Why the drug development pipeline is not delivering better medicines
BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5542 (Published 23 October 2015) Cite this as: BMJ 2015;351:h5542
- Huseyin Naci, assistant professor of health policy1,
- Alexander W Carter, policy fellow2,
- Elias Mossialos, professor of health policy1
- 1LSE Health, Department of Social Policy, London School of Economics and Political Science, London, UK
- 2Institute of Global Health Innovation, Imperial College London
- Correspondence to: H Naci h.naci{at}lse.ac.uk
- Accepted 8 October 2015
Many in the pharmaceutical sector suggest that the industry is in crisis. Industry analysts fret that financial rewards are no longer sufficient for companies to maintain the investment needed to develop clinically useful drugs.1 Despite these concerns, regulators in the US and Europe granted marketing authorisations to a record number of new medicines in 2014. However, the majority of new medicines offer few clinical advantages over existing alternatives. We discuss how both government and drug company practices contribute to the ongoing innovation deficit in the sector.
Paucity of clinically superior medicines
Patients and clinicians commonly understand innovation to mean a medicine that has transformed management and treatment,2 either by providing treatments for conditions with no current (satisfactory) remedies or by offering meaningful improvement over existing options. In recent years, however, industry analysts have adopted other definitions to measure innovation (box 1).3 Currently, the most common approach to measure innovation is to count the number of new drug approvals.3 The number of drug approvals has increased over the past five decades, culminating in 41 approvals in the US and 40 in Europe in 2014 alone; this compares with a 50 year average of 20 approvals a year.4 5
Box 1: Measures of innovation
Number of new drug approvals—used by regulators, drug companies, and policy makers
Technological and pharmacological novelties—for example, changes in pharmacokinetic properties that may or may not be clinically relevant
Number of patents associated with new medicines—used alone or together with citations of new patents
Clinical superiority over existing alternatives—increasingly measured using surrogate endpoints rather than outcomes relevant to patients
Large …
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