OG 304 Complementary and Alternative Medicine

Last reviewed:
19 October 2015
Last updated:
14 February 2017

Policy Statement/Overview

GUIDANCE UNDER REVIEW: Please note that this guidance is currently under review. When this review is completed, changes may be made to this guidance. During the course of the review we may need to carry out additional checks when assessing applications for registration which fall within the scope of this guidance.

Complementary medicine and alternative medicine (referred to in this guidance as 'CAM') can be used to promote health, relieve sickness and alleviate a variety of medical conditions.  The very nature of diagnosing, treating or curing illness and disease, whether conventionally or through CAM, will involve considerable risk of harm -­ for example, as a result of misdiagnosis or the wrong treatment.  So when we consider an application to register an organisation promoting CAM as a charity, we must carefully assess the benefits against the potential harm.

Our approach when considering such cases is set out in Annex A of the Commission's decision dated 29 February 2012 about Soteria Network (1146183). Caseworkers should read the Soteria Network decision in conjunction with this guidance.

Summary of the guidance

This guidance is intended to help caseworkers make decisions about whether organisations using CAM have aims which would fall within s.2(2)(d) of the list of descriptions of charitable purposes in the Charities Act 2011, ie the 'advancement of health or the saving of lives' (which includes the relief of sickness and the promotion of health) and be for the public benefit.

It explains:

      • how to identify the evidence needed to assess the efficacy of a CAM in relation to the trustees' claims for it, and
      • how to assess the impact of any potential for harm and how this affects public benefit

in order to make this decision.

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Casework Guidance

Four key points

 

  • It is important to understand the difference between ‘complementary’ and ‘alternative’ medicine (‘CAM’). See B1 for what ‘complementary’ and ‘alternative’ mean in this context. 
  • When considering applications from organisations using CAM to fulfil their purposes we need to identify:
    • the purposes of the organisation - what the purposes are and whether they fall within the descriptions of purposes in the Charities Act 2011
    • whether the purpose is for the public benefit. (This guidance deals only with consideration of the 'benefit' aspect of public benefit. Caseworkers will still need to consider whether the 'public' aspect has been demonstrated). This means identifying what CAM is being used or promoted and taking an evidence-based approach to identify:
      • what the benefits are - is it capable of fulfilling the health benefits claimed for it? The greater the claims made for the treatment or therapy being offered, the more convincing the evidence will need to be. See section B5 for more information about the evidence we need to consider an application
      • any potential harm from use of the treatment or therapy and being satisfied that the harm does not outweigh the benefits. See Sections B5-B7 for more information on how we assess this.
     
  • To be taken into account, evidence must:
    • be of the quality that a court can recognise
    • relate specifically to how the method is used by the applicant organisation
  • When considering the potential for harm, this will be reduced where:

    • the treatment or therapy is non-invasive
    • people will not be at risk of abuse or exploitation (eg the treatment is not hands-on or does not require the removal of clothing)
    • the treatment or therapy is subject to regulation, whether statutory or by voluntary agreement, meaning:
      • practitioners must be professionally qualified and eligible to practice
      • there is a supervisory and complaints regime
      • compulsory insurance is required to protect those receiving the treatment
     

See section B7.1 for more information about our approach to assessing the risk of harm in relation to CAM. See B8 for more information about regulation of CAM.

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B1        Key terms you need to understand when considering CAM cases 

  • CAM’ is shorthand for ‘complementary and alternative medicine’.
  • Complementary’ medicine is medicine that is offered alongside conventional medicine (ie to complement it). It is not intended as a substitute for conventional medicine.
  • Alternative’ medicine is offered separately from (ie as an alternative to) conventional medicine. It may be offered both alongside and instead of conventional medicine
  • The same treatment or therapy might be offered as a complementary or alternative method, depending on the circumstances of the particular organisation. But where a method is intended to be used as a complementary method we would expect an organisation to use it for this purpose and not as an alternative to conventional medicine.

 

In this guidance, when we use the terms ‘treatment’ or ‘therapy’ we mean the method being used to administer the CAM.

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B2        Essential information we need for all CAM applications

In any application for charity registration from an organisation promoting CAM we need the following information:

 

To identify purpose:

  • The charitable purpose or purposes that the organisation is seeking to carry out by administering CAM

 

To identify benefit:

  • the particular treatment or therapy used by the proposed charity to carry out its purposes, and how it will promote the health of the recipient - such as the medical condition or conditions (ie charitable need) that the treatment is intended to relieve
  • whether the method will be used to diagnose, relieve or cure a condition
  • whether it will be provided as a complementary or alternative method
  • the full extent of the claims made by the promoters about the health benefits that recipients will gain
  • evidence (where necessary) of the efficacy of the method when used for the purposes which the organisation intends. See B5 for more information about what we mean by evidence

 

To consider the potential for harm:

  • evidence (if necessary) that any potential for harm is reduced so that the harm does not outweigh the benefit. See B7.2 for information on what evidence we expect trustees to provide to show this.

