Memorandum by GlaxoSmithKline
INTRODUCTION
1. GlaxoSmithKline is committed to playing
its full part in helping to address the healthcare challenges
of the developing world by working in partnership to develop innovative,
responsible and sustainable solutions.
2. GSK is proud of its long history in working
in developing countries and our work is focused on four key areas[24]:
preferential pricing of our antiretrovirals, anti-malarials and
vaccines; investing in research and development (R&D) that
targets diseases disproportionally affecting the developing world;
community investment activities and partnerships that foster effective
healthcare; and working on innovative partnerships and solutions.
3. There are no easy solutions to the challenge
of improving healthcare in developing countries. In many countries
people do not have enough food, clean water, hospitals, clinics
or healthcare professionals to care for them. Often the Governments
of these countries simply do not have the resources needed to
address the healthcare needs of their people. Significant additional
funding from new national and international sources must be mobilised
to make a real difference.
4. However, lack of resources can be no
excuse for lack of action. HIV/AIDS, TB and Malaria are robbing
communities and nations of their greatest asset—their people.
That is why prevention and developing and distributing treatments
is so critical. While it is primarily the responsibility of Governments
and intergovernmental agencies, supplemented by the work of many
NGOs, to deliver the holistic healthcare needed in these countries,
the pharmaceutical industry can play a significant role in supporting
their work.
5. The UK is a world leader in addressing
these challenges. As a UK company GSK is always keen to explore
ways of working with the UK Government on these issues. We urge
the UK to continue to encourage the G8 and other developed nations
to follow its lead. For example, others must show a similar focus
and sense of urgency in delivering on the Gleneagles and UNGASS
commitments, to achieve the Millennium Development Goals (MDGs).
6. This Call for Evidence noted that each
organisation responding need only answer those questions in which
it had a particular interest. Accordingly, GSK offers responses
to questions 5, 6, 7, 11, 12 and 14.
7. GSK would like to thank the Committee
for the opportunity to contribute to this important inquiry and
we look forward to providing any additional information the Committee
may require.
Question 5. What do you consider to be the
principal blockages to achieving progress in the prevention or
control of the four diseases? And how might these blockages be
removed by more, or better-targeted coordinated intergovernmental
action?
8. GSK believes that significant progress
could be made in addressing these issues by:
(1) Greater sustainable and predictable provision
of financial resources
(2) Greater action by developing countries
to strengthen their own healthcare systems
(3) Ensuring that the right environment exists
to encourage and support R&D for the developing world
(4) Addressing the issue of counterfeit medicines
(5) Encouraging the removal of tariffs and
taxes on medicines
(6) Continuing to build a framework that
encourages voluntary preferential pricing
(7) Putting in place a global influenza pandemic
preparedness plan to help developing countries
In terms of how these issues could be addressed,
GSK suggests:
9. Greater sustainable and predictable provision
of financial resources: The UK Government has played a leading
role supporting multilateral funding mechanisms such as the GAVI
Alliance and the Global Fund to Fight HIV/AIDS, TB and
Malaria as well as playing a leading role in developing innovative
financing mechanisms such as the International Finance Facility
for Immunisation.
10. These mechanisms are making a significant
difference but more needs to be done and the UK should encourage
other high-income countries to play their full part in supporting
these organisations. In addition ensuring adequate funding it
is vital to look at ways of introducing greater predictably and
sustainability of funding.
11. In terms of the International Finance
Facility for Immunisation GSK remains committed to working with
the UK and the World Bank to ensure that Advance Market Commitments
(AMCs) are designed in a way that maximises their effectiveness.
AMCs offer a powerful and cost-effective market-based financing
mechanism to accelerate the development and availability of priority
new vaccines against diseases that currently kill millions of
people in developing countries. The mechanism complements existing
prevention, treatment and research efforts by providing a financial
commitment to subsidise the future purchase of vaccine. Early,
guaranteed commitments encourage potential vaccine suppliers to
invest in R&D and production capacity to serve developing
countries, secure in the knowledge that there will be a viable
market if they supply products that eligible countries want to
buy. Such mechanisms, as well as others such as Advanced Purchase
Agreements (APAs), if designed well, have huge potential in improving
healthcare in developing countries.
