Sunday, 5 March 2017

Regulation of Veterinary Homeopathy #1

This post has been prompted by interacting with veterinary surgeons who have been campaigning against the use of homeopathy. Indeed, the Royal College of Veterinary Surgeons (RVCS) are reviewing their current guidelines on homeopathy as part of a broader review of CAM treatments.

This post will deal mostly with prescribing, supply, etc of homeopathic medicines. The next post will look at ethics and animal welfare.

Who can treat animals?
Although common law allows anyone to treat humans, as long as they do not claim to be a doctor, this is not the case with the treatment of animals. The Veterinary Surgeons Act 1966 restricts "veterinary surgery" to qualified veterinary surgeons. The definition of veterinary surgery is basically what vets do! The RVCS provide clear guidance on the implications of the Act 1966.

In short, apart from vets, the only people permitted to treat animals are the owners or a person in their employ. Lay homeopaths can not treat animals. To quote from the Society of Homeopaths' Code of Ethics -
49) Registered and student clinical members should be aware of and observe the law with regard to the treatment of animals with homeopathy.
Although they fail to say what the law is.

There are veterinarian surgeons who do practice homeopathy. There are also farmers who do. Dog breeders as well as some pet owners.

Homeopathic Veterinary Medicines
Veterinary medicines are regulated by the Veterinary Medicines Directorate and to some extent the Medicines and Healthcare product Regulatory Agency (although that only applies to manufacturers who produce both human and veterinary medicines).

Veterinary medicines are covered by the Veterinary Medicines Regulations 2013 (which are renewed periodically).

The Regulations 2013 contain a definition of veterinary medicines - 
Definition of “veterinary medicinal product”, interpretation and scope 
2.—(1) In these Regulations “veterinary medicinal product” means— (a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
And a definition of homeopathic remedies - 
PART 9 
Homeopathic remedies  
Meaning of “homeopathic remedy”  
62. For the purposes of these Regulations, a homeopathic remedy is a veterinary medicinal product (which may contain a number of principles) prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia(a) or, if it is not described there, in a pharmacopoeia published by the British Pharmacopoeial Commission or by the competent authority of any member State. Placing a homeopathic remedy on the market in accordance with a registration.  

It is interesting to note the use of "remedy" rather than "medicine".


The implementation of EU Directives lead to a similar situation that occurred with homeopathic medicines for human use that were on the market in 1971 which given Product Licence of Right (PLR) - but that has gone now. Homeopathic medicines that were on the market at the time were "grandfathered". They required no registration per se, it was only necessary for the manufacturer to inform the VMD that the products existed. A list of these products can be found here (excel file).

For new products not on the grandfather list, the registration process is virtually identical to that of the Simplified Scheme for products intended for human use. Strangely, sarcodes and nosodes do not need to be registered. 

The grandfather list is very interesting. The manufacturers on the list are -
And the list of registered products is very small (not a direct link) and the only manufacturer that appears on the list is Freeman's.

Manufacturing
The process of obtaining a manufacturer's license is complicated and expensive. Good Manufacturing Practice (GMP) certification is required which is likely to be beyond very small outfits.

There are two sorts of manufacturer's licence - Manufacturing Authorisation (ManA) and Manufacture of Extemporaneous products (Specials) authorisation (ManSA). As stated previously, there can be some overlap in regulatory oversight if a manufacturer produces both human and veterinary medicines. Both Ainsworths and Freeman's have ManSA licences, Helios do not - they only have a "specials" licence for human medicines. Blue Merle Ltd, Ffynnonwen Natural Therapy Centre and Dr Reckeweg do not hold any manufacturing licence of any kind.

Given the above, it would seem manufacturers of only grandfather homeopathic medicines do not require a Manufacturer's license. Freeman's and Ainsworths could compound extemporaneous homeopathic medicines on the basis of their ManSA licence. Helios could as they are registered pharmacies but the implication of regulations is that represents a last resort (see Cascade below). There aren't the same kind of exemptions for veterinary homeopathic products as there are for human ones (see the Medicines Act 1968 section) - only vets are allowed to request compounding, not members of the public.

