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Increasing access to medicines 167side of caution. However, if the regulator only considers potentiallyharmful side effects, this will have the unintended consequence ofraising the cost, and delaying or preventing the approval of newdrugs.One consequence of an excessively precautionary approach isthat regulatory authorities allow new medicines or vaccines to besold to the public only after extensive pre-clinical and clinical trialshave been performed. These trials examine the safety, quality andefficacy of the new drug in treating or curing diseases. Estimates ofthe average time it takes to for a new drug to go through these trialsrange from 8.5 to 13.5 years, a process which adds considerablecosts to the drug development process (DiMasi, 1995; Adams &Brantner, 2003; Dranover & Meltzer, 1994).Estimates of the cost of bringing a new drug to market vary;some researchers suggest that the total cost is over US $800 million(DiMasi et al., 2003). As such, manufacturers have strong incentivesto concentrate their resources on developing ‘blockbuster’ drugsthat will provide a return on that significant investment. Meanwhile,there is less incentive to invest in drugs for rarer conditionsin the richer world (such as psychiatric disorders) and even for relativelycommon diseases in lower-income countries.Professor Sir Michael Rawlins, Chairman of the UK’s NationalInstitute for Health and Clinical Excellence, has argued that many ofthe preclinical and clinical studies required by various regulatoryagencies add little to the safety of the final product, but instead contributeunnecessarily to the estimated US $300–450 million cost ofclinical development (Rawlins, 2004). Clearly removing excessivelyprecautionary regulatory barriers would speed up drug developmentand reduce costs, creating stronger incentives to invest in thedevelopment of new drugs for diseases that may otherwise be relativelyunprofitable.To some extent, the length of time it takes for new drugs to enterthe market, and the consequent cost to society of delays, is an issuerecognised by regulatory agencies. The FDA has adopted ‘fast-trackapproval’ and ‘accelerated approval’ for certain classes of drugs,