Thank you, and many thanks to the standing committee for inviting our organization to appear before you today.

I'm joining you from western Canada, the beautiful unceded territories of the Musqueam, Tsleil-Waututh and Squamish nations.

Our group focuses on overall pharmaceutical policy, but many of us also have expertise in specific areas, including drugs to treat cancer, Alzheimer’s and other conditions. My expertise is in the area of drugs to treat diabetes, with a focus on insulin.

The first time I appeared before the standing committee was in 2003. I was part of a national campaign, organized by a group called the Canadian Society for Diabetic Rights, to fight for ongoing access to animal-sourced insulin products. I appeared during the two days of hearings that the committee conducted to study the issue.

Insulin is sometimes called the “poster child” for pharmaceutical supply issues. Between 1995 and 2006, 26 different types of insulin were withdrawn from the market by Eli Lilly and Novo Nordisk, a move that left almost 45,000 people scrambling to find appropriate alternatives. That move had nothing to do with the safety and efficacy of the insulin products, all of which had been standard treatment since the 1950s and earlier.

The withdrawals were part of a marketing strategy to force people to switch to much higher-cost brands. At the time, and because of the work of this committee, Health Canada acknowledged that there was a significant minority of people whose lives and safety depended on ongoing access to animal insulin, and at the urging of the committee the ministry worked, and in fact, continues to work to this day, to ensure access.

What that experience taught me is that there are two key barriers that patients confront when trying to access medicines. One is supply, and the other is affordability.

It’s the job of the price review board to ensure that the introductory price of new drugs is fair. Our organization supports the PMPRB as an important regulatory tool, and we've spent the previous year and more arguing for stronger guidelines. We were pleased earlier this year to see that the guidelines developed by the board took a positive step in that direction. While there is always room for improvement, we hope the committee will support the price review board and, in fact, recommend that its role be strengthened even more.

The decisions of the price review board have a ripple effect across the country and they contribute either to fairness or to inequality in access. As the story of Lantus insulin shows, which was part of the brief we submitted, a decision that results in unreasonable prices for drugs shifts a significant burden to consumers, as well as to public and private insurers.

In the case of insulin, the overwhelming evidence showed that recombinant human insulins, which were introduced beginning in 1983, provided no additional benefit or significant reduction in harm compared to animal insulins, yet prices skyrocketed, including after the founding of the Patented Medicine Prices Review Board in 1987.

As Eli Lilly informed this committee in 2003, the introductory price of its beef-pork insulin was $4.87 for a 10-millilitre vial in 1980. Then, in 1983, the company introduced its recombinant DNA insulin, known as Humulin, at an introductory price of $12.50 for a 10-millilitre vial. That was a threefold increase in the price, yet according to the Cochrane Collaboration, which reviewed all the evidence, Humulin offered no therapeutic advantage over its animal-sourced counterparts.

Then, in 1995, the first analog was introduced at a price of $30, another insulin product that was shown not to offer any therapeutic advantage over recombinant human insulin, and by extension, animal insulin.

Since 1987, the price review board has approved the introductory prices of new insulins, and I would argue, has allowed the price of insulin to increase despite the evidence before it that patients not only don’t experience a significant increased benefit in terms of safety and efficacy, but also pay a price that is entirely unjustified. This is precisely why the tools available to the price review board have to be strengthened.

The ones affected the most by a weak price-review mechanism are those who are usually the least able to carry that burden, meaning people who are uninsured or under-insured, poor and in poor health. Of course, during this period when the COVID pandemic has been sweeping across the world, those numbers have increased.

A recent survey of people with disabilities and chronic conditions found that the average number of prescriptions for this group is five and the cost burden is between $200 and $3,000 per month. These are some of the people who need access to safe, effective and affordable medicines, and it is in their interest that the board should act when making decisions about what is fair and reasonable.

Governments often say that after marketing authorization has been granted, they have no control over supply. I don’t buy that, and I’m not alone. We believe governments have tools and that if they don’t have those tools, they can develop them. This is especially urgent now, in part because global pharmaceutical companies are threatening to stop supplying Canadians with new medicines if the guidelines go into effect. That is totally unethical.

In response, we urge the standing committee to recommend that the House of Commons implement legislation to strengthen its compulsory licensing capacity and to establish a public manufacturer of drugs and vaccines. If Canada utilized its ability to issue compulsory licences, it would mean that Canadians would no longer be vulnerable in situations in which patent holders are unable or unwilling to supply medicines. The Government of Canada could also work with other interested countries that want the intellectual property rules in the WTO TRIPS agreement to be relaxed. For example, other countries such as the Netherlands may be interested in developing policies that meet population needs while upholding obligations undertaken in the WTO.

Compulsory licensing—or even the possibility of compulsory licensing—would shift some of the power over price from the patent holder to government, while at the same time protecting the patent holder's right to make a profit. This would strengthen negotiations with manufacturers over bulk purchasing of essential medicines and strengthen the role of the prices review board.

Finally, Canada has a long history of publicly producing and supplying drugs and vaccines at cost to Canadians, including public and private drug plans, as well as consumers. Connaught Labs, where insulin was discovered and which became a major vaccine producer internationally, played a key role in the establishment of provincial drug plans, providing medicines and vaccines at cost. We continue to pay a very high price for the decision in 1984 to privatize Connaught, but if we can decide to privatize a Crown corporation, we can also decide to create one. We urge the committee to include this in its recommendations to the House of Commons.

The Patented Medicine Prices Review Board is an essential player in efforts to maintain some control over prices in Canada, especially since patents on medicines are granted for longer and longer periods. The new regulations and guidelines are a positive step in providing Canadians with more effective tools, but they aren't enough. The prices review board needs the backing of Parliament and the Government of Canada to ensure it plays a role in supporting access to medicines.

Canadians need to trust that the federal government is using all the tools at its disposable to support access to safe, effective and affordable medicines, and if those tools aren’t there, that Ottawa will develop and implement them.

Thanks again for allowing me to present our views and recommendations, and I hope that we've made a contribution to your discussions. I am happy to answer any questions you might have.

Thank you.

Transcript

Discussions (0)