Thursday, 22 December 2016

Norway and Homeopathy

Currently, Norway has no specific legislation relating to homeopathic medicines. This is will change and will have major implications for Norwegian lay homeopaths.

Norway and the European Union
Although Norway is not a member of the EU, it is a member of the European Economic Area. In short, Norway implements much of EU law in order to gain access to the European Single Market. It has some key exemptions though that relate to fisheries and agriculture.

Regulatory Background
Norway does permit the practice of alternative therapies by the non-medically qualified although this is a recent innovation. Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) is the law in question. Fortunately, Google Translate does a very good job of turning it into English.

The key point about this law is that it prohibits the non-medically qualified from  -

  • Performing treatments or interventions that carry a serious health risk
  • Treatment of communicable diseases (although it does permit treatment to alleviate symptoms there of or side effects of conventional treatment - but only a medical professional can treat the disease itself.
  • Treatment of serious conditions and diseases (although, again, alleviation etc are permitted)
Where Norwegian law differs from UK law is that it makes doing any of the above a criminal offence, carrying possible fines and prison sentences. It also regards a patient not seeking proper treatment as the fault of the non-medical practitioner as well as making ignorance of putting a patient at danger inadmissible as a defence.

There are also restrictions on advertising which can only be a factual description of the business.

Norwegian medicines law does make mention of homeopathic medicines. Lov om legemidler m.v. (legemiddelloven) (Law on Medicinal Products, etc (Medicines Act)) is the main law but it doesn't explicitly mention homeopathy. Forskrift om rekvirering og utlevering av legemidler fra apotek (Regulations relating to the requisition and provision of medicines from pharmacies) mentions homeopathic medicines very briefly to say that they must carry a statement that the effects of the medicine are not "considered" or "rated". It talks in terms of homeopathic medicines that are available without prescription.

Forskrift om legemidler (legemiddelforskriften) (Regulation on Medicinal Product (Medicinal Products Regulations)) is probably the most important law. It came into force in January 2010. Again, Google Translate does a very good job of making sense of it. Some of it is very familiar, which is unsurprising. A cursory examination of the references reveals reference to EU Directives.

The law requires medicines to have a Marketing Authorisation. There are exceptions. The most important from the perspective of this article are -

  • Magistral formulas - medicines compounded by a pharmacy on according to a specification provided by a customer (although the nature of that customer is not clear ie medical professionals only?)
  • Officinal formulas - medicines compounded by a pharmacy in accordance with a pharmacopoiea for dispensing to customers of the pharmacy only.
  • Homeopathic medicines - providing them meet specific requirements.

This law allows the import of homeopathic medicines into Norway as long as they are registered in another EEA member country for a period of seven years. It also creates a Simplified Scheme for the registration of homeopathic medicines in the same manner as EU regulations. Norway does not have any homeopathic medicine manufacturers itself.

It places restrictions on the advertising of homeopathic medicines. As no claims are permitted, essential only flat lists are permitted.

Although the law provides exemptions for doctors and dentists to obtain medicines other than authorised/registered in Norway, in the case of homeopathic medicines it only allows those registered in other EEA member states.

It's also worth pointing out that Norway takes a strong line on the personal importation of medicines - effectively only allowing what is authorised/registered in Norway . Medicines can be seized and destroyed.

What is about to happen?
The seven year period is about to expire on 12/01/2017. The Statens legemeddelverk (SLV) will publish a list of homeopathic medicines registered up to that point. After a three month transition period, anything not on that list will not be permitted to be sold. How many registered homeopathic medicines will be on that list is unknown. Whilst the registration fees are set at a nominal level, the preparation of documentation is onerous (even if SLV will accept English). Norway is a small market and homeopathy is much less common than some other EEA member states. It does not seem likely that many products will be registered.

The supply of homeopathic medicines could be restricted to a handful of products. This has implications for both lay and medical homeopaths. It could make practice very difficult if not impossible.

Update 03/04/2017
The SLV has now published the list of registered homeopathic medicines. 
Hom√łopatiske legemidler tillatt omsatt etter 1.7.2017 - laveste fortynningsgrad
Is what you mean to look at. The associated news item states that these will be the only permitted homeopathic medicines in Norway come the 1st July 2017.

