Wednesday, 18 April 2018

Suggestions on Naturopaty/Homeopathy in Canada

This is a very different post from the majority of the post on this blog. There is heightened concern about the activities of naturopaths in Canada. Naturopathy often includes the use of homeopathy - which explains the interest - as does some of them offering CEASE therapy. This blog post outlines some legal and regulatory aspects regarding naturopathy and practical steps that those concerned could take.

Some of steps are tactical and fairly immediate, some are more strategic and likely take a lot of time and effort to enact.

It is not intended to look too deeply at the regulation of homeopathic medicines. A future post will do this. Some understanding of the regulation of naturopathy and some other legislation is necessary before discussing potential actions.

What applies to naturopathy also applies to chiropractic.

Regulatory Framework

Recogition
Six Canadian provinces license naturopathic doctors: Ontario, British Columbia, Manitoba, Saskatchewan, Alberta and Nova Soctia. Ontario also licenses homeopaths. They fall into two groups - laws that explicitly recognise naturopathy/homeopathy and those that enable the recognition of naturopathy/homeopathy. Some details will be glossed over.

The laws are -
Saskatchewan is problematic to deal with and will be ignored for now. Nova Scotia's legislation is minimal to say the least and again will be ignored. The various Acts will be referred to as HPA.

With the exception of Quebec, the Provinces/Territories that do not recognise naturopathy have low populations. In these provinces, naturopaths enjoy no special status other than as an ordinary citizen under common law. Their ability to prescribe certain medicines and perform certain procedures is that a member of the public.

Quebec is a civil law jurisdiction. Under such jurisdictions there is no "common law" right to "practice" medicine. Quebec has professional orders - each of which have their own remit and protected title. It would seem that naturopathy is tolerated to a degree in Quebec but naturopaths are often conducting activities that are reserved for professional orders. Illegal practice of medicine is dealt with by the Collège des médecins du Québec Inquiries Division. In essence, the practice of naturopathy by anyone other than a medical doctor is illegal and there have been convictions. Many naturopaths have left Quebec for Provinces that recognise Naturopathy or maintain registration there. Some patients travel to Ontario for treatment.

Naturopaths in Provinces/Territories where naturopathy is not recognised are campaigning for recognition. There is an opportunity for campaigners/activists to act before this happens.

Initial Application
Professions which wish to be recognised generally have to apply for recognition to the Provincial Minister of Health (although the Minister does have the power to consider the need for regulation without the need for application). The form that the application takes and the fees vary. Professions that seek recognition generally already have some form of organisation (tend to be called "colleges") but there may be more than one - consolidation would be required.

The Minister has the power to reject applications at this stage, if not rejected the application is passed to an Advisory Board, although the Minister does have the power to grant recognition without this step (but this could be subject to legal challenge).

However, some Provinces had pre-existing - now repealed - legislation regarding naturopathy. It is unclear if applications were actually made or previous legislation simply re-written. Nonetheless, the same kind of decision making process should have gone on. Simply transposing existing legislation into new legislation should never happen. Firstly, there would be little point in doing so and secondly, even minor amendments should require scrutiny as there can be unintended consequences.

Advisory Board
The composition of the Advisory Board may vary by Province as may whether they are permanent or temporarily recruited. The role of the Advisory Board is to advise the Minister - they make recommendations, they have no decision making powers themselves. Their basic duty is to determine whether a profession should be recognised. 

Factors that they may take into account include whether the "profession" is actually a profession (as opposed to say - a group of persons who claim to be of profession X but actually practice many disparate therapies - or not really a health profession at all), level of qualifications of the profession, the level of risk posed by the profession, the ability of the profession to regulate itself. There doesn't seem to be any emphasis on considering efficacy (beyond whether a profession is actually a healthcare profession), just (relative) safety.

Their powers vary but they can have the power to request information, hold hearings and so forth. In addition to recommending whether a profession be recognised, they can also make recommendations regarding the scope of practice - in other words what medical procedures are permitted/forbidden. Essentially, the scope of practice is a list of what are described as controlled acts under the HPA.

The recommendations will be provided to the Minister who will make the decision to recognise of not.

