The European herbal & natural products market: European markets are on their way to harmonization, which will present new challenges and opportunities. (Euro Trends).
The European market situation for herbal herbal, early botanical book containing descriptions and illustrations of herbs and plants with their properties, chiefly those qualities that made them useful as medicines or condiments. Most of the herbals were written between c.1470 and c. and natural products is a complex one. This is because the market is large and fragmented and encompasses natural products whether they fall under food or medicinal medicinal /me·dic·i·nal/ (mi-dis´in-il) having healing qualities; pertaining to a medicine.
Of, relating to, or having the properties of medicine. law. While the main product categories are herbals and plant extracts, there are a wealth of other natural products used in foods and medicines including items such as fish oils, vitamins and minerals.
The present European regulatory situation in herbal and natural products is characterized by a huge discrepancy between the tough regulators such as Germany and the liberal countries such as the U.K. Due to complicated legislation, it is nearly impossible for non-EU (e.g., Asian and U.S.) companies to market their herbal and natural products in an EU country. However, this situation will dramatically change within the next 10 years.
Pan-European regulations are expected within the next few years and this development will increase marketing opportunities for natural products. Specifically, the introduction of two directives by the European Community European Community: see European Union.
European Community (EC)
Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. in the defined period will have a major impact on the market. These are:
* The proposed Traditional Herbal Medicine herbal medicine, use of natural plant substances (botanicals) to treat and prevent illness. The practice has existed since prehistoric times and flourishes today as the primary form of medicine for perhaps as much as 80% of the world's population. Product Directive (THMPD -- Medicine Law) amending the directive for medicinal products medicinal product,
n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. 2001/83/EC and including herbs, combinations of herbs and combinations of herbs and nutrients.
* The Food Supplement Directive (food Law) currently restricted to vitamins and minerals is expected to be extended to include many natural products like plant and herbal extracts Herbal extract is a liquid solution of herbs and alcohol. The dried or fresh herbs are combined with alcohol, then the solid matter is removed leaving only the oils of the herbs mixed with the alcohol. This process is called extraction, hence the name, herbal extract. in the near future.
Both new product development and the further development of existing natural products will be shaped by these regulations in the future. Only those companies that have specialized knowledge and expertise in this sector can hope for success in the changing European market.
Reality & Trends
Today the market for natural and herbal products features a broad range of numerous different food and medicinal products. By the end of 2001, the world market sales for herbal medicinal products was reported to be $60 billion ((+60 billion). The growth has primarily been fueled by "hot" segments such as menopause menopause (mĕn`əpôz) or climacteric (klīmăk`tərĭk, klī'măktĕr`ĭk) , energy, arthritis, sexual performance and sports nutrition Sports nutrition is applied in most sports training, however it is most dominant in strength sports (for example weight lifting and bodybuilding) and endurance sports (for example cycling, running, triathlon). . Well known and top selling herbs such as ginkgo ginkgo (gĭng`kō) or maidenhair tree, tall, slender, picturesque deciduous tree (Ginkgo biloba) with fan-shaped leaves. , valerian valerian, in botany
valerian, common name for some members of the Valerianaceae, a family chiefly of herbs and shrubs of temperate and colder regions of the Northern Hemisphere; a few species, however, are native to the Andes. and echinacea echinacea (ĕk'ənā`shēə), popular herbal remedy, or botanical, believed to benefit the immune system. It is used especially to alleviate common colds and the flu, but several controlled studies using it as a cold medicine have have stable sales.
The herbals market in Europe is valued in excess of +4 billion, supported mainly by local products with few pan-European brands. In Europe, the legislation for foodstuffs foodstuffs npl → comestibles mpl
foodstuffs npl → denrées fpl alimentaires
foodstuffs food npl → and medicines is still in the process of harmonization har·mo·nize
v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es
1. To bring or come into agreement or harmony. See Synonyms at agree.
2. Music To provide harmony for (a melody). of strict regulations and liberal law. New and innovative products can only be found in free markets, as opposed to closed markets, which have virtually no new products.
