Analysis

Making medicines evergreen

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7941 (Published 29 November 2012) Cite this as: BMJ 2012;345:e7941
  1. Andrew W Hitchings, specialty registrar (ST7) in clinical pharmacology,
  2. Emma H Baker, professor of clinical pharmacology,
  3. Teck K Khong, senior lecturer in clinical pharmacology
  1. 1Division of Biomedical Sciences, St George’s, University of London, London SW17 0RE, UK
  1. Correspondence to: A W Hitchings ahitchin{at}sgul.ac.uk
  • Accepted 9 November 2012

Andrew Hitchings, Emma Baker, and Teck Khong examine how drug companies maximise profits after patents expire and show why regulatory agencies, policy makers, and prescribers need to be alert to the use of these techniques

Over the next three years, the pharmaceutical industry is projected to lose about £5.4bn in UK revenue as exclusivity rights on major brands expire.1 To prevent or mitigate losses from sales of cheaper generic versions, drug companies use a range of “evergreening” strategies to maintain market share. Many of these involve minor modification or reformulation of drugs that do not necessarily provide additional benefit for patients. In 2011, the National Health Service spent £13.6bn (€17bn; $21bn) on medicines, of which about £10bn was spent on branded or proprietary products.1 In an assessment of drugs that accounted for about a fifth of the primary care prescribing budget, the National Audit Office identified over £200m of unnecessary spending on branded products.2 Greater awareness of evergreening techniques could save money and avoid exposing patients unnecessarily to new drugs, with their inherently uncertain risk-benefit profiles.

The profit cycle of medicines

Developing medicines is risky, costly, and time consuming. It takes 12-14 years3 4 and costs nearly $900m (£560m; €700m)5 to bring a medicine to market. Protecting pharmaceutical intellectual property and maximising its commercial exploitation are therefore crucial to recoup these costs. Patents are central to this, providing exclusive rights to commercialise an invention for a limited period, usually 20 years from filing. Because obtaining marketing authorisation (previously known as a product licence) is a lengthy process that delays commercialisation, provisions exist to extend exclusivity rights to partially compensate for this.

Once exclusivity rights over a medicine have expired, others may produce and market it as a generic (non-proprietary) product. The licence terms of the generic usually reflect …

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