CPME puts forward its position on the EU pharma legislation revision

Whereas the publication of a new legislative proposal following the revision was originally planned for Q4 of this year, it is estimated to suffer delays until at least Q2 2023.
The position paper is one of many perspectives and points of concern put forward by key stakeholders at EU level about the shaping of this historical reform - and touches upon some of the trickiest points of discussion, such as resilient supply chains, system of incentives, and market exclusivity. The achievement of the priorities outlined by CPME could highly benefit from the employment of In Silico technologies, whereas the revision envisions fostering the use of artificial intelligence and data analytics for drug discovery and development.

With its position, CPME calls upon the EU to prioritize among others the following aspects within the revision:

• To ensure availability of centrally approved medicines, pharmaceutical companies should be obliged to launch their products in all Member States.
• Ensure that the revised legislation will require that the R&D costs of medicines are transparent and include a breakdown between private and public investments.
• Prevent and manage medicine shortages by implementing notification requirements, safety stocks of medicines and deterring penalties for non-compliance.
• That any exclusivities granted to pharmaceutical companies to incentivise medicine development must be proportionate and prevent excessive prices and profits.
• To ensure the safety and high quality of approved medicines, the revised legislation should limit the use of accelerated and conditional procedures and strengthen the obligations and requirements for market authorisation holders.
• Medical professionals should have a clear process to feedback any adverse events experienced by their patients to promote patient safety.

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The CPME is the European association representing national medical associations across Europe, and is devoted to representing the medical profession’s point of view within EU policy-making.