In a letter dated November 6, 2019, Steve Oldfield, Chief Commercial Officer at the Department of Health and Social Care (DHSC), expresses gratitude to the industry for the high levels of preparation ahead of the October 31, 2019, Brexit deadline. 

However, he states that the multi-layered approach put in place by the DHSC remains central to helping ensure the continued supply of medicines and medical products across the UK if we leave without a deal on January 31, 2020.

In the letter, DHSC provides updates on the six components of the multi-layered approach it has required of industry in its no-deal Brexit planning, summarised as follows:

1) Improving trader readiness for new border arrangements (the dedicated trader readiness ‘Support Unit’ remains operational)

2) Building up buffer stocks (the DHSC states that “whilst we recognise that the end of year period creates specific challenges regarding inventories, nevertheless, we ask that suppliers make every effort to retain the level of stockpiles they had in place in advance of 31 October)

3) Procuring extra warehouse space for stockpiled medicines (DHSC to make available “at market rates”)

4) Securing freight capacity (the Department for Transport put in place a four-year framework for freight capacity, which DHSC is able to call-off against as needed. The current Government freight contracts, announced on 11 October, provides 6 months’ worth of capacity covering all the requirement for medical products, therefore covers the next possible no-deal date of January 31, 2020. The DHSC’s procured Express Freight Service is on hold until January 2020 when it expects to “remobilise” the service)

5) Clarifying or changing regulatory requirements (the no-deal legislation on medicines, medical devices and clinical trials put out by DHSC remains in place) 6) Strengthening the processes and resources used to deal with shortages (the serious shortages protocols (see previous blog posts on these powers) remain in place but the National Supply Disruption Response (NSDR) function has been reduced to core operating hours pending being stood up again for extended hours if we approach January 2020, 31, without a ratified deal

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

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