regulation
Health Canada is a government agency responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks. Health Canada regulates consumer health products that are sold directly to consumers and do not require a prescription or the oversight of a health care professional. In the past, Health Canada has approved more than 8,500 homeopathic products. A recent survey by Health Canada showed that 11% of parents and guardians believe that alternative practices such as homeopathy or naturopathy can replace vaccines.
Now, Health Canada is proposing changes to the labelling and evidence requirements for homeopathic products, as part of the proposed guidance document: Labelling Requirements for Natural Health Products. These changes would require that all homeopathic products that are sold over the counter include on the front panel of their label the statement “This claim is based on traditional homeopathic references and not modern scientific evidence.” Health Canada is also consulting on the introduction of risk-based evidence standards for homeopathic products, which would align requirements with those of other natural health products. The public consultation opens June 26, 2021 and closes September 4, 2021. For more information on how to participate, visit Consultation – Proposed Amendments to the Natural Health Products Regulations.
I hope you agree with me that it might be worth participating in this public consultation with a view of preventing regulations that could open the door to quackery in Canada. So, please do have a look at the documents and make sure that Canadian consumers are adequately protected.
The UK Society of Homeopaths (the organization of the UK non-medically trained homeopaths) has featured on this blog many times, e.g.:
- The UK Society of Homeopaths, a hub of anti-vaccination activists?
- The Society of Homeopaths have a Code of Ethics, but seem to ignore it. I wonder why!
- How the UK ‘Society of Homeopaths’ prevents its members from practising homeopathy
- The UK ‘Society of Homeopaths’ is surpassing itself
- Drowning in a sea of misinformation. Part 2: The UK ‘Society of Homeopaths’
- The UK ‘Society of Homeopath’ is an anti-vaxx hub that endangers public health (in my humble opinion)
- HOMEOPATHS AGAINST VACCINATION: “The decision to vaccinate and how you implement that decision is yours and yours alone”
- Homeopaths ordered to stop claiming that homeopathy can treat medical conditions
- ‘Dr V’, diabetes, homeopathy and the ‘catastrophic’ consequences of homeopathy
- When the UK homeopathy sector issues a joint statement, hilarity is never far
- Enneagram + homeopathy = ??? (spoiler: nonsense + nonsense = nonsense)
- A truly homeopathic survey
- Homeopathy: does killing holidaymakers via bad advice count as ‘high standards’?
- Homeopathy = hubris in allopathic doses
- Is the BBC biased against homeopathy?
Now, the Society has released the following statement:
The Society of Homeopaths (the Society) has taken part in the Accredited Registers Programme run by the Professional Standards Authority (the Authority) since 2014. This accreditation has provided additional assurance to our members and their patients of the professional standards that we have promoted and maintained for over 40 years.
Public protection, patient safety and patient choice are paramount and built into all the Society’s processes and governance. Accountability is ensured through a balance of representation by practitioners and independent members on the Board as well as on the Society’s professional standards and education committees.
Since July 2020 the Society and its members have put tremendous effort into addressing the concerns of the Authority and following the suspension of our accreditation in January 2021, we said we would take time to consider both the Authority’s report and our own position. This has since been superseded by the Authority’s review of its own accreditation scheme and fee structure in the light of the proposed withdrawal of its government funding.
After a number of consultations with the Authority, it has become clear to the Society that the new fee structure for the Accredited Registers Programme disadvantages smaller organisations in favour of larger bodies, and the fee increase proposed by the Authority to the Society, aside from lacking clarity for the future, effectively prices us out of the scheme. Further changes to the Authority’s standards and criteria are also still to be confirmed. The Board has therefore made the decision to withdraw from the Authority’s voluntary accreditation scheme.
We will continue to strengthen our 43-year tradition of being the most highly valued and professional organisation for homeopaths in the UK. The Society’s mission remains to ensure that patients receive the highest standards of care from our trusted members.
I wonder from which organization the Society of Homeopaths might now obtain an accreditation.
Is there an ‘Unprofessional Standards Authority’?
If not, might they create one?
Watch this space!
In 2020, a German court had ruled that pharmacies should be allowed to advertise homeopathic products by naming their alleged source materials, even if the dilution is so high that there is nothing in the products. An appeal against this was launched and it has now ended in defeat. The consequences for homeopathy could be far-reaching.
