The 2-year mark since Prime Minister Theresa May's announcement that the UK would in fact be leaving the European Union (EU) is fast approaching, and a deal is nowhere in sight. Stories about stockpiling food and medicines, as well as the need for duplicate testing of drugs and the potential for patients not to have access to their medications in the event of a no-deal Brexit, have been plentiful.
Theresa May and other officials have insisted that government measures to stockpile medications, for example, are simply precautionary and that ‘delivering the deal negotiated with the EU remains the government's top priority’ (Department of Health and Social Care (DHSC), 2019). However, after the recent parliamentary vote not to accept May's Brexit deal, the reality of a ‘hard Brexit’ is looking increasingly likely.
Medication stockpiles
According to the Minister of State for Health and Social Care, Stephen Hammond, the storage for medicine stockpiles in the event that the UK withdraws from the EU on 29 March 2019 without an agreement in place will cost tens of millions of pounds, an estimated £1 million of which will go to refrigerated storage alone (Wickware, 2019). In October of 2018, the lack of appropriate cold-chain storage was reported, and the contract put out to tender that month is now scheduled to begin in February 2019.
This contract will last for 12–18 months and will provide capacity for 53 000 pallets of ambient storage, 5000 pallets of refrigerated storage and 850 pallets of controlled drug storage (Praities, 2018; Wickware, 2019). In the apparently unlikely event that a deal is achieved, some costs already incurred by the contractors will still need to be covered by the DHSC.
Drug companies have been asked to stockpile a rolling 6-week supply of medicines for a period of 6 months in case of a no-deal Brexit to account for anticipated disruptions at the UK/EU border after 29 March this year (Wickware, 2018).
Changes to regulation
At the beginning of this year, the government released new guidance addressing how medicines, medical devices and clinical trials will be regulated if there is no deal in place when the UK exits the EU (DHSC, 2019). The UK is currently integrated into the EU medicines regulatory network (EMRN), which includes the European Medicines Agency (DHSC, 2019).
If there is no exit deal, however, the UK's participation in the EMRN will come to an end, and any of the aspects regulated by the EMRN will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), which is already the UK's national regulator for human medicines, medical devices, clinical trials and blood products (DHSC, 2019). There will also be changes to the law via the Human Medicines Regulations (2012), and a consultation regarding some of these proposed changes to legislation will be held in autumn of this year (DHSC, 2019).
If Brexit goes ahead without a deal, the UK will also need to consult on the regulation of paediatric medicines and orphan medicines, which have been developed to treat rare diseases. New UK paediatric investigation plans will need to be implemented to ensure that necessary data provided by studies in children that can support the authorisation of children's medicines are available; these are currently provided by EU legislation. The government also acknowledges that incentives to continue to encourage both paediatric and orphan medicines in the UK market will be required, and that this will be consulted upon (DHSC, 2019).
Looking ahead
The tremendous uncertainty surrounding the imminent exit of the UK from the EU is bound to raise questions and cause some anxiety both for patients and for the health professionals and prescribers who deliver their care and medicines.
Simon Dukes, who is the chief executive of the Pharmaceutical Services Negotiating Committee, says the committee is ‘deploying all necessary resources’ to ensure that patients do not end up running short of their medications in the event of a no-deal Brexit, but that they are also continuing to work with the DHSC to plan for all possible outcomes (Robinson, 2019).
All nurses and prescribers in the community will benefit from remaining up to date with developments in this area, and the upcoming MHRA consultation in autumn will provide an update of the regulation of medicines, medical devices and clinical trials.