The CMA: Transforming Procurement to Ensure API and Excipient Supply Chain Resilience

In this part 1 of a 3-part interview regarding the presentation “The Critical Medicines Act: Game-Changing Opportunity for a Sustainable and Resilient Supply Chain?” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, Maggie Saykali, Director – Specialty Chemicals, Cefic (European Chemical Industry Council), provides insight into the origins and development of the European Union’s proposed Critical Medicines Act (CMA). The push for the CMA originated during the 2020–2022 pandemic, during which medicine shortages underscored Europe's deep dependency on other regions—particularly Asia—for critical medicines, a situation aggravated by years of pharmaceutical offshoring. The core goal of the legislation is to identify the root causes of these shortages and drastically reduce them, explains Saykali.

The European Commission, working with major stakeholders, including API manufacturers, generics and branded medicine producers, patient associations, and member states, first developed a methodology to define what constitutes a "critical medicine." This methodology relies on such factors as a medicine’s supply chain structure, therapeutic family, and the number of suppliers. The concept of the CMA itself emerged in 2023, modeled after similar European legislation focusing on raw materials or semiconductors. This process involved the formation of a Critical Medicines Alliance, which included approximately 200 stakeholders. Published in March 2025 by the Directorate General for Health (DG SANTE), with assistance from the directorates for industry and medical emergencies, the act is now undergoing consultation with the European Parliament and Council, with a final vote anticipated by the end of this year or the first quarter of 2026, according to Saykali.

A primary focus of the CMA is reforming procurement practices. Currently, procurement is often based solely on price, resulting in a "one winner takes the whole tender" system that lacks guarantees regarding quality, security of supply, or adherence to environmental and social norms. This setup is detrimental to European manufacturers who must comply with strict EU regulatory frameworks. By reforming procurement criteria, introducing multi-winner tenders, and embedding environmental standards, the CMA seeks to ensure that compliance with stringent requirements becomes an advantage rather than a penalty for European producers. Furthermore, vulnerabilities must be addressed throughout the entire pharmaceutical supply chain. Saykali emphasized the often-overlooked components:

"We should not forget excipients because a lot of the critical medicines, generics or branded, actually depend on the excipients for their mode of action,” says Saykali. “And if we have a shortage and excipients, we… cannot make this medicine."

Check out Part 2 and Part 3 of this interview and access all our CPHI Europe coverage!

Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Maggie Saykali. I am the director of the European Fine Chemicals Group, and that is the trade association that represents the European manufacturers of active pharmaceutical ingredients, excipients. Intermediates and the key inputs, in fact. So our members are mostly CDMOs or some of them also make finished dosage forms, but mostly they are CDMOs and manufacturers of excipients or active pharmaceutical ingredients.

So the Critical Medicines Act is something that took a long time to elaborate. It originated during the pandemic, the idea of it. During the pandemic, we were witness to quite a few shortages that illustrated actually the existing situation that we all knew about, that for some critical medicines and with the offshoring that has been going on for years from Europe to Asia due to different factors that we were very dependent on other regions for the supply of some of our critical medicines. And this is more acute in generics of course, so we can go into the numbers behind that, But so, during the pandemic in 2020 until 2022, it was very obvious that the situation was exacerbated and that the solution must come. The European Commission worked with major stakeholders, meaning us as active pharmaceutical ingredient manufacturers, the generics manufacturers, and the branded medicines manufacturers mainly, but also patients associations, pharmacists, and member states to come up with a solution, first of all to identify the root causes for the shortages, and then, of course with the purpose of finding solution to alleviate them or to reduce them drastically.

So that started with a methodology to determine what is actually a critical medicine, what makes for the criticality. And the commission came up with a methodology with different factors based on the structure of the supply chain of a medicine. It's therapeutic a family factors like the number of suppliers, et cetera.

So there was a rather complex matric that would then identify what is a critical medicine and what is and differentiated from medicines that might be short but not qualify for the criticality. After that, in 2023, the idea came that we need a critical medicines act for Europe on the same model as the one for the chips or for raw materials, et cetera.

And this idea originated with a few member states that pushed it really hard together with the commission, European Commission, and there was a Critical Medicines Alliance formed. With the stakeholders, there was about 200 stakeholders, but the critical alliance board, steering board was these associations that I mentioned, plus representatives of patients, pharmacists, et cetera, and member states.

And we worked on what were the possible solutions. And then the commission went to work, put this all together. And in March, 2025, the Critical Medicines Act was published, and it was published by the director General for Health (DG SANTE). So the directorate in the European Commission that is responsible for everything that concerns health, but it was also helped by the directorate for industry and the one for medical emergencies.

So since then the Critical Medicine Act entered the European decision-making process, which involves consultations with the European Parliament and the council, meaning the member states, the European member states, and this is where the process is now. The council, the commission, and the parliament are discussing, and the final vote will happen we think, at the end of this year or first quarter of 2026. And then it'll be it'll have legal value.

First of all what we see today is a situation, for instance, in procurement that is completely based on cost, a price only meaning one winner takes the whole tender and it's only based on price. Meaning there are no guarantees on quality, on security of supply, on any other factors on the fact that it's produced, respecting environmental norms or social norms, all of that doesn't enter into account.

And is actually detrimental to European manufacturers because we have a set of standards, environmental, social that we have to comply with. That's normal. These are the European re regulatory frameworks. And some of the other suppliers from other world regions are not abiding by these, and they have different cost structures.

By addressing the issue of the criteria for procurement, this might give European manufacturers better possibilities to be competitive. Plus in putting environmental criteria in there as we asked for, that will give value. To the fact that we produce according to a very strict and very tight ESG requirements.

And this means that we will not be penalized because of it, but that will become rather an advantage for us. Plus then we are asking for not to go for the one one winner takes it all. But to have multi-winner tenders, which will put at an advantage Also people who manufacture in Europe.

Be it finished dosage, forms, active pharmaceutical ingredients excipients, et cetera. We should not forget excipients because a lot of the medicines critical or sorry, generics or branded actually depend on the excipients for their mode of action. And if we have. Shortage and excipients. We are at the same point that we cannot make this medicine.

So the role throughout the supply chain, we have to make sure that there are no causes for vulnerability and no possibilities for shortages or delivery of faulty or not up to standard quality ingredients.