ABHI Membership

ABHI at 30 Guest Blogs. The Role of the Regulator in Balancing Prosperity and Protection

Industry associations like the ABHI are vitally important interlocutors for regulators, especially if they can generate and act upon the collective views of their members, which constitute a broad cross-section of the industry.

ABHI was founded in order to be inclusive and reflect the breadth of the medical device industry. They have been effective in ensuring that the industry’s views on policy and regulation have been collected and collated in ways that help the MHRA to understand the implications of changes to legislation, policy and implementation.

Regulation is at its most effective when the industry have a strong engagement with and understanding of the regulatory context in which they are operating.

Initiatives such as the ABHI Code of Ethical Business Practice support the development of such an environment and I would like to see greater partnership working between MHRA and ABHI in the future to continue to build a healthy and vibrant sector, recognising the pivotal role a regulator can have in balancing prosperity and protection.

It is no coincidence that the ABHI was founded during the formative days of the development of a European regulatory system. Stakeholders from the UK were highly influential in pushing the case for a harmonised EU system and saw the benefits of regulatory harmonisation, both European and on a global scale, for all parties. Patients benefit from consistent standards applied across often complex global supply chains in terms of both safer products and the removal of duplication of regulatory demands which can drive up costs and prices.

At a practical level the MHRA needs to consult on a wide variety of issues and relies on the ABHI, and like organisations, to respond with well-considered and drafted consensus positions which can help the MHRA, and UK Government more broadly, generate proportionate and workable policy and legislation.

The dual challenge of a comprehensive upgrade of EU medical device legislation and the impact of Brexit require a surefooted approach so that patients in the UK are not put at risk and the benefits of the hard work put in over many years to improve the performance of the regulatory system are not lost or compromised. I am confident that, whatever the challenges, the ABHI will continue to be a key stakeholder for the MHRA to help to support the transition to whatever the future holds. The significant challenge is managing this in a way that focuses on the dual goals of improving patient outcomes and getting the best out of the UK life sciences ecosystem in support of patients, the NHS and our potential as world leaders in the development and commercialisation of innovative technologies.

John Wilkinson OBE, Director of Devices, The Medicines and Healthcare products Regulatory Agency