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MHRA poised to scrap controversial approval scheme for homeopathy

The UK medicines regulator is proposing to scrap a controversial scheme to approve indications for the marketing of homeopathic remedies, after only one treatment was approved in five and a half years.

The National Rules Scheme for homeopathic treatments was introduced by the Medicines and Healthcare products Regulatory Agency in September 2006, but it is being mooted for the axe as part of the Government's ‘medicines red tape challenge' alongside other rules on traditional herbal medicines and the regulation of clinical trials.

The scheme enables manufacturers to register indications for the treatment of minor conditions if they could supply a dossier of data on quality, safety and efficacy. But since 2006 only one homeopathic treatment has been given an indication – Nelson's Arnicare Arnica 30c pillules – which was able to market itself as providing ‘symptomatic relief of sprains, muscular aches and bruising or swelling after contusions'.

The scheme was heavily criticised in the House of Common's Health Committee ‘evidence check' report on homeopathy in 2010, that said the same ‘rigorous scrutiny' on safety, quality and efficacy applied by the MHRA for other medicines should apply to homeopathic products.

An MHRA spokesperson said: ‘The Red Tape Challenge asks whether existing regulations are really providing the protection that is intended, or are they unnecessary or overcomplicated and need to be improved or go altogether.'

‘Even where regulations are EU derived, as many of these regulations are, there may still be scope to improve implementation and enable greater efficiency.

We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections.'

Professor Edzard Ernst, professor of complementary medicine at Peninsula Medical School in Exeter and a prominent critic of the scheme, said: ‘In the past, the MHRA repeatedly stressed that the regulation comes from the EU and they have no choice but have to implement it, but the regulation is clearly nonsense and flies in the face of science.'


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