Haemophilia Scotland have been receiving a steady flow of enquiries from members asking about how Brexit, and the possibility of a no-deal Brexit, might affect treatment and care for inherited bleeding disorders in Scotland.
Obviously, nobody knows what relationship the UK will have with the EU by the end of the month and predictions are hotly contested politically. Therefore, this post will simply provide the public statement on Brexit from relevant organisations and, where possible, explain why what they are saying might affect people with inherited bleeding disorders in Scotland.
The Haemophilia Society UK
Also, The Haemophilia Society (UK) have produced a useful briefing paper on what a no-deal Brexit could mean for people with inherited bleeding disorders in the UK. As it focuses on the impact on the availability of clotting factor products, rather than any potential impact on staffing in the NHS, and Scotland purchases products as part of the UK tendering process, then it is applicable to our community in Scotland. You can read it in full on The Haemophilia Scotland website.
The briefing stresses that the UK tender means that the companies involved in the tender process must hold 3 months stock in the UK and that many are increasing that by another 6 weeks in case of a no-deal Brexit. Assurances have been given that this is expected to be sufficient to prevent any disruption affecting patients. Some companies have told us that they are holding even more stock in the UK, up to 6 months in some cases.
However, the briefing also discussed the the prospect that if there is a no-deal Brexit and that leads to problems bringing any specific product into the UK then some patients may be asked to switch to an alternative product until any supply issues are resolved. We are asking questions in Scotland about how it would be decided which Centres and patients would be asked to switch. In the unlikely event that there is a limited supply of any product we want to make sure that any decision about how much of that comes to Scottish Centres is well thought out.
Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA are the UK regulator. A recent briefing paper from PWC says,
The Medicines and Healthcare Regulatory Agency (MHRA) is responsible for UK regulation – implementing many European Regulations and Directives. The MHRA and other UK bodies currently have significant influence in shaping European
regulations, setting the European and even global standard. The level of this influence will be impacted by the type of deal UK and EU reach.
The European Medicines Agency (EMA), which is to relocate to Amsterdam following Brexit, is responsible for European regulation of medicines. This includes the centralised authorisation procedure for licensing medicines. This grants a single marketing authorisation for all EU and EEA countries.
Should the UK government decide not to join the EEA upon leaving the EU, the UK will no longer be a part of this process. The MHRA will then need to perform the same task, requiring companies to submit a separate UK marketing authorisation application.
However, this increased demand on the MHRA could result in a slower authorisation procedure, and as a result, slower UK market access. Furthermore, the MHRA currently undertakes an estimated 30% of EMA casework. Without the capacity and expertise of the MHRA, the European regulatory system may also experience delays and disruption.
On leaving the EU, if the UK is not covered by the Unitary Patent, they would be denied access to Europe’s Unified Patent Court (UPC), which could result in potentially lengthier and more costly patent disputes for companies. The UPC for Life Sciences is currently planned to open in London, but this location decision may now be revisited.
While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.
The European Medicines Agency (EMA)
The EMA have put a statement on their website which says,
One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.
The Agency continues its operations in accordance with the timelines set by its rules and regulations.
EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.
The UK Government
The Department of Exiting the European Union is the primary source of information about the UK Government’s preparations for Brexit. The Department has published 165 documents on it’s website covering a wide range of issues relating to Brexit.
The Department of Health and Social Care (England) has also produced guidance on Ensuring blood and blood products are safe if there’s no Brexit deal. The Department also issued an Update on medicines and medical products supply as we exit the EU at the end of February.
The Scottish Government
The Scottish Government provide an overview of their position in relation to Brexit, including several detailed papers at www.gov.scot/brexit/. Of these, the paper on Science & Research and the paper on People, Jobs, & Investment are the most relevant for considering the potential impact of Brexit on bleeding disorders.
They also provide ‘information on the UK’s possible exit from the European Union (Brexit) and how it may affect people and businesses in Scotland.’ at www.mygov.scot/eu-exit/.