ready spring 2023

The proposal of European pharmaceutical law reform will be ready for adoption this spring. This is confirmed by sources from the European Commission (EC) to Medical Writingwho ensure that the project, which germinated in 2020 with the harshest of the Covid-19 pandemic and opened a public consultation at the end of 2021, is expected to be ready to ‘take off’ at the end of March.

“The reform of pharmaceutical legislation is one of the main priorities of the Commission in the field of health since the beginning of the mandate of this Commission in 2019”, they explain from the EC and confirm that the work “is in progress” and that the Commission aspires “to an adoption as soon as possible”. At the moment, the project is in the middle of the internal quality control process applicable to the important legislative proposals related to this reform.

“This quality control process is essential, and we will always give preference to quality over speedespecially in the case of a proposal as significant and far-reaching for our patients and the industry as this one”, they explain from the EC. Thus, in this sense, the proposal is expected to be ready in March.

This reform will undoubtedly be the basis of the reform of the drug law that is being prepared in Spain. The Law on Guarantees and Rational Use of Medicines, which aims to start a new era for the sector, has not yet seen the light of day, and everything indicates that part of it will be based on the new European pharmaceutical regulation. As well as the Strategic Plan for the Pharmaceutical Industry, which has objectives such as advancing in the promotion of public-private collaboration frameworks and the consolidation of a solid innovation ecosystem with strong national and European industrial capacities, in order to promote rapid and equitable access of patients to new medicines.

“Fundamental” Spanish role in the new strategy

Another of the events that will have a direct impact on the implementation of this Strategic Plan and the reform of the Law on Guarantees is the Presidency of the European Union, which Spain will assume in the second half of 2023, between July 1 and December 31. Antonio Blázquez, head of the Department of Medicines for Human Use of the Spanish Agency for Medicines and Health Products (Aemps), assured Medical Writing that this presidency “will help our country lead the pharmaceutical law revolution at the community level.”

Blázquez highlighted that although the European pharmaceutical strategy “has been underway for years”, the ‘culmination’ of its development will coincide with the role of Spain in the presidency of the Community Council. “It’s easy that it’s up to us to pivot this process and we have to face this new legislative package. Support for pharmaceutical innovation and for Europe to continue to be a benchmark in drug R&D will be important points,” he noted.

reform with four pillars

The last review of European pharmaceutical legislation was carried out twenty years ago. From the EC they have explained that, from that moment, social and scientific changes have arisen, as well as new challenges, for which the reform is necessary. This new modification has four fundamental pillars:

• guarantee the patient access to affordable medicines and address unmet medical needs (eg in the areas of antimicrobial resistance, cancer and rare diseases).

• Promote competitiveness, innovation and sustainability of the EU pharmaceutical industry and the development of high-quality, safe, effective and more ecological medicines.

• Improve the mechanisms of crisis preparedness and response address security of supply.

• watch over a strong voice of the EU in the worldpromoting high standards of quality, efficacy and safety.

Modernize the regulatory framework

At the time the public consultation was opened, Stella Kyriakides, Commissioner for Health and Food Safety, stated that the EC’s objective was to achieve “a modernized and fit-for-purpose regulatory framework for pharmaceutical products”, as well as achieve “a strong European Health Union”which is “crucial to address the many challenges facing this sector.”

Since the adoption of the Strategy, the Commission has been working on various actions in close cooperation with the authorities of the Member States, the European Medicines Agency (EMA) and stakeholder organizations.