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ABSTRACT
In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam’s eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement – more than halving the proportion currently treated.
Acknowledgements
We would like to thank Dong Do Dang, Chairperson of Vietnam Network of People Living with HIV/AIDS (VNP+), and Nguyen Thanh Huong, from the Center for Supporting Community Development Initiatives (SCDI) in Hanoi for invaluable help in accessing data on Vietnamese patents and on medicine prices in Vietnam. This paper is dedicated to our co-researcher Emma Beruter, a health economist and Ph.D. student who cared deeply about access to medicines in developing countries. The research reported here stemmed from her desire to use her skills to draw attention to the negative effects the TPPA could have on access to medicines in the developing world. Sadly, Emma passed away unexpectedly in the early stages of our work together. We are indebted to her for her initiative, and for the work she put into the literature search and assessing models for later stages of the research. We are saddened by our loss but determined to continue the work she initiated.
Disclosure statement
DG often represents the Public Health Association of Australia (PHAA) on matters related to trade agreements and public health. She has accepted funding from various government and non-government (not-for-profit) sources to attend speaking engagements related to trade agreements. BT is affiliated with the PHAA and People’s Health Movement Australia, which has been advocating for a more just trade agreement. HM and RL declare that they have no competing interests.
Notes
1. The 2013 leaked IP text is available at https://wikileaks.org/tpp/ and the May 2014 version is at https://www.wikileaks.org/tpp-ip2/#article_e4.
2. World Bank GDP in current $US at http://data.worldbank.org/indicator/NY.GDP.PCAP.CD.
3. For a detailed review of the literature see Moir, Tenni, Gleeson, and Lopert, Citation2014.
4. The trade agreement required patent term extensions to offset marketing approval delays, limits to parallel importing and compulsory licensing, five years of data protection (three years for new uses) and patent linkage notification (Oxfam International, Citation2007, p. 7).
6. This scenario is based on Vietnam’s Law on Intellectual Property (No. 50/2005/QH11), the 2006 Regulation on Data Security of Drug Registration Records and the 2009 Law Amending and Supplementing a Number of Articles of the Law on Intellectual Property. We also drew on comparisons by Kiliç and Maybarduk (Citation2011) of current Vietnamese law and the 2011 US TPP proposals in developing this scenario.
7. First-line treatments are those given initially; second-line drugs are prescribed if the patient develops resistance to first-line medications.
8. Altogether Gilead filed 10 US applications for combinations of TDF and FTC. Two are pending, four have been granted and four abandoned. The one granted in Vietnam (WO2004064845, US application 10/540794) was one of the abandoned US cases. Its child, application 12/204,174, was eventually granted by the USPTO, but only after being rejected five times as being obvious (numerous changes were made to the claims, including by the examiner, and a terminal disclaimer referring to an earlier application, meaning a shorter patent life).
9. Gilead has appealed the revocation (T0725/11), and the appeal is still pending as at 15 August 2016.
10. Vietnamese patent VN1-0002847-000 granted in July 2002.
11. Application 08/091418, granted as patent number 5,366,972 on 22 November 1994. The patent was also granted by the EPO.
12. Calculated as the period from marketing approval on 21 June 1996 to patent expiry on 13 July 2013.
13. The specification of the hypromellose component was also changed, but only by deleting the trademark name.
14. Note, however, the real-world challenges in issuing compulsory licenses even when importation is not involved (Arup & Plahe, Citation2016).
15. Drug Administration of Vietnam (http://www.dav.gov.vn/Default.aspx).
16. Depending on the supplier, Vietnam is classed either as a category 1 or as a category 2 country. Bristol Myers Squibb and Gilead class Vietnam as category 1, while Abbvie/Abbott, Boehringer-Ingelheim and Merck all class Vietnam as category 2 (Médecins Sans Frontières (MSF) 2013a: 73-77).
17. This is consistent with a 2012 Viet Nam Administration of HIV/AIDS Control (VAAC)/ US Centers for Disease Control and Prevention (CDC)/World Health Organization (WHO) study reporting first-line ART provision at US$365 per patient per year for the first year and US$312 for subsequent years.
18. in Duong et al., Citation2014, showed the average cost of first-line treatment ARVs as 37% in the first year and 47% in subsequent years. Here we use the average of 42%. We also know that only 3% of people treated are on second-line ARVs. Because this is such a low proportion, and our estimates are quite rough, we have chosen to ignore second-line treatments in our calculations.
19. For example removal of the qualifier that patents could not be denied solely because they did not result in enhanced efficacy.