Cari amici, vi invio questa lettera alla quale vi chiedo di aderire con la vostra firma, in merito ad una risoluzione che il Kenya ha presentato al Segretariato dell'OMS perche sia discussa ed approvata in sede di Executive Board la prossima settimana. La risoluzione, cui sto lavorando on behalf di DNDi (Drugs for Neglected Diseases Initiative), riguarda un nuovo modo di promuovere la ricerca nel campo medico, ed invita gli stati membri dell'OMS a considerare una nuova possibile convenzione per la ricerca scientifica. Qui di seguito il testo della lettera che punta a coinvolgere direttamente la comunita scientifica, affinche essa esprima il suo sostegno all'iniziativa del Kenya, viste alcune resistenze procedurali che l'OMS ha opposto alla risoluzione negli ultimi due mesi. E' stata scritta da John Sulston e Tim Hubbard, e vi prego di farla circolare a largo raggio, nei circuiti internazionali di vostro riferimento, per la firma. La raccolta di adesioni scade il 23 gennaio, primo giorno di avvio dell'Executive Board dell'OMS. In calce alla lettera di Sulston, trovate il tetso della risoluzione, ed il relativo background document.
Grazie! Nicoletta Dentico policy and advocacy, DNDi Geneva Dear Fellow Scientist, We enclose below the text of an open letter from scientists to the World Health Organisation Executive Board. The letter is in support of a resolution entitled "Global Framework on Essential Health Research and Development" proposed by the Government of Kenya for discussion at the January 2006 meeting next week (also included below). We've also included some background on the resolution immediately below. We're sorry for the very short noticed, however the resolution has only become public in the last few days. We wondered if you would be prepared to add your name to the letter to support the resolution, which we will both be attending as delegates? Best wishes, Tim Hubbard and John Sulston -------Background on Resolution------------- The dual problems of the lack of medical R&D to develop treatments for neglected diseases (including Malaria, TB) and of access to expensive medicines (i.e. treatments for AIDS) have been in the news for many years. We have both been involved with NGOs such as Medecins sans Frontieres, Oxfam and others concerning these issues for several years which is why we have drafted this sign-on letter and are asking you to support it by signing. In the last few years there has been some progress in increasing the amount of R&D carried out into treatments for neglected diseases, such as through the setting up public private partnerships (PPPs - many of whom are financed by charities such as the Gates foundation). A number of programs have also been initiated to provide medicines, such as treatments for AIDS, to developing countries at greatly reduced prices. However, the scale of the problem is far beyond these limited steps, which also lack a stable mechanism of funding. Every day over 35,000 people die from infectious diseases such as AIDS, malaria tuberculosis, and other neglected diseases such as Leishmaniasis, Chagas disease and sleeping sickness. Where drugs do exist, million are unable to access them, frequently due to high prices. Indeed, high drug prices constitute increasing barriers to access in all countries, regardless of healthcare system. It is clear to many of those involved in this area that significant progress will only be made if major, permanent changes are made to global public policy structures to address these issues. There is growing consensus that there are new candidate mechanisms for supporting and incentivising medical R&D while addressing the above issues. PPPs are one such innovation to address R&D. One of us has also been involved in proposing a treaty structure to address sustainable funding and access issues (Hubbard and Love (2004). "A New Trade Framework for Global Healthcare R&D." PLoS Biology 2(2): 147-150). There have been a series of workshops discussing such mechanisms hosted by the Rockefeller Foundation and jointly with economists such as Jeff Sachs. In 2003 WHO set up a commission on "IP innovation and Public Heath" (CIPIH) to look at innovation mechanisms, amongst other things. In February 2005 162 scientists, public health experts, law professors, economists, government officials, members of parliaments, NGOs and others called on CIPIH and WHO to evaluate proposals for a new global trade framework on medical R&D. The WHO invited opinions from a number of respected economists (see http://www.who.int/intellectualproperty/en/ for comments and replies) The government of Kenya has now submitted a resolution that takes into account many of these points and ideas and if passed would be a major step towards a establishing a permanent solution to these issues. The main points of the Kenyan resolution are as follows: It points to the need to provide a sustainable system of finance for R&D on diseases that are most important to the poor, such as malaria and various other neglected diseases, as well as important global projects like a vaccine for AIDS. It notes the situation with financing for various PPPs addressing these issues is not adequate, and not sustainable. It provides a process to build a new global regime that is consistent with human rights and public health priorities, not only for neglected diseases, but for medicines in general. That is, it frames the global debate as being about the support for medical R&D, recognizing explicitly that both access and innovation are important policy goals. The proposed resolution recognizes, appropriately, the importance and relevance of public sector and open source methods of supporting and doing R&D, something that trade agreements like the TRIPS and or TRIPS+ bilateral trade agreements basically ignore. However, importantly and worth emphasizing is that the Kenya resolution is not anti-IPR. It acknowledges the importance of IPR mechanisms in simulating investment in R&D, and anticipates that any serious global regime to