BAKGRUNN (fra Kommisjonsforslaget)

EU pharmaceutical legislation has enabled the authorisation of safe, efficacious and high-quality medicinal products. However, patient access to medicinal products across the EU and security of supply are growing concerns, mirrored by recent Council conclusions and resolutions of the European Parliament 2 . There is also a growing problem of shortages of medicinal products for many EU/EEA countries. Consequences of such shortages include decreased quality of treatment received by patients and increased burden on health systems and on healthcare professionals, who need to identify and provide alternative treatments. While the pharmaceutical legislation creates regulatory incentives for innovation and regulatory tools to support timely authorisation of innovative and promising therapies, these medicinal products do not always reach the patient, and patients in the EU have differing levels of access.

Moreover, innovation is not always focused on unmet medical needs, and there are market failures, especially in the development of priority antimicrobials that can help address antimicrobial resistance. Scientific and technological developments and digitalisation are not fully exploited, while the environmental impact of medicinal products needs attention. In addition, the authorisation system could be simplified to keep up with global regulatory competition. The pharmaceutical strategy for Europe is a holistic answer to the current challenges of the pharmaceutical policy with legislative and non-legislative actions interacting together to achieve its overall goal of ensuring EU’s supply of safe and affordable medicinal products and supporting the EU pharmaceutical industry’s innovation efforts. Reviewing the pharmaceutical legislation is key to achieving these objectives. However, innovation, access and affordability are also influenced by factors outside the scope of this legislation, such as global research and innovation activities or national pricing and reimbursement decisions. Hence, not all problems can be addressed by the reform of the legislation alone. Despite this, EU pharmaceutical legislation can be an enabling and connecting factor for innovation, access, affordability and environmental protection.

The proposed revision of the EU pharmaceutical legislation builds on the high level of public health protection and harmonisation already achieved for the authorisation of medicinal products. The overarching aim of the reform is to ensure that patients across the EU have timely and equitable access to medicines. Another objective of the proposal is to enhance security of supply and address shortages through specific measures, including stronger obligations on marketing authorisation holders to notify potential or actual shortages and marketing withdrawals, cessations and suspensions in advance of a foreseen interruption to continued supply of a medicinal product to the market. To support the sector’s global competitiveness and innovative power, right balance needs to be struck between giving incentives for innovation, with more focus on unmet medical needs, and measures on access and affordability.

The framework needs to be simplified, adapted to scientific and technological changes, and contribute to reducing the environmental impact of medicinal products. This proposed reform is comprehensive but targeted and focuses on provisions relevant to achieving its specific objectives; therefore it covers all provisions apart from those concerning advertising, falsified medicinal products, and homeopathic and traditional herbal medicinal products.