Health policy remains on the European agenda

With Europe’s beating cancer plan, the European Health Union, the adoption of the EU HTA Regulation, as well as environmentally driven issues such as the ban on dental amalgam, the last legislative period saw a strong emphasis on health policy. According to the European political parties EPP, PES, EGP and EL, this should continue. Medicinal products and medical devices will also continue to be addressed.

Medical devices – new regulations after expiry of the transitional periods 

Last year, the transitional periods for the application of the new provisions of the Medical Devices Regulation were extended. The backlog of work at too few regulatory authorities but also difficulties on the part of the manufacturers have made this step necessary to avoid supply bottlenecks. Regardless of this, health policymakers from Germany have been campaigning for a further revision for some time now. It should be remembered that it was deficits in patient safety that made the reform of medical device legislation necessary in the first place. Readjustments must not lead to the standard of protection guaranteed by the new medical device regulations being weakened.

Medicines

In April this year, the EU Parliament surprisingly succeeded in adopting a position on the draft legislation to reform European pharmaceutical legislation. These form the legislative core of the European pharmaceutical strategy, which aims to improve the accessibility, availability and affordability of medicinal products. At the same time, the competitiveness of European pharmaceutical companies is to be strengthened. It can be assumed that the discussion about how long medicinal products should enjoy exclusive rights and be protected from imitators will flare up again in the trialogue in the coming legislative period.

The “Critical Medicines Alliance” was also launched in April 2024, calling on the pharmaceutical industry to find new answers to avoid supply and delivery bottlenecks. Starting with eleven products from the list of critical medicinal products, their supply chains are to be examined and made resilient. Recommendations should be available by the end of 2024. The DSV believes in working together to tackle these challenges. This requires especially one thing: transparency.