Access to Medicines
66. Access to medicines is influenced by a range
of factors, including the price of medicines, the existence of
sufficient and sustainable financing arrangements, the condition
of local health services and supply systems, the proper selection
and use of medicines and the level of research and development
undertaken for new drugs. During our inquiry we attempted to establish
what impact one of these factorsIntellectual Property Rights
(IPR) or Patentshad on access to medicines by those who
need them.
67. In recent years there have been breakthroughs
in the development of drugs to treat many of the world's most
serious infectious diseases or to deal with resistant strains
which have emerged. Developing new drugs, however, is one thing:
ensuring that they can be readily accessed by the sick people
who need them is another. Drug development is an expensive and
risky enterprise: firms who undertake it employ highly qualified
staff, sometimes for many years, and with no guarantee that the
investment will be recovered. A number of witnesses emphasised
the role that IPR played in providing the incentives necessary
to encourage companies to make major investments in the development
of new drugs.
68. There are, however, some real problems with
the patent system as applied to global health. There is the obvious
difficulty that, by conferring temporary exclusivity on a pharmaceutical
product, patents can result in the price of new medicines being
beyond the reach of people in the world's poorer countries. There
is also the reciprocal problem that the unaffordability of many
new drugs in developing countries, which is often where the greatest
need for them lies, means that there is less incentive for pharmaceutical
firms to invest in the research and development needed to bring
about necessary innovation.
69. A key issue here is what is known as TRIPSthe
World Trade Organisation (WTO) Agreement on Trade Related Aspects
of Intellectual Property Rights. TRIPS, which came into force
in 1995, requires WTO Member States to adopt minimum standards
of intellectual property protection that are often greater than
the protection previously granted. The patent system has been
criticised by global health campaigners and some independent experts
for a number of reasons. It has been argued that, by conferring
temporary exclusivity on new medical products, patents shield
these products from the effects of competition, thereby putting
the price of new medicines and vaccines beyond the reach of poorer
people, many of whom may need them most. Thus, the International
HIV/AIDS Alliance wrote that "new and future ART [anti-retroviral
treatment] will not be so cheap. New intellectual property legislation
in countries like India is pricing treatment beyond the reach
of poor countries and poor people" (p 181).
70. Others argue that the TRIPS Agreement contains
exceptions, exclusions and qualifications designed to mitigate
the potentially adverse effects of patents on access to medicines
in poor countries. WTO noted that "the TRIPS Agreement contains
considerable flexibility in regard to patent rights, for example
transition periods, compulsory licensing, government use, other
limited exceptions and parallel imports" (p 572) and
drew our attention to a Ministerial Declaration (the Doha Declaration)
on the TRIPS Agreement and Public Health which was adopted in
2001.
71. The Doha Declaration, the Government told
us, states that "the TRIPS Agreement 'does not and should
not prevent Members from taking measures to protect public health
and, in particular, to promote access to medicines for
all'. The Declaration highlighted the flexibilities that exist
in TRIPS to facilitate access to medicines" (p 13).
The Government added that "many pharmaceutical companies
have instituted differential pricing policies for selected products
and countries, under which they charge lower prices in least developed
and low-income countries, in particular for drugs targeted at
HIV/AIDS, TB and malaria".
72. A number of those who gave evidence to us
were inclined to be sceptical as to the effectiveness of the TRIPS
flexibilities. UNITAID stated in written evidence:
"Despite the Doha Declaration in 2001 and
the possibility for developing countries to make use of the TRIPS
Agreement flexibilities and especially to be able to issue compulsory
licences, its use has been very limited so far. Bilateral or regional
free trade agreements are superseding global agreements in many
countries" (p 266).
Dr Bermejo, of the International HIV/AIDS Alliance,
told us:
"The flexibilities introduced to the TRIPS
Agreement on paper have been very good, they are the type of thing
we need; but it has been the implementation of them that has been
difficult
A number of countries, when signing up to a Free
Trade Agreement, either have been asked to introduce into their
domestic legislation some legislation that would prevent the exercising
of those flexibilities or that has been written into the Agreement
itself" (Q 425).
UNAIDS argued that,
"based on an analysis conducted on some
recently concluded bilateral trading agreements, countries appear
to be committing themselves to obligations that extend significantly
beyond those contained in the TRIPS Agreement and which may prove
contrary to the objectives contained in the Doha Declaration"
(p 153).
And Mr Philippe Petit, from the World Intellectual
Property Organisation (WIPO), gave it as his view that
"there is little doubt that bilateral or
regional trade agreements may be dangerous for the flexibilities
and exceptions in the TRIPS Agreement, since the strongest partner
may impose its conditions more easily than would be the case in
a multilateral framework and in the framework of the WTO"
(Q 873).
73. Dr Elhadj Amadou Sy, Director of Partnerships
and External Relations at UNAIDS, saw a need to balance incentives
to developers against affordable prices for consumers. In his
view the solution was "to support countries in negotiating
differential pricing, because we have seen that in some countries
some pharmaceutical companies are able to reduce the price of
the drugs by 80%".
