Framework, with a target to increase the availability of oral morphine in facilities providing palliative care from 25% to 50%. Over 15 million people in the South-East Asia Region are estimated to experience serious health-related suffering, with a significant gap in access to adequate pain relief. The medical use of opioids for pain relief is low in the Region compared with other regions and significantly below the globally accepted adequate level of 200 S-DDD per million inhabitants per day. 7Access to medical products in the South-East Asia Region, 2021: Review of progress Fig. 3. Total opioid consumption, excluding methadone* (defined daily dose/million population/day (S-DDD)) 0 50 100 150 200 250 BAN BHU DPR Korea IND INO MAL MYN NEP SRL THA TL Asia *Methadone is mainly used as part of treatment for addiction to narcotics, hence it is excluded from this analysis. 200 S-DDD per million inhabitants per day threshold below consumption considered inadequate according to INCB5 With the growing prevalence of chronic diseases, cancer and other disorders associated with severe pain, it is timely to consider how to improve access to medicines that relieve severe pain. National medicines policies National medicines policies provide the framework for how a country intends to organize, finance and regulate the pharmaceutical sector to ensure equitable access to quality medicines and other health technologies to meet health-care needs. WHO recommends that national policies be updated every five years. National medicines policies have been updated in four South-East Asia Region countries in the last five years. Table 2. Latest year of national medicines policies being updated BAN BHU DPR Korea IND INO MAV MMR NEP SRL THA TLS 2016 2007 2019 2012 2006 2018* 2019 2007 2020 2020 2018 *National Medicine Policy 2007 has been reviewed in 2018 Source: Country pharmaceutical profile information (Part 3) Essential medicines lists The concept of essential medicines is a long-established approach to improve access to pharmaceuticals. The 1st edition of WHO’s Model List of Essential Medicines was published in 1977. Since then, all countries have developed their own national essential medicines lists (EMLs) in the Region. National essential medicines lists are used both to 8 Access to medical products in the South-East Asia Region, 2021: Review of progress improve efficiency of public sector procurement and promote rational use. The criteria for the selection of medicines in such lists include common morbidities, evidence of cost–effectiveness, and affordability for government or health insurance schemes. WHO suggests that countries update their EMLs every two years. Since 2019, five countries have updated their national EMLs (Table 3). Table 3. National essential medicines lists: dates of most recent revision BAN BHU DPR Korea IND INO MAV MMR NEP SRL THA TLS 2016 2018 2019 2015 2019 2020 2016 2020 2014 2020 2015 Source: Country pharmaceutical profile information (Part 4) EML updates in South-East Asia Region countries are now incorporating WHO’s Access/Watch/Reserve “AWaRe” classification for antibiotics, introduced in 2017 (Box 1). Antibiotics have been grouped into the three categories, with recommendations on when each category should be used. The change aims to ensure that antibiotics are available when needed, and that the right one is prescribed for the appropriate infection. Box 1. The WHO AWaRe categorization The overall goal is to reduce the use of Watch Group and Reserve Group antibiotics and to increase the use of Access antibiotics where availability is low. Watch antibiotics should be Reserve antibiotics should used for specific, limited only be used as a last indications resort when all other antibiotics have failed. Watch and and Reserve category antibiotics are at higher risk of resistance or too precious to use all the time. A Access Wa Watch Access antibiotics should be the preferred choice for common and serious infections. Access antibiotics should be available at all times, affordable and quality-assured Re Reserve 9Access to medical products in the South-East Asia Region, 2021: Review of progress The Fig. 4 showcases the inclusion of essential antibiotics as per the “AWaRe” classification in the essential medicines lists in 10 countries of the South-East Asia Region6 Fig. 4. Essential antibiotics listed in the national essential medicines lists of 11 countries of the WHO SEA Region according to the WHO AWaRe classification 13 17 14 14 12 18 16 16 14 20 16 2 7 2 10 7 12 10 5 9 15 10 1 3 1 0 5 10 15 20 25 30 35 40 Ba ng la de sh Bh ut an D PR K or ea In di a In do ne si a M al di ve s M ya nm ar N ep al Sr i L an ka Th ai la nd Ti m or -L es te N um be r of a nt ib io tic s in n at io na l E LM s Access antibiotics (N) Watch antibiotics (N) Reserve antibiotics (N) Source: Adekoya et al, 2021. Comparison of antibiotics included in national essential medicines lists of 138 countries using the WHO Access, Watch, Reserve (AWaRe) classification: a cross-sectional study. The Lancet Infectious Diseases 2021. 1-12. (https://doi.org/10.1016/ S1473-3099(20)30854-9 – accessed 31 July 2021).

PART 2 Improving access to quality medical products: what interventions are being used? 11

13Access to medical products in the South-East Asia Region, 2021: Review of progress improving quality, Safety and efficacy of medical productS A first-of-its-kind pilot virtual current good manufacturing practices (cGMP) online workshop in December 2020 was organized and implemented by all three levels of WHO (country office, Regional Office and headquarters) in collaboration with JSS Academy of Higher Education & Research, Mysuru, India, the Ministry of Health and Family Welfare of India, partners, USAID-funded programmes, MTaPS (the Medicines, Technologies and Pharmaceutical Services Programmes) and PQM+ (Promoting the Quality of Medicines Plus). The workshops are in pursuit of World Health Assembly resolution on the Global Strategy and Plan of Action on public health, innovation and intellectual property (GSPA) (resolution WHA61.21), and in line with the resolution of the Seventy-fourth World Health Assembly in May 2021 on “Strengthening local production of medicines and other health technologies to improve access” (resolution WHA74.6). The six series of workshops that began with a pilot contributed to further improve access to quality, safe, effective and affordable medicines and other health technologies and efforts to achieve the objectives of the SEA Region health ministers’ Delhi Declaration of 2018. Table 4. Pilot and subsequent cGMP workshops Workshop Category Dates 2020–2021 Number of Participating Units Number of Participants Duration (in days) Pilot Formulation 1–14 December 33 101 12 1. Formulation 5 May–18 May 40 143 12 2. APIs 24 May–5 June 35 139 12 3. APIs 14 June to 26 June 49 166 12 4. Medical Devices 5 July to 9 July 51 165 05 5. APIs 19 July to 30 July 115 401 12 Total 323 1115 The COVID-19 outbreak with the consequent restrictions on in-person workshops was turned into an opportunity whereby pharmaceutical unit personnel could attend workshop sessions while also attending to shop-floor production and related activities, thus improving outcomes. The workshops were offered at no cost to pharmaceutical units so as to cover a wide range of pharmaceutical manufacturers including small-scale producers of quality products. The workshops were rolled out with technical assistance from the Indian Pharmaceutical Alliance to ensure meaningful and relevant content and outcomes. 14 Access to medical products in the South-East Asia Region, 2021: Review of progress The selection of participating pharmaceutical units was done randomly using statistical sampling methods. The Annual Survey of Industries database of registered Indian pharmaceutical units till 31.03.2019 under the Factories Act and maintained by the Ministry of Statistics and Programme Implementation formed the basis of selection. Mentorship: The workshops are being followed by a mentorship programme designed to assist adoption of WHO prequalification in the units to promote access to quality medical products. It is envisaged to expand the activity for pharmaceutical units in other countries; and based on initial discussions it has been suggested that the course content may be aligned to specific country requirements. South-East Asia Regulatory Network (SEARN) update Since 2016, the South-East Asia Regulatory Network (SEARN) has been working to promote regional collaboration, convergence and reliance in medical product regulation to improve their quality and safety. The SEARN annual meetings enable one-to-one interaction among regulators from the Region, resulting in better understanding of the complex regulatory systems for different medical products – medicines, vaccines, devices, diagnostics. The following meetings were organized by SEARN in recent years: ~ First Annual Meeting of SEARN in New Delhi, India, on 11–12 April 2017: resulted in setting up a Steering Group and four Working Groups (WGs) on (i) quality assurance and standards of medical products; (ii) good regulatory practices (GRP); (iii) vigilance for medical products; and (iv) the SEARN information sharing platform. ~ Second SEARN Meeting in Colombo, Sri Lanka, on 21–23 March 2018: set up a fifth Working Group on (v) medical devices and diagnostics to cater to the special needs of the sector. ~ Third SEARN Meeting in New Delhi, India, on 22–23 April 2019: led to specific regional collaborative activities to improve quality assurance and regulation practices, to move forward on WHO prequalification, medical product vigilance and medical device regulation. Progress was also achieved through the successive annual meetings on regulatory cooperation on five specific areas identified by the regulatory agencies. Information on all the 11 state drug regulators in the SEA Region has been made accessible to the public through a single ISP gateway. The ISP gateway can be accessed here: https:// www.searn-isp.org/ The activities outlined below were guided by regulatory agencies of Member countries of the South-East Asia Regulatory Network: (1) WHO External Quality Assurance Assessment Scheme (EQAAS) workshop for laboratories from the South-East Asia Region on 3–5 December 2019 in New Delhi, India. 15Access to medical products in the South-East Asia Region, 2021: Review of progress (2) One-day satellite meeting on 12 November 2019 in Bangkok, Thailand on joint assessment of fixed-dose combinations of antiretrovirals for accelerated registration of priority health products. (3) Vigilance guidance for SEARN being developed with the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom of Great Britain and Northern Ireland. (4) Workshop on SEARN Working Group 5 on Medical devices regulatory requirements for assessment of in vitro diagnostic medical devices (IVDs) on 11–12 December 2019 in Jakarta, Indonesia. (5) Three national regulatory authorities also took up self-assessment using the WHO global benchmarking tool and are implementing institutional development plans. SEARN activity for COVID-19 In 2020, virtual meetings of SEARN were held for scaling up regulatory approval for diagnostics, medicines and vaccines for the COVID-19 response as outlined below: (1) SEARN Virtual Meeting on Regulatory Updates on the COVID-19 pandemic on 7 May 2020 to provide updates on regulatory parameters for access to medical products related to the pandemic. (2) Virtual meetings have been organized on 29 April 2020 and 10–11 December 2020 with SEARN regulatory authorities and vaccines manufacturers to fast- track COVID-19 vaccine rollout in Member countries and decide timelines for fast-track registration of COVID-19 vaccines in countries using the emergency use listing procedures while factoring in the COVID-19 vaccine production scales in the Region. (3) Regulatory brief and virtual session on vaccine clinical trial solidarity protocol on 28 August 2020. Regulatory updates including sharing of regulatory information on quality personal protective equipment/diagnostic kits/devices and related updates from international agencies for COVID-19 were provided to regulators through the information sharing platform. Member State-led international conferences promoting access to medical products The World Conferences (2017, 2018, 2019) on Access to Medical Products in India focused on the GSPA-PHI agenda including TRIPS flexibilities and IPR licensing mechanisms. In addition, Thailand’s annual International Trade and Health (ITH) virtual Conference contributed to sustained engagement on access issues for health products. As part of the run-up to the Prince Mahidol Award Conference (PMAC) 2021, the following meetings held by Thailand and supported by WHO contributed to global discussions: 16 Access to medical products in the South-East Asia Region, 2021: Review of progress ~ Assessing the situation of COVID-19 and international trade and health, on 4 November 2020 virtual conference from Thailand. ~ Making international intellectual property and trade regimes work to address the health response to COVID-19, on 5 November 2020 virtual conference from Thailand . Discussions during PMAC 2021 on the above-mentioned topics focused on drawing the world’s attention to access to medical products during the prevalence of COVID-19. improving affordability of medical productS The recent national surveys in four countries of the Region showed that the availability of a defined basket of essential medicines is better in private facilities compared with public facilities. Since the availability of medicines in the public sector is often low, there is no choice for individuals but to purchase medicines from the private sector. Even more disconcerting is the fact that many households may have to forgo the expenses of buying necessary medicines and face adverse health outcomes as a consequence. This inequity has long-term social and economic consequences for the countries of the Region. Several countries in the Region where prepaid and/or public financing of medicines is very low, access to essential medicines for the population is affected. This impedes the progress towards universal health coverage (UHC). In about one third of the WHO SEA Region countries, a large proportion of households face catastrophic expenditures due to unaffordable prices of medicines in the private sector. Pricing policies Pricing policies play a key role in keeping the prices of medicines affordable. WHO conducted an analysis and organized an expert consultation virtually in February 2021 to discuss pricing policies adopted in the Region and their implications. Results show that policies commonly used in all countries are promotion of generic medicines, tendering, and making available free essential medicines in the public sector. All these policies are recommended by the WHO pricing guideline. Some policies such as value-based pricing and price negotiation or special price agreements are used in only a few countries as these policies require technical capacity and continuous investment. There is, however, limited evidence on the effectiveness of these policies in many countries of the Region. Countries are encouraged to invest in studying the impact of their pricing policies. Conflict of interest management policies and practices Weak pharmaceutical sector governance is one of the factors that contributes to poor access and inappropriate use of essential health products, inflated prices, and wastage of scarce health system resources. Pharmaceutical systems are technically complex 17Access to medical products in the South-East Asia Region, 2021: Review of progress and involve extensive interactions between the private sector and the public sector. Private sector interests can influence what products are selected for reimbursement or procurement, prices of health products, and how health products are used. Without adequate regulation, public trust and confidence in policy-makers, the policy process and its outcomes can be undermined. Conflicts of interest are situations in which the existence of personal or private interests risk compromising an individual’s primary obligation. Private sector ownership, employment, receipt of payments for consulting or advisory roles, and gifts and hospitality offers create conflicts of interest for committee members. Because conflicts of interest are a situation, rather than an act, they do not in themselves constitute a breach of duty or trust. Conflict of interest thus differs from corruption, which is defined by outcome and intent as “the abuse of entrusted power for private gain”. Members of public sector pharmaceutical committees are entrusted to make decisions on behalf of the public and in the interest of public health; thus, conflicts of interest should be prevented wherever possible. Thus, appropriate policies and standards are needed to assure that conflicts of interest are appropriately disclosed and managed. Though many countries use disclosure mechanisms to address conflicts of interest, other management strategies are possible but may be underutilized. Pharmaceutical committees are often heavily reliant on technical and clinical experts. Globally, financial relationships between experts and the pharmaceutical industry are pervasive. As in many high-income countries, physicians and researchers in SEA Region Member States rely on pharmaceutical industry funding for continuing education and research or serve as consultants and advisors to industry. In countries with a limited pool of experts, identifying experts that are independent of industry influence is a key challenge. Thus, mechanisms are needed to promote stakeholder engagement and access necessary expertise while also ensuring transparency, independence and integrity in decision-making processes. WHO conducted an analysis on conflict-of-interest management policies and practices in the pharmaceutical sector in the Region. The results show that only few policies explicitly addressed conflicts of interest, many discussed committee governance, ethics, integrity and underlying values more generally. Processes for preventing or managing conflicts of interest are much less well developed, overall, with the exception of a few key public procurement processes. To strengthen good governance, there is a need for capacity-building in Member States around the management of such conflict; this must include defining and identifying the types of conflict, developing criteria for the selection of independent committee members with requisite expertise, and creating effective redressal mechanisms. 18 Access to medical products in the South-East Asia Region, 2021: Review of progress collaboration on procurement Initiative for Coordinated Antidote Procurement (iCAPS) Improving access to safe, efficacious, quality and affordable medicines remains a critical focus of the South-East Asia Region. The Regional Committee Decision (SEA/RC70(3)) advised the Regional Director to convene technical consultations to develop intercountry cooperation, on a voluntary basis, that included initiating a collaboration on the procurement of antidotes for improved access to limited supplies of medicines for life- threatening conditions. The Initiative for Coordinated Antidotes Procurement in the South-East Asia Region (iCAPS) was launched in early 2018 to procure antidotes for a number of common poisonings. This systematic approach for antidote procurement is expected to improve procurement efficiency by aggregating demand, reducing costs and coordinating quality assurance. Mahidol University of Thailand was designated as a WHO collaborating centre (WHO CC) in 2018 for the control and prevention of poisoning as part of the efforts to support the initiative. A High-Level Virtual Regional Meeting was conducted in October 2020. The meeting was attended by representatives from all the Member states and persons involved in health policy, poison management and procurement agencies. The objective of the Regional Meeting was to review, agree and adopt the operational framework to guide countries in accessing essential antidotes through iCAPS. This Regional Meeting led to the finalization and publication of the iCAPS manual and the promotional video. The manual was based on the inputs provided by representatives of the Member States of the WHO South-East Asia Region, the Thai Working Group, regional experts and WHO. It provides clear guidance on the steps to be followed to ensure the effective coordination and timely provision of antidotes in response to poisoning emergencies. There has been significant interest in accessing essential antidotes even from countries outside the Region. In 2020 two countries outside the SEA Region accessed antidotes through the emergency response pathway in response to poisoning emergencies. improving acceSS to medical abortion medicineS It is estimated that 44% of the total number of pregnancies recorded annually in the world are unintended, and 56% of them end in abortion. Unsafe abortions remain a major public health issue and cause 8–11% of global maternal deaths that occur predominantly in low- and middle-income countries where the most restrictive access policies are concentrated. Access to safe comprehensive abortion care remains uneven and complications due to unsafe abortion are still significant causes of maternal morbidity and mortality. 19Access to medical products in the South-East Asia Region, 2021: Review of progress In the SEA Region, very few countries have included all the medical abortion (MA) medicines (mifepristone, misoprostol and the mifepristone 200 mg + misoprostol 200 mcg combination pack) in their national essential medicine lists. Bangladesh, India, Maldives and Nepal have included at least two of the medicines in their NEML. The combi-pack has been included in the NEML of only Thailand and Nepal. In Indonesia, misoprostol 200 mcg and 100 mcg are currently under review and a decision regarding their inclusion in the NEML is awaited. Market authorization of medical abortion medicines is still very low in the Region. At least eight countries in the Region do not have market authorization of at least one of the medical abortion medicines. Only Bangladesh, India and Nepal have authorized the use of all the different medical abortion medicines in the country. Fig 6: Overview of access to medical abortion medicines in SEA Region - 1 2 3 Bangladesh Bhutan DPR Korea India Indonesia MaldivesMyanmar Nepal Sri Lanka Thailand Timor-Leste legal status policies & guidelines market authorisation national EML inclusion financing supply chain access model Policy-makers should encourage registration and market authorization of multiple sources of products for each MA medicine to ensure sustainable access and encourage market competition for better pricing. In countries where legal and policy provisions permit, misoprostol 200 mcg, mifepristone 200 mg and their combi-pack should be included in the NEMLs. Task-sharing, and the potential use of telemedicine, to expand the provider base will be required to strengthen and expand the capacity of the supply chain. For the public sector, access to medicines through non-physician health workers such as nurses and midwives should be considered, and for the private sector, access through certified pharmacists. 20 Access to medical products in the South-East Asia Region, 2021: Review of progress A comprehensive set of policies and interventions aimed at ensuring the availability and easy access to safe, effective and quality-assured MA medicines is key to improving or expanding access to medical abortion medicines. Access to MA medicines can be promoted in the Region as they are safe, non-invasive and inexpensive. improving acceSS to Safe blood and blood productS Safe blood and blood products save lives in all sorts of circumstances, not least in emergency and epidemic settings. Safe, effective and quality-assured blood products contribute to improving and saving millions of lives every year, as they are of immense importance in tackling child mortality and maternal health – improving the life expectancy and quality of life of patients suffering from life-threatening inherited blood disorders such as haemophilia, thalassaemia, immune deficiency, and acquired conditions such as cancer and traumatic haemorrhage. Ensuring access of all patients who require transfusion to safe, effective and quality- assured blood products is a key component of an effective health system and is vital for patient safety. WHO has provided guidelines, physical standards, training and technical support to improve blood product quality, safety and availability in countries for last several decades and has established a Global Database on Blood Safety (GDBS) to understand country needs in order to advance access to safe blood. The WHO Regional Office has organized several online workshops on the recruitment of voluntary non- remunerated donors. quality assurance system in blood safety, hemovigilance, and establishing an integrated quality assured system of blood transfusion services based on voluntary non- remunerated donations. combating antimicrobial reSiStance Global antimicrobial resistance and use of the surveillance system (GLASS) for antimicrobial consumption Antimicrobial resistance (AMR) is a significant threat to health and human development, affecting our ability to treat a range of infections. Consumption and use of antimicrobials are the main drivers for the development of AMR. To obtain a thorough and comprehensive picture of AMR and to be able to identify areas in which actions are needed, data from surveillance of antimicrobial consumption (AMC) are essential. These data should be easily compared and exchanged, and should be used locally, nationally, regionally and globally. WHO developed a methodology for the global programme on surveillance of AMC that was extended as a component of the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2020. GLASS-AMC provides a common technical basis for setting up national surveillance systems on AMC that can produce reliable and comparable data at national and global levels. The methodology will be used by all countries, regardless of the level of development of a country’s national AMC surveillance system. 21Access to medical products in the South-East Asia Region, 2021: Review of progress Enrolment into GLASS-AMC is underway in the Region. Currently Bhutan, Indonesia, Maldives, Nepal and Timor-Leste have enrolled into GLASS-AMC and set up AMC surveillance systems. Bangladesh, Maldives and Nepal have been supported by WHO to conduct initial antimicrobial consumption multiyear data analysis using the standardized WHO methodology. A pool of regional experts was trained in February 2020 and the consultants are available to support national AMC surveillance and use in Member States. Maldives and Nepal have benefited from the technical support provided by these regional experts. To understand how antibiotics are imported, manufactured and sold, Thailand mapped out all antibiotic distribution channels across all sectors to ensure complete data registration. The Thai Working Group on Surveillance of Antimicrobial Consumption developed an integrated method to collect consumption data and validated the methodology through an external peer-review mechanism. Bangladesh has established the Antimicrobial Consumption Monitoring Task Force with WHO support. As over 95% of pharmaceuticals are produced by the domestic pharmaceutical sector in Bangladesh, most of the antimicrobial production and sales information is collected at the regulator level. Information from distribution (distributor and wholesaler) and retail sales (pharmacies and medicine stores) has not yet been digitized, therefore it was necessary first to apply Anatomical Therapeutic Chemical (ATC) classification and build a database of antimicrobials to be monitored. The Antimicrobial Consumption Monitoring Task Force developed the database for data collection and is progressing with implementation of the AMC monitoring system. Maldives conducted a data analysis on the antimicrobial consumption for human use for the year 2017,2018, and 2019 using the standardized methodology developed by the WHO. The three years of data generated good evidence for trends and patterns on the level of use and type of antimicrobial used in the country. The Defined Daily Dose (DDD) and the DDD per 1000 inhabitants per day (DID) was used to analyze antimicrobial consumption in the country. Table 5 summarizes the trends and patterns in consumption of antimicrobial in Maldives. Antimicrobial stewardship Antimicrobial stewardship is a coherent set of actions which promote the responsible use of antimicrobials. This definition can be applied to actions at the individual level as well as the national and global levels, and across human health, animal health and the environment sectors. To support such actions, the Antimicrobial Stewardship Programme, an organizational or system-wide health-care strategy to promote appropriate use of antimicrobials through the implementation of evidence-based interventions, has been established by the Member States and WHO. It has carried out the following activities. ~ A training of trainers on antimicrobial stewardship was conducted in March 2020 at the Christian Medical College in Vellore, India. A total of 13 regional consultants participated in the training. Two webinars were facilitated in May and June 2020 on AMS soon after the outbreak of the COVID-19 pandemic. 22 Access to medical products in the South-East Asia Region, 2021: Review of progress Table 5: Three-year antimicrobial consumption trends in Maldives Maldives 2017–2019 antimicrobial consumption analysis ~ Total national DIDs consumed: Total national antimicrobial consumption, i.e. DDDs/1000 inhabitants/day (DID) for three years was: 29.48; 25.46; and 16.14. It is a good sign that from 2017 to 2019 the total consumption of antimicrobials has drastically decreased (Fig. 1). Total national DID consumed over three years in Maldives 29.48 25.46 16.14 2017 2018 2019 0 10 20 30 D ID Number of DID over three years ~ Relative contribution of the access group of antibiotics in these three years has been 23.2%; 35.7% and 43.3% (Fig. 5). Over the three years consumption of the access group is increasing but it is far from the targeted value of at least 60% as recommended by WHO. One antibiotic (linezolid) from the reserve category was consumed in 2017 and 2019. 23.2 35.7 43.3 75.7 63.2 55.8 2017 2018 2019 0.0 20.0 40.0 60.0 80.0 100.0 Pe rc en ta ge s Relative consumption of AWaRe category of antibiotics over three years Access Watch Not recommended Reserve 2017 2018 2019 0 500000 1 000 000 1 500 000 2 000 000 2 500 000 3 000 000 3 500 000 4 000 000 4 500 000 5 000 000 D D D s Pattern of consumption of top seven antimicrobial medicines over three years J01DB05 J01CA04 J01AA02 J01MA02 J01DC02 J01FA10 J01CR02 J01DD08 2017 2018 2019 0 500 000 1 000 000 1 500 000 2 000 000 2 500 000 3 000 000 3 500 000 4 000 000 4 500 000 U S$ Expenditure on top five antimicrobial agents over three years J01DH02 J01CR05 J01AA02 J01FA10 J05AB01 J01DD08 J01DC02 J01CR02 Note J01CR02-amixicillin+beta-lactamase inhibitor, J01DC02-cefuroxime, J01DD08-cefixime, J05AB01-aciclovir, J01FA10-azithromycin, J01AA02-doxycycline, J01CR05-piperacillin+beta-lactamase inhibitor, J01DH02-meropenem. 23Access to medical products in the South-East Asia Region, 2021: Review of progress ~ A virtual series of webinars was conducted in May and June 2020 on antimicrobial stewardship during COVID-19. A total of 651 participants from the Region attended this series of webinars. During the current COVID-19 pandemic there are potential threats that could affect antimicrobial stewardship activities and drive antimicrobial resistance. For instance, many individuals presenting with mild disease without pneumonia or moderate disease with pneumonia receive antibiotics. A review of studies published on hospitalized COVID-19 patients identified that while 72% of patients received antibiotics, only 8% demonstrated superimposed bacterial or fungal coinfections. WHO has also reports that azithromycin is being widely used with hydroxychloroquine although it is not yet recommended outside of COVID-19 clinical trials. AMS and COVID-19 ~ Antimicrobial stewardship activities should be integrated into the pandemic response across the broader health system through five measures: (4) Increase clinical competence among health workers to manage COVID-19. (5) Ensure the continuity of essential health services and regular supply of quality assured and affordable antimicrobials. (6) Reduce the turnaround time of COVID-19 testing by improving testing methods and expanding testing facilities. (7) Exercise maximum caution in the use of biocides for environmental and personal disinfection. (8) Address gaps in research to ensure that antimicrobial stewardship activities become an integral part of the pandemic response and beyond. monitoring progreSS Monitoring access to essential medicines is a priority item on the global development agenda. WHO is in the process of developing indicators to monitor the enablers of access. In February 2019, a Global and Regional Informal Expert Consultation on Monitoring the Enablers of Access to Medicines in New Delhi identified approximately 60 indicators to monitor the performance of the core functions of a national pharmaceutical system. Regional experts from the SEA Region then met to select a sub-set for reporting in the Region. They selected: ~ Eleven “core” indicators: Financial protection (2), Pricing (1), Rational Use (1), Selection (1), Availability (2), Regulation (3), and Pharmacovigilance (1). ~ Two “aspirational but important” indicators, given current information systems in low- and middle-income countries (LMICs). 24 Access to medical products in the South-East Asia Region, 2021: Review of progress ~ One “complementary” indicator: an ABC analysis to determine the top medicines by expenditure and volume in each country as a way to determine efficiency of selection as well as to diagnose areas for pricing interventions. Experts also noted several complementary indicators that could be derived from the core indicators on financial protection. Core and complementary indicators are presented in Table below. Table 6: Recommended key performance indicators to monitor progress on access in the South-East Asia Region Core indicators Complementary indicators Availability ~ SDG 3.b.3: Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis. ~ SDG 3.b.1 Proportion of the target population covered by all vaccines included in their national programme. ~ % of medicines on the essential medicine list monitored through a tracking, traceability, or authentication system. Financial protection ~ Total expenditure on medicines, US$ per capita. ~ Share of public and OPP spending on medicines (US$ and %). ~ Government expenditure on medicine as proportion of total government health expenditure. ~ Out-of-pocket expenditure on medicines as proportion of out-of- pocket expenditure on health. ~ Out-of-pocket expenditure on medicines as a proportion of total expenditure on medicines. Pricing ~ Median price ratio (PPP$) per basket of medicines above reference price. Selection and rational use ~ % of public procurement based on EML. ~ Quality of prescribing / dispensing in public and private facilities: A. % of medicines from EML, B. % prescribed as generics C. % antibiotics prescribed in Out- patient settings ~ Quality of prescribing / dispensing in public and private facilities: D. % injectable (optional) E. % poly-pharmacy (optional) ~ ABC analysis (top medicines by expenditure/volume) 25Access to medical products in the South-East Asia Region, 2021: Review of progress Core indicators Complementary indicators Regulation ~ NRA Maturity Level according to Global Benchmarking Tool: – based on self-assessment – based on WHO-assessment – with assessment information publicly available – % of products at point of dispensing that have market authorization – % of failed tests out of total sampled and tested medicines at point of dispensing (specifying whether risk-based sampling was used): A. in total B. with results publicly available ~ Pharmacovigilance – Number of adverse events per million population ~ Pharmacovigilance – % of ADRs reported, investigated, and acted upon. To enable routine, sustainable monitoring of the price and availability of medicines, WHO has developed the MedMon, the mobile application to monitor the price and availability of WHO-approved essential medicines and health products. MedMon is an innovative multilanguage electronic tool, building upon the SARA and WHO/HAI methodologies, allowing users to rapidly collect and analyze data on the price and availability of medicines in health facilities and pharmacies regardless of sector or location. Users can routinely monitor medicines’ access with MedMon in a sustainable, cost- effective and timely manner. In 2019, WHO further developed MedMon to include an interactive data visualization and analysis platform enabling automated, real-time reporting. The tool has been piloted in 25 countries in four regions. Member States, such as Bangladesh, Bhutan, Nepal, Sri Lanka, and others will be using it as a way of integrating regular monitoring mechanisms to generate data on availability and affordability of a basket of tracer medicines. 