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Info Service on Health Issues (May15/08) WHO: Health Assembly steps up Global Vaccine Action Plan implementation Geneva, 26 May (Mirza Alas and K.M. Gopakumar) – The World Health Assembly (WHA) adopted a resolution for the effective implementaion of the Global Vaccine Action Plan on 25 May 2015. The resolution was originaly proposed by Libya on 19 May during the discussion on the Plan. The draft resolution attracted the support of a very large number of WHO Member States. It was proposed while the WHA was considering the 2014 Assessment Report of the Global Vaccine Action Plan. The WHA is meeting in Geneva from 18 to 26 May. [The
65th WHA endorsed the Global Vaccine Action Plan in May
2012 (http://www.who.int/immunization/global_vaccine_action_plan/ The original resolution proposed by Libya underwent some changes due to the opposition from developed countries such as Japan, the United States of America and Canada. Procedural issues, transparency of vaccine pricing by manufacturers, and a reference to intellectual property barriers were the key contentious issues. However, the original draft resolution obtained widespread support from developing country regional groups from Africa and the Eastern Mediterranean as well as individual countries. (For
the Libyan draft see: http://apps.who.int/gb/ebwha/pdf_files/WHA68/ While introducing the resolution Libya stressed the importance of continued immunization services during crisis and epidemics. It reminded countries that the region is facing particular challenges due to conflict and this has had an important effect on immunization coverage. Further, Libya reiterated that vaccine affordability is a challenge to introducing and sustaining vaccines, in particular the newest vaccines. It commended the effort by donors like GAVI and the Vaccine Alliance to provide subsidies for initial introduction of new vaccines in low income countries, but governments which do not benefit from donor support, nor lower negotiated prices, need solutions as well. Countries that receive donor support today will face similar challenges (as Libya has now) in the future as they will inherit the full cost of vaccines and immunization programs, Libya stressed. Therefore, the draft resolution invited WHO Member States and the Director-General to take forward actions that have been proven to increase affordability. Further, the draft resolution called for the urgent need for transparent pricing of vaccines and clearer documentation of price barriers, including regulatory and intellectual property barriers that undermine the introduction of priority vaccines; the importance of competition to reduce prices and the need to support local manufacturing capacity in developing countries so that they can produce WHO-prequalified vaccines and make vaccines more affordable through generic medicines coming onto the market; and the role of pooled regional procurement as a key strategy - especially for the 24 middle-income countries that have graduated from GAVI support this year. Due to the disagreement from developed countries, the discussion and the decision of adoption was suspended. Even though a number of bilateral meetings between Libya and some developed countries, including the European Union, took place between 19 and 22 May these meetings did not yield any result. Finally on 22 May Libya raised the issue to the Chair of the WHA Committee A and paved the way for informal consultations due on 23 May and this led to a consensus. On 23 May itself Libya presented the first revised version of the draft resolution with the support of Algeria, Egypt, Morocco, Nigeria, Pakistan, Qatar, Saudi Arabia, Thailand and Tunisia. In response to the new version of the resolution, the United States and Canada proposed the postponement of the resolution to the 138th Session of the Executive Board in January 2016 citing the normal practice of discussing resolutions at the Executive Board prior to their consideration at WHA. [There is no legal barrier to the introduction of resolutions at the WHA without first introducing them at Executive Board]. Canada requested that the decision be postponed and discussion referred to Executive Board 138. While the representative from the USA recognized that no rules have been violated in relation to the necessary procedure for tabling a resolution, he stressed that Member States should follow ‘best practices’ and considered that Libya had not done so. Latvia took the floor to request further amendments, especially the dilution of Operational Paragraph 1(3). The revised resolution read “to provide, where available, timely vaccine price data to WHO for publication, with the goal of increasing affordability through improved price transparency, particularly for the new vaccines; …” Latvia proposed to replace “available” with “possible” to allow government to respect commercial secrecy agreements signed with manufacturers. During the discussion Thailand opposed the amendment proposed by Latvia and requested the inclusion of the original language regarding intellectual property barriers, and several developing countries also reiterated their support for this language