Health Experts Debate Solutions For New Treatments, Access To Medicines08/06/2005 by William New, Intellectual Property Watch 1 CommentShare this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)IP-Watch is a non-profit independent news service, and depends on subscriptions. To access all of our content, please subscribe now. You may also offer additional support with your subscription, or donate.Experts from across the political and socioeconomic spectrum spent three days last week at the World Health Organisation engaged in debate about the best ways to stimulate the development of new treatments for underserved illnesses and to improve poor countries’ access to available medicines.The task of summarizing the results of the meeting and other input falls to the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which convened the meetings as the last step in the information-gathering phase of a three-year study on possible solutions.The meetings on 30-31 May were by invitation only, followed by a public forum on 1 June. Attending all three were academics, industry representatives, and non-governmental organisation representatives from around the world.Day one was broken into four simultaneous all-day sessions on the topics of: the burden of disease and research and development priorities; intellectual property, research and development and access; how to best promote innovation for public health; and policies to build innovative capacity.The results of the first day meetings were presented and discussed in a plenary forum held on day two. In that forum, efforts were made to present areas of agreement, but this proved difficult in some cases. The third day offered more discussion on the same issues.The first group, on disease burden, generally agreed that the diseases afflicting the most developed 10 percent of the world will be addressed, and that there is an unavailability or lack of accessibility of drugs for low and middle income countries. The group wrestled with definitions of levels of income and the social, economic and political determinants of ill health, but saw a need for continual incentives and matching priorities.They made recommendations for the role of government and the use of regulation, and highlighted advantages and shortcomings of pharmaceutical and biotechnology companies, calling for a broadening of the field of players and scope of potential partners to address neglected diseases.The referencing of the U.S. Orphan Drug Act, aimed at encouraging R&D to develop treatments for drugs occurring in too small of a population to be profitable, set off debate. A number of participants said it is not an appropriate model for developing countries and criticized its cost-effectiveness in the United States. In this, as with a number of issues covered during the event, participants said more and better data is needed.A heated exchange came on day two after a U.S. biotechnology industry representative, Lila Feisee of Bio, lashed out at the WHO policy process, calling it “extremely discouraging,” as her industry is ready to help but is not being called upon and instead is facing the possibility of their patents being ignored for public health reasons.“I’m going to have to let people know their livelihoods are in jeopardy,” Feisee said, noting that many biotech companies are small but willing to take risks because of the patents they hold. “If you all really want to do something, take these patent issues off the table. Instead of sitting there threatening the livelihood of these people you ought to work with them.”Meeting chair Jean Larivière, an Ottawa consultant and former official, then said that “the other side of the equation” is that there are people in developing countries who say they need more access.Jamie Love, director of the Consumer Project on Technology, told Feisee that instead of worrying about U.S. livelihoods, “You should spend some time thinking about how lives are stake.” He asserted that hundreds of billions of dollars are earned each year by the pharmaceutical industry from high prices, but that “not much” of that goes back into R&D.The second group’s views were so polarized that agreement was not attempted and presenting results became problematic. Some participants suggested that more data could help clear up diametrically opposed assertions. The third day, John Walsh, a professor at the University of Tokyo, re-summarized the session and presented a few areas of common ground. These included that patenting is not stopping academic research and drug development, and that there is some excluding of competition as a result of patents. He said it is unknown whether stronger or weaker patents will lead to more research.In the session, assertions were made, for instance, that compulsory licenses, which allow developing countries to circumvent patents on particular drugs or other items for public interest reasons such as health emergency, are not an instrument for fostering research and development. But some debate later arose as to whether this is an important or relevant distinction.Another recommendation was to exclude chapters on intellectual property from free trade agreements in order to prevent inclusion of provisions that extend beyond those agreed to under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).In the third session, ideas for stimulating innovation for neglected diseases and promoting access were discussed. Participants generally agreed that a single solution is unlikely, but rather a mix of push and pull mechanisms, public-private partnerships and strengthening capacity.The fourth session, on building local innovative capabilities in developing countries, covered a range of existing and proposed strategies. Existing industry programs targeting training in developing countries were discussed, and it was noted that the WHO has a tropical diseases research program that could be modified. Suggestions also were made to better convert academic research into applied R&D and development, for a more effective role for government, and for improving drug regulatory authorities’ processes. There also was an emphasis on how traditional medicines can be used more effectively to generate new products and lead to affordable treatments.At the public forum on day three, a wide range of speakers presented views. CIPIH has posted the presentations to its website at: http://www.who.int/intellectualproperty/events/openforumpresentations/en/index.htmlThe CIPIH was created after WHO member nations at the May 2003 World Health Assembly agreed on the need to further consider the relationship between intellectual property rights, innovation and public health, particularly in the context of developing countries. The commission began work in February 2004, has gathered input until now (and will continue through its website), and will analyze and prepare a draft report on the results by January. After workshops in February, the studies will be finalized at the end of March 2005.The commission requested a series of papers on the four themes from key stakeholders, which provided a basis for in-depth discussions in each area. Topics receiving significant attention included public-private partnerships and other incentives to innovation, pricing and availability of medicines. Traditional knowledge received a greater degree of attention than before in the commission.Commissioned Papers Show Diversity Of ViewsStudy findings showed a lack of incentives for firms to develop medicines for diseases primarily afflicting people in developing countries have been “weak or nonexistent,” according to Frank Lichtenberg of Columbia University. This could account for the lack of a relationship between the burden of disease in developing countries and the amount of pharmaceutical innovation, he said.Peter Hall, a consultant, found that a “significant need” exists for basic research, product R&D, and operational and health systems research in the field of reproductive health. Among other recommendations, he called overall funding for R&D in reproductive health “bleak” and proposed international donors form a global reproductive health commodity access facility to act as a financing facility. The western private sector has little incentive to participate in “difficult” developing world markets when the “accessible” developed world is buying products with a total sales value more than 50 times greater, he said.Anthony So, Arti Rai and Robert Cook-Deegan, all of Duke University, co-authored a study on how intellectual property and technology transfer practices influence the availability and affordability of biomedical technologies related to developing countries. Using available data and focusing on academic research centers, non-profit institutions and the public sector, the authors surmised that the “rush towards proprietary rights in public sector biomedical research” could have an impact on developing countries even if the patents are not filed in those countries. They recommended humanitarian licensing, and collective action, possibly through pooling and by the scientific community.Sisule Musungu of the South Centre and Cecilia Oh of the WHO found that the flexibilities allowing countries to avoid restrictive terms under the World Trade Organization Agreement on Trade-Related Intellectual Property Rights in cases of public interest could be used to promote access to medicines. They recommended the implementation of intellectual property rules and policies ensure a response to public health needs; a sustainable supply of affordable, quality medicines; competition; and the provision of a wide range of pharmaceuticals and equal opportunities for countries in need.They also made recommendations regarding effective use of the WTO declaration on TRIPS and public health, such providing broad grounds for the granting of compulsory licenses; limiting time for negotiations for voluntary licenses; preventing national-level restrictions on the declaration terms; and preventing litigation by patent holders from suspending implementation of a compulsory license.Sudip Chaudhuri of the Indian Institute of Management said that in India, some new drugs emerged primarily from the government laboratory, but that the lab’s drug development program is limited by its lack of commercial orientation. Indian companies have adopted a model of developing new molecules and licensing these to multinational corporations in early phases, which has resulted in Indian companies not targeting the neglected diseases of developing countries but rather the global diseases of interest to the corporations, he said.Jean Lanjouw of the University of California, Berkeley, said that it is intuitive that fixed costs associated with launching new products would mean weaker price regulation and stronger intellectual property would facilitate product entry due to firm profit. But, she said, an “interesting economic problem” is that intellectual property ownership also gives control over launch decisions to multinational firms with global interests, and they may delay or even avoid launching drugs in lower-priced countries out of concern for pricing in other markets.Lanjouw and Margaret MacLeod of the University of Delhi found in a separate study that statistics showed the level of innovative activity related to diseases specific to poor countries “remains extremely low relative to pharmaceutical research overall.” For instance, survey results showed that in 2003, no more than 10 percent of R&D expenditure in India was directed at creating new products specifically suited for developing country markets.Jon Merz of the University of Pennsylvania reported on interviews of U.S.-based product development public-private partnerships, which are non-profit entities sponsoring or performing R&D in basic research, testing, licensing and manufacturing. Most survey respondents did not see intellectual property issues as “insurmountable,” but as “clearly requiring substantial efforts in time and money to manage,” he said.Padmashree Gehl Sampath of the United Nations University found in a study that Indian firms will face “severe challenges” in adapting to the new patent regime there. He recommended more Indian government investment in building local regimes for handling patent protection, such as competition enforcement agencies. He said the new Indian patent law has several provisions that raise questions about whether TRIPS flexibilities are permissible, and recommended that other rules affecting industry only be adopted after considering the impact on India’s generics industry. He also recommended the promotion of awareness of compulsory licensing, and of R&D into diseases of the developing world.Stephen Maurer of University of California, Berkeley, compared proposals on funding research. One