12. In addition to existing and innovative
funding mechanisms inevitably new resources will be required to
tackle emerging threats, such as pandemic influenza. The WHO's
Strategic Advisory Group of Experts on immunization (SAGE) recently
recommended that WHO builds a stockpile of 150 million doses of
H5N1 influenza vaccine. One third of these doses will be reserved
to help contain an initial human outbreak, should H5N1 attain
the ability to transmit from human to human, and the remainder
would be reserved to help low and middle income countries fight
a pandemic should it be caused by H5N1.
13. GSK fully supports efforts to help all
countries, particularly the most vulnerable, prepare for an influenza
pandemic. In June 2007 GSK announced that we intended to donate
50 million doses of H5N1 pre-pandemic influenza vaccine to the
WHO's stockpile. In addition GSK announced that we would provide
additional vaccine to WHO at a preferential price. The key issue
now is ensuring that the stockpile has sustainable funding. The
UK Government can play a leading role in providing new funding
for, and increased commitment to, this and other global immunisation
partnerships.
14. Greater action by developing countries
to strengthen their own healthcare systems: The UK should continue
to encourage, and financially assist, developing countries to
prioritise health in their national budgets, strengthen their
health systems and take a holistic approach to providing healthcare.
This should embrace prevention—education and immunisation
programmes—as well as the safe administration of quality
treatment and be backed up with measures to address social factors
such as stigma and discrimination and the migration of health
workers. In supporting national health systems, the UK must seek
a balance between the need for accountability and the desire for
simplicity that comes from direct budgetary support. It is vital
to monitor and evaluate and where appropriate take action.
15. Ensuring that the right environment
exists to encourage and support R&D for the developing world:
To help address diseases of the developing world, GSK is committed
to investing in R&D and working in Public-Private Partnerships
(PPPs) to help develop new medicines and vaccines for diseases
of the developing world.
16. The PPPs that GSK is working with include
Medicines for Malaria Venture (MMV), The Global Alliance for TB
Drug Development (GATB), the Malaria Vaccine Initiaive (MVI) and
the International AIDS Vaccine Initiative (IAVI).
17. PPPs such as these are transforming
the landscape of R&D into diseases of the developing world.
Many of these PPPs are now showing real promise and there is a
growing need for additional sustainable funding if we are to ensure
that they deliver on their true potential ie that people in the
developing world receive the new vaccines and medicines they produce.
To ensure that promising vaccines and medicines make it through
late stage development there is a need to strengthen the capacity
of developing countries to carry out clinical trial activity.
Developing this capacity will require all stakeholders to work
together.
18. Addressing counterfeit medicines: The
international community, and the G8 in particular, recognise that
counterfeit medicines are a serious threat to public health in
many developing countries. Sustained action is required to ensure
that the threat from counterfeiting of medicines, in Africa, China
and elsewhere continue to be recognised and that appropriate early
warning alert mechanisms and regulatory procedures are in place
and enforced. Not only do counterfeit medicines waste scarce resources,
at their worse they kill.
19. Encouraging the removal of tariffs and
taxes on medicines: In many developing countries affordability
is significantly affected by high taxes and tariffs. GSK urges
the UK Government to ensure that the EU supports proposals in
international fora to eliminate tariffs imposed on medicines and
medical devices. This will have a significant impact on reducing
prices and hence affordability.
20. Continue to build a framework that encourages
voluntary preferential pricing for therapies needed in developing
countries: To enable companies to offer preferential prices to
the poorest and most vulnerable countries, it is important that
medicines reach the patients they are intended for and are not
diverted by middlemen back into rich countries. Such illegal diversion
of preferentially priced medicines must be condemned and appropriate
measures put in place to prevent diversion along with penalties
for those that carry out this illegal trade. Other developed world
Governments should be encouraged to follow the EU's lead in introducing
anti-diversion measures specifically aimed at ensuring preferentially
priced products reach the people who so desperately need them
and are not diverted to richer markets.
