PUTTING HEALTH FIRST
A new pharmaceuticals incentives agenda for the EU
Incentives for pharmaceutical innovation available in EU legislative instruments are up for review following the Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States of 17 June 2016.
As a contribution to this review, EPHA hosted Medicines Law & Policy experts to launch a set of recommendations to improve the effectiveness of data exclusivity, the supplementary protection certificate and the orphan drug regulation in Europe. Medicines Law & Policy’s recommendations aim to introduce a better balanced incentive structure in the EU, to ensure new medicines are developed and become available at affordable prices.
The report EU Review of Pharmaceutical Incentives: Suggestions for Change launched at the event is available for download.
Re-live the discussion
"Take an old used drug used off label for orphan disease, buy all products, control raw material, apply for orphan destination w EU/EMA, remove competition, launch your version as orphan drug. With 10 years market exclusivity, raise the price, game the system." #HealthFirst pic.twitter.com/zoDAdO8O9Y— EPHA (@EPHA_EU) June 3, 2019
Only in 1% of cases #orphan designation has been obtained through the ROI route. This means, withdrawal clause in the Regulation cannot be triggered if these medicines become sufficiently profitable @ellenthoen @MedsLawPolicy #healthfirst pic.twitter.com/qpyt44sHJC— Ancel·la Santos (@ancelsantos) June 3, 2019