Health Canada is proposing a new way of allowing certain drugs that Canadians need into the country.
Instead of conducting a detailed review of the evidence — to make sure the product meets acceptable standards for safety, efficacy and quality of manufacturing — the regulator would rely on decisions made by drug regulators in a small number of other regions, including the United States and Europe.
In a notice about this proposal, Health Canada explicitly states that it would only “conduct a cursory clinical review of the submission package.”
These are drugs that are on an “urgent public health needs” list, particular formulations for children, the elderly and those made available to individuals with serious or life-threatening conditions through Health Canada’s Special Access Programme.
They are drugs that would not otherwise make it onto the Canadian market. Usually, this is because the company making the product doesn’t think enough people will use the drug to justify the cost of getting it through the regulatory system and then marketing it.
Is this a good idea? Should Canada rely on what regulators in the United States or Europe have to say about drugs?
On the surface it seems fine. The standards these countries use are comparable to those in Canada. But there are some issues that Health Canada’s announcement does not address, and some information that raises serious questions about this proposal.
Increased exposure to harms
One study from the U.S. has examined what would happen if a policy similar to Health Canada’s was adopted there.
The study lists 110 new drugs that were approved in Europe and/or Canada before the United States between 2001 and 2010. A number of those drugs had been examined by the U.S. Food and Drug Administration and rejected for safety reasons. Two of the drugs approved in Europe were subsequently withdrawn because of unacceptable side effects.
The conclusion of the study was that “reciprocal approval legislation would most likely benefit only a small number of U.S. patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms.”
Even when drugs are approved in both the U.S. and Europe, there are still differences in what the regulators allow.
Forty-two cancer drugs were approved by both regulators for 100 different uses, but in 47 cases there were differences in those uses. For 19 of these, the difference was that one agency approved a specific use, whereas the other agency did not. In 10 cases, there were discrepancies in therapeutic indications between Europe and the U.S. that were considered clinically relevant.
This raises the question: If there is a drug that is not marketed in Canada but is available in both Europe and the U.S., which foreign evaluation will Health Canada use?
National therapeutic cultures
Health Canada’s proposal also ignores the reality that drug regulation is more than just technical specifications.
Regulatory frameworks are a reflection of the therapeutic culture that has developed in an individual country.
Therapeutic cultures arise from networks of individuals and organizations that produce regulatory policy, determine testing standards and ultimately decide on market access for new drugs.
It would be a serious mistake to think that national networks are the same across different countries. It misses the point that drug regulation exists at the intersection of values, science, medical culture, patient needs and expectations and politics.
Inadequate consultation time
Health Canada is also in the process of developing regulations that would allow it to release detailed information about the safety and efficacy of the clinical trials that companies submit when they want to market a new drug. This type of information allows doctors, patients and researchers to look at the studies on their own.
If Health Canada relies on the decisions of foreign regulators, would it be able to release the same type of information? If not, that would mean no independent evaluations.
Finally, Health Canada is doing a telephone consultation on its proposal on this Friday, Feb. 9, 2018. The announcement about that consultation was not issued until Jan. 31.
Nine days is an unacceptable amount of time to allow people to develop informed opinions on this important issue.