6th November 2023: Reform of the European Union (EU) Pharmaceutical Legislation

Wien, 06.11.2023 – Text: Catarina Carrão

Pharmaceutical Legislation Revision: objectives

In April 2023, the European Commission (EC) has adopted a proposal for a new Directive and a new Regulation, which revises and replaces the existing general pharmaceutical legislation.1 The purpose is to create a future proof regulatory framework that supports the industry in promoting research and technologies to reach patient’s needs faster, while addressing market failures. Much of the impulse to revise the existing general pharmaceutical legislation came from the weaknesses exposed by the coronavirus pandemic; as such, the revision wants to ensure access to affordable medicines, foster innovation, improve security of supply, adapt to new technological developments, and reduce red tape.2 In summa, the revision aims to achieve the following objectives:

– Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines.

– Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU.

– Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe.

– Make medicines more environmentally sustainable.

– Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.

Consultations and high-level meetings

Since the publication of the strategy roadmap in June 2020,3 the EC has conducted a series of consultations and meetings to inform the designing of the strategy, with the objective of considering the positions and priorities raised by interested parties, the public, and Member State authorities in the context of its consultative committees.

In May 2023, the stakeholders dialogue of the pharmaceutical package highlighted the importance of patient’s involvement in the development of the scientific guidelines on unmet medical needs, and the inclusion of quality-of-life criterion. Healthcare professionals welcomed the measures to improve access and earlier generics entry, while representative of researchers appreciated the provisions catering for innovation and incentives for academia.5

In June 2023, the rapporteurs of the 4 workstreams of the structured dialogue initiative regarding security of medicines supply (robust supply chains, critical medicines, vulnerabilities and dependencies, and innovation) presented the preliminary outcomes of their work at the EC high-level event.4 The workstreams were asked to provide evidenced based data on the functioning of pharmaceutical supply chains; although, some issues were still considered unresolved, such asthe criteria to establish the list of critical medicines, or the documentation of the vulnerabilities.6

Next Steps

The legislative proposal has now been submitted to the European Parliament and the Council, which will now examine the EC’s proposal for approval or for amendments.

Pharmaceutical bottles for decorative purpose for Gouya Insights' Decentralized Clinical Trials Press Release.

Image Source: Stock image


References

All references assessed 6th November 2023.

1. https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

2. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12963-Revision-of-the-EU-general-pharmaceuticals-legislation_en

3. https://health.ec.europa.eu/system/files/2021-02/pharma-strategy_report_en_0.pdf

4. https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/structured-dialogue-security-medicines-supply_en

5.  https://health.ec.europa.eu/system/files/2023-06/mp_20230510_sr_en.pdf

6. https://health.ec.europa.eu/events/structured-dialogue-initiative-2nd-event_en

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