Why Bill C51 is important to you
Bill C51 almost invisibly moved through the parliamentary process unobserved by the majority of Canadians. That ended with Prime Minister Stephen Harper’s public announcement and the ensuing debate regarding the inclusion of Natural Health products in the Bill.
This legislation, which modernizes the Canadian Drug Regulatory System, is long overdue having not been changed in any significant way since the 1960s. David K. Lee, Director, Office of Patented Medicines and Liaison, Health Canada and the Health Canada team have encouraged input from all stakeholders in an open, transparent and inclusive process over a number of years.
Natural Health products have been regulated for some time, this is not new. Previous to regulating these products no one could ever be sure if what was purchased at a pharmacy or health food store actually contained what the label stated. The heightened awareness that is occurring with the current and emotionally charged debate is an effective public relations campaign by some in the natural and alternative medicine products industry. They fear additional scrutiny into their products.
CAPA has long held the position that just because a product states that it is “natural” does not mean it is safe. Natural Health products can have adverse reactions and interactions, just like pharmaceuticals.
In the proposed regulations, if a natural product makes a health claim, that claim needs to be supported by evidence. The level of evidence required for an herbal tea that claims to sooth and relax will be much different than the level of evidence required for a product that claims to cure cancer.
When a drug is approved for use in Canada, not everything is known about that drug. Clinical trials are conducted in very small segments of the population, frequently not resembling the patient population in which the drug will be used. Bill C51 will incorporate a life cycle approach to medicines and more real world, post approval data. There are two things we know for sure: This legislation will make the system safer for Canadians and there will be bumps in the road as it progresses.
Change is never easy.
Comments
Wow,thank goodness Bill C51 was passed. Unfortunate that the government still feels the need to “sneak thing’s by us” in Parliment. At least this seem’s like a positve start to a long process.