Let me first say that I believe in government regulation. As a former civil servant with 18 years of experience, I have seen how regulations can be structured and implemented to protect Canadians and actually provide a good frame of reference for organizations and businesses operating in Canada. Finding this balance is of course no easy task. The politician, the civil servant and the stakeholder all need to come together in order to ensure equity and fairness. That is why the actual development requires time and thoughtful consideration of the various issues which necessitate the regulation.
In this regard, the new Access to Cannabis for Medical Purposes Regulations (ACMPR) must be recognized for the incredible amount of work it took to create them in only six months. Government lawyers, policy analysts, senior management, and elected officials across at least three separate departments all had to come together to create regulations that responded to the Federal Court decision (Allard et al v Canada) allowing patients the right to grow marihuana for their own medical use, while ensuring consistency with the existing Marihuana for Medical Purposes Regulations (MMPR), the Controlled Drugs and Substances Act, and the Food and Drugs Act.
Having done this work before, I can assure you this is no easy task – nor should it be, given the complexity, history and emotion associated with this topic. While the Government often comes across criticism for creating regulations that are either too burdensome or too weak – they need to remember that this is their job – they are the ones with the mandate and the expertise to undertake this work.
Unfortunately, the ACMPR is a regime which makes this difficult: for Licensed Producers to reasonably cultivate and produce marihuana that is cost effective; for consumers to have consistent access; and for the Government to manage the requirements of the ACMPR in a timely and efficient manner.
Like the MMPR before it, the ACMPR provides a level of regulatory oversight that is not aligned with the costs and risks associated with the production and distribution of marihuana for medical purposes. While the government will argue that such a restrictive system is necessary given that marihuana is a controlled substance – such an explanation does not properly comprehend the current market, science, or level of risk associated with its use. I offer two examples for consideration.
First – lets examine the security requirements outlined in the ACMPR for Licensed Producers and potential applicants. The ACMPR is far more restrictive and costly for Licensed Producers when compared to any other life sciences industry regulated by the government. I would argue that it is much easier to become a manufacturer of any other controlled substance (which could be far more dangerous and more lucrative on the black market) when compared to marihuana.
Health Canada continues to cite the risk of diversion and the presence of organized crime in the industry as one of the reasons for the overly burdensome and costly security requirements. However, no evidence is offered by the department. In his written decision, Judge Phelan (Allard et al v Canada) even went so far as to chastise the Crown for not presenting any credible evidence that would support the government’s argument that every single gram of marihuana produced must be recorded and accounted for, and if it wasn’t, would result in product being diverted to the black market.
I believe that Licensed Producers would, in their own best interests, want to secure their inventories and protect their product and thus their bottom line. When the prohibition on alcohol came to an end in Canada and the United States in the 1930’s, both governments did not enact legislation that required alcohol producers to institute any security measures. The security requirements specified in the ACMPR mean that a gram of marihuana is a substance far more lucrative than a gram of gold.
"I would have thought that the government would have taken the opportunity to recognize some of these issues with the MMPR and fixed them in the ACMPR. The fact that they did not is troubling"
However, this is not even the most perplexing part. As per the Allard decision, the ACMPR allows individuals to grow marihuana at home for medical purposes, but there are no security requirements in order to undertake this activity – only “suggestions.” And while this is a good thing, the question then becomes – why the difference? Of course one reason given by Health Canada is that the risk of diversion could be greater with Licensed Producers when compared to an individual grower. But is it – where is the evidence? Perhaps the real reason the government did not stipulate any security requirements for individual growers is that it knows it would not be able to enforce them, nor would it survive a challenge under the Charter of Rights and Freedoms.
Second – the ACMPR requires anyone wanting to grow their own marihuana to register with Health Canada. And yes, we have been down this road before – this was a requirement under the old Marihuana Medical Access Regulations (MMAR). And as it was with the MMAR, such a requirement will prove to become unworkable over time.
When I was at Health Canada and working on the marihuana file, it was evident that the MMAR had to be changed, given that registering individuals proved to be costly and burdensome for both the department and its stakeholders. The result was long processing times, burned out civil servants, and frustration among patients. And yet here we are again. Why Health Canada would want to take on this role once more is, to say the least, mystifying.
I understand that Health Canada had to respond to Allard, but surely there must have been a more palatable policy option than simply turning a portion of the department into a licensing bureau.
The concern is that, in the past, the department did not have a very good record under the MMAR when it came to registering patients in a timely and efficient manner. It gets worse when you consider how long it currently takes Health Canada to process a prospective applicant to become a Licensed Producer. It can take anywhere between two and three years – that is 24 to 36 months just to get through the regulatory process.
Compare this timeline to the time it takes Health Canada to review a new or improved medicine (e.g. pharmaceutical, biologic). If all of the required data (e.g. clinical trial information) is submitted, a decision can be reached within a year. And this is a far more complex process (as are the repercussions to Canadian’s health if the department gets it wrong – e.g. thalidomide) than deciding whether or not a prospective applicant can cultivate, grow, harvest, and distribute marihuana in a safe and secure fashion.
To be clear, I am not arguing that regulations should not exist, or that there are not any risks associated with the production of marihuana for medical purposes. I am saying that there has to be a proper balance between the costs and benefits, while the government has an obligation to be transparent in how it interprets, undertakes, and manages the implementation of these rules. To-date, this has not been the case with the MMAR, MMPR and now the ACMPR.
I would have thought that the government would have taken the opportunity to recognize some of these issues with the MMPR and fixed them in the ACMPR. The fact that they did not is troubling given the country is on its way to legalizing the recreational use of marihuana within the next twelve months. One would hope that the next iteration of any new regulation would recognize the scientific and policy evidence that exists, and seek to correct the issues of the past with some new and innovative thinking. As I said at the beginning, regulation can be a very good thing if done right – and of course, that is the challenge before us.
- Ivan Ross Vrána
Mr. Vrána is the founder of Aslan Ross Consulting – a firm that assists corporations and non-for-profit organizations in their interactions with provincial and federal governments. Previously Mr. Vrána worked for the Federal Government for over 15 years. He worked at the Patented Medicine Prices Review Board, Finance Canada and in various senior policy positions at Health Canada. At Health Canada he was in charge of the team that developed the policy rationale which led to the implementation of the Marihuana for Medical Purposes Regulations.
Between 2006 and 2008 Mr. Vrána took a sabbatical from the federal government and worked at Canada’s Research-Based Pharmaceutical companies as the Director of Government Affairs. Since 2007 Mr. Vrána is also a regular Lecturer at both Carleton and Concordia universities and teaches a course that examines the internal communication tools governments use to development and implement public policy.