The Medicines and Healthcare products Regulatory Agency (MHRA) has sought to reassure drugs manufacturers by issuing a statement emphasising that following Brexit, European Union (EU) regulation is likely to continue to apply for the foreseeable future.
It has pledged that “adequate notice” of any changes will be given to “ensure the minimum disruption and burden on companies” affected.
In December 2017 the European Council formally agreed that sufficient progress had been made to move on to the second phase of Brexit negotiations, adopted guidelines for the second phase, and published a joint report on progress made so far.
That report says that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”
The UK has proposed a time-limited implementation period following its withdrawal from the EU in March 2019 during which time access to markets would continue under current terms and be based on existing EU rules and regulations. After that, the UK Government has said it is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety guidelines. The guidelines for the second phase of negotiation reconfirm the EU’s desire for a close partnership with the UK.
However, pharmaceutical companies have been seeking reassurances from the MHRA on what will happen if there is no implementation period after March 2019, or no ongoing relationship with European Medicines Agency networks.
In a statement, the MHRA said that should there be no implementation period or continuing relationship it has ”been working closely with industry associations and other stakeholders”, adding that ”further details on all these issues and more – both our Day-One and longer-term proposals – will be published when appropriate.”
In such a scenario, the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.
Then, the MHRA said, it would be “pragmatic” in establishing UK regulatory requirements. It “would give adequate notice and ensure that companies had sufficient time to implement any changed requirements”; where possible make use of the information it already has to complete administrative tasks for continuity of work and licences; and “ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms”.
The Association of the British Pharmaceutical Industry (ABPI) welcomed the MHRA’s reassurances for companies “who are already actively making plans and taking decisions in advance of the UK’s departure from the EU”.
However, it added that planning for a scenario where cooperation could not be agreed does “require further detail, and further highlights why a realistic implementation period needs to be urgently agreed”.
“For patients and the public, there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the Commission to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks,” the ABPI said.