No Product is Uniformly Marketed Across Europe
The strongest and most stable markets are in Germany and France, with very few market openings. The open markets show high competition with price pressure due to generic products. In the main markets, new product launches are rare. But smaller markets such as Scandinavia and Eastern Europe Eastern Europe
The countries of eastern Europe, especially those that were allied with the USSR in the Warsaw Pact, which was established in 1955 and dissolved in 1991. are growing, although Eastern Europe has tough marketing regulations, similar to Germany.
Trends in global developments show that natural healthcare products will continue to be an internationally growing field but growth will slow. After the boom in the 1990s, market figures indicate consolidation and concentration due to several developments. One is the negative press coming from the U.S., specifically in relation to news of interactions and side effects Side effects
Effects of a proposed project on other parts of the firm. from herbal preparations such as kava kava kava kava /ka·va ka·va/ a preparation of the rhizome of Piper methysticum, (kava plant), having muscle-relaxing, anticonvulsive, anxiolytic, and sedative effects; used for the relief of stress and restlessness, and for sleep induction; also used in and St. John's Wort St. John’s wort
indicates animosity. [Flower Symbolism: Flora Symbolica, 177]
See : Hatred
St. John’s wort
defense against fairies, evil spirits, the Devil. [Br. . Two, there are only a few new herbs with thorough and convincing scientific documentation, and only herbs with strong documentation show promising growth rates Growth Rates
The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures.
Remember, historically high growth rates don't always mean a high rate of growth looking into the future. . Third, government restrictions on re-imbursement interfere with strong market development. Finally, the industry faces continuous regulatory and trade barriers interfering with the creation of innovative products. Despite this, however, the future outlook is positive and the actual observable ob·serv·a·ble
1. Possible to observe: observable phenomena; an observable change in demeanor. See Synonyms at noticeable.
2. trends show that the importance of natural products in healthcare will increase.
Worldwide healthcare started with plants, and today 80% of the world's population still relies on natural medicine as a main source of healthcare. As healthcare costs continue to rise and governments maintain support of self-treatment, the trend toward natural, often lower priced products in all areas of healthcare is growing, especially in the industrialized in·dus·tri·al·ize
v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es
1. To develop industry in (a country or society, for example).
2. nations. Global health concerns, include obesity, heart and bone disease, diabetes and diseases related to aging and an industrialized lifestyle. World Health Organization (WHO) activities also point in this direction by supporting the use of safe traditional herbal products from developing countries in order to support these countries and as a way for many countries to meet their healthcare needs.
In the past, natural plant-based ingredients have been successfully applied in functional foods, cosmeceuticals and cosmetics. These categories gained substantial market shares and the still growing variety of natural ingredients can stabilize stabilize
See peg. and further promote their growth by providing new opportunities and creativity for solutions to all the needs of consumers.
European Regulatory Situation & Activities
The continuous high interest of the population in natural alternatives and traditional medicines speaks volumes about the market potential of natural products, and as the harmonization of EU-wide legislation is underway, it seems there are good chances for realization. Harmonized har·mo·nize
v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es
1. To bring or come into agreement or harmony. See Synonyms at agree.
2. Music To provide harmony for (a melody). regulations will provide a further strong growth of plant-derived food and medicinal products, whereby liberal countries will loose some flexibility and tough countries will gain new opportunities.
Over the last five years there have been several important regulatory activities that have taken place in Europe: The establishment of an EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. (European Agency for the Evaluation of Medicinal products) Working Party on herbal medicines in 1997; the directive on "well-established use" of medicines in 1999; the proposal for an official committee for herbal medicinal products (CHMP CHMP Committee for Medicinal Products for Human Use
CHMP Cultural Heritage Management Plan
CHMP Centrale Humanitaire Médico-Pharmaceutique
CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ) in the EMEA in 2001; the proposal for a directive on traditional herbal medicinal products (THMPD) in January 2002 and the Directive 2002/46/EC on food supplements issued in July 2002.
The movement to harmonize the huge discrepancy between tough regulators like Germany and liberal countries like the U.K. will result in profound changes within the next 10 years. Beside the U.K., France and Germany have plans for ease of introduction of natural products.
Marketing Possibilities for Natural Products in Europe
In principle, natural products may be sold as food, food supplements or as medicine, whereby the complexity of the regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. increases with the need for evidence for claims made as medicinal status is reached.
