Australia's federal government has begun a review of the "appropriateness" of the current extension arrangements for pharmaceutical patents.
The existing provisions, which allow drug patents in some circumstances to be extended for up to five years beyond the normal term, were introduced in 1998 and are due for review, said Mark Dreyfus, the Parliamentary Secretary for Industry and Innovation, as he announced that an expert panel has been commissioned to conduct the review.The government, which describes the move as a "practical" step which it is taking to ensure access to affordable medicines while fostering innovation and research, notes that concerns have been raised about a number of aspects of drug patents, including bringing generics to market and the effect of patents in terms of innovation.
Specifically, the expert panel has been asked to consider:
- issues that impact on competition in the pharmaceutical industry, such as the ability of generics to enter the market;
- the importance of the patent system in providing employment and investment in research and industry;
- the impact of pharmaceutical patent provisions on government health expenditures;
- the impact on the Pharmaceutical Benefits Scheme (PBS);
- international approaches to extensions of term for pharmaceutical patents;
- Australia's obligations under international agreements, including Free Trade Agreements (FTAs) and World Trade Organisation (WTO) accords; and
- Australia's position as a net importer of patents and medicines.
Commenting on the review, the research-based industry association Medicines Australia called on the federal government to use the initiative to consider the "compelling case" to extend the patent life of innovative medicines.