[PL-02]
POSSIBILITIES AND LIMITATIONS OF MEDICINAL PLANT PRODUCTION IN HUNGARY

Jenő BERNÁTH
Szent István University, Faculty of Horticultural Sciences, Department of Medicinal and Aromatic Plants,
1114 Budapest, Villányi str. 29-45 Hungary

ABSTRACT

The utilisation of medicinal and aromatic plants is growing continuously, which is motivated by both psychological and rational factors. By the latest data of Traffic International (Lange 1998) the overall importation of medicinal and aromatic plants into European countries increased between 1992 and 1996 by 21%, and in particular, the consumption in Germany was in 1996 almost 30% higher than in 1992. Even, the production and consumption of phytopharmaceuticals (phytomedicines) shows much higher increase in Europe being about 10%, yearly. This new situation required changes in both legislation and production of medicinal and aromatic plants on national and international level as well. The efforts making new legislation system in this filed is obvious from the latest EU directives being reported, while the changes of the production is going on parallel, which are determined by many biological, agronomic and economical factors. Evaluating the European export-import situation analysis has to be prosecuted by every producer countries - including Hungary -how to develop national activity on this special field.


1. INTRODUCTION

The accelerated utilisation of medicinal and aromatic plants and their products was an universal phenomenon in the last decades of 20th century and were motivated by both emotional and rational factors (Lewington 1990, Lange 1996, 1998). Beyond the emotional factors (the natural products believed to be less toxic, having no adverse effects, and being more acceptable for the human body), there are practical and scientific evidences which justify the widening application of these products. Based on the new scientific achievements medicines of plant origin were developed for such therapeutic fields, which could not be treated by synthetics at all. The active agents of Catharanthus roseus and Taxus brevifolium (or T. baccata), the immunstimulant compounds of Echinacea spp., the geriatric activity of Ginkgo biloba and the Cavinton - synthesised from Vinca alkaloids could be mentioned as examples. However the fields in which medicinal and aromatic plants are utilised are widening day by day and beyond the traditional consumption forms production of nutraceuticals is in progress and homeopathy does mean a new challenge for both producers and practitioners.

Medicinal and aromatic plants, especially for self-consumption was produced in the territory of Hungary many centuries backs (Bernáth 1993, 1994). However, the intensification of the production started in the first years of 20th century, only, and in spite of many political and economical contradictions the medicinal and aromatic plant sector became a successful part of Hungarian Agriculture. Some of the national products had been accepted as a special Hungarian product ("Hungaricum") evaluated by most respectfully in the world market (Chamomillae flos, Basilici herba and folium). To stabilise, even to develop the production of medicinal and aromatic plants in Hungary the understanding of the actual word situation became essential. The appropriate synthesis of the international processes seems to be one of the preconditions to develop national strategy of high efficacy.


2. RECENT CHANGES IN EUROPEAN MEDICINAL AND AROMATIC PLANT SECTOR

2.1. Actual definition of medicinal plants and their products in EU

According to the EEC Directives 65/65, 75/318 and 75/319 herbal medicines are defined as follows (Lange 1998):

a) "vegetable drugs" consisting of plant materials accumulating active ingredients and used for medicinal purposes. The quality of these drugs is described in different references like ESCOP monographs (1996-1999).

b) "vegetable drug preparations" are comminuted or powdered vegetable drugs, extracts, tinctures, fatty or essential oils, or expressed juices, used for medicinal purposes as well. However, chemically defined, isolated plant constituents or their mixtures are excluded from this definition. Exact criteria to ensure a consistent quality for these products are laid down in EEC Directive 75/318 and the Guideline of Herbal Remedies. These preparations are requested to be licensed and, as with all pharmaceuticals, they have to be tested to ensure quality, safety and therapeutic efficacy. The example of licensing advised by EU recommendations is demonstrated in Table 1.


Table 1. Licensing of phytomedicines (vegetable plant preparations) advised by EU recommendation
Status of product: Phytomedicine (OTC drug) produced on the basis of 65/65 EC Directive
Authorization agency: CPMP (Committee for Proprietary Medicinal Products)
Name of the product: Medicines of plant origin (Phytomedicines)
Requirements for legislation of the product
Quality: Has to be proved (GMP, GLP)
Safety: Simplified procedure using literature data (in the case of known plants, ESCOP, ESCOP)
Efficacy: Simplified procedure using literature data (in the case of known plants)

2.2. Development of EU market

Since 1992, overall importation of medicinal and aromatic plants ("vegetable drugs") to Europe has increased by 21%, from 109.000, to 132.000t in 1996. The average annual volume of medicinal and aromatic plant material imported to Europe in this time period was almost 120.000 t valued at more than 335 million USD. Nearly 90% of this volume, 100.000 t were destined for EU countries. As it is demonstrated by the data given in table 2.


