business of generics

❑ HEALTH CANADA - review and approval of Rx (branded/ethical) and Gx (generic) pharmaceutical products ❑ International trade agreements (eg WTO, NAFTA –USMCA; CETA) ❑ Intellectual property regime (Patent Act, Patent regulations) ❑ CANADA HEALTH ACT

❑ Delivery of health care including drug programs ❑ Significant variance in inter-provincial listings, coverage, fees.

science, economics, law

Total spend $331 Billion ➢ Annual Growth 4%

➢ 1. Hospitals (24.34%) ➢ 2. Physicians (13.60%) ➢ 3. Drugs (13.58%) (2% are generic drugs)

➢ - 12.2% 2022 ➢ - 13.8% 2020 (COVID)

74.4% -saved governments, employers and patients more than 37 billion$

❑ Prescription drug coverage not part of Canada Health Act – changes can be made more easily (delisting, co-payment /fees, deductibles, etc.) but not politically popular ❑ Cost-benefit ratio: quality of life, hospitalisation ❑ In-patient ➔ out-patient costs

12% of canadians, each of whom has 2500$ worth of prescription drugs paid for by public programs

• Health Canada deems products bioequivalent • Provincial Ministries of Health designate as interchangeable (substitutable). • In BC, QC, NB, PEI decision at discretion of College of Pharmacy

98$

medicare patients

❑ Patented Medicines Price Review Board (Federal) Controlled ❑ Comparator Countries – ❑ PMPRB09: France, Germany, Italy, Sweden, Switzerland, UK and USA ❑ PMPRB11: Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom

❑ Provincially Controlled ❑ Comparator - Brand

all regardless of payer

10 000 in canada while the brands is 15 000

❑ $615-million + annually on R&D (focus is Development) ❑ More than 100 products in development

❑ Exports: 40% of sales volume through export to 120 countries

Manufacturing: Vast majority of generic pharmaceuticals sold in Canada are produced domestically (drug products not drug substances)

Insufficient domestic manufacturing left Canada at the mercy of other countries to access drugs manufactured in foreign plants. US implemented an emergency law that prohibited Pfizer and Moderna from exporting the vaccine until US needs were first met.

❑Growing demand for medicines – demographics, lifestyle, aging population ❑Rapid emerging market growth ❑Increasing access to health care ❑Unremitting cost pressures from public and private payers ❑Increasing acceptance and penetration ❑Stable flow of patent expiries

-New Medicine (including cost of failures) Development time >10 years Cost $1-3 Billion -Biosimilar (cost of failures n/a low attrition) Development time ~ 5 to 9 years Cost $> 100 million -Small-Molecule Generic Development time ~ 2 years Cost $~ 2 million

bioequivalence

-formulation: same quality of ingredients -bioequivalence: adme profiles must have equivalent pk -same standards: all manifacturers have the same standards