Recent medicine shortages across Europe have highlighted critical gaps in the resilience and security of our healthcare systems, prompting decisive action from the European Commission. Through an ambitious overhaul of pharmaceutical legislation, the Commission aims to strengthen supply chains, ensure reliable access to essential medicines, and foster sustainable innovation. But will these measures go far enough to secure Europe’s health future? How will they impact other aspects of the pharmaceutical sector, from cost and production to job availability? This article explores the key pillars of the proposed Directive and Regulation, examining the far-reaching implications of these changes and addressing pressing questions on the path to a more resilient and responsive healthcare framework for the EU.

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation that revise and replace the existing general pharmaceutical legislation, under the following documentation:

• Proposal for a Directive of the European Parliament and the Council of the Union code relating to medicinal products for human use, repealing Directive 2001/83/ EC and Directive 2009/35/EC.

• Proposal for a Regulation of The European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use, establishing rules governing the European Medicines Agency, and amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014, and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

The new proposed Directive is based on four pillars, which include legislative and nonlegislative elements:

1. Ensuring access to affordable medicines for patients and addressing unmet medical needs (in areas such as anti-microbial resistance and rare diseases).
2. Supporting competitiveness, innovation, and sustainability of the EU’s pharmaceutical industry, and the development of high-quality, safe, effective, and greener medicines.
3.  Enhancing crisis preparedness and response mechanisms, securing diversified and resilient supply chains, and addressing medicine shortages.
4. Ensuring a strong EU voice in the world, by promoting a high standard of quality, efficacy, and safety.

In this article, we will focus mainly on the third pillar ‘Enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, and addressing medicine shortages’; at the same time, we will discuss the common elements across all four pillars and how they relate to each other. For instance, developing high-quality, safe, effective, and greener medicines inevitably impacts the robustness and sustainability of the supply chain, awareness of utilisation, and medicine shortages. As stipulated in the new proposed Directive, a Marketing Authorisation Holder must ensure the appropriate and continuous supply of a medicinal product throughout its lifecycle, regardless of whether it is covered by a supply incentive.