AI in the pharmaceutical sector
AI is revolutionizing and the pharmaceutical sector was no exception. The legal and ethical challenges surrounding this ever-evolving area are going to be many, but are we prepared?
Iberian Lawyer spoke with Carlos Pérez Sanz, partner in charge of Fieldfisher’s Tech & Data area in Spain, and Héctor Jausàs, partner in charge of the firm’s Life Sciences department, about the impact of AI in the pharmaceutical sector, the main lines of future European regulations and their impact.
by mercedes galán
AI is transforming research and development projects by accelerating the discovery process, optimizing clinical trials, and personalizing treatments. However, this also poses legal and ethical challenges, such as data privacy and the regulation of AI algorithms.
AI is going to be a revolution in the pharmaceutical and healthcare sector, where do we start from at a regulatory level?
Carlos Pérez Sanz (CPS): The starting point is the current proposal for a European Regulation on Artificial Intelligence, which is in the approval phase. This proposal places emphasis on High-Risk Artificial Intelligence solutions, which will most likely include AI applications in the healthcare and pharmaceutical sectors. The future regulation contains a series of high-level obligations for high-risk AI solutions, with the aim of respecting technological neutrality and ensuring respect for the fundamental rights and security of citizens.
And in Spain?
Héctor Jausàs (HJ): In this area we are ahead of the rest of Europe. We are the first country in the EU to designate and articulate the operation of its own artificial intelligence regulatory authority, the AESIA (see box, ed); and it is well advanced in the regulations for the creation of controlled test environments for the development of AI solutions. Spain has all the necessary elements to ensure the immediate application of the future Regulation and to give full security to AI projects.
