Patients with unmet needs are our starting point. We aim to bring value, bridge gaps, and give physicians disease-altering options to offer patients and their families. Increasingly, solutions for serious health problems are complementary including diagnostics, medicines, and treatment effect monitoring. The pace at which these complementary and connected solutions are delivered is accelerating with the digital transformation of healthcare and the efficiency powers of AI.
Yet the benefits of scientific innovation and digital transformation are at risk of being blunted in Europe without modern, agile healthcare regulation. For us, this means a robust regulatory and legal framework that is interactive, dynamic and digitally enabled. Any framework needs to avoid pain points such as those experienced around implementation of the In Vitro Diagnostics Regulation (IVDR). Assigning EMA as an orchestrator authority on integrated solutions should help avoid this in the future, alongside a sandbox approach to provide the needed plasticity for adaptive approaches where the novel solution has no defined regulatory pathway.
By working together, leveraging well respected harmonization activities and best practices for work-sharing and reliance, regulators can support each other to manage the global workload necessary to meet the needs of patients
Further, the framework needs to include a common, multistakeholder understanding of unmet medical needs. Too stringent a definition could stymie innovation as well as negatively impact healthcare capabilities. Given the societal and patient burdens of chronic conditions, we call for the definition to be inclusive, such that highly prevalent, chronic conditions, including quality of life aspects, are recognized as conditions of need as well.
Last not least, Europe’s regulatory and legal framework needs to include work-sharing and reliance across global regulators. The looming shortage of skilled professionals puts tremendous pressure on regulatory and health systems. By working together, leveraging well respected harmonization activities and best practices for work-sharing and reliance, regulators can support each other to manage the global workload necessary to meet the needs of patients. Such collaboration has already lowered the multilateral costs and timelines of medicine assessments, but there is more to do. And technology can only help us yield these benefits all the sooner.
Such a regulatory framework can be a decisive unlock for Europe’s healthcare innovation environment. It will take political will combined with a sense of urgency, given the snowballing speed of digital technology and innovative scientific healthcare solutions. Already, Europe’s leadership has benefited the world with the regulatory framework for consumer-facing digital technology. Now, Europe has another global leadership opportunity - to move fast, with conditioned flexibilities, to ensure the European regulatory framework provides timely assessments of healthcare innovations, enabling patients in need to benefit in real time.
See further at Six bold actions for regulatory reform.
In partnership with
This article is produced in partnership with Roche.