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On Tech Ethics Podcast – Unpacking the EU Biotech Act

Season 1 – Episode 48 – Unpacking the EU Biotech Act

Discusses the EU Biotech Act, which is a legislative proposal focused on health biotechnology, streamlining clinical trials, and boosting biomanufacturing.

 

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Podcast Chapters

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  1. Episode Introduction and Disclaimer (00:00:03) Daniel opens the episode by introducing Eline D’Joos, framing the conversation around the proposed EU Biotech Act, and noting that the podcast is for educational purposes only.
  2. Eline D’Joos’s Background in Life Sciences Regulation (00:01:00) Eline introduces her work as a life sciences associate focused on regulatory issues, product lifecycle matters, commercial transactions, intellectual property, and data protection questions.
  3. Purpose and Structure of the EU Biotech Act (00:01:44) Eline explains that the proposed act is intended to strengthen Europe’s biotechnology sector by improving competitiveness, increasing biomanufacturing capacity, and maintaining health and safety standards.
  4. Simplification and Industry Enablers (00:03:09) The discussion outlines the act’s two main policy buckets: simplifying fragmented regulatory processes across EU member states and creating incentives that encourage biotech investment in Europe.
  5. Health Biotechnology and Biotech Act II (00:05:17) Eline describes the proposal’s focus on health biotechnology, including human medicines, veterinary medicines, and GMOs, while noting that a separate Biotech Act II is expected to address industrial biotechnology.
  6. Why Biotech Innovation Is Shifting Outside Europe (00:06:30) Eline discusses Europe’s strong research base, the funding gap at the scale-up stage, and why biotech companies often move to regions such as the United States to grow and commercialize products.
  7. Funding Access and Strategic Projects (00:08:24) The conversation covers proposed funding measures, strategic project designations, cross-border high-impact projects, and incentives such as public-private funding, regulatory support, and faster permitting.
  8. Supplementary Protection Certificate Extension (00:10:46) Eline explains the proposed 12-month extension for certain biotechnology and advanced therapy medicinal products, including eligibility criteria, manufacturing requirements in the EU, and the expected high threshold for qualification.
  9. Mid-Episode Message About On Research (00:14:39) Alexa McClellan briefly promotes CITI Program’s On Research podcast and invites listeners to subscribe before returning to the main discussion.
  10. AI, Advanced Data Tools, and the EU AI Act (00:14:58) Eline explains how the Biotech Act supports AI use across the biotech lifecycle by requiring guidance from authorities while remaining aligned with the broader EU AI Act.
  11. Trusted AI Testing Environments and Strategic Project Opportunities (00:18:10) Eline notes that trusted environments for AI testing and high-quality data inputs may qualify as strategic projects, potentially unlocking funding and other benefits.
  12. Regulatory Sandboxes for Innovative Biotech Products (00:18:58) The discussion explains why regulatory sandboxes and early engagement with regulators may help innovative or hybrid biotech products that do not fit neatly into existing regulatory categories.
  13. Biotechnology Products of Concern and Biosecurity Obligations (00:22:36) Eline discusses how the Biotech Act addresses dual-use risks through legitimate need screenings, suspicious transaction tracking, reporting mechanisms, penalties, and obligations that can apply to non-EU suppliers.
  14. Clinical Trial Simplification and Time to Market (00:26:10) Eline explains how accelerated timelines, harmonized templates, combined study pathways, and minimal intervention clinical trials could reduce complexity and make Europe more attractive for clinical research.
  15. What to Watch as the Biotech Act Moves Forward (00:29:27) Eline describes the EU legislative process, including negotiation mandates and trialogue negotiations, and encourages listeners to monitor public developments while considering future compliance obligations and opportunities.
  16. Episode Closing and Tech Ethics Training Promotion (00:33:18) Daniel thanks Eline, encourages listeners to explore CITI Program’s podcasts, courses, and webinars, highlights the Tech Ethics Training Solution, and thanks the production team.

