Select Committee on International Development Minutes of Evidence


Memorandum submitted by the National AIDS Trust

INTRODUCTION

  NAT is the UK partner for the International AIDS Vaccine Initiative (IAVI) and NAT's Vaccines Programme has been established to advance that partnership. IAVI's goal is the development of "safe, effective, accessible preventive HIV vaccines for use throughout the world". This is increasingly seen as an integral part of the international response that is needed to the HIV/AIDS pandemic. The UK's Department for International Development has endorsed this in becoming the first governmental funder of IAVI.

  HIV vaccine development has been adopted as a national priority by a number of countries including the USA (from May 1997), Brazil and South Africa. Other countries including France, Thailand and Uganda have also committed significant resources to vaccine research. The UK Medical Research Council is currently updating its own HIV vaccine strategy, which is mentioned in the English National HIV/AIDS Strategy now being developed by the Department of Health.

  This submission relates IAVI's goal to the questions considered in the current IDC inquiry, with particular reference to:

    —  the likely prospects for and potential impact of vaccine development;

    —  the extent to which DFID and other agencies are supporting that goal;

    —  potential synergy between that goal and other needed responses to HIV; and

    —  lessons that may be learned from vaccines for other possible interventions.

IDC question 1(a) the projected impact on the workforces of developing countries, both skilled and unskilled, in terms of mortality, sickness, morale

  Although HIV was identified as the cause of AIDS in 1983-84, the first full-scale efficacy trial for a preventive vaccine did not begin until the summer of 1998. Most observers regard that vaccine (AIDSvax, produced by the Californian biotech company VaxGen) as unlikely to give much protection, if any, although the trial results will begin to emerge next year and may yet surprise us all. A second AIDSvax trial is now under way in Thailand; beyond that, there are very few vaccines close to full-scale trials that might be completed within five years and only a handful of trials likely to be completed within 10 years.

  Anita Alban, Chief Economist at UNAIDS, has argued that a vaccine would not have an immediate impact on the epidemic's costs, or would even require increased expenditure in the short term, but should have a massive positive impact in the longer term. The extent and speed of any payback would depend critically on how rapidly and effectively any vaccine was put to use.

  Maximising this positive impact would depend on preparation in advance of the vaccine becoming available, with particular attention to two issues. Who should first receive the vaccine? And how well can other prevention efforts be maintained, especially if-as seems likely-the first vaccines have only limited efficacy?

  Vaccine development research may have an important role in maintaining hope and morale in many of the countries most affected by HIV and AIDS. The impact on healthcare professionals of the helplessness that many feel when they are aware that treatments exist, but have no access to them, even as their colleagues are dying, is a serious issue. To counter this, it is important to invest some resources in looking at how to use state-of-the-art technologies, including antiviral drugs and immune-based therapies as well as preventive vaccines, in developing countries. It is essential that scientists and clinicians from developing countries are able to participate as equals in the international effort to respond to HIV and AIDS. Such professionals have an immensely important role in mobilising and sustaining political commitment in developing countries to respond to HIV and AIDS in a rational manner, and in advocating for the needs of the people worst affected by HIV and AIDS worldwide.

  Vaccine development should involve cross-sectoral partnerships between government, academic researchers, vaccine developers, clinicians and communities affected by HIV. Brazil and South Africa both afford examples of such partnerships being developed. In Brazil, community organisations responding to HIV have been instrumental in advancing preparations for vaccine trials and are well represented on the working group responsible for Brazil's national HIV vaccine development plan (of which an English translation is available). The South African AIDS Vaccine Initiative (SAAVI) is funding both academic research and community-based work on the ethics of participation in vaccine efficacy trials.

  The partnerships required for successful vaccine development and eventual deployment, which are now actively being formed, provide examples of new forms of governmental, corporate sector and community alliances and have relevance for the development of and access to other "public goods".

