Committee on Public Health Ordinary meeting Joint meeting Committee on Industry, Research and Energy Joint SANT-ITRE meeting
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SANT European Parliament
Follow its sittingsOlivér Várhelyi
It is designed to simplify the rules and cut down approval timelines for clinical trials. For multi-country trials, authorization times will decrease from 106 days to 75 days. And for single-country trials, this will go down from 75 to 47. How do we make it possible? By strengthening coordination between the member states, increasing reliance on the reporting member state, and integrating ethical reviews, all without compromising scientific quality or participants' safety.
But the Biotech Act goes well beyond clinical trials. It breaks new ground on industrial policy for the sector, including a new framework for designating strategic health biotechnology projects. Key innovation will benefit from meaningful incentives like an extra year of patent protection through the supplementary protection certificate. To unlock the full potential of biotechnology, we need to make better use of health data. We will also use artificial intelligence to speed up development and improve trial success rates.
This is where the European health data space will come in by promoting access to data, but we need to implement it now, together with the member states. And one last.
Point. Scaling biotech startups in the EU face one big bottleneck. There is not enough access to capital. The numbers speak for themselves.
The US invests 9 times more in health biotech startups than we do here in Europe. Nine times more. And almost all EU startups who are going public do so in the US, 66 out of the 67 in the last six years. The Biotech Act aims to change this by improving the financing environment in the EU and boosting the activities of the European Investment Bank Group. Given the urgency of financing, we have already taken action.
This year and next, the European Investment Bank aims to get about €10,000,000,000 of investments flowing into the sector through the biotech EU program, bridging the time, and paving the way for the next MFF period. So honorable members, if we want ideas and innovation to turn into treatment and cures here in Europe fast, we need to act now to create the right conditions. I look forward to hearing your views. And, of course, I'm more than happy to answer your questions.
Stine Bosse
Thank you so much. And I will now give the floor to the SENT committee, mister Andrew Kaites. You are the corrupter from SENT. Please, the floor is.
Yours.
Vytenis Povilas Andriukaitis
Thank you. Thank you, madam chair. The commissioner, commend your leadership in delivering truly robust legislation that as you prepared for the articulated on its release in December, holds a potential, I quote, to create a hub for making Europe a global powerhouse for industrial, financial, and regulatory innovations. We are facing a dramatic collapse in orphan medicines. Of the top 10 best-selling products, none were marketed by EU-based companies.
EU companies, your company's share of the orphan medicines market fell from 40% in 2012 to less than 5% in 2022. For advanced therapy medicinal products, global market sales reached approximately €8,000,000,000, of which only €1,000,000,000 was in the EU. This collapse is the single most powerful statistic available to justify the biotech act. The dedicated Health Biotech Act is carved out of the need to reach patients faster, more timely, and in a truly equitable way. The Health Biotech Act stands as a beacon for promise, offering a clear path to overcome the persistent fragmentation identified by esteemed figures such as Draghi, Leta, Nenisto, and Haetor, which undermine Europe's competitiveness and attractiveness compared to the US and China.
While the act introduces many welcome initiatives, we urge a holistic review to address unmet needs of many patients and specific challenges, particularly for novel orphan treatments and smaller developers who are often overlooked yet represent a crucial engine for innovation. Investing in and supporting these innovators is a critical investment in the future of our health care system. Consider the plausible mechanism framework adopted by the United States, which accelerates the development and approval of individualized therapies for ultra-rare diseases. This approach could be highly relevant for Europe where multi-country trials and fragmentation pose too big a barrier for small enterprises investigating rare diseases with limited patient cohorts. Furthermore, for prevention of prevalent conditions, we must ensure that a stronger role for the reporting member states does not inadvertently create new inequalities in early access, disadvantaging smaller countries.
Regarding industrial enablers, it is imperative that we prioritize attracting private investment to Europe. This includes, furthermore, developing our biotechnological, omic-based, and digital infrastructures alongside fostering a robust expertise network. Specifically, we must consider and address the specificities of orphan medicinal products by complementing the incentives set out by the general pharmaceutical package with short term clinical trial timelines and bespoke regulatory sandboxes, needs to strengthen and connect existing clusters, thereby fostering closer collaboration, building nexus through connectivity and interoperability between health care providers, academia, and industry across all the EU to accelerate delivery to patients, thus creating truly functioning pan European ecosystem. Their commissioner, last sentence, we share your vision. But to achieve this, we must ring fence dedicated funding within the multi annual financial framework, sending up unmistakable signal that Europe is prepared to reset its leadership on global scale.
Stine Bosse
Thank you very much, Mister Andre Keites. And now over to the ITRA committee, Mr. Beke. You have the floor for three minutes and a bit.
Wouter Beke
Yes. Thank you. Thank you. Dear commissioner, dear share, dear colleagues, biotech was identified as one of the key industries for Europe's future in the political guidelines of the new commission, von der Leyen, at the very start of her mandate. And that recognition was not accidental.
