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FOCUS 33
Taking the risk OUT OF
REGULATION By HITESH PATEL & IAN JACKSON
Establishing a risk resilient culture and effective monitoring processes are critical to preventing unethical behaviour within pharmaceutical and life sciences companies. A smarter, data-led, ‘forensic’ approach can identify unacceptable practises before they cause wider damage. Such advances, allied with a more transparent culture, should help the industry to rise to the complex challenge of addressing fraudulent behaviour.
M
any sectors, including the pharmaceutical and life sciences industry, have come under increased scrutiny from regulators, shareholders and
the press. Stories of suppressed disclosure of side-effects in clinical trials have come on top of alleged reports of over-aggressive sales techniques, bribing of doctors and administrators, and ‘off-label’ marketing of drugs for non-approved therapeutic areas.
A contribution to this has been an increasingly competitive marketplace – including high growth territories where regulations appear to be less developed. The cost of developing new drugs has soared while pipelines have dried up, with fears that the days of the lucrative mega-drug have passed for ever.
Creating a risk resilient culture and effective monitoring is key to preventing unethical behaviour within pharmaceutical and life sciences companies
© 2014 KPMG LLP, a UK limited liability partnership, and a member fi rm of the KPMG network of independent member fi rms affi liated with KPMG International Cooperative, a Swiss entity. All rights reserved.
REGULATION
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