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166 Fighting the Diseases of Poverty◆patent might not be justified – these might apply, for example,to research tools and certain genetic sequences.Competition between patenting authorities. While it may bedesirable to have common minimum standards for patents,such as those to which members of the WTO have agreedunder TRIPS, it is important also to retain a degree ofcompetition between authorities in order to ensure that theappropriate breadth of patents may be discovered. 30Pre-market regulationsCompanies are required to comply with an increasing number ofregulations before they can launch a pharmaceutical product ontothe market. This drives up the costs of supply, making the endproduct more expensive and thus less affordable for customers inlower-income countries. According to a survey of 20 leading pharmaceuticalcompanies conducted by the CMR Institute for RegulatoryScience in 2003, 65 per cent of companies felt that the changein the regulatory environment over the preceding three years hadincreased the cost and time of bringing new medicines to market.Furthermore, 23 per cent of those surveyed felt that the increasingregulatory burden was directly responsible for the decline in NMEsubmissions (CMR, 2004). In South Africa, the situation is exacerbatedby the Department of Health’s stipulation that it approve allnew drugs, even if they have been approved already in the EU, USor Japan. This can add delays of two or more years before new medicinesare available in South Africa.Because regulatory bodies are beholden to national governments,their tendency is to ensure that the potential side effects ofnew drugs are minimised as far as possible. This is because the publicitysurrounding the discovery of an unsafe drug in the marketleads to a public outcry, resulting in high political costs for nationalregulatory authorities. The missed gains from new medicines thatare delayed or refused approval are less obvious (or even intangible)to the general public, so regulators have an incentive to err on the