Recognition
The recognised Colleges are -
Recognition gives colleges a number of powers and also imposes certain duties. The HPA also specifies how Colleges are structured in terms of Councils (governing body) and committees. It also specifies the make up of these bodies and who appoints them.

Most of the detail is dull and not particularly relevant.

Councils have the power to make bylaws. Bylaws relate to how the College functions and to a degree how members conduct themselves. 

Duties vary. One key duty is to provide the Minster of Health with an annual report. These annual reports, if not already in the public domain, should also be obtainable by FIPPA. What these annual reports must contain varies. Some Councils will produce reports that go beyond the mandatory minimum - after all, although not exactly a marketing tool, they can have an effect on public confidence. 

Reconsideration of Recognition etc
Some Provinces' laws could be read in such a way as indicating that once a profession is recognised, once a college is establised, end of story. Whilst a Minister may have the powers to remove College council members etc, they do not have the explicit power to remove recognition. If a College is failing to effectively regulate members, that might make sense, but if it becomes apparent that self-regulation simply isn't possible?

(Members who don't want to abide by regulation can always leave or be expelled. Some professions, such as Chiropractic are deeply divided - under regulatory pressure, it could fragment. Chiropractic has also spawned a number of off shoots that often see themselves as separate professions. Loss of members can have profound financial implications for a College.)

Also, in these cases, there appears to be no way to vary the scope of practice of a profession. This effectively prevents the prohibition of, say, a particular treatment that is new evidence suggests to be ineffective and dangerous. It could also prevent the adoption of novel new treatments treatments - although this is less likely as the scope of practice of naturopathy is very ill defined.

Ontario's law does have a provision that allows for reconsideration of recognition. 

Of course, making changes to scope of practice via reconsideration by an Advisory Board is cumbersome compared to simply changing the bylaws of a College - although this could only achieve further restriction on practice.

Scope of Practice
What naturopaths are permitted to do varies considerably. Arguably, British Columbia has the most lax, Ontario the most restrictive.

It is worth pointing out that historically, naturopathy often saw itself as "drugless medicine". It used therapies such as hydrotherapy, herbal medicine, homeopathy and eliminating overeating, tea, coffee and alcohol. Vitalistic beliefs were (and still seem to be amongst some) key. Benedict Lust is considered the Father of US (and by extension Canadian) naturopathy. Over time, some naturopaths have expanded way beyond this (although a few stick more closely to the original practice - with the addition of supplements). It is a trend that some wish to continue. At one point Ontario had a Drugless Practitioners Act.

The Regulated Health Professions Act contains a list of controlled actsOntario naturopathic Scope of Practice can be found in the Naturopathy Act linked to above. More detailed information can be found in Ontario Regulation 168/15. This is a long document. It lists which of the controlled acts are allowed for naturopaths.

It places limits on internal examinations. It places limits on drugs that can be injected/inhaled. Chelation would appear to be forbidden, from the list of drugs that can be prescribed. The number of drugs that can be prescribed/compounded/dispensed/sold is very limited. There are also limits placed on spinal manipulation including a long list of contraindicated conditions. It also mentions the limited number of blood tests that are permitted. No specific mention is made of hyperbaric therapy or ozone therapy - presumably they are forbidden. Certain controlled acts require additional qualifications. 

What is interesting that the Regulation places makes it mandatory to refer clients to physicians (ie real doctors), extended practice nurses and other registered health professions when i) client is in imminent danger ii) beyond the scope of naturopathy (which is not defined in clear terms iii) diagnostics are required unavailible to naturopaths and iv) if client (or their representatives request it).

British Columbia's Naturopathic Physicians Regulation is much more permissive. It allows chelation, it allows ozone therapy. It allows a much wider range of spinal manipulation and has no contraindicated  It even allows minor surgery. It allows much wider prescribing (including Tramadol!), ordering of tests, use of equipment (including fetal ultrasound imaging). Most worryingly, there is no mandatory requirement for referral. Essentially, it allows BC naturopaths to treat any disease.

Code of Ethics et al
There is a hierarchy of HPA, regulations, bylaws and then it gets a bit murky beyond that. Codes of Ethics exist, and notionally members of a College are supposedly contractually bound by those but considerable leeway is granted to disciplinary committees to intrepret. Below exist "guidance" and "best practice" - there is an expectation that certain things should be done and that there is a right way to do them but there is no means of enforcement. Of course, if a member of a College finds themselves in front of a disciplinary committee, it may or may not be taken into account.

