Prof Alan Fraser knows the value of evidence-based innovation in cardiology – and the need for sound regulation. In a long career going back to the 1970s, he has seen how advances in medical technology have delivered better outcomes for patients. He is also painfully familiar with the risks brought by weak regulation.
A renowned expert on regulatory science and a distinguished cardiologist, Prof Fraser took on a leading role in shaping European medical devices regulations after first-hand experience with a heart valve device. Although it had been approved for use, the valve was associated with devastating adverse outcomes for patients.
Rather than being evaluated on its own merits, the valve had been approved on the basis of equivalence – meaning data from other, similar valves were used to determine its safety. ‘Patients died and the product was withdrawn, but it was always on my mind,’ he recalls. ‘I needed to understand how the regulatory system had allowed this product on the market.’
Like most cardiologists – and patients – Prof Fraser had assumed that approved cardiac implants were strictly regulated to ensure they were safe and effective. ‘That was my primary motivation for getting involved in regulatory science,’ he recalls. ‘The system must make decisions based on evidence, and this requires input from medical experts.’
A European outlook
In hindsight, Prof Fraser’s involvement at European level looks inevitable. He qualified from Edinburgh University in the 1970s, shortly after the United Kingdom joined the European Economic Community (a forerunner to the modern EU). He spent an elective period studying European health systems in Leuven, Brussels and Amsterdam, before organising a symposium on the topic in Edinburgh. He went on to play an active role in the European Society for Cardiology and in the Biomedical Alliance in Europe.
‘In 2008, the European Commission launched a public consultation on the Medical Devices Directives and, as co-chair at that time of the ESC committee on EU Affairs, I felt it important that we reply,’ he says. ‘As a result, I was invited by the Commission to contribute to an ‘exploratory process’ on behalf of the ESC.’
From there, his own role expanded to include a range of contributions to the regulatory system, with ESC setting up a task force on medical devices which would evolve to become the Regulatory Affairs Committee. He also took on key positions in the Biomedical Alliance in Europe, attending meetings in Brussels on everything from medical technology and pharmaceuticals to data protection, AI and cybersecurity. More recently he led the CORE-MD project that was managed by the ESC (Coordination of research and evidence for medical devices).
Prof Fraser is Emeritus Professor of Cardiology at Cardiff University and has stepped back from leadership roles in the ESC and Biomedical Alliance. His task now is to persuade more colleagues to undertake this kind of regulatory and policy work at European level. ‘The EU health agenda has exploded over these years,’ he says. ‘We need more doctors at the table.’
The voice of independent experts must be heard
One thing that surprised Prof Fraser when he began working in this area was how few doctors were advising EU officials and regulators. While there are thousands of experts working with Notified Bodies to assess medical devices, including many doctors, these specialists are dispersed across the system, and have less influence on shaping regulations and policy.
‘I believe there’s a strong need for unbiased external advice from clinical and scientific experts so that decisions are informed by a real understanding of health and scientific discipline,’ he says. ‘That voice is missing unless clinical experts get involved.’
Prof Fraser believes the ESC and Biomedical Alliance can play an important role in addressing this ‘evidence gap’. However, this work requires the support of more cardiologists, and a willingness to study regulatory science so that medical experts can navigate the system.
Frustration, followed by satisfaction
One challenge for clinicians entering the world of policymaking is that decisions can take a long time to come to fruition – and it can be difficult to see precisely how any given meeting or publication helped to shape the policy landscape. But, patiently promoting sensible policy in as many forums as possible will eventually deliver results. ‘It can be frustrating, but also quietly satisfying when we achieve our goals,’ Prof Fraser says.
For example, in 2011, the ESC advised that there should be a dedicated governance body to regulate medical devices, as well as special pathways for open devices and breakthrough technologies. While these were not adopted at that time, both are back on the agenda today as the EU reviews its medical technology legislation.
‘Every physician wants to make a difference not just for their individual patients, but to improve the systems and policies that affect the whole population,’ he says. ‘This is one way to achieve that. It’s very rewarding to offer science-based proposals to receptive politicians and regulators who need our support and value expert advice.’