Thank you.
My name is Stephen Dibert. I'm the president and CEO of MEDEC. MEDEC is the national medical device association representing the medical device industry in Canada.
I didn't have a formal submission here for today. I'll just be speaking from some notes. However, I did send in two written letters, one on March 19 and one on April 10, which I assume were circulated.
I'll just go over my background briefly. I've spent my entire career in health care. I have a degree in kinesiology. I was a respiratory therapist for eight years, working in hospitals, and in many cases working with the medical devices that we'll be talking about a little bit later. For the last three and a half years I've been at MEDEC, working with the industry on various issues.
Just quickly on the industry, the medical device industry is a broad industry. It's defined by the Food and Drugs Act here in Canada. It ranges from orthopedics to ophthalmology to cardiac devices, including various hospital products and medical devices and equipment.
The industry is fairly large in Canada. There are 35,000 people who work in the medical device industry in Canada. About 1,500 facilities produce medical devices in Canada. There's a strong Canadian small to medium-sized enterprise base in Canada. We're doing fairly well as an industry.
As MEDEC, the trade association, we have about 100 companies that belong to the association. About one-third of those are those Canadian small and medium-sized enterprises. Again, we look after the needs of our sector through various areas.
I won't be using the entire ten minutes this morning. I'll leave time for the true experts on the science related to the act.
I'm going to begin by saying that MEDEC and our members do support the health objectives of this act. However, we have several concerns. I'll go through those concerns one by one.
The first concern we have is that a ban on phthalates would have a profound effect on patient access to the medical devices and technology that they need, in many cases, to maintain their health and to improve their health. These devices are as simple as oxygen masks and oxygen tubing, IV bags, IV sets, ventilator tubing. These thousands of devices that are used every day in patient care would be severely affected as the act is currently structured.
We're also concerned that the industry would not be able to provide the viable alternatives that would be needed by the patients. They wouldn't be able to do the research, the development, prove the viability, and get the data and the evidence required to bring these new substitutes or alternates to the marketplace.
Our other concerns include the fact that none of Canada's trading partners have banned phthalates relative to medical devices. They have concerns around some of the chemicals that are used, but no one has banned the DEHP that are used in medical devices.
We are concerned about the lack of science, again, on those alternatives. As you're all aware, in our health care system, Health Canada, through the Medical Devices Bureau, which assesses products based on risk, looks at these products for safety and effectiveness, and we're concerned that some of the products wouldn't be able to meet those risk assessments and get to the patients.
The industry is conducting research, and will continue to conduct research, and to look at substitutes and alternatives as they continue. We have one company here with us today, but I've spoken with several others, such as Tyco, Hospira, Becton Dickinson. They continue to do research on looking at alternate products that meet the needs of patients in our health society.
That outlines my major concerns with the act as it's currently worded. I would ask that the committee consider deleting the reference to medical devices in the act so that patients can get access to the much-needed medical devices they require.
That's my presentation. Thank you.