(Un)Ethical issues in the Pharmaceutical industry

Exploratory Research Pre-clinical development

Clinical development

Registration Procurement and

manufacturing

Marketing Distribution and Phase IV

Recycling

R&D Laboratory development

Commercialization

ResearchAnimal testing

Clinical trial

Drug registration

Mass production

Marketing & post-marketing

Drug recycling

Control of publication and research outcomes

R&D for orphan drug and neglected diseases

R&D for developing countries diseases

Clinical trial disclosure

Respect for persons, beneficence and justice

Children and women in clinical trialClinical trial in developing countriesAnimal welfare

Patent protection and extension with lobbying

Political contributions to promote legislation friendly drug to manufacturers

Drug safety in manufacturingm distribution and post-marketing processes

Pricing for medicine; Influence over professionalsLabeling and promotional information and materialDrug pricing transparency

Air emission

Solid and hazardous waste

Spill and release in water

Hazardous materialWater waste

BiodiversitySource: Evaluation of CSE performance , Palazzo, G. et al, UNIL 2010

Unethical Issues in the pharmaceutical industry

TOTAL (1991-2012)239 settlements, 30.2 billion $

Increasing number of cases, increasing costs (1991-2012)

Number of settlements

Financial penalties

Source: Pharmaceutical Industry Criminal and Civil Penalties: An Update, Public Citizen, September 27, 2012 (2012 figures limited to first Semester!)

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

Type of frauds

The Heat of Bribing Doctors in ChinaNov, 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“”.

• 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

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 the transport bureau of the Ministry of Railways

bribe-taking 13 years imprisonment

Jan, 2013

The recent (heavy) hand of the Government (1)

The recent (heavy) hand of the Government (2)

Name Position Crime Sanction Date

LIU ZhihuaFormer vice

mayor of BeijingTaking bribes of 1

million US$Death with a two-

year reprieveJan, 2009

CHEN TonghaiFormer chairman of Sinopec Corp.

Taking bribes of 28 million US$

Death with a two-year reprieve

July, 2009

WEN QiangFormer

Chongqing justice chief

Taking bribes of 2.4 million US$

Death penaltyApril, 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

XU MaiyongFormer vice-

mayor of Hangzhou

Bribery (145million yuan ($22.2

million)) embezzlement

(53.6 million yuan)

Death peneltyJuly, 2011

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 president of the

China Development Bank

Taking bribes totaling RMB 11.96

million (US$1.76 million)

Death with a two-year reprieve

April, 2010

CHEN LiangyuFormer Shanghai Communist Party

Chief

Taking bribery of US$340,000

18 years in jail April, 2008

ZHENG Xiaoyu

Former director of China’s top food and drug safety

agency

Taking bribes of 6.49 million RMB (US$ 850,000)

Death penalty Jun, 2007