Mitigating medicines shortages in Europe

While unsolicited and burdensome, medicine shortages are an obstacle faced by the pharmaceutical industry. In 2023, a combination of factors, including increased demand (particularly for critical medicines), economic inflation, as well as international geopolitical unrest, has led to Europe’s supply chain being acutely affected.

Consequently, regulators, trade groups and other organisations have worked to prevent and alleviate medicine shortages in the region. Short-term measures to take control of current shortages in addition to longer-term, preventative actions have been part of the industry’s collective response.

For instance, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) reported in January that due to manufacturing delays, production capacity issues and supply difficulties of antibiotics across most Member States, it was “closely monitoring” and responding to shortages. This included engaging with key players in the supply sector in relation to the key antibiotic amoxicillin.

Then, new guidance by the European Medicines Agency (EMA) published in May, highlighted recommendations and a list of good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact”. One recommendation sought the optimisation of pharmaceutical quality systems and increased resilience of complex, multinational supply chains.

However, in recent months, a range of European organisations have made progress in addressing medicine shortages, through new actions, working groups and more.

Preparing for future medicine shortages

On 11 Oct 2023, the Council of Europe’s European Directorate for the Quality of Medicines & HealthCare (EDQM) announced a new project that will work to compile monographs to help to prepare for potential future medicine shortages. In certain cases, they could also be developed “to provide immediate, real-time support in an ongoing shortage”.

Under the new project, The European Drug Shortages Formulary, these monographs will describe “methods for the preparation and quality control of standardised unlicensed pharmaceutical preparations.” They could provide a temporary replacement for potentially unavailable, essential licensed medicines, the EDQM explained in its statement.

To facilitate this initiative, the European Pharmacopoeia Commission (EPC) declared that it is looking for experts. They will be tasked with verifying “proposed production methods or analytical procedures to develop and verify the monographs before their launch”.

A corresponding working party (EDSForm WP) will develop the monographs, as well as establish the rules and working methods for the European Drug Shortage Formulary, EDQM affirmed.

EU level regulatory actions

Last week, the European Commission (EC) adopted a new set of actions that aim to better prevent and mitigate medicine shortages in the EU and ensure Europe’s medicine supply chains are more robust in the long term.

The measures focus particularly on the most critical medicines, for which supply security is critical, according to the EC.

These actions build on recent work on this issue, including the proposed EU legislative reform, published in September, and the European Medicines Agency (EMA)’s preparation for shortages of key antibiotics in Winter 2023.

EMA confirmed in July that it had created recommendations for averting shortages in the Autumn/Winter 2023-2024 season.

Two of the main recommendations sought the increased production of key antibiotics and the monitoring of supply and demand. “It is important that manufacturers take early action, ahead of the winter season, so that they can ramp up manufacturing capacity where necessary,” Emer Cooke, EMA’s Executive Director noted when commenting on the EMA’s first recommendation.

Mitigating medicines shortages – actions adopted by the EC on 24 October

• The launch of a European Voluntary Solidarity Mechanism for medicines in October 2023. This mechanism alerts Member States when a State needs a particular medicine. Other States can then redistribute medicine from their available stock.
• A Union list of critical medicines, available by the end of 2023, will be the first step to analyse the supply chain of selected medicines by April 2024, by highlighting where additional measures are needed
• Regulatory flexibilities: Member States can use regulatory exemptions to accelerate medicine access, including extending shelf-life or the quick authorisation of alternatives. According to the EC, a dedicated Joint Action in 2024 will promote effective use of these flexibilities.
• EU guidance on procurement of medicines to strengthen security of supply issued by the Commission by early 2024.
• EU joint procurement for next winter for antibiotics and treatments for respiratory viruses.

In its announcement, the EC also highlighted that to diversify supply as well as stimulate and modernise production of critical medicines with all stakeholders, the Commission plans to set up a Critical Medicines Alliance. Once operational in early 2024, this will “allow national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at EU level against the shortages of medicines and to address supply chain vulnerabilities”. The Alliance will focus on critical medicines with the highest risk of shortages and “could pave the way for a possible Critical Medicines Act’ in the future.

Industry response

On 26 October, the industry’s trade association, the European Federation of Pharmaceutical Industries and Associations (EFPIA), welcomed the Alliance as a platform for providing “structural solutions rather than treating symptoms”.

However, in response to the actions adopted by the Commission, the EFPIA urged: “The failure to utilise the information stored in the European Medicines Verification System (EMVS) remains a missed opportunity to mitigate and manage shortages that could be readily implemented.”

By providing “real time data on the quantities of individual medicines in the supply chain at Member State level… [it offers] the most complete picture of the root causes of shortages, where and how shortages occur in Europe”.

On 24 October, Medicines for Europe commented the Commission’s actions. Its views align with the EFPIA’s, sharing the opinion that the EMVS is a valuable tool for alleviating shortages. Medicines for Europe added that the EC’s actions must include “digitalisation of the regulatory system and more use of data” to address the root cause of shortages.

Therefore, continued collaboration and streamlined regulation are among the major factors that the pharmaceutical industry must work on, to build a robust supply chain that provides efficient access during future medicine shortages in Europe.