Vikas Krishan, chief digital business officer at the global data and digital engineering solutions firm Altimetrik, outlines the implications of the European Union’s forthcoming AI Act for the pharma industry and urges for the need to adopt a proactive approach in evaluating AI roadmaps and governance.
The pharmaceutical industry’s unyielding pursuit of new and improved therapies has long been fuelled by innovation. In recent years, the rise of artificial intelligence (AI) has emerged as a transformative force, offering unprecedented opportunities to accelerate drug discovery, optimise clinical trials and enhance patient outcomes. However, the impending EU AI Act threatens to complicate this promising future, potentially hindering the pharma sector’s ability to take advantage of these cutting-edge technologies.
Bringing a new drug to market is an arduous, and complex resource-intensive endeavour. According to industry estimates, the average timeline from initial discovery to patient access is a staggering 10-15 years, requiring an average investment of USD 2.6 billion. This immense investment of time and capital has driven pharmaceutical companies to explore ways to streamline the development process, and AI has emerged as a promising solution.
Generative AI, in particular, holds immense potential for the pharma industry. These advanced algorithms can rapidly analyse vast troves of data, identify promising drug candidates, and even simulate clinical trial processes – tasks that traditionally required armies of human researchers and years of painstaking work. By harnessing the power of AI, pharmaceutical companies can potentially shave years off development timelines and bring lifesaving treatments to patients faster.
However, the EU AI Act, which came into force at the beginning of August 2024, threatens to complicate this promising future. The Act will help to regulate the use of AI technology within the European Union, setting stringent standards for transparency, accountability and human supervision.
The pharma industry, known for its meticulous compliance with existing regulations, now faces the challenge of navigating this new, more ambiguous regulatory landscape. Unlike the well-defined, sector-specific guidelines that govern drug development, the AI Act casts a wide net, encompassing a broad and evolving definition of AI that has already been amended multiple times within its drafts.
Definitional Ambiguity
This definitional ambiguity is a potential source of considerable concern for pharmaceutical companies. Without a clear, unambiguous understanding of what constitutes AI, and which of their AI-powered platforms will fall under the Act’s purview, pharma firms face the daunting prospect of expending significant resources on compliance, rather than on innovation.
Adding to the complexity, the AI Act takes a risk-based approach, categorising AI systems into “unacceptable risks,” “high risk,” “lower risk,” and “minimal/no risk” buckets. Crucially, many of the pharma industry’s AI use cases, such as predictive analytics in clinical trials or precision medicine applications, would likely be classified as “high risk” – subjecting them to stringent conformity assessments and heightened regulatory scrutiny.
The burden of compliance, coupled with the threat of hefty fines for non-compliance, could serve to decrease the velocity of pharma’s adoption of AI technologies. After all, the industry is already heavily regulated, with compliance being a fundamental requirement across all operations. The prospect of an additional, loosely defined regulatory framework, one that could potentially conflict with existing obligations, creates a potentially ambiguous scenario, if not managed well.
Proactivity is Key
To navigate this uncharted territory, pharmaceutical companies must take proactive steps to assess their technical landscape, evaluate their data and AI roadmaps, and establish robust governance structures. The role of a Chief AI Officer, tasked with overseeing the comprehensive risk management framework required for compliance, will be crucial.
Equally important is the need for effective communication and coordination across the pharma ecosystem. Raising awareness and aligning on the Act’s implications, not just within individual organisations but also among suppliers, clients, and regulators, will be essential to mitigate the confusion and uncertainty that currently surrounds the legislation.
Stronger legal clarity and harmonisation across the EU, UK, and US regulatory bodies would go a long way in providing the pharmaceutical industry with the certainty needed to confidently investigate and utilise AI innovations. The alternative, a fragmented, self-regulatory approach, risks creating inconsistencies and ambiguities that could undermine the Act’s intended goals.
Ultimately, the success of the EU AI Act in the pharmaceutical industry will hinge on the ability of regulators and pharma companies to find a delicate balance. By proactively addressing the Act’s requirements and working collaboratively with policymakers, the industry can unlock the full potential of AI to accelerate drug development, improve clinical trial efficiency, and enhance patient outcomes. But this will require a nuanced understanding of the Act’s scope, clear definitions and a regulatory framework that fosters innovation while prioritising patient safety and fundamental rights.
The stakes are high, as the pharmaceutical industry’s proven track record of innovation has the potential to save millions of lives. With the right approach, the EU AI Act can serve as a catalyst, driving pharma to adopt AI in a way that balances cutting-edge technologies and rigorous compliance. By embracing this challenge, the industry can pave the way for a future where ground-breaking advances in healthcare go hand in hand with responsible, ethically-aligned innovation.
