Tuesday, 29 November 2016

The Society of Homeopaths and the Professional Standards Authority

This is a long story. 

For many years the Society of Homeopaths (SoH) have sought ways to enhance their standing and that of homeopathy overall. Several initiatives came to nothing. 

The SoH achieved Accredited Voluntary Register status with the Professional Standards Authority (PSA) in September 2014.

Professional Standards Authority
The PSA was created under the auspices of the NHS Reform and Health Care Professions Act 2002, subsequently amended by the Health and Social Care Act (2012). The latter gave the PSA responsibility for accredited voluntary registers.

The PSA used to be the Council for Healthcare Regulatory Excellence (CHRE) prior to the 2012 Act. Its main function then, and still is, oversight of statutory regulators, who are -

It was a Government decision to foist voluntary regulators on the PSA. For some of the voluntary registers, such as those associated with psychotherapy, accreditation could be regarded as a halfway house on the road to full statutory regulation. For others, it seems highly unlikely that they would desire statutory regulation and even if they did, stand zero chance of doing so. It requires legislation.

Accredited Voluntary Register
A voluntary register (VR) is just that. A list of people that can be signed up to. In the case of the SoH, if you meet their entry critieria and cough up the money, you can be on their register. 
Access to registration with the Society of Homeopaths is automatic for those who have qualified from one of the professional homeopathy courses recognised by the Society at the point when they qualified.
There is another route by which homeopaths can apply - evaluation of non-recognised qualifications and experience.

Registration does not seem to offer very much beyond discounted insurance. In theory, a register that has a Code of Ethics and Practice provides consumers with a certain amount of protection.

That a VR is accredited by the PSA apparently means - 
Accredited registers help people get better care by ensuring that the health practitioners they register are competent and trustworthy. They set standards for people working in unregulated health and care occupations, encourage them to meet them and take action to protect the public when necessary. They ensure that the information they and their registrants provide is clear and helps you to make informed choices about the practitioner you want to see and about the treatments, therapies, care and products they offer.
It also means they can use a "quality mark".

Accreditation Process and Approval
The PSA provide a guide on the accreditation process. In short, what happens is that an aspiring VR goes through a self-assessment process to see if meets the PSA's standards. If it feels it does, possibly after discussion with the PSA, it can complete an application form and populate a risk matrix and send them to the PSA along with payment.

The PSA will request that interested third parties submit information.

The PSA will review the documentation, make site visits, interview various senior staff of the VR, sit in on board meetings and (hopefully) sit in on a disciplinary hearing.

Then a panel will make a decision. A negative decision does not prevent a VR from applying again.

The PSA do not consider plausibility or efficacy of therapies in the accreditation process. Those questions are legally beyond their remit. The PSA have said at various points that they also lack the skills/knowledge to make judgments about efficacy.

The PSA can also make suggestions for changes to how a VR operates. They can also impose conditions on membership - changes that have to be made by the (next) review or accreditation 

