Back in 2011, a consultation was launched regarding consolidation of the Medicines Act 1968 and the plethora of other medicines legislation/regulations that can grown up around it. Medicines regulation had become fragmented, difficult to comprehend and in places even contradictory.
The intention of consolidation was not to make any substantial changes to legislation, some minor tidying up at most but it did cause some consternation amongst homeopaths, the homeopathic pharmacies and supporters of homeopaths.
This is well documented elsewhere. In essence, the concern was that the consolidation would make the supply of certain homeopathic medicines to/by lay homeopaths illegal. In reality, it was already illegal and still is.
Such was the concern amongst homeopathy supporters that they made representations to the Department of Health (as it was then called). It responded in the form of a letter.
Denial is a common mental state in homeopathy. Selective reading of clear English is a common cognitive problem. Misrepresentation of facts is deeply engrained in homeopathy.
The letter does not say what homeopaths made it out to say. Far from it.
Lord Howe Letter
Earl Howe, Frederick Curzon, was at the time the letter was written, Parliamentary Under-Secretary of State for Health. His letter (to the Society of Homeopaths) is reproduced below -
Thank you for your letter dated 20 June 2012 concerning the Consolidation and review of the Medicines Act 1968 (Consultation MLX 375) and its impact on the continued availability of unlicensed homeopathic products.
I understand that you have also written to the Medicines and Healthcare products Regulatory Agency (MHRA) about this issue. Please accept this as a response to both letters.
You asked for clarification as to why Section 10 of the Medicines Act is not being consolidated. The MHRA's response to the consultation is now available on the Agency's website; the document presents a summary of responses received and a commentary on key issues raised, including those raised by homeopathic interests. In summary the response indicates that the decision not to consolidate section 10 of the Medicine Act was made following careful consideration of the potential legal consequences of doing so. Ultimately it was felt that consolidation could not safely be done without compromising the legal effect of these regulations.
As you know the consolidation does not, and was never intended to, change either the current regulatory status of regulations governing homeopathic medicinal products or their sale and supply. It was also never the intention to change the way the MHRA approached the enforcement of these provisions. I think would be useful if I clarified the effects of Section 10 as they affect homeopathic products. Starting with Section 10(4)(a); this does not apply to the supply of homeopathic products in isolation, but relates to the supply of an extemporaneously prepared medicine in a pharmacy by a pharmacist using their professional judgement as requested so to do by a patient present in the pharmacy at the time of the request. Section 10(4)(a) broadly exempts the pharmacist from the requirements for a manufacturer's licence to be able to prepare the product, and for a product licence, to be able to supply the product to the patient.
Section 10(3) of the Act on the other hand provides an exemption to pharmacists from the requirements for a product or manufacturer's licence, for the supply of a medicinal product prepared to the specification of the client of the pharmacist. The supply of unlicensed products under Section 10(3) does not require a face-to-face consultation and so a product may be ordered by telephone, mail order or by way of the internet, although such products can only be supplied to an individual for their own use or administration to a member of their immediate family (for example supply to the parent or guardian of a child). I understand it is under the scope of Section 10(3) that the registered homeopathic pharmacies operate their online "remedy stores".
Changes such as those suggested by the Society and others both to me and in response to the consultation would require detailed consideration of both the policy and legal implications; not only in terms of how they would impact on homeopaths or pharmacists but also on public safety. For example exempting homeopathic medicines prepared at a dilution of one part in a million (6X) or greater, from the provisions of section 10 and regulation 195 of the Act would need detailed consideration of the safety implications. Dilution alone is not sufficient to ensure the biological safety of the first safe preparation and needs to be considered with a number of other factors.
You are, I know, aware that I recently met with a number of representatives of the homeopathic sector to discuss these issues. At this meeting I made clear that the Government's position on patient choice and the availability of homeopathic products has not changed. It should also be remembered that any proposals for change in medicines legislation to relax regulation in respect of homeopathy would require a full public consultation and therefore would need to be considered separately from these Regulations coming into force.
It should also be kept in mind that any changes in this area would inevitably prove controversial, and would likely lead to pressure for other changes in an adverse direction for homeopathy. While I cannot realistically see this being a priority in the immediate future I would be happy to meet with representatives of the homeopathy sector if there were any significant changes to the present situation.
What does this mean?
It means that back in 2012 the Society of Homeopaths (SoH) were aware of the legal restrictions on the supply of unlicensed medicines re lay homeopaths. It indicates that "representatives of the homeopathic sector" were also aware - this is understood to include the homeopathic pharmacies. It is believed that other trade associations such as the Alliance of Registered Homeopaths know of the legal restrictions.
Yet these restrictions are widely ignored. Enforcement of regulations pertaining to unlicensed medicines is rarely a priority for the MHRA or the General Pharmaceutical Council (GPhC) which sets standards for pharmacies and pharmacists. However, a very strong case can be made that enforcement re products used in CEASE therapy absolutely should be a priority. Dealing with these products in theory could lead to a situation where regulation was enforced across all unlicensed homeopathic medicines but historically, the MHRA have only ever dealt with individual problem products (the diet scam homeopathic hCG for example).
This is issue is a "loaded gun" for the SoH if they wish to retain Professional Standards Agency (PSA) Accredited Register status.
A next step?
Whilst it would be difficult, it would be possible to create a list of nearly every practising lay homeopath in the UK. This list would also include naturopaths (who often use homeopathy). It could be extended to include those regulated medical professions who used homeopathy but do not have (sufficient) prescribing rights to prescribe unlicensed products.
This list could be supplied to the homeopathic pharmacies, the MHRA and the GPhC and trade associations representing lay homeopaths, naturopaths etc along with text pointing out the legal restrictions on supply.
Individual practitioners could be contacted pointing out the restrictions. It may well be the case that they have no idea that they exist. If they belong to a trade association, there are some questions that need to be asked but...
These kinds of measures would not be required if the UK homeopathy community took public safety seriously, rather than paying mere lip service to them. If it dealt with things like CEASE therapy, restricted its activities to "treating" those able to consent and to minor conditions, did not dispense "advice" and spread misinformation that is injurious to individual and public health, there would be no problem.