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.

No comments:

Post a comment