The number, 420 (excluding variations in potency) is surprisingly high - more than the UK. As applications for registration can be made in Danish, Swedish and English, it's no surprise to see products from a Swedish manufacturer, but Austrian and German? It's not known what language their submissions were made in. It may be the case that those manufacturers had already prepared dossiers for registration in other countries (e.g. Denmark and Sweden, both of which are bigger potential markets than Norway) they could simply reuse them. What is telling is that Boiron could not be bothered to register any products. Nor could any of the UK manufacturers. Perhaps Brexit and being outside of the Single Market represented too much risk for them? Speculation is pointless.

Further analysis of the list is required and the SLV do need to be asked some questions but in general, homeopathy practitioners should be happy with the outcome. 

Tuesday, 6 December 2016

Regulation in Eire

Irish law relating to homeopathic medicines is similar to UK law. This is not surprising given a lot of it comes from EU Directives. However, Irish law is structured differently. The situation in Eire is potentially more problematic than in UK.

Recognition of Homeopathy
The situation regards the recognition of homeopath is largely the same as in the UK. As a partly common law jurisdiction, Eire does not prohibit the practice of homeopathy but does not it recognise it or its practitioners. A lay homeopath in Ireland has no special status. They are just another member of the public. Medically qualified homeopaths are recognised because of their qualifications and registration.

Medicines Regulation
Eire, like the UK, implemented EU Directive 92/73/EEC which was replaced by 2001/83/EC. Both are long documents. Article 13 of the later states
1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.
This also imposes the duty on Member States to ensure that unregistered or unauthorised homeopathic medicines are not placed on the market. In the case of Eire, these duties fall to the Healthcare Products Regulatory Agency. This Directive also provides an exemption for medicines prepared in a pharmacy under certain conditions.

In terms of Irish legislation the Medicinal Products (Control of Placing on the Market) Regulations 2007 is a good place to start. Irish legislation is a little hard to follow as it comes in multiple regulations.

Requirement for an authorisation or certificate to place a medicinal product on the market.
6. (1) Subject to the provisions of these Regulations, a person shall not place a medicinal product on the market unless such product is the subject of—
(a) a marketing authorisation,
(b) a Community marketing authorisation,
(c) a certificate of registration, or
(d) a certificate of traditional-use registration,
and, in each case, such authorisation or certificate is for the time being in force.
(2) A person shall not in the course of a business carried on by him, sell, supply, manufacture, or procure the sale, supply or manufacture or have in his possession a medicinal product unless he or she has reasonable cause to believe that the product was or is intended to be—
(a) placed on the market in compliance with paragraph (1), or
(b) placed on the market in another EEA State in accordance with the corresponding provisions as required by that State pursuant to the 2001 Directive.

A certificate of registration is for homeopathic medicines.

Authorisation of homeopathic medicinal products under national rules.
11. (1) Notwithstanding the provisions of Regulations 9 and 10 insofar as those provisions relate to the requirements for pre-clinical tests and clinical trials, the Board may grant a marketing authorisation in respect of a homeopathic medicinal product other than a product referred to in Article 14.1 of the 2001 Directive.
(2) For the purposes of obtaining an authorisation in accordance with this Regulation and subject to paragraph (3), the applicant shall demonstrate to the satisfaction of the Board—
(a) that the product is a homeopathic medicinal product which conforms with the principles and characteristics of homeopathy as practised in the State;
(b) that the indication sought is appropriate to such a homeopathic medicinal product;
(c) that any such indication shall be suitable for use without the intervention of a registered medical practitioner for diagnostic purposes or for prescription or for the monitoring of treatment;
(d) that the efficacy of the product shall be established on the basis of evidence that the particular class of homeopathic medicinal product has been in use in the State as a homeopathic treatment for the indication sought; and
(e) that the safety of the homeopathic medicinal product has been established in the manner set out in paragraph (3).
(3) For the purpose of this Regulation and subject to subparagraph (4), the safety of the homeopathic medicinal product shall be demonstrated—
(a) by reference to relevant published literature or original data having regard to the proposed route of administration and the dilution involved; or
(b) in the case of stocks derived from substances commonly used in food, by means of a statement setting out the homeopathic nature of the product and the absence of any change to the route of exposure for the substance concerned; or
(c) in the case of an active principle used in allopathic medicinal products, by establishing that the dilution of the stocks is at least 1 in 10,000 of the mother tincture or not more than one hundredth of the smallest dose of the said active principle as used in allopathy; or
(d) by establishing that the medicinal product contains not more than one part per 10,000 of the mother tincture.
(4) In regard to the active principles referred to in subparagraphs (3)(c) and (d), the Board may refuse to grant an authorisation where it is satisfied that the active principle concerned is toxic and as such would present concerns in regard to the safety of the product. For the purposes of this subparagraph, the Board may publish and update from time to time a list of the substances that it considers to be in this category.
(5) A homeopathic medicinal product that is placed on the market on foot of a marketing authorisation granted in accordance with this Regulation shall, in addition to compliance with the requirements of Regulation 16 (relating to labelling and package leaflets), be presented in such a manner as to show—
(a) that the product is a homeopathic medicinal product in respect of which an authorisation has been granted in accordance with this Regulation;
(b) that any evidence of efficacy on the part of the product has not been based on the outcome of clinical trials;
(c) that use of the product is only intended for the symptomatic relief of the condition to which the indication specified relates; and
(d) that the user is advised to consult a doctor or other healthcare professional if the symptoms persist.

