On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next mandate. In these guidelines, which evolves around Europe’s ‘prosperity and competitiveness’, a strong focus is on the life sciences and healthcare industry. In the guidelines, a twofold focus for the industry can be uncovered. On the one hand, the guidelines propose changes to bolster the life sciences industry in Europe and on the other hand the developments are focussed on improving healthcare for the people living in Europe. 

One of the main aims described in the guidelines is to (generally) achieve a more circular and resilient economy. The EU is faced with a shortage of critical medicines and medical devices. To remedy this scarcity, the European Commission will propose a Critical Medicines Act which will reduce dependencies on these scarce medicinal products and ingredients. A further aim is to further strengthen the European Health Union, which includes continuing to work on anti-microbial resistance. Furthermore, as part of improving the health of the people living in the Europe, preventive health must also be further enhanced, especially regarding mental health. 

Interestingly, both the upcoming Reform of the EU Pharma Legislation and the European Health Data Space are not mentioned, but these are of course major developments the industry is facing as well. 

Security of health systems 

Furthermore, focussing on digital aspects, the security of health systems must also be worked on, as they are increasingly becoming the target of cyber and ransomware attacks. A European action plan on the cybersecurity of hospitals and healthcare providers will be proposed within the first 100 days of the mandate and is thus seen as one of the priorities. 

AI and supercomputing 

A more general aim, but also very relevant for the industry, is boosting productivity with digital tech diffusion. The European Commission will do so by ensuring access to ‘new, tailored’ supercomputing capacity in the first 100 days for start-ups and industry through an AI Factories initiative. An Apply AI Strategy will also be developed, in collaboration with the Member States, the industry and civil society, to push for new industrial uses of AI, with the aim to also improve services in the (public) healthcare sector. In addition, it is proposed to create a European AI Research Council (similar to CERN). A European Data Union Strategy will also be set up, where businesses and administrations will be able to share data while respecting the privacy and security standards. 

Research and Innovation 

In the guidelines it is included that the European Commission wants to put research and innovation at the heart of our economy. In order to make the most of the biotech revolution, it is stated that the EU’s research spending needs to be increased.

New legislation is on the horizon for the biotech sector as well, as the European Commission will propose a European Biotech Act in 2025, to simplify bringing biotech from laboratory to factory and then onto the market. This will fall under the Strategy for European Life Sciences, which looks at how EU’s green and digital transitions can be supported and how high-value technologies can be created. Additionally, cooperation between research departments, higher education and businesses will be bolstered through University Alliances. 

Data and Innovation

A key highlight of the guidelines is the emphasis on open access to data within the European market, reflecting the EU's ambition for a comprehensive and bold strategy to foster European innovation.

The management of publicly available data that contains personal data remains however a significant issue which the guidelines recognise but do not fully address or resolve. Nonetheless, companies active in the life sciences and healthcare industry should be aware that the data privacy rules, for example the GDPR principles, must always be observed and complied with, even if personal data is openly available, and even when it has been made public by the research participant/ patient itself. This necessitates amongst others identifying a legal basis and documenting relevant assessments, such as data protection impact assessments or, when the legal basis is legitimate interest, conducting a legitimate interest assessment to perform the balancing test. For instance, a healthcare company developing an AI model using publicly available social media data must perform a DPIA to assess and mitigate privacy risks. Data subjects may change their preferences over time, such as deciding to withdraw consent or requesting the deletion of their data. Companies must be agile in responding to these changes while ensuring compliance with GDPR. For example, a healthcare company that aggregates publicly available patient reviews must have mechanisms in place to delete reviews if a research participant/ patient exercises their right to be forgotten.

At a time when the European life sciences sector is facing serious competition from the US and China, a truly competitive mandate would be welcomed by the industry. However, with significant (legislative) changes on the horizon to an already complex regulatory framework, it will be interesting to see how these plans will work out in practice.