21. Additionally, Middle Income Countries
must accept their responsibilities and not seek the lowest prices
offered to the world's poorest countries and developed countries
should not use the preferential prices offered to the developing
world as benchmarks for their domestic drug prices.
22. Putting in place a global pandemic preparedness
plan to help developing: Recognising that many developing countries
may not have the necessary resources to protect themselves, a
global pandemic preparedness plan is urgently needed. GSK is fully
committed to working with WHO and others to address this issue.
23. Importantly, advances in technology
and science have given us an unprecedented opportunity to prepare.
Until recently one of the biggest challenges in confronting a
pandemic has been that vaccines could only be produced after a
pandemic had started. Identifying and isolating the virus and
manufacturing lead times meant that the first vaccines would only
become available some 4-6 months after a pandemic has been declared.
In today's interconnected world, a pandemic virus could easily
circumnavigate the globe within a matter of weeks. The first wave—which
is usually the most deadly—could be over by the time the
first pandemic specific vaccines become available.
24. This problem has led companies like
GSK to develop what are often called pre-pandemic vaccines—vaccines
which can be stockpiled in advance of a pandemic and which can
be used as soon as, or even before, a pandemic has been declared.
A number of rich countries are already stockpiling these vaccines.
25. GSK's pre-pandemic H5N1 vaccine uses
novel proprietary adjuvant technology. Adjuvants are substances
that boosts the body's natural immune response. Improvements in
adjuvant technology mean that reduced amounts of antigen is needed
for each dose of vaccine—so that potentially up to 12 times
more vaccine can be produced in the event of a pandemic.
The ability to stockpile pre-pandemic H5N1 vaccine
now, and the potential increases in pandemic production capacity
mean that potentially all countries—including the poorest—
have the tools to put in place a comprehensive pandemic preparedness
plan if resources are mobilised.
26. GSK believes that the international
community should:
— Ensure that enough pre-pandemic H5N1
vaccine is stockpiled to address developing countries' needs.
As noted above GSK has announced its intention to donate 50 million
doses but additional sustainable funding is also needed.
— Take steps to ensure that developing
countries are able to secure access to the actual pandemic vaccine
which will only become available after the pandemic strain has
been identified and isolated. Many developed countries approach
this problem by putting in place Advanced Purchase Agreements
(APAs) to guarantee access to vaccine. GSK believes that APAs
are one instrument which could be established to cover developing
countries with the help of WHO and other supranational organisations.
— Ensure sustainable global manufacturing
capacity for pandemic vaccine by sustainable increases in demand
for seasonal vaccine. Pandemic vaccine will be made in the same
plants as seasonal vaccines are currently made thus increasing
seasonal production results in extra manufacturing capacity which
could be switched to production of pandemic vaccine.
Question 6. What role does your organisation
play in combating the four diseases? Do you believe that it is
correctly configured and adequately resources to do the job? With
which other organisations do you collaborate? How would you assess
the degree of synergy?
27. As noted above GSK's approach to combating
these four diseases is based on preferential pricing; investing
in research and development (R&D); community investment activities
and partnerships that foster effective healthcare; and, innovative
partnerships and solutions.
28. Preferential pricing. GSK has offered
sustainable preferential pricing for antiretrovirals (ARVs) since
1997 and for vaccines for over 20 years. Our AIDS medicines and
anti-malarials are available at not-for-profit prices to public
sector customers and not-for-profit organisations in 64 countries—including
all the Least Developed Countries (LDCs) and all of sub-Saharan
Africa (SSA). In addition, all private employers in SSA who provide
care and treatment to their uninsured staff can purchase our ARVs
at not-for-profit prices and all CCM-led programmes fully funded
by the Global Fund to Fight AIDS TB and Malaria are also
eligible as are projects run by the US President's Emergency
Plan for AIDS Relief (PEPFAR).
29. In total this means that our not-for-profit
prices are now available in around 100 countries. Our prices are
sustainable—we do not make a profit on them, but we do cover
our costs. This means that we can sustain supply of these high-quality
products for as long as they are needed.
