EP votes for stronger role for European Medicines Agency

The European Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the European Union’s medicines regulator with 655 votes in favour, 31 against and eight abstentions.

The European Medicines Agency’s (EMA) capacity to manage the availability of medicinal products and medical devices will be strengthened with the creation of two “shortages steering groups”, for medicines and medical devices respectively. These steering groups will meet regularly and whenever the situation requires, in preparation for or during a public health emergency. They will welcome expert advice from observers representing patients and medical professionals, as well as marketing authorization holders, wholesale distributors or any other relevant healthcare stakeholders.

During negotiations, Parliament successfully insisted that the members of these groups must not have interests in related industry sectors that could affect their impartiality. Summaries of the proceedings and recommendations must be made publicly available.