Unfortunately neither the original approval document or the third party submissions are available on the PSA website. The only document is the current Review. Copies of the original accreditation have been obtained (via a Freedom of Information Act (FOIA) request). It makes for partially interesting reading. It is a long document, much of which is very dull. only some of which will be quoted. But first, Andy Lewis did make a submission to the PSA which he documents here. Returning to the PSA document...
The Panel considered whether homeopathy, as practiced by the Society’s registrants, could be defined as a health occupation. The Panel noted Call for Information submissions arguing that homeopathy is without a basis in evidence and not a health care practice, therefore unable to meet this Standard. The Panel noted that it is not its role to determine the efficacy of a therapy but to decide whether the Accreditation Standards are met.
Whilst this may have been disappointing to some, it is consistent with the legal framework that the PSA operates in.
The Panel discussed the division between the six professional and three lay members on the Society’s Board of Directors, noting that the statutory health and care professions regulators require 50% of each. The Panel emphasized that accredited voluntary registration is not statutory regulation and that the required outcome was to demonstrate that through effective lay involvement the public would be protected.
This is unsurprising. There are historical questions about SoH governance and its Board of Directors not always acting as such. Additional lay members could help with that.
The Panel considered a Call for Information response alleging that members of the Society had been associated with the ‘Andrew Wakefield / MMR vaccine’ controversy and related public health risks, such as ‘Steiner schools as unvaccinated communities’ leading to increased occurrences of disease outbreaks. The Panel noted the damage to public confidence in the Society that such allegations could cause. The Panel noted relevant actions carried out by the Society such as introducing guidelines for registrants and placing a public position statement on its website stating that it does not endorse the use of homeopathic medicines as an alternative to vaccination for the prevention of serious infectious diseases.
Could cause? Certainly the "prescribing" of homeopathic remedies to prevent malaria (homeoprophylaxis in the term used and it is highly controversial even among homeopaths) damaged the reputation of the SoH. Even more in terms of how it dealt with the subsequent complaints. If some members of the SoH do still offer homeoprophylaxis that clearly does represent a risk. 
The Panel noted Call for Information responses suggesting a risk that Society registrants have insufficient medical training to diagnose conditions that should be referred for medical treatment. The Panel noted that the Society’s risk matrix addressed those concerns, as their training requires ‘each course to provide a substantial amount of education in Anatomy and Physiology, Pathology and Disease, and to ensure that this knowledge and understanding is reinforced and integrated in the Clinical Education of students’. The Panel also noted the Society’s Code of Ethics and Practice states that ‘registered and student clinical members must be aware of their professional competence and where appropriate, will refer to other practitioners ensuring that the practitioner to whom they refer is suitably qualified’.
"Substantial" is debatable. Given that there are tensions between homeopathic concepts of "dis-ease" and what disease actually is, the value of such education is questionable. As for members being aware of their competence, there is evidence to suggest that some SoH members are not.
The Panel also noted the adjudication decision made by the Advertising Standards Authority (ASA) in July 2013 which instructed the Society ‘not to discourage essential treatment for conditions for which medical supervision should be sought, including offering specific advice on or treatment for such conditions.’ The Panel noted that the AVR team had contacted the MHRA, ASA and the GPhC to ensure they had no ongoing or further concerns.
Which seems strange. No concerns about who? The SoH or its members? Presumably the former as it seems very likely that at least the ASA would have ongoing complaints about SoH members' advertising.
The Panel noted a reduction in the Society’s reserves which it had attributed to the current economic climate, an aging core membership and expenditures such as its website re-design. The Panel noted however that the Society’s reserves were still in excess of their minimum requirements and that it aimed to build these further over the next year. The Panel noted that the Society’s financial sustainability would be reviewed again at annual review, if accreditation was obtained.
Worries about an aging core membership imply that the SoH has a recruitment problem. This could be due to a drop in the numbers of those studying homeopathy or it could be that joining the SoH is less attractive than other trade associations or not joining a trade association at all.
The Panel considered a concern raised about a YouTube link posted by the Society’s former Chair on Twitter, entitled ‘Homeopathy for Health in Africa – HIV/AIDS – Finding the Genus Epidemicus’ and whether this could impact the public’s confidence in the Society’s ability to manage its register. The Panel noted that the AVR team as part of its due diligence had confirmed the former Chair had posted the link after stepping down from that position but was still a registrant of the Society. The team suggested that posting this link did not appear to be in breach of the Code of Ethics and Practice or the ASA’s adjudication decision.
On the face of it, astonishing but it relates to the posting of the link. It is likely that the person concerned is Jeremy Sherr. Homeopathy for Health in Africa is chilling to look at but Sherr proposed a hugely unethical medical trial. This has been documented elsewhere (and do read the comments). Sherr would no longer appear to be a member of the SoH.
The Panel referred to a Call for Information response that suggested that homeopaths may prescribe products not licensed by the MHRA. The Society advised that although the advertising of unlicensed homeopathic remedies is prohibited, the supply of unlicensed remedies via pharmacies is not prohibited. The Society referred to a letter from Earl Howe, Parliamentary Under Secretary of State for Quality, writing on behalf of both the Department of Health and the MHRA in July 2012 regarding the Medicines Act 1968. The letter states: 
Section 10(4)(a) broadly exempts the pharmacist from the requirements for a manufacturer’s license to be able to prepare the product, and for a product license, to be able to supply the product to the patient. 
Section 10(3) of the Act on the other hand provides an exemption to pharmacists from the requirement for a product or manufacturer’s license, for the supply of a medicinal product prepared the specification of the client of the pharmacist.
The Society advised that manufacturers of unlicensed homeopathic remedies in the United Kingdom are pharmacies who are under the remit of the GPhC. The Panel noted that the AVR team contacted the GPhC to clarify if it had any concerns with regard to this issue and the Society. The GPhC responded that any of its registrants involved in the preparation, sale or supply of homeopathic remedies/medicines must ensure that they meet its Standards and the requirements of other regulators, as well as any legal requirements. GPhC registrants must practise only in areas in which they are competent and refer to others if needed. The GPhC would investigate complaints about the sale of homeopathic products where the individual or practice was considered to be in breach of its standards and refer aspects regarding the licensing or illegal sale of these products to the MHRA in the first instance.
This is in many ways the most troublesome element of the document. It may help to see Section 10 (3) and (4) of the Medicines Act 1968.
(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a)the product is prepared or dispensed for administration to that person or to a person under his care, or 
(b)the product, not being a vaccine, plasma or serum, is prepared or dispensed for administration to an animal or herd which is in the possession or under the control of that person.
(4)Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or 
(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business;
As can be seen, there are considerable differences between what is quoted from the Lord Howe letter and the actual legislation. The Lord Howe letter seems to omit that 10 (4) relates to activities that happen on the pharmacy premises involving a patient and the pharmacist. 10 (3) is a lot less clear in terms of what it means. It does not specify where the transaction can take place. The definition of a "person under his care" is a question that much of the legality of UK lay homeopathy revolves around. This will be examined in more depth in another post.

