Written question asked by Lord Warner (Crossbench) on Monday, 7 January 2019, in the House of Lords. It was due for an answer on Monday, 21 January 2019. It was answered by Baroness Manzoor (Conservative) on Monday, 21 January 2019 on behalf of the Department of Health and Social Care.
NHS: Drugs
- Question
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To ask Her Majesty's Government, in relation to the proposed changes to the Human Medicines Regulation 2012, as outlined in the document Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal, published on 4 January, what will constitute a ‘serious shortage’ in the Serious Shortage Protocol; how such a circumstance will be determined by the Department of Health and Social Care; what is the procedure for determining the content of the Serious Shortage Protocol; what governance processes will be applied to the protocol including how (1) manufacturers, and (2) Market Authorisation Holders will be engaged in any governance; and whether manufacturers must be the primary party to establish which products are listed as being in “serious shortage”.
- Answer
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The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.
A protocol is only one of the tools that can be used to manage shortages. The Department has well-established governance processes for managing shortages in collaboration with manufacturers and suppliers, clinicians and the National Health Service and the Medicines and Healthcare products Regulatory Agency. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder.
Whether a serious shortage protocol is issued is a decision by Ministers but that decision would be taken after discussion with the manufacturer and/or marketing authorisation holder. Manufacturers are not the primary party to establish which products are listed as being in serious shortage.
Secondary information
- Type
- Written question
- Reference
- HL12632
- Session
- 2017-19
- Subjects
- Drugs NHS Manufacturing industries Medical equipment Regulation Shortages Clinical trials Brexit
- Legislation
- Human Medicines Regulations 2012
- Link
- View this Written question on www.parliament.uk
Librarians' tools
- Timestamp
- 2019-01-21 17:21:39 +0000
- URI
- http://data.parliament.uk/writtenparliamentaryquestion/lords/2017-19/HL12632
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