Fair pricing forum 2019 meeting report: Johannesburg, South Africa, 11-13 April 2019

Fair Pricing Forum 2019 Meeting Report Johannesburg, South Africa 11-13 April 2019 WHO/MVP/EMP/IAU/2019.09 © World Health Organization 2019 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). 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Introduction In 2017, WHO convened the first Fair Pricing Forum in Amsterdam, The Netherlands, to enable stakeholders to discuss options for a fairer pricing system for pharmaceuticals. The second Forum, held 11-13 April 2019 in Johannesburg, addressed the following objectives:  To share experiences in employing regulatory and non-regulatory measures for achieving ‘fair’ prices for pharmaceutical products that are affordable to patients and healthcare systems while incentivizing enterprise, efficiency and innovation  To explore tools, approaches and system factors that could facilitate affordable and sustainable pricing of pharmaceutical products  To identify areas of actions that would support countries in achieving fairer pricing of pharmaceutical products The Forum was hosted by the South African National Department of Health together with WHO, and attended by representatives from Member States, non-governmental and patient organizations, and the innovator and generic pharmaceutical industry (full list of participants available in Annex A). The Forum consisted of a series of participatory workshops, followed by plenary and parallel panel discussions on key issues of current interest, and concluded by a plenary discussion on key learnings and commitments for further action (See agenda and speaker affiliations in Annex B). Additional information and meeting presentations are available at https://www.who.int/medicines/access/fair_pricing/en/. Key Takeaways and Next Steps The second Fair Pricing Forum achieved the following outcomes:  Exchange of experiences in achieving better access through pricing measures  Enabling networks for sharing of information relating to tools and approaches that could be used to achieve more affordable and sustainable prices  Enhanced understanding of the merits and challenges of pricing and financing approaches that might bring about fairer pricing  Common understanding and shared commitment towards the areas of actions identified for supporting countries in achieving fairer pricing. Participants acknowledged difficulties in defining a price that is truly fair, but also that it is most important to think practically about what fairness means in practice and how all stakeholders can work together to achieve it. To that end, a set of technical working groups will focus on specific areas of pricing to determine what is achievable in the short- and medium-term, reporting to the next Fair Pricing Forum in 2021. These working groups will have focused terms of reference and concrete deliverables, with an established process for nomination and representation. Stakeholders are invited to provide feedback by 15 September 2019 on these next steps towards achieving a fair pricing system. Further instructions are available at https://www.who.int/medicines/access/fair_pricing/en/. Summary of proceedings Plenary Session: Fair pricing in practice Fatima Suleman moderated the opening plenary on the topic of “fair pricing in practice,” an attempt to unpack the definition of fair pricing and its interplay with affordability. Suerie Moon noted that fairness can be considered from either the buyer’s or seller’s perspective, with a price floor needing to cover the cost of supply and price ceiling above which there would be a loss of access. Between the floor and the ceiling, there is a “fair pricing zone” that could accommodate concepts such as rewarding higher value medicines, differential allocation of certain cost components, and pricing of generic medicines. Thomas Cueni acknowledged that finding the right balance between affordability and innovation is challenging, and that industry is open to new models of ensuring affordability in resource- constrained settings. However, this must be accompanied by a clear process from governments for attaining UHC, including regulatory clarity and efficiency. Salmah Bahri shared the experience of Malaysia relating to the situation where products disappeared from the market when the incentives for industry were perceived to be inadequate. She also presented the challenges of using value-based approaches for pricing when the true value of a medicine in the real world would only emerge over time and therefore subject to considerable uncertainties at the time of pricing. These include predicting patient uptake and the extent of upfront payment. During the subsequent discussion, the need for reliable international information on prices was emphasized, as this would enable countries to be better informed about the actual prices of medicines in different markets. However, such an approach would necessitate not including countries with much lower GDP per capita in external referencing pricing baskets and not parallel importing from such countries. Parallel Session 1: Improving transparency Moderator Jacqui Miot set the scene regarding transparency in South Africa, where the government has set a generic substitution policy, established a pricing committee, defined a single exit price and dispensing fee, and have no confidential discounts. Reaching this point was not a speedy process with various legislative and regulatory challenges, however via stakeholder engagement and constant updating of data and information, the pricing committee has achieved an important degree of certainty and consistency. Luca Li Bassi discussed the draft World Health Assembly resolution on transparency of markets for health products and its potential to support decision-making on pricing and reimbursement, improve capacity to negotiate, enhance market efficiency by promoting competition, improve international benchmarking, better allocation of health resources, establish clear lines of accountability and confidence in public institutions, and facilitate dialogue. Richard Torbett acknowledged alignment on the ultimate end goal of access, but polarization on a complex debate often fails to account for nuanced or unintended consequences such as price convergence undermining access to medicines in poorer countries, rewarding inefficiencies in development instead of value, disincentivizing high-risk research, or establishing policy barriers to differential pricing. Andrew Hill discussed his recent research comparing cost of production and medicine prices, to demonstrate how much countries can save by paying better prices and maximizing use of generics. Such an initiative may require a re-evaluation of cost-effectiveness for patented medicines versus generic alternatives. Gaëlle Krikorian discussed the MSF example of access to pneumococcal vaccine, where some low- and middle-income countries pay higher prices than high-income countries. She argued for price transparency by asserting that “countries cannot negotiate fair medicine prices blindfolded.” During the discussion, participants and panelists focused mainly on various elements of price and cost transparency, and the availability of data and potential impact of such transparency initiatives. The complexity of the research and development system was acknowledged but seeking transparent information may be a potential solution. A key concern was jeopardizing access in low-income countries, suggesting that perhaps a global system of differential pricing could be piloted for select molecules before advancing to further transparency. Parallel Session 2: Improving information sharing Vinzent Rest presented several cross-country initiatives in which Austria is participating, namely BeNeLuxA, the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, and the EURIPID price database, noting that the voluntary provision of information by the member countries has contributed to the success of each network. The main challenges encountered are lack of political commitment, legal barriers, and lack of resources, with the lesson learned that dialogue between stakeholders is essential. The PIEMEDS price database in the WHO Western Pacific Region was presented by Socorro Escalante, whereby information on procurement price is provided on a voluntary basis by the Member States. The main challenges cited are the high turnover at the Ministry level causing changes to focal points and delays in obtaining data. However, the database has improved procurement practices in some countries that compare prices between countries before purchase. Johanna Fihman presented the market information for access (MI4A) initiative, which helps to enhance understanding of global vaccine demand, inform discussion and decision making, and inform on the market to influence global market analysis and supply. Countries provide a landscape on their immunization programmes on a regular basis where information on procurement and supply are extracted. There has been strong engagement from 150 countries that maintain data flow and reporting, with quality check and masking system to guarantee confidentiality to avoid issues with negotiated price disclosure. Parallel Session 3: Garnering purchasing power through pooled procurement The session provided an opportunity to discuss different approaches to pooled procurement, exploring opportunities and challenges related to large-scale multi-country pooled procurement, procurement across a limited number of countries and national-level pooled procurement. Across the range of experiences, common themes emerged related to benefits for payers, suppliers, and patients of pooled procurement, in addition to critical lessons for ensuring successful implementation. Key benefits from pooled procurement on a multi-national level for countries included improved pricing, as well as consolidated technical support in product selection and assessment, quality assurance, timely and continuous supply and payment, and financial stability through access to credit for payment. Multi-country pooled procurement also had substantial benefits for suppliers particularly related to reliable and rapid payment and the limited transaction costs of contracting and negotiating agreements. Challenges to multi-national pooled procurement included maintaining transparency especially where this may risk raising prices, the ability to effectively forecast demand across countries, as well as approaches for tiered pricing and negotiations for sole-supply products. Lessons for multi-country procurement on a more limited scale included the importance of managing the heterogeneity between countries, including different language and legal frameworks. On a national level, it was demonstrated that substantial savings can be achieved through a comprehensive and coordinated pooled purchasing strategy, including prioritizing line items by linking to an essential medicines list and concurrently establishing electronic procurement monitoring system. It was emphasized that pooled procurements go beyond supply-side aggregation of demand to achieve low prices, and that further actions to improve systems and regulatory and legal frameworks are required to enable effective pooled procurement. Pooled procurement initiatives should include strategies to implement procurement legislation, regulatory harmonization and necessary regulation to create the space for effective competition. Discussants noted that governments should seek opportunities for multinational collaboration to participate in pooled procurement, but this should be done under a clear strategy that addresses country requirements including language, supply arrangements and legal frameworks. Governments could also develop and enhance existing national pooled procurement, ensuring that major supply-side, system and legal and regulatory frameworks are addressed. Participants recommended that WHO should continue to support countries through sharing information and knowledge exchange on