TPP: Ambiguous provision regarding biologic medicines a major worry for NZ

The delayed publication of the final TPP text on Thursday has raised concerns amongst health experts that the victory Australia and New Zealand have claimed over the US demand to extend monopolies on biologic medicines could be undermined by ambiguities in the text.

“The actual legal terms of the TPP are what will matter in any dispute that arises, rather than the understandings the trade ministers feel they reached in Atlanta” said Dr Deborah Gleeson, a public health researcher from Australia’s La Trobe University who has been following the TPP negotiations for over four years and has published extensively on the TPP and access to medicines.

“The text offers two options: at least eight years of protection of clinical trial data; or at least five years of data protection along with other measures to deliver a comparable outcome in the market” said Dr Gleeson. “This leaves room for the US to continue to pressure countries to use administrative delays to keep affordable medicines off the market for an equivalent period of time. Whatever the mechanism used, the effect would be the same: rising costs and delays in access.”

US pharmaceutical companies are already calling for extending these time periods, and have the support of Orrin Hatch, the powerful chair of the US Senate Finance Committee. He has suggested the US Congress will not support the deal unless negotiators go back to the table and force other countries to agree to even longer monopoly times, up to 12 years, for biologics.

“All New Zealanders should be concerned, as these biologic medicines are increasingly involved in treating or preventing a wide range of conditions,” says David Menkes, a PhD pharmacologist and University of Auckland Associate Professor based at the Waikato DHB. “This comes on top of the changes that our Prime Minister has conceded will increase what we pay for medicines, based on patent extensions and changes to PHARMAC’s processes.”

“Recently released TPP provisions give no assurance that the US will accept New Zealand’s current system for approving and funding biologics, so future access to affordable medicines for Kiwis is in considerable doubt. The text also confirms the fears of Doctors for Healthy Trade that the terms of the TPP serve the needs of multinational drug companies at the expense of patients and taxpayers.” says Dr Menkes.

Dr Gleeson’s preliminary analysis of the biologics provisions can be found at: http://itsourfuture.org.nz/wp-content/uploads/2015/11/Biologics-provisions-in-the-final-TPP-text.pdf

ENDS

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