Report on SEA-ACHR subcommittee on drug and vaccine development.

Thirty-second Session of WHO South-East Asia Advisory Committee on Health Research Bangkok, Thailand 11-13 October 2011 SEA/ACHR/32/2.6 5 October 2011 Agenda Item 2.6  Introduction As a follow up of the recommendation made by 31st Session SEA ACHR, the Sub-committee of SEA ACHR on Vaccine and Drug Development was established with terms of reference as follows: To review the existing situation in the Region, including issues and challenges for vaccine and drug development relevant to the regional and country office To review the research being carried out in the countries in the Region in the field of drug and vaccine development in government, nongovernment and pharmaceutical centres To identify the priority areas and gaps prevailing in the existing situation To stimulate, support and monitor appropriate research collaboration in those areas identified as priority areas. To assist research institutions in the development of regional and national capacity strengthening, including networking and partnership in drugs and vaccine development To advise on resource mobilization, to catalyse policy formulation, and to suggest choices to support research and capacity building actions in drug and vaccine development. Members of the Sub-committee (tenure: 2 years): (1) Dr N.K. Ganguly, India (2) Dr Ranjit Roy Chaudhury, India (3) Dr Nyoman Kandun, Indonesia (4) Dr Somsak Chunharas, Thailand (5) Dr Harun Ar-Rashid, Bangladesh WHO serves as the secretariat. The Sub-C met twice. The following are the outputs: Regional Policy on Immunization for South-East Asia 2011-2015. Regional Vaccine Policy for South-East Asia developed in 2003. The revision was needed in view of considerable developments in the vaccine area and the progress made in the Region in implementing the recommendations outlined in the Regional Vaccine Policy (2003). Based on the subsequent development and deliberations during the Sub-committee meeting, IVD has developed the Regional Policy on Immunization 2011-2015. Regional Immunization Policy was presented at the Immunization Technical Advisory Group-SEAR meeting on 2-3rd March 2011 and in EPI Managers meeting in 3-4th August 2011. Current status on Influenza Vaccines and drugs production and trend in SEAR countries. In the first SEA-ACHR Sub-committee meeting, Prof Ganguly reported the current situation on influenza vaccines production and trend in SEAR countries. As the Region would be in short supply of the vaccine, there is a critical need to enhance regional production capacity. Added to this, countries need to have in place proper plans for introducing the vaccine, and currently it appears that only Thailand has made high progress in this area. He further stated that it was in vaccine manufacturer’s interest to know how much vaccine would be required, and countries noted that predicting demand was challenging. However, at present, the situation has been changed and H1N1 was highly potential to be identified as seasonal influenza. He further revealed that there were three countries in the Region having the capacity to produce H1N1 vaccine – India, Indonesia and Thailand. India has five companies able to produce the vaccine, while Indonesia and Thailand have one each. India will not depend on local vaccine production only but will obtain vaccine from one of the four companies currently producing the vaccine. India will do bridging studies to bridge the needed information. Phase II and Phase III studies and post-marketing surveillance will be done for immunogenicity and safety for the vaccines obtained from these companies. It is recommended that WHO should support for mapping vaccine production capacity in pharmaceutical industry in four countries: Bangladesh, India, Indonesia and Thailand. India has already launched a study on the vaccine production capacity in the country so the rest of the countries mentioned should be also assessed. WHO should support to organize a consultation on the regional production of pandemic vaccine in the spirit of public-private partnerships. It is further recommended that countries expedite legal and regulatory mechanisms for national registration of new drugs, vaccines and supplies, and for the process of custom clearance. 