It reflects a growing awareness that biotech sits at the crossroads of innovation, health, and industrial policy, and that Europe's position in this field will shape both our economic and our societal future. This sector is thus not only essential for our competitiveness, strategic autonomy, and economic security. It's also directly relevant to our citizens. It is a sector that delivers new therapies, advanced diagnostics, and breakthrough treatments, offering hope to patients suffering from diseases that were until recently considered untreatable. In that sense, biotech is not an abstract policy domain.
It's about tangible improvements in people's lives and the resilience of our health care system. At the same time, we must be clear-eyed about the global context, like you already mentioned. In an increasingly competitive world, Europe is under pressure. The United States continues to lead in commercialization and access to capital, while China is rapidly strengthening its position, particularly in scaling up production and deploying new technologies. Too often, innovation developed in Europe is further financed, produced and brought to market elsewhere.
This is not only an economic concern, it also raises questions about our capacity to ensure timely access to innovation for our European patients. This is precisely why the Biotech Act is so timely and important. It offers an opportunity to address long-standing shortcomings in our ecosystem, whether in access to finance, regulatory framework, fragmentation, or industrial scale up. More importantly, it also allows us to move from a fragmented approach towards a more coherent strategy that connects research, innovation, and production. Our objective should be clear, not only to preserve Europe's strong scientific base, but also to translate it into global leadership.
If we get this right, the Biotech Act can become a cornerstone in strengthening Europe's biotech sector and securing its place in the global race. If we do nothing, we could lose an entire sector in the coming decades. Dear Commissioner, let me thank you for the good starting point of the proposal that was put forward, and conclude with two. And I wanted to ask you two questions. First, how can we ensure the defragmentation of our internal markets and avoid cold plating by member states, which continues to slow down innovation and scale up?
And second, access to finance. Access to finance will be decisive. Yet the current provisions in the biotech remain somewhat general. Could you elaborate on how the commission intends to effectively mobilize and channel investments into the European biotech sector? Thank you.
Stine Bosse
Thank you very much. And now I will give the floor to the shadow repertoires from both Sandd and Itrev for 1.5 minutes each. And here, please stick to the timing so that we will get everybody on board. First, Ingebor Terlak from the EPP.
Ingeborg Ter Laak
Thank you. Thank you, Chair, and thank you, Commissioner, for being here and being so passionate about this proposal. And I think it's very timely because Europe has all the ingredients to be this global leader in biotech technology. We have excellent science, we have robust research institutes, and a highly skilled workforce. The key question is how we ensure that innovation continues to take place here, and that patients benefit from these advantages.
Creating an attractive environment for the biotechnology industry is therefore essential. A strong Made in Europe approach with innovation is core, can help ensure that research, development, and production remain within the European Union. This is not only about competitiveness, it's also about enabling patients to access innovative and effective treatment in a timely manner. We are also seeing that clinical research and investments are increasingly moving to other regions, as you said. This highlights the importance of continuing to improve our framework and making progress more efficient.
In that regard, the efforts to streamline clinical trials are a positive step. At the same time, it's important that this progress takes place in a careful and balanced way. Patient safety, the protection of people and the environment, and our strong approach to biosecurity remain essential. This underpins trust and provides stability with innovation needs. Can you please elaborate a little bit on this part of the proposal?
Your proposals have promising elements, particularly on accelerating clinical research and supporting strategic projects that can strengthen Europeans' innovation ecosystem. But as my colleagues were saying, can you also elaborate a little bit on how we can make this internal capital market more robust so people, so biotech actors can have better access to financing? Thank you.
Dario Nardella
Thank you, chair. Dear commissioner, the biotech actor represents a crucial step to strengthen European competitiveness in a sector that is strategic for health, sustainability, and innovation. We must close the innovation gap that today separates us from the United States and China, as you mentioned. And these proposals lay the groundwork for the health care biotechnology sector to develop further and offer patients broader and timelier access to better treatments. I welcome these initiatives, which go in the right direction.
Particularly, I strongly support the reduction of approval times for multinational clinical trials. However, commissioner, there are some priorities I consider essential to ensure its effectiveness. Biotech development must proceed responsibly, maintaining public trust, and ensuring clear shared ethical standards. The regulation addresses regulatory fragmentation among member states, and rightly so. But the risk that the intended simplifications will be nullified by new asymmetries in implementations remains real.
Intellectual property protection must be strengthened because without effective protection, there are no investments. And concrete support is needed for small enterprises, which are the heart of the biotech ecosystem, but remain systematically disadvantaged. So two questions, dear commissioner. One, do you need to do you not believe that regulatory simplification should be accompanied by equally decisive simplification in access to financing? And how can we guarantee specific funds in the next MFF as colleague Katis said? And finally, how do you intend to ensure that the instruments provided for in the regulation are truly accessible to small enterprises, which often lack the resources necessary to navigate complex regulatory processes?
Thank you.
Stine Bosse
Thank you very much. And now I give the floor to PFE, Saint Macarita Della Pisa.
Margarita de la Pisa Carrión
Thank you. I'll be speaking in Spanish. Thank you. On behalf of Sant and Eitri, first of all, I wanted to thank you for the Biotech Act, which is a positive thing in this current environment. Biotech with other tools will help us push forward when it comes to care for rare diseases and other issues, for example, mainly in diagnostics.
We are key players in Europe. We have the talent, we have the research culture, the knowledge, and the innovation. Europe needs to look at solutions for financing, for regulatory frameworks, not only in this sector, but also in cross-cutting sectors, which can also affect these activities. So we need to prioritize those to make up for the lack of the talent that we are losing. And so the biotech act is a way to move towards this, and to get more innovation in Europe.
We welcome the approach to facilitate the development of strategic products and improve the connection between markets and laboratories. This is a turning point, a moment of opportunity.
Margarita de la Pisa Carrión
Terms of innovation, what instruments will biotech act introduce to improve the innovation of Europe in terms of health care and improve its global competitiveness? In that vein, how will the funding of these measures be set out through the EIB? And what volume and kind of support will be mobilized for this? How will the commission make sure that the legislation doesn't become an obstacle to innovation and the competitiveness of the biotech sector linked to strategic projects? We think it's essential that for critical medicines, we need to strengthen manufacturing within member states.
And so, along that line, how does the commission guarantee that those projects really strengthen the manufacturing capacity in Europe? Thank you.
Kristoffer Storm
Thank you, chair. And dear commissioner, Europe has world-class research and brilliant sciences in biotechnology. Yet too often our innovators leave The United States or Asia because of heavy bureaucracy and slow approvals. Today, biotech creates 900,000 jobs in Europe and adds €40,000,000,000 to our economy. 80% of that comes from health biotech alone.
It's not everything I agreed with in the Draghi report, but the Draghi report shows that we are falling behind, and that Europe does not have the time to continue the left's mistakes, as you also said in your opening. We need to change things. Denmark is one of Europe's strongest biotech nations with global leaders like Novo Nordisk showing that we can achieve what we can. Yet even our Danish success stories are increasingly moving abroad due to heavy bureaucracy and slower approvals. We need to deliver faster market access, simplified rules, and real funding solutions for innovation while, of course, upholding the highest standards of patient safety.
So my following questions are simple, but still need to be asked. How can we make sure that innovation stays in Europe? That job stays in Europe, and that leading health care and patient security stays in Europe? Thank you.
Stine Bosse
Thank you, Mr. Storr. And now I give the floor to myself. First of all, thank you very much for the starting point of this work. I have a couple.
Stine Bosse
Questions. First of all, we talk far too little about, when we talk about competitiveness and tariffs and so on, we talk far too little about Trump's most favored nation policy. This is a true killer for our industry. So we need to be bold, and we need to do a lot to make sure that we don't see the industry leaving us, because once they have left, they will not come back. And we know all of us that this is the place where we still have a chance to keep our competitiveness at a very high level.
So let's not miss this. So I have two questions for you. One is, I really like your ideas on the SPC. I mean, this is good. This is a good starting point.
But I would like to hear your comments also on how do we balance this out with the better access discussions? What is your idea here? And then perhaps for an idea, I would like you to elaborate on this. Now we have seen the 28th regime in other areas. Could we be inspired by this?
And knowing that from the approval on EMA, so when it leaves the European Union and goes to the nations, there is a timeline between 200 for the fastest and close to 850 days for the slowest approval rates. Now this cannot be. We cannot have that kind of difference. And I know it's not necessarily in your hands, but we need to talk about it. This is where it becomes extremely uncompetitive.
That's not with the EMA, but it's when it goes to the nations. Could we think about a twenty-eighth regime for the scale-ups to make it even easier for them here in Europe? Thank you. And then I give the floor back to you, Commissioner, I guess, for seven minutes. Sorry?
Okay.
Kristoffer Storm
Thanks. The Biotech Act proposal achieves in Europe, as Europe risks falling behind globally, with The U. S. And Asia is investing rapidly in biotech innovation. To stay competitive, Europe must foster an environment where research capital and companies can free up locally.
We welcome two proposal highlights. First, it's prioritized investment, especially scaling up. While Europe excels in research, it often fails to turn science into industry and economic value. Second, the proposal aims to simplify regulation and reduce fragmentation. SMEs and startups need clear, faster, and more predictable processes to drive innovation.
Again, against this backdrop and acknowledging that important gaps still remain, I would like to ask the commission. How do you intend to secure sufficient investment in industrial infrastructure and effectively scale up discoveries? Last but not
Please slow down a little.
Kristoffer Storm
Last but not least, can you ensure that a robust skills strategy is developed and implemented to attract and retain talent in biomanufacturing? Thank you on behalf of ETIA Ito.
András Tivadar Kulja
Commissioner, the new biotechnology regulation is very important in the EU health policy. Modern health care systems, personalized therapies can offer breakthrough solutions in cancer, rare diseases, and resistant hospital infections. Strengthening academic and market-driven research and investors to the sector are key pillars of the plan. However, there are significant disparities among member states in terms of the institutional capacities required for such modern infrastructure. Therefore, I have two questions for you.
