1. Position Paper---China Global South Dialogue on HIV/AIDS and Access to Treatment 05,Aug., Mexico city, Mexico 06/08/2008

2. The evolution of the HIV/AIDS epidemic in the China First case was reported in 1985. By the end of Dec 2007, the cumulative numbers reported ： -The total number of HIV positives was 230643, among which there were 66392 AIDS cases. -The total number of AIDS related death was 23963. In 2007, the Ministry of Health (MOH), UNAIDS and WHO jointly released the new estimation (by the end of 2007) ： -The current HIV positives were approximately 700000, among which there were 85000 AIDS cases. -The estimated new HIV positive cases in 2007 were 50000 and there were an estimated 20000 AIDS related deaths.

3. The evolution of the HIV/AIDS epidemic in the China

7. Among the 50,000 estimated new infections during 2007 Heterosexual transmission was 44.7%, homosexual transmission was 12.2%, transmission through IDU was 42%, while MTCT transmission was 1.1%.

9. The legal framework related to the right to health services and treatment in general In China The Health Care Settings include: Emergency Department Urgent Care Clinics Primary Care Settings Impatient Service Correction Health Care Facilities TB/STD clinics Public Health Clinics Community Clinisc

10. The legal framework related to the right to health services and treatment in general In China Main bodies responsible—centers for disease prevention and control at national, provincial, prefecture and county level. There are 3586 centers for disease prevention and control at all levels nationwide and 209.8 thousand public health workers. Cities and townships have been covered by three leveled prevention and health care within community and rural basic public health services. The systematic framework of disease prevention and control with Chinese characteristics has been established.

11. The legal framework related to the right to health services and treatment in general In China A series of key measures have been carried out Promulgation of The Chinese Law of Infectious Disease Control and Prevention Regulations on the Urgent Response of Public Health Emergencies Management Regulations of Vaccine Circulation and Prevention Inoculation Regulations on AIDS Prevention and Control Regulations of Schistosomiasis Prevention and Control Other laws and regulations; development China's Action Plan for Reducing and Preventing the Spread of HIV/AIDS (2006-2010) The plan for Tuberculosis Prevention and Control (2001-2010) Guidelines of Mid-long Term Plan for Schistosomiasis Prevention and Control (2004—2015) 2006-2010 Plan for Hepatitis B Prevention and Control and so on.

12. The legal framework related to the right to health services and treatment in general In China Series of Plans for diseases prevention and control were developed, as well as schemes for prevention and control of diseases such as SARS, human- avian influenza, pestis and malaria, etc. Prevention and control of major disease has made progress in China. Principles and steps: 1 、 Promote Medical system and Medical Security System reformation; 2 、 Strengthen management of Medical institutions; 3 、 Make the procurment procedure of medicine and medical instrument more transparant and better; 4 、 Strengthen mornitoring system of medicine price; 5 、 Regulate the procedure/order of medicine production; 6 、 Promote anti corruption in the field of Medicine procurement and sale.

13. The legal framework for industrial property with emphasis in pharmaceutical patents Chinese Patent Law came into force on April 1,1985, and was revised in 1992 and 2000. According to the Patent Law of 1985, no patent right shall be granted for following subjects: methods for the diagnosis or for the treatment of diseases; pharmaceutical products or substances obtained by chemical process. However, the process of making of pharmaceutical products or chemical material is patentable.

14. The legal framework for industrial property with emphasis in pharmaceutical patents The provision on the nonpatentability of pharmaceutical products or substances obtained by chemical process was repealed in the first revision in 1992. Current Patent Law still provides that pharmaceutical products and chemical products are patentable.

15. The legal framework for industrial property with emphasis in pharmaceutical patents-- Patentable Subject Matter Invention Product ： chemical product, pharmaceutical, medical instrument, etc. Process ： process used for the manufacturing of pharmaceutical product, new medical use of a substance,etc. Utility Model New technical solution relating to the shape, the structure, or their combination ： medical instrument Design New design of the shape, the pattern, or their combination, or the combination of color,shape and/or pattern of a product.

