- Clear case for joint action of countries. - Updated, comprehensive - Not just prices
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1 Consultation on Access to HIV Medicines in Middle-Income Countries June, 2013 Brasilia, Brazil nisdxyu Consultation on Access to HIV Medicines in Middle-Income Countries &~lbmu WHO UNAIDS UNITAID aaa:n4rw4asaiai4~q.ud4:bwfl Brazil 5fl~4j19~~i ~ ~UIUU 2556 $ Pan American Health Organization (PAHO) m n24 Brasilia ei4awfl Brazil lmu~tmqel4"asdoabuayuni4 a w w ahffsui6iula?vl %u Middle-Income Countries u~a.uiiauei~x~uel=i:ui~ 70 mu oin Low Middle-Income Countries aaaz Upper Middle-Income Countries lmu ~Ri~umni~ei~:~umiu~~nai5 wm w w aauu 1 fl4~w~asaisi~~q.u~nas~auiiaud~x~uoinel4~awfl~wu 3 flu 16san' Dr. Duanqtip Hongsamoot o1ndign~iups~nel~~5uq"11niwa~p44~di~ Ms. Achara Eksaengsri oinosani~an5vn45u aaa- Mr. Chalermsak Kittitrakul oinyafi5shffsaoma' lmu{aawuoinosdni4an5vn54u b%iaauo Country Experience %u'sessions: Pharmaceutical R&D and Local Production: What Role in Increasing Access to Medicines in Middle-Income Countries oinnisei~nwi~i~o aaax~ps"maiua~u~udel4%~%~ haawudsrawfl Middle-Income Countries l6sgu a'l Medicines Patent Pool (MPP) mechanism psqo voluntary llcensinq ~ ~ ~ ~ 1 ~ 4 f l l 4 ~ ~ ~ ~ 1 ni~ah5sui.ua~uiieaic ~~~DU'1~~4ti~~lm4n14 TRIPS Flexibilities a h pre-grant opposition, revocation, compulsory licensing &~iosaauuim4ni5a~~n vcrd aaa~~6~a~unisa"~insvouiaic~, uonoin<%uni4d~afiuqiu.uos MPP mas~ni4ro=ioih Agreement oeiisleiis%a aaasr8ua=i=iu ~ni~diuwo~awm~uiadoeii~o4~ds aaaz~ni=iromn~iqm"iu geographical scope and Limitation diu?u Point of action for south-south coilaboration a~amaiuiau~o5u~~anscmn14d4x~u aiui4oa2eizk 3 cis-rm'u $4: 1. Proposals related to pricinq Immediate Term - Map out what has worked and in which context - When has it worked? Has such mechanism been burned out? - Delineate groups of countries by affinity, but not necessarily geography Information platform - Updated, comprehensive - Not just prices - Harmonization with existingefforts - Clear case for joint action of countries Policy Dialogue between MoH with Ministry of Commerce ma4
2 Urgent support to countries outside of those which are already benefiting from existing strategies 2. Joint action to address manayement of intellectual property right in a public health oriented way? Information platform/exchange Develop cooperation mechanisms with respect to the adoption and use of all TRIPS compliant flexibilities such as strenythening patentability criteria and bring MlCs together to discuss patent law reform to improve access to medicines inter alia. Examine options and strategies for MlCs to increase access to second-line, thirdline and pipeline since there are no generic drugs for some products Coordinate government action on free trade aqreements (FTAs) Mobi!ise resources and factitate coordinate civii society communication and advocacy. Improve transparency on VL negotiations/-agreements (MPP, bilateral, etcl. 3. ColLaboration on Regulatory lssues Strengthen collaboration between WHO PQ and National Drug Regulatory Authorities including but not limited to improve efficiency and timeliness; Need to have a secure platform to share regulatory data and improve data sharing and cooperative work among regulatory authorities Capacity buildinp of Druq Regulatory Agencies by WHO/Regional Offices/Governments; Fight perception that quality-assured generics cannot be trusted
