Will Clinical Trials Be Impacted By Brexit?

How will clinical trials be impacted by the UK’s decision to leave the European Union? The United Kingdom’s decision to leave the European Union (EU) will present significant implications to the pharmaceutical industry. Clinical trial sponsors and associated partners should be prepared for a variety of scenarios arising from Brexit which could impact on the manufacturing, licensing and distribution of health products between Ireland and the UK.   Clinical trial sponsors will have to navigate different sets of guidelines, which could potentially increase study times and inflate costs. Firstly, the manner in which clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation comes into application. The Regulation (EU No 536/2014) harmonises the assessment and supervision processes for clinical trials throughout the EU, via a centralised portal, and will come into force in 2020. Since this will happen after the UK leaves the EU, the UK will not be in line with EU regulations and UK’s future alignment will be subject to negotiations with the EU. In the case of No-Deal Brexit scenario regarding medicinal products between the EU and the UK, the following issues concerning clinical trials with medicinal products must be observed:

Establishment requirements for a sponsor or legal representative

The sponsor of a clinical trial or his legal representative must be located in a Member State of the EU or in another State party to the Agreement on the European Economic Area (EEA). In the case of clinical trials where the sponsor or the legal representative are still established in the UK, their registered office must be transferred to the EU/EEA or a legal representative in the EU/EEA must be designated by the time Brexit becomes effective.

Manufacture and batch release of investigational medicinal products

The batch release of investigational medicinal products must take place in the EU/EEA. After Brexit, manufacturers responsible for final batch release who are established in the UK will no longer be able to certify clinical trial batches for the EU.

Shipping of investigational medicinal products/medicinal products from the UK will now constitute an import

After Brexit, the shipping of investigational medicinal products and other medicinal products from the UK to the EU/EEA will constitute an import. This also applies if only parts of the manufacture take place in the UK, e.g. study-specific packaging or labelling of investigational medicinal products. Implications of Brexit and the issue of clinical trials need to be highlighted as some of the most important aspects of the negotiations. In addition, the Irish clinical trials infrastructure is showing growth at a steady pace with increasing number of trial sites now open across the Irish network. With the UK planning on leaving the EU, Ireland is perfectly positioned to take on the country sponsor role for more clinical trials. Acorn Regulatory is assisting clients in preparing for Brexit, assessing the impact of different Brexit scenarios, and how to mitigate risks identified.

What We Are Doing To Prepare Our Clients

We have established an internal task force to generate action plans based on various scenarios and ensure our teams are prepared for whatever agreements are finally signed and actions are taken in areas including clinical study continuity, regulatory, insurance, and site and client contracts. Our Clinical Team will be responsible for leading client teams through project risk assessment and the action planning needed to assure smooth project delivery during this period of transition. Contact us today to discuss your requirements on 00353 52 61 76  706 or complete the webform below and we will get back to you. [ninja_form id=1]

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.