Committee on Public Health Ordinary meeting Joint meeting Committee on Industry, Research and Energy
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SANT European Parliament
Follow its sittingsVytenis Povilas Andriukaitis
This is bad for researchers, bad for companies and above all bad for patients. Our report therefore strengthens coordination, shortens timelines and creates clearer procedures.
Vytenis Povilas Andriukaitis
We reinforce the role of European Medicines Agency and propose a clinical trial expert committee. We also include accelerated procedures for public health emergencies, serious cross-border health threats, rare and ultra-rare diseases, and critical medicines. Another major idea is to break the silo mentality.
Europe has excellent hospitals, universities, innovative companies, clusters, biobanks, genomic initiatives, European reference networks, and public research infrastructures, but they are still too disconnected. Our draft report therefore strengthens biotechnology strategic projects, high-impact projects, and pan-European high-impact projects. The aim is to make Europe work as one ecosystem, with less duplication, faster permitting, better regulatory coordination, and stronger cross-border cooperation. This is also why interoperability and interconnected European reference networks are so important in this report.
ERN must become a stronger backbone for rare diseases, rare cancers and so on and so on for real world evidence and cross-border expertise. For many rare complex diseases, no member states can do this alone. Europe can. Data and artificial intelligence are another core part of the report. Innovation needs highly qualified, interoperable and secure data.
We therefore strengthen data quality accelerators, links with European health data space, federated learning and privacy-preserving data models.
We want AI to support diagnostics, personalised medicine, evidence generation and better clinical development, but always with meaningful human oversight, cybersecurity, data protection and safeguards against bias. We also include new approach methodologies that provide better science and better evidence and can improve the development of medicines and other biotechnological products. On financing, the problem is too many companies can start in Europe but cannot scale in Europe. The draft therefore strengthens the investment pilot, proposing a European Biotechnology Scale-up Fund and support better coordination with the European Investment Bank Group, national promotional banks, institutional investors and Union programmes. We need more risk-tolerant capital, especially for late-stage development, advanced therapies, orphan medicines, manufacturing capacity and scale-up.
The report also strengthens biosecurity and preparedness. Biotechnology brings enormous opportunities, but we must also address risks of misuse, such as AI-enabled biological research or the possible development of mirror life systems. This is why we include the EU biotech radar, nucleic acid synthesis screening and stronger guidance, better cooperation and of course together with all agencies on One Health approach. Finally, the report keeps a strong health focus while recognizing biotechnology as a broader enabling technology.
It covers biomanufacturing, advanced therapies, biosimilars, novel foods, where biotechnology can also support health, nutrition, and patient care. Europe cannot afford to put an entire sector on innovative food production on hold while United States and China are moving forward. Colleagues, our ambition is simple: Europe should not only discover the biotechnology of the future, Europe should develop it, manufacture, regulate, and be a leader. Thank you.
Adam Jarubas
Thank you so much, Vytenis. On behalf of ITRE, Tom Berendsen, the floor is yours, please.
Wouter Beke
Yes, thank you, dear colleagues. First and foremost, I also want to thank my co-rapporteur Andriukaitis and both of our teams for the incredible job that they have done in the last months. With almost 400 amendments, I believe that we have managed together to add an additional layer of ambition to the Commission's proposal while reducing administrative burden and streamlining procedures. First and foremost, I would have to underline the importance of this Biotech Act and the need of a strong European biotech sector. Biotech is not simply another industrial sector.
It's the future of medicine. Today, more than half of all new medicines are biotech-based. And some of them, the most promising breakthroughs in healthcare, from gene therapies and cell therapies to personalized treatments tailored to individual patients, are built on biotech innovation. At the same time, biotech is a major economic engine and one of the fastest growing sectors in our economy. Europe's biotech sector generated 38 billion in GDP in 2022 and supported more than 913,000 jobs, with over three-quarter of those jobs linked to health biotech.
For the past decades, Europe has been treating biotech primarily as a health policy issue. That was a mistake. Biotech has become deeply geopolitical. This new reality is no more tangible than ever. Across almost every stage of the biotech life cycle, from venture capital and clinical trials to manufacturing, commercialization, and thus access to patients, Europe is losing market share to global competitors.
This Biotech Act gives us the opportunity to regain some strength, not merely for the sake of the industry, but ultimately for the benefit of the patients. In that sense, we've proposed some adjustments to the Commission's proposal. It would take us too far to tackle all 400 amendments now, but let me give you three important elements. On the strategic projects, we have decreased the administrative burden and the complex eligibility criteria.
For the strategic and high-impact strategic projects, we also altered the admissibility criterion of participating Member States. With the conception of the pan-European high-impact strategic projects, which require organizations of two or more Member States, we estimated that strong projects in one Member State should be able to become strategic projects, over the need of superficial construction of cross-border cooperation. This will strengthen the ecosystem in all our countries, without compromising excellence. With our proposal for clinical trial expert committee, we are trying to harmonize and accelerate the approval procedure for clinical trials even more.
With a strong coordination of the EMA, we ensure the highest quality with streamlined procedures while avoiding unnecessary delays by the Member States. On funding, we have added the European Biotech Scale-up Fund that should complement and succeed the ongoing pilot with a fund-of-fund approach. This will be crucial to combine forces on one of the most precious issues, namely overcoming the valley of death for our startups. That being said, I'm looking forward to hearing your creative ideas to further strengthen this important sector for the future. This for my four minutes.
Adam Jarubas
Thank you, Wouter.
Thank you to both co-rapporteurs for the presentation of the draft report. Now I will give the floor to the shadows rapporteurs of both committees for two minutes time each, Ingeborg Ter Laak as a first, please.
Ingeborg Ter Laak
Thank you. Thank you, Chair, and dear colleagues. First of all, I also would very much like to thank the rapporteurs for their constructive and substantively very strong work for this very important file.
The draft report clearly strengthens the ambitions of the Biotech Act by placing greater emphasis on innovation, manufacturing capacity, strategic resilience, and regulatory conditions across the Union. For our group, this proposal ensures that Europe remains an attractive place to discover, develop, and manufacture biotechnology. That requires a regulatory framework that is predictable, science-based, and innovation-friendly, sorry, while reducing unnecessary administrative burdens and improving coordination between Member States, Union agencies, and relevant expert bodies.
It's important to unify within Europe. We particularly welcome the strong focus on high-quality data. Not only we, but we also learned that the biotech industry is really welcoming this. A well-functioning clinical trials framework and placing patients at the center, alongside strengthening the competitiveness of the Union through innovative and supportive scale-ups and investments, these are essential to ensure that patients receive the timely care they need and they deserve. That is key building blocks for Europe and it's key to remain globally competitive.
At the same time, we see scope to further strengthen and accelerate the proposal in a constructive and cooperative manner. We should continue exploring how to improve the framework for clinical research across the Union, how to make better use of existing European data infrastructures in full coherence with the European Health Data Space. And how to ensure that strategic investment translate to real benefits for patients, researchers, and innovators throughout all Member States.
Finally, we also believe it's worth examining whether the Biotech Act can do more to support Europe's broader life science ecosystem, including those sectors that contribute to resilient supply chains, advanced manufacturing capacity, and long-term competitiveness. This Biotech Act is long-awaited by the biotech sector and our patients. It is important to enhance the infrastructure and we need to be united and act swiftly across Europe. We look forward to discuss these issues constructively with all my colleagues in the upcoming stages of the legislative process. Thank you.
Thank you, Ingeborg. On behalf of Dario Nardella, Vytenis Andriukaitis once again, please.
Vytenis Povilas Andriukaitis
Thank you. Thank you so much, colleagues.
On behalf of Dario Nardella, dear colleagues, with the Biotech Act one, we are working to build an integrated European biotech ecosystem, connect research, hospitals, regulators, patients and industry. European biotech sovereignty must be strengthened, with public support tied to social, environmental and access conditions. We need a coherent European Union funding framework covering the full biotech value chain and stronger collaboration between academia and industry through regional hubs and knowledge transfer mechanisms.
On clinical trials, reducing approval timelines from 106 days to 75 days is welcome, but given that the US, UK, and China operate within 30-day windows, we should be more ambitious. On data and AI, responsible use, full GDPR compliance, and interoperability of clinical data are non-negotiable. Finally, on intellectual property, the S&D group remains cautious about broad SPC extensions without clear supporting evidence. We firmly support biosimilar and off-patent innovation as a fundamental driver of affordability.
The right balance between supporting European healthcare systems and strengthening European pharma industry will guide our approach to amendments through this process. Thank you.
Adam Jarubas
Thank you. Next speaker is Margarita de la Pisa Carrión on behalf of two committees, please.
Sí, eso es presidente, hablo en nombre de ITRE y de ENVI. Sí, hablo en español. Me alegra comprobar que coincidimos con muchos de los puntos reforzados por los ponentes.
Margarita de la Pisa Carrión
La biotecnología tiene un potencial enorme tanto para la salud como para la industria europea, a la vez que debe solventar riesgos y ser bien evaluados. Hoy la biotecnología nos proporciona la capacidad de encontrar herramientas terapéuticas innovadoras que transformen la vida de millones de personas, a la vez ser útil para reforzar la competitividad y autonomía estratégica de la Unión. Valoramos el trabajo de los rapporteurs de ambas comisiones porque los cambios presentados tienen la inquietud de dinamizar el sector. La biología no solamente es una cuestión sanitaria, también es una palanca industrial, tecnológica y científica para Europa, donde los proyectos y empresas de diferente naturaleza necesitan la cooperación entre ellas y con las instituciones para poder tener éxito, especialmente cuando se trata de startups y pymes.
