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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.
