The Pharmaceutical Journal reports that the delay means that the new EU clinical trials regulations (Clinical Trial Regulation EU No.536/2014 – “the Regulation”) may not be implemented until after the UK is due to leave the EU in March 2019. If this occurs the UK will be unable to convert the Regulation into British law through the Repeal Bill.
The Repeal Bill allows for EU law that applies to the British legal system directly, to be converted into domestic law after Brexit. Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the EU portal and database through an independent audit. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. European Medicines Agency's (EMA’s) Management Board endorsed a delivery timeframe in December 2015. However, due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. The EMA will shortly announce the new delivery time frame.
The government admitted that British law on clinical trial regulation may be out of step with EU clinical trials regulation once Britain leaves the European Union.
In a letter from Robin Walker MP, minister at the Department for Exiting the European Union, in response to questions from Norman Lamb, chair of the House of Commons Science and Technology Committee, Mr Walker said:
“The new[EU] 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, he also stated that 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”.
“The development of new drugs, upon the completion of properly conducted clinical trials, is critical to the patients and wider society. The UK remains at the cutting edge of developing new drugs, this is underpinned by a strong pharmaceutical industry and leading research organisations.
“The UK government will need to determine whether it wishes to remain in sync with our European neighbours or whether we wish to navigate our own course. As the deadline to Brexit approaches, it would be a significant ‘own-goal’ for the government to risk losing our pre-eminent position by failing to put forward proposals that ensure that the EU Clinical Trials Regulation is implemented into national law in any event. Anything short of this will leave the British pharmaceutical industry at a disadvantage and potentially jeopardise the safe development of life saving drugs.”