support innovation be inclusive and balanced (recognizing the strengths and limitations of every mechanism to stimulate R&D, and both public and private sector R&D efforts). The proposal is to create a committee of a working group of interested Member-States to consider proposals to establish a global framework for supporting R&D, with the instructions to submit a progress report Sixtieth World Health Assembly (May 2008) and a final report with concrete proposals to the Executive Board at its 121st session (January 2009). ---------Text of sign on letter------------- Sign-on Letter to ask World Health Organization Executive Board members to support the resolution on a "Global Framework on Essential Health Research and Development" proposed by the Republic of Kenya at the January 2006 meeting. If you would like to add your name to the letter, send your name and preferred identification to [EMAIL PROTECTED], if possible by Monday January 23rd, 2006. January 23rd, 2006 Open Letter to the WHO Executive Board Dear Members of the WHO Executive Board: As scientists, many of whom work in fields connected with biomedicine, we are writing to express our support for the resolution submitted by the Republic of Kenya at the 117th meeting of the WHO Executive Board on January 23rd 2006. Although we have very varied scientific backgrounds, from basic research to specific clinical research, we are all deeply concerned with deficiencies in the way that biomedical research science is supported and translated into treatments that improve health outcomes around the world. In the research setting we see many possibilities to develop drugs to treat neglected diseases, but a lack of sustainable support for the R&D process. In the clinical setting we see the problem of affordable drugs to a greater or lesser extent in health care systems in all countries. At a time of huge progress in basic research science and more money being spent on biomedical R&D than ever, we are deeply concerned about the ability of existing mechanisms to translate this into a global improvement in public health. We have all felt the impact and promise of the free availability of genome sequence data, notably from the human genome project. At the same time we see research activities increasingly complicated by legal restrictions, such as intellectual property rights, which can interfere with free data exchange and can limit biomedical research progress. We do not see a good balance between medical need and resource allocation in the existing system to support R&D. For example, there is less focus on neglected diseases, vaccines or replacement antibiotics than their potential impact on global health outcomes would justify. The resolution appears to address all of these issues in a balanced way. For example, it does not seek to eliminate the use of patents to incentivise commercial innovation, but instead allows other incentive systems to be used along side and considered under trade rules. It also proposes long term solutions to sustainable funding, prioritisation and access issues. We call upon the Executive Board to support this important and timely resolution. Sincerely, [To sign, send an email to [EMAIL PROTECTED], with your name and the way you would like to be identified, including county of residence.] -------Text of proposed resolution---------- WORLD HEALTH ORGANIZATION Executive Board 117th Session January 2006 Global Framework on Essential Health Research and Development The Executive Board, Having considered current developments regarding access to medicine and the need to urgently develop new medicines and other health care technologies, RECOMMENDS to the Fifty-ninth World Health Assembly the adoption of the following resolution: The Fifty-ninth World Health Assembly, Recalling Resolutions WHA52.19, WHA53.14, WHA54.10, WHA56.27, and WHA57.14; Considering the paucity of safe, adapted and affordable new medicines developed for infectious diseases like Aids, malaria and tuberculosis, and the lack of drugs, vaccines and diagnostics for tropical diseases or other illnesses that primarily affect the world's poorest, Recognizing the importance of supporting the development of treatments for diseases that have small client populations, Concerned about the need for appropriate, effective and safe health tools for patients living in resource- poor settings, Noting that more than 70 percent of new drug approvals are for medicines that do not provide incremental benefits over existing ones, Considering the importance of developing new medicines to address emerging health threats such as multi-drugs resistant TB, and other poverty-related and infectious diseases. Noting the insufficient funding for research and development for new vaccines for AIDS and other illnesses, Recognizing the importance of global public goods such as the Human Genome Project, and the increasing relevance of open and accessible public research in advancing science and the transfer of technology, Noting in addition the promise of new open models for the development of medical science, the enhanced participation and access to scientific advances, and increase knowledge; Noting the importance of public private partnerships (PPPs) devoted to the development of new essential drugs and research tools, but concerned about the necessity for the governments in setting a needs- based priority agenda for health, and granting political support and sustainable sources of funding for such initiatives, Recognizing the importance of public and private investment in the development of new medical technologies, . Considering that a number of developing countries have been strengthening their capacity for new health technologies, and that their role will be increasingly critical, Recognizing that intellectual property rights are one of several important tools to promote innovation, creativity activity and the transfer of technology, Recognizing at the same time the importance of providing for a proper balance between intellectual