Compulsory Licensing Decided by Member States, European Commission Says

The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis.

The statement comes in response to concerns raised by a member of the European Parliament that the high price of drugs, such as Gilead’s Sovaldi, hampers public health efforts to aid the thousands of people in Europe who need urgent treatment for hepatitis C.

At $84,000 for a full 12-week course, Sovaldi (sofosbuvir) has come under intense criticism for its price.

In March, Spanish lawmaker Ernest Urtasun asked the Commission if hepatitis C patents could be purchased at the EU level or if the European Medicines Agency could jointly negotiate their purchase.

In a response, Commissioner Elzbieta Bienkowska says neither the Commission nor the EMA has the authority to acquire patents or issue compulsory licenses. Patent law — including compulsory licensing — is mostly determined by national laws and “it is for each member state to … assess whether the applicable conditions for exceptions and limitation apply,” she explains.

Jarrod Tudor, a professor at Kent State University in Ohio and an expert on EU law, says there are other ways to address the issue of drug pricing and patient access. The Court of Justice of the European Union can use its antitrust authority to take action against a drug company it believes is abusing a monopoly position by directly or indirectly imposing unfair prices.

Read the question and answer, respectively, at www.fdanews.com/6-15-EP-Question.pdf and www.fdanews.com/6-15-EC-Answer.pdf. — Jonathon Shacat