Marketing Authorisation/Registration
Homeopathic medicines do not require a Market Authorisation (MA) if they are registered under the homeopathic scheme above or on the grandfather list. However, the scheme forbids any indications. Any new homeopathic product with indications would require a MA and would be exceedingly unlikely to obtain one. To quote from guidance
Remedies classified as sarcodes or nosodes do not need to be registered.The following remedies are considered veterinary medicines and require a Marketing Authorisation (MA):
  • remedies making specific therapeutic claims including immunological ones
  • remedies not considered sufficiently dilute to guarantee safety
  • remedies where the route of administration is not as described in the European Pharmacopeia, or an official pharmacopeia of a member state
The question of immunological claims does call into question the labelling of nosodes and whether the actual name of them can be seen as a therapeutic claim. Nosodes and sarcodes are not included in the grandfather list.

The definition of immunological product is given as -
“immunological veterinary medicinal product” means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity;
Homeoprophylaxis, whatever words homeopaths wish to use, is based on the notion of modifying the immune response. 

The registration of homeopathic medicines is covered by this -
Placing a homeopathic remedy on the market in accordance with a registration 63.—(1) By way of derogation from the provisions of these Regulations requiring a marketing authorisation for a veterinary medicinal product, a homeopathic remedy may be placed on the market in accordance with a registration by the Secretary of State instead of in accordance with a marketing authorisation if it complies with this paragraph.  
(2) It must not be an immunological product. 
(3) The route of administration must be as described in the European Pharmacopoeia or, if it is not described there, by a pharmacopoeia currently used officially in any member State. 
(4) There must be a sufficient degree of dilution to guarantee the safety of the product, and in any event it must not contain more than one part in 10,000 of the mother tincture.  
(5) All other provisions relating to marketing authorisations apply in the same way to registrations of a homeopathic remedy
All other provisions? Mostly medicines for food producing species -
Marketing authorisations for food-producing species 23.—(1) The Secretary of State must not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless all its pharmacologically active substances appear in Table 1 in the Annex to Commission Regulation (EU) No 37/2010.  
(2) This does not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption; but in this case the product must not include an active substance that appears in Table 2 in the Annex to Commission Regulation (EU) No 37/2010 and must not be intended for the treatment of a condition for which a veterinary medicinal product is already authorised for horses. 
There are a few homeopathic medicines that appear in Table 1. They are -
  • Adonis vernalis
  • Aesculus hippocastanum
  • Agnus castus
  • Ailanthus altissima
  • Allium cepa
  • Apocynum cannabinum
  • Aqua levici
  • Arnicae radix
  • Artemisia abrotanum
  • Atropa belladonna
  • Bellis perennis
  • Calendula officinalis
  • Camphora
  • Cardiospermum halicacabum
  • Convallaria majalis
  • Crataegus
  • Echinacea
  • Eucalyptus globulus
  • Euphrasia officinalis
  • Ginkgo biloba
  • Ginseng
  • Hamamelis virginiana
  • Harpagophytum procumbens
  • Harunga madagascariensis
  • Hypericum perforatum
  • Lachnanthes tinctoria
  • Lobaria pulmonaria
  • Okoubaka aubrevillei
  • Phytolacca americana
  • Prunus laurocerasus
  • Ruta graveolens
  • Selenicereus grandiflorus
  • Serenoa repens
  • Silybum marianum
  • Solidago virgaurea
  • Substances used in homeopathic veterinary medicines
  • Syzygium cumin
  • Thuja occidentalis
  • Turnera diffusa
  • Urginea maritima
  • Virola sebifera
  • Viscum album
It might come as a surprise that Arnica is not on the list. It is, but for topical use only. That is true for some other common herbal products. "Substances used in homeopathic veterinary medicines" is unclear in meaning. Does that mean, perhaps, that are currently used? Or literally anything? The latter is more likely. Homeopaths do use pharmaceutical medicines at times - the justification being isopathy - it is unclear whether the restrictions on the use of these pharamaceuticals would also apply to the homeopathic ones.

