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A Perspective on New Zealand’s Medicines Regulatory Environment

This paper is a broad review of the regulatory system applied to therapeutic products in New Zealand. The responsibilities and procedures of the Health Authority, Medsafe, are described. Medsafe applies a risk category approach to the processing of applications to market new medicines. Medsafe also works closely with the pharmaceutical industry and the Advertising Standards Authority in the development of a guiding authority to allow direct-to-consumer advertising of prescription medicines. The subsidization of medicines by government is administered by PHARMAC. This government agency uses strategies such as reference pricing and sole supply tendering to reduce the country’s drug bill. The overall effect of this agency’s policies is to create a generic industry which is perceived as hostile to innovative companies. This has an impact on patients and on the amount of investment by the industry in research and development. Unless this negative climate is altered, New Zealand is likely to be disadvantaged in the development of its fledgling biotech industry — one of the major growth areas of the twenty-first century.