Acronyms and Abbreviations 3

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2 Table of Contents Title Page No. Acronyms and Abbreviations 3 BACKGROUND 5 OBJECTIVE 5 METHODOLOGY 6 RESULTS 6 Survey completion rate 6 Section I: ART coverage level 7 Section II: ART programme funding and expenditure 8 Section III: Adoption and implementation of the World Health Organization 9 (WHO) 2010 Guidelines on ART Section IV: ARV sources and costs 10 Section V: ARV patent status 12 Section VI: Legal environment 14 Current patent law status 14 Use of TRIPS flexibilities compulsory licences (CL) 15 Potential areas for strengthening legal frameworks 16 Free Trade Agreement (FTA) status 18 Other issue: Strengthening domestic production capacity 20 KEY LEARNING POINTS 21 TABLES AND GRAPHS Table 1: Section completion overview 6 Table 2: Adoption and implementation of 2010 WHO Guidelines on ART 9 Table 3: Channels of accessing ARVs 10 Table 4: Selected ARV procurement costs 11 Table 5: Patent status of key first and second-line ARVs 13 Table 6: Adoption of key TRIPS flexibilities in national patent laws 15 Table 7: Overview of ongoing and proposed FTA negotiations 19 Graph 1: ART coverage level 7 Graph 2: ART programme funding and expenditure 8 ANNEXES Annex 1: General instructions for the TRIPS mapping exercise

3 Annex 2: Terms of references for the TRIPS mapping exercise Annex 3: Instructions per section for the TRIPS mapping exercise Annex 4: TRIPS Mapping Excel Forms Annex 5: TRIPS Briefing Notes (1) Annex 5b: TRIPS Briefing Notes (2) Annex 6: Section VI of the TRIPS Mapping Exercise

4 Acronyms and Abbreviations 3DF 3TC ABC ACTA AEM AIDS API APN+ ARV ART AZT CL CSOs d4t ddi EFV EU FDC FTA FTC GARP GFATM GFPQR HIV ITPC IPR LDC LPV/r MNC MOPI MPP NHSO NVP PEPFAR Three Diseases Fund Lamivudine Abacavir Anti-Counterfeit Trade Agreement Asia Epidemic Model Acquired Immuno-Deficiency Syndrome Active Pharmaceutical Ingredient Asia Pacific Network of People Living with HIV Anti-retroviral Anti-retroviral Therapy Zidovudine Compulsory Licence Civil Society Organisations Stavudine Didanosine Efavirenz European Union Fixed Dose Combination Free Trade Agreement Emtricitabine Global AIDS Response Progress Global Fund to Fight AIDS, Tuberculosis and Malaria Global Fund Price and Quality Reporting Human Immunodeficiency Virus International Treatment Preparedness Coalition Intellectual Property Rights Least Developing Country Lopinavir/ritonavir (Kalletra) Multi-National Corporation Malaysian Organisation of Pharmaceutical Industries Medicine Patent Pool National Health Security Office Nevirapine President s Emergency Plan for AIDS Relief

5 PLHIV TDF TREAT Asia TRIPS UA UNAIDS UCC UNDP UNICEF USA WHO WTO People Living with HIV/ AIDS Tenofovir Therapeutics Research, Education, and AIDS Training in Asia Trade-Related Aspects of Intellectual Property Rights Universal Access The Joint United National Programme on HIV/AIDS UNAIDS Country Coordinator United Nations Development Programme The United Nations Children s Fund United States of America World Health Organization World Trade Organization

6 Summary of Country Mapping Exercise BACKGROUND In the Asia Pacific Region, the number of people receiving anti-retroviral treatment (ART) has increased steadily to an estimated 922,000 people by the end of 2010, representing an estimated 39% of all people eligible for ART according to 2010 WHO Guidelines. This progress has largely been made possible by the dramatic drop in antiretroviral (ARV) prices over the last ten years due to generic competition. However, the region continues to lag behind the average global treatment coverage level of 47%, and the annual number of new HIV infections cases is still 50% higher than the annual increase in the number of people receiving ART. In addition, most people in low and middleincome countries do not have access to the newer generation of treatment regimens. Progress towards universal access (UA) has also been challenged by the decrease in international AIDS funding since Legal space has been created for countries to produce and procure generic medicines through the flexibilities described in the 2001 Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health. India, Indonesia, Malaysia and Thailand have made productive use of such flexibilities to procure or produce life-saving generic drugs including ARVs. In the case of India, this has benefited millions of people living with HIV (PLHIV) in the region and beyond. However, most countries in the region have not yet made full use of these flexibilities. Moreover, in recent years, the EU and the USA have proposed the inclusion of so-called TRIPS plus provisions in bi- and multi-lateral, and regional free trade agreements (FTAs) with low and middle-income countries in the region. If adopted, these provisions would adversely impact access to generic medicines, including ARVs, tuberculosis and hepatitis C treatment. OBJECTIVE As a response to the increasingly complex HIV access landscape, a Regional Consultation and Planning Workshop on the Use of TRIPS Flexibilities to Access Affordable ARVs in Asia was organised by the Asia Pacific Network of People Living with HIV (APN+), International Treatment Preparedness Coalition (ITPC), Medicins Sans Frontieres (MSF), Therapeutics Research, Education, and AIDS Training in Asia (TREAT Asia), UNAIDS, UNDP, UNICEF and WHO from 29 to 31 May The primary objectives of the workshop included: To enhance knowledge and understanding of the TRIPS flexibilities as interpreted in the 2001 Doha Declaration and the possible impact of TRIPS+ provisions in FTAs (and other Intellectual Property Rights (IPR) enforcement initiatives) on access to affordable ARVs To develop country plans for optimal utilisation of TRIPS flexibilities by 2015 To facilitate the establishment of country working groups with an agreed commitment to promote the implementation of the country plans To identify areas of support from regional and global partners and agree on roles and responsibilities in providing that support. Nine countries were invited to participate in the workshop: Cambodia, China, India, Indonesia, Malaysia, Myanmar, Philippines, Thailand and Vietnam.

