Novartis America is sued again, super national treatment becomes the death free card in China

2013-05-03 source: the U.S government, which once issued huge fines to Pfizer, GlaxoSmithKline, Abbott and Johnson & Johnson, recently targeted Novartis, another leading global pharmaceutical company With two prosecutions in ten days, Novartis became the center of the storm Recently, the U.S Justice Bureau announced on its website that it formally sued Novartis The reason is that through the "Speaker Program", Novartis gives kickback benefits and expensive entertainment enjoyment to participating doctors, resulting in the loss of millions of dollars in the reimbursement costs of the federal medical welfare plan According to the U.S Department of justice, from 2002 to 2011, the speaker program covered more than 38000 doctors, with a total cost of about $65 million Some of them are even held in places where it is almost impossible to do propaganda, such as leisure restaurants and fishing trips along the coast of Florida, etc., and thousands of per capita catering and direct kickbacks are common Novartis may face a civil penalty of three times the illegal income penalty for alleged violation of the federal false declaration act In terms of the company's management structure, the compliance system of foreign pharmaceutical companies is globally unified and loose, but the reality of repeated lawsuits is almost isolated from the Chinese market "This is still related to the super national treatment of foreign pharmaceutical enterprises in China Such compliance problems happen every day and exist for a long time," a senior pharmaceutical marketing person told reporters In China, as long as pharmaceutical companies do not bribe with real gold and silver, they are generally not likely to be investigated " Novartis, the "habitual offender", has been sued for compliance within ten days, and has been reconciled for many times in the previous two years due to kickback litigation Novartis has been regarded as a "habitual offender" by the U.S government On April 23, local time, the U.S government sued Novartis, a Swiss pharmaceutical company, for medical fraud, saying it had paid rebates to relevant pharmacies in order to let organ transplant patients abandon their competitors' drugs and switch to Novartis' mycophenolate mofetil sustained-release tablets "Novartis paid kickbacks to at least 20 pharmacies in the form of rebates and discounts, which resulted in millions of dollars of misrepresentation for Medicare and Medicaid programs, in violation of the U.S false reporting act." On April 26, the U.S Department of justice focused on the compliance of Novartis' speaker program In order to increase the sales volume of its three drugs: valturne, lotrel and starlix (the common name: nateglinide), Novartis was accused of entertaining and giving money in violation of the compliance requirements According to the content of the internal investigation of Novartis quoted in the relevant litigation documents, for the speakers or participants of the "speaker program", the benefits provided by Novartis, such as entertainment and kickbacks, are a "high return investment" Since then, the proportion of doctors who change to prescribe relevant drugs of Novartis has greatly increased Take lotrel, an antihypertensive drug, as the combination of benazepril, an ACE inhibitor of Novartis, and amlodipine, a calcium antagonist of Pfizer After its launch in the United States in 1995, this drug has long maintained the market leader position of ACE inhibitors in the United States, and even accounted for about 80% of the sales in the U.S market segment in the peak period However, after the expiration of patent protection in 2007, Novartis also encountered challenges from competitors including GlaxoSmithKline in the new ACE inhibitor combination drug market Doctors holding the right of prescription have naturally become the focus of propaganda and guidance of major pharmaceutical enterprises However, Novartis China is very secretive about whether starlix, a diabetes drug already marketed in China, also has compliance risks "Novartis China has always operated in accordance with the laws and regulations of various countries, and also strictly implemented the high requirements of global compliance of Novartis Specific US litigation questions need to be answered by global headquarters " Min Xi, communication director of Novartis (China), told reporters According to incomplete statistics of China's compliance test, since 2012, the United States government's three fines for drug companies have amounted to $6.8 billion Last July, GlaxoSmithKline, a British pharmaceutical company, pleaded guilty to charges of illegal marketing of prescription drugs and agreed to pay a $3 billion fine to settle the case Johnson & Johnson also ended the U.S government's investigation into the illegal marketing of its psychotherapeutic drug risperidone and several other drugs last year at a high price of $2.2 billion In 2009, Pfizer and Lilly also paid $2.3 billion and $1.4 billion in fines for their earlier violations In September 2010, Novartis agreed to pay $422.5 million to settle criminal and civil lawsuits against its payment of kickbacks and illegal marketing As part of the settlement, Novartis also signed a five-year corporate integrity agreement with the U.S Department of health and human services (HHS), during which it may be denied access to the U.S federal health care program in the event of a material breach of the agreement It also makes the impact of the two lawsuits this month even more profound The reporter learned that in addition to such a "frank and lenient" compliance active reporting system, the origin of professional managers of major pharmaceutical enterprises also led to the trend of new officials to actively report the old problems left by their predecessors after taking office in order to draw a clear line of their own Under the same compliance system, the foreign tycoons who have been punished repeatedly in the European and American markets are safe and sound in China, but the compliance departments of the major enterprises involved in China have not heard the news of dismissal However, domestic medical workers are often found to take bribes in the news, the lack of accountability of bribers leads to a lot of questions "China's regulatory system for compliance of pharmaceutical enterprises is not perfect Many foreign enterprises directly cooperate with government departments in projects Over the years, the basis of government public relations has played a key role in the outbreak of compliance risks." "Novartis has a particularly strong government relationship," said the marketer However, the compliance pressure of major pharmaceutical companies in China is also increasing rapidly Zuo yuzeng, media director of rdpac (pharmaceutical research and development industry committee of China Association of foreign funded enterprises), told reporters that the compliance of foreign pharmaceutical enterprises is basically a global line down, and the loopholes found in compliance will be blocked, which is generally more and more strict For those involved in finding compliance issues, a one vote veto system is adopted, no matter how good their performance is After all, it is related to the overall image of the company and the direct interests of shareholders Moreover, many foreign pharmaceutical companies are subject to additional restrictions under the FCPA "With the change of the general environment in recent years, the internal review of enterprises is increasing Local companies will have their own compliance officers to conduct daily review, and these pharmaceutical companies will send personnel from their headquarters to branches in different countries for two rounds of review every quarter Similar product publicity materials and means shall be subject to the approval of medical department, legal department, public relations department and other departments at all levels " Zuo yuzeng pointed out