The U.K. Government triggered the formal procedure to exit the European Union on March 29, 2017. The U.K. and the EU institutions are now determining the arrangements for the orderly withdrawal of the U.K. Unless an extension is agreed, this process must be completed by March 29, 2019, and so while negotiations on the terms of the U.K.’s departure have not yet officially begun, EU institutions and government departments in the U.K. have started their planning activities.
Unsurprisingly, the nature of the U.K.’s departure and its relationship with the EU once it ceases to be a Member State has attracted a great deal of speculation. There is considerable uncertainty surrounding how Brexit will actually work, not least because no Member State has left the EU in its current form.
Once the U.K. leaves the EU, it will have no legal obligation to abide by the EU Treaty principle of “sincere cooperation” with EU institutions, and will not be required to comply with EU laws relevant to clinical research. This will clearly affect the regulation of multi-center clinical trials that involve the U.K. If the parties wish to maintain the current cooperative framework, it will have to be rebuilt through agreement.
What are the options?
There has been a great deal of speculation about whether the future relationship between the U.K. and the EU will adopt one of the existing trading models operated by countries such as Norway and Canada. However, none of these models take full account of the unique situation of the U.K., which has been a key Member State for nearly 45 years, and where EU laws have been fully integrated into the fabric of the U.K. legal system.
At present, it is widely reported that the U.K. government intends to pursue a “clean break” from the EU. However, the Great Repeal Bill (the key legislation that will be used to implement Brexit in the U.K.) contemplates converting all directly applicable EU laws into U.K. law, and these laws will continue to apply until U.K. legislators decide otherwise. The Bill will also preserve those laws the U.K. has made in order to implement its EU obligations. It follows that the Great Repeal Bill will, at least in the short term, preserve the legislative framework for clinical trials in the U.K. That said, the Great Repeal Bill will also grant the Government significant powers to make adjustments and corrections in relation to those directly applicable EU laws that do not operate appropriately after withdrawal. It is uncertain as to how and whether U.K. Ministers will exercise such power and in what circumstances.
What impact will Brexit have on clinical research in the UK?
The EU laws that govern pharmaceuticals and medical technologies are all based on the EU’s internal market principles. In the context of clinical trials for pharmaceuticals, the initial directive, Directive 2001/20/EC, was adopted in 2001 to facilitate clinical trials conducted in the region. The process has evolved since the Directive’s introduction, and close cooperation amongst national regulatory authorities has facilitated and streamlined the approval of multi-center trials across the EU. This cooperative process was reflected and formalized by the recently adopted Regulation 536/2014/EU, which is expected to come into operation in 2018.
Until it formally exits the EU, the U.K. will continue to be subject to this legislation, and also to enjoy the broader benefits afforded to all EU Member States, including (a) taking an active role in developing regulatory policy, (b) participating in the EU process for approving clinical trials that will be conducted in more than one Member State, and (c) accessing the EU portal for clinical trials, once it has been finalized. Whether the U.K. will be able to enjoy the same level of benefits as a “third country” outside the EU will depend on the agreement reached between the U.K. Government and the EU institutions during the forthcoming negotiations.
We set out below certain key considerations that will need to be addressed in order to maintain a fertile environment for collaborative clinical research in the U.K. post-Brexit:
1) Investment in clinical research
Over the last few decades, the U.K. has continued to punch above its weight in terms of innovative scientific research. Clinical or translational research is increasingly collaborative between industry, academia and governmental organizations. The U.K. has been the second largest recipient of EU funding for clinical research after Germany, and unsurprisingly the institutions which benefit from this funding have raised concerns about whether they will continue to access it after Brexit. While the U.K. Government has indicated an ongoing commitment to scientific research, it is uncertain whether such a commitment will be realized, particularly in view of increasing pressures on public expenditure.
Researchers are the engine that drives the progress of research, and a country’s research base is critically dependent on the individual contributions of the researchers affiliated with its institutions. A trial site is selected by its expertise, know-how and personnel. Concerns have been raised by various royal societies and academies of sciences that once EU rules around free movement of workers cease to apply, the U.K. may no longer be able to attract and retain the talent required to undertake multidisciplinary and complex clinical and translational research.
3) Management of clinical trials
A country’s attractiveness for clinical research is linked to commercial considerations around launch strategy and reimbursement, and the U.K. may become less attractive as a country in which to launch new products if it is not part of the EU regulatory network. Further, any divergence of U.K. and EU rules after Brexit will increase the complexities, administrative burden and cost for companies in conducting clinical research in the U.K. It remains unclear whether, post-Brexit, EU institutions will grant the U.K. regulator access to the EU databases that are being set up under the Regulation, which will be critical to proper management of multi-center trials, or if additional fees will be imposed in order to do so. Nor is it clear whether the U.K. will be able to participate in the ‘streamlined’ clinical trial approval process introduced by the new Regulation.
4) Supplies of investigational medicinal products
Once EU rules around free movement of products cease to apply, there will be a hard border between the U.K. and the EU. This is likely to have a significant impact on the export of investigational medicinal products manufactured in the U.K. for use in trial sites located in the EU, and vice versa. Whatever is finally agreed, there are likely to be cost implications associated with duplication of the administrative and regulatory procedures required in order to enable clinical studies to be conducted on a cross-border basis.
All these factors (if not fully recognized and addressed) will render the U.K. less attractive for clinical research. The uncertainty has worried some in the sector, who are concerned about the U.K.’s competitiveness in an increasingly globalised and regionally competitive research environment.
Arnold & Porter Kaye Scholer LLP
PHOTO CREDIT: stubblepatrol.com