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The DHSC guidelines for a ‘No-deal EU exit plan in light of the extension of the Article 50 period to 31 October 2019

Pharsafer received a notification on 26th June 2019, from Steve Oldfield, Chief Commercial Officer at Department of Health & Social Care. See below a brief synopsis of the contents.

Continuity of supply of medicines and medical products in the event of a 31st October no-deal EU exit scenario.

This is an update on the UK Governments approach to the shared intent to maintain a continued supply of medicines and medical products to UK patients in the event of a no-deal EU exit on 31st October 19 and to set out achievable objectives to the suppliers of these products in the UK.

The main aim in the event of a no-deal EU exit, is to maintain an unhindered supply of medicines and medical products into the UK, via the European ports. Approximately 75% of medicines and in excess of 50% of all clinical consumables to the UK come from (or via) the EU and the majority use these use the channel straits for entry.

The contingency for the original 29th March 19 exit, was to have a co-ordinated National Supply Disruption Response system, to address issues following that date. This included procuring additional warehousing space and freight capacity on routes out of the channel straits.

The Government’s Border Delivery Group, has been reviewing the border infrastructures and trader’s compliance with customs and borders processes, between the UK and EU in readiness for the new exit date 31st October 19.

While it is believed that the disruption rates will have improved since 29th March 19. There would still be significant disruption in the six months following a no-deal exit. Seeing the most severe of these in the first three months.  Many companies have arranged detailed re-routing and stock management plans, many others continue to review their position on contingency measures.

All no-deal preparation plans by Medicines suppliers should therefore contain any or all of
the following:

  •  Secured capacity to re-route freight away from the short straits following a no-deal exit day.
  •  Stockpiling products above the usual usage of an extra 6 weeks stock.
  •  Assurance on the readiness of a company’s logistics and supply chains in line with new customs
    and border requirements
  •  For products with a short shelf life or where stockpiling is not possible, for example, medical
    radioisotopes, alternative air freight plans will be required.

The DHSC we will require suppliers to notify them of any subsequent changes to their plans.

The above is primarily aimed at suppliers of prescription only and pharmacy medicines, with an EU
touchpoint, however, the DHSC have also considered the implications of the latest border planning
assumptions on suppliers of other categories of medicinal products.

It is highly recommended that suppliers of medicines and medical products review their supply
routes and have in place robust plans to re-route supply away from the disrupted routes into the
UK, especially during the first three months following 31st October 19.

The Government has taken steps towards delivering solutions to support product re-routing, in the
event of urgent need, where suppliers’ arrangements encounter difficulties.

There will be continued updates by DHSC on developments towards Government led solutions, once more information is available.

The Government will be Changing or clarifying regulatory requirements, so that companies will be
able to continue to sell their products in the UK, even if we have no deal.

The MHRA has published, further guidance on how medicines, medical devices and clinical trials will
be regulated. In February and March 2019 parliament approved legislation that will take effect on
“exit day” in the event of no deal.

The DHSC will also be operating a National Supply and Disruption Response (NSDR) unit.

Medicine suppliers should continue to use existing medicine reporting arrangements and alert the
Department’s Medicine Supply Team in the event of supply issues, so the Team can undertake a risk
assessment and implement a management plan to mitigate any potential impacts affecting patients.
Guidance about the information that should be reported can be found at the following link:

https://www.gov.uk/government/publications/reporting-requirements-for-medicine-shortages-and-discontinuations.

Contracts have been agreed for additional warehouse space, including ambient, refrigerated and controlled drug storage. Warehousing capacity will continue to be provided. The industry will continue to be updated on how they can access this additional storage in advance of 31st October 19.

Health and social care service providers are being asked to avoid local stockpiling over and above business as usual ahead of 31st October as it could cause shortages in other areas, which could put patient care at risk. Patients do not need to personally stockpile medicines.

The DHSC are committed to sharing information and guidance at the earliest possibility to enable correct planning, also to ensuring that the number, length and complexity of requests for information is minimised before being issued.

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