Accessability Links

Can Brexit improve the UK Clinical Trial industry?

27 Oct 17 - 12:00AM Carl Marotta  | Recruiter2 Recruiter blog |  Skills Alliance blog

Over the past 16 months we have grown accustomed to hearing the word BREXIT followed by colourful adjectives such as ‘mistake’, ‘catastrophe’ and ‘risk’. How does this general negativity actually impact Clinical Trials? And is it really all doom and gloom? 
In a year where we have seen InVentiv Health and INC merge, Chiltern being taken over by Lab Corp and Parexel acquired by Pamplona Capital, isn’t Brexit just another hurdle to overcome in an ever changing industry? If we take a leap of optimism, how can we push forward the discussion of Brexit’s positive impact on clinical trials and patient access to drugs?
Looking at the regulatory framework of how clinical trials are approved in the UK and EU, the EU Clinical Trials Directive 2001/20/EC sets out the rules on the conduct of clinical trials on medicinal products for human use with each member state requiring to comply with this Directive. Since its inception, the EU Directive has been marred by inconsistencies, added layers of bureaucracy and is limited in its transparency. This caused applications for clinical trials in Europe to fall by 25% and in the UK by 5% between 2007 and 2011. The directive was also responsible for a 90 percent increase in delays.  
This is a strong argument for leaving the EU and creating a more streamlined approach, however this has already been addressed with the imminent launch of a new EU Regulation No 536/2014 on clinical trials and medicinal products which will come into effect by October 2018. The Clinical Trials Regulation is underpinned by a set of integrated principles of EU law, the question is which will be converted into EU law and which will be rejected after leaving the EU?
The new Regulations are one step toward less bureaucracy and quicker patient access. But, how can one country standing alone take these improvements even further? How can the competitive advantage of 1 decision maker rather than 26 competing needs be capitalised on by the UK industry and government?
A useful example we can look to is Switzerland. Generally speaking, Switzerland is seen as an attractive location for clinical trials. Whilst Europe was experiencing a decrease in clinical trial approval, the Swiss were approving more than ever. The 2011 Swiss Human Research Act created favourable conditions for research and amongst all quality and transparency of research; the approval processes were simplified and made it easier to conduct multicentre studies. 
It seems conceivable that the UK will have its own research act. It can most likely adopt parts of Regulation EU 2014 that remove undue burdens on the clinical trials industry whilst adhering to directives such as The Good Clinical Practice Directive. This will leave Britain with more flexibly to reject certain regulations that do not improve and enrich the research environment and get on with the important job of getting drugs approved and into the hands of patients. 
Free from the ‘bureaucracy of Brussels’, the UK may also be able to create new systems when investment from philanthropists can kick-start a new era of cutting edge studies and mitigate some of the negative impacts of powerful EU lobbying groups. These two examples alone present ways in which we can actually take advantage of BREXIT rather than being overwhelmed by the negativity.
Troy Neenan
Senior Consultant

+44 2072206237
troy.neenan@skillsalliance.com
www.linkedin.com/in/troy-neenan-6a6869b0/


In a year where we have seen InVentiv Health and INC merge, Chiltern being taken over by Lab Corp and Parexel acquired by Pamplona Capital, isn’t Brexit just another hurdle to overcome in an ever changing industry? If we take a leap of optimism, how can we push forward the discussion on how Brexit’s positive impact for clinical trials and patient access to drugs?

Looking at the regulatory framework of how clinical trials are approved in the UK and EU, the EU Clinical Trials Directive 2001/20/EC sets out the rules on the conduct of clinical trials on medicinal products for human use with each member state required to comply with this Directive. Since its inception, the EU Directive has been marred by inconsistencies, added layers of bureaucracy and is limited in its transparency. This caused applications for clinical trials in Europe to fall by 25% and in the UK by 5% between 2007 and 2011. The directive was also responsible for a 90 percent increase in delays. 

This is a strong argument for leaving the EU and creating a more streamlined approach, however this has already been addressed with the imminent launch of a new EU Regulation No 536/2014 on clinical trials and medicinal products which will come into effect by October 2018. The Clinical Trials Regulation is underpinned by a set of integrated principles of EU law, the question is which will be converted into EU law and which will be rejected after leaving the EU?

The new Regulations are one step toward less bureaucracy and quicker patient access. But, how can one country standing alone take these improvements even further? How can the competitive advantage of 1 decision maker rather than 26 competing needs be capitalised on by the UK industry and government?

A useful example we can look to is Switzerland. Generally speaking, Switzerland is seen as an attractive location for clinical trials. Whilst Europe was experiencing a decrease in clinical trial approval, the Swiss were approving more than ever. The 2011 Swiss Human Research Act created favourable conditions for research and amongst all quality and transparency of research; the approval processes were simplified and made it easier to conduct multicentre studies.

It seems conceivable that the UK will have its own research act. It can most likely adopt parts of Regulation EU 2014 that remove undue burdens on the clinical trials industry whilst adhering to directives such as The Good Clinical Practice Directive. This will leave Britain with more flexibility to reject certain regulations that do not improve and enrich the research environment and get on with the important job of getting drugs approved and into the hands of patients.

Free from the ‘bureaucracy of Brussels’, the UK may also be able to create new systems when investment from philanthropists can kick-start a new era of cutting edge studies and mitigate some of the negative impacts of powerful EU lobbying groups. These two examples alone present ways in which we can actually take advantage of BREXIT rather than being overwhelmed by the negativity.

 

 

 

Troy Neenan

Senior Consultant - Clinical

 

+44 2072206237

troy.neenan@skillsalliance.com

www.linkedin.com/in/troy-neenan-6a6869b0/



Sources:

http://blogs.bmj.com/bmj/2017/04/20/emma-cave-brexit-and-the-regulation-of-clinical-trials/

http://blogs.bmj.com/bmj/2017/03/30/carl-heneghan-should-the-clinical-trials-directive-be-scrapped/