As previously mentioned Bylaws relate mainly to the internal functioning of a College. 

Codes of Ethics vary. The Ontario one can be found here. The British Columbia one here. They tend to deal very much in generalities but both example cite the need to comply with legislation and regulations. They also both cite human rights - which obviously includes the rights of children and the disabled.

Other Legal and Similar Matters

Freedom of Information
Each Province has its own Freedom of Information legislation -

Acronyms may vary but FIPPA will be used. Whilst FIPPA does not extend to the Colleges themselves, it will cover correspondance between the Colleges and Federal and Provincial Government and their agencies. The are exemptions - Provinces may refuse to disclose on certain grounds but there is a right of appeal and a legal escalation route.

Child Protection
Each Province has its own Child Protection laws. They may vary in wording but not in intent. To quote from the Alberta Child, Youth and Family Enhancement Act -
(2.1)  For the purposes of subsection (2)(c), a child is neglected if the guardian
                           (a)    is unable or unwilling to provide the child with the necessities of life,
                           (b)    is unable or unwilling to obtain for the child, or to permit the child to receive, essential medical, surgical or other remedial treatment that is necessary for the health or well‑being of the child, or
 (c)    is unable or unwilling to provide the child with adequate care or supervision.

Certainly in Provinces where naturopathy is not recognised, reliance by parents on naturopathy as primary care would be considered neglect - naturopathy is not medical treatment. In those Provinces where it is recognised, the test would be "essential" treatment.

It is important to note that the law generally places the burden of liability on the parent(s)/guardians of a child. A naturopath would not be necessarily held liable for giving poor advice that resulted in harm although they would be if a prescribed drug or treatment did. That would be dealt with under separate legislation/regulations - medical negligence and there are lawyers who specialise in this.

Disability Rights
Where this really matters in the case of those unable to give consent due to mental incapacity. It is much the same as with Child Protection. Typically, this involves learning disabled adults and elderly with dementia.

Aboriginal Rights
Aboriginal healers/midwices are generally exempt from HPA etc. This does not mean that a naturopath who is an an aboriginal would be exempt - the use of the title "Naturopathic Doctor" would override that. 

Advertising Regulation
Canada does have a voluntary advertising regulator - Ad Standards. It has an Advertising Code and also publishes various guidance. The Code is not as highly specific as those of some European advertising regulators but it has made several key rulings against complementary and alternatively medicine provides under Clause 1 and Clause 8 of the Code.

The Code is essentially an understanding of consumer protection legislation. Like the US, consumer protection is a mix of Provincial/Federal legislation/agencies. The most important piece of legislation is the Federal Competition Act which is enforced by the Competition Bureau. The section of interest is PART VII.1 - Deceptive Marketing Practices - Europeans will be surprised at how sparse it it. The Competition Bureau has extensive powers though.

Specific Actions
The variations in the Codes etc of the Colleges and the differences between Provinces' laws make it difficult to be specific. 

Legal Challenges to Ministerial Decisions
The deliberations of the Advisory Board and the reasoning of the Minister in granting recognition should be available via FIPPA. 

One key question about the recognition of naturopathy/homeopathy would be whether (i) the Advisory Board carried out sufficient risk assessment, etc, of the profession and the therapies employed and (ii) if so, did the Minister fulfill their duty to public health in light of those recommendations? Another question would be whether a College misrepresented the nature of the profession and the therapies involved.

Scope of practice is likely more important. In the case of naturopathy, it is known unsupervised (by a real doctor) chelation is permitted (at least in some provinces) as well as ozone therapy. It is also known that some naturopaths practice CEASE therapy (see here for a UK perspective). Naturopaths are notorious for ordering all manner of expensive tests that often have little or no practical value. Some use bogus "diagnostic" machines.

Comparisons with other jurisdictions not granting recognition or imposing limits on scope of practice would be useful, especially if the deliberations involved could be gained by FIPPA type requests. Safety reviews, medical authorities (eg US FDA, UK NICE) rulings/guidance on individual therapies may also be helpful. 

