Statement | 17 April 2019 | Download PDF

BRUSSELS— Following the European Parliament’s approval of a Supplementary Protection Certificate (SPC) manufacturing waiver for export, Jaume Vidal, Policy Advisor with Health Action International (HAI) made the following statement:

Today’s European Parliament approval—by a huge majority—of the SPC manufacturing waiver for export almost completes the consultation process started by the European Commission in May last year.

The compromise adopted today is more closely aligned with the public health perspective than the merely commercial nature of the Single Market Strategy that shaped the consultation in the first place.

The inclusion of an evaluation mechanism to measure the waiver’s impact on access to medicines and public health is a very positive step. Allowing generic competitors to stockpile, and therefore enter domestic markets on day-one of the expiration of a patent, is evidence that MEPs have grasped the implications, opportunities and, indeed, shortcomings of the SPC.

However, the revision of IP-incentives mechanisms and other forms of market exclusivity does not end here. With increased scrutiny on orphan drugs and the national level examination of SPC, the debate around how to better guarantee access to medicines in a time of excessive prices and IP protection abuses remains wide open.

For interview requests and further information, please contact: Alex Lawrence, Communications Manager, Health Action International T: +31 20 412 4523 | E: