No-deal Brexit and the impact on patient safety

20 September 2018

On 23 August 2018 the Secretary of State for Health and Social Care Matt Hancock sent a letter to all NHS organisations, GPs, community pharmacies and other service providers as an update on the government's on-going preparations for a  no-deal Brexit scenario and what the health and care system needs to consider in the lead up to March 2019.

Mr Hancock has told pharmaceutical companies to ensure that they have an additional 6 weeks' supply of medicines on top of their normal stock levels to avoid disruptions caused by a possible no-deal Brexit. This is in case imports from the EU through certain routes are affected. 

It has since come to light that Britain’s biggest insulin supplier Novo Nordisk is building up a four-month stockpile to ensure that diabetic patients are not left without vital medications in the event of a no-deal Brexit. Novo Nordisk is a Danish healthcare company and supplies more than half of the UK's insulin. Fellow insulin manufacturer French firm Sanofi has also pledged to build a 14-week stockpile, increasing its reserves by nearly a third.

This is a worrying time for both NHS clinicians and patients reliant on medication. The government is clearly concerned that a no-deal Brexit will lead to a shortage of medication in the UK and is dealing with this eventuality by advising pharmaceutical companies to stockpile. Adequate measures need to put in place to ensure the continued supply of medicines throughout the UK. Anything less could have a devastating impact on the NHS and patient safety. 

Mr Hancock’s letter was sent on the same day that Brexit Secretary Dominic Raab released the first tranche of technical notices advising businesses and the public on how to prepare in the event of a no-deal Brexit. Six of the published papers cover health matters and are of relevance to the NHS and patient safety.   

In the event the UK leaves the EU without a deal, the UK will be a ‘third country’ outside of the EU, and EU legislation will no longer apply.  In practice, the UK’s Withdrawal Bill means that for the time being EU legislation will, wherever possible, be turned into UK legislation. As a third country, the UK will no longer be eligible for participation in EU organisations and the UK will attempt to deal with this situation by adapting or creating its own domestic systems. 

Under EU membership, the UK is integrated in the EU medicines regulatory network, including the European Medicines Agency. In the event of a no-deal scenario the UK’s participation in the European regulatory network would cease. The Medicines and Healthcare Products Regulatory Agency, the UK’s national regulator for human medicines, will take on the functions currently undertaken by the EU for medicines on the EU market, including approval and marketing of medicines in the UK, approving new applications and pharmacovigilance, necessary to maintain standards.

According to the technical notices in the event of a no-deal Brexit:

  • The UK will continue to recognise EU approved medical devices.
  • Currently manufacturers can batch test medicines anywhere in the EU, EEA or other third countries with whom the EU has a mutual recognition agreement.  If there is a no-deal Brexit, the UK will no longer be part of the European Medicines Agency.  In order to ensure continuity in supply medicines, the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the Medicines and Healthcare Products Regulatory Agency. This list will include all EU countries, other EEA countries and those third countries with which the EU has a Mutual Recognition Agreement. The UK will also continue to accept batch testing of investigational medicinal products (i.e. substances being used in medical trials) manufactured in the EU and EEA states. 
  • Clinical trials are currently managed nationally, UK clinical trial applications will therefore continue to be authorised by the Medicines and Healthcare Products Regulatory Agency and ethics committees as they are now.  The UK’s ability to participate in multinational trials will not change.
  • EU Blood Directives would no longer apply to the UK. Therefore arrangements for sharing blood, blood components and information with EU partners would be based on the UK’s status as a third country. If there is no-deal, the current blood safety and quantity standards for blood and blood components would not change. To import and export blood or blood components into or out of the UK from any country, including EU/EEA countries, each unit of blood and blood component imported/exported will need to conform with standards in the EU.
  • At present organs, tissues and cells move between UK and EU countries, but also between UK and non-EU countries (third countries).  In the event of a no-deal Brexit availability of organ, tissues and cells should not be affected, the UK will become a third country and current EU law already allows for third country organ/tissue exchange.

Whilst the technical notices go a long way to addressing what will happen in the event of a no-deal Brexit and to ensure the continuity in the supply of medicines, medical devices and organs etc, there remain areas of concern. In the future the UK will have to authorise medicines separately from the EU, which could lead to lengthy delays. In relation to rare diseases, medicines that have been developed to treat such diseases are known as orphan medicines. Orphan medicines may not be commercially viable for the UK market alone and therefore it may be difficult to get such medicines on the UK market, which will inevitably have implications for the treatment of rare diseases and patient safety. With regards to blood, tissues and organs, as a third country the UK will need to form new written agreements for the import/export of blood, tissues and organs with existing EU partners. This could lead to delays in obtaining vital lifesaving blood, organs and tissues.

The government has promised to provide more detailed guidance in the event of a no-deal Brexit. The hope is that a deal will be struck which is in the best interests of the NHS and patient safety. However, with around 6 months to go there seems to be a lot of work that still needs to be done.

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