Latest developments on Brexit and access to medicines

Published Date
Jonathan Kingsley

As we approach 31 October, the date when the UK is currently scheduled to leave the EU, we have been monitoring the situation around access to medicines for UK patients living with a muscle-wasting condition.

This applies both to the supply of medicines which are currently available in the NHS, and also in the longer term the regulation of new medicines which is undertaken by the European Medicines Agency for all European Union member states.

With political developments at Westminster changing daily, it is yet to be determined whether the UK will leave on 31 October in a no-deal Brexit, whether a deal between the UK and the EU will be agreed, or whether there will be an extension to the UK staying in the EU for several months or longer.

Concerns about a no-deal Brexit

We are in contact with other charities and key organisations in the life sciences sector about ensuring UK patients can continue to access the medicines they need after Brexit.

With the help of our parliamentary supporters, we have expressed our concerns about the potential detrimental impact on access to medicines for UK patients, which are mostly aligned with the concerns that have been expressed by Association of Medical Research Charities (AMRC), of which we are a member. The AMRC’s points include:

  • “Even with the best preparation a no-deal Brexit would have a damaging effect on patients and medical research;
  • We should be under no illusions of the consequences for patients if a Brexit deal is not reached;
  • We urge both the UK and the EU government to work together and do everything they can to protect patients in the event of ‘no deal’;
  • If the UK were to leave the EU without a deal, then we believe that there should be agreements in place to protect patients.”

Preparations to continue supply of medicines

The Department of Health and Social Care has been working with the NHS and pharmaceutical companies to plan for the possible eventuality of a no-deal Brexit, providing guidance on the supply of medicines. This would include the supply of steroids, which is of particular relevance to a large number of people living with muscle-wasting conditions.

In terms of specialist treatments for specific muscle-wasting conditions, PTC Therapeutics, the pharmaceutical company which manufactures the Duchenne muscular dystrophy treatment Translarna, has reiterated its comment from February 2019:

“In response to the United Kingdom’s planned withdrawal from the European Union, PTC Therapeutics have made plans to ensure the continued supply of Translarna (ataluren) to patients and hospitals. We are working with the Department of Health and Social Care and have provided details of our contingency plans to the Department.”

Biogen commented regarding the supply chain for the SMA treatment Spinraza:

“Biogen’s key priority is to ensure a continuous supply of medicine to all our patients. To prepare for a no-deal Brexit, the UK government has requested all companies stock pile an additional six weeks of stock over and above their normal inventory.  Biogen intends to meet and exceed these minimum recommendations and, for all of our products including Spinraza, is targeting to stockpile approximately 3 to 6 months’ worth of product in the UK prior to exit day.”

Santhera shared the following statement regarding the supply of Duchenne muscular dystrophy treatment Raxone (idebenone):

“Santhera, like most pharmaceutical companies, have been working tirelessly in collaboration with the Department of Health and Social Care to ensure that patients and the Health Service have continued access to Raxone (idebenone) after Brexit. Raxone is available to over 70 patients with Duchenne muscular dystrophy in the UK via an Early Access to Medicines Scheme (EAMS) programme. We are collaborating with all centres participating in EAMS to ensure the medicine continues to be available to their patients. It is worth noting that Raxone is air-freighted into the UK from Germany, which minimises risks of disruption following any Brexit scenario.”

Regulation of medicines and possible future scenarios

Guidance on how new medicines would be regulated through the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) after a no-deal Brexit has also been issued by the UK Government, which covers medicines that are in the middle of European Medicines Agency processes and those which are yet to go through the regulatory approval system within the European Union.

If the UK continues to be a member of the European Union after 31 October, current arrangements for regulation and supply of medicines will stay in place.

We will be looking out for details on any alignment with the European Medicines Agency in any future deal which is made with the European Union, either ahead of the 31 October or afterwards.

We will keep you updated with any significant and definitive developments regarding Brexit, including the impact on access to medicines, reciprocal healthcare rights and research funding programmes.

If you have any questions about your care and access to treatments, please speak to your consultant.

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