The GPhC's response is problematic but has no bearing on the SoH's accreditation.

It is also important to note that homeopathic remedies are registered not licensed. 
The Panel discussed Call for Information responses suggesting instances where registrants’ websites could potentially breach ASA guidelines or otherwise have potential to mislead the public. It noted examples provided that could be perceived as a breach of the Cancer Act 1939 or where homeopathy was being recommended as an alternative treatment to conventional therapies rather than a complementary one. The Society confirmed that its policy, when advised of such websites, was to contact the owner and advise them to change the disputed areas accordingly and that it would take action if they did not. 
The Panel noted that the Society had contacted the owners of the named sites which had since either removed or modified the pages in question accordingly. The Panel noted the Society’s current proposals for a process to monitor registrants’ websites and published guidelines for advertising. The Panel restated that the Society would be expected to act if a registrant appeared to be in breach of its Codes.
The SoH confirms that it will take action against non-compliant member websites.
The Panel noted the Board’s ratification of Adjudication Panel and Appeals Panel decisions. The AVR team had been informed that this was intended to be a procedural review of the handling of complaints. The team had advised the Society that ratification of complaints decisions by the Board of Directors may impact on the independence and impartiality of the Society’s complaints procedure and it is not good practice. The Panel noted that the Society was considering removing the requirement for ratification of such decisions and introducing an independent reviewer to provide oversight of Adjudication and Appeals Panel decisions. The Panel decided to make this an instruction.
The SoH is instructed to remove Board ratification of complaint decisions to ensure greater impartiality.

First Review of Society of Homeopaths Accreditation
Every year, the PSA go through a review of the VRs that are accredited with them. The VR has to complete an application form, update risk information, respond to any Call for Information and pay a fee. The review can, in theory, result in removal of accreditation. It can also impose conditions on retaining accreditation.

