5b Pharmaceuticals and the Health Care System Flashcards
(36 cards)
How much was spent on drugs (dollars and percentage of total health expenditures) in 2004?
$21.8 billion, 16.7%
Are drug expenditures increasing faster, slower, or at the same rate as total health expenditures?
Increasing at a faster rate than total health expenditures.
What was The Patent Act of 1923?
The Patent Act was amended to provide for
compulsory licensing for manufacturing purposes for
food and drug patents.
• allowed a compulsory licence to be granted if a medicine’s
active ingredients were manufactured in Canada.
What is a compulsory licence?
A compulsory licence is a statutory licence that gives the
licensee the right to manufacture, use, or sell a patented
invention before the patent expires. Licences could be
granted without the consent of the patent holder and
the licensee was required to pay a royalty.
What was changed in the Patent Act in 1969?
The Patent Act was amended to permit
compulsory licences to import medicines into
Canada.
What did the 1969 changes to the Patent Act result in?
allowed generic drug producers to import a
medicine’s active ingredients and process them into
final form for sale.
Generic drug manufacturers gained significant market
share
low levels of research and development (R&D)
investment (about 4.9 percent of sales in 1969)
What did the federal Minister of Consumer and Corporate Affairs call for in 1983?
The federal Minister of Consumer and
Corporate Affairs called for a rebalancing of the 1969
policy on compulsory licensing in order to generate
growth in the pharmaceutical industry.
What was the 1987 Bill C-22? (Amended the Patent Act)
10 years of protection against compulsory licences
to import and 7 years’ protection against
manufacture.
What is general patent law?
general patent law; term of a patent would be 20
years from the date on which a patent application
was filed, rather than 17 years from the date the
patent was issued.
What is the Patented Medicine Prices review Board (PMPRB)?
independent, quasi-judicial body.
It is responsible for ensuring that prices charged by manufacturers of patented drugs are not excessive.
Who does the PMPRB (Patented Medicine Prices Review Board) report to?
The PMPRB reports to Parliament through the Minister of Health
Does PMPRB set prices?
No
What are the guidelines for reviewing prices by the PMPRB (Patented Medicine Prices Review Board)?
reviews prices of individual products to determine if they
are excessive:
(1) Existing cannot increase by more than the Consumer
Price Index (CPI).
(2) New drug is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with existing drugs in the same therapeutic class.
(3) The price of a breakthrough drug is limited to the
median of its prices in France, Germany, Italy, Sweden,
Switzerland, Britain, and the United States. In addition,
no patented drug can be priced above the highest price
in this group of countries.
What is the 1991 Bill C-91? (and what were the effects following negotiations under the General Agreement on Tariffs and Trade (GATT) and the North America Free Trade Agreement (NAFTA)?
Increased patent production up to 20 years
Eliminated compulsory licensing.
What occurred in August 2003 (what did the WTO do)?
WTO allowed generic copies of patented pharmaceutical products under compulsory licenses for export to developing and least-developed countries that did not have the capacity to manufacture such products domestically.
What are some approaches the provinces are using to cut costs?
Formularies, generic substitution, reference-based pricing, price freezes, controls on markups and dispensing
What is a formulary?
Manufacturer makes a submission to a provincial government to have the drug covered by a particular drug program, which “covers” a specified list of prescription drugs (the formulary)
What is the CDR (Common Drug Review)?
The Common Drug Review (CDR), at the Canadian
Agency for Drugs and Technologies in Health
(CADTH), is a pan-Canadian process for conducting
objective, rigorous reviews of the clinical, cost-
effectiveness, and patient evidence for drugs. CDR
also provides formulary listing recommendations to
Canada’s publicly funded drug plans (except
Quebec).
What is generic substitution?
Provincial (and other) drug programs use generic
substitution to control expenditures. If a drug is
available from multiple sources, provincial
programs usually pay the price of the lowest-cost
alternative.
What is reference-based pricing? (RBP)
Reference-based pricing categories are identified. The “reference product” in each category (drug family) is that with the lowest price. The drug benefits program will only reimburse - for any drug in the category - the price of this reference product.
What is the difference between
Generic substitution - the meds are chemically equivalent
Reference-based pricing - the meds need only to be therapeutically equivalent, not chemically identical.
What is the Pharmacoeconomics Program?
BC - is multi-disciplinary team consisting of physicians, economists, bio-statisticians, pharmacists and epidemiologists.
What does the Pharmacoeconomics Program do?
Undertakes many different projects in a number of areas of study, including pharmaceutical prices and regulation, health and technology assessment, economic burden of illness and health services research.
Who established the the Therapeutics Initiative and when?
Established in 1994 by the Department of Pharmacology and Therapeutics in cooperation with the Department of Family Practice at UBC
