As usual, this blog post is inspired by a series of events, conversations, news, and opinions I collected in the last few weeks, which condensated the need to share an opinion piece through this channel publicly. As always, for everything posted in this blog, these are my personal opinions, which do not necessarily represent the official views of my employer or any of the organisations I am affiliated with in various roles.
The topic is complex and politically sensitive. It is also very general, dealing with how the European Union produces its policies. My narrow perspective refers to the specific domain of in silico medicine technologies. I am not qualified to generalise, but I suspect the problem I am describing below is not specific to a particular area of innovation.
I always have been a champion of the European Union. Compared to the USA, the European Union has been, for many years, the land of rights. Coherent with the values of the majority of its citizens, we created a society where healthcare and education are rights, citizens' privacy is protected, and so on. I am very proud of this. But I am afraid the last few years transformed the EU into the land of rules and bureaucracy. This is crippling our ability to innovate and compete, I believe.
The introduction of in silico medicine is revolutionising healthcare. The ability of computer models, built with advanced techniques such as Artificial Intelligence, to predict changes in the health state of individual subjects opens amazing opportunities but also, as is always the case with disruptive technologies, a whole new set of potential risks for individuals and society. The differences in recent policy-making between the USA and the EU are creating dramatic disparities between researchers and companies working in this field.
When the General Data Protection Regulation (GDPR) was introduced in 2016, many, including myself, praised the European Commission. Eight years ago, it was already evident that information technology companies were abusing the personal data they collected, health information being very sensitive, which was already having a major impact on my research domain. However, as the GDPR was enforced, biomedical researchers in some member states faced huge difficulties. The idea of demanding the member states define the rules under which exceptions to the GDPR could be made for scientific research, while it was probably a smart political move to achieve complex legislation within a reasonable timeframe, created a nightmare in which every member state has different rules and multicentric studies across member states are very difficult. I am sure the legislators had no intention to prevent ethically robust biomedical research, but de facto, this is what has happened.
This story is well known to all operators in the field and shows, in my opinion, a pattern. The European Parliament decides to legislate on a socially relevant topic, which has significant implications for complex innovations, usually technological. Technical advisors are mobilised to support the legislative process, and the legislation tries its best to capture all possible implications of such innovation and how the legislation will impact the socioeconomic processes that involve such innovation. The results are large, complex legislations aimed to “cover all bases”.
However, for disruptive innovation, no group of experts, no matter how good, can foresee all the special cases and all the implications that such extensive policies can have. And the more complex the legislation is, the higher the chance it will produce unforeseen and undesired effects. In many cases, the issues are related to the correct interpretation of the law and its application into procedures that streamline whatever legal process economic operators need to do to comply with. The problem is that no one is in a position to handle this post-legislative process. The European Parliament cannot manage the application of its laws, and the European Commission does not always have the in-house technical expertise necessary to do this.
I suggest that for such complex pieces of legislation, a federal agency should be appointed to oversee the application of such legislation, providing guidelines addressing concrete cases as they emerge, offering support and training, and uniforming the procedures across the union.
In silico medicine, particularly In Silico Trials, has been one of these disruptive innovations. In the USA, where such federal authority exists (Food and Drug Administration, FDA), the first guideline on using computer modelling and simulation in the certification of medical devices was published in 2016. The Medical Device Regulation (EU 2017/745) acknowledges the growing role of software artefacts in medical products. However, in 2024, we still do not have a guideline that assists notified bodies in deciding when evidence obtained in silico can be accepted. The only technical standard for in silico methodologies is the ASME VV40:2018, whose production was driven by the FDA, which recognised the need. Only this year, the IEC-ISO started a workgroup on the topic that will produce an EU-harmonised standard in some years, but this is only because the community of practice has lobbied for it. When a new in silico methodology for all types of medical products is developed, one can ask the FDA for qualification advice to explore if such methodology suits regulatory purposes. In Europe, the European Medicine Agency (EMA) provides this only for drug development tools; nothing is available for medical device development tools.
Such a condition is reversing the flow: historically, medical companies would certify their products first in the EU and then in the USA. Today, for in silico solutions, many companies choose the opposite strategy and start with the USA regulator, ensuring clear, reliable regulatory pathways for such products.
In front of us, we have the application of the Artificial Intelligence Act in the next three years and the completion of the legislative process for the European Health Data Space regulation. Both pieces of legislation could have a tremendous impact on health technology innovation. Without central authorities with the technical skills to provide guidelines on these new legislations, the EU will face the same shortcomings as the MDR and GDPR.
“European Union: from the land of rights to the land of rules” © 2024 by Marco Viceconti is licensed under Creative Commons Attribution-NoDerivatives 4.0 International.
