As the Government has now agreed, in principle, the Withdrawal Agreement with the European Commission, the Department has assessed that market access to medicines and medical equipment under the terms of that agreement will remain unchanged for industry and
the National Health Service during the implementation period, which will run from March 2019 until December 2020.
As a responsible Government, however, we continue to prepare proportionately for all scenarios, including the unlikely outcome that we leave the European Union without any deal in March 2019.
The Department has held confidential discussions with logistics companies and trade associations representing the vast majority of the medical suppliers in developing its plans.
On 23 August 2018, the Department wrote to pharmaceutical companies that supply the United Kingdom with selected pharmacy or prescription-only medicines, including non-national programme vaccines, from, or via, the EU/European Economic Area, asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no deal EU exit. On the same date, the Government published two technical notices on the batch testing and regulation of human medicines in the event of a no deal, together with a further technical notice on the submission of regulatory information on medical products.
Officials in Public Health England are leading a programme to ensure the continuity of supply for all centrally procured vaccines which are distributed to the NHS for the UK National Immunisation Programme.
On 23 August, the Department also announced contingency measures to increase stock holding at a national level for medical devices and clinical consumables. To this end, we are working with suppliers that routinely import products from EU countries to determine what measures they need to take so that they can continue to provide products in the unlikely event of a no deal EU exit.
Since these initiatives were announced, the Department has received very good engagement from industry who share our aims of ensuring continuity of medical supplies 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.
On 23 August, the Department also wrote to all NHS trusts, pharmacies, healthcare providers and general practices to inform them of our contingency plans for ensuring continuity of supply of medical supplies. The NHS was asked not to stockpile medicines and clinicians were advised to tell patients that the Government has plans in place to ensure a continued supply and they will not need to and should not seek to store extra supply at home.