Transcript Slides of the Session

(Un)Ethical issues in the
Pharmaceutical industry
Unethical Issues in the pharmaceutical industry
Exploratory Research
R&D
Pre-clinical
development
Clinical
development
Registration
Procurement
and
manufacturing
Laboratory
development
Animal testing
Marketing
Distribution
and Phase IV
Commercialization
Drug registration
Research
Clinical trial
Recycling
Drug
recycling
Mass production
Marketing & post-marketing
Control of
publication and
research outcomes
R&D for orphan
drug and neglected
diseases
R&D for developing
countries diseases
Clinical trial disclosure
Patent protection and extension with lobbying
Air emission
Respect for persons,
beneficence and justice
Political contributions to promote legislation friendly drug to
manufacturers
Solid and hazardous
waste
Children and women in
clinical trial
Clinical trial in developing
countries
Animal welfare
Drug safety in manufacturingm distribution and post-marketing
processes
Spill and release in
water
Pricing for medicine;
Influence over professionals
Labeling and promotional information and material
Drug pricing transparency
Hazardous material
Water waste
Source: Evaluation of CSE performance , Palazzo, G. et al, UNIL 2010
Biodiversity
Increasing number of cases, increasing costs (1991-2012)
Number of settlements
Financial penalties
TOTAL (1991-2012)
239 settlements, 30.2 billion $
Source: Pharmaceutical Industry Criminal and Civil Penalties: An Update, Public Citizen, September 27, 2012
(2012 figures limited to first Semester!)
Type of frauds
Pharmaceutical industry falls under numerous rules and legislations, from the FDA’s regulations (Food and Drug
Administration) to tax and competition laws. Their types of violations can be summarized according to the
stakeholder who is directly harmed in the process:
- Environment
- FDA and federal/state government:
overcharging government health programs,
financial violations
- Competitors: monopoly practices,
kickbacks
- Patients*: unlawful promotion, poor
manufacturing practices, illegal distribution,
concealing study findings
* Most violations have a final impact on patients since
they result from a short term financial concern,
regardless of global health concerns
Source: Pharmaceutical Industry Criminal and Civil Penalties: An Update, Public Citizen, September 27, 2012
The Heat of Bribing Doctors in China
Nov, 4, 2011: GlaxoSmithKline has reached a record $3bn (£1.9bn) settlement in principle with the US
government over aggressive sales and marketing practices of blockbuster medicines, including its lung
treatment Advair and the diabetes drug Avandia, over more than a decade.
A year later, GSK was pleading guilty saying “the misconduct related to "a different era“”.
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July 12, 2013: China has accused GlaxoSmithKline of being at the centre of a "huge" scheme to raise drug
prices in three of the country's biggest cities and said the UK-based drugmaker's staff had confessed to
bribing government officials and doctors
July 26, 2013: GlaxoSmithKline has replaced the head of its China operations with one of its top two
European managers, as the UK-based drugs company seeks to battle a widening corruption probe .
August 12, 2013: Chinese authorities have launched an investigation into a whistleblower's claim that staff
at Sanofi bribed hospital doctors, drawing the French pharmaceutical company into a widening probe of
the industry
August 23, 2013: Eli Lilly became the latest western pharmaceutical group to be drawn into rising
allegations of corruption in China , with media reports that it paid Rmb30m ($4.9m) in kickbacks to
doctors to prescribe its products for diabetics.
Sept 13, 2013: Chia Tai Tianqing Pharmaceutical Group
Beijing has taken the first step to extend its probe of pharmaceutical corruption in China to domestic drug
companies, with state television broadcasting claims that a Chinese drug company bribed doctors with
overseas trips.
Sept 24, 2013: Sales of GlaxoSmithKline's medicines in China are thought to have dropped 30 per cent
since officials accused the UK pharmaceutical group of corruption , according to provisional analysts'
estimates.
Dec 17, 2013: GSK declares stopping all payments to doctors. Marketing forces are no more remunerated
according to sales
The recent (heavy) hand of the Government (1)
Name
Position
Crime
Sanction
Date
BO Xilai
former Communist
Party leader
bribe-taking,
embezzlement
and abuse of
power
Life sentence
Sept, 2013
LIU Zhijun
former railways
minister
bribe-taking,
abuse of power
Death sentence
with two-year
reprieve
Jul, 2013
YANG
Hongwei
former Yunnan
Chuxiong Yi
Autonomous
Prefecture governor
bribe-taking,
abuse of power
Life sentence
Feb, 2013
LIU Zuoqi
former division chief of bribe-taking
the transport bureau
of the Ministry of
Railways
13 years
imprisonment
Jan, 2013
The recent (heavy) hand of the Government (2)
Name
Position
Crime
Sanction
Date
LIU Zhihua
Former vice
mayor of Beijing
Taking bribes of 1
million US$
Death with a twoyear reprieve
Jan,
2009
CHEN Tonghai
Former chairman
of Sinopec Corp.
Taking bribes of
28 million US$
WEN Qiang
Former
Chongqing justice
chief
Taking bribes of
2.4 million US$
Death penalty
April,
2010
HUANG
Guangyu
Founder & CEO
of GOME
Electrical
Appliances
Holdings Ltd,
Bribery, insider
trading and illegal
business dealings
14 years of prison,
fine: RMB 600M, &
property
confiscated: RMB
200 M
May 18,
2010
Former vicemayor of
Hangzhou
Bribery (145million
yuan ($22.2
million))
embezzlement
(53.6 million yuan)
Death penelty
July,
2011
XU Maiyong
Death with a twoyear reprieve
July,
2009
The recent (heavy) hand of the Government (3)
Name
Position
Crime
Sanction
Date
LI Peiyang
Former head of
Beijing airport's
management
company
Taking bribery and
embezzling of
US$16 million
Death penalty
Aug, 2009
WANG Yi
Former vice
Taking bribes
president of the totaling RMB 11.96 Death with a twoChina Development million (US$1.76
year reprieve
Bank
million)
April, 2010
Former Shanghai
CHEN Liangyu Communist Party
Chief
Taking bribery of
US$340,000
18 years in jail
April, 2008
Former director of
China’s top food
ZHENG Xiaoyu
and drug safety
agency
Taking bribes of
6.49 million RMB
(US$ 850,000)
Death penalty
Jun, 2007