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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.
In a short October 1999 decision, Pfizer Inc v Canada, the Federal Court of Appeal affirmed a lower court decision that Canadian law currently provides only 17 years protection for drug patents filed before October 1989, and that the 20-year minimum period stated in intellectual property treaties negotiated under the auspices of the World Trade Organization have not (yet) taken effect in Canada with respect to these drugs.
On 6 December 2005, the World Trade Organization (WTO) amended the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow WTO member states to produce, under compulsory licences, lower-cost generic pharmaceutical products for export to countries that lack domestic production capacity to make such products. The amendment makes permanent the previous decision of 30 August 2003, which has not yet proven to be an effective mechanism to encourage the supply of more affordable medicines and other pharmaceutical products to countries in need.
The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established minimum universal standards in all areas of intellectual property. It is intended to implement these standards globally through a WTO enforcement mechanism. The present article proposes a strategy for alleviating the potentially negative impact of TRIPS in Thailand in relation to the following: purchasers; prescribers and dispensers; producers; products; price control; patent-to-third-party; parallel imports; power of the customer; patentable new drugs; personnel; and prevention policies. The following TRIPS provisions are pertinent to the pharmaceutical industry in Thailand: the limited term of product and process patents; the conditions of protection; and the broad scope for compulsory licensing and enforcement procedures in the national patent system.
In May 2000, supplementing an earlier complaint filed in May 1999, the US filed a complaint against Argentina, alleging that its patent laws violate the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Agreement). The gist of the US complaint was that Argentina's law failed to provide: (1) adequate protection against "unfair" commercial use of undisclosed test data submitted in order to get market approval of pharmaceutical products; (2) certain safeguards for compulsory licences on an invention granted on the basis of inadequate working by the patent holder; and (3) adequate measures to prevent infringements of patent rights. The US also alleged that Argentina denies certain exclusive rights of patent holders, such as the exclusive right to import the patented product into the country. At the end of May 2002, the US and Argentina notified the WTO that they had reached a "mutually agreed solution," without prejudice to their respective rights and obligations under WTO agreements, and the US has withdrawn its complaint.
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A TOPICAL SUBJECT: The patentability of living material provokes debate in the scientific and medical world, but also concerns the political and legal circles. REGARDING PATENTS: Laws govern intellectual property rights and patients. There are contradictory arguments advanced by those who are in favour or who are opposed to patents, and particular problems related to the patenting of living organisms, particularly since the progress made in genomic research. ESSENTIAL PUBLIC HEALTH REQUIREMENTS: It is important to underline the limits imposed by the protection of intellectual property, regarding the access by all to any progress issued from research. The provisions must be widened in order to bypass the patents, when the health and nutrition of populations are at stake. It is essential to come to the universal accessibility, particularly in developing countries, to all innovations and that all knowledge be shared.
In November 2001, the 4th Ministerial Conference of the World Trade Organization adopted a Ministerial Declaration on public health and the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement"). The declaration represents a modest advance in addressing concerns that strict patent laws, and threats of trade sanctions, will be a barrier to most of the world's people with HIV/AIDS accessing affordable medicines. The full significance of the declaration remains to be seen, as it depends on what political impact it has at the WTO and on its member countries, and what legal impact it will have in the interpretation of the TRIPS Agreement.
Globalization of trade, marketing and investment has important implications for public health, both negative and positive. This article considers the implications of the single package of World Trade Organization (WTO) agreements for public health research and policy, focusing on three themes: commodities, intellectual property rights, and health services. The main aims of the analysis are as follows: to identify how trade issues are associated with the transnationalization of health risks and possible benefits; to identify key areas of research; and to suggest policy-relevant advice and interventions on trade and health issues. The next wave of international trade law will need to take more account of global public health issues. However, to become more engaged in global trade debates, the public health community must gain an understanding of the health effects of global trade agreements. It must also ensure that its own facts are correct, so that public health is not blindly used for political ends, such as justifying unwarranted economic protectionism. "Healthy trade" policies, based on firm empirical evidence and designed to improve health status, are an important step towards reaching a more sustainable form of trade liberalization.
