Contract Award

What company was awarded the contract for the production of marijuana?
The contract was awarded to Prairie Plant Systems Inc. of Saskatoon, Saskatchewan.

What is the value of the contract?
The value of the contract is $5,751,250.

What is the length of the contract?
The contract runs for a period of five years.

What capacity does the location have? How many plants can it grow?
The contractor has sufficient space to be able to cultivate the quantity of marijuana required to meet the contract requirements including any options which the government may exercise.

What quantity of marijuana will be produced by the contractor?
For the first year, 185 kg of standard cigarettes and bulk processed marijuana will be produced and 420 kg on the second year. There are also five different options that can be exercised by the Crown covering additional quantities and different concentrations of some of the cannabinoids during two to five years of the contract.

When was the request for proposal (RFP) posted and when did it close?
The RFP was posted on MERX, the government's electronic tendering system, on May 5, 2000 and closed on June 28, 2000.

What trade agreements applied to this procurement?
NAFTA and WTO-AGP did not apply; however, the requirement is subject to the Agreement on Internal Trade (AIT) and the Canadian content was set at 80 per cent. There was also an RFP requirement that the facility be located in Canada.

Why did it take so long to award the contract?
The evaluation of the bids was quite a complex procedure, given the nature of this procurement.

How many proposals were received?
A total of 34 proposals were received.

What companies submitted proposals on the project?
This information may be obtained by contacting Public Works and Government Services Canada.

How many compliant proposals were received?
One compliant proposal was received.

What were the key evaluation criteria?
Bids were evaluated on a wide variety of criteria including: financial status, qualifications (education and experience) of personnel, security requirements respecting personnel, operation located in Canada, technical understanding, management capability, and financial proposal.

Was there a requirement to have experience in growing marijuana?
No. The mandatory requirement was to have had experience in growing plant material for human consumption.

If the contractor has never had experience in growing marijuana, what guarantees do we have that they can do the job?
One of the mandatory requirements was to have had experience in growing other plant material for human consumption. The contractor was required to have at least 5 years experience in each of the following areas: analytical chemistry, natural products chemistry, producing plant material and Good Manufacturing Practices (GMP) for therapeutic products or relevant pharmaceutical sciences.

What work will be performed by this company?
The main elements of the contract are:

• setting up a marijuana growing, processing, fabricating and storage establishment in Canada;
• cultivation of the marijuana plants;
• drying the marijuana plants;
• laboratory analysis of marijuana constituents throughout the product life cycle;
• ensuring adequate concentration, quality and consistency of marijuana components;
• fabrication of marijuana cigarettes and bulk marijuana product;
• packaging the marijuana product;
• storage of marijuana cigarettes and bulk material;
• labelling of marijuana product;
• distribution of marijuana product to recipients authorized by Health Canada;
• conforming with all of the relevant statutory and regulatory requirements included in the Controlled Drugs and Substances Act and the Food and Drugs Act and their regulations, including all security aspects of such a facility and its operations.

Where will the contractor obtain the seeds for growing the product?
Health Canada will, if requested by the contractor, seek to import the seeds from the National Institute for Drug Abuse (NIDA) for the first year of the contact. However, should the contractor wish to obtain seeds from an other legal source, it may do so. In such a case, the contractor will need to find the source and obtain the required permits.

What type of cannabis (marijuana) is the contractor going to produce?
For the first year of the contract, cannabis sativa with a THC content of 5-6% will be produced. There is provision in the contract for the grower to produce marijuana with various THC levels in the following years.
 

Security and Quality of Product

What measures have been/must be taken to ensure that the contractor meets all the security requirements imposed by the contract?
All security requirements provided for in the Narcotic Control Regulations plus those found in the Department's Directive on Physical Security Requirements for Controlled Drugs must be met. Finally, the contract contains a large number of minimum standards that must be met regarding marijuana cultivation. These minimum standards cover everything from fencing to closed circuit television to random searches of personnel. With respect to personnel, all personnel who will have access to any licensed facility must be security cleared to the "enhanced reliability" level. As well, key employees of the contractor have provided a criminal record check showing that they were not convicted of certain drug offences either in, or outside, Canada.

Who ensures security?
While the RCMP helped design the physical security requirements, Health Canada inspectors will inspect the facilities from time to time to ensure compliance.

How often will Health Canada inspect the operation?
The contractor will be inspected and audited in a manner similar to that used for companies that produce pharmaceuticals under the provisions of the Food and Drugs Act and its Regulations, and to pharmaceutical companies licenced under the Narcotic Control Regulations of the Controlled Drugs and Substances Act.

What would the contractor do with oversupply of the product or rejected product?
The amount that the contractor may cultivate in any period of time will be stipulated on his licence and will reflect the quantity of bulk marijuana and marijuana cigarettes which are to be produced in that time. Excess marijuana will be destroyed.

