Section 12(1) of the Medicines Act 1968

The disagreement between herbalists who want to be recognised by the state and those who don’t want to be organised is as old as the hills. Those of you who have willed for statutory regulation (SR) are on the eve of achieving your dream, and we hope you will make the very best you are able of the trials and the opportunities it will present. However, there is one last bit of business to attend to, which might even unite us briefly, in countering the proposal to reform Section 12(1) of the Medicines Act 1968. We hope you will take up this cause as it profoundly affects the future and security of those choosing to work in a regulated environment, as well as the rest of us.

Firstly, here is Section 12(1) itself:

Section 12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—

(a) the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and

(b) the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.’

Secondly, here is an extract from the statement released by the MHRA on February 16th 2011:

‘If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.’*

*Greater detail on the background to this, for instance, what Article 5(1) is all about, is covered in ‘Statutory Regulation Facts & Fictions’. Meanwhile, here’s our analysis of the current situation:

Why we all need to keep Section 12(1) of the Medicines Act 1968 unchanged

To the UK Government: Reforming 12(1) is not necessary to comply with the Traditional Herbal Medicine Products Directive (THMPD). Restricting all unlicensed medicines to the exclusive use of regulated practitioners would effectively outlaw the many herbalists who will not register with the HPC. This is not simply a matter of bowing to pressure groups or even the wishes of the majority:  it’s also important to protect individual choice, applicable where such choices neither cost the public purse nor cause harm. Those who for whatever reason choose to consult with unregulated herbalists should still be able to do so legally under the caveat emptor principle, thus upholding fairness and common law rights. It also avoids the future potential embarrassment of prosecuting UK citizens for doing no harm.

It is clear from the disclusion of acupuncturists from the regulatory process that the Department of Health sees no need to regulate complementary therapies per se. To regulate herbalists beyond what is required to comply with the THMPD makes a mockery of the principle of proportional legislative impact, and thus inexplicably discriminatory.