 

A note about public benefit

This guidance is concerned with assessing the 'benefit' aspect of public benefit. We also need to consider whether there are any factors that impact on the 'public' aspect. An issue that can arise for organisations promoting CAM is personal benefit - where, for instance, trustees are used as practitioners of the method being used. Caseworkers should follow the approach set out in our public benefit guidance when considering issues around personal benefit.

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B3        Our approach when considering applications from organisations promoting CAM

When assessing applications we use the same overall approach in all cases, as set out in Annex A of the Charity Commission Decision dated 29 February 2012 ‘Soteria Network’ 

 

We first establish that the purposes of the organisation fall within the descriptions of purposes in s3 of the Charities Act 2011.  Having done so, we consider these purposes in the context of the particular circumstances of the organisation – the ‘factual matrix’ - to determine whether the purposes are capable of being for public benefit. 

To establish if the purpose is for public benefit:

  • the particular therapy or treatment must be capable of curing, diagnosing or providing palliative relief in respect of any particular illnesses or conditions according to the claims made by the organisation seeking registration  (see B5)
  • the treatment or therapy must be capable of being delivered safely and effectively for the public benefit, with any potential harm minimised or reduced so that the risk of harm does not outweigh the benefits (see B7)

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B4        CAMs and purposes which are capable of being charitable

How do we identify a ‘CAM charity’?

A CAM charity will not necessarily identify itself in those terms. However, the information provided by the trustees about what the organisation is set up to achieve will indicate whether CAM is involved. 

 

An organisation using CAM to achieve its purposes is likely to have purposes falling within s(1)(d) of the Charities Act 2011 - the advancement of health or saving of lives. 

 

Other purpose descriptions that may apply are:

  • s3(1)(b) - the advancement of education (eg where carrying on research for public benefit)
  • s3(1)(j) - relief in need on grounds of ill-health (for instance where addressing a specific health need)

 

When considering applications from organisations using CAM to achieve their purposes we apply the same criteria as for any other organisation established for similar purposes.

 

Taken together, the information listed in B2 will help caseworkers identify which charitable purpose is being furthered through the provision of the CAM method in question and therefore what the organisation needs to demonstrate in its application. 

 

For more information about the descriptions of charitable purposes and the characteristics that need to be met, see our guidance on how to write charitable purposes

 

See also:

 

lawyer_referCaseworkers should refer to a legal officer in all cases where the charitable purpose is not clear or in doubt.

 

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B5          Evidence of efficacy of a CAM method and what we need to consider this

When assessing whether a CAM method as used by the applicant charity is capable of fulfilling the claims made for it, we look for objective, scientifically-based evidence that the method being used impacts beneficially on health according to those claims.    

 

For some methods, efficacy has already been accepted. Where this is the case, the trustees don’t need to provide us with detailed scientific evidence to support their application.

 

For example, an organisation aims to diagnose and relieve pain arising from musculo-skeletal problems using chiropractic and osteopathy. Chiropractic and osteopathy are methods recognised on the basis of medical science as being capable of doing that.

 

lawyer_refer Caseworkers should seek advice from a mentor or legal officer if they are unsure whether there is sufficient evidence of the efficacy of the CAM in question.

 

See B6 for our approach when considering CAM methods already recognised as being beneficial. 

 

B5.1     Suitable forms of evidence

All claims made for the efficacy of a method must be substantiated with evidence. We recognise that not all forms of alternative or complementary treatment may lend themselves to conventional research methods. However, the evidence must be evidence that a court can recognise. 

 

Examples of suitable evidence include;

  • peer-reviewed research (ie research scrutinised by fellow professionals) in recognised medical journals, for example The Lancet or BMJ  
  • recognition by the Department of Health or other governmental health regulatory or health provision body. 

 

Examples of evidence which is not sufficient to demonstrate efficacy include:

  • testimonial or anecdotal evidence (see B5.5)
  • articles or features of a non-scientific nature promoting the method, treatment or therapy

 

Deciding whether evidence is sufficient in relation to the claims made is not always straightforward. Factors that can help include:  

  • the source of the evidence – is it sufficiently independent and authoritative?
  • is the evidence accepted in academic or scientific circles?  If not, can any differences of expert opinion be rationally explained?
  • does the evidence fully address the claims made for the method?
  • is the method recognised and/or supported by the Department of Health or other governmental health provision body?
  • what is the method’s relationship with conventional medicine?