best procurement practice and extending the scope of procurement support beyond medicines to include diagnostics and products for vector control. Participants also discussed potential benefits of pooled procurement to the pharmaceutical industry, including reduction in transaction costs and financial stability, and recommended further open discussion and information sharing, particularly around improving traceability and documentation for line items. Parallel Session 4: Emerging approaches This session explored several emerging approaches to tackle high drug prices and their potential applicability as sustainable solutions for both higher- and lower-income countries. Valérie Paris discussed the OECD challenges for policy makers related to high-priced medicines, along with existing and emerging strategies to cope with such prices. She discussed the importance of horizon scanning in updating spending projections, setting clear criteria and rules to manage budget constraints, addressing uncertainties on clinical benefits, and the role of competition authorities in off-patent markets. Wilbert Bannenberg then focused on legal options for challenging unfair pricing practices for therapies, which was defined as a necessary treatment unaffordable to patients or health systems, resulting in unreasonable and socially unacceptable profit margins. In addition to existing policy mechanisms to control unfair medicine prices, he founded the Pharmaceutical Accountability Foundation in the Netherlands to challenge the issue of unfair pricing in court and ensure medicines are available in a sustainable and socially acceptable manner. Douglas Clark then presented the recent drug pricing reforms in Canada, including the creation of the Patented Medicines Pricing Review Board (PMPRB) to manage costs and balance competition policy objectives by strengthening patent protection for manufacturers to incentivize pharma R&D in Canada as well as ensuring consumer protection from unreasonably-priced patented medicines. Although Canada is unable to leverage national buying power in the same way as other countries, the PMPRB regulates ceiling prices for all medicines in Canada and assesses new medicines for level of therapeutic benefit relative to existing therapies. James Love suggested possible mechanisms for a transition to delinking the costs of R&D from the price of the medicine. Such an approach would aim to reduce barriers for access, create competitive prices for health products, and potentially save governments money while more efficiently targeting subsidies and incentives. It would also modernize the approach to market entry rewards via an innovation fund of a fixed size with a multi-year coopetition among suppliers of innovations for shares of the fund. The transition approach would progressively decrease the maximum monopoly patent term allowed, with corresponding progressive increases in market rewards for entry. Parallel Session 5: Intellectual Property and Pricing This session focused on intellectual property and trade as key elements to getting access to medical technologies. Marumo Nkomo discussed proposed reforms to the Patent Law in South Africa that seeks to strike a balance between IP and trade and economic development and potential alternative ways of stimulating innovation. He noted that no element of access can be modified in isolation, and the importance of public engagement in progressing reforms. Esteban Burrone then discussed the role of the Medicines Patent Pool (MPP) in increasing access to new medicines in low- and middle-income countries. The initial MPP experience in HIV demonstrated that it is possible to give timely access to the best possible standard of care at an affordable price. However, subsequent experience with Hepatitis C revealed regulatory challenges as well as the need to scale up diagnosis and testing along with access and affordability measures. With the planned expansion of MPP to other patented essential medicines, often candidate medicines were not registered in many countries or only available in private sector, demonstrating a need to work with patent holders, government, civil society and patients to find win-win solutions. Tendai Mafuma then returned to the national experience in South Africa, specifically to recent experiences with access to cancer medicines. The Thobeka Daki Campaign launched in 2016 for access to trastuzumab resulted in the Department of Health adding trastuzumab to the national EML and awarding a tender that resulted in a price reduction of over 70% for this medicine. However, a subsequent study demonstrated that on-patent medicines were mostly unaffordable in South Africa, and that systemic changes such as the proposed reforms to the Patents Act outlined above are necessary. Finally, Petra Laux discussed the industry perspective that IP is necessary to ensure investments, faster launch of products, and technology diffusion. IP does not guarantee either commercial or scientific success, but it does foster fair competition and accelerates technology development. This also paves the way for generic entrants and doesn’t necessarily guarantee a high price. It is important for payers to be explicit about what they want to see in the value argument. During the subsequent discussion, participants and panelists discussed the need for cross- stakeholder collaboration and that systematic reforms and individual price negotiations must be considered together and not as mutually exclusive pathways. There is a need to develop a system of comparing prices in different countries which is standardized and acceptable by all. Access should not be an after-thought once medicines have been launched but must be considered before launch and find ways to implement new initiatives. A fair pricing zone does need to bring in affordability, but then an affordability threshold must be addressed. Parallel Session 6: Addressing market failures This session aimed to share experiences and solutions aimed at addressing market failures encountered in access to medicines. Margaret Ewen presented the results of addressing the challenges and constraints of insulin sources and supply (ACCISS) study, a collaboration between multiple institutions demonstrating that prices are highly variable with big differences in affordability for human insulin versus analogues. Proposed next steps include regular monitoring of insulin availability, evidence-based standard treatment guidelines, strengthening supply systems, addressing regulatory issues, and developing a more comprehensive approach on insulin pricing issues. Salmah Bahri then discussed Malaysia’s experience with compulsory licensing for sofosbuvir to treat Hepatitis C. Malaysia’s national patent laws mandate the national authorities to allow third parties to use a patented invention without the authorization of the patent owner to address unwanted consequences. This was not an immediate process; it took several years to attempt price negotiations, declare the disease a public health issue, obtain cabinet approval for the government use license, and exhaust the possibility for voluntary licensing. Following compulsory licensing, the Government is also able to expand their services to screening and diagnostics to increase coverage of care and is looking to introduce more competition to drive down treatment prices in the private sector. Key success factors included strong political will within Malaysia to address the issue, engagement between pharma industry and government, and strong collaboration between health and other industries, agencies and NGOs. Josep Tabernero then presented on the relationship between pricing and shortages of cancer medicines. The European Society of Medical Oncology (ESMO) recently conducted a study examining availability of oncology medicines on the WHO Model List of Essential Medicines, noting that low-income countries frequently lack access to even the low-cost essential medicines that represent 80% of the EML. Inexpensive essential medicines are indispensable to treat and sometimes cure all types of cancers. While it is important for governments and health systems to place medicines in context of the continuum of cancer care, virtually all cancer patients need some of these agents as part of their care. There are several potential causes for shortages, and ESMO has convened an international consortium to study the availability, OOP costs and accessibility of medicines in and outside of Europe. This consortium has recommended early notification requirements, establishment of strategic plans for medicines shortages at global and local levels, development of catalogues of shortages and an essential medicines list to assess the shortages, incentives for production infrastructure improvements, and procurement models designed to prevent medicines shortages. Finally, Vivian Fratelli presented the shortages issue from the International Generic and Biosimilar Medicines Association (IGBA) perspective, noting that there are numerous root causes of shortages, including deflating generic prices, centralized manufacturing for specific medicines and APIs, awarding of specific tenders to a small group of companies, regulatory systems, international trade agreements, and a lack of forecasting. Given that 80-90% of all medicines used globally is generic, the importance of overcoming such complex access challenges cannot be understated. Further participant discussion centered around the elements of fair pricing that go into addressing these market failures, including medicines selection, tiered pricing, procurement capacity, OOP spending, prescribing authority, and taxes and subsidies. Plenary Session: Learning from the experience of HIV medicines pricing Chair Marijke Wijnroks asked whether fair pricing is achievable for other disease areas and health systems, by leading a discussion on the history of HIV. Over the course of the past two decades these medicines have gone from costing more than 10 000 USD per year to less than 80 USD. Mariângela Simão revisited early experiences towards access under a public health approach to HIV treatment, including simplification of regimens and price reductions. Although coverage expands when prices go down, tiered pricing brought prices down, but not as much as generics. As for applicability to other disease areas, she noted a similar trend for Hepatitis C, with scaling up of treatment and medicines becoming more available as generics enter the markets. A key learning is the importance of all stakeholders to progress toward a vision, including both generic and originator industry. Precious Matsoso then presented lessons learned from South African experience. The country faced unique challenges and opportunities at the height of the HIV debate, as this was somewhat concurrent to post-apartheid amendments and redrafting of the national medicines law and other aspects of the health system. There was concern about the potential impact on industry, and a negative perception of generics, however the government was able to attain generic substitution, single exit pricing, and some transparency measures. These elements provide potential learnings as stakeholders seek to find a solution to fair pricing. Nic de Jongh discussed the contribution of the generic industry in improving access to HIV medicines in the past, and how all stakeholders can enable this in the future. Reductions in cost can address adherence problems, and manufacturers could also potentially make improvements on older products. Stakeholders must be willing to compromise, for example his company takes on a certain number of “Chairman’s Projects” that don’t make commercial sense but that guarantee access. Key enabling factors include timely registration and manufacturing site approvals, price negotiation preferred to tender, patent law amendments, minimum uptake guarantees or volume predictability, and delivery to central warehouses to ease logistics costs. Othoman Mellouk then noted that while there have been important steps forward, fair pricing and equitable access is still not a reality for HIV medicines, let alone other conditions. A key consideration is middle-income countries, where progress can lag global efforts in price and access. It can be easy to over-simplify the buyers as the public and the innovators as the pharmaceutical industry, but this ignores the important contribution of public subsidies for R&D. Plenary Discussion: Balancing Access and Innovation The Forum plenary began with key learnings from the previous day’s parallel sessions for the benefit and discussion of all participants. See session summaries above, with the following themes drawn out for additional discussion among the delegates:  Transparency emerged as an end goal with broad consensus among stakeholders, although its exact definition and means of achieving it remain polarizing. On the cost front, it was suggested to set up systems for public visibility on government investments in research. As for price transparency, the utility of governments agreeing to confidential prices was questioned, although the impact of doing so on access in low- and middle-income countries and smaller markets is an area for continued monitoring.  