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168 Fighting the Diseases of Poverty
while the European Medicines Agency has instituted stiff targets for
the marketing approval of orphan drugs. These represent a step in
the right direction, but governments are often tempted to impose
further regulations on drugs manufacturers when they come under
political pressure. A recent example comes from the United
Kingdom, where the health minister Lord Warner revealed that he
is considering a fourth stage of clinical trials to alleviate safety fears
surrounding new drugs. Legislators should resist the temptation to
assuage public fears through such excessive regulation, because it
would increase the time and expense of getting a drug to market.
This would be most harmful for the development of drugs for
regions or diseases where returns are the lowest – most typically,
diseases endemic to lower-income countries.
One solution that would ensure new drugs reach markets as
quickly as possible – in part by reducing the ability of local drug regulatory
agencies to impose arbitrary and overly stringent requirements
on new registrations – would be to enable competition
between existing national drug regulators, as well as between
private certification boards (Sauer, 2005).
Such accountable, competitive regulators would set the standards
of regulation at levels demanded by those making choices
about drug regimens. For many drugs, this would mean swifter
approvals and a reduction in development costs, leading to an
increase in the number of drugs developed for most diseases – especially
those which affect the poorest and those which affect relatively
smaller populations – while also reducing the price of
medicines to all.
Public health would be safeguarded by the desire of these
agencies to defend their own reputations. The importance of reputation
in maintaining clients and attracting new ones, the existence
of a free press engaging in investigative journalism, and
expected penalties through the legal system for corrupt and dangerous
decisions by these regulators, should lead to a well-functioning
market in drug approval. A drug approval agency that
bends to pressure from pharmaceutical companies, for example,