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Regulatory practitioners and those who favour complementary health therapy should be aware of changes in the practice of herbal medicine, writes Melissa Coutinho.
There cannot be many of us who, despite spam filters, have not been exhorted on a regular basis to purchase a medicinal product that has promised to change our lives. Depending upon whether one wants to improve one’s performance professionally, physically or socially, there appears to be a product marketed directly for such a purpose.
Herbal preparations are the latest growth area in medicines, appealing to those who want to use more natural treatments. However, the correlation between “natural” and “harmless” is not an obvious one, as a recent change in the law highlights.
Before 30 April 2011, most herbal medicines in the UK reached the consumer as unlicensed herbal remedies. The Medicines and Healthcare Products Regulatory Agency (“MRHA”), the government agency responsible for regulating medicines and healthcare products, did not need to be notified of such products so long as they met certain criteria. The legislation containing the relevant criteria was section 12 of the Medicines Act 1968, (as amended), which set out exemptions, if there was a personal consultation and a remedy was prepared for the individual consumer, or if the product in question was made using a non-industrial process. (These are shown on the following page.)
After 30 April 2011 (the date at which transitional protection was offered by the Traditional Herbal Medicines Directive 2004/24/EC), a new way of registering traditional herbal medicines has been introduced. The MHRA decided that it was no longer realistic to regard herbal medicines supplied under section 12(2) as exempt from medicines regulation, simply because they were not “industrially produced”, given that the nature of production of some of the simplest preparations can involve potentially potent products. Accordingly, this exemption was removed and remedies previously relying upon it now have to be registered. Purchasers can tell if a product is registered under the Traditional Herbal Registration Scheme (THR), by the THR number on the packaging. Alternatively look out for this symbol (Fig 1) which is a registered certification mark for THR.
The issue has been raised in Parliament repeatedly and the question of the safety of herbal products have been before the courts. In December 2003, judicial review was refused to the National Association of Health Food Stores who challenged the ban on the availability of Kava-kava (Piper Methysticum), a pepper grown in the South Pacific and traditionally used as a herbal remedy to reduce anxiety and insomnia as a natural tranquilliser. Amongst those supporting the challenge was actress Jenny Seagrove who urged that we “roll back the duvet of the nanny state”. However there was evidence that the herbal product had been implicated in 70 reports of suspected liver damage.
More recently, in February 2010, Ms. Wu, a practitioner of traditional Chinese medicines found herself in the dock at the Old Bailey, charged with administering a noxious substance so as to endanger life or inflict grievous bodily harm. The patient, previously healthy save for a dry skin complaint, after consumption of the products then suffered kidney failure and multiple tumours. The evidence from the MHRA was that the products supplied contained the herbal ingredient Aristolochia which, like Kava Kava, is the subject of a Prohibition Order on account of its toxicity. Ms Wu eventually pleaded guilty to selling a banned substance after the judge directed an acquittal on the charge of administering a noxious substance because of the lack of regulation and because there was no evidence that she knew of the potential harm. Ms Wu was given a 2 year conditional discharge and the judge made a point of calling for regulation of the sale of such products as well as registration of practitioners to prevent further tragic cases.
Those within the herbal sector have a mixed view on the new regulatory framework. It now seems to be widely accepted that the previous arrangements gave the public little protection and left the way open for inexpert, or unscrupulous, operators to take advantage of the consumer’s inability to identify products made to acceptable standards. Some in the sector continue to argue that the new regulations are too onerous and will lead to a substantial diminution in consumer choice. Others believe that the new standards, although demanding, are necessary and will in fact ultimately serve to strengthen the sector. Research conducted by Ipsos MORI for the MHRA indicates that 77 per cent of all UK adults support the need for herbal medicines to be regulated, a figure that rises to 87 per cent among users of herbal medicines. Given the law in this area, the following are some of the issues arising:
Standards for herbal medicine
In principle, manufactured herbal medicines placed on the market are like any other medicine and should be licensed in the same way, based on a demonstration of safety, quality and efficacy. The European Parliament however, recognised that many relatively low-risk herbal medicines have been traded in European markets outside the normal legal framework for medicines for many years beneficially, or least without any reported problems. More problematic was the varying extent to which evidence of efficacy for many of these products was available. This was in part due to the chemical complexity and variability of plants.
It was not considered a realistic proposition to require all such products to be removed from the market unless and until the product could satisfy efficacy. This would have been more likely to drive products into a less regulated environment underground rather than improve safety. Accordingly, the EU and Member States adopted a pragmatic approach in relation to efficacy for low-risk products intended for minor indications. Under the Herbals Directive products have to meet safety standards, but the usual requirements for medicines to be proven as efficacious, mandated under the Medicines Directive (2001/83/EC), do not exist. Instead this criterion has been replaced with the requirement to demonstrate 30 years traditional use for the particular medicinal indication, as a pragmatic way of allowing access to traditional herbal medicines of acceptable safety profile to continue within a regulated environment.
