House of Commons - Evidence Check 2: Homeopathy - Science and Technology Committee

Evidence Check 2: Homeopathy - Science and Technology Committee Contents

3 MHRA licensing

112. Our inquiry also looked at the Medicines and Healthcare products Regulatory Agency (MHRA) licensing regimes for homeopathic products.

The policy

113. We started with the MHRA's purpose. It declares boldly on its website: "What we regulate: Medicines."[133] It continues:

Whether it's a medicine you buy, or one prescribed for you as part of a course of treatment, 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.¹³³

114. Normally, medicines are licensed by the MHRA as follows:

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; and
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.[134]

115. Homeopathic products are not subject to this process. As we explained in the previous chapter, homeopathy has a long tradition of use in the UK and homeopathic products were available before a comprehensive regulatory system was introduced. There are currently three licensing regimes in operation for which the MHRA has varying degrees of responsibility. First, the Medicines Act 1968, which required medicines to be licensed before being allowed onto the UK market, led to Product Licences of Right (PLRs) being automatically issued to all products already on the market when the Act was implemented in 1971.[135] Products with PLRs were allowed to stay on the market with their medical indications attached to them.[136]

116. Second, in 1992, the Simplified Scheme for homeopathic medicinal products was introduced under European Directive 92/73/EC. There is no requirement in the Directive (and therefore in the Simplified Scheme) for data to demonstrate clinical efficacy of the product. The scheme is regarded as simplified because its purpose is to ensure the safety and quality of products, not efficacy. Products certified under the Simplified Scheme are not permitted to make medical claims.[137]

117. Third, in 2006, the MHRA sought to address inconsistencies in homeopathic product licensing, where products with PLRs could make medical claims and products certified under the Simplified Scheme could not.[138] Following a public consultation (MLX 312), the MRHA introduced the National Rules Scheme (NRS), the purpose of which, according to the MHRA website,

is to enable homeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor). Applications under the National Rules Scheme must be supported by a dossier of data on quality, safety and efficacy, together with appropriate product labelling and product literature.[139]

Our expectations of the evidence base

118. On the basis of these licensing arrangements for homeopathic products it is clear to us that the "rigorous scrutiny" on safety, quality and efficacy applied by the MHRA before medicines can be used by patients does not apply to homeopathic products. Indeed, in its response to our evidence check questions the Government stated that the "three elements of the licensing regime probably lie outside the scope of [the] Inquiry, because government consideration of scientific evidence was not the basis for their establishment".[140] It explained:

Firstly, the Product Licences of Right were granted to all existing marketed medicines in 1971, under the provisions of the Medicines Act 1968.

Secondly, the Simplified Scheme derives from European Directive 92/73/EC, so probably lies outside the scope of the Inquiry; and

Thirdly, no scientific evidence was examined in drawing up the National Rules Scheme, which also derives from a European Directive. Definitions of 'product safety' and 'product quality' are commonly understood and did not need to be embedded in the scheme itself. Therefore, the onus to provide supportive scientific evidence is on each individual product that manufacturers put through the scheme—to demonstrate that the product is used as a homeopathic medicine, that it is safe, and that it is of suitable quality.[141]

119. We cannot accept this approach. First, the MHRA, as a regulatory agency, has a responsibility to scrutinise the safety and quality of the medicines and healthcare products that it licenses, and to scrutinise the efficacy of products which make any medical claims (medical indications). Where there is no evidence of efficacy, or scrutiny of efficacy, we question whether products should make claims or indeed be subject to any MHRA processes or endorsement.[142] Second, there are three licensing regimes—the old PLR, the NRS and normal medicinal licensing—which permit or have permitted medical claims. When the MHRA allows claims to be made we would expect all their licensing approaches to be based on the process outlined in paragraph 114, that is, the same process (requiring evidence of efficacy) that medicines permitted to make medical indications would undergo. Both of these issues feed through to the labelling of homeopathic products, which enable informed choice. Third, the NRS process places an "onus to provide supportive scientific evidence […] on each individual product that manufacturers put through the scheme", which creates the expectation that the MHRA will review the basis of this evidence.

