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166 Fighting the Diseases of Poverty
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patent might not be justified – these might apply, for example,
to research tools and certain genetic sequences.
Competition between patenting authorities. While it may be
desirable to have common minimum standards for patents,
such as those to which members of the WTO have agreed
under TRIPS, it is important also to retain a degree of
competition between authorities in order to ensure that the
appropriate breadth of patents may be discovered. 30
Pre-market regulations
Companies are required to comply with an increasing number of
regulations before they can launch a pharmaceutical product onto
the market. This drives up the costs of supply, making the end
product more expensive and thus less affordable for customers in
lower-income countries. According to a survey of 20 leading pharmaceutical
companies conducted by the CMR Institute for Regulatory
Science in 2003, 65 per cent of companies felt that the change
in the regulatory environment over the preceding three years had
increased the cost and time of bringing new medicines to market.
Furthermore, 23 per cent of those surveyed felt that the increasing
regulatory burden was directly responsible for the decline in NME
submissions (CMR, 2004). In South Africa, the situation is exacerbated
by the Department of Health’s stipulation that it approve all
new drugs, even if they have been approved already in the EU, US
or Japan. This can add delays of two or more years before new medicines
are available in South Africa.
Because regulatory bodies are beholden to national governments,
their tendency is to ensure that the potential side effects of
new drugs are minimised as far as possible. This is because the publicity
surrounding the discovery of an unsafe drug in the market
leads to a public outcry, resulting in high political costs for national
regulatory authorities. The missed gains from new medicines that
are delayed or refused approval are less obvious (or even intangible)
to the general public, so regulators have an incentive to err on the