Health and Sport Committee

Meeting date: Tuesday, October 8, 2019

Official Report 674KB pdf

Subordinate Legislation

National Health Service (Serious Shortage Protocols) (Miscellaneous Amendments) (Scotland) Regulations 2019 (SSI 2019/284)

Food Information, Labelling and Standards (EU Exit) (Scotland) (Amendment) Regulations 2019 (SSI 2019/285)

Agenda item 3 is consideration of two instruments that are subject to negative procedure, one of which—SSI 2019/285—we have just discussed.

The other—SSI 2019/284—is intended to allow pharmacists in a community pharmacy to supply an alternative quantity, an alternative pharmaceutical form, an alternative strength or a therapeutic equivalent without going back to the prescriber. At its meeting on 24 September, the Delegated Powers and Law Reform Committee determined that it did not need to draw Parliament’s attention to the instrument on any grounds within its remit. I invite comments from members.

I have an interest in SSI 2019/284. I attended an event about bioequivalence of medications and provision by different companies of medicines that are essentially the same. I am interested to find out whether issues of bioequivalence have been explored. Different definitions are used by the World Health Organization, by the Therapeutic Goods Administration in Australia, and in Europe and the USA, where the Food and Drug Administration has its own definition of bioequivalence.

I understand that pharmacists might be best placed to decide whether a drug has bioequivalents, but I also understand that GPs can take a long time to support patients with, for example, anti-epileptic medicines, warfarin and levothyroxine. I therefore think that the issue is not cut and dried.

I take your point, which is substantial. We need to report by 6 November. If the committee is so minded, we can seek clarification from the Scottish Government then consider the matter again at our next meeting or the following one. Do members agree?

Members indicated agreement.

We have discussed the Food Information, Labelling and Standards (EU Exit) (Scotland) (Amendment) Regulations 2019, which are subject to negative procedure. If members have no comments, does the committee agree to make no recommendation on the instrument?

Members indicated agreement.