Wednesday, 23 November 2016

Antipathy towards the Advertising Standards Authority #1

Whilst it is understandable that homeopaths and other alternative therapists may be unhappy that ASA rulings may go against them and that the CAP Codes and advertising guidance does place limitations on the claims that can be made, the level of antipathy shown by some is less understandable. To a reasonable observer, it can appear irrational to say the least.

What Homeopaths say
The kind of statements that certain homeopaths are making about the ASA include (in no particular order) -
  • The ASA disregards positive evidence for the efficacy of homeopathy
  • The ASA is biased against homeopathy
  • The ASA has no legal authority
  • The ASA has no moral authority
  • The ASA misrepresents itself as a branch of government
  • The ASA is guilty of bullying homeopaths. Harassment is also mentioned
  • The ASA is guilty of criminal offences
  • The CAP Codes do not represent the legislation that covers advertising (and thus have no force)
  • The ASA is unduly influenced by groups such as Sense about Science and the Nightingale Collaboration who are in turn financed by the pharmaceutical industry
  • Subject matter experts used by the ASA have no expertise in homeopathy and thus unqualified to give an opinion
  • The ASA is part of a conspiracy
  • The ASA's actions are a breach of the right to free speech and a form of censorship
  • The ASA is anti-competitive
Probably some more as well. Skepticat discusses some of the above here. The ASA is more than capable of defending itself as well. The focus of this post is different though...

Free Speech and Advertising
It is sometimes claimed that the ASA are somehow restricting freedom of speech. However, if you are advertising or marketing something, free speech no longer applies (in full). Although the UK is not the US, because they have a written constitution and the First Amendment protects free speech, there have been some Supreme Court judgments that do aid in understanding. In the UK, until the Human Rights Act 1998 (HRA), there was no explicit right to free speech. Instead, there was a situation where there were a number of laws that restricted free speech in certain circumstances but beyond that, nothing. UK law can work on the principle that was is not expressly forbidden is permitted whereas other jurisdictions work under the principle of what is not expressly permitted is forbidden. Whilst it can be argued that the HRA materially changes nothing regarding the right to free speech, it does make explaining things easier!

The HRA places the European Convention on Human Rights (ECHR) into UK law. The ECHR, despite the perceptions of many comes from the Council of Europe (CoE) rather than the EU. No member state of the EU is not a member of the CoE but there are members of the CoE (Russia for example) that are not members of the EU. The European Court of Human Rights (ECtHR) represents the ultimate court of appeal.

Some homeopaths have quoted -
Article 10 – Freedom of expression
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers.
But that's not the whole of it...
Article 10 – Freedom of expression
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. This article shall not prevent States from requiring the licensing of broadcasting, television or cinema enterprises.

2. The exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary.
Which is rather different. 

The EU has corresponding legislation - the Charter of Fundamental Rights of the European Union. The European Court of Justice (ECJ) represents the ultimate court of appeal. Some homepaths have quoted -
Title II - Freedoms  
Article 11 Freedom of expression and information 
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. 
2. The freedom and pluralism of the media shall be respected.
And then fail to read further down.
Title VII - General provisions governing the interpretation and application of the Charter  
Article 52 Scope and interpretation of rights and principles 
1. Any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms. Subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others.
Which does effectively mirror 2. above although it does not explicitly spell out the justifications for limitation.

Whilst the ECtHR and ECJ are separate bodies, it is certainly true that in some cases the ECJ takes note of ECtHR rulings in coming to its own determinations. 

The US Supreme Court in Valentine v. Chrestensen established the notion of commercial speech which is a much more useful concept than advertising or marketing - some of those with ASA rulings against them have stated that they did not regard what they have written as advertising. That they holding an opinion and imparting information and ideas. There is no explicit definition of commercial speech in either the ECHR or EU law but...

A definition of commercial speech (expression) can be found in Opinion of Mr Fennelly — Cases C-376/98 And C-74/99.
The case-law of the European Court of Human Rights indicates that all forms of expression merit protection by virtue of Article 10(1) of the Convention. This includes what is commonly known as commercial expression, that is, the provision of information, expression of ideas or communication of images as part of the promotion of a commercial activity and the concomitant right to receive such communications.
"as part of the promotion of a commercial activity" is key.

