Bitter Pills:Medicines & The Third World Poor | Page 151

qualification in drug use). In practice these controls are easily by-passed, as an
anthropologist observed: "Licensed pharmacists or idoneos often appear at the
store only to sign the appropriate documents for the renewal of the pharmacy
licence, in early January, and thereafter simply to pick up their pay checks on
a monthly basis. Their time is spent pursuing other business interests." (621
Another policy option considered by some governments is to limit the range of drugs
that untrained retailers can sell, in much the same way as restricting paramedics
to an agreed list. This system has been adopted in Mozambique.(631 But regulatory
authorities in most developing countries have little more than a handful of drug
inspectors. It would be an impossible task for them to monitor the vast number
of scattered retailers, not to mention illegal traders. So most have concentrated
any efforts made on trying to control the drugs that come onto the local market.

DRUG REGISTRATION
In the rich world stringent controls are applied to new drugs before they can be
marketed. In Britain, for example, the main objective of licensing procedures
is to ensure that the usefulness of drugs outweighs their possible hazards and that
they are effective for each use recommended by the manufacturer. Criteria of
cost-effectiveness, vital to poor countries, are not taken into consideration in
allowing a new drug onto the market.
Most developing countries operate some, often minimal, registration procedures.
Few regulatory authorities in the Third World are in a position to evaluate the
evidence produced by manufacturers to support their claims. Few have access
to unbiased scientific evaluations, much less facilities to make their own clinical
trials. They have to rely on regulatory decisions taken in Europe and the US. These
are often contradictory, but should keep dangerous or ineffective drugs off the
market. However, they offer poor countries no guarantee that a new drug
represents value for money in meeting their specific needs.
The registration system operated in Cuba before the 1959 revolution illustrates
the problems faced by other developing countries today. This is described in a
recent UNCTAD report as "merely a bureaucratic formality with a firm presenting
a large volume of information, which no one read, and then making the required
payment of excise taxes as well as other irregular payments." (64)
Today the Cuban National Formulary Commission makes a detailed evaluation
before any new drug is approved for use in the country. Controlled clinical trials
are carried out to assess whether the new drug has clear medical advantages over
cheaper drugs already on the market. According to the UNCTAD report, the
experience of the Cuban regulatory authorities has shown that disregarding "the
subjective factors introduced by commercial propaganda, ... when economic
studies are made, it is found that in the majority of cases, the cost per treatment
with the new drug is four to ten times higher than with the one in current usage,
with more or less the same effectiveness". (65)
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