The United Kingdom’s Medicines and Healthcare Products Regulatory Agency says that it is taking steps to ensure that clinical trials taking place in the country will not be adversely affected by Brexit.
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) says that it is taking steps to ensure that clinical trials taking place in the country will not be adversely affected by Brexit.
The MHRA said this month that, as part of the UK- and EU-agreed “implementation period” for Brexit, which will span from March 2019 to the end of 2020, the United Kingdom will continue to operate under EU rules for clinical trials.
However, it is unclear whether the United Kingdom will become subject to the European Union's new Clinical Trials Regulation (CTR) given the fact that the timeline for the CTR’s launch has been delayed by the European Medicines Agency (EMA)'s need to scale back its activities as it prepares for Brexit, and the CTR may not come into force during the implementation period.
The CTR, which is now expected in 2020 rather than 2019, will replace the European Union's current Clinical Trials Directive and national laws concerning clinical trials in EU member states, and represents a major shift in in the way that trials will be aligned across Europe. Under the regulation, the same rules will apply to trials in every member state and information on the authorization, conduct, and results of every trial will be made publicly available.
The CTR provides for harmonized electronic submissions and assessment processes for trials that are conducted at centers in multiple member states, and it involves an online portal and database that will form the single point for submitting and accessing trial information throughout the European Union.
According to the MHRA, “If the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the [European Union’s] CTR legislation that are within the [United Kingdom’s] control, in order that researchers conducting clinical trials can plan with greater certainty.” However, the United Kingdom would have no access to the online portal, nor would it be able to take part in the trial assessment process. In order for sponsors to involve UK sites in multicenter studies that also involve EU sites, they would have to separately apply to the MHRA.
The MHRA says that it remains committed to offering “a competitive clinical trials environment,” and that it is investigating ways to work together with sponsors in a streamlined fashion that would allow for a smoother application route for UK trials.
However, it remains unclear whether sponsors will seek to conduct their trials in the United Kingdom given the extra layers of regulatory clearance that will be needed, as well as the uncertainty of future UK regulation.
That fact is raising concerns among a variety of stakeholders; the Brexit Health Alliance (a group with members including the Academy of Medical Royal Colleges, National Health Service providers, the Medical Schools Council, the Faculty of Public Health, and other bodies) has warned in a report that a lack of UK—EU harmonization could lead to serious problems for research, especially for rarer diseases. According to the report, because recruiting enough patients for clinical trials is already a challenge in rare indications, a scenario in which UK trials cannot recruit EU patients could hamper scientific advancement and keep patients from benefitting from these trials.
Furthermore, because research often requires the transfer of participants’ personal data, a lack of clarity regarding United Kingdom's future involvement with the European Union’s General Data Protection Regulation could lead to “significant problems in transferring personal data, in particular from the EU to the UK” for multicenter studies.