[Ip-health] References from GSK G-8 document to IGWG

[Thiru Balasubramaniam]

--
[ Picked text/plain from multipart/alternative ]
The following references to IGWG from this interesting GSK paper have
been extracted.  The WHO IGWG meets from April 28 to May 2, 2008.


------------

<SNIP>

JAPAN G8 PAPER FROM GLAXOSMITHKLINE

<SNIP>

Ensure a strong and vibrant economic environment which encourages
innovation by (1) supporting harmonisation of Data Exclusivity periods
to 10 years and ensuring that, even after the period of exclusivity, the
data remains confidential, even though other companies can refer to it
(2) ensuring that discussions on the Convention of Biological Diversity
(CBD) and the WHO Intergovernmental Working Group (IGWG) on Public
Health, Innovation and Intellectual Property do not reduce incentives to
carry out research and development and (3) preserving effective minimum
international standards of IP protection by ensuring appropriate use of
TRIPs flexibilities.


<SNIP>

The Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property

In May 2006 the World Health Assembly (WHA) asked the WHO to establish
an Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG).  The Working Group's mandate was to
prepare a global strategy and plan of action related to =93the growing
burden of diseases and conditions that disproportionately affect the
developing countries, and particularly women and children=94. The
resulting global strategy and plan of action is due to be presented to
the WHA in May 2008.

GSK supports efforts to stimulate increased research into diseases of
the developing world. However the discussion within IGWG is being
largely driven by ideological positions whose primary motive appears to
be to weaken intellectual property rather than to develop concrete
proposals to increase research for the developing world. A number of
commentators are promoting unproven and possibly counterproductive
proposals such as patent pools and prize based mechanisms. Such
proposals should be treated with extreme caution as they could
significantly reduce the incentives to carry out research and
development and hence the total amount invested in R&D when more, not
less, research is needed.

GSK supports the focus of the IGWG on diseases that disproportionately
affect developing countries. Going beyond this mandate and looking at
other diseases is unnecessary, a waste of scarce WHO resources, and
detrimental to moving this process forward. GSK would therefore urge the
G8 to work to ensure that implementation of the IGWG strategy and plan
of action focuses on diseases that disproportionately affect developing
countries and do not reduce incentives to carry out research and
development. New initiatives must complement the existing IP-based
system and must be voluntary.

<SNIP>

The G8 should:

<SNIP>

Ensure that the development of the strategy and action plan of the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG) and its implementation focuses on diseases
that disproportionately affect developing countries and does not reduce
incentives to carry out research and development. New initiatives must
complement the existing IP-based system and must be voluntary.



Begin forwarded message:

