business of generics Flashcards
federal government: responsibilities
❑ 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
provincial governments: responsibilities
❑ Delivery of health care including drug programs
❑ Significant variance in inter-provincial listings, coverage, fees.
what is the generic pharmaceuticals reality aka what is the interplay
science, economics, law
Health Spending in Canada 2022
Total spend $331 Billion
➢ Annual Growth 4%
what are the top e spending categories
➢ 1. Hospitals (24.34%)
➢ 2. Physicians (13.60%)
➢ 3. Drugs (13.58%) (2% are
generic drugs)
Healthcare as % of GDP
➢ - 12.2% 2022
➢ - 13.8% 2020 (COVID)
in 2022, generic medecines were dispensed to fill…. of all prescriptions in canada
74.4%
-saved governments, employers and patients more than 37 billion$
what are the reasons of the rising healthcare costs
❑ 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
more than 60% of public money is used for.. of canadians
12% of canadians, each of whom has 2500$ worth of prescription drugs paid for by public programs
Pricing & Reimbursement: Who Pays?
- 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
how expensive is insulin in the us
98$
New US Bill capping
insulin at 35$ applies
ONLY to
medicare patients
Brand Drug Pricing
❑ 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
Generic Drug Pricing
❑ Provincially Controlled
❑ Comparator - Brand
Drug pricing in Canada applies to ….
all regardless of payer
generic industry: jobs
10 000 in canada while the brands is 15 000
generic industry: innovation
❑ $615-million + annually on R&D (focus is Development)
❑ More than 100 products in development
generic industry: exportations
❑ Exports: 40% of sales volume through export to 120
countries
generic industry: manifacturing
Manufacturing: Vast majority of generic pharmaceuticals
sold in Canada are produced domestically (drug products not drug
substances)
lessons learned from covid 19: manifacturing
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.
Market Trends Favour Generics & Biosimilars
❑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
Drug development comparison
-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
generics requirement is for what?
bioequivalence
Generic Development & Regulatory Approval
-formulation: same quality of ingredients
-bioequivalence: adme profiles must have equivalent pk
-same standards: all manifacturers have the same standards