7 As part of the workshop preparation, a country mapping exercise was conducted. Unfortunately, no response was received from Indonesia. Specific areas about which information was gathered and reviewed were: Country ART coverage levels Progress on adoption and implementation of 2010 WHO guidelines on ART Funding for ART programmes and procurement of ARVs Legal environment for production, importation and exportation of generic medicines, including patent status of key ARVs and challenges and opportunities for the use of TRIPS flexibilities and protection against TRIPS-plus provisions. METHODOLOGY A simple mapping instrument 1, including guidance notes, Excel forms, a Word questionnaire, and an Annex, were developed by a consultant, workshop organising team and an IP expert. Workshop introductory s, including mapping tools were sent to UNAIDS Country Coordinators (UCCs) by the workshop organising team in mid-march. In the absence of an UNAIDS country office in Malaysia, s were channeled through UNDP country office. UN country teams were encouraged to nominate an UN focal point for both in-country and regional-level communication and coordination. For the mapping exercise, countries constituted a country core team including resource persons and those with specific expertise on the respective mapping sections. Data collection, including at least one in-person meeting between the core team members and additional resource persons, took place between mid-march and mid-may. RESULTS Survey completion rate Quasi-complete responses were received from Cambodia, China, Malaysia, Myanmar, Philippines and Vietnam, with India and Thailand providing partial responses. Table 1 provides a breakdown of the section completion status by country. MYN MYS PHL THA VN Table 1: Section completion overview Sections/ CAM CHN IND Countries 2 I. ART baseline Partial II. ART programme funding and expenditure III. Implementation of WHO 2010 Guidelines on ART 1 See Annex 1-6 for complete mapping instrument. 2 CAM (Cambodia); CHN (China); IND (India); IDN (Indonesia); MYN (Myanmar); MYS (Malaysia); PHL (Philippines); THA (Thailand); VN (Vietnam).

8 IV. ARV Partial Partial Partial Partial medicines procured V. ARV patent N/A N/A status update * VI. Legal environment * Section not applicable (N/A) Section I: ART coverage level Generally, ART coverage among adults and children is increasing in most countries. However, as we can see, most countries reported coverage rate of around or below 50%. This is consistent with the end 2011 estimate of 49% for the regional coverage. It is important to be aware of the source and reliability of ART coverage estimates. While the numerator for coverage estimation (i.e. the number of people receiving ART) is relatively easy to collect and relatively reliable, calculating the denominator figure (i.e. the estimated number of people eligible for ART) in more problematic. WHO and UNAIDS recommend to use the EPP-Spectrum tool to estimate this number, and some countries use the Asian Epidemic Model (AEM) which also produces reliable estimates. However, not all countries use these methodologies, use the resulting estimate of people eligible for ART as the denominator to estimate their coverage, or regularly update their estimates and projections. Graph 1: ART coverage level The Philippines reported a quite sudden increase in ART coverage in 2011 which is due to both the revision of the number people eligible for ART (from 2,500 in 2010 to 2,219 in 2011) and the increase in the number of people receiving ART (1,274 in 2010 to 1,992 in 2011). In the case of Cambodia, an 89.5% ART coverage rate based on the 2007 estimate of people eligible for treatment by 2011was reported in the country Global AIDS Response Progress (GARP) report. However, the 2011 (not yet officially endorsed) national HIV estimates and projections update led to an increased number of estimated people eligible for treatment (by approximately 6,000). This would result in a drop in estimated ART coverage from 89.5% to 78%.

9 For India, the coverage was calculated using estimate for the number of eligible people from 2010 (i.e million) China used the number of reported AIDS cases (166,229) in the GARP report, which is much lower than the estimated number of eligible people. In the absence of an official update, we used last year s estimate of 270,000 people eligible for treatment. Similarly, in its GARP report, Indonesia used a denominator close to the cumulative reported AIDS cases (29,879). In the absence of another more relevant denominator we have preferred not to report a 2011 ART coverage estimate while awaiting the validation of Indonesia s GARP data by the WHO and UNAIDS head office teams. Section II: ART programme funding and expenditure The mapping exercise shows an increasing trend in spending on ART, even if the pace is still too slow to reach UA coverage in most countries. In India, expenditure for ART increased from 56 million to 92 million USD. In China, an estimated 85 million USD was spent on ARV drugs alone in Domestic funding accounts for more than 90% of the total ART programme spending in Malaysia, Indonesia and Thailand. Domestic contributions are increasing in the Philippines. On the other hand, ART programmes in Cambodia and Myanmar, two least-developed countries (LDC), but also in India and Vietnam, a lower middle-income country, depend heavily on international funding, including the Global Fund To Fight AIDS, Tuberculosis and Malaria (GFATM) in Cambodia, the Three Diseases Fund (3DF) in Myanmar, and the President s Emergency Plan for AIDS Relief (PEPFAR) in Vietnam. In the last reported years, the domestic contribution was 0% in Cambodia and India, 2% in Myanmar, and 6% (down from 10 %) in Vietnam. Graph 2: ART programme funding and expenditure

