Sheldon Baker07.16.10
The principal of the Toronto-based company, Natural Products Consulting Corp, Lionel Pasen is a 53-year veteran of the natural health products industry in Canada. Mr. Pasen is a founding member of the Canadian Health Food Association (CHFA), Canada’s largest national trade association for the natural products and organics industry. He is an ex-member of the Board of Directors and was the Chairman of the Oversight Committee on Regulatory Affairs and is regularly in contact with the Natural Health Products Directorate (NHPD) of Health Canada. In addition, Mr. Pasen was an active industry stakeholder when the NHPD conducted open consultation meetings in creating the Natural Health Products Regulations. He was effective in voicing changes to the regulations so they would better serve industry. With experience and contacts in the natural products industry, Mr. Pasen advises companies in completing product license applications and finding the distributors or manufacturers that help successfully move products in the Canadian marketplace.
I met Lionel during a business trip to Toronto several years ago and have always found his industry insight quite interesting…
Health E-Insights: Are you optimistic that the Canadian Health Foods Association recent Regulatory Amendment draft will set the stage for likely legalization of about 10,000 products currently in product licensing application review stage?
Mr. Pasen: As matters stand today, products that have been applied for with a complete submission and do not have any known health risk, are being sold without interference by Health Canada so for all intents and purposes, nothing will change except the interpretation of the law. The changes in the law (not the regulations) came from the NHPD in response to the Quebec Pharmacists Association forcing the issue. Sometime this summer, unlicensed applications will have the legal right to sell products for a period of time, probably until the applications are properly disposed of. It is unfortunate that the NHPD painted itself into a corner by first demanding an NPN license in order to sell a product and secondly not being able to process applications in a more proficient manner. The action of the pharmacists was really uncalled for as it merely meant that the law had to be changed to accommodate the NHPD’s ability to complete its job. At this time, I am not aware if these temporary exemption numbers that will bridge the gap between the applications and the final NPN licenses will allow for advertising. Somehow I doubt it and this is something that the CHFA should have pushed for.
Health E-Insights: Health Canada announced upcoming changes to the Application for International Trade Certificates for Natural Health Products. Do you consider this good news?
Mr. Pasen: Yes I do. Actually, Health Canada’s actions to date have been very much in favor of supporting natural products and expanding the industry.
Health E-Insights: Canada's pharmacy regulators issued a surprise directive recently urging druggists to stop selling unlicensed natural remedies. Good or bad?
Mr. Pasen: It was ridiculous. It only forced changes to the laws so that the sale of natural products could continue uninterrupted. It did nothing constructive. I have a feeling that the pharmacists were pushed to act this way by companies that are not in the natural products business as this industry is growing quite well, and might even be considered to be growing too strong.
Health E-Insights: How does your company, NPC, help people navigate the regulatory maze?
Mr. Pasen: I have personally been in regulatory matters in Canada for about 53 years, specializing in NPNs since the inception of the new regulations in 2004. When Bill Reynolds (past president of the CHFA) and I (past board member of the CHFA) met for breakfast some seven or eight years ago, we decided that the regulations at the time were inappropriate for the products we sold. We decided to run a grass roots campaign against the federal government, urging that we get our own regulations. Our products were neither a drug nor a food. We were successful in getting the government to agree to our suggestions and the Health Minister accepted 53 recommendations and hired a naturopath with an MBA to set up and head a brand new department to regulate natural products. At that time, I decided the process was going to be difficult so we invested a lot of time and money in developing a computer program to do the work for us. This fantastic program has been evolving along with the work of the NHPD. As we made mistakes, we corrected them in the program so that they were not repeated. Today, we can do a complete application with all of the necessary back-up, meeting the NHPD needs in a fraction of the time it takes for others to do, without expensive people with titles, and other overhead, and we pass those savings on to the client. Our programs include Site Licenses, Canadian food labeling, homeopathic products and various other less common product types that require licensing. To date, we have submitted well over 3000 applications to Health Canada with an excellent success rate.
Health E-Insights: Do you believe there is intelligent life in outer space?
Mr. Pasen: It is very hard to dispute the possibility. I recently saw an Imax show called “Hubble”. It shows the unbelievable depths of the cosmos. With billions of stars in billions of galaxies, I would say the chances of life as well as intelligent life out there, somewhere, are pretty good.
For more information and interview consideration, contact Sheldon Baker at sbaker@bakerdillon.com or visit his website at www.bakerdillon.com.
