For this episode of Karger’s The Waiting Room Podcast, we spoke with Claudia Louati about the revision of the EU’s pharmaceutical legislation.
Claudia Louati joined the European Patients’ Forum (EPF) as Head of Policy in May 2023. She leads EPF’s policy and advocacy work and steers EPF’s engagement with EU and international stakeholders on key policy issues. Before joining EPF, she worked at the Europe Office of the U.S. Food and Drug Administration in Brussels, where she promoted EU–U.S. regulatory collaboration on medical products. Claudia holds two master’s degrees in European Affairs from SciencesPo Paris and the London School of Economics.
Note: The statements and opinions contained in this podcast are solely those of the speaker.
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Welcome to The Waiting Room, Claudia.
Thank you very much, Susanne.
I come to the first question. This is: In April 2023, the European Commission proposed to revise the EU’s pharmaceutical legislation. Claudia, could you please explain why this revision of the EU pharmaceutical legislation is so important?
Yes, indeed. It’s a very important development. So, just to go back to the basics, maybe. Before a medicine reaches patients at the local pharmacy or at the hospital, it has to go through a very strict authorization process to check that it is of high quality, it is safe and effective. And scientific experts from public regulatory authorities have to look at all the evidence that the company produced in order to support their marketing authorization, and they need to decide if the product can be put on the market. And that allows then the company to apply for reimbursement at a national level whenever they get this authorization.
So, excuse me to interrupt. They need the European approval to market their drug nationally?
Yes. So, for most innovative products, of course, you know, there are some products that can still be approved from a regulatory standpoint, at national level. But for most of the new cancer drugs, the new gene therapies that are coming onto the market, they have to be approved first at the EU level.
And that then allows them to be reimbursed at the national level. And so, what this legislation does is that it puts in place the standards and the requirements for the granting of marketing authorizations throughout Europe. It ensures a harmonized approach to the requirements at all levels. And it creates, as well, the European Medicines Agency. So, of course, you know, this framework is not new in the sense that it’s been a few years now that that is in place. But the first legislation that harmonized those requirements was made 20 years ago, about 20 years ago.
And so, of course, now there is a need to update it and to make sure that it’s fit-for-purpose and that really it’s adapted to the 21st century. So, for example, you know, manufacturers are using artificial intelligence in the development of their products and then using new types of evidence, you know, that were not foreseen in the initial legislation. And that framework has to be adapted. So, that’s why it’s an important piece of legislation, because it has a direct impact on people, obviously. You know, the medicines that you’re using on a daily basis, you know, have to be regulated somewhere. It’s in that legislation.
And when you say it was adapted 20 years ago – 20 years ago, EPF was founded. So, obviously the first or the last revision was made without the inclusion of patients.
Yes. So, of course, that was long before my time. So, I can’t comment on how involved we were at the time. But indeed, EPF is 20 years old now, and I think we’ve gone a long way in terms of bringing the patient voice to the legislative and to the policy process and ensuring that the framework for the authorization of medicines is much more patient-focused. That’s the voice that we bring now in this current debate with this new proposal to ensure that it is more patient-centered.
Yeah. And what are EPF’s main requests regarding this legislation then?
So, I would say there are three big buckets that kind of bring our priorities:
The first one is really about patient involvement across the life cycle of medicines. We believe that more can be done, you know, in order to make sure that the medicines that come into the market answer patients’ needs. Of course, they have to be effective and of high quality, but they also have to have an impact, a positive impact on the quality of life of patients, for example. And so, we’re asking, for example, to have more patients’ experience data included in the marketing authorization that the manufacturer pushes forward. We also want to make sure that patients are involved in the different scientific working groups that exist within the European Medicines Agency, so that patients can bring their perspective to the regulatory discussions that are happening, into the scientific discussions that are happening.
Another focus for us is really on the availability of medicines. And so, we’ve seen in the press, you know, there is a lot of talk about shortages and some medicines that are just not available. And we know that not all countries are affected the same way. But still, even for cancer drugs or drugs that in the past were not affected by shortages. But now with the supply chains that have become more global and more complex, obviously this creates a lot of issues. So that’s another one of our priorities to make sure that enough is done and that more is done at EU level in order to strengthen the availability of medicines.