One thing that is clear is that no homeopathic preparation of Aristolochia spp is NOT permitted.
Duties on the holder of a marketing authorisation relating to an immunological product 29.—(1) Before placing an immunological product on the market the holder of the marketing authorisation must either— (a) notify the Secretary of State asking for written approval to do so; or (b) if the holder has already received written approval from another member State permitting the release of the product, send a copy of that approval to the Secretary of State.  
(2) If notified under sub-paragraph (1)(a) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable. 
(3) No person may place an immunological product on the market without a written approval issued by the Secretary of State or (if the approval was issued by another member State) without sending a copy of that approval to the Secretary of State. 
Again, the question is raised about nosodes, sarcodes and homeoprophylaxis. Which are partially answered by this press release.

Products for small animals are exempt from the need for an MA or registration, but a Manufacturer's licence is still required. The Scheme is found in Schedule 6 of the Regulations.
Animals to which this Schedule applies 1. This Schedule applies in relation to veterinary medicinal products intended solely for the following animals kept exclusively as a pet—  
(a) aquarium animals;  
(b) cage birds;  
(c) ferrets;  
(d) homing pigeons; 
(e) rabbits; 
(f) small rodents; and  
(g) terrarium animals. 
Poultry, rabbits and fish meant for food obviously do not fall into this category.

There is a list of permitted ingredients by animal type. Any new active ingredient would require applying to the VMD for approval. Notice that the list does not contain any homeopathic ingredients.

Labelling
Labelling requirements for registered homeopathic medicines are very clear.
Homeopathic remedies 53.—(1) A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.  
(2) There must be no specific therapeutic indication on the labelling or in any information relating to it. 
(3) The labelling (or labelling and package leaflet) must contain the following and no other information— ( 
(a) the words “homeopathic remedy without approved therapeutic indications for veterinary use”;  
(b) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);  
(c) the name and address of the registration holder and (on the package leaflet) of the manufacturer; 
(d) the method and, if necessary, route of administration; 
(e) the expiry date; 
(f) the pharmaceutical form;  
(g) the contents of the pack;  
(h) any special storage precautions;  
(i) the target species;  
(j) any necessary special warnings; 
(k) the batch number; and  
(l) the registration number. 

The prohibition on therapeutic indications is very clear. Also, the mention of target species is of interest.

The labelling requirements for grandfathered veterinary homeopathic medicines are sarcodes and nosodes is unclear.

Categories of Veterinary Medicines
The distribution categories for authorised medicines are:

  • Prescription Only Medicine – Veterinarian (POM-V)
  • Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS)
  • Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS)
  • Authorised Veterinary Medicine – General Sales List (AVM-GSL)
Registered veterinary homeopathic medicines are considered AVM-GSL. Presumably, so are those on the grandfather list. Sarcodes and nosodes possibly as well.

Wholesale
Wholesaling of veterinary medicine requires a Wholesaler's Licence, although a manufacturer does need one. No special regulations apply to the wholesaling of veterinary homeopathic medicines.

Retail
As veterinary homeopathic medicines are considered AV-GSL, there are no restrictions on who can sell them.

Import
Generally speaking, a foreign manufacturer of homeopathic medicines would need to apply for a UK Manufacturer's licence (search for "import") via UK subsiduary and register their products with the VMD although this is not made very clear. This seems very unlikely with veterinary homeopathic medicines. The market is very small.

However, there is a route by which small amounts of products can be imported. However, it is very unlikely that the VMD would grant permission for this.

No further discussion is required.

Export
There are rules governing the export of veterinary medicines -
Exports 31.—(1) No person may export a veterinary medicinal product for use in another member State unless the veterinary medicinal product may be lawfully supplied or administered in that member State.  
(2) If a veterinary medicinal product has been manufactured in accordance with a marketing authorisation, or if a product without a marketing authorisation has been manufactured under a manufacturing authorisation, and the product is intended for export outside the European Union, the Secretary of State must, at the request of the exporter or the competent authorities of the country to which it is being exported, provide a certificate to that effect.  
(3) When issuing the certificate the Secretary of State must take account of the model certificates issued by the World Health Organization 
(4) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State must ensure that the exporter or the competent authorities of the third country has access to the summary of product characteristics. 
For export to EU member states, that means that the product must be registered there as well. Whether any UK homeopathic manufacturer would bother to do this is another matter. Vendors of such products seem very happy to ship them abroad.

Advertising of Homeopathic Remedies
The VMD guidance on advertising is very clear. As veterinary homeopathic remedies are assumed to be AVM-GSL they can be freely advertised. However, as registered products are not allowed therapeutic indications on labelling, they would not be permitted them in advertising. There are no specific regulations that seem to cover the advertising of grandfathered homeopathic medicines or nosodes or sarcodes.

However, advertising of all veterinary homeopathic medicines is subject to exactly same consumer protection laws and advertising regulation as human homeopathic medicines. This previous post deals with these aspects. The guidance to homeopaths provided to homeopaths applies to vets who practice homeopaths and advertisers of veterinary homeopathic medicines as they do their human equivalents. It is worth reproducing part of the previous post.

To quote from ASA detailed guidance -
The need for evidence One of the key rules in the CAP Code is that advertisers need to hold evidence for ‘objective’ claims made in marketing communications. These are claims that consumers are likely to regard as objective i.e. they have a factual basis. The Code states the following: 

  • 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
The words ‘before... publication’ are crucial. As the marketer, you have a pre-publication responsibility for ensuring that your claims are borne out in fact and, where necessary, supported by robust evidence. Rule 3.7 is further clarified in the section specific to medicines and health-related products:

  • 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.
And later -

Claims to avoid In the simplest terms, you should avoid using efficacy claims, whether implied or direct, that aren’t supported by robust evidence. If you are stating or implying that you, your service or a product can be effective in doing something, you need to ensure that you have the evidence to prove the claim. 
If you are making claims for a homeopathic product, or for a treatment based on a specific product, or combination of products, you may only make such claims as are permitted by the product licence(s). You will need to consult the MHRA for advice on this point. 
To date, the ASA has have not seen persuasive evidence to support claims that homeopathy can treat, cure or relieve specific conditions or symptoms. We understand this position is in line with other authoritative reviews of evidence. 
We therefore advise homeopathy marketers to avoid making specific claims of efficacy for treatments where robust evidence is not held to substantiate them. 
Even if a specific product is not cited, marketers of homeopathy services should not state or imply that conditions or symptoms can be relieved or cured by homeopathy. This means marketing of homeopathy services should not use words such as ‘cure’ or ‘treat’, nor list medical conditions because the ASA has a long-standing position that, by doing so, readers are likely to infer that the conditions or symptoms listed can be alleviated. We advise that these claims are not used either directly or indirectly, including through the use of imagery.
And further on still - 
Telling consumers about published research on homeopathy The online environment has greater scope for providing information in a discursive or detailed way. Providing links to information such as published research is likely to fall outside the remit of the ASA if they are presented in a section of the website that is not directly connected with the sale or supply of your products or service. For example, under a separate tab labelled ‘research’ or ‘further reading’.
The guidance is very clear.

A press release was mentioned earlier. It is worth reproducing part of that -
Some herbal and homeopathic products are claiming medicinal benefits without scientific proof, meaning they may not properly treat or prevent serious diseases, leaving pets at risk. 
The Veterinary Medicines Directorate’s (VMD) Director of Operations, John FitzGerald, said: 
“Some of these products are claiming to be effective and safe when no scientific evidence has been presented to us to show they are. 
“Animal owners have a right to know if a product does what it claims. The products claim to treat diseases which can cause serious welfare problems and in some circumstances kill animals if not properly treated. So in some cases owners are giving remedies to their pets which don’t treat the problem.”
Next
The next post will consider the ethical and animal welfare issues surrounding the use of veterinary homeopathic medicines.

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