The First Minister of Scotland spoke out this week over the uncertainty surrounding the supply of medicines and the implications for the National Health Service of Scotland when the UK leaves the EU in a few months time.

Nicola Sturgeon said:

“It’s now time the UK Government came clean on the scale of the cost to our health service. The Prime Minister failed to guarantee there would be no interruption in medicine supplies after Brexit. This came after UK ministers published a truncated tender, at a cost of tens of millions of pounds, associated with medicines stockpiling.

“There is no good Brexit for our health service. Even with a deal we face a loss of millions of pounds in research funding which could hit clinical trials.

The situation will be extremely serious for the supply of medicines and medical products should the UK leave the EU with no deal.

Medicines

If there is no deal the UK will continue to accept batch testing of human medicines carried out  in   EU countries, other EEA countries and those third countries with which the EU has an MRA (Mutual Recognition Agreement).

For medicines produced in the UK there will be no change to arrangements.

Blood and Blood Products

A no deal Brexit would mean that the EU Blood Directives would no longer apply to the UK.

“Blood establishments importing blood or blood components from the EU for transfusion would be required to add a description of activity to cover import to their blood establishment authorisation.”

The current blood safety and quality standards for blood and blood components would not change.

 UK blood and blood components will have to comply with EU regulations. In the case of exporting those products to an EU country  each unit of blood and each blood component exported will need to  conform with the EU testing requirements and meet the equivalent standards of quality and safety.

Organs for Transplantation,tissues and cells for human use, including reproductive cells

The EU has a common set of standards to ensure the quality and safety for these.

“The UK imports donated sperm, primarily from commercial sperm banks in the USA and Denmark. Approximately 4,000 samples were imported from the USA and 3,000 samples from Denmark in 2017, as well as a small number from other EU countries. Imports of eggs and embryos are far less common (usually fewer than 500 a year) and come mostly from EU countries.”

If there is a no deal Brexit the UK will continue to use the safety and quality standards set by the EU. Written agreements will need to be made with EEA organisations  to continue importing or exporting these products. The UK Government feels that this “will for the most part be a minimum burden on industry.”

The UK Government has assured the public that the availability of organs or the safety or quality of organs, tissues and cells in the UK will not be affected. Additionally however, written arrangements will require to be made with organisations to ensure organs can still move between the UK and EU countries. This will be the same for tissues and cells for human use, including reproductive cells.

Drug Precursors

Drug precursors are chemicals that are primarily used for the legitimate (legal) production of a wide range of products, like medicine, perfumes, plastics, cosmetics etc. They can, however, also be used for illegal purposes and so they are strictly regulated.

After Brexit , industries who import/export drug precursors will  need the same licences and registration to trade with the EU as they currently need to trade with non-EU countries.

If trade is only within the UK then there will be no  change in requirements.

Import/export licences will be required for trade with the EU or other countries. There are also additional applications to be made e.g. for some drug precursor chemicals it must be registered with the Home Office if you want to trade within the EU regardless of volume.

Fees are payable for all ‘domestic’ licences/registrations and range from £109 to £3,655, depending on whether an applicant already holds a licence. The fee for an individual export or import licence is £24. All import licences are normally valid for 3 months and export licences will be valid for 2 months or in line with the importing country’s permit, whichever expires first. Domestic licences are valid for a period of one year.

Should a deal not be agreed with the EU, the import and exporting licensing requirements will come into place at 23:00 on 29 March 2019. The Home Office will process applications in date order  – it may take a 7 working day processing time.

Shared Systems

The EU has a shared system for medicines and medical devices. A Brexit UK will no longer be part of the shared system. This includes the sharing of data. The UK Government is developing  some new systems  for March 2019.  Information will require to be sent separately through EU systems and the UK portals. The UK Government has said that the systems will be  up and running for March 2019 to be further developed as required.

The information in this article and those previously published by The Orkney News has all been provided by the UK Government.

Their ‘Technical Notices’ should there be a no deal Brexit have been described by Michael Russell, The Constitutional Relations Secretary in the Scottish Government as a ‘nightmare’.

Michael Russell said:

Photo Scot Gov

“These technical notices reveal the ‘no deal’ Brexit nightmare facing Scotland and lay bare the risks facing Scottish businesses, the economy and public services.

“From the bureaucratic burden that will be imposed on EU imports and exports to the need to strike a wide range of ‘no deal’ deals before the end of March, these notices only add to the uncertainty surrounding Brexit. “

Matt Hancock, The Health Minister in the UK Government has said that vaccines and blood products could be stockpiled ahead of a possible ‘no-deal’ Brexit.

He said:

We are working right across government to ensure the health sector and industry are prepared, and that people’s health will be safe-guarded in the event of a no-deal Brexit

‘This includes the chain of medical supplies [such as] vaccines, medical devices, clinical consumables, blood products, and I have asked the department to work up options for stockpiling by industry … we are working with industry to prepare for the potential need for stockpiling in the event of a no-deal Brexit.’

‘We need to make sure that we get the balance right between being prepared for all eventualities and making sure that people are going to be able to access all the drugs that they need. Obviously, there is a cost implication of doing this.”

It is also possible that the supply chain will take longer due to hold ups at new border checks which will be required. It should also be noted that some medical products have a short shelf life. 

Reporter: Fiona Grahame