How can the draft ensure that member states benefit equally from the EU funds in biotech? And how do you plan to address regional disparities in infrastructure and HR? My second question is that, unfortunately, the current Hungarian government's measures restricted university autonomy in Hungary, and therefore, our universities are excluded from European networks and are no longer able to benefit from the Horizon and Erasmus programs. As a Hungarian commissioner, can you confirm that it is a priority for you to ensure that excellent Hungarian universities and their students would be valued members of the European academic networks and integral parts of the emerging biotechnology networks and research consortia.
Stine Bosse
Thank you very much, Andreas. And then I have two more speakers, and then I will give the floor back to the commissioner. So first, Nicolas Gonzalez Caceres from NVSND.
Thank.
Nicolás González Casares
You, Madam Chair, and welcome, Commissioner. I think the proposal that we have is a good one, but there's room for improvement. And the first question we have to ask, and that I would put to you, think, is do we want a biotech act to solve problems for citizens and the diseases they suffer from? Or do we want it for the industry? I think we need to strike a balance.
Obviously, we need to assure that advances in biotechnology are made accessible to citizens, but at the same time, we need a genuine biotechnology ecosystem in Europe. And as such, I think, nonetheless, there are likely to be problems as we try to answer this initial question. I don't think there has been sufficient evaluation. But if we follow down this path, what we do have to ensure and assure ourselves of as legislators and European citizens is that the benefits benefit all European citizens, and at the same time that the technological and industrial development, the research development, remains in Europe. This tool has to benefit Europeans.
I think in the pharmaceutical package, we haven't taken this sufficiently seriously, considering the geopolitical challenges currently facing us.
Stine Bosse
And now on to the URI opinion-giving committee, Vithenes Povilas, and Ruikaites on behalf of S and D.
Vytenis Povilas Andriukaitis
On behalf of Tiemo. I will because, as you know, yesterday, due to a strike in Germany, Tiemo is unable to be here. And he is jury rapporteur for the opinion on the biotech act. As a committee competent, so in matters of intellectual property, you review, especially take a close look as a commission proposal to extend the supplementary protection certificate by twelve months for medicinal products developed using biotechnologies, technological process and for advanced therapy medicinal products. Having just concluded negotiations on the pharma package, the companies, for example, only receive a six-month extension for a pediatric investigation plan.
And given that, we are currently awaiting the council's position on the unitary SPC. Is quite skeptical about the commission's proposal. The commission has failed to provide a comprehensive cost benefit analysis of the proposed twelve months SPC extension, and particularly regarding its expected impact on member states' health care budgets, including the additional expenditure resulting from delayed market entry of generic and biosimilar medicinal products. Furthermore, it remains unclear whether the commission has examined alternative regulatory, financial, or market-based incentives, instruments, and as substitutes for an SPC extension. In this context, Tema would welcome an explanation as to why the commission has opted for twelve months SPC extension and why it considers this measure to be more effective, proportionate, targeted opinion.
He would also like to see the cost-benefit analysis. All of the question could have been addressed if the commission had taken the need time to provide a proper impact assessment as it used to. Lastly, we ask the commission to answer this written question on this matter. Thank you.
Stine Bosse
Thank you very much, Andrew Kaites, and then over to the commissioner for the first round of answers.
Olivér Várhelyi
Thank you very much. Let's go, one by one. So Andrew Kite started with the orphan medicines. I think that, for orphan medicines and for rare diseases, the Biotech Act is the best news possible. Because if you look at the technology that we would like to promote through the Biotech Act, most of it is going to help these diseases.
Gene and cell technologies, these are the very heart of the proposal, are actually the best therapies for orphan medicines and also for rare diseases. So I have very high hopes that with the adoption of the Biotech Act, we will have a completely new reality when it comes to orphan medicines and rare diseases. On your second point related to the investments, and maybe here, I open a broader remark and reply. And with this, I want to, of course, reply to all who have raised it because it wasn't an overarching question. Yes.
This is the big challenge, I would say, apart from the regulatory measures that we are proposing to you. The big challenge is, are we going to be able to have a real response to the global challenge, which is also related to investment? And it is for that reason that we have not only provided you with a regulatory proposal, we are also providing an economic one. And with that, we have not waited until the core decision is complete. We have not waited until the next MFF, but we have already rolled out the very tool we think could be the response to the problem.
It is called a pilot. It is also part of the Biotech Act. But it is a pilot to which we have allocated already €10,000,000. And this is unique in the initiative because here, we want to model what you should expect coming also under the next MFF in a much larger scale, I hope. And the model should be very much like what you see in the U. S.
Because they're very successful. They are the most successful in this, as you have all confirmed. But to be successful, it means that we need to learn from their example. The most important difference, if you look at the U. S.
And us, is that the risk taking is at a much higher level when it comes to investments in biotechnology than in Europe. The investors in Europe, including the institutional investors, have not been very active in investing in this industry, although this is really one of the fastest growing industries, double the pace always of the rest of the economy. And this is the industry which is capable of creating innovation long term and in a sustainable way. So what we have tried to do with this pilot is to address the problem of risk avoidance in Europe. This is why the involvement of the EIB is central.
