Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans‐Pacific Partnership Agreement

Abstract

Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved. Three of the greatest concerns for Australia in the recent draft include 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. Data from the 2013 Pharmaceutical Patents Review, and from various submissions made to it, show that pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars each year. Provisions still being considered for the TPPA would further entrench and extend costly monopolies, with serious implications for the budget bottom line and the sustainability of the Pharmaceutical Benefits Scheme.

Advancing Public Health on the Changing Global Trade and Investment Agenda Comment on "The Trans-Pacific Partnership: Is It Everything We Feared for Health?"

“…28 As a result, some of the original US proposals were excluded from the TPP, and others were mitigated to a significant degree. 29,30 However, provisions included in the final text of the TPP will still have a significant impact on access to medicines in developing countries, which were successful in securing only short and inflexible transition periods for implementation. 1 …”

Financial costs associated with monopolies on biologic medicines in Australia

“…1 Biologic medicines (biologics) are produced from living organisms through biotechnological processes. 1,2 They include many new medicines for cancer and other serious illnesses, such as rheumatoid arthritis and multiple sclerosis. 2 These complex products tend to be very expensive, particularly while they are under patent.…”

“…1,2 They include many new medicines for cancer and other serious illnesses, such as rheumatoid arthritis and multiple sclerosis. 2 These complex products tend to be very expensive, particularly while they are under patent. 1 For example, pembrolizumab (Keytruda, Merck Sharp & Dohme), a drug for metastatic melanoma, cost patients approximately A$150 000 for a year's treatment before it was subsidised by Australia's PBS.…”

“…The pharmaceutical industry, however, has been lobbying for longer monopolies on biologics through trade deals such as the proposed Trans-Pacific Partnership (TPP). 2,7,8 The final text of the TPP, signed in 2016, included a novel set of provisions specifically targeting biologics. 7 Although it seems probable that the TPP will not proceed in its original form following the withdrawal of the United States, the remaining 11 TPP countries are seeking to revive the deal, albeit possibly with the biologics provisions suspended pending re-entry of the US 9 .…”

The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines

“…7 Nine TPP countries provide no guaranteed exclusivity periods for safety and efficacy data associated with biologic drugs because the complex manufacturing processes required to create these medicines naturally makes for fewer follow-on biologic competitors and fewer cost reductions arising from that competition. Notably, in the United States, the Federal Trade…”