10 Section III: Adoption and Implementation of the World Health Organization (WHO) 2010 Guidelines on ART In 2010, WHO updated its guidelines on ART for adults, infants and children. The main changes involved eligibility criteria for initiation of ART; optimal 1 st and 2 nd line ARV regimens (e.g. phasing out of stavudine (d4t), introduction of tenofovir (TDF) as first-line option); management of HIV co-infection with tuberculosis and chronic viral hepatitis; and management of ART failure. Country teams were invited to report on progress and delays/gaps in the adoption and implementation of the 2010 WHO guidelines. Table 2 summarizes current status per country. Table 2: Adoption and implementation of the WHO 2010 Guidelines on ART STATUS Full adoption*, officially endorsed, rollout started Full adoption, awaits official endorsement, rollout has not yet started Partial adoption**, officially endorsed, rollout started with plans for full adoption in later dates No new guidelines, unofficial adoption, rollout has started COUNTRIES Myanmar, Thailand, Vietnam China Cambodia, Malaysia Philippines No new guidelines, no changes in treatment programmes India * Full adoption refers to both ART guidelines on treatment of adults and adolescent and infants and children ** Partial adoption includes partial adoption of the guidelines and/or adoption of one of the two guidelines Although the new WHO guidelines have been fully adopted in Myanmar at the central level, rollout has been slow and difficult to monitor at the local level. Dissemination workshops have been conducted in selected regions but it is believed that partners are in different stages of adaptation. While Thailand has fully adopted and endorsed the new WHO guidelines, the Thailand National Health Security Office (NHSO) in charge of health budget allocations has not given approval for the actual application of the new CD4 eligibility recommendation. As a result, Thai people living with HIV (PLHIV) while having access to newer treatment options (e.g. TDF-based first-line regimens), cannot access ART before CD Vietnam has fully adopted the new guidelines and rollout has started. Challenges to rollout include late diagnosis and treatment of patients (e.g. 56% started with CD4<100 in 2010), lack of access to TDF-based fixed dose combination (FDC) ARVs and limited access to early infant diagnosis for timely initiation of treatment in infants. In comparison with other countries, Vietnam has made considerable progress in phasing out d4t, with 39% of patients still on d4t-based first-line regimen at the end of In China, the revised national ART guidelines, including a two-year d4t phase-out plan, have been proposed and waiting for endorsement by the Ministry of Health (MoH). The revise

11 guidelines reflect the new WHO recommendations for initiation of treatment. The d4t phase-out plan gives priorities to sero-discordant couples and patients experiencing d4t side-effects. Apparently, approval of the revised guidelines is pending approval of a budget increase by the Ministry of Finance for the new rollout. The additional costs associated with the increased number of people eligible for treatment and the cost of TDF were key considerations for Cambodia during the review of its treatment guidelines in There was a particular concern with regard to programme sustainability in light of the cancellation of the GFATM Round 11. As a result, the new treatment initiation criteria were adopted but the use of TDF has been deferred until a steady supply of affordable alternative medications [TDF] can be guaranteed in the future. 3 Malaysia revised its ART guidelines on treatment of adults and adolescents in December Plans for revision of guidelines on infants and children have been set for The new guidelines include early initiation and the use of TDF-based first-line ARVs. d4t is maintained as a first-line option ARV in the revised guidelines. Despite the lack of official adoption, patients in the Philippines are benefiting treatment based on the revised WHO guidelines. Transition of d4t-based patients onto TDF-based regimens has also started. This is largely due to commitments by the relevant HIV departments and physicians to provide quality treatment. Neither new guidelines nor changes in treatment programmes have taken place yet in India. Section IV: ARV sources and costs Procurement information for 2011 and/or 2012 ART programmes was provided by Cambodia, Malaysia, Myanmar and the Philippines 4. Partial information on China, Thailand and Vietnam was obtained through the Global Fund Price and Quality Reporting (PQR) database which captures procurement information related to countries GF programmes. A great diversity in how and where countries procure their ARVs was found. They are mainly determined by two main factors: domestic capacity for the production of generic medicines and level of access to generic medicines. Table 3: Channels of accessing ARVs CATEGORY COUNTRIES Domestic production of all currently recommended ARVs available Mainly domestic production, import of patented second-line ARVs for which there are no compulsory licenses (CLs) Mainly domestic production, import of patented ARVs India Thailand China 3 National Guidelines for the use of Antiretroviral Therapy in Adults and Adolescents, Ministry of Health, Cambodia. January Cambodia (2012), China (2010), Malaysia (2012), Myanmar (2011), Philippines (2011 & 2012), Thailand (2010) and Vietnam (2011).

