The European Commission launches a new Critical Medicines Alliance

Background on medicines shortages and recent policy-making

• Medicines shortages have been identified as a major health concern in Europe for many years now. A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” The European Parliament also “notes with concern that the EU lags behind the USA as regards a standardised and transparent reporting mechanism on the causes of medicines shortages.” A 2020 European Parliament resolution said that the problem had “worsened exponentially in recent years.” Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., and Canada, according to a report from the Organisation for Economic Cooperation and Development (OECD).
• In response to challenges brought to light during the Covid-19 pandemic, including shortages of medical products, the European Commission issued proposals to establish a “European Health Union.” Regulation (EU) 2022/123 became applicable on March 1, 2022, except for most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages at the E.U.-level, as well as establish lists of critical medicines during major events that affect public health. EMA takes a leading role in the coordination shortage prevention, management and communication among Member States, industry and the public, and also consults with industry and Member States to determine if a certain situation requires specific recommendations. It also established the Health Emergency and Preparedness and Response Agency (HERA). [See AgencyIQ’s analysis of EMA’s milestones.]
• The new regulation established an Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) within the EMA to support E.U.-level coordination to address critical shortages. The regulation set up the MSSG to ensure a robust response during public health emergencies and major events. It provides advice and recommendations to ensure the continued supply of safe and effective medicines. During the pandemic, the MSSG was tasked with developing a list of medicines critical to addressing the public health emergency. Subsequently, the Commission directed the MSSG to develop a Union list of critical medicines outside of public health emergencies and major events. [Read AgencyIQ’s analysis of the list of critical medicines.]
• A non-paper drafted by the Belgian government in May 2023, obtained by POLITICO Pro EU, called attention to the continuing issue of medicine supply shortages. The document, titled “Improving the security of medicines supply in Europe,” noted that antibiotics, thrombolytics and insulin have been “difficult to obtain” over the past few months and that antipyretics and painkillers are in short supply. The non-paper (an informal document used in closed negotiations within E.U. institutions) then reviewed the multi-factorial causes for these shortages across the E.U.
• The non-paper suggested three action points complementary to current legislation. In the short term, the non-paper called for installation of a solidarity mechanism within the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) as a temporary bridge strategy. For the mid-term, the non-paper proposed monitoring the supply and production chain of a list of critical medicines. And in the long-term, it recommended a “Critical Medicines Act” to reduce dependency on only a few suppliers of critical medicines and ingredients. [Read AgencyIQ’s analysis of the non-paper.]
• In October 2024, the European Commission published a communication putting forth imminent and longer-term structural changes to address medicines shortages. Responding to calls for a Critical Medicines Act, STELLA KYRIAKIDES, European Commissioner for Health, replied by noting during a Parliament plenary discussion in early October that proposing a new legislation is a significant undertaking. The Commission’s communication was accompanied by a Q&A document defining key terms and ideas. The tools introduced included developing a Union list of critical medicines, demand forecasting, a Union rapid alert system, and joint procurement. [Read AgencyIQ’s analysis of the Parliament discussion, the communication and establishment of the list of critical medicines.]