Table 2. Import and export of medicinal and aromatic plant material by European countries (UNCTAD COMTRADE database, Lange 1998)
Country
Imports
(t)
Exports
(t)
Net imports
(t)
Value of import
(USDx1000)
Value of export (USDx1000)
Germany
45 400
14 910
30 490
107 060
72 550
France
19 800
5180
14 620
46 340
28 208
Italy
10 380
3560
6820
39 100
13 240
UK
7410
660
6750
24 460
6880
Spain
7370
3060
4310
24 420
8480
Switzerland
4270
140
4130
17 530
1600
Belgium
4770
1790
2980
15 370
7510
Slovákia
3040
580
2460
1890
1620
Austria
2590
1820
770
9850
12 010
Slovakia
1220
550
670
2910
1870
Finland
580
10
570
1690
160
Sweden
670
100
570
4360
3220
Denmark
590
45
545
3450
380
Greece
1180
1000
180
1820
2300
Norway
130
1
129
1250
13
Lithuania
120
12
108
300
50
Latvia
45
9
36
130
30
Iceland
10
1
9
70
60
Netherlands
1510
1630
-120
4020
4670
Moldova
12
180
-168
45
130
Portugal
260
530
-270
2220
560
Romania
40
1010
-970
250
1860
Croatia
430
1510
-1080
1290
4020
Czech Republic
920
2820
-1900
3340
2320
Turkey
170
3550
-3380
410
10500
Poland
1770
5470
-3700
4950
11380
Ireland
2750
6730
-3980
13 490
25040
Hungary
710
5480
-4770
1990
6720
Bulgaria
420
7350
-6930
850
11 970

Germany is by far the leading country of import for medicinal and aromatic plant into Europe, importing over one-third of total volume and value imported into Europe. It is obvious from the data that 18 countries taking place in the upper position of the Table 2 - finishing with Iceland - can be characterised by import activity, being consumer countries, mainly. The rest of the countries, including Hungry, have negative net import values, which refer to their production orientation. The later group of countries could take the advantage of the increasing demand for drugs and raw materials in Europe.

According to the data of Traffic International (Lange 1998) the European market of phytomedicines ("vegetable drug preparations") is growing at a higher rate, than the pharmaceutical market in general. For 1998 and 1999 the growth rate for the phytomedicine market is estimated to be 5-10%. Country-specific growth rates are available for 1993: 35% in Spain, 15% in Germany, 11% in Italy, and 10% in UK. From 1993 to 1995 the German phytomedicinal market grew by 30%, from value of 2500 million USD to 3260 million. At the same time the annual turnover of the German phytomedicinal market amounted to 30% of the total German market for non-prescription pharmaceuticals in 1996. Analysing the above mentioned trends the further increase of the phytomedicine market might be forecasted, which has to be considered by any countries interested in production and processing of medicinal and aromatic plants.

2.3. Regulations for production of raw material

The regulation of raw material production, either it is going on by collection of wild species, or by managing agrarian-system came into centre of interest of EU countries. In the case of wild growing plants the aspects of protection, while in cultivation the aim of promotion seems to be appear.

Because of the negligible collection of indigenous species in EU, the regulation concerning to the wild flora is based on the control of importation process, only. The recent Council Regulation (EC- No.338/97) and Commission Regulations (EC- No. 938/97 and 2307/97) are created for these purposes. These regulations are fully implement the provisions of Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) within the Union and include a number of stricter measures than does CITES, and list species in four annexes, A, B, C and D, affording increasing degrees of protection, and controlling their imports in that order.

In contrast to the regulation concerning wild growing species the cultivation of medicinal and aromatic plants is supported in EU, by both direct and indirect measures as well. The species are included into the „non-food" plant group and supported by the subvention system defined in EEC Council Regulation No. 1765/92, with its updates (334/93, 608/94, 762/94 and 1786/97). As an extreme for UK 8 million USD grant was directed by EU for promoting cultivation on 1200 ha area producing raw for „drugs, cosmetics and aromatherapy". Some of the species cultivated by using EU subvention system are listed in table 3. Additionally medicinal and aromatic plants are allowed and supported to e produce according to the EU regulations worked out for organic production.


3. POSSIBILITIES AND LIMITATIONS OF NATIONAL PRODUCTION

3.1. "Quasi" EU compatible Hungarian regions specialised for medicinal plant production

The regional specialisation in Hungary for utilisation of indigenous flora has long traditions. This specialisation took place spontaneously effected by different biological, conomical and social factors. As a result of spontaneous specialisation well-defined production areas have appeared (Fig. 1.)


Figure 1. Main regions specialised for collection and cultivation of medicinal and
aromatic plants in Hungary (Bernáth 1998)

Region 1.: The Great Plan of Hungary is the most important region specialised for production of wild growing medicinal plants, including camomile (Matricaria recutita). From socio-economical point of view the formation of these special region was promoted by the abundance of labour in this special region. By the data of trade companies in the harvesting time of camomile flowers as much as 15.000 - 20.000 people are involved into the collection even nowadays. Because of the short duration of camomile harvest and processing (one or two month under optimum condition) the regional activity had to be completed by utilisation of other medicinal and aromatic plants being indigenous in the region (Juniperus communis, Achillea collina, Gypsophyla paniculata, Crataegus spp. Rosa spp. etc.).

Region 2.: The development of special region for utilisation of indigenous plant flora was obvious in mountainous areas of Hungary from the beginning of our century. In the production areas of Rosa spp., Sambucus nigra, Prunus spinosa, Crataegus spp. etc. buying up systems and centralised processing facilities were installed.

Region 3.: That special region had been created for lavender cultivation (Lavandula angustifolia and L. intermedia) based on ecological considerations, mainly. The plantation was made on the south slopes of Tihany Peninsula and in the neighbouring territories (Balatonakali, Daránypuszta etc.) which have some kind of Mediterranean climatic character.

Region 4.: Both ecological and economical considerations lead to the formation of region specialised for marjoram (Origanum majoranna) and basil (Ocimum basilicum) in the South part of Hungary being relatively warm and equipped by appropriate sunshine. Its climate meets the ecological requirement of species being of Mediterranean and subtropical origin. From economical point of view this area is known as a main cultivation area for red pepper too. The drying and post harvest processing of red pepper and medicinal and aromatic plant spices show lot of similarity.

Region 5.: The formation of cultivation area of ergot (Claviceps purpurea) was motivated by both ecological and economical considerations. From the wide-ranging cultivation areas of host plant (Secale cereale) such a special area had to be chosen in which the ecological conditions were suitable for the development of fungi. As a result of compromise the southwest slopes of Bakony Mountain were selected for the purpose.

Region 6.: The cultivation of poppy (Papaver somniferum) has a great tradition in Hungary. The cultivation region can be divided into two sub-regions. The cultivation of spring sown type varieties (Region 6a) is concentrated into the Great Plane of Hungary and some parts of the northwest regions of the country. The cultivation of the autumn sown type varieties, because of their overwintering risk is situated at the west part of Hungary (Region 6b) where the winter is usually much milder and the snow covers the field more frequently.

Region 7.: There are several medicinal and aromatic plants which can be cultivated under various conditions in Hungary (Foeniculum vulgare, Carum carvi, Anethum graveolens, Coriandrum sativum, Pimpinella anisum etc.), mustard (Sinapis and Brassica spp.) Sylibum marianum, Cucurbita spp. etc.) with exception of mountainous and extreme areas.

3.2. Structure of the medicinal and aromatic plant sector effected by political and economical changes

The medicinal and aromatic plants are produced in special sector of agriculture, which had been developed traditionally and modified by the recent political and economical changes. Its structure is demonstrated in Fig 2.

The raw material production (Subsection I.) is going on by the similar system has been developed in the second half of the last century. About half of the raw material has been collected in natural habitats, while the other half has been produced by cultivation (Bernáth, 1987, Németh, 1996, Tóth and Németh, 1996). However, beyond the biological considerations - discussed later - the new situation generates a change in the productivity of the medicinal and aromatic sector from economical and social point of view: among others the effect of privatisation of forests, meadows etc., the increasing labour coming from other sectors of Hungarian economy (industry, social institutions etc.), and the special requirements of new "farm" like production is well observable.

The wholesale companies (Subsector II.) are playing an increased role in the activity of the medicinal and aromatic plant sector, recently: they are dealing with purchase of raw material, cultivating plants, producing (processing) and marketing them. The number of these companies has increased in the past few years, unexpectedly.


