The Pharmaceutical Industry in Canada
D R U G
RECOMMENDATIONS
Having to pay physicians for enrolling their sufferers in Clinical Scientific Studies
Probably the most critical player in the interface between this sort of profession and also the pharmaceutical industry (Brody, 2007
Based on research, Pharmaceutical reps
regularly misinform MDs about drug negative effects (Ubelacker, 2013).
Employing Physicians
as consultants
as speaker in industry-
backed
"educational" programs
The
PHARMACEUTICAL INDUSTRY
and also the
Profession Of Medicine
Funding for Ongoing Medical Education
Caring
for that world…
one
person
at any given time
Serving the requirements of
HUMANITY
.
Our
ultimate
mission
is compare unique car features through our medicines for
patients, their own families, our stakeholders, and society generally.
Inspired with a single goal:
Your Wellbeing
We lead to
improved HEALTH
Focused on increasing the
HEALTH
of
CANADIANS
Handles
global rules of
trade between nations
Trade Related Facets of Intellectual
Property Legal rights Agreement (Journeys)
(agreement under WTO) protection for intellectual
property and supply greater predictability and stability in worldwide economic relations.
NAFTA United States Free Trade Agreement
resolve trade disputes between national
industries and/or governments
(Canada, Mexico, & U . s . States)
inside a timely and impartial manner
Legislative Bills
Protects patented drugs from
violation (copying) by other (generic) drug manufacturers.
In 1960’s, certainly one of significant reasons drug prices in
Canada is high.
BILL C-22
Pharmaceutical industry was against compulsory licensing
Patented medicine is protected against compulsory licensing to import for ten years and also to manufacture for many years in the date of filing.
COMPULSORY LICENSING
provides the licensee the authority to manufacture,
use, or sell a patented invention prior to the
patent expires.
might be granted
With No CONSENT
from the patent holder.
THERAPEUTIC PRODUCTS DIRECTORATE (TPD)
Controlled safety, quality, and effectiveness of medication.
HEALTH PRODUCTS AND FOOD BRANCH
(HPFB)
Manage health-related risks and advantages of health products and food
Federal department responsible to
maintain and improve
Canadians’ health
R E S E A R C H A N D
D E V E L O P M E N T
ARGUMENT 1
The pharmaceutical
industry says…
Our prime profit is simply an
accounting illusion created
by treating the R&D expenses
as
operating expenses
and never as
capital expenses
or
investment
(Bolaria, 2009).
Let’s EXAMINE…
Year 1 2 3 Total
Sales 500 500 500
R&D expenses 100 150 100
Revenue 400 350 400
R&D expenses as operating expenses
1150
R&D expenses as capital expenses
(investment) with 10% interest.
Year 1 2 3 Total
Sales 500 500 500 1500
R&D expenses 100 150 100 350
Interest (loss) 10 16 26
Revenue
1124
We’re really losing
lots of money!
The CRITICS say…
The
real after-tax cost
of the
$100
R&D
expenditure would vary from
roughly
$56 to as little as $37
(Development and research in Ontario, 2011)
…Not to say other made-in-Ontario
incentives for example:
a.
4.5% non-refundable
R&D tax credit
b.
20% refundable
Business-Research Institute tax credit
ARGUMENT 2
The pharmaceutical
industry says…
We’ve created
25 breakthrough
and 11 new
derivative
medications in
2013.