120. The continuation of the PLR scheme is problematic as it allows medical claims to be made. When consulting on whether to introduce the NRS in 2006, the MHRA explained that:

It was intended to review PLRs against current standards of quality safety and efficacy. In 1973, the UK joined the EU, European legislation came into force and the review of PLRs became mandatory.

By the time of the Review it became obvious that proof of efficacy for homeopathic products would be difficult if clinical trials were required and homeopathics were therefore, exempted from the review and PLRs remain in force. Currently almost 3,000 PLRs are extant.[143]

The Government has told us that PLR licences are next due for review in September 2013 as legislation requires PLRs to be reviewed over a seven-year-period from 1 September 2006 (following the introduction of the NRS).[144]

121. 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.

USER-TESTING OF LABELS FOR HOMEOPATHIC PRODUCTS

122. As we outlined in the previous chapter, patient choice is not real choice unless it is informed. The DH, in its written submission to this inquiry, stated that:

The Government takes the view that consumers who choose to use homeopathic medicines should be fully informed about their purpose.[145]

Our expectation is that being "fully informed" requires the consumer to have an understanding of the content and efficacy of the homeopathic product and, moreover, not to be misled by the label. Therefore we would expect user-testing of labels for homeopathic products to test whether the participants could determine from the label that:

the product did not contain any active ingredient (or contained only a few molecules); and
the product was not proven to be efficacious in the treatment of any medical complaint.

The Evidence Check

Evidence of efficacy

123. In Chapter 2 we reached the conclusion that homeopathy was not efficacious and any perceived effectiveness was in fact solely due to the placebo effect. When we took oral evidence from Professor Woods, Chief Executive of the MHRA, we asked his view on the efficacy of homeopathy and he responded:

One has to look at the totality of the evidence and in my view there is no single piece of evidence that gives that reassurance. […] In aggregate I do not think there is anything there that one would take as robust evidence of an effect over and above the placebo effect.[146]

124. Professor Woods claimed that the MHRA does not seek evidence of efficacy under the NRS[147] yet the MHRA's guidance on the NRS states:

The applicant must submit data on the efficacy of the product which is the subject of the application.[148]

The guidance continues:

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.[149]

125. The RPSGB expressed concern that "homeopathic literature can be used as evidence for medical claims despite the fact that it may not have been subjected to the same level peer review as more main stream scientific literature".[150] It added that "the reliance on such evidence for homeopathic preparations is in stark contrast to the stringent tests that conventional medicines must undergo prior to obtaining a licence".[151] We share the RPSGB's concerns about the evidence that the MHRA accepts in assessing homeopathic products under the NRS. As we made clear in the preceding chapter, homeopathic provings do not provide a sound evidence base for efficacy. Indeed, when we asked Robert Wilson, Chairman of the British Association of Homeopathic Manufacturers (BAHM), whether homeopathic provings represented good evidence, he replied: "No, a homeopathic proving is a technical term for when homeopathic medicines are assessed. It is not a way of doing a trial."[152]

126. We asked Professor Woods why the MHRA accepted provings as evidence. He responded:

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.[153]

127. On the basis of Professor Woods' evidence, we found the reference in the NRS's guidance to efficacy misconceived and confusing. In our view the juxtaposition of efficacy with provings could establish an implication that homeopathic provings are acceptable as evidence of efficacy, which is unsupported by the evidence. The MHRA subjects neither homeopathic products nor provings to the analysis it applies to conventional medicines. Given that homeopathic products are pills that consist of sugar and water we cannot see how the MHRA could apply credible scientific assessments of efficacy that showed any result other than the placebo effect.

128. The absence of a requirement to show evidence of efficacy means that the MHRA's current arrangements would allow a person to seek, for example, a licence for a confectionary product as long as he or she persuaded a number of people that it was a homeopathic product with therapeutic effects. Such a development would, rightly, bring the licensing arrangements into disrepute. We are concerned that the lack of rigour in the MHRA's licensing processes by, for example, allowing the use of provings is allowing homeopathic products to build medical claims unsupported by any evidence. We conclude 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

129. Given that the NRS is not based on evaluating or assuring the efficacy of homeopathic treatments we probed what purpose the NRS served. In 2006, the MHRA recommended to Government the introduction of the NRS in response to European Directive 2001/83. Ms Brown from Sense About Science explained that:

the EC Directive makes provision for national agencies to introduce their own national rules. Under the EC Directive it would have been perfectly acceptable to require homeopathic products to go through the same licensing procedures as other products if they wanted to make medicinal claims, so it was not the only option.[154]