In homeopathy, it is customary to label and advertise products by naming the starting material or ‘mother tincture’. A German pharmacy thus named one of its products “HCG C30 globules” – HCG is a pregnancy hormone, C30 means it is diluted 30 times in the ratio 1:10o. A group sued arguing that this was misleading.
The Darmstadt Regional Court first ruled that just because the original substance is no longer detectable does not mean that it is no longer present. And in any case, proponents of homeopathy would consider a high dilution to be important in order to reduce side effects. This ruling and the way it was justified caused considerable criticism. However, the plaintiff did not let up and appealed.
In the second instance, the Frankfurt Higher Regional Court (Case No. 6 U 49/20) took a completely different view of the matter. In the appeal hearing, it clarified first that advertisements for homeopathy address not only enthusiasts of homeopathy but the general public. Therefore, it must be in accordance with the general understanding of the population. And the public expects a product labeled “HCG” to actually contain the pregnancy hormone. If this ingredient cannot be detected, the product labeling would be misleading.
In essence, this means that all high potency homeopathic remedies (all beyond a C12) may no longer print the name of the mother tincture on the label. One can expect that this will seriously impact the sales of homeopathic products in Germany. This might re-open the discussion on the question of whether pharmacies should sell homeopathic preparations in the first place. As I have pointed out ad nauseam (e.g. here, here, and here), if pharmacists offer them to their customers pretending they are effective medicines, they violate their own ethical code. In other words, there is no place for homeopathy in pharmacies.
In the UK, a new post-Brexit regulatory framework is being proposed for food supplements by the government. The nutraceutical sector is estimated to be worth £275bn globally and £4bn in the UK. A new report claims that “science is starting to point the way to a new sector of nutritional products with increasingly explicable and/or verifiable medicinal benefits, which needs to be reflected in our regulatory framework.” Tory MP George Freeman, one of the authors of the report, was quoted saying:
“We are living through an extraordinary period of technological change – not just in life science but in host of sectors: from AI to robotics to agri-tech, nutraceuticals, nanotechnology, synthetic biology, biofuels, satellites and fusion energy. The UK is indeed a ‘science superpower’. But we have traditionally been woeful at commercialising here in the UK. There are many reasons. But, in recent years, the EU’s increasingly slow, bureaucratic and ‘precautionary’ approach – copied in Whitehall – has made the EU and the UK an increasingly poor place to commercialise new technology.”
If a product like a food or a herbal remedy makes ‘medicinal’ claims, it is currently regulated by the MHRA. If a product only makes general ‘health’ claims, it is regulated by the Department of Health and Social Care in England, by the FSA in Wales and Northern Ireland, and by Food Standards Scotland in Scotland. This ‘patchwork of regulators’ is bound to change as it is deemed to create additional costs and uncertainty for businesses who would like to see the relevant functions brought together in a central regulatory body and a clearer UK landscape.
In response to the task force’s report, PM Boris Johnson stated that bold and ambitious ideas such as these are needed to encourage growth and innovation:
“The Government, through our Better Regulation Committee, is already hard at work on reform of the UK’s regulatory framework. Your bold proposals provide a valuable template for this, illustrating the sheer level of ambitious thinking needed to usher in a new golden age of growth and innovation right across the UK. So we will give your report the detailed consideration it deserves, consult widely across industry and civil society, and publish a response as soon as is practicable.”
Am I the only one who feels more than a little uneasy about all this? I honestly do not see much new science that, according to the report, points to ‘verifiable medicinal benefits’ of food supplements or nutraceuticals. What the report does however point to, I fear, is that the UK government is about to deregulate quackery with a view to making some entrepreneurs wealthy snake oil salesmen at the cost of public health and wealth.
I hope I am mistaken.
A PROVOCATION is an action or speech that makes someone annoyed or angry, especially deliberately. In law, provocation is when a person is considered to have committed an act partly because of a preceding set of events that might cause a reasonable person to lose self-control.
An INSULT is an expression, statement, or behavior which is disrespectful or scornful. Insults may be intentional or accidental. An insult may be factual, but at the same time pejorative.
An AD HOMINEM ATTACK is an attack on the character of a person who tends to feel the necessity to defend himself or herself from the accusation.
Despite all my attempts to keep the exchanges on this blog reasonably polite, civil, and respectful, I seem to have been less than successful. This, of course, is not least my fault. I am as prone to lose my temper as anyone else, and I admit that, after decades of discussing with irrational people, my patience wears thin.
What should we do about it?
To start with, we need to understand what typically happens. In most cases, things start with a provocation. Let’s consider a recent example. As a response to my perfectly non-provocative post entitled A LOOK AT MY OWN PUBLICATIONS, I got this response:
“Surprisingly, not many of these papers are in the ‘top 100’. I am not sure whether this is meaningful and if so how I should interpret this.”
Perhaps your fame was overshadowed after Hahn showed that you manipulate data and now you are taken seriously into account only by foreign lobbies (such as the “Questao da Ciencia Institute”) and German lobby that you run from your country. It’s normal, Ernst, it’s not surprising that your colleague Natalia Pasternak pathetically cites your book in her article to justify the elimination of homeopathy in Brazil.
As we had discussed Robert Hahn’s misunderstanding of my research several times previously on this blog, my response was to simply post one of the posts that had dealt with the issue. The comment that followed was even more insulting than his previous one. My reaction was to ban the author.
This course of events is fairly typical. Normally, the sequence is as follows:
- I (or someone else) post something that displeases a reader.
- He responds with a provocation.
- I give him back accordingly.
- Things escalate until he posts one or more full-blown insults or ad hominem attacks.
- Eventually, I ban the author.
I wonder how these unpleasantries might be avoided.
- I could phrase my posts in a way that is less provocative to fans of so-called alternative medicine (SCAM). I have often considered doing this. So far, I have mostly decided against it, because I feel a certain amount of provocation is healthy and needed to stimulate discussions. If I changed my style, it would be at the cost of the interest this blog often attracts.
- I could refuse to give back in the same coinage as I receive. This is precisely what I very often try. Yet, sometimes I fail. Sorry!
- I could be much stricter and ban people at the first signs of misbehavior. This, I fear, would take much of the spice and excitement out of our discussions and reduce the entertainment value of my blog.
There is no easy solution, as far as I can see.
For the time being, I will try harder to be polite and civil, and I do beg all of my readers to do the same. Other than this, there is not much that I will change. Oh, I almost forgot: there is also this previous post of mine which I usually send to people who, in my view, have overstepped the mark. It might serve as a caution that I am considering banning that person if things don’t improve.
Bottom line: thanks everyone for your efforts to control your aggressions!
As I have reported previously, homeopathy has recently had a hard time in Germany. The following short note appeared in the German Medical Journal. Allow me to translate it for you:
The Higher Administrative Court of Bremen has rejected as inadmissible the application for a judicial review by a Bremen physician against the deletion of the ‘HOMEOPATHY’-title from the further training regulations of the Bremen Medical Association (decision of June 2, 2021). Thus, the new regulation for postgraduate training of the Bremen Medical Association without the additional designation of homeopathy has been upheld.
“We are very pleased that the Court shares our legal opinion and has rejected the plaintiff’s application,” said Heike Delbanco, Chief Executive Officer of the Bremen Medical Association. “This is also a clear signal for other German medical associations where comparable lawsuits against the removal of homeopathy from the canon of additional designations are pending.”
The Assembly of Delegates of the Medical Association had decided in September 2019 on a new training regulation, which – unlike the previous regulation – no longer provided for the postgraduate training in homeopathy. After the expiry of a transitional period, the qualification of homeopathy can therefore no longer be acquired at the Bremen Medical Association; however, titles already acquired can continue to be held.
A physician from Bremen, who holds the title of homeopathy, brought an action before the Higher Administrative Court against the cancellation of the additional title. He claimed that the removal of the additional designation from the continuing education regulations interfered with his fundamental right to freedom of profession and his fundamental right to property and complained of a violation of the general principle of equality. The medical association considered the action inadmissible.
The Higher Administrative Court now rejected the application, since a violation of the plaintiff’s rights could not be recognized. The plaintiff can continue to use his title HOMEOPATHY also under the new regulations.
The expectations presented by him – in particular, the expectation to find suitable practice representatives and to be able to sell his practice on retirement at a profit – do not justify any legal positions protected by fundamental rights and consequently also no obligation of the Bremen Medical Association to enable physicians to obtain the additional title of homeopathy in future.
________________________
As several further medical associations in Germany have banned homeopathy in the same way as Bremen and were consequently also taken to court by homeopathy enthusiasts, one can be optimistic that these cases will also go against homeopathy.
