[Ip-health] Data exclusivity and its elusive exception in EU EPAs

Baker, Brook b.baker at neu.edu
Fri Dec 10 10:39:07 PST 2010

Although the leaked text of the EU-India proposal on data exclusivity has not yet been broadly leaked, we might be able to infer likely content from Europe’s previous EPA negotiation with Peru and Columbia.  There, the EU imposed presumptive five-year period of data exclusivity like that previously attained by the US in its prior FTA negotiations with Peru.  The EU language is:  “the party shall grant an exclusivity period of normally five years.”    Also like the prior US FTA, the EU/Peru-Columbia EPA also directly incorporates references to the Doha Declaration on the TRIPS Agreement and Public Health and the August 30 export/import System, but the EU does so in the general principle section, not in the data exclusivity exception section.  This could be interpreted as not creating a general acknowledgment of public health interests, but not a direct, textually based exception to the data exclusivity rule.

On breaking data exclusivity, the EU FTAs with Peru and Colombia state that parties “may” regulate the terms of breaking data exclusivity for “reasons of public interest, situations of national emergency or extreme urgency, when it is necessary to allow access to those data to third parties.”   By comparison, the U.S. FTA states "a party may take measures to protect public health in accordance with the Declaration on the TRIPS Agreement and Public Health."  The USTR has subsequently clarified that there can be exceptions to data exclusivity both in the case of compulsory licenses (when a patent must be circumvented) and in non-patent cases when public need needs so require.

I think that Europe has been trying to impose a stricter interpretation of the Doha flexibilities than did the US by requiring that exceptions to data exclusivity must “necessary” rather than broadly permissive. The strict necessity threshold, which generally requires proof that there is no alternative, could limit the likelihood the EU would allow a data exclusivity period to be broken by a trading partner for the generic manufacture of drugs for public health needs.

Although the European law allows data exclusivity periods to be waived for export of drugs produced within the EU as part of its implementation of the paragraph six amendment of the Doha Declaration on the TRIPS and Public Health, the EU's rigid stance that data exclusivity periods not be breached for drug shipments among its own member states is arguably being reflected in the EU interpretation of Doha Declaration codified within its previously negotiated EPAs.  Although European national legislation on data exclusivity actually varies, the EC espouses an “absolute form of data exclusivity” among member states whereby the data exclusivity period should not be breached even if a compulsory license is obtained and even if there is an emergency situation. For example, in 2006 a subdivision in the European Commission said generic drug manufacturers armed with a compulsory license wanting to produce Tamiflu for an outbreak of the bird flu could not overcome the data exclusivity period without providing their own test data or obtaining the marketing authorization data from the original producer.

As I understand it, some degree of product registration is required in India to produce medicines for export.  Much more certainly, registration is required for domestic marketing approval.  Accordingly, if data exclusivity is indeed in the proposed EU/India EPA and if it includes exception language as restrictive as that in the EU/Peru-Columbia EPA, then exercising that exception might prove difficult, even when a compulsory licenses that allows export is issued.  Of course, the presence of data exclusivity would also tie generic producers ability to supply need in India as well during the period of exclusivity.


Professor Brook K. Baker
Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

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