74. How can this conflict between providing financial
incentives to pharmaceutical companies to develop new medicines
and ensuring that they are affordable by sick people in some of
the world's poorest counties be resolved? Dr Silberschmidt,
from the Swiss Federal Office of Public Health, suggested to us
that one of the problems in ensuring exploitation of trade agreements
relating to the supply of pharmaceuticals was that there are too
few officials in developing countries who have the necessary expertise
to negotiate and make use of the required flexibilities. In his
view there was a need to train 'health diplomats'. He told us:
"There are very, very few good negotiators
both in the bilateral and multilateral fields on the recipient's
side
If there is a free trade agreement negotiation and
Nigeria, Kenya or whoever has a competent health diplomat from
the Ministry of Health involved in the negotiation, the outcome
will be significantly better"(QQ 614,615).
Dr Sy, from UNAIDS, echoed this view, referring
to the need to "build up capacity and support developing
countries in their negotiations with partners" (Q 384).
75. We therefore recommend that the Government
should support, within WHO and other relevant IGOs, the development
of health diplomacy training to enable developing countries to
make the fullest use of the flexibilities in the WTO's Doha Declaration
on TRIPS.
76. We recommend also that the Government
should consider whether the UK might provide a lead either by
establishing relevant training courses in this country, perhaps
under the auspices of DFID, for suitable officials from developing
countries or by sponsoring officials from developing countries
to attend existing courses, such as the Summer Programme on Global
Health Diplomacy at the Graduate Institute of International Studies
in Geneva or by seconding suitably-trained UK officials to support
selected developing countries in their negotiation of individual
agreements.
77. We further recommend that the Government
should throw its weight against the inclusion, in bilateral or
regional trading agreements, of proposals inhibiting the use by
developing countries of the Doha flexibilities.
78. It is clear to us that getting medicines
to those who need them at affordable prices cannot be left to
the operation of the TRIPS Agreement, even with the flexibilities
provided by the Doha Declaration, and that other, complementary
mechanisms are needed. Our attention was drawn to a number of
such mechanisms which are being pioneered in order to improve
access to medicines. 'Push' mechanisms provide additional resources
to reduce the risks and costs of pharmaceutical research and development:
they include basic research funding and product development public-private
partnerships (PDPs). 'Pull' mechanisms are designed to create
a more visible market for the downstream fruits of research and
development and thereby to stimulate investment by pharmaceutical
firms. They include the International Finance Facility for Immunisation
(IFFIm) and Advance Market Commitments (AMCs).
BOX 1
The GAVI Alliance
The GAVI Alliance (formerly the Global Alliance for Vaccines and Immunisation) is a public-private partnership (PPP), established in January 2000. Its partners include National Governments, UNICEF, WHO, the World Bank, the Gates Foundation, the vaccine industry, research and technical health institutions, and civil society organisations
GAVI's mission is to save lives and improve health by increasing access to immunisation in poor countries through the raising and disbursement of funds for the purpose. By the end of 2007, GAVI had received funds and long-term pledges from donors exceeding $US 7.5 billion. WHO estimates that in the first seven years of its existence GAVI has averted 2.9 million future deaths.
As part of its drive to find new ways of raising and disbursing funds for immunisation, GAVI has helped to develop the International Finance Facility for Immunisation (IFFIm) and Advance Market Commitments (AMCs). With the former, donor countries make 10-20 year, legally-binding aid commitments, against which IFFIm borrows on capital markets. AMCs are mechanisms to attract private sector investment into new vaccine products for poor countries by guaranteeing purchase volumes at agreed prices over a period of time.
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79. Dr Lob-Levyt, from GAVI, told us more
about IFFIm and AMCs:
"The International Financing Facility, in
which the UK Government was a major driver, allows us to have
ten years of legally binding finances. We can go to countries
and say 'We can enter into ten-year programmes to support you,
so that you can build your budgets' and industry responds well
when they see a market where there was not a market before
So we see the competition build up as more companies come in
The next step beyond that is the Advance Market Commitment, which
is basically saying, at its simplest, 'If you produce a vaccine
in this disease area, with this effectiveness, and at a price
at the end of the day that is affordable' (and we will set the
price) 'we will buy it'" (Q 815).
80. We consider that 'pull' mechanisms, such
as IFFIm and AMCs, have much to offer. While leaving commercial
risk with the product developer, which is where it should lie,
they offer an attractive and stable market and have the potential
to stimulate competition. Organisations such as UNITAID and the
Global Fund to fight AIDS, Tuberculosis and Malaria are in a strong
position, with their long-term funding streams, to provide such
incentives. It is important, however, that there should be rigorous
analysis of options so that investments are not wasted. OECD suggested
to us in evidence that it was well-placed to provide the necessary
analytical capability (Q 1038).