> From: "Peter Chowla"
> Date: April 21, 2008 1:28:05 PM GMT+02:00
> To: ip-health@lists.essential.org
> Subject: [Ip-health] JAPAN G8 PAPER FROM GLAXOSMITHKLINE
>
> Dear ip-health,
>
> In July, 2008, the G8 will meet in Japan.  The following is the paper
> distributed by GSK to governments. I thought it might be of some
> interest
> to people on this list.
>
> Best regards,
>
> Peter Chowla
>
>
> ----------
> JAPAN G8 PAPER FROM GLAXOSMITHKLINE
>
> GSK welcomes the focus the Government of Japan has put on the key
> themes
> of the World Economy and Development and Africa as part of its
> chairmanship of the G8 during 2008. The research-based pharmaceutical
> and bioscience industry has a key role to play in supporting
> progress on
> these two vital themes and GSK looks forward to working in partnership
> with the international community in helping deliver concrete
> progress on
> both issues.
>
> This paper sets out a number of areas where the G8 can make a
> difference
> in both the developed and developing world.  It is split into two
> sections reflecting Japan=92s key themes and focuses on issues that
> could
> be usefully addressed by the G8.
>
> The main points of this paper are:
>
> On the World Economy, the G8 can:
>
> Mitigate the economic cost of an influenza pandemic to the world
> economy
> by putting in place a global pandemic plan which ensures adequate
> medical provisions are in place each G8 country and undertakes not to
> close borders automatically in the event of a pandemic. The benefit,
> if
> any, of closing borders would be massively outweighed by the cost.
> Such
> a pandemic plan and corresponding open-border agreement will
> strengthen
> business confidence and ensure global supply chains remain open
> which in
> turn will reduce the likely economic impact of a pandemic.
>
> Ensure a strong and vibrant economic environment which encourages
> innovation by (1) supporting harmonisation of Data Exclusivity periods
> to 10 years and ensuring that, even after the period of exclusivity,
> the
> data remains confidential, even though other companies can refer to it
> (2) ensuring that discussions on the Convention of Biological
> Diversity
> (CBD) and the WHO Intergovernmental Working Group (IGWG) on Public
> Health, Innovation and Intellectual Property do not reduce
> incentives to
> carry out research and development and (3) preserving effective
> minimum
> international standards of IP protection by ensuring appropriate use
> of
> TRIPs flexibilities.
>
> Continue to ensure that the threats from counterfeiting, in all
> parts of
> the world, are recognised and that appropriate early warning
> mechanisms
> and enforcement programmes are put in place in both =93source=94 and
> =93recipient=94 countries, that they are adequately funded, and that
> counterfeiters face penalties which act as real disincentives.
>
> On Development and Africa, the G8 can:
>
> Ensure that an holistic approach to managing the challenges of HIV/
> AIDS
> is adopted by all partners.
>
> Ensure that the world=92s poorest countries are able to respond to the
> challenges of a potential influenza pandemic by putting in place a
> global pandemic plan which addresses their needs and vulnerabilities.
>
> Look at ways of ensuring the long-term sustainable funding of
> promising
> Public-Private Partnerships (PPPs) that have been established for R&D
> into diseases that disproportionately affect developing countries.
>
> Look at creative ways of financing vaccines for the developing
> world, in
> particular making sure that Advanced Market Commitments (AMCs) are
> designed in such a way that provides appropriate risk sharing, greater
> clarity and greater sustainability, especially with respect to demand.
>
> Design and put in place an Advanced Purchase Agreement (APA) for
> malaria
> vaccine so that as soon as vaccines are licensed (potentially from
> 2011)
> vaccination can start without delay.
>
> Establish a programme of technical assistance to build clinical
> expertise in developing countries.
>
> Ensure that local taxes and tariffs on medicines in developing
> countries
> are removed, thereby increasing affordability.
>
>
> SECTION 1: THE WORLD ECONOMY
>
>
> 1.1  MITIGATING THE ECONOMIC COST OF A POTENTIAL INFLUENZA PANDEMIC
>
> Using the evidence from SARS, in which there was an immediate economic
> loss of around 2% of East Asian GDP, the World Bank has estimated that
> an influenza pandemic could result in a downturn in the world
> economy of
> $800 billion in one year. This estimate could be very conservative,
> as a
> pandemic would lead to a downturn in world trade more severe than that
> caused by SARS, which was concentrated in one region. According to