to be brought back into the resolution. Japan opposed the language proposed by Thailand but supported the revised resolution. In the face of such strong support for the resolution, Australia proposed that an informal drafting group be formed to find acceptable language for all. Switzerland aligned itself with the USA regarding the procedural issue of introducing the resolution directly at the WHA without first introducing it at the EB. However, Switzerland agreed to an informal consultation. A large majority of developing countries stressed on the need to ensure affordability and accessibility of vaccines. They also emphasized the importance of price transparency. Ethiopia made a statement on behalf of the African Region (AFRO) strongly supporting the resolution as revised and many other Member States from the AFRO region echoed the same sentiment. Strong support for the resolution to be adopted at the assembly was heard in many of the country statements, including from Tunisia, Pakistan, Indonesia, India, Iran, Sudan, Brazil, Jordan, Democratic Republic of Congo, Lebanon, Bolivia, China, Timor Leste, Zimbabwe, Maldives, Ecuador, Myanmar, Niger, Botswana, Eritrea, Oman, Papua New Guinea, Mali, Gabon, Afghanistan, Benin, Venezuela, Azerbaijan, Argentina, Morocco, Chile, South Africa, Bangladesh, Cameron, Ghana, Congo and Togo. Argentina stressed that the resolution is a tool against unacceptable practices by large manufacturers that use their monopoly situation to put pressure on countries, even to the extent of interrupting immunization programs. WHO Director-General Dr. Margaret Chan emphasized the importance of the subject given the range of interventions. She noted that many delegations supported the draft resolution and urged for its adoption, and proposed to follow the suggestion of Australia and Switzerland to convene informal consultations. The operational paragraphs (OP) that underwent important changes are OP1(3), OP1(5) OP2(1) and OP2(6). OP1(3) urges Member States: “ To provide, where possible and available, timely vaccine price data to WHO for publication, with the goal of increasing affordability through improve price transparency, particularly for the new vaccines”. The original version stated: “to consider providing timely vaccine price data to WHO for publication, with the goal of increasing affordability through improved price transparency, particularly for the new vaccines”. OP1(3) as it stands now dilutes the responsibility on the part of Member States to provide price data by qualifying with the words “where possible and available”. This gives a good excuse not to share price data. The lack of price data often limits the ability to negotiate prices effectively with vaccine manufacturers. Another noteworthy change related to the role of public investment in vaccine development. OP1(5) reads: “to create mechanisms to increase the availability of comparable information on government funding to vaccine development and work towards strategies that enhance public health benefit from government investments in vaccine development”. (Emphasis added.) The original OP1(5) read: “to create norms and mechanisms to increase the available information on government funding to vaccine development and ensure government investments in vaccine development be put towards improving the public’s health through affordable vaccine prices ”. Thus OP1(5) has turned into an exploratory provision instead of putting a concrete obligation on Member States to ensure public investment in vaccine development. OP2 aims to strengthen efforts for pooling vaccine volumes in regional and interregional or other groupings, as appropriate, that will increase affordability by leveraging economies of scale. OP2(1) requests the Director-General: “to explore ways to mobilize funding to fully support collaborative efforts with international partners, donors, and vaccine manufactures to support low-middle-income countries in accessing affordable vaccines of assured quality in adequate supply”. The original OP2(1) requests the Director-General: “to secure funding to fully implement collaborative efforts with international partners, donors, and vaccine manufacturers to support low- and middle-income countries in accessing affordable vaccines of assured-quality in adequate supply”. According to observers this paragraph merely obligates the Director-General “to explore ways to mobilize funding” and not even to explore funds mobilization. The most important change took place in OP2(6) requests the Director-General “to report upon technical, procedural and legal barriers, that may undermine robust competition that can enable price reductions for new vaccines and address other factors that can adversely affect the availability of vaccines”. The original OP2(6) requested the Director-General: “to report upon technical and legal barriers, including regulatory and intellectual property barriers, that may undermine robust competition that can enable price reductions for new vaccines”. The reference to intellectual property barriers was removed from the text due to the opposition from developed countries. For instance, Japan stated that intellectual property is an essential tool