Source: EuroStat – European Statistics
European Commission Speech Brussels, 02 Jul 2025 Thank you very much.
I think what you see today and what you’re going to read is a very clear roadmap, or if you will, a clear expression of a European offer: how to make Europe the global leader in life sciences by 2030.
Because if you look at all the sectors of our economies, what you will find is that it is the biotech sector and the health sector where Europe has the biggest potential to become or to stay a leader.
If you look at the Draghi report, it is very clear that this is where Europe needs to up its game and where Europe has the basics to create itself as the hub for innovation and investment in long-term and sustainable healthcare. But for this to happen, we need to do a major overhaul of how we do things and also to use our assets even more strategically. Strategically meaning attracting science, attracting innovation, attracting investments and this way ensuring that our patients will always have the most state-of-the-art healthcare throughout the times to come.
But for this to happen, we need to do things urgently. Urgently because there is a very clear global race for this. If I want to put it into three major challenges, what we need to achieve is first of all we have a trade challenge.
This is the sector which is the second biggest exporter from the EU. This is a sector which is contributing very largely to the trade surplus that we are having. And this is the sector which is truly global, and this is the sector which is still leading globally.
The second challenge is the challenge of investments. How do we create a climate in which we have long-term vision ensured for everyone to invest into these new technologies. New technologies are around the corner we all know and in the healthcare sector this might come even faster than anywhere else.
We have new therapies emerging by the day. We have completely new combinations of innovations that we have not seen before based on artificial intelligence, European health data space just to name two of the main cornerstones. But for this to be turned into real economic output and also patient outcomes, we need to do an overhaul of the European legislative framework.
And this is what we have sketched out in a broad term in this paper today. Some of the elements are already on the way.
The pharma review is already very well advanced. We hope that this will be concluded already this year. And this should already give a very clear and strong signal to the innovators that we want them to stay. And not only that but we want them to invest more because the ground for innovation has been reinforced.
The second is of course the very important Critical Medicines Act which should act to create the markets on the ground for all innovative products, but which should also create the accessibility for the patients to all these new technologies. And of course, when it comes to talking about the rest of this year, the most important elements we anticipate to come forward with is going to be first of all a full review of the medical devices sector, a Biotech Act and also that should include a revision of the Clinical Trials Regulation.
And to bring all these innovations into therapies, a very comprehensive European cardiovascular health plan. We do hope that we can achieve all this still this year, and we can put it on the table of the co-legislators because we have no time to lose. So, let’s go one by one.
The medical devices. The medical devices is an area maybe overlooked by many, but the medical devices area is a backbone of our healthcare system. And it has a huge potential for the development of the healthcare system because we are living in the age when innovators are combining different products that have not been seen before.
Ozempic is the talk of the town. Ozempic is a pharmaceutical product, but it is marketed together with a medical device. And for this to be authorised it had to be done twice.
It had to be authorised as a pharmaceutical product, and it had to be authorised as a medical device. Of course, we do not want to compromise on health and safety. We don’t want to compromise on efficacy.
But we have to make sure that, when we will have medical devices that are also using artificial intelligence, we will be the first and the fastest to authorise them. And we will be the place that these are going to be developed and innovated. So, we need a major overhaul for this sector which is mainly composed of SMEs so that they can really unravel the whole new avenue of medtech innovation.
This should come still this year. Second big proposal we are trying to make is going to be the Biotech Act. If you ask me, if I want to translate it into everyday language, the Biotech Act should serve two things.
One is to break the boundaries of innovation. So far we have silos. We have the pharmaceutical sector, we have the medical devices sector, we have the chemical sector, and I can go on with all the interlinked sectors.
But our goal here is to make innovation easier. And when you have a genuine idea which crosscuts the different sectors that we have you should be able to go much faster and you should be able to go much easier into creating new products in Europe and hopefully manufacturing them also in Europe. But for this to happen, we also need to look into the other field of major international competition which is the clinical trials.
It is clear that we are challenged in Europe on two main fronts. One is the clinical trials; the other one is the basic life science research where we are losing ground. We are losing ground to competitors like the US and China.
And Europe has been at the forefront of all this 10 years ago. So, we need to really change our mindset and this starts with a full review of the clinical trials and how to make it more effective and also faster. Also, by using new technologies because there are ways in which we can speed up things by using simply the new technologies.
We need the therapies to enter the markets much faster and we need also innovation to be translated into patient outcomes much much faster. So, as you know we are now at the stage of consulting the public about the Biotech Act and, if it is up to me, I still want to deliver this this year because again we have no time to lose.
And finally, on the cardiovascular health plan, this should be the vehicle that brings these new therapies to the patients. Cardiovascular health, I think, is the biggest challenge of Europe currently. We have a comprehensive plan already for cancer but still the single biggest cause of death in Europe is the cardiovascular diseases. And unfortunately, the situation is not improving but actually deteriorating.
If you look at only the figure related to the young generation, what you see is that the young generation, meaning the under 30s, 40% of them are either obese or having diabetes or both. That means that, 10 years from now, we will have a generation with a condition. A whole generation in the prime of their life having a condition, most probably cardiovascular condition.
We have to act now, and we have to make it much easier and much faster for them to access new therapies that are personalized, that are also based on predictive medicine, that are changing the realities, and which are creating real personal choices that people can make.
I think if you look at our little paper you will see a vision, but I want to translate this very fast into action as well.
Thank you, I am now happy to answer your questions.