TPP regulations could hinder access to medicines for developing countries, says Australian professor

Published: 11-Feb-2015
Regulatory Patient Experience

US has pushed for a system that prevents market approval for a generic medicine if there is an outstanding patent claim by a brand name company


Intellectual property regulations proposed during the ongoing Trans-Pacific Partnership (TPP) negotiations could hinder access to medicines in developing countries, a law professor at the University of Sydney, Australia, who specialises in trade agreements and intellectual property (IP) issues, said.

Prof Kimberlee Weatherall said regulations sparked by a TPP deal could make it more difficult for developed countries to help developing countries have 'an effective public response as health issues and medicines evolve'.

According to Prof Weatherall, the US has pushed for a system that prevents market approval for a generic medicine if there is an outstanding patent claim by a brand name company. The US has also proposed exclusive rights for patent holders regarding access to clinical trial information, which can delay generic entry if the manufacturers cannot rely on existing public clinical data proving that a drug is safe, she said.

Currently, under the World Trade Organisation (WTO)’s trade-related aspects of intellectual property rights (TRIPS) agreement article 31, countries may issue licences to a generic drug maker allowing it to copy patented medicine without the consent of a patent-owning pharmaceutical company, because of a national health emergency. This can include epidemics such as HIV/AIDS, tuberculosis, or malaria – where the drug is needed.

The US’s proposed IP regulations could make these emergency supports unworkable, said Prof Weatherall, maybe putting a TPP deal in conflict with TRIPS.

According to leaked records from the trade talks, New Zealand, Canada, Chile and Malaysia have proposed a TPP passage that states 'nothing in this chapter shall limit a party’s rights and obligations under article 31 of the TRIPS Agreement'. But Prof Weatherall said she is concerned this provision might have been removed in subsequent negotiations.

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