How will the quality and consistency of the product be assured and monitored?
The Contractor must meet relevant requirements of the Food and Drugs Act and its Regulations with respect to a pharmaceutical products as well as those of the contract. In addition, Health Canada may test the marijuana cigarettes from time to time in Health Canada laboratories.

When will marijuana be available for distribution to recipients?
The first quantity of the product will be available for distribution within one year of the contract award.

Why will it take so long to distribute the marijuana?
The Contractor will have six months to put their physical plant in place and obtain the required licences from Health Canada's Office of Controlled Substances; following that, time will be required to cultivate, grow, test and cure the product.

Who will be eligible to receive the marijuana?
Recipients authorized by Health Canada will be eligible to receive the product. These will include researchers conducting clinical trials and Canadians authorized by Health Canada to use marijuana for medical purposes under the Controlled Drugs and Substances Act who agree to provide information to Health Canada for monitoring and research purposes.
 

Production and Distribution of Product

Does the law permit the production of marijuana?
The authority to grant permission to cultivate marijuana is contained in the Controlled Drugs and Substances Act and the Narcotic Control Regulations. In addition, the United Nations Single Convention on Narcotic Drugs, 1961, as amended by the 1972 protocol, requires Canada to apply strict controls, such as the designation of a government agency to take possession of the marijuana crop and to act as a distributor.

Will this marijuana be provided to current and future exemptees?This marijuana will be made available to people participating in structured research programs and to exemptees (Canadians authorized by Health Canada to use marijuana for medical purposes) who agree to provide information to Health Canada for monitoring and research purposes.

What if an exemptee does not agree to provide information to Health Canada?
Providing a domestic source of marijuana is key to Health Canada's research strategy. The information provided by exemptees will contribute to the research into the safety and effectiveness of marijuana for medical purposes. Persons who refuse to provide this key information may be denied access to the marijuana.

Will police forces be instructed not to charge those using marijuana for medical purposes in public places?
Because marijuana is a controlled drug in Canada, there is still a need to ensure that its use, even in a clinical trial, will be done with the cooperation and full knowledge of law enforcement agencies. All efforts will be made to ensure that legitimate recipients of marijuana are in legal possession of the drug and that police officers can readily obtain information to identify legitimate recipients.

Until the crop is in, why not just use marijuana seized by law enforcement agencies? Government uses seized marijuana for training dogs, why not use it for humans?
Health Canada has access to seized marijuana. However, marijuana used for medical or research purposes should be of standardized quality, free from contaminants. Seized marijuana may be contaminated with unknown and harmful substances. The illicit drugs seized by peace officers across Canada are used in the preparation of kits to train dogs to detect the drugs. Manufactured drugs do not have the same smell for dogs.
 

Clinical Trials

How is marijuana for clinical trials obtained until the Canadian supply is available?
Health Canada submits, on behalf of the researchers, requests to the US National Institute for Drug Abuse (NIDA) to obtain research-grade marijuana in a smokable form.

Who will take part in the clinical trials and how is this determined?
Clinical trials are designed to study a specific number of patients for a specific period of time. Therefore, as in any clinical trial, subjects are recruited by the investigator of the trial according to selection criteria defined in the design of the study in question.

How much will the clinical trials cost and who is paying for them?
Health Canada is committed to fund clinical trials for a period of 5 years and, depending on the number of approved protocols, several million dollars could be spent for these research initiatives. A partnership has been established with the Canadian Institutes for Health Research (CIHR) whereby Health Canada reviews for relevance and financially supports clinical trials on marijuana through the Medical Marijuana Research Programme, while CIHR reviews the proposals for scientific merit and administers the programme.

If patients want to participate in the clinical trials, what should they do?
Patients who are interested in participating in clinical trials should first discuss their treatment options with their primary health care provider. Announcements about the clinical trials will be made by CIHR as soon as they are approved for funding.

How do the clinical trial participants obtain the drug?
Marijuana will be made available to the clinical investigators by Health Canada.

How soon will information from the clinical trials be made available?
The contract for the supply of marijuana will span a five (5) year period during which the data will be accumulated. While it is anticipated that some preliminary results from the research projects may be made available prior to that, it may be some time before the results are submitted, peer-reviewed and published.
 

Other questions

Why is marijuana also spelled "marihuana"?
Both spellings are commonly acceptable. In Canada, the spelling with the "h" goes back to 1961 when the predecessor statute, the Narcotic Control Act, was enacted. The Controlled Drugs and Substances Act also uses the spelling with the "h". However, in its regular correspondence, Health Canada has decided to use the "j" spelling as it appears to be more consistently used. Legal documents refering specifically to the Controlled Drugs and Substances Act will continue to use the "h" spelling.

Who can I contact for more information?
More information on marijuana for medical purposes is available on the Health Canada website (www.hc-sc.gc.ca) under the topic "Marijuana", or by calling (613) 954-6540.

Carole Bouchard: Carole_Bouchard@hc-sc.gc.ca TEL: (613) 954-6540, FAX: (613) 952-2196