Despite annual revenues approaching $1 trillion, the global pharmaceutical industry has lately experienced a critical decline in the rate of profit, for which it lays most of the blame on regulatory requirements. A US think tank has estimated the cost of new drug development at $5.8 billion per drug, of which 90 per cent is incurred in Phase III clinical trials mandated by the US Food and Drug Administration and similar agencies in Europe.41 (These are tests administered to large groups of human subjects in order to confirm the effectiveness and monitor the side effects of new vaccines and other medicines.) The international business consulting firm McKinsey & Company called the situation “dramatic” and urged Big Pharma executives to “envision responses that go well beyond simply tinkering with the cost base” – primarily the relocation of clinical trials to emerging markets, where drug safety testing is seen as relatively cheap, speedy, and lax.
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