The Pharmaceutical Industry and Product Liability Exposures

In the broadest sense, the Pharmaceutical Industry comprises various different business models which cover all or only some parts of the pharmaceutical product life cycle. Traditionally, the pharmaceutical industry segment was constituted by research-based pharmaceutical companies which had an integrated business model from the research laboratory to distribution, meaning they developed, manufactured and distributed medicinal products. A pharmaceutical product is defined in the term medicinal products within the European Union in Article 1 of Directive 2001/83/EEC as follows: Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack Medicinal Product: Any substance or combination of substances presented for treating or preventing diseases in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.