30. GSK keeps its not-for-profit ARV prices
under constant review. Our latest review in May 2006 resulted
in price reductions of up to 30% to our abacavir containing ARVs
(Ziagen and Trizivir), and also added two new ARVs—Kivexa
and Telzir—to our not-for-profit offering.
31. While it is difficult to estimate the
number of patients treated as a result of our preferential pricing
agreements a report from the Accelerating Access Initiative (AAI)—
a partnership of UNAIDS, the World Health Organization, UNICEF,
the UN Population Fund, the World Bank, and seven research-based
pharmaceutical companies (Abbott Laboratories, Boehringer Ingelheim,
Bristol-Myers Squibb, GlaxoSmithKline, Gilead Sciences, Merck
& Co., Inc. and F. Hoffmann-La Roche)— suggested that
by June 2007, some 694,400 patients in developing countries were
receiving at least one ARV treatment supplied by the seven pharmaceutical
companies in the AAI. This includes 458,700 patients in Africa.
Overall shipments and patient numbers are still low given the
scale of the AIDS epidemic in Africa but there has been an over
45-fold increase in the number of people being treated with medicines
supplied by the AAI companies in Africa since the establishment
of the AAI in May 2000 which is encouraging.
32. In terms of our investment in research
and development, as well as on-going research into HIV/AIDS (which
is not just a disease of the developing world) GSK has a dedicated
research centre in Tres Cantos, Spain where over 100 full-time
research staff are committed solely to working on diseases of
the developing world, primarily TB and Malaria. This dedicated
resource operates on a no-profit, no-loss basis and much of the
activity is done in conjunction with the product development Public-Private
Partnerships (PPPs) who help to fund around half of the scientists.
33. In terms of community investment, GSK
funds community-led initiatives in over 100 countries around the
world. We have a wide range of partnerships, with a focus on health
and education programmes for under-served communities. In the
developing world, GSK's activities span four major developing
world diseases (lymphatic filariasis, HIV/AIDS, malaria and diarrhoeal
disease), a number of regional health initiatives, health education,
product donations, and employee involvement. The examples below
are indicative of our activities.
— HIV/AIDS—Since 1992, Positive
Action has pioneered support for community organisations who are
frequently the only source of HIV/AIDS education, treatment literacy
and care for people living with HIV/AIDS in developing countries.
During 2006 Positive Action supported 19 programmes in 17 countries.
In 2005, GSK announced that it will provide $1.8 million over
the next three years for a new Positive Action community programme
with AMREF, an African-based NGO, to train healthcare professionals
and improve access to HIV/AIDS services at 70 sites across Kenya.
— Malaria—Our African Malaria
Partnership has supported education and behaviour change programmes
in eight African countries, through partnerships with three non
profit organisations. Since 2003 we have invested £0.9m targeting
some 2 million people. In November 2005, GSK's African Malaria
Partnership (AMP) announced a new £0.9m grant to the Malaria
Consortium, an international non-profit organisation dedicated
to improving malaria control. The three-year grant will support
the Coalition Against Malaria a new advocacy programme that aims
to raise awareness of malaria in Europe and throughout Africa
to bring greater resources to bear against the disease. GSK won
the Frost and Sullivan 2006 Global Excellence Award in Malaria
Prevention and Treatment.
34. In terms of innovative partnerships
GSK is constantly looking for creative ways and partnerships to
help countries improve access to medicines. For example given
the gravity of the HIV/AIDS crisis in sub-Saharan Africa, we granted
our first licence in October 2001 to Aspen Pharmacare, sub-Saharan
Africa's largest generics company, for the manufacture and sale
of versions of Combivir, Epivir and Retrovir. The licence now
covers both the public and private sectors across all of sub-Saharan
Africa. In 2006 we granted our 8th voluntary licence for our antiretrovirals
(ARVs) in Africa, where HIV/AIDS is having a devastating impact.
This includes eight VLs in South Africa and two in Kenya. In 2006
our licencees supplied over 120 million tablets of their versions
of Epivir and Combivir to Africa, more than we shipped ourselves.
