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What you need to know about herbal products in light of legislative changes

By Benedict Lam

The new EU directive for herbal medicines comes into effect at the end of April 2011. Benedict Lam takes a look at how the legislation came about and its implications for pharmacy

 

On 30 April 2011, the transitional protection under the directive on traditional herbal medicinal products (Directive 2004/24/EC) expires. This means that the herbal exemption from licensing under Section 12(2) of the Medicines Act 1968 will no longer be available and retailers, including pharmacies, will be unable to buy herbal products to sell in their premises that do not have a suitable licence.

The herbal directive was adopted by the European Parliament and the Council on 31 March 2004. It gave manufacturers a transitional period of seven years to register herbal medicinal products that were already on the market.

Traditional herbal remedies that make therapeutic claims will need to be registered as conventional medicines. Alternatively, they can be registered under the traditional herbal registration (THR) scheme.

Under the scheme, a traditional herbal medicinal product must be shown to have been in use for 30 years in the EU, or for 15 years in the EU and 15 years elsewhere. The quality and safety of the product must be demonstrated, as well as regulated manufacturing standards. The product must also provide patient information (eg, contraindications, side effects, safety for pregnant women and children, etc) and minor health claims based on traditional use.

In the future, some herbal products can only be sold as dietary supplements. No health indications are allowed for these. It is possible for the same product to be sold as a dietary supplement and as a herbal remedy under the THR scheme.

Cosmetic products containing herbs will not come under the new EU legislation and will continue to be sold as usual and it is expected that most herbal teas will not be affected by the legislation.

Pharmacists may continue to use an unlicensed herbal product if the remedy is recommended and dispensed under Schedule 12(1) of the Medicines Act. This schedule allows a practitioner to recommend and dispense an unlicensed herbal remedy in a consultation with a patient.

What your customers should know

The THR certification markJayne Lawrence, chief scientific adviser at the Royal Pharmaceutical Society, says pharmacists should encourage patients to use only herbal products that display the THR symbol (see image right) because these are the only products where the quality and safety are guaranteed.

“The RPS wants greater high quality information available for the public and professionals so they can make an informed choice about herbal products, in particular what does licensing mean in the context of the THR regulations — namely, that herbal products are licensed for their quality and safety, but not their efficacy, although this does not mean that many of the herbal products licensed under the THR are not efficacious,” she says.

“We believe that the fact that herbal products are now licensed for quality and safety is a definite improvement on the previous situation,” she adds.

Elizabeth Williamson, chairman of the British Pharmacopoeia Commission Expert Advisory Group on herbal and complementary medicines, says pharmacists have an ethical obligation to sell products of good quality. “Since the whole point of the THR scheme is to guarantee quality and safety, if not efficacy, a pharmacist should always recommend [a registered product] in preference to an unlicensed product,” she says.

She believes this legislation will be good for pharmacy because there are patient information leaflets accompanying the registered herbal products, which include drug interactions and contraindications, etc. “Together, with assured quality, [herbal products] can be recommended with much more confidence than previously,” she says.

Steven Kayne, member of the MHRA’s herbal medicines advisory committee, also advises pharmacists to recommend registered products that come with the THR symbol, so that consumers are protected in terms of quality and safety of the product. (The THR symbol has been added to many previously registered products.)

Peter Cattee, board member, Pharmacy Voice, says it is likely that there will be fewer herbal medicines on the market, but the changes will give the public the confidence that the products they are purchasing are of a high standard.

However, he says that the changes could be alarming to patients, particularly if they have purchased herbal products from a pharmacy in the past and have now been told that the product has been removed because it is unlicensed.

“It is important for [customers] to consult their pharmacist before taking any herbal [products] because these can interact with conventional medicines,” he says.

Reference guide from the RPS

The Royal Pharmaceutical Society will be publishing a quick reference guide on the herbal directive.

It will be available for members on www.rpharms.com at the end of the April 2011 and appear in The Journal in May 2011.

Why the THR scheme was developed

There is continuing evidence that low grade, and sometimes dangerous, unlicensed products are available.

In the past, problems have included products containing the wrong herb and sometimes toxic herbs. Also, some so-called herbal products have been adulterated with random quantities of potent pharmaceutical substances to enhance their effect (PJ, 19 February 2011, p186).

The Medicines and Healthcare products Regulatory Agency highlights that one of the main issues with unlicensed herbal products is the lack of or weak product information. It says that consumers do not know whether there would be interactions with other medicines, any known side effects or if the product would be safe to be taken during pregnancy or by children.

The agency says that the THR scheme has been designed so that the public will no longer have to guess the safety and quality of herbal medicines.

Richard Woodfield, MHRA head of herbal medicine policy, says that the growth of the THR scheme means that consumers will have access to a wide choice of over-the-counter herbal medicines made to assured standards.

