More on our position on UK and EU homeopathic legislation
Our article on the recent developments in UK homeopathy certainly stirred some controversy. Although this was never our intention, we knew when we published the piece that we could expect some strong responses – and so it turned out. Homeopathy is so controversial these days that any article about it that doesn’t set out to dismiss it as sugar pills and wishful thinking is almost guaranteed to elicit angry responses from the skeptic crowd. This time, though, things were a little different.
Zooming in on homeopathic legislation
We have no doubt that homeopathy works in many cases. However, the legal situation surrounding this most unique of healthcare modalities is far from clear. This legal confusion led directly to a recent campaign by representatives of UK homeopathy, worried that they were about to lose cherished prescribing rights under a reorganisation of UK medicines law being undertaken by the country’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). We decided to take a microscope to the laws pertaining to homeopathy, and came to a surprising conclusion: that homeopaths cannot lose any prescribing rights, because they never had them in the first place.
Our intention in publishing the article was to offer our opinion on the legal situation in the interests of stimulating an open and frank debate. That said, we had to think long and hard before going public with our opinion, which conflicts with the picture painted by the homeopaths’ own campaign. We weren’t surprised when we received messages from certain sectors of the homeopathic community objecting strongly to our article; they felt that we had undermined their campaign and, in the process, aligned ourselves with a member of the skeptic community. More on that later.
Anyone interested in the details of our reasoning on the legal situation should read our article in full, as all I want to do here is clarify a couple of things. The key thing to realise is that power over medicines legislation in the UK was handed from Parliament to the European Union (EU) in Brussels a long time ago, and that this affects homeopathy as much as anything else. It’s a sad reflection of an ongoing process whereby British common law is being replaced by the civil legal system common to countries like France and Germany, so-called Napoleonic law. The former essentially allows everything, except where it is specifically forbidden, whereas the latter forbids everything, unless it is specifically permitted.
At the heart of the issue, when it comes to determining the definition and scope of what constitutes a medicine, is the EU medicinal code, EU Directive 2001/83/EC, commonly referred to as the Human Medicinal Products Directive (HMPD). In this context, the most important amending Directive was 2004/27/EC, for the dual reason that it added a specific definition of ‘homeopathic medicinal product’ [Article 1(5)] and provided for simplified registration procedures for homeopathic medicines in EU Member States. In the UK, the result was the creation of the UK National Rules Scheme for homeopathic medicines. For clarity, I shall refer to the consolidated version of 2001/83/EC that includes all amendments.
Definitions and exemptions
First off, the definition of a medicine in Article 1(2) of the HMPD is wide enough to include a glass of water, so it definitely covers homeopathic remedies. Here it is in full, for completeness’ sake:
“(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
Article 2(1) of the HMPD amendment of 2004 goes on to define the Directive’s scope:
“This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.”
So, the Directive covers all ‘marketed’ medicines that are produced industrially. Licensed homeopathic medicines obviously fall into this category, but what of unlicensed ones? Again, regardless of the scope in Article 2, the definition of a medicine in Article 1(2) brings homeopathic medicines under the Directive’s sway. But, the regulator is given a loaded gun in what the European Court refers to as the ‘rule of doubt’. One article [Article 2(2)] in particular has the power to classify any substance a drug, should there be any doubt as to its status:
“In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.”
The main point at issue here is that of exemptions to the HMPD, whether for homeopathic medicines themselves or homeopathic pharmacies. Article 3 defines some exemptions to the Directive’s provisions:
“This Directive shall not apply to:
1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).
2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula).”
Since professional homeopaths don’t have medicinal prescribing rights, Paragraph 1 of Article 3 does not apply to them or to their patients. As for Paragraph 2, we believe that this is the source of some confusion – or, at least, differing interpretations of the law. Why? Well, because Paragraph 2 clearly says that pharmacies may supply medicinal products “directly” to patients. This includes unlicensed homeopathic medicines, which may be supplied to patients following a face-to-face consultation with the pharmacist, on the pharmacy premises – our interpretation of ‘direct’.
Section 10: the role of pharmacies
However, Section 10(4) of the UK Medicines Act 1968 – which the MHRA is in the process of ‘tidying up’ – provides more detail on the role of homeopathic pharmacies, muddying the waters in the process. It’s not the easiest piece of legislation to wade through, but the important bits are in Paragraphs 3 and 4:
(3) Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where —
(a) the product is prepared or dispensed for administration to that person or to a person under his care...
(4) ...the restrictions...do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of —
(a) preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist's own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed...
Paragraph 4 makes it clear that “preparing or dispensing” medicinal products, including unlicensed ones, by pharmacists for patients is fine as long as the patient is “present in the pharmacy at the time of the request”. Paragraph 3 is more ambiguous in terms of the exemption it provides, but again, it refers to “preparation or dispensing in a registered pharmacy”. We cannot see that either Paragraph 3 or Paragraph 4 of Section 10 of the UK Medicines Act 1968 allow homeopathic pharmacists to post remedies to either patients or professional homeopaths. Besides, in the eyes of the law, it’s largely academic what Section 10 says, because EU law takes precedence over UK law and Article 3(2) of the HMPD talks about “direct” supply to patients.
Messenger versus message
That, in an alarmingly bulging nutshell, is our interpretation of the law as it applies to homeopathic products and pharmacies. Purely on points of law, our interpretation happens to largely agree with that of the blogger Malleus Homeopathicum (MH), hence we pointed interested readers to the blog in our original piece. We did not lift our interpretation from MH’s blog, and neither do we agree 100% with his or her position – as we emphasised at the time. Whoever MH turns out to be, and whatever their position and beliefs on homeopathy, much of the analysis in the blog is both useful and credible. Time will tell whether this is a case of ‘consorting with the enemy’, but ANH-Intl is not in the business of dismissing relevant information on important topics.
Encouraging news and a disparaging response
MH’s response to a piece of apparent good news may be indicative on that score, however. On 27th June 2012, when homeopaths met the UK Health Secretary, Member of Parliament (MP) Andrew Lansley, he reassured them that the status quo would continue and homeopaths would be able to practise as before. Putting aside for one moment the fact that Mr Lansley has a politician’s relationship with the truth, this is worth celebrating – yet MH’s response was to grumpily hurl toys from his or her pram.
For now, it looks like professional homeopathy is here to stay in the UK, and we unreservedly welcome that decision. We also hope that our little contribution to the debate may help to provide a firm grounding as the profession cements its relationship with the existing legislation, albeit that those laws have been uncomfortably imported from the EU.