And then finally, our third area of priority is about addressing access inequalities across the EU. So, as I was mentioning, once this regulatory approval is in place, the company goes to each member state to ask for reimbursement at national level. And obviously it’s a difficult process to receive a reimbursement because especially for expensive products, you know, the government and the company have to agree on the price that is okay for the both of them, which is not always easy. And so that can take years sometimes. And in certain countries, obviously, that have lower purchasing power or don’t have the same economic situation that means that some medicines are just not available for years and years. And those inequalities, we find them really unacceptable.
So, of course, there is only so much that can be done at EU level considering that all those processes are national. But still we believe that there are mechanisms and incentives that can be put into place to really encourage companies to launch their products across the EU within a certain timeline.
That’s very important. And obviously the legislation has to balance the interests of different stakeholders, namely patients, industry, health care professionals, regulatory authorities, payers, etc. So, what are the topics groups can generally agree on?
Yes, it’s true. It’s a very contentious process in the sense that everybody has their own interest. Of course, you know, there are certain things that everybody can agree upon and there are some general goals, you know, that everybody can accept. But obviously, how to achieve them is often the subject of more debates. But I think one thing that everybody can agree on is that we need a strong European Medicines Agency that is able to function in an effective way where there is less bureaucracy, where it is possible to cut that bureaucracy. And that is really well known and that ensures really the safety and quality and effectiveness of the medicines that are on the market.
That’s something everybody can rely on then.
Yes, exactly, and a strong regulator. I think, on the shortages’ aspect as well, you know, everybody agrees that it’s not good when patients don’t have access to the medicines that they need. Again, industry and others have different views on what the problems are. But again, this is at least something that everybody agrees on. Environmental issues, I believe, you know, it’s something new. Again, that was not necessarily included in the framework 20 years ago. But, you know, the impact of the manufacturing of medicines on increasing climate change, for example, or even the antimicrobial resistance as well, that is a very threatening issue as well.
Everybody agrees that something needs to be done. We’re not exactly sure how, but it’s still, you know, it’s to make sure that antimicrobials are used in the adequate way and in a way that respects, you know, the stewardship and that maintains their efficacy. And then, of course, you know, there are some specific areas like pediatric medicines, rare disease medicines, where, again, everybody agrees that we need those products and that the market itself is not delivering them and that there needs to be specific incentives for research in these areas. But again, how these incentives should be put into place is something that is open for discussion for some stakeholders.
But at least you agree that these are topics that the parties agree on. My next question is where do the interests and claims of the stakeholders differ? Because naturally there will be differences.
Yeah, of course there are differences and based on, you know, everybody’s interests. So, one of them, for example, is when generics and biosimilar medicines should be available. These are copies, you know, of original medicines. They are much cheaper, and they actually improve patient access significantly. And of course, you know, for the branded pharmaceutical industry, you know, it’s something that is threatening their monopolies on the markets. So obviously, it can be open, you know, ideologically for discussion of when those products should be able to enter the market and when the protection of the branded medicines expires.
Another area, you know, again, is about incentives for pharmaceutical research and development. So how do you encourage innovation? And that’s a very philosophical question, you know, because, of course, you can give some carrots or some rewards to products that bring extraordinary innovation. But you also have to take into account the environment. You know, you have to create an environment that promotes research with good access to funding, for example, and these kinds of things. There are other areas about regulatory flexibilities. And so, for those very innovative products where perhaps you don’t have all the necessary evidence at the beginning, but you see that the product could bring a lot of benefits, you know, the level of evidence is something that is also open for debate sometimes.
There is something new out there. Everybody wants to have it, but it’s not yet approved. Yes. It’s a dilemma. Could you please describe the process, the how, who, when, where of the revision? And an additional question, when do you expect the revision will come into effect?
So here we get really into the intricacies of the EU system. And I know, in the press sometimes it’s difficult to convey that complexity, and we often say, oh, Brussels did this or Brussels did that, you know. And that’s not exactly how things happen in practice. So, to keep it simple, you know, there are three main institutions in the European Union:
The European Commission is the one that acts as the executive of the European Union. It’s as a kind of secretariat. It has to follow some political directions from the member states and also has its own pool of commissioners that define the priorities. And it’s the only institution that has the power to draft and to put forward a new legislation. It doesn’t do that in a vacuum. Usually, it has to answer some kind of need, you know, that has been identified. There’s a lot of different consultation processes that take place, but that leads to a proposal being drafted, and that’s just a draft. Generally, it changes quite a lot afterwards when you go through the process.
