After years of negotiations, the USA has reached a deal with Japan and 10 other nations on the Trans-Pacific Partnership, a deal which has left pharmaceutical companies and their opponents non-plussed.
The pact creates uniform intellectual property rules and closes thousands of import tariffs. As well as the USA and Japan, the other states are Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – in total, the 12 are responsible for about 40% of the world’s economic output.
Few details have been released yet but it appears that data protection on new biologics will be set at eight years, down from the 12 years market exclusivity currently in place in the USA. Some other countries, including Australia, had been pushing for an arrangement that will prevent biosimilar competition by only five years.
Pharmaceutical Research and Manufacturers of America CEO John Castellani said that strong IP protection is necessary for the discovery and development of new treatments and “we are disappointed that the ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation”. His view was echoed by Biotechnology Industry Organization CEO Jim Greenwood who claimed that 12 years of data exclusivity “is a prerequisite to attract the investment required to continue medical innovation”, saying “the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments”.
On the other side of the coin, Médecins Sans Frontières believes this is a terrible deal. Judit Rius Sanjuan, legal policy adviser for MSF’s Access Campaign, spoke of “dismay that TPP countries have agreed to US government and multinational drug company demands that will raise the price of medicines for millions by unnecessarily extending monopolies and further delaying price-lowering generic competition”.
Negative impact on public health ‘enormous’
She added that the TPP will “go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies”. Ms Rius Sanjuan went on to say “the negative impact of the TPP on public health will be enormous, be felt for years to come and it will not be limited to the current 12 TPP countries, as it is a dangerous blueprint for future agreements”.
The trade agreement now goes back to the 12 countries for final approval, and Ms Rius Sanjuan said “we urge all governments to carefully consider before they sign on the dotted line whether this is the direction they want to take on access to affordable medicines and the promotion of biomedical innovation”.