The marketing of natural products as food supplements is limited by the following requirements of the EU directive (European Union Directive) A set of privacy requirements that took effect in 1998 and ordered European member nations to enact compliant legislation. It deals with the establishment of Data Protection Authorities, people's rights to personal information and enforcement. : 1) To date, the food supplements directive lists only specific vitamin and mineral preparations; additional categories of substances like herbals may be included later but the time frame is not yet clear; 2) products containing vitamins, minerals and ingredients not listed must be removed from the market by December 2009 at the latest; 3) food supplements are not usable for medicinal indications and 4) only nutritional claims are permitted.
The addition of herbals with mainly medicinal use to foods is restricted, if allowed at all, to only very low non-pharmacologically active dosages. Therefore producers of herbal products are recommended to focus primarily on the marketing and development of traditional herbal medicines.
Regarding the medicinal path for plant-derived preparations, one has to bear in mind that the existing European Directive (2001/83/EC) requires that no medicinal product be placed on the market without having obtained a marketing authorization, on the basis of requirements that have been harmonized throughout the EU. Usually an application for marketing authorization must contain tests, clinical trials and detailed documentation showing quality, safety and efficacy. In addition, the products must be pure and contain defined constituents, requirements hardly possible to fulfil for most botanicals due to the complex matrix of plants and herbals. Full drug development of herbal products under pharmaceutical law (2001 /83/EC) is therefore extremely costly and time intensive. Consequently it has not been very successful in the past.
A possible alternative may be the EU Directive 99/83 for products with "well established" medicinal use in the EU. It gives greater flexibility in the use of scientific bibliographic data instead of tests and clinical trials. As a period of at least 10 years of use as medicines in Europe is needed, it is not applicable for non-European herbal products.
The third and latest alternative, the proposed Traditional Herbal Medicine Product Directive (THMPD), was issued in January 2002. It allows, through a simplified registration procedure, the marketing of certain traditional medicinal products without requiring details of tests and trials on safety and efficacy. However, the product in question must have a period of at least 15 years of safe use in the European community.
At the moment there is still a global controversy about the regulatory status of herbals: Should herbals be regulated as food or as pharmaceuticals? The new EU food supplement directive is supposed to lower trade barriers but so far only vitamins and minerals are regulated. Therefore the marketing possibilities of herbals in food supplements will stay unclear for the near future. It is recommended that herbal product producers focus on the application of the THMPD.
Marketing of Herbals as Traditional Herbal Medicinal Products
The proposed THMPD amends AMENDS. A satisfaction, given by a wrong doer to the party injured for a wrong committed. 1 Lilly's Reg. 81.
2. By statute 24 Geo. II. c. 44, in England, and by similar statutes in some of the United States, justices of the peace, upon being notified of an the Directive 2001/83 /EC,--being the main European legislation for human medicines--regarding traditional medicinal products. THMPD defines herbal medicinal products as any medicinal product, containing as active ingredients An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. , one or more herbal substances or one or more herbal preparations, or one or more substances in combination with one or more such herbal preparations. In addition, the following eligibility criteria must be considered for herbal traditional medicinal products:
* Not harmful;
* Solely for indications without intervention of a medical practitioner (so-called minor indications);
* Evidence of traditional use of medicine or corresponding product(s) for 30 years in the EU, up to 15 (probably lowered to 10) of the 30 years maybe from outside the EU;
* Bibliographic report on safety with an expert report (the regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest
administrative body, administrative unit - a unit with administrative responsibilities could ask for additional safety data where justifiable jus·ti·fi·a·ble
Having sufficient grounds for justification; possible to justify: justifiable resentment.
* No requirement to demonstrate efficacy, but can be refused if efficacy is not plausible" (efficacy plausible on the basis of long-term use and experience);
* With specified strength;
* Herbal preparations for oral, external use or inhalation inhalation /in·ha·la·tion/ (in?hah-la´shun)
1. the drawing of air or other substances into the lungs.inhala´tional
2. the drawing of an aerosolized drug into the lungs with the breath.
* Not applicable for products which could have marketing authorization by full registration based on proven evidence of efficacy, safety and quality.
This means that there is no requirement to demonstrate efficacy with tests and trials in order to get the registration. The required evidence of traditional use for at least 30 years will indicate that there may well be some efficacy of the herbal product.