Invertir en innovación en el sector salud supone siempre un riesgo. Por eso, proporcionar claridad, predictibilidad y seguridad jurídica es esencial para atraer el capital, como puede ser la protección de la propiedad intelectual o la regulación de la parte corporativa. La creación de nuevas categorías de proyectos estratégicos puede ser útil, pero nos gustaría comprenderlo mejor. Entender cuál es la diferencia práctica del Strategic Project y el Pan-European High Impact Strategic Project y qué ventajas concretas tendría cada uno.
Nos gustaría también saber más de cómo los ponentes piensan que serán las convocatorias y las bases de la selección de proyectos. Nos preocupa que la letra pequeña se quede fuera del control parlamentario. Debemos conseguir la participación de proyectos que cubran todas las etapas de cadena de valor: investigación, innovación, desarrollo y producción en Europa. Tener presente cada uno de los escalones para atender las necesidades antes de que haya problemas y se interrumpa la actividad y nos deje otra vez en desventaja. Valoramos positivamente la inquietud de acelerar la innovación, reducir los tiempos de ensayos clínicos y facilitar la llegada de nuevas soluciones al mercado, pero la rapidez será solo positiva si no compromete la seguridad de los pacientes ni la evaluación ética.
En un sector tan sensible como este, la confianza pública depende precisamente de que la innovación...
Margarita de la Pisa Carrión
Yes, sorry. En un sector tan sensible como este, la confianza pública depende precisamente de que la innovación y el rigor avancen juntos, de la mano de la ética. No deben repetirse las malas experiencias que hemos tenido en este sentido. Europa ha sido un faro para el mundo en el respeto de la dignidad de la persona.
Debemos mantenernos firmes y distanciarnos de tentaciones que puedan llevarnos a destinos de los cuales podamos arrepentirnos, tanto a corto como a largo plazo. Encontrar el equilibrio entre oportunidades y desafíos, entre el beneficio y riesgo, especialmente cuando las consecuencias puedan ser irreversibles. Acabo diciendo que tenemos el talento, el conocimiento y la base cultural de cuidado de la vida del ser humano para que la biotecnología europea no pueda quedarse en una promesa. De este reglamento depende que seamos líderes no solo en publicar artículos, sino también en conseguir la transferencia tecnológica. Todo depende de que Europa se comprometa y alimente esta iniciativa y las oportunidades para que las nuevas herramientas terapéuticas lleguen a los pacientes que más lo necesitan.
Muchas gracias.
Adam Jarubas
Thank you so much. Christopher Storn on behalf of himself and Carlo Ciccioli as well. Please.
Kristoffer Storm
Thank you. First of all, I would like to thank the co-rapporteurs for the excellent cooperation and work invested in preparing this draft report.
The Biotech Act is very important for the European Union, and together we now have the opportunity to become the viable option and to be truly proud of the biotech sector in Europe. While greater coordination at EU level is desirable, it is essential that reforms support faster approval of clinical trials without undermining Member State competence. Efforts should focus on simplifying procedures, reducing administrative burdens, and improving coordination mechanisms while preserving national oversight and flexibility.
A balanced approach can accelerate approvals while maintaining the effectiveness of the current decentralized model and ensuring member states retain the ownership of decisions affecting their territory. The Commission proposed extending the SPC should, if you ask me, be expanded and made technology neutral. This would ensure a level playing field across different types of health biotechnology innovations and avoid unintended distortions between technologies and thereby support innovation and investment across the sector.
With all that said, I truly wish and think that we can be even more ambitious with this Biotech Act. I want to be able to say that we deliver the best possible outcome for our industry and most importantly, that we secure the best deal for our citizens. That was my first two minutes. Because as you said, I also have to read for my, for my colleague who, who couldn't be here today. The beginning is the same.
I think you have been doing a great job working together with this, with this report. You've been doing a good, great work. The Biotech Act is a key opportunity to strengthen Europe's competitiveness.
We welcome the efforts to reduce regulatory fragmentation, accelerate clinical trials, and make Europe more attractive for research and investment. However, one essential issue requires greater ambitions. Innovation incentives, particularly supplementary protection certificates. If Europe wants to compete globally, incentives must be more effective.
The evidence shows that the real challenge is not only their duration, but also ensuring that eligibility is flexible. Overly restrictive cumulative conditions risk excluding valuable innovation and reducing the impact on investments. At the same time, we must preserve technology neutrality. Innovation is driven by both biotechnologies and chemical medicines, and our framework should support both equally.
If we are serious about competitiveness, we should also remain open to more ambitious incentives, including a 24-month extension combined with broader eligibility. Europe must create the conditions for the next generation of innovation to be developed and brought to the market here. Once again, thank you for your work together as co-rapporteurs, and we are looking forward to working together with you on this file.
Thank you, Christopher Steneberg. Thank you so much, dear colleagues, dear all, and especially dear rapporteurs.