Free speech is not absolute
As mentioned above, there may be limitations to free speech in law - varying from jurisdiction to jurisdiction. Whilst there is a moral duty and responsibility not to abuse the right to free speech, many do abuse. The laws that set these limitations (and court decisions that arise) can seem arbitrary or wrong - indeed some of them have been challenged in the ECJ and ECtHR and governments have been ruled against.

To quote from Wikipedia, the UK limitations on free speech are -
...threatening, abusive or insulting words or behaviour intending or likely to cause harassment, alarm or distress or cause a breach of the peace (which has been used to prohibit racist speech targeted at individuals), sending another any article which is indecent or grossly offensive with an intent to cause distress or anxiety (which has been used to prohibit speech of a racist or anti-religious nature), incitement, incitement to racial hatred, incitement to religious hatred, incitement to terrorism including encouragement of terrorism and dissemination of terrorist publications, glorifying terrorism, collection or possession of a document or record containing information likely to be of use to a terrorist, treason including advocating for the abolition of the monarchy (which cannot be successfully prosecuted) or compassing or imagining the death of the monarch, sedition, obscenity, indecency including corruption of public morals and outraging public decency, defamation, prior restraint, restrictions on court reporting including names of victims and evidence and prejudicing or interfering with court proceedings, prohibition of post-trial interviews with jurors, time, manner, and place restrictions, harassment, privileged communications, trade secrets, classified material, copyright, patents, military conduct, and limitations on commercial speech such as advertising.
Commercial speech is subject to more limitations that "ordinary" or "pure" speech. Consumer protection is the most obvious.

The Consumer Protection from Unfair Trading Regulations 2008
This is the primary legislation that controls commercial speech amongst other things. Other legislation exists (and there is a lot of it) but is often industry/product specific.

Even though it is much clearer than the legislation it replaces, it is not easy to read. In short, this is where the legal, honest and truthful requirements come from. Rather cut and paste chunks of the legislation, SCHEDULE 1 - Commercial practices which are in all circumstances considered unfair has several clauses that are of particular relevance.
9. Stating or otherwise creating the impression that a product can legally be sold when it cannot. 
17. Falsely claiming that a product is able to cure illnesses, dysfunction or malformations.
It is worth pointing out that the Regulations do implement various EU Directives, so parts of them can not be changed without changes first to the EU Directives or securing a UK opt-out.

The Human Medicines Regulations 2012
This is the legislation that kicked up a stink among homeopaths although for different reasons that the restrictions it places on what they can say. It's a consolidation (bar one section - which is extremely problematic) of prior legislation. Again, much clearer than what it replaces but still difficult to read.

What is considered advertising by the Regulations?

PART 1 General

Advertisements relating to medicinal products

7.—(1) In these regulations “advertisement”, in relation to a medicinal product, includes anything designed to promote the prescription, supply, sale or use of that product.
(2) This includes, in particular, the following activities—
(a)door-to-door canvassing;
(b)visits by medical sales representatives to persons qualified to prescribe or supply medicinal products;
(c)the supply of samples;
(d)the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefitor bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;
(e)the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and

(f)the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses in that connection.

There are exemptions but the key thing is the anything designed to promote the prescription, supply, sale or use of that product. This is both broad in scope yet talks about a "product".

PART 4Requirement for authorisation

Requirement for authorisation

46.—(1) A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product.
(2) A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.
(3) A person may not possess an unauthorised medicinal product if the person knows or has reasonable cause to believe that the product is intended to be sold or supplied to another person within the European Economic Area.
(4) A person may not in the circumstances mentioned in paragraph (5)—
(a)manufacture or assemble a medicinal product; or
(b)procure the sale, supply, manufacture or assembly of a medicinal product.
(5) Those circumstances are that the person knows or has reasonable cause to believe that the medicinal product has been or is intended to be sold or supplied contrary to paragraph (1).
(6) For the purposes of this regulation a medicinal product is unauthorised if none of the following is in force for the product—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.

It is the offer to sell or supply that is key here in terms of what can be said. The restrictions on sale or supply are well known but will be revisited in a future post. Many homeopathic medicines are not registered.

