Some pharmaceutical companies are openly warning that they could delay bringing their medicines to Europe. Solène Jouan is not willing to accept it. The policy officer at the European Patients’ Forum believes such warnings place undue pressure on member states and already overstretched health systems. Ultimately, she argues, the consequences fall on patients.
The pressure comes from the United States. Under the “most favoured nation” (MFN) approach, Washington wants to lower US drug prices by linking them to what other wealthy countries pay. European Patients’ Forum (EPF) fears the knock-on effect could push European prices up, and that companies will use it as leverage.
In an exclusive interview with EU Perspectives, Ms Jouan set out EPF’s concerns across the files now shaping European health policy. Across every file, from medicine pricing to the EU budget, she returns to the same point: competitiveness is meaningless if patients cannot access treatment.
‘Such warnings have a strong impact on patients’
Some companies are already saying they could postpone launching their products in Europe, partly under US pricing pressure. How concerned are you?
We are a little bit scared. We have heard pharmaceutical companies say that they would postpone their launch in Europe. They always say they develop the medicine for the patients. So it is a little bit concerning that they are openly saying this.
Raising the price is not the answer.
— Solène Jouan, Policy Officer, European Patients’ Forum
Raising the price is not the answer. In the US, the medicines are very high and they don’t have a very good healthy population. So I don’t think increasing the price of a medicine would be the solution. Postponing the launch of a product is impacting patients.
At a time when our healthcare systems are under great strain, it is dangerous for pharmaceutical companies to make these types of statements. We need to ensure that we are strong in the EU. Member states need to show that we are united in our response.
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We still don’t know exactly how the most favoured nation policy would work. Does that uncertainty worry you?
It’s a concern for sure, but for the moment we are just having a debate. We don’t know exactly what this most favoured nation is. No one saw really the contract. Everything is private. I discussed it with an American consumer organisation. They are not in favour either, because everything is secret. They don’t want prices increasing in Europe that can have a strong impact on patients.
The two systems are not comparable. In the US they don’t have a pricing and reimbursement system. So the price is high, while we have a universal system in Europe. I think it is also the time for the EU and the member states to work together on healthcare. And maybe to do more joint procurement.
The ‘elephant in the room’: what medicines really cost
New medicines are arriving fast, and many are very expensive. Where is the problem on pricing?
We know more and more innovative medicines will come to the market, and yes, they will be expensive. But we need to ensure why. We need to have the data that are proving that it benefits for the patients. We also need to know the origin of the investment. Because most of the time, we don’t know how much the company put to develop these medicines.
At the same time, our infrastructure is often outdated. In France, with the recent heat waves, we discovered that most of the hospitals didn’t have any air conditioning. So we have to set priorities, and maybe we need to talk about the prices of the medicines, or to have proof that they are really efficient for the system and for the patient community.
Access still splits Europe in two
Access to medicines is still unequal across the 27 member states. Why does that gap persist?
It’s not only the fault of the EU. Healthcare is a national competency, and it depends on the budget and the priorities of each member state. But there is also a big inequality because of company strategy: they first go to the markets where they know they will have a better return of investments. So we have medicines available in France, Spain, Italy and Germany, and then years after in Eastern Europe.
The revision of the pharmaceutical legislation may help. Now, if a member state requests a negotiation on pricing and reimbursement, the company will not be able to say no, only in specific circumstances, and this still needs to be well defined. But I don’t think the pharmaceutical legislation in itself will solve the issue of access.
Honestly, this is not acceptable. We are in a union. Yes, it’s a national competency, but we can do something together to improve the process. We showed during COVID-19 that it was possible. We don’t need to wait for a pandemic crisis to make it happen.
Wins and compromises in the recent files
The EU recently overhauled its pharmaceutical legislation, including new rules aimed at improving access to medicines across member states. How do you assess the outcome for patients?
We advocated a lot to ensure that patients are part of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) (editor’s note: the committee which decides whether medicines should be approved). Some specialist committees will not be created any more, such as the Committee for Orphan Medicinal Products, where patients used to have a permanent seat, will not exist anymore. There will be only the CHMP, and it was normal for us that patients are part of it. We managed to have two patient representatives as permanent members with one voting right. The vote matters, because if you don’t have voting rights, you can say something, but it’s not taken into account. I’m still looking forward to seeing how article 56A, the launch article, will be implemented, with all its exceptions.
The EU also adopted the Critical Medicines Act to strengthen medicine supply chains after years of shortages. What do you make of that law?
I’m still studying the final text. There is no joint procurement, which is a bit of a pity, but the Commission can still do procurement on behalf of a member state when the member states request it, and now not only for a pandemic but also for critical medicines and medicines of common interest, like orphan drugs. Overall, it’s good progress for patients in Europe. But we can have a good legislation on paper. If it’s not well implemented, it will not solve some issues.
The Health Technology Assessment Regulation has started introducing joint EU clinical assessments of new medicines. Do you think it will improve access?
We will not see the effect right now on if the regulation will help to ensure better access to treatment across Europe, but maybe in two, in three, four years, we will manage to see it.