Stine Bosse
Thank you for a very constructive and excellent report starting point. So, speaking on behalf of Renew Europe, I would like to say the following. The Biotech Act is an incredibly important initiative at a time when Europe is under attack. It sounds dramatic. It is dramatic.
Our continent once led the world in biotechnology. Today we are struggling to compete for a bronze medal. We are losing ground in pharma innovation, investment and manufacturing. And as for food biotech, Europe innovates but makes it much harder to translate innovations to real products than others do.
The gravity of the situation really needs to sink in. Once clinical research and manufacturing leaves Europe for the US or China, which is doing every day, it will never come back. And our patients will be the first to pay the price. As the foundation of patients' access to medicine is our ability to invent and make these medicines here in Europe.
So we must use Europe's edge in biotechnology or we will lose it. This is why Renew believes that we must fight for an ambitious Biotech Act now, to deliver for our citizens, not only Draghi, and to ensure that we invent, invest, manufacture and use biotech in and for Europe. And to fight back against the harmful effect of Trump's administration's most favored nation policy.
The price of our citizens' health cannot be set in the White House. On industrial policy and IP, we will propose to ensure that EU sets a strategic direction for its industrial policy that incentivizes to invent and make in Europe and made in Europe are as valuable as possible, and that we send the right signals to investors to attract capital to the right products and the incentives apply to a meaningful number of products to make a real difference to protect EU patients' access to innovative medicines.
We will also propose better conditions for biosimilars. On clinical trials, we believe that we must move from a group of trial nations to a trial union, delivering a single market for clinical trials. Giving the catastrophic situation for rare disease patients in light of Trump's policies, we propose a fast track for clinical trials for orphan drugs and a 28th regime which will centralize ethic assessment across the union while respecting the red lines of the member states. On strategic projects and centers of excellence for ATMPs, cell and gene therapies, we want to ensure that these joint European projects benefit every member state and every citizen, no matter where they live.
Our top priorities for these projects would be to fund the scale-up of biosimilar manufacturing, genetic drugs, which will be available to as many as possible. As for center of excellence for ATMPs, these must have a cross-border effect and we must begin trialing pilots for cross-border pathways for diagnosis and treatment. This will be good both for our patients and our innovative life science ecosystem.
And on food biotech, we need to enable our EFSA to work with innovation, bringing clear and more sustainable products to market. Across the proposal, we will prioritize rare diseases, patient's involvement, women's health, phasing out of animal trials, sustainable and long-term investments in biotech and many other priorities. I look forward to presenting our text on July 7th and to working with all of you in the coming months. Thank you very much.
Katri Kulmuni
Thank you, Chair.
And thank you for the rapporteurs for their work. I see it very constructive basis for the forthcoming negotiations. As mentioned here already on behalf of many of many of the colleagues, Biotech Act is a very welcome step towards strengthening Europe's biotechnology and biomanufacturing base, as biotechnology and biomanufacturing are among the fastest growing parts of the EU economy in terms of gross value added. So no, it's not a surprise that Europe needs a consistent framework that removes barriers to scale up and market uptake so that this growth potential can fully be realized.
And we must uphold safety while also taking measures to ensure faster market access for the products. I was very happy to see that the report includes practical ways to boost competitiveness and innovation in scale-ups.
There are also very good provisions for the regulatory sandboxes covering the novel foods, for example, which I certainly do support. If considered then a bit broader, I will be lifting up the theme or the definition related to biomanufacturing because it is obvious that I see it to be a bit broader and covering also the forthcoming Biotech Act too, because it will definitely be related to lot of mechanical processes to convert renewable resources into bio-based products. And also, as already in the rapporteur's proposal, the broader scope is very supportive when it comes from health biotechnology to biotechnology.
It is very supportive while it touches food, agriculture, environment, bio-based products, but obviously we need to be cautious when doing the changes while it has knocks off so that we do them coherently rather than article by article. And then finally to conclude, there was also the suggestion about these geographically concentrated high-impact biotechnology strategic projects. I'm despite coming from the high up north, I'm not really sure whether geographic concentration is a good idea in these terms while it is indeed better to have all the best excellence-based bio products that we only can imagine, so why to centralize it to only some specific regions? And finally, I do support the idea to in the article 27 to keep the 12-month extensions for the patent.
But this was on my side. Thank you very much so far and we look forward for the next negotiations.
Thank you so much. The next speaker is Ville Niinistö from ITRE as well.
Ville Niinistö
Thank you chair. I'll speak also on behalf of Marit Sos so I have one set of notes for both of us so trying to save your time. I'd also like to thank our rapporteurs for their work. It's obvious that Europe needs a strong biotechnology sector. Our group therefore supports this initiative, but for us the objective is not simply more biotechnology, it's better biotechnology.
Biotechnology that delivers public value, strengthens European resilience, and maintains public trust. On the draft report, we particularly welcome the stronger recognition of research, technology transfer, cross-border collaboration, and the uptake of new approach methodologies. We also support efforts to reduce unnecessary administrative barriers, improve the functioning of clinical trials, and strengthen Europe's innovation ecosystem. So these are all positives. However, we also believe that there are several elements we would like to improve during the negotiations.