130. The MHRA held a public consultation (MLX 312) prior to introducing the scheme. The MHRA invited responses to their basic proposals for the NRS as well as the four possible options for handling existing PLRs:

Option 1: Do nothing;
Option 2: Revoke all PLRs, forcing products to apply for licences under the Simplified Scheme or new NRS;
Option 3: Revoke all PLRs and force products to apply for licences under the new NRS; and
Option 4: Renew and keep PLRs (reviewing those for more serious conditions), while encouraging companies to consider applying for new licences instead.[155]

131. Ms Brown told us:

from a public health point of view none of these options has a rationale in terms of public health, they all have a rationale in terms of the industry, […] So that is why they preferred option four—it allowed indications and levelled the playing field for the industry; there was no other justification.[156]

132. We noted that some consultation respondents (including those classed by the MHRA as supportive of the scheme) were concerned about the lack of evidence behind homeopathy and the introduction of a scheme that would permit medical indications.[157] In response to this concern the MHRA stated:

The National Rules scheme does not endorse clinical efficacy of homeopathic products, as clinical efficacy is understood in the context of conventional pharmaceutical medicines.[158]

133. The MLX 312 consultation document explained that:

Our proposals will benefit both the general public, by strengthening the public health protection of users of homeopathic medicinal products and the homeopathic industry by levelling the playing field and increasing the range of products that can be marketed. The associated increase in costs for MHRA and the homeopathic industry are offset against the benefits outlined above.

The risk of leaving things is that the expansion of the homeopathic industry will be inhibited by the prevention of the development of new products with indications.[159]

134. Yet when we asked Professor Woods whether the NRS was introduced to facilitate the growth of the homeopathic industry, he responded:

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.[160]

135. We have two concerns about the consultation (MLX 312) which led to the introduction of the NRS. First, although derived from an EC Directive, the MHRA had some freedom to design the regulatory regime. It could have pursued the logical route of requiring evidence of efficacy for products whose labelling could make medical claims, or what would be perceived by the public to be medical claims, to be in line with the requirement for medical products. Second, respondents' concerns about lack of evidence behind homeopathy were largely brushed aside. Having looked at the evidence we fail to understand why the MHRA threw away the opportunity, when formulating the NRS for homeopathic products, to make efficacy supported by clinical evidence a requirement before medical claims were allowed. We consider that the MHRA's consultation, which led to the introduction of the NRS, was flawed and we remain unconvinced that the NRS was designed with a public health rationale.

LABELLING OF HOMEOPATHIC PRODUCTS

136. The MHRA licensing regime regulates what can be written on the label of a homeopathic product. Dr Goldacre considered that:

The MHRA approved label on homeopathy sugar pills is misleading. A great deal of effort has gone into making patient literature, leaflets, and labels more easily understood, explaining the benefits and risks of treatments clearly, so it seems perverse and anomalous that the MHRA have settled on a plainly misleading convention for labelling these homeopathic sugar pills. The MHRA may deploy sophistry, or invoke technical readings of the statements, but the public read these labels as saying that the homeopathic sugar pills are effective for the conditions listed.[161]

137. Currently, under the Simplified Scheme, homeopathic product labels must include the phrase "Homeopathic medicinal product without approved therapeutic indications".[162]We asked Professor Woods about the labelling on Arnica Montana 30C, the only product currently granted a licence under the NRS. Professor Woods explained that:

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.[163]

138. We have two concerns about this label. First, the mere use of a product in the homeopathic tradition, without any actual evidence of efficacy, does not provide any information as to whether a product actually works, and therefore is a poor basis for allowing medical indications on a product label. Second, we are concerned about how the public would interpret the label. We asked Professor Woods whether the average person would conclude from the labelling that the product worked for symptomatic relief of the listed minor conditions or whether they would realise there was no evidence of efficacy. He replied:

[B]y law all packaging and patient information leaflets are subjected to user testing to ensure that they are comprehensible to the man in the street, and indeed that seems to be a very straightforward statement of the reality. This is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches and bruising or swelling after contusions. That is what it says and the user testing is part of the approval of that leaflet, has the labelling been tested on the average man in the street.[164]

139. We were not reassured by this answer and so we requested further information on the MHRA's user testing of the Arnica Montana 30C product label. The MHRA explained in a supplementary memorandum that as part of the label testing on Arnica, they carried out three rounds of user tests, in each round asking 10 participants a set of questions.[165] The questions included the following:

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?

