ENVI committee adopts reform of EU Pharmaceutical Law: a clear step forward for access to medicines, transparency and environment

Today, a majority of MEPs in the European Parliament’s ENVI Committee adopted the two reports for a reform of the EU pharmaceutical law. An important step towards revising the European Union’s pharmaceutical law. The reports include substantial wins for transparency in the pharmaceutical market, which will help to improve the balance between the public and private interests. 

The negotiating team of the Greens/EFA Group in the European Parliament was led jointly by MEPs Tilly Metz (Luxembourg) and Margrete Auken (Denmark). 

Tilly Metz comments: Negotiations for the reform of the EU pharmaceutical law were not easy, mainly due to the strong pharma lobby. As Greens/EFA, we would of course have loved to improve the pharmaceutical system even more, but what we managed to reach is an agreement that is an acceptable compromise. It will have a positive impact on patients across Europe through increasing transparency of R&D costs, sustainable incentives for new antimicrobials, additional safeguards attached to the transferable exclusivity voucher, as well as ambitious measures to address medicine shortages. On top of this I am pleased to say that we managed to strengthen alternatives to animal testing and ensure greater inclusion of women in clinical trials”.

Margrete Auken comments: I tend to say that dealing with the pharmaceutical industry makes the tobacco lobbyists seem like good people. Negotiating this law did not make my impression any better, but I am proud of what we achieved. We won environmental risk assessments in both manufacturing, use and waste of medicine. We secured stronger provisions to stop the rise of antimicrobial resistance. There are new rules on advertisement of medical products – also by influencers and an obligation to launch products in all member states. The fight about protection periods was neither won nor lost. It is a compromise, and we avoided a nightmare for the member states’ health sector economies. 

The position  of the ENVI committee represents a long-negotiated compromise and is a good starting point for negotiations with the Council. The plenary vote is scheduled for 11 April. The inter-institutional negotiations will start once the Council adopts its mandate.