26 Access to medical products in the South-East Asia Region, 2021: Review of progress the way forward Member States can allocate resources more effectively through evidence-based decisions to ensure that essential health products, depending on a country’s disease burden, are included in its essential medicines list, essential diagnostics list or reimbursement list, and through more efficient procurement and supply processes, and rational use of medicines. Support for fair pricing and policy implementation to reduce OOP expenditure will be important. The need for good governance is increasingly recognized as a key step on the road to achieving UHC. Weak governance complicates access to health products by fuelling inefficiency, distorting competitive mechanisms, and leaving the system vulnerable to undue influence and abuse. The relationship between governments and the private sector, such as pharmaceutical companies and medical device companies, requires attention. A question of growing importance is how to support governments to collaborate effectively with the private sector and develop public policies while avoiding the risks of undue influence and maximizing public benefits. To make accurate and useful decisions to improve access to essential medical products, there is the need for timely and accurate data and information on access to medicines in the country. This may cover the gamut of national expenditures on health products; the procurement of health products, supply chains and distribution; health insurance coverage; prescription prices of health products; and the availability of medicines, vaccines and other health products in health facilities. Monitoring access to health products is a complex endeavour that requires gathering information from multiple sources and ensuring the interoperability of various data collection systems. More complete and timely data on access to medicines will better enable countries to identify access disparities between population groups and understand the effects of interventions across their medicine supply and distribution chains. Ensuring appropriate use of medicines is part of ensuring access. Medicines, diagnostics and devices need to be used correctly and rationally to be effective and efficient. Clinical guidelines and essential lists for medicines and for other medical products can help. It is encouraging to see the increasing development of national essential diagnostics lists. However, adherence to guidelines by health professionals is still irregular, and an area worthy of more attention for which the strengthening of pharmacovigilance and post-marketing surveillance is required. There is a need for effective implementation of the Initiative for Coordinated Antidotes Procurement in the South-East Asia Region and for robust collaboration between key stakeholders and participating countries. The systematic approach to procuring and managing the supply and distribution of quality-assured antidotes and assuring their appropriate use can be used to build further procurement collaboration of essential medical products. To build resilient supply chains, especially during a global pandemic, efforts are needed to reduce risks and ensure supply security by reducing dependency, increasing domestic production, diversifying the supply base, and financing and securing sufficient 27Access to medical products in the South-East Asia Region, 2021: Review of progress safety stockpiles. Health systems need to establish mechanisms to define shortages and monitor and trace stocks in real time and anticipate any surge in demand and potential shortages early. Partnership with the private sector and regulatory system strengthening are needed for technology transfer and consequent enhanced local production of high- priority medical products while ensuring their quality, safety and efficacy. Initiatives such as the COVID-19 Technology Access Pool (C-TAP) can be very useful. Such initiatives aim to provide a global one-stop shop for developers of COVID-19 therapeutics, diagnostics, vaccines and other health products to share their intellectual property, knowledge and data with quality-assured manufacturers. 28 Access to medical products in the South-East Asia Region, 2021: Review of progress References 1. Ministerial Roundtable: Improving access to essential medical products in the Region and beyond. Document no. SEA/RC71/3. New Delhi: World Health Organization, Regional Office for South-East Asia, 2018. https://www.who.int/southeastasia/about/governance/regional-committee/seventy- first-session - accessed 26 June 2021. 2. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. 3. Regional immunization coverage with three doses of diphtheria, tetanus, and pertussis (DTP3) -WHO_UNICEF coverage estimates: Vaccines monitoring system, 2021 Global Summary (https:// apps.who.int/immunization_monitoring/globalsummary/timeseries/tswucoveragebcg.html)-accessed on 4th January 2021. 4. United Nations. SDG Indicators, Goal 3, Target 3.b . New York. https://unstats.un.org/sdgs/ metadata/?Text=&Goal=3&Target=3.b - accessed 25 June 2019. 5. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/ documents/Narcotic-Drugs/TechnicalPublications/2020/Narcotic_Drugs_Technical_publication_2020. pdf - accessed 4 January 2021. 6. Adekoya et al, 2021. Comparison of antibiotics included in national essential medicines lists of 138 countries using the WHO Access, Watch, Reserve (AWaRe) classification: a cross-sectional study. The Lancet Infectious Diseases 2021. 1-12. (https://doi.org/10.1016/ S1473-3099(20)30854-9 - accessed 31 July 2021. PART 3 Country profiles 29

31 BangladeshMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines COUNTRY AT A GLANCE 164 689 Population (in 000s)1 74.3 Life expectancy at birth (in years)2 1855.7 GDP (per capita in current US$)3 Bangladesh medical products profile 2021 MEDICAL AND PHARMACY WORKFORCE 6.4 Medical doctors/10 000 population6A 1.8 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B No Continuing professional development for pharmacists6B 0 5 10 15 20 25 30 35 40 45 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $42 74% 26% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2009 2011 2013 2015 2017 Pe rc en ta ge (% ) No data available Pe rc en ta ge ( % ) 44.6% 0 20 40 60 80 100 2005 2008 2011 2014 32 Medical products profile 2021 Bangladesh KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation5 National Medicine Policy5 National Essential Medicines List5 National Standard Treatment Guidelines5 Drug Control Ordinance Amendment Act 2006 National Drug Policy 2016 Essential Drug List 2016 Individual guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers 11 Least developed country status since12 Member of World Trade Organization since13 TRIPS flexibilities used14 864 pharmaceutical manufacturers including 266 allopathic & around 500 manufacturers of T&CM medicine products: 261 Unani, 161 ayurvedic and 76 homeopathic, and around 100 or more street vendors or smaller-scale producers 1975 1995 Not applicable until graduation from least developed country status ACCESS TO MEDICINES Tuberculosis treatment coverage7 Diphtheria-tetanus-pertussis (DTP3), hepatitis B BD and MCV2 immunization coverage8 Gaps in diagnosis and management of hypertension and diabetes9 Levels of consumption of narcotic drugs10 81% 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 0 20 40 60 80 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 95%98% Data from STEPwise approach to surveillance (STEPS) or equivalent population surveys Treated and controlled Treated but uncontrolled Diagnosed but untreated Undiagnosed 0% 20% 40% 60% 80% 100% Male Female Male Female Hypertension Diabetes Total Methadone Total-methadone* Morphine 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency No data available for Hepatitis B BD immunization coverage 33 BangladeshMedical products profile 2021 Pharmaceutical system flowchart Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority5: Directorate-General of Drug Administration (DGDA) www.dgda.gov.bd Regulated products5: Medicines: YES Vaccines YES Medical devices: YES Traditional medicines: YES Medicine quality control laboratory5: National Control Laboratory, Dhaka and Central Drug Testing Laboratory, Chittagong ISO 17025 certified15: YES WHO prequalified16: YES Number of registered medicines5: Total 39 844, allopathic – 27 624, ayurvedic – 3877, unani – 5624, herbal – 406, homeopathic & biochemical – 2313 Agency responsible for selection5: Directorate-General of Drug Administration Number of products on essential medicines list: By active ingredient5: 285 allopathic drugs By dosage form5: Not available Traditional medicines products included in essential medicines list11: NO Medicines availability is indicated by health facility level17: NO National formulary5: Bangladesh National Formulary (BDNF) 2015 Public sector Agency responsible for public procurement5: Central Medical Stores Depot (CMSD) Procurement done at Central5: State: Facility5: (local procurement for district facilities and hospitals) Commonly used procurement methods5: National/ International bidding Public sector Agency responsible for distribution22: Essential Drug Company Limited and CMSD Public sector facilities5: Referral hospitals: 46 District level hospitals: 64 Specialized hospitals: 124 Public sector Price control5: YES Agency responsible for price control5: DGDA Patient prices for essential medicines in public sector: Free medicines5: YES Private sector Number of wholesalers5: 1005 Private sector Number of retail outlets5: 123 800 Licensed retail pharmacies per 10 000 population5: 7.7 Number of traditional medicines outlets5: 353 Ayurvedic retail outlets, 616 unani outlets, 10 herbal outlets & 2056 homeopathic outlets Private sector Agency responsible for price control5: Price Fixation Committee for 117 primary health care medicines. Pricing mechanism5: Manufacturer: (Maximum retail price is based upon cost of raw material and packaging plus a mark up) Wholesale: Retailer: DGDA controls retail margin (partially) Mark-ups regulated: YES Fixed or regressive: Fixed 34 Medical products profile 2021 Bangladesh References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/ data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports. aspx?source=world-development-indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/ handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view. main.UHCTBTREATMENTv - accessed on 2nd January 2021. 8. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_ monitoring/globalsummary - accessed on 2nd January 2021. 9. National Institute of Preventive and Social Medicine (NIPSOM). National STEPS Survey for Non-communicable Diseases Risk Factors in Bangladesh 2018. https://apps.who.int/iris/bitstream/handle/10665/332886/STEPS-BAN- eng.pdf?sequence=1&isAllowed=y -accessed on 1st February 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic- drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 11. As reported by traditional & complementary medicine products information from WHO Country Collaborating Centers, February 2021 (Internal communication). 12. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 13. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www. wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 14. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ -accessed on 6th January 2021. 15. 16th edition of the BAB Newsletter of Accreditation, December 2018- http://bab.portal.gov.bd/sites/default/ files/files/bab.portal.gov.bd/page/da50a02f_6c38_4f3e_a79c_c7912367d434/Complete_opt.pdf - accessed 6th January 2021. 16. WHO List of Prequalified Quality Control Laboratories, 2020. https://extranet.who.int/pqweb/sites/default/files/ documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 17. Health facility level & drug availability level indicated in Essential health Service Package (ESP) of Ministry of Health & Family Welfare- www.mohfw.gov.bd/index.php%3Foption%3Dcom_docman%26task%3Ddoc_ download%26gid%3D9484%26lang%3Den+&cd=1&hl=en&ct=clnk&gl=in -accessed on 6th January 2021. 35 BhutanMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 772 Population (in 000s)1 73.1 Life expectancy at birth (in years)2 3316.2 GDP (per capita in current US$)3 Bhutan medical products profile 2021 0 20 40 60 80 100 120 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $103 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) 13% 87% MEDICAL AND PHARMACY WORKFORCE 4.6 Medical doctors/10 000 population6A 0.6 Pharmacists/10 000 population6A Partly Pharmacy education accreditation6B Yes Continuing professional development for pharmacists6B 0 20 40 60 80 100 Pe rc en ta ge ( % ) 9.7% 2005 2008 2011 2014 67% 33% 0 20 40 60 80 100 2005 2007 2009 2011 2013 sh ar e as p er ce nt ag e % 36 BhutanMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11 National Medicine Policy12 National Essential Medicine List13 National Standard Treatment Guidelines5 1. Medicines Act of the Kingdom of Bhutan, 2003 2. Bhutan Medicines Rules and Regulations, 2012 3. Blood and Blood Products Regulation, 2016 National Medicine Policy 2007 National Essential Medicine List 2018 National Standard Treatment Guidelines 2014, distributed to all district facilities INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers 14,b Least developed country status since15,c Member of World Trade Organization since16 TRIPS flexibilities used17 7 1971 No Not applicable ACCESS TO MEDICINES Tuberculosis treatment coverage7 Diphtheria-tetanus-pertussis (DTP3) and Hepatitis B BD and MCV2 immunization coverage8 Gaps in diagnosis and management of hypertension and diabetes9 Levels of consumption of narcotic drugs10 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 80% 0 20 40 60 80 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 92%86% 97% Treated and controlled Treated but uncontrolled Diagnosed but untreated Undiagnosed 0% 20% 40% 60% 80% 100% Male Female Male Female Hypertension Diabetes Total Methadone## Total-Methadone* Morphine 0 200 400 600 800 1000 1200 1400 1600 1800 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency; ##Data for Methadone consumption not available Data from STEPwise approach to surveillence (STEPS) or equivalent population surveys 37 BhutanMedical products profile 2021 Market authorization/ Licensing/Quality assurance Patient Medicine Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authorityd: Drug Regulatory Authority of Bhutan www.dra.gov.bt Regulated products18: Medicines: YES Vaccines YES Medical devicese: NO Traditional medicinesf: YES Medicine quality control laboratory19: Drug testing Laboratory, Royal Centre for Disease Control, Ministry of Health, Bhutan, and other testing laboratory outside Bhutan based on contract service agreement ISO 17025 certified: NO WHO prequalified20: NO Number of registered medicines21,22: Total 1875, Human allopathic – 1473 & Herbal Medicines – 218 (till 2018), Veterinary allopathic medicines – 184 Agency responsible for selection5: Essential Medicines & Technology Division, Department of Medical Services, Ministry of Health Number of products on essential medicines list13: By active ingredient: 341 By dosage form: 437 Traditional medicines products included in essential medicines listg: YES Medicines availability is indicated by health facility level: YES National formulary23: Bhutan National Formulary (BNF) 2019 Number of products in national formulary23: 437 Public sector Agency responsible for distribution26: Medical stores and distribution division under Department of Medical Supplies & Health Infrastructure Public sector facilities26,i: Hospitals: 49 Primary health centre #: 186 Sub-post: 53 Thromde health centre *: 3 Outreach clinics: 542 Health Information and service centre (HISC): 6 Private sector Number of retail outlets27: 75 Licensed retail pharmacies per 10 000 population27,j: 0.93 Number of traditional medicines outlets22: Stand alone – 1, co-located – 78 in public health facilities Public sector Agency responsible for public procurement24: Medical Supplies Procurement Division under Department of Medical Supplies and Health Infrastructure (DMSHI), Ministry of Health Procurement done at Central12,h State Facility Commonly used procurement methods5: International tendering Private sector Number of wholesalers25: 31 Public sector Price control5: NO Health insurance reimbursement price5: No health insurance scheme Patient prices for essential medicines in public sector: Free medicines5: YES Private sector Agency responsible for price control18: Drug Regulatory Authority Pricing mechanism5: Price structure to be submitted at the time of registration of product Manufacturer Wholesale Retailer5 Mark-ups regulated5: YES Fixed or regressive5: Fixed maximum retail price (MRP), which is the same MRP as in India Pharmaceutical system flowchart 38 BhutanMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/ Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#- accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 8. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 9. Department of Public Health, Ministry of Health, (2020). Non-communicable disease Risk Factors: Bhutan STEPS Survey 2019, Thimphu. https://cdn.who.int/media/ docs/default-source/searo/ncd/noncommunicable-disease-risk-factors-bhutan-steps-survey-report-2019.pdf - accessed on 10th February 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports. html - accessed on 4th January 2021. 11. Drug Regulatory Authority, Bhutan. Bhutan: DRA. http://dra.gov.bt/dra-guidelines-and-regulations/ - accessed 10 January 2021. 12. National Drug Policy, 2007, Bhutan. http://www.moh.gov.bt/wp-content/uploads/ict-files/2021/02/National-Drug-Policy-2007.pdf- accessed 10 March 2021. 13. National Essential Medicines List, 2018. http://www.moh.gov.bt/wp-content/uploads/ict-files/2021/02/NEML_2018.pdf - accessed on 10th March 2021. 14. Data as reported by Drug Regulatory Authority, Bhutan, February 2021. 15. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/ desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 16. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e. htm -accessed on 6th January 2021. 17. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/ country_profile/ -accessed on 6th January 2021. 18. Drug Regulatory Authority of Bhutan, Bhutan 2021, www.dra.gov.bt- accessed on 10th January 2021. 19. Drug Regulatory Authority, Bhutan. https://dra.gov.bt/?page_id=132- accessed 10th January 2021. 20. WHO List of Prequalified Quality Control Laboratories, 2020. https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 21. Drug Regulatory Authority, Bhutan. Bhutan: DRA. https://docs.google.com/spreadsheets/d/1mecY8dp48S0zVddJjpmzSJwho-mEgyGnICJSxiexXps/ edit#gid=188431815 - accessed 10th January 2021. 22. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng.pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 23. Drug Regulatory Authority, Bhutan. Bhutan: DRA. https://drive.google.com/file/d/1BSu9lngwXeO2j_SZaHtvs9azxZYQ9kwJ/view- accessed 11th January 2021. 24. Bhutan: Health Sector Development Program. Procurement Capacity Assessment, Asian Development Bank, 2018. https://www.adb.org/sites/default/files/linked- documents/51141-002-sd-02.pdf - accessed on 11th January 2021. 25. Drug Regulatory Authority, Bhutan. Bhutan: DRA. https://dra.gov.bt/?page_id=2036 - accessed 11th January 2021. 26. Ministry of Health, Bhutan. Health management and information system, policy and planning division: Annual Health Bulletin, 2020. http://www.moh.gov.bt/wp- content/uploads/ict-files/2017/06/health-bulletin-Website_Final.pdf - accessed 11th January 2021. 27. Drug Regulatory Authority, Bhutan. Bhutan: DRA. https://docs.google.com/spreadsheets/d/10U6Oz4BDytmxd7zyIg03aqd4DVkLHaS8YZrDzy2Nxys/edit#gid=0- accessed 11th January 2021. Notes: a. NELM 2018 was being revised in 2020 but due to COVID-19 pandemic, the review could not be conducted. b. 1. Nethsel Private Limited, Pekarzhing, Phuentsholing (API manufacturer) 2. Menjong Sorig Pharmaceuticals, Kawajangsa, Thimphu (traditional medicine manufacturer) 3. Biological Production Unit, NCAH, DoL, MoAF, Serbithang, Thimphu (manufactures veterinary vaccine) 4. Azista Bhutan Healthcare Limited, Motanga, Samdrupjongkhar (manufactures allopathic finished product for human use) 5. Quality Gases Private Limited, Pasakha, Phuentsholing (medical gases manufacturer) 6. Aha-oxy Gases Private Limited, Pasakha, Phuentsholing (Medical gases manufacturer) 7. Medical and Industrial Gases Industry, Pelrikhatoe, Gelephu ( medical gases manufacturer). c. Latest single data; General Assembly resolution A/73/L.40/Rev.1 adopted on 13 December 2018, decided that Bhutan will graduate five years after the adoption of the resolution, i.e. on 13 December 2023. d. Regulates both allopathic and traditional medicines. e. The Medical Device regulation is drafted. Currently, only TTI test kits are regulated. f. Bhutanese traditional medicine gSo-ba Rig-pa is regulated. g. Manufactures 128 products are included in the national essential traditional medicines list. h. As per Section 3.2 of National Drug Policy 2007. i. # earlier referred as satellite clinic; *BHU-II- changes in accordance with Nomenclature change for health facilities (as per the notification no: MoH/DMS/HCDD/ DHSP/17/2008-2023/9349 dated 13/01/2020). j. 72 operational pharmacies spread across the country. 39 Democratic People’s Republic of KoreaMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$) Share of government vs out-of-pocket spending on health SPENDING ON MEDICINES Spending on medicines as share of total health-care cost Share of public and out-of-pocket spending on medicines COUNTRY AT A GLANCE 25 779 Population (in 000s)1 72.6 Life expectancy at birth (in years)2 Not available GDP (per capita in current US$)3 Democratic People’s Republic of Korea medical products profile 2021 No data availableNo data available No data available No data available MEDICAL AND PHARMACY WORKFORCE 36.8 Medical doctors/10 000 population4A 3.9 Pharmacists/10 000 population4A Yes Pharmacy education accreditation4B Yes Continuing professional development for pharmacists4B 40 Democratic People’s Republic of KoreaMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation8 National Medicine Policy8 National Essential Medicines List8 National Standard Treatment Guidelines9 National Pharmaceutical legislation(2018), 8th edition 1. National legislation, Rule & Regulation for Narcotic Control was revived on 9 November 2016 2. National legislation, Rule & Regulation for drug management was revised & adapted on 9 May 2019 National List of Essential Medicines 2019 Available INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers9,a Least developed country status10 Member of World Trade Organization since11 TRIPS flexibilities used 12 210 manufactures for traditional medicinal products No No Not applicable ACCESS TO MEDICINES Tuberculosis treatment coverage5 Diphtheria-tetanus-pertussis (DTP3), hepatitis B BD and MCV2 immunization coverage6 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs7 No data available 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 73% 0 20 40 60 80 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 97% 98%98% Total Methadone## Total-methadone* Morphine 0 500 1000 1500 2000 2500 3000 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency; ##Data for Methadone consumption not available 41 Democratic People’s Republic of KoreaMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority9: National Drug Regulatory Authority (NDRA) Regulated products9,13: Medicines: YES Vaccines: YES Medical devices: NA Traditional medicines: YES Medicine quality control laboratory9,13: One central laboratory under NDRA and one per province ISO 17025 certified9: NO WHO prequalified14: NO Number of registered medicines9,10,a: 3000–4000, 671 traditional medicines registered as of 2010 Agency responsible for selection9,13: National Drug Regulatory Authority (NDRA), Ministry of Public Health Number of products on essential medicines list: By active ingredient9,13: 439 By dosage form9,13: Not available Traditional medicines products included in essential medicines list15: YES (28 products included) Medicines availability is indicated by health facility level9,13: YES Number of products in national formulary9,13: 1607 (Year 2016) Public sector Agency responsible for public procurement9,13: Medicines Management Department, Ministry of Public Health Procurement done at9,13 Central State Facility Commonly used procurement methods9,13: Local tendering and international tendering for drugs not procured domestically through UN agencies Public sector Agency responsible for distribution9,13: Central medicines warehouse, Medicines management department Public sector facilities9,13: Hospitals: 1708 Primary health care units: 6263 Ri clinics/hospitals per village: 1–2 Public sector Price control9,13: No Health insurance reimbursement price9,13: Not applicable Patient prices for essential medicines in public sector: Free medicines9,13: YES Private sector Number of wholesalers9,13: Not available Private sector Number of retail outlets9,13: 260 government owned people’s drug stores available in Pyongyang city Licensed retail pharmacies per 10 000 population9,13: Not available Number of traditional medicines outlets15: Stand alone – 21, co-located – 8004 in all public health facilities Private sector Agency responsible for price control9,13: National Price Control Committee Pricing mechanism9,13: Method unknown. Manufacturer Wholesale Retailer Mark-ups regulated9,13: Method unknown Fixed or regressive9,13: Method unknown Pharmaceutical system flowchart 42 Democratic People’s Republic of KoreaMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/ data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports. aspx?source=world-development-indicators#-accessed 23rd December 2020. 4. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 5. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view. main.UHCTBTREATMENTv - accessed on 2nd January 2021. 6. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_ monitoring/globalsummary - accessed on 2nd January 2021. 7. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic- drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 8. As reported by Ministry of Public Health. Democratic People’s Republic of Korea, March 2021 (Internal communication). 9. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/ handle/10665/326829 - accessed on 5th February 2021. 10. Traditional & complementary medicine products information as reported by WHO Country Collaborating Centers, February 2021 (Internal communication). 11. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 12. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www. wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 13. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ -accessed on 6th January 2021. 14. WHO List of Prequalified Quality Control Laboratories, 2020. https://extranet.who.int/pqweb/sites/default/files/ documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 15. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/ bitstream/handle/10665/340393/9789290228295-eng.pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. Notes: a. Information reviewed by Ministry of Public Health. Democratic People’s Republic of Korea, March 2021. 43 IndiaMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 1 380 004 Population (in 000s)1 70.8 Life expectancy at birth (in years)2 2099.6 GDP (per capita in current US$)3 India medical products profile 2021 0 10 20 30 40 50 60 70 80 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $73 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) 37% 63% MEDICAL AND PHARMACY WORKFORCE 9.3 Medical doctors/10 000 population6A 8.8 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B Partly Continuing professional development for pharmacists6B Pe rc en ta ge ( % ) 34.7% 0 20 40 60 80 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e % 10% 90% 0 20 40 60 80 100 2005 2008 2011 2014 44 IndiaMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11 National Medicine Policy12,13,14 National Essential Medicines List15 National Standard Treatment Guidelines16,17,18 Drugs and Cosmetics Act, 1940 and Rules 1945 as amended up to 31 December 2016 1. Pharmaceutical Policy 2002 2. National Vacine Policy 2011 3. National Pharmaceuticals Pricing Policy 2012 National List of Essential Medicines (NLEM) 2015 Both individual disease and state-level standard treatment guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers5,19 Least developed country status20 Member of World Trade Organization since21 TRIPS flexibilities used22 4900 for formulations, 1500 for active pharmaceutical ingredient, 30 for vaccines, 350 for medical devices and 2800 for surgical dressings, blood banks and disinfectants, 8667 for traditional and complementary medicine (7439 for Ayurvedic, 585 for Unani, 235 for Siddha, 408 for homeopathy (till 2017) No 1995 Yes ACCESS TO MEDICINES Tuberculosis treatment coverage7 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage8 Gaps in diagnosis and management of hypertension and diabetes9 Levels of consumption of narcotic drugs10 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 82% 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 91% 56% 84% 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine Treated and controlled Treated but uncontrolled Diagnosed but untreated Undiagnosed 0% 20% 40% 60% 80% 100% Male Female Male Female Hypertension Diabetes Data from STEPwise approach to surveillence (STEPS) or equivalent population surveys #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency 45 IndiaMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority23: Central Drugs Standard Control Organization (CDSCO) www.cdsco.nic.in Regulated products23: Medicines: YES Vaccines YES Medical devices: YES Traditional medicines24: YES Medicine quality control laboratory26,27,a,b: Total 8: 1- Indian Pharmacopoiea Commission (IPC) Ghaziabad; 5-central drug testing laboratories and 2-regional drug testing laboratories ISO 17025 certified28,c: YES WHO prequalified29: YES (IPC, Ghaziabad) Number of registered medicines30: Traditional medicines – 985 Ayurveda, 1229 Unani and 399 Siddha formulations (as of 2017) Agency responsible for selection31: Core Committee on National List of Essential Medicines, Ministry of Health & Family Welfare Number of products on essential medicines list31,d: By active ingredient: 376 By dosage form: Approximately 1000 Traditional medicines products included in essential medicines list32,e: YES Medicines availability is indicated by health facility level5: YES Number of products in national formulary5,33: National Formulary 2016, Products – 521 Public sector Agency responsible for public procurement34: Ministry of Health and Family Welfare (Central Medical Services Society) Procurement done at Central5 State Facility Commonly used procurement methods5: Competitive tendering (Two bid system) Public sector Agency responsible for distribution34,36: Centralized/decentralized at central/state or local government level Public sector facilities5: Total hospitals: 210 998 District hospitals: 1251 Sub-district hospitals: 2724 Community health centres: 1146 Primary health centres (PHCs): 31 824 Sub centres: 164 053 Public sector Price control5: YES Agency responsible35: National Pharmaceutical Pricing Authority Price mechanism34,37: Lowest procurement price considered Patient prices for essential medicines in public sector: Free medicines38: YES Fixed price39,40: YES (Jan Aushadhi Scheme) Private sector Number of wholesalers5: Not available Private sector Number of retail outlets5: 800 000 Licensed retail pharmacies per 10 000 population5: Not available Number of traditional medicines outlets43: 3628 AYUSH hospitals, 550 AYUSH teaching hospitals, 26 405 PHCs with AYUSH dispensaries Private sector Agency responsible for price control35: National Pharmaceutical Pricing Authority, Ministry of Chemicals and Fertilizers Pricing mechanism: Market based pricing41 Manufacturer Wholesale Retailerf Mark-ups regulated: YES Fixed or regressive42,g: Fixed. Ceiling of drug prices based upon Market Based Pricing (MBP) Pharmaceutical system flowchart 46 IndiaMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 8. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 9. Indian Council of Medical Research-National Centre for Disease Informatics and Research (ICMR-NCDIR), National Noncommunicable Disease Monitoring Survey (NNMS) 2017–18, Bengaluru, India. 2020. https://www.ncdirindia.org/nnms/ - accessed on 7th February 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 11. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. Acts and Rules. https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/index.html- accessed on 16th January 2021. 12. Department of Pharmaceuticals. Ministry of Chemicals & Fertilizers. Pharmaceutical Policy 2002. India. http://pharmaceuticals.gov.in/policy/pharmaceutical-policy-2002 - accessed on 16th January 2021. 13. Ministry of Health & Family Welfare. India. National vac cine policy 2011. https://www .nhp.gov.in/sites/default/files/pdf/NATIONAL_VACCINE_POLICY.pdf - accessed on 16th January 2021. 14. Department of Pharmaceuticals. Ministry of Chemicals & Fertilizers. Pharmaceutical Pricing Policy,https://pharmaceuticals.gov.in/sites/default/files/National%20Pharmaceutical%20Pricing%20 Policy%202012_1.pdf - accessed on 16th January 2021. 15. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. National List of Essential Medicines 2015, India. https://cdsco.gov.in/opencms/opencms/system/modules/ CDSCO.WEB/elements/download_file_division.jsp?num_id=MTUyNw== - accessed on 16th January 2021. 16. Ministry of Health & Family Welfare. The Clinical Establishments Act, 2010: Standard Treatment Guidelines. Ministry of Health & Family Welfare. Delhi. http://www.clinicalestablishments.gov.in/ En/1068-standard-treatment-guidelines.aspx - accessed on 16th January 2021. 17. National Institute for Health & Family Welfare, Ministry of Health & Family Welfare. National health Portal. Ministry of Health & Family Welfare. India. https://www.nhp.gov.in/standards-and-protocols_ pg - accessed on 16th January 2021. 18. A systematic review of standard treatment guidelines in India. Koli et al, Indian J Med Res 149, June 2019, pp 715-729, DOI: 10.4103/ijmr.IJMR_902_17. https://www.ijmr.org.in/temp/ IndianJMedRes1496715-3399817_092638.pdf - accessed on 16th January 2021. 19. Mid-Term Evaluation Report of National AYUSH Mission (NAM). Centre for Market Research and Social Development. 2017. https://namayush.gov.in/sites/all/themes/webcms/images/org_str/Final_ evaluation_report.pdf - accessed on 10th February 2021. 20. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/dpad/wp-content/uploads/ sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 21. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 22. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ -accessed on 6th January 2021. 23. Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. https://cdsco.gov.in/opencms/opencms/en/Home/ - accessed on 10th February 2021. 24. Ministry of AYUSH. Government of India. http://ayush.gov.in/ -accessed 16th January 2021. 25. Central Drugs Standard Control Organization, Directorate General of Health Services. 26. Ministry of Health & Family Welfare, Government of India- https://cdsco.gov.in/opencms/opencms/en/About-us/Laboratories/- accessed on 16th January 2021. 27. Indian Pharmacopoiea Commission, Ministry of Health & Family Welfare, Government of India- http://www.ipc.gov.in/- accessed on 16th January 2021. 28. National Accreditation Board for Testing and Calibration Laboratories. Quality Council of India. https://nabl-india.org/wp-content/uploads/2020/04/Testing-directory-as-on-31.03.2020.pdf -accessed on 16th January 2021. 29. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 30. As reported by traditional & complementary medicine products information from WHO Country Collaborating Centers, Internal communication, February 2021. 31. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. National List of Essential Medicines 2015, India. https://cdsco.gov.in/opencms/opencms/system/modules/ CDSCO.WEB/elements/download_file_division.jsp?num_id=MTUyNw== - accessed on 16th January 2021. 32. Ministry of Ayush. National AYUSH Mission. List of essential Medicines.https://namayush.gov.in/content/list-essential-medicines- accessed on 16th January 2021. 33. Indian Pharamcopoeia Commission, Ministry of Health & Family Welfare. India. 2016. https://www.ipc.gov.in/images/news/NFI-0414979118.pdf - accessed on 16th January 2021. 34. Central Medical Services Societies, Ministry of Health & Family Welfare. Government of India. http://www.cmss.gov.in/ -accessed on 16th January 2021. 35. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. http://nppaindia.nic.in/- accessed on 16th January 2021. 36. Singh PV, Tatambhotla A,Kalvakuntla R, et al. Understanding public drug procurement in India: a comparative qualitative study of five Indian states. BMJ Open 2013;3:e001987. 37. doi:10.1136/bmjopen-2012-001987- https://bmjopen.bmj.com/content/bmjopen/3/2/e001987.full.pdf- accessed on 16th January 2021. 38. Ministry of Health and Family Welfare, Government of India. Operational Guidelines free Drugs Service Initiative- https://nhm.gov.in/New_Updates_2018/NHM_Components/Health_System_ Stregthening/Drugs_&_logistics/Operational_Guidelines_Free_Drugs_Service_Initiative.pdf- accessed on 16th January 2021. 39. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India.https://nppaimis.nic.in/nppaprice/newmedicinepricesearch.aspx- accessed on 16th January 2021. 40. Bureau of Pharma PSUs of India, Department of Pharmaceuticals, Government of India. http://janaushadhi.gov.in/pmjy.aspx- accessed on 16th January 2021. 41. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. Drug Price Control Order 2013. http://www.nppaindia.nic.in/wp-content/uploads/2018/12/ DPCO2013_03082016.pdf -accessed on 16th January 2021. 42. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. https://www.nppaindia.nic.in/wp-content/uploads/2018/08/national_pharmaceutical.pdf - accessed on 16th January 2021. 43. Mid-Term Evaluation Report of National AYUSH Mission (NAM). Centre for Market Research and Social Development. 2017. https://namayush.gov.in/sites/all/themes/webcms/images/org_str/Final_ evaluation_report.pdf - accessed on 10th February 2021. Notes: a. 5 Central drug testing labs are CDL, Kolkata; CDTL, Chennai; CDTL-Hyderabad; CDTL, Mumbai; CDL, Kasauli; 2 Regional drug testing labs are RDTL, Guwahati & RDTL, Chandigarh. b. Indian Pharmacopoiea Commission (IPC), Ghaziabad. c. Total 3422 labs accredited as of 31st March 2020. d. By self-calculating all the strengths listed. e. Four separate lists of EMs published by Ministry of AYUSH, namely, i. Essential Drugs List- Ayurveda-https://namayush.gov.in/sites/all/themes/webcms/images/essential_drugs/Ayurveda_EDL_list_final.pdf (200 medicines). ii. Essential Drugs List-Siddha Medicine- https://namayush.gov.in/sites/all/themes/webcms/images/essential_drugs/Essential_Drug_List_Siddha.pdf (200 medicines). iii. Essential Drugs List- Homoepathy- https://namayush.gov.in/sites/all/themes/webcms/images/essential_drugs/FINAL_Homoeopathy_EDL_list_final.pdf (200 medicines). iv. Essential Drugs List-Unani Medicine- https://namayush.gov.in/sites/all/themes/webcms/images/essential_drugs/Unani_EDL_list_final.pdf (200 medicines). Of this list few overlaps observed in NLEM with List of Homeopathy Medicines. f. P(c) = P(s).(1+M/100), where P(s) = Average Price to Retailer for the same strength and dosage of the medicine ; M = % Mar gin to retailer and its value =16. g. Document states that a manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this order or any order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen per cent thereof in the case of Scheduled drugs. 47 IndonesiaMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 273 524 Population (in 000s)1 71.3 Life expectancy at birth (in years)2 4135.5 GDP (per capita in current US$)3 Indonesia medical products profile 2021 0 20 40 60 80 100 120 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $112 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) 65% 35% MEDICAL AND PHARMACY WORKFORCE 4.7 Medical doctors/10 000 population6A 0.8 Pharmacists/10 000 population6A Partly Pharmacy education accreditation6B Partly Continuing professional development for pharmacists6B 25.5% 0 20 40 60 80 100 2005 2008 2011 2014 Pe rc en ta ge (% ) 21% 79% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 Sh ar e as p er ce nt ag e (% ) 48 IndonesiaMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation5 National Medicine Policy5 National Essential Medicines List10,a National Standard Treatment Guidelines10 Law on registration of medicines 2008 National Medicine Policy 2006 National List of Essential Medicine 2019 MOH Decree 4 year 2019 – Technical Standards for Meeting the Quality of Services Policy on the Minimal Service Standards in the Filed of Health INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers11,b Least developed country status12 Member of World Trade Organization since13 TRIPS flexibilities used14 174 No 1995 Yes ACCESS TO MEDICINES Tuberculosis treatment coverage7 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage8 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs9 Updated data not available 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 67% 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 85% 71% 84% 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency 49 IndonesiaMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authorities5: National Agency for Drug and Food Control (NADFC), Republic of Indonesia (BADAN-POM) Regulated products15: Medicines: YES Vaccines YES Medical devices: YES Traditional medicines5: YES Medicine quality control laboratory5: Drug Testing Laboratory of National Quality Control Laboratory ISO 17025 certified16,c: YES WHO prequalified17,d: YES Number of registered medicines5,18: 15 072 allopathic and 9,057 traditional medicines (till 2018) Agency responsible for selection10: Ministry of Health Number of products on essential medicines list10,e: By active ingredient: 386 By dosage form: 559 Traditional medicines products included in essential medicines list: No data available Medicines availability is indicated by health facility level: Primary care, Referral care (hospitals) Latest National Formulary19: 586 Public sector Agency responsible for public procurement5: Directorate General of Pharmaceutical and Medical Devices Procurement done at Central20 State Facility12 Commonly used procurement methods20,f: Local tendering Public sector Agency responsible for distribution20,h: Directorate- General of Pharmaceutical and Medical Devices Public sector facilities22: Primary health facilities (which include puskesmas) – 9993 (till Dec 2018) comprising 3623 puskesmas with inpatient care and 6370 puskesmas without inpatient care; 8841 clinics, consisting of 924 main clinics and 7917 primary clinics; General hospitals (RSU) – 2269; Specialized hospitals (RSK) – 554; Blood Transfusion Unit (UTDs) – 421 (2017) Public sector Price control: YES Price mechanism5: Lowest price bid accepted Health Insureance reimbursement price21: Universal Health Coverage, Badan Penyelenggara Jaminan Sosial (BPJS) Kesehatan Patient prices for essential medicines in public sector: No data available Private sector Number of wholesalers5: 2846 Private sector Number of retail outlets22: Pharmacies – 28 233; Drug Stores – 10 773 Licensed retail pharmacies per 10 000 population: Not available Number of traditional medicines outlets: Not available Private sector Agency responsible for price control: Ministry of Health Pricing mechanism: Market based pricing Manufacturer Wholesale5 40% Retailer Mark-ups regulatedg: YES Fixed or regressive5: Generic medicines prices fixed by Ministry of Health and other medicines prices set by manufacturers Pharmaceutical system flowchart 50 IndonesiaMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/ wpp/Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/ indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development- indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid- term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 8. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 9. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/ narcotic_drugs_reports.html - accessed on 4th January 2021. 10. Ministry of Health, National List of Essential Medicines 2019. Jakarta, Indonesia, 2021 (Internal communication). 11. WHO global report on traditional and complementary medicine 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/traditional-complementary-integrative-medicine/WhoGlobalReportOnTraditionalAndComplementaryMedicine2019.pdf - accessed on 10th February 2021. 12. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/ development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 13. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/ whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 14. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ ipstats/en/statistics/country_profile/ -accessed on 6th January 2021. 15. National Agency for Drug and Food Control (NADFC), Republic of Indonesia (BADAN-POM). https://www.pom.go.id/new/home/en -accessed on 17th January 2021. 16. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK, New Delhi, India, 23–25 April 2019, https://searn-isp.org/SEARN/export/ sites/SEARN/Pdf_documents/Publication/3RDANNUALMEETING.pdf -accessed on 17th January 2021. 17. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_ QCLabsList_28.pdf - accessed on 6th January 2021. 18. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng. pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 19. National Health Insurance (JKN). National Health Formulary 2013. National health Insurance. Badan Penyelenggara Jaminan Sosial (BPJS). Indonesia. http://www.jkn.kemkes.go.id/attachment/unduhan/KMK%20No.%20328%20ttg%20Formularium%20Nasional.pdf - accessed on 17th January 2021. 20. As reported by Ministry of Health, Jakarta, Indonesia, 2021 (Internal communication). 21. National Health Insurance (JKN). National health Insurance. Badan Penyelenggara Jaminan Sosial (BPJS). Indonesia. http://www.jkn.kemkes.go.id/ attachment/unduhan/KMK%20No.%20328%20ttg%20Formularium%20Nasional.pdf - accessed on 17th January 2021. 22. Ministry of Health. Indonesia Health Profile 2018. Ministry of Health, Republic of Indonesia. Jakarta, 2019. kemkes.go.id/resources/download/ pusdatin/profil-kesehatan-indonesia/indonesia-health-profile-2018.pdf - accessed 17th January 2021. Notes: a. Developed based on MOH decree Kepmenkes HK.01.07 / MENKES / 688/2019. b. Around 1000 small-, medium- and large-scale manufacturers produce traditional medicine products. c. Indonesia has received ISO 17025 accreditation since 1998. d. The assessment was held in February 2019. e. Estimated by self-calculation based on medicines enlisted in the National List of Essential Medicine 2019 shared by MoH, Indonesia, 2021. f. Medicine procurement is processed electronically based on medicine e-catalogue and through transparent e-purchasing mechanism. The whole mechanism is regulated in MOH Decree no 5 year 2019 (PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR 5 TAHUN 2019 TENTANG PERENCANAAN DAN PENGADAAN OBAT BERDASARKAN KATALOG ELEKTRONIK). g. Mark ups regulated - Maximum Retail Price (MRP) h. Pharmaceutical manufacturers are expected to deliver the medicine procured at national, subnational, and facility level. The supervision of procurement is carried out by Directorate General of Pharmaceutical and Medical Devices, MoH and the process of distribution should follow the Good Distribution Practice regulated by Indonesia FDA. 51 MaldivesMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 541 Population (in 000s)1 79.6 Life expectancy at birth (in years)2 10 626.5 GDP (per capita in current US$)3 Maldives medical products profile 2021 $974 0 200 400 600 800 1000 1200 2008 2010 2012 2014 2016 2018 C ur re nt U S$ 21% 79% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) MEDICAL AND PHARMACY WORKFORCE 17.1 Medical doctors/10 000 population6A,a 3.5 Pharmacists/10 000 population6A,a Yes Pharmacy education accreditation6B Partly Continuing professional development for pharmacists6B Pe rc en ta ge ( % ) 9.7% 0 20 40 60 80 100 2005 2008 2011 2014 48% 52% 0 20 40 60 80 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e (% ) 52 MaldivesMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation10,11 National Medicine Policy10,b National Essential Medicines List12,c National Standard Treatment Guidelines5,13 1. Medicines Act – 1994 2. Medicine Regulation (R-46) in force since, 2015 3. Medicine Regulation Amendment (R-49/2016) National Medicine Policy 2007 Essential Medicines List 2020 Individual disease guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers5 Least developed country14 Member of World Trade Organization since15 TRIPS flexibilities used16 0 No 1995 Not applicable ACCESS TO MEDICINES Tuberculosis treatment coverage7 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage8 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs9 0 20 40 60 80 100 80% 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 99% 99% 99% 0 200 400 600 800 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency Updated data not available 53 MaldivesMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority: Maldives Food and Drug Authority (MFDA); http://health.gov.mv/ GetDepartmentDetails/1005 Regulated products12: Medicines: YES Vaccines: YES Medical devicesd: YES Traditional medicines: YES Medicine quality control laboratory5: National Health Laboratory. ISO 17025 certified17: NO WHO prequalified18: NO Number of registered medicines19,20: Total – 1473 (till June 2021) and traditional medicines – 241 (till 2018) Agency responsible for selection5: Maldives Food and Drug Authority Number of products on essential medicines list: By active ingredient21,e: 440 By dosage form13,e: 751 Traditional medicines products included in essential medicines list: NO Medicines availability is indicated by health facility level21: YES National formulary21,f : No national formulary manual Public sector Agency responsible for public procurement5,g: State Trading Oganization (STO) Procurement done at Central5,22,h State Facility Commonly used procurement methods5: Purchasing directly from manufactures and from third parties for importing medicines Public sector Agency responsible for distribution5: Health Supply Unit, Administration Division Public sector facilities13,o: Hospitals: 20 Tertiary hospital, i.e. IGMH: 1 Regional hospitals: 5 Atoll hospitals: 14 Primary healthcare centres: 169 Health posts: 30 Health centres: 139 Public sector Price control10,23,i: YES Health insurance reimbursement price23,j: National social health insurance scheme (Aasandha) to provide free medical assistance to entire population Patient prices for essential medicines in public sector: Free medicines24,k: YES Fixed price10,l: YES Private sector Number of wholesalers5: 15 Private sector Number of retail outlets10,p : 227 Licensed retail pharmacies per 10 000 population10: 7 Number of traditional medicines outlets10: 10 Private sector Agency responsible for price control5: MFDA and Ministry of Economic Affairs Pricing mechanism10,m: YES Manufacturer Wholesale Retailer Mark-ups regulated10,n: Structure finalized Fixed or regressive10: Structure finalized Pharmaceutical system flowchart 54 MaldivesMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/ Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator- details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development- indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 8. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 9. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_ reports.html - accessed on 4th January 2021. 10. As reported by Ministry of Health, Republic of Maldives, March 2021 (Internal communication). 11. As reported by Ministry of Health, Republic of Maldives, March 2021. Medicine Regulation Amendment (R-49/2016)- http://health.gov.mv/Uploads/ Downloads//Laws/Laws(16).pdf - accessed on 17th March 2021. 12. As reported by Maldives Food & Drug Authority, Ministry of Health, Republic of Maldives, March 2021. 13. Ministry of Health, Maldives, Health Master Plan, 2016- 2025.Maldives, 2014- http://extwprlegs1.fao.org/docs/pdf/mdv188848.pdf- accessed on 17th January 2021. 14. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/ development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 15. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/ tif_e/org6_e.htm -accessed on 6th January 2021. 16. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/ statistics/country_profile/ -accessed on 6th January 2021. 17. World Health Organization, Regional Office for South East Asia. Report of South East Asia Drug Testing Laboratories, 2013. New Delhi, 2013. https://apps. who.int/iris/bitstream/handle/10665/204982/B5031.pdf?sequence=1&isAllowed=y - accessed on 17th January 2021. 18. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_ QCLabsList_28.pdf - accessed on 6th January 2021. 19. Ministry of Health, Republic of Maldives, Approved Drug List, January, 2021. http://health.gov.mv/ - accessed on 17th January 2021. 20. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng. pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 21. Ministry of Health, Republic of Maldives, Maldives Food and Drug Authority, Medicine and Therapeutic Goods Division, Essential Medicine List, 2018. http://health.gov.mv/Uploads/Downloads//Informations/Informations(141).pdf - accessed on 17th January 2021. 22. SPRP report World Bank, 2020 April 2020-http://documents1.worldbank.org/curated/en/771021585949657798/pdf/Maldives-COVID-19-Emergency- Response-and-Health-Systems-Preparedness-Project.pdf- accessed on 17th January 2021. 23. National Social Protection Agency, Male, Maldives. https://www.nspa.gov.mv/v2/index.php/aasandha-2/ -accessed on 17th January 2021. 24. Ministry of Health, Maldives, Health Master Plan, 2016- 2025.Maldives, 2014.- http://extwprlegs1.fao.org/docs/pdf/mdv188848.pdf- accessed on 17th January 2021. Notes: a. 2018, single latest data available. b. National Medicine Policy– 2007 has been reviewed in 2018. c. Medicines are selected from the Essential medicine List and MFDA is responsible for the updation of EML. Recently list has been reviewed and it will be approved soon. d. Medical Device Act is not finalised yet but regulating of Medical Device is one of the Mandates of MFDA. Therefore, it will be mandatory to register the Medical Devices from September 2021. e. Based on self calculation using Essential Medicine List, 2018 as Essential Medicines List– 2020 yet not available from Ministry of Health, Maldives. f. Approved list of registered drugs is available, but there is no national formulary manual. g. Currently, there is no public procurement agency, however, State Trading Organization (STO) is responsible for procuring medicines for government health facilities as per their need. h. STO may undertake procurement on behalf of the government & may be considered for some cases that are not hindered by the current stock shortages. i. Maximum Retail Price Policy has been approved and a structure has been finalised and will be implemented soon. j. Aasandha covers inpatient and outpatient treatment, including drugs and diagnostics (though subject to certain specified exclusions and conditions), within an overall cap of 100,000 MRF per person per year. k. Health care services including medical examination, investigations, immunization, antenatal care, drugs etc. are provided free to all Maldivian citizens. l. Will be fixed for maximum retail price. m. Pricing being included under medicine regulation as MFDA has worked on a costing structure for MRP in consultation with stakeholders & its finalization ongoing. This will address price control mechanisms at manufacturer, wholesaler and retailer level & mark-ups will be regulated according to the costing structure. n. MFDA is working with the Ministry of Economic Affairs to set a Maximum Retail Price (MRP) for their medicines. o. Primary level health care in Maldives is provided through health posts, health centres and Atoll and Regional hospitals and in Male’ city through a separate PHC centre (Dhamanaveshi). p. Greatest number of retail outlets in Male’. 55 MyanmarMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost 5 Share of public and out-of-pocket spending on medicines 5 COUNTRY AT A GLANCE 54 410 Population (in 000s)1 69.1 Life expectancy at birth (in years)2 1407.8 GDP (per capita in current US$)3 Myanmar medical products profile 2021 0 10 20 30 40 50 60 70 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $59 76% 24% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) MEDICAL AND PHARMACY WORKFORCE 7.4 Medical doctors/10 000 population6A 0.8 Pharmacists/10 000 population6A No Pharmacy education accreditation6B Yes Continuing professional development for pharmacists6B 5.5% 94.5% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e (% ) 28.8% 0 10 20 30 40 Pe rc en ta ge ( % ) 50 60 2005 2008 2011 2014 56 MyanmarMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11 National Medicine Policy12 National Essential Medicines List13 National Standard Treatment Guidelines14 1. National Drug Law 1992 2. Amendment to National Drug Law 2014 National Medicines Policy 2019 National List of Essential Medicines 2016 National Standard Treatment Guidelines – 2013 for primary health care providers and disease specific guidelines INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers15 Least developed country status since16 Member of World Trade Organization since17 TRIPS flexibilities used18 12 1987 1995 Not applicable until graduation from least developed country status ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage7,8 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage9 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs10 0 200 400 600 800 1000 1200 1400 1600 1800 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 77% 76% 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 90% 80% 17% #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency Updated data not available 57 MyanmarMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority19: Department of Food and Drug Administration (DFDA) http://www.fdamyanmar.gov.mm Regulated products: Medicines19: YES Vaccines19: YES Medical devices19: YES Traditional medicines20,a: YES Medicine quality control laboratory21: One main drug testing laboratory in Nay Pyi Taw and two small branch labs in Mandalay and Yangon ISO 17025 certified21: YES WHO prequalified22: NO Number of registered medicines5,21: 21 000 allopathic as of January 2019, there are 14 529 registered drugs in the National Traditional Medicine Formulary Agency responsible for selection13: Essential Drug Program, Medical Care Divison, Department of Medical Services Number of products on essential medicines list: By active ingredient13,b: 486 By dosage form13,b: 795 Traditional medicines products included in essential medicines list20: YES (59 products included) Medicines availability is indicated by health facility level13: NO National formulary13,c: Not available Public sector Agency responsible for public procurement12,d: Central Medical Supplies Department (CMSD) and some decentralized procurement Procurement done at Central15 State15 Facility15,e Commonly used procurement methods5: Mainly procured from Myanmar Pharmaceutical Factory and for other products through national competitive tenders Public sector Agency responsible for distribution5: Central Medical Supplies Department (CMSD) and local warehouses Public sector facilities24,25: Hospitalsi: 1054 Primary and secondary health centres: 87 Maternal & child health centres: 348 Rural health centres:1684 Traditional medicines hospitals:16 Traditional medicine clinics: 237 Public sector Price control15,f: YES Mechanism5: Lowest priced quotation is chosen Health insurance reimbursement price12,g: No health insurance Patient prices for essential medicines in public sector: Free medicines5: YES Private sector Number of wholesalers5: 170 Private sector Number of retail outlets5,j: 10 000 outlets selling both allopathic and traditional medicines Licensed retail pharmacies per 10 000 population5,j: 1.9 Private sector Agency responsible for price control5: Myanmar Pharmaceutical and Medical Equipment & Entrepreneur Association in collaboration with Ministry of Commerce Pricing mechanism5: Manufacturer Wholesaleh Retailerh Mark-ups regulated5: NO Pharmaceutical system flowchart 58 MyanmarMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/ Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator- details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development- indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ estimated-antiretroviral-therapy-coverage-among-people-living-with-hiv-(-) - accessed on 2nd January 2021. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 9. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_ reports.html - accessed on 4th January 2021. 11. Ministry of Health and Sports, Food and Drug Administration, Myanmar, Quality, Safety and Protection. https://www.fda.gov.mm/?p=176- accessed on 19th January 2021. 12. THE REPUBLIC OF THE UNION OF MYANMAR, Ministry of Health and Sports, National Medicines Policy, June 2019. http://www.doms.gov.mm/wp-content/ uploads/2019/12/National-Medicines-Policy.pdf- accessed on 19th January 2021. 13. Ministry of Health and Sports, Republic of Union of Myanmar. National List of Essential Medicines 2016. Myanmar, 2016. http://mohs.gov.mm/Main/ content/publication/essential-medicine-national-list-of-essential-medicines-2016 accessed on 19th January 2021. 14. THE REPUBLIC OF THE UNION OF MYANMAR, Ministry of Health and Sports. https://www.mohs.gov.mm/main/content/publication/SOPs%20and%20 Guidelines/list/2/12 - accessed on 19th January 2021. 15. Ministry of Health and Sports, The Republic of Myanmar, 2021 (Internal communication). 16. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/ development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 17. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/ tif_e/org6_e.htm -accessed on 6th January 2021. 18. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/ statistics/country_profile/ -accessed on 6th January 2021. 19. Department of Food and Drug Administration (DFDA), Myanmar. Myanmar: DFDA. http://www.fdamyanmar.gov.mm/index. php/en/-accessed on 19th January 2021 20. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng. pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 21. Promoting the Quality of Medicines (PQM) program, U.S. Pharmacopeial Convention (USP), USAID- https://www.usp-pqm.org/results/strengthening- myanmar-capacity-test-quality-medicines - accessed on 19th January 2021. 22. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_ QCLabsList_28.pdf - accessed on 6th January 2021. 23. Traditional & Complementary Medicine products information from WHO Country Collaborating Centers, 2021, Internal communication. 24. EUROPEAN CHAMBER OF COMMERCE IN MYANMAR (Eurocham), Healthcare Guide 2018. https://www.eurocham-myanmar.org/uploads/b5ec5-eurocham_ health-care_guide_2018.pdf- accessed on 19th January 2021. 25. THE REPUBLIC OF THE UNION OF MYANMAR, Ministry of Health and Sports. https://mohs.gov.mm/Main/content/publication/myanmar-health- statistics-2020 - accessed on 19th January 2021 Notes: a. In Myanmar, National Food and Drug Authority(FDA) is responsible for regulating TRM manufacture and products including labeling, licensing, advertising and registration. b. Self calculated based on the NELM 2016. c. There is no national formulary manual but was proposed to be developed by 2020 end (not available in public domain till July 2021). d. Decentralized procurement at hospitals with 200 beds and those managed by regional/state health authorities. e. Hospitals with 200 beds. f. Central Tender for price arrangement and decentralized procurement in Dept of Public Health in 2019–2020 fiscal year and central tender for price arrangement and decentralized procurement in both Dept of Public Health and Dept. of Medical Services for selected medicines in 2020–2021 fiscal year. g. Myanmar’s National Health Plan (NHP) for 2017–2021 has laid out the vision of achieving Universal Health Coverage (UHC) by 2030. In line with the Myanmar National Health Financing Strategy, the government shall provide the mechanism for social health insurance and reimbursement to cover the cost of medicines to minimize out-of-pocket expenditure (OOPE). h. Wholesale level mark-ups (5–7%) and retailer level mark-ups (5–10%). i. 988-under Ministry of Health and Sports; 66-under other Ministries. j. Information reviewed by Myanmar WHO collaborating office (WCO), 2021. 59 NepalMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$) 4 Share of government vs out-of-pocket spending on health 4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 29 137 Population (in 000s)1 70.9 Life expectancy at birth (in years)2 1071.1 GDP (per capita in current US$)3 Nepal medical products profile 2021 0 10 20 30 40 50 60 70 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $58 51% 49% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) MEDICAL AND PHARMACY WORKFORCE 8.1 Medical doctors/10 000 population6A 1.3 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B Partly Continuing professional development for pharmacists6B 29.1% 0 20 40 60 80 100 2005 2008 2011 2014 Pe rc en ta ge (% ) 12% 88% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e (% ) 60 NepalMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation12 National Medicine Policy13,14 National Essential Medicines List15,a National Standard Treatment Guidelines16,17,18,19,20 Drugs Act, 2035 (1978) 1. National Drug Policy 1995 2. Draft National Medicine Policy 2007 National Essential Medicines List 2020 Guidelines for Primary Health system and disease specific clinical guidelines for treatment available INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers21,b Least developed country status since22 Member of World Trade Organization since23 TRIPS flexibilities used24 165 1971 2004 Not applicable until graduation from least developed country status ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage7,8 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage9 Gaps in diagnosis and management of hypertension and diabetes10 Levels of consumption of narcotic drugs11 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 63% 46% 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 93% 76% 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine Treated and controlled Treated but uncontrolled Diagnosed but untreated Undiagnosed 0% 20% 40% 60% 80% 100% Male Female Male Female Hypertension Diabetes #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency No data available for Hepatitis B BD immunization coverage Data from STEPwise approach to surveillance (STEPS) or equivalent population surveys 61 NepalMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority5: Department of Drug Administration(DDA), Ministry of Health www.dda.gov.np Regulated products: Medicines15: YES Vaccines15: YES Medical devices15,c: YES Traditional medicines25: YES Medicine quality control laboratory26: National Medicine Laboratory ISO 17025 certified27,d: NO WHO prequalified28: NO Number of registered medicines26,29,e: Total –19 106 and traditional medicines – 260 (till 2018) Agency responsible for selection30: Department of Drug Administration Number of products on essential medicines list15: By active ingredient: 393 By dosage form: 510 Traditional medicines products included in essential medicines list29: YES (60 products included) Medicines availability is indicated by health facility level: NO Latest national formulary31: Nepalese National Formulary 2018 (3rd Edition) Public sector Agency responsible for public procurement32: Logistic Management Division Procurement done at Central5 State5 Facility5 Commonly used procurement methods: Tendering from list of standard manufacturers identified by government Public sector Agency responsible for distribution5: Logistics Management Division for centrally supplied drugs and District Public Health Offices (DPHOs) and hospital directors for locally purchased drugs Public sector facilities32: Hospitals: 135 Primary health centres (PHCCs): 196 Primary health care outreach clinic (PHCORC) sites: 12 532 Expanded Programme Immunization (EPI) clinics: 16 428 Public sector Health insurance reimbursement32,h: Health Insurance Program (HIP) covers 46 districts in the country and 7 districts are in pipeline Patient prices for essential medicines in public sector: Free medicines32,i: YES, upto district level Fixed price12,j: YES Private sector Number of wholesalers26,g: 3351 Private sector Number of retail outlets26,k: Allopathic – 14 099 Licensed retail pharmacies per 10 000 population26,l: 6.9 Number of traditional medicines outlets26,k: 3425 (Ayurvedic: 2811, Homeopathy: 597, Unani: 17) Private sector Agency responsible for price control5: DDA and Drug Pricing Monitoring Committee Pricing mechanism5: To fix the maximum retail price using mean median method Manufacturer5 Wholesale5 Retailer5 (Mark up 8-10%) (Mark up 16%) Mark-ups regulatedk: YES Pharmaceutical system flowchart 62 NepalMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at- birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/estimated-antiretroviral-therapy- coverage-among-people-living-with-hiv-(-) - accessed on 2nd January 2021. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 9. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 10. Noncommunicable Disease Risk Factors: STEPS Survey Nepal 2019. https://nada.searo.who.int/index.php/catalog/76 - accessed on 3rd February 2021. 11. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 12. Government of Nepal, Ministry of Health and Population, Department of Drug Administration. https://www.dda.gov.np/content/drugs-act-2035 - accessed on 21st January 2021. 13. Government of Nepal, Ministry of Health and Population, Department of Drug Administration. https://www.dda.gov.np/content/national-drug-policy-1995 - accessed on 21st January 2021. 14. Ministry of Health, Nepal. National medicines policy 2007. Kathmandu. https://www.mohp.gov.np/downloads/National%20Medicine%20Policy.pdf -=accessed on 20th January 2021. 15. As reported by Department of Drug Administration, Ministry of Health and Population, Nepal, March 2021 (Internal communication). 16. Government of Nepal, Ministry of Health and Population, Department of Health Services, Standard Treatment Protocol (STP) for Mental Health Services into the Primary Health Care System, 2016 https://www.dda.gov.np/content/essential-drug-list- accessed on 21st January 2021. 17. Government of Nepal, Ministry of Health and Population, Department of Health Services, NATIONAL MALARIA TREATMENT PROTOCOL 2019. https://www.dda.gov.np/content/essential- drug-list- accessed on 21st January 2021. 18. Government of Nepal, Ministry of Health and Population, Department of Health Services, Clinical Guidelines, 2017. National Guideline for Sickle Cell Disease and Thalassemia Management- http://www.edcd.gov.np/resources/download/draftnational-guideline-for-sickle-cell-anaemia-and-thalassemia - accessed on 21st January 2021. 19. Government of Nepal, Ministry of Health, National Centre for AIDS and STD Control, National HIV Testing and Treatment Guidelines 2017. https://mohp.gov.np/downloads/National%20 HIV%20testing%20and%20Treatment%20Guidelines%202017.pdf - accessed on 21st January 2021. 20. Government of Nepal, Ministry of Health and Population, Department of Health Services, National Antibiotics Treatment guidleines-2014. https://mohp.gov.np/downloads/National_ Antibiotic_Treatment_Guidelines.pdf - accessed on 21st January 2021. 21. Government of Nepal, Ministry of Health and Population, Department of Drug Administration, Drug Bulletin of Nepal 30v3. https://www.dda.gov.np/content/drug-bulletin-of-nepal - accessed on 21st January 2021. 22. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/dpad/wp-content/ uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 23. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 24. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ -accessed on 6th January 2021. 25. Department of Health Services (DoHS), Nepal, National Health Policy 2074, Annual Report 2075-2076 (2018-2019). http://dohs.gov.np/wp-content/uploads/2020/11/DoHS-Annual- Report-FY-075-76-.pdf - accessed on 21st January 2021. 26. Government of Nepal, Ministry of Health and Population, Department of Drug Administration, Drug Bulletin of Nepal 30v3. https://www.dda.gov.np/content/national-medicine-laboratory - accessed on 21st January 2021. 27. World Health Organization, Regional Office for South East Asia. Report of South East Asia Drug Testing Laboratories, 2013. New Delhi, 2013. https://apps.who.int/iris/bitstream/ handle/10665/204982/B5031.pdf?sequence=1&isAllowed=y - accessed on 17th January 2021. 28. WHO List of Prequalified Quality Control Laboratories, 2020. https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 29. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY- NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng.pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 30. Government of Nepal, Ministry of Health and Population, Department of Drug Administration. https://www.dda.gov.np/content/about-us - accessed on 21st January 2021. 31. Government of Nepal, Ministry of Health and Population, Department of Drug Administration. https://www.dda.gov.np/content/nepalese-national-formulary-nnf - accessed on 21st January 2021. 32. Department of Health Services (DoHS), Nepal, National Health Policy 2074, Annual Report 2075-2076 (2018-2019). http://dohs.gov.np/wp-content/uploads/2020/11/DoHS-Annual- Report-FY-075-76-.pdf - accessed on 21st January 2021. Notes: a. Approved by Drug Advisory Committee and is in process of MOHP approval. b. Till June 2019- Allopathy- 73, Veterinary- 12, Ayurveda/Herbal- 80. c. Health Technology Product and Medical Device Directive 2074 available, however, currently DDA is regulating Intraocular lenses only. d. 1 Training on ISO 17025 certification done. e. 9940 Foreign products and 9166 Domestic products. f. Based on self calculation using National Essential Medicines List 2020. g. Data based on Number of registered Pharmacy outlets (upto Ashar 2076 (Jul 2019 as updated on DAMS) Allopathic: 2775, Veterinary: 408; Ayurvedic: 140, Homeopathic: 25, Unani: 3. h. It is a voluntary program based on family contributions. Family up to 5 members have to contribute NPR 3500 per year and NPR 700 per additional member and Government bears contribution for people with Poverty Identity Card and Red Card. i. Above district level, patients must purchase drugs from private pharmacies. j. If the Department fixes the price of any drug, a notice thereof shall be published in the Nepal Gazette (Inserted by Second amendment of the Act). k. Nepal has fixed MRP of selected essential medicines as per the provision of Drug Act 1978, Section 26. l. Data based on Number of registered Pharmacy outlets (upto Ashar 2076 i.e. July 2019 as updated on DAMS) m. Data calculated as per registered pharmacy outlets including Allopathic, Veterinary, Ayurveda, homeopathy and Unani pharmacies. 63 Sri LankaMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines COUNTRY AT A GLANCE 21 413 Population (in 000s)1 76.9 Life expectancy at birth (in years)2 3853.1 GDP (per capita in current US$)3 Sri Lanka medical products profile 2021 0 20 40 60 80 100 120 140 160 180 2008 2010 2012 2014 2016 2018 $157 C ur re nt U S$ 51% 49% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) No data available MEDICAL AND PHARMACY WORKFORCE 11.5 Medical doctors/10 000 population6A 0.9 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B Yes Continuing professional development for pharmacists6B 26.5% 0 20 40 60 80 100 2005 2008 2011 2014 Pe rc en ta ge (% ) 64 Sri LankaMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11 National Medicine Policy12 National Essential Medicines List13 National Standard Treatment Guidelines5 National Medicines Regulatory Authority Act No. 5 of 2015 Sri Lanka National Medicines Policy 2020–2025 National List of Essential Medicines 2014 Specialist colleges and Sri Lanka Medical Association specific guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers14 Least developed country status15 Member of World Trade Organization since16 TRIPS flexibilities used17 19 No 1995 Not applicable ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage7,8 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage9 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs10 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge (% ) 99% 99% 51% 61% 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 0 50 100 150 200 250 300 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency Updated data not available No data available for Hepatitis B BD immunization coverage 65 Sri LankaMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority18: National Medicines Regulatory Authority (NMRA) http://nmra.gov.lk/ Regulated products: Medicines11: YES Vaccines11: YES Medical Devices11: YES Traditional Medicines19,a: YES Medicine quality control laboratory20: National Medicines Quality Assurance Laboratory (NMQAL) ISO 17025 certified21: NO WHO prequalified22: NO Number of registered medicines12,23: Approximately 6000 medicines in NMRA database and 960 traditional medicines (till 2018) Agency responsible for selection5: Medical Supplies Division, Ministry of Health, Nutrition and Indigenous Medicine Number of products on essential medicines list: By active ingredient5: 361 By dosage form5: >400 Traditional medicines products included in essential medicines list5: None Medicines availability is indicated by health facility level13: YES Number of products in national formulary24: 209 Public sector Agency responsible for public procurement25: State Pharmaceutical Corporation Procurement done at Central5 State Facility5 Commonly used procurement methods26,b: International, National Competitive Bidding; Limited/restricted International Competitive Bidding (LIB) Public sector Agency responsible for distribution29: Medical Supplies Division Public sector facilities30: Hospitals: 641 Central dispensaries/Primary medical care units: 515 Public sector Price Control12,c: YES Mechanism5: Tenders are scheduled according to ascending prices and evaluated technically Health insurance reimbursement Price27,28,d: Only available for public health sector employees Patient prices for essential medicines in public sector: Free Medicines5: YES Private sector Number of wholesalers12: 2000 Private sector Number of retail outlets12: 4500 Licensed retail pharmacies per 10 000 population12: 2.04 Number of Traditional Medicines outlets31: 270 institutions providing TM services in the country including 62 Ayurvedic hospitals and 208 central dispensaries (2019) Private sector Agency responsible for price control11: Ministry of Trade and Industry with Sri Lanka Manufacturers Association and Sri Lankan Standards Institute Pricing mechanism: Manufacturer5 Wholesale5 Retailer12,e Mark-ups regulatedf: NO Pharmaceutical system flowchart 66 Sri LankaMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/ Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#- accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/estimated- antiretroviral-therapy-coverage-among-people-living-with-hiv-(-) - accessed on 2nd January 2021. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 9. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports. html - accessed on 4th January 2021. 11. Ministry of Health, Nutrition & Indigenous Medicine, National Medical Regulatory Authority, Sri Lanka. https://nmra.gov.lk/images/PDF/Legislation/5e_nmdra_07. pdf- accessed on 22nd January, 2021. 12. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka. National Medicines Regulatory Authority of Sri Lanka, July 2020 (Internal Communication). 13. Ministry of Health, National Medicines Regulatory Authority, Sri Lanka. Sri Lanka: NMRA. https://nmra.gov.lk/images/PDF/publication/publication_003.pdf - accessed on 22nd January 2021. 14. Ministry of Health, Nutrition & Indigenous Medicine, National Medical Regulatory Authority, Sri Lanka. https://nmra.gov.lk/index.php?option=com_content&view=ar ticle&id=77&Itemid=187&lang=en#local-gmp-inspections- accessed on 22nd January, 2021. 15. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/ desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 16. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e. htm -accessed on 6th January 2021. 17. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/ country_profile/ -accessed on 6th January 2021. 18. Ministry of Health, National Medical Regulatory Authority, Sri Lanka. https://nmra.gov.lk/index.php?lang=en- accessed on 22nd January, 2021. 19. WHO global report on traditional and complementary medicine 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.https://www.who. int/traditional-complementary-integrative-medicine/WhoGlobalReportOnTraditionalAndComplementaryMedicine2019.pdf - accessed on 10th February 2021. 20. Ministry of Health, Nutrition & Indigenous Medicine, National Medical Regulatory Authority, Sri Lanka. https://nmra.gov.lk/index.php?option=com_ content&view=article&id=89&Itemid=228&lang=en- accessed on 22nd January, 2021. 21. World Health Organization, Regional Office for South East Asia. Report of South East Asia Drug Testing Laboratories, 2013. New Delhi, 2013. https://apps.who.int/ iris/bitstream/handle/10665/204982/B5031.pdf?sequence=1&isAllowed=y - accessed on 17th January 2021. 22. WHO List of Prequalified Quality Control Laboratories, 2020. https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 23. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng.pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 24. Ministry of Health, Nutrition and Indigenous Medicine, Medical Supplies Division, Approved list of Pharmaceutical items (Formulary revision 2016/2017), Sri Lanka. https://www.msd.gov.lk/files/publications/revised%20item%20list%20(pharmaceuticals)%20year%202016-2017.pdf - accessed on 22nd January 2021. 25. State Pharmaceutical Corporation of Sri Lanka. https://www.spc.lk/about-spc.php - accessed on 23rd January 2021. 26. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka, Medical Supplies Division, Guidelines for Procurement of Pharmaceuticals &Medical Devices 2006. https://www.msd.gov.lk/files/publications/CDDA%20act.pdf- accessed on 23rd January 2021. 27. Smith, O. 2018. “Sri Lanka: Achieving Pro-Poor Universal Health Coverage without Health Financing Reforms”. Universal Health Coverage Study Series No. 38, World Bank Group, Washington, DC- php - accessed on 23rd January 2021. 28. Kumar, R. Public–private partnerships for universal health coverage? The future of “free health” in Sri Lanka. Global Health 15, 75 (2019). https://doi.org/10.1186/ s12992-019-0522-6- php - accessed on 23rd January 2021. 29. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka, Medical Supplies Division. https://www.msd.gov.lk/index.php/about-us- accessed on 23rd January 2021. 30. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka. Annual Health Bulletin 2018. http://www.health.gov.lk/moh_final/english/public/elfinder/files/ publications/AHB/2020/AHB_2018.pdf - accessed on 23rd January 2021. 31. Traditional & Complementary medicine products information from WHO Country Collaborating Centers, March 2021 (Internal communication). Notes: a. The regulation “Ayurvedic code” was established in 1929 and renewed in 2012. b. International Competitive Bidding (ICB) and National Competitive Bidding (NCB). c. For selected medical products in accordance with Government gazette no. 2167/17 of March 20th of 2020, 2167/1 of March 16th 2020, 2123/35 May 15th 2019, 2086/37. August 31st 2018, 2049/31 of December 14th 2017, 2030/47 August 4th 2017, 2006/45 of February 17th 2017. d. Agrahara is a mandatory social health insurance scheme providing coverage mostly for inpatient care for the public sector employees in Sri Lanka. e. For selected medical products price controlled under an MRP regime through gazette notifications for essential and life-saving medicines. f. Mark ups regulated with Maximum Retail Price (MRP). Price ceiling introduced for 48 essential noncommunicable diseases medicines. 67 ThailandMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 69 800 Population (in 000s)1 77.7 Life expectancy at birth (in years)2 7806.7 GDP (per capita in current US$)3 Thailand medical products profile 2021 0 50 100 150 200 250 300 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $276 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) 89% 11% MEDICAL AND PHARMACY WORKFORCE 9.2 Medical doctors/10 000 population6A 6.3 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B Yes Continuing professional development for pharmacists6B 55.5% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 Pe rc en ta ge (% ) 91% 9% 0 20 40 60 80 100 2005 2008 2011 2014 Sh ar e as p er ce nt ag e (% ) 68 ThailandMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11,12,13,a National Medicine Policy14,b National Essential Medicines List15,16 National Standard Treatment Guidelines5 1. Drug Act (No. 6), B.E. 2562 (AD 2019) 2. Narcotics Act B.E. 2522 (1979) and Psychotropic Substance Act B.E. 2559 (2016) 3. Herbal Products Act, B.E. 2562 (AD 2019) National Drug policy B.E. 2563–2565 (AD 2020–2022) National List of Essential Medicines B.E. 2563 (AD 2020) Individual disease guidelines and treatment protocols exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers5,c Least developed country status17 Member of World Trade Organization since18 TRIPS flexibilities used19 Allopathic 186 and Traditional 964 No 1995 Yes ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage7,8 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage9 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs10 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 97% 99% 87% 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 84% 80% Total Methadone Total-methadone* Morphine 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency Updated data not available 69 ThailandMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National regulatory authority20: Thai Food and Drug Administration (Thai FDA) https://www.fda.moph.go.th/Pages/HomeP_D2.aspx Regulated products5: Medicines: YES Vaccines: YES Medical Devices: YES Traditional Medicines: YES Medicine quality control laboratory5: National Drug Testing Laboratory, Bureau of Drugs and Narcotics ISO 17025 certified5: YES (since 1994) WHO prequalified21: YES (since 2012) Number of registered medicines22,23,d: Allopathic: 22 726, Biologicals: 647, Narcotics: 145, Traditional: 14 805 (till 2018), Veterinary: 3537 Agency responsible for selection5: Division of National Drug Policy, Thai FDA Number of products on essential medicines list: By active ingredient24,25,e: 740 By dosage form24,25,e: 1126 Traditional medicines products included in essential medicines list26,27: YES (74 products) Medicines availability is indicated by health facility level28: YES National formulary5,c: Specialties National Formularies available. No national formulary booklet Public sector Agency responsible for public procurement5: National Medicine Systems Development Committee Procurement done at Central5 State5 Facility5 Commonly used procurement methods5: Competitive tendering Public sector Agency responsible for distribution5: Directly from supplier to hospitals Public sector facilities30,c,g: Hospitals: 59 District and provinicial hospitals: 891 Health centers: 9768 Community medical centers: 365 Public sector Price Control29: Reference Prices (RPs) for Public Procurement have purposely been implemented for pharmaceutical cost containment during 5 years (2014–2018) Mechanism29: Prices at or below reference price sets a maximum purchasing price to enable negotiation Health insurance reimbursement price29,f: Universal Coverage Scheme (UCS) covers most of the population Patient prices for essential medicines in public sector: Free medicines5: YES Private sector Number of wholesalers5,c: Normal: 16,892 (include retail also) Private sector Number of retail outlets29,c,h: 20 000 Licensed retail pharmacies per 10 000 population29,c,i: 2.8 Number of Traditional Medicines outlets5,c: 2083 Private sector Agency responsible for price control5: Ministry of Trade/ Commerce Pricing mechanism: Manufacturer Wholesale Retailer5 Mark-ups regulated5,29: No price cap/maximum retail price (MRP), price negotiation between industry and purchaser Pharmaceutical system flowchart 70 ThailandMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/ Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life- expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#-accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/estimated-antiretroviral- therapy-coverage-among-people-living-with-hiv-(-) - accessed on 2nd January 2021. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 9. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 11. Herbal Products Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021- https://www.fda.moph.go.th/Herbal/SitePages/law_herbal2.html- accessed on 29th March 2021. 12. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021- http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/A/050/T_0220. PDF - accessed on 29th March 2021. 13. Narcotics Control Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021- https://www.fda.moph.go.th/sites/Narcotics/EBook/PIC_ACT59_VJ_0760. pdf - accessed on 29th March 2021. 14. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://ndi.fda.moph.go.th/uploads/policy_file//20210330101713. pdf - accessed on 1st May 2021. 15. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://www.ratchakitcha.soc.go.th/DATA/PDF/2563/E/254/T_0003. PDF- accessed on 1st May 2021. 16. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://www.ratchakitcha.soc.go.th/DATA/PDF/2564/E/012/T_0015. PDF - accessed on 1st May 2021. 17. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/dpad/ wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 18. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm -accessed on 6th January 2021. 19. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_ profile/ -accessed on 6th January 2021. 20. Thai Food and Drug Administration (Thai FDA), Ministry of Public Health, Thailand. Thai FDA, Thailand. https://www.fda.moph.go.th/Pages/HomeP_D2.aspx -accessed 24th January 2021. 21. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 22. Data as per internal database from Thai Food & Drug Administration, Ministry of Public Health, Thailand, Latest update 29 March 2021 (Internal communication). 23. Traditional medicine in the WHO South-East Asia Region; Review of progress 2014–2019. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.- https://apps.who.int/iris/bitstream/handle/10665/340393/9789290228295-eng.pdf?sequence=1&isAllowed=y -accessed on 17th August 2021. 24. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://www.ratchakitcha.soc.go.th/DATA/PDF/2563/E/254/T_0003. PDF - accessed on 1st May 2021. 25. Medicines Regulation Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://www.ratchakitcha.soc.go.th/DATA/PDF/2564/E/012/T_0015. PDF - accessed on 1st May 2021. 26. Herbal Products Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://www.ratchakitcha.soc.go.th/DATA/PDF/2563/E/254/T_0003.PDF - accessed on 1st May 2021. 27. Herbal Products Division, Food and Drug Administration, Ministry of Public Health, Thailand, 2021. http://dmsic.moph.go.th/index/detail/8392 - accessed on 1st May 2021. 28. Drug and Medical Supply Information Center, Ministry of Public Health, Thailand, March 2021 (Internal communication). 29. Thai Drug Systems 2020. Journal of Health Science, Health Technical Office, Ministry of Public Health Vol. 29 Special Issue, January - February 2020, Thailand. National Drug Policies in Thailand: Evolution and Lessons for the Future. https://thaidj.org/index.php/JHS/article/download/8408/7721+&cd=2&hl=en&ct=clnk&gl=in- accessed on 24th January 2021. 30. Resilient and people-centred health systems: Progress, challenges and future directions in Asia, Asia Pacific Observatory on Health Systems and Policy, 2015. http://www. searo.who.int/entity/asia_pacific_observatory/publications/country_comparative_studies/thailand.pdf?ua=1 - accessed on 24th January 2021. Notes: a. The Herbal Act came into force since 29th June 2019 and now Ministry of Public Health, Thailand is in process of database improvement regarding number of local pharmaceutical manufactures and number of registered traditional medicines. b. National Medicines Policy 2017-2021: To get cabinet approval. c. Information reviewed by Ministry of Public Health, Thailand in 2021. d. Does not include 122 traditional veterinary medicines. e. Based on self-calculation from National List of Essential Medicines- B.E. 2563 (AD 2020). f. Total three insurance schemes. Other two are the Civil Servant Medical Benefits Scheme (CSMBS) & Social Security Scheme (SSS). g. Specialized Hospitals- 48 and University Hospitals-11; District Hospitals- 734, Provincial Hospitals -71, Regional Hospitals-26, Other hospitals- 60. h. There are 14,000 drugstores in type 1 (koryor 1)(5) in which there are pharmacists available in the stores during opening hours. i. Calculated by using retail pharmacies/Thai pop. *10,000 = 20000/69800*10,000 = 2.8. 71 Timor-LesteMedical products profile 2021 OVERALL SPENDING ON HEALTH Current per capita spending on healthcare (current US$)4 Share of government vs. out-of-pocket spending on health4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost5 Share of public and out-of-pocket spending on medicines5 COUNTRY AT A GLANCE 1318 Population (in 000s)1 69.6 Life expectancy at birth (in years)2 1560.5 GDP (per capita in current US$)3 Timor-Leste medical products profile 2021 0 20 40 60 80 100 120 2008 2010 2012 2014 2016 2018 C ur re nt U S$ $94 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2010 2012 2014 2016 2018 Pe rc en ta ge (% ) 93% 7% MEDICAL AND PHARMACY WORKFORCE 7.7 Medical doctors/10 000 population6A 2.1 Pharmacists/10 000 population6A Yes Pharmacy education accreditation6B No Continuing professional development for pharmacist6B 12.8% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 Pe rc en ta ge (% ) 63% 37% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 Sh ar e as p er ce nt ag e (% ) 72 Timor-LesteMedical products profile 2021 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11,a National Medicine Policy12 National Essential Medicines List13 National Standard Treatment Guidelines13 DECREE-LAW NO. 12/2004 National Medicines Policy 2018 Timor-Leste Essential Medicines List 2015 Available for Primary Healthcare and Referral hospitals & disease specific guidelines available INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of Local pharmaceutical manufacturers5,b Least Developed country status since14 Member of World Trade Organization since15 TRIPS flexibilities used16 None 2003 No Not applicable until graduation from least developed country status ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage7,8 Diphtheria-tetanus-pertussis (DTP3), Hepatitis B BD and MCV2 immunization coverage9 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs10 0 20 40 60 80 100 2009 2011 2013 2015 2017 2019 Pe rc en ta ge ( % ) 63% 36% 0 10 20 30 40 50 60 70 80 90 100 2008 2011 2015 2019 Pe rc en ta ge ( % ) 83% 80% 70% 0 50 100 150 200 250 2008 2010 2012 2014 2016 2018 S- D D D /m ill io n/ da y# Total Methadone Total-methadone* Morphine #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency Updated data not available 73 Timor-LesteMedical products profile 2021 Market authorization/ Licensing/Quality assurance Medicine Patient Medicine selection Medicine procurement Pricing and reimbursement Distribution National Regulatory Authority17: National Regulatory Authority, National Directorate of Pharmacy and Medicines Regulated products: Medicines5: YES Vaccines5: YES Medical devices5: YES Traditional Medicines18: NO Medicine Quality Control Laboratory19,c: None ISO 17025 certified19: NO WHO prequalified20: NO Number of Registered Medicines21: 833 Agency responsible for selection17,d: National Directorate of Pharmacy and Medicines (DNFM) Number of products on essential medicines list: By active ingredient5: 274 By dosage form5: 402 Traditional medicines products included in essential medicines list5: NO Medicines availability is indicated by health facility level5: YES Number of Products in National Formulary5,22: No national formulary manual Public sector Agency responsible for Public Procurement22: Servico Autonomo de Medicamentos e Equipamentos de Saude (SAMES) Procurement done at Central23 State23 Facility23 Commonly used procurement methods24: Competitive or public bidding Public sector Agency responsible for distribution24: SAMES Public Sector Facilities26,27: Referral hospitals: 5 National hospital: 1 Regional hospitals: 3 Community health services: 65 Servisu Integrado Sude Communita (SISCA) Centers: More than 600 Health centres: more than 200 Public sector Price control23: YES Mechanism5,25: Bid evaluation based upon lowest price criteria Health insurance reimbursement price5: No insurance but national health service provides free treatment of patients Patient prices for essential medicines in public sector: Free medicines5: YES Private sector Number of wholesalers12,f: 21 Private sector Number of retail outlets12: 53 Licensed retail pharmacies per 10 000 populationh: 0.4 Number of Traditional Medicines outlets12,i: No data available Private sector Agency responsible for price control17,g: Marketing Authorization Department, National Regulatory Authority, National Directorate of Pharmacy and Medicines Pricing mechanism24: Under development Manufacturer Wholesale Retailer Mark-ups regulated24: Policy under development Pharmaceutical system flowchart 74 Timor-LesteMedical products profile 2021 References 1. United Nations, Department of Economic and Social Affairs, Population Division, World Population Prospects 2019. https://population.un.org/wpp/Download/ Standard/Population/- accessed 23rd December 2020. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/ life-expectancy-at-birth-(years) -accessed 23rd December 2020. 3. The World Bank. World development indicators 2020. Washington DC. https://databank.worldbank.org/reports.aspx?source=world-development-indicators#- accessed 23rd December 2020. 4. World Health Organization. Global Health Expenditure Database (GHED): current health expenditure. Geneva. https://apps.who.int/nha/database/ViewData/ Indicators/en- accessed 30th December 2020. 5. Access to medical products in the South-East Asia Region, 2019: Review of progress. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO. https://apps.who.int/iris/handle/10665/326829 - accessed on 5th February 2021. 6. A. Global Health Observatory data repository. https://apps.who.int/gho/data/view.main.UHCHRHv- accessed on 1st July 2021. B. World Health Organization. Regional Office for South-East Asia. (2020). Decade for health workforce strengthening in SEAR 2015-2024, mid-term review. World Health Organization. Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/334226. License: CC BY-NC-SA 3.0 IGO - accessed on 6th February 2021. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/estimated- antiretroviral-therapy-coverage-among-people-living-with-hiv-(-) - accessed on 2nd January 2021. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. https://apps.who.int/gho/data/view.main.UHCTBTREATMENTv - accessed on 2nd January 2021. 9. WHO vaccine-preventable diseases: monitoring system. 2020 global summary. https://apps.who.int/immunization_monitoring/globalsummary - accessed on 2nd January 2021. 10. International Narcotics Control Board. Narcotic Drugs-Technical Report. https://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/narcotic_drugs_reports.html - accessed on 4th January 2021. 11. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/docs/law/degree/Decree%20 Law%20No.122_2004_English.pdf - accessed on 25th January 2021. 12. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee, March 2021 (Internal communication). 13. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/docs/law/degree/Decree%20 Law%20No.122_2004_English.pdf - accessed on 25th January 2021. 14. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2020. https https://www.un.org/development/desa/ dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf - accessed 6th January 2021. 15. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e. htm -accessed on 6th January 2021. 16. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/ country_profile/ -accessed on 6th January 2021. 17. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/index.php?lan=eng - accessed on 25th January 2021. 18. Traditional and complementary medicinal products information from WHO Country Collaborating Centers, March 2021 (Internal communication). 19. World Health Organization, Regional Office for South East Asia. Report of South East Asia Drug Testing Laboratories, 2013. New Delhi, 2013. https://apps.who.int/iris/ bitstream/handle/10665/204982/B5031.pdf?sequence=1&isAllowed=y -accessed 25th January 2021. 20. WHO List of Prequalified Quality Control Laboratories, 2020. New source- https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf - accessed on 6th January 2021. 21. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/aim2.php?lan=eng - accessed on 25th January 2021. 22. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/sm2.php?lan=eng - accessed on 25th January 2021. 23. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://www.ms.gov.tl/dnfm/dnfm1/poli.php?lan=eng - accessed on 25th January 2021. 24. National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee. https://dnfm.ms.gov.tl/dnfm1/docs/policy/TL%20NMP_2017-ENG.pdf. 25. Rousselle MH. Starting from scratch in Timor-Leste: Establishing a Pharmaceutical and Medical Supplies System in a Post-Conflict Context. Health, Nutrition & Population Discussion paper. The World Bank: 2009.USA. https://openknowledge.worldbank.org/bitstream/ handle/10986/13760/498270WP0HNP0d110EastTimorCaseStudy.pdf?sequence=1&isAllowed=y- accessed on 25th January 2021. 26. Government of Timor-Leste. National Health System, Timor-Leste. http://timor-leste.gov.tl/?p=3374&lang=en&n=1 -accessed 25th January 2021. 27. 11th National Rural Health Conference, 2011, Implementation of integrated health systems at the community level (SISCa) in Timor-Leste, speech by Madalena Hanjan Soares, Vice Minister of Health, Republic Democratic of Timor-Leste. https://www.ruralhealth.org.au/11nrhc/papers/11th%20NRHC%20Hanjan%20Soares_ Madalena_KN1.pdf - accessed on 25th January 2021. Note: a. In 2015, the MoH revised the decree law No.12/2004 and produced two draft legislations namely Decree Law for Pharmacy Establishments and Decree Law for Medicines. As per information received from the Cabinet of Ministers, these draft legislations will be submitted for the revision and approval in 2021. b. Timor-Lestee has only importers of Medicines and medical products. A list is available from National Regulatory Authority, National Directorate of Pharmacy and Medicines, Timor-Lestee- https://www.ms.gov.tl/dnfm/dnfm1/aim.php?lan=eng - accessed on 25th January 2021. c. Functional laboratory does not exist. A mini laboratory under warehouse of Drugs and Equipment under Central Medical Stores, SAMES exists. d. The DNFM is to study and propose legal measures on the use of medicinal products, as well as to keep the National List of Essential and Supplementary Medicines up to date and to ensure their compliance. e. All suppliers, including the SAMES shall only be allowed to participate in tenders if they are registered with the NRA, DNFM. f. 21 local licensed importers in Timor-Leste. g. Monitoring of local and international prices of medicines by an appropriate committee to establish reference pricing, detect undue price increases, and develop policies for fair pricing of medicines in the private sector. h. Calculated by using retail pharmacies/Timor pop. *10,000 = 53/1318000*10,000 = 0.35; Majority of the pharmacists, pharmacy technicians and pharmacy assistants in Timor-Lestee working at the public institutions and only few work at private and non-governmental organizations. i. No data available on traditional medicines but some data exists on herbal medicines. Based on the information from DNFM, there are four importers who have a valid product registration for total of 13 herbal medicines. Proargy (6 herbal medicines), GOMI 2 (4 herbal medicines), ACIBEE (1 herbal medicine) and Melia Herbal (2 herbal medicines). Access to medical products in the South-East Asia Region 2021 Review of progress 9 789290 228967