property rights and the public domain, and the need to implement intellectual property rules in a manner that is consistent with the basic human right to health and the promotion of follow-on innovation, Concerned about the impact of high drug prices on access to medicine, and the need to implement intellectual property laws in a manner that reconciles incentives for development of new medicines with the need to promote access to all, consistent with Paragraph 4 of the Doha Declaration on TRIPS and Public Health, Aware of the need for a new global framework to provide adequate and sustainable levels of financial support for patient-driven research, and including in particular for priority medical research, Having considered a 24 February 2005 request from 162 scientists, public health experts, law professors, economists, government officials, members of parliaments, NGOs and others calling for an evaluation of proposals for a new global trade framework on medical R&D. Considering the Global Appeal on R&D for Neglected Diseases launched on 8th June 2005 with the support of 18 Nobel Laureates, and the support of over 2500 scientists and health experts, academics, NGOs, public research institutes, governments officials and members of parliament, calling for new policy rules to stimulate essential health R&D, especially for the most neglected patients; Noting the need to promote innovation in the mechanisms that support innovation, Recognizing the importance of strengthening research capacity of local public institutions and businesses in developing countries to contribute and participate in research and development efforts, Urges Member States: (1) to make global health and medicines a strategic sector and take determined action to direct R&D priorities according to the needs of the patients, especially those in resource-poor settings, and harness collaborative R&D initiatives involving disease-endemic countries; (2) to take an active part, together with the World Health Organization and other international actors, in the development and establishment of a global framework for defining global health priorities, supporting essential medical research and development predicated upon the principle of equitable sharing of the costs of research and development, and incentives to invest in useful research and development in the areas of patients' need and public interest. (3) to ensure that progress in basic science and biomedicine is translated into improved, safe and affordable health products - drugs, vaccines and diagnostics - to respond to all patients' needs, especially those living in poverty, and that essential medicines are rapidly delivered to people; Requests the Director-General: (1) to establish a working group of interested Member -States to consider proposals to establish a global framework for supporting needs-driven research, consistent with appropriate public interest issues. (2) to submit a progress report of the working group of interested member -States to the Sixtieth World Health Assembly (May 2008) and a final report with concrete proposals to the Executive Board at its 121st session (January 2009). ------------text of background document---------------- WORLD HEALTH ORGANIZATION Executive Board 117th Session January 2006 Background Document for Proposed Resolution on Global Framework on Essential Health Research and Development 1. This resolution is a response to a growing concern over the inadequacy of the current global system for supporting innovation in new medicines and other health technologies, as well as concern about the impact of an increasing percentage of people without access to essential medicines and other technologies for health care, both in terms of their financial affordability and availability. 2. The resolution seeks the establishment of a global framework for supporting essential medical research and development predicated upon the principle of equitable sharing of the costs of research and development, and incentives to invest in useful research and development in the areas of patients' need and public interest. The process to carry this forward include the creation of a working group of interested Member-States that would submit a progress report to the Sixtieth World Health Assembly (May 2008) and a final report with concrete proposals to the Executive Board at its 121st session (January 2009). As the lead global agency on health needs, WHO plays a crucial role in priority setting and the development of policy recommendations on how priority research can be carried out. 3. Member States are also asked to make global health and medicines a strategic sector and take determined action to ensure that R&D efforts address the areas of priority for patient needs, especially for those living in resource-poor settings, to harness collaborative R&D initiatives involving disease-endemic countries, and to ensure that progress in basic science and biomedicine is translated into improved, safe and affordable health products - drugs, vaccines and diagnostics - and that such systems work to ensure that essential medicines are rapidly delivered to people, with special attention to those living in poverty. 4. Global trade agreements that focus solely on drug patents or drug prices do not provide sufficient incentives for development of priority medicines, including but not limited to medicines that are essential to treat and cure diseases that primarily affect patients living in poverty, or many of the public goods that are essential for the development of new medical technologies. High drug prices constitute increasing barriers to access in all countries. There are also inadequate mechanisms to enhance the capacity of all countries to contribute and participate in medical innovation efforts. 