The government has asked drug manufacturers to increase stockpiles of medicines to ensure continued supply in the event that the UK leaves the EU in a ‘no-deal’ scenario.
In a letter to the health and care sector, Matt Hancock, the secretary of state for health and social care, insisted that the government has made “significant progress in negotiations with the EU and remains confident we will leave with a good deal for both sides”.
However, “we now have robust plans in place to protect patient safety and healthcare provision” if a deal is not reached, he said.
“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 six weeks supply of medicines in case imports from the EU through certain routes are affected.”
The ABPI has welcomed the guidance, but stressed that 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.”
Chief executive Mike Thompson added: “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.
Also responding to the announcement, Niall Dickson, co-chair of the Brexit Health Alliance, said: “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.”
“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.
“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.”
Steve Bates, chief executive of the BioIndustry Association, said the new guidance “gives greater clarity on how UK medicines regulation will work in the scenario of ‘no deal’, something we do not want to see.”
“As we have repeatedly articulated since 2016, it is now clear that a ‘no deal’ Brexit would mean a significant increase in replicative bureaucratic red tape for developers of innovative medicines.
“Introducing additional regulatory process for a market worth less than 3% of the world’s value adds additional time and expense for companies who have a choice as to where they launch new therapies.
“It would not add to the UK’s attractiveness for life science businesses. It would likely mean that NHS patients would get access to new therapies later than other countries in Europe.”