In this guest post, Dr. Deborah Gleeson discusses the final negotiations of the recently agreed trade accord, the Trans-Pacific Partnership, and resulting implications for access to medicines. Deborah is a lecturer in the School of Psychology and Public Health at La Trobe University in Melbourne, Australia. Her research focuses on the impact of international trade agreements on health.
Battles over medicine monopolies almost completely derailed the negotiations for the controversial Trans Pacific Partnership Agreement in the final days of negotiations in early October.
At issue was the United States’ efforts to use the TPP as a vehicle to extend market exclusivity for biologic products, an emerging class of cancer and immunotherapy treatments and vaccines. Extending monopolies on these very expensive products was expected to delay the market entry of more affordable medicines for hundreds of millions of people in TPP countries, placing them out of reach indefinitely for people in developing countries and adding significantly to pharmaceutical expenditure even in wealthy countries.
Transnational pharmaceutical companies headquartered in the US, and their industry association PhRMA, had been very clear about their key objective in the negotiations: to obtain 12 years of market exclusivity for biologics, matching the length of the monopoly in US law. And according to the Sunlight Foundation, the pharmaceutical industry was by far the industry most actively lobbying to influence the negotiations from 2009-2013.
That monopolies for biologic drugs became the final sticking point to be resolved in the TPP reflects just how out of step the US intellectual property settings are with the rest of the world, and how unpalatable the US pharmaceutical agenda was to the other TPP countries. While Japan and Canada provide eight years of exclusivity for biologics, most of the TPP countries currently provide either five years, or none.
The Australian Government, responding to pressure from health and community organisations, and fully aware of the degree of political opposition to anything that would increase the cost of medicines, refused to budge from its existing 5 years of data protection. The US had to make a humiliating retreat in order to conclude the agreement before the US election cycle made further negotiating progress impossible.
So now that the dust has settled, where do things stand? And to what extent does Australia’s victory over biologics in the final hours represent a real victory for global health?
The final text of the TPP has not yet been publicly released but in the interim, Wikileaks has released a leaked copy of the intellectual property chapter agreed between the parties at the conclusion of negotiations.
While there is no doubt that some of the worst elements of the initial US proposals for the TPP’s intellectual property chapter have been mitigated along the way, the final outcome is still no less than a disaster in global health terms.
Many of the initial harmful provisions proposed by the United States remain in the text. These include, among others: patents for new uses and new methods of using existing products, a low inventiveness threshold for issuing patents, patent term extensions for delays in granting patents or processing marketing approval applications, at least five years of data protection for new pharmaceutical products, and patent linkage provisions likely to result in delays in marketing approval for generics.
For the first time in a trade agreement, the TPP also includes a provision requiring countries to provide a minimum of five years’ market exclusivity for biologics. The wording of this provision is ambiguous, allowing considerable room for the US to pressure other countries to increase the length of the exclusivity period.
In some cases, the initial US proposals have been softened. For example, the first US IP proposal sought to make it mandatory for countries to provide patents for new forms, new uses and new methods of using existing products. The other TPP countries refused altogether to accept the requirement to provide patents for new forms, and the final TPP text requires countries to provide patents for “at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.” The patent term extension and patent linkage provisions have also been made more flexible and less onerous than earlier drafts.
But there is still much in the IP chapter that will expand and extend monopolies and delay competition from more affordable follow on products in many countries. Even in wealthy countries like Australia, the TPP obligations will lock in current intellectual property standards, making it difficult or impossible to reform IP laws to improve access to affordable medicines in future.
The four poorest countries – Vietnam, Malaysia, Mexico and Peru – have been given transition periods, but at only three to ten years in length, these are far too short for the realities these countries face, and they apply to far too few of the TPP’s obligations. For example, Vietnam will only have three years to implement a patent linkage process and three to five years to introduce patent term extensions. When the TPP comes into force, Vietnam will be immediately locked into a low inventiveness threshold and will need to grant additional secondary patents.
Vietnam’s situation is of particular concern because, with the lowest GDP per capita of the TPP countries, it already struggles to provide affordable medicines for its population. A study based on the provisions in a 2014 leaked draft of the IP chapter indicated that, assuming its budget of 25.1 million USD for HIV treatment remained constant, Vietnam’s treatment coverage for eligible people living with HIV could fall from 68% to around 30%. Many of the provisions on which this analysis was based remain in the final text.
The pharmaceutical industry has expressed disappointment over the failure of the US to obtain 12 years of exclusivity for biologics, but in reality it has gained enormous concessions. If the TPP countries ratify the deal, Big Pharma will have succeeded in cementing intellectual property standards that will stymie access to medicines for up to 800 million people in the short term, and more if additional countries sign up in future. Furthermore, the TPP’s intellectual property chapter sets a new norm that is likely to become the template for future trade agreements: its implications are global as well as regional.
Civil society advocacy has blunted some of the most extreme US proposals for the TPP. But if ratified and enforced, it will still prevent untold numbers of people from gaining access to affordable medicines.