Access to Medicines: Who Pays for Innovation,

Who Pays for the Pills?

GIGA Berlin 14 November 2013 Prof. Dr. Wolfgang Hein GIGA Institute of Latin American Studies Wolfgang.Hein@giga-hamburg.de

Dr. Suerie Moon Harvard Global Health Institute & Harvard School of Public Health Smoon@hsph.harvard.edu

1. Introduction: global health & intellectual property

2. Globalization, global society & human rights

3. Access to medicines: Battles fought, won, lost & ongoing

4. What can we learn about global governance?

Overview

INTRODUCTION: GLOBAL HEALTH & INTELLECTUAL PROPERTY

Source: IMS Health. (2013) "White Paper: Securing IP and Access to Medicines: Is Oncology the next HIV?"

Source: IMS Health. (2013) "White Paper: Securing IP and Access to Medicines: Is Oncology the next HIV?"

Introduction to Intellectual Property National rights: patents, copyrights, trademarks, industrial designs, trade secrets, geographical indications

Patents as (national) social contracts

To promote innovation, technology transfer & dissemination

Inventor: Time-limited monopoly

Society: Inventors disclose publicly information about their invention

State right to regulate patent rights to protect public interest

Pre-1994 International patents regimes

Variation: eg 5-10 yr patents in South vs 15-17 yrs in North

Social considerations: eg food and medicines unpatentable

Non-invasive / difficult to enforce

The Global IP Regime: 1994 TRIPS Agreement

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Controversial: major expansion in GATT/WTO subject matter

Enforceable, Western-standard IP in all Members

Uniform minimum requirements , e.g.:

Patents on medicines and food/agriculture

20 year patent terms

Flexibilities:

Transition periods for LDCs and developing countries

Compulsory licensing, patentability criteria, others

Global burden-sharing for R&D finance

Multisectoral effects: medicines, food security, education, culture, industrial development

IP and Access to Medicines: 2 Key Questions

1. TRIPS impact on medicines prices

Higher prices

As way to extract rents to finance global R&D

2. TRIPS impact on R&D

How to ensure R&D where market fails, eg for ‘neglected’ diseases?

How to share global burden of R&D finance in politically sustainable manner?

GLOBALIZATION, GLOBAL SOCIETY & HUMAN RIGHTS

Economic, social and cultural human rights: An example of soft law?

• Another View on Access to Medicines: What are Human Rights?

• The Universal Declaration of Human Rights

• Human Rights Covenants (1966): International law

• Hard law vs. soft law

• Enforceability in a world of sovereign states

• Primary vs. secondary rules

• National Reports and CSOs: „Blaming and shaming“

Human Right to Health

• WHO constitution: „the enjoyment of the highest attainable standard of [ESC Rights add: physical and mental] health”

• Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures (art.2(1)).

• Norm implementation: Obligation to deliver progress reports/ reaction by civil society organizations (“blaming and shaming”)

• CESCR commissions „General Comments“ on the human right to „access to medicines“ (autoritativ, but not binding)

Human Right to Access to Essential Medicines

• General Comment No.14 – Access to essential medicines as a “core

obligation” (§ 43) – Transfer of resources to poor countries (“that

the right to health is given due attention in international agreements”, § 39)

– Problem of intellectual property rights (“In relation to the conclusion of other international agreements, States parties should take steps to ensure that these instruments do not adversely impact upon the right to health”, § 39)

– “Moreover, coordinated efforts for the realization of the right to health should be maintained to enhance the interaction among all the actors concerned, including the various components of civil society” (§64)

• UN Sub-Commission on Human Rights + UN Special Rapporteur on the Right to Health

• CSOs: Access to Medicines Campaign (public pressure)

Global norms: the Westphalian System of International Relations

• IR (realistic school): anarchy of sovereign states

• Governments as agents of aggregated national interests

• Maximizing power/security

• Cooperation as a win-win situation (IGOs)

• After 1945: Transformation of cooperation and conflict

• On the path towards globalization

The United Nations: Norms and multiple international regimes

• Strong normative foundation

• Human Rights

• Decolonization, Development cooperation

• International social affairs (WHO, UNICEF etc.)

• Multiple international regimes

• Growing inter/ transnational interaction

Globalization and global society

• Intensification of trans-border flows of people, good, services and ideas (Held et al. 1999)

• Intensification of the density of social and political interactions on a global scale.

