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TWN Info Service
on Intellectual Property Issues (May09/05) Sangeeta Shashikant (Geneva): The swine flu outbreak has once again brought to the forefront vulnerability of developing countries in the event of a pandemic and the need for concrete mechanisms within WHO that will deliver for benefit sharing as well as overcome barriers of IPRs related to research, development and production of anti-virals as well as of vaccines. It has been more than a week since WHO alerted the international community to the possibility of a full-scale pandemic, and yet it is not clear for developing countries whether sufficient quantities of needed anti-virals or vaccines as well as associated technology and know-how will be made available on an urgent basis to developing countries. Instead developing countries have to often rely on the charity and goodwill of developed countries and their manufacturers, to supply for their needs. The
US Health and Human Services (HHS) Secretary Kathleen Sebelius recently
announced that the Compare this to the mere 400,000 treatment courses, representing less than 1% of the total American stockpile sent by HHS to Mexico, a country severely affected by the flu outbreak and the meager 2.4 million courses recently shipped by WHO to developing countries to help stop the spread of the virus. The upcoming negotiations on virus and benefit sharing on 15-16 May offers an ideal opportunity for WHO and developing countries to formulate mechanisms for benefit sharing and overcoming the IP barriers that will infuse WHO’s influenza system with transparency, fairness and equity and address the needs of developing countries. WHO is now the subject of criticism in mainstream media for keeping mum on IP issues, although oseltamivir is patent protected in some countries. An Associated Press’s news report of 11 May links WHO’s lack of enthusiasm for generic versions of oseltamivir with the reluctance to anger multinational drug company which supply WHO with stockpiles of anti-virals. Boosting generic production will go a long way in reducing the costs of anti-viral that is currently unaffordable to many countries. Roche sells Tamiflu for government pandemic stockpiles at €15 ($20) for richer countries and €12 for poorer ones while CIPLA has offered a course of Oseltamivir (generic version of Tamiflu) at US$ 10. Recent notices also reveal that patent owners of key technologies related to commercial vaccine production are likely to require licensing agreements, albeit the terms and conditions of such agreements including royalties that will be charged are unclear. For
instance the website of the National Institute for Biological Standards
and Control (NIBSC), a WHO centre known as an Essential Regulatory Laboratory
in a notice dated 11 May 2009 states that “Commercial use of reverse
genetics viruses is subject to a licence with Reverse
genetics is a technology that is used to create vaccine seed strains.
It is covered by patents owned by MedImmune, a This patent has the resulting effect that vaccines developed using seed strain for commercial purpose will have to sign a licensing agreement with MedImmune. It is almost certain that vaccine seed strains using reverse genetics technology being developed by WHO Centers in particular the Centers for Disease Control and Prevention (CDC) in Atlanta, the Centre for Biologics Evaluation and Research (CBER) in US; St. Jude Children's Research Hospital in US and the National Institute of Infectious Diseases (NIID) in Japan will be provided on similar terms. The receipt of the vaccine seed strain may also be subject to a Material Transfer Agreement (MTA), as was in the case of H5N1 outbreak. In the latter case, the MTAs used by WHO centres like NIBSC contained clauses that restricted use of vaccine seed strain to experimental use (not for commercial production) and clearly mentioned that IPRs of the vaccine seed virus subsist in the provider (i.e. in NIBSC) A similar situation can be envisaged in the case of the swine flu outbreak. Patents over reverse genetics is only one cause of concern, there are many other technologies relevant to vaccine production that are in a similar situation. For example several adjuvants (substances added to a vaccine in order to enhance its immunological effect, thus reducing the amount of antigen needed per vaccines dose, thus its importance during a pandemic) are proprietary e.g. MF 59 is owned by Novartis; AS03 is owned by GS); AF03 is owned by Sanofi Aventis; Biotech adjuvants are owned by companies such as Juventus, Intercell etc. Further except for “Egg-based ‘classic’ flu vaccines which has few IPR impediments (except where proprietary adjuvants are used), newer vaccine producing technologies such as cell-culture produced vaccines, live attenuated (LAIV) and second generation biotech vaccines, (e.g. virus like particles, DNA vaccines) have or will have robust IP protection. The scope of protection includes patents on cell lines and production systems, trade secrets on safety profile of cell lines and other formulations. IPRs over technologies have been a cause of concern among experts for a long time. In 2004, in a “WHO technical consultation on priority public health interventions before and during influenza pandemic” held in Geneva and participated by 100 experts from 33 countries, several conclusions and recommendations in relation to IP were made. In particular it concluded that “Rapid production requires access to patented technologies, such as reverse genetics for strain development and adjuvants for improved immunogenicity, adding that “although patent issues are manageable for the larger vaccine companies, other manufacturers may have difficulty securing access to these technologies” and that “important constraints to rapid and large-scale production of a pandemic vaccine include intellectual property rights”. It was also recommended that a “A global approach to the sharing of intellectual property rights should be adopted to encourage vaccine production by more manufacturers, including those located in developing countries. Such an approach could extend access to important production technologies, notably reverse genetics and the use of adjuvants.” However to-date WHO has been unable to recommend to member states any concrete mechanisms for overcoming the IP barriers particularly for entities in developing countries. The