Information sharing can take place on a formal or informal basis, with proven benefits but also many challenges. There must be a logic model and strategic plan to ensure that information collected is useful, and while such systems can be cost-saving they frequently require initial expenditure. There must be collaboration to ensure comparability and trust to enable sustainability.  Pooled procurement, while not necessarily a new concept, is receiving renewed attention among stakeholders to attain sustainability of supply. There are opportunities for multinational collaboration to address supply issues, given a clear strategy, potentially expanding beyond medicines to include areas such as diagnostics and vector control. Responding to a concern regarding potential barriers, potential pooling designs were noted that preserve tiered pricing among countries of different income levels.  Emerging approaches are an important area for continued dialogue and ongoing study to further refine sharing of good practices. Areas suggested for further study include feasibility of delinkage models, and costs versus benefits of managed entry instruments and policies. Such studies must be rigorously designed to examine potential pitfalls, studied by trusted objective sources, with an eye towards how best to design a system that can deliver.  Intellectual property was another area suggested for further study, specifically whether patents truly serve as an incentive or a block to innovation. It was suggested that policies could allow for a public R&D approach or other alternative models of financing R&D. However, the barriers for carrying forward such an approach were acknowledged, such as the political will to invest in an alternative infrastructure. All relevant stakeholders must come together for further work in this area, including WHO and other relevant agencies.  Market failures were acknowledged as a multi-faceted issue, highlighting the importance of managing variability in access to essential medicines. National EMLs are an important first step but this must be translated into actionable policies for regulation, pricing, and procurement. Early notification is an option to overcome shortages, but they must also be dealt with at a more systemic level, with an acknowledgement that while affordability is paramount, pricing policies are not a “race to the bottom”. During the subsequent plenary discussion, participants acknowledged a trust gap among stakeholders that must be addressed to move forward. The Fair Pricing Forum can serve as an important convening mechanism to achieve this, but only if the dialogue can move beyond traditional arguments and blanket statements to true collaboration toward creative solutions. Specifically, further discussion occurred on the question of transparency of prices and costs. Regarding prices, there is an ongoing need to ensure that transparency does not jeopardize access in lower-income countries and smaller markets. Regarding costs, many acknowledged the need for accountability in public return on public investment. This area requires further examination to determine specific areas where market incentives are not working, to demonstrate what the costs are to enable incentives that deliver both innovation and access. Plenary Discussion: Next steps towards Fair Pricing Mariângela Simão offered the following take-home messages expressed by participants:  Fair pricing and transparency both fall under the broader rubric of public health governance, sustainability, and ability to pay  There is a need for more information sharing among all stakeholders, including but not limited to more data on cost of production, pricing, efficacy, and volumes  There is a need to better understand alternatives to exclusive rights because this is often approached from an academic perspective; how can it be more actionable?  Forum participants acknowledge the global problem and the need for clarity on determinants of price to achieve common ground Finally, Anban Pillay led a discussion reflecting on progress made since the first Fair Pricing Forum in 2017, and next steps to progress until the next Forum in 2021. Participants noted an increasing sense of urgency around affordability and access to medicines yielding discussion around what constitutes fairness, on public funding and accounting in price, and on building relationships and trust. There is acknowledged momentum around the issue of transparency, although this cannot be considered in isolation but rather as one piece of the system that enables access to health products. It is important to look for a global shared understanding of relevant issues while considering practical implementation in country context, and thus the ability to bring together the international community for stock-taking was a valuable opportunity that should continue. Annex A: List of Participants I - Member States Australia Karen Binnekamp, Adviser, Office of Health Technology Assessment, Department of Health, Canberra Austria Vinzent Rest, Deputy Head of Unit, Policy Advisor, Federal Ministry of Health, Vienna Brazil Priscilla Loze, Technical Consultant, Ministry of Health, Brasília Clementina Corah Lucas Prado, Technical advisor, Ministry of Health, Brasilia Lara Pereira, Health Regulation Specialist, Ministry of Health, Brasília Canada Douglas Clark, Executive Director, Patented Medicine Prices Review Board, Ottawa Central African Republic Eugène Kpizingui, Inspecteur Central en matière de Santé publique et de la Qualité des Soins, Ministère de la Santé et de la Population, Bangui Ecuador Amjad Abdulla, Technical Secretary of Drug Pricing, Ministry of Public Health, Quito Daniel López, Institutional Advisor, Quito Finland Eero Lahtinen, Minister Counsellor, Ministry for Foreign Affairs, Geneva Gabon Corrinne Nseng-Nseng Ndong, Directeur Technique, Office Pharmaceutique National, Libreville Indonesia Wahyu Nurcahyani, Government Official, Ministry of Health, Jakarta Sadiah Sadiah, senior Government, Ministry of Health, Jakarta Sri Endah Suhartatik, Official Government, Ministry of Health, Jakarta Italy Armando Bartolazzi, Undersecretary of State, Ministry of Health, Rome Luca Li Bassi, Director General, Italian Medicines Agency, Rome Latvia Signe Bokta, Director of Medicines and Medical Devices Department, National Health Service of Latvia, Riga Antra Fogele, Deputy Director of Department of Medicines and Medical Devices, National Health Service of Latvia, Carnikava Malaysia Roshayati Mohamad Sani, Director, Pharmacy Practice & Development, Ministry of Health, Petaling Jaya Salbiah Mohd Salleh, Deputy Director, Medicines Pricing, Ministry of Health, Petaling Jaya Salmah Bahri, Retired Senior Director of Pharmaceutical Services, Ministry of Health Netherlands Huibert Kooijman, Management Team Pharmaceuticals & Medical Technology, Ministry of Health, Leidschendam Nigeria Mashood Oluku Lawal, Director, Food & Drug Services, Federal Ministry of Health, Abuja Republic of Korea Jee-Ae Kim, Senior Research Fellow, Health Insurance Review and Assessment Services,Yangsan-Si Geun Woo Lee, Researcher, Health Insurance Review & Assessment Service, Wonju-Si Saudi Arabia Fahad Alnutafy, Director, Pricing & Pharmacoeconomic Department, Saudi Food & Drug Authority, Riyadh South Africa (Host) Khadija Jamaloodien, Director, National Department of Health, Pretoria Neo Kitsa, Member of Pricing Committee of South Africa, Johannesburg Nombulelo Leburu, Director: Communication, National Department of Health, Johannesburg Oumakie Mabusela, Administration Clerk, National Department of Health, Pretoria Vincent Rabbie Madisha, Deputy Director, National Department of Health, Pretoria Isaac Makhubele, Administration Clerk, National Department of Health, Pretoria Lester Ralf Marais, Sao, National Department of Health, Pretoria Matshediso Marima, Senior Administrative Officer, National Department of Health, Pretoria Morongwa Florah Mashaba, Administrative officer, National Department of Health, Pretoria Tshepisho Mothoa, Revenue Manager, National Department of Health, Pretoria Patricia Ngobese, Administration, National Department of Health, Pretoria Marumo Nkomo, Director DTI, National Department of Health, Pretoria Norman Norman, Administrative Officer-NHI, Pretoria Ephodia Nyathi, Senior Pharmaceutical Policy Specialist, National Department of Health, Pretoria Shireen Pardesi, Chief Director, National Department of Health, Pretoria Didintle Phatshwane, Personal Assistant, National Department of Health, Pretoria Thamizhanban Pillay, DDG, National Health Insurance, Centurion, Gauteng Anne Roos, Case Manager, National Department of Health, Pretoria Frieda Seete, Personal Assistant, National Department of Health, Pretoria Motlakapele Aquina Thulare, Technical Specialist, Health Economics for National Health Insurance, National Department of Health, Pretoria Tlou Tlhako, Senior Communication Officer, National Department of Health, Pretoria Kholofelo Tsipa, Senior Admin Officer, National Department of Health, Pretoria Sri Lanka Dinusha Dassanayake, General Manager, State Pharmaceuticals Corporation, Gothatuwa Renuka Maha Thanthreege, Chief Financial Officer, Ministry of Health, Colombo Sweden Almina Kalkan, Desk Officer, Ministry of Health and Social Affairs, Stockholm Switzerland Nora Kronig Romero, Ambassador for Global Health, Federal Department of Home Affairs, Federal Office of Public Health, Bern Haller Veronique, Deputy Head of Mission, Embassy of Switzerland in South Africa, Pretoria Matebe Chisiza, Foreign Policy Advisor, Embassy of Switzerland in South Africa, Johannesburg Turkey Enver Kagan Atikeler, Health Technology Assessments Expert, Turkish Medicines and Medical Devices Agency, Ankara Uganda Timothy Musila, Assistant Commissioner Health Services, Ministry of Health, Kampala Joseph Mutasaaga, Manager Business Development, National Drug Authority, Kampala Morries Seru, Commissioner Pharmaceutical services, Ministry of Health, Kampala Ukraine Oleksandr Komarida, Director General of Pharmaceutical Directorate, Ministry of Health, Kyiv United Kingdom of Great Britain and Northern Ireland Sophia Berry, Senior Policy Manager, Medicines Pricing, Department of Health and Social Care, London United Republic of Tanzania Sako Mayrick, Director of Finance and Planning, Medical Stores Department, Dar Es Salaam Daudi Msasi, Director Pharmaceutical Services, Chief Pharmacist, Ministry of Health, Dodoma Ambwene Mwakalobo, Pharmaceutical Officer, Policy and Practice, Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma Robert Nyamwika, Chief Internal Auditor, Medical Stores Department, Dar Es Salaam United States of America Emiliy Bleimund, Director, Trade & Health, Department of Health, Washington DC Nancy De Lew, Associate Deputy Assistant Secretary, Department of Health and Human