Link to EAHP Statements
Section 1 – Introductory Statements and Governance: Statements – 1.1, 1.3, 1.5
Abstract
Building on the 2020 pharmaceutical strategy for Europe, in 2023 the EU Commission presented the largest reform of the EU’s pharmaceutical sector in over 20 years, addressing the main identified challenges. The overarching goal of this legislation is the so-called “3-As” – affordability, accessibility, and availability.
Equal access and security of supply for patients across the EU is one of the key objectives. Measures to prevent and manage medicines shortages need to be introduced. The new regulations require improved monitoring, reporting obligations, and stockpiling strategies. Innovation for pharmaceutical industry is meant to be strengthened through a number of incentives with regard to market exclusivity. Environmental sustainability is another key focus, with new requirements for the safe disposal of medicines and reduced pharmaceutical waste. Further changes include stricter pharmacovigilance obligations and digital transformation in medication management. Last, not least, comprehensive recommendations regarding combatting antimicrobial resistance are included.
In April 2024, the European Parliament finally adopted its position on the reform. However, the final legislation will involve more lengthy discussions. Final reforms will probably not come into effect before 2028. Hospital pharmacists need to be aware of the many different areas comprised by this reform, as they may directly affect hospital pharmacy practice.
This seminar will provide hospital pharmacists with a status quo update on the main elements of the EU pharma legislation relevant for the healthcare and hospital pharmacy sector, critically reflect, and discuss these changes.
Learning objectives
After the session, the participant should be able to:
– Explain the main components of the reformed EU pharma legislation relevant to hospital pharmacists.
– Outline controversial and critical aspects as judged by different stakeholder perspectives.
Educational need addressed
Hospital pharmacists need to understand and critically appraise changes arising from the reform of EU pharmaceutical legislation relevant to hospital pharmacy practice.
Keywords
Legislation, pharmaceutical industry, pharmacovigilance, drug shortages, access.