So some thoughts on those.
First, strategic projects and public support must be tied to a clear European added value and genuine social benefit. Public investment should deliver public returns, including affordable access for patients, greater transparency and stronger public oversight. Secondly, we believe that the scope should be strictly limited to health biotechnology at this stage. Different biotechnology sectors face very different regulatory challenges and a one-size-fits-all framework risks creating unnecessary overlaps with existing legislation rather than solving real problems. And we will have the Biotech Act too then later on where we can look at the broader issues.
Third, we reject the extending supplementary protection certificates. Longer exclusivity delays biosimilar competition, increases costs for public healthcare systems and patients, and there is little evidence that it would significantly strengthen European innovation or manufacturing. So this is an issue we would like to have a look at. We have also some concerns regarding regulatory sandboxes, even though I understand that why they have been proposed. Regulatory flexibility must never become a shortcut around Europe's high standards for safety, transparency and patient protection.
Innovation and precaution must go hand in hand.
And finally, we believe biosafety deserves a broader perspective. Alongside biosecurity and dual-use risks, we should also consider environmental impacts throughout the life cycle of biotechnology products, fully reflecting the precautionary principle and making sure that biotechnology solutions are sustainable. Overall, we believe Europe can become a global biotechnology leader by combining scientific excellence with high standards, public trust, and equitable access. And with these principles, we look forward to working together with all of you on this file. Thank you.
Yeah, thank you, Chair. Thank you, thanks to the rapporteurs for their presentation.
Christine Anderson
When looking at this, our main priority is actually safety of patients participating in clinical trials. As Article 3 of the Clinical Trial Regulation, which is being amended with this act, states that the rights, safety, and dignity and well-being of subjects prevail over all other interests. We learned, however, from a petition to Parliament that this is not being applied currently. Their injuries were not reported as part of the Pfizer-BioNTech COVID-19 mRNA product. So, a petition, by the way, which this committee refused to even take a look at.
And my question is, how will the faster authorization be any safer? What we would strongly caution against would be giving any more competencies to the Commission and EMA, because what credibility they had prior to 2020 has all been lost through rushed product approval, a rapid upsurge in excess death, which has not returned to normal, by the way, large-scale serious side effects, and now, thanks to the US State Department's disclosure, finally the confirmation that the novel gain-of-function coronavirus was indeed developed in Wuhan lab with USAID funding. So, and this Biotech Act proposes that the Commission should be the agency to protect member states from biothreats?
This is how concerned you all are.
Are you kidding me? Then you only seem to be concerned with the speed of approval of these products. The Commission's proposal repeats in various places that it intends to cut safety standards. If that were even possible, it would make me question the original legislation, which I certainly do, and the safety of the revision.
Patients cannot, should never be treated as guinea pigs or cash cows for big pharma. Then it's talking about extending even further protection for patents of best-in-class biotech medicines. By doing so, you would give even further rewards to an already incentivized big pharma industry and keeping generics or biosimilar products from coming to patients. Distorting the market in this way will likely not serve the patient's best interest, but only those of the shareholders. The Commission proposes the economic operator shall refuse to make the biotechnology products of concern available in the case of a suspicious transaction.
Yet, novel, unknown, and engineered harmful pathogens, when released from labs that had no business creating them in the first place, follow absolutely no legislation. That makes me kind of wonder what this act is actually proposing to do. It seems to be more concerned with the interests of the shareholder rather than the interests of the patients. Thank you.
Adam Jarubas
Thank you. Now I will give the floor to rapporteurs of opinion-giving committees for two minutes each. Tiemo Wölken from JURI, please.
Tiemo Wölken
Thank you very much, dear colleagues.
So, starting with the rather less political part of the JURI competence, I would like to focus on the ethical use of AI. We are by now all aware of the potential benefits of AI in healthcare, from improved diagnostic accuracy, optimized treatment plans, to personalized care. The benefits are, I think, undeniable. However, these benefits must be balanced against the associated risks, including algorithmic biases, a lack of transparency, and the potential reduction of human oversight in critical decision-making processes.
So I believe that without robust ethical safeguards, AI systems could undermine patient autonomy or result in harmful outcomes due to errors or biases in data and system design. In this regard, my aim is to further strengthen the provisions within the Biotech Act by ensuring the rigorous implementation of ethical rules which are of paramount importance in the healthcare sector. Now coming to the probably most controversial part of the Act. First of all, I want to thank the Commission for providing a staff working document. However, an actual impact assessment looking into different incentives would have been appreciated and is obviously appreciated.
