On Wednesday 10 April in Brussels, the European Parliament endorsed its position to reform EU pharmaceutical legislation in order to encourage innovation and strengthen the security of supply and accessibility of medicines.
The ‘pharmaceutical legislative package’, which substantially amends the European Commission’s proposals on medicinal products for human use, was adopted by a very large majority: the report by Pernille Weiss (EPP, Danish) amending the proposed directive was adopted with 495 votes in favour, 57 against and 45 abstentions, and the report by Tiemo Wölken (S&D, German) amending the draft regulation with 488 votes in favour, 67 against and 34 abstentions (see EUROPE 13374/11).
The issue will be followed up by the new Parliament after the European elections from 6 to 9 June. The Council of the EU has not yet adopted a position on the package.
MEPs are introducing a minimum regulatory data protection period of seven and a half years, in addition to a two-year market protection period following marketing authorisation. Pharmaceutical companies will be able to benefit from additional data protection periods under certain conditions.
MEPs support the introduction of a transferable data exclusivity title for priority antimicrobials, providing a maximum of 12 additional months of data protection for an authorised product.
On behalf of the European Commission, Commissioner Margarítis Schinás noted the great convergence of views in the European Parliament on the reform. “We can meet the needs of patients and the expectations of the market”, he said. (Original version in French by Lionel Changeur)