Saturday, 18 March 2017

Brexit and Homeopathy

Many of laws that relate to homeopathic medicines originate from EU Directives. In fact, UK law contained no references to homeopathy until the EU introduced them. Will have Brexit have any effect on this?

Others have blogged about this too - here and here

Brexit means Brexit
Whatever your opinion on Brexit is, one thing that is very clear is that almost everything is unclear. It's unclear what form it will take. The thorniest question is whether the UK remain a member of the Single Market or negotiate access to it.


Leaving the EU is not the simple process presented by some. 

European Communities Act 1972
It is said by some that leaving the EU is a simple matter of repealing the European Communities Act 1972. This is not the case. It would mean that many laws would no longer have any standing thus creating a huge legal black hole. 

The Great Repeal Bill
The title is a misnomer. It would actually be a Great Incorporation Bill. The idea behind the bill is to incorporate the full language and meaning of (the majority of) EU Directives into UK law where previously laws refer to EU Directives so that the Act 1972 can be repealed and the status quo can be preserved when Brexit actually happens (although not everything can be). The intention is that post Brexit, the process of amending law can begin. However, it is clear that many believe that the Great Repeal Bill offers an opportunity to get rid of EU Directives that they do not like.

The extent to which UK law depends on EU Directives is moot. Various figures are quoted but any existing analysis is likely to be trivial. It's not just a question of searching through legal databases to see which laws contain reference to EU Directives. A specific piece of legislation may make no mention of EU Directives but it may relate to legislation that does.

Nor is the Great Repeal Bill a simple matter of search and replace as this could change the meaning of the law and result in unintended consequences. It will need to done carefully and with much scrutiny.

The Library of the House of Commons has a very good analysis here. It is well worth reading. It makes clear how much is unknown at this stage. One thing that it does not spell out is how long the process of drafting such a bill would take even before it is made law. Nor does it spell out the resources required. How long it would take to pass the bill is unknown. It is entirely possible that the Great Repeal Bill would almost paralyse the drafting and passing of other legislation. The Bill has to come into force as soon as the actual moment of Brexit. That is a very tight deadline.

Whilst it may be tempting to repeal or amend the essence of certain EU Directives from UK law, attempts to so necessarily increase the time and resources required. Various lobby groups are already making noises about repeal/amendment. However, Government has indicated that it would prefer this to occur post-Brexit.

EEA 
It is not clear is whether the UK will be able to remain within the European Economic Area (EEA) post Brexit as it depends on the "four freedoms". Mainly of those in favour of Brexit oppose Freedom of Movement and it may well prove impossible to remain within the EEA. It wouldn't matter if the UK joined the European Free Trade Association (EFTA) or had a series of bilateral treaties a la Switzerland. It would only be by exception that the UK could be part of the EEA and not have Freedom of Movement and although Brexit negotiations are yet to begin, at the time of writing, an exception is very unlikely to be made.

Being a member of the EEA and having access to the Single Market does require EEA member states to implement EU Directives in their domestic law. This had implications for homeopathic medicines in Norway

Council of Europe
The Council of Europe is not the same as the EU although many are confused about its nature. Although the semi-autonomous European Directorate for the Quality of Medicines falls under the Council's umbrella, it has no important bearing on homeopathic medicines.

Consequences
Not knowing the form that Brexit will take means that it difficult to predict what effect it would have on UK homeopathy. The most likely scenarios would have little if any impact on the practice of homeopathy but the import/export of homeopathic medicines could be affected.

There is no mechanism for EU wide registration of homeopathic medicines. Registration is at member state level. However, having a product registered in one member state can make the process of registration slightly easier in some ways. This is different from pharmaceutical medicine where a centralised route for marketing authorisation exists via the European Medicines Agency (EMA). As the EMA is based in London, Brexit may cause it to move.

If the UK does not manage to negotiate some sort of trade deal with the EU/EEA, there could well be tariffs applied to homeopathic medicines. Being outside of a customs union does also increase costs because of the administrative requirements. Whilst manufacturing homeopathic medicines would appear to be a profitable business overall, some markets are less profitable than others. UK manufacturers may find it unprofitable to do business in certain EU member states and the reverse could be true as well. 

