ASIA-PACIFIC AIDS Groups support UN experts call for human rights impact assessment of TPPA
AIDS Groups Alarmed as US-led Trans-Pacific Partnership Agreement continues to threaten access to affordable generic medicines; call for immediate moratorium on TPPA negotiations
The Asia Pacific Network of Positive People (APN+), Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) and the Vietnam Network of People living with HIV (VNP+) are sounding the alarm at the ongoing Trans-Pacific Partnership Agreement (TPPA) negotiations led by the United States with seven countries in the Asia-Pacific region i.e. Vietnam, Malaysia, Japan, Australia, New Zealand, Singapore and Brunei. The negotiations that appear to have entered their last leg have drawn the concern of UN experts who are warning against the adverse human rights impacts of this agreement.
In June 2015, 10 United Nations experts issued a joint statement calling for a human rights impact assessment of trade and investment agreements including the TPPA. The UN experts have highlighted concerns that the TPPA may contain provisions that cater “to the business interests of pharmaceutical monopolies and extending intellectual property protection.”
"Today, in the Asia-Pacific region, 2nd and 3rd line AIDS medicines are exorbitantly priced. US multinational pharmaceutical company Gilead is playing games with the lives of people living with Hepatitis C by creating a complex pathway of licenses, price negotiations and collection of personal data before patients can access sofosbuvir. Cancer treatment prices have skyrocketed. This is what the US-promoted patent rules in the WTO that require 20 year monopolies on medicines to be granted have resulted in. Now the next generation of international intellectual property obligations pushed by the US through the TPPA would keep even more medicines unaffordable for longer periods of time,” said Edward Low of MTAAG+.
Leaked TPPA negotiation texts show that the US is pushing intellectual property provisions far in excess of what developing countries like Vietnam and Malaysia have agreed to in the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Known as ‘TRIPS-plus,’ these measures are contrary to the WTO’s Doha Declaration which re-affirmed that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO member’s right to protect public health and, in particular, to promote access to medicines for all.”
“In Vietnam, we are already concerned by announcements from international aid agencies including the US’ PEPFAR programme of their withdrawal of funds and treatment programmes from our country,” said Do Dang Dong of VNP+. “Estimates suggest that under our current budget, if Vietnam was forced to agree to all of the US’ demands on patents and intellectual property in the TPPA, only 30% of people living with HIV who need treatment would receive it. This is an unthinkable scenario for us.”
The UN experts have also highlighted the risks of investor-state dispute mechanisms that allow corporates to sue governments in private arbitration. They note that experience demonstrates that the ability of governments to legislate in the public interest have been put at risk including in relation to access to generic and essential medicines, and reduction of smoking.
“The call by the UN experts is a confirmation of our fears over the TPPA negotiations. APN+ members are in 6 of the TPPA countries: Malaysia, Vietnam, Singapore, Australia, New Zealand and Japan and will be among the first to face the consequences of the TPPA on their health and lives. We are therefore calling on all governments negotiating the TPPA to immediately cease the negotiations and conduct an independent human rights review and impact assessment,” said Shiba Phurailatpam of APN+. “Any trade agreement that further strengthens the hands of the multinational pharmaceutical industry to play games with the lives and health of millions of patients in the Asia-Pacific region is immoral and unconscionable,” he added.
UN Experts Joint Statement, 2 June 2015: This month, 10 UN experts, including the UN Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health issued a joint statement highlighting human rights concerns over ongoing Free Trade Agreement (FTA) negotiations including the TPPA. The experts are calling for transparency in the negotiations, consultation with all stakeholders, publication of all draft texts, human rights impact assessments both before and after the FTAs are concluded for governments to explain how they will uphold human rights obligations if they sign trade and investment agreements and for the trade agreements to include robust safeguards to ensure full protection and enjoyment of human rights. http://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=16031&LangID=E@
TRIPS-plus provisions in the TPPA that are of concern:
· DATA EXCLUSIVITY that prevents governments from relying on clinical trial data to register generic versions of medicines even if they are off-patent, their patents have expired or are revoked & complicates the issuance of compulsory licences. Reports suggest that the US is asking for 12 years of data exclusivity for biological medicines.
· PATENT TERM EXTENION that will extend patent life beyond 20 years.
· INCREASING PATENT SCOPE that significantly increases the number of medicines under patent by forcing governments to give 20-year monopolies on new uses & new forms of old medicines thus allowing the extension of monopolies on these medicines through minor changes in drug formulation or process.
· PATENT LINKAGE that prevents the registration of generic versions of patented medicines and undermines the early working & research exceptions thus delaying generic entry even when a compulsory licence is issued, the patent expires or is revoked.
· INVESTMENT RULES that allow foreign companies to sue governments in private international arbitration over domestic health policies like compulsory licences, health safeguards in patent laws, price reduction measures & may prevent governments from promoting local production.
· BORDER MEASURES that will deny medicines to patients in other developing countries with custom officials seizing generic medicines being imported, in transit or that are being exported.
· INJUNCTIONS that undermine the independence of the judiciary in developing countries to place the right to health of patients over profits of multinational companies.
· OTHER IP ENFORCEMENT MEASURES that put third parties like treatment providers at risk of government actions & court cases and may draw the whole manufacturing, distribution & supply chain for generic medicines into litigation.
For an in-depth analysis of the TPPA proposals that may adversely impact access to medicines and public health see UNITAID’s report on the TPPA:http://www.unitaid.eu/en/rss-unitaid/1339-the-trans-pacific-partnership-agreement-implications-for-access-to-medicines-and-public-health
- Study on the Impact of the TPPA on access to HIV treatment in Vietnam: In 2014, an impact assessment of the provisions being negotiated in the TPPA on intellectual property on access to HIV treatment in Vietnam was published. Highlights from the study titled, “Assessing the impact of alternative patent systems on the cost of health care: Vietnam, the TPPA and HIV treatment in Vietnam”, include: · Official estimates suggest that in 2014 Vietnam had around 256,000 people living with HIV. By the end of 2013 antiretroviral (ARV) therapy was provided to 82,687 people – 68% of those meeting the clinical criteria for such medicines. · Using the current Vietnamese patent regime as our base case, we analyse the potential impact of alternative patent regimes on access to ARVs in Vietnam. The two other scenarios investigated are a patent regime making full use of TRIPS flexibilities, and a regime based on the US proposals in the 2014 leaked draft of the TPPA intellectual property chapter. · Our results indicate 82% of the HIV population eligible for treatment would receive ARVs under a full TRIPS flexibility scenario, while only 30% of Vietnam's eligible HIV patients would have access to ARVs under the US 2014 TPPA proposals – more than halving the proportion treated compared to the current 68%. Similar price impacts can be expected for other countries participating in the TPPA, though these are less economically vulnerable than Vietnam.
The complete study is available here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2536254
- The Bangkok Declaration on Free Trade Agreements and Access to Medicines: http://www.bilaterals.org/?the-bangkok-declaration-on-free&lang=fr