Abstract:
The pharmaceutical industry is actively seeking new sources of innovative drug discovery as well as any methods that reduce the extraordinary expense of drug development. The rapid expansion in industry outsourcing has led to increasing competition from countries wanting to capitalise on the opportunities presented. An understanding of New Zealand’s (NZ’s) drug development industry from the perspectives of expertise, enablers and barriers to its development, and economic benefits would enable NZ to compete more effectively in the drug development arena. Theoretical frameworks were developed to assess the NZ drug development industry and questionnaires were designed to obtain appropriate data from senior representatives of almost all of NZ’s organisations. There is specific expertise in drug discovery, as indicated by the number of novel compounds identified, and in clinical research, as shown by the increasing number of industrysponsored clinical trials. A framework was developed and applied to propose policy models for categorising a country’s strategy, the policies and factors affecting NZ’s industry development, and the policies to support further growth. Government funding policies for basic science, medical research and drug development projects have been the most influential factors, followed by polices affecting education, knowledge sharing and pharmaceutical price control. The economic analyses show that clinical research provides substantial revenue to NZ and that drug discovery could also provide significant returns. NZ’s revenue from pharmaceutical industry-sponsored clinical trials has increased steadily since 1998. However, NZ’s clinical research industry needs to be supported by the policies, such as rapid review of clinical trial applications and reasonable cost structures, to ensure it remains competitive. Support is also required to expand NZ’s drug discovery expertise so that the potential returns can be realised. Out-licensing of NZ-discovered compounds has the advantage of the possibility of ongoing revenue to NZ rather than the fee-for-service revenue generated by clinical research. The research results are specific to NZ; however the method of assessing the viability of a drug development industry from the three overlapping perspectives of expertise, policy and economic returns could be implemented by other countries. It is applicable to countries and regions with a similar sized industry to NZ or it could be modified to assess the drug development industry of larger countries.