Good Manufacturing Practice (GMP) certification could become a problem. At the moment, the Medicines and Healthcare product Regulatory Agency (MHRA) conducts GMP inspections which are recognised by the EU. They do cost money. Unless the UK made a mutual recognition agreement with the EMA, exporting to the EU would require GMP inspection by another EU regulator and vice versa. The cost could be passed onto consumers but...

The regulations relating to homeopathic medicines are couched in terms of them being defined by the method of preparation as documented in EU/EEA member states' pharmacopoeias which basically means the French and German ones. There was a UK homeopathic pharmacopoeia produced by the Faculty of Homeopathy but it has not been updated in many years. It is also very difficult to get hold of. However, not all homepathic medicines are prepared by the general methods. Which is permissable if a monograph exists in a homeopathic pharmacopoeia that desribes the method for a particular product. There is nothing to prevent regulations referring to the homeopathic pharmacopoeias of other countries as validation but it's hardly "taking back countrol".

The veterinary cascade also makes reference to products licensed in other EU/EEA member states but given the uncertainty in where homeopathic products fit in the cascade, it is moot whether there are any implications.

Amendments to Law

It is not clear what amendments UK homeopathy would want. Which is very similar to the situation back in 2012 when the consolidation of medicines regulation took place. Some of the issues that upset UK homeopathy have nothing to do with EU Directives or even legislation, for example, the Advertising Standards Authority (ASA).

It is very unlikely that Government would consider amendments to the law regarding homeopathy a priority. In reality, the use of homeopathy in the UK is very low. There are no votes in it. Whilst it might be thought that CAM groups working together might have a better chance of lobbying Government, different groups have often very different goals. 

Regulating homeopathic medicines in a similar way to medicines could be seen as giving some "official" status to homeopathy as a whole. That it has unfortunate consequences regarding legal supply is conveniently ignored. UK homeopathy might wish for a different system of regulation of homeopathic medicines - for example, a system that licenses manufacturers rather than products. Given the nature of homeopathic medicines i.e. that they are inert lactose and/or sucrose pillules (barring contamination, etc) it would be more expedient to de-recognise them as medicines and treat them as food. But that loss of status is difficult for UK supporters of homeopathy to swallow and could open up the homeopathic medicines market to almost anyone. EU Directives forced recognition of homeopathic medicines onto the UK, so Brexit would allow a change to how they are treated. 

"Official" recognition seems very important to some of UK homeopathy. Recognition of the practice of homeopathy would doubtless involve statutory regulation. This has nothing to do with EU Directives. Indeed, variations in who is allowed to practice medicine across member states demonstrate this quite clearly. In some countries such as France only doctors etc are permitted to practice medicine, in others anyone can (subject to certain restrictions) and then in Germany, there is recognition of Heilpratik.

Marketing claims for homeopathic medicines - and by extension - homeopathic services are legally restricted by both medicines and consumer protection law. Whilst both certainly do incorporate EU Directives, both existed in a similar form before the UK joining the then Common Market. In fact, it could be argued that UK law strongly influenced certain EU Directives. Arguments for special treatment of homeopathic products and services in law fail on the basic principle of natural justice. It would create a bias in law in favour of homeopathy. Which would also be anti-competitive. It is extremely unlikely that any Government would seek to dilute consumer protection post Brexit. A reversion to caveat emptor is very unlikely. It would be seen as a very regressive step - consumer protection is one of the hallmarks of more advanced nations. Something that may need pointing out to US readers is that in the EU and other countries, the advertising of prescription medicines to the public is totally forbidden. As is the promotion of any medicine that is not licensed/registered.

Brexit is extremely unlikely to have any significant effect on the Advertising Standard Authority (ASA) or any other voluntary self regulatory body. Best practice is different from the law.











Saturday, 11 March 2017

Regulation of Veterinary Homeopathy #2

This post is about the ethics and some of the practicalities of veterinary homeopathy. It also needs with animal welfare issues and some specific legislation that relates animal husbandry. Some readers may have difficulties with some of the news stories linked to that involve neglect.


Animals are not Humans
This may seem rather obvious but is worth stating the obvious at times. The ethics of treating animals are different to those of treating humans - especially consenting adults. The law is different and perhaps most importantly, if homeopathy works on animals that absolutely proves that isn't placebo, surely?

