Ternational Conference on Harmonisation

Write 12 pages thesis on the topic roche. ternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is the global regulatory body that determines quality, safety, efficacy, and multidisciplinary (e.g. medical terminology) standards pertaining to the pharmaceutical industry. Failure to meet these standards may prevent a firm from marketing its products in other countries. (Social & Environmental Factors, 2009)In 2007, the world pharmaceutical market was valued at $664 billion at ex-factory prices (EFPIA, 2009), with the US accounting for 60% of global sales (The Pharmaceutical Industry, 2008) While the big pharmaceuticals have the market cornered on patented products, the growth of the generic drug segment has capitalized on the lower cost of producing drugs whose patents have already expired. (The Pharmaceutical Industry, 2008) Furthermore, newly emergent market institutions such as health maintenance organizations (HMO) and pharmacy benefit managers (PBM) has expanded the market for pharmaceuticals. Whereas formerly, drug companies targeted prescribing physicians in their marketing efforts, they now also vie for placement in health plan protocols and contracts with HMOs. There has also been a rush in acquisitions of PBMs by drug companies in their efforts to consolidate, both horizontally and vertically. (The Pharmaceutical Industry, 2008)By the nature of its product, pharmaceutical research and development has provided much benefit to society in general in terms of lengthening of life expectancy and improving the chances of recovery from illness. There is evidence that on the basis of statistics garnered in Europe, the number of deaths due to cancer has decreased proportionately to the number of cases diagnosed in the European Union (EFPIA, 2009). The same is true for HIV/AIDS and cardiovascular diseases.

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