As many of you have been asking about the supply of medicines and consumables in a no deal Brexit, we asked the Department of Health what their plans are. The short summary is that they are working on it and have asked companies to increase the supplies they store by an additional 6 weeks. They say that if everyone does what they need to do, supplies will continue without disruption. They also said that they are unable to give us detail on specific medicines as any planning info they have received has been in confidence. The full contents of the letter are at the bottom of this blog. We are asking the government to be more open about their planning in order to reassure kidney patients.
As we wanted a bit more information we approached manufacturers of items needed for dialysis (often referred to as consumables) and specialised medicines for kidney patients directly. The companies explained that they are in touch with the Department of Health and Social Care (DHSC) planning teams and are building their stocks in line with - or in excess of - government recommendations. There are two DHSC teams doing planning work with kidney doctors; one for consumables and one for drugs, so expert advice on important medication is being given to the planners.
We know this is something patients are concerned about. Amanda, one of our supporters, recently appeared on BBC Newsnight to talk about her fears around how Brexit was going to have an impact on her dialysis - which you can watch here.
We are now having regular conversations with manufacturers to be able to understand their planning activities. We’d like to thank them for their willingness to discuss them and the clear commitment to patient safety. If you have specific worries you should of course take them up directly with your healthcare teams.
Every single company we have spoken to has put plans in place in line with, or in excess of government requirements. Baxter, Fresenius and BBraun have told us that they have several teams planning and working on Brexit preparation. Most NXStage products are made in the US but they are building their supplies of critical products in the UK. Amgen, Astellas, Stanningley Pharma and Chiesi have told us that they are actively working on future regulatory requirements, drug supply and patient safety. This list of companies talking to us is growing every day. We welcome assurances on serious preparatory work and will update patients whenever we receive new information.
What you can do
Whilst we know that patients are worried about disruption to their medicines over the immediate period that we leave the EU, it’s important that you do not try to stockpile your own medications. If everyone does this then it will lead to a serious shortage. If you have concerns please raise them directly with your own renal team.
This is the email from the Department of Health and Social Care about medical supplies.
“You may be aware that in 2018, the Department undertook an analysis using Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency (EMA) data on the supply chain for all licensed medicines, including renal medicines. This identified those products that have a manufacturing touch point in the European Union (EU) or wider European Economic Area (EEA) countries. Without a deal, we recognise that there is potential for the supply of these products to be disrupted. It was decided that all prescription-only medicines and pharmacy medicines (with an EU/EEA touchpoint) are in scope of our stockpiling programme so that there is no disruption to medicines that can be prescribed for a UK patient.
That is why, in August 2018, the Department wrote to all pharmaceutical companies that supply Prescription-only medicines and pharmacy medicines to the UK that come from, or via, the EU/EEA asking them to ensure a minimum of six weeks additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019 in a ‘no deal’ scenario.
The reasonable worst-case scenario border disruption planning assumptions, announced on 7 December 2018, showed that there will be significantly reduced access cross the short straits to and from Dover and Folkestone, for up to six months.
This means that whilst the six-week stockpiling activities remain a critical part of our medicine supply contingency plans, we are now supplementing that with additional actions.
In December 2018, the Government announced that it recognises the vital importance of medicines and medical products and is working to ensure that there is sufficient roll-on, roll-off freight capacity to enable these vital products to continue to move freely in to the UK. The Government also agreed that medicines and medical products will be prioritised on these alternative routes to ensure that the flow of all these products will continue unimpeded after 29 March 2019.
That is why in December 2018, we wrote again to pharmaceutical companies that supply licensed medicines to the UK from or via the EU/EEA, and/or manufacture medicines in the UK, informing them of the reasonable worst-case scenario border disruption planning assumptions and asking them about their current transportation routes and their ability to re-route their supply chains if they currently rely on Dover and/or Folkestone.
We anticipate that you would wish to know more detail about renal medicines. However, the Department is unable to discuss specific renal medicines with you, because to reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme. That means not introducing information about a specific company, medicine, or a supply route into the public domain or to a third party.
We want to let you know that throughout enacting our contingency plans and working with pharmaceutical companies we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ EU exit.
In the light of this engagement the Department continues to consider how best it may support industry taking part in the contingency planning. An example of this support is that, in October 2018, a tender process to procure additional warehouse space for stockpiled medicines, including ambient, refrigerated and controlled drug storage, was undertaken.
We hope that sharing this information provides you with reassurance and greater confidence in the Department’s ‘no deal’ contingency plans. If everyone does what they need to do, supplies will continue unhindered.”