MEPs call for national and EU measures to guarantee all patients have safe and timely access to essential and innovative medicines.
The Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday, with 62 votes in favour, 8 against and 8 abstentions, its recommendations on the implementation of the EU’s pharmaceutical strategy and upcoming revisions to the legislative framework.
Addressing the root causes of shortages
MEPs highlight the need for increasing the affordability and availability of medicines. This means addressing the root causes of shortages, increasing transparency on prices and public R&D funding, promoting collective price negotiations, and introducing measures to support a greater market presence for generic and biosimilar medicines.
MEPs insist that the Commission, member states and the European Medicines Agency should develop an early warning system for medicine shortages, based on a transparent and centralised digital European platform.
Increasing EU resilience and sustainability
The report also stresses the need for the work of the pharmaceutical industry to be environmentally friendly and climate-neutral throughout product life cycles, while still ensuring patients have access to safe and effective pharmaceutical treatments.
Other recommendations include:
-introducing an EU therapeutic guide for antimicrobials and coordinated awareness campaigns on antimicrobial resistance (AMR);
-promoting “Made in Europe” pharmaceuticals by strengthening EU manufacturing and supply resilience;
-developing adequate capacity for the sustainable production of active substances, raw materials and medicines which reduce dependence on external sources;
-facilitating the launch of large clinical trials coordinated at the European level;
-Setting up a wider political High Level Pharmaceutical Forum.
Rapporteur Dolors Montserrat (EPP, ES) said: “The report enhances the EU’s pharmaceutical strategy in view of the next revision and update of EU pharmaceutical legislation, putting patients at the centre of health policies. We must firmly tackle unmet medical needs and foster access to medicines, while promoting the sustainability of our national healthcare systems. At the same time, we must strengthen EU public-private partnerships for a strategically autonomous and resilient pharmaceutical industry, supported by an effective incentives system and ruled by a stable, updated and safety-centred regulatory system”.
All MEPs will vote on the report during the November plenary session, the result of which will then feed into Commission’s proposals for the update of EU pharmaceutical legislation in 2022.
On 25 November 2020, the Commission adopted a pharmaceutical strategy for Europe, a major initiative under the European Health Union. Its goal is to give the EU's pharmaceutical policy a long-term vision: to ensure it is crisis-resilient and sustainable, and to reinforce EU's position as a global leader while ensuring access to affordable medicines for patients.