Impact on consumer choice
Impact upon consumer choice may well happen as initial consolidation in the market, both of products and companies, occurs. Considering what can go wrong if quality controls are absent, however, puts arguments regarding freedom of choice into perspective. Effective quality controls do not come cheap, which will mean that a cost in applying for THR will exist but the safest products should be able to pull together material illustrating expertise and following standards. An additional consequence may be a greater demand for herbal products, given that regulation should address any previous lack of confidence in standards or systematic information about the products. A recent Mintel survey of 25,000 people in the UK suggested that demand for herbal medicines was likely to rise with improved regulation. EU changes could bring herbal products into competition with conventional medicines.
The importance of THR
If a product has a legitimate THR mark upon it, you can be satisfied that it is subject to a regulatory framework specially designed for traditional herbal remedies. One of the things that you can have confidence in is that the product is safe, with an appropriate sell-by date, as the applicants will have had to provide stability data to support the proposed shelf-life of the product before being granted a THR. However, a product that does not have THR registration is not automatically unsafe. A key consideration will be when and where the product was manufactured, given that the MHRA is only mandating THR for manufactured herbal medicines that were not already lawfully on the market at 30 April 2011.
Whether you are a fan or a sceptic of traditional herbal medicines will depend upon many things: your background, your relationship with your doctor, and how eager you are to find a remedy to a problem (real or perceived). The world has become a smaller place with increased communication making the reach of shared experience far wider than ever before. Ultimately, if your herbal medicine is not a licensed product, you do not have the guarantees of safety that medicine regulation ensures. However, if your herbal medicine is a registered THR product, it is safe - although not guaranteed to be efficacious.
Any observations on the law regarding herbal remedies may be made via the MHRA, www.mhra.gov.uk.
Melissa Coutinho.
Sn 12 Medicines Act 1968 (as amended) Exemptions in respect of herbal remedies
1) The restrictions imposed by sections 7 and 8 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.
(2) Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied—
(a) under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy, and
(b) without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.
Melissa Coutinho is a lawyer for the Government Legal Service An accredited arbitrator, qualified PPM practitioner and a magistrate, she also writes and lectures on medical products and their regulation.
Herbal preparations are the latest growth area in medicines, appealing to those who want to use more natural treatments. However, the correlation between “natural” and “harmless” is not an obvious one, as a recent change in the law highlights.
Before 30 April 2011, most herbal medicines in the UK reached the consumer as unlicensed herbal remedies. The Medicines and Healthcare Products Regulatory Agency (“MRHA”), the government agency responsible for regulating medicines and healthcare products, did not need to be notified of such products so long as they met certain criteria. The legislation containing the relevant criteria was section 12 of the Medicines Act 1968, (as amended), which set out exemptions, if there was a personal consultation and a remedy was prepared for the individual consumer, or if the product in question was made using a non-industrial process. (These are shown on the following page.)
After 30 April 2011 (the date at which transitional protection was offered by the Traditional Herbal Medicines Directive 2004/24/EC), a new way of registering traditional herbal medicines has been introduced. The MHRA decided that it was no longer realistic to regard herbal medicines supplied under section 12(2) as exempt from medicines regulation, simply because they were not “industrially produced”, given that the nature of production of some of the simplest preparations can involve potentially potent products. Accordingly, this exemption was removed and remedies previously relying upon it now have to be registered. Purchasers can tell if a product is registered under the Traditional Herbal Registration Scheme (THR), by the THR number on the packaging. Alternatively look out for this symbol (Fig 1) which is a registered certification mark for THR.
The issue has been raised in Parliament repeatedly and the question of the safety of herbal products have been before the courts. In December 2003, judicial review was refused to the National Association of Health Food Stores who challenged the ban on the availability of Kava-kava (Piper Methysticum), a pepper grown in the South Pacific and traditionally used as a herbal remedy to reduce anxiety and insomnia as a natural tranquilliser. Amongst those supporting the challenge was actress Jenny Seagrove who urged that we “roll back the duvet of the nanny state”. However there was evidence that the herbal product had been implicated in 70 reports of suspected liver damage.