The first review was conducted in September 2015. Again, it is a long document that only has short sections of interest.
The Panel reviewed a call for information response stating that ‘homeopathy cannot be considered a health care occupation and therefore the accreditation and re-accreditation of the Society is ultra vires’ (beyond the Authority’s legal power or authority). The response questioned whether the Panel could accept ‘health claims’ made about homeopathy as a form of health care as laid down in the National Health Service Reform and Health Care Professions Act 2002. The Panel disagreed that its initial decision was ultra vires, noting that homeopathy is used by the public as a form of healthcare and is provided by the NHS. The Panel restated that questions of efficacy are outside the remit of the Accredited Registers programme.
Again, the PSA confirms that certain matters are outside of its remit.
When reviewing Standard 2 the Panel noted previous and future planned changes to the Society’s governance including the introduction of a Head of Professional Standards role and recruitment of two new independent (lay) members for its Professional Standards Committee. The Panel also noted that the Society has developed 'Guidelines for Safeguarding Children' and Fitness to Practise guidelines for registrants.
In theory, this should result in more impartial and less doctrinal decisions. The theme of conflicts of interest and lack of impartiality crop up more than once in all the PSA documents.
When reviewing Standard 8 the Panel noted amendments to the Society’s Code of Ethics and Practice including its requirements regarding Advertising and Media. The Codes state registrants must ensure they ‘do not allow misleading advertising and information about their practice’ and must comply with relevant laws relating to advertising. The Panel noted that the revision of the Codes stated ‘the Society may also take into account ... relevant clauses of The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing’ (the CAP Code) when investigating breaches of the Code. The Panel considered that the Advertising Standards Authority’s guidelines and CAP Code reflect good practice in advertising and that it would expect Accredited Registers to follow these. The Panel decided to issue an instruction for the Society to replace ‘may also take into account’ with ‘will also take into account’ to be implemented within three months. In making its decision the Panel considered the impact of the decision on the Society and noted that the Committees of Advertising Practice (CAP) is reviewing its Advertising Guidance (previously Help Notes) on health claims in due course.
Replacing words may not seem terribly significant.
The Panel noted concerns raised within a Call for Information response about sections of the Society’s amended Professional Conduct Procedure. Section 2.1 of the procedure provides a list of who can raise a complaint against a registrant, which might be seen to limit or prevent concerns from being raised. The Panel noted that Section 3.1 states that the Society may accept complaints received outside of those requirements and noted this is not limited to any particular source of concerns, such as through news or social media. The Panel noted this section allows the Society the discretion to investigate concerns outside the criteria of Section 2.1. The Panel noted the Society’s confirmation that it will investigate any concern raised in order to see if it has any validity. The outcome of the investigation will determine if it becomes a formal complaint.
This document shows contains the offending section.
2.1 A complaint can only be brought by: 
a) a member of the public who has sought or received a service provided by a registered member of the Society; or  
b) a current registered member of the Society who may bring complaints for services sought or received directly from another registered member; or who has witnessed poor practice delivered by another registered member; or on behalf of another where their written permission has been obtained, and where that person is unable to bring the complaint on their own behalf (explanation is required in writing as to the nature of the inability); or 
c) a legal guardian or other appropriately authorised adult on behalf of a minor and/or an adult lacking legal capacity for services sought or received; or  
d) a third party who can demonstrate sufficient interest and who has been directly affected by the actions of the practitioner.
Which should also be read in conjunction with
2.2 All complaints will be treated seriously, however under these rules a complaint may be rejected at any time, if in the PCO or PIP’s opinion, the complaint is “frivolous, or vexatious”
The Panel noted a reduction in Society registrants since its initial accreditation and the Society’s plans to promote registration and the occupation it registers accordingly. The Society raised its registration fee by £5 in 2015 and had not yet decided on any changes for 2016. The Panel noted changes implemented by the Society since its initial accreditation will assist it to provide benefits to service users and the public through the information provided on its register and website.
The number of registrants has been in decline for a number of years.

Second Review of Society of Homeopaths Accreditation
This was completed in September 2016. It can be found on the PSA website but it may well disappear when the 2017 review is published.

