The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing. In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance. In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’. As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.
Initial support for a Critical Medicines Act
In May 2023, a number of EU Member States issued a paper calling upon the European Commission and EU authorities to take certain action on critical medicines and medicine shortages issues – in particular, to take action in three specific areas. Firstly, to establish an EU Solidarity Mechanism within the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – whereby EU Member States who experience acute shortages of medicines, or whose stocks are critically low, could send out a notification through the mechanism so that other Member States could provide some temporary relief. Secondly, to more quickly establish a European List of Critical Medicines – detailing medicines where, if there is a shortage, it could have a serious harm to patients or present challenges to health systems. And thirdly, to propose and adopt a “Critical Medicines Act” which would be ‘complementary to the European review of pharmaceutical legislation’ and which would address structural issues to improve robust and assured supply of medicines and ingredients important for health industries.
Following the publication of that paper, the Commission, the European Medicines Agency (EMA) and others quickly reacted. As regards the first issue; on 24 October 2023 – i.e. the same day the Commission published its Communication on ‘Addressing medicine shortages’ – EMA published details of a new MSSG created “Solidarity Mechanism” allowing EU Member States to support one another in the face of critical medicine shortage. As regards the second issue; on 12 December 2023, the Commission, EMA and the Heads of Medicines Agencies (“HMA”) – published the first version of the ‘Union list of critical medicines’. However, as of yet, it seems that there has been no specific action on the third issue – namely the adoption of “Critical Medicines Act”. Instead, EU authorities have taken a number of related steps such as: (1) the EMA/MSSG Recommendations of 19 April 2024 to strengthen supply chains of critical medicinal products, and (2) the creation of the Critical Medicines Alliance.[1]
The Commission has previously stated that the work of the Critical Medicines Alliance (“CMA”) “could pave the way for a possible ‘Critical Medicines Act’ in the future”.[2] Now, therefore, one of the questions is : Will the CMA’s activities result in a Critical Medicines Act?
Will there be a Critical Medicines Act?
In the May 2023 paper, EU Member States called upon the Commission and EU authorities to draft and adopt a “Critical Medicines Act” which would address structural, long term issues and which would “follow the example of the European Chips Act and the Critical Raw Materials Act”. In other words, the EU Member States called upon the Commission to draft and adopt an EU legal instrument similar to Regulation (EU) 2023/1781 strengthening Europe’s semiconductor industries (The EU “Chip Act”) and/or to Regulation (EU) 2024/1252 ensuring secure supply of critical raw materials (the EU “Critical Raw Materials Act”). The underlying aim of these EU legal instruments being to: reduce dependency on third party countries, improve EU self-reliance, and encourage EU/EEA production and supply by, amongst other things, helping to increase financial support and investment.
Whether a Critical Medicines Act – similar to the European Chip and/or European Critical Raw Materials Act – makes sense, will need to be considered in context.
Whether or not there would need to be a stand-alone Critical Medicines Act similar, for example, to the European Chips Act, will likely depend on the CMA’s work and conclusions – where the mandate and scope of the CMA’s activities, is somewhat limited. The CMA is tasked with focusing on long-term measures in the field of industrial policy to address vulnerabilities in the supply chain. Whereas, in contrast, the MSSG is tasked with developing regulatory and policy recommendations focused on short to medium-term actions. The MSSG Toolkit applies vis-à-vis critical shortages of medicinal products included in the Union list. Although CMA activities have already begun, the CMA Strategy Plan is only due at the end of this year. Once the CMA Strategy Plan is published, the likelihood of a stand-alone Critical Medicine Act may become clearer.
Also, EU Institutions are currently in the process of revising EU Pharmaceutical legislation, and assessing the new Pharmaceutical Package. The Commission announced its intention to revise EU Pharmaceutical Law in its Communications of November 2020 concerning the Health Union and Pharmaceutical Strategy. It then put forward its proposal on 26 April 2023. On 10 April 2024, the Parliament adopted its position. Discussions are therefore currently ongoing on the EU Pharmaceutical Package. Given that current EU pharmaceutical legislation is more than 20 years old and in need of some revision, the discussions are expected to take some time. They will include a focus on critical medicines and medicine shortages. It may, therefore, be possible to include provisions sufficiently addressing critical medicine shortages, in this revision process.
An independent regulatory measure may seem in keeping with the general approach taken for the Chips Act and the Critical Raw Materials Act, but the extent to which a Critical Medicines Act would be substantively similar to those measures, is more in doubt.
What are the requirements on industry concerning critical medicines likely to be?
Although it is not yet clear whether there will be a stand-alone Critical Medicines Act or not, the Commission, MSSG and others have already clearly indicated the types of policies that they believe could be employed to address the underlying concerns regarding critical medicines and shortages. In its recommendations of April 2024, the MSSG include eight recommendations to ensure the security of supply of medicinal products included on the Union list including: (1) increase in EU manufacturing capacity, (2) diversification of suppliers in the supply chain, (3) stockpiling of ‘safety stocks’, (4) joint procurement, and (5) requirements for MAHs to monitor available stocks in the whole supply chains, identify early signals of potential shortages, and put in place shortage prevention plans.
For industry, perhaps one of the most significant new legal requirements – is likely to be the obligation to notify the EU authorities of shortages and potential shortages of critical medicines. The EMA Executive Director, and co-chair of the MSSG, has expressed the importance of early notification by industry of such shortages. However, questions have arisen on whether it is, in fact, possible to foresee such shortages a long period in advance – and whether it is therefore possible to comply with such requirements in reality. There have also been questions on whether, even if foreseeing such shortages is possible, why measures would not then be taken by the relevant entity to address the shortage – rather than informing the authorities and/or referring the issue to them.
Regardless of the general concerns raised, and presuming that industry is required to notify EU authorities of shortages and potential shortages for critical medicines – the issue will be: what precisely will industry be required to notify and when. Lessons can be learned from the medical device field. Last month, June 2024, EU law was adopted amending EU medical device legislation. Under the new medical device requirements, manufacturers of certain devices are obliged to inform the authorities and provide certain information in situations where: (1) the manufacturer anticipates an interruption or discontinuation of the supply of the device, and (2) the interruption / discontinuation “could result in serious harm or risk of serious harm to patients or public health” in an EU Member State. Manufacturers are required to notify the authorities “at least 6 months before the anticipated interruption or discontinuation”. Whether similar or more stringent notification requirements would apply as regards critical medicines – remains to be seen.
The legal and policy framework on critical medicines is a currently key priority issue for the EU. It is also an area in-flux and changing. Pharma companies will need to keep up-to-date and understand the impacts on them and their supply chains.
