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The Ernst & Young Global Pharmaceutical Center

Roundtable Wrap-Up from Basel, Switzerland

In 2006, Ernst & Young Global Pharmaceutical Center leadership held client roundtables around the world to explore the shifting landscape facing pharma companies. What are their challenges? What choices do they need to make to achieve the right balance between risk and reward?

Basel, Switzerland. The following important insights come from the Basel Pharma Roundtable that Ernst & Young hosted on 6 November 2006.

Adapting to Change: Trends in Pharmaceutical Compliance

Compliance Officers: The prominence of compliance officers in multinational pharmaceutical companies is increasing worldwide, in part because of the emergence of new regulatory requirements in Europe and Asia-Pacific that are based on laws and regulations first established in the United States. In some cases, General Counsel, Human Resources, Medical Affairs, or a Finance executive (e.g. CFO) may play a part-time compliance role in a local subsidiary.

Medical Affairs: Traditionally, sales and marketing departments held responsibility for spending on such items as grants, gifts, sponsorships, etc. Increasingly, grant-making is placed in the hands of Medical Affairs departments instead of sales and marketing. Pharmaceutical executives may want to ask themselves the following questions when trying to identify emerging issues in the area of compliance:

  • Have we assessed our portfolio of products and ranked them relative to their risk of off-label use by physicians and potential for off-label promotion within the medical community?
  • How are we putting our company at risk when outsourcing sales and marketing activities to third parties?
  • Do the terms of our contracts with third parties (e.g. contract sales force, co-promotion partners, etc.) allow us to perform audits of their compliance with relevant laws and regulations?
  • When performing due diligence during a proposed merger or acquisition, how do we assess the risk of taking on liability associated with previous non-compliance by the target company?
  • Do employees really understand all of the information they are hearing during compliance training sessions?

    Additional Roundtables:
     Mumbai, India, 9 October 2006
    Shanghai, China, 31 October 2006

    Progressions 2006
    The Ernst & Young Annual Global Pharmaceutical Report

    The focus of Progressions 2006 is "Capturing Global Advantage in the Pharmaceutical Industry". Ernst & Young industry specialists and global pharmaceutical leaders from around the world have contributed their insight and outlooks to make it one of the most important publications we offer.

    To request your own copy of Progressions 2006, The Ernst & Young Annual Global Pharmaceutical Report, please contact your local Ernst & Young pharmaceutical representative.

    • Global Pharmaceutical Center
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    To request your own copy of Progressions 2006, The Ernst & Young Annual Global Pharmaceutical Report, please contact your local Ernst & Young pharmaceutical representative.
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