The AI Act: help or hindrance to the pharma industry?

An Expert View from Vikas Krishan, chief digital business officer at Altimetrik.

Bringing a new drug to market is an arduous and complex process, taking an average of 10 to 15 years and $2.5 billion in investments, according to industry estimates. Pharmaceutical companies are increasingly turning to artificial intelligence (AI) technologies to accelerate drug discovery, streamline clinical trials, and improve overall efficiency. However, the European Union (EU) AI Act which came into force on August 1, poses challenges that will impact the pharma industry's adoption of these transformative technologies.

The EU AI Act aims to regulate AI systems used in the European Union, requiring them to meet strict standards for transparency, accountability and human oversight. It aims to set guidelines and requirements for use, focusing on trustworthy AI that respects fundamental rights. This stands in contrast to the highly regulated nature of the pharmaceutical industry, where compliance is paramount. The broad and somewhat ambiguous definition of AI within the Act has created uncertainty around its scope and application for pharma companies.