UnEthical issues in the Pharmaceutical industry Unethical Issues

(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: Glaxo. Smith. Kline has reached a record $3 bn (£ 1. 9 bn) 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 Glaxo. Smith. Kline 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: Glaxo. Smith. Kline 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 Rmb 30 m ($4. 9 m) 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 Glaxo. Smith. Kline'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 600 M, & property confiscated: RMB 200 M May 18, 2010 Former vicemayor of Hangzhou Bribery (145 million 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 two. China 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