Meet Our Speakers - David K. Lee
Name: David K. Lee
Title: Chief Regulatory Officer for the Health Products and Food Branch of Health Canada
Q: Tell us a little about your work: what do you do on the day to day as Chief Regulatory Officer?
Primarily, I work on regulatory and legislative proposals, helping to form the policy and vision around them. I go to committee to explain these proposals to Members of Parliament so they can better understand the implications of the proposals and ask questions. I also make sure there is internal diligence. Public trust in food, drug, and medical devices is extremely important, so I help to make sure that we are adhering to the rules that are administered.
Health Canada is accountable to the Federal Court, but we also want to be proactive. So, I have an education role as well to make sure that ground rules are understood. Of course, this also comes with a problem-solving role. Its amazing how many points of interpretation there are, especially with older regulations and legislation. I help to figure out whether these issues can be dealt with interpretively or whether the rules need to change. My work also takes on a public dimension. I meet people working in innovation hubs or working with rare diseases. Sometimes, I even get to go to conferences!
Q: How has your career evolved from your time in law school, to your previous Directorships? How did you find your path?
I had no idea what I wanted to do when I was at Queen’s! I came to Ottawa when I was clerking at the Federal Court, and I was exposed to judicial review with Health Canada as well as intellectual property discussions on the drug side. I worked in private practice, but because of my experience with the Federal Court I was asked by Health Canada to help administer some emerging intellectual property issues. However, I really started to notice that the legislation was old, there were very low fines for pharmaceutical companies. I started to think about modernization, so I moved over to the Office of Legislative and Regulatory Modernization. I got to make up two new groups from scratch, and it was a unique experience to create these multidisciplinary teams. Then I was promoted to Chief Regulatory Officer, where I really get to focus on the things I love.
Q: You have given plenty of lectures on intellectual property as well as food and drug law, do you find these areas of the law overlap?
One of the most difficult things is the convergence between these areas, they are complex enough on their own. It’s hard to explain to Parliament, and they are hard to simplify in general. So, I really focus on breaking things down. My favourite, though, is foresight work. I love looking into the future of what we will see as a regulator and opening the discussion to academics and people working at startups. Its great to hear their ideas and where they think things should go on the regulatory level, especially with how much change there is going on with the advent of artificial intelligence.
Q: What is an ongoing or emerging food law or policy issue that you have come across in your work that you feel is important or urgent? What is at stake?
The most recent thing is front of package labeling. It’s a controversial area, and we are still working on the guidance, but its very important. Structurally, we have a set of regulations in Part B of the Food and Drug Regulations that are very old and poorly organized. We currently have the novel food section, but it does not always interact well with the other regulations. So, a true modernization of all the food and safety regulations will be a huge project but will have big returns for Canadians.
Q: Can you give us a hint of something you might discuss at the conference?
I will be providing an update on the modernization of Part B of the Food and Drug Regulations that is set to be published in December. I also want to cover our new authorities at Health Canada, like our precision regulating powers. Regulations are very stable, which is beneficial to the market to be able to rely on, but we needed additional powers to be more responsive to major shifts like COVID-19. We have the power now to bring in foreign products that meet our safety bars, but maybe are not labeled exactly right. We can also prospectively rely on the decisions of other foreign regulators, especially now that regulating is increasingly globalized.
David K. Lee will be presenting at the panel on Updates in Canadian Food Law and Policy.