Technology transfer is the process of commercializing technology and taking it from the laboratory to the marketplace. At some stage in the technology transfer process, a due diligence will be undertaken. A due diligence is an enquiry into the technology and, in particular, its ownership. Research organizations including hospitals, universities, and blood banks need to own the intellectual property that they seek to commercialize. They own the intellectual property created by their staff in the course of employment. But volunteers, students, and collaborators, not being members of staff, will own the intellectual property that they create. This gives rise to due diligence and ownership defects, when intellectual property may in fact be owned by someone other than the research organization that seeks to commercialize it. Joint ownership can sometimes prevent commercialization. An assignment of intellectual property from a volunteer or student may sometimes be required. Such an assignment, if it inadequately deals with all relevant issues, may be void pursuant to laws throughout the world. A void deed of assignment may expose the research organization to legal liabilities. The categories of technology transfer traps to be explored are (1) ownership issues arising from the participation of students and volunteers in research, (2) ownership issues arising from collaborative research relationships, (3) ownership issues arising from the participation in research of visitors from another research organization, and (4) ownership issues arising from inventions made by employees. Each of these is considered in the context of the legal and regulatory framework in Australia, Canada, the United States of America, and the United Kingdom.
BACKGROUND: Threats by enforced Intellectual Property (IP) rights to equitable HIV treatment access by poor populations are impending. India and China's policy directions in the field will be crucial in ultimately affecting the affordability and accessibility of antiretroviral (ARV) therapy in the under-served markets. These directions, together with the exploitation level of IP-bound flexibilities and the evolutionary modelling in partnerships and trade agreements between research-based and generic pharmaceutical industry, will also affect the outcomes of self-sufficiency efforts now at their beginning in the developing world as far as domestic manufacturing of generic ARV drugs is concerned. AIMS: This paper explores key issues, implications and interaction dynamics across these challenging scenarios while attempting to provide equitable solution glimpses into the near future. RESULTS: Access-oriented long-term drug policy strategies entitled to pass muster of governments, research-based as well as generic industries in both developed and developing countries are needed if equitable access to affordable ARV treatments by poor people has to be achieved despite enforced IP rights. Predictable dynamics between western multinationals and transitional country generic corporations let regard IP-bound Voluntary License flexibilities as a fitting measure into just mentioned needs especially if substantial incentives to generic corporations are concurrently secured. Efforts to equitably expand ARV drug access through exploiting IP opportunities should encompass attainment of self-sufficiency in domestic drug manufacturing whenever basic requirements are in place in the developing world as a whole. A credible industrial potential would act, indeed, as a boosting factor for drawing branded drug producers into technology transfer agreements, the terms of which would let all contractors enjoy substantial advantages. These perspectives consistently bind up with the foreseeable long-term trade and drug policy directions of India and China according to frontier crossing implications of their key IP management trends as well as their multifaceted penetration strategies of both the wealthy and under-served markets worldwide. As coherent with these perspectives, more disbursement by wealthy country governments and donors to basic infrastructure development in sub-Saharan African nations with stable governments in place is urged both as a priority for improving Africa's economy and a prerequisite for allowing domestic industrial plants to take off. Aiming at the targets just underscored, WHO's brokering role in negotiated agreements between wealthy and developing country-based firms as well as its technical guidance in setting international standards have always to be sought if equitable and appropriate end results are to be attained. CONCLUSION: Overall insights in this paper would mean that, while research-based corporations are to be praised whenever waiving, on humanitarian purposes, part of their profits, the trade and profit rules cannot basically be given up if long-term sustainable results are the goal to look for. Only negotiated agreements securing all contracting parties lasting advantages may ensure shifting of such a goal from mere vision to a really sustainable attainment.
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.
In the last issue, we reported on a ruling of a Panel of the World Trade Organization (WTO) that Canada was in breach of the international Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). The Panel found that Canada's Patent Act does not provide the minimum patent terms required by the trade agreement. Canada appealed that decision, but on 18 September 2000 the WTO Appellate Body upheld the Panel ruling.
World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.
The first WHO essential drugs list, published in 1977, was described as a peaceful revolution in international public health. The list helped to establish the principle that some medicines were more useful than others and that essential medicines were often inaccessible to many populations. Since then, the essential medicines list (EML) has increased in size; defining an essential medicine has moved from an experience to an evidence-based process, including criteria such as public-health relevance, efficacy, safety, and cost-effectiveness. High priced medicines such as antiretrovirals are now included. Differences exist between the WHO model EML and national EMLs since countries face varying challenges relating to costs, drug effectiveness, morbidity patterns, and rationality of prescribing. Ensuring equitable access to and rational use of essential medicines has been promoted through WHO's revised drug strategy. This approach has required an engagement by WHO on issues such as the effect of international trade agreements on access to essential medicines and research and development to ensure availability of new essential medicines.
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