The team checked that the Society’s Code of Ethics and Practice (August 2015) had been amended and published on the Society’s website, as required by this Instruction, within the required timeframe. This section of the Code has also been amended to reflect other updated guidance such as the Blue Guide: advertising and promotion of medicines in the UK as noted under Standard 3 of the annual review form. The code states that: 
'40) Members should ensure that they do not allow misleading advertising and information about their practice. Advertising should be honest, decent, legal and truthful, and must comply with the relevant laws relating to advertising including The Trade Descriptions Act 1968; The Consumer Protection from Unfair Trading Regulations 2008 and The Blue Guide from the Medicines and Healthcare Products Regulatory Agency (MHRA). Examples of Codes the Society will also take account of are the relevant clauses of The UK Code of Non-Broadcast Advertising, Sales Promotion and Direct Marketing (CAP Code), and the current guidelines of the Society. See also paragraph 34.’ 
The Society advised the team that no other changes to the Code of Ethics and Practice had been made over the past year.

Mentioning the MHRA Blue Guide is important.
The Society had invited the public to debate the use of data from animal research in the field of homeopathy and provided links to articles on this matter. The Society will provide further guidance this year following a membership poll held in July 2016.
Vaguely interesting.
As part of its due diligence the team conducted its own spot check of Society registrants to check adherence to the Society’s standards for advertising. The team identified one example of a website that might be in breach of those standards and referred it to the Society. The Society confirmed the breach and advised that in the first instance, in line with its process, it would attempt to work with the registrant to improve the information provided. Should the registrant fail to cooperate the Society will initiate its Professional Conduct Procedures and may refer to Trading Standards.
May refer?
The Society advised the team in December 2015 that it had been contacted by the Committee of Advertising Practice (CAP). CAP advised it would contact homeopathic practitioners in 2016, providing a one-month deadline for practitioners to meet the standards of the Advertising Standards Authority (ASA) (as outlined in CAP’s ‘Guidance for Advertisers of Homeopathic Services’). After this period, CAP would conduct extensive spot-checks and refer breaches to Trading Standards where necessary. CAP urged the Society as the largest homeopathy trade body, and as an Accredited Register, to support the ASA’s position and work with CAP to enforce practitioners’ compliance with its guidelines. The Society responded that it could not support the one-month deadline but would work with CAP to ensure registrants were compliant with reasonable guidelines. 
The Society advised that it had held meetings with the ASA/CAP team to discuss an approach and develop further guidance for homeopaths, which could be used as a national standard. The Society’s board had approved the guidance and was awaiting further contact from the ASA/CAP team before launching the guidance, with further support for registrants such as FAQ’s in the members’ area.
It is not clear if the CAP spot-check process is under way. This will be discussed in a later post.

Voluntary Regulation <> No Regulation
One implication of the above is that the SoH has to act as a regulator. It has to ensure, to the best of their ability, the compliance of its members and if they do not, take remedial or even disciplinary action against them. If they do not, the PSA has the ultimate sanction of removing accreditation. 

The burden is much heavier that it might first appear.

In effect, the SoH has to take on the role of the ASA with regard to the advertising of its members. If you take a look at an ASA ruling on advertising by a homeopath such as this one you'll notice that it only raises a small number of issues. From experience, there can be many more issues with a website. The SoH will have to exhaustively examine and investigate a website for non-compliance with the CAP Code, possibly social media accounts that link to/from the website and email newsletters and so on. If non-compliance with the CAP Code remains an issue, the SoH may have to have to move to a model where advertising is subject to vetting pre-publication. 

One area of advertising that is particularly awkward is the promotion of unregistered homeopathic medicines. Only those few homeopathic medicines registered with the MHRA can be mentioned and only those registered under the National Scheme can be discussed in terms of what they can be used for and only then in terms of the indications that appear on the packaging, patient information leaflet, etc. Those registered under the Simplified Scheme can be mentioned but with no discussion of what they can be used for. More generally, the SoH will have to refer to the MHRA Blue Guide and the Human Medicines Regulations 2012 when dealing with complaints.

The SoH also have to take consider matters covered by the Consumer Protection from Unfair Trading Regulations 2008 but not explicitly covered by the CAP Code. The Regulations 2008 are a lot clearer about matters such as the omission of important information being misleading. 

