EU reform prompts medicine shortage position
Ireland is set to establish a new national position on the security of supply of medicines in early 2024, following major European reform of pharmaceutical legislation.
On 26 April 2023, the European Commission adopted a proposal for a new directive and a new regulation which revise and replace the existing general pharmaceutical legislation.
Viewed as the flagship action of the Pharmaceutical Strategy for Europe adopted in 2020, the revision of legislation aims to create a single market for medicines and address long-standing issues on medicine access and drug shortages.
In Ireland, and across Europe, medicine supply concerns have been growing for years, with supply challenges becoming even more pronounced during the pandemic and international geopolitical situations.
The EU’s dependence on non-EU countries for importing medicines and their active ingredients had led to three-quarters of member states reporting worsening of drugs shortages in 2022.
In July 2023, the European Medicines Agency said Europe is walking a tightrope, and in the same month, the Health Products Regulatory Authority (HPRA) indicated that there were over 300 medicine shortages impacting the Irish market.
The Commission’s proposals include the control of drug production in the event of a public health emergency, manufacturers to give early warnings of shortages, and a requirement for stockholders to inform Brussels of supply levels.
In response to the proposals, the Department of Health, the lead government department tasked with considering the legislative proposals, has held an initial stakeholder event to inform a preliminary Irish position on the proposals, allowing the Pharmaceutical Strategy Working Group (PSWC) to gather views.
Initially set up in 2020 by the Minister for Health to act as a vehicle to assist in ensuring a universal and coherent national approach to the strategy, the PSWC ran a consultation on shortages, and security of supply until 8 December 2023. The Department was seeking to confirm the national position on the policy topic by the beginning of 2024.
Alongside a single market for medicines, the EU’s reforms include an innovation-friendly framework for research, development, and production of medicines in Europe. It also aims to “drastically reduce” administrative burdens and speed up the time for medicines reaching patients, while enhancing availability to ensure medicines can always be supplied to patients, regardless of where they live in the EU.
A major focus for the fresh legislation is around tackling antimicrobial resistance (AMR), which is considered one of the top three health threats in the EU.
Overuse and misuse of antimicrobials have led to increasing antimicrobial resistance (AMR), meaning that antimicrobials lose their effectiveness, and it becomes more difficult to treat infections. It is estimated that AMR is responsible for 35,000 deaths per year in the EU/EEA and projections estimate 10 million deaths globally each year, reducing 2 per cent to 3.5 per cent in global gross domestic product.
Commenting on the adoption of the proposal, the European Commission’s Stella Kyriakides, Commissioner for Health and Food Safety, says: “Today we add another central pillar to our European Health Union. We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion.
“It is a reform which ensures that Europe remains attractive for business, and our pharmaceutical industry a global innovation powerhouse. Building a single market for medicines is a necessity both for our citizens and our companies.”
