FOI-03409

__Request__ _This request concerns the Department of Health and Social Care’s practice of requesting quarterly “Northern Ireland generics” submissions and quarterly “Category C” submissions from pharmaceutical wholesalers._ _1. Statutory Basis & Interpretation_ _1.1_ _Please identify the specific statutory provision(s) within The Health Service Products (Provision and Disclosure of Information) Regulations 2018 that impose a routine, quarterly reporting requirement for:_ _(a) “Northern Ireland generics”; and_ _(b) “Category C” products._ _1.2_ _If the Department relies on Part 4 of the Regulations as the legal basis for these routine quarterly collections, please provide:_ _the Department’s legal interpretation supporting the use of Part 4 for systematic, cyclical, quarterly collection exercises, and_ _any legal analysis concluding that such use of Part 4 does not constitute an extension of duties beyond those explicitly set out in Parts 2 and 3._ _2. Recording Requirements & Ultra Vires Concerns_ _2.1_ _Please provide any documents, internal DHSC guidance, policy notes, or legal advice identifying where in the Regulations wholesalers are required to record, maintain or classify:_ _“Category C” status of a product; or_ _“Northern Ireland-specific” generic classifications._ _2.2_ _Please disclose any internal DHSC assessments or discussions considering whether the Department’s quarterly NI/Category C requests might be ultra vires, on the basis that:_ _Cat C is not a statutory classification under the 2018 Regulations;_ _The Regulations do not require wholesalers to record Drug Tariff reimbursement categories; and_ _Part 4 does not create new record-keeping obligations, nor does it permit the Secretary of State to require the creation of information that wholesalers are not legally obliged to hold._ _2.3_ _Please provide any DHSC reasoning or analysis addressing the legal principle that a power to request information does not imply a power to require creation of new data fields or classifications not mandated elsewhere in legislation._ _3. Internal Policy Process_ _3.1_ _Please provide any internal decision papers, policy documents, briefing materials, or emails explaining:_ _why these quarterly NI/Category C collections were initiated;_ _why they are conducted on a recurring quarterly cycle;_ _the Department’s basis for treating these as routine obligations despite Parts 2 and 3 listing only generics and specials; and_ _any internal legal review conducted prior to implementing these collections._ _3.2_ _Please provide any Regulatory Impact Assessments, Data Burden Assessments, or Equality Impact Assessments produced in relation to the NI/Category C quarterly collections._ _4. Feasibility & Compliance_ _4.1_ _Please provide any internal DHSC documents or correspondence assessing whether these collection requests may require wholesalers to:_ _generate information they do not hold, or_ _apply classifications they are not legally required to maintain._ _4.2_ _Please include any analysis of the potential impossibility of compliance for wholesalers who do not record Cat C status or NI-specific categorisation, including any discussion of whether such requests could be considered unreasonable, disproportionate, or ultra vires._ __Response__ I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested for Northern Ireland is not held by the NHS Business Services Authority. We only hold information for England. __Advice and assistance__ Having reviewed your request, I believe that it is possible that other organisations may hold some or all of the information you require. __Department of Health (Northern Ireland)__ Weblink: https://www.health-ni.gov.uk/articles/doh-freedom-information Or __Business Services Organisation (BSO)__ Corporate Services Department HSC Business Services Organisation 2 Franklin Street Belfast BT2 8DQ Tel: 028 9032 4431 Website: http://www.hscbusiness.hscni.net/ Email: [email protected] Or __Department of Health & Social Care__ __Freedom of information (FOI) requests__ Ministerial Correspondence and Public Enquiries Unit Department of Health and Social Care 39 Victoria Street London SW1H 0EU United Kingdom Email - [email protected]