12 Some domestic production, import of patented, off-patent and none-patented ARVs from originators and generic Some domestic production, import of mainly generic ARVs No domestic production, import only generic ARVs whenever available, dependence on procurement intermediary for ARVs Malaysia Vietnam Cambodia, Myanmar, Philippines Countries that rely largely on external funding support, such as Cambodia, Myanmar and Vietnam are able to access generics, typically through procurement mechanisms such as UNICEF and the GF s Procurement for Supply Chain Management (also known as Voluntary Pool Procurement system). Furthermore, countries with access to generic medicines pay significantly less for their medicines compared to their counterparts (see Table 4). Table 4: Selected ARV procurement costs ARV/Formulation Pack Cost (USD) Generic* Pack Cost (USD) Originator w/o CL** Pack Cost (USD) Originator w/ CL*** Pack Cost (USD) generic w/ CL*** Abacavir (ABC) 300mg, tablets, 60 s Efavirenz (EFV) 200mg, capsules, 90 s Efavirenz (EFV) 600mg, tablets, 30 s Indinavir (IDV) 400 mg, capsules, 180 s Lamivudine (3TC) 150mg, tablets, 60 s Ritonavir (RTV) 100 mg, tablets, 30 s Ritonavir (RTV) 100 mg, tablets, 168 s [ ] [ ] [ ] Lamivudine + Nevirapine+Stavudine (3TC+NVP+d4T) 150mg+200mg+30mg, tablets, 60 s Lamivudine + Zidovudine (3TC+AZT) 150mg+300mg, tablets, 60 s Lopinavir/Ritonavir (LPV/r) [ ] [ ] mg+25mg, tablets, 60 s Lopinavir/Ritonavir (LPV/r) [ ] [ ]

13 200mg+50mg, tablets, 120 s * Cost prices from Cambodia, China, Myanmar, Philippines, Thailand and Vietnam ** Cost prices from Malaysia. LPV/r (200mg+50mg) prices from China and Malaysia ***Cost prices from Thailand Countries with compulsory licences (CL) in place have often able to negotiate for lower prices from originating companies in addition to gaining access to generic medicines. This has been particularly evident in Thailand. Between 2006 and 2008, the Thai government issued CLs on LPV/r (patent holder: Abbott s Kaletra) and EFV (patent holder: Merck Sharp & Dohme s (Merck) Stocrin). After a CL was issued for the production and importation of generic EFV in late 2006, Merck proposed a price reduction of almost two-thirds 5. Thailand currently purchases generic EFV (600mg, 30 tabs) from Indian generic for approximately 110 THB/bottle (~3.8 USD). LPV/r (200mg+50mg, 120 tabs) was priced at about 8,900 THB (~307 USD) in Thailand before issuing of CL. Thailand currently procures generic LPV/r at approximately 1,600 THB/bottle (~54.42 USD). Section V: ARV patent status ARV patent information per country, including patent application numbers, as available in the Medicine Patent Pool s (MPP) Patent Status Database 6, was provided to each country team at the onset of the mapping exercise. Teams were invited to verify and update the information. LDC countries, Cambodia 7 and Myanmar, currently not required to have intellectual property rights (IPR) laws, were invited to share their government s position(s) and plan(s) beyond the transition period of 2016 in implementation of its TRIPS obligations 8. Updated information was received from Vietnam only which suggests that this information is difficult to obtain. In general, patents on most recommended first-line ARVs have either expired or are about to in most countries. However, patent applications on newer generation first-line ARVs, in particularly, TDF and related formulations, have already been filed or granted in China, India, Philippines and Thailand. No TDF-related application was found in Malaysia. Vietnam presents a unique situation. Prior to 2011, there were no patents on TDF in Vietnam. In 2011, Vietnam was included in the Voluntary Licensing Agreement between Gilead Sciences 9 and MPP as one of the countries where generic TDF can be supplied. Patents for key recommended second-line ARVs, LPV/r and RTV, have either been filed or granted in China, India, Philippines, Thailand and Vietnam. Patent status of LPV/r (tablets formulation) remains unclear to various experts and activists following the issue in Malaysia. 5 EFV, 600mg, 30 tab offered by Merck for 22.54USD/bottle in Source: 7 Cambodia does have IPR laws but does not include pharmaceutical products. 8 Decision of the WTO Council for TRIPS on 27 June 2002: Least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January Source:

14 Patents for newer ARVs including Maraviroc (2007) 10 and Raltegravir (2007) 11 have been granted relatively quickly in China, India, Malaysia, Philippines and Vietnam. While applications for both medicines have been filed in Thailand, decisions on the applications are expected to take some time. Table 5: Patent status of key first and second-line ARVs Compound/ Country Patent holder China (as of Dec. 2010) India (as of Jan. 2011) Malaysia (as of Oct. 2011) Philippines (as of Oct. 2011) Thailand (as of Mar. 2010) Vietna m (as of Mar. 2012) Tenofovir disoproxil fumarate (TDF) Gilead Granted Rejected but process claims granted & div. applic. pending No No No No Ester prodrug Gilead Granted Rejected but divisional No No No No applic. pending Combination with FTC Gilead Filed Rejected but divisional No No Unknown No applic. pending Comination with FTC + RIL Tibotec (Gilead) Filed Unknown Unknown Filed Unknown No Combination with EFV + FTC Gilead & BMS Filed Filed No No Filed No Lopinavir (LPV) Abbott Granted Unknown No Granted Granted No LPV+RTV softgel caps Abbott Granted Withdrawn No Granted Filed No LPV+RTV tablet Abbott Filed Rejected but div. applic. pending No No Unknown Grante d LPV+RTV tablet Abbott Filed Filed Unknown Filed Unknown Publicat ion No: A Maraviroc (MVC) Pfizer Lapsed Granted Granted Granted Unknown Grante d Crystal form Pfizer Granted Granted No Granted Filed Grante d Raltegravir (RAL) Filed Granted No Granted No Grante d Potassium salt Filed Filed Granted Filed Filed Publicat ion No: U.S. Food and Drug Administration (FDA) approval on August 6, 2007 for use in treatment experienced patients 11 U.S. FDA approval for treatment of HIV infection in October The first of new class of HIV drugs, the integrase inhibitors, to receive such approval