This is roughly the same as the National Rules scheme in the UK.

2. The provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to the sale or supply of a medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients, but such sale or supply shall be subject to the conditions specified in paragraph 3.
3. The conditions referred to in paragraph 2 are that—
(a) the medicinal product is supplied to a practitioner or for use in a pharmacy under the supervision of a pharmacist, in accordance with paragraph 2;
(b) no advertisement or representation relating to the medicinal product is issued with a view to it being seen by the general public in the State and that no advertisement relating to the product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling the product by retail or by way of wholesale dealing or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order;
(c) the manufacture of the medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that the product is of the character required by and meets the specifications of the practitioner who requires it;
(d) written records as to the manufacture in accordance with subparagraph (c) are made and maintained and are available to the Board on request;
(e) if the medicinal product is manufactured in the State, or imported into the State from a third country, the product—
(i) is manufactured or imported by the holder of a manufacturer’s authorisation which relates specifically to the manufacture or import of the medicinal product to which paragraph 2 applies; or
(ii) has been manufactured or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the Board in respect of such products under Regulation 37 of the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 or Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007; and
(f) the medicinal product is distributed by way of wholesale dealing by the holder of a wholesaler’s authorisation or by the person who has manufactured or imported the product, being the holder of a manufacturer’s authorisation which relates specifically to the manufacture or importation of the medicinal product concerned.
4. (1) Subject to the following subparagraphs, the provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to anything done—
(a) by a practitioner which relates to a medicinal product specially prepared by him, or to his order, for administration to one or more of his patients, and consists of procuring the manufacture of a stock of the product with a view to administering it to such patients; or
(b) in a pharmacy and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture of a stock of medicinal products with a view to dispensing them in accordance with paragraph 2.
(2) The exemption conferred by subparagraph (1) shall not apply to procuring the manufacture of medicinal products unless those products are to be manufactured by the holder of an authorisation referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture of the medicinal products to which paragraph 2 applies.
(3) The exemption conferred by subparagraph (1) shall not apply to anything done by a practitioner in relation to a stock held by him or her of such medicinal products in excess of 3 litres of fluid and 1 kilogram of solids of all medicinal products to which that subparagraph relates.

Critically the definition of a "practitioner" is given as "a registered dentist or a registered medical practitioner".

4 Exemptions from the requirement that medicinal products be licensed

4. The provisions of article 3 shall not apply as respects —
(a) the sale of a medicinal product by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the product is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;
(b) the importation or sale of a medicinal product by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care;
(c) the importation of a medicinal product by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public;
(d) the importation or sale of a medicinal product solely for the purpose of its being exported;
(e) the manufacture or importation of a medicinal product which is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987).

(a) would appear to grant an exemption to pharmacies. The meaning is not entirely clear. It could be read as applying only to transactions that take place in a pharmacy. The Regulations 1998 do not provide a definition of "medical prescription" but it could be understood as a prescription provided by a registered medical practitioner.

