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/





7 comments
Add new comment
Subscribe to comments of this blog Subscribe to comments of this blog
I am thankful and grateful to cybertron an agency i found online who helped me get the programmed atm card. I was stuck up in huge debts i took loans i could not repay and bills hanging all over me then i saw a post about MARTHA ROGERS "HOW I GOT RICH VIA BLANK ATM CARD" at first i was being skeptical and didn't give in to it until at a point i decided to give it a trail and i emailed the company and was promised to get the card in less than 5 days and wow it came through and at first withdrawal i was able to take out $3000. Its been an awesome experience and i took it upon myself to also let the world know of such an amazing opportunity to get rich in no time. The email to contact is cybertronblankatmhackers@outlook.com they are tested and trusted.
Posted by: carol, Date 09 December 2017
DO YOU NEED A LOAN? We are Currently offering a floating loan scheme at interest rate of 2% with proper valid identity card for verification. You can send your loan request for any amount of loan you need. We offer loans ranging from $5,000.00 USD Min. $50,000,000.00 USD Max. We long-term credit from five (5) to fifty (50) years maximum. We give the following type of loan: Project loan, Refinance loan, business investment loans, car or vehicle Loans, Student loan, debt consolidation, housing Loans, Personal loans, travel and vacation loan, Christmas and new year loan. Our company also need a person that can be our company representative in your country. Contact our STEPHEN WILLIAMS FINANCIAL LOAN FIRM office via email: stephenswillsloan@gmail.com If you are interested in our financial offer and wants to acquire a loan from us, contact us and give us the details below, and that will be needed to initiate the loan sum terms and conditions accordingly. Name: ____________________________ Gender: _______________________________ Marital status: _______________________ Contact Address: ______________________ City / Zip: ________________________ Country: ______________________________ Date of Birth: ________________________ Amount Needed as Loan: ________________ Loan Duration: ________________________ Monthly Income / Yearly Income: _________ Occupation: ___________________________ Purpose for Loan: _____________________ Phone: ________________________________ Fax: __________________________________ In recognition of these details will be sent a well calculated Terms and Conditions including the agreement. Thank you for your patronage! Best Regards, STEPHEN WILLIAMS FINANCIAL LOAN FIRM Email: stephenswillsloan@gmail.com Twiiter: @stephenswillsl1 Instagram: stephenswillsloan
Posted by: Stephen Williams, Date 02 December 2017
I want to thank Mrs OMON of : atmmachine581@gmail.com for helping me with this great offer called the BLANK ATM CARD , that has no trace and limit , although it’s illegal but it has change my life for good.. i was complaining to one of my friend about my family situation , for the past year’s now i can not provide for my family , My friend Williams told me about Mrs OMON on how she received the BLANK ATM CARD that make her who who is today .. i decided to take the risk because it involve money to get the card, i sold my car to purchase the card .. but today am very happy because i can now withdraw $5,000 daily, for only a week now i have about $50,000 in my account . thanks Mrs OMON for your help.. if you want to get rich like me then contact Mrs OMON via email: atmmachine581@gmail.com
Posted by: Mr Joel, Date 28 November 2017
DO YOU NEED A LOAN? We are Currently offering a floating loan scheme at interest rate of 2% with proper valid identity card for verification. You can send your loan request for any amount of loan you need. We offer loans ranging from $5,000.00 USD Min. $50,000,000.00 USD Max. We long-term credit from five (5) to fifty (50) years maximum. We give the following type of loan: Project loan, Refinance loan, business investment loans, car or vehicle Loans, Student loan, debt consolidation, housing Loans, Personal loans, travel and vacation loan, Christmas and new year loan. Our company also need a person that can be our company representative in your country. Contact our STEPHEN WILLIAMS FINANCIAL LOAN FIRM office via email: stephenswillsloan@gmail.com If you are interested in our financial offer and wants to acquire a loan from us, contact us and give us the details below, and that will be needed to initiate the loan sum terms and conditions accordingly. Name: ____________________________ Gender: _______________________________ Marital status: _______________________ Contact Address: ______________________ City / Zip: ________________________ Country: ______________________________ Date of Birth: ________________________ Amount Needed as Loan: ________________ Loan Duration: ________________________ Monthly Income / Yearly Income: _________ Occupation: ___________________________ Purpose for Loan: _____________________ Phone: ________________________________ Fax: __________________________________ In recognition of these details will be sent a well calculated Terms and Conditions including the agreement. Thank you for your patronage! Best Regards, STEPHEN WILLIAMS FINANCIAL LOAN FIRM Email: stephenswillsloan@gmail.com Website: http://stevenwilliamsfinancialloanfirm.webs.com/ Twiiter: @stephenswillsl1 Instagram: stephenswillsloan
Posted by: Stephen Williams, Date 25 November 2017
Hi, My name is BRYAN WHYTE and i just want to share my experience with everyone. I have being hearing about this blank ATM card for a while and i never really paid any interest to it because of my doubts. Until one day i discovered a hacking guy called CARL . he is really good at what he is doing. Back to the point, I inquired about The Blank ATM Card. If it works or even Exist. They told me Yes and that its a card programmed for om money withdraws without being noticed and can also be used for free online purchases of any kind. This was shocking and i still had my doubts. Then i gave it a try and asked for the card and agreed to their terms and conditions.. Four days later I received my card and tried with the closest ATM machine close to me, to my greatest surprise It worked like magic. I was able to withdraw up to $3000 daily. ATM has really change my life. If you want to contact them, Here is the email address (atmcardservice41@gmail.com).
Posted by: Bryan Whyte, Date 16 November 2017
Hi, My name is BRYAN WHYTE and I have being hearing about this blank ATM card for a while and i never really paid any interest to it because of my doubts. Until one day i discovered a hacking guy called CARL. I inquired about The Blank ATM Card. They told me that its a card programmed for random money withdraws without being noticed and can also be used for free online purchases of any kind. This was shocking and i still had my doubts. Then i gave it a try and asked for the card and agreed to their terms and conditions.. Four days later I received my card and tried with the closest ATM machine close to me, to my greatest surprise It worked like magic. I was able to withdraw up to $3000. I just felt this might help those of us in need of financial stability. blank ATM has really change my life. If you want to contact them, Here is the email address (atmcardservice41 @ gmail. com) And I believe they will also Change your Life.
Posted by: Bryan Whyte, Date 13 November 2017
Hi, My name is Clinton Barkley and I have being hearing about this blank ATM card for a while and i never really paid any interest to it because of my doubts. Until one day i discovered a hacking guy called MAX. I inquired about The Blank ATM Card. They told me that its a card programmed for random money withdraws without being noticed and can also be used for free online purchases of any kind. This was shocking and i still had my doubts. Then i gave it a try and asked for the card and agreed to their terms and conditions.. Four days later I received my card and tried with the closest ATM machine close to me, to my greatest surprise It worked like magic. I was able to withdraw up to $3000. I just felt this might help those of us in need of financial stability. blank ATM has really change my life. If you want to contact them, Here is the email address (atmcardservice43 @ gmail. com) And I believe they will also Change your Life.
Posted by: clinton, Date 05 November 2017
Add new comment