Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data Under the TRIPs Agreement
Aaron Xavier Fellmeth
Arizona State University (ASU) - Sandra Day O'Connor College of Law
Harvard International Law Journal, Vol. 45, 2004
The international debate over how to balance access to medicines with the intellectual property protection demanded by their developers divides the economically developed countries from the developing countries. Economically developed countries have pushed for an interpretation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) that would confer on large pharmaceutical companies price-inflating monopolies over drugs that are neither patented nor patentable, through guarantees of exclusive rights to clinical testing data necessary to obtain marketing approval. The purpose of data exclusivity is to ensure that the initial registrant of a new drug can recover the considerable costs of testing the drug for efficacy and safety. Many developing countries see little point in granting exclusive marketing privileges to wealthy foreign drug companies so that they may sell much-needed drugs at a premium price to an impecunious population. Allowing later registrants to free ride on the data submitted by the drug's initial registrant prevents wasteful repetition of testing and facilitates rapid development of competition in drug markets.
The Article analyzes the contentions of both sides of the debate and proposes a resolution that strikes the right balance between maximizing drug developers' incentives to obtain new drug marketing approvals in developing countries and fostering free and fair competition in drug markets. The time has come to propose an alternative approach that is consistent with the requirements of the TRIPs Agreement and satisfies the reasonable policy needs of both the pharmaceutical industry and developing countries.
Number of Pages in PDF File: 60
Keywords: intellectual property, pharmaceuticals, international tradeAccepted Paper Series
Date posted: May 16, 2009
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