Thursday, 15 November 2018

Possible Amendments to UK Legislation to control Quackery

The UK approach to regulating non-medically qualified practitioners has revolved around trying to increase professionalism, educational standards and encourage voluntary self-regulation. It also resulted in the Professional Standards Authority (PSA) Accredited Registers scheme.

This is all well and good and works well for certain professions and sectors but it does not deal with the worst type of quack. Quack here is meant as a non-medically qualified practitioners who pretends special knowledge and skill in medicine (healing or whatever other terms they use) above and beyond that of the ordinary lay person. Whether they deliberately set out to mislead or are deluded is irrelevant. What matters is that they pose potential risk.

(Medically qualified practitioners can get up to all sorts of "quackery" but they are subject to specific regulation. Quacks are not.) 

There have been suggestions regarding protecting specific groups from quacks and their claims especially regarding autism (see this petition) but protecting one vulnerable group is not sufficient.

It is suggested that the most effective way to to deal with quackery is by amending the law to make quacks criminally liable for their (in)actions.

1. Exemptions
As discussed in a previous post, introducing legislation that impedes the functioning of a vast proportion of health and social care provision in the UK would not be a good idea. It is also the case that impinging on the ability of lay persons to come to the aid of person in distress would not be a good idea either.

1.1 Delegation
None of this is intended to exclude medically unqualified lay persons carrying out activities as instructed by (named) medical professionals. There is a liability on medical professionals to ensure that ensure that are correctly instructed in carrying out an activity. There is also a duty on employers to ensure lay persons are competent and correctly trained.

This would also apply to residential homes and the like. Treatment plans are devised by doctors but may be carried by care professionals who are employed by the home. In this case there is a duty both on the doctor and the employer to ensure care assistants are competent.

1.2 Self/carer-administered treatment
Obviously, any law would not prohibit a person taking medicine orally that was prescribed by a doctor. Nor would it prohibit a family member giving such medicine to a dependant. But there are other treatments that are invasive that could potentially could fall foul of poorly framed laws.

For example, type 1 diabetics need to inject insulin. Modern delivery systems are minimally invasive. No-one would have an issue with a carer (as opposed to a care professional) administrating an insulin injection. But other types of injection can involve big needles, are intravenous and so on. They come with more risks.

Which treatments can be self/carer administered by is beyond the scope of this post but it is suggested to a large degree, it would be the judgement of health professionals as to whether a lay person was competent to do so. As this treat is not carried out under the notional supervision of a medical professional, they can not be held liable.

1.3 First Aid and Good Samaritan acts
Obviously, no-one would want to stop trained lay persons from performing first aid in life-threatening or serious situations. Not all jurisdictions explicitly recognise the principle of "Good Samaritan acts although case law implicitly does. Some jursidictions do require persons to come to the aid of those in distress. It is said that sometimes people do not act in certain situations because of a fear of litigation.

2. Criminal Acts
Whilst case law does prohibit certain acts by quacks, there is no clarity in law. It is often the case that charges are brought that do not relate directly to act and that the penalties do not match the crime (see later parts of this).

Whilst consumer protection law effectively forbids marketing of certain acts, the offer to treat in any form should be illegal.

It is not suggested that all the below should be implemented, more than they represent potential models.

2.1 Controlled Acts
Canadian Provinicial legislation in the form of various Regulated Health Professions Acts contain a list of acts that are forbidden to medically unqualified lay persons and even to some regulated professions. To quote from the Ontario Act -

(2) A “controlled act” is any one of the following done with respect to an individual:

1. Communicating to the individual or his or her personal representative a diagnosis identifying a disease or disorder as the cause of symptoms of the individual in circumstances in which it is reasonably foreseeable that the individual or his or her personal representative will rely on the diagnosis.
2. Performing a procedure on tissue below the dermis, below the surface of a mucous membrane, in or below the surface of the cornea, or in or below the surfaces of the teeth, including the scaling of teeth.
3. Setting or casting a fracture of a bone or a dislocation of a joint.
4. Moving the joints of the spine beyond the individual’s usual physiological range of motion using a fast, low amplitude thrust.
5. Administering a substance by injection or inhalation.
6. Putting an instrument, hand or finger,
i. beyond the external ear canal,
ii. beyond the point in the nasal passages where they normally narrow,
iii. beyond the larynx,
iv. beyond the opening of the urethra,
v. beyond the labia majora,
vi. beyond the anal verge, or
vii. into an artificial opening into the body.
7. Applying or ordering the application of a form of energy prescribed by the regulations under this Act.
8. Prescribing, dispensing, selling or compounding a drug as defined in the Drug and Pharmacies Regulation Act, or supervising the part of a pharmacy where such drugs are kept.
9. Prescribing or dispensing, for vision or eye problems, subnormal vision devices, contact lenses or eye glasses other than simple magnifiers.
10. Prescribing a hearing aid for a hearing impaired person.
11. Fitting or dispensing a dental prosthesis, orthodontic or periodontal appliance or a device used inside the mouth to protect teeth from abnormal functioning.
12. Managing labour or conducting the delivery of a baby.
13. Allergy challenge testing of a kind in which a positive result of the test is a significant allergic response.
14. Treating, by means of psychotherapy technique, delivered through a therapeutic relationship, an individual’s serious disorder of thought, cognition, mood, emotional regulation, perception or memory that may seriously impair the individual’s judgement, insight, behaviour, communication or social functioning. 1991, c. 18, s. 27 (2); 2007, c. 10, Sched. L, s. 32; 2007, c. 10, Sched. R, s. 19 (1).