Services, Washington DC Zimbabwe Marlven Gabaza, Pharmacy Logistics and Research Officer, Ministry of Health and Child Care, Harare Ropafadzai Hove, Director Pharmacy Services, Ministry of Health and Child Care, Harare Gugu N. Mahlangu, Director-General, Medicines Control Authority of Zimbabwe, Harare II - NGOs (Non-Governmental Organization) Access to Medicine Foundation Gabrielle Breugelmans, Director of Research, Amsterdam Brazilian Interdisciplinary AIDS Association Clara Alves, Project Assistant, Rio de Janeiro Cancer Alliance Salome Meyer, Project Manager, Cape Town Clinton Health Access Initiative Richard Borain, Senior Program Manager, Johannesburg DNDi Michelle Childs, Head of Policy Advocacy, Geneva European Alliance for Responsible R&D and Affordable Medicines Viviana Galli, Coordinator, Brussels European Public Health Alliance (EPHA) Yannis Natsis, Policy Manager for Universal Access and Affordable Medicines, Brussels European Society for Medical Oncology (ESMO) Josep Tabernero, President, Barcelona Malvika Vyas, Head of Public Policy, Lugano Global Antibiotic Research & Development Partnership (GARDP) Carol Ruffell, Head of Office, Cape Town, South Africa, Global Antibiotic R&D Partnership (GARDP) Jean-Pierre Paccaud, Director BD and Corporate Strategy, Geneva Global Justice Now Heidi Chow, Senior Policy Manager, Loughton Health Action International (HAI) Margaret Ewen, Senior Projects Manager, Amsterdam, Member of the Fix the Patent Laws campaign's Steering Committee Igazi Foundation Caroline Rich, Board Member, Cape Town International Pharmaceutical Federation (FIP) Dominique Jordan, President, The Hague International Treatment Preparedness Coalition (ITPC) Othoman Mellouk, Intellectual Property and Access to Medicines Lead, Marrakech Knowledge Ecology International (KEI) James Love, Director, Washington Knowledge Ecology International (KEI) Thiru Balasubramaniam, Geneva Representative, Geneva Médecins Sans Frontières (MSF ) Gaelle Krikorian, Head of Policy, Paris Candice Sehoma, Access Campaign Advocacy Officer, Johannesburg Medicines Patent Pool (MPP) Esteban Burrone, Head of Policy, Geneva Sandra Nobre, Head of Business Development, Geneva MSH Ivan Loboda, Senior Technical Advisor on Pharmaceutical Finance, Kyiv Pfizer Wayne Holmes, Senior Director of Innovation Policy, New York Pharmaceutical Accountability Foundation Wilbert Bannenberg, Chairperson, Bergeijk Public Citizen Zain Rizvi, Law & Policy Researcher, Washington D.C. Public Eye Patrick Durisch, Health Programme Coordinator, Lausanne Save the Children UK Karrar Karrar, Access to Medicine Adviser, London Section27 Umunyana Rugege, Executive Director, Johannesburg Tendai Mafuma, Legal Researcher, Johannesburg South African Medical Association Shelley Mcgee, Health Policy Researcher, Pretoria Stichting Health Action International (HAI) Jaume Vidal, Policy Advisor, Amsterdam Stop AIDS James Cole, Advocacy Officer, London Wellcome Trust Rachael Crockett, Policy Advisor, London Union for International Cancer Control (UICC) Shalini Jayasekar Zurn, Senior Advocacy Manager, Geneva III - Intergovernmental and Other Organizations (IGO) Organisation for Economic Cooperation and Development (OCDE) Valérie Paris, Senior Economist, Paris Organization of Coordination for the Control of Endemic Diseases in Central Africa (OCEAC) Emilienne Yissibi Pola, Consultant, Yaounde The Global Fund to Fight AIDS, Tuberculosis and Malaria Marijke Wijnroks, Chief of Staff, Geneva UNDP Judit Rius Sanjuan, Policy Specialist, Health Technology Innovation and Access, New York World Health Organization (WHO) WHO HQ Geneva Mariangela Batista Galvao Simao, Assistant Director-General, Access to Medicines, Vaccines and Pharmaceuticals (MVP) Suzanne Hill, Director Essential Medicines and Products (EMP) Daniela Bagozzi, Communication, EMP Andrew Rintoul, Scientist, EMP Allison Colbert, Technical Officer, EMP Kiu Tay-Teo, Technical Officer, EMP Erika Duenas, Technical Officer, EMP Johanna Fihman, Technical Officer, Expanded Programme on Immunization (EPI) WHO Country offices Ghana Edith Annan, Programme Officer, Medicines and Health Technologies, Accra Kenya Regina Mbindyo, Country Team Adviser, EMP, Nairobi Nigeria Omotayo Hamzat, National Professional Officer, EMP, Abuja South Africa Rajesh Narwal, Health Syste Advisor, Pretoria Tanzania Rose Shija Muhangwa, National Professional Officer, EMP, Dar Es Salaam WHO Regional Offices Regional Office for Africa (AFRO), Brazzaville, Republic of Congo Aissatou Sarassa Sougou, Technical Officer Regional Office for the Americas (AMRO), Washington DC, USA Analia Porras, Unit Chief, Medicines and Health Technologies Regional Office for the Western Pacific (WPRO), Manilla, The Philippines Socorro Escalante, Coordinator III - Academia Graduate Institute of International and Development Studies Suerie Moon, Director of Research, Global Health Centre, Geneva Health Economics and Epidemiology Research Office, University of Witwatersrand Jacqui Miot, Division Director, Johannesburg Medicines Law & Policy, University Medical Centre Groningen Elisabeth 't Hoen, Director, Amsterdam Sefako Makgatho Health Sciences University, Pretoria Mothobi Godfrey Keele, Senior Lecturer Moliehi Matlala, Senior Lecturer Mmamosheledi Mothibe, Senior Lecturer, Acting HOD Pharmaceutical Sciences University of British Columbia Steven Morgan, Professor, Vancouver University of Cape Town Tommy Wilkinson, Lecturer University of KwaZulu-Natal, Durban Andrew Gray, Senior Lecturer Varsha Bangalee, Senior Lecturer Fatima Suleman, Professor University of Liverpool Andrew Hill, Senior Research Fellow, London University of Malawi Chikosa Banda, Senior Lecturer, Zomba Utrecht University Aukje Mantel-Teeuwisse, Professor of Pharmacy and Global Health, Utrecht Vallabhbhai Patel Chest Institute, University of Delhi Anita Kotwani, Professor IV - Private Sector Entities CIPLA Medpro Johannes Nicolaas De Jongh, Vice President, Chief Scientific Officer, Cape Town Discovery Health Inez Naidu, Head, Discovery Health Medicines Unit, Sandton Noluthando Nematswerani, Head, Clinical Policy, Johannesburg Niri Bhimsan, Head, Health Technology Assessment, Sandton Fresenius-Kabi South Africa (Pty) Mikko Tiitinen, Managing Director, Midrand Gilead Sciences Europe Graeme Robertson, Executive Director, Africa & CIS, Access Operations & Emerging Markets, Uxbridge International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Thomas Cueni, Director General, Geneva (IFPMA) Fumie Yokota Griego, Deputy Director General, Geneva (IFPMA) Guilherme Cintra, Director, Innovation Policy, Geneva (IFPMA) Sara Amini, Head, International Value and Access Policy and Advocacy, Geneva (IFPMA) Unjela Kaleem, Director of Communications, Geneva, (IFPMA) Mendel Grobler, Director, North Ryde (Amgen Australia) René Imhof, Head Pricing, Basel (F. Hoffmann-La Roche) Petra Laux, Head Global Public Affairs Policy & Advocacy North America, Basel (Novartis International AG) Evan Lee, Director, Geneva (Eli Lilly & Company) Niels Lund, Vice President, Bagsvaerd, Denmark (Novo Nordisk) Christelle Marechal, Director European Affairs and External Relations, Paris (Les Entreprises du Médicament) Colleen Purdy, Country Director, Johannesburg (Amgen South Africa Pty) Alexander Roediger, Executive Director, Oncology Policy Europe, Middle East, Africa and Canada, Zurich (Merck Sharp & Dohme) Takanori Sato, Head of Public Affairs Supranational, Tokyo (Takeda) Dr Konji Sebati, Chief Executive Officer, Bryanston (Innovative Pharmaceutical Association of South Africa) Richard Torbett, Executive Director, Commercial Policy, London (Association of the British Pharmaceutical Industry) International Generic and Biosimilar Medicines Association (IGBA) Vivian Frittelli, CEO, Midrand, Generic and Biosimilar Medicines of Southern Africa Metropolitan Health Solly Motuba, Chief Commercial Officer, Pretoria Office of Health Standards Compliance Bada Pharasi, Independent researcher and consultant (Board Member), Pretoria ZS Associates Ed Schoonveld, Managing Partner, Value & Access, New York Annex B: Programme for The 2nd Global Forum on Fair Pricing 11-13 April 2019, Johannesburg, South Africa Detailed programme Time Activity / Topic Discussants Thursday 11 April 2019 11:00 – 14:00 Registration and Lunch 14:00 – 15:30 Workshops W1: Negotiating with confidence Rintoul (WHO) Porras (PAHO) Pillay (South Africa) Schoonveld (ZS Associates) W2: An interactive introduction into the world of patents and access to pharmaceuticals Dueñas (WHO) t’ Hoen (MLP) Nkomo (South Africa) Rius San Juan (UNDP) Cintra (IFPMA) 15:30 – 16:00 Break with refreshments and networking opportunities 16:00 – 17:30 Workshops W3: Access to medicines in the African region: medicines pricing as a bottleneck? Sougou (AFRO) Colbert (WHO) Mbindyo (WHO Kenya) W4: Pricing implications of policies on biosimilar cancer medicines Vyas (ESMO) Frittelli (IGBA) Tay-Teo (WHO) 17:30 – 20:00 Forum opening dinner Welcome, introducing Forum objectives and commitments towards fairer pricing of pharmaceuticals Moderator: Matsoso (South Africa) Motsoaledi (South Africa) Simão (WHO) Friday 12 April 2019 9:00 – 10:30 Plenary: Fair pricing in practice  Progresses made toward fair pricing  Innovative industry’s role in fair pricing: What has been done and what can be done? Moderator: Suleman (UKZN) Bahri (Malaysia) Cueni (IFPMA) Moon (Graduate Institute) Time Activity / Topic Discussants  Fair price to whom? High prices, rationing and addressing community’s needs for access to medicines 10:30 – 11:00 Break with refreshments and networking opportunities 11:00 – 12:30 Parallel sessions PS1: Improving transparency  Building healthy markets: overcoming information asymmetries  Countries cannot negotiate fair medicine prices blindfolded  Transparency of costs of production Moderator: Miot (Wits) Li Bassi (Italy) Krikorian (MSF) Hill (Liverpool University) Torbett (ABPI) PS2: Improving information sharing  Cross-country initiatives (PPRI, Beneluxa)  Pricing databases  MI4A database for vaccine access Moderator: Morgan (UBC) Rest (Austria) Escalante (WPRO) Fihman (WHO) PS3: Garner purchasing power through pooled procurement  PAHO Strategic and Revolving Funds  SADC Pooled Procurement  Challenges of small markets Moderator: Gray (UKZN) Porras (PAHO) Rius San Juan (UNDP) Fogele (Latvia) TBC (SADC) 12:30 – 14:00 Lunch with networking opportunities 14:00 – 15:30 Parallel sessions PS4: Emerging approaches  Canada’s Patented Medicines Pricing Review Board  Dutch Accountability Foundation  Transition to delinkage  Analyzing innovative approaches Moderator: Breugelmans (Access to Medicine Foundation) Clark (PMPRB) Bannenberg (Farma ter Verantwoording) Love (KEI) Paris (OECD) PS5: Intellectual Property and Pricing Moderator: Dueñas (WHO) Nkomo (South Africa) Burrone (MPP) Mafuma (Section 27) Laux (Novartis) Time Activity / Topic Discussants PS6: Addressing market failures  Accessing insulin: prices issues and other challenges  Malaysia’s experience with Compulsory license  Relationship between pricing and shortages of cancer medicines  Shortages Moderator: Kronig (Switzerland) Bahri (Malaysia) Ewen (HAI) Tabernero (ESMO) Frittelli (IGBA) 15:30 – 16:00 Break with refreshments and networking opportunities 16:00 – 17:30 Plenary: Is fair pricing achievable? A trip back in history of the pricing of HIV medicines  South Africa and Access to Medicines  Revisiting early experiences towards access  Role of the generic medicines industry  Are we there yet? Lessons for today’s pricing problem Moderator: Wijnroks (Global Fund) Matsoso (South Africa) Simão (WHO) De Jongh (Cipla) Mellouk (ITPC) Saturday 13 April 2019 9:00 – 9:15 Welcome and introduction 9:15 – 10:30 Plenary discussion Balancing access and innovation  Key learnings from the parallel sessions Chairs: Hill, Pillay 10:30 – 11:00 Break with refreshments and networking opportunities 11:00 – 12:30 Plenary discussion Towards fair pricing – the next step Unresolved issues for the next Forum Chairs: Pillay, Simão 12:30-1:00 Conclusion  Reaffirming commitments Chairs: Pillay, Simão

