BHA Response Part 5: Product licensing and pharmacies

In the fifth of a linked series, the BHA provides detailed comments on the recommendations of the Science & Technology Committee’s “Evidence Check 2: Homeopathy” issued on 22 February 2010.

Part 5:   Product licensing and pharmacies
(Recommendations 25-32)

25. 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. (Paragraph 121)

Response:
See our response to Recommendation 26 below.

26. 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. (Paragraph 128)

Response:
Homeopathic medicines are safe, there is evidence of their effectiveness, and there is considerable public demand and traditional use.  In these circumstances it would be oppressive for the state to take draconian measures to restrict their availability, which is what these recommendations imply.  Such measures would in any case be ineffective; the main net effect would be to drive the market on to the Internet.  Homeopathic medicines are widely available in the EU and it would be illegal to restrict Internet purchases of them in the UK.

27. 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. (Paragraph 135)

Response:
The legislation was enacted by due process, including an extended consultation period.

28. 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. (Paragraph 140)

Response:
It is factually incorrect to state there is “no scientific evidence” that Arnica montana, diluted beyond Avogadro’s constant, has been demonstrated to be efficacious.  The following RCTs have reported positive findings:

Tveiten D, et al (1998). Effects of the homoeopathic remedy Arnica D30 on marathon runners: a randomized, double-blind study during the 1995 Oslo Marathon. Complementary Therapies in Medicine, 6: 71–74.
Robertson A, et al (2007). Homeopathic Arnica montana for post-tonsillectomy analgesia: a randomised placebo control trial. Homeopathy, 96: 17–21.
Brinkhaus B, et al (2006). Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials. Complementary Therapies in Medicine, 14: 237–246.

29. 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. (Paragraph 141)

Response:
The legislation was introduced by due process, it conforms to EU law, and follows the practice in other EU countries.

30. 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. (Paragraph 146)

Response:
See our response to Recommendation 32 below.

31. 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. (Paragraph 151)

Response:
This is a matter for the RPSGB.

32. 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. (Paragraph 152)

Response:
Like much of this report, this recommendation hinges on the repeated assertion that homeopathy is a placebo.  As we have shown, this view is not supported by scientific evidence.  The legal arrangements were enacted by due process in 2006 and are in line with EU law and practice in other EU states.
Dr Sara Eames, President, Faculty of Homeopathy
Dr Peter Fisher, Director, Royal London Homeopathic Hospital
Dr Robert T Mathie, Research Development Adviser, British Homeopathic Association
Ms Cristal Sumner, Chief Executive, British Homeopathic Association