3. South-East Asia Regional Vaccine Prioritization Dr Arun Thapa made a presentation on review of the report of the South-East Asia Region Vaccine Prioritization. He mentioned that there was a need to examine the available data on vaccine-preventable diseases for which vaccines were already available or for which new vaccines are soon to be available, efficacy, safety and cost effectiveness profiles of each of the available vaccines. He mentioned that there should be a discussion and an agreement should be arrived upon a set of criteria that would be used to objectively judge the appropriateness of any new vaccine within the regional context and agree on a list of vaccines of priority for consideration by countries for introduction in their NIPs. He stated that there was an urgent need for the immediate priority vaccines such as Rubella, Haemophilus influenzae type b (Hib), Conjugate pneumococcal, Typhoid, Seasonal influenza, Rotavirus and Cholera. The Sub-committee recommends: Update immunization policies at Regional and national levels to allow for available new vaccines and technologies Strengthen immunization programmes for achieving disease control as part of the health-related millennium development goals (MDG) Have a rational and comprehensive approach to the introduction of new vaccines rather than addressing each new vaccine individually National Technical Advisory Group on Immunization is essential. The recent establishment by most Member States of a National Committee for Immunization Practices (or NCIP) was fully supported and Member States were encouraged to use the technical capacity of such a body to assist evidence-based decision-making regarding immunization and vaccines. 4 . Possibility of public-private partnership in vaccines development. The presentation on possibility of public-private partnership in vaccines development was made by Dr Arun Thapa, Coordinator, IVD. He mentioned that Vaccine research, development and manufacturing require huge investments and a long incubation period. The risks involved are high and predictability is poor. Regulation was becoming stringent all over the world including developing countries. Private sector ventured into this business only where the risks were well covered. Thus it played a major and successful role in introduction of certain new vaccines for developed countries i.e. Pneumococcal Vaccine and Human Papilloma virus Vaccine. Private companies generally seek the highest returns on their investments which come from developing products for the rich world and which may not necessarily meet the requirements of the poorer countries. The governmental institutions, universities or public sector manufactures alone can not ensure that the needs of new vaccines for the developing world are met. Thus the needs of new vaccine for developing countries remain largely unaddressed. Dr Thapa cited that the objectives of the partnership is to make available new vaccines to developing countries at affordable cost, stimulate vaccine R & D for unmet needs of vaccines such as Dengue, Malaria and HIV for which currently no vaccines are available and technology transfer to developing country manufacturers He mentioned that this partnership works on “Push” and “Pull” mechanisms - state or public funding for research in specific disease areas, tax benefits for research companies, funding for clinical research, easy registration of new products.” Pull” mechanisms - commitment to purchase new products once they are developed, tax benefits on sales, thus making vaccine manufacturing attractive for private sector in developing world He mentioned that there are various constraints or challenges in PPP such as proviision of assured quality vaccine free or at minimum cost and adequate policies and programmes for equity of access. The Sub-committee recommendations were: The role of WHO in the area of this PPP is to be an honest broker in the interests of the needy and to bring about equity in access to affordable vaccines. Balancing role in providing glue and efficiency in PPP, Unbiased technical guidance, vision and strategy to such alliances/partnerships, Assure transparency at all level and avoid “conflict of interest” 6. Harmonize regulatory requirements SEARO supported strengthening the capacity of National Regulatory Authorities (NRAs) in Bangladesh, India, Indonesia, and Thailand. Out of these Member Countries India Indonesia and Thailand have well established vaccine production capacity. Bangladesh is an emerging vaccine producer. Prof Ganguly informed that there were NRA meetings held in Bangladesh and also in Myanmar. Each NRA has to have a standard quality system. Although NRAs of the three vaccine manufacturing countries are well in place, harmonization of the NRAs is still a tough challenge. The EU has recently developed a matrix on harmonization which can be used as reference for the SEARO Region. An NRA Forum was held in Bangkok from 21 to 23 June. IVD/VSQ was actively involved in this process and acting as the Secretariat with WHO IVB in Geneva. This forum was global with the participation of vaccine regulatory experts from high, middle and low income countries throughout the world. The strategies and vision will shape the future of the Region to regulate research, development and production of