140. In our view, these questions are problematic. Question a) implies that the product can be used to treat the ailment in question. Questions b) and c) imply to participants that there is an active ingredient. On the evidence of these questions it appears to us that the MHRA is encouraging participants in the survey to come to the conclusion that the product contains an active ingredient that can be used to provide relief of sprains, muscular aches and bruising or swelling after contusions, which is contrary to what Professor Woods told us was the intention and effect of the label. On the assumption that this is what most of the participants concluded we fail to see why the label test design should be acceptable to the MHRA given that, first, it considers that homeopathic products have no effect beyond placebo and, second, Arnica Montana 30C contains no active ingredient and there is no scientific evidence that it has been demonstrated to be efficacious. We conclude that the user-testing of the Arnica Montana 30C label was poorly designed with parts of the test actively misleading participants. In our view the MHRA's testing of the public's understanding of the labelling of homeopathic products is defective.

141. As a Committee we are strong advocates of evidence-based decision-making and we are firmly of the view that members of the public should have the opportunity to make evidence-based decisions about their health. It follows that all patients should be informed about the lack of evidence of efficacy for homeopathic products, most crucially at the point of sale, so that they can make an informed choice. The current labelling arrangements fail to provide patients with the information to make informed choices about homeopathic products. If the MHRA is to continue to regulate the labelling of homeopathic products, which we do not support, we recommend that the tests are redesigned to ensure and demonstrate through user testing that participants clearly understand that the products contain no active ingredients and are unsupported by evidence of efficacy, and the labelling should not mention symptoms, unless the same standard of evidence of efficacy used to assess conventional medicines has been met.

THE ROLE OF PHARMACIES

142. Homeopathic products are available to buy over-the-counter in pharmacies, which provide advice to many enquiring about homeopathic products. Pharmacists are required to provide advice on complementary therapies and medicines, in accordance with guidance from the RPSGB, particularly the Professional Standards and Guidance for the Sale and Supply of Medicines, which advises pharmacists:

You must ensure that you are competent in any area in which you offer advice on treatment or medicines. If you sell or supply homeopathic or herbal medicines, or other complementary therapies, you must:

1) assist patients in making informed decisions by providing them with necessary and relevant information

2) ensure any stock is obtained from a reputable source

3) recommend a remedy only where you can be satisfied of its safety and quality, taking into account the Medicines and Healthcare products Regulatory Agency registration schemes for homeopathic and herbal remedies.[166]

143. Boots is the leading pharmacy chain in the UK and is a well recognised retailer and brand. The pharmacy section of Boots sells a range of complementary and alternative medicines, including homeopathic products. We asked Paul Bennett, Professional Standards Director at Boots, why they sold homeopathic products. Mr Bennett replied:

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.[167]

144. Beyond the issue of consumer choice, Professor Lawrence, Chief Scientific Adviser for the RPSGB, considered there were reasons why pharmacies should continue to sell homeopathic products:

We would contest it is better for the patient for pharmacists to be present […] because they are able, if appropriate, to offer advice to that patient, and there are two things that are important. It is important that patients should realise there is not any evidence for the particular preparations and, also, it gives the pharmacist an opportunity to ensure that the patient is not actually taking something unnecessary.[168]

We found this response unsatisfactory. As the RPSGB takes the view that "there is no scientific or clinical evidence to support homeopathy"[169] the only advice pharmacists could give is that the products are placebos. Pharmacists should ensure that patients with symptoms that may require further medical investigation and treatment are not led to believe that a homeopathic remedy is effective beyond the placebo effect. The RPSGB itself has described pharmacists as "scientists in the high street"[170] and therefore has a particular responsibility to ensure that pharmacists provide scientifically accurate advice to patients.

