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6 J. World Intell. Prop. 139 (2003)
An International Standard of Protection for Test Data Submitted to Authorities to Obtain Marketing Authorization for Drugs: TRIPS Article 39.3

handle is hein.journals/jwip6 and id is 135 raw text is: An International Standard of Protection for Test Data Submitted to Authorities to Obtain Marketing Authorization for Drugs TRIPs Article 39.3 Lucas R. ARRIVILLAGA* I. INTRODUCTION A process of marketing authorization for drugs involves a considerable amount of economical and human resources and takes place in different stages over a long period of time-seven years on average in the developed countries. It is easy to be aware of the fact that there are a great number of interests and reasons behind the procedures to obtain marketing authorization for drugs (medicines and agro- chemical drugs): public health policies; large investments; free entry to the markets; unfair competition; and unjust enrichment situations, to name but a few. From an economical point of view, the necessity to regulate the system has been acknowledged and Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), is an initiative to address this issue in the international framework, giving the first international standard of protection for the information involved in this procedure. However, the provision does not seem to be clear enough and thus does not give any kind of certainty to this issue. The lack of clarity over some basic issues related with this process, for example: - what kind of drugs would be considered new, or better; - where the test of newness of the drug should be performed; - information concerning the previous registration of the drugs; - the imprecise limitations of the provision in the framework of the intellectual property category; * Lawyer, University of Belgrano, Buenos Aires, Argentina; Member of the Buenos Aires Bar Association; post graduate in international intellectual property law from the University of Torino and the World Intellectual Property Organization (Wipo) Academy. The author may be contacted at: <ducasarrivillaga@yahoo.frn.

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