The European Union's New Pharmaceutical Strategy for Europe

ABSTRACT

[...]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). (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). Availability, accessibility, and affordability of medicinal products The section on 'Prioritising unmet medical needs' in the strategy reflects the belief within EU Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk. institutions that "current incentive models neither provide an adequate solution for unmet medical needs nor appropriately incentivise investments in innovation" (2).