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The TRIPs Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals. Jakarta, 2-4 May 2000
(2000; 91 pages) View the PDF document
The TRIPS Agreement is not a uniform law, but a framework that sets (minimum) standards and conditions for the protection of intellectual property. These are made operational via the national intellectual property rights (IPR) legislation. Within the TRIPs framework, there is some room for manoeuvre, which can be used to design legislation which is in the best interest of the country. Measures to protect the public interest ought to be included in the national legislation, and should encompass public health aspects. In fact, TRIPS provides for a number of safeguards which may be used to protect public health and promote competition, such as compulsory licensing, and allows for exceptions which may facilitate the marketing of generic drugs ("Bolar exception"). These safeguards can be used to mitigate potential negative impacts of increased IPR protection in the pharmaceutical sector on access to drugs. However, these safeguards can only be used if they have been incorporated in the national legislation. Safeguards such as provisions for compulsory licensing are an essential element of IPR legislation, since they signal to the patent holder that, in the case of abuse of rights and/or non-availability of the product, a third party could be allowed to use the invention. As such, they reduce the risk of misuse of the monopoly rights conferred by a patent. However, to ensure that such safeguards can be used effectively, it is important to carefully state the grounds and conditions for their use in the national legislation. TRIPS requires that patents are granted when the typical standards for patentability, that is, novelty, inventive step and industrial applicability, are met. But the Agreement does not specify how these criteria should be defined; WTO member countries may decide how to apply these criteria. In the pharmaceutical sector, applying these criteria in a flexible way will facilitate the granting of ‘secondary’ patents, such as formulation patents, patents on polymorphs etc. Even if such secondary patents are relatively weak, they can be used aggressively to (threaten to) litigate, in order to stop competition. Therefore, defining the scope of patentability at the national level is an important issue. Similarly, enforcement rules can have significant implications, since, once a patent has been granted, there is a presumption of validity. If countries have strong provisional measures under their enforcement system, these can be used to prevent competition for instance while a lawsuit is pending (which can be several years). In the absence of competition, monopolistic pricing may reduce people’s access. However, if eventually a patent is found to be invalid or an enforcement rule to be unjustified, from a societal point of view it is important to consider who will reimburse the consumers, and how many people have in the meantime been denied access to essential medicines.
Table of Contents
View the documentEXECUTIVE SUMMARY
View the documentI. INTRODUCTION
Open this folder and view contentsII. GENERAL ISSUES
Open this folder and view contentsIII. TECHNICAL ISSUES
Open this folder and view contentsIV. SPECIAL ISSUES
View the documentVI. RECOMMENDATIONS
Open this folder and view contentsANNEXES

The TRIPs Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals. Jakarta, 2-4 May 2000

Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals

Jakarta, 2-4 May 2000

Directorate General of
Drug and Food Control


World Health


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