So maybe you can change your working methods again. So, as a member of JURI and SANT, patient access to medicines is one of the top priorities for me. The Commission's own staff working document states that the proposed 12-month extension could have consequences for patients, namely a fall in the number of patients treated, accompanied by an increase in spending, fewer available treatment options, and delayed expansions of supply for patients, as well as increased spending for national healthcare budgets. So for these reasons, I have deleted the dangerous proposals regarding the SPC in the JURI draft report.
As the Biotech Act is also intended to strengthen the Union's strategic autonomy while increasing production capacities within the EU, in line with the objective of the Critical Medicines Act we adopted a few weeks ago to ramp up production within the EU, I do propose to further extend the stockpiling waiver for biosimilar medicines. This would allow EU-produced biosimilars to be distributed within day one in the European Union after the patent expires, ensuring that they can be used by European patients rather than only being exported to third countries. I'm looking very much forward to working together with all of you, and thank you for extending my speaking time for 30 seconds.
Thank you so much, Timo. We've just heard the co-rapporteurs' shadows and the rapporteurs of opinion-giving committees. So let's move to the catch-the-eye, Peter Liese as a first, please.
Peter Liese
Thank you, Chair, and thank you to the two rapporteurs, but also to the EPP shadow, Ingeborg Ter Laak. I support in general their approach. I would like to react shortly to two points that were made by other shadows. Mr. Stürm, I'm not sure if I understood you right, but you mentioned that member states need to play a big role in all this. My assessment is that member states mainly failed.
So the problem is that we have too many different rules in the member states and we cannot really benefit from the common market. That's why I think the approach to be more harmonized, as the rapporteurs have also suggested, I think is the right. Then from the from the very far right, I think it was again an example of the horseshoe theory. You know, when it comes to attacking big pharma, the far left and the far right are are together. And I think we need to look at the facts here and they were not as you described.
So there is no evidence that COVID was created in a laboratory. This quest yeah, there is no evidence. There we I admit that it's not sure, that we don't really know it, but to say there is evidence is, you know, that is again showing how far you are away from scientific justified statements. On the content, I will focus on clinical trials because I have followed as rapporteur and as a coordinator two revisions, and I think indeed we need to do the next step. We need to more be more European, more harmonized, and we need to be reducing the red tape.
This is important for the patients, for the innovation. On the other end, we also need to look at some possible problems and I think the biggest problem is that EMA has just approved a medicine where the clinical trials only happened in China. And I don't think that's appropriate. First of all, we are not Chinese, so there are some difference also in the metabolism with Asia and Europe. And second, the ethical standards in China, I don't think we are really able to control them.
There we discussed in the former ENVI committee when it was still responsible for health some, you know, not correctly clinical trials in India.
In China, they won't even allow us to see what we need to see. So I don't think we can base our decisions on clinical trials only in China. And I'm happy that the co-rapporteurs have already addressed this point. Thank you.
Thank you, Peter. Lauro Castillo, please.
Laurent Castillo
Merci, merci Monsieur le Président. Merci aux deux co-rapporteurs pour ce texte qui a un intérêt stratégique pour nous Européens. Il y a quelques années, la crise du COVID a révélé notre dépendance des États-Unis mais aussi de la Chine.
Et aujourd'hui, l'Europe ne peut plus rester spectatrice. Nous avons les moyens de devenir des acteurs majeurs en termes de biotechnologie. Et nos capacités scientifiques sont reconnues et l'Union européenne représente déjà 31 % du marché mondial du secteur. Pourtant, nous n'investissons pas suffisamment dans la recherche. Nos dépenses en recherche et développement progressent seulement de 4 % par an lorsque les Chinois progressent de 20 %.
Pendant que la Chine accélère, l'Europe, elle, décroche.
L'extension du certificat complémentaire de protection de 5 à 6 ans est une mesure pour nous bienvenue. Elle renforcera l'attractivité de l'industrie et encouragera l'innovation car sans innovation aujourd'hui, il n'y aura pas de nouveaux médicaments demain, ni futurs génériques, ni biosimilaires. Nous voulons bâtir une véritable indépendance européenne, renforcer les nations en matière de santé. Dans ce cas, nous devons protéger notre recherche, soutenir nos productions et libérer les entreprises des normes qui pèsent sur l'innovation. Ceci doit être une priorité.
Je vous remercie.
Thank you, Andras Kulja, please.
András Tivadar Kulja
Thank you, Chair, dear colleagues. This is an ambitious and timely proposal that will be crucial if Europe is to strengthen its competitiveness and remain global leader in biotechnology. So I would like therefore thank to our co-rapporteurs MEP Beňová and MEP Androukaitis for the excellent work they have done.
I particularly welcome the proposal to simplify and streamline the clinical trials regulation. Reducing unnecessary administrative burden and shortening approval timelines are essential if we want to attract more clinical research to Europe.
But our ambition should not only be to increase the number of clinical trials, it should also be to ensure that they are conducted across all Member States and overall in Europe as Peter Liese just mentioned, so we can be sure that the procedures are clear, safe, transparent and also all patients can benefit from the innovation and research what clinical trials bring to Europe. I also support extending the scope of Article 14b to include orphan medicinal products, while it is important of course to preserving the prioritization mechanism for public health emergencies.
