With six months until Brexit and a deal not yet agreed, the Government is now publishing its plans for a "hard" Brexit. These papers cover a wide range of fields and are being expanded on regularly; in this blog we will be considering the Government's plans in the healthcare space.
Healthcare is a jurisdiction with shared competence between the UK and the EU, however the biggest challenges are likely to come from the supply of medicines and medical devices. While some products obtain their authorisation in the UK through the MHRA, many go through central authorisation with the European Medicines Agency. The contingency papers confirm that existing central authorisations will be automatically converted into UK-applicable authorisations at the point of Brexit to prevent products being immediately frozen out of the market. However, for medical devices to receive their CE mark they must go through a "notified body"; there are very few of these, particularly in the UK, and there is concern that going forward there will be significant backlog in devices receiving the necessary authorisation.
One issue in the licensing of medicines was raised by the Commons Select Committee on Health and Social Care; under EU legislation each batch of medicines manufactured must be quality checked before leaving the manufacturer. If this is done in one European country it does not need to be done in another. However in a previous report the Select Committee expressed concern about how this would work on Brexit, and whether these medicines would have to be checked again in the UK, potentially increasing costs and delays in getting stocks onto the market. The contingency plans state that the UK will continue to accept EU-based batch testing in the event of a no deal Brexit, however there is no guarantee as to what would happen to medicines usually checked within the UK, and whether the EU would continue to accept these.
The immediate concerns at the point of Brexit will be the supply of pharmaceutical products and devices, as very few of these are manufactured in the UK. The contingency papers acknowledge that these supply chains may be hit by a new deal Brexit. To mitigate this, the UK Government intends to ensure there is a six weeks' supply of prescription-only medicines in the UK prior to Brexit; for the time being it suggests that the burden of this is on manufacturers, rather than on the NHS, and we have seen evidence that the NHS are demanding details of their suppliers' contingency plans.
Supply chains for other products, such as general sales and over the counter medicines will also be affected. For these medicines, the Government has noted that the key problem may be delays at ports when importing goods; an emergency introduction of customs controls may lead to long delays in entering or leaving the UK. This would particularly affect medicines that have a short shelf life or require constant refrigeration. To combat this, the Government has suggested suppliers should make provision for the air freighting of medical supplies to avoid these delays, however some experts suggest that there may also be problems in air travel if the appropriate air services agreements are not in place. In addition, if there is a significant increase in the amounts of air freight there may also be delays in this sector.
One final area to consider will be the sharing of human cells, tissues and organs with the EEA. At present the safety and quality standards for human tissues are set by EU legislation, which has been incorporated into UK domestic legislation. In addition, no further import/export requirements need to be met when moving them between EEA countries. While these standards will remain the same in the event of a no-deal Brexit, the contingency plans state that import/export agreements will need to be set up with the UK to allow for the sharing of cells, tissues and organs. This could affect the supply of human sperm (of which the UK is a large importer), as well as the sharing of stem cells and organs, where precise matches are required.
While it is clear that healthcare is a key area of the Government's planning for a no-deal Brexit, the current plans do highlight that there would likely be some disruption; what is unclear is the scale of this disruption. Manufacturers of medicines and medical devices, as well as organisations involved in the sharing of tissues and cells, should make sure that they have their own contingency plans in place to secure supplies into and out of the UK.