US negotiators at the Trans-Pacific Partnership (TPP) free trade talks have said that they will not be making any new proposals relating to intellectual property (IP) protections for pharmaceuticals at the next round of talks, due to take place in Peru in May.US pharmaceutical industry leaders have urged the nations taking part in the US-led free trade talks to ensure the agreement includes a strong IP framework but, speaking in Washington after the 16th round of negotiations concluded in Singapore in March, Deputy Assistant US Trade Representative Probir Mehta said that the US side would not offer any new proposals at the 17th round, taking place in Lima on May 15-24. Rather, the participant nations would continue to exchange information on their national policies with a view to finding possible common ground, he said.
"We are trying to promote innovation and R&D that results in the development of new medicines, but we are also - and this is just as important - we are trying to promote access to medicines for all," Reuters reports the official as stating.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the negotiators to prioritise the protection of IP. "Innovators in biomedicine and the biosciences are increasingly on the cusp of major breakthroughs that will literally redefine how we care for patients today," said Jay Taylor, vice president of international affairs at PhRMA.
"A weak IP framework within TPP would create uncertainty at a time when we need to be doing more to champion researchers and innovators who rely on strong protections," he warned.
PhRMA also points out that, "as multiple studies have proven over time, IP is the lifeblood of innovation and directly contributes to job creation, worldwide economic growth and patient access to medicine."
The US industry group is calling for specific IP provisions for biologic drugs, including 12 years of data protection which would reflect US law. While the Singapore negotiations were held in secret, international aid organisation Medecins Sans Frontieres (MSF) said it had seen leaked texts that show the US is proposing "the most aggressive IP measures ever suggested in a trade deal with developing countries."
According to MSF, among the provisions being sought by the US is the requirement that governments grant new 20-year patients for modifications of existing medicines, such as new forms, uses or methods, even without improvement of therapeutic efficacy. Another provision would make it more expensive and cumbersome to challenge "undeserved" or invalid patents, and another would additional years to a patent term to compensate for administrative processes.
"There is also concern that the TPP will force public health systems to open up their medication programmes to pharmaceutical corporations, giving them greater access and greater control over the price of medications, effectively destroying the ability of the public health system to negotiate for a low price," the aid agency goes on.
"Taken together, these and other provisions will keep medicine prices high and out of the reach of millions in the Asia-Pacific region," says MSF, which also notes that US negotiators have said that the TPP will be a template for its future trade agreements across the globe, "setting a damaging precedent."
Mr Mehta emphasised last week that the US is "still reflecting on input" for TPP provisions for biologic drugs and "discussing this issue with our trading partners."
But by failing to put forward any alternative text - despite "widespread opposition" to its current proposals - the US "is essentially running out the clock," so countries may be forced to accept its original demands in order to meet the October 2013 deadline set for conclusion of the talks, MSF claims.
"If negotiators run out of time and the agreement is hastily signed, it would simply choke off access to affordable medicines for everyone in the region," said Brian Davies, the group's Access Campaign coordinator in Japan.
- 11 nations were involved in the 16th round of TPP negotiations in March - the US, Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam. Japan has now announced its intention to join the negotiations, and Mr Davies called on Japan and the other negotiating governments not to "accept the provisions that will impact so many lives before you sign on the dotted line."