Committee on Legal Affairs Ordinary Meeting
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JURI European Parliament
Follow its sittingsThomas Van Cangh
Thank you, Mr. Repasi, for presenting this on behalf of Mr. Wölken. And now I give the floor to Thomas Van Cangh, Deputy Head of Unit on Policy Strategy in DG SANTE.
Good morning and thank you for the opportunity to address this committee and to attend this exchange of views as you are preparing your opinion on the Commission proposal on a regulation on biotech which forms part of the Biotech Act that was proposed at the end of last year. So the proposal of the Commission really aims at creating an enabling environment to make it easier to really bring biotech innovation from the lab to the market. In that, it really responds to an urgent need to address this competitiveness gap that the biotech sector is experiencing in Europe. I mean, we read it in the Draghi, the Letta report, we see it in data, in trends, but throughout the consultation process we had in the preparatory stage of the Biotech Act, we sensed that urgency. We sensed biotech actors sometimes feeling like they're pushed to go abroad to bring their product to the market, to innovate, to employ, generate value, and launch new innovation in other jurisdictions.
So throughout this consultation process that we had when developing the proposal, I think if I can summarize at a bit of an abstract or meta level, the two main types of bottlenecks or concerns that we heard across the board, academia, private, public, were of two types. Either complexity, Europe can be complex and as such it can be slower than maybe other geographies, or in some extent and in some areas, the EU can be a bit fragmented and by being fragmented it's small and it doesn't tap into the full scale of the European Union and its market. So in the staff working document that was just mentioned and that we published, we really tried to explain how these issues of speed and scale are really addressed in a coherent manner throughout the Biotech Act. So this staff working document basically compiles all the evidence and analysis that we collected along the way when consulting and preparing the proposal and describes the impact and the outcomes that should be achieved with the measures that are included in the proposal.
So again, the scale and the speed. And you will see in all the amendments we do that without lowering any kind of ethical standards, quality or safety standards. Along the same lines, you will see amendments to six other pieces of European legislation where the objective is always the same. It ranges from cell and gene therapy to veterinary medicines, all always with this concern, this pressing need to reduce the time to market for biotech innovation, but always without any lowering of safety and quality standards. Other elements that complement this in the act are more industrial policy measures that aim at boosting the industrial ecosystem to bring together this manufacturing and R&D capacity that we have in the EU through strategic projects where we can really tap into the scale that we can develop together.
The proposal also explores some novel mechanism for funding and investment of biotech companies. Notably, there is an investment pilot where we will aim at mobilizing private risk-tolerant capital by injecting some public funds to maximize the de-risking and the crowding in of private capital in the EU for EU companies. It is indeed true there is also a proposal that incentivizes the development and the manufacturing also of highly innovative biotech products.
Sorry?
Can you speak slowly?
Okay, I'm going too fast, sorry.
Thomas Van Cangh
Apologies. So, proposal to stimulate innovation in biotech through an extension of IP protection, so this indeed extra year of protection through the supplementary protection certificate. I just want to emphasize that, I mean, this measure is well documented in the staff working document. I think we used the best available data to try and quantify its impacts, meaning data from the European Medicines Agency on products that could be eligible and data from the company called IQVIA for the market data. I think that's the best we could use.
We give a, I think, a robust estimate of the implications of such a measure, but I just want to emphasize that it's really very targeted in terms of products that could be eligible and conditions to be met. These conditions are of two types. One is that we really offer a genuine alternative to patients to what is already out there, so not another me-too as it's called. And another set of conditions related to geography, meaning the biotech innovation needs to be developed and at least partly manufactured in the EU. So it's a quite targeted incentive considering that IP is an effective way of boosting innovation in a way that is really tied with clear conditions that are of benefit to patients and the EU competitiveness overall.
A couple more measures maybe that I should emphasize. The act aims at facilitating the use of artificial intelligence and data in general and digital solutions more broadly across the whole life cycle of medicines. But we do that again, as I said from the beginning, in full compliance with the AI Act, the GDPR and other data protection frameworks that exist. There is no cutting corners. Finally, the act also contains some provisions on biosecurity and biodefense because yes, on the one hand, we do introduce certain facilitating provisions for biotech innovation to reach the market, but at the same time, we felt very important to introduce the necessary safeguards to prevent the potential misuse of biotech that can happen.
Apologies again to the translators for the speed, but I thank you very much for your attention and I look very much to this exchange of views with the members of the committee. Thank you.
Ilhan Kyuchyuk
Thank you, and I open the floor for the exchange of views starting with Mr. Axel Voss. Mr. Voss, you have the floor.
