Commentary on provisions of Act Section 3: Section 2: supplementary
Subsections (1) and (6) are self-explanatory.
	Subsection (2) provides that the use of certain types of medicinal products may be "innovative medical treatment" (and therefore covered by the database to be established pursuant to section 2), namely the use of medicinal products outside of their licensed indications (off label use) and the use of unlicensed medicines (e.g. UK manufactured "specials"). Whilst the description of innovative medical treatment in section 2(2) would in any event have been broad enough to include these types of treatment, this subsection makes it explicit that these uses may be innovative. These kinds of treatments are not necessarily always innovative, however, and off label use of medicines in particular may be part of standard care for some conditions.
	Clinicians are currently free to prescribe off-label and unlicensed medicinal products where this is in the best interests of a patient, and in accordance with relevant legislation and guidance. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the General Medical Council have published guidance on the "hierarchy" for the use of licensed medicinal products, off-label use and use of unlicensed medicines. The guidance states that prescribers should first consider using a licensed medicine within its licensed indications, where possible; if that is not possible, then a licensed medicine off-label should be used, and only if neither of these is available should an unlicensed medicine be considered. The guidance explains that licensed products have been assessed by the MHRA and evidence has been provided to demonstrate that the quality, safety and efficacy of the product are acceptable for the therapeutic, diagnostic or preventative use for which the product is licensed. If licensed products are used ‘off-label’, some of this assessment may not apply, but some will still be valid. This is lower risk than using an unlicensed product for which no evidence of safety, quality and efficacy have been submitted to regulatory authorities for review. Lower cost cannot justify off label use or the use of an unlicensed medicine when an alternative licensed product exists. The provisions of the Act have no impact on this hierarchy.
	Subsection (3) includes further explanation about what is understood by the off label use of medicines. It may involve the use of an authorised product (that is, a product in relation to which a marketing authorisation is in force) for a purpose, or condition, other than the one which is specified in the product’s marketing authorisation. It might also involve other departures from the product’s marketing authorisation, such as different target patient populations (e.g. use in children of a product authorised only for use in adults) and different doses or formulations. Subsection (4) cross-refers to certain definitions in the Human Medicines Regulations 2012/1916, which provide the legal framework in the UK for the regulation of medicinal products.
	Subsection (5) ensures that the database established by section 2 may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial). Such inclusion does not affect the regulation of medical research.