 


Episode Transcript

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Daniel Smith: Welcome to On Tech Ethics with CITI program. Today, I’m going to speak with Eline D’Joos, who’s a Life Sciences Associate at Crowell and Moring’s Brussels office. Her practice focuses on regulatory issues and commercial transactions in the life science sector, as well as interplays with general intellectual property and data protection questions. In our conversation, we are going to discuss the EU Biotech Act, which is a legislative proposal focused on health biotechnology, streamlining clinical trials, and boosting biomanufacturing.

Before we get started, I want to quickly note that this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws, regulations, and guidance that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests.

And on that note, welcome to the podcast, Eline.

Eline D’Joos: Hi, thank you so much for having me.

Daniel Smith: It’s great to have you. So I very briefly introduced you, but can you just start by telling us more about yourself and the focus of your practice?

Eline D’Joos: So as you said, I focus on the life sciences sector. I specifically give regulatory advice across the entire product life cycle. So in the clinical trial stage, getting that manufacturing authorization, and then in a commercialization stage, any other issues or questions that come up. And then I also assist with commercial transactions, drafting collaboration agreements, licenses, things like that.

Daniel Smith: Wonderful. Well, as I mentioned, we’re here today to talk about the proposed EU Biotech Act. So can you start off by telling us what the intent of this act is?

Eline D’Joos: So the EU Biotech Act is a proposal. It dates back from December 2025, and it is intended to boost the biotech industry in Europe. So it’s part of a broader strategy of the European Union. They have different strategies ongoing. There’s a broader life science strategy. There’s also an overarching competitiveness strategy, and those are intended to boost the competitiveness, the strategic autonomy of the EU compared to other regions in the world.

And so there’s a lot going on in the EU at the moment. There’s a lot of different new legislations and proposals ongoing. This is just one of them. And so it can sometimes be difficult to keep track of everything that’s ongoing. And this one is a whopper of about 250 pages, so it’s covering a lot, but basically it intends to work on three overarching objectives. So we want to boost, strengthen the competitiveness, we want to increase the biomanufacturing capabilities in the EU while, at the same time, not compromising on health and safety standards for the public. And so with those three overarching objectives, there are different ways that the proposal tries to target those.

So the two main buckets I would say is on the one hand, it’s about simplification of existing processes. I think one of the main issues in the EU is that even though it is often said that it is a single market, you have those 27 member states, the EU is one market, especially when it comes to medicines, that’s not the case. You have the EU, but you also have national legislations, national regulatory processes in all of those member states. So if you, as a company, want to bring your product on the market, you will have to go through processes in all those different countries, which can make it very difficult because the rules are not harmonized. So you have that regulatory fragmentation and a lot of inefficiencies and red tape that come with that. So that’s one area where it’s like, okay, we need to cut the time to market in order to remain competitive with countries like the US or China where we see that it is a lot more streamlined because they are integrated markets.

And then the second aspect is what I would call industry enablers. So it’s about giving incentives to companies for investing in the biotech industry in Europe. So those are the main, I would say, buckets. And then the proposal itself is divided into different chapters, or pillars I could also call them. So there are seven pillars in total which fall within one of those two buckets, so simplification or industry enablers, but it’s a very broad scope. So it targets different things, keeping in mind those larger objectives.

There’s a chapter about funding, there’s a chapter about AI, there’s a chapter about clinical trials. So there’s a lot of different things in that proposal, which makes it interesting to go through different chapters and see what it covers.

Daniel Smith: I think that’s a really helpful overview and gives us a good idea of the intent of the act, and then also how it seeks to accomplish those overarching objectives.

I also mentioned in my introduction that the Biotech Act focuses on health biotechnology. So can you talk a bit about the kinds of technologies that fall under that definition?

Eline D’Joos: You’re right. It covers specifically health biotechnology and the distinction is made with industry biotechnology. So this specific proposal is actually called the Biotech Act I because it only focuses on the health biotechnology sub-industry, I would say. So it covers human medicine, but also veterinary medicines, GMOs, or genetically modified organisms. So that’s the health biotechnology bucket, I would say, but then covering the entire product lifecycle. So in the Biotech Act, there are provisions about development stage, manufacturing, placing on the market. So it’s the entire product life cycle, but focusing specifically on, I would say, the health part of the biotechnology industry.

And then it has already been announced that there will be a Biotech Act II, which will be focusing on the industrial biotechnology, but that proposal is not available, yet, but there will be a Biotech Act II coming soon.

Daniel Smith: Good to know. So overarchingly, you’ve talked about how the Biotech Act is focused on boosting the biotech industry in Europe. So can you talk some more about why this is such a big shift for biotech innovation in Europe?

Eline D’Joos: There is a well-known structural problem in the EU, which is that it has those strong scientific capabilities, those research capabilities. A lot of research is being done in other parts of the world, as well, but especially in the EU. Also, early stage development. So there’s a lot of opportunities to get that early stage development ongoing, funding opportunities. But then once you get to the growth stage, scaling up, late stage development, then we see that there’s a real shift of companies going to, for example, the United States. So there are a lot of studies being done about the financial aspect.

So for example, it’s been shown that there’s a big funding gap, especially when it comes to the scale up and the late stage development between the EU and the US, where in the US, there’s about nine times more funding that is being given to startups compared to the EU. And also, almost all of the bigger biotechnology companies in the EU that went public over the last few years on the stock exchange, they chose to list on non-EU stock exchanges. So you do see that there’s this structural problem with, even if the research and development starts in the EU, at some point, those companies go to other parts of the world to scale up and get their products on the market. So that’s one of the things that they want to address. If the research is being done in the EU, we want to keep it as much as possible in the EU also to ensure access for the patients.

Daniel Smith: And in terms of the funding, does the Biotech Act aim to increase funding of biotech startups to grow and commercialize in the EU?

Eline D’Joos: So there’s different measures being proposed to increase funding access and close that gap that I was talking about. So on the one hand, they are setting up, say, additional public-private funding opportunities that you could qualify for in certain conditions. So there’s, for example, a $10 billion fund being set up in collaboration with the European Investment Bank.

In addition to that, there’s also additional funding available for what they call strategic projects. So this is a concept that was first introduced in another piece of legislation, the Critical Medicines Act, which is for medicines that are important to public health and are subject to shortages. So the strategic project is a project that increases capabilities or provides for new capabilities within the EU, and that focuses on an aspect of the biotechnology industry. So it’s strengthening that capacity, it’s scaling up R&D, scaling up testing facilities. And so if you qualify as a strategic project, there is a process to go through. You can apply with one of the EU member states. They will assess whether you qualify as a biotechnology strategic project. If it is particularly important for the EU or for multiple member states, so if there is a cross-border aspect, you could also qualify as a high impact strategic project, which is one tier higher. If you qualify for one of those designations, then you can get a lot of different incentives.

So there is, for example, additional funding available both at the national level of the member states and at the EU, but you also get other benefits such as additional regulatory and technical support, you get fast track permitting for, well, permit processes for environmental permits, for building permits. So there’s a lot of different incentives that these strategic projects get, and the idea is to draw them to the EU.

Daniel Smith: I know another potential incentive is the extension of the supplementary protection certificate. So can you talk some more about why this extension is significant for biotech and advanced therapy developers and whether or not it creates any incentives for them?

Eline D’Joos: Just to give the background a little bit, the supplementary protection certificate as such is an extension of patent protection. So in the EU, you get 20 years of patent protection, and that starts running from the date that your patent is filed. Now, the problem specifically in the pharmaceutical industry is that the patent is being filed pretty early in the development process because it needs to be novel, et cetera, so it’s filed pretty early in the process, years before the product actually comes on the market. But like I said, the 20 years already starts running from the date of filing, which means that by the time a pharmaceutical product actually gets to market, typically, at least half of that patent protection has already expired, which is why they originally came up with the supplementary protection certificate because it gives five additional years of protection, and it’s specifically for pharmaceutical products and some other products where that gap between when the protection starts running and when it is actually useful.

And so now they’re proposing a 12-month extension, so a sixth year of protection specifically in the biotechnology sphere. So it would be for medicinal products that are developed through biotechnology processes or advanced therapies, and they need to give some sort of therapeutic advantage beyond what already exists. So there are four in the legislation, four cumulative criteria which focus on the one end on that new aspect, that advantage that needs to be there. And on the other hand, because we are trying to boost the industry in Europe, there also needs to be one step in the manufacturing process beyond just the packaging or the testing, but one actual manufacturing step that needs to be done in the EU to qualify for that incentive. And so that’s one of the ways that they’re trying to draw more of the industry to Europe.

The thing is that because those four criteria exist, the threshold is quite high. And so there is a working document from the European Commission where they’ve assessed what the impact or the benefits or the risks would be of all these different proposals. And it is expected that this would only be granted to breakthrough products, I would say. And it’s estimated that it would only be about two or three products a year that could qualify for this. There is no legal limit to it, but in reality, probably only a handful of medicines every year will qualify for that. But there is also a reason why they do that. They make the threshold quite high because that additional year gives you an additional year, basically, of, I would say, a monopoly position in the market. It keeps the competitors off the market.

And so if you are the only or one of the only products on the market, that also of course has an impact on patient access, on the cost for the healthcare system. And so they were trying to find a trade-off between incentivizing the industry, giving them that additional monopoly to get their return on investment, which is important for the biotechnology industry in particular because those complex processes cost a lot of money, so it’s a very costly production and development process, while on the other hand, also making sure that the public healthcare system is not put under too much pressure.

Alexa McClellan: I hope you’re enjoying this episode of On Tech Ethics. If you’re interested in hearing conversations about the research industry, join me, Alexa McClellan, for CITI’s other podcast called On Research with CITI Program. You can subscribe wherever you listen to podcasts. Now, back to the episode.

Daniel Smith: Going back to what you mentioned earlier in the conversation about how the Biotech Act is just one piece of legislation within a lot going on in Europe, and within the past few years, the European Union has implemented the EU AI Act, and you also mentioned how the Biotech Act has a chapter on AI. So can you talk some more about how this Biotech Act encourages the use of AI and advanced data tools across the biotech lifecycle while remaining aligned with the protections that the EU AI Act has put in place?

Eline D’Joos: The EU AI Act is what we call a horizontal piece of legislation, which means it is sector neutral. It applies to the pharmaceutical sector just the same as it applies to other sectors. And so in that sense, the Biotech Act does not change any of the provisions of the EU AI Act. It tries to align some of the, I would say, sector specific legislation that exists with that horizontal piece of legislation because the EU AI Act is currently entering into force.

And so a lot of companies are trying to prepare for the implementation of the EU AI Act, but, of course, they have to take into account other pieces of legislation, as well. And so the big question for a lot of companies is, how does all of that legislation work together? If we have a monitoring requirement in this legislation, one in that legislation, how do we combine those? How do we make sure they don’t contradict each other? So that’s a big topic of focus for the compliance teams in companies, I would say. And so in that sense, the Biotech Act doesn’t change anything of the EU AI Act, but it does put obligations, for example, on the European Medicines Agency to issue guidance to companies to help them with that big question. So if you use AI somewhere in the product life cycle during the research and development stage for monitoring afterwards, the EMA, the European Medicines Agency, has to publish guidance on how you can actually use those AI and those advanced technologies in the process. Because what we see is that AI is becoming more prevalent.

