1. Data Protection, USMCA and Spending on Biologics in Canada
Joel Lexchin MD
Professor Emeritus, York University
Associate Professor, University of Toronto
Emergency Physician, University Health Network

2. Data Protection in Canada
Requirements for data protection
Drug contains a medicinal ingredient never sold before in Canada
Data should have required considerable effort to generate, where considerable effort is defined as the use of clinical trials to produce the data
Currently
Data protected for 6 years after brand-name drug is marketed and Health Canada will not approve a generic/biosimilar until 8 years after brand-name drug marketed (extra 6 months if pediatric trials done)
Data protection cannot be challenged in court unlike patent protection

3. USMCA
Adds 2 more years to data protection for biologics, i.e., 10 years of market protection for biologics from biosimilars
Will only apply to biologics approved once agreement is ratified and comes into effect

4. Increasing Use of Biologics

5. How Much Will Spending on Biologics Increase
Estimates based on applying additional 2 years of data protection to existing biologics
Depends on
Whether data protection or patent protection will expire first
Percent of market captured by biosimilars
Discount from biosimilars

6. Possible Drugs to be Affected by USMCA

7. Price of Biosimilars Compared to Originators

8. Biosimilar Uptake in Canada

9. Top Selling Biologics in Canada

10. Biologics with Data Protection on Canadian Market
Only 2 of the 17 best selling biologics on the Canadian market currently have data protection (aflibercept and pertuzumab–trastuzumab)
Assumes current mean Canadian price reduction of 26%
Lost savings could be $0 if patents expire later than 10 years of data protection

11. Additional Considerations
From January 1, 1995, to March 31, 2018, 139 biologics approved
9 had biosimilars
Only 1 biosimilar would have been potentially delayed by additional data protection
(78 biologics approved too recently to determine if additional data protection would delay biosimilars)
16 biologics with expired data protection
5 potentially would have been affected by additional data protection

12. Bottom Line Based on biologics currently on Canadian market
Potential impact on overall Canadian drug expenditures of a two-year extension in data protection is highly variable
No increase in spending to a $305.8 million over slightly more than two and a half years depending on the strength of patent protection and whether those patents are challenged in court.