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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

To ask Her Majesty's Government whether they intend to include in 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, a legal definition of “serious national shortages of medicines” in any accompanying statutory instruments, to ensure that proposed changes would be (1) time limited, and (2) apply only in the event that there is a significant disruption to the supply of medicines in the event of a no deal Brexit.

Answer

As part of the preparations for a ‘no deal’ exit from the European Union, the Department developed proposals for and informally consulted with the relevant stakeholder representative bodies on a power to modify the application of the Human Medicines Regulation 2012 to deal with serious shortages in the event of a ‘no deal’ exit. This power can only be used in the case of a ‘no deal’ exit from the EU, only have effect until two years after exit day and only apply in the case of a serious shortage where one but not the only significant factor contributing to the shortage is the withdrawal of the United Kingdom from the EU.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

Secondary information

Type
Written question
Reference
HL12628
Session
2017-19
Grouped for answer
Yes
Subjects
Drugs NHS Medical devices Regulation Shortages Clinical trials Brexit
Legislation
Human Medicines Regulations 2012
Link
View this Written question on www.parliament.uk