The release of the Trans Pacific Partnership’s completed intellectual property chapter by Wikileaks on 10 October has raised fresh alarm amongst health organisations, says the Public Health Association of Australia.
The controversial provisions for biologic products are “worryingly ambiguous and unclear”, PHAA says, paving the way for further pressure from the United States to keep cheaper biosimilar products out of the market.
“The Australian Government has assured the public that we will not have to change our laws, and that there will be no adverse impact on our Pharmaceutical Benefits Scheme or the prices of medicines in Australia,” says Professor Heather Yeatman, President of the Public Health Association of Australia.
“We sincerely hope this is the case, as we have repeatedly urged the Government not to sacrifice access to affordable medicines for access to markets.”
But the legal wording in the agreement appears to commit the TPP countries to providing either eight years of clinical trial data protection for biologics, or five years of data protection plus other measures to “deliver a comparable outcome in the market,” says Dr Deborah Gleeson, spokesperson for PHAA.
“We are concerned that our government may face continued pressure to keep cheaper biosimilars out of the market for the full eight years. This pressure may be applied even before the TPP comes into force.”
The legal text agreed between the 12 countries at the conclusion of negotiations includes many provisions that appear harmful by reducing access to affordable medicines at the global level, resulting in much avoidable suffering and death, they say.
“The TPP will be a blow for global health,” says Professor Yeatman, “if it places life-saving medicines out of reach in developing countries and makes it difficult to reform laws, even in developed countries like Australia, to speed up access to expensive new drugs in future.”
“All countries will eventually have to adopt the TPP rules for pharmaceuticals,” says Dr Gleeson.
“The four poorest countries – Malaysia, Mexico, Peru and Vietnam – have negotiated transition periods, but these are far too limited, short and inflexible for the realities these countries face.”
“The aim is to have more countries join up in future; so the worry is that the TPP standards will be the template for future trade agreements,” says Professor Yeatman. “The effects will be felt at the global level. What is agreed now will have major long term impacts.”
“Australia should refuse to be party to any agreement that compromises global health and costs lives” says Dr Gleeson.
“We hope the Australian parliament will consider this very carefully when the time comes. As Dr Margaret Chan, Director-General of the World Health Organization said in her opening address at the World Health Assembly in 2014: “If these agreements open trade yet close access to affordable medicines, we have to ask: Is this really progress at all, especially with the costs of care soaring everywhere? “