Duncan Matthews

Globalising intellectual property rights : the TRIPs agreement

1. Origins of the TRIPS Agreement 2. Negotiating The TRIPS Agreement 3. Content of the TRIPS Agreement 4. Implementing The TRIPS Agreement 5. Impact of the TRIPS Agreement On Developing Countries 6. Future of the TRIPS Agreement

Implementation and Enforcement

European Union (EU) environmental policy is intended to have particular outcomes. Achieving these outcomes requires EU environmental law to be implemented and enforced effectively in the member states. This is the final stage of the ‘loop’, which involves policy being conceived, drafted in legislative form, adopted as EU legislation, and implemented and enforced by the member states. It is only by observing the entire loop that the impact of policy decisions can be fully evaluated. No matter how appropriate the design and form of a legislative instrument may be, objectives will not be met unless EU environmental legislation is correctly implemented into national law, then applied and enforced effectively by the competent national authorities. This, in turn, can have profound implications for the design and content of EU environmental policy in the future.

When Framing Meets Law: Using Human Rights as a Practical Instrument to Facilitate Access to Medicines in Developing Countries

Although it is recognized widely that human rights-based approaches have underpinned substantive arguments in favor of utilizing the full range of flexibilities contained in the TRIPS Agreement to ensure access to medicines, the extent that human rights have been used by health activist NGOs in developing countries is far greater than previously thought. This paper outlines how NGOs have used concrete human rights principles enshrined in national constitutional law as a practical tool in their access to medicines campaigns.

The University: Industry Interface in the Generation of Intellectual Property

This involves effective relations with the corporate sector, within an adaptive, evolving, bargaining framework. Based on an extensive interview programme, this paper explores the nature of that relationship in the context of the organisation and objectives of both partners and in the light of the developing competitive environment. It identifies the key elements on which bargaining tends to be focused and, in the light of organisational and market analysis which is ultimately developed into a bargaining model, offers predictions as to the likely outcomes of the bargaining.

The Climate Change Policy of the European Union

The climate change issue hit the European political agenda amid a set of circumstances which should have benefited the development of an effective policy strategy. Collier (1996a, p. 2) describes the period around the late 1980s as the ‘heyday’ of EU environmental policy, with the advent of qualified majority voting, the acceptance of ‘sustainable growth’ as an objective of the EU and increased emphasis on the need to integrate environmental objectives into all other areas of EU policy. Climate change was also identified as a priority in the fifth Environmental Action Plan. Yet, as Wagner (1997, p. 297) notes, ‘Climate change arguably represents one of the most serious challenges facing European energy and environmental policy now and in years to come’.

NGO Coalitions and the Global Access to Medicines Campaign: The Impact of Intellectual Property Rights on Developing Countries

When the World Trade Organisation (WTO) Agreement on Trade-Related Intellectual Property Rights (the TRIPS Agreement) was being negotiated between 1986 and 1994, it was argued that these benefits would include increased foreign direct investment (FDI), higher levels of technology transfer or licensing leading to the transfer of know-how and expertise that would contribute to local economic growth and higher levels of domestic innovation. However, there was relatively little substantive debate about the potential for adverse effects to result from higher standards of intellectual property rights protection and enforcement in the developing world (Matthews 2002: 108).

Counterfeiting and Public Health

In the debate about counterfeiting and public health there is a tendency to conflate three distinct issues: first, counterfeit goods that infringe trademarks; second, medicines suspected of infringing patents; and, third, falsified medicines which contain the wrong or insufficient active ingredients. By conflating issues of counterfeiting with patent infringement, the seizure of generic drugs by the Dutch customs authorities under the auspices of the EU Border Measures Regulation raises the prospect that public health imperatives are being jeopardized by a tendency to merge concerns about counterfeit goods that infringe trademarks, with the debate about how best to deal with medicines suspected of infringing patents. In fact, the most immediate concern for public health lies elsewhere with falsified medicines which contain the wrong or insufficient active ingredients that may be a risk to human health.

Intellectual Property Rights, Human Rights and the Right to Health

The paper analyses tensions between intellectual property rights, human rights and the right to health in four respects. First, it considers whether intellectual property rights are human rights by reappraising, in particular, Article 27 of the Universal Declaration of Human Rights, Article 15(1) the International Covenant on Economic, Social and Cultural Rights, and the report of the High Commissioner on Human Rights on the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Second, it looks at the tensions between intellectual property rights and the right to health, specifically in relation to whether a rights-based approach to health can be used as a mechanism to facilitate access to medicines, re-examining Article 25 of the Universal Declaration of Human Rights and Article 12 of the International Covenant on Economic, Social and Cultural Rights. Third, it discusses the implications of the right to health for intellectual property rights with reference to the experiences of using a human rights-based discourse to assert the right to health in the context of pharmaceutical product patents, compulsory licences and access to medicines, particularly anti-retroviral drugs for people living with HIV/AIDS in Brazil and South Africa. Fourth, the paper concludes by drawing attention to two significant initiatives at the World Health Organisation (WHO) with human rights implications: the WHO the Resolution on Public Health, Innovation and Essential Health Research and Intellectual Property Rights of 27 May 2006; and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property of 24 May 2008.

Rule Making in Pursuit of a Single European Market

The paper explores the nature of rule systems in the Single European Market. It investigates the influence of firms in the legislative process and examines corporate responses in rule-governed conditions within the Single Market. It demonstrates that there have been very diverse outcomes for different sectors as a result of the manner in which rules have been formulated and implemented, and derives interpretations which may have a future bearing on the revision and refinement of Single Market legislation

Exclusivity for biologics

The chapter focuses on the barriers to market entry that data and market exclusivity can create for biosimilars. The chapter traces the evolution of legislation and recent developments in the United States (U.S.) approach to the market regulation of biologics and biosimilars, identifies the key differences between the U.S. and the European Union (EU) approaches to exclusivity for biologic therapies and analyses the implications of the Trans-Pacific Partnership Agreement (TTPA) for the exclusivity of biologic products and market entry of biosimilars in the future.