Demonstrating evidence direct harm caused by a Minister's decision to grant recognition and/or not place appropriate limits on scope of practice is tricky. All procedures carry risk - the question is whether or not the potential benfits outweigh the risks in an overall context. If the Minister chose to ignore recommendation of the Advisory Board, and direct harm had then occurred, that would be much more clear cut.

Identifying potential risks and harms is relatively simple. However, the likelihood of such risks/harms is difficult to estimate. Legislating for the almost never might be considered over-kill.

In theory, petition (application) for Judicial Review of such decisions is possible on such grounds. It depends on the rules of the Provincial Court and/or associated legislation whether there is any time limit on petition for Judicial Review. For example in Alberta, the limit is 6 months. In British Columbia there is no limit. In any case, any future decisions to grant recognition etc of other professions or in different Provinces could be challenged.

Whether a Court would overturn the recognition of a College is unknown. An order for the College to re-apply, the Advisory Board to consider evidence and make new recommendations and the Minister to make a fresh decision. It may be the view of the Court that the other remedies (which will be discussed).

Application for Judicial Review requires the services of public law lawyers. This will require funding - crowd funding is an obvious solution. In terms of who makes the application, it would have to be a group with "standing". Preferably it would be someone who was adversely affected by recognition or the scope of practice of a College. Representative groups who represent potentially affected persons would have standing as likely would medical associations (they represent not just themselves - they also have a duty to public health).

The Colleges may be become involved if Judicial Review goes ahead - or even at the application stage. However, their involvement is likely to be limited. Judicial Review is not a normal court of law - it is mostly concerned about the decision made. The Court are unlikely to consider the efficacy of therapies offered by naturopaths - indeed it may well accept as fact that the overwhelming scientific and medical consensus is that most of the therapies have no efficacy beyond placebo.

It is not necessary to garner public support for this, except for funding.

Amendment
Amendments could be made to HPA to include additional factors that include child protection, a greater emphasis on public health (including vaccination) in the deliberations of the Advisory Panel. 

Where no powers exists to review the recognition and Scope of Practice, they could be introduced.

Consideration of Scope of Practice could be expanded from just what is permitted in the way of medicines prescribed and procedures to include conditions and vulnerable groups. The Swedish Patientsäkerhetslag (Patient Safety Act) prevents non-medically qualified from treating certain diseases such as cancer and also vulnerable groups such as children and pregnant women - a criminal offence. Other Nordic countries such as Norway have laws like the Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) that place criminal liability on practitioners if a patient does not seek appropriate treatment as a result of their advice. It also does not permit ignorance as a defence if a patient is put at risk. Mandatory referral is an absolute must.

The duties on Colleges could be enhanced - partly to include considerations regarding child protection, public health and so on. A key enhancement would be to increase the amount of information in annual reports as well as other information that must be placed in the public domain. Adverse incident, complaint, etc reporting are important.

It would be difficult to argue against amendments to Provinces' laws that allowed periodic review scope of practice, recognition, etc. Such amendments would add to protection of the public. The only real argument against this is that it creates more bureacracy and an administrative burden. This could be mitigated in part by having different intervals between reviews for different professions - likely driven by scope of practice and the level of risk posed. It could also be mitigated by not so much set timetables for review but by setting criteria that trigger review. For example, increase in number of complaints received, adverse incidents, etc but setting such criteria could create an incentives for Colleges to suppress complaints.

Arguably, a permanent Advisory Board could fill that oversight role and it would look after all regulated professions including Doctors, Nurses, Dentists and so on. This is a very compelling argument. It really is about patient safety not just picking on Naturopaths. It seems very unlikely that the Colleges of actual medical professions would object to this - indeed, they may well be highly supportive and wish to be engaged.

Whilst there is no specific need for harmonisation of HPA, greater harmonisation would reduce the frequency of practitioners/patients moving between Provinces to practice/seek treatment. It could also be argued that could increase the mobility of labour.