5. While the shortcomings of the current system are important everywhere, the impact on those living in poverty is particularly harsh. Every day over 35,000 people die from infectious diseases such as AIDS, malaria, tuberculosis, and other neglected diseases such as Leishmaniasis, Chagas disease and sleeping sickness. These diseases affect hundreds of millions of persons, yet we lack safe, affordable, effective, field-adapted vaccines, diagnostics, and drugs to tackle them. 6. In cases where medicines are needed where significant numbers of patients have higher incomes, there is disproportionate emphasis on products that do not provide incremental benefits over existing ones. A breakdown of the 1,035 new drugs approved by the US FDA (Federal Drug Administration) between 1989 and 2000 revealed that more than 3/4 are classed as having no therapeutic benefit over existing products, so-called 'me too' drugs (NIHCM 2002). At the same time it was noted that less than 1% addressed diseases that primarily afflict the poor and for which new treatments would have the greatest effect on world healthcare (WHO 2003). 7. There is a growing need to develop new medicines to address emerging health threats such as multi-drugs resistant TB, SARS, avian flu, and other infectious diseases. Basic science about infectious diseases exists and biomedicine is developing extremely fast, but there exist inadequate sustainable mechanisms and incentives to turn such knowledge into useful products. There is continued need for new antibiotics, in the race between society and the pathogen, where each new drug provides only a temporary breathing space. The current systems of incentives do not provide sufficient support for the pre- emptive development of new drugs for resistant strains of disease since there is no market until resistance is widespread. Growing resistance of bacteria to existing antibiotics is already a global concern as few new treatments are being developed. The public needs to develop more effective treatments for potential health pandemics, like SARS or avian flu, before such pandemics occur, and to utilize business models for drug development that ensure that treatments are effective and accessible in resource poor settings, and benefit everyone, including persons living in poverty. 8. There is insufficient funding for research and development for new vaccines for AIDS and other illnesses. Most of the 3.1 million persons who died of AIDS related illnesses in 2005 were living in poverty. The development of such vaccines is a global public good, and requires a multilateral strategy for widespread access. Existing market incentives are apparently insufficient to encourage the development of many vaccines, and while some research has been successfully completed outside the commercial sector, new mechanisms are required to support the costs of vaccine development and production. 9. Global public goods such as the Human Genome Project (HGP) and other open and accessible public research projects advance science knowledge, and also facilitate access to that knowledge, and the transfer of technology. It is accepted that health research has been accelerated through immediate free access to the sequence of the human genome and other related genomic datasets. This success can be seen as part of a larger shift in public policy towards requiring research data to be openly accessible (Arzberger et al. 2004) through recognition of the additional benefit it brings. The creation of global public goods relevant to health research could be further incentivised through recognition of each countries support for them. 10. As well as allowing easy data sharing, the Internet has dramatically lowered the cost of collaboration, thereby proving the potential to substantially improve health research productivity. As a result, open collaborative models for research and development are now proving a competitive alternative to traditional closed proprietary models, such as open source software development. These models have the potential to be extended to the development of medical science (Economist, 2004). Open access business models for scientific publishing are also proving successful, as a result of the low cost of disseminating information through the Internet. It has been recognised that their widespread adoption has huge advantages for the dissemination of knowledge and transfer of technology as well as being sustainable (Wellcome Trust 2003). 11. New public private partnerships (PPPs) devoted to the development of new essential drugs and research tools are important, but there is a need for sustainable sources of funding for such initiatives. Recently some encouraging initiatives to accelerate the development and delivery of health tools for the poor have emerged. Not-for- profit partnerships in the field of infectious and tropical diseases have been established, and are beginning to build a pipeline for projects, in response to the needs of neglected patients (Moran 2005). However, the sustainability of PPPs is in question, as the majority are mainly funded by philanthropic actors. It is particularly unclear where the resources to finance the very expensive later stages of development and clinical trials will come from. Moreover, the response of PPPs remains very limited compared to the global needs. The WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR) has contributed significantly to the development of new products to be safely used in developing countries, especially in country disease-control programmes, but its health performance has suffered from increasingly severe funding constraints. Redirecting today's knowledge and scientific expertise to realistically address essential health needs will mean a substantial shift in the way health products are valued, financed and made available. 12. A number of developing countries have been strengthening their capacity for new health technologies, and their role in performing and directing health care research will be increasingly critical. New models and financial mechanisms must be pursued in order to create a better environment for health innovation. Technology transfer and research capacity strengthening in disease endemic countries should be at the heart of the endeavour, by making full and appropriate use of the scientific knowledge and resources that already exist in developing countries. International cooperation on R&D should be encouraged, so as to promote scientific training in all developing countries and their increasing involvement in R&D efforts that respond to public health problems. 