Your opinion matters: Get ready for the revision of the EU general pharmaceutical legislation

On 25 November 2020, the European Commission published its Pharmaceutical Strategy for Europe (Strategy). The Strategy highlights the EU’s long-term objectives and priorities in the area of health and pharmaceutical and biotechnology-derived medicinal products.

These priorities include concrete changes to existing EU pharmaceutical legislation. In this regard, the European Commission started the process of revising what it calls the “general pharmaceutical legislation” (namely Directive 2001/83/EC and Regulation 726/2004). To launch and guide the revision process, the European Commission recently published a Combined Evaluation Roadmap/Inception Impact Assessment (Roadmap). In this document, the European Commission provides its understanding of the current situation, issues, objectives, and possible solutions. It sets the stage for the revision process and defines the subsequent steps to be followed.

It is expected that the current legislation will be replaced by a Regulation for which a legislative proposal will be adopted in the fourth quarter of 2022. Experience shows, especially with regard to what was done with the Medical Devices Regulation recently entered into application, that choosing this type of legislative act could potentially lead to significant changes in terms of legal reasoning, direct applicability, preparedness and compliance for the Life Sciences industry as a whole. Pharmaceutical products are already closely interlaced with other regimes, and it is expected that legislative and regulatory frameworks will become less and less compartmentalised in the future.

This is why it is crucial that citizens, businesses, civil society, public authorities, or any other stakeholder who may be affected, consider these changes well in advance and prepare in time to have their voice heard throughout the legislative process.

To this end, a public consultation will open in the fall of this year, with the purpose of helping the European Commission better understand the industry reality, needs, and expectations. Through this 12-week long consultation, participants will have the opportunity to share their views on the changes proposed. A questionnaire containing targeted questions will be addressed to the public and the responses received will help design the final legislative proposal.

The purpose of this first publication is to put the revision of the EU general pharmaceutical legislation in perspective and provide an overview in ten practical questions.

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