8 Homeopathic medicinal product

8. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medicinal product which satisfies the conditions set out in sub-article (2) to any person who makes application in writing for such certificate and for such purpose the information, documents, samples and other material required by the Board shall be as specified in the Third Schedule.
(2) Subject to sub-article (3), the conditions to be met for the purpose of registration under sub-article (1) are that the homoeopathic medicinal product shall be such that-
(i) it is intended to be administered orally or externally;
(ii) no specific therapeutic indication appears on the labelling of the product or in any information relating thereto; and
(iii) there is a sufficient degree of dilution to guarantee safety.
(3) The homoeopathic medicinal product shall not be considered to have a sufficient degree of dilution to guarantee safety if -
(i) in the case of a medicinal product containing an active principle the presence of which in an allopathic medicinal product would, by virtue of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. Nos. 256 and 309 of 1993), require the presentation of a prescription issued by a registered medical practitioner in order that the said product may be supplied, if it contains either more than one part per 10,000 of the mother tincture or more than one hundredth of the smallest dose of the said active principle as used in allopathy, or
(ii) in any other case, if it contains more than one part per 10,000 of the mother tincture.
(4) The registration referred to in sub-article (1) shall be subject to the conditions specified in the Fourth Schedule.
(5) Unless sooner revoked by the Board, the aforementioned registration shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the certificate concerned.
(6) The provisions of Articles 5 and 9 shall apply to homoeopathic medicinal products to which this article relates as if the references in those articles to efficacy and therapeutic efficacy had been omitted.
Which is the equivalent of the UK Simplified Scheme.

The Problem
It would appear that the supply to and by lay homeopaths of unregistered homeopathic remedies in Eire is of dubious legality.

There would appear to be no pharmacy that compound homeopathic medicines and even if there were, it seems unlikely that they could supply lay homeopaths.

There appears to be one manufacturer of homeopathic medicines in Eire. New Vistas Healthcare and it has the most curious website. It restricts access to certain product listings to those registered with the site. There is an application form on the site which includes the curious wording.
Approved users are able to access the secure Practitioner Support section. Approved users will also be able to access the full product range on the online shop. All customers wishing to buy products need to be approved as legally we are only permitted to ship to an end user who is under the guidance of a trained therapist or a qualified and approved professional themselves.
This would appear not to be the case. It would appear that they can only supply registered medical practitioners.

Saturday, 3 December 2016

Medicines Regulations

The Society of Homeopaths (SoH) as well as the Alliance of Registered Homeopaths and the Homeopathic Medical Association all have Codes of Ethics and Practice that require members to make themselves aware of both civil and criminal laws and to abide by them. The same is true for other voluntary registers that may choose to accept homeopaths.

But there seems to be a problem...

Consolidation of Medicines Legislation
Since the passing of the Medicines Act 1968 there were numerous pieces of legislation passed that either amended the Act or stood along aside it. Medicines legislation had become complicated, unwieldy, unclear and in some cases almost incomprehensible.

It was decided to consolidation almost all legislation into a single piece of legislation. As it transpired, certain key exemptions in the Act were not consolidated.

There were consultations prior to the consolidation. Something that became apparent around this time was that there were legal restrictions on unregistered homeopathic medicines, which many in UK homeopathy seemed to be previously unaware of. There were attempts to lobby for changes to legislation but nothing came of it, unless you count looking foolish. It would not have been possible to amend the legislation without first seeking amendments to EU Directives.

The consolidation resulted in the Human Medicines Regulations 2012.

The Problem
In short, medicines legislation has long placed restrictions on the supply of unlicensed medicines. Unregistered homeopathic medicines are treated in exactly the same as unlicensed medicines in law.

Whilst the supply of unregistered homeopathic medicines by homeopathic pharmacies to the general public, and by lay homeopaths to their clients continued for many years in an uninterrupted manner (less so these days) the legality of both is questionable.

Human Medicines Regulations 2012
This is a huge piece of legislation. The relevant elements that relate to advertising were discussed in a previous post including the most important part that relates to the prohibition on sale, supply or promotion of unlicensed medicines.

There are exemptions to this overall prohibition.