35. The threat of an influenza pandemic
poses a unique challenge. No other public health threat has the
potential, if it happens, to affect every single person on the
globe almost simultaneously. This challenge means that all stakeholders
must work together to ensure that the world is prepared.
36. Since 2000, GSK has invested more than
$2 billion in increasing GSK's production capacity for influenza
vaccines and anti-virals and in the development of more effective
pandemic and seasonal influenza vaccines. In addition we have:
— Stated our intention to donate 50
million doses of pre-pandemic vaccine to the WHO stockpile.
— Stated that we would provide additional
vaccine to WHO at a tiered price.
— Committed to supply H5N1 pre-pandemic
flu vaccines, through individual country agreements, to developing
countries who wish to secure direct supplies at tiered prices,
reflecting a countries' gross national incomes (GNI) as defined
by the World Bank.
— Committed to enter into advance purchase
agreements with individual countries, or with supranational organisations,
again using tiered pricing principles based on GNI to ensure that
pandemic vaccine can be reserved for developing countries.
— Committed to explore, in the medium-term,
partnership opportunities with developing countries for filling
and finishing and in the longer-term opportunities for further
transfer of technology.
— Signed a licensing agreement with
Simcere Pharmaceutical Group of Nanjing, China, granting Simcere
the right to manufacture and sell the anti-viral influenza treatment
zanamivir in a number of countries including all Least Developed
Countries. Zanamivir is the active ingredient in GSK's Relenza®
(zanamivir for inhalation).
Question 7. What are the main non-health causes
(eg global warming, poverty, changes in land use, international
travel, lifestyle, population) of the spread of the four diseases?
To what extent can intergovernmental action in non-health fields
contribute to alleviation of their spread? What action is taking
place or planned in these areas? And what more needs to be done?
Do you consider that there is sufficient "joined-up"
thinking in approaching the problem?
37. GSK believes that poverty is the biggest
barrier to improving healthcare in general. The WHO recommends
a minimum spend on health of £17 per person per year to provide
the most basic health services. Yet the average spend in sub-Saharan
Africa is just £5. The African Region of the WHO suffers
more than 24% of the global burden of disease, but has only 3%
of the world's health workers.
38. It is 10 years since GSK pioneered donation
programmes and sustainable preferential pricing for antiretrovirals
(ARVs) to prevent mother-to-child transmission of the HIV/AIDS
virus. Since then we have learned many lessons. We have learned
that stigma and discrimination are real barriers that limit access
to treatment and that without the necessary healthcare infrastructure,
access to treatment will always be denied to those who need it,
no matter how low price medicines become.
39. Most importantly, we have learned that
only an holistic approach embracing both prevention and treatment
will work—one in which medicines play a supporting role
in a comprehensive programme of prevention, health education,
screening diagnosis and treatment, community care and support.
40. The global community must provide political
will, a significant mobilisation of additional resources and a
spirit of partnership if we are to see an improvement in healthcare
and quality of life across the developing world. We will continue
with our efforts, improving our initiatives by applying lessons
learned and looking for opportunities to do more.
Question 11. What intergovernmental action
is planned or in hand for early detection of the transmission
of Avian Flu from birds to humans and of human-to-human transmission
in potential source countries? Is this proving sufficiently effective
to prevent an Influenza pandemic? What more could be done.
41. The WHO's Global Influenza Surveillance
Network (GISN) plays a vital role in monitoring the evolution
of viruses in potential source countries. The success of the GISN
and the consequent benefits for public healthcare across the world
has been based on all parties sharing and analysing influenza
viruses for research and vaccine development both for seasonal
and H5N1 vaccines. Prompt sharing of, and access to, virus isolates
and related sequence data from GISN centres around the world with
vaccine manufacturers is key in ensuring that all countries have
access to the most effective and up-to-date vaccines.
42. However recent developments have lead
to one country restricting access to viruses. While discussions
are ongoing it is important to remember that production of influenza
vaccine is already performed under tight time and capacity constraints.