> Oxford Economic Forecasting, taking the downturn in world trade into
> account, a pandemic could result in the loss of 4-5% of world GDP,
> equivalent to $1,500 to $2,000 billion.
>
> One of the biggest risks will be if governments start to close
> borders.
> This will severely hamper global supply chains. Not only will this
> mean
> that the production and distribution of medicines and vaccines will be
> severely compromised; it will also undermine business confidence and
> therefore increase significantly the likelihood of greater economic
> damage.
>
> The G8 could:
>
> Mitigate the economic cost of an influenza pandemic to the world
> economy
> by ensuring adequate medical provisions are in place in each G8
> country
> and by putting in place an international agreement which ensures that
> during a pandemic governments will not close borders automatically
> since
> the benefit, if any, will be massively outweighed by the cost. Such an
> agreement will strengthen business confidence and ensure global supply
> chains remain open which in turn will reduce the likely economic
> impact
> of a pandemic.
>
>
> 1.2  A STRONG AND VIBRANT ECONOMIC ENVIRONMENT WHICH ENCOURAGES
> INNOVATION
>
> Research and development into new medicines and vaccines is an
> essential
> response to unmet medical need and to the challenge of increasing
> resistance to some products.  Innovative medicines contribute enormous
> social benefits and reassurance for individual citizens through
> improved
> healthcare - as seen in increased life expectancy and the treatment of
> cancer, diabetes, asthma and other diseases. Pharmaceuticals also
> contribute to economic efficiency and competitiveness for society.
> Innovative medicines deliver healthy working populations able to work
> longer and healthier elderly populations making fewer demands upon
> social security systems; and they enable more efficient use of
> healthcare budgets. The pharmaceuticals sector provides substantial
> investment in research and development, leading to high quality jobs
> for
> science graduates, unrivalled job multiplier benefits, and support for
> the academic research community.
>
> A strong IP system is necessary to provide incentives for the high
> risk
> and high cost of developing new medicines and vaccines. It creates the
> conditions under which industry can generate the returns needed to
> fund
> R&D, including for diseases that disproportionately affect the
> developing world. Strong global IP rights drive innovation and
> investment and ensure a level playing field between developed and
> developing countries, to the benefit of economies and patients around
> the world.
>
> It is therefore important that the G8 promotes and protects a balanced
> IP framework.
>
>
>
>
> Data Exclusivity
>
> The research-based pharmaceutical industry is virtually unique in
> being
> required to provide significant amounts of confidential test data
> (such
> as preclinical and clinical data) to regulatory authorities as part of
> the product registration process. Data Exclusivity recognises the
> proprietary nature of this data by ensuring that it is not referred to
> by other companies (for a defined period) when they are registering
> their products and, even after that defined period, it remains
> confidential. This protection provides incentives for the substantial
> financial investment involved in generating the data in the first
> instance. Data Exclusivity is of particular significance where patent
> protection for a particular product or indication may not be available
> or where the patent has been eroded by a long development phase. The
> level of Data Exclusivity varies greatly across the G8 and other
> countries, and GSK believes that a more harmonised approach, in which
> all G8 countries have 10 years of Data Exclusivity, would further
> incentivise R&D.
>
>
> Convention on Biological Diversity (CBD)
>
> GSK supports the CBD=92s role in providing a framework for the
> conservation of biological diversity and the sustainable use of its
> components. GSK also supports the CBD objective =93to provide fair and
> equitable sharing of the benefits arising from the use of genetic
> resources=94.
>
> However, given the diversity of biological materials and the many ways
> in which they are used in research and development, it is not possible
> to generalise as to the role they play in biomedical research or the
> fundamental value of any particular material to any particular project
> or product.
>
> A careful balance therefore needs to be struck in seeking to define,
> implement and monitor appropriate access to genetic resources and the
> sharing of benefits arising from their use. Go too far one way, and
> society risks damaging the search for medicines and vaccines to treat
> and cure diseases like HIV/AIDS, cancer, malaria and pandemic
> influenza.
> Go too far the other way, and the legitimate interests of countries
> and
> communities from where the genetic resources were sourced can be
> undermined.
>
> In GSK=92s opinion, the best way of achieving the CBD=92s access and
> benefit-sharing (ABS) objectives is for countries to introduce
> national
> laws governing access to their genetic resources and for mutually
> agreed
> contracts to define how any benefits arising from their use should be
> shared.  This approach allows national governments the flexibility to
> determine what guidelines will best serve their national interests,
> and
> gives users the opportunity to reach agreements which are
> appropriate to
> each particular case.
>
> In this respect, GSK broadly supports the Bonn Guidelines of 2002,
> which
> advise governments on how to set fair and practical ABS conditions (we
> do not, however, share the Bonn Guidelines support for disclosure
> obligations in patents). We believe that once countries have adopted
> local laws reflecting this advice, they will receive the protection
> and
> compensation envisaged under the CBD.
>
> Notwithstanding GSK=92s support for national legislation and contracts
> based on the Bonn Guidelines, we recognise the CBD=92s mandate to
> =93elaborate and negotiate an International Regime on access and
> benefit-sharing=94. However, we do not accept the need to use patent
> law,
> in the form of a disclosure requirement in patent applications, to
> help
> facilitate access and benefit-sharing. The legal and commercial
> uncertainties associated with a disclosure requirement would
> significantly reduce incentives to develop products which in any way
> involve =93genetic resources=94.  This could lead to a reduction in
> innovation (and the societal benefits that arise from it) as well as
> the
> benefits to be shared (ie. a key objective of the CBD).
>
> GSK also believes that pathogens and their derivatives, such as
> influenza viruses, should be excluded from the International Regime
> under discussion. The CBD was designed to preserve biodiversity.
> Pathogens are organisms which the world would be better off without.
>
>
> The Intergovernmental Working Group on Public Health, Innovation and
> Intellectual Property
>
> In May 2006 the World Health Assembly (WHA) asked the WHO to establish
> an Intergovernmental Working Group on Public Health, Innovation and
> Intellectual Property (IGWG).  The Working Group's mandate was to
> prepare a global strategy and plan of action related to =93the growing
> burden of diseases and conditions that disproportionately affect the
> developing countries, and particularly women and children=94. The
> resulting global strategy and plan of action is due to be presented to
> the WHA in May 2008.
>
> GSK supports efforts to stimulate increased research into diseases of
> the developing world. However the discussion within IGWG is being
> largely driven by ideological positions whose primary motive appears
> to
> be to weaken intellectual property rather than to develop concrete
> proposals to increase research for the developing world. A number of
> commentators are promoting unproven and possibly counterproductive
> proposals such as patent pools and prize based mechanisms. Such
> proposals should be treated with extreme caution as they could
> significantly reduce the incentives to carry out research and
> development and hence the total amount invested in R&D when more, not
> less, research is needed.
>
> GSK supports the focus of the IGWG on diseases that disproportionately
> affect developing countries. Going beyond this mandate and looking at
> other diseases is unnecessary, a waste of scarce WHO resources, and
> detrimental to moving this process forward. GSK would therefore urge
> the
> G8 to work to ensure that implementation of the IGWG strategy and plan
> of action focuses on diseases that disproportionately affect
> developing
> countries and do not reduce incentives to carry out research and
> development. New initiatives must complement the existing IP-based
> system and must be voluntary.
>
>
> Preserving effective minimum international standards of IP protection
>
> The international IP system has become a touchstone for concerns about
> the impact of globalisation. Some of those concerns are
> well-intentioned; others are deliberately aimed at undermining the
> system of global free trade.  The net result is that global IP is
> under
> threat in a number of fora.
>
> However, international standards of IP protection are not just tools
> for
> developed world businesses. If appropriately tailored, they are good
> for
> development as well. IP protection encourages local businesses in the