PART 10Exceptions to requirement for marketing authorisation etc


Supply to fulfil special patient needs

167.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—
(a)the medicinal product is supplied in response to an unsolicited order;
(b)the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;
(c)the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and
(d)the following conditions are met.
(2) Condition A is that the medicinal product is supplied—
(a)to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or
(b)for use under the supervision of a pharmacist in a registered pharmacy, a hospital or a health centre.
(3) Condition B is that no advertisement relating to the medicinal product is published by any person.
(4) Condition C is that—
(a)the manufacture and assembly of the medicinal product are carried out under such supervision; and
(b)such precautions are taken,
as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.
(5) Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.
(6) Condition E is that if the medicinal product is manufactured or assembled in the United Kingdom or imported into the United Kingdom from a country other than an EEA State—
(a)it is manufactured, assembled or imported by the holder of a manufacturer’s licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or
(b)it is manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the licensing authority for the purposes of regulation 36 of the Clinical Trials Regulations.
(7) Condition F is that if the product is imported from an EEA State—
(a)it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State; or
(b)it is manufactured or assembled as an investigational medicinal product in that State by the holder of an authorisation in relation to its manufacture or assembly in accordance with Article 13 of the Clinical Trials Directive as implemented in that State.
(8) Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer’s licence in relation to the product in question.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising). 

From the above, it is clear that this exception relates purely to "a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber" and really only to the former two. Also, "is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient".

This exception would not apply to a lay homeopath.

Medicines Act 1968
The Regulations 2012 crucially did not repeal Section 10 (3) and (4) of the Act 1968. These relate to particular exemptions for pharmacists in the supply of unlicensed medicines. Although they were presented in a previous post, they be repeated here.
(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, or 
(b)the product, not being a vaccine, plasma or serum, is prepared or dispensed for administration to an animal or herd which is in the possession or under the control of that person.
(4)Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act 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, or 
(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business;

(4) is easiest to understand. (b) is largely irrelevant as only one pharmacy that prepares homeopathic remedies has a branch. Essentially (a) states that a pharmacist can dispense an unregistered homeopathic medicine to a person who is present in a pharmacy. It does not state "under the supervision of a registered pharmacist" or similar and may prevent a pharmacy assistant from dispensing. It also has implications for any pharmacy that has lay homeopaths onsite providing unregistered homeopathic medicines to customers if the whole premises is registered as a pharmacy. It also has implications for the supply of unregistered homeopathic medicines to such lay homeopaths.

(4) (b) turns out to be a little more complicated. It permits a pharmacy to hold stocks that can supplied in circumstances described in (3) (a) and (4) (a) (the subsection (1) (a) referred has been transposed in the Regulations 2012).

(3) (a) is less than clear. It makes no mention of where this transaction takes place. "That person" is clear enough but "a person under his care" is not. No interpretation is provided, nor has research revealed a legal definition. However, there are certainly situations when it clear that someone is under the care of another -
  • A child or other family member dependent (eg elderly relation lacking mental capacity) on the person
  • A child and a foster carer (although less straight forward in the case of specialist therapeutic fostering)
  • A person (ward) under the protection of a legal guardian (be they a minor or of diminished capacity - tend to learning disabled adults)
  • A person (ward) under the protection of the Courts
  • A person of diminished capacity and someone who is either a deputy or has power of attorney
The question of being under the "care" of a doctor would seem to be redundant as there are other exemptions in legislation that would allow a doctor to obtain unlicensed medicines full stop, let alone unregistered homeopathic medicines - although if they are employed by an organisation such as an NHS Trust, that organisation may have its own rules about the use of unlicensed medicines (see here for an example). Lay homeopaths do not enjoy those exemptions - they are merely members of the general public as far as legislation is concerned. It is also important not to confuse "a person under his care" with duty of care.

It would seem unlikely that the client of a lay homeopath would be "a person under his care", however without case law this is not certain. If the definition of "a person under his care" did include the patient of a medical professional, the client of a lay homeopath would still not meet this definition. Whilst the law does not forbid the practice of homeopathy, it does not recognise it as medical treatment. It recognises the professional status of the medically qualified.

The Lord Howe Letter
Lord Howe was formerly Parliamentary Under-Secretary of State for Health. During the confusion that preceded the passing of the Regulations 2012, Lord Howe, purportedly behalf of the Department of Health (DH) and the MHRA, sent a letter in that capacity. To whom it is unclear and the exact contents of that letter are currently unknown. Bits of it have been quoted as seen in the previous post but the key points are -
Section 10(4)(a) broadly exempts the pharmacist from the requirements for a manufacturer’s license to be able to prepare the product, and for a product license, 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 requirement for a product or manufacturer’s license, for the supply of a medicinal product prepared the specification of the client of the pharmacist.
This appears very different from the Act 1968. Lord Howe does not have a legal background himself. The interpretation of this part of the Act 1968 must have been supplied to him. The interpretation of the Act would, at face value, appear to be incorrect. Also, it must be understood that a letter from a Minister has no legal value in itself. It may represent a position but it is not legislation.