In contrast, the quality requirements are as demanding as for licensed medicines and all products have to be manufactured under pharmaceutical GMLFs (Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. ). This could act as a barrier to entry for some companies.
There will be a simplified registration procedure for products containing herbs included on a positive list without needing to prove their traditional use and providing bibliographic safety data. The applicant however, would still need to demonstrate quality. The CHMP as part of the European Agency for the Evaluation of Medicines (EMEA) will establish the proposed positive list at the community level. It will be an agreed list of herbal substances with therapeutic indications, specified strength, route of administration and any safety information. At the moment the list is still in development and the process of reviewing the medicinal potential of hundreds of herbs will continue at least until the middle of this year.
Regarding advertising and labeling of traditional herbal products, the general rules for medicinal products have to be applied. In addition, the labeling and user package leaflets should state that:
* The product is an herbal medicinal product for traditional use in a specified indication and that the efficacy of the product has not been clinically proven but relies on long-term use and experience.
* The user should consult a doctor or a qualified practitioner if the symptoms persist during the use of the medicinal product.
The advertising must also include the following statement: "...traditional herbal medicinal product for use in (specified indication) for which efficacy has not been proven."
So what is the timeline of the proposed EU directive on traditional medicinal products? The draft directive is now proceeding through the various legislative stages within the EU, and it is likely to be some time before it becomes clear whether the draft Directive will be passed in its present form. Member states must implement the Directive into national law within two years after adoption. The intention at the moment is that it will be adopted into law by the end of 2003. Herbal products that are already on the market would need to comply with the directive within five years.
The introduction of the THMPD provides a new route to market for natural product manufacturers, which is an exciting opportunity, the significance of which should not be underestimated. Many potential advantages would arise for business, particularly for middle-sized and non-European companies to successfully market their herbal products in Europe. The current disincentive dis·in·cen·tive
Something that prevents or discourages action; a deterrent.
something that discourages someone from behaving or acting in a particular way
Noun 1. resulting from the sophisticated full licensing procedure for medicines would be strongly reduced. Additionally, the ability to make agreed medicinal claims would further improve marketing opportunities and the public confidence in herbalism herbalism /her·bal·ism/ (er´-) (her´bal-izm) the medical use of preparations containing only plant material. would increase, especially in the ethnic medicines sector where current concerns exist in relation to quality. In the long run, the market for plant-based medicinal products would be stabilized and promoted.
Also, for the consumer numerous advantages would arise from the adoption of the THMPD. He/she would be assured of the safety and quality of such products. Besides clear product information, systematic public health protection (e.g. better arrangements where safety concerns arise) would guarantee health protection, thereby enhancing confidence in and usage of herbal products. Finally, it may improve the EU-wide access to herbal medicines currently available elsewhere, resulting in greater options as a wide range of herbal medicines have a traditional use in the EU.
However, the regulatory situation is still a dynamic process and for the next few years it will continue to be a rather complex "jungle," which will slowly clear up. The successful development and marketing of new and old natural products will be shaped by these regulations in the future. Therefore only those companies that have a specialized understanding of the regulatory requirements can profit from these changing European regulations and market.
Joerg Gruenwald, Ph.D., is president and Cordula Mueller, Ph.D., is scientific consultant of Phytopharm Consulting, Institute for Phytopharmaceuticals, which is a consulting company Noun 1. consulting company - a firm of experts providing professional advice to an organization for a fee
business firm, firm, house - the members of a business organization that owns or operates one or more establishments; "he worked for a for herbal medicines and dietary supplements Noun 1. dietary supplement - something added to complete a diet or to make up for a dietary deficiency
diet - a prescribed selection of foods
vitamin pill - a pill containing one or more vitamins; taken as a dietary supplement specializing in international alliances, product and partner findings for new product development and regulatory advice worldwide. Both are authors of the PDR PDR
A trademark for Physicians' Desk Reference, a group of reference books containing drug listings, especially one for prescription drugs.
PDR for Herbal Medicines. Dr. Gruenwald and Dr. Mueller can be reached at Waldseeweg 6, D-13467 Berlin, Germany; 49-30 4000 8100; Fax: 49-30-4000-8400; E-mail: email@example.com, firstname.lastname@example.org; Website: www.phytonet.com.