The law is very clear. A full discussion of the ethics of the treating animals would be far too lengthy to include here but, perhaps, the fact that animals can not legally consent to treatment places an onus on owners and veterinary surgeons to act in the best interests of an animal. Owners do not always act in the best interests of their animals which places a duty on veterinary surgeons to at least suggest that owners should not act in a certain way, not be complicit in the owner's action. A vet going along with an owner's preference for homeopathic treatment could be seen as complicit.

The arguments against homeopathy in general were discussed in a previous post. All of these still apply and if anything, the low numbers of trials of veterinary homeopathy and their even poorer quality makes any claim of efficacy beyond placebo less credible. But a key part of homeopathy is the detailed consultation process. This would be impossible with an animal. Veterinary homeopathy is thus even more implausible that its use in humans.

Legislation covering Veterinary Surgeons
As mentioned in the previous post,  the Veterinary Surgeons Act 1966 is the most important piece of legislation. To quote from Act 1966 -
An Act to make fresh provision for the management of the veterinary profession, for the registration of veterinary surgeons and veterinary practitioners, for regulating their professional education and professional conduct and for cancelling or suspending registration in cases of misconduct; and for connected purposes.
The Act gives various powers to the Royal College of Veterinary Surgeons (RCVS) including setting standards for professional conduct and enforcing them. The RCVS is a statutory regulator.

  1. Code of Professional Conduct for Veterinary Surgeons
  2. The RVCS provide their code here along with supporting guidance. The Code is not a lengthy document. 


Professional responsibilities
Veterinary surgeons have professional responsibilities in the following areas:

1. Veterinary surgeons and animals
 
1.1 Veterinary surgeons must make animal health and welfare their first consideration when attending to animals. 
1.2 Veterinary surgeons must keep within their own area of competence and refer cases responsibly. 
1.3 Veterinary surgeons must provide veterinary care that is appropriate and adequate. 
1.4 Veterinary surgeons in practice must take steps to provide 24-hour emergency first aid and pain relief to animals according to their skills and the specific situation. 
1.5 Veterinary surgeons who prescribe, supply and administer medicines must do so responsibly 
1.6 Veterinary surgeons must communicate with each other to ensure the health and welfare of the animal or group of animals. 
1.7 Veterinary surgeons must ensure that clinical governance forms part of their professional activities. 
2. Veterinary surgeons and clients 
2.1 Veterinary surgeons must be open and honest with clients and respect their needs and requirements. 
2.2 Veterinary surgeons must provide independent and impartial advice and inform a client of any conflict of interest. 
2.3 Veterinary surgeons must provide appropriate information to clients about the practice, including the costs of services and medicines. 
2.4 Veterinary surgeons must communicate effectively with clients, including in written and spoken English, and ensure informed consent is obtained before treatments or procedures are carried out. 
2.5 Veterinary surgeons must keep clear, accurate and detailed clinical and client records. 
2.6 Veterinary surgeons must not disclose information about a client or the client’s animals to a third party, unless the client gives permission or animal welfare or the public interest may be compromised. 
2.7 Veterinary surgeons must respond promptly, fully and courteously to clients’ complaints and criticism.

3. Veterinary surgeons and the profession
 
3.1 Veterinary surgeons must take reasonable steps to address adverse physical or mental health or performance that could impair fitness to practise; or, that results in harm, or a risk of harm, to animal health or welfare, public health or the public interest. 
3.2 Veterinary surgeons who are concerned about a professional colleague’s fitness to practise must take steps to ensure that animals are not put at risk and that the interests of the public are protected. 
3.3 Veterinary surgeons must maintain and develop the knowledge and skills relevant to their professional practice and competence, and comply with RCVS requirements on the Professional Development Phase (PDP) and continuing professional development (CPD). 
3.4 Veterinary surgeons must ensure that all their professional activities are covered by professional indemnity insurance or equivalent arrangements. 
3.5 Veterinary surgeons must not hold out themselves or others as specialists or advanced practitioners unless appropriately listed with the RCVS, or as veterinary nurses unless appropriately registered with the RCVS.