81. We therefore recommend that the Government
should support, both bilaterally and multilaterally, the development
of sound long-term funding mechanisms which are able to offer
incentives to pharmaceutical companies to develop new medicines
at prices which can be afforded by poorer countries.
Natural or Intentional?The
Threat from Bioterrorism
82. While the predominant threat from infectious
diseases arises from those occurring naturally, in the world in
which we live today the possibility has to be recognised that
infections could be released deliberately for political purposes
as an instrument of international terrorism. We therefore sought
the views of many of those who gave evidence to us as to the effectiveness
of intergovernmental arrangements for dealing with this problem.
83. There was agreement that the potential for
deliberate release was there. Indeed, Professor Borriello
of the HPA suggested that successes in combating some serious
infectious diseases, such as smallpox, could actually increase
the impact of such incidents on the population at large:
"As the world eradicates certain pathogens,
the population becomes naïve; there are no vaccinations,
therefore the release of such an organism, if it is retained,
could have quite devastating effects" (Q 178)
Professor Borriello drew attention also to the
danger that an animal pathogen might be deliberately engineered
to infect humans, while Professor Ferguson felt that animal
pathogens might be used not so much to infect humans as to cause
economic dislocation.
84. On the other hand, there was general consensus
among those who gave evidence to us that the improved arrangements
which were being established for detecting and controlling the
accidental spread of infectious diseases were, to all intents
and purposes, identical with those which were needed for detection
and response to incidents involving deliberate release. Indeed,
Professor Johnson saw concerns over the latter as an important
factor in the building of improved capabilities for the former.
She told us:
"Concerns about bioterrorism probably have
strengthened our health protection function in this country
It has been one of the drivers for improving the health protection
structure. The Health Protection Agency has been significantly
strengthened over the last decade and taken on a broader range
of activities" (Q 255).
Professor Ferguson took the view that "it
is much more cost-effective to invest in dual-capability response
measures which can be used against acute natural occurrences as
well as deliberately-introduced agencies than the very specific
measures against particular pathogens, which may or may not be
used, are very expensive to develop, and you do not get very good
value for money for the size of the investment when you actually
do it" (Q 256).
85. Dr Scott Dowell, from the US Centers
for Disease Control in Atlanta, agreed on the need for dual-use
strategies. "If we focus on strengthening capacity to deal
with naturally occurring events", he told us, "then
we have got most of the way to dealing with bioterrorist events
as well" (Q 418). Dr Maureen Baker of the Royal
College of General Practitioners believed that "the work
that has gone on in the UK on pandemic planning is a very good
model for dealing with a major outbreak of communicable disease,
however it arises" (Q 361). Dr Williams, from the
Royal College of Pathologists, told us:
"The detection of any disease, whether it
is bioterrorism or a naturally occurring one, depends entirely
on having a good infrastructure, which is about having alert clinicians
when patients present, it is about having good diagnostics available,
people thinking outside of the normal things when something is
abnormal and having good surveillance systems and good communication
systems in place" (Q 361).
86. Dr Silberschmidt told us that the new
International Health Regulations implicitly covered terrorist-inspired
events as well as naturally occurring outbreaks of disease (Q 602).
Professor David Fidler, from Indiana University School of
Law, agreed that the preparations for and response to naturally
occurring and deliberately released pathogens were similar. "Anything
you do to prepare for a biological weapons attack", he told
us, "will stand you in good stead if it is an outbreak of
naturally occurring infectious diseases, and vice versa"
(Q 1016). He also concurred with Professor Borriello's
view that the eradication of certain diseases, such as smallpox,
and the subsequent cessation of vaccination could leave populations
more at risk in the event that a terrorist organisation were to
gain possession of such pathogens and succeed in disseminating
them.
87. We have concluded that, so far as controlling
the spread of infectious diseases is concerned, the deliberate
release of toxic organisms should not be considered as in a separate
category from the normal arrangements for controlling natural
outbreaks. We recommend that the Government should support, both
nationally and intergovernmentally, generic surveillance and response
systems which are capable of addressing both deliberate and naturally-occurring
outbreaks of infectious diseases.
1 United Nations Population Division, The World
at Six Billion, (New York, UN, 1999), Pages 5-6 Back
2
Directly-Observed Therapy Short-Course, a WHO-sponsored TB control
programme directed at ensuring that anti-tuberculosis drugs are
taken regularly in order to ensure that the disease does not recur
in antibiotic-resistant form. Back
3
Non-Government Organisation Back
4
The witness is referring to the date of a WHO Conference, at Alma
Ata, where it was agreed that there should be a greater focus
on the promotion of primary care. The agreement was not, however,
subsequently implemented. Back
5
See, for example, QQ 620 and 801 Back
6
World Organisation for Animal Health Back
7
"Healthy Development: The World Bank Group Strategy for Health,
Nutrition and Population Results" Back
8
Directly Observed Therapy Short Course Back
9
"Achieving Universal Access-The UK's strategy for halting
and reversing the spread of HIV in the developing world" Back