16. The legal framework for industrial property with emphasis in pharmaceutical patents-- Unpatentable Subject Matter Invention that is contrary to the laws or social morality, or that is detrimental to public interest Scientific discoveries Methods for the diagnosis or for the treatment of diseases

17. The legal framework for industrial property with emphasis in pharmaceutical patents-- Compulsory License Types of Compulsory License Compulsory License in the situation that the patentee unreasonably refuses to license(Article 48) Compulsory License for the purpose of public interest; (Article 49) Compulsory License on the request of dependent patent holders(Article 50)

18. The legal framework for industrial property with emphasis in pharmaceutical patents-- Compulsory License Compulsory Licensing for the public interest Where a national emergency or any extraordinary state of affairs occurs, or where the public interest so requires, SIPO may grant a compulsory license to exploit the patent for invention or utility model. The person qualified to request The competent department concerned under the State Council.

19. The legal framework for industrial property with emphasis in pharmaceutical patents-- Compulsory License The granting of compulsory license only be limited to invention or utility model; shall be authorized predominantly for the supply of the domestic market; be granted by SIPO ； where party concerned is not satisfied with the decision, he may, within three months, institute legal proceedings in the people's court; the compulsory license shall nonexclusive ； licensee of the compulsory license shall not have the right to authorize exploitation by any others, and shall pay a reasonable fee to the patentee.

20. The legal framework for industrial property with emphasis in pharmaceutical patents-- Perfecting of Legislation on Compulsory License Measures on the Compulsory License for Exploitation of a Patent （ 2003 ） to standardize the procedures of granting compulsory license of patents, such as content of the request, the hearing of the request, the content of the decision,etc.

21. The legal framework for industrial property with emphasis in pharmaceutical patents-- Perfecting of Legislation on Compulsory License Measures to Implement Public Health-Related Compulsory Licensing （ 2005 ） public health problems shall be regarded as a kind of national emergency set forth in Article 49 of Paten law ； SIPO may grant a compulsory license to allow the licensee to import pharmaceutical products specially made for China by WTO member under the system established by the Decision of the General Council of WTO; SIPO may also grant a compulsory license to allow the licensee to make pharmaceutical products and export the products specially to a eligible WTO Member or a Least-developed Country.

22. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health The process of current revision After widely soliciting advice and intensive study, SIPO submitted the draft revision of Patent Law to the State Council on Dec. 27, 2006. The amendment of Patent Law has been listed in the Legislation Agenda of the State Council of 2008 as a priority task. At present, the draft is under reviewing by the State Council. After approving by the State Council, a bill on the revision of the Patent Law is going to be submitted to Standing Committee of NPC latter half of this year. It is supposed to be adopted by the Standing Committee of NPC after three readings.

23. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health To solve the public health problems in China In order to solve the public health problems in China, SIPO may, as suggested by a competent department under the State Council, grant the entity designated by the department a compulsory license.

24. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health To help other country to solve the public health problem in that country developing country or a Least-developed Country who have no or insufficient capability to manufacture a pharmaceutical product, and hopes to import this product from China, SIPO may grant an entity which is able to exploit, a compulsory license to manufacture the said pharmaceutical product and to export it to the said country.

25. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health Allow Parallel Importation To make full use of flexibility provided in TRIPS Agreement, the proposed provision provides that where a patented product or a product obtained directly from a patented method is sold by patentee or a licensee in foreign country or region, the action of importing that product shall not be deemed as infringement.

26. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health Introduction of “Bolar Exception” The act of manufacturing, using or importing a patented drug or a patented medical apparatus, by any person, solely for the purposes of obtaining and providing the information needed for the administrative approval of the drug or medical equipment, and the act of manufacturing, importing or selling a patented drug or a patented medical apparatus to the said person, shall not be deemed as infringement.

27. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health The amendment of Implementing Regulations of Patent Law(“IRPL”) In February 2007, SIPO started the amending of IRPL In December 2007, 21 project teams submitted their research reports in relation to 16 important issues, including the perfecting of legislation on compulsory license In March 2008, the Legal Affairs Department of SIPO finished the preliminary draft of IRPL, and is discussing the draft inside SIPO

28. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health in the draft of IRPL Give a definition to “pharmaceutical product” according to the THE PROTOCOL AMENDING THE TRIPS AGREEMENT Reasonable measures should be taken to prevent the diversion of pharmaceutical products that is imported from “exporting member”, and prescriptive information should be notified to the TRIPS Council.

