FACTSHEET 6

Laws and regulations relating to conservation, trade and use of medicinal plants

Medicinal and aromatic plants (MAPs) can be protected by international, national or local laws, or by self-regulation by those involved. Laws and regulations can help ensure the sustainability of supplies of MAPs in relation to:

• the protection of plants and their habitats;

• trade - from the field to the counter; and

• authentication of quality, safety and efficacy, including in relation to the sources of the plants.

Laws and regulations related to the first two points are relatively well-developed, with differing levels of effectiveness depending on several factors – not least enforcement. There is a need to add sustainability criteria to those concerned with quality and safety.

PROTECTION AND CONSERVATION

The Convention on Biological Diversity (CBD), in force since 1992, is the major international conservation convention. In April 2002, a conference of signatories to the CBD in The Hague adopted a Global Strategy for Conservation of Plants. This aims to strengthen plant conservation across the board, for example by encouraging greater sustainability in the use of plant resources, and promoting education, training and more effective networks.

The strategy has worldwide support. Planta Europa, backed by the Council of Europe, has agreed to a Plant Conservation Strategy for Europe, structured along the lines of the global strategy. Colombia has already adopted a national strategy in anticipation of the global strategy. Ethiopia, speaking at the conference on behalf of the African continent, proposed that a regional strategy for Africa should now be developed.

The global strategy is intended to harmonise with existing international initiatives addressing various aspects of plant conservation. Some of the most significant are UNESCO’s Man and the Biosphere (MAB) Programme (concerned with ecosystem management and scientific research), the Plant Conservation Programme of the Species Survival Commission of IUCN, the Convention on International Trade in Endangered Species (CITES) and the FAO Global Plan of Action for Plant Genetic Resources for Food and Agriculture. Major relevant regional initiatives include the Plant Conservation Strategy for Europe mentioned above, and the Southern African Botanical Diversity Network (SABONET).

Plant protection laws may provide either total protection, through prohibiting the collection of plants or parts of certain species (though permits can generally be obtained for scientific research), or partial protection, usually prohibiting the uprooting or excavation of subterranean parts of plants, but allowing the collection of aerial parts in small quantities. Plants not listed as totally or partially protected may usually be collected freely, but some European countries ban the collection of all wild plants. This is a measure which could prove counter-productive in the case of MAPs, given that the sale of wild MAPs makes significant contributions to some local economies and complete bans may serve to merely drive the trade underground.

The UK Wildlife and Countryside Act (1981) prohibits the uprooting of any species of wild plant except by landowners or other authorised people. In several Italian regions, Austrian länder and Swiss cantons, not only is the uprooting or the collection of subterranean parts of plants prohibited, but there are also restrictions on the gathering of aerial parts. The number of flowering stems or branches which may be picked varies from five to 20, according to local laws. In some cases the maximum quantity allowed is a handful.

Few countries have laws specifically for medicinal plants (Lange 1998). However, Poland lists species of MAPs that cannot be collected without permit, and Italy passed a law in 1931 which regulates the collection of medicinal plants. This stipulates that permits for the commercial collection of listed species will only be issued to people who hold degrees in herbalism from schools of pharmacy. However, the public may collect small (specified) quantities for personal or household use. Some Italian regions have enacted stricter rules.

In some countries the commercial collection of MAPs is controlled by permit. In all, 341 species of MAPs are affected by the combined national legislation of Bulgaria, France, Germany, Hungary, Spain and Turkey, affording them either full or partial protection (Lange 1998). In France, a permit from the Ministry of the Environment is needed for the commercial collection of 31 taxa, including many MAPs. A permit is needed in the Democratic Republic of Congo for the collection of Rauwolfia species. Permits are required for commercial collection of all species of vascular plants in the state of Western Australia, even by landowners. Under federal law in Switzerland, a permit is not required for collecting mushrooms, berries and medicinal herbs for home consumption, but it is needed for commercial collection (many Swiss cantons override this, requiring a permit for the commercial collection of any wild plant). In some Italian regions, for example Val d’Aosta, no commercial collection of wild plants is allowed, except for a small number of medicinal species under permit. Bulgaria has set up a quota system for the gathering of MAPs that is reviewed annually. The collection of 23 plant species is illegal without prior authorisation. Quantities which may be gathered vary considerably according to species and region.

Permits generally specify the name of the species, the quantities that may be collected, the dates and places of collection and, sometimes, the methods of collection that may be used. Enforcement is relatively easy in Europe, since the possession of quantities exceeding those which have been authorised is generally sufficient to establish that an offence has been committed. Penalties are usually fines and sometimes even imprisonment, but the most effective is the temporary withdrawal of the permit. Permits can be revoked permanently. Plants illegally collected, and tools and vehicles used to commit offences, are usually confiscated.

Habitat protection may be as important to the survival of a species as the setting of collection quotas. An act passed in 1977 by the Val d’Aosta region relates to the protection of alpine flora and stipulates that only certain implements, such as sickles, may be used for collection. The digging up of subterranean parts of MAPs can be authorised when it is these parts which have medicinal properties, but the survival of the species and the stability of the soil at the place of collection must not be impaired. The collector has to repair damage to the soil (de Klemm 1988).

