Since the publication of the Department of Health (DH) consultation document on statutory regulation (SR) on 3 August 2009 a number of practitioners of traditional western herbal medicine have been gripped by, what can be best described as, regulation hysteria. A pro-SR demonstration was held outside the Houses of Parliament, letters demanding SR have been fired off to MPs, and an article entitled ‘Herbal drug crackdown: Millions face having to buy remedies on black market as Europe tightens the rules’ recently appeared in the Daily Mail. The European Herbal and Traditional Medicine Practitioners Association (EHTPA) and its members are offering herbalists a stark choice: get behind SR or face oblivion from European legislation! But is herbal medicine really on brink? Below we attempt to separate fact from fiction (with a little help from the MHRA).

Fiction: Unless SR is implemented by 2011, section 12(1) of the Medicines Act 1968 will be superseded by the Traditional Herbal Medicinal Products Directive (THMPD) and European medicines legislation, effectively banning the practise of herbal medicine in the UK.

Fact: Section 12(1) of the Medicines Act 1968 remains available to herbalists in the UK beyond 2011, whether SR is implemented or not.

In an email (dated 6 November 2009), Richard Woodfield of the MHRA clearly stated that beyond 2011 ‘the s12(1) exemption [will remain] available where herbal practitioners are carrying out activity in accordance with the terms of that exemption.’

What exactly are the terms of the section 12(1) exemption? The exemption appears in statute in the following form:

12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—

(a) the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and

(b) the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.’

In 2011, only section 12(2) of the Medicines Act 1968 will be replaced by the THMPD. Mr Woodfield picks up the story… ‘[H]istorically, OTC unlicensed herbal remedies supplied under the s12(2) exemption in the Medicines Act 1968 were regarded as non industrially produced – and hence not required to comply with European medicines legislation.  However, with the advent of the European Directive on traditional herbal medicinal products [the THMPD] which provides a suitable regulatory home for OTC manufactured traditional herbal medicines, MHRA is switching its interpretation position to regard typical manufactured herbal medicines as being industrially produced.  Whether a product is supplied for retail or for supply via practitioners does not affect whether it is viewed as industrially produced.’

Fiction: Unless SR is implemented by 2011, section 12(1) herbalists would not have access to unlicensed herbal medicines. Only registered/licensed herbal medicines or homemade remedies would be available to their patients.

Fact: Section 12(1) herbalists can continue to access unlicensed herbal medicines from their UK suppliers whether SR is implemented or not.

Richard Woodfield has confirmed the following to be accurate, ‘If a supplier is supplying ingredients for a herbal practitioner to prepare, e.g. blending into s12(1) remedies, this doesn’t require the supplier to have THR/MA [a registration or licence] for the product. [I]t is well known that many herbalists will buy in stocks e.g. of bulk tinctures and use them as [start-up] materials/ingredients to blend as individualised remedies. So in that situation, unless there are other factors, the MHRA wouldn’t need to challenge the supplier as to why they hadn’t got THRs etc.’

Mr Woodfield goes on to say, ‘In preparing their remedies to meet the needs of individual patient identified in consultation under s12(1) some practitioners will no doubt blend ingredients. Whether an item (e.g. a tincture) is itself a product or whether it is supplied as an ingredient for someone to use in making up a product is of course case specific. Overall, we expect the current position to be that some herbal practitioners rely mainly on s12(1) in their practice whereas others make more use of unlicensed herbal medicines manufactured by a 3rd party.’

Fiction: Unless SR is implemented by 2011, section 12(1) herbalists would be unable to access a wide range of ‘manufactured’ herbal medicines.

Fact: In 2011, ‘manufactured’ herbal medicines will come within the scope of the Traditional Herbal Medicinal Products Directive (THMPD) and will continue to be available to herbalists regardless whether SR is implemented or not.

Richard Woodfield states that, ‘These products [‘manufactured’ herbal medicines] would require either a marketing authorisation [MA] or traditional herbal registration [THR], unless it is possible to construct a UK scheme under the derogation in Article 5.1 of Directive 2001/83/EC [European medicines legislation].’

The only way for herbalists to bypass the THMPD (which Mr Woodfield says ‘represents a major advance… in terms of safety, quality standards, and systematic consumer information.’) and access unlicensed ‘manufactured’ herbal medicines commissioned from a 3rd party would be via the above mentioned derogation (which is a type of escape clause or exemption). To do so, herbalists would have to be recognised as ‘authorised health-care professionals’. This status, the DH has indicated, is most probably not attainable unless herbalists submit to SR. However, Mr Woodfield also reveals, ‘If there were to be a version of this arrangement for herbal practitioners [i.e. a UK scheme under Article 5.1 of Directive 2001/83/EC] this would require further specific consultation…’

A Note on Rights and Privileges

A number of herbalists believe that SR will preserve their ‘right to practise traditional western herbal medicine’. This is a misconception. SR is a government-granted ‘privilege’ to practise. Privileges are benefits that governments create and delegate; their terms can be altered or even revoked at any time. Rights are unalienable and cannot be taken away. By submitting to SR herbalists would not be asserting their rights, instead they would be taking a government conferred benefit.

The dangers of taking a benefit are illustrated in the DH consultation document. On page 11 of the ‘Impact Assessment’ report, under the heading ‘Risks’, is the following statement: ‘There is some evidence that some herbal medicines … are supplied for use on vulnerable patient groups, such as children and people who have serious illness.’ Does the DH really believe that herbalists should not be treating children and the seriously ill? Remember, it is alleged that the poor practice of herbalists is putting patients and the public at risk. DH bureaucrats view herbalists as a danger to the public. If herbalists submit to SR, then they are tacitly agreeing to these terms. Under such circumstances it would be perfectly reasonable and necessary for the government to ban herbalists from treating vulnerable patient groups.

To summarise, with or without SR

  • Section 12(1) of the Medicines Act 1968 remains available to herbalists in the UK.
  • Herbalists can continue to access unlicensed herbal medicines from their UK suppliers under the terms of section 12(1).

  • ‘Manufactured’ herbal medicines will continue to be available to herbalists by way of the THMPD.

Any herbalists submitting to SR in the hope of making use of Article 5.1 of Directive 2001/83/EC –  in order to access unlicensed ‘manufactured’ herbal medicines commissioned from a 3rd party –  should bear in mind that this derogation does not currently exist in UK statute for herbalists and will require further consultation before being enacted, if at all.

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