15 A Ritonavir (RTV) Abbott No No No Granted No No Crystalline polymorph Abbot Granted Opposed Granted Granted Filed No

16 Section VI: Legal environment The first step countries must take to make use of health related TRIPS flexibilities, including their ability to procure or produce life-saving generic medicines such as ARVs, is to incorporate those provisions into their own national legal frameworks. Even in countries where this has been done successfully, such provisions can be undermined by TRIPS-plus and anti-counterfeiting legislation adopted by countries, often, as part of commitments under free trade agreements (FTA) 12. This section asked countries to provide a rapid assessment of their legal framework relating to TRIPS and public health/access to generic medicines. Country mapping teams were encouraged to involve relevant experts and resource persons and organise a working meeting to complete this section. A set of related background documents was provided and participants were required to review the documents prior to the working meeting. Country teams were also requested to forward a copy of their national Patent Law to the regional mapping team. National Patent Law status World Trade Organization (WTO) members 13 are required to adopt national intellectual property rights (IPR) legislation 14 in compliance with WTO mandated standards for protecting and enforcing IPR under the TRIPS Agreement. Flexibilities pertaining to public health protection and granting of patents on pharmaceutical products and processes were also incorporated into the Agreement and reaffirmed through the Doha Declaration in November 2001 to ensure that patent protection of pharmaceutical products and processes does not prevent access to medicines. These flexibilities include extended exemptions on pharmaceutical patent protection for LDC countries until at least In line with the WTO requirements, eight (8) of the nine (9) countries who participated in the regional meeting, China, Cambodia, India, Indonesia, Malaysia, the Philippines, Thailand and Vietnam, have either enacted or amended their IPR legislations. Specifically, patent laws in non-ldc countries that are WTO members have all been amended to comply with the 1995 WTO TRIPS Agreement and several have created the legal space for the use of TRIPS flexibilities as re-affirmed in the 2001 Doha Declaration. In line with the current exemption period for LDCs, the Cambodian Patent Law specifies that no patents will be granted on pharmaceutical products in Cambodia before In Myanmar, a draft IPR Law is currently being circulated for comments amongst members of parliament, relevant departments and government legal experts Please see Annex 5 and 5b for detailed explanations on TRIPS Plus and examples of anti-counterfeiting legislation. 13 Year of WTO membership: Cambodia (2004), China (2001), India (1995), Indonesia (1995), Malaysia (1995), Myanmar (1995), Philippines (1995), Thailand (1995), Vietnam (2007). 14 Types of IPR: 1) copyright and related rights; 2) trademarks, including service marks; 3) geographical indications; 4) industrial designs; 5) patents; 6) layout-designs (topographies) of integrated circuits; and 7) undisclosed information, including trade secrets. 15 With specific reference to pharmaceutical products, Paragraph 7 of the Doha Declaration, as implemented by the TRIPS Council Decision of June 2002, exempts LDCs from having to grant patents and from providing the protection of undisclosed information until 1 January These transition periods are subject to further extension upon duly motivated requests under Article 66of the TRIPS Agreement. 16 In Myanmar, a draft IPR Law has been developed and drafted by the Ministry of Science and Technology and Attorney General Office.

17 Table 6 summarizes existing key TRIPS flexibilities in national patent laws based on information provided by the country teams and available public resources. MYS PHL THA VN Table 6: Adoption of key TRIPS flexibilities in national patent laws Key TRIPS CAM CHN IND IDN Flexibilities 17 /Countries 18 I. Flexibilities in Acquisition of Patent Disclosure requirements -* Patentable subject matter N/A** Pre-grant oppositions N/A N/A N/A N/A N/A II. Flexibilities in the Scope of the Patent Bolar exception - - Research exception International Exhaustion N/A - - (parallel imports) Compulsory licences (CL) N/A Government use N/A III. FLEXIBILITIES AFTER THE ACQUISITION OF A PATENT Post grant oppositions N/A - - N/A - Revocation of a patent Enforcement of patents (specific prohibition of patentregistration linkage) Competition Law N/A IV. Others Test data protection (specific prohibition of data exclusivity) Utility models or petty patents Trademarks and International Non-proprietary Names (INN) Exemption for LDCs * - - Information not provided/could not be verified ** N/A Provisions not available Use of TRIPS flexibilities As the table shows, most countries have adopted most, if not all, of the provisions under Flexibilities in the Scope of the Patent (category II). Among these, the provisions on CLs 19, including government use 20, have been considered one of the key flexibilities that could be exercised by countries. 17 See Annex 5 and 5b for detailed explanations on the flexibilities. 18 CAM: Cambodia; CHN: China; IND: India; IDN: Indonesia; MYS: Malaysia; PHL: Philippines; THA: Thailand; VN: Vietnam. 19 See Annex 5 and 5b for detailed explanation on CL. 20 Government use order is a specific type of CL usually issued in the form of an order by a competent administrative or judicial authority, authorizing a government or a party acting on behalf of the government to exploit a patent provided that such exploitation is in the interest of the country in question.