29. The legal framework for industrial property with emphasis in pharmaceutical patents-- Proposed revision related to public health Proposed revision of the provisions related to public health in the draft of IRPL Statutory requirements should be observed when a compulsory license of exporting pharmaceutical products to other countries is granted, such as notification to the TRIPS Council, entirety of exportation, specific labelling or marking, publication of information concerned, etc.

30. The historical framework of the right to treatment of PLHA and Access to Drugs There is no cure for AIDS; to relieve symptoms needs lifetime ART. In 2003, the State Council developed the “Four Free ， One Care” policy, which provides free ART to rural AIDS patients and the patients with living difficulties in cities and townships. The Central Gov. provide free medicine (1st line drugs) to farmers or those in the cities without social insurance; Free VCT from CDC; Free medicine for pregnant mothers and free testing for infants; Free education for children orphaned because of AIDS; One care:Gov. Subsidies for those PLHA and their families to help them improve their liveng conditions;

31. The historical framework of the right to treatment of PLHA and Access to Drugs ART among adults: by the end of Dec 2007, ART covered 1232 counties (districts) in 31 provinces (autonomous regions and municipalities). The cumulative number of people aged 15 and above who commenced treatment was 41777, with 33980 currently receiving ART. Pediatric ART: by the end of Dec 2007, a total number of 799 children from 150 counties (districts) of 20 provinces (autonomous regions and municipalities) had received ART, with 766 remaining on ART. The pilot project of second line drugs treatment was launched.

32. The historical framework of the right to treatment of PLHA and Access to Drugs ART among adults: by the end of Dec 2007, ART covered 1232 counties (districts) in 31 provinces (autonomous regions and municipalities). The cumulative number of people aged 15 and above who commenced treatment was 41777, with 33980 currently receiving ART. Pediatric ART: by the end of Dec 2007, a total number of 799 children from 150 counties (districts) of 20 provinces (autonomous regions and municipalities) had received ART, with 766 remaining on ART. The pilot project of second line drugs treatment was launched.

33. The historical framework of the right to treatment of PLHA and Access to Drugs In 2007, the State Council approved maintaining customs exemption for the import of ARV drugs and approving tax exemptions for the local production of ARV drugs, which aims to promote production and import of ARV drugs.

34. Production of Antiretrovirals (ARVs) --Local China SFDA take it seriously about the procedure of registration and production of ARVs Applicants can raise application for special evaluation and reviewing procedure of ARVs.The evaluation and reviewing center of the SFDA will organize experts to discuss whether to approve the application; Under urgent situation such as sudden public health affair,the SFDA can decide to approve ARVs through special procedure according to laws and regulations.

35. Production of Antiretrovirals (ARVs) --Local Only under the precondition of 1.Not lower down the criteria of the technology, 2.make sure the safety of the medicine, can SFDA provide special procedure for ARVs approving through E&R procedure with time limitation. Regulation on Management of Medicine registration (SFDA order No. 28), Article 45.---for AIDS drugs SFDA special approvement procedure (SFDA order No. 21),Article 3.---for Urgent situations

36. Production of Antiretrovirals (ARVs) --Local Registered application for ARVs---Chinese Medicine: total 20 till now One is already approved and available on the Market (Beijing Qijieyuan medical and technology Ltd.) There are another 5 enter into clinic trial process;

