1. Trade and Access to medicines
Imbalances, trade-offs and compromises
Jaume Vidal
Policy Advisor. Health Action international (HAI)
Barcelona Global Health Summer Course (BGHSS)
ISGLOBAL
Barcelona, July 18th 2017

2. Health Action International (HAI)
Independent, non-profit organization dedicated to strengthening medicines policy; including Intellectual Property, pharmaceutical R&D, free trade and clinical trial data transparency.
We want all people to receive the right medicine, in the right dose, for the right amount of time, at a price they can afford.
Comprehensive approach to advocacy; including research, awareness raising, holding governments accountable and capacity building.
ACCIS
Trade and R&D
Anti-snake venom
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3. Foreword Globalization and Trade. Upsides and downsides.
Imbalances and inequalities both globally and nationally. Major factors.
Trade and pharmaceutical products. Specificities
Public Health needs and Intellectual Property Imperatives. Need for compromise
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4. Trade agreements and acess to medicines
I. Basic concepts. Evolution and historical perspective.
II TRIPS agreement. Milestones and controversies
III Post-WTO world? Bilateralism and regionalism
IV Public Health response
Conclusions
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5. Intellectual Property Rights
Basic Information
Intellectual Property Rights
Patents
MFN/NT
Access
SEUBA, X Trade, Public Health and the 2030 Agenda for sustainable development International Center for Trade and Sustainable Development (ICSTD) March 2017 pp
UNITED NATIONS SECRETARY-GENERAL’SHIGH-LEVEL PANEL ON
ACCESS TO MEDICINES Report of the HLPN Promoting innovation and access to health technologies September pp. 5-6

6. Globalization and Trade
General Agreement on Trade and Tariffs (GATT). Uruguay Round ( )
World Trade Organization (1995). Significance
8th Round of the Multilateral Trade Negotiations developed since 1948 with the frame of GAT; 1ST. To include services, intellectual property, investment policy
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WORLD TRADE ORGANIZATION WTO accessions map 1995 Accessible at

7. Globalization and Trade
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WORLD TRADE ORGANIZATION WTO accessions map 2017 Accessible at

8. Summary Creation of WTO milestone in growth of global trade.
Multilateral mechanisms for deliberation and difference solving.
Negotiation process involving very different parties
Major changes in domestic legislations
IPR and Pharmaceuticals included for the first time
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9. Relevant Treaties and Forums
WTO agreements:
Technical Barriers to Trade (TBT)
Sanitary and Phytosanitary Measures (SPS agreement)
General Agreement on Trade and Services (GATS)
Trade Related Aspects of Intellectual Property Rights (TRIPS)
WIPO conventions
Patent Cooperation Treaty (PCT)
WHO resolutions
WHA Resolution International Trade and Health
The WHA Resolution on International trade and health calls upon WHO to provide support for Member States to understand the implications of international trade and trade agreements for health and to address relevant issues through policies and legislation.
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10. Trade Related Aspects of Intellectual Property Rights (TRIPS)
1st multilateral agreement to set standards for IP protection. Intergovernmental dispute settlement
TRIPS
Threshold
No need for further protection than TRIPS. Art.1
Objective: technology transfer Art. 7
Flexibilites
Voluntary/Compulsory Licensing Art. 31
Exhaustion of Rights Art. 6
Research Exemptions Art. 30
Patentability
No discrimination in technology field; products and processes.Art.27
Length of Patent term protection 20 years since filing. Art. 33
Data protection of undisclosed test data (submitted to regulatory agency) against unfair commercial use Art. 39
Main novelty of TRIPS, obligation for Member States to grant patents to pharmaceutical processes and products
Implementation of patent on pharmaceuticals felt most directly on HIV drugs, monopolies contribute to high prices
Compulsory Licences Brasil, Thailand, Ecuador Malaysia
Patentability criteria India, Philippines, Argentina (restrictions on new uses and new forms of old medicines)
Data protection preventing unfair commercial use and unnecesary disclose of registration-related data
Objectives “the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge “
49 of the 98 members of the Paris Convention excluded medicines from patentability or had shorter protection periods
Andean Community excluded WHO essential medicines from patents
Medicines Patent introduction France 60 Switzerland 77 Italy 78, Sweden 78 Spain 92 India 05
To qualify for a patent, an invention has to be new (“novelty”), it must be an “inventive step” (i.e. it must not be obvious) and it must have “industrial applicability” (it must be useful)
ORGANIZACIÓN MUNDIAL DE LA SALUD Globalización y Acceso a medicamentos. Perspectivas sobre el acuerdo ADPIC/OMC. Economía de la Salud y Medicamentos. Serie Dap No. 7
World Trade Organization Obligations and exceptions Under TRIPS, what are member governments’ obligations on pharmaceutical patents? FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS September 2006 Accessible at
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11. Declaration on the TRIPS agreement and public health
…..
