Mr. Speaker, it is fair to say that Bill C-51 has attracted a fair bit of attention. We have been debating it again today.
Bill C-51 is an act to amend the Food and Drugs Act and to make consequential amendments to other acts. Needless to say, the Food and Drugs Act definitely needs updating. It is an old act. It goes back to about 1934. It has had a few tweaks along the way, but certainly it is time for some updates to the Food and Drugs Act.
There are some good provisions in the bill, that is for sure, including life cycle monitoring of pharmaceutical drugs and mandatory reporting of adverse events. These are very positive things that need to be done because there are serious concerns about these products.
The public response overwhelmingly on the negative side has been over concerns about what will happen to the natural health products industry under the regulations.
In illustrating some of those concerns, I wish to make reference to a letter that I received recently from a number of very distinguished and concerned scientists, which illustrates the concerns that are out there. I received this letter on May 4. It is a copy of a letter to the minister and states:
We, the undersigned, are physicians, scientists and practitioners of international origin with considerable experience in the use of natural health products. We are gathered in Vancouver at the Fairmont Hotel to attend the 37th Annual International Conference on Orthomolecular Medicine...
We are most concerned that the Bill will lead to loss of access to valuable food supplements and other nutritional products for our patients and for many others, who have often found such products to be essential in maintaining their health.
Another point they make is this:
Nutritional products are qualitatively different from pharmaceutical products and carry an undetectably small risk of harm....
They provide a reference from the journals about that. They continue:
There are therefore no grounds to impose on them the same risk-benefit analysis structure that is proposed for all therapeutic products under this bill.
The majority of organizations and commercial bodies operating in the natural product field are run by individuals or are small businesses. The regulatory hurdles proposed will be too high for many of them to achieve, and the penalties proposed for infringements of this bill are grossly disproportionate and unnecessarily severe.
They go on to state:
We are also concerned at the potential impact on the regulatory climate in our own countries, given the international trend to harmonization.
We encourage your department to open dialogue with our Canadian colleagues in the hope we can find a workable solution.
This letter is signed by scientists from around the world. They are from the Netherlands, Japan, the United States, Finland and Norway. There is a PhD neurochemist from the U.S.A. Others are from Switzerland, Spain, Mexico, and other countries. There is Professor Harold Foster, PhD, from Victoria.
I use this only by way of illustration. This discussion we are having in Canada about Bill C-51 to amend the Food and Drugs Act is being noticed by health care practitioners from other countries. They are concerned about the impact it will have on regulations in their own countries.
One of the points they raised at the end is that they encourage the department to “open dialogue with our Canadian colleagues in the hope we can find a workable solution”.
I know that since the bill has been introduced most of my colleagues here in the House have had a fair bit of representation from concerned citizens. I am sure that most members have heard from constituents. At the latest count in my office, I have had 380 responses raising concerns about the bill. I am sure that others have had dozens if not hundreds of representations and I know there has been a fair bit of concern and discussion.
In response to that, the Minister of Health has launched some consultations with industry across the country. The minister and his team were out in Vancouver for consultations and in Toronto and other major centres as they consulted with industry leaders about how to remedy the concerns that are out there. I know that he is working on some amendments and I look forward to seeing them presented in the House shortly.
At this second reading stage of the bill, it is certainly not possible for the minister to introduce amendments, but I understand that there will be a forthcoming indication of some amendments that our government members will bring forward at the health committee if and when the legislation passes second reading.
Therefore, I welcome those amendments. I look forward to what I understand will include an attempt to create a legislative third category. That is something that people have been interested in. That is one of the major concerns that have been expressed and there will be other substantial amendments to alleviate the way the bill would be applied as well as to clarify concerns that have been raised. We look forward to those amendments coming forward and being able to go over in detail what those changes mean.
The minister stated that it is not his nor the government's intention to restrict natural health product availability in Canada. I am sure and I have every reason to believe that he is very sincere in making those statements. I have no reason not to believe him or the government in their intentions.
The problem is that, given the history of actions by Health Canada over the past several years, the increased powers and the changes proposed by Bill C-51 give informed Canadians a very great cause for concern. In that regard, I would like to review some of the history and illustrate a couple of the concerns related to the bill as it stands.
Going back over at least four previous health ministers, there was an effort to regulate natural health products as drugs under the Food and Drugs Act. By the way, I think everyone recognized that there was a need to bring in regulations for natural health products. Everyone wants to make sure that we have good manufacturing practices, we need office inspections and some quality control measures there, and we certainly want to make sure that what is on the label is actually in the bottle.
