161st CoR Plenary Session (19 - 20 June 2024)

Medicines shortages have been a growing problem in the European Union (EU) in recent years. As the coronavirus outbreak unfolds, the risk of bottlenecks in the supply of medicines to patients has become particularly high. More broadly, problems with the availability of, and access to, new medicines – most frequently associated with high-priced medicines – have also been a central topic in political debates for some time now. Solutions to the problem are believed to entail collaboration and joint action, as well as the involvement of multiple stakeholders, including regulators, industry, patients, healthcare professionals, and international players.

Health is a fundamental human right, and achieving equality in access to medicines is crucial for ensuring public health. The current system of innovation strongly relies on the private sector, while remuneration of innovation is mainly based on exclusivities. This system presents several issues, such as innovation being driven by market size, the partial misalignment between industry’s research and development (R&D) priorities and public health goals, access constraints, and the scarcity of disruptive innovations. In this context, this study analyses the impact of different R&D incentive mechanisms and alternative frameworks that may contribute to pharmaceutical innovation and public health. In particular, the study analyses the implications for innovation and accessibility, in terms both of prices and of availability. Based on an extensive review of the literature combined with interviews with expert stakeholders, the study offers a range of policy options.

As part of building a European Health Union, as well as in response to the Covid 19 pandemic, the European Commission proposed in November 2020 to reinforce the European Medicines Agency's role in crisis preparedness and the management of medicines and medical devices. The proposed regulation seeks to better anticipate possible shortages and to ensure timely development of high-quality medicinal solutions, to allow the EU to react to health crises more quickly, efficiently, and in a coordinated manner. The agreement on the proposal reached in trilogue negotiations now needs to be confirmed by the European Parliament.

During its April I plenary session, the European Parliament is expected to adopt its position at first reading on two Commission proposals to revise the EU's pharmaceutical legislation. The revision seeks to enhance the security of supply of medicine, making medicines more available, accessible and affordable across EU countries, while supporting the attractiveness of the EU pharmaceutical industry by fostering research and innovation.

On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU's pharmaceutical legislation. The revision seeks to enhance the security of supply of medicines, making them more available, accessible and affordable across EU countries, while supporting the attractiveness of the EU pharmaceutical industry by fostering research and innovation. The 'pharmaceutical package' includes proposals for a new directive and a new regulation that would replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. The Council has not yet adopted its position. Third edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.