Today, the European Commission launched the Critical Medicines Alliance

• Launched today, the Critical Medicines Alliance is a “consultative mechanism” bringing together various stakeholders, including the European Commission, Member State representatives, industry, patients and healthcare providers. The European Commission had issued a call for participation in the alliance in January 2024. The current list of over 250 members includes organizations representing civil society, such as Cancer Patients Europe and the European Patients Forum; various companies; some trade associations including EFPIA and EUCOPE; universities throughout the E.U.; and national and regional public bodies. The World Health Organization regional office for Europe is an observer.
• The alliance aims to provide a transparent and inclusive platform to discuss key action areas to ensure a resilient medicines supply. Initially, the group has two key objectives in tackling supply chain weaknesses for critical medicines: strengthen manufacturing capacity and diversify the international supply chain. There are also three wider aims, with goals to identiy vulnerabilities in the supply chain of critical medicines identified by the EMA, discuss options to address vulnerabilities though combined expertise, and propose priority actions and new tools to address the challenges.
• The alliance is governed by three main components: the Steering Board, Working Groups, and The Forum.
• The Steering Board sets the “strategic orientation” of the alliance’s work, developing and implementing a multi-year strategic plan to guide E.U. decision makers such as the European Commission and Member States. The Steering Board is chaired by the European Commission, and member state representatives are provided by the countries representing the past, current, and next-up presidency of the European Council – Spain, Belgium, and Hungary, respectively. Industry is represented by several large associations such as EFPIA, EUCOPE and Medicines for Europe. The remaining representatives are provided by members of civil society such as the European Patients’ Forum, the EMA i(ncluding the MSSG), and the working group chairs.
• Thematic working groups focus on specific topics within the overall aims. There are currently two working groups with one focused on “strengthening EU manufacturing capacities for critical medicines” and the other looking into diversification of supply chains, international partnerships and cooperation. All alliance members with relevant expertise can join the working groups. Recommendations from the working groups feed into the Steering Board’s strategic plan.
• The Forum serves as a venue for high-level policy discussions. All members of the alliance can participate in the Forum, which meets at least once a year. It will also be responsible for endorsing the strategic plan.
• The Strategic Plan, expected later in 2024, will give the alliance’s first recommendations. In achieving its stated aims, the alliance will make use of tools already available, including the Strategic Technologies for Europe Platform (STEP) to identify projects in biotechnology and pharmaceuticals. The alliance also plans to partner with third countries and provide incentives.

Why an alliance, and why now?

• The alliance is the European Commission’s current policy response to the call for a Critical Medicines Act. It “could pave the way for a possible Critical Medicines Act in the future,” according to the European Commission Q&A document. Launched today, the alliance was set up for an initial term of five years. Although the initial call for membership has closed, the alliance will review applications on an ongoing basis, including those from entities based in non-E.U. countries. The idea is that having these entities participate in the alliance will support partnerships with third countries and bring in their expertise and experience with supply chain bottlenecks, since most medicines or active pharmaceutical ingredients are manufactured outside of the E.U.
• The alliance was set up to complement two existing forums, the MSSG and the Joint Industrial Cooperation Forum (JICF), while not interfering with their work. MSSG co-chairs participate in the Steering Board of the alliance, which expands the reach of discourse around shortages and solutions. The JICF is focused on medical countermeasures and the raw materials needed, a different focus than that of the alliance. However, the alliance will consider JICF findings when evaluating bottlenecks in supply chains for medical countermeasures and draw on the expertise of that forum.

Separately, the EMA’s shortages group recently proposed eight mechanisms to strengthen critical medicines supply chains

• The MSSG recommendation paper reinforces that the body’s work is complementary to the Critical Medicines Alliance. The group will develop recommendations for regulatory actions addressing medicines shortages in the short- to medium-term, and collaborate and consult with the alliance to address shortages in the long-term. In October 2023, the MSSG released a toolkit to address critical shortages, seen as a living document to be updated as needed. Yesterday, the MSSG released a recommendation paper providing eight actions to strengthen supply chains.
• The recommendations provided will be applied on a “case-by-case basis taking into account their proportionality.” Implementation will be tailored to the supply chain vulnerabilities identified and the specific product characteristics. For example, a product’s shelf life may determine which actions are appropriate. The eight “pick-and-choose” recommendations are:
• 1. Increasing manufacturing capacity: Marketing authorization holders may be requested to increase manufacturing capacity to meet E.U. demand.
• 2. Diversifying suppliers: Marketing authorization holders may be required to add additional suppliers to reduce dependency on a few suppliers, or even a single supplier, to build resilience into the supply chain. Choice of suppliers should take into account geopolitical risks such as conflict that can impact site access by the marketing authorization holder or authorities, and the potential need to update the medicine’s dossier.
• 3. Inventory management through monitoring of available stock, supply and demand: The MSSG may also recommend that marketing authorization holders forecast supply and demand to ensure the supply chain can meet demand. Marketing authorization holders should implement warning mechanisms alerting to the potential of shortages.
• 4. Keeping a certain “safety inventory” in stock: The MSSG points out that several Member States implemented national provisions requiring contingency stock to be used during a short-term shortage. The group may recommend that marketing authorization holders keep a contingency stock of active pharmaceutical ingredient as well as finished product, and that the European Commission builds a stockpile.
• 5. Implementing joint procurement mechanisms: This would require the European Commission to facilitate negotiations for central or joint purchase of medicines for the E.U.
• 6. Implementing a shortage prevention plan: Marketing authorization holders for medicines on the Union list of critical medicines may be required to implement a shortages prevention plan. This provision is already included in the European Commission proposal for the pharmaceutical legislation and is also supported by the Council.
• 7. Regulatory flexibility and enhanced support: The EMA may be required to provide additional scientific advice and regulatory support to address supply chain vulnerabilities. Additionally, any changes to dossiers should be able to happen quickly, requiring vooperation between national regulators.
• 8. Implementing investment incentives: More tools, including financing mechanisms, might be needed to ensure the manufacture of critical medicines and their components in the E.U. New initiatives to support investment should be brought before the Critical Medicines Alliance to “facilitate the use of available EU and national funding.”

