REGULATORY CONTROLS ON HERBAL MEDICINES IN EUROPE

THE USE OF HERBAL MEDICINE IN EUROPE


Herbal products are available in all Member States of the European Union (EU), although the relative size of their markets varies between countries. Since the late 1980s, the regulation of herbal products has been a major issue within the EU because of the differences between Member States in the way herbal products are classified and the difficulties this might present in the completion of the single market for pharmaceuticals.

According to Council Directive 2001/83/EEC, as amended, a medicinal product is defined as 'any substance or combination of substances presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a diagnosis.'(31)

Herbal products are considered as medicinal products if they fall within the definition of the Directive. However, the legal classification is complicated by the fact that in most Member States herbal products are available both as medicinal products with therapeutic claims and also as food/dietary supplements without medicinal claims.

The situation is further complicated in that some Member States, including the UK (see Current regulatory position of herbal products in the UK), have national provisions which permit certain herbal medicinal products to be exempt from the licensing provisions under specific conditions. In general, in all Member States, herbal products are classified as medicinal products if they claim therapeutic or prophylactic indications.

The advent of the new pan-European marketing authorisation system in 1993 raised questions with regard to herbal products and, in particular, concerns that major differences in their classification/assessment would hinder free circulation within the EU. The new systems for marketing authorisations involve three procedures: centralised, decentralised (mutual recognition) and national.

The centralised procedure is mandatory for biotechnology products and since November 2005 was mandatory for orphan medicinal products and any medicinal product for human use containing new active substances (i.e. one not previously authorised in the Community) for the treatment of AIDS, cancer, neuro-degenerative disease and diabetes.

The decentralised procedure or mutual recognition system involves agreement of assessment between the Member States involved; this procedure became compulsory from January 1998, for products requesting authorisation in more than one Member State. Since then, simultaneous national applications have been
possible, but the mutual recognition system automatically becomes involved once an authorisation has been granted in the first Member State.

The original intention was to retain existing national procedures for medicinal products requesting authorisation in a single Member State only. However, the European Commission agreed that national procedures could continue for bibliographic applications, including those for herbal products until the harmonisation issues could be resolved.

In 1997, upon the initiative of the European Parliament, the European Commission and the (then) European Medicines Evaluation Agency (EMEA), now European Medicines Agency, an ad hoc Working Group on Herbal Medicinal Products (HMPWG) was established at the EMEA. The main thrust of the HMPWG was the protection of public health by preparing guidance to help facilitate mutual recognition of marketing authorisations in the field of herbal medicines, and to minimise CHMP (Committee on Human Medicinal Products) formerly the Committee on Proprietary Medicinal Products (CPMP) arbitrations.

A major study undertaken by the AESGP (Association of the European Self-medication Industry) in 1998 at the request of the European Commission confirmed the different approaches taken by Member States in the regulation of herbal medicinal products. Different traditions in the therapeutic use of herbal preparations, coupled with different national approaches to their assessment, have resulted in differences in the availability of some herbal medicines.

For example, ginkgo (Ginkgo biloba) is available as a prescription-only medicine in some EU countries, but as a food supplement in others. Similarly, St John's wort (Hypericum perforatum) is accepted as a treatment for depression in some Member States, but not in others.

The AESGP study revealed that, in general, herbal medicinal products were either fully licensed with efficacy proven by clinical trials or by bibliography (in accordance with Article 10.1 a (i) of Council Directive 2001/83/EC), or that herbal products had a more or less simplified proof of efficacy, according to their national use. Furthermore, the study found major discrepancies between Member States in the classification of individual herbal preparations and products into one of these categories, as well as in the requirements for obtaining a marketing authorisation (product licence).

The report highlighted the need for clarification of the regulatory framework and harmonisation of the regulatory requirements to ensure that herbal medicinal products could have access to the single market for pharmaceuticals.

An important initiative in the harmonisation process has been the formation of the European Scientific Cooperative on Phytotherapy (ESCOP), an organisation representing national associations for phytotherapy. ESCOP was founded in 1989 by six EU national scientific associations with the objective of establishing
a scientific umbrella organisation to provide harmonised criteria for the assessment of herbal medicinal products, to support scientific research and contribute to the acceptance of phytotherapy in Europe.

ESCOP now comprises 13 national associations across Europe, and the American Botanical Council. The ESCOP Scientific Committee has published 80 monographs for individual herbal drugs; the monographs follow the European Summary of Product Characteristics (SPC) format.

The EMEA Herbal Medicinal Products Working Party (HMPWP) formerly used the ESCOP monographs as a basis for its work in developing core SPCs from ESCOP monographs. The HMPWP has now been superseded by the Herbal Medicinal Products Committee (HMPC) as discussed below and the collaboration with ESCOP continues in accordance with the new EU regulations.


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HERBAL MEDICINES AND PHYTOTHERAPY BASICS AND TUTORIALS

PHYTOTHERAPY AND HERBAL MEDICINES BASIC INFORMATION


Herbal medicines are also referred to as herbal remedies, herbal products, herbal medicinal products, phytomedicines, phytotherapeutic agents and phytopharmaceuticals. The use of herbal medicines in an evidence- or science-based approach for the treatment and prevention of disease is known as (rational) phytotherapy.

This approach to the use of herbal medicines contrasts with traditional medical herbalism which uses herbal
medicines in a holistic manner and mainly on the basis of their empirical and traditional uses. Although these two approaches – traditional/holistic and rational/evidence-based – are entirely different, in some instances they use the same terminology.