3 @UNAlDS - SUS& bf@$ & Organization %As G A 2,.&* G O V? * h * T I Min!s[ry of Health m 1l.I World Health CONSULTATION ON ACCESS TO HIV MEDICINES IN MIDDLE-INCOME COUNTRIES June, Brasilia, Brazil 5:30-9:00 1 Registration - I 1 BrazilTan Government 3:00-10:OO Welcome remarks: setting the scene l0:oo -.l0!30 ~dffee Break UNITAID Session 1: Markets and Prices for HIV medicines in 10:30-12:30 Chair: (TED) middle-income countries 10 min Country experience Brazil Patricia Uribe and Sebastian Garcia, Mexico ~ 15 min ARV prices: an overview Jos Perriens, WHO 10 min. Procurement of ARVs for MlC: achievements and challenees -~~ Analia Porras, PAHO 10 min. Untangling the Web of Antiretroviral Price Reductions Rohit Malpani, MSF 20 min Discussion 12: Lunch* Session 2: Intellectua! Property Rights and access to HIV Chair: Uc Marlent. Cruz 14:OO - 15:30 medicines Gibert (Cuba) 10 min TRIPS, flexibilities and economics of IP Jayashree Watal (WTO) Indonesia 10 min Country experience Ms Aradhana Johri, India Andres Ycaza, Ecuador 10 min Competition law Tenu Avafia, UNDP 10 min Civil society's role and strategies Marcela Vieira, ABIA/GTPI 30 min Discussion G:?.O-1 $00., 1~.6ffee;#~ak..., 16:OO - 17~30 Working groups Group 1: Markets and Prices for HIV medicines in MlCs Group 2: Intellectual Property Rights and access to HIV medicines ppt medicines ~i +i_ patent pool
4 ~ ~. QUNAlDS df x-g )j World Health Organization Ministry of.. wm.,, h-.. w L G O " E I I I " E N 1 20 rnin income countries: issues and challenges Regulatory status of ARVs in selected MICs: overview and challenges Cornelis De Joncheere, WHO %~ pr \/ 2,,{ 10 min Country experience Dr Dirceu Barbano, Brazil (10 min Country experience 1 10 min Country experience 1 30 rnin. Discussion Aliya Utegenova, Kazakhstan :30-11:OO 1 Coffee Break Anban Pillay, South Africa Chair: Jorge Bermudez 11:OO - 12:30 Session 4: Voluntary Licensing (FIOCRUZ) 10 min. Voluntary licensing: trends, advantages and limitations Peter Beyer, WHOIPHI 15 min. Terms and conditions in voluntary licenses Greg Perry, MPP 10 min. Civil rociew.. perspective. on the use of voluntaw licenses Lieve Vanleeuw, TAC min Discussion I in-nn I Lunch Session 5: Pharmaceutical R&D and local production:?4:00-15:30 what role in increasing access to medicines in middle income countries? 10 rnin Country experience 1 Chair: Ms Konji Sebati (WIPO) Leonardo Paim, Brazil China Ms Achara Eksaengzri, GPO, Thailand 10 rnin Country experience Anban Pillay, South Africa 10 min Country experience (TED) Addressing Gaps in Innovation for Neglected Patients: 10 rnin Lessons Learned from DNDi's Experience with NTDs & EricStobbaerts, DNDi Overview of the DNDi Pediatric HIV/AIDS Program 30 min Discussion, 15:30-16:00 ) Coffee break 16:OO - 17:30 1 Working groups Group 3: Regulatorv status of HIV medicines in middle income countries Group 4: Voluntary licensing p
5 ' ' ),World Health - 4&! v g 1O:OO - 10:30 I Closing Plenary: South-South collaboration and next steps Chair: UNAIDS and UNITAID p:30 - ll:00 Coffee Break e / l1:oo - 12:30 1 Closing Plenary: South-South collaboration and next steps (cant.) :30-13:OO 1 Closing remarks I Il3ao 1 Lunch I r?\ medicines pa tent 5.i<*e]
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