Herbal Medicine in Europe - Relaxing Regulatory Standards

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This article is from the lates New England Journal of Medicine.

 

Herbal Medicine in Europe — Relaxing Regulatory Standards

Peter A.G.M. De Smet, Pharm.D., Ph.D.

N Engl J Med. 2005 Mar 24;352(12):1176-8.

 

Full text should be accessible this link, and I've included the text below:

 

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=15788494

 

 

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NEJM, Volume 352:1176-1178 March 24, 2005 Number 12

 

Herbal Medicine in Europe - Relaxing Regulatory Standards

Peter A.G.M. De Smet, Pharm.D., Ph.D.

 

 

 

Herbal medicine is big - and relatively mainstream - business in Europe:

in 2003, European countries spent almost $5 billion (at manufacturers'

prices to wholesalers) on over-the-counter herbal medicines. But not all

European countries have embraced herbal treatments with equal warmth.

Germany and France are indisputably in the lead in over-the-counter sales

(see graph), and they have also had noteworthy markets for prescription

herbal preparations. In 2003, German health insurance paid $283 million in

reimbursements for prescribed ginkgo, St. John's wort, mistletoe, saw

palmetto, ivy, hawthorn, stinging nettle root, myrtol, phytosterols, and

cucurbita, and in 2002, French health insurance paid $91 million in

partial reimbursements for ginkgo, saw palmetto, and pygeum prescriptions

with a total value of $196 million. Few physicians in the United Kingdom,

on the other hand, prescribe herbal medicines, which are generally not

covered by the National Health Service, although approximately 1300 herbal

practitioners may lawfully sell unlicensed herbal remedies, provided that

they do so after consultation with a patient.

 

Companies that make herbal preparations have usually found it difficult to

meet the conventional requirements for proof of medical efficacy, and

European countries have also varied in their approaches to this issue. On

their own, some countries, such as Germany and France, created simplified

registration procedures for herbal products, whereby conclusive evidence

of efficacy was no longer required. Other countries, such as the United

Kingdom, clung to the principle that industrial herbal preparations should

meet the same requirements as conventional medicines, even if this meant

that most herbal products could not be licensed and would therefore

continue to be sold without firm regulatory control.

 

The European Community has taken two legislative steps to harmonize these

differences. In 1999, it adopted a directive permitting greater

flexibility in the use of bibliographic data in proving the safety and

efficacy of so-called well-established medicines. Applicants for a

marketing authorization are no longer required to submit data from new

preclinical tests and clinical trials if they can demonstrate through

detailed references to published scientific literature that their herbal

products have a well-established medicinal use with recognized efficacy

and an acceptable level of safety.

 

In March 2004, another directive was passed, creating a simplified

registration procedure for all traditional herbal medicines that, despite

long use, do not fulfill the requirements for classification as

well-established medicines. To be eligible for this registration, herbal

medicines must meet several criteria. They must contain exclusively one or

more herbal ingredients; the addition of vitamins or minerals is allowed

only if their safety is well documented and their action is ancillary to

that of the herbs. The proposed indications for use must not require the

diagnostic or therapeutic supervision of a medical practitioner. Products

must have a specified strength and dosage and be administered orally,

externally, or through inhalation. The data on traditional use must be

sufficient to show that they are not harmful in the specified conditions

of use and that pharmacologic effects are plausible. And they must have

been used medicinally for at least 30 years, including at least 15 years

within the European Community.

 

The new directive also called for the creation of a special committee on

herbal products within the European Agency for the Evaluation of Medicinal

Products, which will, among other tasks, generate or approve monographs on

herbs and draft a list of herbal substances and preparations that may be

licensed as traditional herbal medicines. This list will provide the

appropriate indications, specified strength and dosage, route of

administration, and any other information necessary for safe use.

 

The new legislation will offer public health benefits, especially for

member states that did not yet have a simplified registration procedure

for herbal medicines. It will help to clarify which preparations are on

the market and who is legally responsible for putting them there. This

clarification will facilitate recalls and may open new venues for

cooperation between health authorities and the industry for safety

improvement. The directive will guarantee a premarketing check of product

quality and safety by the health authorities, reducing the risk that

preparations with an unsafe ingredient, adulterant, or contaminant will

enter the market. The planned positive list of acceptable herbs is

preferable to any negative listing, which could only swab up leaks while

leaving the tap running. The directive also permits health authorities to

require labeling that includes all necessary warnings against incorrect or

unsafe uses. Furthermore, companies that hold licenses for herbal

medicines will be obliged to conduct adequate post-marketing surveillance

and to report all suspected adverse events to the authorities.

 

By introducing a list of acceptable herbs and mandating adverse-event

reporting, the European legislation goes beyond the new rule for Good

Manufacturing Practice that the U.S. Food and Drug Administration proposed

in 2003 to improve the quality of dietary supplements. It should therefore

be an inspiration for anyone striving for better regulation of herbal

products in the United States. Besides expected public health benefits,

however, the new European legislation also carries important caveats.

 

First, the focus on industrial preparations necessitates additional

measures to help ensure the quality and safety of crude herbal ingredients

used in locally compounded medicines. Additional measures are also needed

to ensure that nonmedical practitioners who prescribe herbal treatments

receive adequate training and continuous education to reach and maintain a

high standard of practice. The United Kingdom Department of Health is

already making progress in this domain, having proposed statutory

self-regulation of herbal practitioners.

 

Second, the new directive explicitly allows nonmedicinal herbal products

to be regulated under legislation covering foods. This raises the question

of to what extent it will remain possible to market the same herb as both

a medicine and a food supplement. Furthermore, positive listings and

general monographs on herbs may not necessarily guarantee that all

products licensed on their basis have the same chemical and pharmacologic

properties. In Germany, which has had a simplified registration procedure

based on general monographs for many years, the same herb may appear in

both phytomedicines and food supplements. And recent studies of St. John's

wort preparations on the German market have shown substantial variation in

the level and in vitro dissolution of a major constituent, hyperforin.

 

Third, traditional experience is not always a reliable tool for the

detection of rare or late reactions, and it has limited value in

predicting risks associated with nontraditional preparations or with use

under nontraditional circumstances (e.g., in combination with conventional

drugs).

 

Finally, and most controversially, the new European directive results in a

double standard for different types of medicines, since the scientific

proof of efficacy required for conventional medicines is no longer needed

for herbal medicines, as long as they are used for minor health problems

and labeled as " traditionally used. " It could be argued that conventional

efficacy requirements are not an end in themselves but a means of

safeguarding public health and that the relaxation of these requirements

for self-care with herbs reflects a permissible principle of

proportionality. But the new legislation relaxes an iron grip on claims of

efficacy for medicines and may provide a further disincentive for

manufacturers to submit their herbal products to randomized, controlled

trials. Perhaps this disincentive may be countered best by allowing herbal

medicines to qualify for public reimbursement only after their efficacy

has been satisfactorily proved. In this context, it is noteworthy that as

of April 2004, most herbal medicines no longer qualify for reimbursement

in Germany, because they are " pharmacy-only " medicines, unless they appear

on a list of exceptions. Currently, only four herbs are included on this

list.

 

 

 

Source Information

 

Dr. De Smet is from the Scientific Institute of Dutch Pharmacists, The

Hague; and the Department of Clinical Pharmacy, University Medical Center

St. Radboud, Nijmegen - both in the Netherlands.

 

 

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