Thank you so much.
Diana and I both represent MEDEC, the trade association representing the medical technology industry in Canada, which includes surgical equipment, pacemakers, in vitro diagnostic blood tests and medical imagining equipment; that's the breadth of our membership.
I'm going to give you a little bit of background in terms of the environment for small technology businesses.
What we know is that jurisdictions that have robust technology business ecosystems have efficient regulatory processes and health system adoption practices that enable timely adoption of medical technology solutions that improve patient outcomes. We absolutely need that sort of situation to occur in Canada.
Access to the Canadian marketplace is very complicated. There have traditionally been licensing hurdles to overcome at the federal level and procurement issues at the provincial level. The other thing to remember, which has been stated by some of the other witnesses around the room, is that human and financial resources are very limited. Some companies have fewer than 10 employees, so it's important that we look at red tape and the amount of burden that we have in terms of processes to actually better enable these businesses.
In the seven minutes, we'd like to quickly go through some of the licensing hurdles that exist out there, including authorization timelines and slow or unpredictable regulatory approval times for medical technologies. We have global harmonization efforts, which we applaud and which should absolutely be made, but they should not introduce Canada-specific requirements. Implementation should be harmonized as much as possible. With regard to the auditing process, which is very important for safety, there needs to be recognition of small business capacity and reduction of red tape in terms of multiple short-term audits. What we're talking about there is duplicative audits within a short time frame. We need to relieve the burden on small Canadian businesses.
Another hurdle is the difficult clinical trials framework for devices. Conducting clinical trials is important and it's a real draw for business and an important aspect for business. Novel and digital technologies are another hurdle.
Next we will go through each of these very quickly and also talk about what Health Canada has been putting into place. For about the last year, we've noted that Health Canada's consultations have increased dramatically, and the amount of work that has been done by Health Canada to try to improve the situation has increased. There has been progress, but what you're going to see here is that it's important that it continue. The work done to date is appreciated and it's been well accepted by small Canadian businesses, but it must continue.
For authorization timelines—that's the approval of your product—slow or unpredictable regulatory approval times for medical technologies are a disincentive for those particular companies. For the companies that want to launch products in Canada, want to export products or want to invest in R and D, it is highly important that this regulatory approval occur in Canada.
One of the great things is that Health Canada has been addressing those processes, as I mentioned earlier, to meet the target timelines. They've been developing the process, and have also been providing training and new guidance documents. Under something called MDSAP, close to 200 companies have participated in Health Canada training so that situation could get better, but as I said earlier, it's really important that this continue, because it's just starting.
With regard to unique Canada requirements, as I mentioned earlier, we're dealing with the process of global harmonization, which is key if someone is exporting from Canada. Canada is only 1%-2% of the world, so our Canadian-headquartered companies have to be able to export, and global harmonization is key to reducing that regulatory burden. We and Health Canada play an active role in these particular processes. It is key, but no harmonization effort should introduce Canada-specific requirements. Harmonization with global initiatives, such as those taken by the International Medical Device Regulators Forum, IMDRF, must be maintained. They must go on. The challenge with these is, at present, the need for regulators to implement the agreed processes across the board, which means all countries doing it at the same time.
A recent example highlighted here is the implementation of the medical devices single audit program, with only Canada mandating its use. MDSAP can be used with the four other authorities, but it has not been mandated. It's really important that we maintain that degree of harmonization.
Health Canada did react well to the input provided by the auditing organizations and industry to ease the burden on manufacturers, but in the future it would be good if we were more harmonized.
On the increased audit burden, scheduling multiple audits within short time frames is inefficient for small business. For example, small Canadian companies have reported to us undergoing an extensive medical device single audit, followed approximately three months later by a Health Canada MDEL audit. This is a large drain on their resources. The audits are essentially very similar in process, so we have to realize the impact of that red tape when conducting audits in the future.
Clinical trials are a very important element we were talking about earlier. Canada needs to stay competitive with the rest of the world, and we need to change the process regarding investigational testing authorizations, ITAs, to future-proof the regulations and bring innovation to Canada. At this time, Canadian start-up companies are being forced to go outside Canada for studies on low-risk products for timely adoption. This has huge impacts on small businesses. Health Canada tried to address this by coming out with guidance to facilitate the process. Unfortunately, that guidance had the opposite effect: it doubled the review time and the bureaucracy required by the investigator is significantly more.
We know Health Canada has an action plan to continue, and we look forward to their addressing this particular issue.
In the area of novel technologies, a new approach to the Canadian approval and adoption of innovative medical technologies would enable growth for the sector and deliver better patient outcomes. Health Canada has already begun to focus on this area with the creation of a new digital health division within the medical devices bureau and a new standing scientific advisory committee. The division is welcomed by industry, but more work is required there.
For the regulatory review of drugs and devices, we see very positive comments from Canadian-headquartered organizations on the early pre-submission scientific advice discussions with manufacturers during the development stage of innovative products. You get to talk to the regulator about how you should improve your submission and what information will be required to make this submission more efficient. Further, it allows the regulator to see what types of capability they'll need inside to conduct that review.
I have some final thoughts as we move into these areas of novel technology and digital health. Health Canada should focus more on developing guidance documents rather than regulations because there's going to be a lot of change management in the regulations as they develop them. Guidance documents are easier to revise than regulations, so they should stay on top of it and, wherever they can, put out guidance rather than regulations.
They should continue to drive global harmonization and implementation, and always consider additional burden when introducing new initiatives to reduce that audit burden. We made prior submissions.
Again, as I stated at the beginning, the biggest thing is that Health Canada is moving forward. I think if your committee can put forward a plan so they continue to be resourced to go forward, we'll end up very shortly in a much better situation.
Thank you.