In the past there have been complaints that members of the SoH have acted outside of their competence which were brushed aside, attempting to prevent/treat serious medical conditions. This is no longer possible. Determining the boundaries of an individual's competence is not a simple matter but appropriate training is often a consideration. 

It may also be the case that the SoH are no longer in a position to let criticism of individual members that is not in the form of a direct complaint pass them by. Rather react to submitted complaints, if they become aware of possible non-compliance through, for example, something like the Newsnight investigation into homeopaths offering homeoprophylaxis, they may have to proactively investigate without the prompt of a complaint.

What is not clear is that beyond the sanctions open to the SoH, what they would do the case of non-compliant members when questions of illegality are raised. They say they may refer non-compliant members to Trading Standards but what about other authorities? 

There are tensions between an organisation serving the interests of its members and regulating them. Sometimes, there is conflict. Membership can lose faith in a distant corporate body that seems unsympathetic to their interests and frequently acts against them or their peers. In the case of a VR, members can simply walk away. 

A Rock and a Hard Place
The PSA would be placed in a difficult position if the SoH do not achieve sufficient member compliance. So far, the PSA has not had to remove accreditation from a VR. If they did it could be seen as a failure of the whole business of accrediting fringe groups. If they don't, it could be seen as a failure of the PSA to uphold the rigourous standards they stand for. Both would undermine public confidence in the PSA.

It's not only the SoH that pose this problem for the PSA. The Complementary and Natural Healthcare Council (CNHC) do as well. Their accreditation did draw some criticism. The CNHC does have a peculiar history - which is outside of the scope of this blog.

However, the public at large are unlikely to be aware of the PSA and its role and powers. It tends not to interact directly with the public. What probably matters more are the PSA's relationships with other VRs, statutory regulators such as the General Medical Council, professional trade bodies in regulated profession (eg Royal College of Physicians) and Parliament who ultimately have oversight over the PSA. They can also be summoned by the Health Committee to answer questions (see an example - homeopathy is discussed and it is illuminating - the issue of homeoprophylaxis yet again). The video mentions that the fees from each VR are ringfenced and the intention is that the oversight of each VR will become self-funding.

Would a VR that struggles with compliance be more costly to oversee or are the costs of oversight fixed?

The results of the SoH re-accreditation process were due in September 2017 - at least four months ago at the time of writing. The SoH re-accreditation is not the only one overdue though as indicated on this page. It isn't the most delayed (that distinction belongs to Treatments You Can Trust - who are problematic to say the least).

It's not clear why the re-accreditation process is taking so long. It could simply be that the PSA have resource issues. It is worth pointing out that currently, accreditation of registers is partly funded by fees and partly by the Department of Health (DH). According to the PSA annual report, accreditation is handled by 3.4 staff. How many become involved in the process of (re-)accrediting an individual register is unknown but it is not difficult to imagine that an influx of new aspiration registers or a particularly difficult re-accreditation process could delay others.

It is understood that the intention is that PSA activities regarding voluntary registers will become self financing and that the DH money will go. Unless the PSA can increase the efficiency of their processes enormously etc it would seem that fees will increase - a rough estimate suggests 66% increase would be necessary if funding was cut in one go. Individual members of voluntary registers could end up paying an additional, say, £5 to their register for the privilege of it being accredited. If the PSA are struggling with the workload of VRs, then it would need to employ more staff, thus raising costs and thus potentially raising fees.

Whether the SoH would be able to absorb any increase in fees without passing them onto members is a moot point. It is known it is having trouble with membership numbers and recruitment. It is known that various members of the SoH agitate against advertising regulation amongst other things and dealing that will have cost the SoH. Intelligence suggests that the SoH may well encounter other regulatory issues as well - see the further update here.

It is not difficult to envisage a scenario in which some SoH members will leave due to increased fees and restrictions by the SoH on both their marketing and their practice. They may come to view being a member of a PSA accredited VR as being too expensive and too much trouble.

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