Evidence Check 2: Homeopathy - Homeowatch

Evidence Check 2: Homeopathy 35The purpose of the National Rules Scheme129. Given that the NRS is not based on evaluating or assuring the efficacy of homeopathictreatments we probed what purpose the NRS served. In 2006, the MHRA recommended toGovernment 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 ownnational rules. Under the EC Directive it would have been perfectly acceptable torequire homeopathic products to go through the same licensing procedures as otherproducts if they wanted to make medicinal claims, so it was not the only option. 154130. 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 fourpossible options for handling existing PLRs:• Option 1: Do nothing;• Option 2: Revoke all PLRs, forcing products to apply for licences under the SimplifiedScheme 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), whileencouraging companies to consider applying for new licences instead. 155131. Ms Brown told us:from a public health point of view none of these options has a rationale in terms ofpublic health, they all have a rationale in terms of the industry, […] So that is whythey preferred option four—it allowed indications and levelled the playing field forthe industry; there was no other justification. 156132. We noted that some consultation respondents (including those classed by the MHRAas supportive of the scheme) were concerned about the lack of evidence behindhomeopathy and the introduction of a scheme that would permit medical indications. 157 Inresponse to this concern the MHRA stated:The National Rules scheme does not endorse clinical efficacy of homeopathicproducts, as clinical efficacy is understood in the context of conventionalpharmaceutical medicines. 158133. The MLX 312 consultation document explained that:154 Q 46155 “Consultation Document MLX 312; Licensing of homeopathics: Proposals for a new National Rules Scheme and for areview of Product Licences of Right”, Medicines and Healthcare products Regulatory Agency, 20 June 2005156 Q 50157 Ev 77–89158 As above