Not all of this is compatible with UK law. For example, in the UK psychotherapy is not regulated (although there are arguments that it should be). It would also outlaw lay practitioners from offering colon hydrotherapy although it would not prevent a healthcare assistant etc being delegated the task of giving an enema or performing manual evacuation by a medical professional. Obviously this does not relate to consensual sexual activity either but "intravaginal manipulation" is known in some manual therapies, including quack ones.

The restriction on lay persons offering diagnosis is particularly important. One obvious area where this could well apply is in fictional conditions such as adrenal fatigue and vaccine damage

The Dutch Wet op de beroepen in de individuele gezondheidszorg als restricts certain acts to by profession. Google translate doesn't do a good job with Dutch but the acts and associated professions -
  • Surgery - Doctors, Dentists, Midwives, Physician Assistants and Specialised Nurses - the latter four are restricted in scope.
  • Midwifery procedures - Doctors and Midwives
  • Endoscopy - Doctors, Physician Assistants and Specialised Nurses - the latter two are restricted in scope
  • Catheterisation - Doctors, Midwives, Physician Assistants and Specialised Nurses - the latter three are restricted in scope.
  • Injection - Doctors, Dentists, Midwives, Physician Assistants and Specialised Nurses - the latter four are restricted in scope.
  • "Punktie" biopsy etc - Doctors, Midwives, Physician Assistants and Specialised Nurses - the latter three are restricted in scope.
  • Anaesthesia - Doctors and Dentists - the latter are restricted in scope.
  • Radiology and Radiography (ionising radiation) - Doctors and Dentists - the latter are restricted in scope.
  • Cardioversion - Doctors, Physician Assistants and Specialised Nurses - the latter two are restricted in scope.
  • Defibrillation - Doctors, Physician Assistants and Specialised Nurses - the latter two are restricted in scope.
  • Electroconvulsive therapy - Doctors.
It also deals with prescribing rights. Physician Assistants are called Physician Associates in the UK but to be clear they are not statutorily recognised but they are in the Netherlands. Specialised Nurses means Advanced Practice Registered Nurses (APRN) - the UK differs in detail.

These kind of restrictions would be largely compatible with UK legislation. 

2.2 Scope of Practice
For a particular profession, a specific list of what acts are permitted. It's impossible to do for doctors but not so for other professions. It can be argued that in the case of UK osteopaths and chiropractors there is a good case for introducing amendments to legislation to explicitly control what they can do. What is not in the scope of practice is not permitted. This is a side issue though.

There are issues with some medical professionals who have a side line in self-employed quackery whilst being (self-)employed elsewhere. This is a complex area but in short, practising outside of even a notional scope of practice means that they can not use a protected title in that context and they have no more qualification/entitlement than a medically unqualified lay person yet would be held to a higher level of accountability by a Court for harms done (they should know better etc). 

2.3 Restricted Groups/Conditions
This concept exists in a number of jurisdictions. In Sweden, the Patientsäkerhetslag states lay persons can not.
1. treat such infectious diseases as according to infectious diseases (2004: 168) are notifiable diseases, 
2. treat cancer and other malignant tumours, diabetes, epilepsy or conditions in connection with pregnancy or childbirth; 
3. examine or treat another person during general anaesthesia or during local anaesthesia by injection of anaesthetics or under hypnosis, 
4. treat someone else with radiological methods, 
5. Without personal examination of the person seeking him or her, provide written advice or instructions for treatment; 
6. examine or treat children under eight years; or 
7. try out contact lenses.
The Norwegian Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) prevents lay persons from -
  • Performing treatments or interventions that carry a serious health risk
  • Treatment of communicable diseases (although it does permit treatment to alleviate symptoms there of or side effects of conventional treatment - but only a medical professional can treat the disease itself.
  • Treatment of serious conditions and diseases (although, again, alleviation etc are permitted)
Alleviation can be defined as a reduction in intensity of symptoms. Pain relief is one obvious example.