Legislation not enforced
The MHRA are responsible for Human Medicines Regulations 2012 enforcement. Whilst the MHRA are very proactive in some areas regarding non-compliance, in others they are not. It is very clear that unregistered homeopathic medicines etc are not a high priority. Enforcement actions are rare against vendors are rare but not unknown.

However, enforcement is irrelevant if a (voluntary or otherwise) regulator has a Code of Ethics and Practice that requires compliance with legislation. Some regulators may overlook certain non-compliance but this is not possible for all, especially those that have overseeing bodies.

Homeopathic Pharmacies
There are a number of pharmacies and manufacturers of homeopathic medicines in the UK. In no particular order -
  • Helios - manufactures GSL remedies, pharmacy (and London branch), supplies unregistered homeopathic medicines, has clinic with lay homeopaths
  • Ainsworths - manufactures GSL remedies (on separate site), pharmacy, supplies unregistered homeopathic medicines, has clinic with lay homeopaths
  • Nelsons - manufacturers GSL remedies (on separate site) which are also rebranded by Boots, pharmacy, supplies unregistered homeopathic medicines, has clinic with lay homeopaths
  • Freemans - pharmacy, supplies unregistered homeopathic medicines
  • Buxton and Grant - pharmacy, supplies unregistered homeopathic medicines
  • Sanjivani pharmacy, supplies unregistered homeopathic medicines, has clinic run by pharmacist
There are also importers and distributors of homeopathic medicines. These will be discussed in a later post. Weleda is ignored here.

Implications of Medicines Regulation for Pharmacies
It is clear that all of the above are permitted to supply unregistered homeopathic medicines to patients in their pharmacy if the pharmacist is dispensing.

It is also clear from a previous post that advertising of unregistered homeopathic medicines is strictly forbidden. To quote from the MHRA Blue Guide again.
These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.
What is said elsewhere to be acceptable is a flat list of remedies with no direct online purchase facility. An online free text order form is considered acceptable. However, Helios, Ainsworths, Nelsons, Buxton and Grant, and Sanjivani all do so. Only Freemans meets the requirement.

It is understood that this has been the subject of complaint to both the MHRA and the General Pharmaceutical Council (GPhC). That these online purchase facilities still exist suggests that neither organisation is troubled by them.

None of the websites state anywhere the restrictions on who can purchase unregistered homeopathic medicines. No test is made during purchase, no mention is made in their terms and conditions. However, Helios do offer discounts to lay homeopaths who set up an account so their status to known to them.

It is unclear what requirements there are for a pharmacist to determine whether a customer who is not a patient present in the pharmacy falls into the category of a person who will administer the unregistered homeopathic medicine to themselves or a person under their care. It is also unclear whether failing to do so would incur any liability on the part of the pharmacist. Given that the supply of unlicensed medicines does place a liability on pharmacists, it would not be totally unreasonable to suggest that it does.

Potential abuse of Section 10 exemptions
This is not to say that any of the above Manufacturers do abuse these exemptions, merely that there is the potential for abuse and also a lack of clarity.

There are various ways in which the exemptions could be abused but only two are of real concern and they are getting round the requirement for a Manufacturer's "Specials" Licence or, if a pharmacy that is also a Manufacturer, getting round the restrictions placed on the supply and advertising of "specials".

Helios, Ainsworths and Freemans have specials licences. Nelsons (or A Nelson as it gets called in other places) does not.

A regular high street pharmacy does not have the equipment to compound medicines (beyond the very trivial). Nor has it the ability to synthesise the active components of a medicine. The days of individual pharmacists compounding medicines, by and large, are long gone. Whilst it is true that some medicines are still obtained from natural products by a process of extraction and purification, many involve complex chemical reactions, possibly including the use of dangerous reagents. That is well beyond a regular high street pharmacy.

Compounding pharmacies still exist in hospitals. What hospital pharmacies do varies according to the specialism of the hospital. Increasingly, there is a tendency for "centres of excellence" - a few very specialist centres will treat certain rarer/more difficult conditions rather than the local general hospital. 