Axel Voss
Vielen Dank, Herr Vorsitzender, ich würde gerne auf Deutsch sprechen. Ja, vielen Dank für den Vortrag hier zu Biotechnologie. Ich möchte in diesem Zusammenhang gerne mal darauf hinweisen, ich glaube bei Biotechnologie ist Europa noch gut. Und wir sollten uns da hinsichtlich Quantum, Biotechnologie, ähnliche Dinge, wo wir noch gut sind, das auch entsprechend konzentriert weiter nach vorne bringen. Deshalb ist das, was Sie vorgetragen haben mit den Stichworten auch Wettbewerbsfähigkeit und Marktorientierung sehr, sehr wichtig.
Deshalb würde ich Sie gerne dazu ermutigen, in dieser Hinsicht eigentlich wirklich schon in Businessmodellen zu denken. Dass wir sagen, so, da ist jemand, der forscht, da ist jemand, der ein Businessmodell daraus machen kann, dass man das direkt mitdenkt, um dann im Grunde auch zu sagen, wir haben das in der Hand, wer entwickelt was und wie kriegen wir das hin. Natürlich geht es hier viel um Finanzierung. Und ich glaube, dort, wo wir tatsächlich auch noch gut sein können als Europäer, sollten wir das auch als Priorität ansehen, damit wir überhaupt noch irgendwo einen Fuß in der Tür haben. Deshalb ist natürlich die Frage der Standards, jeder, wir wollen immer schönste Standards haben.
Es ist nur immer die Frage, ab wann überzieht man es. Wir haben eher die Tendenz zu sagen, oh, 150 Prozent müssen wir abgesichert sein, es reicht aber manchmal vielleicht auch 100 Prozent. Vielleicht da zu sensibilisieren. Ich würde auch sagen, weil AI angesprochen wurde, auch hier könnte man ja mal versuchen, Unabhängigkeit und Bürokratieabbau zusammen zu denken. Ich habe das versucht bei dem AI Omnibus, was in der Lage oder in der Runde nicht gewünscht war, die gleiche Idee aber bei der European Business Wallet finden alle toll.
Also vielleicht könnte man hier sagen, solange ihr euch im europäischen System bewegt, EU-Compute irgendwie habt und nicht irgendwie den Angriff von außen irgendwie mitmacht, dass man dann auch bürokratische Dinge auch abbauen kann und nicht einfach nur in diese Richtung geht. Die Stichworte Fragmentierung und auch Geschwindigkeit sind hochwichtig. Wenn wir nur noch, jetzt mal etwas übertrieben ausgedrückt, immer nur noch in 27 unterschiedlichen Ländern uns irgendwie das vorstellen, dann ist das nicht mehr hilfreich. Wenn wir tatsächlich Weltmarktführer oder zumindest mal in die Nähe diesbezüglich kommen wollen, dann brauchen wir die Bündelung der Kräfte und auch ein entsprechendes Vorgehen. Also deshalb würde ich auch da sagen, versuchen die Fragmentierung so weit es geht aufzuheben zwischen den Mitgliedstaaten und eben auch sehen, wo können wir hier Flaggschiffe schaffen, damit wir überhaupt noch wahrgenommen werden.
Und dabei spielt Geschwindigkeit eine große Rolle. Und da würde ich auch ungern sehen, dass man wegen der Geschwindigkeit, die wir brauchen, auf einmal wieder irgendwelche besonderen Absicherungen einführt, die das alles nur behindern.
Also ich glaube, die Zielsetzung muss in der Tat sein, Wettbewerbsfähigkeit, dann Fragmentierung aufheben, Geschwindigkeit haben und sehen, dass man an Souveränität entsprechend dazugewinnt. Eine andere Frage ist noch mal, wie kriegen wir eigentlich die Erfolge innerhalb der Biotechnologie hin? Nach meinem Verständnis wäre das einmal Nutzung von Daten, die Menge der Nutzung von Daten, um überhaupt auch Forschung KI-basiert betreiben zu können, werden Sie eine Unmenge an Daten brauchen. Und da wird es auch nicht ganz ohne personenbezogene Daten abgehen und deshalb muss man auch da weiter dran bleiben. Und am Ende brauchen wir alle viel Geld.
Und wenn man das jetzt wirklich mal prioritär angeht, dann sollte man das jetzt auch wirklich sich darauf konzentrieren und nicht wieder nur so einen halben Versuch starten, wo es schön aussieht, sondern konsequent nach vorne priorisieren und dann managen.
Ilhan Kyuchyuk
Thank you, Mr. Voss. I don't see any other request to speak on the matter and the floor goes back to European Commission.
