The Trans-Pacific Partnership (TPP) is a multilateral free trade agreement that is being negotiated by the U.S. and 11 Asia-Pacific nations. More than half of the people living with HIV who are currently receiving antiretroviral therapy through Vietnam's public health system could be forced to go without treatment due to higher prices if the expanded patent protections for pharmaceuticals that are currently being proposed by the U.S.'s trade representatives are implemented in the final agreement, according to a modeling study presented at the Asia-Pacific Innovation Conference held Nov. 27-29, 2014, in Sydney, Australia.
Although the negotiations have been highly secretive, draft text of the agreement released by WikiLeaks has revealed that the TPP will impose aggressive intellectual property rules that activist organizations and international nongovernmental organizations involved in the global HIV response say are likely to jeopardize access to affordable medicines in developing nations -- including access to generic antiretroviral therapy.
Today most of the HIV treatment programs in the world rely upon the importation or production of generic antiretrovirals, which is permitted by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and subsequent World Trade Organization (WTO) decisions such as the Doha Declaration that clarify the agreement. Under TRIPS and the subsequent decisions, any country participating in the WTO is allowed some flexibility with regard to intellectual property rights if its national government deems it necessary to protect the public's health. For instance, governments may issue compulsory licenses authorizing the production, sale and import of generic medicines without the patent holder's consent. In addition, countries such as India are permitted to export generic medicines to countries without their own manufacturing capacity.
However, the Obama administration and European trade officials have been aggressively negotiating bilateral and multilateral agreements with countries mandating more restrictive intellectual property language. The language would limit compulsory licensing and grant the originator pharmaceutical companies new rights facilitating secondary and abusive patenting that could further limit access to generic medications.
The most recent leak released on Oct. 16, 2014, suggests that U.S. trade negotiators have gone even further with the TPP. According to a press release from James Love of Knowledge Ecology International, the draft agreement would "lock-in many of the worst and most controversial features of U.S. law and export them around the world."
"Our first impression in reading the document is the extent to which the United States has sought hundreds of changes in intellectual property norms, some small and subtle, others blunt and aggressive, nearly of all of which favor big corporate right holders, and undermine the public's freedom to use knowledge," Love wrote, adding that it might take a while for the public to "sift through the text and fully appreciate the ramifications of the proposals for new regulations."
The Study on Antiretroviral Therapy Costs in Vietnam
The study presented by Moir and colleagues in Sydney on access to antiretroviral therapy in Vietnam is one of the first to calculate just how TPP -- as it is currently drafted -- could affect people living with HIV in resource-constrained settings.
The study analyzed the potential impact of alternative patent regimes on access to antiretrovirals in Vietnam, which has the lowest gross domestic product per capita of the 12 countries participating in the TPP negotiations. At present, the patent regime in Vietnam does not make full use of TRIPS flexibilities. However, some generic antiretrovirals are available, allowing Vietnam to provide antiretroviral therapy to roughly 68% of those who qualify for HIV treatment under current guidelines.
The researchers then investigated how a patent regime making full use of TRIPS flexibilities would affect the cost of -- and therefore access to -- first-line antiretroviral treatment, versus a regime based on the U.S. proposals in the recently leaked draft of the TPP intellectual property chapter.
The researchers examined the patents that had been registered for nevirapine (Viramune), tenofovir (Viread) and lamivudine (3TC, Epivir) in detail, and used information and claims made within the patents to determine how the Vietnamese patents might change under TPP. The researchers then drew upon the literature to estimate what the prices might be under the different patent scenarios.
The analysis was not exact: The preferred first-line regimen in Vietnam is tenofovir, lamivudine and efavirenz (Sustiva, Stocrin) -- though nevirapine can be substituted in cases where efavirenz is not tolerated or contraindicated. However, since complete patent data could not be obtained for efavirenz, the study could only use nevirapine in its cost models.
Under the current patent regime, the researchers estimated that Vietnam is currently paying a price of US$127 per patient year for the first-line regimen. Under full TRIPS flexibilities, Vietnam ought to be able to purchase this regimen at best world price, which currently is US$76 per patient year. Meanwhile, under the TPP regime, the country would be forced to pay the originator price, which for the lowest income countries is currently US$501 per patient year.
Adding in an amount of US$176 per patient year for the non-medicines cost of treatment, Moir et al concluded that if Vietnam were to take full advantage of the flexibility in TRIPS, it would be able to provide antiretroviral therapy to 82% of the HIV population eligible for treatment. In contrast, under the U.S. 2014 TPP proposals, only 30% of Vietnam's eligible HIV patients would have access to antiretrovirals -- less than half of those currently receiving treatment.
The study authors also note that "similar price impacts can be expected for other countries participating in the [TPP], though these are less economically vulnerable than Vietnam."
It should also be remembered that the U.S. is pushing similar intellectual property language in trade negotiations with other low-income countries -- and is pushing to limit the manufacture of generics by countries such as India. Furthermore, the availability of generics is largely what has brought down the originator price for antiretrovirals. Thus the study probably underestimates the full impact of TPP and similar trade packs on access to treatment over the long run.
Theo Smart is an HIV activist and medical writer with more than 20 years of experience. You can follow him on Twitter @theosmart.