medicine in Britain and Europe: regulation and practice

Chapter 35 Herbal medicine in Britain and Europe


regulation and practice



S.Y. Mills



REGULATORY BACKGROUND 487

INDUSTRY STANDARDS 488

THE HERBAL PRACTITIONER 488

HERBAL PRACTICE IN THE UK 496


REGULATORY BACKGROUND


The supply of herbs as healthcare products in Europe is more tightly regulated than other commodities. It is also notoriously complex, covering over-the-counter sales through various outlets, as well provision of ‘phytomedicines’ by health professionals (i.e. doctors and pharmacists in most of Europe and herbal practitioners in the UK and Ireland). The vague and less regulated ‘borderline’ area within which many natural products have been supplied direct to the consumer is becoming much more constrained and is intended to disappear altogether after 2010. Essentially, in the case of the direct sale of herbs, there are two regulatory options: food supplements or medicinal products.


Herbal products used for therapeutic purposes are classified as medicines by default under European law. If the UK Medicines and Healthcare products Regulatory Agency (MHRA) determines that a herbal product is a medicinal product then it is a criminal offence to supply it without a licence or registration (or transitional protection until 2011 for products on the market before 2004). In addition, the scope for selling herbs as foods is increasingly limited by ‘novel foods’ legislation and also by the European Food Standards Agency (see below).


There have been exemptions from requirements of formal licensing in European law for herbal medicinal products provided by professionals. However, this legislation did not envisage exemptions for non-registered practitioners. Herbalists exist in appreciable numbers only in the UK, where, by contrast, there is relatively little interest in herbal medicine by orthodox registered health professionals. There have been exemptions provided in UK law for the provision of herbal remedies on a one-to-one basis but this is not secure in a European framework and the legal status of herbal practitioners is thus undefined. However, with government support, herbal practitioners in the UK are moving towards statutory registration by 2010.


Since the early twentieth century, legislation relating to foods and to medicines has diverged, with natural products gradually falling out of the medicine stream from the 1930s. By the time of the thalidomide tragedy in the early 1960s, and the ensuing new raft of drug laws throughout much of the developed world, natural medicines were largely discounted as a significant force in healthcare. In Europe, the pivotal harmonizing measure, to which all member states of the European Union have subsumed their individual legislations, was passed in 1965. EC Directive 65/65/EEC (now supplanted by Directive 2001/83/EEC) defined medicinal products as any substance or combination of substances:


• presented for treating or preventing disease in human beings or animals;

• which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals.

These definitions are sweeping. They clearly include any natural materials used for therapeutic ends. In Europe, if one claims for any product an active effect on the human body, one needs by law to have a medicines licence for that product. This means convincing the medicines regulators that any therapeutic effect is warranted, generally by producing controlled clinical trial evidence. It also means that such products have to meet pharmaceutical standards of quality and safety. This default status as medicines is clearly distinct from that applying in the USA, where natural products are in the first instance considered as foods.


In Germany, France and the United Kingdom especially, a large number of herbal medicinal products have obtained marketing authorizations, according to laws within each member state but within theterms of this European legislation. Nevertheless, the governments of Germany, France, the Netherlands and the UK provided exemptions in their own national legislatures to protect herbal medicines from some of the requirements imposed upon synthetic drug manufacturers. These exemptions were highlighted in a report to the European Commission in 1999 and have led to moves for greater harmonization of herbal regulations within new applications of the pivotal 65/65/EEC Directive. The first amendment was enacted quickly and allowed products with ‘established use’ as medicines to establish their efficacy by reference to this use.


More significantly, and only for ‘herbal products with traditional use’ registration as a medicine (rather than full licensing) is now possible (Directive 2004/24/EC—an amendment to Directive 2001/83/EC). This will excuse the manufacturer from providing evidence of efficacy, although not from assuring standards of pharmaceutical quality and on-going safety monitoring. Registrations will thus require significant investment by manufacturers and importers. At the time of writing there are concerns that this will be too difficult for many. This option is only available for herbal products where there is evidence of at least 15 years of traditional use somewhere in the European Union, plus at least 15 years elsewhere (i.e. a total of 30 years).