37. Production of Antiretrovirals (ARVs) --Local 齐多夫定 AZT （ Domestic ：片剂、胶囊、注射剂、口服液。 Imported ：片剂、胶囊） 拉米夫定 3TC （ Imported ：片剂、口服液） 去羟肌苷 ddI （ Domestic ：散剂、颗粒剂、分散片、咀嚼片、胶囊。 Imported ：分散片、肠溶胶囊） 司他夫定 d4T(Domestic ：片剂、胶囊。 Imported ：胶囊 ) 阿巴卡韦 ABC （ Imported ：片剂、口服液） 奈韦拉平 NVP （ Domestic ：片剂、胶囊、分散片。 Imported ：片剂、口服混悬液） 依非韦伦 EFV （ Imported ：片剂、胶囊） 沙奎那韦 SQV （ Imported ：胶丸、胶囊） 茚地那韦 IDV （ Domestic ：片剂、胶囊。 Imported ：胶囊） 利托那韦 RTV （ Domestic ：口服液。 Imported ：软胶囊、口服液 奈非那韦 NFV （ Improted ：片剂） 恩夫韦肽 T-20 （ imported ：注射剂） 齐多拉米双夫定 AZT/3TC （ Imported ：片剂） 洛匹那韦 / 利托那韦 LPV/RTV （ Imported ：口服液、软胶囊、片剂） 阿巴卡韦双夫定 ABC （ Imported ：片剂 )

38. Production of Antiretrovirals (ARVs) --Local first line drugs First-line ARV drugs Drugs of domestic production （ AZT ） （ DDI ） （ D4T ） （ NVP ） （ IDV ） Imported drugs （ 3TC ） （ AZT/3TC ） （ EFV ） （ IDV ）

39. Production of Antiretrovirals (ARVs) --Local According to SFDA official statistics,there are 16 ARVs in China,9 imported,1 Chinese Medicine and 6 can be domestic produced.

40. Production of Antiretrovirals (ARVs) --Local 进口药 国产药 国产 / 进口 阿巴卡韦双夫定 ABC 唐草片 利托那韦 RTV 甲磺奈非那韦片 NFV 硫酸茚地那韦 IDV 拉米夫定 3TC 奈韦拉平 NVP 硫酸阿扎那韦 齐多夫定 AZT 沙奎那韦 SQV 去羟肌苷 DDI 司他夫定 D4T 依非韦伦 EFV 恩夫韦肽 T20 洛匹那韦 / 利托那韦 LPV/RTV 齐多拉米双夫定 AZT/3TC

41. Production of Antiretrovirals (ARVs) --Local-International Domestic Co.International Co. AZT NE;FEILIKE;TIANFANG;MO RDERN PUDONG;QILU;TOTAL 16 CO. GSK(CHINA) 3TC GSK(CHINA) DDI NE;MINSHENG;DISAINUO; HUAHAI;TIANFANG; TOTAL 5 CO. D4T NE;DISAINUO;WUJING;SH UANGLU;MAIKE TOTAL 5 CO. Bristol-Myers Squibb Company ABC GSK(CHINA)

42. Production of Antiretrovirals (ARVs) --Local-International Domestic Co.International Co. NVP Haichen;Maike;Huahai;Xind ong bay;Bangyu; Total 8 Co. Shanghai 柏林格 殷格翰 EFV MSD (CHINA)

43. Production of Antiretrovirals (ARVs) --Local-International Domestic Co.International Co. SQV SHANGHAI ROCHE IDV NE;TIANFANG;QILU;HU AHAI;MAIKE; Total:5 Co. MSD(China) RTV MAIKE ABBOT NFV SHANGHAI ROCHE

44. Production of Antiretrovirals (ARVs) --Local-International Domestic Co.International Co. T-20 SHANGHAI ROCHE

45. Production of Antiretrovirals (ARVs) --Local-International Domestic Co.International Co. AZT/3TC GSK(Tian Jin) GSK(CHINA) LPV/RTV Abbott Laboratories ABC GSK(CHINA)

46. Performance of transnational pharmaceutical companies’ affect in China and Foreign ones’ strategy Chinese patients can access to some first line drugs; Lower down of drug price;

47. Performance of transnational pharmaceutical companies’ affect in China and Foreign ones’ strategy Foreign Companies prefer donation rather than lower down the price or give up patent; Promote patent file/registration and Ever green strategy; Patent linkage; Political pressure combined with commercial pressure; Secret deal with MOH; Divided and rule;

