EU Council agrees on the revision of the general pharma legislation

The European Council of Minister last week said it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the European Union’s (EU) pharmaceutical sector fairer and more competitive.

The proposals for a regulation and directive that make up the so-called ‘pharma’ package constitute the biggest reform to the EU’s laws on medicines in over two decades, it claimed. They aim to ensure that patients across the EU have fair access to safe and affordable medicines, regardless of where they live.

It also aims to enhance the competitiveness of the EU’s pharmaceutical industry by reducing the regulatory burden and simplifying the regulatory framework, and to address issues relating to security of supply through measures aimed at monitoring and preventing shortages. Additionally, it should mitigate the environmental impact of medicines via better enforcement of environmental rules.