Sundheds- og Forebyggelsesudvalget 2014-15 (1. samling)
SUU Alm.del Bilag 136
Offentligt
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The Dutch Medicinal
Cannabis Program
Marco van de Velde, PhD, MBA
Office of Medicinal Cannabis (OMC)
Ministry of Health, Welfare & Sport
The Netherlands
December 2014; Copenhagen
 SUU, Alm.del - 2014-15 (1. samling) - Bilag 136: Materiale fra Sundheds- og Forebyggelsesudvalgets lukkede ekspertmøde om medicinsk cannabis torsdag den 4. december 2014
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Overview
•
•
•
•
Policy and legislation
Responsibilities
Production and distribution
Quality control
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Multiple sclerosis
: chronic disease with high impact on quality of life
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MS The Netherlands
 SUU, Alm.del - 2014-15 (1. samling) - Bilag 136: Materiale fra Sundheds- og Forebyggelsesudvalgets lukkede ekspertmøde om medicinsk cannabis torsdag den 4. december 2014
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Reasons for a new policy
From 1993 onward:
Increasing pressure from society against prohibition of medicinal use;
Health Council advised (1996):
insufficient evidence of efficacy;
trials done with ill-defined products.
Existing practice of illegal medical use
No quality control;
No medical coaching of patients;
Patients at the mercy of illicit trade.
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Microbiology:
recreational
cannabis coffee
shop
(Source: A. Hazekamp et al; University of Leiden, the Netherlands,
Cannabis sample
Bedrocan
2)
Bedrobinol
A
B
C
D
E
F
G
H
I
J
K
2)
aerobic bacteria
(cfu/gram)
1)
<10
<10
<10
4500
<10
70
13000
80000
180
27000
350
23000
5900
aerobic fungi
(cfu/gram)
1)
< 100
< 100
480000
900
1000
120
6500
4800
350
1300
4200
91000
3600
Identified
pathogens
E. coli
Penicilium
Cladosporium
Aspergillus
1) : CFU = colony forming units
2) : limit: total areobic bacteria and fungi <100 cfu
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Illegal cannabis
Heavily contaminated with fungi
Up to 600.000 colony forming units/gram
(source: Hazekamp);
50% of samples contaminated with pesticides
(source: Rikilt, The Netherlands);
Heavy metals;
No constant content (st dev: 15%).
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Foundation of OMC
In 1998 the Dutch government decided to establish an agency
as regulator for medicinal cannabis according to art. 28 of
Single Convention (UN);
Foundation of the Office of Medicinal Cannabis (OMC)
(1 March 2000);
Office of Medicinal Cannabis empowered as national agency
(1 January 2001);
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National legislation
Amendment to the Opium Act (2002-2003)
•
With respect to hemp, hashish and hemp oil Our Minister is, to the
exclusion of others, authorized:
to bring it inside or outside the Netherlands;
to sell and deliver it;
to have it available, with the exception of stocks maintained by
those who have a license to cultivate, work up and convert.
Amendment to the Royal Decree (2002)
Royal Decree on prescribable and dispensable controlled
substances.
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Main responsibilities of the OMC
Ensure constant quality of medicinal cannabis produced which
meets pharmaceutical standards;
Establish an effective procedure for distribution;
Prevent leakage to the criminal circuit (tracking procedure /
recordkeeping);
Ensure availability of medicinal cannabis;
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Organisational aspects
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Policy within the Ministry of Health
Part of pharmaceutical affairs policy
and NOT
Part of addiction care policy because:
1. Patients using cannabis as a medicine should not be
stigmatised as drug abusers.
2. Cannabis as a medicine should meet all
pharmaceutical requirements.
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Production and distribution model
Office of Medicinal Cannabis
(OMC)
distribution
growers
packager
logistics service
provider
invoicing
collection
pharmacy
laboratory
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Contracted third parties:
Cultivation
(Bedrocan BV)
Quality control
(Sinensis - Farmalyse BV)
Packaging and distribution
(Fagron BV)
Pharmacy/Research/Product development
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Laboratory analysis
Monography available;
Validated testing methods;
Every batch tested;
Approval by OMC;
Certificate of analysis for pharmacists.
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Medicinal cannabis complies with pharmaceutical
quality guidelines
Standardized product with constant content (dronabinol,
cannabidiol and other)
Within ranges of regulatory authorities
Very low concentration of degradation compounds (e.g. CBN)
Free of contamination
Micro-organisms
Pesticides
Heavy metals
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Standardization
Concentration THC (CBD) %
25
20
Bedrocan
15
Bedrobinol
Bediol (THC)
Bediol (CBD)
10
5
Bedica
0
1
2
3
4
Batches
5
6
7
8
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Products
Cannabis flos, variety Bedrocan: 22% THC, <1% CBD
Cannabis flos, variety Bedrobinol: 13,5% THC, <1% CBD
Cannabis flos, variety Bedica granulated: 14% THC, <1% CBD
Cannabis flos, variety Bediol, granulated: 6,3% THC, 8% CBD
Cannabis flos, variety Bedrolite granulated: <1% THC, 10% CBD
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Products
Cannabis flos, variety Bedrocan
Approx. 19% dronabinol,
<1% cannabidiol,
other cannabinoids very low
Cannabis flos, variety Bedrobinol
Approx. 12% dronabinol,
<1% cannabidiol,
other cannabinoids very low
Cannabis flos, variety Bediol, granulated
Approx. 6% dronabinol and 7,5% cannabidiol,
other cannabinoids very low
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Bedrocan dried flowers
 SUU, Alm.del - 2014-15 (1. samling) - Bilag 136: Materiale fra Sundheds- og Forebyggelsesudvalgets lukkede ekspertmøde om medicinsk cannabis torsdag den 4. december 2014
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Bediol granulated
 SUU, Alm.del - 2014-15 (1. samling) - Bilag 136: Materiale fra Sundheds- og Forebyggelsesudvalgets lukkede ekspertmøde om medicinsk cannabis torsdag den 4. december 2014
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Pharmaceutical characteristics:
- Pharmaceutical raw material;
- Standardised herbal medicinal product;
- Not registered as a medicine;
- Opium Act.
