Dutch Measures to Control Medical Grade Marijuana: Facilitating Clinical Trials

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0092-86 I X O O I Copyright 0 2001 Drug Information Association Inc.

DUTCH MEASURES TO CONTROL MEDICAL GRADE MARIJUANA: FACILITATING CLINICAL TRIALS WILLEMK. 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

There is an emerging interest in the clinical use of cannabis (marijuana), but there is almost no evidence of its eflcacy. The Dutch government has a policy that aims at collecting clinical data to determine whether cannabis curl be used as a medicine. A n 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 vatying 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 maniifacturing 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 This article is hased 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: [email protected].

in certain diseases, but evidence is lacking. As a result, no registered marijuana preparations are available. Another difference between cannabis and morphine is the ideological charge associated with the medicinal use of cannabis, which leads to ardent discussions. However, the use of any substance as a medicine should be regarded as a scientific problem, and the questions arising from it should be solved using available clinical evidence. For this reason, the Dutch government took several measures to foster clinical trials with cannabis. Cannabis is the word of choice if used in a medical context; words such as pot, weed, and marijuana are linked too closely to the drug scene, suggesting that patients using this drug as a medicine are drug abusers. The words cannabis (being the Latin name given by Linneaus) and hemp are