> developing world to invest in innovation without fear of free riding
> by
> competitors. It also encourages developed world businesses to enter
> into
> partnerships and collaborations with local businesses elsewhere and to
> invest in their markets.
>
> Within the context of the access to medicines debate, patents should
> not
> be condemned as key barrier to access to medicines. The World Health
> Organisation compiles and regularly updates an Essential Medicines
> List
> as a guide for countries developing their own essential medicines
> lists
> according to their priority health needs. 95% of the medicines on the
> WHO=92s list are not subject to patents and can be manufactured by
> generic
> companies: most are. However, according to the WHO, a third of the
> world=92s population still does not have access to these essential
> medicines. In India, which until recently had no intellectual property
> protection for pharmaceutical products, and has the most developed
> generics industry in the world including many companies manufacturing
> AIDS medicines, it might be expected that AIDS treatments would be
> widely available. However, WHO estimates suggest that the proportion
> of
> HIV/AIDS patients that need antiretrovirals, to those actually
> receiving
> them, is no higher than in Africa.
>
> GSK fully recognises the right to grant compulsory licenses (both
> import
> and export) as a flexibility of TRIPS. Some commentators have
> criticised
> the WTO decision of August 2003 to amend TRIPS with respect to
> compulsory licensing for export as being too complex and ineffective.
> However, in August 2007 the process was successfully used by the
> Government of Rwanda. This enabled the Canadian generics company
> Apotex
> to manufacture a generic fixed dose combination (FDC) antiretroviral
> (ARV), containing two molecules over which GSK has patent rights
> (zidovudine and lamivudine) for the treatment of HIV/AIDS. This shows
> that the solution is both workable and effective.
>
> However, we would not expect to see widespread use of this mechanism
> not
> least since it does not fundamentally address the key barriers to
> access, which have nothing to do with IP. The main constraint is local
> capacity to absorb and effectively use the drugs being offered, and
> lack
> of demand. In some cases, insufficient political will is a problem. As
> Dr. Kevin de Cock, WHO Head of HIV, said in July 2006, "If you work in
> these countries it is very obvious, very quickly, that the elephant in
> the room is not the current price of drugs. The real obstacle is the
> fragility of the health systems, particularly in Africa." Compulsory
> licensing would do nothing to address these challenges - but
> injudicious
> use of compulsory licensing would have a negative impact on investment
> in R&D in certain disease areas.
>
> The G8 recently recognised that the benefits of innovation for
> economic
> growth and development are increasingly threatened by infringements of
> intellectual property rights worldwide. These benefits would equally
> be
> threatened by the overuse of the flexibilities in TRIPs.
>
>
> The G8 should:
>
> Strengthen and harmonise on a period of Data Exclusivity of 10 years
> and
> ensure that even after the period of exclusivity, the data remains
> confidential, even though other companies can refer to it.
>
> Support the Convention on Biological Diversity=92s access and
> benefit-sharing (ABS) objectives through national laws governing
> access
> to the genetic resources and for mutually agreed contracts to define
> how
> any benefits arising from their use should be shared.
>
> Ensure that any International Regime on Access and Benefit-Sharing
> emerging from current discussions within the Convention on Biological
> Diversity faithfully reflects the CBD and excludes pathogens (such as
> influenza viruses) and derivatives.
>
> Oppose attempts to introduce a disclosure of origin obligation in
> patent
> applications (especially through an amendment to TRIPs or inclusion in
> the CBD International Regime).
>
> Ensure that the development of the strategy and action plan of the WHO
> Intergovernmental Working Group on Public Health, Innovation and
> Intellectual Property (IGWG) and its implementation focuses on
> diseases
> that disproportionately affect developing countries and does not
> reduce
> incentives to carry out research and development. New initiatives must
> complement the existing IP-based system and must be voluntary.
>
> Preserve effective minimum international standards of IP protection by
> ensuring appropriate use of TRIPs flexibilities.
> 1.3 COMBATING COUNTERFEIT MEDICINES
>
> Strong copyright and trade mark protection, and efficient enforcement
