One Pharmaceutical Strategy for Europe

The Pharmaceutical Strategy focusses on a competitive sector, which allows all EU citizens equal access to high-quality, effective, safe, and affordable medicinal products. Moreover, the strategy aims to provide more legal certainty for the industry. In accordance with that, the EU-wide launch of medicinal products could in future become a prerequisite for current or new incentives.

The Commission intents to address the present unmet medical need in different areas, such as rare diseases: appropriate treatment options are still lacking for 95 % of approximately 7,000 currently identified rare diseases. In addition, more research shall be performed to provide suitable treatments for pediatric, geriatric, and pregnant as well as breastfeeding populations. The strategy also incorporates pre-existing aims of the EU, such as the "Europe's Beating Cancer Plan", which has a special focus on pediatric and rare cancer types, but also shall provide the access to innovative therapies within the Union. Furthermore, new types of incentives shall drive the development of innovative antimicrobials and vaccines. The successes currently seen in the development of vaccines against SARS-CoV-2 demonstrate the potential of new technologies.

The Industrial Strategy for Europe is designed to provide incentives for companies of all sizes within the EU to promote and protect innovation and thus keep companies competitive on an international level. EU-wide patents and supplementary protection certificates in the pharmaceutical sector are also to be harmonized and simplified to improve effectiveness and reduce repetition of work.

To provide industry and regulators within Europe cross-border access to health data, a proposal to establish a robust and interoperable data access infrastructure will be developed as part of the Digital Strategy by 2025. This includes the creation of a database of 10 million genomes to stimulate innovative research, for example, personalized medicine and improved disease prevention. In parallel, collaborative projects are to be funded until 2022 to advance high-performance computing and artificial intelligence in the handling of health data. Moreover, the strategy should bring the pharmaceutical market in line with Europe's "Green Deal".

The Commission foresees great potential in the field of personalized and patient-oriented therapies, especially based on gene and cell therapies. However, the increasing uncertainty about efficacy and costs due to high-priced "niche-busters", which target smaller patient groups and correspondingly provide less evidence, needs to be addressed.

This is of great relevance from a market access perspective, as in particular the increasing drug budgets of hospitals are brought out. Consequently, current financial protection mechanisms for the development of rare diseases will be reviewed and adjusted, if deemed necessary. In addition, the Commission has set itself the objective of coordinating pricing and reimbursement – itself a matter for member states – with a group of appropriate authorities over the next four years.
A follow-up blog article will further outline, which explicit changes have been proposed by the Commission, in relation to medicines for rare diseases and children (Revision of the EU legislation on medicines for children and rare diseases), as part of the pharmaceutical strategy.

If you would like to understand the potential impact that regulatory changes could have on the market access of your product, please feel free to contact us.

• https://ec.europa.eu/health/human-use/strategy_de
• https://www.destatis.de/Europa/DE/Thema/Basistabelle/Bevoelkerung.html