The Government has published its technical notices on how to prepare if the UK leaves the EU with no deal. It includes guidance for health, pharma and medical suppliers in a no deal Brexit scenario.
The notices include a section on regulating medicines and medical equipment such as: batch testing medicines, ensuring blood and blood products are safe, how medicines, medical devices and clinical trials would be regulated, submitting regulatory information on medical products, and quality and safety of organs, tissues and cells.
Added to this, the Secretary of State for Health and Social Care, Matt Hancock has written to all NHS organisations, GPs, community pharmacies and other service providers; pharmaceutical companies; and suppliers of medical and clinical consumables.
“a ‘no deal’ scenario is not in the interest of patients. Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”
His letter to NHS organisations and service providers sets out what the health and care system needs to consider in the period leading up to March 2019, including the continued supply of medical products in the event of no deal, and business continuity plans.
In his letter to pharmaceutical companies, he asks suppliers to increase their medicines stocks by at least six weeks on top of their usual buffer stocks, and ensure plans are in place to air freight products with a short shelf life that cannot be stockpiled.
Finally, his letter to medical devices and clinical consumables states that separate contingency plans are being developed, stock holding at a national level will be increased, and further information will be provided to industry in September.
The Department of Health and Social Care has then published additional guidance for the pharmaceutical and medical devices industry on its medicines supply contingency planning programme.
The ABPI has welcomed the publications and letter from the Department of Health and Social Care on medicines supply contingency planning, saying it gives guidance to pharmaceutical companies as they prepare for Brexit.
It says that, the technical notices offer more clarity that, in the event of a ‘no deal’, the UK Government will take a pragmatic approach to the regulation of medicines by recognising and using medicines and vaccines which have been licensed and manufactured in the EU. They said that companies can now focus on those medicines which have the most complex supply chains.
The ABPI also welcomed the guidance on increasing stocks of medicines. However, it said that is important to recognise that increasing stocks of medicines is just one important part of detailed contingency planning that will be needed by pharmaceutical companies, the Government and the NHS.
Mike Thompson, Chief Executive of the ABPI, said: “The pharmaceutical industry is doing everything in its power to minimise disruption of medicine supply in every possible Brexit outcome – including a ‘no deal’.
“By agreeing to recognise and use medicines and vaccines licensed and manufactured in the EU, the UK Government has taken an important step to protect patients. We urge the EU Commission to do the same.
“We need to be clear that a ‘no deal’ scenario is not in the interest of patients. Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”
Niall Dickson, co-chair of the Brexit Health Alliance, said: “What we need is a categorical assurance that patients will continue to get the medicines and treatment they need, no matter what happens in the negotiations. This guidance is a first step, but only a first step, towards that.
“The NHS will now want to see more comprehensive operational advice on issues such as the stockpiling of medicines and equipment, medical research and public health, in time for them to take robust action locally well before the UK leaves the EU.
“We will continue to work with the UK Government to make sure these issues are addressed in future guidance and that the NHS is able to care for its patients without disruption of any kind.
“As we have seen time and again, the NHS is fantastic when it comes to dealing with emergencies and with the right planning and support at national level it can deal with this challenge. These are unprecedented times and it is critically important everyone responsible for frontline care is given the tools they need to deliver.
“Of course, the real prize must be no disruption in supply to or from the UK – it may be acceptable to argue about delays to some consumer products at the border – it cannot be acceptable when patients’ lives are put at risk. We cannot afford to get this wrong.”