The report published by the Committee is called "Evidence Check 2: Homeopathy
". It consists of two main sections: a section that looks at whether the Government should continue to fund homoeopathy and homoeopathic hospitals and another section that looks at whether the Government should continue to issue licences for homoeopathic products
In this article, I take a look at what the report says about the licensing of homoeopathic products. A previous article
dealt with the part about Government funding of homoeopathy.
In the UK, the sale of healthcare-related products is regulated by the MHRA
, the Medicines and Healthcare products Regulatory Agency. The report quotes the agency's website:
it’s reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.
And this is how medicines are licensed by the MHRA:
To begin the process, companies and/or researchers must apply to the MHRA for permission to test drugs through clinical trials, if these trials are to be conducted in the UK
All the test results from these trials on how well the medicine works and its side effects, plus details of what the medicine contains, how it works in the body, and who it is meant to treat, are then sent to the MHRA for detailed assessment
Once the MHRA is satisfied that the medicine works as it should, and that it is acceptably safe, it is given a marketing authorisation or product licence
This sounds very reassuring, but there is a catch: homoeopathic products are completely exempt from this procedure. They have a procedure of their own or rather, three procedures. One reason is historic.
Homoeopathy is over two centuries old, and when the UK started its comprehensive regulatory system, it had to deal with the then existing reality. As a result, the Medicines Act of 1968
(implemented in 1971) required new medicines to be licensed before they could enter the UK, but products that were already on the market were automatically issued so-called product licences of right (PLR
). Homoeopathic products were no exception to this rule.
In 1992, the "Simplified Scheme for homeopathic medicinal products
" was implemented in accordance with the European Directive 92/73/EC
. Under this directive, homoeopathic products are explicitly exempt from having to provide evidence for their efficacy. They only have to provide evidence for safety and quality. Products certified according to the Simplified Scheme are not allowed to make medical claims.
This double scheme introduced an unfairness in the system, since PLR homoeopathics were allowed to make medical claims, whereas those certified under the Simplified Scheme were not. In 2006, the MHRA addressed this by introducing the National Rules Scheme or NRS
On top of that, the government had informed the Committee of its opinion that these three schemes were probably outside the scope of the inquiry "because government consideration of scientific evidence was not the basis for their establishment".
The members of the Committee don't accept this approach. In their view, the MHRA has created an expectation that it would review the basis of the evidence for safety, quality and efficacy. Also, continuing the PLR scheme is problematic, because it allows to make medical claims.
The Committee concludes:
We are concerned that homeopathic products were, and continued to be, exempted from the requirement for evidence of efficacy and have been allowed to continue holding Product Licences of Right. We recommend that no PLRs for homeopathic products are renewed beyond 2013.
Earlier in the report, the authors already noted that patient choice is not real choice unless it is informed. The Department of Health agrees:
The Government takes the view that consumers who choose to use homeopathic medicines should be fully informed about their purpose.
The authors therefore expect that consumers would be able to find out from the label of a homoeopathic product that it does not contain any active ingredient (or only a few molecules) and that it has not been proven to be efficacious in the treatment of any medical complaint.
The Evidence Check
Evidence of efficacy
According to the authors Professor Woods
said that "I do not think there is anything there that one would take as robust evidence of an effect over and above the placebo effect". He also claimed that the MHRA does not ask for evidence of efficacy under the NRS. However, the website of the MHRA says this:
The applicant must submit data on the efficacy of the product which is the subject of the application.
The guidance then goes on:
It should be noted that results of clinical trials are not required to support applications for marketing authorizations under the National Rules Scheme.
However, the applicant must provide one or more of the following:
• Study reports in relation to the product which is the subject of the application;
• Published scientific literature;
• Homeopathic provings
expressed concern about the quality of the homoeopathic literature, and the Committee quotes Robert Wilson
as saying that homoeopathic provings
are not good evidence. So, they asked Professor Woods why the MHRA accepts homoeopathic provings as evidence of efficacy. His reply:
They are not accepted as evidence of efficacy: they are accepted as evidence that this is a product used by homeopaths within the homeopathic tradition for that indication. It does not mean to say we endorse that indication; it is simply a marker that that product is used within the homeopathic community for the purpose for which the homeopath wishes to use it.
The authors conclude that the reference to efficacy in the guidance for the NRS is therefore misleading. They think that the MHRA should seek evidence of efficacy to the same standard for all the products examined for licensing which make medical claims and we recommend that the MHRA remove all references to homeopathic provings from its guidance other than to make it clear that they are not evidence of efficacy.
The purpose of the National Rules Scheme
The National Rules Scheme has been created and implemented in such a way regarding the absence of the requirement of clinical evidence for efficacy that the authors of the report have the impression that the Scheme has been created to benefit the homoeopathic industry, but not the patients. When asked if the NRS was introduced to facilitate the growth of the homoeopathic industry, Professor Woods replied "No, and, if it were, it has failed because since the National Rule Scheme was introduced we have exactly one product registered under it since 2006." However, he fails to convince the Committee that they had other reasons.