By guest blogger Michael Scholz
For several years, the “flower essences” invented by Dr. Edward Bach had a difficult time in the European Union and especially Germany. The manufacturers were regularly taken to court for violating the EU Health Claim Regulation. This now culminates in the fact that the manufacturer, Nelsons, who sells the “Original Bach Flowers” in Germany, was forced to rename its popular “Rescue” remedies.
What happened?
The “Rescue” remedies were promoted with statements such as “calm and strong through the day” and “recommended use in emotionally exciting situations, e.g. at work” or to “face emotional challenges”. The competitor, Annoyax Nutripharm, regarded this as a health-related statement that is prohibited according to the EU Health Claim Regulation. Since the “Bach Flower Remedies” are not considered to be medicinal products in Germany, they are treated as food supplements, according to a ruling by the Oberlandesgericht (Higher Regional Court) Hamburg in 2007.
As it is strictly forbidden to advertise food supplements with health-related claims that are unproven, Annoyax Nutripharm filed a lawsuit against Nelsons that all the way to the Bundesgerichtshof (Federal High Court of Justice) in Karlsruhe. Since the case concerned European law, the judges in Karlsruhe referred it to the European Court of Justice in Luxemburg.
The judges wanted two questions clarified: 1. Are the “Rescue” remedies to be regarded simply as Brandy due to their alcohol content of 27%? (in which case, health-related claims would be strictly forbidden). 2. Does the product’s name “Rescue” itself constitute a violation of the Health Claims Regulation?
The Luxemburg judges ruled “No” and “Yes”. “No”, it is not Brandy, although the „essences“ consist of a considerable quantity of alcohol, the recommended dose is too small to be intoxicating. But “Yes”, the term “Rescue” does indeed violate the Health Claim Regulation. So the plaintiff won – and what is the result?
When the Health Claims Regulation was enacted in 2005, a transition period until 2022 was established. This applied to all products that were sold using the same brand name and composition before 2005. This now gave the defendant – Nelsons – the opportunity to use Edward Bach’s 135th anniversary for launching an advertising campaign that praises the court-ordered renaming as „modernization“ for the 21st century. And as you see, the new name is a paragon of creativity, innovation & modernism, indeed (//irony:off): “Rescue” becomes – drum roll – “Rescura”. Yes, I looked just like that too…
This pyrrhic victory for the plaintiffs shows how important it is to protect the European citizens against misleading advertising. And – far more important – it is now established through a ruling of the Federal High Court of Justice that “Bach Flowers” are an esoterical concept devoid of medical evidence.
The COMPLEMENTARY AND NATURAL HEALTHCARE COUNCIL describe themselves as follows:
We were set up by the government to protect the public. We do this by providing an independent UK register of complementary healthcare practitioners. Protection of the public is our sole purpose.
We set the standards that practitioners need to meet to get onto and then stay on the register. All CNHC registrants have agreed to be bound by the highest standards of conduct and have registered voluntarily. All of them are professionally trained and fully insured to practise.
We investigate complaints about alleged breaches of our Code of Conduct, Ethics and Performance. We impose disciplinary sanctions that mirror those of the statutory healthcare regulators.
We make the case to government and a wide range of organisations for the use of complementary healthcare to enhance the UK’s health and wellbeing. We raise awareness of complementary healthcare and seek to influence policy wherever possible to increase access to the disciplines we register.
At present, the CNHC are looking for new board members:
Are you interested in setting standards in the public interest? CNHC is the independent regulatory body for complementary healthcare practitioners, established in 2008 with support and funding from the Department of Health. Our public register of over 6,300 qualified therapists provides confirmation that individuals have met UK standards for safe and competent practice.
The Board meets for a half-day four times a year. In normal circumstances meetings are held in London. There is no remuneration but travel costs are reimbursed.
We have vacancies for one Lay and two Registrant Board members.
Although not essential, CNHC are particularly interested in applications from individuals with a background in financial management or accounting.
Deadline for applications is 26 March 2021. Interviews for a Lay member will be held via Zoom on 15 April and for Registrant members on 14 April.
Full information about the work of CNHC is available on our website.
I think it would be desirable for new members to be rational thinkers. I, therefore, encourage all skeptics and rationalists to apply via their website … but expect the job to be a challenge!