called “end-to-end” would use subsidies to boost prices that least-developed countries pay for new drugs, reinvigorating incentives for private sector investments while leaving R&D decisions in the private sector. The other he examined is called “pay-as-you-go” and would create the non-profit equivalent of private drug makers, leaving control of R&D with the public sector but outsourcing most of the work to private vendors. Maurer said neither method would be perfect and recommended the decision be made on cost, not ideology and sentiment.Adrian Towse of the Office of Health Economics reviewed market and intellectual property-related proposals and said that most research in neglected diseases is conducted through public-private partnerships. But he said commercially-based incentive mechanisms have the potential to complement the partnerships. He referenced two existing incentive mechanisms — orphan drug legislation and a pediatric initiative — in concluding that several “pull” incentives have the greatest potential to generate the needed innovation to help developing countries.These incentives cited by Towse include transferable intellectual property rights under which a company is awarded additional intellectual property on a product of its choice in exchange for developing a given neglected disease product. Other options are to give the company more rapid regulatory review for a product of its choice, or to give advance purchase commitments through a guaranteed purchase fund.A paper on public-private partnerships for product development by Elizabeth Ziemba made a number of recommendations for addressing financial sustainability, scientific challenges, governance and accountability, role in developing capacity in low-income countries, product delivery to developing countries.Bhushan Patwardhan of University of Pune, India, said traditional medicine offer a vehicle for affordable health to underserved populations in developing countries, but highlighted a number of policy concerns. He compiled recommendations such as WHO inviting a collaborative project to collect primary data on traditional medicines in developing countries, and for WHO collaborative centers to be developed to conduct research in traditional medicine.Other recommendations are for WHO to lead a social marketing campaign to disseminate data on traditional medicine, develop ways to treat diseases afflicting developing country populations based on traditional medicine, and fast track through world bodies intellectual property rights protection so that knowledge is kept available to modern science but the major portion of profits from TM-derived knowledge and technology be channeled to the needs of populations that historically kept that knowledge.The Centre for Management of IP in Health R&D (MIHR) contributed a paper on innovation in developing countries to meet health needs, looking at the cases of Brazil, China, India and South Africa. The centre found a need to develop national systems of innovation directed at health and diseases of the poor, as the private sectors in the four countries mirror their developed country counterparts in not being oriented toward such diseases.The group recommended pursuing increased trade between developing countries and seeking to establish price controls on a regional basis, and leaving it to each country to expand domestic markets to underserved rural areas as their economies grow. It also said governments should provide tax incentives to small companies in biotechnology, expand R&D centres, encourage the continued growth of the generic drug production industries, and expand capabilities in intellectual property management and policy formulation, plus explore ways to work with the TRIPS framework. In addition, it called for governments to promote the formation of public-private partnerships.Reiko Aoki of Hitotsubashi University and Tomoko Saiki of the Tokyo Institute of Technology discussed Japan’s situation since the introduction of product patents there in 1976, finding that the availability of products has not been harmed, among other things. The authors recommended considering public health policy and industrial policy separately, since in Japan product patents were introduced from the industrial policy standpoint.Qian Jia of the Institute of Science and Technology in China discussed traditional Chinese medicine, which dates back thousands of years and currently accounts for about 40 percent of all health care delivered. The author said there is a need to ensure the sustainable supply of wild animals and plants used in traditional Chinese medicines, and that methods to protect traditional knowledge including Chinese medicines from unauthorized use need to be developed. Practical measures would be to create a database of traditional Chinese medicine knowledge, and intellectual property service agencies. In addition, the government also should promote training in the appropriate use of these medicines, and their place in the existing framework of science and technology should be better understood, he said.Muge Olcay of the CIPIH secretariat and Richard Laing of the WHO studied tariffs on medicines internationally and found that many countries do not impose such tariffs, and those who do put them more on finished pharmaceutical imports than on vaccine imports. The authors concluded that tariffs have a “very limited impact” on pharmaceutical prices in most countries, and recommended that such tariffs be discontinued altogether.Sauwakon Ratanawijitrasin of Chulalongkorn University in Thailand provided a paper on drug regulation and incentives for innovation in the countries of the Association of Southeast Asian Nations (ASEAN). They found that drug regulatory frameworks in ASEAN do not appear to discourage R&D of drugs and vaccines, and that the region lacks human and financial resources. Only Singapore has a registration system that relies on product assessment and approval of other competent drug regulatory frameworks. All of the ASEAN countries are net importers of pharmaceuticals, and only Singapore has capability for new drug development. Health insurance levels across ASEAN vary. The author made recommendations to address these issues.Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Related"Health Experts Debate Solutions For New Treatments, Access To Medicines" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.