Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges

Regulatory NewsRegulatory News | 29 October 2020 |  By 

Anthony Humphreys

The idea that regulatory agencies can come up with solutions in isolation is “very dangerous” and underscores the need for multi-stakeholder responses to emerging challenges, said Anthony Humphreys, of the European Medicines Agency (EMA), at the Euro Convergence 2020 virtual meeting.
Speaking during a session on supporting innovation, Humphreys, head of EMA’s regulatory science and innovation taskforce, set out the importance of gathering the views of other stakeholders when strategizing for the future of regulation. That collaborative model, in which agencies’ plans are shaped by the challenges being experienced in the areas they regulate, is well established. What is changing is the range of stakeholders that contribute to addressing the challenges.
“[Strategy] has to be co-developed, not just with the ‘usual suspects’ in terms of the pharmaceutical development industry, but also with academia, with healthcare professionals and, increasingly, patients,” Humphreys said. “Society has moved on. It can no longer be a bilateral relationship with the development industry and the regulator.”
Humphreys listed clinical trials, good manufacturing practices, the 3R animal research agenda and use of real-world evidence as areas in which he foresees key stakeholder platforms being set up in coming years.
In regard to drug-device combination products, Humphreys sees them as “a very high priority” for EMA. He believes the agency needs a “navigable framework” for companies wanting to use devices in combination with drugs – for example, to deliver a drug to targeted diseased cells – as a way of ensuring regulations are not an impediment to patient access. Establishing a streamlined path to market may be harder in the EU than the US, but Humphreys sees it as a challenge EMA needs to tackle. 
“Due to various sorts of remits of responsibility in Europe, the picture is more diverse than [the one our] FDA colleagues enjoy. But, rather than hang around for some sort of utopian situation that may take years to drop into place, we [have] to actually deal with the reality of the regulatory framework as it is today,” Humphreys said.
EMA began tackling the challenges around drug-device combinations years ago. Humphreys used  the focus the Committee for Advanced Therapies (CAT) has placed on combination products since the late “aughts” as an example of the agency’s recognition of the trend. The rise of drug-device combinations has taken longer than was anticipated when CAT was originally formed, Humphreys said, but the boom in advanced therapy medicinal products (ATMPs) suggests EMA’s prediction is now holding up.
ATMPs that rely on delivery devices are part of a wave of products pushing at the boundaries regulators draw between different fields. Humphreys highlighted the emergence of software, such as apps that can improve outcomes, as another area in which EMA and its counterparts need to find ways to stop their processes from becoming an impediment to access.   
“The regulator’s role is to enable that future, rather than saying ‘these are the obstacles, these are the hurdles’,” Humphreys said. “We can certainly have a discussion about what the obstacles and the hurdles are, but our main drive, and I think it’s a collective drive, is how you get over those ... so that these futuristic solutions can be enabled, not just in Europe, but on a global basis.”
Humphreys’ view is underpinned by a belief that patients and healthcare professionals care little about how the products they interact with are defined. Rather, their focus is on accessing innovations that improve outcomes. In fields such as diabetes, where closed-loop systems are redefining how patients manage their condition, that will mean gaining access to software-enabled products.
Euro Convergence 2020


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Tags: EMA, strategizing

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