Fair Pricing Forum 2019 Meeting Report Johannesburg, South Africa 11-13 April 2019 WHO/MVP/EMP/IAU/2019.09 © World Health Organization 2019 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). 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Introduction In 2017, WHO convened the first Fair Pricing Forum in Amsterdam, The Netherlands, to enable stakeholders to discuss options for a fairer pricing system for pharmaceuticals. The second Forum, held 11-13 April 2019 in Johannesburg, addressed the following objectives:  To share experiences in employing regulatory and non-regulatory measures for achieving ‘fair’ prices for pharmaceutical products that are affordable to patients and healthcare systems while incentivizing enterprise, efficiency and innovation  To explore tools, approaches and system factors that could facilitate affordable and sustainable pricing of pharmaceutical products  To identify areas of actions that would support countries in achieving fairer pricing of pharmaceutical products The Forum was hosted by the South African National Department of Health together with WHO, and attended by representatives from Member States, non-governmental and patient organizations, and the innovator and generic pharmaceutical industry (full list of participants available in Annex A). The Forum consisted of a series of participatory workshops, followed by plenary and parallel panel discussions on key issues of current interest, and concluded by a plenary discussion on key learnings and commitments for further action (See agenda and speaker affiliations in Annex B). Additional information and meeting presentations are available at https://www.who.int/medicines/access/fair_pricing/en/. Key Takeaways and Next Steps The second Fair Pricing Forum achieved the following outcomes:  Exchange of experiences in achieving better access through pricing measures  Enabling networks for sharing of information relating to tools and approaches that could be used to achieve more affordable and sustainable prices  Enhanced understanding of the merits and challenges of pricing and financing approaches that might bring about fairer pricing  Common understanding and shared commitment towards the areas of actions identified for supporting countries in achieving fairer pricing. Participants acknowledged difficulties in defining a price that is truly fair, but also that it is most important to think practically about what fairness means in practice and how all stakeholders can work together to achieve it. To that end, a set of technical working groups will focus on specific areas of pricing to determine what is achievable in the short- and medium-term, reporting to the next Fair Pricing Forum in 2021. These working groups will have focused terms of reference and concrete deliverables, with an established process for nomination and representation. Stakeholders are invited to provide feedback by 15 September 2019 on these next steps towards achieving a fair pricing system. Further instructions are available at https://www.who.int/medicines/access/fair_pricing/en/. Summary of proceedings Plenary Session: Fair pricing in practice Fatima Suleman moderated the opening plenary on the topic of “fair pricing in practice,” an attempt to unpack the definition of fair pricing and its interplay with affordability. Suerie Moon noted that fairness can be considered from either the buyer’s or seller’s perspective, with a price floor needing to cover the cost of supply and price ceiling above which there would be a loss of access. Between the floor and the ceiling, there is a “fair pricing zone” that could accommodate concepts such as rewarding higher value medicines, differential allocation of certain cost components, and pricing of generic medicines. Thomas Cueni acknowledged that finding the right balance between affordability and innovation is challenging, and that industry is open to new models of ensuring affordability in resource- constrained settings. However, this must be accompanied by a clear process from governments for attaining UHC, including regulatory clarity and efficiency. Salmah Bahri shared the experience of Malaysia relating to the situation where products disappeared from the market when the incentives for industry were perceived to be inadequate. She also presented the challenges of using value-based approaches for pricing when the true value of a medicine in the real world would only emerge over time and therefore subject to considerable uncertainties at the time of pricing. These include predicting patient uptake and the extent of upfront payment. During the subsequent discussion, the need for reliable international information on prices was emphasized, as this would enable countries to be better informed about the actual prices of medicines in different markets. However, such an approach would necessitate not including countries with much lower GDP per capita in external referencing pricing baskets and not parallel importing from such countries. Parallel Session 1: Improving transparency Moderator Jacqui Miot set the scene regarding transparency in South Africa, where the government has set a generic substitution policy, established a pricing committee, defined a single exit price and dispensing fee, and have no confidential discounts. Reaching this point was not a speedy process with various legislative and regulatory challenges, however via stakeholder engagement and constant updating of data and information, the pricing committee has achieved an important degree of certainty and consistency. Luca Li Bassi discussed the draft World Health Assembly resolution on transparency of markets for health products and its potential to support decision-making on pricing and reimbursement, improve capacity to negotiate, enhance market efficiency by promoting competition, improve international benchmarking, better allocation of health resources, establish clear lines of accountability and confidence in public institutions, and facilitate dialogue. Richard Torbett acknowledged alignment on the ultimate end goal of access, but polarization on a complex debate often fails to account for nuanced or unintended consequences such as price convergence undermining access to medicines in poorer countries, rewarding inefficiencies in development instead of value, disincentivizing high-risk research, or establishing policy barriers to differential pricing. Andrew Hill discussed his recent research comparing cost of production and medicine prices, to demonstrate how much countries can save by paying better prices and maximizing use of generics. Such an initiative may require a re-evaluation of cost-effectiveness for patented medicines versus generic alternatives. Gaëlle Krikorian discussed the MSF example of access to pneumococcal vaccine, where some low- and middle-income countries pay higher prices than high-income countries. She argued for price transparency by asserting that “countries cannot negotiate fair medicine prices blindfolded.” During the discussion, participants and panelists focused mainly on various elements of price and cost transparency, and the availability of data and potential impact of such transparency initiatives. The complexity of the research and development system was acknowledged but seeking transparent information may be a potential solution. A key concern was jeopardizing access in low-income countries, suggesting that perhaps a global system of differential pricing could be piloted for select molecules before advancing to further transparency. Parallel Session 2: Improving information sharing Vinzent Rest presented several cross-country initiatives in which Austria is participating, namely BeNeLuxA, the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, and the EURIPID price database, noting that the voluntary provision of information by the member countries has contributed to the success of each network. The main challenges encountered are lack of political commitment, legal barriers, and lack of resources, with the lesson learned that dialogue between stakeholders is essential. The PIEMEDS price database in the WHO Western Pacific Region was presented by Socorro Escalante, whereby information on procurement price is provided on a voluntary basis by the Member States. The main challenges cited are the high turnover at the Ministry level causing changes to focal points and delays in obtaining data. However, the database has improved procurement practices in some countries that compare prices between countries before purchase. Johanna Fihman presented the market information for access (MI4A) initiative, which helps to enhance understanding of global vaccine demand, inform discussion and decision making, and inform on the market to influence global market analysis and supply. Countries provide a landscape on their immunization programmes on a regular basis where information on procurement and supply are extracted. There has been strong engagement from 150 countries that maintain data flow and reporting, with quality check and masking system to guarantee confidentiality to avoid issues with negotiated price disclosure. Parallel Session 3: Garnering purchasing power through pooled procurement The session provided an opportunity to discuss different approaches to pooled procurement, exploring opportunities and challenges related to large-scale multi-country pooled procurement, procurement across a limited number of countries and national-level pooled procurement. Across the range of experiences, common themes emerged related to benefits for payers, suppliers, and patients of pooled procurement, in addition to critical lessons for ensuring successful implementation. Key benefits from pooled procurement on a multi-national level for countries included improved pricing, as well as consolidated technical support in product selection and assessment, quality assurance, timely and continuous supply and payment, and financial stability through access to credit for payment. Multi-country pooled procurement also had substantial benefits for suppliers particularly related to reliable and rapid payment and the limited transaction costs of contracting and negotiating agreements. Challenges to multi-national pooled procurement included maintaining transparency especially where this may risk raising prices, the ability to effectively forecast demand across countries, as well as approaches for tiered pricing and negotiations for sole-supply products. Lessons for multi-country procurement on a more limited scale included the importance of managing the heterogeneity between countries, including different language and legal frameworks. On a national level, it was demonstrated that substantial savings can be achieved through a comprehensive and coordinated pooled purchasing strategy, including prioritizing line items by linking to an essential medicines list and concurrently establishing electronic procurement monitoring system. It was emphasized that pooled procurements go beyond supply-side aggregation of demand to achieve low prices, and that further actions to improve systems and regulatory and legal frameworks are required to enable effective pooled procurement. Pooled procurement initiatives should include strategies to implement procurement legislation, regulatory harmonization and necessary regulation to create the space for effective competition. Discussants noted that governments should seek opportunities for multinational collaboration to participate in pooled procurement, but this should be done under a clear strategy that addresses country requirements including language, supply arrangements and legal frameworks. Governments could also develop and enhance existing national pooled procurement, ensuring that major supply-side, system and legal and regulatory frameworks are addressed. Participants recommended that WHO should continue to support countries through sharing information and knowledge exchange on best procurement practice and extending