There is an increasing tendency for hospitals to seek "specials" from manufacturers. There are various reasons for this. Some are way beyond the scope of this blog but it is fair to say that economies of scale could be achieved by having a single source for multiple hospitals for frequently requested unlicensed medicines.

There have been problems in the US with compounding pharmacies. The US has a different regulatory system, which has been changed as a result of this scandal. However, it does demonstrate that once a pharmacy moves beyond compounding medicines in response to individual prescriptions, it could be considered to be in the business of manufacturing. The Section 10 exemptions do not permit this in the UK.

It has been mentioned in other places that the MHRA would prefer that a Manufacturer's "Specials" Licence is held if the volumes of unlicensed medicines produced are above an unspecified limit or the synthesis and compounding of the unlicensed medicines involved is judged to require more serious standards and oversight.

Very complicated
To register a pharmacy with the General Pharmaceutical Council (GPhC) an application form has to be completed along as part of the process. Crucially, plans of the pharmacy are required 
11.3. Plans The plans you submit should: 
  • Identify the dimensions of the registered area (please indicate area in m2).
  • Be drawn to scale.
  • Identify the dimensions of the dispensary (please indicate in m2).
  • Clearly show the internal layout showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored.
  • Detail the postal address of the building in which the premises is situated.
  • Detail any other relevant information including access points.
It is key that an "area" is registered. It is common now for some supermarkets to have a pharmacy inside them. The whole of the supermarket is not registered, just the "area" that is the pharmacy.

To register for a Manufacturer's "Specials" Licence also requires completion of an application form along with the submission of a Site Master File (SMF) which is a vastly detailed document including plans that go well beyond the requirements of registering a pharmacy. A full discussion of SMFs is far beyond the scope of this blog but suffice to say, the plans submitted as part of one do effectively define the area(s) that the licence applies to.

Whilst this may seem somewhat esoteric it does have potential implications for those companies that have both a pharmacy and manufacture homeopathic medicines, especially in the case where the sites are geographically different and beyond that, where areas defined in applications do not overlap.

Put simply, if unregistered homeopathic medicines are made in an area that is covered by (and only by) a "specials" license, they can only be advertised and supplied under the terms of that license ie only to medical practitioners, simple price lists, no online purchase facility - a prescription is required. If unregistered homeopathic medicines are made in an area that is a registered pharmacy, then the Section 10 exemptions are valid. If unregistered homeopathic medicines are made in an area that is both, it is unclear what the implications are although if other types of medicine were involved, it is likely that the "specials" registration would be seen as more important.

Implications for Lay Homeopaths
As the Section 10 exemptions of the Act 1968 only apply to registered pharmacies they do not apply to lay homeopaths. No mention is made of lay homeopaths in any piece of medicines regulations. So advertising and supply of unregistered homeopathics medicines by them are prohibited.

Whilst advertising of unregistered homeopathic medicines by a lay homeopath is always going to be illegal, if a very generous reading of the "a person under his care" is taken to include clients of a lay homeopaths. But even that most generous interpretation would prevent stockpiling of unregistered homeopathic medicines just in case a future client might require them. As they are not for personal use or use on a person under the care of a lay homeopath, supply by a pharmacy to lay homeopathy would be in breach of regulations.

That generous interpretation carries with it an unpleasant surprise - it places much more liability on a lay homeopath. As lay homeopaths are not regarded as medical practitioners, cases in which patients have died or been seriously harmed relying on homeopathy et al and ignoring medicine advice etc, have tended to regard the patient being responsible for their own misadventure as long as consent was given (or in the case of children being harmed, the parents). Medical practitioners are held to much higher standards and could be found criminally negligent as well as being subject to investigation by their own regulator which could strike them off. 

The only way for lay homeopaths to be certain that they are compliant with regulations is to direct their clients to order unregistered homeopathic medicines directly from a homeopathic pharmacy. However, it is clear that many do not do this. Cursory examination of websites shows that the majority of lay homeopaths include the cost of homeopathic medicines in their consultation fee. This means that either i) the lay homeopath has a stockpile or ii) the lay homeopath orders the homeopathic medicines from a homeopathic pharmacy. One thing which has been seen on some websites is the sale or offer to lend of "remedy kits". Some with indications eg "childbirth kit" - there are no re-packaged remedy kits available in the UK that are permitted that kind of indication. 