That’s where the other two institutions come in. That’s the European Parliament, which acts like a parliament at national level, you know. It is the representatives of the people that are directly elected. The next elections are taking place in 2024, so it’s always good to call on people to actually go and vote because it has a lot of impacts. And the other institution is the Council of the European Union, which gathers the representatives of the member states. And the Parliament and the Council have to discuss, you know, and to find an agreement, and they put forward their own amendments on the legislation.
And at the end of the process, they get to a text normally that would reconcile all their different interests. So, member states have a lot of power in this process. They can really put forward their own interests, and then they have the opportunity really to amend a lot of the proposals that come initially from the commission. This process can take a while, probably three, five years sometimes of negotiations. It can go faster, but for such a complex dossier – it will probably be a long time before the legislation is actually in place.
I just wondered when you said that every member state has a vote or has their say. I just wonder how any legislation passes the EU because – I think it’s a good process and a democratic process – but so many member states with such different interests. One can sometimes really wonder how that parliament, or the EU, is really working, which of course is great. So, you think three to five or maybe more years because health of course is a very complex issue or topic.
Yeah, and because this legislation is very complex and addresses so many different issues, you know, of course there are the standards and there are the regulatory requirements for marketing authorizations. But it’s so much more, it’s about really access to products, making sure that the framework is fit-for-purpose. So that’s why, and obviously, you know, it has a big impact also on the competitiveness of the industry. It’s an important piece of legislation.
Yeah. And it has an input on the national level of every country. So, you just mentioned the European Commission as one body of legislation, of lawmaking in the EU. And obviously, the European Commission mentions that this legislation is part of efforts to create a European Health Union. Can you explain what this is? When and why was the European Health Union founded, or is it still an idea? Is it going to be founded? And what is the aim of the European Health Union, and how does or will it work?
Yes, that’s an excellent question. So, the European Union per se doesn’t have a lot of powers in the field of health. It’s regulating products, like medical products, medicinal products or medical devices. But in terms of the functioning of health care systems or even prioritizing diseases, addressing certain diseases, it doesn’t have any real power in that area. And of course, that creates some shortcomings, as we saw during the COVID pandemic, where every single member state was doing their own thing whereas the pandemic was actually a pan-European threat that needed a coordinated approach. And as a result of the pandemic, and also as a result of national healthcare systems really struggling and not having resources to address the issue, I think there was a realization that we actually need a little bit more coordination at EU level in the field of health.
And that’s what this European Health Union is about. It’s about strengthening the EU’s ability to respond to pandemics and to respond to health threats and to ensure, you know, a little bit more coordination. And of course, that has also some implications for access to medicines and access to patients, ensuring that wherever you are in the EU, whether you are in Croatia, whether you’re in Germany, that you can have access to the medicines that you need. So, that’s the idea behind this European Health Union. Of course, it’s a difficult process. You know, there are a lot of member state interests that come into place and a little bit of reluctance as well, because obviously, you know, they want to keep their powers in this area.
But still, it’s work in progress. And I think we’re talking today about things that we did not talk about five years ago. You know, for example, exchanging information on reimbursement of medicines between countries, even purchasing products together, like what happened with the vaccines, the COVID vaccines. It’s something that is very new and it’s very promising.
But it’s still an idea or a plan, and it’s not something I could address now and say I have a question for the European Health Union. It doesn’t exist yet.
I mean, it exists in certain ways, in the sense that there are new institutions that have been created. So, for example, the Health Preparedness Authority and Response, who is really focused on ensuring better preparedness for health crises and for future pandemics – so, there’s concretely a new agency. The European Medicines Agency, the European Center for Disease Control also have more power now through the European Health Union. So that’s also something tangible, you know, but it’s true that in the concept itself, it’s still a little bit theoretical, you know, because of course it will take time for countries to get into the habit of exchanging information and doing things together in the field of health.
So, let’s just hope that this one pandemic taught us a few lessons, and we learned a lot of it and don’t need a second one to really act on it. Claudia, thank you very much for your time and insight. I learned a lot about how the European health policy works. Thank you very much!
You’re welcome. Thank you very much for having me.