> systems, not only protect the investment in the innovation they
> represent, but protect consumers as well. Counterfeit and sub-standard
> medicines represent a major public health risk. At best, fake
> medicines
> waste scarce resources, at worst they kill people. The G8 must
> therefore
> take the necessary steps to ensure that appropriate early warning
> mechanisms and enforcement programmes are put in place in both
> =93source=94
> and =93recipient=94 countries; that they are adequately funded; and that
> counterfeiters face penalties which act as real disincentives.
>
>
> The G8 should:
>
> Continue to ensure that the threats from counterfeiting, in all
> parts of
> the world, are recognised and that appropriate early warning
> mechanisms
> and enforcement programmes are put in place in both =93source=94 and
> =93recipient=94 countries, that they are adequately funded, and that
> counterfeiters face penalties which act as real disincentives.
> SECTION 2: DEVELOPMENT AND AFRICA
>
> Recent years have seen significant efforts by all sectors of global
> society to work together to address the challenge of developing world
> healthcare. The G8 has been at the forefront of these efforts, and
> much
> progress has been made.  However, significant challenges remain.  WHO
> recommends a minimum spend on health of =A317 per person per year to
> provide the most basic health services. Yet the average spend in
> sub-Saharan Africa is just =A35. The African region of WHO suffers 24
> percent of the global burden of disease, but has only 3 percent of the
> world=92s health workers. This chronic under-investment means that
> healthcare infrastructure in many countries is woefully inadequate.
>
>
> 2.1 HIV/AIDS
>
> GSK supports the Gleneagles target of achieving as close as possible
> to
> universal access to antiretroviral therapy by 2010. For this target to
> be reached, an holistic approach is needed.
>
> GSK believes that to make progress towards the 2010 target the G8
> should
> commit itself to a series of actions which incorporate the following
> key
> elements.
>
> 1.  Identify and commit additional funding
>
> Effective and well-established funding mechanisms, such as the Global
> Fund, PEPFAR and GAVI, now exist to help ensure that medicines are
> made
> available, and the increased focus on innovative financing
> mechanisms is
> warmly welcomed. However, funding remains inadequate.
>
> The Global Fund to Fight AIDS TB and Malaria, PEPFAR, GAVI and other
> funding mechanisms must be adequately and predictably resourced over
> the
> long-term. Therefore:
>
> Wealthy nations should make achieving the target allocation of 0.7% of
> GNP for overseas aid a key priority.
> African governments should plan towards the Abuja Declaration target
> of
> allocating at least 15% of their annual budget to health.
>
> 2. Develop an holistic approach to fighting the epidemic by ensuring
> that prevention measures, and action against stigma and
> discrimination,
> are fully incorporated into national strategies.
>
> Developing countries should be encouraged to:
>
> Increase efforts at education and prevention, including condom use,
> harm
> reduction measures for drugs users and sex workers, and Mother-to-
> Child
> Transmission prevention for pregnant women.
> Address gender inequality and discrimination against women.
> Scale up treatment of children: improve diagnosis, standardise
> treatment, and develop improved paediatric formulations.
> Establish proactive national HIV testing programmes. In all cases,
> testing must be combined with effective counselling and treatment
> programmes. Legislation to prevent discrimination on the basis of HIV
> status should be implemented and enforced, as should the African
> Charter
> on Human and People=92s Rights.
> Integrate people living with HIV/AIDS into AIDS policy development and
> programme activity.
>
>
>
> 3.  Create a favourable environment to support R&D
>
> The development of new antiretrovirals, including improved paediatric
> formulations, is crucial to fight the development of resistance.
> Therefore:
>
> A framework must be built to set up ethical clinical studies on the
> prevention of HIV infection, using ARVs.
> Local registration requirements should be harmonised and registration
> facilitated if drugs are already approved by a stringent regulatory
> agency (FDA, EMEA, etc.).
> International IP treaties should be respected in tenders and all
> procurement processes.
> As endorsed at Gleneagles, new R&D Public-Private Partnerships
> (PPPs) on
> vaccines and microbicides, in addition to the G8 Global HIV/AIDS
> vaccine
> enterprise, should be encouraged.
>
> 4. Continue to build a framework that encourages voluntary
> preferential
