On Tuesday (March 11, 2025), the European Commission presented its new Critical Medicine Act (CMA). Science Media Center Espana writes that CMA aims:
… To overcome the severe shortage of drugs and healthcare products, reduce external dependence on important drugs and ingredients – especially from Asia – and guaranteeing the supply of cheap drugs in the European Union.
My colleague Antony Miale was quoted Politician Giving his views on CMA:
Senior Managing Director in FTI Consulting and Head of Health Care and Life Sciences Antony Miale said the Act “The manner in which drugs have been historically purchased in the European Union have an earthquake.” “Construction on experience gained during Kovid -19 epidemic, [European Commission] Now widely wants to open the door to buy a wide range of second drugs, including Abhinav. ,
As mentioned by Mr. Miale, the requirement of CMA was initially powered by a lifeline, high quality drugs by the supply of Covid-19 epidemic. Additionally, the ongoing geopolitical instability in recent years has created more danger for the global supply chains of essential medicines and shortage in Europe.
The European Commission performs the main features of CMA as follows:
- Strategic projects It can be designated for important drugs or their ingredients, so that they benefit from easy access to funding and fast-track processes.
- public procurement To encourage the flexibility of important drug supply chains or improve access to other drugs of normal interest.
- Collaborator procurement The request of the member states in separate member states will be supported by the Commission, to address the availability and reach the inequalities of important drugs and other drugs of general interest.
- International participation To make the supply chain wider and reduce dependence on single suppliers, the discovery will be done with equal countries/regions.
- state aid Guidelines To assist member states in financially supporting such strategic projects.
Ropes and Gray noted that the European Commission tracked the CMA rapidly, which means that they have opted for a dedicated impact assessment or not to conduct public consultation. Especially note that the purpose of CMA is to use more procurement requirements other than the value (eg, supply chain reconsideration) that selects suppliers.
The European Federation of Pharmaceutical Industries and Association (EFPIA) referred to general support to use more strong supply chains and access to important drugs, but some doubt also voiced that the collaborative purchases would be optimal. There were also some risks of increase in administrative costs.
… while these options can be suitable under very specific conditions where they accelerate the patient’s reach for important drugs, a systematic application can cause more losses than offering more permanent solutions to reach related issues. Therefore, it requires clarity to identify the circumstances where the collaborative procurement options will improve access to the existing national pricing and reimbursement routes …
EFPIA believes that the Act needs to go ahead and provide an effective response to the national casual stock requirements that disrupt the functionality of the single market.
Regarding the obligations for market actors to provide information, we urge the authorities to use the existing data system to avoid repetition of reporting requirements. Information already stored in the verification system of European drugs provides timely intelligence information on the number of packs for all prescription products being supplied in various member states
A Politician The article notes that while Belgium was one of the major drivers of applying CMA, some Belgian politicians are not happy with the end results.
“This is the lack of urgency required for our health care and safety protection,” Frank Wandenboke, who is also the Deputy Prime Minister of Belgium, told Politico.
While he admitted that the Act is a “important step ahead,” he said “the proposed funding is inadequate, and there is no normal strategy to stock the required medicines.” Belgium has called for a partial funding the Act to the Act partially by the defense strategy of Europe.
Politician The article also has different types of approaches on the CMA.
What do patients think? The platform of European patients (EPF) said that it:
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However, additional efforts and supplements are strongly needed to ensure that the Act effectively fulfills its objectives of strengthening the security of the supply, ensuring availability of important medicinal products for all European Union patients, and maintains high level of public health protection.
We are very worried about how these initiatives will be funded in short and long periods …From our perspective, in the processes of decision -making at the national and European level, on the definition of public procurement criteria, for example, inadequate focus on structured cooperation and participation of civil society, especially patient organizations.
Many commentators mentioned that the purpose of CMA for a safe supply chain and reliable access to medicines is a laudable goal, requiring enough money and concrete tasks to become the reality of CMA.
