WORKSHOP ON TRADE AND PUBLIC HEALTH. Organized by the WTO Secretariat. in collaboration with the Secretariats of WHO and WIPO

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1 WORKSHOP ON TRADE AND PUBLIC HEALTH Organized by the WTO Secretariat in collaboration with the Secretariats of WHO and WIPO Geneva, 6-10 November 2017 Programme Monday, 6 November h30 09h00 09h00 09h15 Registration of Participants Opening of the Workshop Mr Xiaozhun YI, Deputy Director-General, WTO 09h15 09h45 09h45 10h15 Introduction of Participants Theme I 10h15 11h45 Setting the Scene Roundtable : Mapping the Interface between Health, Trade and Intellectual Property Mr Antony TAUBMAN, Director, Intellectual Property, Mr Hoe LIM, Director, Trade and Environment Division, WTO Mr Alejandro GAMBOA-ALDER, Counsellor, Market Access Division, WTO Dr Peter BEYER, Senior Advisor, Department of Essential Medicines and Health Products, WHO Mr Hans Georg BARTELS, Senior Program Officer, Global Challenges Division, WIPO 11h45 12h15 Economics of Medical Technologies Innovation and Access Ms Jayashree WATAL, Counsellor, Intellectual Property, 12h15 12h30 12h30 13h30 Centre William Rappard Rue de Lausanne 154 Case postale CH Genève 21 Téléphone: (+41 22) Fax: (+41 22) Internet:

2 WTO OMC Page 2 Theme II 13h30 15h00 The Innovation Dimension The Intellectual Property System as Determinant for Innovation in the Pharmaceutical Sector: Implementing and Managing IPRs Mr Wolf MEIER-EWERT, Counsellor, Intellectual Property, Mr Julio RAFFO, Senior Economic Officer, Innovation Economics Section, Economics and Statistics Division, WIPO Dr Peter BEYER, WHO 15h00 15h15 15h15 15h45 Selected Country Experiences Presented by Participants Ms María José SEPÚLVEDA VERGARA National Intellectual Property Institute Chile Mr Munir CHOWDHRY Ministry of Commerce Bangladesh 15h45 16h15 16h15 17h15 Models for Collaboration - WIPO Re:Search - Public-Private Partnerships for Innovation and Access - Industry Partnerships Mr Charles Randolph, Head, Global Health, Global Challenges Division, WIPO Mr Jean-Pierre PACCAUD, Director, Business Development and Corporate Strategy, Global Antibiotic R&D Partnership (GARDP), Drugs for Neglected Diseases initiative (DNDi) Mr Thaddeus BURNS, Senior Counsel, Intellectual Property and Trade, General Electric 17h15 17h30 Tuesday, 7 November 2017 Theme III 09h00 10h00 The Access Dimension Using the IP System and its Policy Options to Further Global Access in Health Ms Tomoko MIYAMOTO, Head, Patent Law Division, WIPO 10h00 10h15 10h15 10h45

3 WTO OMC Page 3 10h45 11h15 The Doha Declaration on the TRIPS Agreement and Public Health: Creating Legal Avenues for Access to Medicines Mr Roger KAMPF, Counsellor, Intellectual Property, 11h15 11h30 11h30 12h30 The Public Health Context and Overview of Determinants Related to Access Dr Peter BEYER, WHO 12h30 12h45 12h45 13h45 13h45 14h45 Breakout Session Antimicrobial Resistance How to Foster Innovation, Access and Appropriate Use of Antibiotics Moderated by Ms Sarah PAULIN, Technical Officer, Department of Essential Medicines and Health Products, WHO 14h45 15h15 Human Rights and Access to Medicines Ms Lynn GENTILE, Human Rights Officer, Human Rights and Economic and Social Issues Section, Office of the United Nations High Commissioner for Human Rights 15h15 15h30 15h30 16h00 16h00 17h30 Case Study: Pharmaceutical Industry Policy, Local Production of Medicines, Access Strategies, and Technology Transfer Moderated by Mr Christoph SPENNEMANN, Legal Officer and Officer-in- Charge, Intellectual Property Unit, Division on Investment and Enterprise, UNCTAD 17h30 18h00 Introduction to Case Study

4 WTO OMC Page 4 Wednesday, 8 November 2017 Making Effective Use of Special Compulsory Licences for Export: A Procurement Tool for Medicines 09h00 09h15 Introduction to the Paragraph 6 System Mr Antony TAUBMAN, WTO I. Taking Stock 09h15 09h30 09h30 10h15 Overview and Context Why was a new TRIPS flexibility adopted? What needs does it address? When is it intended to be used? Ms Jayashree WATAL, WTO Putting the System to Work: Key Practical Steps Identification and notification of pharmaceutical needs Identification of supply sources Compulsory licence procedures Transparency and safeguards against diversion Relevance of regulatory approvals Coordination Use at regional level Mr Antony TAUBMAN, WTO 10h15 10h45 10h45 11h15 Implementing Measures Taken by WTO Members Which Members have export mechanisms in place? Mr Roger KAMPF, WTO 11h15 11h30 Entry into Force of the TRIPS Amendment Mr Roger KAMPF, WTO 11h30 12h30 Case Study: Medicines Innovation & Access, The IP, Procurement & Competition Dimension (Patent Task Force, TRIPS Amendment Task Force) Moderated by Ms Josefita PARDO DE LEON and Mr Roger KAMPF, WTO 12h30 13h45 II. Matching Supply under the System with Patients' Needs 13h45 14h30 Mapping Patents in Supply Countries Mr Elangi Ituki BOTOY, Industrial Property Information Officer, WIPO 14H30 15H00 Using Medicines Price Data and Meeting Regulatory Requirements Mr Andrew RINTOUL, Scientist, Department of Essential Medicines & Health Products, WHO 15h00 15h30