The UK Professional Standards Authority has just made this announcement:
The Professional Standards Authority has suspended the accreditation of the Society of Homeopaths (SoH) following its failure to meet Conditions set by the Authority during 2020. The suspension is effective from today.
Under the Accredited Registers programme, organisations can apply for accreditation of registers they hold of unregulated healthcare practitioners and must meet Standards set by the Authority. The SoH was first accredited in 2014. In February 2020 accreditation was renewed, subject to a Condition that included making its position statements clear that registrants must not practise CEASE, practise or advertise adjunctive therapies, or provide advice on vaccination.
Accreditation of registers is renewed annually, however where there are serious concerns, we conduct an in-year review. We undertook an in-year review of the SoH during the summer of 2020, after concerns were raised in relation to the appointment of a key official. As set out in the outcome of our in-year review three further Conditions were issued, the first two of which were due in October 2020. In December 2020, a Panel met to consider whether these had been met.
We found the Conditions were not met and that the SoH did not fully meet a number of our Standards. In view of the recurrent nature of the concerns, and that several Conditions had already been imposed on the SoH since February 2020, we decided to suspend accreditation.
The suspension will be reviewed after 12 months. To be lifted the SoH will need to demonstrate that it prioritises public protection over professional interests in its handling of complaints and governance processes. If the SoH can demonstrate that this is achieved through fulfilment of the Conditions and Standards earlier than 12 months then we will consider lifting the suspension sooner.
END OF QUOTE
For background information, the following posts might be helpful:
The UK Society of Homeopaths, a hub of anti-vaccination activists? (edzardernst.com)
As though the UK does not have plenty of organisations promoting so-called alternative medicine (SCAM)! Obviously not – because a new one is about to emerge.
In mid-January, THE COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMIH) will launch the Integrated Medicine Alliance bringing together the leaders of many complementary health organisations to provide patients, clinicians and policy makers with information on the various complementary modalities, which will be needed in a post COVID-19 world, where:
- patient choice is better respected,
- requirements for evidence of efficacy are more proportionate to the seriousness of the disease and the safety of the intervention,
- and where benefit versus risk are better balanced.
We already saw this in 2020 with the College advocating from the very beginning of the year that people should think about taking Vitamin D, while the National Institute for Clinical Excellence continued to say the evidence was insufficient, but the Secretary of State has now supported it being given to the vulnerable on the basis of the balance between cost, benefit and safety.
Elsewhere we learn more about the Integrated Medicine Alliance (IMA):
The IMA is a group of organisations and individuals that have been brought together for the purpose of encouraging and optimising the best use of complementary therapies alongside conventional healthcare for the benefit of all.
The idea for this group was conceived by Dr Michael Dixon in discussion with colleagues associated with the College of Medicine, and the initial meeting to convene the group was held in February 2019.
The group transitioned through a number of titles before settling on the ‘Integrated Medicine Alliance’ and began work on developing a patient leaflet and a series of information sheets on the key complementary therapies.
It was agreed that in the first instance the IMA should exist under the wing of the College of Medicine, but that in the future it may develop into a formal organisation in its own right, but inevitably maintaining a close relationship with the College of Medicine.
The IMA also offers ‘INFORMATION SHEETS’ on the following modalities:
- Acupuncture
- Alexander Technique
- Aromatherapy
- Herbal Medicine
- Homeopathy
- Hypnotherapy
- Massage
- Naturopathy
- Reflexology
- Reiki
- Tai Chi
- Yoga Therapy
I find those leaflets revealing. They tell us, for example that the Reiki practitioner channels universal energy through their hands to help rebalance each of the body’s energy centres, known as chakras. About homeopathy, we learn that a large corpus of evidence has accumulated which stands the most robust tests of modern science. And about naturopathy, we learn that it includes ozone therapy but is perfectly safe.
Just for the fun of it – and free of charge – let me try to place a few corrections here:
- Reiki healers use their hands to perform what is little more than a party trick.
- The universal energy they claim to direct does not exist.
- The body does not have energy centres.
- Chakras are a figment of imagination.
- The corpus of evidence on homeopathy is by no means large.
- The evidence is flimsy.
- The most robust tests of modern science fail to show that homeopathy is effective beyond placebo.
- Naturopathy is a hotchpotch of treatments most of which are neither natural nor perfectly safe.
One does wonder who writes such drivel for the COMIH, and one shudders to think what else the IMA might be up to.