the scope of procurement support beyond medicines to include diagnostics and products for vector control. Participants also discussed potential benefits of pooled procurement to the pharmaceutical industry, including reduction in transaction costs and financial stability, and recommended further open discussion and information sharing, particularly around improving traceability and documentation for line items. Parallel Session 4: Emerging approaches This session explored several emerging approaches to tackle high drug prices and their potential applicability as sustainable solutions for both higher- and lower-income countries. Valérie Paris discussed the OECD challenges for policy makers related to high-priced medicines, along with existing and emerging strategies to cope with such prices. She discussed the importance of horizon scanning in updating spending projections, setting clear criteria and rules to manage budget constraints, addressing uncertainties on clinical benefits, and the role of competition authorities in off-patent markets. Wilbert Bannenberg then focused on legal options for challenging unfair pricing practices for therapies, which was defined as a necessary treatment unaffordable to patients or health systems, resulting in unreasonable and socially unacceptable profit margins. In addition to existing policy mechanisms to control unfair medicine prices, he founded the Pharmaceutical Accountability Foundation in the Netherlands to challenge the issue of unfair pricing in court and ensure medicines are available in a sustainable and socially acceptable manner. Douglas Clark then presented the recent drug pricing reforms in Canada, including the creation of the Patented Medicines Pricing Review Board (PMPRB) to manage costs and balance competition policy objectives by strengthening patent protection for manufacturers to incentivize pharma R&D in Canada as well as ensuring consumer protection from unreasonably-priced patented medicines. Although Canada is unable to leverage national buying power in the same way as other countries, the PMPRB regulates ceiling prices for all medicines in Canada and assesses new medicines for level of therapeutic benefit relative to existing therapies. James Love suggested possible mechanisms for a transition to delinking the costs of R&D from the price of the medicine. Such an approach would aim to reduce barriers for access, create competitive prices for health products, and potentially save governments money while more efficiently targeting subsidies and incentives. It would also modernize the approach to market entry rewards via an innovation fund of a fixed size with a multi-year coopetition among suppliers of innovations for shares of the fund. The transition approach would progressively decrease the maximum monopoly patent term allowed, with corresponding progressive increases in market rewards for entry. Parallel Session 5: Intellectual Property and Pricing This session focused on intellectual property and trade as key elements to getting access to medical technologies. Marumo Nkomo discussed proposed reforms to the Patent Law in South Africa that seeks to strike a balance between IP and trade and economic development and potential alternative ways of stimulating innovation. He noted that no element of access can be modified in isolation, and the importance of public engagement in progressing reforms. Esteban Burrone then discussed the role of the Medicines Patent Pool (MPP) in increasing access to new medicines in low- and middle-income countries. The initial MPP experience in HIV demonstrated that it is possible to give timely access to the best possible standard of care at an affordable price. However, subsequent experience with Hepatitis C revealed regulatory challenges as well as the need to scale up diagnosis and testing along with access and affordability measures. With the planned expansion of MPP to other patented essential medicines, often candidate medicines were not registered in many countries or only available in private sector, demonstrating a need to work with patent holders, government, civil society and patients to find win-win solutions. Tendai Mafuma then returned to the national experience in South Africa, specifically to recent experiences with access to cancer medicines. The Thobeka Daki Campaign launched in 2016 for access to trastuzumab resulted in the Department of Health adding trastuzumab to the national EML and awarding a tender that resulted in a price reduction of over 70% for this medicine. However, a subsequent study demonstrated that on-patent medicines were mostly unaffordable in South Africa, and that systemic changes such as the proposed reforms to the Patents Act outlined above are necessary. Finally, Petra Laux discussed the industry perspective that IP is necessary to ensure investments, faster launch of products, and technology diffusion. IP does not guarantee either commercial or scientific success, but it does foster fair competition and accelerates technology development. This also paves the way for generic entrants and doesn’t necessarily guarantee a high price. It is important for payers to be explicit about what they want to see in the value argument. During the subsequent discussion, participants and panelists discussed the need for cross- stakeholder collaboration and that systematic reforms and individual price negotiations must be considered together and not as mutually exclusive pathways. There is a need to develop a system of comparing prices in different countries which is standardized and acceptable by all. Access should not be an after-thought once medicines have been launched but must be considered before launch and find ways to implement new initiatives. A fair pricing zone does need to bring in affordability, but then an affordability threshold must be addressed. Parallel Session 6: Addressing market failures This session aimed to share experiences and solutions aimed at addressing market failures encountered in access to medicines. Margaret Ewen presented the results of addressing the challenges and constraints of insulin sources and supply (ACCISS) study, a collaboration between multiple institutions demonstrating that prices are highly variable with big differences in affordability for human insulin versus analogues. Proposed next steps include regular monitoring of insulin availability, evidence-based standard treatment guidelines, strengthening supply systems, addressing regulatory issues, and developing a more comprehensive approach on insulin pricing issues. Salmah Bahri then discussed Malaysia’s experience with compulsory licensing for sofosbuvir to treat Hepatitis C. Malaysia’s national patent laws mandate the national authorities to allow third parties to use a patented invention without the authorization of the patent owner to address unwanted consequences. This was not an immediate process; it took several years to attempt price negotiations, declare the disease a public health issue, obtain cabinet approval for the government use license, and exhaust the possibility for voluntary licensing. Following compulsory licensing, the Government is also able to expand their services to screening and diagnostics to increase coverage of care and is looking to introduce more competition to drive down treatment prices in the private sector. Key success factors included strong political will within Malaysia to address the issue, engagement between pharma industry and government, and strong collaboration between health and other industries, agencies and NGOs. Josep Tabernero then presented on the relationship between pricing and shortages of cancer medicines. The European Society of Medical Oncology (ESMO) recently conducted a study examining availability of oncology medicines on the WHO Model List of Essential Medicines, noting that low-income countries frequently lack access to even the low-cost essential medicines that represent 80% of the EML. Inexpensive essential medicines are indispensable to treat and sometimes cure all types of cancers. While it is important for governments and health systems to place medicines in context of the continuum of cancer care, virtually all cancer patients need some of these agents as part of their care. There are several potential causes for shortages, and ESMO has convened an international consortium to study the availability, OOP costs and accessibility of medicines in and outside of Europe. This consortium has recommended early notification requirements, establishment of strategic plans for medicines shortages at global and local levels, development of catalogues of shortages and an essential medicines list to assess the shortages, incentives for production infrastructure improvements, and procurement models designed to prevent medicines shortages. Finally, Vivian Fratelli presented the shortages issue from the International Generic and Biosimilar Medicines Association (IGBA) perspective, noting that there are numerous root causes of shortages, including deflating generic prices, centralized manufacturing for specific medicines and APIs, awarding of specific tenders to a small group of companies, regulatory systems, international trade agreements, and a lack of forecasting. Given that 80-90% of all medicines used globally is generic, the importance of overcoming such complex access challenges cannot be understated. Further participant discussion centered around the elements of fair pricing that go into addressing these market failures, including medicines selection, tiered pricing, procurement capacity, OOP spending, prescribing authority, and taxes and subsidies. Plenary Session: Learning from the experience of HIV medicines pricing Chair Marijke Wijnroks asked whether fair pricing is achievable for other disease areas and health systems, by leading a discussion on the history of HIV. Over the course of the past two decades these medicines have gone from costing more than 10 000 USD per year to less than 80 USD. Mariângela Simão revisited early experiences towards access under a public health approach to HIV treatment, including simplification of regimens and price reductions. Although coverage expands when prices go down, tiered pricing brought prices down, but not as much as generics. As for applicability to other disease areas, she noted a similar trend for Hepatitis C, with scaling up of treatment and medicines becoming more available as generics enter the markets. A key learning is the importance of all stakeholders to progress toward a vision, including both generic and originator industry. Precious Matsoso then presented lessons learned from South African experience. The country faced unique challenges and opportunities at the height of the HIV debate, as this was somewhat concurrent to post-apartheid amendments and redrafting of the national medicines law and other aspects of the health system. There was concern about the potential impact on industry, and a negative perception of generics, however the government was able to attain generic substitution, single exit pricing, and some transparency measures. These elements provide potential learnings as stakeholders seek to find a solution to fair pricing. Nic de Jongh discussed the contribution of the generic industry in improving access to HIV medicines in the past, and how all stakeholders can enable this in the future. Reductions in cost can address adherence problems, and manufacturers could also potentially make improvements on older products. Stakeholders must be willing to compromise, for example his company takes on a certain number of “Chairman’s Projects” that don’t make commercial sense but that guarantee access. Key enabling factors include timely registration and manufacturing site approvals, price negotiation preferred to tender, patent law amendments, minimum uptake guarantees or volume predictability, and delivery to central warehouses to ease logistics costs. Othoman Mellouk then noted that while there have been important steps forward, fair pricing and equitable access is still not a reality for HIV medicines, let alone other conditions. A key consideration is middle-income countries, where progress can lag global efforts in price and access. It can be easy to over-simplify the buyers as the public and the innovators as the pharmaceutical industry, but this ignores the important contribution of public subsidies for R&D. Plenary Discussion: Balancing Access and Innovation The Forum plenary began with key learnings from the previous day’s parallel sessions for the benefit and discussion of all participants. See session summaries above, with the following themes drawn out for additional discussion among the delegates:  Transparency emerged as an end goal with broad consensus among stakeholders, although its exact definition and means of achieving it remain polarizing. On the cost front, it was suggested to set up systems for public visibility on government investments in research. As for price transparency, the utility of governments agreeing to confidential prices was questioned, although the impact of doing so on access in low- and middle-income countries and smaller markets is an area for continued monitoring.  