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KEYCODE BAYER 548

April 17, 2013
Coalition against Bayer Dangers

Annual Stockholders ' Meeting on April 26, 2013

We hereby notify you that we will oppose the proposals of the Board of Management and the Supervisory Board as regards Items 2 and 3 of the Agenda, and will induce the other stockholders to vote in favor of the following countermotions.

Countermotion to Item 2: The actions of the members of the Board of Management are not ratified

Fatal clinical trials in India
The Indian government states that hundreds of subjects die every year in the course of clinical trials. A list drawn up by the Drugs Controller General of India (DCGI) for 2011 shows that 57 trial subjects died during clinical trials sponsored by Novartis alone. BAYER and Pfizer come next on the list, with 20 fatalities each. Between 2007 and 2010, 138 Indian citizens died during trials sponsored by BAYER, four of them as a result of the side effects of the controversial anticoagulant drug Xarelto. BAYER paid their surviving dependants just USD 5,250 in compensation.

Companies like Novartis, BAYER and Pfizer knowingly put the lives of Indian trial subjects at risk. Investigations in India repeatedly show that trial participants are not informed of the dangers associated with the medications being tested – they often don't even know that they are taking part in a trial. It is therefore hypocritical for pharmaceutical companies to claim that the same standards apply in India as in Europe.

Trials are outsourced to India because the costs are lower there and, more particularly, because of the low level of regulatory oversight. An investigation commission instructed by the Indian parliament recently identified serious shortcomings at CDSCO, the regulatory authority responsible for medicines: "For decades it has served primarily the interests of the pharmaceutical industry and consequently neglected consumer interests," is the conclusion drawn by the report. In marketing authorization procedures for medicines the CDSCO has relied on opinions from experts working at the behest of the pharmaceutical manufacturers. The commission names Xarelto, a product from BAYER containing the active substance rivaroxaban, as an example: "The three expert opinions for rivaroxaban (BAYER), a medicine used to thin blood, are almost identical copies." The health of trial subjects is knowingly being put at risk.

A few weeks ago, BAYER in China was ordered by a court to pay compensation of some EUR 50,000 to a woman who had taken part in a trial with Xarelto. The plaintiff had only barely survived the tests.

more information on clinical trials in India