Bulletin of the World Health Organizationhttps://scielosp.org/feed/bwho/2006.v84n5/2016-01-01T00:02:00ZUnknown authorVol. 84 No. 5 - 2006WerkzeugIn this month's BulletinS0042-968620060005000012016-01-01T00:02:00Z2001-01-28T00:08:00ZPublic health, innovation and intellectual property rights: unfinished businessS0042-968620060005000022016-01-01T00:02:00Z2001-01-28T00:08:00ZTürmen, TomrisClift, Charles
<em>Türmen, Tomris</em>;
<em>Clift, Charles</em>;
<br/><br/>
The impact of open access upon public healthS0042-968620060005000032016-01-01T00:02:00Z2001-01-28T00:08:00ZBarbour, VirginiaChinnock, PaulCohen, BarbaraYamey, Gavin
<em>Barbour, Virginia</em>;
<em>Chinnock, Paul</em>;
<em>Cohen, Barbara</em>;
<em>Yamey, Gavin</em>;
<br/><br/>
Intellectual property and public healthS0042-968620060005000042016-01-01T00:02:00Z2001-01-28T00:08:00ZKrattiger, AnatoleMahoney, Richard T
<em>Krattiger, Anatole</em>;
<em>Mahoney, Richard T</em>;
<br/><br/>
Public health ethics and intellectual property policyS0042-968620060005000052016-01-01T00:02:00Z2001-01-28T00:08:00ZPakes, Barry N
<em>Pakes, Barry N</em>;
<br/><br/>
Access to AIDS medicines stumbles on trade rulesS0042-968620060005000062016-01-01T00:02:00Z2001-01-28T00:08:00ZWise, Jacqui
<em>Wise, Jacqui</em>;
<br/><br/>
Rich and poor countries divided on patent treatyS0042-968620060005000072016-01-01T00:02:00Z2001-01-28T00:08:00ZNew, William
<em>New, William</em>;
<br/><br/>
Protecting traditional knowledge: the San and hoodiaS0042-968620060005000082016-01-01T00:02:00Z2001-01-28T00:08:00ZMeeting the need for treatment: the initiativesS0042-968620060005000092016-01-01T00:02:00Z2001-01-28T00:08:00ZGerhardsen, Tove Iren S.
<em>Gerhardsen, Tove Iren S.</em>;
<br/><br/>
Do patents work for public health?S0042-968620060005000102016-01-01T00:02:00Z2001-01-28T00:08:00ZCIPIH report: main recommendationsS0042-968620060005000112016-01-01T00:02:00Z2001-01-28T00:08:00ZRecent news from WHOS0042-968620060005000122016-01-01T00:02:00Z2001-01-28T00:08:00ZA clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions?S0042-968620060005000132016-01-01T00:02:00Z2001-01-28T00:08:00Zvan Zimmeren, EstherVerbeure, BirgitMatthijs, GertVan Overwalle, Geertrui
<em>Van Zimmeren, Esther</em>;
<em>Verbeure, Birgit</em>;
<em>Matthijs, Gert</em>;
<em>Van Overwalle, Geertrui</em>;
<br/><br/>
In genetic diagnostics, the emergence of a so-called "patent thicket" is imminent. Such an overlapping set of patent rights may have restrictive effects on further research and development of diagnostic tests, and the provision of clinical diagnostic services. Currently, two models that may facilitate access to and use of patented genetic inventions are attracting much debate in various national and international fora: patent pools and clearing houses. In this article, we explore the concept of clearing houses. Several types of clearing houses are identified. First, we describe and discuss two types that would provide access to information on the patented inventions: the information clearing house and the technology exchange clearing house. Second, three types of clearing houses are analysed that not only offer access to information but also provide an instrument to facilitate the use of the patented inventions: the open access clearing house, the standardized licences clearing house and the royalty collection clearing house. A royalty collection clearing house for genetic diagnostic testing would be the most comprehensive as it would serve several functions: identifying patents and patent claims essential to diagnostic testing, matching licensees with licensors, developing and supplying standardized licences, collecting royalties, monitoring whether users respect licensing conditions, and providing dispute resolution services such as mediation and arbitration. In this way, it might function as an effective model for users to facilitate access to and use of the patented inventions. However, it remains to be seen whether patent holders with a strong patent portfolio will be convinced by the advantages of the royalty collection clearing house and be willing to participate.Managing the effect of TRIPS on availability of priority vaccinesS0042-968620060005000142016-01-01T00:02:00Z2001-01-28T00:08:00ZMilstien, JulieKaddar, Miloud
<em>Milstien, Julie</em>;
<em>Kaddar, Miloud</em>;
<br/><br/>