The CRITICS say…
Breakthrough:
9 cancer, 3 Chronic obstructive pulmonary disease,
1 seizure, 1 Parkinson’s,
1 Attention deficit hyperactivity disorder, 10 others
Derivatives:
glaucoma, HRT, diabetes, fever, cancer discomfort
GOVE
R
NANCE
TR
A
NSP
A
RENCY
A
CCESS
USE
O
F
DRUGS
APPR
O
PRIATE
Utilization Of GENE
R
IC
D
R
UGS
PRICI
N
G Of Medication
OUR RECOMMENDATIONS
Elevated R&D on neglected illnesses rich in social value
Consistent dedication to safety and effectiveness
Effective regulating marketing practices
Hoechst Marion Roussel Study
Eflornithine = ineffective as≠
an Anticancer
Eflornithine = African sleeping
sickness
Bristol-Myers Squibb and
Gillette
Vaniqa (eflornithine HCl) =
undesirable hair on your face
About
CRESTOR
AstraZeneca =
Rosuvastatin = Branded
InnoGen Pharmaceutical =
Rustor = Generic
Depends Upon 3 MAJOR FACTORS
1. Development and research
2. Advertisements
3. PMPRB or Patented Medicine Prices Review
Board–established underneath the
Patent Act
(PMPRB, 2011)
Opening PRICES
Breakthrough
Substantial improvement
Moderate improvement
Slight or no improvement
(PMPRB, 2011)
THEN…
Generic charges 80% of the trademark
Brand Generic
$100 $80
*generic companies give free products,
sometimes allow “buy 1 get 2 free” promos (ranitidine), and provides rebate to pharmacies
NOW…
Today in Ontario, the federal government
decreased the price of generic drugs:
25% of the trademark
Brand Generic
$100 $25
*Rebates are
NOT
permitted
*Ontario has got the cheapest price of generic
drugs
(Canadian Pharmacy Association, 2013)
THEN (before patent ends)
Comparison of costs for
CRESTOR 20mg
Implication:
Different prices between civilized world and developing country.
Critics ask…
Cost of brand name = Cost of generic???
Pharmaceutical
Industry solutions…
Generic drug manufacturers aren’t needed to
repeat the costly studies that brand
name firms have gone through.
Critics ask…
“Me-too” drugs
Versus
drugs for uncommon illnesses
BOLARIA states…
“When profit and health factors enter into conflict
using the profit…. Then profit wins”
(Bolaria, 2009, p.451)
P R I C E S
Degree of therapeutic improvement
Critics ask…
Public good
Versus
private profit
NOW (patent ended)
C A N A D I A N P A T E N A C T
Sets the criteria, directs the procedure, and
provides protection for patency.
(Douglas & Jutras, 2008)
PATENT PROTECTION
(Bolaria & Dickinson, 2009 Douglas & Jutras, 2008) )
(Douglas & Jutras, 2008)
BILL C-91
Compulsory licenses are eliminated with 2 EXCEPTIONS:
Early Working
– generic drug manufacturers can
get the drugs and affect Health Canada for
approval prior to the patent expires.
Stockpiling
– manufacture and convey the
drugs to become offered six several weeks prior to the patent expires.
(WTO, 2013 NAFTA, n.d.)
BILL C-91 AFTER SIGNING Journeys & NAFTA Contracts
Regulating patent term altered to twenty years
Stockpiling exception no more permitted.
(Health Canada, 2012)
HPFB and PHARMACEUTICALS RELATIONSHIP
HPFB lacked funds to attempt clinical
and preclinical trials
Pharmaceutical industry grew to become certainly one of
the main funders of HPFB
INFLUENCES ON HPFB
Delegation of presidency authority to Rx&D
– growth and development of first draft of the new policy.
COST RECOVERY
– to be able to continue operations, HPFB turns to PHARMA COMPANIES for FUNDS.
Weakened Direct-to-consumer Advertising
(DTCA) standards of prescription medications
“HPFB and also the Fda (Food and drug administration) implemented USER Charges payable by INDUSTRY. In exchange, the regulatory agencies decided to Accelerate APPROVALS.” – Batt, 2005
Food and drug administration reviewers 1998 survey demonstrated 27 new drugs shouldn’t happen to be approved.
Are You Aware?
Bill C-51
An Action to Amend the
Food and medicines Act
Using Sales
Representatives
Supplying DRUG SAMPLES
Supplying GIFTS
Drug reps are selected for his or her appearance and outgoing natures, and therefore are educated to be observant, friendly, and useful.
The priority is when the practice affects the prescribing decisions from the physician and just how it could, therefore, modify the cost and quality of healthcare.
Studies consistently reveal that samples influence prescribing choices.
College of Family Physicians of Canada revealed 70% of accredited programs had pharmaceutical company funding
Physicians possess a duty to handle existing and potential conflicts of great interest.
Resourse: https://prezi.com/ghvsbkolpk85/profits-first-the-pharmaceutical-industry-in-canada/