quality vaccines in sufficient quantity for South East Asia and Globally. Objectives of the NRA Forum: Vision and strategic objectives: develop a shared vision and identify strategic objectives to build and sustain regulatory capacity in the area of vaccines. Technical expertise: identify existing regional and sub-regional technical expertise (HUB) that can be shared and used within the country and outside the country and propose innovative ways to expand access to high level technical expertise and skilled resources. Harmonization and sharing of information: discuss areas of harmonization, current progress and new needs and propose solutions to foster existing initiatives through parallel review mechanisms and exchange/twinning programmes or bilateral/multilateral initiatives. Synergies with global and regional initiatives, international and bilateral aid: discuss feasible options to increase existing coordination mechanism to sustain or enhance regulatory cooperation and coordination and translate it into regulatory agencies' institutional development plans (IDP). Fundraising approaches to identify support and potential for NRA strengthening activities, public and/or private, including NGOs or foundations, banks and other potential donors. Review existing funding, scope of current funding in the area, innovative ways to fund activities including registration fees, grants, loans and other sources of funding. Expected Outcome A shared vision including defined strategic objectives that will be translated into each NRA institutional development plan (IDP). List of commonalities, gaps and constraints, resources needed from government budget and international and bilateral aid to be able to achieve the shared vision for building regulatory capacity in the area of vaccines. List of available expertise and future needs to be able to sustain and develop further regulatory capacity. List of harmonization initiatives and areas of work to be enhanced through NRA IDP. List of areas where sharing of information is critical and needs to be organized and activities reflected in NRA IDP.  The Sub-committee proposes follow up action: -IVD to prepare a report on status of NRAs in the countries of SEAR -Review the EU matrix of harmonization as one possible tool to move forward 6. Establishment of National Committee for Immunization Practice (NCIP) All SEAR countries except DPRK and Timor-Leste have established NCIPs and have developed strategies to assist evidence based decision making regarding immunization practices. Maldives have limited expertise and Indonesia Nepal and Bhutan have conducted orientation programmmees on strengthening the capacities India has done some analysis of functioning of their NCIP. Countries’ engagement in the process of the establishment of NCIPs is leading to independency and the neutrality. 7. Public Private Partnerships in Drugs Prof Ganguly informed that 4-5 PPPs have been established in the region ( e.g. PPP on Leishmaniasis whereby Sri Lanka, Thailand and Bhutan would like to join), The Government of India has spent huge funding for PPP on H1 N1. A WHO document on product development partnerships has been developed by Dr Elly Ranganathan at WHO HQs. 8. Traditional Medicine (TM) Dr Khin Shein/TIP-TM was invited to join the meeting. At the same time Dr Holloway and Dr Atulla were invited to join the meeting. The recommendation pertaining to TM in the report of the 31st SEA-ACHR (July 2009) states as follows:“ Studies should be initiated for the possible development of traditional medicine for the prevention and treatment of avian influenza. Several claims for this type of activity have been made and these could be assured.” The relevant recommendation of the report of the First Meeting of Subcommittee for SEA-ACHR on Vaccines and Drug Development (May 2010) also states that; “(4) Traditional medicines should be looked at in the context of AI.” Dr Khin Shein provided briefs about the activities on research in the area of TM in the region where in 2009 the meeting on Traditional medicine put up recommendations to WHO RO and country offices. The discussion at the meeting was on 1) Digitization or development of Traditional Knowledge Digital Library, 2) Standardization, 3) Regulation and 4) Clinical trials. As requested by the Sub-committee, Dr Kin Shein has prepared a paper on Current Situation on Traditional Medicine Research in South East Asia Region (attached). 9. Promotion of rational use of drugs including clinical trials As requested by SEA-ACHR Sub-committee on drugs and vaccine development, Dr Kathleen Holloway has prepared a brief notes on: An Expertise map of countries of the Region on drug development An overview on Clinical trials in the SEA Region     5 Report on SEA-ACHR Subcommittee on Drug and Vaccine Development