> pricing for ARVs, testing and other commodities
>
> To ensure that the poorest countries can still get access to the
> lowest
> prices (i.e. not-for-profit prices) other developing countries,
> procurement agencies and other organisations should not seek a single
> price for all developing countries.
> Developed and developing countries should act to prevent product
> diversion of preferentially-priced products.
> As agreed at the G8 Evian meeting in 2003, developed countries should
> not benchmark against preferential prices offered to the developing
> countries and should not use these discounted prices in reference
> pricing systems.
>
> Taken together, these actions could play a major part in ensuring
> significant progress towards the 2010 target.
>
>
> 2.2 PANDEMIC INFLUENZA
>
> Governments in developing countries, including those in Africa, are
> understandably concerned about securing access to pandemic influenza
> vaccines for their citizens.  Under WHO=92s leadership a number of steps
> have been taken to address these concerns, but more needs to be done.
>
> Last year WHO agreed to establish a stockpile of 150 million doses of
> H5N1 vaccine with one third of the doses reserved to help contain an
> initial human outbreak, should H5N1 attain the ability to transmit
> from
> human to human. The remainder would be reserved to help low and middle
> income countries fight a pandemic should it be caused by H5N1.
>
> GSK fully supports the creation of a H5N1 stockpile and in June of
> last
> year we announced our intention to donate 50 million doses of
> vaccine to
> WHO=92s stockpile. What is needed now is for new funding to be
> identified
> to ensure the stockpile is financed on a sustainable basis. GSK has
> stated its intention to supply additional doses of vaccine to the
> stockpile, over and above our donation, at a highly preferential price
> to WHO.
>
> In addition to this GSK is committed to selling vaccine direct to
> developing country governments at tiered prices which reflect a
> country=92s Gross National Income (GNI) as defined by the World Bank for
> both pre-pandemic H5N1 vaccine and for pandemic vaccine.
>
> As well as stockpiling H5N1 vaccine developing countries will want to
> have access to the actual pandemic vaccine, once it becomes available.
> Many developed countries have secured their supply of pandemic
> vaccines
> through Advanced Purchase Agreements (APAs). The poorest and most
> vulnerable developing countries lack the resources to enter into such
> agreements by themselves. GSK believes that these countries could be
> helped by creating a APA operated by WHO working in partnership with
> donors and industry, with donors providing funding and industry
> committing to tiered pricing principles. Creating such a mechanism
> requires partnership and political leadership which is why the G8
> could
> have a key role in addressing these issues.
>
> The G8 should also work to ensure that the long-established WHO Global
> Influenza Surveillance Network is protected and maintained. This
> unique
> system, in existence for 50 years, is a vital mechanism for ensuring
> that the world responds quickly to the threat of new viruses. It
> allows
> all parties to share and analyse influenza viruses for research and
> vaccine development. The Network=92s success, and the consequent
> benefits
> for healthcare across the world, has been based on all parties sharing
> and analysing influenza viruses. If governments desist from freely
> sharing information on viruses circulating in their countries, as has
> been threatened, the implications for global healthcare could be
> significant. The development and supply of both seasonal and pandemic
> influenza vaccines, and of other vaccines, would be impacted.
>
> The G8 can:
>
> Work with WHO to identify new sustainable funding to support the WHO=92s
> stockpile of H5N1 vaccine.
>
> Work with WHO and industry to develop an APA for pandemic vaccine for
> the poorest and most vulnerable developing countries, guaranteeing
> them
> access to vaccine in the event of a pandemic.
>
> Work together to protect the WHO=92s Global Influenza Surveillance
> Network, which facilitates the research and production of new vaccines
> against influenza and ensure that countries continue to share viruses
> freely.
>
>
> 2.3 SUPPORTING R&D INTO DISEASE OF THE DEVELOPING WORLD
>
> The return on investment on R&D for diseases of the developing world
> is
> often too low to justify an adequate allocation of resources.
> Public-Private Partnerships (PPPs) are therefore needed. Companies
> provide the technology that they have invested in for decades, as well
> as their development and distribution expertise, to the partnership.