18 Between late 2006 and early 2008, the Government of Thailand issued a total of six CLs. CLs were issue based on the principle that: Essential drugs are humanitarian products and must be made universally accessible to everyone who needs them. When a government such as ours [Thailand] declares a compulsory licence we are doing so to increase access to these essential, often life-saving, medications for the poor and marginalized members of our communities Mongkol na Songkla, Minister of Health, Thailand (October 2006 to February 2008) CLs for ARVs have also been issued previously in Malaysia (2003) 21 and Indonesia (2004 and extended in 2007) 22. In March 2012, India issued its first CL for a cancer medicine. Recently, civil society organisations (CSOs) in Malaysia, headed by the Malaysian AIDS Council, called upon its government to consider issuing a CL for government use on two key second-line ARVs LPV/r and ritonavir. The Government of Malaysia has not issued an official response to the CSO s CL request at the time of finalizing this report. In China, while the Chinese Patent Law and Implementing Regulations have been in place since 2008, CLs have never been issued 23. Meanwhile, the threat of CL usage has been instrumental in China s price negotiation with various multi-national pharmaceutical companies. Key informants commented that the mere existence of CL provision greatly influenced Gilead s decision to lower the price of TDF in China in late Although CLs have never been issued in the Philippines, various TRIPS flexibilities have been utilized through the provisions of Republic Act 9502, otherwise known as the Universally Accessible Cheaper and Quality Medicines Act of The law includes the Bolar exemption to allow local generic manufacturers to register their generic versions of the patented drugs so that they could be sold immediately upon the expiration of the patents or when a patent is revoked or a CL is issued. Another significant aspect of the Philippines patent law is to allow parallel importation of products into the country once they have been placed on the market any-where in the world. Similar to the Philippines, Vietnam has never exercised their right to issue CLs. In addition to CLs, the Vietnamese Patent Law also includes provisions on Bolar exemption and exhaustion of rights, which allows parallel import. An additional flexibility incorporated in the Law is the provision on pre and post-grant oppositions. As mentioned above, the Cambodia Patent Law stipulates that no patents will be granted on pharmaceutical products before As reflected in Table 6, Cambodia has yet to incorporate all TRIPS flexibilities into its laws. At the same time, pressures from various sources have resulted in patent-protecting laws and regulations that go beyond those required by TRIPS Agreement for LDCs. 21 Government-use order was authorized by the Government of Malaysia for a local company (Megah Pharmaceuticals Sdn Bhd) to import three ARVs from India to supply public hospitals. 22 CL was first issued through a presidential decree in 2004 for 3TC and NVP and renewed in 2007 to include EFV. 23 Revised CL procedure is now in the Measures for Compulsory Licensing of Patent Implementation issued on 15 March and entered into force on 1 May Act became effective on 4 July 2008 issued and promulgated jointly by the Department of Health (DoH), the Department of Trade and Industry (DTI), the Intellectual Property Office (IP) and the Food and Drugs Administration (FDA).

19 Previously, two draft laws with potential to (negatively) affect access to medicines were proposed. The draft legislation on the Implementation of Paragraph 6 of the Doha Declaration on TRIPS Agreement and Public Health, initially proposed by the Ministry of Commerce but substantially revised and submitted by the Department of Drug and Food (DDF), could potentially be interpreted as a replacement to, rather than as an effort to strengthen the existing compulsory licensing provisions in the current Patent Law. The second draft law and sub-decree on Undisclosed Information and Trade Secrets, initiated and prepared by the Ministry of Commerce, contains provisions on data exclusivity and patentregistration linkage. Both of these provisions would severely hinder access to medicines. Potential areas for strengthening legal frameworks While most countries have amended their patent laws to include flexibilities in the scope of the patent (category II), additional space for further amendments of the laws and better use of those flexibilities could and should still be explored. As observed in the table, these include provisions related to acquisition of patent (category I) and after the acquisition of patent (category III). Patentable Subject Matter Patentability criteria including, new/novel, inventive step/non-obviousness and industrial applicability have been left intentionally undefined by the WTO s TRIPS Agreement and Members are free to define their own standards for patentability criteria in national laws. While this has created opportunities for countries to strengthen their legal frameworks and to enhance access to medicines in their countries, multi-national corporations (MNC) have also used the lack of clarity on patentable subject matter as a ground for legal actions and opportunities for ever-greening of patents 25. In this regard, India s Patent Law, Section 3(d) has been championed as the model for developing countries interested in preserving their public health objectives in the region and the world. Section 3(d) prohibits patents for new uses of existing pharmaceuticals and restricts patents for new forms of existing pharmaceuticals unless the new form show a significant increase in efficacy. In short, it seeks to prevent ever-greening of patents. The Philippines patent law also restricts patents for new forms and new uses of existing pharmaceuticals. Cambodia and The Malaysian Organisation of Pharmaceutical Industries (MOPI) have identified Patentable Subject Matter as a specific area to be strengthened within their national patent laws. Pre- and Post-grant Opposition Currently, only the Indian, Thai and Vietnamese patent laws allow for pre- and post-grant opposition filings. Such mechanisms provide an important space for civil society, including health and patient groups to challenge patent applications and granted patents. Although the effectiveness of the opposition proceedings depends heavily upon access to patent application information, including complete specification of the applications and clear guidance on oppositions filing; nevertheless, it has been a critical tool in India and Thailand for protection of access to medicines. 25 Ever-greening of patents is the practice whereby the duration of time that a patent holder enjoys exclusive rights on a particular drug is effectively extended by the reapplication for patents for essentially the same drug with slightly modified formulations, presentations or compositions.

