Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance

Summary:

Communication adopted by the European Commission on 26 April 2023, providing an overview to a proposed reform of the pharmaceutical legislation and proposed Council Recommendation on antimicrobial resistance (AMR).

Further information:

The European Union's pharmaceutical legislation has for decades sought to set the highest standards of quality, safety and efficacy for the authorisation of medicines while promoting the functioning of the internal market and a competitive pharmaceutical industry. However, continuous transformation alongside health and geopolitical crises led to an understanding that action was required to modernise the existing framework.

In 2020, the European Commission adopted its Pharmaceutical Strategy for Europe, looking to create a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate , flourish, and reaffirm its position as a global leader. In this context, the Commission set out a revision of the EU's pharmaceutical legislative framework to achieve the following objectives:

• Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
• Enhance security of supply and ensure medicines are always available to patients, regardless of where they live in the EU;
• Offer an attractive, innovation- and competitiveness friendly environment for research, development, and production of medicines in Europe;
• Make medicines more environmentally sustainable;
• Address antimicrobial resistance (AMR) through a One Health approach, encompassing human health, animal health and the environment.

The proposed reform drew on extensive consultations of relevant stakeholders. The legislative package includes:

• Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency;
• Directive on the Union code relating to medicinal products for human use;
• Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach.

• Primary Source

Official

European Commission: Priorities 2019-2024: European Health Union: Reform of the EU pharmaceutical legislation https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union/reform-eu-pharmaceutical-legislation_en

European Commission: Public Health: Reform of the EU pharmaceutical legislation https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

European Commission: Press Release, 26/04/2023: European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines https://ec.europa.eu/commission/presscorner/detail/en/IP_23_1843

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