48. Patent situation and access to ARVs 一线药 二线药 Stavudine 司它夫定 Indinavir 茚地那韦 Zidovudine 齐多夫定 Didanosine 地达诺新 Nevirapine 奈韦拉平 Tenofovir 特诺福韦酯 Abacavir 阿巴卡韦 Lamivudine 拉米夫定 Didanosine EC Lamivudine/zidovudine 双汰芝 Lopinavir/ritonavir 克立芝 Efavirenz 依非韦仑 Ritonavir 利托那韦 Saquinavir 沙奎那韦 d4T/3TC/NVP* Atazanavir 阿扎卡韦 (Blue is in the process of patent reviewing;Pink is in the process of patent authorization)

49. Patent situation and access to ARVs 一线药 二线药 Stavudine 司它夫定 Indinavir 茚地那韦 Didanosine 地达诺新 Nevirapine 奈韦拉平 Zidovudine 齐多夫定 Abacavir 阿巴卡韦 Lamivudine 拉米夫定 Didanosine EC Lamivudine/zidovudine 双汰芝 Lopinavir/ritonavir 克立芝 Efavirenz 依非韦仑 Ritonavir 利托那韦 Tenofovir 特诺福韦酯 Saquinavir 沙奎那韦 d4T/3TC/NVP* Atazanavir 阿扎卡韦 (Blue:Generic and original; Green:generic; Black:only original; Pink: No sale on the market)

50. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property Background: The Limitation of “Four Free,One Care” Policy Unstable AIDS drug allocation/providing system

51. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property CS’ participation: Most of CS organizations regard the rules of intellectual property as a barrier for treatment access---Common sense in China now; Some main organizations/PLHA groups try to promote CL through advocacy---as the main strategy;

52. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property Main Achievement Community mobilization Knowledge and education (Translation and theory preparation--GF Watch) Networking Example: Network: IP&Access to drugs research team ITPC China Organization: AIDS Care China Beautiful life Shanghai Henan HIV/AIDS watch

53. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property--Achievement

54. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property---Achievement 29/06/2006 ， MSF Belgium China office initiate a conference on AIDS drugs; Participants ： Zhanglu, Lixiang (Red Maple ）， Ye xiaoli （ Xiao Kanweilai ）， Xiao Peipei, Menglin （ Ark of love ）， Zhang liping （ CHAIN ）， Liu Jie （ CHAIN ）， Xiaoqiang （ volunteer ）， Xiaozhou （ China ITPC ），周骥 （ China ITPC ）， Xiaokang ， Liang yanyan （ Aizhixing ）， Selina Lo （ Clinton Fundation ）， Jia Ping （ Lawyer ）， Casey （爱知行）， Ayesha Gordon （北京大学公共卫生学院）， Katrina Wong （ Dongzhen ）， Yujie, Yang yuning, Suerie and Hu yuanqiong from MSF Introduction of Access to first line and second line drugs---focus on TDF 3 representatives from ITPC China,Red Maple and Ark of Love to Submit a opposing letter to SIPO and SFDA Submit petition letters to China MOH,CDC during Canada World AIDS conference; Successfully stop TDF get patent in China

55. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property---Achievement Experience Learnt from the TDF case: Unify and speak out: over 7000 PLWHA, AIDS groups and other people signed the petition letter; Learnt how to deal with situation in emergency (Without this advocate, Gilead with get the patent); Find key proof and problems,which makes a powerful action; Cooperate with different activists, groups; Strong leadership.

56. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property---Achievement 3TC Advocate 1 、 December,2007 Beautiful Life Shanghai 2 、 13/03/2008 He Nan 3 TC case Networking,Lobby and Policy promotion 23/Feb,2008 AIDS drugs and Patent law/Trips meeting （ GF Watch;MSF Beijng;PLHA Groups;Government sector;I-NGO;Academic field)

57. Performance of local civil society in respect to AIDS treatment and access to ARVs and, Intellectual Property ---Challenge of the future How to make knowledge and information spread into the community in a simple way; The capacity of CS and the need of theory preparation---learn from Other countries; How to balance Gov. sector and CS; How to balance interests in/outside China; How to unified and speak out together---Forget about personal issue,and target on MOH; How to keep balance among the CS groups---fight for right of life,not for reputation and power,or achievement; We should responsible for the Positive community and the whole society, not only for donors;

58. Thanks! Jia Ping China Global fund Watch Initiative Jiapingfree@gmail.com