A Comment On PMPRB Regulations

Today’s blog comes from Lilly Canada’s new President and General Manager, Rhonda Pacheco. This was drawn verbatim from a statement we provided to Reuters, in response to an inquiry. A Reuters journalist was asking about this report from Life Sciences Ontario, which summarizes the impact of the new regulations and guidelines governing the prices of patented medicines in Canada from our industry’s perspective.

These new regulations, which lower the list prices of patented medicines here, make it harder to launch new medicines in Canada in a timely fashion. At Lilly, we’ve already suspended an application for approval to sell one new medicine here, and the regulations haven’t even taken effect yet. We’re now questioning whether it’s economically viable to invest the financial and human resources required to make this new medicine available in Canada.

That’s a tragedy, from our perspective. New medicines save lives, extend people’s lives, and improve the quality of life for people facing serious challenges to their health. Pharmaceutical innovation produces new tools for caregivers in their work to slow or halt the progression of disease. Our purpose at Lilly is to make life better for people with our work and our products.

If we determine that it remains possible to launch this medicine, then the new PMPRB regulations will have merely delayed its availability for Canadians who are living with disease and needing treatment options. If ultimately there is no path forward, then the launch of this medicine will have been cancelled by these onerous, complex, and heavy-handed bureaucratic machinations.

What’s worse is that these regulations cause this cascade of additional problems while failing to meet their objective of addressing the challenges of affordability—challenges that we acknowledge, and that our industry is working to address. The pharmaceutical industry is already at the table, negotiating rebates that save taxpayer-funded drug plans more than $2 billion per year. We also proposed alternative measures for balancing affordability with the availability of new medicines, and the government appears to have ignored them.

We believe no one should go without a necessary medicine because they cannot afford it, but these regulations, in causing the delay and/or cancellation of the availability of new medicines, produce new problems without addressing the issue they purport to solve.