Should Patient Preferences Shape Drug Development Decisions?

Official title: Release of draft (step 2) ICH E22: General Considerations for Patient Preference Studies

Open Regulations & Permits Health & Safety
Health Canada wants feedback on international guidelines for studying what patients actually want from their medications. Right now, there's no standard way to measure patient preferences during drug development. This draft guideline would create a global framework so drug companies and regulators use the same approach everywhere.

Why This Matters

Ever been prescribed a medication that technically works but makes your life miserable? This guideline could change how drug companies factor in what patients actually care about—not just whether a drug works, but whether the side effects are worth it. It's about making sure your voice counts before drugs hit the market.

What Could Change

Drug companies worldwide would need to follow the same rules for studying patient preferences. This could mean more surveys asking patients what trade-offs they'd accept—like tolerating nausea if it means better pain relief. Regulators in Canada, the US, Europe, and Japan would all use the same framework when reviewing new drugs.

Key Issues

  • How should patient preferences be measured during drug development?
  • What global standards should apply to patient preference studies?

How to Participate

  1. Download the ICH template for public consultations to format your comments.
  2. Submit your completed comments to ich@hc-sc.gc.ca by the deadline.

Submit Your Input

Draft Email