In April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, aimed at revising and replacing the existing General Pharmaceutical Legislation (GPL). The proposal focuses on modernising the pharmaceutical sector with a patient-centred approach, while also fully supporting an innovative and competitive industry.

Through the proposal, the EU aims to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe. The EU plans to create this environment by promoting world-class innovation, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs.

One of the sectors impacted by the proposal is that of biotechnology, which has been instrumental in the discovery and development of therapies, diagnostics, vaccines and, most importantly, advanced medicines. These ‘next generation medicines’ are delivered through a complex and interdependent biotechnology ecosystem, where companies of all sizes contribute to establishing a pathway to patients.

General Pharmaceutical Legislation. Questions to be discussed include:

• How can Europe’s biotechnology industry maintain its competitiveness in the global medical market?
• How can we establish a framework that fosters the growth of small biotech innovators?
• What are the reactions of investors to the challenges faced by small biotech companies, and how do these reactions influence the trajectory of innovation in the biotech industry?
• What strategies can be employed to establish a successful innovation pathway for biotech companies, while considering and aligning with the objectives of the reformed GPL?