> Public sector partners help fund the development costs while also
> helping to ensure that the medicines and vaccines developed get to the
> people that need them. This has the double benefit of encouraging R&D
> and accelerating the product=92s uptake in the developing world. A
> number
> of these PPPs have been established and have transformed the
> pipeline of
> R&D projects for diseases of the developing world.
>
> Increased funding for existing products and partnerships has
> undoubtedly
> already helped progress research in many disease areas by helping to
> share the financial risk involved. However, the vast majority of this
> funding has come from Private Foundations, such as the Bill and
> Melinda
> Gates Foundation.
>
> Recognising the early successes of PPPs, and as a follow up to the
> commitment at Gleneagles for increased investment, the G8 should
> intensify its support for PPPs.
>
>
> Building up R&D and regulatory capacity in developing countries
>
> As successful PPPs start to bring new medicines and vaccines into late
> stage development it is becoming increasingly clear that there is a
> need
> to develop and strengthen the ability of developing countries to
> conduct
> clinical research. Clinical trials require suitable sites with trained
> personnel, sufficient resources and infrastructure, and appropriate
> regulatory and ethical oversight. As the pipelines of the product
> development Public Private Partnerships, such as MMV and GATB, mature
> the capacity of the few suitable clinical facilities, especially in
> Africa, will be dangerously over-stretched.
>
> PPPs, Advanced Market Commitments (AMCs) and Malaria
>
> GSK believes that AMCs can offer a powerful and cost-effective
> market-based mechanism to accelerate the development and
> availability of
> priority new vaccines against diseases that currently kill millions of
> people in developing countries. Early, guaranteed commitments that
> create a viable market could encourage vaccine manufacturers to invest
> in research and development and production capacity to serve
> developing
> countries, which would otherwise be commercially unviable. The
> result of
> this will be more vaccines available to developing countries in a
> shorter time frame at an affordable price. GSK strongly supports the
> launch of the Pneumo AMC in 2007.
>
> The Malaria Vaccine Initiative (MVI), a PPP in which GSK is a partner,
> is making significant progress in developing a vaccine. The current
> timetable is to file in 2011, just three years from now. The G8 should
> start now on creating an Advanced Purchase Agreement (APA) for malaria
> vaccine now, ensuring healthcare systems, manufacturers and others
> have
> time to prepare and invest in the necessary capacity, so that as
> soon as
> the vaccine is available widespread vaccination can be started without
> delay.
>
> The G8 should:
>
> Establish a programme of technical assistance to build clinical
> expertise in developing countries.
>
> Establish a working group to evaluate and recommend appropriate
> financial mechanisms to strengthen R&D through PPPs and ensure that
> the
> products developed through PPPs get to the people who need them as
> quickly as possible.
>
> Start work now on an APA for Malaria vaccine, working on the
> assumption
> that a vaccine could be available from 2011.
>
>
> 2.4 REDUCING TAXES AND TARIFFS ON MEDICINES
>
> Local taxes and tariffs are a factor in reducing access to affordable
> medicines, as acknowledged in the recent report of the WHO
> Commission on
> Intellectual Property Rights, Innovation and Public Health. The impact
> of tariffs tends to be greatest in those developing and least
> developed
> countries that have the greatest public health needs, and their
> removal
> would help in addressing those needs. Every dollar that a
> pharmaceutical
> company has to pay in tariff duties raises the cost of medicines in
> importing countries. The removal of tariffs on both finished medicines
> and on pharmaceutical intermediates would also be a powerful
> demonstration of the political will needed to address the issue of
> access to medicines. GSK welcomes the moves at the WTO by the US,
> Switzerland and Singapore to eliminate tariffs imposed on the trade of
> medicines and medical devices.
>
> The G8 should:
>
> Support moves to eliminate tariffs on medicines and vaccines in the
> WTO.
>
>
>
>
> *************************************
> Peter Chowla
> peter@chowla.org
> http://www.chowla.org
> Skype ID: pchowla
> *************************************
> _______________________________________________
> Ip-health mailing list
> Ip-health@lists.essential.org
> http://lists.essential.org/mailman/listinfo/ip-health
>


------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997