The EIB is capable of lowering its participation, and its rating allows for a significant reduction in the risk assessment, meaning that commercial banks, institutional investors will start to chip in more with their funding, and that should also trigger investments from the industry itself. And I do hope that to this, we can also add the funding of our research funds kicking in the next MFF, designed at €19,000,000,000 only in the horizon, and €22,600,000,000 dedicated for biotech and health in the Competitiveness Fund. So I think that this pilot is designed to already kick start a new approach and to call for investments even before we adopted the Biotech Act. The other element, of course, if you want to promote investments, is that you have to make sure that the value which is created can also be translated to the economy, so that you are not only providing a set of regulation, but you help the companies to create real economic value. This is why, for me, it was important to give economic incentives also with the Biotech Act.
For example, the supplementary protection certificate extension is a major economic incentive, an economic incentive which has a market value. So if you want to create economic value on the basis of which you can attract investors, this is the way to go. So for start ups, scale ups, this is something they can market immediately. If their science is good, and we know that our science is good, this is something with which they can attract investors. This is why, for me, it was absolutely necessary to have such economic incentives in the package.
The multi-country trials. Yes, I agree with you. Multi country trials is where we lose the most time, and this is where we, I think, we're losing this whole race, this global race. This is why we have significantly reduced the complexity and all the bottlenecks in the design and carrying out of the multi-country trials. Here, I would also add one more element where I think that our regulation is currently well ahead of everybody.
Because in the design of the clinical trials, we are the first to propose the extended use of artificial intelligence. With the use of artificial intelligence, for example, the Phase two part, the chemical part, which takes the longest and which is the most expensive, we can reduce the average time of 5 to 6 years to less than two years. And we can drive down the costs of these parts of the clinical trials to 10%, not by 10%, but to 10% of the current cost levels. We are doing our utmost to put Europe back on the map of clinical trials. And that leads me to the other question you raised about the shorter clinical trials for orphan drugs.
I think that for orphans, it's not the length, it's the market size. And this is why if you look at the broader picture, what we are proposing with the Critical Medicines Act, we try to create a larger market for the orphans so that this way, we can really promote their coming on the market. On your question on the MFF, I think I responded. To Mr. Becker, the global context, I fully agree with you.
We are in the last minute to save our still existing competitive advantage, because we have very solid, good science. If you look at the most successful science in the U. S, which attracts most investments, I would say a very large part, if not the overwhelming majority, of these products are done by European scientists, financed from the horizon. This is science we should also exploit for ourselves, and this is also part and parcel of our proposal. Then on the gold plating, this is a very valid point.
This is why, this time, we went for a regulation. So we want to make sure that there is no gold plating in the Member States, and we want to make sure that everybody implements the rules as they are, and they don't start developing new conditions preventing innovation to stay in Europe. On your question on financing, I think I've answered Mrs. Terlak, Made in Europe approach needed. I fully agree.
And this is why when we have designed the supplementary protection certificate, we have two sets of conditions to benefit from this additional economic gain or incentive. One is, of course, that it has to be a novel biotechnological mechanism. It has to be a novel active substance. And most importantly, it has to be innovated in Europe. It has to be clinically tested in Europe, and it has to be manufactured in Europe.
Because this is the way to keep the production in Europe, because I am convinced that the only way to ensure that these products are going to be available, and this is also a response to all of you who are asking me about access and availability. The only way to ensure availability is by insisting on the clinical trials being done here. Because the rule of thumb is that where you do the clinical trial, most likely you're going to manufacture. And where you do the clinical trial and the manufacturing, most likely you will market the product. So this is our incentive, to save the European health care model because the European health care model is at very many challenges.
The aging population, I mentioned, the rising number of chronic diseases. Last time I was here, we discussed the SafeHEARS plan. By 2050, the number of people with a cardiovascular condition will double in Europe. Double in Europe. Imagine the burden on the health care system.
So the only way out of this impasse, because we also have major budget limitations in the member states when it comes to increasing the budgets, is to redesign the whole system by promoting innovation with which you always have the latest therapy, anchoring it within incentives to market it like the SPC extension and making sure that we start to spend much more on prevention. Currently, we are depending on a member state, we are spending 3% to 6% out of the national health care budgets. And they are spending 80% on therapy and care. As opposed to a model, if we would at least double or triple the prevention, we could significantly lower the cost of therapy because we could prevent many of the cases that are ending up in hospital and care. And basically, we could easily afford spending more on innovative products from the exact same budget without touching the budget ceilings.
So we have to change everything to keep everything the same. Then, to Mister Nardella, ethical standards. Yes. It's a very important principle in the whole health package, including the biotech, that we are not touching any of the ethical standards. We are not lowering or even amending any of the safety and efficacy conditions in our regulations.
This is also a value, not only a public value for our patients and the guarantee for our patients, but also it is a global value of the European health care system. So we do not make any compromises on that. On the contrary, we even want to heighten the level of patient safety and protection. Then you had a question on how we are going to simplify the access to finances. I have already started sitting down with the investment groups to drag them into this new way of thinking and associate themselves with the EIB pilot project.
And, of course, in the forefront of all these are the SMEs. Most of the innovation that is coming in the biotech sector starts out from SMEs or universities or academia. So naturally, it should help, especially them, to scale up their production. The support we are providing, I don't think, is necessary for large pharma companies. On the contrary, we want the science to be mainstreamed into the economy much faster from European academy, from European SMEs, because they are very successful in the US.
