The European Commission presented its draft for a comprehensive reform of the pharmaceutical legislation on 26 April 2023. The so-called EU Pharma Package essentially comprises a revision of the Directive on the Community Code relating to Medicinal Products for Human Use1 and a Regulation to replace Regulations (EC) No. 726/2004 (authorisation and supervision of medicinal products) and No. 141/2000 (orphan medicinal products) as well as parts of Regulation (EC) No. 1901/2006 (paediatric medicinal products).2
Both the Directive and the Regulation are intended to promote innovation and improved access to medicines. The striving for a "balanced pharmaceutical ecosystem" will be the main focus. These goals are to be achieved by means of an increase in efficiency and an innovation-friendly design of the regulatory system through targeted economic incentives. Furthermore, administrative barriers are to be reduced through a lower regulatory burden, in particular to improve the availability of required medicinal products. While the directive additionally aims to ensure better environmental compatibility of medicinal products, the regulation aims to counter the problems of antimicrobial resistance (AMR) through appropriate measures.
The new directive amends and replaces Directive 2001/83/EC (Community code relating to medicinal products for human use) and incorporates parts of the paediatric regulation (EC) No 1901/2006 (paediatric regulation).
The draft provides for the following changes, among others:
- New regulations on data protection: Reduction of the current standard duration of legal data protection from eight to six years with the inclusion of various options for extending exclusivity (data and marketing protection) up to a total of 12 years. For new therapeutic uses of already authorised medicinal products ("repurposing"), a new, one-time document protection of four years applies.
- Simplification of the market entry of generics and biosimilars: According to the simplified wording of the new directive, only the equivalence of the generic medicinal product with the reference medicinal product has to be proven for the authorisation of generic medicinal products. For the authorisation of biosimilars, the draft clarifies that applicants must submit the results of appropriate comparability tests and studies. The so-called "Bolar" exception for the development of generic medicinal products and biosimilars despite an existing patent or supplementary protection certificate is extended and, with regard to the hitherto inconsistent handling in the Member States, more clearly regulated, among other things by explicitly including suppliers and service providers.
- Reduction of regulatory hurdles in the authorisation of medicinal products: The statutory duration of the marketing authorisation procedure will be shortened from 210 days to 180 days. This also applies to centralised marketing authorisations under the new draft regulation. In future, pharmaceutical marketing authorisations are to be valid for an unlimited period, although a limitation of the duration to five years shall be possible in certain cases. The so-called sunset provision, according to which the authorisation expires if the product is not placed on the market within a period of three years after the granting of the authorisation or is not marketed for a continuous period of three years, will be abolished.
- New rules on advertising: In accordance with current case law, the regulations on advertising of medicinal products now explicitly apply to advertising measures that do not refer to a specific product. Comparative advertising suggesting that the advertised product is safer or more effective than another product is prohibited, unless the superiority is proven by summarising the product characteristics.
- Reduce the environmental impact of medicinal products by tightening the requirements for environmental impact assessment (EIA) in the marketing authorisation process.
The new regulation amends and replaces Regulation (EC) No 726/2004. Regulations from Regulation 141/2000/EC on orphan medicinal products and Regulation (EC) No 1901/2006 (paediatric medicinal products) are amended and incorporated into the new regulation; the two special regulations are repealed.
The draft provides for the following changes, among others:
- Medicinal products for orphan conditions (so-called orphan drugs): More flexible rules on the duration of market exclusivity (ten years in the case of "high unmet medical need", five years for bibliographic marketing authorisations and nine years in all other cases) and the possibility of extension in the case of closure of a significant healthcare gap (one year), market access in all Member States (another year) or development of new therapeutic indications for an already authorised orphan medicinal product.
- Encouraging the development of paediatric medicines: More detailed rules on paediatric investigation plans (PIP), continuing to grant an additional six months of protection under the supplementary protection certificate.
- Improving the availability of medicines: further detailed rules on paediatric investigation plans (PIP), which continue to grant an additional period of protection of six months under the supplementary protection certificate.
- Encouraging the development of antimicrobial agents against multidrug-resistant pathogens: Under well-defined conditions, transferable vouchers can be issued as a reward for the development of specific antimicrobial agents, which can be used to extend the data protection period for the medicinal product in question or another centrally authorised medicinal product by one year.
The proposals will now go through the ordinary legislative procedure. The European Parliament and the Council will examine and comment on the proposals. It is not yet foreseeable at which point in time and with which content the legal acts will be adopted. As things stand, the new regulation will apply 18 months after its entry into force and the member states will have 18 months to transpose the new directive into national law.
1 Directive of the European Parliament and of the Council on the Community code relating to medicinal products for human use and repealing Directives 2001/83/EC and 2009/35/EC.
2 Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules for the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006.
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