[THE EUROPEAN PHARMACEUTICAL LEGISLATIVE PACKAGE]

[EUROPEAN UNION LAW - DATA PROTECTION - MEDICINAL PRODUCTS - HEALTH - HARMONISATION - INNOVATION - MODERNISATION]

🚨 On 26 April 2023, the European Commission proposed a recast of the European Union's pharmaceutical legislation (COM/2023/192 final and COM/2023/193 final) to address issues relating to the availability, accessibility and affordability of medicines in the internal market. The aim of this major reform, which covers the entire life cycle of medicinal products, is twofold: to protect public health and to harmonise the internal market for medicinal products in Europe.

(See also Directive 2001/83/EC; Regulation (EC) No 726/2004; Orphan Regulation (EC) 141/2000; Paediatric Regulation (EC) 1901/2006; ATMP Regulation (EC) 1394/2007)

⚖️ Faced with a shortage of medicines and the high price of innovative treatments, the pharmaceutical legislative package (‘Pharmaceutical Package’) suggests a balanced pharmaceutical ecosystem. Taking account of scientific and technological progress, the proposals encourage innovation and the modernisation of the European pharmaceutical industry. They encourage the adaptation of existing rules to digital transformation and new technologies, as well as the simplification of administrative procedures.

The Commission's proposals concern in particular

- the modulation of the regulatory protection period (data protection and marketing) applicable to pharmaceutical companies prior to the entry of generic and biosimilar medicinal products, including the various additional conditional protection periods.

- the introduction of a strengthened scientific and regulatory support regime and accelerated assessment mechanisms for medicines meeting an unmet medical need.

- Requiring companies to submit an environmental risk assessment (ERA) when applying for marketing authorisation, emphasising the principle of mitigation. This obligation is in line with the aspirations set out in the Green Pact for Europe, presented by the European Commission on 11 December 2019.

- the introduction of a production chain monitoring system (prior notification of critical stocks and risks of shortages) to verify compliance with legal requirements on the manufacture, distribution and use of medicinal products

- the declaration of public funds received by laboratories as part of their R&D activities, in the interests of transparency.

In addition to these reforms, the Council of the European Union EPSCO had previously made a recommendation (2023/C 220/01) on strengthening the fight against antimicrobial resistance on 13 June 2023.

⚠ The Committee on the Environment, Public Health and Food Safety (ENVI), one of the European Parliament's subcommittees, voted in favour of these proposals on 19 March 2024.

The next vote will take place, according to the final draft agenda for the plenary session, on 10 April 2024.