However, biotechnology is not only about innovation, it's about people. This is what I worked deeply as EPP shadow for the healthcare workforce shortages reports, because the success of advanced therapies depends on a highly specialized healthcare workforce, and we must therefore invest in centers of excellence not only as treatment centers, but also as hubs for specialization, education, continuous professional development, and multidisciplinary training. Finally, I would like to thank our EPP sun-shadow, Ingeborg Ter Laak, for the close cooperation and for remaining us, reminding us that innovation only has value if it reaches patients.
With this act, we must ensure high quality, interoperable health data, including patient reported outcomes, while fully leveraging the European health data space. Let us make this proposal not only a competitiveness agenda, but one that delivers innovation where it matters the most, the patients. Thank you very much.
Unfortunately, Mr. Andreasen just left the room, but I will say what I wanted to say anyway. It is interesting.
Stine Bosse
I really agree with Mr. Andersen on the fact that we should take the citizen's position in especially files like this. But then everything, of course, regarding agreeing stops. Because not seeing that our pharmaceutical sector and healthcare sector as such is exactly what we're talking about here, and that this is key to benefit our citizens in now and in the future, I just do not get that. And then thank you to colleague Liese for being so clear on exactly also these issues, but also being clear on the fact that we need to do more together. And here I just want to say to Christopher Storm, I think you heard him right.
And to work nation by nation on these issues does not make a lot of sense.
We are under a great pressure. And if we don't see these pressures from the United States as of now and from China, then we are just a little bit naive, I'm sorry. And then on the China issue, we will also put forward there, Mr. Liese, and thank you for raising that subject, also an amendment regarding making sure that that there is a better balance regarding the trials and and Europe. So thank you for putting that subject up.
Adam Jarubas
Thank you, Stine. Thank you all speakers for their interventions.
And now invite the Commission to take the floor for two minutes in total. The Commission is represented today by Thomas Van Cangh, Deputy Head of the Policy Strategy Unit in DG SANTE. The floor is yours, please.
Thomas Van Cangh
Thank you. Good afternoon and thanks to the SANTE and ITRE committees for inviting us to this very interesting discussion on your draft report on the Commission proposal for a regulation on biotechnology, which forms part of the biotech package.
I also want to thank in particular the co-rapporteurs for your and your team as well for your tireless work on this crucial initiative. We very much appreciate the Parliament's recognition of the need to act both swiftly and boldly to enhance the competitiveness of this very strategic sector that is biotech. And that is very much in the spirit of the Commission proposal.
Because the proposed measures target the whole value chain of biotechnology, from the clinical research down to the biomanufacturing, to ensure that we have a thriving European ecosystem, and including also, I insist, important biosecurity safeguards. So to try and react comprehensively in under two minutes, I'd say that the proposal combines three things mainly. Measures to indeed accelerate the time to market for biotech innovation, without reducing our high safety and quality standards. And that's very much the case for our clinical trial framework, where we propose faster, more predictable, and innovation-friendly rules, but again, without cutting safety nor ethical standards. It contains also initiatives to really tap into Europe's scale.
As MEP Bușoi said, I think there is a force in joining forces at European level, be it in terms of access to capital, be it in terms of use of data and AI, or be it in terms of use of infrastructure to strategic projects. And thirdly, yes, the proposal includes several more industrial policy measures to really try and stimulate biotech in Europe. That includes indeed market-based incentives for the development and manufacture of innovative biotech products in the EU via an extension of the IP framework, so these 12 months of supplementary protection certificates. But there also, I must insist, it's not a gift.
It comes with very strict conditions in terms of where you conduct your clinical research and where you manufacture. So when people say they may be not effective, well, if there is no impact on where clinical research is done and where production happens, there is no cost because there is no SPC granted. And there also may be worth highlighting that basically by supporting innovative biotech products today, we are also creating the conditions to develop more affordable biosimilar products in the future.
So basically taken together and in complementarity with other initiatives like the new pharma legislation, the critical medicines act, the proposal on medical devices, this proposal can significantly contribute to address Europe's competitiveness gap, or as MEP Bekes said, to really regain strength in biotech. So this we do for the benefit of patients, of course, for academic spin-offs, for startups, for scale-ups, for the biotech workforce that is also important in Europe, and maybe more importantly for society at large. After all, biotechnology is very literally about life. We look very much forward to engaging and working with you on this very important file. Thank you.
Thank you, Mr. Kank.
Now I will give the floor back to the co-rapporteurs for concluding remarks. Voter Beck, please.
Wouter Beke
Well, dear colleagues, I'm happy to see that almost, almost all of you are acknowledging the necessity of this Biotech Act and share the ambition to move forward with this important file. And of course, we will certainly have some discussions upcoming. For example, on the SPC extension, which is an important piece of the puzzle to keep the industry here in Europe. But nevertheless, I see that all of us are willing to work on a stronger Europe and European biotech ecosystem.