5 WTO OMC Page 5 15h30 15h50 Contributing to the Effective Working of the System as an Exporting Country Ms Frédérique DELAPREE, First Secretary, Permanent Mission of Canada to the WTO 15h50 16h15 Engaging in the Production of Generic Medicines Under the System Mr Sergio NAPOLITANO, International Generic and Biosimilar Medicines Association (IGBA); Legal Affairs and Trade Director, Medicines for Europe III. Looking at the Way Forward 16h15 17h30 Roundtable Moderator: Panelists: Mr Antony TAUBMAN, WTO Mr Patrick GITHENDU The Global Fund to Fight AIDS, Tuberculosis and Malaria Ms Roberta VARGAS DE MORAES Ministry of Health, Brazil Mrs Cynthia DAPAAH Food and Drugs Industry, Ghana Ms Amne Nassor Issa MOHAMED Zanzibar Food, Drugs and Cosmetics Board - Tanzania Ms Olena CHUMAKOVA Ministry of Economic Development and Trade Ukraine Thursday, 9 November h00 10h00 How to Enhance Synergies between Public Health Objectives and Trade Agreements: Industry and Civil Society Perspective Mr Sergio NAPOLITANO, IGBA/Medicines for Europe Mr Grega Kumer, Head of DG Office & Legal Issues, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Ms Yuanqiong HU, Legal & Policy Advisor, Médecins Sans Frontières (MSF) 10h00 10h15 10h15 10h45 Trade-Related Access Determinants (1): Trends in Trade of Public Health Products and Other Trade-Related Access Determinants (Tariffs and Non-Tariff Measures) Mr Darlan MARTI, Trade Policy Specialist, Market Access Division, WTO 10h45 11h00 11h00 11h30

6 WTO OMC Page 6 11h30 12h30 Trade-Related Access Determinants (2): Trade in Health Services Mr Joscelyn MAGDELEINE, Economic Affairs Officer, Trade in Services and Investment Division, WTO 12h30 12h45 12h45 13h45 13h45 14h45 Trade-Related Access Determinants (3): Procurement Rules and Practices Ms Lisa HEDMAN, Technical Officer, Department of Essential Medicines and Health Products, WHO Mr Philippe PELLETIER, Legal Affairs Officer, Intellectual Property, Government Procurement and Competition Division, WTO 14h45 15h00 15h00 16h00 16h00 16h30 16h30 17h15 Breakout Session Non-Communicable Diseases Multilateral Initiatives and International Programmes Trade and NCDs Moderated by Dr Benn MCGRADY, Technical Officer (Legal), Prevention of Non-Communicable Diseases, WHO Trade-Related Access Determinants (4): Health-Related Provisions in RTAs Ms Josefita PARDO DE LEON, Legal Affairs Officer, Intellectual Property, Government Procurement and Competition Division, WTO Ms Maegan MCCANN, Junior Legal Affairs Officer, Intellectual Property, Government Procurement and Competition Division, WTO Dr Benn MCGRADY, WHO 17h15 17h30 Friday, 10 November 2017 Theme IV 09h00 10h00 The Regulatory Dimension Competition Policy and Rules Ms Anna Caroline MÜLLER, Legal Affairs Officer, Intellectual Property, Government Procurement and Competition Division, WTO Mr Harald MISCHE, Administrator, DG Competition, European Commission

7 WTO OMC Page 7 10h00 11h00 Case Study: Medicines Innovation & Access, The IP, Procurement & Competition Dimension (cont'd) (Procurement Task Force, Competition Policy Task Force) Moderated by Ms Anna Caroline MÜLLER, WTO and Mr Harald MISCHE, European Commission 11h00 11h30 11h30-12h30 Approval, Quality Control and Effectiveness of Medicines, including Counterfeit, Falsified and Substandard Medicines 12h30 12h45 12h45 13h45 Ms Pernette BOURDILLON-ESTEVE, Analyst, WHO Global Surveillance and Monitoring System on Substandard and falsified medical products, WHO Mr Roger KAMPF, WTO 13h45 14h30 14h30 14h45 14h45 15h15 Protection of Clinical Trial Data Policy, Legal and Economic Aspects Ms Jayashree WATAL, WTO Standards, Health Regulation and Trade Ms Christiane WOLFF, Counsellor, Agriculture and Commodities Division, WTO Mr Devin MCDANIELS, Economic Affairs Officer, Trade and Environment Division, WTO 15h15 15h30 15h30 16h00 15h30 16h30 Health-Related Measures in the TBT and SPS Committees: Selected Specific Trade Concerns Raised by Members Ms Christiane WOLFF, WTO Mr Devin MCDANIELS, WTO 16h30 17h30 Case Study: Specific Trade Concerns Moderated by Ms Christiane WOLFF and Mr Devin MCDANIELS, WTO 17h30 18h00 Closing Remarks: Experiences and Lessons Learned from the Workshop

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