It used to be legal, without a licence, to sell in the UK a simple herbal medicinal product—without claims or brand name (under ‘Section 12.2’ of the 1968 Medicines Act); this no longer applies. The new traditional use Directive was published on 30 April 2004. Any product that was legally on the UK market under ‘12:2’ on that date has ‘transitional protection’ and is not required to comply with the Directive until 30 April 2011. After that date, it must have either a traditional herbal registration or a marketing authorization (full licence) or it can no longer be placed on the market. This transitional protection does not apply to any products placed on the UK market at any time after 30 April 2004.


Alone among major industrial countries, the UK has maintained a common law basis to its legal system, in which historical practice provides the default precedent in a court of law. In the delivery of medical care this has meant that there have been very many fewer restrictions than in other developed countries. The statutory rights of doctors, pharmacists and other health professionals have not been monopolies: the common law right of every subject to pursue the health care he or she wishes is still formally protected. Thus unlicensed health professionals and health-food shopkeepers are legally able to provide any service not formally proscribed by Acts of Parliament.


The main statutory control on the supply of medicines is the 1968 Medicines Act. All herbal remedies included on a ‘General Sale List’ could be freely supplied and under the provisions of section 12.2 for:


2) … 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 use the remedy.

Although 12.2 has fallen, the General Sale List (GSL) still is referred to as a directory of herbal remedies. Over 300 herbal substances are named for internal use (Schedule 3[A]). Some 30 are listed for external use (Schedule 3[B]). Where maximum doses (MD) or maximum daily doses (MDD) are listed for GSL products it is implied that any dose in excess of that figure cannot be marketed over the counter (OTC) and the medicine becomes prescription only. Herbal remedies on the various schedules are listed in Table 35.1.



Table 35.1General sale list.

image image

Under the terms of the second stage of the Medicines Act (1971) ‘Licences of Right’ were provided to established medicines already on the market, subject to review before 1990. Around 2000 herbal products obtained these medicines licences. However, the review process was very demanding, with manufacturers having in effect to become modern pharmaceutical companies, ensuring conventional standards of quality medicine production. After 1990, around 600 were successfully reviewed, and now have full medicine licences. However, only a proportion of these are still available on the market and their future in relation to the enactment of the Traditional Use Directive remains uncertain.



INDUSTRY STANDARDS


The British Herbal Medicine Association (BHMA) has, since its founding in 1964, engaged the legislature in productive discussions about the controls of herbal medicines. Its most prominent achievement has been the production of the British Herbal Pharmacopoeia, first in 1983 and then, through substantial revisions, to the latest, with 169 monographs published in 1996. The Pharmacopoeia has been widely used by regulators in the UK and elsewhere around the world as an effective practical quality standard where official monographs do not exist. The herbal monographs covered in the final 1996 edition are listed in Table 35.2.


Table 35.2 Monographs in the British Herbal Pharmacopoeia 1996.











































































































































































































































































































































































































































































































































































































































































