20 In Vietnam, the Vietnam Network of People Living with HIV/AIDS (VNP+) has recently filed the first ever pre and post-grant oppositions on a key second-line HIV medicine LPV/r. A post-grant opposition has been filed against the first approved LPV/r application 26 with a patent expiration date in A pre-grant opposition has been filed against the second LPV/r application. The second LPV/r application is currently pending and if approved, the patent expiration date is expected to be in Cambodia and Malaysian civil society groups have identified the use of pre- and post-grant oppositions as additional provisions to be included in their patent laws. Patent-registration linkage Ensuring that, TRIPS-plus measures such as patent-registration linkage and data exclusivity are not implemented in developing countries, has been identified as a key step in ensuring that countries can benefit from the full use of TRIPS-flexibilities. Some countries like the Philippines have specific provisions in their legislation which delink patent status from the registration of generic versions of medicines, also known as patent-registration linkage and prevent data exclusivity 27. Others like India and Thailand simply do not have provisions enforcing these measures. In Vietnam, although patent-registration linkage is not in the Vietnamese Patent Law, as a result of free trade agreements, it has been included and implemented through the Vietnamese Ministry of Health s Guidance for Registration (Circular 22). Health and legal advocates have advocated for the article to be removed and the Circular to be amended to be in line with the law. In Malaysia, statements from civil society groups and MOPI indicate increased concern around the practice of patent-registration linkage by the MoH despite the lack of specific laws requiring such linkage. The National Pharmaceutical Control Bureau has recently been documented to be making systematic queries regarding the patent status of drugs for which registration applications from generic manufactures have been made. Further to that, if there is a patent, the generic company is required to make a declaration as to the status of related patents, if any. Such a practice is considered by civil society groups to be in direct contradiction of the Bolar provision provided under Section 37(1A) of the Malaysian Patent Act. The Malaysian government has also recently imposed data exclusivity on medicines. Free Trade Agreement (FTA) Status The Governments of China, Cambodia, India, Philippines, Thailand and Vietnam have expressed their commitments, either formally (e.g National IP Strategy, official press statements) or informally (e.g. informal consultations) to ensuring access to affordable medicines for their citizens. However, these commitments have often been put to test through various FTA negotiations. Specifically, provisions that go beyond the standard of intellectual property protection required by the TRIPS Agreement, thus creating opportunities for ever-greening of patents (also known as TRIPS plus provisions), have been and continue to be proposed and included in various bilateral and multi-lateral FTAs and other trade-related agreements. 26 Vietnamese LPV/r application #1 No (WO ); application #2 No (WO ). 27 Philippines RA No. 9502: Data Protection from unfair commercial use stipulated that patent holders are protected as provided under TRIPS Article However, Bureau of Food and Drug shall not be precluded from using all data, including, but not limited to, pre-clinical and clinical trials, of an applicant when evaluating other applications.

21 Examples include the case of patent-registration linkage in Vietnam mentioned above and data exclusivity in China and Malaysia. In FTAs and other trade agreements signed by Malaysia, Thailand and some of the other countries, IPR has been included in the Investment Chapter and subject to the Investor-State Dispute Settlement mechanism (ISDS). There is concern that this mechanism would allow MNCs to claim damages from these governments in the event of loss of profits due to the use of TRIPS flexibilities. TRIPS plus provisions including date exclusivity and patent-registration linkage have also been proposed in the ongoing EU-India FTA negotiations and also feature in the Trans-Pacific Partnership (TPP) negotiations between the US and Malaysia and Vietnam. In Thailand, the government suspended its FTA negotiations with the US after a series of protests from Thai civil society groups regarding the various provisions, including TRIPS-plus measures, proposed in the Thailand-US FTA. Similarly, as a response to the rising concern from civil society groups on the EU-India FTA negotiations, the Government of India issued a clear position stating its opposition to any TRIPS-plus provisions being included in the FTA. The Anti-Counterfeit Trade Agreement (ACTA) is another potential avenue for TRIPS-plus measures to make its way into national patent legislations. At the time of writing this report, none of the mapping countries have taken up the agreement. Based on public information and information provided by the country teams, Table 7 provides a brief overview of the various FTA negotiations, both ongoing and those being proposed, in the mapping countries. Table 7: Overview of ongoing and proposed FTA negotiations Country Key FTA Status Cambodia EU- ASEAN (stalled?*) US-Cambodia (Trade and Investment Framework Agreement, 2006) China EU-China Partnership and Co-operation Agreement (ongoing?) US-China Bilateral Investment Treaty (not certain if it will cover IP) Multiple bilateral investment treaties (signed, proposed and ongoing) India Japan-India (signed) EU-India (ongoing) EFTA-India (ongoing) US-India (?) Multiple bilateral investment treaties (signed, proposed and ongoing) Indonesia Japan-Indonesia FTA (signed) US-Indonesia TIFA (?) ASEAN-Indonesia TIFA (?) EU-Indonesia FTA (ongoing) EU-ASEAN FTA (stalled?) Multiple bilateral investment treaties (signed, proposed and ongoing) Malaysia Japan-Malaysia FTA (signed) US-Malaysia TPPA (ongoing) EFTA-Malaysia (?) EU-ASEAN (stalled?) Multiple bilateral investment treaties (signed, proposed and ongoing) Myanmar Still under economic sanction and not engaged in FTAs; however, with the political transition, US and EU have shown potential signs of wanting to engage Myanmar in FTA negotiations. Thailand Japan-Thailand FTA (signed) US-Thai FTA (stalled? Re-start?)

