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The Life Sciences Law Review aims to provide an overview of legal issues of special interest to pharmaceutical, biotechnology and medical device companies in 27 jurisdictions. The life sciences sector is of vital importance to the health and well-being of persons around the world. Innovative manufacturers play a key role in the discovery and development of new therapies, while generic manufacturers serve an equally important function by ensuring availability of inexpensive products once patents and regulatory exclusivity periods expire. Throughout the lifespan of a drug or device – from the earliest discovery stage, through non-clinical tests and clinical trials, the governmental approval process, and after entry to the market – lawyers play a central role as advisers to the industry.
In addition to product pre-clearance procedures, many jurisdictions impose requirements for approval of pricing or reimbursement of pharmaceuticals and, to a lesser extent, devices. These are addressed in the entry for each country. We also set out basic information on administrative and judicial remedies, controls on financial relationships with prescribers and payors, special liability systems, and transactional and competition issues that are specific to pharmaceuticals and medical devices.