This is likely to involve a lot of campaigning. There needs to a display of grassroots support for amendments to the law. "Skeptics" often lack the experience of effective campaigning nor are they particularly well organised. Patient advocacy groups and medical associations generally have more experience and are better organised. Effective campaigning costs money ultimately, but a lot can be done for very little - many people will give up their time for free. A large proportion of the public will be sympathetic to the issues but they are unlikely to be aware of them - raising awareness is key. Public support can be demonstrated in all sorts of ways - petitions, sending letters to politicians (although this can be counter-productive) and other potential individuals/groups who have influence on politicians and even public opinion surveys. However, it is important to have a consistent, factually correct and concise message. One observation of "quack" groups (especially homeopathic supporters) is that their campaigning is ineffective because it is often factually incorrect and indulges in whataboutery and paranoid conspiracy theories. "Big Pharma", doctors, critics of homeopathy are all part of an evil conspiracy. They often involve "rights" that simply do not exist in law.

Creating that message is key. The message needs to be seen as coming from a number of different groups in order to protect and enhance public health. It needs to be seen as protecting, especially vulnerable groups, not seeking to inhibit naturopathy simply because the authors of the message don't like it. Health and science educators with experience of successfully delivering messages to the public will need to be involved. Patient etc advocacy groups will need to be involved. The medical professions will also need to be involved.

Involving the media is also important although with the advent of social media, less so. At times someone with a large following can reach more people than conventional media. It can be dificult to get the media interested, 

It's not necessary to state what specific amendments are required to each Province's HPA should be. What needs to be done is create a "best practice" model of what the HPA should look like, what the role of the Advisory Board should be and so forth. Experience in drafting legislation would be useful but not essential.

Finding politicians who would be sympathetic to amending HPAs should not be too difficult. They will be the ones who will push through amendments to legislation. Patient etc advocacy groups will know who they are.

It is worth pointing that the Colleges will likely mount their own campaign to counter any amendments, especially the BC College. Their livelihoods are at stake. Naturopathy can be lucrative and potentially any campaign could be well-funded (but the Colleges themselves might not be). The Colleges may be able to call on support from other groups such as the "health freedom" movement - some organisations are well funded and organised. Some are essentially run by lawyers who make money from challenging public health protection laws. Supplement and alternative medicine manufacturers may offer financial support. There is also a considerable pool of disorganised anti-vaccinationists and "natural medicine" enthusiasts to call upon, not just in Canada but in the US too.

Consideration will need to to given as to what tactics the Colleges and their allies may employ. Lessons need to be learned from the campaigns that the Colleges may have mounted in order to gain recognition, campaigns that health freedom groups have mounted on issues such as mandatory vaccination, fluoridation and removing restrictions on the supplement market. There are likely to be some politicians who will be sympathetic to their campaign - but likely on the grounds of a free-market, anti-regulation, consumer "choice" stance rather than a special liking for naturopathy. It is very likely that any campaign will be couched in terms of portraying what is essentially a drive for greater consumer/public health protection as an "attack". 

There is an argument that naturopathy exists and that no legislation can make it disappear. The argument goes on to state that it is better to have sort of regulation than none at all. This ignores the fact that laws exist that prevent ordinary members of the public prescribing medicines, performing certain procedures and so on. 

Changes to College Codes etc
Convincing Colleges to change bylaws, Code of Ethics, etc likely to be difficult. If they took duties to public health, child protection and so on seriously, they would have done so already. It would be much quicker that amending legislation.

The kind of pressure - political, social and medical - that would need to be applied is enormous. Possibly greater than getting legislation amended and it would be political pressure that would be most effective. There has been some talk of reviews of self-regulation but they do not seem to have materialised. The value of such reviews are moot unless they concern themselves primarily with changes to legislation. The threat of changes to legislation might convince some Colleges to voluntarily change codes bylaws, codes, guidance etc but other Colleges might possibly passively/actively resist any pressures.

It's very much the same story as with campaigning for changes to legislation but with the additional twist that voluntary change could be presented in such as a way as a College acting responsibly. But such changes can be merely lip service. Without the will to enforce those changes, nothing really has change. Colleges would very likely lose members. They might face legal challenges from members that they discipline. The financial status of individual Colleges is unknown but some of them could face real difficulties.

Ignoring pressure? Naturopathy has a strong element of ignoring evidence that is contrary to its beliefs as well as a casual disregard for legislation and regulation. 

Complaining to the Colleges
Some say that this is pointless given the history of the Colleges' indifference to previous complaints. 