4. Veterinary surgeons and the veterinary team
 
4.1 Veterinary surgeons must work together and with others in the veterinary team and business, to co-ordinate the care of animals and the delivery of services. 
4.2 Veterinary surgeons must ensure that tasks are delegated only to those who have the appropriate competence and registration. 
4.3 Veterinary surgeons must maintain minimum practice standards equivalent to the Core Standards of the RCVS Practice Standards Scheme. 
4.4 Veterinary surgeons must not impede professional colleagues seeking to comply with legislation and the RCVS Code of Professional Conduct. 
4.5 Veterinary surgeons must communicate effectively, including in written and spoken English, with the veterinary team and other veterinary professionals in the UK. 
5. Veterinary surgeons and the RCVS 
5.1 Veterinary surgeons must be appropriately registered with the RCVS. 
5.2 Veterinary surgeons must provide the RCVS with their PDP and CPD records when requested to do so. 
5.3 Veterinary surgeons, and those applying to be registered as veterinary surgeons, must disclose to the RCVS any caution or conviction, including absolute and conditional discharges and spent convictions, or adverse finding which may affect registration, whether in the UK or overseas (except for minor offences excluded from disclosure by the RCVS). 
5.4 Veterinary surgeons, and those applying to be registered as veterinary surgeons, must comply with reasonable requests from the RCVS as part of the regulation of the profession, and comply with any undertakings they give to the RCVS. 
6. Veterinary surgeons and the public 
6.1 Veterinary surgeons must seek to ensure the protection of public health and animal health and welfare, and must consider the impact of their actions on the environment. 
6.2 Veterinary surgeons must certify facts and opinions honestly and with due care, taking into account the 12 Principles of Certification. 
6.3 Veterinary surgeons promoting and advertising veterinary products and services must do so in a professional manner. 
6.4 Veterinary surgeons must comply with legislation relevant to the provision of veterinary services. 
6.5 Veterinary surgeons must not engage in any activity or behaviour that would be likely to bring the profession into disrepute or under­mine public confidence in the profession
There is no specific mention of homeopathy in this or the associated guidance. However, it is clear from the above and the guidance that use of homeopathy and homeopathic medicines by veterinary surgeons would raise difficult questions

Details of disciplinary cases by the RCVS can be found here

The RVCS did investigate vet Roger Meacock for misleading advertising. The grounds were bringing the veterinary profession into disrepute. This is a landmark case. Whether there will be further cases of this kind is moot - complaints would have to be brought first. The charges against Meacock involved claims relating to -
It is understood from sources that Meacock has been the subject of multiple complaints to the RCVS. Whilst the action did not involve specific mention of homeopathy, the implications of that the RCVS even looked at the case compared to other regulators is interesting. A full analysis of Meacock's activities are beyond the scope of this post and some might be considered sub judice. 

The "Cascade"
The prescribing cascade is a fundamental issue in veterinary practice. Because of the economics of approval of veterinary medicines, there can be circumstances in which a veterinary surgeon finds there is a not a medicine that is approved for treatment of a certain condition in a certain species. But there is a route to providing treatment - the "cascade". Guidance on legislation states -
The steps, in descending order of suitability, are:
  • a veterinary medicine authorised in the UK for use in another animal species, or for a different condition in the same species
If there is no such product, either:
  • a medicine authorised in the UK for human use, or
  • a veterinary medicine not authorised in the UK, but authorised in another member state for use in any animal species in accordance with the Special Import Scheme; in the case of a food-producing animal the medicine must be authorised in a food producing species
  • a medicine prescribed by the vet responsible for treating the animal and prepared especially on this occasion (known as an extemporaneous preparation or special) by a vet, a pharmacist or a person holding an appropriate manufacturer’s authorisation (so called specials manufacturers)
  • in exceptional circumstances, medicines may be imported from outside Europe via the Special Import Scheme
You or the person acting under your supervision may administer a product prescribed under the cascade; however, the prescription and use of the product remains your responsibility.
Where veterinary homeopathic medicines fall in the cascade is unclear. They are registered with not authorised by the VMD (or in the case of human medicines, the MHRA). 

The least generous interpretation of the cascade would prohibit the use of veterinary homeopathic medicines by veterinary surgeons and confine its use to owners. A slightly more generous would allow the use of homeopathic "specials". The most generous interpretation would treat registered homeopathic medicines as authorised but that would still leave the problem of them have no permitted therapeutic indications or target species. Justifying the use of veterinary medicines as a first choice treatment is extremely problematic when an authorised medicine exists as they will have therapeutic indications and likely a target species.