There are strong arguments for prohibiting quacks from treating those who can not legally consent to treatment. Children are the obvious example but it also applies to some with learning disabilities, mental health conditions and those suffering from dementia. UK law case is clear where parental wishes conflict with medical opinion - the rights of the child to appropriate medical treatment come first. Preventing quacks going near anyone who can not give consent would be consistent with that.

Prohibiting the treatment of pregnant women is justified in terms of protecting the unborn child from quackery. However, the status of the foetus in English (and even European) law is unclear. That doesn't mean that such a prohibition would be impossible - it's more that it could be argued that it is an infringement of a woman's human rights.

As for a list of conditions - yes, there are some very obvious candidates that quacks should not claim to treat but coming up with an exhaustive list is beyond the scope of this post.

The question of alleviation of symptoms is tricky. Arguably it is incompatible with the philosophy of certain forms of quackery that treat "the whole person" or "root causes". Making those kind of statements and offering to alleviate the side effects of chemotherapy such as nausea? Treating foot conditions that result from diabetes? No. 

In the case of herbal quackery, there is the risk that nostrums may interact with medicines and/or have other adverse effects. It is suggested that such treatment should only be allowed if permission is granted by the patient's medical practitioner. This is what happens with use of CAM (often by volunteers) in palliative care settings. Hospices and NHS Trust (should) have very clear policies in place to mitigate risk.

Outside of those controlled settings, the offer to "alleviate" or "help with" symptoms of conditions etc can disguise the intention to treat said conditions, hence why restrictions on marketing claims are insufficient.

2.4 Mandatory Referral etc
The Norwegian Law on Alternative Treatment etc regards a patient not seeking proper treatment as the fault of the quack as well as making ignorance of putting a patient at danger inadmissible as a defence. Some of the Canadian Provincial Colleges (which are regulated) have as part of their Code of Ethics etc a duty to refer patients to real medical professionals if they present with certain conditions.

One issue with mandatory referral is that with undiagnosed conditions, it depends on the ability of the quack to recognise the symptoms of a potentially serious condition. As the example of CEASE therapy clearly demonstrates, some quacks would not recognise them and indeed would seem them as positive signs.

2.5 Medical Tests and Medical Devices
There has been a large growth in both private testing clinics and direct to consumer medical tests. For some types of tests, it is no longer necessary to visit a doctor (NHS or private) to arrange for tests.

Some types of medical tests require interpretation by a professional. It is often the case that a test on its own is insufficient to diagnose a particular condition. It is also the case that tests for certain conditions do require pre/post-diagnosis counselling.

There are some tests on the market that are completely useless or that have limited uses but are widely abused and misrepresented by quacks but arguably, restrictions on diagnosis would curtail this.

Obviously, what applies to tests also applies to diagnostic devices. But therapeutic devices? In theory, the controls on medical devices should prevent quacks getting their hands on anything potentially dangerous. Marketing claims by manufacturers are one thing but the claims made by quacks are another. 

2.6 Contracts, Waivers and Consent forms
Making certain acts illegal has an impact on any contracts etc that might be signed. Generally, seeing a practitioner involves filling in various forms that may or may not be considered to be a contract. A contract that involves illegality can be ruled as void.

Sometimes quacks will ask clients to sign what are essentially liability waivers - the legality of these is questionable. This may or may not take the form of a consent form.

Informed consent is a difficult issue with quackery. There are two elements to this - the inability/unwillingness of the quack to explain the risks/benefits of the treatment in clear (and truthful) terms and secondly, the ability of the client to understand what is said and evaluate the risks/benefits. Can someone give informed consent to an act that is explained into fictional or allegorical terms? Can someone give informed consent based on incomplete or erroneous information?

It should pointed out that the client signing a waiver or a consent form does not remove liability from a quack. Here is an example of a consent form (plus guidance) from the Society of Homeopaths (SoH( regarding homeoprophylaxis. The guidance says -
Homoeopaths may supply or prescribe homoeopathic medicines for prophylactic purposes only if they have been specifically requested by the patient. Practitioners should always document sign and date all discussions, advice and treatment with the patient. Such documentation should be kept for a period of at least 6 years. Members may wish to use a consent form, but we need to remind members that use of such a form will not offer any protection against liability in the event of legal action: it is never possible to exclude liability for injury caused by negligence.
As this post points out the supply of the products used in homeoprophylaxis by quacks is largely illegal and they have no prescribing rights but as the SoH points out this sort of form offers no protection against liability.

