Blog: Clinical Trials and Brexit

In this blog, Brian Cleary looks at clinical trials and Brexit.  He also looks at the issues surrounding the UK’s departure from the European Union.

The UK, as everybody at this stage knows, has decided to leave the EU and with that they have begun to make pronouncements on how they, the UK government, see their relationship with the EU post Brexit.  The UK government, as it currently stands, does not wish to remain a member of the single market or the customs union.  Departing both mechanisms was a long held wish of many of the most ardent Brexiteers.  However, the events surrounding the Brexit negotiations in December 2017 will have muddied the waters somewhat. In an attempt to address the thorny issue of a border between Northern Ireland (soon to be outside the EU) and the Republic of Ireland (continuing to remain a member of the EU), the UK government had to commit to a level of regulatory alignment between both territories.  The political situation surrounding Northern Ireland has always been a difficult issue for the UK’s London based government to handle and the agreement that Northern Ireland and the Republic of Ireland would be aligned while the rest of the UK would not, invoked the ire of the Democratic Unionist Party in Northern Ireland.  Usually, this would not be an issue of concern.  However, the same grouping is keeping British Prime Minister Theresa May in power and, as such, they hold considerable power in UK politics.  An amended agreement was tabled to the EU in early December 2017 that allowed for the entire UK to commit to regulatory alignment with the EU. While it defused the political situation in Northern Ireland, it also leaves the door open for the UK’s clinical trials sector to continue to play a major role in European clinical trials.

A commitment to regulatory alignment, albeit while being outside of the EEA, the single market and the customs union, might reduce the negative impact that Brexit might have on the sector.  Many of the interests that advocated for an exit from the Union have been keen to promote a divergence from EU standards.  However, the likelihood of a regulatory divergence of any consequence in the clinical trials sector is unlikely as UK companies will seek to maximise their ability to access the single market. Additional impediments caused by regulatory divergence to a trading relationship would not be welcomed by companies in the UK.

Clinical Trials Regulation 536/2014 came into force on the 16th of June 2014.  The new regulation allows for a single application to conduct Clinical Trials in the European Union.  Once enacted, this application will allow for a single application to be made through an online centralised portal.  The above referenced regulation was due to come into place in October 2018.  However, there are a number of obstacles in its path.  Firstly, the database to facilitate the online portal is not yet ready and there does not seem to be a date set for its launch.  There is a possibly greater obstacle preventing the October 2018 enactment of the regulations and that is the need for the European Medicines Agency to relocate to Amsterdam as a result of the UK’s decision to leave the EU. (The scheduled date for commencement of operations in Amsterdam is April 1st 2019 and that is seen as being a challenging deadline that may not be met). While the Clinical Trials Regulation 536/2014 might be delayed there is a slight possibility that its terms will be adopted into UK law upon the UK leaving the EU.  That will happen only if the regulations come into force within the EU before the UK leaves and enacts the Great Repeal Bill.  While this is unlikely, there is a slight possibility that it might happen.  If the Clinical Trials Regulations 536/2014 is enacted after the UK leaves the EU then the UK will not be in line with EU regulations.  Therefore, the UK’s future alignment will be subject to negotiations with the EU and this might be a long drawn out process that will have an adverse impact on businesses.

The issue of not being aligned was raised in a written parliamentary question by Liberal Democrat MP Norman Lamb in late 2017.  Writing in response, Robin Walker, Minister at the Department for Exiting the European Union, stated thatWe are aware that the implementation of the EU Clinical Trials Regulation has been postponed and the application of the Regulation is dependent on the decision of the EU’s medicines regulator, the European Medicines Agency (EMA). The EMA’s Management Board is expected to discuss this in its October 2017 meeting. As you have indicated in your letter, the new Regulation may take effect after we leave the EU and therefore will not be covered by the Repeal Bill and so our future alignment with the new EU Clinical Trials Regulation will be subject to negotiations.  However, as the Secretaries of State for Health and for Business, Energy and lndustrial Strategy jointly set out in an open letter in the Financial Times on 5 July, the UK is fully committed to continuing the close working relationship we enjoy with our European partners across the field of medicines regulation that will include any future EU regime on clinical trials“.

Critics of the new clinical trial regulations in the UK see the opportunity to bypass or avoid implementing the new regulations as an opportunity to ‘turbo-charge’ good research.  Others, in the same camp, look at it from a different perspective and believe that the new regulations facilitate risk taking.

There is no doubt that a United Kingdom operating at a remove from the EU’s Clinical Trial Regulations 536/2014 or creating its own framework will lead to an isolating effect within the overall global clinical research community.  Many people see this possibility as one that will impede the UK’s ability to play an effective role in issues such as combating antimicrobial resistance and other global health issues.  Nevertheless, the issue of clinical trials and the implications of Brexit upon the sector from both a UK and European perspective need to be highlighted as, perhaps, some of the most important aspects of the entire negotiations.

While the body politic will, for some time to come, keep a keen eye on the machinations of Brexit, we will keep you updated on the implications for the life science sector.  If you would like to keep up to date, then we suggest that you subscribe to our monthly newsletter.  You can do so by completing the form below.

Further Reading: Clinical & PV Articles

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

Pharmacovigilance of Medicines for Rare Diseases

Dr. Danica Cvetkovic looks at the issue of pharmacovigilance for orphan or rare diseases.  Many issues associated with the sector are challenged by the small patient population. This article looks at the commonly used strategies for evaluation of post-approval safety and the effectiveness of rare and orphan drugs.

Read the article here.

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.

Read the article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.

Download the e-book here.