Blog
30/03/2027
EU AI Act for pharma and biotech
EU AI Act for pharma and biotech: 5 most pressing issues to consider in 2026
The EU AI Act is becoming fully operational in August 2026. But what are the implications of the EU AI Act for pharma at this stage?
First and foremost, let’s be real: EU regulations are valuable, but are also slow innovation and create financial burden—particularly to smaller companies.
However, large multinationals face similar pressure, albeit for different reasons.
Below are the top aspects that companies need to consider in 2026 in the context of the EU AI Act.
Bureaucratic structures as bottlenecks
Larger companies, not as agile as startups, operate with significant bureaucratic structures. It is the multinationals that face an impossible dual burden right now. They need to implement AI solutions asap. However, dependency on vendors, legacy data governance structure and lack of tech talent are slowing down innovation.
In addition to bureaucracy, lack of clarity from the EU side decelerates innovation further. An entire sector is yet waiting for the usual guidelines that accompany any EU Act or Directive.
Most urgently, the industry is awaiting clear guidance on one key question: to what extent does the research and development exception for low-risk AI apply to pharma and biotech companies? Until the EU provides confirmation, hesitation and reluctance remain, and, quite frankly and sadly, slowing down EU competitiveness.
Are you ready and is your organization prepared? Or will many have a GDPR-like summer where organizations aim to be AI Act ready at the last minute.
H2: EU AI Act elements to consider in 2026:
This is not a EU only matter. In times of global datasets, where data is heterogeneous and deriving from different jurisdictions, compliant global data governance is needed. The EU AI Act is the first of its kind, but Brazil, Canada and the ASEAN region are already following and implementing EU standards into their local legislations. More to come.
Establish clear “human oversight mechanisms” now. This is one of the central concepts of the Act, mentioned 17 times and shall ensure robustness and accuracy on the data output level at any time.
Be aware of the fines. In a nutshell we are looking at up to €35M or 7% global turnover for breaches.
Conduct due diligence and inventory on existing data governance now. 2025 saw a peak in budget allocation for AI experts in pharma and biotech companies. Inventory diligence on LLM systems already in place are running at full speed until August 2026.
Collaborate with compliant AI vendors. Due diligence is key to be ready to scale compliant AI clinical trial solutions.
The EU AI Act is publicly available, and the EU has already published many guidelines on AI system definition and risk evaluation approaches. More guidance is expected to come. We’ll share any updates once new guidelines have been published. Stay tuned!
