On January 16, 2018, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) issued update to pharmaceutical companies on its exit preparations from the European Union (EU). It said that it will ensure minimum disruption and burden on companies as the UK exits the EU; there would be no sudden changes to the regulatory framework. The agency would also be pragmatic in establishing UK regulatory requirements and would give adequate notice and ensure that companies have sufficient time to implement any changed requirements38.
Update on negotiations
The European Council formally agreed in December last year that sufficient progress has been made to move on to the second stage of the negotiations and adopted guidelines for the same39. This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December, 201740. In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report made clear 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."
Preparing for all outcomes
The agency has stated that it is aware that companies that market pharmaceuticals in the EU and UK will need to plan and make decisions prior to the UK's departure from the EU in March 2019. The agency further reiterated that UK's intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree to a deep and special future partnership. The agency will continue to advise businesses on the basis of the UK position and will continue to work with the EMA while planning for the UK's withdrawal from the EU and future relationship.
Current regulatory relationship between UK and European network
The agency stated that it is also important to note that the UK's current regulatory relationship with the European network remains unchanged. The UK has reiterated to Member States and to the EMA on several occasions that at present:
- The UK continues to be a full member of the EU: the agency will fulfil all its responsibilities, and, in turn expect to be treated as such.
- The UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019 - the agency, for example, was putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.
- MHRA has committed to complete all assessments under evaluation by the time the UK departs from the EU and will make assessment reports available to the network.
- The UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.
- The UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.
UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks
Companies have been asking for detail about UK legislative requirements in different scenarios. The agency has been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals.
The UK intends to agree to a time-limited implementation period with the EU, and both parties have recognized it as important. However, should there be no implementation period, MHRA's approach would be in line with the following principles:
- 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.
- The agency would be pragmatic in establishing UK regulatory requirements and would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.
- Wherever possible, the agency would be making use of the information it already has to complete administrative tasks for continuity of work and licenses.
- The agency has assured that it would ensure minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.
The trade unions in the United Kingdom, the Association of the British Pharmaceutical Industry (ABPI), and UK Bioindustry Association (BIA) reacted positively to MHRA's statement and welcomed the agency's reassurance that it would take a pragmatic approach to instituting new regulatory requirements if a deal with the EU is not reached.
Footnotes
38 https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations
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