 

We must be satisfied that, taken overall, the evidence is of the quality that would be accepted by a court or Tribunal as demonstrating benefit. For more guidance about how we evaluate evidence, see our decision in relation to the Soteria Network, which shows how our approach is applied in practice.

 

lawyer_referCaseworkers should take legal advice if, based on the evidence provided, they are uncertain that sufficient evidence of efficacy has been provided.

 

 

B5.2     Evidence appropriate to circumstances 

The evidence we require will depend on the claims made for the CAM.  In particular, where a treatment or therapy claims to cure or diagnose (as opposed to providing relief for) a condition there is an inherent increased risk of harm to recipients.  They may receive this diagnosis and treatment in place of conventional medical assessment and treatment of demonstrated clinical effectiveness.  In these circumstances it is likely to require particularly clear and compelling evidence of efficacy to demonstrate benefit which outweighs the potential harm.

 

The issue is most acute where a method is actually offered as a substitute for conventional treatment, particularlly where it is claimed that the method is capable of diagnosing or curing the conditions in question.

 

 Section B7 explains our approach when assessing the risk of harm in relation to CAM.

 

In Annex A of the Soteria Network decision we illustrate our approach as follows:

  • An organisation claims to diagnose and cure all illnesses by offering treatment X. Charity Commission will want evidence to demonstrate it can diagnose and cure all illnesses
  • An organisation claims to cure a particular illness, for example addiction to substances. Charity Commission will want evidence to demonstrate that the particular treatment cures substance abuse.
  • An organisation claims to provide palliative relief for a particular illness by reducing stress and pain. Charity Commission will want evidence to demonstrate that the particular treatment does provide this palliative relief.

 

 

B5.3     Complementary or alternative?

Although we don’t need the trustees in all cases to provide us with detailed evidence of efficacy of the method (see B6 for when this is the case), we do always need them to tell us, for the reasons given in B5.2, whether the method is being used as a complementary or alternative method.

 

  

B5.4    Finding the evidence

The onus is on the trustees to provide us with the necessary evidence that the method offered by the organisation is capable of delivering the claimed benefits. However, where helpful, we may also want to consider other sources of information. Examples include:

  • the organisation’s website or promotional material, as this can tell us how potential beneficiaries are advised that they will benefit from the method

 

 

  • the website of any membership body of which the organisation is a member, as this can show what measures there are to supervise and regulate the organisation in its delivery of the CAM method in question

 

B5.5     Testimonials and other anecdotal evidence

We cannot accept testimonials as evidence of a method’s benefit because they lack the rigour needed for formal recognition.

None of the following are credible evidence of a method’s benefits because they are all based on personal opinion and are not scrutinised by medical science:

  • patients’ testimonials
  • testimonials of other practitioners of the method
  • results of customer satisfaction surveys
  • general (non-scientific) media articles endorsing the treatment
  • results attributed to treatment where not part of a scientific trial  

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B6        Methods already recognised as being beneficial

Where an applicant has demonstrated that it will adopt a particular recognised CAM method and it has already been recognised as beneficial to health we don't need to see the detailed scientific evidence of the efficacy of the method in order to decide if the purpose is for the public benefit.  This is because recognition of the method will have been gained following robust and independent scrutiny of the available evidence. In these cases we can accept that the efficacy of the method has been demonstrated. See B6.1,  B6.2 and B6.3 for more about recognition of CAM methods and the information we need from organisations using these methods to achieve their purposes.  

 

bewareFor methods where efficacy has been accepted we still need to be satisfied, in line with the trustees' duty to operate the charity for the public benefit, that the organisation is capable of delivering the method safely and effectively.  Key to this is how the method is regulated and the risk of harm managed.  For more information about the risk of harm in relation to CAM, and how we assess this, see B7.

 

 

B6.1     Beneficial methods regulated by statute

The law has already accepted the efficacy of some treatments and, where this is the case, we will not require further evidence.  

Methods regulated by statute include:

For these CAM methods, we need to know that practitioners used to deliver treatments are registered with the statutory regulatory body and meet all the requirements of that body. See Group 1 of the ready reference table in B9 for more information about what the trustees need to confirm.

 

B6.2     Beneficial methods not regulated by statute

Organisations using methods not currently subject to statutory regulation, but which

  • have gained wide recognition through clinical trials and scientific medical research as being capable of delivering health benefits

 and

  • are subject to voluntary self-regulation by a recognised body

need not provide detailed scientific evidence of the CAM’s effectiveness.  Where a method is subject to voluntary self-regulation, we can accept this on the same basis as one that is regulated in law.

 

Methods subject to voluntary self-regulation include:

The trustees will need to show that practitioners used to deliver treatment are registered with the appropriate voluntary self-regulatory body for the method, and that they meet all the requirements of that body.