3 We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices.
We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.
In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS agreement, we recognize that these flexibilities include:
In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.
Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.
The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4
…...
HIV/AIDS pandemic and general concern conflict between TRIPS and public health objectives
Political endorsement of flexibilities
Importance pressure from Developing Countries.
WORLD TRADE ORGANIZATION Declaration on the TRIPS agreement and public health Adopted on 14 November 2001 WT/MIN(01)/DEC/2 20 November 2001 Accessible at
CORREA, C Implications of the Doha declaration on the TRIPS agreement and Public Health.Health Economics and Drugs Series. No. 12. World Health Organization. 2002
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12. Para 6 Doha declaration Challenge of Paragraph 6:
6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.
ABBOT, F The WTO medicines decisión: world pharmaceutical trade and the protection of public health. American Journal of International Law, Vol. 99, pp , 2005
WORLD TRADE ORGANIZATION Declaration on the TRIPS agreement and public health Adopted on 14 November 2001 WT/MIN(01)/DEC/2 20 November 2001 Accessible at
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13. Doha declaration Importance Significance Implications
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14. Controversies and opportunities
South Africa 2001 Sued by 39 pharmaceutical companies after Reform of patent law to include TRIPS flexibilities.
Brazil Achieves a 72.5% ARV cost reduction through import substitution between reaches agreement for price reduction after invoking Article issues Compulsory License (CL) for Merck´s Efivarenz
Thailand CL on ARVs 2006, 2008 CL on anti cancer drugs letrozole, docetaxel, erlotinib, and imatinib
Holland 2009 Dutch authorities seize generic medicines in transit (India-East Africa) upon suspicion of being counterfeit.
Colombia 2016 (ongoing) Government attempts to reduce price of Imatinib (declaration of public interest)
T´HOEN, E Private patents and public health. Changing Intellectual Property Rules for Access to medicines. Health Action International 2016 Accessible at pp.79-80
SILVERMAN, K Colombia plans to proceed with cut on Novartis cancer Drug Stat News September 16th 16 Accesible at
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15. Summary
Developing countries most affected by initial TRIPS application
Doha declaration seen as at the time, an endorsement of the use of flexibilities.
Attempts at the use of flexibilities met with pressures
Pressure from developing countries
Doha declaration
Obstacles to implementation
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16. Post-WTO instruments TRIPS+
FTA/EPAs international legally binding agreements (changes in law and policy)
TRIPS+ : dispositions aimed at increasing the level of protection for patent holders beyond the level given in the TRIPS agreement and those measures aimed at reducing the scope or effectiveness of various limitations and exceptions that are provided for the intellectual property rights
Limit exceptions
Provisions that limit use of compulsory license (commercial use, emergencies, competition)
Ban parallel importation (exhaustion of rights)/ limit compulsory licenses (
Restrict Use of price controls, therapeutic formularies/reimbursement schemes.
Patentability
Obligations concerning subject matter or standards for granting patent, expands scope of patentability (new forms, new uses, new formulations, new combinations…)
Extension of patent protection term/extent patent life/due to regulatory delays (patent or registration). Evergreening.
