By Shawn Buckley
As I write this, many in the natural health product industry are upset with the recent news that pharmacists may stop selling unlicensed natural health products. This has come about because the National Association of Pharmacy Regulatory Authorities adopted a policy that directs pharmacists to stop selling unlicensed products. The upset caused by this policy is understandable. Imagine the impact to the NHP industry if a large number of pharmacists follow the new policy.
If you think that is upsetting, consider this: what would happen if Health Canada inspectors targeted a handful of large health food store chains, seized all the unlicensed products they were selling, and charged the owners with criminal charges.
How many stores would they have to raid, and how many owners and managers would they have to charge criminally before the majority of stores would step into line and stop selling unlicensed products? I think the number “will” be surprisingly small. Once store owners realize the time has come for enforcement of the NHP Regulations, they will not be able to afford a large part of their stock being seized. Nor will the small stores be able to afford the cost of defending themselves against criminal charges. When faced with bankruptcy and jail, I think the majority will be scared into submission.
Some may think this is a hypothetical worst case scenario that cannot happen. I think it is inevitable. It is no secret that over the past couple of years Health Canada has hired more inspectors. It is also no secret that there was an enforcement initiative planned for this year on the assumption that the NHP licensing back-log would be eliminated. The industry celebrated when this enforcement initiative was “delayed” until the back-log is cleared. It should be crystal clear to everyone that once the licensing back-log is gone, Health Canada will be taking enforcement action to remove unlicensed products. The transition period will be over and more products will disappear. Health Canada has no choice, they are mandated to enforce the Regulations.
Similarly, it should not be a surprise to anyone paying attention that the NHP Regulations as they are currently drafted can only lead to the loss of the majority of NHPs that we have traditionally had the freedom to use. Under our current regulatory regime, all natural health products are deemed by law to be dangerous and illegal. The starting point is that all must be removed from the market. The only exceptions are those products that can overcome a number of barriers created by the Regulations. The barriers will change over time, but anyone thinking that changing them will solve the problem is missing what is happening.
The over-regulation of the NHP industry is not an accident. It is not a mistake. It is not due to any misunderstanding of the meaning of the NHP Regulations. The death of the NHP industry as we knew it is the inevitable result of the Regulations as they are currently written. Doing nothing, or trying to achieve minor concessions can only lead to the result we are witnessing unfold.
If we continue to go down this path, we are going to lose 75% of the products we have enjoyed access to. Half of the license applications fail. There are a large number of products for which no attempt to license will be made. Health food stores have lost access to thousands of foreign products. The character of products available to us will also change. We will have access to single ingredient products. Many of the innovative multi-ingredient products we rely on for our health will disappear. Innovation into new multi-ingredient products will be stifled. Eventually we will face cost recovery. Many quality firms and practitioners will not survive.
The transition of the natural health community from what it was, to Health Canada’s truncated version is more than a over-regulation problem. It presents us with an ethical problem. The NHP Regulations, and their enforcement, are in theory for our “safety”. At the same time, Health Canada has never done a risk analysis to determine the risk of removing natural health products from people who rely on them. There has been no risk analysis to determine what the risk of forcing us into the pharmaceutical model is when NHPs we rely on are no longer available. There has not been a comparative risk analysis done by Health Canada to see if NHPs pose enough of a risk to justify the strict regulations that have been imposed. The truth is the government is pretending NHPs are dangerous and need strict regulations. The government is also pretending that there is no health risk to removing natural health products.
If natural health products are delivering the health benefits that Canadians taking them say they do, then we are participating in a dangerous game. We are also acting unethically by allowing our brothers and sisters to be put at risk. Finally, we are letting down the next generation. Will our children have access to the safe and effective natural health products that our generation has enjoyed? Not unless we do something.
The question is: have we had enough yet or do we need to lose more NHPs before we are willing to act? The only reason Health Canada has been so effective in taking NHPs away is the complacency in the natural health community. There has been no concerted effort to stop the regulations. Many do not know what to do. Many do not believe Health Canada can be stopped. I disagree. The passion that we witnessed from Canadians who opposed Bill C-51 convinced me that we do not have to compromise. There is no reason why we cannot have reasonable and balanced regulations which protect our access to products we rely upon. There is no reason why as adult Canadians we cannot choose how we are going to support our health.
When faced with an unpleasant future, there is a tendency to disbelieve that the unpleasant future will arrive. This leads to inaction until there is an absolute crisis. It could be that Health Canada raids on health food stores will be the wake up call the natural health community needs. Unfortunately, at that point it will probably be too late. Health Canada is unlikely to enforce the NHP Regulation licensing requirement until the licensing back-log is cleared. That is not likely to happen in 2010. With producers and practitioners disappearing yearly, will we have enough voices in 2011 to bring about change?