Monograph name Botanical name Action
Agnus castus Vitex agnus-castus L. Hormonal modulator
Agrimony Agrimonia spp. Astringent
Aloes, Barbados Aloe barbadensis Miller. Stimulant laxative
Aloes, Cape Aloe ferox Miller. Stimulant laxative
Ammoniacum Dorema ammoniacum Expectorant
Angelica root Angelica archangelica L. Aromatic bitter, spasmolytic
Aniseed Pimpinella anisum L. Expectorant; carminative
Arnica flower Arnica montana L. Topical healing
Artichoke Cynara scolymus L. Hepatic
Asafoetida Ferula assa-foetida and other F. spp. Spasmolytic
Ascophyllum Ascophyllum nodosum Le Jol. Thyroactive
Balm leaf Melissa officinalis L. Sedative; topical antiviral
Balm of Gilead bud Populus nigra and other P. spp. Expectorant
Barberry bark Berberis vulgaris L. Cholagogue
Bayberry bark Myrica cerifera L. Astringent
Bearberry leaf Arctostaphylos uva-ursi Spreng Urinary antiseptic
Belladonna herb Atropa belladonna L. Antispasmodic
Birch leaf Betula pendula and other B. spp. Diuretic; antirheumatic
Black cohosh Cimicifuga racemosa Nutt Anti-inflammatory
Black haw bark Viburnum prunifolium L. Spasmolytic
Black horehound Ballota nigra L. Anti-emetic
Bladderwrack Fucus vesiculosis L. Thyroactive
Blue flag Iris versicolor, I. caroliniana Watson Laxative
Bogbean Menyanthes trifoliata L. Bitter
Boldo Peumus boldus Molina Cholagogue
Broom top Cytisus scoparius Link. Anti-arrhythmic, diuretic
Buchu Barosma betulina Bartl. et Wendl. Urinary antiseptic
Burdock leaf Arctium lappa L. A. minus Bernh. Dermatological agent
Burdock root Arctium lappa L. A. minus Bernh. Dermatological agent
Calamus Acorus calamus vars Carminative
Calumba root Jateorhiza palmata Miers. Appetite stimulant
Caraway Carum carvi L. Carminative
Cardamom fruit Elettaria cardamomum Maton. Carminative
Cascara Rhamnus purshianus DC. Stimulant laxative
Cassia bark Cinnamomum cassia Blume. Carminative
Catechu Uncaria gambier (Hunter) Roxb. Astringent
Cayenne pepper Capsicum frutescens L. Rubefacient, vasostimulant
Celery seed Apium graveolens L. Diuretic
Centaury Centaurium erythraea Rafn. Bitter
Cinchona bark Cinchona pubescens Vahl. Bitter
Cinnamon Cinnamomum zeylanicum Nees. Carminative
Clivers Galium aparine L. Diuretic
Clove Syzygium aromaticum L. Carminative, topical analgesic
Cocillana Guarea rusbyi Expectorant
Cola Cola nitida, C. acuminata Central nervous stimulant
Comfrey root Symphytum officinale L. Vulnerary
Coriander Coriandrum sativum L. Carminative, stimulant
Corn Silk Zea mays L. Diuretic; urinary demulcent
Couch grass rhizome Agropyron repens P. Beauv. Diuretic
Cranesbill root Geranium maculatum L. Astringent
Damiana Turnera diffusa and possibly other spp. Thymoleptic
Dandelion leaf Taraxacum officinale Webber. Diuretic; choleretic
Dandelion root Taraxacum officinale Webber. Hepatic
Devil’s claw Harpagophytum procumbens DC. Antirheumatic
Echinacea root Echinacea angustifolia DC. Immunostimulant
Elder flower Sambucus nigra L. Diaphoretic
Elecampane Inula helenium L. Expectorant
Eleutherococcus Eleutherococcus senticosus Maxim. Adaptogen; tonic
Equisetum Equisetum arvense L. Diuretic; astringent
Eucalyptus leaf Eucalyptus globulus Labill. Antiseptic
Euonymus bark Euonymus atropurpureus Jacq. Laxative
Fennel, bitter Foeniculum vulgare Miller. Carminative
Fennel, sweet Foeniculum vulgare Miller. Carminative
Fenugreek seed Trigonella foenum-graecum L. Demulcent, hypoglycaemic