See Group 1 of the ready reference table in B9 for more information about what the trustees need to confirm where a method  has gained recognition of efficacy and is self-regulated.

 

B6.3     Methods whose benefits have been previously accepted on evidence

We will not require detailed scientific evidence of efficacy where the method is one which we have previously accepted on the basis of evidence and law in respect of the particular benefits claimed. An example of this is the Decision of the Commission 15 August 2002 in respect of the application to register NFSH Charitable Trust Limited (1094702), where we recognised that spiritual healing is capable of giving palliative relief in a complementary setting.

 

In these cases the trustees will need to show how the method is regulated, and that practitioners are registered with, and meet all the requirements of, the regulatory body.  For information about regulation of CAM, see B8.

 

lawyer_refer Caseworkers should seek legal advice if they are unsure about whether the method being promoted has previously been accepted as beneficial.

 

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B7        The risk of harm and how this impacts on public benefit

When considering whether the purpose of an organisation which uses CAM to achieve its purposes is for the public benefit our approach is based on the law. 

The law recognises that

  • treatments which have not been rigorously tested before being made available for use carry an increased risk of harm to those receiving them; and that
  • people who are ill may be willing to try (and pay for) treatments in the hope of a cure and may experience harm as a result

 

Public benefit will be affected if the potential for people to experience harm from a CAM method outweighs the benefits that can be gained. To satisfy the public benefit requirement, therefore, an organisation using CAM to achieve its purposes must be able to show that any risk of harm has been minimised or reduced so that the harm does not outweigh the benefits.

 

The main risks associated with CAM are:

  • poorly administered, a CAM method could cause physical or psychological harm
  • CAM has the potential to exploit people who, because of their condition, are especially vulnerable   
  • using CAM as an alternative to conventional medicine may mean that people who need a medical diagnosis and treatment do not get it

 

See B7.2 for further information on the evidence that trustees must provide to deal with these harm factors.

 

B7.1     Assessing the risk of harm

When considering harm factors in relation to CAM, what we are looking for is evidence that any potential for harm is minimised or reduced so that the harm does not outweigh the benefit. The greater the risk, the more compelling the evidence will need to be that those risks will not outweigh the benefits.

 

The risk of harm will be greater where:

  • methods claim to cure, or diagnose conditions
  • treatment is offered as an alternative to conventional medicine
  • the way the treatment is administered means those receiving it could be vulnerable to harm or abuse
  • there is little or no formal regulation and/or supervision of practitioners carrying out the method to ensure it is delivered safely

 

The risk will be reduced where:

  • The method offers relief from a condition but does not claim to cure or diagnose it
  • Treatment is offered alongside but not instead of conventional medicine (and people receiving the treatment are told that they are receiving it on that basis)
  • Treatment is non-invasive
  • Treatment does not require recipients to remove clothing or make themselves vulnerable in other ways
  • Practitioners are required to register with a single regulatory body and adhere to defined professional standards when administering the treatment
  • Regulation includes formal complaints and grievance procedures for when standards are not met
  • Practitioners have compulsory insurance to protect those receiving the treatment

 

Section B7.2 sets out the information we require from trustees to show how the risk of harm is managed.

 

Our approach to assessing this information follows the approach taken in the Soteria decision. Annex A of the Soteria Network decision (‘Benefit or Harm’) gives an indicative list of those circumstances where the greatest potential for harm exists, and describes two scenarios which show what low and high risk might look like for an organisation using CAM to achieve its aims. The Soteria Network decision itself shows the working out of our approach when the evidence is more finely balanced.

 

lawyer_refer Caseworkers should take advice from a mentor or legal officer if they are unsure whether the evidence provided demonstrates that the risk of harm does not outweigh the benefit.

 

B7.2     Information the trustees need to provide to show the risk of harm resulting from use of the CAM does not outweigh the benefit

 

The information we need the trustees to provide in relation to managing the risk of harm will depend on the CAM method in question, and the potential for harm associated with it. In general, the trustees should be able to confirm most, if not all, of the following points to us as evidence that the CAM they are using is safe:

 

  • The practitioners they use to administer treatments are (where one exists) members of the professional standard-setting regulatory body applicable to the CAM method being used, and are bound by its codes of ethics, conduct and practice

 

  • Practitioners used to administer treatments must demonstrate a required standard of competency to deliver the method safely

 

  • If a method is intended to be used as a complement to conventional medicine beneficiaries are told this and advised to contact their GP or other practitioner of conventional medicine

 

  • Where a patient’s condition is outside the practitioner’s area of expertise (and therefore beyond the scope of what the method is capable of achieving), the practitioner advises them to contact their GP

 

  • Practitioners do not act contrary to the advice of the recipient’s practitioner of conventional medicine

 

  • There are complaints and/or disciplinary procedures in place for when a treatment or course of treatments fails to benefit the patient in the way they have been told it will, or if it harms them

 

  • Where the nature of the treatment warrants this, practitioners have insurance to protect those receiving the treatment  

 

See also section B8 on Regulation.

 

lawyer_referWhen assessing this information we must be satisfied that, taken overall, the evidence is of the quality that would be accepted by a court or Tribunal as demonstrating benefit.

 

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B8        Regulation of CAM

Regulation of a CAM, whether by statute or voluntary self-regulation, can be a significant factor in deciding whether the risk of harm is outweighed by the benefits. Where a CAM method is used it is important that there are controls and safeguards to ensure the treatment is administered safely. The presence of a formal regulatory framework (usually through a single regulator) will be helpful in showing how this is achieved and what the proven benefits of the method are in relation to the risk of harm.

 

Where there is no such framework, we take into account the nature and level of the risk of harm to recipients of the treatment in the particular circumstances of the applicant organisation, using the criteria for assessing benefit or harm described in Annex A of the Soteria Network Decision. The greater the risk, the more necessary it will be for the organisation to show how the method and its practitioners are regulated, in order to confirm that the risks are outweighed by the benefits. 

 

Where the CAM method is regulated by a recognised body, ie those listed in Group 1 of the ready reference table or the Complementary and Natural Healthcare Council, we don’t need to examine the regulator’s requirements in detail. In these cases the trustees should confirm that the organisation and its practitioners will operate fully within the requirements of the regulator. 

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B9    CAM ready reference table

The following table is based on the findings of the House of Lords Select Committee on Science and Technology 1999-2000 and covers most recognised forms of CAM which proposed charities use. It is intended to help caseworkers identify quickly what information they need when assessing applications from organisations using CAM to achieve their aims. It is not determinative, and we should be prepared to consider any further medical and scientific evidence which may have emerged subsequently. 

 

 

Group 1: Professionally organised alternative methods

 

Information trustees must confirm to us
  • Chiropractic (statutorily regulated)
  • Osteopathy (statutorily regulated)
  • Herbal medicine (voluntarily self-regulated)
  • Acupuncture (voluntarily self-regulated)
  • Homeopathy (voluntarily self-regulated) - efficacy questioned in 2010 but as yet no change to its position as a Group 1 therapy)

 

Key features of Group 1 methods

  • Professionally organised and regulated
  • May be used as alternatives to conventional medical care (but may also be used to complement it)
  • May be used to diagnose and treat conditions 
  • efficacy of method has been recognised - generally little or no need for more evidence of efficacy if trustees' claims made are consistent with recognised areas of efficacy (but see Note for Herbal Medicine)
  • The conditions the method is used to treat (ie charitable need being met)
  • Practitioners are registered with the statutory or voluntary professional regulatory standard-setting body applicable to the method and adhere to its code of conduct and ethics, ie as below:
  • Professional indemnity Insurance cover is in place to allow a patient who sues a practitioner to seek damages through the courts 
  • There are complaints and disciplinary procedures in place through which people can raise concerns and where unsatisfactory conduct or standards can be addressed

 

 

See Section B6 for our approach when considering these methods

 

 

 

Group 2: Complementary methods

Information trustees must confirm to us
  • Alexander Technique
  • Aromatherapy
  • Bach and other flowers remedies
  • Body work therapies (including massage therapy)*
  • Counselling stress therapy
  • Healing (including spiritual healing)*
  • Hypnotherapy*
  • Maharashi Ayurvedic Medicine*
  • Meditation*
  • Nutritional therapy*
  • Reflexology*
  • Shiatsu*
  • Yoga*

 

Key features of Group 2 methods 

  • Those methods marked with an asterisk are registered with the Complementary and Natural Healthcare Council. (Others not yet registered should tell us how they are regulated)
  • May be used to complement conventional medicine but are not intended to be used as an alternative
  • May not be used to diagnose conditions

 

  • The conditions the method is to treat (as part of satisfying us that their claims are reasonable and consistent with the method's recognised efficacy)
  • The method is provided to complement and not as an alternative to conventional medical care and beneficaries understand this
  • They do not use the method to diagnose conditions
  • Practitioners:

 

Note: For methods whose practitioners are not registered with the CNHC, we need to know how the risk of harm is otherwise managed. This may or not include regulation by an alternative body.

 

See Sections B5 and B7 for our approach when considering these methods

 

Group 3: other alternative methods Generally unacceptable as a means of carrying out a charitable aim
  • Anthroposophical medicine
  • Ayurvedic medicine
  • Chinese herbal medicine
  • Dowsing
  • Easter Medicine
  • Iridology
  • Kinesiology
  • Naturopathy*  NOTE: naturopathy practitioners can now register with CHNC. However, there are issues in relation to naturopathy because treatment entails using an individually tailored package of therapies, not all of which may be capable of demonstrating efficacy.
  • Radionics
  • Traditional Chinese medicine

Key features of Group 3 methods

  • Not professionally organised
  • Claim to give diagnostic information and to treat
  • Generally follow a philosophical approach not influenced by the scientific principles of conventional medicine
  • No established evidence of efficacy 

Organisations using these methods have not demonstrated to date that they are capable of relieving sickness or advancing health, ie relate to aims that fall within s2.2(b) of the Charities Act 2011. Unless they can provide convincing scientific evidence of efficacy, we will not be able to accept them as charities.

 

lawyer_referOnly further consider these if the trustees have provided convincing scientific evidence of efficacy. Caseworkers must then refer such evidence to a lawyer.

 

Group 4 Any other methods

Any methods not falling into Groups 1, 2 or 3

Key features of Group 4 methods

Lacking the essential characteristics needed for charity registration ie:

  • recognition of efficacy
  • evidence that the risk of harm is outweighed by the benefits, demonstrated by, eg, a satisfactory regulatory regime

It is highly unlikely that we will be able to accept other methods as capable of carrying out a charitable aim because of the lack of evidence demonstrating their efficacy, together with the probable absence of a satisfactory regulatory framework showing how any risk of harm is managed.

We can only consider other methods if the trustees submit independent scientific evidence of efficacy and tell us about standard-setting and how they are administered and by whom. 

 

lawyer_referGroup 4 applications are potentially novel or high risk. Any evidence submitted in support of the application which appears to meet the required criteria should therefore be referred to a lawyer for formal consideration.

 

 

 

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Legal / Policy / Accountancy Framework

E1 The law relating to complementary and alternative medicine

E1.1 Charity law: Charities Act 2011

An organisation seeking to be registered as a charity must:

  • be established with purposes which fall within one or more of the descriptions of purposes in s.3 of the Charities Act 2011 and
  • demonstrate that those purposes are for the public benefit.

The use, promotion or study of CAM is capable of falling within one or more of the purpose descriptions in s3 of the 2011 Act.

Organisations concerned with the promotion of  CAM are most likely to be established with purposes falling within the description 'the advancement of health and the saving of lives', ie the purpose description at s.3(1)(d) of the Charities Act 2011. They may be involved in direct delivery of the method, or may regulate its delivery by others, as in the case of the National Federation of Spiritual Healers. To satisfy the public benefit requirement, an organisation using CAM has to show, with evidence, that the method, therapy or treatment is capable of delivering health benefits and is safe.  Any potential for harm must not outweigh the benefits that the therapy delivers.

CAM and individual CAM methods may also be the subject of study or research for the purposes of advancing education for the public benefit (ie within the purpose described in s.3(1)(b) of the Charities Act 2011). Where the organisation’s purpose is to advance education, the law requires that the subject or educational process is of sufficient merit for public benefit to be demonstrated. 

E1.2 Case law

The first reference to the relief of sickness as a purpose in charity law is in the Preamble to the Charitable Uses Act 1601, which refers to ‘the relief of the impotent’. A number of subsequent cases have considered the relief of sickness as a charitable purpose.

The courts have rarely had to consider whether CAM methods are capable of furthering purposes of promoting health or relieving sickness. The cases of Re Kerin (1966, The Times 24 May) and Re Le Cren Clarke [(1996) 1 All ER 715] made reference to healing, but this was primarily in a religious context, ie whether healing could be deemed as capable of furthering a religious, rather than a relief of sickness purpose. However, in Re Le Cren Clarke, the Court also considered whether healing was a method of relieving illness and it concluded that healing is a ‘recognised activity of public benefit’.

The Commission has published a number of decisions which are relevant to CAM. 

The most relevant case for the purposes of considering applications from organisations promoting CAM is the Soteria Network decision.  This demonstrates our policy in action, and is helpful in showing our approach when a CAM method is on the margins of what can be accepted for registration.

Others include:

 

E1.3    Cancer Act 1939

The law has recognised that people suffering from, or believed to be suffering from cancer may be particularly vulnerable to exploitation and harm in relation to treatment of their condition.  s.4(1) of the Cancer Act 1939 made it an offence for anyone independent of government or the general medical profession to take part in the publication of any advertisement containing an offer to treat any person for cancer, or to prescribe any remedy or to give any advice in connection with treating it. There are limited circumstances when such advertisement may be defensible and these are set out in section 4(4) of the 1939 Act.

Organisations dealing with the care or treatment of people suffering from cancer must comply with the terms of the 1939 Act when advertising what they do.

(Note that s4 is essentially all that remains of the Cancer Act 1939, the other parts having now been repealed).

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E2           Regulation of CAM

The extent and form of regulation to which a CAM method is subject is important when we consider applications to register a CAM charity.

E2.1 Statutory regulation

Statutory regulation of a method means that it is:

  • regulated and safeguarded by an Act of Parliament and
  • administered by a professional standard-setting body which the method’s practitioners must join.

Chiropractic and osteopathy are currently the only methods subject to statutory regulation. They are regulated by law because of the inherently high risk of physical injury to those receiving treatment; statutory regulation helps to ensure that these methods will be administered safely by professionals who are trained to a sufficient standard. 

The Chiropractors Act 1994 established the General Chiropractic Council. It is illegal for anyone in the UK to use the title ‘chiropractor’ or to imply that they are a chiropractor unless they are registered with the General Chiropractic Council (GCC). (Trained chiropractors who are not registered with the GCC can continue to practice as long as they do not call themselves chiropractors).

The Osteopaths Act 1993 established the General Osteopathic Council (‘GOsC’). It is an offence for anyone to call themselves an osteopath if they are not registered with the GOsC. The British Medical Association’s guidance for general practitioners states that doctors can safely refer patients to osteopaths.

In assessing applications from charities using either of these CAM methods, we take into account that there is a statutory regulatory framework within which its practitioners must operate which addresses professional standards and practice, including safeguarding recipients of the treatment from harm.

E2.2 Voluntary self-regulation

Voluntary self-regulation of a method means that it is regulated by its own standard-setting body (rather than under an Act of Parliament).  Practitioners of methods subject to voluntary self-regulation may be required to become members of their regulatory body and be bound by codes of professional conduct and safe practice.

If administered by a single professional body, voluntary self-regulation is recognised as offering similar standards of safeguarding as if it were subject to statutory regulation.

Methods currently subject to voluntary self-regulation include acupuncture, herbalism and homeopathy. Traditional Herbal Medicine is also subject to an EC directive on the registration of manufactured herbal medicines suitable for use without medical supervision. 

The Complementary and Natural Health Care Council (‘CNHC’) was established with government support to regulate the following complementary therapies: Alexander Technique teaching; Aromatherapy; Bowen Therapy; Craniosacral Therapy; Healing; Hypnotherapy; Massage Therapy; Microsystems Acupuncture; Naturopathy; Nutritional Therapy; Reflexology; Reiki; Shiatsu; Sports Therapy; Yoga Therapy.

The Department of Health has recommended that, where CNHC registers the complementary therapists in question, service users consult with someone who is CNHC registered.

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E3  Policy on the use of CAM as a means to carry out a charitable aim

E3.1        Our regulatory remit and approach

It is not our role to give, or attempt to give, recognition to a method. When assessing applications for registration from organisations promoting CAM we are concerned only with establishing that the organisation has purposes that are charitable for the public benefit.

To do this we require evidence, of the quality that a court would recognise, proving that the particular therapy or treatment is capable of curing, diagnosing or providing palliative relief in respect of any particular illnesses or conditions according to the claims made by the organisation seeking registration, and is safe.  We follow the approach set out in the Charity Commission decision of 29 February on The Soteria Network.

E3.2  Report of the House of Lords Select Committee on Science and Technology 1999 – 2000

The House of Lords Select Committee on Science and Technology 1999 – 2000 considered a number of complementary and alternative therapies and treatments; it categorised these into three broad areas:

“The First Group embraces what may be called the principal disciplines, two of which, osteopathy and chiropractic, are already regulated in their professioal activity and education by Acts of Parliament. The others are acupuncture, herbal medicine and homeopathy. Our evidence has indicated that each of these therapies claims to have an individual diagnostic approach and that these therapies are seen as the ‘Big 5’ by most of the CAM world.  

The Second Group contains therapies which are most often used to complement conventional medicine and do not purport to embrace diagnostic skills. It includes aromatherapy; the Alexander Technique; body work therapies, including massage; counselling; stress therapy; hypnotherapy; reflexology and probably shiatsu; meditation and healing.

The Third Group embraces those other disciplines in Box 1 which purport to offer diagnostic information as well as treatment and which, in general, favour a philosophical approach and are indifferent to the scientific principles of conventional medicine, and through which various and disparate frameworks of disease causation and its management are proposed. These therapies can be split into two sub-groups.  Group 3a includes long-established and traditional systems of healthcare such as Ayurvedic medicine and Traditional Chines medicine. Group 3b covers other alternative disciplines which lack any credible evidence base such as crystal therapy, iridology, radionics, dowsing and kinesiology.”

Although not determinative, the Report is helpful in identifying the characteristics of most of the CAMs we are likely to encounter and highlighting the need for an evidence based assessment. We will take into account its conclusions and the way it approached evidence where relevant, together with any subsequent legal consideration of these or other methods.

This guidance contains a ready reference tool to help caseworkers decide what evidence they need when assessing a CAM method.  It uses the categories established in the 2000 House of Lords Report and describes the key features of each category together with the information which an applicant organisation needs to provide. 

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Q & A

F1 What is CAM?

 

CAM is the general term for complementary and alternative medicine. It encompasses treatments and therapies that support conventional treatment as well as those intended to provide an alternative to it.  A treatment or therapy offered as an alternative to conventional medicine will involve greater risks for recipients than complementary methods and we take this into account as part of our consideration.

See B5.2 for more information about our approach when considering the different forms of CAM.

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F2 What qualifies an organisation promoting CAM to be a charity?

To be considered charitable, an organisation using CAM to achieve its purposes must be able to show

  • The organisation’s purposes are wholly charitable (and the benefits delivered by the method are linked to this purpose)
  • evidence of the method’s efficacy, except where this is already widely recognised (see B5 for examples of what we mean by this)
  • that the method is capable of being delivered safely, so that where there is potential for harm, this does not outweigh the benefits.  Our approach is assessing this is set out in B7.

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F3  Why is it important to prove the benefits in relation to CAM?  

The law has recognised that, in relation to CAM:

  • Treatments which have not been rigorously tested before being made available for use carry a risk of harm to those receiving them; and
  • People who are ill may be willing to try (and pay for) treatments in the hope of a cure and may experience harm as a result.

 

Because of this, it's important that organisations using CAM to carry out their aims are able to prove the benefits of the treatment or therapy they offer, and demonstrate that any potential for harm to those receiving it is minimised and does not outweigh the benefits.  If this is not achieved, the public benefit of the organisation will affected. 

 

Our objective to increase public trust and confidence in charities could also be compromised if we accept a method to be charitable as promoting health when it is not, either where the benefit is not clearly proven or where the risk of harm is great and safeguards are not in place.

 

See B7 for more information about the main risks associated with CAM and how we assess this in relation to the benefits claimed.

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F4  What evidence do we need to decide that these requirements are met?

The evidence we need depends on:

  • the recognition that a method has gained
  • the extent of the claims made for the method

 

Methods that are subject to statutory regulation need not provide detailed medical evidence of their efficacy. The existence of statutory regulation demonstrates acceptance by the law that the method is capable of providing benefits to health. See B6.1 for methods that are regulated by statute.

 

We can also accept methods whose benefits are already widely recognised as a result of clinical research. For more information see B6.2 and B6.3.

 

For methods not already accepted, we need to see robust evidence of the efficacy of the method and the benefits it provides. All claims must be substantiated by evidence, and the evidence must be the quality that a court or Tribunal would accept. See B5 for more information about evidence of efficacy.

 

In deciding whether an organisation promoting CAM is capable of carrying out the treatment safely and effectively, we would expect its practitioners to operate within a regulatory framework responsible for defining and monitoring professional standards, ethics and conduct. For information about regulation of CAMS see B8.

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F5  Can we accept testimonial evidence - for instance, from people who have experienced the treatment or therapy, or practitioners who administer it?

No, testimonial or anecdotal evidence - however compelling - will not be sufficient to demonstrate efficacy, because this type of evidence is subjective, lacks the rigour of scientific medical research, and may be inconsistent, unrepresentative and therefore unreliable. See B5.5 for examples of testimonial evidence.

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F6  Why do we require more evidence for the efficacy of alternative methods than for complementary forms?

Treatment or therapy offered as an alternative to conventional medicine carries a greater risk of harm because it could mean people do not receive a medical diagnosis of their condition, or the opportunity to benefit from effective and clinically proven conventional treatment which may be available to them.

Because of this particular risk of harm, it is a fundamental requirement that the applicant organisation demonstrates the benefits claimed for the treatment according to clear and compelling evidence, and that those benefits outweigh risk of harm. See B7.1 for more information about assessing the risk of harm.

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F7  Is homeopathy still accepted as being able to deliver benefits related to an aim of promotion of health or the relief of sickness?

Yes. The efficacy of homeopathy was called into question in 2010 when Parliamentary and media coverage suggested that the claimed health benefits are unfounded and that there is no evidence that its benefits exceed a placebo effect. However, there has been no subsequent Parliamentary or legislative determination which has changed recognition of its efficacy. Our current position is to regard homeopathy as a method for which we need little or no further supporting evidence of efficacy so long as the trustees' claims for it are in line with its recognised benefits. See Group 1 of the ready reference table which sets out the information we need from organisations using homeopathy to deliver their purposes.

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