Figure 2. Structure of the medicinal and aromatic plant sector of Hungary
(Bernáth and Németh 1998)

The retail trade (Subsector III.) was effected by the political and economical changes too. The number of dealers (and shops) selling medicinal and aromatic plant drugs and their products has increased since the changes of the political situation enormously.

The export-import activity (Subsector IV.) of the medicinal and aromatic plant drugs and their products which were done by exclusive licence of the state enterprises before, started to diversificate. The liberalisation of the export-import licence resulted a new situation: the number firms dealing with export-import of medicinal and aromatic plants increased, the competition among Hungarian and other former Comecom and western firms became more intensive on the same market.

3.3. Biological background of medicinal and aromatic plant production

Considerable amount of medicinal and aromatic plant drugs, which is produced and commercialised by the representatives of Hungarian Medicinal and Aromatic Plant Sector comes from indigenous sources even nowadays. If the amount of medicinal and aromatic plant drugs, which are produced for industrial processing is calculated in, the ratio of plant material coming from indigenous flora is about 35-40 per cent. It does mean, however, that an enormous amount of plant material, about 10.000-15.000 t of dry biomass is taken off from the Hungarian indigenous flora year by year.

Evaluating the commercial data of the medicinal and aromatic plant drugs it is a difficult task to identify, either the plant material comes from wild, from cultivation or both of them. From this point of view Hungarian medicinal and aromatic plants can be classified into three groups (Table 4.).

The first and largest group, consisting of about 80 species compiles plants, which are occurring in the local flora naturally and their drug is produced by collection, only, even nowadays. Looking through the list of the plants collected from the natural systems it seems to be obvious that many of those species like Crataegus spp., Rosa canina, Hedera helix, Juniperus communis, Vinca minor will remain on the list of the collected ones in the future too.

The second group of plant gathers species, which can be produced in both natural and agrarian systems. Whether the plant is cultivated or collected are determined by many factors, including requirements for stability or homogeneity of the production, getting special chemical composition etc. Matricaria recutita and Origanum spp. are two of the characteristic example of this group. In the case of camomile for instance, if special chemical composition is required, the cultivation of special variety could be the solution, only (Franz, 1994).

There are about 40 species, listed into the third group including several members of Apiaceae (Anethum graveolens, Coriandrum sativum, Carum carvi, Foeniculum vulgare etc.), and Lamiaceae family (Lavandula officinalis, Mentha piperita, Satureja hortensis, Thymus vulgaris etc.), which can be produced in agrarian-systems only (Bernáth 1992).

3.4. Effect of the European market on the Hungarian drug production

Evaluation of the actual tendencies of the drug exportation, the Hungarian Medicinal and Aromatic Plant Sector depends on the requirement of the West-European, especially on the German market, considerable (Lange, 1996). The volume of the exported Hungarian drugs may reach even the 50% of the total home production.


Table 3. Medicinal and aromatic plants listed into the „non-food" category in EU and cultivated by the help of subvention system (Lange 1998)
Country
Cultivation using subvention (ha)
Selected species
France
6.205

Foeniculum vulgare, Arctium lappa, Melilotus officinalis, Angelica archangelica, Claviceps purpurea, Equisetum arvense, Digitalis lanata

Germany
589

Digitalis lanata, Calendula officinalis, Hypericum perforatum, Matricaris recutita, Echinacea purpurea

Netherlands  

Digitalis lanata, Calendula officinalis, Echinacea purpurea

UK
1.200

8 million USD grant was directed by EU for promoting cultivation on 1200 ha area producing raw for „drugs, cosmetics and aromatherapy"

The policy and requirements of the main consumer countries determine the extension of medicinal and aromatic plant production and export volumes - beyond the existing biological and economical potential -. However, this policy was not formulated in any written documents its existence can be recognised easily. Analysing the information available on the present export activity of Middle- and South European countries (Lange 1998), including Hungary, the future tendencies can be estimated:


Table 4. List of medicinal and aromatic plant drugs of Hungarian origin produced in different type of systems (Bernáth and Németh 1998)
Medicinal plant drugs produced in natural ecosystems (collected species)