So they should be successful here, but we need to create then also the financial incentives for them, and we're going to do that. And I hope that the pilot is already starting to deliver on that. To Missus Della Pisa, what are the instruments to increase the innovation capacity? Most important is, of course, to reward the innovation. So everything we do has two intentions.
One is to provide a direct reward for innovation. The other one is to make sure that when innovation is successful, it becomes much faster therapy and available for the patients. And we do this with the combination of the Safe Hearts Plan and the Biotech Act, because the very technology that we're going to develop through the Biotech Act could be very easily and quickly mainstreamed, especially in the prevention side, into therapy. Currently, the time is very long between a successful research on finding a molecule until the actual treatment of the patient. But with all the tools that are emerging now and these new combination products, like a combination of a medical device and an active substance, or a combination of a medical device, artificial intelligence and an active substance, we can really fasten this up.
And this is a very important element in all the, all the Biotech Act. This is why, for example, we have single authorization procedures provided in the Biotech Act, and this is why we have single authorization procedures also in the medical devices reform. Financial investments, I think I have covered, promoting European manufacturing as well. To Mr. Storn, faster market access is needed, I fully agree with you.
This is why we have to speed up the clinical trials, where we have been tremendously behind. The number of days is still too long for me. But because if you compare a multi country trial to, let's say, a UK trial, which is a country which has just left the EU. In Europe, we are now going down to 170. In the UK, it's 60.
But if it is a single-country trial, it's going to be 47. So I do hope that this also gives an incentive for the national authorities to understand that if you want access, you need much faster clinical trials. And the science is going to be much faster with biotechnology. The speed at which they are developing is tremendous, not even comparable to any other part of the economy. Then to the chair, on the MFN.
Yeah. You have put it exactly as it is. Now the question is, do we have a response? Yes or no? And my assessment is that we have it, and it's called the health package.
It is the health package. It is the pharma review that we did. It is the Critical Medicines Act. This overhaul, what we are putting forward, is also to be understood as a response, as an offer, if you wish, for European companies to stay here, continue to innovate here, do the clinical trials here, manufacture here, and market the products here. For us, this is also a very important reason why we are proposing all of this.
And this is also a very important reason why we are proposing it now. We have no time to waste. And I want to ask you to also consider this when we start taking positions, when we start working on the actual test. It's of utmost importance to get this report response also translated into action on the markets. Otherwise, we would be losing this race.
On the twenty-eighth regime, well, it sounds nice, but if I start to trickle it down into our realities where, for example, you have the EMA market authorizations and you have the national ones. You have some products that are exclusively authorized by the EMA, some that are possible to be authorized nationally, but also by the EMA. The choice is there for companies to always use the EMA, but there are some who are still relying on the national authorities. But if I open this can of worms, I think we will be discussing this in the next three, four years, and we will end up in most probably a clash with the council. For me, what is very important is to provide this health package as a new basis for innovation in Europe, which should also guarantee much faster market access, regardless of which way you choose.
And this is why we want to make sure that the implementation is then going to be the same across the board. For that, we will be extremely insistent, with everybody. To mister Stern's second question, I think I have already answered to mister Curia, the differences between the member states. Yes. There are clear differences among the member states.
I fully agree with you, be it the economic development, be it the funds. But what is interesting in the biotech sector is that these differences are less and less visible, because the nature of biotechnology to innovate and to get to a critical point of innovation is not so investment intensive. So very many of the innovations coming from this area are coming from smaller member states, coming from academia of smaller member states. So excellence is there, which is capable of propelling this innovation everywhere. But what is very important is that we should put the financing next to where the innovation is.
So to create these investment hubs is going to be very important. And I agree with you that it has to be done in each member state. But for this, we need to promote innovation everywhere, in the member states. And I agree with you that it is not a sustainable situation to keep the universities of one member state out, from this. Because science knows no borders, and these scientists are extremely good. And they have been actually extremely successful.
Just think about Colin Corico. So I'm working, of course, also as a Hungarian, to help them and to get them fully involved. So, I also ask your support in this house to get them back into the Horizon program, because they deserve to be there. They produce excellent signs. To Missus Gonzales Cazares, yeah.
But he left. Anyhow, I answer. Whether we are supporting industry or patients, we are supporting both. So the whole idea behind the proposal is that if we want to maintain patient access at the universal system as we know it in Europe, and we want to maintain the availability of the most state of the art treatments for everybody in Europe, the only way to do it with all the constraints that we all know is to promote innovation and to promote innovation here in Europe, testing and manufacturing. This is the best way to do it.
And I'm quite convinced that with the other measures like the Safe Hearts Plan, we will ensure that everybody will actually benefit from everything that we create through the Biotech Act. And finally, to Mr. Andrew Coytis on the SPC, or rather to the colleague from the jury committee. It's difficult to compare the SBC extension that we are providing here to any other SBC extension. The SBC extension for the pediatric products basically is unconditional.