Feverfew Tanacetum parthenium Schultz Bip. Migraine prophylactic
Frangula bark Rhamnus frangula L. Stimulant laxative
Fumitory Fumaria officinalis L. Choleretic
Galangal Alpinia officinarum Hance. Carminative
Garlic Allium sativum L. Hypolipidaemic; antimicrobial
Gentian Gentiana lutea L. Bitter
Ginger Zingiber officinale Roscoe. Carminative; anti-emetic
Ginkgo leaf Ginkgo biloba L. Vasoactive; platelet aggregation inhibitor
Ginseng Panax ginseng C.A. Meyer. Adaptogen; tonic
Goldenrod Solidago virgaurea L. Diuretic; anticatarrhal, diaphoretic
Goldenseal root Hydrastis canadensis L. Anti-inflammatory
Grindelia Grindelia robusta Nutt. Expectorant
Ground ivy Glechoma hederacea L. Expectorant
Guaiacum resin Guaiacum officinale L. G. Sanctum L. Anti-inflammatory
Hamamelis bark Hamamelis virginiana L. Astringent
Hamamelis leaf Hamamelis virginiana L. Astringent
Hawthorn berry Crataegus monogyna Jacq. Cardiotonic
Hawthorn flowering top Crataegus monogyna Jacq. Cardiotonic
Heartsease Viola tricolor L. Expectorant; dermatological agent
Helonias Chamaelirium luteum A. Gray. Uterine tonic
Holy Thistle Cnicus benedictus L. Bitter
Hops Humulus lupulus L. Sedative; bitter
Horse-chestnut seed Aesculus hippocastanum L. Venoactive
Hydrangea Hydrangea arborescens L. Diuretic
Hyoscyamus leaf Hyoscyamus niger L. Antispasmodic
Hyssop Hyssopus officinalis L. Expectorant
Iceland moss Cetraria islandica L. Demulcent
Ipecacuanha Cephaelis ipecacuanha, C. acuminata Expectorant; emetic
Irish moss Chondrus crispus Stackh. Demulcent
Ispaghula husk Plantago ovata Forssk. Bulk-forming laxative
Ispaghula seed Plantago ovata Forssk. Bulk-forming laxative
Jamaica dogwood Piscidia piscipula Sarg. Analgesic
Java tea Orthosiphon aristatus, (Blume) Miq. Diuretic
Juniper berry Juniperus communis L. Diuretic
Kava-kava Piper methysticum G. Forst. Anxiolytic
Lady’s mantle Alchemilla xanthochlora, Rothm. A. vulgaris L. S. l. Astringent
Lily of the valley leaf Convallaria majalis L. Cardioactive
Lime flower Tilia cordata Mill. and other spp. Antispasmodic; diaphoretic
Linseed Linum usitatissimum L. Bulk forming laxative; demulcent
Liquorice root Glycyrrhiza glabra L. Respiratory stimulant
Lobelia Lobelia inflata L. Respiratory stimulant
Lovage root Levisticum officinale Koch. Carminative; mild diuretic
Lucerne Medicago sativa L. Tonic
Marigold Calendula officinalis L. Anti-inflammatory, vulnerary
Marshmallow leaf Althaea officinalis L. Demulcent
Marshmallow root Althaea officinalis L. Demulcent
Maté Ilex paraguariensis A. St.-Hil. Stimulant
Matricaria flower Matricaria recutita L. Anti-inflammatory; antispasmodic
Meadowsweet Filipendula ulmaria Maxim. Anti-inflammatory
Melilot Melilotis officinalis Pall. Venotonic, vulnerary
Milk thistle fruit Silybum marianum (L.) Gaertn. Hepatoprotective
Mistletoe herb Viscum album L. Hypotensive
Motherwort Leonurus cardiaca L. Antispasmodic
Mugwort Artemisia vulgaris L. Emmenogogue
Mullein leaf Verbascum densiflorum Bertol. Expectorant
Myrrh Commiphora molmol Engler and other spp. of C. Antiseptic
Nettle herb Urtica dioica L. Diuretic
Nettle root Urtica dioica L. Prostatic
Oak bark Quercus robur L. and other Q. spp. Astringent
Parsley herb Petroselinum crispum Diuretic
Parsley root Petroselinum crispum Carminative, diuretic
Passiflora Passiflora incarnata L. Sedative
