EU proposes reform on pharma market

By Agnes Szucs

BRUSSELS (AA) - The European Commission proposed on Wednesday to reform the bloc’s pharmaceutical market by reducing the length of authorization processes and imposing stricter reporting rules on pharma companies.

By creating a single EU market for medicines, the proposal seeks to tackle the challenges of “high prices for innovative treatments and shortages of medicines” and differences in access and prices among EU countries, the EU executive body said in a statement.

The new legislation will speed up the European Medicines Agency’s authorization procedure to 180 days from the average of 400 days.

The draft also aims to facilitate the use of generic medicines by reducing regulatory protection from 10 to 8 years, and cutting red tape for getting a marketing license for a new brand name with the same active-ingredient formula.

However, marketing exclusivity rights can be extended up to 12 years if the developing companies decide to launch the medicines in all EU countries or if the drug addresses “unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed,” the European Commission explained.

To avoid shortages, the law will impose stricter reporting rules for the pharma industry and will strengthen the EMA’s mandate to monitor and coordinate between national authorities and companies.

The proposal also reinforces the European Commission’s mandate to impose legally binding measures if the supply of critical medicines is at risk.

The EU members and the European Parliament have yet to approve the reform.