EU pharmaceutical legislation: The European Commission sets a new course!

EU pharmaceutical legislation is the foundation for the quality, safety, and efficacy of medicinal products in Europe. In light of current developments and new challenges in the pharmaceutical industry, the EU Commission is pursuing a significant revision of this legislation after more than two decades. In the following article, you will learn more about the EU Commission's specific plans and how this reform could revolutionise not only the pharmaceutical industry, but also access to medicines and healthcare for patients in Europe.

The supply of medicinal products is a fundamental pillar of our healthcare systems, not only providing life-saving treatments but also contributing significantly to improving the quality of life of many people. In this dynamic environment, pharmaceutical legislation plays a crucial role, providing the legal basis for the safety, efficacy, and quality of medicines and ensuring clear and consistent standards across the EU.

In the face of constant changes and new challenges in the healthcare landscape, such as increasing global dependence on medicines, inequality in access to medicines within the EU, rising costs of innovative therapies, and growing antimicrobial resistance, the European Commission published two comprehensive proposals on April 26, 2023, to reform EU medicines law and repeal Directives 2001/83/EC and 2009/35/EC with an extensive annex.

The new pharmaceutical strategy for Europe: proposals of the EU Commission at a glance!

The European Commission's reform plans are ambitious and comprehensive. They aim to make the legal framework of EU pharmaceutical legislation more dynamic and flexible, meeting the needs of both the population and companies in the EU. One of the key aspects of the reform is to improve healthcare by making access to medicinal products easier and cheaper. It also aims to strengthen the innovative capacity, competitiveness, and attractiveness of the EU pharmaceutical industry, while always focusing on higher environmental standards.

The main points of the reform are as follows:

1.Creating a single market for medicinal products: the reform aims to create EU-wide market access in order to provide all patients throughout the EU with equally timely access to safe, effective, and affordable medicinal products.

2.Maintaining attractive framework conditions for research and development: The proposals also include measures to promote the research, development, and manufacture of medicinal products in Europe to both improve the EU’s attractiveness for investment and to strengthen the EU’s position in the global development of medicinal product.

3.Reducing administrative burdens and speeding up approval procedures: The Commission aims to significantly reduce the time between application and approval of medicinal products to obtain faster availability for patients, while maintaining high standards of quality, safety, and efficacy for approval.

4.Ensuring security of supply and combating drug shortages: The reform proposals also include measures to improve the availability of medicines and prevent drug shortages, with the European Medicines Agency (EMA) playing an important role.

5.Combating antimicrobial resistance and promoting environmental sustainability: The Commission proposes measures to combat resistance to antibiotics and reduce the input of medicinal products into the environment.

From accelerated approval procedures to drug repurposing: consequences of the reform for patients and companies!

The changes in drug law will significantly impact both patients and companies. Patients will benefit from fairer access to medicines, while companies will benefit from accelerated approval procedures, improved quality of applications, more flexible regulation, incentives for drug repurposing and orphan drugs, legal protection of innovative medicinal products, and measures to future-proof and reduce animal testing.

From draft to implementation: next steps and prospects of the EU pharmaceutical law reform!

The planned reform of EU pharmaceutical legislation is a bold step towards improving the supply of medicines, which will benefit both patients and companies in the EU. Currently, the reform is still in the early stages of the legislative process and has yet to be approved by the EU Member States and the European Parliament. It remains to be seen how the details of the reform will be negotiated and what impact it will ultimately have on the supply of medicines in the EU. One thing is certain, however: this reform has the potential to fundamentally change the supply of medicinal products in the EU and ensure sustainable and future-proof healthcare.

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