Dutch measures to control medical grade marijuana: Facilitating clinical trials

Dutch measures to control medical grade marijuana: Facilitating clinical trials

Scholten, Willem K

There is an emerging interest in the clinical use of cannabis (marijuana), but there is almost no evidence of its efficacy. The Dutch government has a policy that aims at collecting clinical data to determine whether cannabis can be used as a medicine. An Office of Medicinal Cannabis was established in March 2000. This office will act as a regulator for the horticulture of cannabis and for clinical trials, as required by the Single Convention on narcotic drugs. It will also coordinate the research that can be done with several dosage forms of varying composition and for multiple indications. Several aspects of these elements are described. The office will also see to the prevention of leakage of the cannabis crops to illicit circuits. To this end growers will be contracted under certain conditions only. The manufacturing of the finished medicinal products will be a matter of private companies in a “free” market, regulated by the requirements of the Single Convention.

Key Words: National Agency for the Horticulture of Hemp; Hemp; Cannabis; Marijuana; Legislation; Medicinal use

INTRODUCTION

THERE IS AN EMERGING interest in the medicinal use of cannabis (marijuana). Cannabis, like morphine, is a controlled substance. However, there are many differences between medicinal use of morphine and medicinal use of cannabis. The use of morphine is fully accepted in Western medicine, there are preparations available, and its therapeutic use is evidence based. For cannabis there exists only indications that it could be useful in certain diseases, but evidence is lacking. As a result, no registered marijuana preparations are available.

REFERENCES

1. Scholten WK. Legal aspects on medicinal use of hemp, historic overview and present policy of The Netherlands. Drug Inf J. January-March 2000; 329332.

2. Anonymous. Marihuana als Medicijn (Marijuana as a medicine). Rijswijk: Gezondheidsraad; 1996:10. (In Dutch, with an executive summary in English.)

3. Anonymous. Opium Act Amendment of December 16, 1998, to differentiate between controlled substances when making rules for the prescription of controlled substances. (Wet van 16 december 1998 tot wijziging van de Opiumwet om onderscheid te kunnen maken tussen Opiumwetmiddelen bij het geven van regels voor het voorschrijven van Opiumwetmiddelen op recept). Staatsblad. 1999;10.

4. Anonymous. Royal Decree on Prescribing and Ordering Opium Act Related Medicinal Products. (Besluit voorschrijven en bestellen opiumwetmiddelen) Staatsblad. 1999;256.

5. British Medical Association. Therapeutic Uses of Cannabis. Australia: Horwood Academic Publishers; 1997, ISBN 90-5702-318-0.

WILLEM K. SCHOLTEN, MSC, PHARM, MPA

Head of the Office of Medicinal Cannabis, Department of Pharmaceutical Affairs, Ministry of Health, Welfare and Sport, The Hague, The Netherlands

This article is based upon a presentation given at the 36th DIA Annual Meeting, June 10-15, 2000, San Diego, California.

Reprint address: Willem K. Scholten, Head of the Office of Medicinal Cannabis, Ministry of Health, Welfare and Sport, Department of Pharmaceutical Affairs, PO Box 20350, NL-2500 EJ The Hague, The Netherlands. E-mail: wk.scholten@minvws.nl.

Copyright Drug Information Association Apr-Jun 2001

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