problem of lack of access to technology and know-how is further compounded
by the fact that more than 90% of the global capacity for vaccine manufacturing
is located in Europe and in Developed countries through “advance purchase agreements” with manufacturers have already reserved a good portion of the limited current manufacturing capacity. With present global capacity being limited, in the event of a pandemic the world would be billions of doses short of the expected demand. Both WHO and developing countries would again be at the mercy of those with manufacturing capacity, i.e. multinational companies that are likely to be more concerned with supplying the rich markets. The difficulty of developing countries in having available immediately sufficient quantities of anti-virals and vaccines at an affordable price in the event of a pandemic came up approximately 2 years ago. At
the 2007 World Health Assembly the unfairness of WHO’s influenza system
came under close scrutiny as However developing countries were at a vast disadvantage since they had little vaccine manufacturing capacity and the cost of the vaccines made it unaffordable for developing countries to stockpile, while developed countries had already made arrangements for needed stockpiles. It also emerged that WHO centres and other commercial entities were filing patent applications on viruses and parts thereof, including on products developed using the biological material. The lack of transparency surrounding the sharing of influenza viruses, the absence of mechanisms for fair and equitable benefit sharing as well as for sharing IPRs led to the establishment of the Intergovernmental Meeting, which was tasked with coming up with terms and conditions for virus and benefit sharing. For the past 2 years developing countries led by Indonesia, Thailand, India, Nigeria, Brazil have been fighting for reforms in the WHO influenza system to ensure that developing countries (many of which contribute their viruses for research and for manufacturing vaccines) are assured of access to technology and know-how to build capacity in preparation of a pandemic as well as affordable and timely treatments when pandemics break out. However
there has been fierce resistance from developed countries particularly
the For the world to prepare for, or combat, a pandemic there needs to be international solidarity, a call made also by the Director General of WHO, Dr. Margaret Chan. This
international solidarity needs to be realized in the upcoming negotiations
on influenza virus and benefit sharing that resumes on 15 May in There needs to be serious consideration of what a fair and equitable system for benefit sharing should be and measures that will need to be put in place to overcome patent and other intellectual property barriers. Developing
countries have proposed several measures on benefit sharing including: ----Obligating manufacturers to contribute a portion of their profits to a fund, which could be used for purchasing the needed vaccines or anti-virals as well as building manufacturing and other relevant capacity in developing countries. On
measures to overcome patent and other IPR barriers there are the following
proposals i.e. --that recipients of virus samples that are designated as WHO centres i.e. as WHO Collaborating Centre, H5 Reference Laboratory or as Essential Regulatory Laboratory should not claim patents over products or processes developed using biological materials --that recipients of virus samples that are commercial entities should not claim patents over products or processes developed using biological materials or alternatively should grant on request royalty free licenses to developing countries. Knowledge Ecology International (KEI), a prominent US based NGO has in a letter to Dr. Margaret Chan dated 4 May 2009 proposed establishing an influenza patent pool (IPP). The pool should include sufficient rights to use patents to manufacture any necessary medicine or vaccine needed to address an influenza pandemic, including to address the needs for stockpiles of products, the letter adds. KEI also spoke of the need to evaluate new approaches to the management of patent rights for stockpiled medicines and vaccines. One proposal it put forward is to permit governments to acquire treatments freely for stockpiles from generic suppliers, on the condition that if they were used to treat people, the patent owner would receive royalties. This makes it much cheaper to acquire the stockpiles but also increases the value of the patented invention, as long as there is some probability that the emergency use will occur, KEI added. In its letter, KEI also raised concern about restrictive contracts with generic suppliers of oseltamivir phosphate entered into by multinational companies. It said that it had received information that Roche (patent holder of Tamiflu) had entered into contracts that limited the ability of generic manufacturers to sell products only for use in developing country government stockpiles. It asked WHO to formally review the terms of these contracts, and if such restrictions in fact exist, to ask the relevant patent holders to immediately revise the contract terms. Without a system of fair and equitable benefit-sharing in place and measures to overcome the intellectual property barriers, developing countries are likely to be left without affordable vaccines or treatments since the companies making them are located in developed countries which would want to ensure the scarce supplies are given to their own people first. For example in November 8, 2005 the former Secretary of HHS Michael Leavett said that in an emergency pandemic, countries will block exports of medicines, so they can be used for local populations. testimony to the US Congress. This scenario is anticipated by many health experts thus it would seem imperative to build developing country’s capacity to manufacture anti-virals and vaccines that would be used in a pandemic. It is obvious that millions of lives are at stake. The only question that remains is whether WHO will show extraordinary leadership to take realistic action that is much needed to move in the right direction, and whether developing countries will make full use of the ideal opportunity presented to them in the context of the intergovernmental meeting on pandemic influenza preparedness, to persist for the right solutions.
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