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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.

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For several years, research at the Max Planck Institute for Intellectual Property and Competition Law (MPI) - in collaboration with experts from all over the world - has examined the trend of bilateral and regional agreements that include provisions on the protection and enforcement of intellectual property (IP) rights. By building on this research, the following principles – express core concerns regarding the use of IP provisions as a bargaining chip in international trade negotiations, the increasing comprehensiveness of international IP rules and the lack of transparency and inclusiveness in the negotiating process; and – recommend international rules and procedures that can achieve a better, mutually advantageous and balanced regulation of international IP. These principles emanate from several consultations within the MPI and especially from a workshop that was held with external experts in October 2012 in Munich, Germany. They represent the views of those first signatories and are open to signature by scholars who share the objectives of the Principles

The recognition and enforcement of patents in developing countries has raised considerable controversy, particularly in relation to the implications of patents for access to drugs. Questions have arisen, among other issues, on the role of the public sector in discovering new drugs, the strategic use by the pharmaceutical industry of patents to protect not only new drugs, but also to block or delay competition. The difficulties that some developing countries have faced to use the flexibilities allowed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), such as parallel imports and compulsory licenses, have also highlighted the imbalances created by the extension of patent protection to developing countries under the World Trade Organization (WTO) rules. keywords access to medicines, patents, pharmaceutical R&D A RT I C L E 261Global Social Policy

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