Information sharing can take place on a formal or informal basis, with proven benefits but also many challenges. There must be a logic model and strategic plan to ensure that information collected is useful, and while such systems can be cost-saving they frequently require initial expenditure. There must be collaboration to ensure comparability and trust to enable sustainability.  Pooled procurement, while not necessarily a new concept, is receiving renewed attention among stakeholders to attain sustainability of supply. There are opportunities for multinational collaboration to address supply issues, given a clear strategy, potentially expanding beyond medicines to include areas such as diagnostics and vector control. Responding to a concern regarding potential barriers, potential pooling designs were noted that preserve tiered pricing among countries of different income levels.  Emerging approaches are an important area for continued dialogue and ongoing study to further refine sharing of good practices. Areas suggested for further study include feasibility of delinkage models, and costs versus benefits of managed entry instruments and policies. Such studies must be rigorously designed to examine potential pitfalls, studied by trusted objective sources, with an eye towards how best to design a system that can deliver.  Intellectual property was another area suggested for further study, specifically whether patents truly serve as an incentive or a block to innovation. It was suggested that policies could allow for a public R&D approach or other alternative models of financing R&D. However, the barriers for carrying forward such an approach were acknowledged, such as the political will to invest in an alternative infrastructure. All relevant stakeholders must come together for further work in this area, including WHO and other relevant agencies.  Market failures were acknowledged as a multi-faceted issue, highlighting the importance of managing variability in access to essential medicines. National EMLs are an important first step but this must be translated into actionable policies for regulation, pricing, and procurement. Early notification is an option to overcome shortages, but they must also be dealt with at a more systemic level, with an acknowledgement that while affordability is paramount, pricing policies are not a “race to the bottom”. During the subsequent plenary discussion, participants acknowledged a trust gap among stakeholders that must be addressed to move forward. The Fair Pricing Forum can serve as an important convening mechanism to achieve this, but only if the dialogue can move beyond traditional arguments and blanket statements to true collaboration toward creative solutions. Specifically, further discussion occurred on the question of transparency of prices and costs. Regarding prices, there is an ongoing need to ensure that transparency does not jeopardize access in lower-income countries and smaller markets. Regarding costs, many acknowledged the need for accountability in public return on public investment. This area requires further examination to determine specific areas where market incentives are not working, to demonstrate what the costs are to enable incentives that deliver both innovation and access. Plenary Discussion: Next steps towards Fair Pricing Mariângela Simão offered the following take-home messages expressed by participants:  Fair pricing and transparency both fall under the broader rubric of public health governance, sustainability, and ability to pay  There is a need for more information sharing among all stakeholders, including but not limited to more data on cost of production, pricing, efficacy, and volumes  There is a need to better understand alternatives to exclusive rights because this is often approached from an academic perspective; how can it be more actionable?  Forum participants acknowledge the global problem and the need for clarity on determinants of price to achieve common ground Finally, Anban Pillay led a discussion reflecting on progress made since the first Fair Pricing Forum in 2017, and next steps to progress until the next Forum in 2021. Participants noted an increasing sense of urgency around affordability and access to medicines yielding discussion around what constitutes fairness, on public funding and accounting in price, and on building relationships and trust. There is acknowledged momentum around the issue of transparency, although this cannot be considered in isolation but rather as one piece of the system that enables access to health products. It is important to look for a global shared understanding of relevant issues while considering practical implementation in country context, and thus the ability to bring together the international community for stock-taking was a valuable opportunity that should continue. Annex A: List of Participants I - Member States Australia Karen Binnekamp, Adviser, Office of Health Technology Assessment, Department of Health, Canberra Austria Vinzent Rest, Deputy Head of Unit, Policy Advisor, Federal Ministry of Health, Vienna Brazil Priscilla Loze, Technical Consultant, Ministry of Health, Brasília Clementina Corah Lucas Prado, Technical advisor, Ministry of Health, Brasilia Lara Pereira, Health Regulation Specialist, Ministry of Health, Brasília Canada Douglas Clark, Executive Director, Patented Medicine Prices Review Board, Ottawa Central African Republic Eugène Kpizingui, Inspecteur Central en matière de Santé publique et de la Qualité des Soins, Ministère de la Santé et de la Population, Bangui Ecuador Amjad Abdulla, Technical Secretary of Drug Pricing, Ministry of Public Health, Quito Daniel López, Institutional Advisor, Quito Finland Eero Lahtinen, Minister Counsellor, Ministry for Foreign Affairs, Geneva Gabon Corrinne Nseng-Nseng Ndong, Directeur Technique, Office Pharmaceutique National, Libreville Indonesia Wahyu Nurcahyani, Government Official, Ministry of Health, Jakarta Sadiah Sadiah, senior Government, Ministry of Health, Jakarta Sri Endah Suhartatik, Official Government, Ministry of Health, Jakarta Italy Armando Bartolazzi, Undersecretary of State, Ministry of Health, Rome Luca Li Bassi, Director General, Italian Medicines Agency, Rome Latvia Signe Bokta, Director of Medicines and Medical Devices Department, National Health Service of Latvia, Riga Antra Fogele, Deputy Director of Department of Medicines and Medical Devices, National Health Service of Latvia, Carnikava Malaysia Roshayati Mohamad Sani, Director, Pharmacy Practice & Development, Ministry of Health, Petaling Jaya Salbiah Mohd Salleh, Deputy Director, Medicines Pricing, Ministry of Health, Petaling Jaya Salmah Bahri, Retired Senior Director of Pharmaceutical Services, Ministry of Health Netherlands Huibert Kooijman, Management Team Pharmaceuticals & Medical Technology, Ministry of Health, Leidschendam Nigeria Mashood Oluku Lawal, Director, Food & Drug Services, Federal Ministry of Health, Abuja Republic of Korea Jee-Ae Kim, Senior Research Fellow, Health Insurance Review and Assessment Services,Yangsan-Si Geun Woo Lee, Researcher, Health Insurance Review & Assessment Service, Wonju-Si Saudi Arabia Fahad Alnutafy, Director, Pricing & Pharmacoeconomic Department, Saudi Food & Drug Authority, Riyadh South Africa (Host) Khadija Jamaloodien, Director, National Department of Health, Pretoria Neo Kitsa, Member of Pricing Committee of South Africa, Johannesburg Nombulelo Leburu, Director: Communication, National Department of Health, Johannesburg Oumakie Mabusela, Administration Clerk, National Department of Health, Pretoria Vincent Rabbie Madisha, Deputy Director, National Department of Health, Pretoria Isaac Makhubele, Administration Clerk, National Department of Health, Pretoria Lester Ralf Marais, Sao, National Department of Health, Pretoria Matshediso Marima, Senior Administrative Officer, National Department of Health, Pretoria Morongwa Florah Mashaba, Administrative officer, National Department of Health, Pretoria Tshepisho Mothoa, Revenue Manager, National Department of Health, Pretoria Patricia Ngobese, Administration, National Department of Health, Pretoria Marumo Nkomo, Director DTI, National Department of Health, Pretoria Norman Norman, Administrative Officer-NHI, Pretoria Ephodia Nyathi, Senior Pharmaceutical Policy Specialist, National Department of Health, Pretoria Shireen Pardesi, Chief Director, National Department of Health, Pretoria Didintle Phatshwane, Personal Assistant, National Department of Health, Pretoria Thamizhanban Pillay, DDG, National Health Insurance, Centurion, Gauteng Anne Roos, Case Manager, National Department of Health, Pretoria Frieda Seete, Personal Assistant, National Department of Health, Pretoria Motlakapele Aquina Thulare, Technical Specialist, Health Economics for National Health Insurance, National Department of Health, Pretoria Tlou Tlhako, Senior Communication Officer, National Department of Health, Pretoria Kholofelo Tsipa, Senior Admin Officer, National Department of Health, Pretoria Sri Lanka Dinusha Dassanayake, General Manager, State Pharmaceuticals Corporation, Gothatuwa Renuka Maha Thanthreege, Chief Financial Officer, Ministry of Health, Colombo Sweden Almina Kalkan, Desk Officer, Ministry of Health and Social Affairs, Stockholm Switzerland Nora Kronig Romero, Ambassador for Global Health, Federal Department of Home Affairs, Federal Office of Public Health, Bern Haller Veronique, Deputy Head of Mission, Embassy of Switzerland in South Africa, Pretoria Matebe Chisiza, Foreign Policy Advisor, Embassy of Switzerland in South Africa, Johannesburg Turkey Enver Kagan Atikeler, Health Technology Assessments Expert, Turkish Medicines and Medical Devices Agency, Ankara Uganda Timothy Musila, Assistant Commissioner Health Services, Ministry of Health, Kampala Joseph Mutasaaga, Manager Business Development, National Drug Authority, Kampala Morries Seru, Commissioner Pharmaceutical services, Ministry of Health, Kampala Ukraine Oleksandr Komarida, Director General of Pharmaceutical Directorate, Ministry of Health, Kyiv United Kingdom of Great Britain and Northern Ireland Sophia Berry, Senior Policy Manager, Medicines Pricing, Department of Health and Social Care, London United Republic of Tanzania Sako Mayrick, Director of Finance and Planning, Medical Stores Department, Dar Es Salaam Daudi Msasi, Director Pharmaceutical Services, Chief Pharmacist, Ministry of Health, Dodoma Ambwene Mwakalobo, Pharmaceutical Officer, Policy and Practice, Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma Robert Nyamwika, Chief Internal Auditor, Medical Stores Department, Dar Es Salaam United States of America Emiliy Bleimund, Director, Trade & Health, Department of Health, Washington DC Nancy De Lew, Associate Deputy Assistant Secretary, Department of Health and Human Services, Washington DC Zimbabwe Marlven