to promote research and development for new vaccines although it might cause the cost to increase. Japan expressed its doubt regarding intellectual property as a real barrier for putting forward the national immunization programs and wanted to reiterate the need for further analysis for this. With regard to the resolution, Japan proposed to delete the phrase “and intellectual property barriers”. The amended draft resolution tabled on 23 May already removed the words. It read: “to report upon technical and legal barriers that may undermine robust competition that can enable price reductions for new vaccine”. However, when seeing the change in the language Thailand, the co-sponsor of the resolution, asked for the reinsertion of the language in the original version of the draft resolution. Even though Thailand’s proposal obtained support from many Member States like Argentina, Brazil, Bangladesh, Ecuador and Chile the reference to intellectual property was ultimately dropped. However, many observers and delegates told Third World Network that the term “technical legal and procedural barriers” includes barriers posed by intellectual property rights and therefore the removal of words “intellectual property “does not make any difference in the nature of obligation on the part of the Director-General. Accordingly the Director-General has to include intellectual property in the report outlining technical, legal and procedural barriers that may undermine robust competition in vaccines supply. The opposition of certain developed countries to explicitly recognize intellectual property as a barrier to robust competition in the vaccine market goes against the principle of the Global Strategy and Plan of Action on (GSPOA) on Public Health, Innovation and Intellectual Property (http://www.who.int/phi/publications/Global_Strategy_Plan_Action.pdf?ua=1). One of the principles of the GSPOA states: “Intellectual property rights do not and should not prevent Member States from taking measures to protect public health”. A January
2015 report of Medecins Sans Frontiers (MSF) identified many problems
affecting access to affordable vaccines, which includes the opacity
in vaccine price data, the problematic financing model of GAVI, challenges
in middle income countries and barriers posed by legal and procedural
requirements. (http://www.msfaccess.org/sites/default/files/MSF_assets/Vaccines/Docs The report found that “even at the lowest global prices, the three newest vaccines – against pneumonia, diarrhoea and human papillomavirus – account for 86% of the price of the full WHO-recommended vaccines package”. On legal and regulatory barriers the MSF report stated: “Barriers to entry are high, because of capital-intensive and time-consuming research and development (R&D) and intellectual property (IP) restrictions, high sunk and fixed costs (sunk costs are those that, once committed, cannot be recovered – e.g. the cost of equipment that is designed o produce a specific product and cannot readily be diverted to other uses) and the regulatory processes required to obtain and maintain plant and product prequalification.” The WHA resolution further urged Member States on the following: “to allocate adequate financial and human resources for introduction of vaccines into national immunization schedules and sustaining strong immunization programmes in accordance with national priorities; to strengthen efforts, as and where appropriate, for pooling vaccine procurement volumes in regional and interregional or other groupings as appropriate that will increase affordability by leveraging economies of scale ; to seek opportunities for establishing national and regional vaccine manufacturing capacity, in accordance with national priorities, that can produce to national regulatory standards, including WHO-prequalification; to support the ongoing efforts of various partners coordinated by WHO to design and implement the strategies to address the vaccines and immunization gaps faced by the low -and middle-income countries that request assistance; to improve and sustain vaccine purchasing and delivery systems in order to promote the uninterrupted and affordable safe supply of all the necessary vaccines and their availability to all immunization service providers; to strengthen immunization advocacy and provide training to health professionals and information to the public regarding immunization issues to achieve a clear understanding of the benefits and risks of immunization”. Further, the resolution request the Director-General: to continue developing and adequately managing publicly available vaccine price databases, like the WHO Vaccine Product, Price and Procurement project, working with Member States to increase availability of price information; to monitor vaccine prices through annual reporting of the Global Vaccine Action Plan to provide technical support and facilitate financial resources for establishing pooled procurement mechanisms where appropriate for use by Member States; to strengthen the WHO prequalification programme and provide technical assistance to support developing countries in capacity building for research and development, technology transfer, and other upstream