Implications for members of the Society of Homeopaths
As the SoH has Professional Standards Authority (PSA) Accredited Voluntary Register status, it must take all reasonable steps to ensure the compliance of its members or run the risk of losing accreditation status.

Interestingly, although the issue of the legality of supply of unregistered homeopathic medicines has been raised with the PSA by third parties, they seem to have chosen to be reassured by the SoH quoting the Lord Howe letter. It is impossible to know why. If the PSA's understanding of this issue changes then the SoH will have to act against its members.

If the SoH understand the risks of this happening, then there are arguments they should act now.

The SoH has a page on homeopathic medicines. When this was published in its current form is unknown.

The information is mostly correct but there are some omissions that make things less that clear.

Remedies from overseas
The majority of medicines can be sourced in the UK from one of the established pharmacies. However, patients may occasionally seek to purchase medicines from pharmacies outside the UK, for example if they are on holiday and need a remedy. In such situations, to ensure that the remedies are of good quality, it is advisable to check that the pharmacy is regulated by the relevant medicines agency in that country.

Importing homeopathic medicines from within the European Union comes within the ‘free movement of goods’, established in 1993 as one of the freedoms of the single market. However, medicines imported from outside the EU could be subject to confiscation by customs, unless they are for personal use.
It is not just a question of confiscation by customs, the MHRA have the powers to prosecute those importing medicines from overseas for distributions/supply to third parties without the correct licence.
Unlicensed medicines 
While they are prepared to quality standards, the majority of homeopathic medicines are ‘unlicensed’. The MHRA regulates the manufacture of unlicensed medicines supplied to doctors and pharmacies. The supply of medicines to homeopaths and the general public comes under the remit of the General Pharmacy Council. The main manufacturers in the UK are also pharmacies and pharmacists may legally supply unlicensed remedies to individual patients. These medicines may be ordered either by telephone or through the internet, or by going to the pharmacy in person.
Curiously, no mention is made of how unregistered homeopathic medicines are supplied to lay homeopaths legally. 

The Society of Homeopaths has updated its information on homeopathic medicines yet again although it now appears in the Find a pharmacy section. Most important of all is -
Although homeopaths prescribe remedies, they do not sell them. Only pharmacies regulated by the General Pharmaceutical Council can sell most of the homeopathic medicines available in the UK. 
These remedies are mostly classified as unlicensed medicines and are prepared in accordance with the standards of official homeopathic pharmacopoeia, which describes the manufacturing procedure and provides assurances of safety and quality. 
Pharmacies and pharmacists may legally supply unlicensed remedies to individual patients, and they may be ordered either by telephone or through the internet, or by going to the pharmacy in person.
The sale of homeopathic medicines would include where their cost is included in the consultation fee. Why this has changed is not exactly known. Of course, as explained above, it is legally questionable but this has been generally known in some circles from at the very latest 2012. This recent change is highly suggestive of the SoH either being pressured to change its guidance by a third party or having taken advice from a regulatory expert.

One implication of this is that SoH members are now prohibited from stating that the cost of homeopathic remedies is included in their consultation fee etc. Whether or not the SoH is interested in policing this is another matter. It may have no choice. It is unknown whether the Advertising Standards Authority are aware of this. As this kind of non-compliance is easy to detect, if the SoH were so minded, it would be relatively easy for them to police the marketing of members. What line the Professional Standards Agency would take if it were known that the SoH were aware of cases of non-compliance but did nothing is unknown.

However, where this is not advertised but goes on is difficult to police. In theory, it would be a matter for the MHRA. In reality they are unlikely to be concerned about individuals selling small amounts of harmless inert sugar pills. If they did anything, which is unlikely, it would be to issue a statement that sale is prohibited.

One thing that should have happened as a result of this guidance - although not explicitly stated - is that members should have disposed of any stocks of unlicensed homeopathic medicines that they hold except for any that are for personal use (including use on family members).

It is unknown exactly what the SoH have communicated to their members if at all. It seems odd that the issue has not been mentioned in Board minutes as it seriously impinges on the ability of members to do business.

For some members of the SoH who find compliance with advertising regulation difficult, this may be yet another reason for them to leave and join the Alliance of Registered Homeopaths.