Maggie Saykali on the Critical Medicines Act and the Mandate for Local Production

In this part 2 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), offers strategic insights into the necessary structural shifts for the European biopharmaceutical manufacturing sector, focusing on competitiveness, innovation, and crisis preparedness. Her analysis centers on the premise that the European industry cannot effectively compete on salaries or basic costs, necessitating a fundamental pivot toward quality and technological advancement to ensure long-term resilience and secure critical supply chains.

Saykali stresses that innovation is driven by the mandate for competitiveness, arguing that manufacturers must create added value compared to other regions that may use older techniques or processes with lower environmental requirements. By valuing criteria, such as implementing more efficient and environmentally friendly processes, achieving better control of emissions, and improving the recycling of solvents, Europe actively pushes for the technological advances that yield a competitive edge.

Furthermore, she argues that the approach to security and crisis readiness must evolve beyond simple stockpiling and instead focus on maintaining robust, adaptable production capacity. This strategic focus on maintaining industrialization is critical because if Europe loses its current level of pharmaceutical manufacturing capability, the ability to produce necessary medicines will inevitably dwindle. Saykali provides a crucial strategic overview of why production capability is paramount for crisis readiness:

“Crises, by definition, are unpredictable,” Saykali says. “It's not that you should have a stockpile of what is needed. The essential notion here is that you should be able to produce it when you need it, and actually that you should have the equipment and the infrastructure to produce what you need when you need it”.

She notes that other regions, such as the US, are adopting similar models to encourage national production, often because they have already lost significant domestic manufacturing capability, leaving them potentially more vulnerable than Europe. The proposed Critical Medicines Act addresses this dual challenge by emphasizing both preparedness (encouraging local production at the highest standards) and securing international alliances and cooperations for times of crisis, according to Saykali. Relying on only a single option for supply creates vulnerability, a risk clearly demonstrated during the early phases of the COVID-19 pandemic, when the delivery of key ingredients to Europe was disrupted. Ultimately, Saykali emphasizes that stakeholders must actively "put value on something other than just the price" to push for the innovation necessary to maintain this competitive edge, prompting the industry to question whether it can afford to rely solely on cheap medicines moving forward.

Check out Part 1 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.

Competitiveness and innovation are two very important things for European manufacturers. This is the way that they can create an added value compared to production in other regions of the world that still use maybe older techniques or older manufacturing processes and lower environmental requirements. So by giving an advantage and valuing this, these criteria, actually, we are pushing for innovation and pushing for more efficient, more environmentally friendly processes, better control of emissions, better recycling of solvents, things like that. So innovation is pushed by the need for competitiveness. So the two go together, and we cannot compete on salaries or costs. We will compete on quality innovation, and that's it.

Well, we see that other world regions are actually adopting something very similar. I mean, look at the US. Everything that is happening to encourage national production is actually happening more or less on the same model as what is happening in the EU. I mean, it's not one acting on the same model as the other. They are advancing in parallel, because that is the solution if you want to have control on your supply chain and have the guarantee that whatever crisis happens, that you have what is needed to address the crisis. Crises, by definition, are unpredictable. So it's not that you should have a stockpile of what is needed. The essential notion here is that you should be able to produce it when you need it, and actually that you should have the equipment and the infrastructure to produce what you need when you need it. And if Europe does not maintain the level of industrialization and of manufacturing that we have for the pharmaceutical supply chain, then this ability to be able to produce what is needed when it's needed will dwindle, and therefore we have a problem. And this is more or less where the US are at now, because they've lost a lot of their manufacturing capability and are now more vulnerable even than Europe.

The Critical Medicines Act actually saw it really well. You have the chapter on preparedness, and you have the chapter on cooperations and international cooperations. And I think that if you want to be crisis ready, which is the final purpose of what we're doing, you need to act on both. You need to be able to encourage local production at the best and highest standards of quality possible to be able to make what you need when you need it, but you also need to secure alliances and cooperations for times of crisis, when you need to have other options as well. By having only one option for the moment, we are making ourselves vulnerable. And we have seen it during the early phases of COVID, where some supplies were not arriving to Europe, that there was really an issue in delivery of some of the ingredients to make the medicines that we needed. Actually, the pandemic really highlighted some of the issues that could happen if we don't prepare.

It's a very difficult question to ask, and one that I don't think I have all the information to answer it. I can only answer from my perspective, which is that for us, the only way to go forward is to really put value on something other than just the price, and to push for innovation, push for technological advances that will give us this competitive edge. If we don't do that, we lose the battle, and that is obvious. So we in some ways, have to ask ourselves, “Can we afford to go along as we have always done, and can we afford to only rely on cheap medicines?” They are cheap for a reason.