So, certainly regulation is necessary. Everyone is in support of regulation. It is the type of regulation that is being considered here and the concerns about whether those regulations are appropriate for the low risk and the natural character of these products. By nature they are low risk, they are low cost, they are non-patentable items, they are more akin to food, concentrated food items, vitamins, minerals, amino acids, which are components of protein, and that is the stuff we are made out of, and therefore by nature it is low risk and well tolerated in biological systems.
Going back through a bit of the history, there was a huge public response out of the attempt by former minister David Dingwall to regulate natural health products as drugs. It was followed up by Allan Rock. Allan Rock, as minister, put the brakes on the process and commissioned the health committee to investigate and produce a report. There were widespread consultations and a report was tabled in 1998, making some 53 recommendations.
That was followed by the creation of a transition team of experts. Some 17 experts came together to try to organize how would this new office of natural health products come together and what form it would take. They made recommendations that were published in a report in the year 2000.
I note that the transition team, in their report, had a vision that they articulated there. They hoped that the minister would be a champion for a new era for NHPs, natural health products; that vitamins and minerals would take their place in improving the health of Canadians and the health care system in Canada, that the minister would be a champion for helping natural health products find their way to taking their rightful place in strengthening Canadians, improving prevention of disease, promoting wellness, and helping keep people off the waiting lists that are so troubling to anyone trying to access health services for serious health failures.
In the 37th Parliament I introduced Bill C-420 which was to move the natural health products department office, which changed names from the office of the ONHP to the natural health product directorate, under the food side of regulations. So we had food and drugs, and we would take it from the drug side and move it under the food side because it was more akin to foods than it was to drugs.
That bill died when the election of June 2004 was called and it reappeared in the 38th Parliament with the help of my colleague, the member for Oshawa, who tabled the bill and we got agreement to keep the name.
The outcome of that was that NHPs were placed not where we wanted them under food, but they remained as a subclass under the drug side of the regulations. So, this is where are we since that day.
Currently, natural health products are regulated as a subclass of drugs for regulatory purposes, although they have their own regulations. That has been the status since 2006. When we started this process there were some 50,000 to 60,000 products on the market. What has been happening in the interim is that there are about 6,000 products that have been approved.
I notice the member for Yukon, who is still with us in the debate, in his speech earlier mentioned there were some 33,000 to 40,000 products backlogged and that is probably accurate. There are about 6,000 that have gone through the approval process of that huge number that were out there a few years ago.
About half of the products applying do not make it through the regulatory process. A lot of good products are dropping off the shelves in Canada under the current regulatory regime. Those that are approved are the simple ones. They are single monograph products, not the combined products. Many of the more effective well-known and popular remedies that are out there are multi-ingredient products. Most of those have not even started into the process yet. So a lot of products are not making it through.
Complicating it further is the fact that many good products that come from outside the country from the United States, for example, are not being shipped into Canada because the producers find the regulatory regime is too onerous and the market is too small. They have just stopped shipping their product to Canada, so we are losing products that way. That is the current situation.
People in the industry are frustrated at the lengthy delays in receiving an NPN and lengthy requests for more information. It seems products like Red Bull or an energy drink gets an NPN fairly readily. They will never have a hope of impacting anybody's health, but they might give people a kick or a little better high, or keep them awake if they are mixed, as some young people do, with alcohol which we would not recommend. We would end up with a drunk who is a little more alert.
Those products seem to make it through the regulatory process in a flash, but natural health products that could have a real impact on serious illnesses seem to be having a hard time getting through.
I want to return to the letter from the scientist. Speaking at a conference just a month ago, so we are not talking ancient history, Dr. Bonnie Kaplan from the University of Calgary spoke about her experience with the product Empowerplus. I know others in the House have mentioned this product already and probably most members have some knowledge of this vitamin and mineral product produced in Alberta. It had a profound impact on people with bipolar disease.
This product attracted some attention in Alberta. The government of Alberta said whoa, there is a huge problem, a lot of people seem to be taking this. It had the Alberta Science and Research Authority examine the product and it commissioned a study at the University of Calgary with some $544,000 in funding. The initial results were very promising. In fact, there were some four peer review articles published.
