A little under a year ago, the New York Times reported on do-it-yourself insulin pumps. Tech savvy people, mostly parents to diabetics, were pairing glucose sensors with insulin pumps. These would allow caregivers to constantly monitor glucose levels. Some even made what are, in effect, artificial pancreas, with the glucose sensor triggering the insulin pump, automating insulin delivery.
In September, the FDA approved MiniMed 670G, a mostly automated insulin pump, for sale to the general public. The device was made available spring 2017. The device is only available in the US, and Medtronic, the device manufacturer, has stated there is no timeline to bring it to other markets—diabetics can only access the years old previous version.
Automated insulin pumps illustrate two important aspects of drug and medical device regulation. First, existing regulatory systems have been slow to adapt to changes in the development of new medical devices, and medical innovation more broadly. Second, safe and effective medical devices are often unavailable in the UK, while British newspapers abound with stories of life-saving drugs unavailable in Britain.
Brexit gives the UK the opportunity to tackle both challenges and to become a leader in medical innovation. The European Medicines Agency (EMA), as well as the Medicines & Healthcare products Regulatory Agency (MHRA), the UK’s own regulatory body, were both designed for a different era.
They were created for big medicine, when large, multi-national corporations were the primary drivers of innovation. The world is in the early stages of changes in the nature of medical innovation. The era of big medicine will soon be behind us. To take full advantage of the coming changes in the structure of innovation, regulatory policy must adapt.
The UK has two advantages which could allow it to lead the charge in medical innovation.
First, the UK has a well-educated population, even relative to other developed countries, scoring near the top of the pack in maths and science, according to the multi-national TIMSS exams. It also has disproportionately strong higher education, with more universities in the world top 10, top 50, and top 500 than any country except for the US, according to most rankings. It has the human capital 2 necessary to be at the cutting edge of innovation.
Second, Brexit caused a large regulatory shock. Most regulatory changes take substantial time because of slow moving bureaucracies. Because of Brexit, the UK must make rapid changes. The question is, what type of changes should they make?
Read the whole paper.