So companies are already using AI to find the one molecule that will be interesting to study, are using it to streamline clinical trials, and so the EMA is already working actively on deciding how to deal with that because it provides for a lot of opportunities. It can really speed up the process, make it faster, make it less costly, which is good for everyone. It drives down the cost, it increases the access, but always keeping in mind that in the end, we don’t want to compromise on health and safety. So how trustworthy is the AI we are using in the development process or in the product life cycle? So that’s one of the things in the Biotech Act. There’s a lot of obligations on the authorities to issue guidance to help the companies.

And secondly, there’s also, when I was talking about those strategic projects, there are a couple of specific examples listed in the legislation that would qualify as strategic projects or even as those EU-wide high impact strategic projects. And so for example, creating trusted environments for testing with AI or for delivering high quality data input, those types of projects would qualify as those strategic projects that I mentioned, which would benefit from funding and all those additional benefits.

So I would say those are the two main aspects of the Biotech Act talking about AI, but it doesn’t change anything about the AI Act itself.

Daniel Smith: So in terms of those testing environments, can you talk a little bit more about why regulatory sandboxes and also other mechanisms, such as the guidance from authorities that you were mentioning, why those are important for highly innovative or hybrid biotech products that might not fit neatly into existing frameworks?

Eline D’Joos: The EU is, I think, finally realizing that they cannot keep up with innovation, especially when it comes to pharmaceutical sectors or highly scientific sectors, I would say. And so this concept of the regulatory sandboxes is popping up in the different legislations that are currently being revised or being developed. So the idea is that we want to think along with companies who are making these highly innovative products. We have the legislation that is trying to work with definitions. We want to put products into a certain box so we can say, “This is the process you need to follow to get approval. These are the obligations you need to comply with.” But the reality is that with the current science and technology that’s only speeding up, there’s a lot of hybrid developments going on. There’s traditional pharmaceutical products with AI, there is combinations with medical devices where they’re using sensors and they’re putting medicinal products in there.

So there’s a lot of products nowadays that are so innovative, so complex that they don’t fit into the categories that were written in the legislation. But of course, we still want to approve those products, put them on the market for the patients. So then the question is, okay, how do we do that? It doesn’t fit in the boxes. How do we, again, get that assurance on the health and the safety if the regulatory framework is not fit for purpose? And so the regulatory sandbox is a concept where the company can basically, they can request, if we’re talking about a sandbox, a playground being open. So it’s a controlled environment. There is regulatory oversight. The European commission or the national member states will be supervising carefully what companies are doing, but it is the very stringent regulatory framework. There will be exceptions there. There will be derogations from those requirements so that companies can do the testing, can do the development for those innovative products and get them to market.

So that’s what those sandboxes are. You can use them for innovative products. Also for if you have a idea for a clinical trial that is out of the ordinary, I would say there’s also regulatory sandboxes for clinical trials. But the main idea is that you are working together with the regulators from a very early stage, which reduces the uncertainty because companies, especially if you’re talking about startup companies, smaller companies, it’s a very complex regulatory world. I would say they don’t necessarily have the expertise. They have that scientific expertise, they have that innovative idea, but then they stumble across that regulatory framework, all the red tape they need to deal with. So then it’s very helpful to have that idea of the sandbox where they can work together with the regulators about, okay, how can we get this product to market in a safe way? But that doesn’t compromise on health and safety, but it still brings a product to market in the end.

Daniel Smith: And with these innovative products and advances in biotechnologies, another piece of the protection of health and safety is obviously they can sometimes raise what the Biotech Act calls biotechnology products of concern. So what risks is the EU trying to manage and how does this affect developers and suppliers?

Eline D’Joos: So the chapter about biodefense is about providing safeguards for, let’s say, dual use technology. So these are biotechnology products that are intended for civil use, but there is concern that there is a potential for misuse, for example, for military purposes or other nefarious purposes, I would say. So the biodefense and biosecurity obligations in the Biotech Act try to address that. So there’s this new concept being worked out, like you said, biotechnology products of concern. Those are products where there is a significant potential for misuse. There’s no list of what these products are, but the criteria is that there has to be a potential for misuse. And so there’s a lot of new obligations where basically you, as a provider, cannot provide it to customers before demonstrating that there is a legitimate need for the customer to have this. So the idea is that we still want to support, for example, legitimate research purposes, that would be a legitimate need, but we want to avoid any misuse.

