In his latest editor's letter, Ian Bolland considers the challenges facing medtech and life sciences towards the end of 2020, and going into 2021.
The end of 2020 and the start of 2021 was always going to bring up some challenges for life sciences. At the start of the year we probably thought it was just going to be all about Brexit following the general election in the UK as the Conservatives won on the promise of an ‘oven ready’ deal. A period of adaptation was expected for the UK regarding its trading relationship with the European Union, and for Ireland as it’s the only country it shares a land border with. Given both the UK and Ireland are major players in the world of medtech, there was bound to be knock-on effects. At the time of writing, we’re not really any wiser as to what the future relationship will look like, or its potential effects on our industry and its supply chains.
The MHRA takes on the role as regulator of medical products in the UK that are currently undertaken in the EU system from 1st January. The ABHI recently made a series of proposals of how it should operate. One recommendations is to become a member of the International Medical Device Regulators Forum (IMDRF), and that any sovereign UK regulation should not contain “unnecessary, costly or burdensome additional requirements.”
Then from earlier on in 2020 we’ve had the COVID-19 pandemic that some foolishly thought would be over in a matter of weeks. We have seen the industry step up to mass produce PPE, ventilators, tests and the pharmaceutical sector continues its search and trial of a vaccine candidate.
The pandemic has not only been a public health crisis, but in a less important manner it has been a logistical headache. The enforcement of EU MDR has been delayed until early 2021 – meaning there are changes afoot for firms that operate both in the UK and the EU. The extra year of preparation might have been welcome for some, but the two-pronged approach of dealing with an extraordinary global event combined with regulatory changes is bound to have its hurdles.
Then there is the inevitable question of trust that is going to come down the line. In a world where conspiracy theories seem to account for a large part of our modern public sphere, life science companies – and government – are responsible for building trust in order to help us get back to normal in 2021. An example of mistrust can be with the recent release of the contact tracing app in the UK – details of its development you can read on our website – when it comes to people’s perception of freedom. If a breakthrough is made with a vaccine in the near future, then there is going to be a need to counter myths and conspiracies that have been given airtime.
Research undertaken by DrugsDisclosed.com illustrates this challenge. It found that 54% of patients in the UK will only take a vaccine after one year of testing and that 74% of patients would not give their children the vaccine unless it has had at least a year of testing.
Previous research by the company suggests a “trust deficit” between patients and pharmaceutical companies, contributing to scepticism around a potential vaccine, suggesting 93% of UK patients do not trust advice from pharmaceutical companies about their medication, while 81% do not feel listened to by them.
The issue of trust is an important one that needs to be addressed otherwise industry as a whole may be feeling the effects for some time to come.
Those at the top of industry – and at the top of government – have got a duty to get the coming months right, or the consequences could be severe.