Labelling of homoeopathic products
Under the Simplified Scheme, homoeopathic product labels must display the phrase: "Homeopathic medicinal product without approved therapeutic indications".
This is what Professor Woods says about Arnica montana 30C
, the only product that is currently licensed under the NRS:
The descriptor on the packet says […]: ‘A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches, bruising and swelling’. That is what we wish to confirm and this is used within the homeopathic tradition for that purpose. It is not the same as us accepting it as evidence.
Dr. Ben Goldacre
thinks that this label is misleading, and is interpreted by the public as meaning that homoeopathic sugar pills are effective for the conditions indicated.
By law, the product information must be tested on the "man in the street". Professor Woods explained that they do three rounds of testing on 10 people, asking them questions, such as:
a) What does the label say that this medicine is for?
b) What does the label say is the active ingredient in this medicine?
c) This medicine contains Arnica montana 30C. What are the other ingredients in this medicine?
The Committee is concerned that these questions imply that the product can indeed be used to treat the ailment in question and that it contains an active ingredient. Hence, the Committee does not understand how these tests could be acceptable to the MHRA since it acknowledges that homoeopathic products have no effect beyond placebo, that Arnica montana 30C contains no active ingredient and that there is no scientific evidence that it has been demonstrated as efficacious. In other words, the Committee thinks that the MHRA's testing of the public's understanding of homoeopathic product labels is defective.
Role of pharmacies
During his testimony for the Committee, Paul Bennett
, Professional Standards Director at Boots, the leading UK pharmacy chain, was asked why they sold homoeopathic products. His reply:
It is about consumer choice for us. A large number of our consumers actually do believe they are efficacious, but they are licensed medicinal products and, therefore, we believe it is right to make them available.
When asked why pharmacies should continue to sell homoeopathic products, the Chief Scientific Adviser for the RPSGB, Professor Lawrence
, said that she thinks that pharmacists should be present so that they can inform the patients that there is no evidence that these products work, and to make sure that the patient does not take something unnecessary.
The Committee is not happy about this and thinks that pharmacists, the "scientists in the street", should provide scientifically accurate advice to patients, i.e. tell them that homoeopathic products are placebos, and should also make sure that the patients are not led to believe that homoeopathic remedies are effective beyond the placebo effect.
The availability of homoeopathic products in pharmacies could be interpreted by patients as an endorsement of efficacy, especially since the Government allows indications for over the counter products. However, the authors of the report think that removing these products from pharmacies is pointless because pharmacies sell lots of products for which there is no evidence of efficacy and because these products are easily available over the Internet anyway.
The authors consider that any medical claims as well as any implied efficacy endorsement by the MHRA should be removed from homoeopathic products and that the labelling must make it explicit that there is no scientific evidence that homoeopathic products work beyond the placebo effect. The only exception to this, should be made where the homoeopathic product meets the MHRA's evidential standards for conventional medicines.
Enforcement of the RPSGB's guidelines
There are two ways in which the RPSGB becomes aware of breaches of the Professional Standards and Guidance for the Sale and Supply of Medicines. The RPSGB has inspectors that occasionally visit the shops and, among other things, check that pharmacists are following the ethical guidelines. The other way is through complaints from members of the public.
In 2006, a BBC investigation had uncovered that some homoeopathic pharmacies were claiming that their products could treat malaria, in place of conventional anti-malaria drugs, a case the RPSGB is still investigating. Dr. Andy Lewis
goes further and says that:
Homeopathic pharmacies are full of products with direct and implied claims. […] Visiting a homeopathic pharmacy website will show many products with implied indications. […] The remedy lists of Ainsworths show products for each Influenza strain going back 20 years. You will find homeopathic replacements for Measles vaccine, Parotitis vaccine (mumps) and Rubella. You find homeopathic sugar pills for all forms of Hepatitis, strains of TB, and Typhoid.
Asked if she could assure the Committee that pharmacies are not selling homoeopathic anti-malarial prophylaxis
in the absence of evidence-based prophylaxis, Professor Lawrence replied:
Obviously I cannot assure you that every pharmacy is not, but I can assure you that the pharmaceutical society has made it very clear to its members that it is completely inappropriate to use homeopathy for the treatment of malaria.
The Committee concludes that it is unacceptable that the MHRA licences placebos, giving them to some degree the status of genuine medicines. Even if medical claims on these products are prohibited, the simple fact of the MHRA licence gives the products a credibility they do not deserve. Since licensing opens the way for sale in pharmacies, the credibility of homoeopathy may increase even more in the view of patients. The MHRA's licensing schemes fail the evidence check and the MHRA should therefore withdraw them.