IDC question 2(c) on the human and legal rights of those living with HIV/AIDS in developing countries

  The development and testing of preventive vaccines in developing countries has been seen to raise a range of human rights issues and legal issues that need to be addressed. UNAIDS has undertaken a lengthy series of consultations leading to the publication of Ethical Guidelines on the conduct of HIV vaccine research.[1]

  One of the most contentious issues has been the standard of care owed by research sponsors to people who become HIV-positive in the course of vaccine trials. Should they have access to the same treatment and care that their counterparts in Europe, North America or Australia would have, or to the best available standard of treatment and care currently available in the country where the trial is taking place? UNAIDS concludes that this is a matter for local negotiation, and that the outcome should lie somewhere between those two options.

  This issue demonstrates that vaccine research is not an excuse to avoid developing a range of other interventions to improve HIV prevention, to minimise the harmful social and economic impact of the epidemic, and to extend access to treatment and care on a global basis. These different responses to the global challenges of HIV and AIDS need to proceed together and in a co-ordinated way that builds productive partnerships among all those involved. Indeed, vaccine research can contribute directly to existing or planned health promotion and care programmes for people living with or vulnerable to HIV.

  Researchers or a company dedicated to preventive vaccines may not necessarily have the expertise to deliver long-term treatment themselves, but they may usefully work in partnership with other health professionals in improving the technical capacity of health systems to deliver such care.

  It is essential that adult participants in vaccine efficacy trials also have access to the best available means of protecting themselves from HIV transmission, including access to condoms and counselling. Again, vaccine researchers may not be best placed to provide such support but could work effectively with other organisations to provide effective health promotion to participants with potential benefits for the wider community.

  At a fundamental level, there is no conflict between promoting the human rights of people living with HIV and AIDS and developing preventive HIV vaccines. Indeed, there is increasing recognition that respect for human rights is an essential underpinning for successful HIV vaccine development. It is vital that people volunteering for preventive vaccine trials should know their own HIV status before, during and after trials, in order to participate on the basis of informed consent. This means that there must be no avoidable disincentives for people finding out their status, eg discrimination against HIV-positive people in access to treatment and care.

  Thus, vaccine research requires the implementation of voluntary counselling and testing programmes in the countries in which trials are to take place. Resourcing such facilities has a direct benefit for other initiatives that seek to deliver health promotion programmes or clinical care.

  If or when effective preventive vaccines against HIV become available, they should help to reduce the stigma associated with the disease by lessening people's personal fear of contracting it. For example, healthcare workers in developing countries would be less at risk of becoming HIV-positive through occupational injuries.

IDC question 2(b) on responsibilities and opportunities for private sector involvement in HIV prevention

  There is a definite problem in mobilising private sector resources to research and develop preventive vaccines against HIV, as distinct from treatments. Reasons include scientific uncertainty, the long timescale, and perceived lack of a market.

  This "market failure" can be addressed in two distinct ways. Firstly, through "push" mechanisms, involving international investment towards developing what will become international public goods. Secondly, through "pull" mechanisms, strengthening reassurances that a market will ultimately be available. In practice, vaccines would be bought on behalf of the poorest populations by international agencies such as the World Bank. This in turn can be financed out of loans repaid from future savings on international aid, which therefore need not add to the indebtedness of the countries concerned. The World Bank AIDS Vaccines Taskforce has recently produced a strategy document that builds strongly on the "push/pull" approaches advocated by IAVI and NAT[2]

  IAVI believes that private sector involvement in vaccine research and development is essential. In the early states, this centres largely on small biotech companies, in some of which IAVI is investing as a "social venture capitalist", seeking not to maximise financial returns but to maximise future access to vaccines designed for use in developing countries. However, in the later stages of bringing a product to market, larger pharmaceutical companies have unique expertise. There are special technical challenges to be faced when scaling up the production of complex products to produce the thousands of millions of doses that would ultimately be needed, requiring massive investment. The area is also beset by complex regulations designed, for very good reason, to protect consumers.