Thomas Van Cangh
Thank you very much for this reaction. A quick reaction to your points, maybe. First, I could not agree more. I mean, in biotechnology, let it be known, it's a crown jewel of the EU. We are a top leader for the time being.
We have the best science in the world, we have best scientists, excellent infrastructure, there is capital available. Yes, we're really not talking about subsidizing a suffering, dying sector that has no future. It's the opposite, it's really about unleashing that potential. But yes, there are some hurdles to remove because the trend is not exactly positive. We try to really show that in this staff working document.
I mean, just we lost half of our share of clinical trials in the EU over the last decade. So if clinical research, if the early stage doesn't happen here, it's unlikely that the end product also starts takes place in the EU. So yes, we are in a good place, but we should not take it for granted. Yeah, on the business model also very interesting points. I think throughout the development of the proposal, we had this idea of biotech companies from cradle to grave and in the different measures we have, we do that.
Typically, a university scientist developing an idea, we have strategic projects that are about pilot facilities where such an academic discovery can be tested out to see if it has an industrial potential and that then helps you for your proof of concept to go to venture capitalist where we try to propose an instrument that can also, I mean, there is a coherence, I think, in the tools that we propose that make it a coherent whole to make biotech doing biotech in the EU attractive. Clinical trials, same example. We do request for this additional IP protection that clinical trials are conducted in several member states. But at the same time, we do make it more attractive to conduct clinical trials in the EU and we do have strategic projects proposed to boost the biomanufacturing capacity of the EU. So, I mean, really for me, that one measure doesn't fix everything, certainly.
As a whole, I think the package offers very interesting avenues for biotech. Getting rid of bureaucracy, that was also a concern. But again, I mean, everybody, the industry itself, says we should not lower standards. In biotech, trust is very important. And I think we all take pride in the regulatory system we have with the Food Safety Authority and the Medicines Agency that are really gold standard.
Nobody wants to lower that. So we did identify places where there were duplications or lead time that could be reduced, but really opportunities to reduce inefficiencies, but never lowering the standards. On the fragmentation, I said between countries, but also along the value chain with the examples that I just mentioned from the startup to the big scale-up companies.
Usually we're not too bad in startups when you look at the data. It's when you move to venture capital rounds, the later rounds, I think many end up having to go and get financed somewhere else basically. And then on the resources, I fully agree. I mean, for every legislation, the proof is in the implementation, I would say, there maybe even more than in other areas. We have proposed ambitious measures.
They will require some funding attached. There is an ongoing negotiation on the competitiveness fund which has a dedicated window on biotechnology. We certainly welcome or count on the support of this house to try and meet this level of ambition also in the numbers. Thank you.
Ilhan Kyuchyuk
Thank you very much for this discussion and also for answering the questions of Mr. Voss. The presentation of the draft opinion will take place in the next JURI meeting. The deadline for amendments will be set at 25th of June, noon time. Going back to point six, jurisdiction, applicable law, recognition and enforcement of measures and cooperation in matters relating to the protection of adults. The rapporteur Yana Toom is not present today, so on her behalf I will present the outcome of the second and final trilogue on the protection of adults which took place on 12th of May in the Council.
It is my pleasure to report that the successfully concluded interinstitutional negotiations with the Cyprus presidency at the trilogue organized on 12th of May, a very long meeting with extensive discussions, and I can confirm that, on the outstanding issues. Thanks to goodwill from the side of both co-legislators, we were able to agree on a common text. The key points on the European Parliament position are well reflected in this provisional agreement. The approach of the Parliament was to put the adults at the center of the legal framework we are creating. In practice, this meant ensuring that we fully respect the autonomy of people that end up in such vulnerable situations and that we do all that is possible and legally feasible to help the adults that will have to use the procedures in this regulation.
The final text ensures these principles by focusing on the transition to supported decision-making, by emphasizing the obligations of the United Nations Convention of the Rights of Persons with Disabilities, and by asking for the provision of support for the matters under this regulation. I want to thank all the political groups involved in these negotiations because the success of the negotiations was only made possible by the great collaboration among them. The fact that we had a united house behind the European Parliament position made clear that an agreement could only be reached by going further on the respect and alignment with the principles of UN CRPD. This is consistent with the track record of this house always defending the rights of people in vulnerable situations, and I'm proud that together we could deliver another great result in this regard. I want to thank the negotiation team from the Cyprus presidency for their hard work and goodwill throughout the negotiations.
We will vote today to endorse the provisional agreement and on behalf of my good colleague Yana Toom, I hope you can also support it.
And I would like to give the floor to the shadow rapporteurs if they wish to take the floor. Mr. Vavrikevics, that is not the case. Okay. That was good and sufficient. We break the meeting for 15 minutes and then we continue with in camera.
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