PART 14Advertising

CHAPTER 2Requirements relating to advertising


Products without a marketing authorisation etc
279.  A person may not publish an advertisement for a medicinal product unless one of the following is in force for the product—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.
General principles
280.—(1) A person may not publish an advertisement for a medicinal product with a marketing authorisation, traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.
(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.

(3) A person may not publish an advertisement for a medicinal product that is misleading. 

280.(2) is problematic. It depends on an understanding of the terms "rational", "objective" and "exaggeration". Misleading speaks for itself.

Advertising to the public

Material relating to diagnosis
286.—(1) A person may not publish an advertisement relating to a medicinal product that states, or implies, that a medical consultation or surgical operation is unnecessary.
(2) A person may not, in particular, publish an advertisement relating to a medicinal product that offers to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the Communications Act 2003.
(3) A person may not publish an advertisement relating to a medicinal product that might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis. 

286.(3) is problematic for some.
Material about effects of medicinal product
287.—(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—
(a)are guaranteed;
(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or
(c)are not accompanied by any adverse reaction.
(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—
(a)changes in the human body caused by disease or injury; or
(b)the action of the medicinal product on the human body.
(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.
(4) A person may not publish an advertisement relating to a medicinal product that suggests that—
(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or
(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to regulation 292 (exception for approved vaccination campaigns). 

(4).(a) has implications for "constitutional remedies".

Homoeopathic medicinal products

Advertisements for registered homoeopathic medicinal products
301.—(1) A person may not publish an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates unless the advertisement meets the following conditions.
(2) Condition A is that the advertisement does not mention any specific therapeutic indications.
(3) Condition B is that the advertisement does not contain any details other than those mentioned in Schedule 28 (labelling requirements for registrable homoeopathic medicinal products).
(4) Nothing in regulation 291(2) (form and content of advertisement), 294 (general requirements) or 295 (abbreviated advertisements) requires an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates to contain any detail not specified in Schedule 28.

Yes, there are some other chapters and paragraphs that have some bearing on the advertising of homeopathic medicines but the above are the most relevant. But all this dry legislation relates to "products". How does that relate to homeopathic "services"?

Again, it is worth pointing out that the Regulations do implement various EU Directives, so parts of them can not be changed without changes first to the EU Directives or securing a UK opt-out.

Interpretation - The Blue Guide
The Medicines and Healthcare product Regulatory Agency (MHRA) helpfully provide a guide for advertisers (and others) - the Blue Guide. It is quite easy to understand and spells out the implications of legislation on advertising in very clear terms. It even has a section on homeopathy and the very clear statement -

5. Advertising homeopathy services Homeopathic practitioners may promote the service they provide for the public, e.g. the availability of a homeopathic consultation service. Details of products in any advertising must be limited to those licensed by the MHRA and must comply with the requirements set out in section 4 above.  
These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.  
Any service that offers advice about treatment options based on answers to questions online should ensure that it does not suggest that a medical consultation is unnecessary. Only licensed products for minor, self limiting conditions may be offered without an individual consultation with a homeopathic practitioner.  
For more information, the Borderline Unit has provided specific guidance on how a company can give customers information on websites without making medicinal claims.
Which raises the thorny question of the definitions of "medical consultation" and "homeopathic practitioner". The latter will be discussed in a later post.

Interpretation - CAP Codes and specific ASA guidance
The Committee for Advertising Practice (CAP) produce the CAP Code. Quoting from the Preface -
The Committee of Advertising Practice (CAP) is the self-regulatory body that creates, revises and enforces the Code. CAP's members include organisations that represent the advertising, sales promotion, direct marketing and media businesses. Through their membership of CAP member organisations, or through contractual agreements with media publishers and carriers, those businesses agree to comply with the Code so that marketing communications are legal, decent, honest and truthful and consumer confidence is maintained.
It also says -
The Code supplements the law, fills gaps where the law does not reach and often provides an easier way of resolving disputes than by civil litigation or criminal prosecution. In many cases, self-regulation ensures that legislation is not necessary. Although advertisers, promoters and direct marketers (marketers), agencies and media may still wish to consult lawyers, compliance with the Code should go a long way to ensuring compliance with the law in areas covered by both the Code and the law.
It is certainly the case that most of the Code mirrors legislation and also the MHRA Blue Guide. Perhaps not in exact wording but certainly in meaning. Note the CAP Code fills gaps in legislation as well, removing the need for specific legislation. Where these gaps are is not always clear.