So the Biotech Act requires providers to, I would say, audit or ask questions to their customers first before providing these products. So for companies who are subject to anti-money laundering, it’s the same know your customer concept. You need to know who is my customer, what are they going to use this for? And if there is this legitimate need, okay, you can sell it to this customer. So there’s this screening obligation, you need to track suspicious transactions, there are reporting mechanisms that is all similar to how it works for anti-money laundering.

The idea is that for the majority of companies, this won’t be an issue. There won’t be a heavy, I would say, burden because of these new obligations because we’re going to assume that they are legitimate research organizations, they are legitimate developers. So in that sense, it should create minimal burden because they’re really trying to weed out the, hopefully, more exceptional cases of potential misuse. But what is specific here is that this is one of the only parts of the Biotech Act where there’s also a reference to penalties. So these are really binding obligations, the screening, the reporting, and there would be fines, a certain percentage of your annual turnover if you have intentionally or otherwise negligently infringed on those obligations.

And what’s also important here, if we’re talking about non-EU companies, is that there is the, what we call, extraterritorial reach. So it applies to biotechnology products that are coming on the EU market, but it doesn’t matter who the supplier is. So even non-EU suppliers in the US or otherwise who are putting these products on the EU market would have to comply with these legitimate need screenings and this reporting, et cetera, and they can be subject to the fines.

Daniel Smith: So we’ve obviously covered a lot of ground here today about the Biotech Act. So just a few closing questions to wrap up our conversation. The first is, what do you think the most meaningful changes the Biotech Act makes to clinical trial and related EU regulations, and how might these reduce time to market for new therapies?

Eline D’Joos: The clinical trials part of the Biotech Act is, for me, one of the most important parts because you see there that the EU is really lagging behind compared to other countries for how long it takes to have clinical trials approved, the whole process. Again, if we’re talking about that fragmentation with the different member states, if you want to do a multinational clinical trial in the EU in different countries, that adds a whole other layer of complexity with all the national member states being involved. And so there is a lot of red tape there that the EU is trying to cut and is trying to simplify to attract clinical trials to Europe again, because we see that the numbers show that the share of clinical trials in the EU is eroding. So this is a big point of focus.

So there’s different things that they’re doing for the clinical trials to simplify the process. There are accelerated timelines to become more competitive with other countries. There’s also harmonized templates that are being used. There is combined pathways. If we’re talking, again, about those complex combination products, if you’re using a medical device and a medicinal product, those are two separate parallel streams. And this is, for example, something where you’d say, “Okay, let’s combine this. We’re going to create a combined study pathway,” which is important for companies that are really focused on, for example, personalized medicine, combination products. They can have a combined study for the medical device component and a medicinal product component.

Same with, for example, the new category of minimal intervention clinical trials. So clinical trials when it comes to monitoring and oversight, it’s based on the risk of the trial to the patients participating in the trial. And so there was already a low risk class, but now they will make even a lower class, the minimal intervention clinical trials, which has even fewer oversight requirements, et cetera, and that should create a faster pathway to access for the companies.

So there’s different things for clinical trials to, again, try to harmonize that fragmentation in some way, which I think is a really important one for companies, especially companies, for example, who are working on products for rare diseases where there are fewer patients, which means that they need to go to a lot of different countries in order to get a representative pool of trial subjects. But the more countries you include in your clinical trial, the more complex it gets. So I think especially for companies like that who do multinational clinical trials in the EU, this is a good thing.

Daniel Smith: Wonderful. And my final question for you is, just what should our listeners watch out for next, and where can they learn more as the Biotech Act moves forward?