Gabaza, Pharmacy Logistics and Research Officer, Ministry of Health and Child Care, Harare Ropafadzai Hove, Director Pharmacy Services, Ministry of Health and Child Care, Harare Gugu N. Mahlangu, Director-General, Medicines Control Authority of Zimbabwe, Harare II - NGOs (Non-Governmental Organization) Access to Medicine Foundation Gabrielle Breugelmans, Director of Research, Amsterdam Brazilian Interdisciplinary AIDS Association Clara Alves, Project Assistant, Rio de Janeiro Cancer Alliance Salome Meyer, Project Manager, Cape Town Clinton Health Access Initiative Richard Borain, Senior Program Manager, Johannesburg DNDi Michelle Childs, Head of Policy Advocacy, Geneva European Alliance for Responsible R&D and Affordable Medicines Viviana Galli, Coordinator, Brussels European Public Health Alliance (EPHA) Yannis Natsis, Policy Manager for Universal Access and Affordable Medicines, Brussels European Society for Medical Oncology (ESMO) Josep Tabernero, President, Barcelona Malvika Vyas, Head of Public Policy, Lugano Global Antibiotic Research & Development Partnership (GARDP) Carol Ruffell, Head of Office, Cape Town, South Africa, Global Antibiotic R&D Partnership (GARDP) Jean-Pierre Paccaud, Director BD and Corporate Strategy, Geneva Global Justice Now Heidi Chow, Senior Policy Manager, Loughton Health Action International (HAI) Margaret Ewen, Senior Projects Manager, Amsterdam, Member of the Fix the Patent Laws campaign's Steering Committee Igazi Foundation Caroline Rich, Board Member, Cape Town International Pharmaceutical Federation (FIP) Dominique Jordan, President, The Hague International Treatment Preparedness Coalition (ITPC) Othoman Mellouk, Intellectual Property and Access to Medicines Lead, Marrakech Knowledge Ecology International (KEI) James Love, Director, Washington Knowledge Ecology International (KEI) Thiru Balasubramaniam, Geneva Representative, Geneva Médecins Sans Frontières (MSF ) Gaelle Krikorian, Head of Policy, Paris Candice Sehoma, Access Campaign Advocacy Officer, Johannesburg Medicines Patent Pool (MPP) Esteban Burrone, Head of Policy, Geneva Sandra Nobre, Head of Business Development, Geneva MSH Ivan Loboda, Senior Technical Advisor on Pharmaceutical Finance, Kyiv Pfizer Wayne Holmes, Senior Director of Innovation Policy, New York Pharmaceutical Accountability Foundation Wilbert Bannenberg, Chairperson, Bergeijk Public Citizen Zain Rizvi, Law & Policy Researcher, Washington D.C. Public Eye Patrick Durisch, Health Programme Coordinator, Lausanne Save the Children UK Karrar Karrar, Access to Medicine Adviser, London Section27 Umunyana Rugege, Executive Director, Johannesburg Tendai Mafuma, Legal Researcher, Johannesburg South African Medical Association Shelley Mcgee, Health Policy Researcher, Pretoria Stichting Health Action International (HAI) Jaume Vidal, Policy Advisor, Amsterdam Stop AIDS James Cole, Advocacy Officer, London Wellcome Trust Rachael Crockett, Policy Advisor, London Union for International Cancer Control (UICC) Shalini Jayasekar Zurn, Senior Advocacy Manager, Geneva III - Intergovernmental and Other Organizations (IGO) Organisation for Economic Cooperation and Development (OCDE) Valérie Paris, Senior Economist, Paris Organization of Coordination for the Control of Endemic Diseases in Central Africa (OCEAC) Emilienne Yissibi Pola, Consultant, Yaounde The Global Fund to Fight AIDS, Tuberculosis and Malaria Marijke Wijnroks, Chief of Staff, Geneva UNDP Judit Rius Sanjuan, Policy Specialist, Health Technology Innovation and Access, New York World Health Organization (WHO) WHO HQ Geneva Mariangela Batista Galvao Simao, Assistant Director-General, Access to Medicines, Vaccines and Pharmaceuticals (MVP) Suzanne Hill, Director Essential Medicines and Products (EMP) Daniela Bagozzi, Communication, EMP Andrew Rintoul, Scientist, EMP Allison Colbert, Technical Officer, EMP Kiu Tay-Teo, Technical Officer, EMP Erika Duenas, Technical Officer, EMP Johanna Fihman, Technical Officer, Expanded Programme on Immunization (EPI) WHO Country offices Ghana Edith Annan, Programme Officer, Medicines and Health Technologies, Accra Kenya Regina Mbindyo, Country Team Adviser, EMP, Nairobi Nigeria Omotayo Hamzat, National Professional Officer, EMP, Abuja South Africa Rajesh Narwal, Health Syste Advisor, Pretoria Tanzania Rose Shija Muhangwa, National Professional Officer, EMP, Dar Es Salaam WHO Regional Offices Regional Office for Africa (AFRO), Brazzaville, Republic of Congo Aissatou Sarassa Sougou, Technical Officer Regional Office for the Americas (AMRO), Washington DC, USA Analia Porras, Unit Chief, Medicines and Health Technologies Regional Office for the Western Pacific (WPRO), Manilla, The Philippines Socorro Escalante, Coordinator III - Academia Graduate Institute of International and Development Studies Suerie Moon, Director of Research, Global Health Centre, Geneva Health Economics and Epidemiology Research Office, University of Witwatersrand Jacqui Miot, Division Director, Johannesburg Medicines Law & Policy, University Medical Centre Groningen Elisabeth 't Hoen, Director, Amsterdam Sefako Makgatho Health Sciences University, Pretoria Mothobi Godfrey Keele, Senior Lecturer Moliehi Matlala, Senior Lecturer Mmamosheledi Mothibe, Senior Lecturer, Acting HOD Pharmaceutical Sciences University of British Columbia Steven Morgan, Professor, Vancouver University of Cape Town Tommy Wilkinson, Lecturer University of KwaZulu-Natal, Durban Andrew Gray, Senior Lecturer Varsha Bangalee, Senior Lecturer Fatima Suleman, Professor University of Liverpool Andrew Hill, Senior Research Fellow, London University of Malawi Chikosa Banda, Senior Lecturer, Zomba Utrecht University Aukje Mantel-Teeuwisse, Professor of Pharmacy and Global Health, Utrecht Vallabhbhai Patel Chest Institute, University of Delhi Anita Kotwani, Professor IV - Private Sector Entities CIPLA Medpro Johannes Nicolaas De Jongh, Vice President, Chief Scientific Officer, Cape Town Discovery Health Inez Naidu, Head, Discovery Health Medicines Unit, Sandton Noluthando Nematswerani, Head, Clinical Policy, Johannesburg Niri Bhimsan, Head, Health Technology Assessment, Sandton Fresenius-Kabi South Africa (Pty) Mikko Tiitinen, Managing Director, Midrand Gilead Sciences Europe Graeme Robertson, Executive Director, Africa & CIS, Access Operations & Emerging Markets, Uxbridge International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Thomas Cueni, Director General, Geneva (IFPMA) Fumie Yokota Griego, Deputy Director General, Geneva (IFPMA) Guilherme Cintra, Director, Innovation Policy, Geneva (IFPMA) Sara Amini, Head, International Value and Access Policy and Advocacy, Geneva (IFPMA) Unjela Kaleem, Director of Communications, Geneva, (IFPMA) Mendel Grobler, Director, North Ryde (Amgen Australia) René Imhof, Head Pricing, Basel (F. Hoffmann-La Roche) Petra Laux, Head Global Public Affairs Policy & Advocacy North America, Basel (Novartis International AG) Evan Lee, Director, Geneva (Eli Lilly & Company) Niels Lund, Vice President, Bagsvaerd, Denmark (Novo Nordisk) Christelle Marechal, Director European Affairs and External Relations, Paris (Les Entreprises du Médicament) Colleen Purdy, Country Director, Johannesburg (Amgen South Africa Pty) Alexander Roediger, Executive Director, Oncology Policy Europe, Middle East, Africa and Canada, Zurich (Merck Sharp & Dohme) Takanori Sato, Head of Public Affairs Supranational, Tokyo (Takeda) Dr Konji Sebati, Chief Executive Officer, Bryanston (Innovative Pharmaceutical Association of South Africa) Richard Torbett, Executive Director, Commercial Policy, London (Association of the British Pharmaceutical Industry) International Generic and Biosimilar Medicines Association (IGBA) Vivian Frittelli, CEO, Midrand, Generic and Biosimilar Medicines of Southern Africa Metropolitan Health Solly Motuba, Chief Commercial Officer, Pretoria Office of Health Standards Compliance Bada Pharasi, Independent researcher and consultant (Board Member), Pretoria ZS Associates Ed Schoonveld, Managing Partner, Value & Access, New York Annex B: Programme for The 2nd Global Forum on Fair Pricing 11-13 April 2019, Johannesburg, South Africa Detailed programme Time Activity / Topic Discussants Thursday 11 April 2019 11:00 – 14:00 Registration and Lunch 14:00 – 15:30 Workshops W1: Negotiating with confidence Rintoul (WHO) Porras (PAHO) Pillay (South Africa) Schoonveld (ZS Associates) W2: An interactive introduction into the world of patents and access to pharmaceuticals Dueñas (WHO) t’ Hoen (MLP) Nkomo (South Africa) Rius San Juan (UNDP) Cintra (IFPMA) 15:30 – 16:00 Break with refreshments and networking opportunities 16:00 – 17:30 Workshops W3: Access to medicines in the African region: medicines pricing as a bottleneck? Sougou (AFRO) Colbert (WHO) Mbindyo (WHO Kenya) W4: Pricing implications of policies on biosimilar cancer medicines Vyas (ESMO) Frittelli (IGBA) Tay-Teo (WHO) 17:30 – 20:00 Forum opening dinner Welcome, introducing Forum objectives and commitments towards fairer pricing of pharmaceuticals Moderator: Matsoso (South Africa) Motsoaledi (South Africa) Simão (WHO) Friday 12 April 2019 9:00 – 10:30 Plenary: Fair pricing in practice  Progresses made toward fair pricing  Innovative industry’s role in fair pricing: What has been done and what can be done? Moderator: Suleman (UKZN) Bahri (Malaysia) Cueni (IFPMA) Moon (Graduate Institute) Time Activity / Topic Discussants  Fair price to whom? High prices, rationing and addressing community’s needs for access to medicines 10:30 – 11:00 Break with refreshments and networking opportunities 11:00 – 12:30 Parallel sessions PS1: Improving transparency  Building healthy markets: overcoming information asymmetries  Countries cannot negotiate fair medicine prices blindfolded  Transparency of costs of production Moderator: Miot (Wits) Li Bassi (Italy) Krikorian (MSF) Hill (Liverpool University) Torbett (ABPI) PS2: Improving information sharing  Cross-country initiatives (PPRI, Beneluxa)  Pricing databases  MI4A database for vaccine access Moderator: Morgan (UBC) Rest (Austria) Escalante (WPRO) Fihman (WHO) PS3: Garner purchasing power through pooled procurement  PAHO Strategic and Revolving Funds  SADC Pooled Procurement  Challenges of small markets Moderator: Gray (UKZN) Porras (PAHO) Rius San Juan (UNDP) Fogele (Latvia) TBC (SADC) 12:30 – 14:00 Lunch with networking opportunities 14:00 – 15:30 Parallel sessions PS4: Emerging approaches  Canada’s Patented Medicines Pricing Review Board  Dutch Accountability Foundation  Transition to delinkage  Analyzing innovative approaches Moderator: Breugelmans (Access to Medicine Foundation) Clark (PMPRB) Bannenberg (Farma ter Verantwoording) Love (KEI) Paris (OECD) PS5: Intellectual Property and Pricing Moderator: Dueñas (WHO) Nkomo (South Africa) Burrone (MPP) Mafuma (Section 27) Laux (Novartis) Time Activity / Topic Discussants PS6: Addressing market failures  Accessing insulin: prices issues and other challenges  Malaysia’s experience with Compulsory license  Relationship between pricing and shortages of cancer medicines  Shortages Moderator: Kronig (Switzerland) Bahri (Malaysia) Ewen (HAI) Tabernero (ESMO) Frittelli (IGBA) 15:30 – 16:00 Break with refreshments and networking opportunities 16:00 – 17:30 Plenary: Is fair pricing achievable? A trip back in history of the pricing of HIV medicines  South Africa and Access to Medicines  Revisiting early experiences towards access  Role of the generic medicines industry  Are we there yet? Lessons for today’s pricing problem Moderator: Wijnroks (Global Fund) Matsoso (South Africa) Simão (WHO) De Jongh (Cipla) Mellouk (ITPC) Saturday 13 April 2019 9:00 – 9:15 Welcome and introduction 9:15 – 10:30 Plenary discussion Balancing access and innovation  Key learnings from the parallel sessions Chairs: Hill, Pillay 10:30 – 11:00 Break with refreshments and networking opportunities 11:00 – 12:30 Plenary discussion Towards fair pricing – the next step Unresolved issues for the next Forum Chairs: Pillay, Simão 12:30-1:00 Conclusion  Reaffirming commitments Chairs: Pillay, Simão