The VMD did not grandfather in nosodes and sarcodes. Nor will they register these homeopathic medicines. They seem to fall outside of the cascade. If this the case then their use by veterinary surgeons is not permitted. It is also the case that nosodes and sarcodes have been illegally placed on the market by vendors.

Review of Guidance on CAM
Current RCVS guidance on CAM states -
As the regulator of the veterinary profession, we emphasise the importance of evidence-based veterinary medicine. We recommend that there should therefore be a cautious approach to homeopathy for animals and that normal evidential standards be applied to complementary treatments. We believe it is also essential that such treatments, until they can be proved, are complementary rather than ‘alternative’ and that they are therefore used alongside conventional treatment.

However, whatever views there may be within the veterinary profession, it is clear that there is a demand from some clients for complementary therapies for their animals. It is better that they should seek advice from a veterinary surgeon - who is qualified to make a diagnosis, and can be held to account for the treatment given - rather than turning to a practitioner who does not have veterinary training.
Furthermore, homeopathy is currently accepted by society and recognised by UK medicines legislation and does not, in itself, cause harm to animals. While this is the case it is difficult to envisage any justification for banning a small number of veterinary surgeons from practising homeopathy.
The reasons mentioned for the review are changes to NHS position on homeopathy and the line taken by the ASA but it has also been reported that Meacock is another of the motivations. It is also the case that attitudes towards CAM in the veterinary professional have become somewhat firmer on the issues. There are signs that human homeopathy is in decline. It is suspected that one reason for this is that homeopathy practitioners are retiring and new practitioners are increasingly fewer in number. This might also apply to veterinary profession. 

Food Animals and Organic Certification
As mentioned in the previous post, there are restrictions on the medicines that can be used on food animals and how the permitted ones can be used. It would appear that homeopathic medicines are permitted for food animals but the above comments regarding the cascade would also apply.

Whilst many might think that organic is a good thing, organic certification of food animals places additional limitations on what medicines can be used. Organic certification bodies implement EU standards but the EU standards are difficult to read. Fortunately, the Soil Association publish their standards. Section 10.9 deals with veterinary treatment. It is far too long to reproduce here but - 
10.9.1 If you need to use veterinary treatments you must use complementary therapies and trace elements, preferably with professional veterinary guidance, and provided that their healing effect works for the species and the condition you are treating. 
10.9.2 You may only use other veterinary treatments, as advised by your vet, if: - complementary therapies and trace elements don’t work or are unlikely to work effectively and you need to treat to avoid suffering or distress to your animal, or- you have identified a disease risk which prevents you from keeping your animals healthy through management alone. We would, for example, allow the use of cyromazin for fly strike, when this is known to be a problem. You must detail known disease risks in your health plan. 
10.9.3 You must:- use veterinary treatments for your animals, buildings, equipment and facilities if national or EU legislation requires it, even if this means your animals will lose their organic status- have veterinary approval for using unlicensed herbal preparations. 
10.9.4 You must not:- use veterinary medicines as a preventative treatment without our permission - use substances (such as antibiotics or coccidiostats) to increase the growth rate or production of your animals, or- use surgical or chemical procedures on any animal unless it is to improve their health or well-being or that of the group.
The rules are for farmers. As soon as a veterinary surgeon becomes involved, the cascade comes into play as does the RCVS position on CAM, which may change as a result of their review. And what vet would approve the use of unlicensed herbal preparations? There is a concern that farmers will resort to ineffective CAM treatments to preserve organic status when an effective authorised veterinary medicine exists thus, at best, prolonging the suffering of an animal.

Biodynamic certification doubtless is even more restrictive.


Animal Welfare Legislation
The Animal Welfare Act 2006 is the over arching legislation but there is other legislation that covers more specific matters. The Act 2006 does not mention homeopathy or CAM treatment of any kind but there are some provisions in that do cover neglect and the causing of unnecessary suffering and the use of CAM can be considered neglect in some cases.

The Royal Society for the Prevention of Cruelty to Animals (RSPCA) can and do mount private prosecutions against animal cruelty. And some of them have involved homeopathy. Fortunately, they are few and far between. Be aware that some of the listed stories contain upsetting images - 

This story is somewhat different - it is about the potential consequences. There could have been an outbreak of parvovirus. One thing that is not clear is the status of the dog breeder. Dog breeders are covered by the Breeding and Sale of Dogs (Welfare) Act 1999, Breeding of Dogs Act 1991 and Breeding of Dogs Act 1973. To quote from the Act 1973 -
(4) In determining whether to grant a licence for the keeping of a breeding establishment for dogs by any person at any premises, a local authority shall in particular (but without prejudice to their discretion to withhold a licence on other grounds) have regard to the need for securing—

(a)that the dogs will at all times be kept in accommodation suitable as respects construction, size of quarters, number of occupants, exercising facilities, temperature, lighting, ventilation and cleanliness;

(b)that the dogs will be adequately supplied with suitable food, drink and bedding material, adequately exercised, and visited at suitable intervals;

(c)that all reasonable precautions will be taken to prevent and control the spread among dogs of infectious or contagious diseases;

(d)that appropriate steps will be taken for the protection of the dogs in case of fire or other emergency;

(e)that all appropriate steps will be taken to secure that the dogs will be provided with suitable food, drink and bedding material and adequately exercised when being transported to or from the breeding establishment;
And not abiding by these conditions can lead to suspension, loss of license and even prosecution. Vaccination of dogs is a reasonable precaution and there have been prosecutions of breeders who have not vaccinated animals. The idea that homeopathy can be used to vaccinate animals is NOT reasonable. However, if the numbers of litters/puppies is below a certain limit, a license may not be required (but the Animal Welfare Act 2006 would still apply).

There is similar legislation for the boarding of animals, the Animal Boarding Establishments Act 1963. Some boarding establishments are known to accept "certificates" of homeopathic vaccination from vets. This would only breach the terms of the boarding kennel's license, it would raise difficult questions about the vet in question. There is also the Riding Establishments Act 1964 that requires local authority licensing has has similar provisions.

For livestock, there is the Welfare of Farmed Animals (England) Regulations 2007. It does not have anything that particularly adds to the Animal Welfare Act 2006 except - 
1.  Animals must be cared for by a sufficient number of staff who possess the appropriate ability, knowledge and professional competence. 
Competence? There is a course but the claim "Teaching the responsible use of homeopathy on the farm since 2001" seems odd when there is extensive mention of use of nosodes in their newsletter although to be fair, nosodes are always used in "homeopathic vaccination". The legality of supply question is raised again.

There is mention of Bovine TB in reducing the stress experienced by animals during testing.

The Animal Welfare Act 1981 has draconian powers. It is intended to prevent the spread of infectious diseases that can have a devastating effect on livestock. Non-compliance is a criminal matter. The Act 1981 has been amended several times. There is a list of diseases that must be reported to the authorities. This page has a list in a very unhelpful format but Bovine TB is there. Note that it can be passed onto humans and animals. Control of Bovine TB is an emotive subject because of badger culling. There are other approaches to the problem but organic certification can get in the way of, say, setting up a ring fence of vaccinated cattle. Also other countries do ban import of UK animal products such as happened with BSE.

There is no intended implication that any of these farmers would not report Bovine TB or any other notifiable disease if it were detected. There is routine, mandatory testing for Bovine TB.

Implications
Because some of the law and guidance is unclear, unfortunately clarification can only be gained by testing both. 

In some ways it would be better for animals, owners, vendors and veterinary surgeons to take a very precautionary approach as view veterinary homeopathic medicines as as a secondary complementary therapy of unknown value. Using veterinary homeopathic medicines as a first-line exclusive treatment is not ethically tenable. Veterinary surgeons could face disciplinary action for doing so by the RSVC and possible criminal prosecution. Breeders, boarding kennels and riding establishments face loss of licence and possible criminal prosecution. Owners risk prosecution if their animals do not get better and they don't seek veterinary treatment.

The most important vendors of non-grandfathered/unregistered veterinary homeopathic medicines are registered pharmacies. They risk suspension and being struck off by the General Pharmaceutical Council (GPhC).

But most of all for all of the above, the UK is an animal loving nation and the stench of bad publicity does not go away.





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.