Patent opposition
Ban pre grant/ post grant opposition and limit grounds for patent revocation
Intellectual Property Enforcement
Enhanced enforcement mechanisms (criminal sanctions, border measures)
Enhanced remedies (injunctions, full compensations…) for patent holders
Patent Linkage
Prevents registration of generic when patent claim is made
Less transparency
Low disclosure standard
Data Exclusivity (prevents use of registration data for reference or reliance for 5 years for biologicals- + 3 years for each new use)
Investment chapters
Investors right to sue country directly at arbitration tribunals
T´HOEN, E. TRIPS, Pharmaceutical Patents and Access to Essential Medicines:
Seattle, Doha and Beyond Contribution to the Commission on Intellectual Property Rights, Innovation and Public Health pp Accessible at
RIUS, J. Intellectual Property and Access to Medicines: TRIPS + Campaign for Access to Medicines. Medicines Snas Frontieres (MSF) Accessible at
BAKER, B Trips plus pressure: Trade Agreements and New Trade Policy OSI-Kiev, IPRs and A2M Septmber 16th 2009 Accessible at
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17. Post-WTO agreements
Unilateral: 301 USTR, WTO Accession negotiations. National legislations (counterfeiting)
Bilateral US-Jordan FTA Data exclusivity Delayed generic competition by 79% btw
Multilateral-NAFTA (ISD Lilly vs CAN), US-CAFTA-DOR
Regional TTIP, TTP patents on new forms of old medicines, no pre-grant oppositions, longer patent term and data exclusivity, investment provisions targeting price control and price negotiations RCEP; EU/EFTA-India proposed IP enforcement-border measures, patent term extension, enforcement measures, investment provisions; EU-Andean Countries Patent term extension for 4 years increase of 159 USD millions of pharmaceutical expenditure by 2025
ISDS Lilly vs Canada Investment: Patents for two pharmaceutical products, Strattera and Zyprexa. Summary: Claims arising out of the invalidation of the claimant's Strattera and Zyprexa pharmaceutical patents by Canada.
OXFAM All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines Oxfam Briefing Paper. March Accessible at
IFARMA Impact of the EU-Andean Trade Agreement on Access to Medicines in Peru
HAI, October Accessible at
BUTHANI, S A “new” recipe for trade Economic & Political Weekly Vol. 52, Issue No. 7, 18 Feb, 2017
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18. Post-WTO world? Bilateralism and regionalism
Source: Chunghua Institution of Economic Research.
MSF MSF Calls on Japan and South Korea to drop harmful RCEP measures
February 23rd Accessible at
GOLDMAN, A TPP IP provisions relevant to Access to Medicines Knowledge Ecology International (KEI) accesible at
BAKER, B Trans-Pacific Partnership (TPP) provisions in Intellectual Property, transparency and investment chapters threaten Access to medicines in US and elsewhere PLoS Med 13(3): e Accesible at
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19. Summary
New generation of trade agreements seek more stringent forms of protection.
Most negotiations taking place beyond international organizations deliberating bodies
Erosion of public health policy spaces
New trade agreements outside WTO
More stringent IP protection requirements
Gradually closing policy spaces
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20. Public Health Response
Public Health implications of trade being addressed from comprehensive approaches
Need for involvement of State-members to fulfill institutional mandates
WIPO-WHO-WTO Trilateral Cooperation on Public Health, Intellectual Property and Trade.
UNCTAD Database on ISDs
UNDP Extensive work/capacity building on flexibilities
WORLD INTELLECTUAL PROPERTY ORGANIZATION WHO, WIPO, WTO Trilateral Cooperation on Public Health, IP and Trade WIPO Accesible at
United Nations Conference on Trade and Development (UNCTAD) Investment Policy Hub UNCTAD Accesible at
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21. Public Health Response
Established in 2006 by France, Norway and Chile to prevent, diagnose and treat HIV/AIDS, tuberculosis and malaria; focus on fast-track access and reduce costs of more effective medicines, technologies and systems
Created in 2010 works to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. The organization encourages generic manufacture and the development of new formulations through patent pooling.
Initiative of the United Nations Secretary General who convened a high-level panel to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies”
Agenda 2030 endorses TRIPS flexibilities to guarantee access to health technologies (SDG 3.8)
MPP created by UNITAID in 2010
UNITAID About Us Unitaid invests in better ways to prevent, diagnose and treat diseases. UNITAID Accessible at
MEDICINES PATENT POOL About the MPP MPP Accessible at
Report of the United Nations Secretary General´s High Level Panel on Access to Medicines .Promoting Innovation and Access to Health Technologies p. 7Accessible at
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22. New organizational structures able to better respond
Summary
Assessment of public health impacts of trade agreement necessary part of negotiations
Greater involvement of UN agencies and other international organizations is needed.
Public health response to trade agreements must be in coordination with other actors
Importance of taking into account regional and sub-regional specificities
New organizational structures able to better respond
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23. Thank you for your attention Gràcies per la vostra atenció
Jaume Vidal
Policy Advisor. Health Action international (HAI)
Barcelona Global Health Summer Course (BGHSS)
ISGLOBAL
Barcelona, July 18th 2017