  There will be scope for technology transfer to developing countries such as Brazil, China, India and perhaps South Africa, but IAVI would expect the first successful vaccines to be developed by one of the half-dozen companies—such as Aventis Pasteur and Glaxo SmithKline—which currently make and sell most of the vaccines sold commercially.

  Intellectual property (IP) law is both a vital underpinning for private sector investment in research and development and a potential barrier for access to new drugs and vaccines by the poorest sections of the world's population, who have most need of them. IAVI believes the answer is not to abandon IP protection, but to make a radical distinction from the outset between the prices charged in different markets. This should be centred on tiered pricing, where the poorest countries pay only marginal costs of producing vaccines while richer countries and populations bear the full costs of research and development. Traditionally, such price differentiation has been achieved by making developing countries wait years or decades until new drugs or vaccines were out of patent protection, but IAVI argues that this traditional approach is morally unacceptable in the case of a development emergency such as HIV.

  UNAIDS recently announced (11 May 2000) that it had brokered a new agreement with five major pharmaceutical companies to provide anti-HIV pharmaceuticals at dramatically lower prices than were previously available. While this move is welcome there are still many obstacles to making these drugs practically available to people in the poorest countries who need them. These include supporting the development of health delivery structures and expertise. The IDC might ask how such support can best be developed and sustained.

IDC question 2(d) on the response of DFID and the UN, EU, World Bank and IMF to the above issues

  DFID led the UK to become the first government to make a substantial investment in IAVI, through a grant first announced in 1998. This reinforces investments via the Medical Research Council in vaccine research carried out in a partnership between the universities of Oxford and Nairobi, aimed at developing and testing a preventive HIV vaccine in Kenya. The first human trials of this vaccine are due to start later this year, with IAVI funding and endorsement as its leading vaccine development partnership. There is no guarantee that this vaccine will succeed, and it will take several more years to find out whether it is able to protect against infection, to reduce the severity of disease or decrease the likelihood of onward transmission. Nonetheless, whether it succeeds or not, this work should greatly advance our understanding of immunity against HIV.

  NAT strongly supports this investment by DFID and hopes that the IDC will call for it to be maintained and extended both by further investment in preventive vaccines and in the development of other accessible technologies such as microbicides.

  NAT and IAVI work with a number of UN agencies, especially UNAIDS (the joint UN programme on HIV/AIDS) and WHO which has now assumed responsibility for HIV preventive vaccine development within the UN system.

  The European Commission is actively involved through a number of its directorates in responding to HIV/AIDS at a global level. There are structural problems of co-ordinating these responses across directorates, nonetheless, the strategy now being promoted by Dr Lieve Fransen including research funded directly under the Fifth Framework Programme for science does take serious account of global needs. There are interesting and useful developments under way to create and use "orphan drug" legislation at a European level to support products such as HIV vaccines which are seen as having a limited market in Europe.

  The EC is funding a major collaborative research programme called EUROVAC in which a number of UK centres are partners. We do have some concern over public support to private industry (in this case Aventis Pasteur). On the one hand private industry must be engaged in the effort to develop vaccines and it is appropriate for public money to be invested in this effort. On the other hand, this should carry an obligation to make the results of such research available rapidly to less developed countries at lower prices than in wealthier countries, and it is not yet clear to us that such conditions have been incorporated in the EUROVAC agreements.

  The World Bank recently established a bank-wide task force to explore how best to support preventive HIV vaccine development. The recommendations of this task force should be studied. It has also been an active partner in the Global Alliance on Vaccines and Immunisation, which has sought to ensure availability of a range of vaccines to people in developing countries. This is a valuable reinforcement for the message that if or when an effective preventive HIV vaccine is developed, there will be an international commitment to pay for it to be made available to those who most need it.[3]

Julian Meldrum and Saul Walker
National AIDS Trust
May 2000


1   Available at: http://www.unaids.org/publications/documents/vaccines/index.html. Back

2   Available at: http://www.worldbank.org/aids-econ/vacc/index.htm. We have also attached a summary of this document for your convenience (Attachment 2) Back

3   See http://www.vaccinealliance.org/. Back


 
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