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  2. From bench to bedside
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From bench to bedside

BMJ 2005; 331 doi: https://doi.org/10.1136/sbmj.0509346 (Published 01 September 2005) Cite this as: BMJ 2005;331:0509346
  1. Manique Wijesinghe, third year medical student1
  1. 1University of Southampton

Manique Wijesinghe explains how new drugs become licensed and how the pharmaceutical industry ensures a good return from its investment

Pharmaceutical innovations in the past several decades have accounted for vast improvements in public health the world over. In 2003, 650 million prescription items were dispensed in the United Kingdom. And the pharmaceutical industry has been described as “a jewel in the crown of the UK economy.”1 The NHS spent more than £7bn ($13bn; a10bn) on drugs in 2003, and branded drugs accounted for 80% of this figure (box).1

Branded and generic drugs

When a drug company produces a successful new molecular entity, patents protect it legally and commercially from duplicitous production by other companies. The patenting process, usually complete by the phase II trial stage, gives exclusive production and marketing rights to the originating company for 10 years.

After a patent expires, other manufacturers are able to put out the same drug onto the market, in an unbranded (generic) form. In 2002, 53% of all prescriptions dispensed in England were for unbranded medicines but accounted for only 20% of total drug costs.1 Generic forms of a drug tend to be about 80% cheaper than the branded version.1

In UK hospitals, generic drug names are automatically substituted in place of branded products, and general practitioners are encouraged to write prescriptions for generics.

Drug development

Drug research and development is a costly and uncertain process. Many new molecular entities fail stringent tests for safety and efficacy (figure 2).

Phase I, II, and III trials are done before a marketing licence is granted, but phase IV trials form a postmarketing surveillance system. Adverse drug reactions in this time should be reported to the country's drug licensing authority—in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) and in the United States, the Food …

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