Lead Author: Low Cheap Foh
Additional Author: Elisha Kor
Organization: Positive Malaysia Treatment Access & Advocacy Group (TAAG+)
Country: Malaysia
Abstract
The Trans-Pacific Partnership Agreement (TPP) is a recently signed free trade agreement which has stronger intellectual property protection for medicines which is incoherent with the right to health obligations of the countries which have signed the TPP. The TPP is expected to be ratified over the next two years and due to its expected adverse effect on human rights including the right to health, MTAAG+ is recommending TPP countries do not ratify the text. Furthermore, other countries should not join the TPP, especially developing and least developed countries, while it has these provisions which harm: the right to health and the ability to achieve the sustainable development goals.
Submission
The Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) was formed in 2005 after a group of local PLHIV was empowered during a ITPC Regional Access To Treatment workshop held in Pattaya in September, 2004. They realized the need to form a platform of strong positive representatives in Malaysia to speak out and be heard in international events and decision-making venues. It has a board of 3 directors, one male and 2 female. Each director has more than 15 years of experience and various skills including community-based training and advocacy targeting government bodies.
The Trans-Pacific Partnership Agreement (TPP) involving 12 countries: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam was concluded in October 2015, the text was released in November 2015 (legally scrubbed version released in January 2016[i]) and signed in February 2016.[ii] It will come into force after ratification.[iii]
The intellectual property (IP) rules in the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) have already made medicines including for AIDS, Hepatitis C and cancer unaffordable. The TPP requires even stronger and longer IP protection known as ‘TRIPS-plus’.
For example the TPP requires longer patent terms, marketing exclusivity and harsh patent enforcement provisions that undermine TRIPS flexibilities to protect public health. It also has investment provisions that will allow investors from other TPP countries to sue governments for pro-health policies.
The TRIPS Plus provisions in the TPP undermine the Sustainable Development Goals and the new WHO HIV treatment guidelines that call for immediate initiation of treatment.
‘The Sustainable Development Goals that all UN members including TPPA countries signed in September include ambitious health goals and call on countries to make use of the Doha Declaration to ensure access to treatment for communicable and non-communicable diseases.’[iv] (Sustainable Development Goals, September 2015: Goal 3.b: “Support the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights [TRIPS] regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.” ).[v]
‘More recently the WHO released new HIV treatment guidelines recommending that everyone who tests positive for HIV should be put on treatment immediately instead of waiting for a lowered CD4 count. Under the latest guidelines millions more need HIV treatment including people living with HIV in TPP countries.’[vi] (WHO Guidelines on when to start antiretroviral therapy 2015: “…antiretroviral therapy (ART) should be initiated in everyone living with HIV at any CD4 cell count…recommendations is based on evidence from clinical trials and observational studies released since 2013 showing that earlier use of ART results in better clinical outcomes for people living with HIV compared with delayed treatment.”)[vii]
‘Study on the Impact of the TPP on access to HIV treatment in Vietnam: In 2014, an impact assessment of the provisions being negotiated in the TPP 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 TPP 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 TPP 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 TPP proposals – more than halving the proportion treated compared to the current 68%. Similar price impacts can be expected for other countries participating in the TPP, though these are less economically vulnerable than Vietnam.’[viii]
“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 TPP, only 30% of people living with HIV who need treatment would receive it. With the new HIV treatment guidelines from the WHO, the TPP’s impact for people living with HIV will be even more severe. This is an unthinkable scenario for us.”[ix]
The price of patented medicines in Malaysia are already high enough to be of concern. For example a 2005 study using WHO methodology found that for a family of three receiving the lowest level of Malaysian civil servant salary, it would take two-months’ salary to pay for one month of patented medicines.[x] Similarly, an article by Azmi and Alavi found that patented medicines can be 1,044% more expensive than their generic equivalents in Malaysia.[xi]
The TPP countries are party to human rights treaties which include the right to health. For example Malaysia is party to the Convention on the Rights of the Child[xii] which includes the right to health[xiii]. Yet the TPP text that was released has TRIPS-plus provisions in the TPP that can harm access to affordable medicines and thus the right to health as outlined below.
United Nations Special Rapporteurs including for the right to health have already expressed concern about the TPP’s potential adverse impacts on human rights.[xiv]
Some of the TRIPS-plus provisions in the TPP that can harm access to affordable medicines and thus the right to health:
· MARKET EXCLUSIVITY that prevents governments from giving marketing approval to generic versions of medicines even if they are off-patent, their patents have expired or are revoked. The TPP text requires 5 years of exclusivity for small molecule medicines[xv] and 5 or 8 years of exclusivity for biological medicines[xvi].
· PATENT TERM EXTENSIONS that extend patent life beyond 20 years for delays by the patent office or medicine regulatory authority.[xvii]
· STRONGER ENFORCEMENT PROVISIONS that restrict access to generic medicines.[xviii]
· INVESTMENT RULES that allow foreign companies to sue governments in private international arbitration over domestic health policies like health safeguards in patent laws.[xix]
RECOMMENDATION:
MTAAG+ reaffirms the call it made with other NGOs in the Bangkok Declaration on Free Trade Agreements and Access to Medicines[xx] and calls on:
· Those countries which have signed the TPP to reject ratification of the TPP.
· Additional countries not to join the TPP while it has these rules which can harm the right to health.
For moreanalysis of the leaked TPP proposals that may adversely impact access to medicines and public health see UNITAID’s report on the TPP.[i]
Bibliography and References
[i] : http://www.unitaid.eu/en/rss-unitaid/1339-the-trans-pacific-partnership-agreement-implications-for-access-to-medicines-and-public-health
[2]https://www.mfat.govt.nz/en/about-us/who-we-are/treaty-making-process/trans-pacific-partnership-tpp/text-of-the-trans-pacific-partnership. References to the TPP text are to this version.
[3] http://dfat.gov.au/trade/agreements/tpp/official-documents/Pages/official-documents.aspx
[4] Article 30.5
[5] http://www.apnplus.org/main/
[5] https://sustainabledevelopment.un.org/?menu=1300
[6] http://www.apnplus.org/main/
[7] http://www.who.int/hiv/pub/guidelines/earlyrelease-arv/en/
[8] http://www.apnplus.org/main/. Full study at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2536254.
[9] http://www.apnplus.org/main/
[10] Members of the hypothetical family suffered depression, peptic ulcers, a viral infection and asthma. ‘A Survey of Medicine Prices, Availability, Affordability and Price Components in Malaysia using the WHO/HAI methodology: Research Report’, Babar, Ibrahim, Singh, Bukhari, University College Sedaya Interntional and Universiti Sains Malaysia in collaboration with the World Health Organization and Health Action International, Malaysia, October 2005.
[11] ‘TRIPS, Patents, Technology Transfer, Foreign Direct Investment and the Pharmaceutical Industry in Malaysia’, Ida Madieha Azmi and Rokiah Alavi, Journal of World Intellectual Property, Vol 4 No. 6, November 2001.
[12] https://treaties.un.org/Pages/ViewDetails.aspx?src=IND&mtdsg_no=IV-11&chapter=4&lang=en
[13] http://www.un.org/documents/ga/res/44/a44r025.htm
[14] http://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=16031&LangID=E@
[14] Article 18.50
[15] Article 18.51
[16] Article 18.46 and 18.48
[17] Section I of the IP chapter
[18] Chapter 9
[19] http://www.bilaterals.org/?the-bangkok-declaration-on-free&lang=fr
[20] : http://www.unitaid.eu/en/rss-unitaid/1339-the-trans-pacific-partnership-agreement-implications-for-access-to-medicines-and-public-health