The House of Lords received evidence on the Terminally Ill Adults (End of Life) Bill last week. Subject to certain safeguards, the Bill, if passed in its present form, would allow a medical practitioner who is a “coordinating doctor” to provide a terminally ill person with an approved substance that the terminally ill person could use to end their life. The Bill provides for the Secretary of State to list approved substances in Regulations. Only the coordinating doctor can provide the approved substance, but it seems likely that the coordinating doctor would obtain the substance from a pharmacy that has a wholesale dealer’s licence.
In evidence on 5 November, according to a report in the Pharmaceutical Journal, the Lords were told by Greg Lawton, a pharmacist and barrister, an approved substance would not be a medicinal product because:
“regulations define a ‘medicinal product’ as a substance with properties of preventing or treating disease in human beings or that can be used for restoring, correcting or modifying a physiological function. The drugs being used would not be medicines if being used to facilitate suicide. Such a purpose is not encompassed by the definition of medicinal product in the human medicines, regulations and case law,”
Regulation 2 of the Human Medicines Regulations 2012 defines a medicinal product as:
“any substance or combination of substances that may be used by or administered to human beings with a view to—
(i) … modifying a physiological function by exerting a pharmacological, immunological or metabolic action …”
Although the intended use of an approved substance would obviously not be a therapeutic one, some may find it hard to see why an approved substance would not be a medicinal product if it is being used to modify a physiological function (lungs and/or heart, for example) by exerting a pharmacological or metabolic action.
If an approved substance is a medicinal product, it will be an unlicensed one, which may give rise to other issues.
The Bill will go to its Committee stage in the House of Lords on 14 November. If the Bill progresses, we will keep you updated.
Very interesting, thanks for sharing. I would’ve thought that any such products would indeed be classed as medicines but likely unlicensed or used off license, such as use of misoprostol.
I believe Dechra’s euthanasia product for animals (Euthasol?) is a veterinary POM. So defitely a medicine.