to downstream vaccine development and manufacturing strategies that foster proper competition for a healthy vaccine market; to assist in mobilizing resources for countries that request assistance in the introduction of new vaccines in line with the Global Vaccine Action Plan and in accordance with national priorities; to continue to assist Member States to improve and sustain their vaccine delivery systems and to continue to provide technical support to Member States to strengthen the knowledge and skills of their health care professionals in vaccination programmes; to report back on progress in implementing this resolution to the World Health Assembly through the Executive Board in the annual report on the basic document.” MSF in its statement during discussion on the Global Vaccine Plan of Action on 19 May stated: “Last year, approximately 20 Member States expressed concern over high prices of new vaccines, calling for WHO to help increase affordability. As an organization struggling to afford new vaccines for our patients, MSF sympathizes with these concerns. Many Member States, especially those excluded from donor support and price negotiation mechanisms, cannot afford the newest vaccines. These so-called middle-income countries (MICs), which are not Gavi-eligible, represent 30% of the global birth cohort. This will increase as more countries lose Gavi support. WHO estimates that 82% of vaccine-preventable deaths will occur in MICs in 2025.” Medicus mundi International (MMI) and the Peoples’ Health Movement (PHM) stated: “We are concerned about the pressure on countries to introduce new vaccines in the absence of surveillance and information systems covering epidemiology, delivery, and evidence of safety and efficacy. The opportunity costs of introducing new vaccines need to be measured in terms of cost and health outcomes forgone. “We call upon WHO regional offices and country offices to provide the necessary support for fully informed decisions by countries on this issue, including guidance on the opportunity costs of expensive vaccines for low incidence conditions. This also requires that countries, which have not done so, proceed to establish and strengthen their National Immunisation Technical Advisory Groups as reflected in the Global Vaccination Action Plan.” Below are highlights of selected country interventions during the discussions on the draft resolution on 23 May: Tunisia noted that immunization is one of the most effective public health interventions, and is absolutely vital. Tunisia ensures 95% of coverage but this is difficult to maintain because of prices. It said that we are a middle-income country so we do not get full benefit; we have contributed to efforts composing this paper (the resolution), price transparency and access to middle income countries for adequate supplies of vaccinations. Indonesia confirmed that immunization is one of the most effective tools in public health, and in order to make sure that the resolution will be fully implemented we need to consider follow up steps to ensure full implementation, including a proper mechanism of pooling vaccine procurement. Ethiopia said that AFRO discussed and agreed to support the draft resolution in accordance with the Global Action Plan. Thailand thanked Libya for its leadership and coordination, co-sponsorship and support for the resolution and amendments. It requested that OP2.6 bring back after the word barriers, “including regulation and intellectual property”. India expressed strong support for the draft resolution. Congo noted that some African states, because of the difficult situation of our economic indicators, had benefited from GAVI but not anymore, and that some vaccines are expensive and depends on changing oil prices. Congo supported the resolution especially on the transparency and affordability of the vaccines. It stressed the importance to ensure that Member States are aware of the importance of affordable vaccines as it is very important to a country like us. Brazil observed how immunizations are a key priority for Brazil. It supported the resolution especially for developing countries, adding that it brings to the table guaranteed access to vaccines so it must be approved at this Assembly. Supported Thailand’s amendment on IP language Jordan said it realized the importance of providing affordable quality vaccines for low and middle-income countries, and that the EMRO region (Eastern Mediterranean) is going through crisis and lack of vaccines would cause added problems to the crisis. Lebanon reiterated that in line with the recommendation of the Strategic Advisory Group of Experts emphasizing that transparency of vaccine pricing is required to improve affordability, Lebanon would like to support and co‐sponsor the draft resolution proposed by Libya. China thanked Libya for the resolution since it had comprehensively introduced the main issues from the Global Vaccine Action Plan; has proposed feasible action plan. Supported and hoped the Assembly can adopt this resolution Zimbabwe aligned with the statement of Ethiopia, and noted with concern the number of many African countries getting out of GAVI support so we support the resolution. It