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Going beyond TRIPS: TRIPS plus provisions
In recent years, many developing countries have been coming under pressure to enact or implement tougher or more restrictive conditions in their patent laws than are required by the TRIPS Agreement – these are known as ‘TRIPS plus’ provisions.  Countries are by no means obliged by international law to do this, but many, such as Brazil, China or Central American states have had no choice but to adopt these, as part of trade agreements with the United States or the European Union.  

Common examples of TRIPS plus provisions include extending the term of a patent longer than the twenty-year minimum, or introducing provisions that limit the use of compulsory licences or that restrict generic competition.  

Data exclusivity
One of these provisions is known as data exclusivity.  This refers to exclusive rights, granted over the pharmaceutical test data submitted by companies to drug regulatory authorities for obtain market authorisation.  It means that information concerning a drug’s safety and efficacy is kept confidential for a period of, say, five or ten years.

If a generic manufacturer wants to register a drug in that country, it is not allowed simply to show that their product is therapeutically equivalent to the originator product.  Instead, it must either sit out the exclusivity period, or take the route of repeating lengthy clinical trials to demonstrate the safety and efficacy of the drug – trials that have already been undertaken.  This happens even when the originator product is not patented.  

In other words, data exclusivity is another way of preventing competition, so that even when a medicine is not protected by a patent, a pharmaceutical company will receive a minimum period of market monopoly when artificially high prices can be charged.

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Last updated: January 2009