There is no point in reproducing huge chunks of the CAP Code given that more detailed guidance was given back in 2011(!) - and that in September 2016 a letter and a FAQ was sent to homeopaths (and others) prompting them to look at the CAP Code again (which now specifically mentions homeopathy).

To quote from the detailed guidance -
The need for evidence One of the key rules in the CAP Code is that advertisers need to hold evidence for ‘objective’ claims made in marketing communications. These are claims that consumers are likely to regard as objective i.e. they have a factual basis. The Code states the following: 
  • 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
The words ‘before... publication’ are crucial. As the marketer, you have a pre-publication responsibility for ensuring that your claims are borne out in fact and, where necessary, supported by robust evidence. Rule 3.7 is further clarified in the section specific to medicines and health-related products:
  • 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.
And later -

Claims to avoid In the simplest terms, you should avoid using efficacy claims, whether implied or direct, that aren’t supported by robust evidence. If you are stating or implying that you, your service or a product can be effective in doing something, you need to ensure that you have the evidence to prove the claim. 
If you are making claims for a homeopathic product, or for a treatment based on a specific product, or combination of products, you may only make such claims as are permitted by the product licence(s). You will need to consult the MHRA for advice on this point. 
To date, the ASA has have not seen persuasive evidence to support claims that homeopathy can treat, cure or relieve specific conditions or symptoms. We understand this position is in line with other authoritative reviews of evidence. 
We therefore advise homeopathy marketers to avoid making specific claims of efficacy for treatments where robust evidence is not held to substantiate them. 
Even if a specific product is not cited, marketers of homeopathy services should not state or imply that conditions or symptoms can be relieved or cured by homeopathy. This means marketing of homeopathy services should not use words such as ‘cure’ or ‘treat’, nor list medical conditions because the ASA has a long-standing position that, by doing so, readers are likely to infer that the conditions or symptoms listed can be alleviated. We advise that these claims are not used either directly or indirectly, including through the use of imagery.
And further on still - 
Telling consumers about published research on homeopathy The online environment has greater scope for providing information in a discursive or detailed way. Providing links to information such as published research is likely to fall outside the remit of the ASA if they are presented in a section of the website that is not directly connected with the sale or supply of your products or service. For example, under a separate tab labelled ‘research’ or ‘further reading’.
The guidance is very clear. Much clearer than the SoH guidance referenced below.

Interpretation - Society of Homepaths Code of Ethics and Practice and specific Guidance
The Society of Homeopaths Code of Ethics and Practice have undergone changes over the years (some of which stem from compliance with the Professional Standards Authority requirements - see here). The most recent version is dated August 2015 but it seems likely that it will require further updating. A lot of the content is irrelevant to advertising and promotion. Firstly -
Section 4 - Legal Obligations  
Criminal and civil law  
34) Registered and student clinical members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.  
35) Registered and student clinical members must observe and are responsible for keeping up to date with all legislation and regulations relating directly or indirectly to the practice of homeopathy. 
36) References to any legislation or regulations throughout this code shall include any amendments or other alterations, repeals or replacements made in law since the date they came into force. Any reference to the singular shall include the plural and references to the feminine shall include the masculine.
This would obviously cover the Consumer Protection from Unfair Trading Regulations 2008 and the Human Medicines Regulations 2012. The latter says something interesting though.

Misleading actions

5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).
(2) A commercial practice satisfies the conditions of this paragraph—
(a)if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and
(b)it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.
(3) A commercial practice satisfies the conditions of this paragraph if—
(a)it concerns any marketing of a product (including comparative advertising) which creates confusion with any products, trade marks, trade names or other distinguishing marks of a competitor; or
(b)it concerns any failure by a trader to comply with a commitment contained in a code of conduct which the trader has undertaken to comply with, if—
(i)the trader indicates in a commercial practice that he is bound by that code of conduct, and

(ii)the commitment is firm and capable of being verified and is not aspirational,

Which basically means that if a member of the SoH states that they abide by the SoH Code and does not, they are in breach of consumer protection regulations although technically, they may breach other regulations in order to breach the SoH Code.

