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Increasing access to medicines 167
side of caution. However, if the regulator only considers potentially
harmful side effects, this will have the unintended consequence of
raising the cost, and delaying or preventing the approval of new
drugs.
One consequence of an excessively precautionary approach is
that regulatory authorities allow new medicines or vaccines to be
sold to the public only after extensive pre-clinical and clinical trials
have been performed. These trials examine the safety, quality and
efficacy of the new drug in treating or curing diseases. Estimates of
the average time it takes to for a new drug to go through these trials
range from 8.5 to 13.5 years, a process which adds considerable
costs 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 incentives
to concentrate their resources on developing ‘blockbuster’ drugs
that will provide a return on that significant investment. Meanwhile,
there is less incentive to invest in drugs for rarer conditions
in the richer world (such as psychiatric disorders) and even for relatively
common diseases in lower-income countries.
Professor Sir Michael Rawlins, Chairman of the UK’s National
Institute for Health and Clinical Excellence, has argued that many of
the preclinical and clinical studies required by various regulatory
agencies add little to the safety of the final product, but instead contribute
unnecessarily to the estimated US $300–450 million cost of
clinical development (Rawlins, 2004). Clearly removing excessively
precautionary regulatory barriers would speed up drug development
and reduce costs, creating stronger incentives to invest in the
development of new drugs for diseases that may otherwise be relatively
unprofitable.
To some extent, the length of time it takes for new drugs to enter
the market, and the consequent cost to society of delays, is an issue
recognised by regulatory agencies. The FDA has adopted ‘fast-track
approval’ and ‘accelerated approval’ for certain classes of drugs,