 SUU, Alm.del - 2014-15 (1. samling) - Bilag 136: Materiale fra Sundheds- og Forebyggelsesudvalgets lukkede ekspertmøde om medicinsk cannabis torsdag den 4. december 2014
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Indications
Spasticity: multiple sclerosis, spinal cord injury, etc;
Anti-emetic: chemotherapy, radiotherapy, etc;
Appetite loss: HIV/AIDS, cancer, etc;
Chronic pain / neuropathic pain: multiple sclerosis;
Gilles de la Tourette syndrome;
Glaucoma.
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Prescription behaviour of physicians
Only if treatment in conformity with
guidelines or protocols does not work
sufficiently or gives too many side effects.
A Dutch physician is free to prescribe
medicinal cannabis for every indication
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Patient
Physician
(prescription)
Pharmacy
(administration)
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Patient characteristics
Age
Sex
Mail
Female
Variety
Bedrocan
Bedrobinol
Bediol
Bedica
Therapeutic indication
Multiple Sclerose
Chronic pain
Nausea / vomiting
Cancer of AIDS
Mental disorders
Others
Therapeutic use
Decreased spasticity
Pain relieve
Anxiety
Decreased drowsiness
Appetite stimulation
Improvement daily functioning
Improvement state of mind
Others
N
53,1 ^
Percentage
(24-81) ^
35
42
(45,5%)
(54,5%)
38
19
16
4
(49,4%)
(24,7%)
(20,8%)
(5,2%)
16
51
7
5
10
18
(20,8%)
(66,2%)
(9,1%)
(6,5%)
(13,0%)
(23,4%)
37
63
8
42
10
26
15
7
(48,1%)
(81,8%)
(10,4%)
(54,5%)
(13,0)
(33,8)
(20,8%)
(9,1%)
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Bedrocan
Bedrobinol
Bediol
Bedica
Route of administration
Tea
Inhalation
Vaporiser
Smoking
Others
11 (29,7%)
25 (67,6%)
9*
23*
2 (2,7%)
3 (15,8%)
15 (78,9%)
5*
11*
1 (5,3%)
3 (18,8%)
13 (81,3%)
4*
10*
0 (0%)
1 (25,0%)
3 (75,0%)
2
1
0 (0%)
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Retrospective study 2003-2010 (Hazekamp et al, 2012)
N= (%)
Study
population
Average
Average
duration of
number of Average daily
use (days) dispensations use (grams)
5,540 (100)
251
6.43
0.68
Age
≤ 20
21-40
41-60
61-80
> 80
29
93 (1.7)
846 (15.3)
2,551 (46.0)
1,722 (31.1)
303 (5.5)
181
316
304
174
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5.57
8.73
7.44
4.51
3.01
0.82
0.72
0.66
0.67
0.74
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Dependency - Tolerance
Low average daily dosage points to a low potential of misuse;
Absence of widespread development of tolerance;
No signs that use of medicinal cannabis by Dutch patients may
increase recreational use;
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Study on (co)medication
Observations:
40,4 % decrease of comedication;
48,6 % unchanged;
0,9 % increase of comedication;
10,1% of patients did not use other medication
(
PHARMO Institute, april 2004
)
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Need for information and (education)
Healthcare providers / health insurers:
•
•
•
•
•
Lack of information;
No guidelines available;
Limited scientific evidence about efficacy;
Difficult to determine therapeutic value;
Lack of well-designed clinical trials / studies.
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Guidelines: evidence-based
Example: Guideline ‘Treatment of cancer pain’
<2008: ‘oral cannabinoïds
may not be used
for
treatment of cancer pain’
>2008: ‘oral cannabinoïds
are not recommended
for
treatment of cancer pain’
Argumentation:
Therapeutic value of cannabinoïds for the treatment of
cancer pain is not evidence-based;
Clinical experience is insufficient.
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Supply of information in the
Netherlands
Leaflets for physicians, pharmacists and patients;
Presentations for organizations involved;
Direct contact with patients, general practitioners
and specialists;
Website and call center OMC;
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Thank you for your attention.
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Office of Medicinal Cannabis
CIBG / Ministry of Health, Welfare and Sport
PO Box 16114
2500 BC The Hague
The Netherlands
[email protected]
www.cannabisbureau.nl
Phone 0031 70 340 5113
Fax
0031 70 340 7426
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