13. Intellectual property rights are one of several important tools to promote innovation, creativity activity and the transfer of technology. At the same time, it is important to recognize the need for the proper balance between intellectual property rights and the public domain, and the need to implement intellectual property rules in a manner that is consistent with the basic human right to health. and the promotion of follow-on innovation. Stronger intellectual property rights do create incentives to invest in some types of medical innovation, although in some cases, at a cost of reduced access. It is also well recognized that in some areas, intellectual property rights are not an effective or appropriate tool to stimulate innovation. It is important that the global framework for supporting medical innovation recognise all mechanisms that stimulate and incentivise R&D, including public sector funding of R&D, or new business models for stimulating private investments, such as innovation prizes. There are increasing worries that in some cases R&D is slowed by the complexities of dealing with large numbers of patents (CIPRGPRI, 2005). A recent survey has quantified how serious the situation is, showing that more than 20% of human genes are patented, some as many as 20 times (Jensen and Murray 2005). Patent thickets can make licensing difficult and inhibit follow on innovation. A balanced framework for medical innovation does not rely upon a single incentive mechanism to stimulate innovation, but rather considers a wide range of mechanisms, each with its own strengths and weakness, within different institutional, cultural and social settings. 14. Awareness that the current system for driving innovation requires serious examination was reflected in the establishment by WHO of the Commission on Intellectual Property, Innovation and Public Health to "produce an analysis of intellectual property rights, innovation and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries." It has also led to a number of private calls for a new global framework to support medical innovation, including for example a 24 February 2005 request from 162 scientists, public health experts, law professors, economists, government officials, members of parliaments, NGOs and others asking the WHA Executive Board for an evaluation of proposals for a new global trade framework on medical R&D, and a "Global Appeal on R&D for Neglected Diseases" launched on 8th June 2005 with the support of 18 Nobel Laureates, and the support of over 2500 scientists and health experts, academics, NGOs, public research institutes, governments officials and members of parliament, calling for new policy rules to stimulate essential health R&D, especially for the most neglected patients. There are also many other more narrowly targeted calls for increasing R&D funding for vaccines or microbicides to prevent the spread of AIDS (IAVI, 2005), new treatments for TB, hepatitis, and other areas where safe, affordable, and effective treatments are needed. 15. Other UN bodies are also considering aspects of these issues in a serious and determined manner: in 2004, the World Intellectual Property Organization (WIPO) began a debate on a new "Development Agenda," which includes discussions of how to fashion intellectual property systems in order to promote both innovation and access. Parallel to the UN agencies, the World Trade Organization (WTO) adopted the Doha Declaration on TRIPS and Public Health in 2001, which asked Members to implement intellectual property laws in a manner "to promote access to medicine for all." 16. It is now timely and appropriate to create a forum where WHO Member-States can evaluate various proposals to create sustainable mechanisms for the support of needs drive medical R&D, that are consistent with the need for the development of and access to essential medicines for all, including those living in poverty. REFERENCES Arzberger P, Schroeder P, Beaulieu A, Bowker G, Casey K, et al. (2004). Science and government. An international framework to promote access to data. Science 303: 1777-8. WHO (2004). Priority medicines for Europe and the World http:// mednet3.who.int/prioritymeds/report/final18october.pdf CIPRGPRI (2005). Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health, National Academies of Science. http:// www4.nationalacademies.org/news.nsf/isbn/0309100674?OpenDocument Economist (2004). An open-source shot in the arm? 10th June 2004. IAVI, "Why women especially need an AIDS vaccine," May 2005. Jensen K and Murray F (2005). Intellectual property. Enhanced: intellectual property landscape of the human genome. Science 310: 239-40. Moran M (2005). A breakthrough in R&D for neglected diseases: new ways to get the drugs we need. PLoS Med 2: e302. NIHCM (2002). Changing Patterns of Pharmaceutical Innovation. http:// www.nihcm.org/innovations.pdf. Wellcome Trust (2003). Costs and Business Models in Scientific Research Publishing. http://www.wellcome.ac.uk/doc_WTD003185.html WHO (2003). World Health Assembly Resolution 27: Intellectual property rights, innovation and public health. http://www.who.int/gb/ EB_WHA/PDF/WHA56/ea56r27.pdf. -- ---------------------------------------------------------------------------- Dr Tim Hubbard email: [EMAIL PROTECTED] Head of Human Genome Analysis Tel (direct): +44 1223 496886 Wellcome Trust Sanger Institute Tel (switch): +44 1223 834244 Wellcome Trust Genome Campus, Hinxton Fax: +44 1223 496802 Cambridgeshire. CB10 1SA. UK. URL: http://www.sanger.ac.uk/Users/th ---------------------------------------------------------------------------- -- www.e-laser.org Laser@inventati.org