22 EU-Thai FTA (to start) EFTA-Thailand (?) EU-ASEAN FTA (stalled?) Multiple bilateral investment treaties (signed, proposed and ongoing) Philippines Japan-Philippines (signed) US-Philippines TIFA (?) US-ASEAN TIFA (?) EU-Philippines (ongoing) EU-ASEAN (stalled?) US-Philippines FTA (?) Multiple bilateral investment treaties (signed, proposed and ongoing) Vietnam Japan-Vietnam FTA (signed) US-Vietnam FTA (signed) EU-Vietnam FTA (ongoing) EU-ASEAN (stalled?) US-Vietnam TPPA (ongoing) EFTA-Vietnam (announced 29 May 2012) Multiple bilateral investment treaties (signed, proposed and ongoing) *? situation unclear Other issue: Strengthening domestic production capacity While not covered by the mapping exercise, the issue of domestic production was raised by four of the eight reporting countries: China, Malaysia, the Philippines and Vietnam. These four countries face different sets of challenges and opportunities. China is the leading global producer of active pharmaceutical ingredients (API) with 80% of the market share. It currently produces six first-generation, off-patent, first-line ARVs, including one FDC, and one second-line ARV 28. Only one of the generic ARVs produced in China has received WHO pre-qualification. Great opportunities exist for China to become another key generic ARV supplier to the world as it continues to work towards improving the quality and capacity of its domestic capacity. According to MOPI, domestic production can play an important role in bringing down the prices of first-line ARVs in Malaysia. At the same time, according to civil society groups and MOPI, the difficulties in obtaining ARV patent information, the limited legal space for exercising CL, and the unclear government stance on trade and patent related issues limit the opportunities and prevent further discussions on this issue. Currently, only FDC of d4t+3tc+nvp is produced locally by a local generic company called CCM Duapharma Biotech Berhad. Various key stakeholders, including government offices and civil society groups, have advocated for the domestic production of ARVs in the Philippines. The country has the required technical knowledge and production facilities. On the other hand, it has to address a number of production and market-related barriers. Currently, Philippines does not have domestic ARV production and nor does it produce the APIs for ARVs. The relatively small domestic market for ARVs detracts domestic producers from investing in this market. Production efficiency and competitiveness of Philippine production would need to be improved to enter the international generic market. 28 Current domestic production of ARVs in China: 3TC (tablets), AZT (tablets), d4t (capsules, tablets, and suspension), ddi (dispersible buffered tablets and enteric-coated capsules), FTC (tablets), IDV (sulfate capsules), NVP (tablet) and 3TC+AZT (FDC).

23 Similar to the Philippines, Vietnam also imports 100% of its APIs for ARVs and has some capacity and production facilities for drug manufacturing. A number of domestic manufactures currently produce some first and second-line ARVs 29 and there is a sizeable domestic ARV market. In general, there is a strong government support for local pharmaceutical production with a target of 70-90% of national medicine needs to be covered by local production by Key areas to be strengthened in Vietnam include boosting manufacturing capacity, establishing production lines that meet WHO prequalification and Good Manufacturing Practice (GMP) requirements, monitoring of drug safety during pre- and post-marketing periods, and increasing technological expertise and research and development. Currently, there are no local manufacturers with WHO prequalification status and no government programmes to support technology transfer. KEY LEARNING POINTS 1. Coordination mechanisms to support the TRIPS and drug access agenda Overall, the collection of the mapping information has been challenging in all countries, and this not only for the patent and legal environment related information. A key barrier has been that the stakeholders involved usually do not (yet) routinely engage with each other. This applies both to interactions among relevant government departments and among various civil society groups (e.g. HIV groups, IP lawyers and academia), and as between these three groups. Another barrier is that some of the information is often very hard to access (e.g. patent information) and/or politically sensitive. This is especially the case for information about ongoing FTA negotiations as they pertain to national economic interests. Actors involved in FTA discussions are usually reluctant to disclose information for fear of jeopardizing negotiations and governments do not always pursue a policy of transparency on these negotiations towards the public. On the other hand, where some level of coordination existed since before, or where an active core team was established, the information collected has been very rich and the discussions fruitful, resulting in a productive learning opportunity. The mapping exercise and workshop proceedings revealed a high level of interest in and awareness of the issues, even if many stakeholders may initially have felt intimidated by the complexity and political sensitivity. There appears to be determination in all countries to establish more formal coordination and collaboration mechanisms to support the TRIPS and drug access agenda. 2. Opportunities for cross-country learning and exchanges There are ample examples of good practices in various areas from across the region to learn from and build on. Several country teams, including India, the Philippines and Thailand, have offered to share their experience and expertise with other governments and civil society groups in the region. Opportunities and mechanisms to facilitate cross-regional learning and collaboration need to be explored and maximized. 3. It is high time to act 29 Current domestic production of ARVs in Vietnam: 3TC (100mg and 150 mg tablet), ABC (tablet), AZT (300 mg, tablet), d4t (30mg, tablet), ddi (tablet), EFV (200mg and 600 mg, tablet), FTC (200mg), IDV (tablet), NVP (200mg, tablet), TDF (300mg), 4dT+3TC+NVP (FDC) and AZT+3TC (FDC).