Regulatory reforms critical to improve patient access to medicines in EU

The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers.

Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.

The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease and diabetes. The regulatory framework must be tailored so that these medicines can readily get to the patients and healthcare professionals who need them.