The European Union’s New Pharmaceutical Strategy for Europe

The current legislative code for medicines (Directive 2001/20/EC) was perceived to be in need of improvements pertaining to weaknesses in areas of research, production, and the distribution of medicines in Europe (failings which were exposed by the COVID-19 pandemic) (1). Accordingly, on 25 Nov. 2020, the European Commission (EC) announced the new Pharmaceutical Strategy for Europe, which is likely to result in significant changes to the European Union (EU) regulatory framework and will have a substantial impact on both the marketing of medicinal products and the strategic business planning of pharmaceutical companies (2).

Following this announcement, the EC issued a public consultation on the revision of the EU’s pharmaceutical legislation in September 2021, after which, the EC intends to implement certain ‘flagship actions’ including a revision of the general pharmaceutical regulatory regime envisaged for the end of 2022. All these actions form part of the EC’s future vision of building a European Health Union.

The strategy

While the strategy aims to introduce new policies and ideas, it also highlights long-standing challenges that have been exacerbated by the coronavirus outbreak. To this end, the strategy puts forward numerous proposals for legislative reforms that are “likely to affect the regulation of the entire life cycle of a medicinal product” (2). The EC’s ‘Communication on the Pharmaceutical Strategy’ identifies the key priority areas for consideration and improvement (3). Summarized by Pinto et al. (2021), the priority areas are as follows:

• The performance and adequacy of the current legislation
• Unmet medical needs—with a definition or set of principles for “unmet medical needs” under discussion
• Incentives for innovation, including the area of unmet needs and a reflexion on regulatory data and market exclusivity
• Antimicrobial resistance that includes measures to support innovation of antibiotic development
• Future-proofing the regulatory framework for novel products
• Improved patient access to, and affordability of, medicines in the EU
• Competitiveness of the European markets to ensure affordable medicines, including considering measures to support patients’ access to affordable medicines
• Encouraging the repurposing of off patent medicines
• Ensuring security of supply of medicinal products in the EU
• Ensuring high-quality manufacture and distribution in the EU including consideration of the need to strengthen or adapt good manufacturing practice (GMP) to reflect new manufacturing methodologies
• Environmental challenges (4).

From amongst these priorities, the main elements of the strategy can be classified into three key areas that include the availability, accessibility, and affordability of medicinal products; streamlined innovation and enhanced competition; and securing supply and controlling shortages of medicines.

Availability, accessibility, and affordability of medicinal products

The section on ‘Prioritising unmet medical needs’ in the strategy reflects the belief within EU institutions that “current incentive models neither provide an adequate solution for unmet medical needs nor appropriately incentivise investments in innovation” (2). The consultation process initiated in September 2021 seeks views on potential changes to the current regulatory data and market exclusivities, which pharmaceutical manufacturers currently enjoy upon receiving regulatory approval for new speciality medicines. In addition, this section also highlights anti‑microbial resistance as a key unmet need, together with paediatric and rare diseases. Here, the consensus within the commission is that investments made by pharmaceutical companies are not necessarily supporting these vital areas where unmet needs are deemed to be the greatest.

One of the incentives being proposed in relation to antimicrobial resistance is the use of a ‘transferable exclusivity voucher’, which grants innovators additional periods of exclusivity upon receiving regulatory approval of a new antibiotic (and subject to certain conditions, could be used by the innovators to extend the protection of any other medicine in their own portfolio or transferred or sold to a third-party) (5).

As for affordability, the strategy focuses on the transparency of R&D costs linked to a review of ‘fair return’. Here, the strategy aims to foster price transparency in the hope that better pricing and reimbursement decisions can be made by individual member states. The strategy also considers how competition law enforcement can help address concerns about the affordability of medicines. To this end, the focus is on generic-drug and biosimilar competition, with the EC considering a review of the current incentives programme for orphan medicinal products.

One of the proposals the EC has put forward for supporting access to affordable medicines is the broadening of the ‘Bolar Exception’, which “exempts from patent infringement the conduct of certain studies and trials for the purpose of applying for marketing authorizations” (5). The EC is also considering the creation of a specific regulatory incentive, potentially an exclusivity period, for a limited number of biosimilars that come to the market first. The aim is to further strengthen the impact that generic-drug and biosimilar competition can have on prices.

Furthermore, the EC is also considering new measures to encourage pharmaceutical manufacturers that have been granted EU-wide marketing authorizations via the centralized procedure to market those products in every EU member state (5). This potential action reflects the long-standing concern of the EC that such decisions are not necessarily in line with the needs of patients.

Streamlined innovation and enhanced competition

The strategy refers to the EC’s policy initiatives on intellectual property and data governance and how those can support innovation and competition. Here, special emphasis is being placed on supplementary protection certificates (SPC) in the hope that the optimization of the SPC system will address duplication and inefficiencies that hamper competition. Other important initiatives that would streamline innovation and competition can be found in an advisory article by J. Mulryne et al. (2).

Securing supply and controlling shortages of medicinal products

The COVID-19 pandemic has brought to light weaknesses in the existing regulatory framework and its inability to ensure the continuous supply of medicinal products while avoiding shortages. In response, EU institutions such as the European Parliament have highlighted the need to revise the current rules by considering both preventative and mitigating measures, which may result in new obligations for the pharmaceutical industry (2).

Next steps

The commission is in the process of evaluating Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use and Regulation (EC) No 726/2004 Laying Down Community Procedures for the Authorization and Supervision of Medicinal Products for Human and Veterinary Use. It is anticipated that a new regulation replacing these directives will be adopted in Q4 2022 (6). It seems likely that there may also be some revisions to the Orphan Regulation, the Paediatric Regulation, and the Medicinal SPC Regulation to target incentives on areas of unmet medical need.

References

1. EC, Directive 2001/20/EC of the European Parliament and of the Council, Legislation, ec.europa.eu, 4 Apr. 2001.
2. J. Mulryne, A. Roussanov, and K. Farkas, “The European Commission’s New Pharmaceutical Strategy for Europe,” Arnold & Porter LLP, Advisory Article, 8 Dec. 2021.
3. EC, Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee, and The Committee of the Regions: Pharmaceutical Strategy for Europe, Communication, eur-lex.europa.eu, 25 Nov. 2020.
4. C.M. Pinto and F. Roy, “Revision of the EU General Pharmaceuticals Legislation—Public Consultation is now Open,” Hogan Lovells, 29 Sept. 2021.
5. J. Fabre, “EU Considers Reform of General Pharma Law,” Pinsent Masons, Out-Law News, 11 Oct. 2021.
6. E. Zhuleku, T. Carmeliet, and R. Allos, “EC Consults on Revision to Pharmaceutical Legislation,” Allen & Overy, Life Sciences Blog, 1 Oct. 2021.

About the author

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 7
July 2022
Pages: 7–8

Citation

When referring to this article, please cite it as B. Piachaud-Moustakis, “The European Union’s New Pharmaceutical Strategy for Europe,” Pharmaceutical Technology Europe 34 (7) 2022.