REGULATION OF TRADE

The Convention on International Trade in Endangered Species (CITES) is the major global treaty regulating international trade in animals and plants. In force since 1976, it is implemented through passing of its measures into the national laws of all 157 signatory countries. Its strength is that its provisions are mandatory. Its enforcement is partly through the threat of suspensions when violations come to light.

Appendix I of CITES contains species believed to be on the brink of extinction. Commercial trade in these species is prohibited, while non-commercial transactions require both import and export permits. Appendix II of CITES contains generally less endangered species and focuses more on considerations of biological sustainability and legal acquisition. Trade in listed species is subject only to the presentation of export permits, importing countries being required not to accept consignments lacking such permits. Artificially-propagated specimens of species listed in Appendix I are subject only to Appendix II controls (Lange 1998).

Forty-seven species of MAPs in trade in Europe are listed in CITES, all in Appendix II. The majority are bulbous plants and most are orchids. Up to 38 species of orchid in 10 genera are used in Turkey to make salep, an extract obtained from the dried tubers (Lange 1998). Salep is an ingredient of medicines, drinks and ice-cream. Orchids are collected for salep in five regions of Turkey. To identify different species correctly requires considerable expertise that is difficult to expect from collectors and customs officials. Therefore, it is possible for plants to be exported from Turkey either incorrectly labelled or under an imprecise customs commodity number that covers 14 bulbous plant species (Lange 1998; Özhatay et al.1998).

The aromatic rhizomes of jatamansi (Nardostachys grandiflora) and kutki (Picrorhiza kurrooa) are prized in Asia, where their essential oils are used as base ingredients in medicines and cosmetics. Populations of both species have declined in parts of their ranges as a result of trade pressure. Both species are listed in CITES Appendix II, but there is still major illegal trade across the Nepal/India border because of the difficulty of enforcement (Mulliken 2000).

CITES is implemented in the European Union by Council Regulation (EC) No. 338/97 and Commission Regulation (EC) No. 939/97, and various amendments. The 47 species of MAPs listed in CITES Appendix II are listed in Annex B of these regulations (equivalent to Appendix II) and a further seven MAP species are listed in Annex D. Imports of the latter into the EU must be notified, so that the trade can be monitored (Lange 1998).

How can sustainable practices be further supported through legal and regulatory instruments?

Further development is needed in laws and regulations to promote sustainable practices for MAPs. However, the regulatory and legal environment is very complex, for instance in relation to the EU.

A number of limited suggestions have been made:

Good Manufacturing Practice (GMP) guidelines for medicinal and herbal products were first published in 1969 by the World Health Organisation and recommended for adoption by member states. The aim of the GMP is to guarantee the consistent quality of a medicinal product. However, for herbal products GMP guidelines do not contain a clause requiring proof of sustainable production. Inclusion of such a clause would stimulate the development of sustainability criteria (Garg et al. 2002).

Medicine laws could be amended to include a clause requiring proof of the sustainability of herbal material. WWF-Germany/TRAFFIC has suggested that German medicine law could be changed to include a requirement for larger manufacturers to appoint a species officer responsible for ensuring that only sustainably-sourced plants and animal parts are used. The use of any endangered or CITES-listed species would require licences (Garg et al. 2002). This requirement could be linked to an inclusion of proof of sustainability of MAP material in the GMP guidelines.

The EU Directive on Traditional Medicinal Products is nearing completion. However, it appears that it will contain no guidelines to improve the conservation and sustainable use of MAPs. The foremost concern of the directive is to provide an improved regulatory framework that guarantees better quality, safety and efficacy of traditional herbal medicine and improve product information for the consumer (Garg 2002). A possible future directive on Good Manufacturing Practice for starting materials of medicinal products and inspection of manufacture, which has been the subject of some initial discussions, might hold out more hope for inclusion of guidelines on the sustainable production (cultivation or wild harvest) of MAPs (James Lambe, pers. comm.)

The European Herb Growers Association (EUROPAM) is currently developing Good Agricultural Practice and Good Wildcrafting Practice guidelines (www.europam.net). These might be included in the Directive on GMP for Starting Materials if and when the directive becomes operational at EU level. Provided these guidelines are well developed to take due consideration of environmental and social sustainability issues, much could be achieved to ensure a continued supply of MAPs from cultivation and wild harvest sources. The draft guidelines, as they stand at the moment, are only of limited use for sustainability. WWF-UK has submitted official comments to EUROPAM and forwarded these also to the European Medical Evaluation Agency (EMEA) who have endorsed EUROPAMs guidelines. At the global level, the World Health Organisation (WHO) is also developing so called Good Sourcing Practice Guidelines. Similarly to EUROPAM’s guidelines they are divided in Good Agricultural Practice Guidelines and Good Field Collection Guidelines (the latter concerned with wild collection). The drafts (April 2002) as they stand at the moment are similarly deficient and need detailed revision to ensure environmental and social sustainability. WWF-UK has submitted official comments to WHO.

There are many positive ways, other than through formal law, that responsible companies and consumers can promote the sustainable and ethical sourcing of MAPs. NGOs, research institutions, companies and community groups can collaborate to develop broad best practice standards for sustainable and ethical sourcing (Laird and Pierce 2002). Different strategies might include company policies incorporating sustainability and fair trade; certification programmes that integrate ecological, organic, fair trade and quality control criteria; participation in national and international policy processes to promote sustainable and ethical sourcing; and raising the awareness of consumers.