Our extension has substantive criteria, quite a few of them. It has scientific criteria and also innovation criteria, meaning that it has to be a biological mechanism. It has to be a new mode of action. It has to be a new active substance. And it has to be, and these are the local conditions, it has to be innovated in Europe.
It has to be clinically tested in Europe, and it has to be manufactured in Europe. And manufacturing doesn't mean fill and finish. Substantive parts of the manufacturing have to happen in Europe. These are very strict conditions. So it's, I think, in balance with the extension that we are providing.
And the extension we are providing is exactly to create the economic value, but also to make sure that these are not going to be manufactured elsewhere. And our economy is going to benefit from it. But this is the balance that we think best represents the asks and the advantages. Now, the cost analysis. First of all, we have a full impact assessment of the pharma review.
In the pharma review, I think it dates back to 2023. In the pharma review, there was a full assessment of the SBC extension and its cost. And what it concludes is it is roughly €160,000,000 per product per year. That's the cost in terms of public health. But it would also mean that we would have access to the product, plus it would mean that we will also have an economic benefit at large for the society.
And on top of it, it will ensure that they are marketed in Europe. We have been looking at alternatives. Yes. We have been looking at, for example, data exclusivity. But we thought that this is the best tool to create also an economic value that can boost investments in the sector.
And if you ask me whether this would have a negative impact on the public finances, what I can tell you is that if we are just statically looking at the budget, it may. But if you look at the dynamics of the whole health care budget design, and the dynamics of the European health care model, things will have to change. We will have to invest more in these therapies if we want to continue to serve all the patients in Europe. This is why I think this is an indispensable element of the proposal.
Stine Bosse
Thank you very much. And these were long seven minutes, but it was all worth listening to. We still have two interventions, but please keep it. I'm sorry. Please keep it just one minute, because otherwise, we won't make it to the end.
First from S and D, Nikos Papandreou.
Nikos Papandreou
Thank you, commissioner. I think I don't envy your job because we have to effort to improve the lives of citizens through biotech, but we don't have the money. And I know you did a good, you made a good story. We have 10,000,000,000 EIB. I'd like an impact assessment, perhaps your cabinet can do that, how we'll get benefit out of that.
And also, you talked about Horizon. So that is also something that, unfortunately, is your job to put together across the different files. So if you can help on that. Third point, we talk about silos for those outside the bubble, organizations that don't talk to each other. Since the DG FISMA is responsible for Capital Markets Union, which is getting the money for the biotech, I think you could get them to work more together, because my understanding, without knowing what's happening behind the scenes, is that they don't talk so much.
So it's very important for the Capital Markets Union to be part of this. And finally, a very practical decision. I'm on the econ committee. Let's organize a meeting with our group to see how we can get more money for health. Thank you.
Ondřej Dostál
Dear commissioner, dear chairman, you spoke rightly about better access and shorter approval and registrations, but would you enforce it? We currently have, for pricing and reimbursement, 165 days maximum period. Sometimes it takes.
Please slow down.
Ondřej Dostál
Sometimes it takes two years to register a drug. If you get shorter time frames in the new act, will you enforce it or not? Secondly, the commission failed to keep the common market common. The pharma dominant actors split it into 27 markets and apply differential pricing, gain the referencing system. This regulatory passivity harms European taxpayers.
Are you going to do something about this also in the new biotechnology area? And then, you mentioned insufficient access to financial capital. But, in the EU, the health care is mostly public, and the health funds can easily leverage the necessary money. Let's allow them to invest and have stake in research, in clinical testing, in manufacturing, in distribution, and using the precious data from our
data space.
Stine Bosse
And I now will have to give the floor to the next speaker, who is Variga. Please.
Aurelijus Veryga
Thank you, chair. Thank you, commissioner. First of all, thank you very much for your initiative, and the numbers you have mentioned here and dynamics are really shocking. We are not just losing competitiveness, but losing the chance to help our patients in a proper and effective way. I have two short questions.
There are a lot of good proposals on the different stages now going on. The pharma package, Critical Medicines Act, and now this initiative are upcoming. So how would you see this could be coordinated in the best possible way in order to create a really sustainable ecosystem of biotechnology and health? And the second question, how would you see possibility to support every member state in order to avoid the concentration of the industries in a very limited number of member states? Thank you very much.
Stine Bosse
Thank you. Thank you for sticking to the time. And then now over to you, commissioner, for a short answer. Two minutes, if possible. Yes.
Olivér Várhelyi
To Mr. Papandre. First of all, we are doing an assessment of impact. It should be with you in May. So that is coming. But again, the basics are already in the impact assessment of the pharma review.
Second, on the Capital Markets Union. We are working very closely with Digifisma, and we have also a project designed in the Capital Markets Union for promoting investment into health. I'm, you know, my mother taught me that I should always go when I'm invited, but I should never go when I'm not invited. Now that you have invited me, I'm more than happy to go and visit you and talk about how to ensure proper funding under the next MFF. Like last time, I'm more than happy to cooperate with you, with the rest of the house to make sure that we have all the funding.
