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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