Returning to the SoH Code -

Advertising and Media  
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.  
41) Professional advertising must be factual and not seek to mislead or deceive, or make unrealistic or extravagant claims. Advertising may indicate special interests but must not make claims of superiority or disparage professional colleagues or other professionals. No promise of cure, either implicit or explicit, should be made of any named disease. All research should be presented clearly honestly and without distortion; all speculative theories will be stated as such and clearly distinguished.  
42) Under the Cancer Act 1939, it is a criminal offence to take any part in the publication of an advertisement (which is likely to include electronic publications, such as websites, emails and social media) containing any offer to treat any person for cancer, or to prescribe any remedy for it, or to give any advice in connection with the treatment of cancer.  
43) Advertising content and the way it is distributed must not put prospective patients under pressure to consult or seek treatment from a registered or student clinical member.  
44) No registered or student clinical member may use their Society registration status in the advertisement or promotion of any product or remedy.
The SoH have also released more specific guidance on advertising. The first is dated December 2013 - which predates the current SoH Code. A key quote from the document...
Please note that this guidance applies to the ways in which we advertise and promote homeopathy: it does not necessarily cover the provision of information or education to patients and the public, unless this is linked with marketing and promotion.
The concept of linkage is important. The document does go on to discuss other matters - mainly revolving around there being insufficient scientific evidence to substantiate any claims to treat, cure or alleviate illness, etc. It offers some suggestions as to permissible content.

The second piece of guidance is dated July 2016. If anything, it is less thorough and less clear than the first guidance document.

The implication of all of the above is that a website that exists to promote the homeopathic practice of an individual will be considered promotion in its entirely, perhaps with the exception of links to research (although discussing the research maybe considered promotion) and what is clearly opinion unrelated to homeopathy or health issues in general. Commenting on wider social issues, for example, Brexit would not be considered part of the "promotion".

What can be said on such a website is subject to legal limitation without a doubt.

Social media also can be considered promotion especially if it links (either via profile or individual posts) to a website that promotes the homeopathic practice of an individual. 

To quote from an email sent out by various homeopaths (see the Quackometer blog for further information) -
ASA and CAP Ltd. are attempting to prevent homeopaths from communicating lawful information of their lawful trade to members of the public who have a legal right to know.
Lawful information? Of course, information about products and services is permitted (and omission can be misleading) but the information presented has to be substantiated as websites that contain the offer of homeopathic services would be considered promotion.

It is clear from the examination of the websites of certain members of the Society of Homeopaths that not only do they make unsubstantiated claims for the efficacy of homeopathy, they also make demonstratably false statements about other medical and healthcare issues, some of which are denigratory. The later is particular true of those vehemently opposed to conventional medicine.

In another context (eg a publication with an intended audience of homeopaths or perhaps a private forum), those comments would be permissible (assuming they were not libelous or breaching other restrictions on "pure" speech as opposed to commercial speech). But placing them on a website designed to promote a homeopathic service necessarily places more restrictions on speech.

Does the ASA restrict free speech?
Strictly speaking, no, not in the case of homeopathy and especially members of the SoH.

It neither makes the laws nor enforces them. It is a voluntary regulator. Whilst it has some sanctions available to it, ultimately a non-compliant advertiser would be referred to a statutory regulator who has the powers to seek injunctions on publication and even to prosecute under criminal law.

If one believes that the ASA restricts free speech then it could argued that the Society of Homeopaths restricts the free speech of its members to an even greater extent in that it has the sanctions of disciplinary action up to and including expulsion. It could also be argued that the Professional Standard Authority restricts free speech in that it is a condition of accreditation of a voluntary register that the members abide by the CAP Code. The PSA has the sanction of removing accreditation if it feels that the voluntary register has not met its conditions and standards.

The next post will consider the question of who is "qualified" to make judgments on homeopathy.


  1. Ah, robust evidence. Of curse the issue here is that the standard for homeopaths is gobustness. As in: if this finding is accurate, will I go bust?

    1. What does mean "robust evidence"?