More recently, in February 2010, Ms. Wu, a practitioner of traditional Chinese medicines found herself in the dock at the Old Bailey, charged with administering a noxious substance so as to endanger life or inflict grievous bodily harm. The patient, previously healthy save for a dry skin complaint, after consumption of the products then suffered kidney failure and multiple tumours. The evidence from the MHRA was that the products supplied contained the herbal ingredient Aristolochia which, like Kava Kava, is the subject of a Prohibition Order on account of its toxicity. Ms Wu eventually pleaded guilty to selling a banned substance after the judge directed an acquittal on the charge of administering a noxious substance because of the lack of regulation and because there was no evidence that she knew of the potential harm. Ms Wu was given a 2 year conditional discharge and the judge made a point of calling for regulation of the sale of such products as well as registration of practitioners to prevent further tragic cases.
Those within the herbal sector have a mixed view on the new regulatory framework. It now seems to be widely accepted that the previous arrangements gave the public little protection and left the way open for inexpert, or unscrupulous, operators to take advantage of the consumer’s inability to identify products made to acceptable standards. Some in the sector continue to argue that the new regulations are too onerous and will lead to a substantial diminution in consumer choice. Others believe that the new standards, although demanding, are necessary and will in fact ultimately serve to strengthen the sector. Research conducted by Ipsos MORI for the MHRA indicates that 77 per cent of all UK adults support the need for herbal medicines to be regulated, a figure that rises to 87 per cent among users of herbal medicines. Given the law in this area, the following are some of the issues arising:
Standards for herbal medicine
In principle, manufactured herbal medicines placed on the market are like any other medicine and should be licensed in the same way, based on a demonstration of safety, quality and efficacy. The European Parliament however, recognised that many relatively low-risk herbal medicines have been traded in European markets outside the normal legal framework for medicines for many years beneficially, or least without any reported problems. More problematic was the varying extent to which evidence of efficacy for many of these products was available. This was in part due to the chemical complexity and variability of plants.
It was not considered a realistic proposition to require all such products to be removed from the market unless and until the product could satisfy efficacy. This would have been more likely to drive products into a less regulated environment underground rather than improve safety. Accordingly, the EU and Member States adopted a pragmatic approach in relation to efficacy for low-risk products intended for minor indications. Under the Herbals Directive products have to meet safety standards, but the usual requirements for medicines to be proven as efficacious, mandated under the Medicines Directive (2001/83/EC), do not exist. Instead this criterion has been replaced with the requirement to demonstrate 30 years traditional use for the particular medicinal indication, as a pragmatic way of allowing access to traditional herbal medicines of acceptable safety profile to continue within a regulated environment.
Impact on consumer choice
Impact upon consumer choice may well happen as initial consolidation in the market, both of products and companies, occurs. Considering what can go wrong if quality controls are absent, however, puts arguments regarding freedom of choice into perspective. Effective quality controls do not come cheap, which will mean that a cost in applying for THR will exist but the safest products should be able to pull together material illustrating expertise and following standards. An additional consequence may be a greater demand for herbal products, given that regulation should address any previous lack of confidence in standards or systematic information about the products. A recent Mintel survey of 25,000 people in the UK suggested that demand for herbal medicines was likely to rise with improved regulation. EU changes could bring herbal products into competition with conventional medicines.
The importance of THR
If a product has a legitimate THR mark upon it, you can be satisfied that it is subject to a regulatory framework specially designed for traditional herbal remedies. One of the things that you can have confidence in is that the product is safe, with an appropriate sell-by date, as the applicants will have had to provide stability data to support the proposed shelf-life of the product before being granted a THR. However, a product that does not have THR registration is not automatically unsafe. A key consideration will be when and where the product was manufactured, given that the MHRA is only mandating THR for manufactured herbal medicines that were not already lawfully on the market at 30 April 2011.
Whether you are a fan or a sceptic of traditional herbal medicines will depend upon many things: your background, your relationship with your doctor, and how eager you are to find a remedy to a problem (real or perceived). The world has become a smaller place with increased communication making the reach of shared experience far wider than ever before. Ultimately, if your herbal medicine is not a licensed product, you do not have the guarantees of safety that medicine regulation ensures. However, if your herbal medicine is a registered THR product, it is safe - although not guaranteed to be efficacious.
Any observations on the law regarding herbal remedies may be made via the MHRA, www.mhra.gov.uk.
Melissa Coutinho.
Sn 12 Medicines Act 1968 (as amended) Exemptions in respect of herbal remedies
1) The restrictions imposed by sections 7 and 8 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.
(2) Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied—
(a) under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy, and
(b) without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.
Regulatory practitioners and those who favour complementary health therapy should be aware of changes in the practice of herbal medicine, writes Melissa Coutinho.
There cannot be many of us who, despite spam filters, have not been exhorted on a regular basis to purchase a medicinal product that has promised to change our lives. Depending upon whether one wants to improve one’s performance professionally, physically or socially, there appears to be a product marketed directly for such a purpose.
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