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