The UK government has published advice in the event of no-deal with the European Union – including recommendations for the healthcare sector.
The Department of Health & Social Care has published general guidance on how medicines, medical devices and clinical trials will be regulated after Brexit if negotiations remain at an impasse, as well as four individual guides covering filing of regulatory information, batch testing requirements, blood and blood products, and ensuring the quality and safety of organs, tissues and cells.
When it comes to medicinal products, the primary concern is that access to therapies will continue without shortages, both for people in the UK and the EU, and in a letter (PDF) published today, Health Secretary Matt Hancock said the government “will ensure the UK has an additional six weeks’ supply of medicines in case imports from the EU through certain routes are affected”.
“Under the medicines scheme, pharmaceutical companies should ensure therefore they have an additional six weeks’ supply of medicines in the UK on top of their own normal stock levels,” he writes, while noting that “hospitals, GPs and community pharmacies” do not need to lay in additional supplies and could face “investigation” if they start hoarding products.
Some of the larger drugmakers have already said they are stockpiling medicines, but whether that will be possible across all medicinal products used in the UK remains open to question.
Regulatory filings
The Medicines and Healthcare product Regulatory Agency (MHRA) will have to handle marketing applications for new medicines in the UK if an agreement is not reached by 29 March, so ‘an initial market authorisation application will need to be submitted to the MHRA and will go through a national assessment’, says the guidance.
‘We would have our own processes and systems to manage UK human medicines and devices regulatory activities. To do this, some new systems are being developed,’ it continues, adding that companies will be required to help test some systems ahead of time.
On the topic of batch testing – the process of confirming that every batch of medicines has the correct composition through lab testing – the MHRA says it will continue to accept tests done on commercial and investigational products from a list of EU and European Economic Area (EEA) countries, to ensure a smooth supply.
Testing of commercial products from third countries with which the EU has a mutual recognition agreement will also be accepted.
The other documents note that the EU Blood Directives would no longer apply to the UK with no deal, so arrangements for sharing blood, blood components and information with EU partners would be based on the UK’s status as a third country. A similar situation would apply to the EU Organ Directives and EU Tissues and Cells Directives, and in both cases, organisations working in these areas may need to seek certification from the EU.
Raab says risk of shortages overblown
All the 25 new ‘no deal’ advice documents (more are on the way next month) insist that such a scenario is unlikely – despite growing public feeling this may be on the cards – and say that ‘it has always been the case that as we get nearer to March 2019, preparations for a “no deal” scenario would have to be accelerated’.
The government acknowledges however that there could be ‘short-term disruption’ in that event, but Brexit Secretary Dominic Raab dismissed as nonsense claims that just-in-time supply chain disruption would lead to shortages of some products, including food.
The Confederation of British Industry and union organisation the TUC both have a different take. CBI deputy director general Josh Hardie said that a no deal will “wreak havoc on economies across Europe”, while TUC general secretary Frances O’Grady said it would be “devastating for working people”.