145. The RPSGB had concerns about the possibly legitimisation of homeopathy caused by the sale of products through pharmacies. It pointed out in its written submission that:

the current Government policy of allowing indications for homeopathic preparations intended for over the counter sale, may be seen to legitimising the practice of homeopathy and may prompt some patients to use, for example, homeopathic preparations for malaria prophylaxis, treatment of HIV, TB, influenza, childhood diarrhoea or in place of immunisation.[171]

146. Although the availability of homeopathic products in pharmacies could be interpreted by patients as an endorsement of efficacy, in our view it would be pointless to seek to remove homeopathic products from sale in pharmacies. Many pharmacies sell ranges of non-evidence-based products and homeopathic products are easily available over the internet in any case. We consider that the way to deal with the sale of homeopathic products is to remove any medical claim and any implied endorsement of efficacy by the MHRA—other than where its evidential standards used to assess conventional medicines have been met—and for the labelling to make it explicit that there is no scientific evidence that homeopathic products work beyond the placebo effect.

Enforcement of the RPSGB's guidelines

147. We asked Professor Lawrence how the RPSGB became aware of breaches of Professional Standards and Guidance for the Sale and Supply of Medicines. She explained that:

One of them is through the Society's inspectorate which visits the shops on an occasional basis, and one of their roles is to check that the pharmacists are adhering to ethical guidelines.[172]

The other way is from complaints from perhaps a member of the public.[173]

148. We also asked Professor Lawrence how pharmacies breaching the RPSGB's guidelines were disciplined. In 2006, a BBC Newsnight investigation revealed that some homeopathic pharmacies were claiming that their products could treat malaria, in place of conventional anti-malarial drugs.[174] Professor Lawrence was not able to tell us whether this investigation had concluded.[175] We are concerned that the investigation of a case that began in 2006 is taking so long to resolve.

149. Concerns were raised that these were not isolated cases. Dr Andy Lewis told us, in his written evidence, 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.[176]

150. We asked Professor Lawrence if she could assure us that pharmacies are not selling homeopathic anti-malarial prophylaxis[177] in the absence of conventional evidence-based prophylaxis and she 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.[178]

151. Although it goes wider than the scope of this Evidence Check inquiry we must put on record our concern about the length of time the RPSGB appears to be taking to investigate and reach conclusions on cases where it has been alleged that its guidelines on the sale of homeopathic products have been breached. We recommend that the Government enquires into whether the RPSGB, and from the 2010 handover, the General Pharmaceutical Council, is doing an adequate job in respect of the time taken to pursue complaints.

Conclusions on the licensing regimes

152. The MHRA, with commendable frankness, told our inquiry that it does not consider that homeopathic medicines have efficacy beyond placebo. The evidence we received during this inquiry supports that conclusion. On that basis, the tests that the MHRA uses to assess non-homeopathic medical products would mean that no homeopathic products would be licensed by the MHRA. Instead of introducing a blanket requirement for evidence of efficacy, the MHRA operates three licensing regimes for homeopathic products, in part, for historical reasons and, in part, it appears, to support the homeopathic industry. It is unacceptable for the MHRA to license placebo products—in this case sugar pills—conferring upon them some of the status of medicines. Even if medical claims on labels are prohibited, the MHRA's licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient's view of the credibility of homeopathy may be further enhanced. We conclude that it is time to break this chain and, as the licensing regimes operated by the MHRA fail the Evidence Check, the MHRA should withdraw its discrete licensing schemes for homeopathic products.

133 "What we regulate: Medicines", Medicines and Healthcare Products Regulatory Agency, www.mhra.gov.uk Back

134 "Medicines and Medical Devices Regulation: What you need to know", Medicines and Healthcare Products Regulatory Agency, April 2008, pp 5-6 Back

135 Ev 60 [DH]; Q 210 [Professor Woods] Back

136 Q 210 [Professor Woods] Back

137 "Homoeopathic Medicines", Medicines and Healthcare products Regulatory Agency, www.mhra.gov.uk Back

138 As above Back

139 As above Back

140 Ev 60 Back

141 As above Back

142 In this Evidence Check the safety and quality of homeopathic products are not examined as (1) it is unlikely that water and sugar pills can be directly unsafe and (2) efficacy is the primary consideration of our Evidence check. Back