Alkannaae radix, Anserinae herba, Apii herba, Asarae herba cum radix, Asperulae herba, Betonicae folium, herba, Betulae folium, Bursae pastoris herba, Calcatrippae flos, herba, Cerefolii herba, Cichorii herba, radix, Clemititis herba, Coryli folium, Crataegi fructus, summitas, Cynodon dactylon rhizoma, Cynosbati fructus, Echii herba, Equiseti herba, Eupatorii herba, Euphrasiae herba, Fagopyri herba, Farfarae flos, folium, Filipendulae herba, Fragariae folium, Frangulae cortex, Fraxini folium, Fumariae herba, Galegae herba, Galeopsidis herba, Galli herba, Gei rhizoma, Glandes quercus testae pulvis, Graminis rhizoma, Hederae herba, Helianthemi herba, Helichrysi flos, herba, Hepaticae folium, herba, Herniariae herba, Juniperi fructus, Lamii albi flos, herba, Lepidii herba, Linariae herba, Menthae aquaticae herba, Mori folium, Myrtilli folium, fructus, Ononidis radix, Papaveris rhoeas flos, Plantaginis lanceolatae folium, Plantaginis majoris folium, Polygalae herba, Polygoni herba, Polygoni hydropiperis herba, Populi gemma, Primulae flos, folium, radix, Pruni spinosae flos, fructus, Pulmonariae folium, Quercus cerris folium, lichen, Rhei rhizoma, Robiniae flos, Salicis cortex, Sambuci flos, fructus, Sedi herba, Serpylli herba, Sideritidis herba, Sorbi aucupariae fructus, Stellariae herba, Taraxaci folium, herba, radix, Tiliae flos, folium, Tormentillae rhizoma, Urticae folium, Verbenae herba, Veronicae herba, Vincae herba, Violae odoratae folium, Violae tricoloris herba, Virgae aureae solidaginis herba, Visci stipes, 

Medicinal plants produced in both natural and agrarian systems
(collected or/and cultivated species)

Absinthii herba, Agrimoniae herba, Althaeae flos, folium, radix, Armoraciae radix, Amygdalae dulcis farina, Centauri herba, Chamomillae flos, Cotinius folium, Hyperici herba, Inulae radix, Leonurii cardiacae herba, Malvae silvestris flos, folium, Marrubii herba, Meliloti flos, herba, Millefolii flos, herba, Origani herba, Saponariae albae.-, Saponariae officinalis herba, radix, Tanaceti flos, herba, Verbasci flos, 

Medicinal plants produced in agrarian systems (cultivated species)

Anethi fructus, herba, Angelicae herba, radix, Anisi fructus, Artemisiae herba, Avenae semen, Basilici herba, folium, Benedicti herba, Borraginis herba, Calendulae flos, herba, Carvi fructus, Castaneae folium, Chamomillae romane flos, Coriandri fructus, Dracunculi herba, Foeniculi fructus, Foenigraeci semen, Helianthi flos, Hyssopi herba, Iridis rhizoma, Juglandis folium, nucis pericarpium, Lavandulae flos, Leonuri lanatea herba, Levistici herba,radix, Lini placentae farina, semen, Liquiritiae radix, Lupuli strobuli, Majoranae herba, Malvae mauritii flos, Maydis stigma, Melissae folium, herba, Menthae crispae folium, herba, Menthae piperitae folium, herba, Petroselini folium, fructus, radix, Phaseoli legumen, Ribes nigri folium, Rosmarini herba, Rubi idaei folium, Salviae folium, herba, Saturejae herba, Sinapis albae semen, Sinapis nigrae semen, Thymi herba, Valerianae radix, 

The export of raw material is the larger and most stable part of activity of medicinal and aromatic plant sector of these countries. The export is oriented to the main consumers of Europe, especially to Germany, England, etc. The requirement for drug quality is a moderate one, high quality required occasionally. The price of the drugs competes with the offers of North African or South American producers, in majority of cases.

The export possibilities of active agents isolated from plant sources are much restricted comparing to the raw. There are some compounds (opiates, ergot alkaloids etc.) which are produced in Middle- and South European countries in a large scale and can be included into this group.

The phytomedicine production of Middle- and South European countries is increasing continuously. Because of the statue of the European harmonisation no actual export of those products can be realised to the West. The market for phytomedicines of Middle and South European origin is opened for home consumption and consumers of former socialist countries.

There are a small, but valuable group of medicines processed by pharmaceutical factories of Middle- and South European countries, based on plant raw. The importance of this group in export activity is a very small one, because of the restricted interest of the West. The market for the export of these medicines exists in the former socialist, or developing countries.

REFERENCES
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[PL-02]