Tuesday, August 21, 2012

Arguments over a data exclusivity regime in Thailand

 Data Exclusivity is a little known area of IP law, but one that the EU and Thailand are now negotiating as part of a proposed Thai-EU Free Trade Agreement (FTA). The issue is whether data submitted for marketing approvals to a government's health authority should remain exclusive, that is locked up from others' use. The Thai government proposing a 5 year data exclusivity term. The usual anti big pharma outcry has ensued!

 Data exclusivity is controversial. Only a few countries use it, mostly developed markets. It is mentioned in TRIPs article 39.3 (but this is a version watered down from the original clearer draft), that WTO members must protect clinical data. But article 39.3 can be interpreted to prohibit only unauthorized disclosure (arguably different from regulatory approval reliance). Article 39.3 doesn't specify any term either.

Generics manufacturers seek to sell generic drugs after patent term expiry, and must provide data when they seek marketing approval. They usually seek to rely on the clinical data for safety and efficacy, submitted by the drug's originator, and then show their own data that the generic version is bioequivalent. Duplicating clinical trials is too costly for most generics companies who are often seeking to undercut the originator's price so this is a convenient shortcut. They argue that further trials are unnecessary, drive up cost to consumers, and are even unethical. Data exclusivity regimes therefore create a further "data monopoly" after the patent.

Pharma companies of course argue the massive cost of clinical trials should not be forced only on them. They seek to prevent others relying on their trials. But in many countries still they cannot prevent it. An interesting middle way is to compensate them, but this is not really used.

Of course countries are free to put in place TRIPS+ IP protection which is what some bilateral agreements seek to do. It will be interesting to see how the arguments play out in Thailand which has a history of overriding pharma protections in favour of access to medicine. 5 years is the usual TRIPS+ level many countries have adopted.

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