Regulatory Roadblocks to Innovation in Surgery: A Case in Point in the UK

Historically, the UK has pioneered surgery very widely, with even smaller research and medical centres like Dundee able to make significant advances in surgery, including the development of keyhole surgery. 

Alfred Cuschieri, a Maltese-British surgeon, who joined the University of Dundee School of Medicine in 1976, is a good case in point. While working at a hospital in the Scottish city, he and his team began researching how minimal access surgery could work, using new smaller cameras which would allow surgery to take place without large incisions in the skin. The first minimally invasive surgery in the UK was carried out at this hospital in 1987. After this breakthrough, Cuschieri’s career took off and the accolades rolled in. He became Professor of Surgery and Chairman of the Surgery and Molecular Oncology Department. He was editor of Journal of the Royal College of Surgeons of Edinburgh from 1987 – 1997. Then he was knighted in 1998 and became Fellow of the Royal Society of Edinburgh in the same year. 

Minimally invasive surgery has given a massive lift to surgery in general and makes so many surgical procedures less daunting for patients “going under the knife”. The laparoscope itself is an amazing piece of medical technology. It is a small tube that has a light source and a camera (see https://www.nhs.uk/conditions/laparoscopy). The camera sends images of the inside of the abdomen, or pelvis, to a television monitor.

Steadily, though, this favourable position for medical research and innovation, which has prevailed for decades in the UK and which enabled innovations like Cuschieri’s keyhole surgery to succeed, has been eroded. In more recent years, many more regulatory hurdles have been erected, which often end up frustrating the creative process of developing new medical and surgical concepts. For example, any new proposed procedure has to be agreed upon by research & ethics committees, situated locally, regionally and nationally. In practice, funding for any new project is largely controlled by researchers working in major centres who are well positioned to be able to adopt novel ideas that get submitted for funding. These ideas can be subtly modified and then re-presented often without reference to the intellectual property of the originator.  

The net effect is to stifle the innovation that used to come from many more sources. This is done in the name of “safety & control”, but it all seems rather misguided and counter-productive compared to the more open environment for innovation years ago. Most successful surgical innovations we’ve witnessed in recent times, such as joint replacement surgery, major transplant surgery, minimally invasive surgery, and so on, would have been very difficult to pioneer and achieve in today’s regulatory framework. 

The bottom line is that it is over-regulation which most often stifles innovation, including in the UK’s medical sector. The challenge is how to maintain a high level of patient safety whilst preserving the true spirit of innovation.  

There are further obstacles such as the purchase of patents by companies to protect their lucrative, but sometimes outdated, products. The inventor is therefore faced with a game similar to playing snakes and ladders. None of this is in the best interests of patients. In war time and during pandemics, such as the coronavirus pandemic, the game suddenly changes, usually allowing a surge of brilliant developments. That’s because necessity is often the mother of invention and there is an overwhelming need to collaborate to overcome the health emergency. Once the crisis is over, however, the regulatory maze and other hurdles for innovation tend to reappear, once again frustrating inventive individuals.

Where, then, are the best places in today’s world to rediscover the creative spirit of discovery in medicine? 

It was this marriage of creativity and science which has always pushed the boundaries of medical knowledge throughout its rich history (please check out our Medical Milestones and Surgical Milestones on the Beyond Heads website)!