MHRA Issues Update to Pharma Companies on Brexit Preparations
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update for pharmaceutical companies on scenarios regarding pharmaceutical regulation dependent on the implementation plan of the UK exiting the European Union (EU) (i.e., Brexit).
The MHRA outlined the current state of negotiations between the UK and the EU with regard to Brexit and further specified the implications for the pharmaceutical industry. In December 2017, the European Council formally agreed that sufficient progress had been made to move to the second phase of the negotiations and adopted guidelines for that second phase. The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the withdrawal agreement.
The guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period and for it to be based on the existing structure of EU rules and regulations, said the MHRA. The EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to agree to the details with the EU in 2018.
“As the UK enters the second phase of negotiations, its position on medicines regulation remains clear,” said the MHRA in an agency state. “The UK is fully committed to continuing the close working relationship with its European partners in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.”
The MHRA said it is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019. The MHRA says it will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency (EMA) in planning for the UK’s withdrawal from the EU and future relationship.
The MHRA emphasizes that the UK’s current regulatory relationship with the European network remains unchanged. It stressed the following points.
- The UK continues to be a full member of the EU: the MHRA will fulfill 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. It says there are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019. For example, it is putting forward UK bids in conjunction with other member states in the centralized procedure to ensure business continuity where procedures are likely to run beyond this date.
- The MHRA has committed to complete all assessments under evaluation at the time that 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.
The MHRA also addressed 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,” said the MHRA in its statement. “We have 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—will be published when appropriate.”
The MHRA says it is preparing for all possible outcomes, including with or without the proposed time-limited implementation period. In the case that there is no implementation period, the MHRA says the EU 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 said this approach would also apply the following principles:
- Establish UK regulatory requirements and give adequate notice to ensure that companies have sufficient time to implement any changed requirements
- Where possible, complete administrative tasks for continuity of work and licenses
- Work to ensure minimum disruption and burden on companies as the UK exits the EU while building on the existing relationship between MHRA and firms
- Continue to engage with business, patient groups, and other stakeholders to help plan ahead with certainty, and look to publish more technical detail if appropriate.