3. Penalties etc
Arguably, any of the above amendments to law could have the effect of making it easier to secure conviction of quacks. Whether this is sufficient to deter the more larcenous/deluded is moot. And among the more extreme there can be a martyr complex - some homeopaths have made noises to the effect that they would rather be referred to Trading Standards and face potential prosecution than withdraw marketing claims re autism and in particular CEASE therapy.

Quackery is generally not lucrative. Fines on conviction and legal costs may act as a deterrent for some but possibly not in all cases. Custodial sentences would likely have more of a deterrent effect. What maximum penalties should be is difficult to say. In the case of serious physical harm or death it is likely that quacks would be convicted for different offences. 

Bear in mind for regulated medical professionals, loss of registration means loss of their livelihood. They can no longer practice and would face criminal sanctions if they did and misrepresented themselves. They could set themselves up as quacks though. Conviction of a quack itself (barring custodial sentences and licence conditions of parole) does not prevent them returning to their bad ways. 

The case of Errol Denton was mentioned in the last post. Part of the ruling against him was a Criminal Behaviour Order (CBO) restraining him from making further misleading medical claims until further order of the court. This falls far short of actually stopping his activities. 
The Anti-social Behaviour, Crime and Policing Act 2014 grants courts to power to restrict the activity for an indefinite period. A law that made it illegal for quacks to diagnose disease as per the Ontario Regulated Health Professions Act combined with an indefinite CBO would put the likes of Denton out of business or face jail.

4. Advertising Restrictions etc
Obviously prohibiting the advertising of illegal acts is one thing but some jurisdictions go further.

In some jurisdictions there is an absolute prohibitions on certain professions advertising beyond simple listings but this tends to be for historical reasons. Traditionally, professions did not advertise - it was seen as uncouth for one thing - and arguably they did not. There was one doctor and one lawyer in a small town etc and those able to afford them would likely have social connections.

In Norway, quacks are only permitted factual advertising as to the existence of a service. Beyond that, no claims can be made. 

In some jurisdictions, quacks have to reveal to clients the nature of the qualifications before even attempting to treat them ie that they are not medical professionals. 

5. Opposing Arguments
There are some very obvious arguments that could be made against any of these suggestions. Some are not discussed as they have no merit whatsover (eg conspiracy theories)

5.1 Suppression of Free Speech
This is easily dealt with. These proposals would not in any way limit free speech, they would limit commercial speech. The distinction between the two is discussed here

5.2 Autonomy
It could be argued that making the offer of certain acts by quacks reduces patient autonomy.

If a person with mental capacity wishes to treat their own condition, with products that are legally marketed and obtained and it results in harm or even death, this is basically permitted. It is possible to "section" someone under the Mental Health Act 1983 if they are assessed to be suffering from a severe mental disorder but the criteria are set very high (partly due to a lack of psychiatric facility beds).  If that course of action also places others at risk of harm can also be a consideration.

Case law does recognise the right of a person with mental to refuse treatment - Do Not Resuscitate are one obvious example. Others include cancer patients who have had multiple rounds of chemotherapy/radiotherapy/surgery and the cancer still progressing. Heroic measures are not as common in the UK as the US.

When others become involved, things are more tricky. Taking an extreme example, assisting suicide is an offence under the Suicide Act 1961. In English law they could be charged with voluntary manslaughter (culpable homicide in other jurisdictions). The point was made above but to restate in different words - a person cannot lawfully consent to anything more than the infliction of minor injury and that the person inflicting the injury can be charged with assault. That an act carries a high risk of harm is a consideration even if it does not necessarily result in actual harm.

But the patient autonomy argument involves the question of whether quackery is actually medical treatment. 

5.3 Parental Rights
In reality, under UK law there is no such concept. There are children's rights and there are parental responsibilities. Of course, parents as adults have their own human rights but these do not supersede children's rights. In most jurisdictions, law limits parental power over children.
Parents do not have absolute power over their children. Parents are subject to criminal laws against abandonment, abuse, and neglect of children. International human rights law provides that manifestation of one's religion may be limited in the interests of public safety, for the protection of public order, health or morals, or for the protection of the rights and freedoms of others.
Children may well have rights under law but from B. (R.) v. Children's Aid Society of Metropolitan Toronto -
While children undeniably benefit from the Charter, most notably in its protection of their rights to life and to the security of their person, they are unable to assert these rights, and our society accordingly presumes that parents will exercise their freedom of choice in a manner that does not offend the rights of their children.
To be clear, those who often shout loudest about "parental rights" are often seeking sanction for behaviour that offends the rights of their children. 

Comments and Corrections
It is likely that this post contains a number of errors, especially on finer points of the law. The ideas expressed here need further development and refinement.

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