Guidance for marketing authorisation holders in the event of a no-deal Brexit.
The UK will exit the European Union (EU) on 29 March 2019. The government has made significant progress in negotiations with the EU and remains confident we will leave with a good deal for both sides, that supports existing and future healthcare collaboration.
However, as a responsible government, we continue to prepare proportionately for all scenarios, including the unlikely outcome that we leave the EU without any deal in March 2019. Given the significant amount of work that has now been done, I am confident this gives a clear basis for the health and care sector and the life sciences industry to plan so that patients can continue to receive high quality care unhindered.
Earlier this year, the Department of Health and Social Care (DHSC) undertook an analysis of the supply chain for medicines, including radioisotopes and vaccines, which identified those products that are imported from the EU and the European Economic Area (EEA). Without a deal, the supply chains for these products may be affected by changes to border processes and procedures.
To address this issue DHSC is working with the relevant marketing authorisation holders to ensure that UK stockpiles of medicines are adequate to cope with any potential delays at the border that may arise in the short term.
In the unlikely event we leave the EU without a deal in March 2019, based on the current cross-government planning scenario we will ensure the UK has an additional 6 weeks’ supply of medicines in case imports from the EU through certain routes are affected. This is the current planning assumption but will of course be subject to revision in light of future developments.
We are therefore asking pharmaceutical companies that supply medicines for NHS patients from, or via, the EU or EEA, to ensure they have a minimum of 6 weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019.
2. The Medicines Supply Contingency Planning Programme
To support this request DHSC has launched the Medicines Supply Contingency Planning Programme.
Through this programme we are seeking information about contingency plans put in place in respect of medicines that meet the relevant criteria. We will consider how the department may support suppliers in making arrangements following receipt of this information.
Separately, we recognise that there are some products that have short shelf lives and cannot be stockpiled. Where such products are at present imported to the UK from the EU/EEA via road haulage and roll-on, roll-off sea, road and rail routes, DHSC is asking suppliers to ensure they have plans in place to air freight those products to avoid any border delays that may arise at the end of March next year in the event of a no-deal exit from the EU. We will consider here too how the department may support suppliers in making arrangements to meet this expectation.
3. What the Medicines Supply Contingency Planning Programme covers
The programme covers products that are prescription-only medicines and pharmacy-only medicines that come from or via the EU/EEA via road haulage and roll-on, roll-off sea, road and rail routes.
This programme does not cover:
- general sales list (GSL) products
- medicines directly entering the UK from outside of the EU/EEA
- medicines entering the UK from the Republic of Ireland
- counter-measures and those vaccines which form part of the national vaccination programme – as these are centrally procured they will not form part of the Medicines Supply Contingency Planning Programme
- medical devices and clinical consumables – the government is also developing contingency plans for these products
- investigational medicinal products
- products that have recently been discontinued, or will be prior to 29 March 2019
- products that are not marketed in the UK
- unlicensed medicines
- raw materials for medicines
4. Actions required from marketing authorisation holders
If you are a marketing authorisation holder with medicines which come from or via the EU/EEA, a letter from the Secretary of State for Health and Social Care, Rt Hon Matt Hancock MP, has been sent via email to a point of contact at your organisation. There is no requirement to respond to this letter. If you have not received this letter and believe you have medicines which fall within the scope of the programme please email firstname.lastname@example.org
The programme also includes parallel importers who supply medicines that are in scope. If you are a parallel importer and believe you have medicines which fall within the scope of the programme but have not received a copy of the letter you should also email the programme team on the email address above.
On 24 August 2018, a password-protected response template will be sent to the point of contact at your organisation. The template you will receive has been pre-populated with the medicines that DHSC considers are in scope of this programme and supplied by your organisation. DHSC is requesting further information from you to better understand the current maturity of your supply contingency plans and to inform delivery of the programme. You have until 10 September 2018 to submit your response.
5. Where to find further information
As well as the template and the accompanying guidance, the email will include details of webinars that DHSC will be hosting for marketing authorisation holders. These will include the opportunity to ask questions. There will be several dates offered to ensure that all marketing authorisation holders have the opportunity to attend one of them.
The programme team can also be contacted at email@example.com and will aim to respond to all queries. We ask that companies wait until they have seen the guidance and attended a webinar before sending in any further queries to this email address.