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Government’s “no-deal Brexit” approach to medicine shortages challenged in High Court – Good Law Project v SSHSC

EU Law

Proceedings have today been lodged against the Secretary of State for Health and Social Care in relation to his approach to dealing with shortages of medicine in the event of a no-deal Brexit. On 9 February 2019, Regulation 9 of the Human Medicines (Amendment) Regulations 2019 came into force. This allows the Government to issue Serious Shortage Protocols where shortages of medicine are foreseen. Such a protocol will allow pharmacists unilaterally to substitute a different medicine or strength, quantity or pharmaceutical form of a medicine prescribed by a doctor. The challenge is brought on the grounds that: (1) the Government does not have the power to make Serious Shortage Protocols; (2) further and/or alternatively, Regulation 9 is unlawful because the Secretary of State conducted no equality impact analysis when making it; (3) the Secretary of State failed to take into account the NHS Constitution and, in particular, the importance of patient involvement when reaching such decisions; and, (4) the consultation undertaken by the Secretary of State – conducted informally with chosen stakeholders over 5 clear working days in December 2018 – was inadequate. Expedition was ordered by Lieven J on the same day. National media coverage on the case can be found in The Times. Stephen Knafler QC and Yaaser Vanderman are acting for the Claimant.

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