With the Irish presidency, we have also found an engaged partner at the level of the Council to make sure that the Biotech Act will be a landmark for the benefit of the entire biotech ecosystem and of course our European patients. We've listened carefully to all of you and of to your proposals and are looking forward to seeing them translated into ambitious and forward-looking amendments to boost the biotech ecosystem in Europe. And after the summer break, we will come back to you with a new set of compromise amendments that should be the starting point for negotiations. I hope that we will conclude can conclude then as soon as possible. But maybe let's give some facts and figures.
Is the pharmaceutical industry important? I heard somebody saying that COVID was created in Chinese labs. There is no medical evidence for that. But there is medical evidence that COVID vaccines prevented millions of lives here in Europe. There is medical evidence for that.
Clinical trials, they are very important. And the facts and the figures are there.
Ten years ago, we had 22% of the clinical trials. Nowadays, 12%. 12. 66 of the 67 IPOs happened not in Europe, but in the United States. And if we want to become dependent on other regions, China or the United States, then we have to say, oh, everything is okay.
But this is not of the importance towards our patients. I don't know, dear colleagues, if you have already heard about kill switch.
I don't know whether there is a kill switch in the F-35 fighter. I know that the United States is using kill switch as export restrictions in chips and artificial intelligence. And I can imagine, I can imagine that they use a pharmaceutical kill switch if they need medicines and if we need medicines. And what are these people gonna explain to the patients at that moment? What are they going to explain?
And for all these reasons, Europe needs this Biotech Act file.
Europe needs this for the patients. Europe needs to become independent, more than it was back as it was in the past, for the sake of our patients, not for the sake of the industry, but we need the industry for the sake of our patients. Thank you.
Adam Jarubas
Thank you, Wouter. Vytenis, could you conclude this discussion, please?
Vytenis Povilas Andriukaitis
Thank you so much. I couldn't agree more with my colleague rapporteur Vytenis. Vytenis, excellent, thank you so much. Being special envoy on universal health coverage at the time of COVID pandemic, I can tell you, and especially those who are now disseminating fake news. Please look into evidence.
Please look into studies. Please look how many government assessing teams were in China and how these reports are open. Not it's about Trump administration, it's about science-based reports which can allow you to deliver true science-based explanation about COVID. And this is the fact. Don't use conspiracy theories.
Don't disseminate fear. Don't lie.
That's the answer from my heart. Being medical doctor, I can tell you now we are speaking about highest patient standards, patient safety, patient ethical conditions, and of course data protection. Those are issues are cornerstone enshrined into Lisbon Treaty and enshrined in in Biotech Act. No compromises on patient safety and patient consent and consent and data protection. No compromises.
Don't worry. It is clearly enshrined in in Commission proposal. If we can strengthen once again, of course keeping mind ethical standards, we also should based on human rights convention, on European treaties, on Charter of Fundamental Rights and our constitutional European Member States constitutional values. It's absolutely constant. Don't disseminate, you know, once again different fears between between between society.
I know very well that now we are all we've just presented our figures.
Of course, we need to keep in mind patient-centered approach. And of course, you know, we can now just see five pillars, five pillars. Regulatory excellence, speed up to market, investment architecture and capital mobilization, equitable, equitable access and the pan-European therapy highways. Of course, also, also, you know, innovation infrastructure and transitional capacities to translate our, you know, innovative ideas into market products and talents, skills, European biotech workforce. Those five pillars must be seen holistically.
And we can address all components, guaranteeing that Europe can lead in biotech in, in the future. Of course, you just mentioned a little bit about supplementary protection certificates.
This is an important point of our discussions. We all share the objective to reward innovation and keeping Europe attractive for investment. We need, of course, assess carefully how incentives interact with access, affordability, supply commitments, national health budgets.
And in many views, this discussion should remain calm, evidence-based and linked to work already ongoing, including your opinion. I think that we need find balanced approach and I am in favor to discuss not only specific, have discussed about all incentives pipelines, because Biotech Act generally, it's real philosophy incentives, different different types of incentives. And we can win if we can present all, you know, all ecosystem of different incentives which are in different clinical trials, in different technologies. We need to find different proposals that all we can can have, you know, additional value when we can present Biotech Act. Thank you so much.
I count on your constructive work.
I, I still very, thank you very much indeed for very constructive work with you, my dear Walter. And I think that we will see how can we propose really excellent, world-class proposal in, in biotech.
Adam Jarubas
Thank you, Vytenis. Thank you all for this excellent debate today. We look forward to continuing work together on this file. Dear colleagues, I'd like to inform you that the deadline for amendments has been set to Tuesday, 7th July at 12:00 at noon. Any other business?
With this, I conclude the debate and I declare the joint meeting closed. Thank you so much.
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