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Trans pacific partnership agreement threat to cheap Australian drug access

Intellectual property protections mooted to be part of the Trans Pacific Partnership Agreement with the United States may have a negative impact on access to affordable medicines in Australia, according to a For Debate published online today by the Medical Journal of Australia.

The recently leaked latest draft of the Trans Pacific Partnership Agreement (TPPA) contains 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.

Dr Deborah Gleeson, from La Trobe University in Melbourne, and her coauthors wrote that if the provisions were agreed to they would “future-proof existing low standards that are antithetical to promoting access to, and affordability of, medicines”.

“These will not only extend monopolies over expensive new treatments, but will also make subsequent reform efforts increasingly difficult.”

“Evergreening” patents are secondary patents held by the owner of the original patent. Evergreening patents could delay generic competition for up to 20 years beyond the date from which generic – and therefore cheaper – drugs should have been available, Gleeson et al wrote.

“Evergreening delays generic market entry and imposes large unnecessary costs on the health care system – and on consumers”, they wrote.

“Australia is supporting a provision that commits countries to make patents available for “any new uses, or alternatively, new methods of using a known product” as this is current Australian practice.

“But acceding to this provision in the treaty text will limit Australia’s options for much needed patent reform in future.”

As a signatory to the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights, Australia is obliged to provide 20-year patents. In 1998 5-year delays were introduced and data from the Pharmaceutical Benefits Scheme showed that between 2003 and 2010 58% of new molecules listed on the PBS were given extension of term. Nearly half of the patent term extensions granted since 1999 have received the full five years.

“The cost of these extensions to the PBS in 2012-13 was estimated at about $240 million in the medium term and about $480 million in the longer term”, Gleeson et al wrote.

The 2013 Pharmaceutical Patents Review (PPR) found that there was “no evidence” that the public investment in longer terms had led to increased investment in research and development of new drugs.

“The PPR concluded that patent term extension was not in Australia’s interests, and recommended reducing the maximum length of extensions or the maximum effective patent life”, Gleeson et al wrote.

“The most recent draft TPPA IP [intellectual property] text includes provisions for term extensions for delays in the processing of patents and in the regulatory approval process.”

The third area of concern in the TPPA involves data protection – “preventing or delaying the reliance, by a generic manufacturer, on clinical trial data produced by the originator to support marketing approval of its product”.

Although no data exists about the impact of data protection on Australian medicine costs, other countries have concluded that “its introduction leads to increased costs”.

“Proposals for the TPPA include 5 years of data protection for new products, an additional 3 years for data produced to support new uses of existing products, and a longer period of data protection for biologics (possibly up to 12 years)”, Gleeson et al wrote.

“Extending data protection to new uses of existing products and allowing longer periods of protection for biologics are likely to lead to significant delays in the market entry of cheaper generics and biosimilars in Australia.”

Gleeson and her coauthors concluded that pharmaceutical monopoly protections already cost the Australian health systems hundreds of millions of dollars each year.

“US ambitions for the TPPA … in the most recently leaked draft would expand and entrench costly monopolies in Australia, with no evidence of any countervailing benefit to the Australian public”, they wrote.

“The government’s stated concern about the need to ensure the sustainability of the PBS can hardly be credible if it ignores this warning in the final stages of the TPPA negotiations.”


Medical Journal of Australia (MJA)