[Ip-health] Possible data exclusivity in free trade agreement negotiations in the Republic of Moldova (South-Eastern Europe)

Francisco Rossi francisco_rossi at hotmail.com
Thu Sep 20 16:17:53 PDT 2012


Colombia was one of the first developing countries entering into a data exclusivity regime, 4 years before the end of the negotiations of the FTA with USA.

Under the ATPDEA (Andean trade promotion (preferences) and drug erradication act) Colombia was pressed to produce the 2085/2002 Decree granting 5 years of data exclusivity,
even though the Andean common legislation considered data eclusivity as a TRIPS Plus measure.
 IFARMA foundation and Health Mission  conducted in 2011 an assement of 10 years of data exclusivity  which is published at the web page, unfortunatelly in spanish. 
Nevertheless I paste an english version of the abstract.

September the 19th 2002, the Colombian government issued Decree 2085,
"which regulates aspects of the information provided regarding
health registration for new chemical entities in medicines" in
the context of the negotiation of ATPDEA preferences. After almost 10
years, LAC-Global Alliance for Access to Medicines and in particular
and Mision
(Health Mission) foundations, present an assessment of the impacts
associated with its implementation. We have two purposes: firstly, to
contribute to the national evaluation and to propose alternatives for
improving the existing system. On the other hand, we hope it will be
useful as input for other countries negotiating or implementing
similar measures.

experience shows that citizens have paid a significant amount of
money (which implies some degree of restriction of access). For
2003-2011 is over $ 790 billion pesos ($ 412 million USD). This
expenditure is equivalent to per capita consumption of about 660,000
Colombian people. However, any of the benefits claimed by those who
defended the data exclusivity was observed. It has not been observed
to stimulate the entry of generics. It did not promote innovation and
genuine local innovation or faster entry of new products into the
market. It certainly has not been an instrument of technology

contents of Decree 2085 of 2002 leave gaps that have allowed
protection for second uses or for chemical entities similar to others
already known in the market. We present recommendations for reform of
Decree 2085, to adjust their content to the Protocol of amendment of
the FTA with the United States.

In 2009, Colombia and Peru negotiated a FTA with the EU and they asked for data exclusivity for 11 years as in your case. We, as Civil society groups, presented a fierce opposition to this extension (from 5 to 11 years) and at the end they removed the 11 years requirement. As far as we know, afterwards, the EU negotiated a similar FTA with Central American Countries without this extension (from 5 to 11 years) on data exclusivity. Certainly the situation is very different because you do not have data exclusivity at all. Any way, I hope this information could be useful for you.

Good luck 

Francisco Rossi


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