ABHI Membership

ABHI at 30 Guest Blogs. A Reflection on the Early Days of ABHI

Thirty years is a long time in business but the origins of ABHI go back further. In the early eighties a group of trade associations, in what is now called HealthTech, combined to provide a single voice to talk to Government. A loose federation was formed and named BHTIC (the British Healthcare Trades and Industries Council). And the main issues to be addressed were – guess what – NHS procurement and product regulation. In 1988 BHTIC merged with the BHEC (British Healthcare Export Council) to form ABHI, adding international trade to the portfolio.

However, it was regulation that initially became the lead issue because of the emerging plans for an EU single market. And it was regulation that provided the background for what was undoubtedly the key achievement of this early part of ABHI’s history. Regulatory systems around Europe varied significantly (where they existed) and it was a group of forward-looking Brits, working under the umbrella of ABHI and Eucomed, who led the way. They took the initiative in proposing to the EU Commission a pan-European system of medical device regulation to harmonise the disparate regimes and thus underpin plans for a single market. Individuals such as Malcolm Carlisle and Peter Styles, working with colleagues from the forerunner departments of the MHRA, led the way in creating a framework for device regulation which is still with us today and which has been a huge benefit for patients and clinicians as well as for the smooth running of the single market.

In today’s febrile political climate, it is important to remember that this initiative was a shining example of what could be achieved by deep and positive engagement in the EU by a proactive group from the UK.

In the next thirty years ABHI continued to follow this positive approach of full involvement in EU processes, particularly in our case in regulation and the supporting product standards. Of course, many more and quite different achievements have followed in subsequent years, but these are not the subject of this reflection. From humble and under-resourced beginnings, ABHI is now a highly professional and widely-respected organisation, staffed by well-qualified experts steeped in experience from across the HealthTech sector.

Contacts at every level of Government are greatly enhanced and the depth of involvement in the major issues of the day is comprehensively covered and necessarily more nuanced. But some things don’t change. We are still inexorably involved in issues flowing from how the NHS procures our members’ products and how those products are regulated. In many ways regulation defines the boundaries of our industry including, for example, the expansion of those boundaries into specifically data-driven products.

The challenges in regulation and trade posed by the UK leaving the EU will hopefully be mitigated by the fact that the EU system (to which we broadly expect the UK will adhere) is recognised internationally by many jurisdictions. Our regulators are already acknowledged as global leaders and are expected to play a major part in future global harmonisation of the rules governing medical devices.

Mike Kreuzer OBE, Advisor, Regulatory Policy, ABHI