Peppermint leaf Mentha piperata L. Carminative
Pilewort herb Ficaria ranunculoides Moench. Astringent
Poke root Phytolacca americana L. Anti-inflamatory
Prickly ash bark Zanthoxylum clava-herculis L. Circulatory stimulant
Psyllium seed Plantago afra L. P. indica L. Bulk-forming laxative
Pulsatilla Pulsatilla vulgaris Miller, P. pratensis (L.) Miller Sedative
Pumpkin seed Cucurbita pepo L. Prostatic
Quassia Picrasma excelsa Appetite stimulant
Queen’s delight Stillingia sylvatica L. Expectorant
Raspberry leaf Rubus idaeus L. Partus praeparator
Red clover flower Trifolium pratense L. Anti-inflammatory
Rhatany root Krameria triandra Ruiz and Pavon. Astringent
Rhubarb Rheum palmatum L., R. officinale Baillon, hybrids Laxative
Roman chamomile flower Chamaemelum nobile All. Antispasmodic
Rosemary leaf Rosmarinus officinalis L. Carminative, spasmolytic
Sage leaf Salvia officinalis L. Antiseptic, astringent
Sarsaparilla Smilax spp. Anti-inflammatory
Saw palmetto fruit Serenoa repens Prostatic
Senega root Polygala senega L. and related spp. Expectorant
Senna fruit, Alexandrian Cassia senna L. Stimulant laxative
Senna fruit, Tinnevelly Cassia angustifolia Vahl. Stimulant laxative
Senna leaf Cassia senna, C. angustifolia Stimulant laxative
Shepherd’s purse Capsella bursa-pastoris Medik. Antihaemorrhagic
Skullcap Scutellaria lateriflora L. Mild sedative
Slippery elm bark Ulmnus rubra Muhl. Demulcent
Squill Drimia maritima Stearn. Expectorant
Squill, Indian Drimia indica J.P. Jessop. Expectorant
St John’s wort Hypericum perforatum L. Antidepressant
Stramonium leaf Datura stramonium L. Antispasmodic
Thyme Thymus vulgaris, T. zygis Expectorant
Valerian root Valeriana officinalis L. Sedative
Vervain Verbena officinalis L. Tonic
Violet leaf Viola odorata L. Expectorant
White deadnettle Lamium album L. Astringent
White horehound Marrubium vulgare L. Expectorant
Wild carrot Daucus carota L. Diuretic
Wild cherry bark Prunus serotina Ehrh. Antitussive
Wild lettuce Lactuca virosa L. Sedative
Wild thyme Thymus serpyllum L. Expectorant
Wild yam Dioscorea villosa L. Spasmolytic, anti-inflammatory
Willow bark Salix alba L. and other spp. Anti-inflammatory
Wormwood Artemesia absinthium L. Bitter
Yarrow Achillea millefolium L. Diaphoretic

The BHMA is also the UK member of a European network of national herbal or phytotherapy associations called the European Scientific Cooperative on Phytotherapy (ESCOP). Since its formation in 1989, ESCOP has been involved in producing harmonized therapeutic monographs for ‘plant drugs’ as formal submissions to the European medicines regulators. A total of 80 such monographs have been published, listed in Table 35.3. More details of this work can be obtained at the ESCOP website (http://www.escop.com).



Table 35.3ESCOP monographs in the medicinal uses of plant drugs

image image image
< div class='tao-gold-member'>

Related posts:

  1. taxonomic approach to the study of medicinal plants and animal-derived drugs
  2. of natural origin
  3. products
  4. glycosides, glucosinolate compounds, cysteine derivatives and miscellaneous glycosides

Stay updated, free articles. Join our Telegram channel
Tags:
Jul 18, 2016 | Posted by in PHARMACY | Comments Off on medicine in Britain and Europe: regulation and practice

Full access? Get Clinical Tree
Get Clinical Tree app for offline access