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: Foi.bso@hscni.net 

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 - dhsc.publicenquiries@dhsc.gov.uk 



Tags: Northern Ireland generics, category c
Organization: Freedom of Information Disclosure Log