Press Release – AFTINET
As TPP trade ministers meet in Atlanta Georgia tomorrow, a proposal based on Japanese practice could provide a secret administrative means for extending monopolies on expensive biologic medicines used to treat cancer and other life-threatening diseases, …TPP: Robb should reject new sneaky tricks to extend medicine monopolies
“As TPP trade ministers meet in Atlanta Georgia tomorrow, a proposal based on Japanese practice could provide a secret administrative means for extending monopolies on expensive biologic medicines used to treat cancer and other life-threatening diseases,” Dr Patricia Ranald, Coordinator of the Australian Fair Trade and investment Network said today.
“Trade Minister Robb has pledged to reject the US TPP proposal to extend data protection monopolies on biologic drugs from 5 to 8 years, which would delay the availability of cheaper versions of these medicines by three additional years. Studies by Health experts show that this would cost the Pharmaceutical Benefits Scheme (PBS) $205 million for each year of delay, and eventually lead to higher prices for patients. This proposal would also require a change to Australia’s Therapeutic Goods Act, which may not pass through the Senate”.
“But US health experts have revealed a new TPP proposal based on Japanese practice which would enable effective extension of monopolies by three years without changing Australia’s or other countries’ laws. Japan’s system of ‘post marketing surveillance’ allegedly for safety reasons, provides effective extension of data protection monopolies through administrative decisions, without requiring a change to the law. This produces the same result as the original US proposal by preventing access to clinical data and registration of cheaper versions of medicines for eight years,” explained Dr Ranald.
The US experts argue that this would expand medicine monopolies at the expense of access to cheaper medicines, without any benefit to safety. Current rules in Australia and elsewhere already provide that cheaper versions of medicines have to be based on the same clinical data as the originals and are separately tested for safety. They describe the proposal as simply a “repackaging” of the US proposal to extend monopolies from 5 to 8 years, which has been rejected by Minister Robb and other trade ministers in the negotiations.
“The danger is that this could be agreed in final trade-offs in exchange for token market access to sugar or other US markets. If such a deal is done, we will not know the details because the text will remain secret for at least a month or longer if any agreement is reached this week, until after it is signed by governments. This would enable governments to magnify claimed benefits of the deal without scrutiny of the details. It would also avoid the need for legislation and would prevent a Senate vote when the implementing legislation comes before the Parliament next year,” said Dr Ranald.
“The possibility of such a scandalous and sneaky deal supports our demand for the full text of the TPP to be released before the decision to sign it is made by governments”.
“Trade Minister Robb should keep to his promise not to extend medicine monopolies and should reject any underhand deal which would extend medicine monopolies by administrative means and avoid parliamentary scrutiny,” said Dr Ranald.