AusBiotech has joined with Research Australia and Medicines Australia to pen an open letter to the Australian Parliament calling for Australia to ensure a globally competitive intellectual property (IP) system, particularly data exclusivity provisions.
The letter, titled ‘Australia’s economic prosperity relies on innovation and innovation needs strong intellectual property protections’, was prompted by recent media commentary on the proposed Trans Pacific Partnership (trade) Agreement.
The commentary raises concerns about the possibility of changes to Australia’s intellectual property system. The alliance of Australia’s medical researchers, developers and manufacturers of innovative health technologies represented by the Open Letter’s signatories, contend that these concerns are entirely misplaced.
The Open Letter notes that IP is the fundamental source of protection for innovation: the new research, the new medicines, diagnostics, medical devices and methods of treatment which have been invented through sustained effort and investment. It is especially critical that local innovation is not disadvantaged in any way. Ensuring that Australia has a globally competitive IP system is the key to our future health and wealth.
“To maintain a reasonable level of protection the system needs to be updated from time to time. Over the last 20 years, major reforms have included: changes to patent terms, enhancement of patentability standards and expansion of exemptions to patent infringement,” the letter says.
“At the moment, this need for reform applies to Australia’s provision of data exclusivity, a niche but critical component of our intellectual property system.
“In some circumstances, a patent, a concept over 400 years old, does not provide adequate intellectual property protection to certain types of new medicines and vaccines, particularly ‘biologic’ medicines. Australia’s five-year data exclusivity provision lags global competitors and collaborators such as the United States (up to 12 years), Canada (eight years), the EU (up to 11 years), Japan (eight years) and even countries like Russia and China (six years). This puts at risk investment in Australia’s rapidly growing domestic pharmaceutical and biotechnology sectors.
“Among other reports, the 2013 ‘Strategic Review of Health and Medical Research in Australia’ (the McKeon Review) called upon the Federal Government to extend the term of data exclusivity to harmonise an important element of the Australian IP system with global best practice. We also note that the Australian Parliament recently granted, without controversy, data protection to veterinary medicines for companion animals, namely medicines for Australia’s dogs, cats and other pets. The level of protection went from zero to ten years. That is twice the level of intellectual property protection provided to new cancer medicines and other medicines - for humans - that rely on data exclusivity.”
There were a number of claims contained in recent media articles that are inaccurate, and were addressed in the letter. The recent so-called “Health Impact Assessment" in relation to the TPP, which was extensively quoted in the media, was prepared by the Centre for Health Equity Training and Research and Evaluation at the University of NSW. Signatories to the letter are not aware of any consultation with their respective sectors in relation to any of the many (largely unsubstantiated) claims contained in this “assessment”.
Strengthening our intellectual property system will further cement Australia’s place among the world’s leading investment destinations for pharmaceutical and biotechnology companies, and ensure ongoing patient access to innovative medicines and vaccines.
Read the full Open Letter here.