And what you see me doing now is that I want to already roll out the content, so that we will have strong arguments about the very high level of financing that we will need. Then to Mr. Dostal, pricing reimbursement decisions, yes, they should be shorter. But unfortunately, those procedures are more budget procedures than actual marketing procedures. We're looking into the enforcement of the transparency directive.
And here, we will be much stricter in applying the rules. Then the 27 different prices is a European reality. Markets are different in terms of size, in terms of their financing capacity. Maybe one answer to this is the Critical Medicines Act. So maybe with the strategic use of joint procurements by member states with smaller markets, prices could also change in their favor.
And also, it could improve their access to the products. And finally, Thomas de Veriga, what is the interplay between the pending initiatives that we have? I do hope that they are not only complementary, but that they are mutually reinforcing. This is how we have designed it. So we will need the Biotech Act for the Safe Heart Plan to succeed, and vice versa.
Biotechnological innovation will only be available much faster to the patients if we have the safe harbor going. Same goes for the pharma review, Critical Medicines Act. They all should create a whole new landscape. This is why I'm rushing this, because it still takes time to get through the legislation. It will take time until they are implemented.
And the things are happening on the other side of the Atlantic now, and things are happening in China now. So this is why it would be tremendously important to push these reforms quick through this house. And finally, the concentration to some member states. The concentration of some member states of biotechnology can only be avoided if we support grassroot innovation. So if we support the scale-ups, the start-ups.
This is what we're doing with the pilot, and this is also the response that I gave to Mr. Cuillier about European universities.
Stine Bosse
Thank you so much. And then now I will give the corruptors two minutes for closing remarks, and then I will close the meeting. Please, first, over to Ando Kites, two minutes. Please keep two minutes.
Vytenis Povilas Andriukaitis
Okay. Thank you so much. Thank you, commissioner. I see that we have good opportunity to cooperate in a very, very, you know, transparent manner. Most, I think, our parliament is keen to be fast.
That is my intention is to propose to help our, European parliament position. Maybe at the end of this year, it will be excellent. But, of course, you know, we need also help from your side because now translation, for example, into all languages, is in the hands of the commission. We need to press, and we need to ask commission to do your best because otherwise, Cyprus is calling, you know, but on the May 15, it is, of course, also, would be good note and to have much closer cooperation assessing situation related to some regulation issues which are enshrined in use USA and in China. We need to have more assessment because we need to pursue to have we can include those positives because we are competing.
And, of course, also, biotech should be as horizontal act as was because generally, we can connect all other eight legislations together because we need to build a very coherent legal frame and also very important to have to propose to member states to give mutual recognition and, of course, cooperation because they need to harmonize ethical standards, harmonize it. We need to press very much for harmonization, and we can do our best. And, of course, finally, it would be good to also draw attention to the definition of biotechnology and biomanufacturing. Such a little bit narrow definition can exclude some areas of nano technologies, of nuclear technologies, which also are bio, and some chemicals which also are bio. And, you know, Emma proposed a little bit broader definition.
It can help us also to see and to create instruments for those start-ups, especially with it. And I think that we can now organize our job in a more proper manner.
Stine Bosse
Thank you. And I will give you the floor again, but I will just ask Mr. Berkey to give his sum-up. Thank you.
Wouter Beke
Yes. Thank you. Well, let me conclude by thank you, Mr. Commissioner, and your team for the solid base that you produced for our discussion today on this proposal of the Biotech Act. I think it's timely and important, and it's an important initiative that clearly recognizes the strategic role of our biotech sector in Europe.
And it's clear that doing nothing would be almost a criminal omission. And we should not let other regions take over our key industry like you mentioned. I'm, therefore, pleased today by the debate that it has shown that we all share among the different committees and different political groups the common strong ambition. I think that we need a very strong and clear coherent mandate to truly enable the strengthening of our biotech sector across the entire union, from cutting edge academic research to successful commercialization, from small innovative startups to well established multinational companies. And only by addressing the full value chain, we can ensure that Europe remains competitive and that an innovative, effective reaches patients.
I would also like to thank all the co-rapporteurs for their valuable insights and their contributions. I think that their input also highlights the shared commitments among the different committees to get this file right. I'm very much looking forward to work closely with all of you in the coming months to shape a strong and balanced mandate, one that delivers tangible and positive results, but both for our industry and for the patients across the future. Thank you.
Olivér Várhelyi
Sorry for asking for the floor again, but I just wanted to have a very quick reaction to mister Andrukaitis, because it has to do with the translation. This is not something I'm very proud about. I would even say, I'm ashamed on behalf of the commission, that it takes six months, in 2026, to translate the legal texts. It takes now even more time than actually writing them. So, I have raised this issue within the college.
I asked the colleague responsible for this just yesterday. I addressed the letter to the secretary general to come to terms with the realities and provide the translation as a matter of urgency. Thank you.
Stine Bosse
Thank you so much, and thank you again, Commissioner, for coming here today. And I hope that you leave the Sandd and Itur Committee with a sense that we are behind you. We as the parliament also want to see this happening. And we actually thank you for the speed that you're doing this with, and we encourage all of us to work closer together in getting it done. Thank you very much.
And thanks to all of you for the good conversation and extensive views, and see you next week. Thank you.
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