stressed the concern of affordability of new vaccines, further noting the need to address the gap between accessibility of the vaccines between high and low-income countries. Ecuador strongly supported the report and thanked Libya for the effort. It accepted the most recent version but after hearing Thailand this morning we would like to adopt the resolution including Thailand’s amendments and adding “possible” instead of “available” and inclusion of intellectual property. Venezuela supported draft as amended by Libya and stressed price reviews so that vaccination can be affordable. Argentina reiterated the social and health value and importance of immunization, stressing that it is unacceptable to interrupt immunization plans underway in our region because of inadequate supply and unaffordable. It also emphasized the importance of negotiating with suppliers and urged other delegations to support the amendment proposed by Thailand regarding intellectual property. Chile supported the resolution and the amendment from Thailand and urged adoption at this Assembly. South Africa joined the AFRO group in supporting the resolution, and said there may be some amendments which can be considered as suggested by Australia but that the resolution does not need to go to the Executive Board. It stressed that prevention is the cornerstone of public health and we want to see this adopted in this Assembly. Bangladesh emphasized high immunization coverage and the need for this resolution; it strongly urged for its adoption in this Assembly and noted the Thai amendment, suggesting that Member States look at OP2(6) “to report on legal and IP barriers” adding that this is an issue of monitoring. Cameroon stressed its position with African states concerning this draft resolution, thanked Libya, and adding we will not be in the GAVI list in 2 years and that is why we support the draft resolution in its current form and we would be really sorry if the draft was not adopted. Developed countries while recognizing the vital importance of immunization for public health expressed concerns regarding the timing of the presentation of the resolution and over bringing language on intellectual property back into the resolution despite the overwhelming support that the resolution had among countries. Australia supported the adoption of the resolution in its current form. Canada expressed appreciation for the efforts of Libya and expressed its wish to see better progress made. It supports immunization but conveyed concerns about the way the resolution was presented to the Assembly. It said that full discussion in January 2016 would have been appropriate to discuss the draft resolution; instead it appeared on the first day of this Assembly. It supported transfer of the discussion to a future Executive Board session (seeking Secretariat advice) and also asked about the budgetary implications for 2016-2017. The United States stressed its role as a major supporter of global vaccine programs. It remarked on the importance of vaccines and noted valuable elements in the resolution including the reporting of publicly available prices. The US circulated some amendments and noted that it was not in a place to support this. It also mentioned that despite the legality of presenting the resolution at the Assembly it was not the best practice and it would have been appropriate at the Executive Board as Canada suggested. Latvia thanked Libya for taking into account the comments made by Member States regarding OP1(3): there is ‘where possible’ but Libya changed it to ‘where available’ but we want to change it back because in some cases prices are available to governments but because of legal reasons it is not possible to publish them. Japan said it can support the draft resolution as proposed and revised; however it cannot agree on the proposal from Thailand on the words “including regulations and intellectual property barriers”. Australia said implementation of the action plan is vital for global health, and that this resolution will help access to developing countries. It said that despite the concern raised by the USA and Canada, because of the amount of effort and goodwill made through the creating of this resolution it would like to see the resolution adopted at this meeting. Australia asked Libya to engage with those who have outstanding comments with a view to adopting the resolution. Switzerland emphasized the implementation of the Global Vaccine Action Plan on immunization and its extreme relevance. Switzerland would like to see greater coverage of immunization in its country and have conducted a new campaign. It aligned with the USA, saying that the resolution was developed outside the formal structures; it would have been better to be developed inside this house. It was also concerned about the proposal by Thailand (on intellectual property) and supported Japan. On the other hand Switzerland aligned with Australia in terms of the need to work in parallel and reach a consensus on this resolution. (With inputs from Susana Barria and the civil society WHO Watch team: Claire Ellise Burdet, Ornella Punzo, Daniel Amoun and Mohamed Gad.)
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