Any delay in availability of the viral strain to manufacturers
could affect the timing of availability of vaccines. The GISN
is at the centre of a network of the world's leading experts on
influenza viruses and calls upon that expertise extensively. In
doing so, the WHO GISN ensures the highest levels of safety and
scrutiny in the handling of viruses. This would be difficult to
replicate if the current arrangements were changed. Therefore
it is vital that the international community maintains and improves
the existing system of collaboration and does not inadvertently
or otherwise destroy a system that has served global public health
well for over 50 years.
43. Early detection is a key part in preparing
for a pandemic. However, by itself it is not enough. Many Governments
in the developed world are stockpiling pre-pandemic vaccines and
putting in place Advanced Purchase Agreements (APAs) for pandemic
vaccines to cover at least priority groups, such as healthcare
workers, public safety workers, and essential service providers.
However, the world's poorest countries currently lack resources
to put in place robust and effective preparedness plans. The international
community needs to help by putting in place an holistic, clear
and coordinated preparedness strategy which combines education,
non-medical and medical interventions, and other preventive mechanisms,
as well as vaccination.
44. An approach based on sustainability,
partnership, shared responsibilities and support for research
and development can address this problem. Ensuring access to vaccines
will require a new public-private partnership between WHO, developed
countries, developing countries, industry and others. That partnership
should seek to deliver the following:
— A stockpile of pre-pandemic H5N1
vaccine large enough to address the needs of developing countries
— Sustainable increased pandemic production
capacity through sustainable increases in demand for seasonal
vaccines
— Technical assistance to address potential
bottlenecks especially in areas such as filling and finishing
and the capacity in-country to run mass vaccination programmes
— Developing countries get access to
pandemic vaccine. Many countries have entered into APAs for pandemic
vaccines. These agreements are based on shared responsibilities
and could be adapted and developed for WHO to operate a centralised
agreement to cover developing countries
— An appropriate global regulatory
framework for the rapid registration and licensure of pre-pandemic
and pandemic vaccines
— An appropriate global framework for
dealing with liability issues, given the unique nature of dealing
with a pandemic.
45. Taken together, GSK believes that this
holistic package of measures, along with the continued free and
unrestricted access to viruses, provides a realistic, pragmatic
and effective approach for helping the world's poorest countries.
Question 12. To what extent do you consider
that the rise in infections in the four diseases is attributable
to increased microbial resistance to antibiotics? What intergovernmental
action is taking place in this area?
46. It is difficult to know if resistance
is attributable to the rise in infection but it is clear that
it resistance in general is a challenge in treating all four diseases
as it is in managing many others.
47. With respect to HIV/AIDS increasing
resistance to first line antiretroviral therapies, underlines
the need for greater progress in prevention, plus continued R&D
to develop new therapies. Incentives to invest the 100s of millions
of pounds required to develop new medicines must be maintained.
48. For TB, multidrug-resistant TB (MDRTB)
is a widespread and growing problem, especially in the former
Soviet Union and China. An estimated 450,000 new MDRTB cases occur
every year.
49. Combating Malaria has become harder,
as drug-resistant forms of Malaria have developed and health infrastructures
in malaria-endemic areas have deteriorated. Because of resistance,
WHO recommends a combination of effective, low-cost interventions
for malaria control and prevention, but these remain very much
underutilized, primarily due to inadequate funding and poor health
infrastructure in endemic countries.
50. What this shows is that there is a continuing
need to discover and develop new medicines, vaccines, diagnostics
and other health products to fight HIV/AIDS, TB and malaria. The
pharmaceutical industry is at the forefront of the growing number
of R&D projects aimed at this working in partnership with
other public and private sector organisations to increase access,
build capacity and bring newer and better medicines to patients.
Detailed examples of some of these partnerships, which shows the
broad range of public and private organisations the pharmaceutical
industry works with, have been published by the International
Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
in a publication entitled "Partnerships to build healthier
societies in the developing world—May 2007", a copy
of which is attached to this submission.
51. Antibiotic resistance more generally
has been recognised as an enormous threat to global public health.
