DG-Enterprise – data exclusivity prevents access to life saving drugs (in the EU), even in an emergency situation

On February 20, 2006, Martin Terberger, the Head of Unit for Pharmaceuticals in the European Commission Directorate-General for Enterprise and Industry, wrote to Greg Perry of the European Generic medicines Association (EGA). The letter was a follow-up to an inquiry from the EGA regarding “the question of data exclusivity under the European pharmaceutical legislation,” in cases where a government overrode the exclusive rights of a patent and granted a compulsory license, and/or in a case of a medical emergency.

The context of the letter was the shortage of Tamiflu within the European Union, at a time when there were increasing concerns about a potential public health emergency stemming from a severe and lethal influenza pandemic, and the inability of Roche to satisfy demand for Tamiflu, which was under patent in many European countries, but off-patent in several countries outside of Europe, including India.

The letter from DG-Enterprise shows how crazy are the EU IP and trade officials, or at least how anxious they are to sound crazy, in order to dissuade developing countries from overriding exclusive rights on data.

From the letter:

4. Conclusion

National emergency provisions in an EU Member State may allow the granting of a compulsory patent license which would allow a generic or other company to use the patented product in the Member State in question.

However, the Community pharmaceutical acquis does not currently contain any provision allowing the waiver of the rules on data exclusivity and marketing protection periods described above in the case of a national or an EU-wide emergency.

Before the expiry of the data exclusivity and marketing protection periods provided for by the European pharmaceutical legislation, applicants for a generic marketing authorization have to either (1) provide the relevant authority with the required document on pre-clinical tests and clinical trials or (2) confirm that the marketing authorization holder has consented to the use of the required documentation by the applicant.

In other words, even in the event of an emergency situation where people living in Europe were dying for lack of the availability of a drug from the patent holder, and generic supplies were available outside of Europe, there would be no way to break the test data monopoly and register the drug for a legal sale. I’m sure people residing in Europe would be surprised if this was explained to them.

Trade negotiations

Today the European Union and the United States want to globalize this insane policy, by introducing bullet-proof data exclusivity provisions in developing countries where most people are very poor. Recent examples of this are the TPP negotiation, and earlier EU positions in the India/EU FTA.

A PDF copy of the letter is attached below: