In the first half of 2017 after being threatened by the Good Thinking Society (a charity that promotes scientific thinking) with an application for judicial review over its failure to remove charities promoting homeopathic remedies from the register of charities, the Commission launched a consultation into the charitable status of CAM organisations.
It received over 670 responses from a wide variety of people and organisations, with a disparate range of views – with those views sometimes strongly held, and not always on matters upon which the Commission considered itself to have jurisdiction, such as, for example, the question as to how the provision of CAM therapies should be regulated.
The Commission published its initial feedback on the responses received in December 2017. Now, a year later, we have the outcomes of its full review, together with its new legal framework for assessing the charitable status of CAM organisations and its updated operational guidance for its caseworkers.
What is staying the same?
The Commission has concluded that the basic legal principles that apply to all charities still apply to its work in assessing applications for charitable status by CAM organisations – in order to be charitable, a CAM organisation must have a purpose that falls within one of the descriptions of charitable purposes found in the Charity Act 2011, and it must meet the public benefit requirement.
What is changing?
The Commission will, however, now change the way it assesses CAM organisations against those continuing legal principles.
Previously, the Commission has focussed on the evidence of medical efficacy of any treatments offered by a CAM organisation when considering whether or not the organisation provides a public benefit.
Following completion of the review, it will now alter its approach in the two following ways:
- To amend its guidance to take account of both the range of evidence sources available to demonstrate public benefit and of developments in knowledge over time.
- To take into account that public benefit may, in some circumstances, be demonstrated by means other than evidence of medical efficacy that a certain treatment has measurable beneficial medical impact, such as findings from scientific trials.
The Commission explains this new approach, in summary, as being: the evidence that an applicant CAM organisation provides will have to match the claims it is making.
So, CAM organisations that claim to diagnose or cure a disease or condition will need to ensure they provide robust medical evidence to demonstrate the efficacy of the treatment offered in order to show they meet the public benefit requirement.
CAM organisations that claim to provide relief from suffering or comfort to patients may be able to rely on other types of evidence to demonstrate public benefit, such as appropriately robust patient reported outcome studies, for example.
What information will CAM organisations now have to provide to the Commission?
The Commission’s updated operational guidance for case workers gives more detail on the changes, and also explains the types of evidence required to support claims of medical efficacy, including the medical databases and types of research to which applicants might be expected to refer.
All applicant CAM organisations will now have to tell the Commission whether a therapy being used by the applicant is complementary or alternative, to allow the Commission to identify what kind of evidence is appropriate for that applicant’s circumstances.
The Commission notes that whether a CAM organisation is providing an alternative or complementary therapy may in particular affect the amount and type of evidence provided to demonstrate that the benefit of the CAM therapy outweighs any potential harm.
This is because an alternative therapy, offering to treat, cure or diagnose a disease or condition, may result in a patient delaying or postponing conventional medical assessment and a treatment of demonstrated clinical effectiveness in favour of the alternative therapy – resulting in an inherent increased risk of harm to patients. In such circumstances, the Commission states “particularly clear and compelling evidence of efficacy to demonstrate benefit which outweighs the potential harm will be required”.
So, while all applicants will need to show that a CAM therapy can be delivered safely and effectively, and provide detailed information to the Commission as part of any application to show that the risk of harm from a CAM therapy does not outweigh any benefit – including information about how the applicant will appropriately manage the risk of harm – CAM organisations providing alternative therapies can expect greater scrutiny in this area.
Any evidence supplied by an applicant CAM organisation, however, must be “sufficiently robust and cogent” that it could be relied upon by a Court.
The Commission’s next steps
The Commission’s outcome report states that it will now consider whether any past registrations of CAM organisations should be “revisited”, although it thinks that for most CAM organisations registered as charities, no action will be required.
It does, however, confirm that in some cases the Commission may recommend that a registered CAM charity amend its objects “so that they are limited to what can clearly be demonstrated by the available evidence", and also that if it appears to the Commission on review that a past registration under the Commission’s previous approach may have been mistaken, and that the relevant organisation cannot properly be considered a charity, then it will be necessary to remove it from the register, in accordance with the Commission’s statutory functions and duties.
The Commission also reminds registered CAM charities of their ongoing safeguarding responsibilities, stating that it “will take very seriously any concerns about the safeguarding and treatment of people, including in the way that a treatment and its benefits are described to potential beneficiaries” (our emphasis).
This seems to be a clear warning that CAM charities cannot simply tell the Commission one thing for the purposes of demonstrating public benefit on registration, and then tell those who might seek advice and treatment something different – for example, misleading patients as to the efficacy or effects of a therapy. Charities that do so may well find themselves receiving the regulatory attention of the Commission.