About this time, Health Canada moved in to shut down the study under the regulations of the day. It called on the RCMP to raid the company and contact 3,000 Canadians, and order them back on their psychiatric drugs even though many of them were taking the product with the knowledge of their physician and many of them had been well for years by simply taking vitamins and minerals.
I want to use that as an illustration of why people are alarmed at the regulations in Bill C-51. It is not simply what is in the bill, it is the behaviour of the department in the last number of years that has people alarmed. Given the tools that are in Bill C-51, it is concerns that with the wrong attitude this could ensure that a lot of very good products will never see the light of day in our country given this response. I mentioned: thousands of Canadians were taking the product, the Alberta response, the early results, and that Health Canada shut down the study, and sent in the RCMP.
Just to go on with Empowerplus for a minute, there was a researcher from Harvard, Dr. Charles Popper, a world renowned psychopharmacologist. He testified at a court case just after the last election. I unfortunately missed it, but I did read his testimony. He testified that he learned how to help people get off drugs from the lay people in this company who have accumulated a lot of experience trying to help people with their condition by taking these vitamins, minerals and amino-acids, and improving their mental health.
I wish members could have been there to hear testimony from a woman named Sabina from Renfrew. She had been on psychiatric drugs for 18 years and in spite of that, in and out of hospital.
Sadly, with the condition she was afflicted with, when she was not trying to take her own life, she was trying to take her husband's life. She had been on vitamins a year and a half, when I met her, and had not had a single failure. That is something that, I think, would attract some attention. Some people may say this is helping, although it is anecdotal evidence, but she was one of about 3,000 Canadians who had improved.
By the time I met her, a year and a half after taking these products, she was no longer trying to kill herself. She was working and paying taxes. I have to admit as a Conservative, I like that. She is also volunteering. She is not on the high needs list but back out in society and producing. When I saw her at the court case, where she testified for this company against Health Canada, she had lost 60 pounds, was off all her medication, and taking nothing but vitamins.
The company she worked for was so impressed with her that it sent her to get a university degree and she is volunteering to train horses on the side. She is a tremendously productive lady, a lady with a tremendous sense of humour. I wish everyone could meet her.
I wish everyone could have met no less than the former deputy prime minister of Norway when he was in Ottawa. He came to meet with Health Canada officials about this product because he had a child that was out of control and nobody in Norway had been able to help him. He heard about this product and ordered it for his child. His child improved so much that he wanted to import this product to help other people in Norway, but he could not because there was a warning on the Health Canada website, which is still there to this day, that says this is an untested and dangerous product. Therefore, even with his connections, he was not able to import the product.
When I had lunch with him, he was later scheduled to meet with Health Canada officials. When they found out why he was here, they cancelled his appointment. It seems, sadly, that no one at Health Canada was willing to meet with Sabina or with this gentleman or with thousands of Canadians. The minister of the day was not willing to meet with them.
Everyone taking the product was concerned when Health Canada was trying to shut down this product at the border because the minister of the day had the attitude or the approach that this was an untested. The minister said, “It could be thalidomide”.
That is disappointing, but that kind of attitude seems to be what is prevailing at Health Canada, even to this day, and that is why people are concerned about the implications in the bill. This is the same Health Canada that could be handed extraordinary and, some might say, draconian provisions by the bill.
There are some concerns. People would like to know that the vision of the transition team would come to pass and that the regulatory regime would be a friendly one that helps natural health products, which by nature are low risk, become more available.
One of the concerns is subsection 15.1(4), which says simply that the minister has the power to put any product or class of products under prescription only status. The challenge is simply that vitamins and minerals, nutritional products, amino-acids are what we are made of. They have always been in the public domain, but under the powers in the bill the minister could simply move something from the natural health product class over to a drug class in certain potencies. The minister has those powers. That is one concern.
Another concern is in regard to clinical trials. The bill says that clinical trials must be approved for designated therapeutic products. We depend on most of the research on natural health products to understand how they work. We found out a little while ago that vitamin D has a big impact on people with multiple sclerosis and now the recommendation is that we should be taking vitamin D to reduce a whole host of other conditions, including many cancers.
We are concerned about the availability of these products. University research could be put at risk. Some would argue that universities could be asked if they applied for a clinical trial for basic research.
Finally, the definition of government has people concerned. I will finish with this simple remark. The government, under this definition, could be another international government or agency that could bring in regulations from the World Health Organization or Codex, for example, and impose them on the Canadian public without due consideration or consultation here at home. Those are some of the concerns.