Health folded into a competitiveness fund
The EU is negotiating its next seven-year budget, the Multiannual Financial Framework (MFF). One proposal would fold health into a new European Competitiveness Fund alongside agriculture, biotech and bioeconomy. Why does that worry you?
When we saw the Commission’s proposal, it was quite a shock. It’s problematic to link health to competitiveness, and usually you lose the public health perspective.
With this change, we will not know every year how much will be allocated to health. Agriculture is very important for big countries right now, so the risk is that far more goes to agriculture and not to health. We are left wondering every year how much funding health will receive. And it has happened before: two years ago EU4Health was cut by 20%.
When we saw the Commission’s proposal, it was quite a shock, because there is no longer a standalone public health programme.
— Solène Jouan, Policy Officer, European Patients’ Forum
We are not against competitiveness. But it’s good to have a holistic approach. As I keep saying, if people cannot have a treatment, it’s useless to have a competitiveness.So we need a ring-fenced funding for public health inside the European Competitiveness Fund (ECF), and an element saying that patient organisations will receive funding to sustain their work.
What is EPF doing about it?
We suggested amendments, and we are working with our national patient associations. For the MFF, it is not the ministries of health that work on this. Rather, it’s the finance and foreign affairs ministries. So it’s complicated for the ministries of health to have a word, and we try to make sure the others are aware too.
Longer patents, no proof
The Commission is considering extending Supplementary Protection Certificates (SPCs), which prolong patent protection for medicines beyond their standard patent life. Why does EPF oppose that?
We are very concerned. We thought the debate on protection had ended with the revision of the pharmaceutical legislation, so it was a surprise to see the SPC in the Biotech Act in December. Our main concern is the evidence: we don’t have any impact assessment showing that extending the SPC will improve research and competitiveness in Europe.
The extension of the SPC comes at the end of the process, when the medicine is already on the market. So this will give a bonus to big pharmaceutical companies and not to SMEs and academics. It will also delay generics, which impacts patients and the healthcare system. And we already have in Europe the most protections on medicines and we still have inequality of access.
What would you do instead?
The first phases of biomedicine development are the hardest, when universities and SMEs run the first clinical trials and struggle to find money for the next phase. That is where we need support. We should put public money at the beginning of a process, for example through milestone payments for SMEs and academics, instead of an incentive at the end of the process. On clinical trials, we are quite supportive of reducing the timelines, as long as patient safety is maintained and the member states have the resources to do correctly their work.
Clinical trials out of reach
The Commission also wants to simplify how clinical trials work across Europe. What still needs to change from a patient’s perspective?
For me the main issue is patient participation in clinical trials. Not every country has the infrastructure, for example for advanced therapies, so we need to ensure that patients can go, for example, to Italy, to France, to Spain where the trials are. That means cross-border access to clinical trials and ensuring that patients can receive information on how to be reimbursed. We also want to make sure a patient can still access the treatment after a clinical trial, because today there is a grey area. And we want patient-friendly, harmonised informed consent across countries.
Patient groups do the EU’s unpaid work
Brussels has been phasing out operating grants, the core EU funding that keeps many patient organisations running between projects. What has that meant for EPF?
Last year, in 2025, the Commission did not include any operating grant in the EU4Health programme, a year after we signed a framework agreement in 2024. The Commission said it was due to the 20% cut on the EU4Health. It should be noted that the operating grants were barely 1% of the EU4Health annual budget.
It had a big impact everywhere. At EPF, seven colleagues have found opportunities elsewhere. Unfortunately, given the current financial situation, we have not been able to replace them. As a result, the remaining staff have had to take on the responsibilities and policy areas previously covered by those who left, placing significant additional pressure on the organization. Other organisations in Brussels had to fire 40% of their staff or close their offices. And we still support the Commission for free: we are the only patient organisation in the medical devices coordination group, we also represent patients at the European Medicines Agency (EMA), and we sit on groups on antimicrobial resistance and others. This is, for the moment, a job that is not paid. We are doing this voluntarily.
Now the Commission again proposed the 2026 work programme very late, in the middle of the year, and again without a secure operating grant. This time many countries decided to vote against or to abstain, so the Commission didn’t have a majority to adopt it. It has now proposed a new draft. We welcome the countries that voted against or abstained. If the operating grants were at the end to be reintegrated, we however need the amount to be enough to sustain our work.
The bottom line
What is EPF’s main priority right now?
Our priority is to make sure patient organisations can defend public voices well. At a time when so much health legislation is being negotiated and implemented, we need strong voices of public health interest to counterbalance private interests. Concretely, that means a strong health envelope in the MFF, and funding to sustain the work of patient organisations, not only for specific activities, but really the entire work.
We are also following medical devices very closely, and we suggested amendments so that patient safety is maintained, despite the different simplifications. We work a lot on digital too, on the European Health Data Space and artificial intelligence. And we recently published our first barometer on patient involvement, which looks at best practices and gaps across Europe. We will have a webinar on the 15th of September. This is the first barometer we have published, and the objective is to continue to follow the situation in the years to come, with follow-up editions.