Analysis

• The Critical Medicines Alliance brings together a diverse set of stakeholders – which can be good, but also not so good. The European Commission states that there are currently more than 250 members and that number might be growing further. This means that the impact of shortages and resolutions can be addressed from a variety of viewpoints, which is good. However, with so many stakeholders, efficiency and agility might be a challenge as the alliance works to develop a strategy to address shortages and tools to ensure supply chain resilience. There could be too many cooks working within the alliance’s proverbial kitchen, which could lead to challenges when trying to provide recommendations that align with all viewpoints.
• The European Commission completed a first analysis of vulnerabilities of a subset of critical medicines on the Union list, Kyriakides said during the press conference. This analysis provides a starting point to strengthen the E.U.’s production capacity of medicines, she added, although the list of medicines included in the pilot and its findings have not yet been published. Hopefully, alliance members will soon have access to this information to inform their discussion and recommendations.
• Medicines shortages is a critical issue in the E.U., yet the instruments addressing them seem to move fairly slowly. The calls for a Critical Medicines Act started about a year ago, but the European Commission communication calling for the establishment of the alliance wasn’t released until October. It took about half a year to get the alliance started with their first meeting. The strategic plan isn’t expected until the end of 2024. That means that implementation of any measures in the plan would likely not happen before 2025 – over a year after the initial communication calling for the body. Although the MSSG does work on short- and medium-term actions, its premise was also restricted to actions to address public health emergencies and major events, but now seems to have broadened.
• As a first action, the Critical Medicines Alliance is supposed to provide concrete actionable recommendations in its Strategic Plan, according to Kyriakides. However, the potential recommendations that she mentioned, such as joint procurement, mirror those of the MSSG. It remains to be seen how different the alliance recommendations are from those included in the proposed pharmaceutical legislation and the MSSG.
• The MSSG included the exploration of investment tools in its recommendations. Industry representation in the alliance could move this option further along, to support the expansion of manufacturing capacity. Industry stakeholders are perhaps the most invested in the challenges and opportunities for reshoring of manufacturing of active pharmaceutical ingredients, intermediates and finished products, and their input via the alliance could prompt consideration of investment tools to support these actions.

What’s next

• The Strategic Plan is the first concrete deliverable to be completed by the end of 2024. It is unclear if the strategic plan covers the whole of the current five-year mandate or if it only covers a portion. However, the strategic plan should give an outline for recommendations and associated implementation timelines.
• The two initial working groups will start collaboration in May 2024. The two working groups look at increasing manufacturing capacity and diversification of the international supply chain, as well as partnerships. No information has been provided yet on when they might meet and who would be participating in each of those working groups, although it should only be the subset of members that have expertise in the specific area. That would likely mean that industry would participate in both working groups.
• The current mandate runs for five years, and new members will be accepted on an ongoing basis. Though the initial call for participation closed in early April, but the application form is still available. Interested parties can apply to participate at any time.

To contact the author of this item, please email Kirsten Messmer ( [email protected]).
To contact the editor of this item, please email / Kari Oakes ( [email protected]).

Key Documents and Dates

• European Commission press release – Commission launches the Critical Medicines Alliance to help prevent and address shortages of critical medicines, April 24, 2024
• European Commission question and answer – Questions and Answers on a European Critical Medicines Alliance, April 24, 2024
• EMA press release – New recommendations to strengthen supply chains of critical medicines, April 23, 2024
• EMA/44164/2024 – MSSG recommendations to strengthen supply chains of critical medicinal products, April 23, 2024