European ministers have pledged their support for a package of measures designed to speed up access to generic medicines in region.
Voting on a draft law this week, MEPs backed proposals to break down some of the barriers delaying the entry of copycat drugs onto the market, including:
Introducing a shorter price and reimbursement approval time-limit - up to 60 days - for generic medicines, to speed up availability and thus save cash for patients and health systems;
Dumping the current system of patent linkage, which links approval of the price/reimbursement of generics and biosimilars to the patent status of the originator reference product, which should help foster a more competitive market; and
Separating competences between pricing and reimbursement and marketing authorisation authorities, by not reassessing the factors on which marketing authorisation was approved (quality, safety, efficacy, etc).
"It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days," said Antonyia Parvanova, who is pushing the legislation through Parliament. "I am convinced that fair practices in our pharmaceutical market would also benefit patients and national healthcare systems", she stressed.
The European Generics Association has welcomed the plans.
“European generic medicines manufacturers are pleased that the European Parliament has correctly tackled unjustified delays and market distortions for generic and biosimilar medicines” Beata Stepniewska, EGA’s Acting Director General said, and added that the Association is "looking forward to a swift follow-up of the legislative process and constructive dialogue with the institutions".
The proposed law racked up 559 votes in favour, 54 against and 72 abstentions, and will now be negotiated with EU ministers.