However, the UK experience is somewhat different. What happened to the UK chiropractic regulator, the General Chiropractic Council (GCC), as a result of British Chiropractic Association (BCA - a trade association - one of several) libel action against Simon Singh (over this article) is instructive. This Guardian article documents how the libel action started to backfire. Alan Henness and others made complaints to the GCC about BCA members. The numbers are astonishing. The effect on the GCC was dramatic to say the least. No regulator is equipped to deal with this number of complaints. The GCC had to employ more staff to deal with the number. The GCC's Annual Report for 2010 gives an idea of that impact. To it's credit, the GCC did take the complaints seriously - it has a legal duty to do so and also regulatory oversight by what is now the Professional Standards Agency. The GCC were never in any serious financial trouble but not every regulator is.

One thing that is clear is that the Colleges have a default position of "it's in the scope of practice" when concerns are raised about activities of members. Obviously this is not the most effective line of attack to take - even in British Columbia there is the lucidrous situation of naturopaths being permitted to treat any condition. 

Advertising is a definite weakness. Referring again to the case of the GCC, complaints were made on the basis of unsubstantiated claims. The Colleges do state that members must abide by legislation and this includes the Competition Act. It's important to realise it's not just the claims that are made for naturopathy that matter but also the claims against conventional medicine eg "vaccines cause autism". There is a presumption in HPA etc that Colleges are the first port of call for complaints. Making it known publically that complaints are being made can be effective, especially if the media pick up on it.

Complaints regarding unfair commercial practices such as "bait and switch" can also be effective. US chiropractors are notorious for these kind of practices - whether they have penetrated Canadian naturopathy is unknown.

Complaints based on child protection and the rights of the disabled are possible but likely tricky as legally because of issues of liability as previous discussed.

If there is a particular claim is common to many naturopaths, omnibus complaints can be made. As can be seen from the case of the UK GCC, these can be highly effective and have the potential to cause real problems for a College. Whether or not Canadian campaigners 

If a College doesn't deal effectively with complaints, this can create adverse publicity. Also, it's not the end of the road...

Complaining to Ad Standards
It isn't necessary to complain to Colleges first but it is likely Ad Standards would prefer that people do. Making mass complaints to Ad Standards is a possibility but flooding them with complaints would likely reduce their effectiveness.

What is likely to be more effective that mass complaints or omnibus complaints is making strategic complaints about single advertisers whose advertising contains one or more examplar problem claims. A ruling by Ad Standards on, say, a particular claim for a particular therapy could then be cited in complaints to colleges.

Ad Standards also allow complaints from Special Interest Groups. This is potentially very useful. For example, it's possible to imagine an association of Public Health professionals making a complaint about anti-vaccination propaganda in a naturopath's advertising. Likewise autism activist groups making complaints about claims for chelation, CEASE therapy, etc as treatment/cure for autism.

Ad Standards may also be amenable to issuing sector specific guidance. The UK Advertising Standards Authority (ASA) has done this for chiropractic and homeopathy.

Of course, Ad Standards is a voluntary regulator. If they rule against an individual naturopath, that should be enough for a College to act on but failing that complaining to the Competition Bureau is possible.

Complaining to Provincial Consumer Protection Agencies
It's very clear that these Agencies don't really want to deal with complaints about advertising. They are more concerned with unfair trading practices in certain business sectors. It's unlikely that they would be particularly interested in the healthcare sector as it mostly covered by HPA and the Colleges.

Complaining to Competition Bureau
The remit of the Competition Bureau does cover advertising. There are many remedies available to it. 

It has the powers to intiate prosecution. Although this Federal database doesn't turn up any particularly relevant rulings, there is an argument that a decisive Federal Court ruling on advertising of naturopathy would have dramatic effects. Even a Provinicial Court ruling would arguably set a precedent (although Quebec as a civil law jurisdiction less likely to take note).

Comments
Obviously, this can't cover everything. Comments are very much invited, especially questions. If people don't wish to comment on the blog and would rather ask questions directly, emails can be sent to ukhomeopathyregulation(at)gmail.com.

3 comments:

  1. Pharma can't patent nature, so they remove access to it.

    ReplyDelete
  2. This is errant nonsense. Firstly, examination of any patent database will reveal that there are many "natural" products that have been patented. Secondly, many of the products/procedures used by modern naturopaths are anything but "natural".

    ReplyDelete
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