The stated purpose of intellectual property protection is to stimulate innovation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all Members of the World Trade Organization (WTO) to enact national laws conferring minimum standards of intellectual property protection by certain deadlines. Critics of the Agreement fear that such action is inconsistent with ensuring access to medicines in the developing world. A WHO convened meeting on intellectual property rights and vaccines in developing countries, on which this paper is based, found no evidence that TRIPS has stimulated innovation in developing market vaccine development (where markets are weak) or that protection of intellectual property rights has had a negative effect on access to vaccines. However, access to future vaccines in the developing world could be threatened by compliance with TRIPS. The management of such threats requires adherence of all countries to the Doha Declaration on TRIPS, and the protections guaranteed by the Agreement itself, vigilance on TRIPS-plus elements of free trade agreements, developing frameworks for licensing and technology transfer, and promoting innovative vaccine development in developing countries. The role of international organizations in defining best practices, dissemination of information, and monitoring TRIPS impact will be crucial to ensuring optimal access to priority new vaccines for the developing world.Benchmarking progress in tackling the challenges of intellectual property, and access to medicines in developing countriesS0042-968620060005000152016-01-01T00:02:00Z2001-01-28T00:08:00ZMusungu, Sisule F
<em>Musungu, Sisule F</em>;
<br/><br/>
The impact of intellectual property protection in the pharmaceutical sector on developing countries has been a central issue in the fierce debate during the past 10 years in a number of international fora, particularly the World Trade Organization (WTO) and WHO. The debate centres on whether the intellectual property system is: (1) providing sufficient incentives for research and development into medicines for diseases that disproportionately affect developing countries; and (2) restricting access to existing medicines for these countries. The Doha Declaration was adopted at WTO in 2001 and the Commission on Intellectual Property, Innovation and Public Health was established at WHO in 2004, but their respective contributions to tackling intellectual property-related challenges are disputed. Objective parameters are needed to measure whether a particular series of actions, events, decisions or processes contribute to progress in this area. This article proposes six possible benchmarks for intellectual property-related challenges with regard to the development of medicines and ensuring access to medicines in developing countries.Essential medicines and human rights: what can they learn from each other?S0042-968620060005000162016-01-01T00:02:00Z2001-01-28T00:08:00ZHogerzeil, Hans V
<em>Hogerzeil, Hans V</em>;
<br/><br/>
Most countries have acceded to at least one global or regional covenant or treaty confirming the right to health. After years of international discussions on human rights, many governments are now moving towards practical implementation of their commitments. A practical example may be of help to those governments who aim to translate their international treaty obligations into practice. WHO's Essential Medicines Programme is an example of how this transition from legal principles to practical implementation may be achieved. This programme has been consistent with human rights principles since its inception in the early 1980s, through its focus on equitable access to essential medicines. This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms.Choosing the right incentive strategy for research and development in neglected diseasesS0042-968620060005000172016-01-01T00:02:00Z2001-01-28T00:08:00ZMaurer, Stephen M
<em>Maurer, Stephen M</em>;
<br/><br/>