For example, traditional herbalism is also described as 'phytotherapy' and refers to preparations of plant material as 'herbal medicines'. Today, a continuum between these approaches exists and many
herbalists also use scientific evidence to support their traditional use of herbal medicines.

Plants have been used medicinally for thousands of years by cultures all over the world. According to the World Health Organization, 80% of the world's population uses plant-based remedies as their primary form of healthcare;(30) in some countries, herbal medicines are still a central part of the medical system, such as Ayurvedic medicine in India and traditional Chinese medicine in China.

Herbal medicine has a long history and tradition in Europe. Herbal medicines and homeopathic remedies are often mistaken by the layperson to be similar. However, homeopathy is based on the principle of 'like should be treated by like', and involves the administration of minute doses of remedies that, in larger doses, produce symptoms in a healthy person mimicking those expressed by people who are ill.

Many, but not all, homeopathic remedies originate from plants. By contrast, herbal medicine (phytotherapy) involves the use of dried plant material or extracts of plant parts in therapeutic doses to treat the symptoms exhibited. In this latter respect, it is similar to conventional medicine.


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HERBAL MEDICINES BASICS AND TUTORIALS

HERBAL MEDICINE BASIC INFORMATION
What Are Herbal Medicines?

Herbal medicines are increasingly popular among the general public, particularly women of childbearing age. These medicines are not only viewed as having clinical benefits but are also generally believed to be safe. In some cases, a systematic review of the evidence-based medicine literature shows that this is not the case.

In pregnancy, soon-to-be mothers are concerned about all medications that may affect their health, the health of their fetus, and the pregnancy outcome. When it comes to the types of evidence for herbal medicines during pregnancy and lactation, not all evidence is created equally.

The type of evidence for the safety of herbal medicines during pregnancy and lactation ranges from theoretical to animal studies, to case reports, to cohort studies and finally to randomized controlled trials.

Herbs that are frequently used during pregnancy, e.g. black and blue cohosh, red raspberry, evening primrose oil

Herbs that are used to treat pregnancy-related complaints, e.g. ginger

Herbs that are known abortifacients, e.g. pennyroyal, parsley

Herbs that have narrow therapeutic indices and are toxic, e.g. digitalis, deadly nightshade, ephedra

Herbs that are used more often by women than men, e.g. red clover, don quai

Herbs that are known to have hormonal effects, e.g. chastetree

The most frequently used herbs, e.g. St. John’s wort (depression), garlic (hyperlipidemia), ginkgo (memory), Echinacea (immune system)

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PHARMACOGNOSY – THE SCIENCE OF NATURAL SOURCE MEDICINES

WHAT IS PHARMACOGNOSY?
PHARMACOGNOSY Info

The study of medicinal plants and their properties is called pharmacognosy. This science has led to the development of many drugs in use today including aspirin (the basic salicylate structure was discovered from the white willow while aspirin was synthesized from meadowsweet), opioids (originally from opium poppies), the birth control pill (synthesized from steroid structures found in a wild Mexican yam), and chemotherapeutic agents like vincristine and vinblastine (from Madagascar periwinkle) or taxol (from the Pacific yew tree).

Today, herbal medicine is big business. However, there is much confusion about what herbal medicine is and is not. While pharmacognosy is a science that deals with the discovery of medicines from natural substances, it is certainly not the same as herbalism.

According to the American Society of Pharmacognosy, its scope includes ‘the study of the physical, chemical, biochemical and biological properties of drugs, drug substances, or potential drugs or drug

substances of natural origin as well as the search for new drugs from natural sources. Research problems in pharmacognosy include studies in the areas of phytochemistry, microbial chemistry, biosynthesis, biotransformation, chemotaxonomy, and other biological and chemical sciences’.

The term herbalism refers to a folk and traditional medicinal practice based on the use of plants and plant extracts. In essence, herbalism is the practice of herb-based care and pharmacognosy is the scientific study of herbs with medicinal purposes. Within the practice of herbalism there are a variety of different traditions including, for example, traditional Chinese medicine or the Indian ayurvedic medicine.

Each of these has a unique paradigm on health, illness, and disease. Unlike pharmacognosists, herbalists are not particularly interested in specific active constituents found within a plant. Instead, they focus on the healing properties of the plant or part of plant (seed, root, leaf, etc.) and how it will benefit the body to heal itself.

Although non-herbalists may also use herbal medicines in their clinical practice, they likely do so under a different health paradigm. Homeopaths also have a holistic approach to health, but their material medica uses a ‘like cures like’ philosophy of treating patients with ultra-dilute formulations unlikely to contain significant (if any) ‘active’ ingredient.

Homeopathy, then, is unlike herbal medicine, herbalism, or pharmacognosy.  The current trend in natural product use follows many different health paradigms – some are popular because of their use in traditional Chinese medicine or Ayurveda, some from the widespread use of herbal medicine in Europe, and some due to increasing published studies on natural medicines, somewhat representative of the renewed interest in pharmacognosy.

So, irrespective of the particular health paradigm from which the natural health products summarized in this text are derived, we will adopt the pharmacology perspective (or perhaps in this case, pharmacognosy would be the more accurate term). As such, individual constituents (chemical entities) of each natural product are discussed with regard to their pharmacologic or toxicologic properties.

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