Financial Costs Associated with Monopolies on Biologic Medicines in Australia

Intellectual property (IP) provisions that were pursued by the United States (US) in the Trans-Pacific Partnership Agreement (TPP) negotiations generated widespread alarm. Subsequent leaks of composite drafts of the IP chapter showed ongoing resistance by most countries to many of the US proposals that would delay access to generic medicines.

A journal article in Australian Health Review by Deborah Gleeson, Hazel Moir and Ruth Lopert focuses on three particular problems for Australia that remained in the 2014 draft. For each of the problems identified, the authors examined existing public domain data to identify the costs to Australian taxpayers of existing patent and data protection, as well as those that would have been likely if the Australian government acceded to US ambitions on these matters.

The authors identify three of the greatest concerns for Australia during the TPP negotiations as provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms and extend monopoly rights over clinical trial data for certain medicines. Pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars a year, and provisions in the TPP would have further entrenched and extended costly monopolies. The authors warn that the government’s stated concern about the need to ensure sustainability of the Pharmaceutical Benefits Scheme would not be credible if it ignored this warning in the final stages of the TPP negotiations.