For the first time in history, worldwide neglected disease budgets may be large enough to deliver a new drug every few years. That said, sponsors will only succeed if they extract maximum value from every dollar spent. This paper reviews possible cost-containment strategies and provides an evidence-based framework for choosing between them. Current proposals can be categorized as "end-to-end" proposals which require the sponsor to set a single reward for companies that complete the entire drug discovery process or "pay-as-you-go" schemes in which sponsors offer repeated rewards as drug candidates progress through the pipeline. A generic weakness of end-to-end proposals is that rewards are likely to be 20-30% higher than they would be in an equivalent pay-as-you-go programme. However, the benefits of pay-as-you-go programmes may be lost if commercial pharmaceutical companies are substantially better at choosing successful programmes than are their non-profit counterparts. The efficiency of pay-as-you-go methods depends on sponsors’ willingness to withdraw funding from failed drug discovery programmes.Data sharing and intellectual property in a genomic epidemiology network: policies for large-scale research collaborationS0042-968620060005000182016-01-01T00:02:00Z2001-01-28T00:08:00ZChokshi, Dave AParker, MichaelKwiatkowski, Dominic P
<em>Chokshi, Dave A</em>;
<em>Parker, Michael</em>;
<em>Kwiatkowski, Dominic P</em>;
<br/><br/>
Genomic epidemiology is a field of research that seeks to improve the prevention and management of common diseases through an understanding of their molecular origins. It involves studying thousands of individuals, often from different populations, with exacting techniques. The scale and complexity of such research has required the formation of research consortia. Members of these consortia need to agree on policies for managing shared resources and handling genetic data. Here we consider data-sharing and intellectual property policies for an international research consortium working on the genomic epidemiology of malaria. We outline specific guidelines governing how samples and data are transferred among its members; how results are released into the public domain; when to seek protection for intellectual property; and how intellectual property should be managed. We outline some pragmatic solutions founded on the basic principles of promoting innovation and access.DNA patenting: implications for public health researchS0042-968620060005000192016-01-01T00:02:00Z2001-01-28T00:08:00ZDutfield, Graham
<em>Dutfield, Graham</em>;
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I weigh the arguments for and against the patenting of functional DNA sequences including genes, and find the objections to be compelling. Is an outright ban on DNA patenting the right policy response? Not necessarily. Governments may wish to consider options ranging from patent law reforms to the creation of new rights. There are alternative ways to protect DNA sequences that industry may choose if DNA patenting is restricted or banned. Some of these alternatives may be more harmful than patents. Such unintended consequences of patent bans mean that we should think hard before concluding that prohibition is the only response to legitimate concerns about the appropriateness of patents in the field of human genomics.The pricing and procurement of antiretroviral drugs: an observational study of data from the Global FundS0042-968620060005000202016-01-01T00:02:00Z2001-01-28T00:08:00ZVasan, AshwinHoos, DavidMukherjee, Joia SFarmer, Paul ERosenfield, Allan GPerriëns, Joseph H
<em>Vasan, Ashwin</em>;
<em>Hoos, David</em>;
<em>Mukherjee, Joia S</em>;
<em>Farmer, Paul E</em>;
<em>Rosenfield, Allan G</em>;
<em>Perriëns, Joseph H</em>;
<br/><br/>
The Purchase price report released in August 2004 by the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) was the first publication of a significant amount of real transaction purchase data for antiretrovirals (ARVs). We did an observational study of the ARV transaction data in the Purchase price report to examine the procurement behaviour of principal recipients of Global Fund grants in developing countries. We found that, with a few exceptions for specific products (e.g. lamivudine) and regions (e.g. eastern Europe), prices in low-income countries were broadly consistent or lower than the lowest differential prices quoted by the research and development sector of the pharmaceutical industry. In lower middle-income countries, prices were more varied and in several instances (lopinavir/ritonavir, didanosine, and zidovudine/lamivudine) were very high compared with the per capita income of the country. In all low- and lower middle-income countries, ARV prices were still significantly high given limited local purchasing power and economic strength, thus reaffirming the need for donor support to achieve rapid scale-up of antiretroviral therapy. However, the price of ARVs will have to decrease to render scale-up financially sustainable for donors and eventually for governments themselves. An important first step in reducing prices will be to make available in the public domain as much ARV transaction data as possible to provide a factual basis for discussions on pricing. The price of ARVs has considerable implications for the sustainability of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) treatment in the developing world.Implications of bilateral free trade agreements on access to medicinesS0042-968620060005000212016-01-01T00:02:00Z2001-01-28T00:08:00ZCorrea, Carlos María
