Bitter Pills:Medicines & The Third World Poor | Page 177

were not among the original signatories, and by May 1982 less than half the WHO
member countries had agreed to participate. (5I) Some exporters would not agree
to comply with all the terms of the scheme. Britain, for example, undertook to
certify only the quality (not safety and efficacy) of drug exports, in accordance
with the Medicines Act. (52)
Governments of drug-producing nations also stress that WHO is already collecting
and disseminating drug information useful to developing co untries. They also
point out that Third World regulatory agencies can always consult reference books
and their better-equipped counterparts in developed countries for assistance in
evaluating drugs. (53) But the existing mechanisms are totally inadequate to meet
the needs of the regulatory agencies throughout the Third World. Data-collection
and dissemination on new products, adverse reactions and drugs withdrawn from
the world market is handled by only a couple of scientists at WHO headquarters.
WHO also runs a computerised system to collect details of drug adverse reactions
in Uppsala in Sweden. But hardly any developing countries are amongst the two
dozen nations to whom information is currently being circulated, despite the fact
that more developing countries would like to participate if they were allowed to.<54)
Some recent initiatives to give more support to developing countries in improving
their regulatory systems have been coordinated within the European Region of
WHO. These proposals have had most active backing from the Nordic countries
(Norway, Denmark, Sweden and Iceland). Some have met with opposition from
other European Governments, notably those of Switzerland, West Germany,
France and Britain. (55)
One recent initiative was a series of discussions between regulatory authorities
from developed and developing countries held in Rome. Referring to one of the
aims behind the meetings ("to propose a scheme for cooperation in registration
and drug control between developed and developing countries") a senior WHO
official felt the need to describe the intention as "innocent" when he addressed
an audience including representatives of the US drug industry. (56) A proposal
that has been fiercely resisted by governments of a number of influential drug
producing nations is to establish a Drug Evaluation Unit in Copenhagen. Amongst
other functions, this would assist developing countries by providing reliable and
impartial assessments on new drugs. Industry may be keen to see more uniformity
in drug registration procedures which would cut their costs, but there is concerted
opposition to any suggestion of supra-national evaluations of new drugs. (57)
In assessing new drugs the question whether they are really needed is central to
poor countries. But amongst developed countries, the Norwegian Government
is exceptional in including a "test of need" for new drugs.<58) Most governments
in the rich world are unanimous in opposing the concept of "need" becoming
a criteria for assessing new drugs. (59) Inevitably this limits the relevance and
usefulness of their regulatory decisions as a guide to Third World health
authorities.
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