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Korean Life Sciences Firms Urged to Adopt U.S. and E.U. Risk Management Practices

SEOUL, KOREA, April 23, 2010 - More than 200 Korean pharmaceutical and other life science executives were warned to implement safety and other best practices or face increased litigation and regulatory risks in U.S. and European markets. U.S. and Korean speakers issued this caution at a seminar organized by Chubb Group of Insurance Companies for the Korea Health Industry Development Institute, Korea Pharmaceutical Manufacturers Association and Korea National Enterprise for Clinical Trials.

"Korean pharmaceutical and medical device manufacturers that conduct business in the United States and European Union need to know the steps they can take to help minimize litigation and regulatory risks they face in these countries," said Moses Ojeisekhoba, senior vice president and Asia-Pacific zone officer for Chubb.

Seminar speakers pointed out that the Korean government has designated the pharmaceuticals and biomedical devices industry as one of the six sectors expected to serve as future drivers of the country's economic growth. A 14-year plan, launched in 2000, includes substantial government support of national biotechnology research and development programs. Speakers also cited statistics from the International Trade Centre that Korean manufacturers in 2009 exported $55 billion of medical devices and pharmaceutical/life science products to the United States and $49.1 billion in such products to Europe.

Frank Goudsmit, vice president of Chubb & Son and international life sciences manager for Chubb, advised manufacturers not only purchase liability insurance but also to implement or expand best practices to reduce their clinical trial litigation exposure both at home and abroad. These best practices include:

  • testing informed consent documents to make sure that participants will understand the risks; 
  • providing adequate disclosure of potential conflicts of interest of that can be construed as impairing an investigator's judgment;
  • assuring that clinical investigators, clinical research organizations and ethics committees have the proper training, accreditation, experience, expertise and workload capacity for the study and that their compliance records are satisfactory;
  • writing fair and balanced contracts in which the manufacturer does not assume liabilities for matters outside its control; and
  • tracking how a product is being used in the marketplace and communicating with doctors about adverse trends.

 

"Juries want to see that companies are actively monitoring the use and adverse reactions of the product and taking action when necessary, not just sitting back and collecting the sales revenues," said Goudsmit. "A plaintiff attorney will have a hard time successfully attacking a company that does these and other things well."

Chubb provides an enterprise-wide approach to helping life sciences firms protect themselves from property and liability exposures that potentially can have a devastating impact on their balance sheets.  A variety of specialized insurance products can respond to loss or damage to property; loss of milestone payments due to property loss or damage; and errors and omissions that can manifest into future bodily injury.

The member insurers of the Chubb Group of Insurance Companies form a multibillion dollar organization providing property and casualty insurance for personal and commercial customers worldwide through 8,500 independent agents and brokers. Chubb's global network includes branches and affiliates throughout North America, Europe, Latin America, Asia and Australia. For more information, visit www.chubb.com.