UK may be out of step with Europe on clinical trials regulations after Brexit, minister accepts

Implementation of new European Union clinical trials regulations has been postponed and may not happen until after Britain exits in March 2019, leaving the UK unable to convert them to British law under the Repeal Bill.

brexit ss sept 17


UK can only convert European legislation into UK law if it is operational before Britain exits, leaving the country out of step with the rest of Europe on clinical trials regulations which may not be implemented until after the country leaves the EU

The government has admitted that future UK law may not be in line with EU clinical trials regulation once Britain leaves the European Union (EU).

In a to a number of queries raised by Norman Lamb, chair of the House of Commons Science and Technology Committee, Robin Walker, minister at the Department for Exiting the European Union, conceded that the delay in implementing the EU regulation would mean that the UK’s future alignment with rules on clinical trials would be “subject to negotiations”.

“The general approach taken in the Repeal Bill (formally known as the European Union (Withdrawal Bill)) is that EU law which applies directly in the UK legal system immediately before exit will be converted into domestic law after exit,” he wrote.

“Under the Bill, direct EU legislation is only converted and incorporated into domestic law ‘so far as operative immediately before exit day’.”

Implementation of new EU clinical trials regulations has been postponed and it may not be fully implemented until after Britain leaves the EU in March 2019, depending on a decision from the European Medicines Agency (EMA).

However, in his response Mr Walker cited an open letter written jointly by the Secretaries of State for Health and for Business, Energy and Industrial Strategy to the Financial Times in July, which stated that the UK was “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”.

Meanwhile, delivering the Medicines and Healthcare products Regulatory Agency’s (MHRA) annual lecture on 10 October 2017, Jeremy Farrar, director of the Wellcome Trust, warned that recent world events such as Brexit had “created an uncertain future for global health”.

“As we enter complex negotiations to leave the European Union, it is vital that we protect regulatory cooperation and create an environment in which medical innovation succeeds not despite the regulatory environment, but because of it,” he said.

“This is a priority issue, an issue of health security, and all sides should push for it to be dealt with as soon as possible in the next phase of the negotiations.”

Citation: The Salvadore DOI: 10.1211/PJ.2017.20203739

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