For example, WHO's 2004 Report Priority Medicines for Europe and
the World highlighted the lack of new antibiotics pointing out
that the current limited size of the market for antibiotics and
the high investment costs and considerable time needed for R&D
for new antibiotics has led many companies to stop investing in
this area. The report says that this trend must be reversed by
providing significant incentives to companies to invest and goes
on to look at options such as creating a special regulatory regime
for antibiotics and ensuring that pricing and reimbursement of
antibiotics reflects the substantial benefits they can bring.
52. It is clear that appropriate incentives
and innovative partnerships are needed to tackle the growing problem
of antibiotic resistance. For our part GSK is committed to the
discovery, development and commercialisation of new antibiotics.
GSK has recently created an Infectious Diseases Centre for Excellence
in Drug Discovery (ID CEDD) exclusively dedicated to discovering
and developing novel treatments for bacterial and other types
of infections.
53. Addressing the problem of antibiotic
resistance needs an international coordinated effort between the
public and private sectors. While there is no "one-size fits
all" solution, GSK stands ready to work with all partners
to ensure that action is taken to address this serious problem.
Priority Medicines for Europe and the World concludes that "If
no such action is forthcoming, we will have lived through a century
(1950-2050) of antibiotics but our children and grandchildren
will face a world without such therapy. This tragedy can be avoided
but only with substantial coordinated investment . . . ".
Question 14. Are there any difficulties with
regard to patents or intellectual property which are impeding
the flow of medicines or other control methods to those infected?
Is intergovernmental action needed to improve the situation?
54. Focus on patents in this debate is misleading
and counter-productive. Patent protection stimulates and fundamentally
underpins the continued research and development for new and better
medicines for diseases including those which occur in the developing
world. Without adequate intellectual property protection, the
medicines that are needed in the developing world would not exist
in the first place.
55. It is clear new medicines and vaccines
to fight all four diseases are needed. We do not, for example,
yet have a cure or a vaccine for AIDS. At the same time existing
medicines are less and less effective as resistance to them grows.
56. Developing a new drug is time-consuming,
risky, and expensive. The average cost of bringing a new pharmaceutical
product to market has been estimated by Tufts University to be
$900 million. It is intellectual property protection that plays
the critical role in stimulating such massive investment in R&D.
57. We want to play an active role in addressing
the healthcare crisis in developing countries. We believe preferential
pricing arrangements are the best way to do this because we are
able to ensure delivery of a safe, quality product at an affordable
price for as long as it is needed. This is where we focus our
efforts. But in some situations, partnerships and voluntary licences
(VL) may also help to increase the supply of medicines. VLs enable
local manufacturers to produce and sell generic versions of our
products. We have granted eight VLs for our ARVs in Africa. This
is a creative response to a unique situation. We discuss VLs with
potential partners on a case-by-case basis, selecting the most
appropriate licensees. We need to be sure that the manufacturer
will be able to provide a long-term supply of good quality medicines
and will implement safeguards to prevent the diversion of medicines
to wealthier markets.
58. Too many people see local manufacturing,
and tearing up intellectual property rules as a panacea. If this
was the answer, India would deal with AIDS better than any country
in the developing world. Until recently, India had no IP protection
for pharmaceutical products, and has the most developed generics
industry in the world, and yet access to ARVs for those who need
them is arguably no better than in Africa.
59. Significantly, of the 325 medicines
on the WHO's Essential Medicines List, over 95% are off patent—that
is have no patent protection - and yet WHO state that a third
of the world's population have no reliable access to these essential
medicines. This is evidence that the lack of healthcare infrastructure
and resources are the real problems, and where the focus should
be, rather than on intellectual property. This means addressing
mobilising resources, addressing stigma; removing import tariffs
and taxes that raise prices and prioritising healthcare in national
budgets. Driving out inefficiencies in the procurement, storage,
prescribing and use of drugs is also important. The World Bank
estimates that some African countries get the benefits of only
$12 worth of medicines for each $100 spent on drugs by the public
sector.
January 2008
24 For more information, please see http://www.gsk.com/responsibility/cr-review-2006/access-to-medicines.htm Back
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