The Critical Medicines Alliance (CMA) was established in January 2024 by the European Commission to help tackle medicine shortages, which is a growing concern for all EU countries. It aims to bring together stakeholders from EU Member States, key industries, civil society bodies, and the scientific community, to identify key areas and priorities for action. Its listed objectives are to:

• Provide an inclusive and transparent consultative platform to the European Commission and other EU decision-makers;
• Focus on critical medicines that face the greatest vulnerabilities;
• Identify vulnerabilities in critical medicines supply chains;
• Pool the expertise and resources of its members, to determine how vulnerabilities in the supply chains could be best addressed; and
• Recommend priority actions and propose new tools to address the identified challenges, particularly through:
  • Encouraging diversification; and
  • Boosting manufacturing.

The European Commission cites “the timely and equal access to medicines for all European patients” as a key priority. Another key recent development is the proposed revision of EU pharmaceutical legislation. The Commission says this will address regulatory aspects of medicine shortages, while the Alliance will tackle “an industrial and competitiveness dimension which requires the mobilisation of all stakeholders”.

HERA

The Critical Medicines Alliance was launched by, and works under the remit of, the European Commission’s Health Emergency Preparedness and Response (HERA). HERA was established in 2021, and its mandated responsibility is, “to ensure that the EU and Member States are ready to act in the face of cross-border health threats . . . both the strengthening of preparedness in advance of future emergencies and the implementation of a swift and efficient response once crisis hits”.

Governance

The Critical Medicines Alliance is set up for an initial period of five years, and the Steering Board provides strategic orientation to the work of the Alliance. The Pharmaceutical Group of the European Union (PGEU), of which the IPU is a member, has been actively involved in the Critical Medicines Alliance, and has been appointed by the European Commission as a member of the Alliance Steering Board. PGEU Secretary General Ilaria Passarani says, “The Alliance offers a unique opportunity for a constructive dialogue among regulators and stakeholders to increase the transparency of the upstream supply chain and help detect and assess supply fragilities earlier and find solutions to address the root causes of shortages. PGEU aims to be an active partner in this initiative and provide the Alliance with community pharmacists’ perspective and best practices for tackling medicine shortages. We are hopeful that this initiative will be able to ensure balanced representation and participation of the various stakeholders to ensure actionable outcomes.”

The Steering Board comprises of:

• Chair: European Commission — HERA;
• Member State representatives: six organisations, comprising two bodies from each country of the current ‘trio’ presidency of the Council of the EU (i.e. current presidency holder, the country which held the presidency immediately before the current, and country coming next);
• Industry representatives:
  • Association of the European Self-Care Industry;
  • European Confederation of Pharmaceutical Entrepreneurs;
  • European Federation of Pharmaceutical Industries and Associations;
  • European Fire Chemicals Groups; and
  • Medicines for Europe.
• Civil society representatives:
  • European Patients Forum; and
  • Pharmaceutical Group of the European Union (PGEU).
• EMA Representatives:
  • European Medicines Agency; and
  • Executive Steering Group on Shortages and Safety of Medicinal Products.
• Chairs of the Working Groups (to be confirmed).

Membership of the Alliance is open on a voluntary basis to all organisations working with, or affected by, critical medicines, for example, in sourcing, production, transport, distribution, financial support, patient care, regulation and coordination, and patients and healthcare professionals representative bodies. There are currently 255 members and six observers of the Alliance.

All Alliance members have the right to participate in the Forum, which meets at least once a year, and is regularly consulted on key milestones of Alliance activity. The Alliance members also collaborate on two Working Groups, which focus on:

• Strengthening EU manufacturing capacities for critical medicines and their active pharmaceutical ingredients; and
• Diversifying international partnerships and cooperation.

The recommendations of the Working Groups will form the basis of a Strategic Plan, which is due to be adopted by the end of 2024.

First meeting

Ms Passarani described the first meeting of the Alliance in April 2024, during which “the European Commission presented a very interesting vulnerability assessment they conducted on the supply chain of 11 molecules which showed how complex and globalised the production of medicines is and that also medicines entirely produced within the EU are affected by shortages.” She said, “from the discussion it emerged that we need more transparency of the upstream supply chain to better detect and assess supply fragilities and find solutions to address the root causes of shortages. The work plan and the objectives they presented are very ambitious and working with the 250 organisations who have been accepted as a member will be quite challenging. We are eager to see how the Alliance will progress, and we hope it will succeed in delivering tangible results”.

Critical Medicines Act discussed at the Medicines for Europe Conference

Medicines for Europe (MFE) held their 30^th Anniversary conference in the Portmarnock Hotel, Dublin on 12 to 13 June, with over 200 attendees from the generic industry across Europe. The second session on day one of the conference was entitled, The future of supply security: towards a Critical Medicines Act. A video address from Emer Cooke, Executive Director of the European Medicines Agency (EMA), in which she highlighted the importance of collaboration and the Critical Medicines Alliance, as well as highlighting the EMA mandate on medicine shortages. This session was chaired by Victor Mendonca, from the MFE board, and had contributors from the generic industry, HERA, HPRA, Amgros (Danish public procurement agency) and from the PGEU/IPU.

There was a lively discussion during this session, and Clare Fitzell, Head of Strategic Policy at the IPU highlighted the length of time pharmacists both in Ireland and across Europe are spending trying to source alternatives when a medicine is in short supply. A key point Ms Fitzell made in this discussion was that all pharmacists across Europe should be allowed to practice to full scope in managing shortages, whether that be generic substituting, therapeutic substituting, compounding and/or sourcing alternatives. The generic industry highlighted the reduction of alternatives, citing the decreasing number of antibiotic suppliers as an example.

Ellen McGrath from the HPRA highlighted her role as the single point of contact (SPOC) to the EMA and the Medicine Shortages Steering Group (MSSG) and the work ongoing within a joint action group called CHESSMEN. Ms McGrath explained that CHESSMEN (Coordination and Harmonisation of the Existing Systems against Shortages of Medicines — European Network) aims to support European Member States to provide a harmonised response to mitigate medicines shortages and to contribute to the appropriate and timely availability of medicinal products.

What was clear at the end of this panel discussion is that many people across Europe are now discussing pro-active ways to improve the medicine shortage issue, and that the EMA are clearly prioritising their work on this issue.

Conclusion

The Alliance was launched during the Belgian Presidency of the EU, and speaking earlier this year, the Belgian Health Minister Frank Vandenbroucke, emphasised the gravity of medicines shortages across the EU: “26 per cent of generic medicines disappeared from the EU market in the past ten years. For 69 per cent (of products), we only have one or two producers left.” Heralding the launch of the Critical Medicines Alliance during his country’s Presidency, Mr Vandenbroucke said, “I am really proud of the leadership Europe is showing in this field. We are taking matters into our own hands. Thanks to the Health Emergency Preparedness and Response Authority (HERA), I believe we can now say that we are one step ahead. That is no small feat.”