Carin Uyl-de Groot is a professor of Health technology assessment at the Erasmus School of Health Policy & Management and director of the Institute for Medical Technology Assessment. Her research focuses on the medical and societal value of new medicines, particularly cancer treatments. Among other things, she analyses what innovative therapies cost, what they yield for patients, and whether they can be used effectively within healthcare.
What is currently happening in the United States?
“The FDA laid off 3,500 employees at the beginning of April, including staff responsible for evaluating new medicines. This measure is, according to Trump, part of his broader aim to downsize the US government.
“Additionally, Trump announced his intention to impose import tariffs on medicines. He invoked his ‘America First’ principle; he wants to move drug production back to the US, in order to reduce dependence on countries like China and India.
“I find it a strange combination. On the one hand, Trump wants to bring drug manufacturing to the US, while he is laying off the experts responsible for their approval. This is concerning, as it can only lead to delays in the evaluation process for new medicines, and existing drugs becoming more expensive.”
How does the situation in the US affect Europe?
“Before a medicine can be marketed, it must first be approved by a regulator. In Europe, this is the European Medicines Agency, the EMA; in the US, it is the Food and Drug Administration, the FDA. Manufacturers often go to the US first and then Europe. Approval in the US often forms the basis for global admission, as other regulators place great value on the FDA’s evaluation. In the next two years, more than two hundred drugs are scheduled to be assessed. These are huge dossiers that simply require manpower.”
Why do companies go to the FDA first?
“The US market is larger, and the willingness to pay for medicines is higher there. Additionally, the negotiating position of insurance companies with respect to the pharmaceutical industry is weaker than in Europe. The approval process for medicines is also faster. It is one market with one authority. In Europe, approval from the EMA does not necessarily mean market access for the medicine. Individual member states want to have their say as well.
“All of this means that manufacturers can demand higher prices in the US. The speed is appealing for investors: the quicker you are on the market and the higher the price, the faster you can recoup your investment.”
How dependent is the EMA on the FDA?
“The FDA and EMA are two separate entities. They are therefore independent, but do work closely together. This collaboration has many benefits. They share data, align safety measures, and sometimes conduct parallel evaluations. This is very valuable for manufacturers. They do not need to submit two entirely different files. However, this also means that delays at one agency have repercussions for the other. If the FDA begins to work less quickly, companies may wait to submit their files for Europe. Or they may only be able to submit them later because they do not complete their FDA dossier in time.”
How should the EU respond to Trump’s actions?
“With someone like Trump, you never know. Today he says one thing, tomorrow the opposite. He is laying off people at the FDA while simultaneously wanting more domestic production. This requires strict quality control, permits, and inspections – all tasks of the FDA. That is contradictory, unstable policy. It is therefore difficult to say what the precise consequences will be.
“At a political level, we need to keep the dialogue going. The EU is doing this, especially concerning the import tariffs. Pharmaceutical products are the most important export items of the EU to the US. In 2024, approximately 110 billion euros’ worth of pharmaceuticals are expected to head that way. The chair of the European Commission, Ursula von der Leyen, remains in dialogue, and I think it is good that she is not overreacting.”
Does this situation also offer opportunities for Europe?
“Perhaps, if we handle it well. If Trump really goes ahead with everything he is currently proclaiming, such a common enemy could lead to better collaboration here. If the EU can streamline the evaluation process, we could become more attractive to manufacturers. Research has been conducted on the time to market in Europe. In Germany, 46 out of 48 medicines were available within a month after EMA approval. In Lithuania, only three became available within three years. Those differences are enormous, and that is costly time.
“Approval by the FDA generally takes place faster than by the EMA, averaging at about eight months. With a quicker evaluation process in Europe, the entire timeframe could be significantly shortened. If we can also accelerate the reimbursement procedures in European member states, it may become more appealing for manufacturers to seek approval here first. Who knows, we might even see ‘EMA first’.”
What are the consequences of these FDA layoffs for the development of new medicines?
“Developing a new medicine quickly costs more than a billion euros. Investors put that money in with the expectation of recouping it within the life of a patent, which is usually twenty years. This timeframe starts during the preclinical phase, even before a manufacturer can begin testing on humans, while research is still in the lab. By the time you bring the drug to market, you often have only eight to ten years left to recoup everything. Each month of delay costs money.
“So, if the entire process takes longer—from research to approval—the window for making a profit shortens. And if the market becomes unstable, investors will look elsewhere. Perhaps even to weapons, given the situation in the world.”
What does this mean for patients?
“Particularly in America, medicines will enter the market later. Delays will also occur in Europe for drugs where the EMA collaborates with the FDA. And without approval, there is no reimbursement, meaning patients cannot access the medicine.
“This mainly affects innovative drugs for diseases that previously had no or less effective treatments. Think of immunotherapies for cancer, or cell and gene therapies such as CAR-T cells. Such treatments can easily cost 300,000 euros per patient.
“There are also medicines for rare diseases, for instance, for certain muscle or mitochondrial disorders, which cost between two and three million euros per patient –for a single injection. In the Netherlands, this may affect perhaps ten patients a year, but the need for these patients is immense. If the approval or reimbursement is delayed, they will receive their treatment later. And for some, that is literally the difference between life and death.”
Trump wants to bring drug production back to the US. Does that make sense, and could it be a good strategy for Europe as well?
“That desire indeed exists, and in Europe, you hear it more often nowadays. The idea is to become less dependent on China and India, where about 80 per cent of generic drug production takes place. We could produce medicines like antibiotics ourselves. But it is not without reason that we moved production there in the first place. In Asia, wages are lower, environmental regulations are less strict, and there are already large factories in place. You can produce much cheaper there, especially for these kinds of medicines where margins are minimal.
“If we want to produce here, we must accept that these medicines will become more expensive, while prices in the Netherlands are currently very low. As a result of those low prices, we already face shortages, so there is a case to be made for a certain degree of self-sufficiency in this turbulent world. But there will be a price tag attached to that. And we must be honest about who will pay that price.”
Trump’s policies are putting pressure on science and institutions. Is Trump an exception, or do you see his approach reflected in broader societal shifts?
“The idea that healthcare is something collective is fading. In America, there is a mentality of ‘I won’t get sick’. The weakest no longer count. Once you become ill, you are written off. That political climate is seeping into Europe. I do worry about that.
“It is no longer about science with Trump; rather it is about repeating something until it is deemed true or until people think it is true. He is an extreme embodiment of this, but the sentiment of mistrust in science and institutions is, of course, more widespread. This became starkly apparent during the pandemic. We are now even witnessing children dying from measles again. People refuse vaccinations because they do not trust them. At the same time, they still want immunotherapy when they get cancer. While everything is based on the same knowledge. I do not understand it.”