Eline D’Joos: So the Biotech Act is currently going through the legislative process in the EU. So we’re still at the proposal stage, and the way it works in the European Union is that then the proposal is made by the European Commission, and then the European Parliament and the Council of the European Union both propose amendments. So they prepare, first, a negotiation mandate with amendments that they want to include in the legislation. And once they’ve both agreed on their own mandates, then the three EU institutions, so the parliaments, the council, and the commission, they enter into what we call the trialogue negotiations.

So the institutions will, between themselves, negotiate a final text for the legislation. So currently, we’re still awaiting on those negotiation mandates. We don’t know the exact amendments that the parliament and the council want to propose. The trialogues are also a, I would say, notorious phase in the process because it’s very obscure. So it happens behind closed doors. Often, information informally leaks out, but the negotiation mandates, the going in positions are public, and then all of a sudden they come out with a compromise. But the process in between is a little bit obscure, and it also is unsure how long it takes. There’s no strict timeline, there’s no deadline that they need to follow. It can take a few months, it can take a few years for bigger pieces of legislation. So even though this is one of the priority legislations, I would say for the EU now, I do think that we should, given that the negotiation mandates are not even available yet, we should not expect this to be available or entering into force before end of ’27 or even 2028, I would say.

But I do think that it’s important to monitor the developments of the legislation, which is, like I said, the negotiation mandates are public information. There are press releases by the EU institutions so you can find them online on their websites. But I think if you want to be proactive, it’s important to maybe already consider, on the one hand, the compliance obligations it will bring, for example, when it comes to the biosecurity products. But on the end, also spotting the opportunities. Like I said, there’s a lot of industry enablers, as we call it. There’s the strategic projects, the regulatory sandboxes, the simplifications to the clinical trials that could warrant already discussing internally within the company if there is potential there in the not so near timeline, I would say. In a couple of years in the pipeline, are there opportunities there for a strategic project? Would it be interesting to go to the EU for a step in the manufacturing process to get that supplementary protection certificate extension?

Things like that can already be considered because it can be assumed. It’s not certain. It can be assumed that even though the conditions can change or the modalities can change, the main idea, so the idea of a strategic concept, we can assume that that’s going to be introduced. Maybe the specific criteria will change or the incentives, but the concept as such is probably going to be introduced. So in that sense, you can already start to anticipate and think within the company about, okay, is there an opportunity here for us in the future?

Daniel Smith: I think that’s a wonderful place to leave our conversation for today. So thank you again, Eline.

Eline D’Joos: Thank you. This is very fun. Thank you for having me.

Daniel Smith: If you enjoyed today’s conversation, I encourage you to check out CITI Program’s other podcasts, courses, and webinars. As technology evolves, so does the need for professionals who understand the ethical responsibilities of its development and use. That is why we developed our new Tech Ethics Training Solution. This new offering brings together practical, thoughtfully designed courses to help professionals navigate ethical and regulatory challenges with confidence. The courses cover responsible AI, software as a medical device and clinical decision support systems, big data and data science, data management, software development, and more. Check out the link in this episode’s description to learn more.

And I just want to give a last special thanks to our line producer, Evelyn Fornell, and production and distribution support provided by Raymond Longaray and Megan Stuart. And with that, I look forward to bringing you all more conversations on all things tech ethics.

 


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Meet the Guest

content contributor Eline D'Joos

Eline D’Joos, LLM – Crowell & Moring LLP

Eline D’Joos is an associate at Crowell & Moring’s Brussels office, focusing on transactional and regulatory issues in the life science sector. Eline has negotiated various agreements and advised multinational companies, start-ups, and research institutes in the pharmaceutical, biotech, and medtech sectors on complex matters, including market access and regulatory incentives.


Meet the Host

Team Member Daniel Smith

Daniel Smith, Director of Content and Education and Host of On Tech Ethics Podcast – CITI Program

As Director of Content and Education at CITI Program, Daniel focuses on developing educational content in areas such as the responsible use of technologies, humane care and use of animals, and environmental health and safety. He received a BA in journalism and technical communication from Colorado State University.