<em>Correa, Carlos María</em>;
<br/><br/>
The TRIPS Agreement of the World Trade Organization (WTO) mandated the introduction of protection of intellectual property rights, notably patents, for pharmaceutical products. While the implications for the access to medicines contained in the terms of this Agreement raised significant concerns, a recent new wave of free trade agreements, negotiated outside the WTO, requires even higher levels of intellectual property protection for medicines than those mandated by that Agreement. The measures involved include the extension of the patent term beyond 20 years; prohibition of use of test data on drug efficacy and safety for certain periods for the approval of generic products; the linkage between drug registration and patent protection; in some cases, limitations to the grounds for granting compulsory licences. This article reviews some of these measures that further limit the competition of generic products and discusses their possible implication for access to medicines.A human rights approach to the WHO Model List of Essential MedicinesS0042-968620060005000222016-01-01T00:02:00Z2001-01-28T00:08:00ZSeuba, Xavier
<em>Seuba, Xavier</em>;
<br/><br/>
Since the first WHO Model List of Essential Medicines was adopted in 1977, it has become a popular tool among health professionals and Member States. WHO's joint effort with the United Nations Committee on Economic, Social and Cultural Rights has resulted in the inclusion of access to essential medicines in the core content of the right to health. The Committee states that the right to health contains a series of elements, such as availability, accessibility, acceptability and quality of health goods, services and programmes, which are in line with the WHO statement that essential medicines are intended to be available within the context of health systems in adequate amounts at all times, in the appropriate dosage forms, with assured quality and information, and at a price that the individual and the community can afford. The author considers another perspective by looking at the obligations to respect, protect and fulfil the right to health undertaken by the states adhering to the International Covenant of Economic, Social and Cultural Rights (ICESCR) and explores the relationship between access to medicines, the protection of intellectual property, and human rights.Round table discussionS0042-968620060005000232016-01-01T00:02:00Z2001-01-28T00:08:00ZStaking claims in the biotechnology KlondikeS0042-968620060005000242016-01-01T00:02:00Z2001-01-28T00:08:00ZSulston, John
<em>Sulston, John</em>;
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Expanding global research and development for neglected diseasesS0042-968620060005000252016-01-01T00:02:00Z2001-01-28T00:08:00ZWinters, David J
<em>Winters, David J</em>;
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Patent policy and public health in developing countries: lessons from JapanS0042-968620060005000262016-01-01T00:02:00Z2001-01-28T00:08:00ZAoki, ReikoKubo, KensukeYamane, Hiroko
<em>Aoki, Reiko</em>;
<em>Kubo, Kensuke</em>;
<em>Yamane, Hiroko</em>;
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Report of the Commission on Intellectual Property Rights, Innovation and Public Health: an industry perspectiveS0042-968620060005000272016-01-01T00:02:00Z2001-01-28T00:08:00ZNoehrenberg, Eric
<em>Noehrenberg, Eric</em>;
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Report of the Commission on Intellectual Property Rights, Innovation and Public Health: a call to governmentsS0042-968620060005000282016-01-01T00:02:00Z2001-01-28T00:08:00Z't Hoen, Ellen
<em>'t Hoen, Ellen</em>;
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Making medicines affordable: studying WHO initiativesS0042-968620060005000292016-01-01T00:02:00Z2001-01-28T00:08:00ZHomedes, Nuria
<em>Homedes, Nuria</em>;
<br/><br/>