He adds: “The current signs are that the market will be lively and competitive. The key difference for consumers is that, in future, they will be in the driving seat and able to make an informed choice when they wish to use these medicines.”

To date, over 100 herbal medicinal products have been registered under the THR scheme.

No time limit to sell existing stock

Unlicensed herbal products already legally on the market before 30 April will not need to be recalled, said a spokesman for the MHRA. Retailers, including online and mail order companies, will be able to sell existing unlicensed herbal medicinal products that they have in stock (see Access to unlicensed herbal products to continue).

There is no time limit on selling these products. Elizabeth Williamson, chairman of the British Pharmacopoeia Commission Expert Advisory Group on herbal and complementary medicines, says that, although some companies may stockpile unlicensed herbal products before the legislation comes into effect, community pharmacies are more likely to sell registered products and stock a smaller range, so she does not expect a major change in choice and selection for consumers who buy herbal products from pharmacies.

Steven Kayne, member of the MHRA’s herbal medicines advisory committee, believes some of the more obscure products will disappear from the shelves but most popular herbs made by reputable manufacturers will still be available (see Panel below: companies with THR products).

He says that some pharmacies that have herbal products packed under their own label by a third party might be affected by the legislation if the third party has not licensed the products.

The THR certification markCompanies with THR products

The following is a list of companies that have products registered under the traditional herbal registration scheme (to date):

  • Laboratoires Arkopharma
  • Bioforce (UK) Ltd
  • Bio-Health Ltd
  • Bionorica SE
  • Bioplanta (UK) Ltd
  • Brunel Healthcare Manufacturing
  • Cassella-Med GmbH & Co. KG
  • Diapharm Regulatory Services GmbH
  • G. R. Lane Health?Products Ltd
  • Kerbina Ltd
  • MH Pharma (UK) Ltd
  • Natures Aid Health Products
  • NBTY Europe Ltd
  • A. Nelson & Co. Ltd
  • Pascoe Pharmazeutische Praparate GmbH
  • Pharbio Medical International AB
  • Phytocon GmbH
  • Plantaphile Ltd
  • Potters Ltd
  • Rutland Biodynamics Ltd
  • Schwabe Pharma (UK) Ltd
  • Dr Willmar Schwabe GmbH & Co. KG
  • Swiss Caps GmbH
  • Viridian Pharma Ltd
  • Wrafton Laboratories Ltd

Herbal ingredients in THR licences granted so far

The following are herbal ingredients that are found in products registered under the traditional herbal registration scheme:

  • Agnus castus
  • Arnica
  • Artichoke leaf
  • Asparagus root
  • Bladderwrack
  • Black cohosh
  • Centaury herb
  • Devil’s claw
  • Echinacea herb/root
  • Elderflower
  • Feverfew
  • Gentian root
  • Ginkgo
  • Hops
  • Horse chestnut seed
  • Ivy leaf
  • Lemon balm
  • Lobelia
  • Lovage root
  • Milk thistle
  • Parsley herb
  • Passion flower herb
  • Pelargonium root
  • Peony root
  • Peppermint leaf
  • Primrose
  • Rhodiola root
  • Rosemary leaf
  • Sage leaf
  • Saw palmetto fruit
  • Sorrel
  • Spruce shoots
  • Squill bulb
  • St John’s wort
  • Valerian root
  • Verbena
  • Wild lettuce

Quality and safety, but not efficacy

Although products registered under the THR scheme must demonstrate quality and safety, efficacy does not need to be shown. Linda Anderson, MHRA pharmaceutical assessor, explains that companies will not have to spend millions conducting clinical trials on herbal medicines to prove efficacy. She also says the situation with herbal medicines is similar to that of some over-the-counter cough and cold remedies, where there is weak evidence of efficacy.

Jayne Lawrence, Royal Pharmaceutical Society chief scientific adviser, says that pharmacists need to ensure patients understand that certain herbal products are not tested for effectiveness in the same way as conventional medicines. “Without information about effectiveness, it is difficult for people to make an informed choice when purchasing these products,” she says.

Impact on Chinese medicine practitioners

From 30 April 2011, traditional Chinese medicine practitioners and herbal medicine practitioners will not be able to supply new stock of unlicensed herbal medicinal products.

However, the UK will derogate from the EU directive by allowing them to supply unlicensed herbal medicinal products once again when they become registered (see Access to unlicensed herbal products to continue), which will begin in April 2012. These practitioners will be regulated by the Health Professions Council, which will hold a statutory register.

They will have to take full responsibility for the quality and safety of unlicensed remedies they prescribe. If they are shown to be negligent, they could be prosecuted.

Citation: The Pharmaceutical Journal URI: 11073409

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Supplementary images

  • St John’s wort flower

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