• Decreasing capacities of national governments to control globally-networked economic, social and political forces

• Growing transnational interdependencies: transnational communities of shared norms and political goals

• Transformation towards a Post-Westphalian System of global politics

Global Politics in a Post-Westphalian System

Global Politics

• New fields of conflicts in an emerging arena of global politics: Various actors assert their claims, defend their interests, debate rules and policies, contest truths, and construct norms

• Aggregation of interests in a global (trans- and international) political arena

• Changing constellations between (globalizing) non-state actors, nation states and international organizations

• Sectoral regimes based on specific sectoral compromises complex normative conflicts

• Importance of informal norms

Global Health Governance • Proliferation of the number and variety of health actors

• Growing impact of civil society organizations (CSOs) and of private corporations (acknowledgement of social responsibility)

• Growing importance of private funders (BMG and others) and of hybrid actors (PPPs, GHPs)

• Tendency towards „open source anarchy“: „anybody can access, use, modify and improve“ (also: „bazaar governance“)

• Quest for coordination, but also: rapid rise of financial resources for global health

Actors in GHG

18.11.2013 23

Rise of financial resources and diversification of donors

Development assistance for health from 1990 to 2011 by channel of assistance (The Lancet 2011)

Informal norms • „Universal access to essential medicines“ as an

informal norm bridgeing the rift between human rights/ health norms and the international IPS regime (TRIPS)

• It can be interpreted as a secondary norm specifying the human right to health in a specific policy field

• This norm rests largely on informal political understandings between the actors involved (governments, CSOs, TNPCs) about a flexible implementation of TRIPS obligations

• The „access norm“ has turned out to be stable during the last decade and inclusive concerning access to HIV/AIDS medicines, but contested concerning access to medicines to treat non-communicable diseases.

ACCESS TO MEDICINES: BATTLES FOUGHT, WON, LOST & ONGOING

Timeline (1 of 2)

• 1990s: AIDS Epidemic: 95% PLWHA in South

• 1994: TRIPS Agreement

• 1996: effective antiretroviral (ARV) treatment (>$10K)

“treatment is in the North, patients are in the South”

• 1997: WHO “Globalization & Access to Drugs” publication

• 2000: UN General Comment 14 on medicines as part of the right to health

• 1999-2001: global political mobilization

– 2001: South Africa court case

– 2001: US anthrax scare & ciprofloxacin shortage

– 2001: WTO Doha Declaration on TRIPS & Public Health

2001 Doha Declaration on TRIPS and Public Health

“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.”

Timeline (2 of 2)

• 2002: First developing country compulsory licenses • 2002: Creation of the Global Fund • 2005: G8 endorses universal access to ART as goal • 2005: India revises patent law to begin granting

medicines patents • 2006: UN General Assembly endorses universal access • 2006: Report of WHO Commission on Intellectual

Property, Innovation & Public Health • 2006-7: Thailand, Brazil compulsory licenses • 2006-8: WHO Global Strategy and Plan of Action on

Public Health, Innovation and Intellectual Property • 2010-2012: WHO (Consultative) Expert Working

Groups on R&D

Generic Competition & Treatment Scale-Up

0

1

2

3

4

5

6

7

$0

$100

$200

$300

$400

$500

$600

$700

$800

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Millionen

People in LMICs on treatment

Lowest generic price first line ARV regimen

Originator price of first-line ARVs

$10,400 $2700

Source: Medicines Patent Pool 2011

HIV Treatment Scale-Up & Access to affordable medicines

Innovation and Access

Source: JA Rottingen 2012

Imbalances in R&D

Only $3 billion (1-2% of total) invested globally on R&D for neglected diseases Source: JA Rottingen 2012

Institutional Innovation in Global Health R&D (1 of 3) PULL:

Advanced market commitments for pneumococcal vaccine (GAVI)

Donor financed (Northern governments, Gates Foundation)

Success in securing production but not yet in innovation

Pediatric AIDS drugs (UNITAID)

Donor financed (Northern and middle-income governments, Gates Foundation)

Success in inducing formulation innovation

Milestone prizes for TB drug synthesis, ALS biomarker (Prize4Life)

Success, questions regarding prizes beyond milestones; re: access with innovation?

PATENT POOLING

UNITAID-supported Medicines Patent Pool for HIV drugs

Early to assess, but two licenses from patent-holders in Year 1; more access-oriented

GSK/BioVentures/WIPO Knowledge Pool for Neglected Diseases

Early to assess, rapidly evolving model

Institutional Innovation in Global Health R&D (2 of 3)

REGULATORY: Priority review vouchers

US FDA : shortened time for regulatory decision on profitable drug

Criticized for poor design, outcomes still unclear

US PTO: shortened decision on patent appeals procedures

Pilot launched in 2012

PRIVATE:

Pharma research into most neglected diseases (sleeping sickness, visceral leishmaniasis, malaria)

Pharma research into mid-range profitable diseases (e.g. TB, dengue…Chagas?),

New research centers in India & China

CSR rationale & emerging markets rationale

Outcomes still unclear, very early for some initiatives

Institutional Innovation in Global Health R&D (3 of 3)

New approaches proposed:

Large-scale end product prizes

e.g. Sanders bill, Health Impact Fund, Finkelstein/Temin (MIT), Patent buy-outs

R&D Treaty (Hubbard & Love 2004)

Revising TRIPS Agreement

All require greater public involvement, coordinated state action

2012 CEWG Report

Assessment of 15 grouped proposals

Key recommendations

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Financing commitments Pooled funding

Global R&D Observatory Advisory functions

at WHO

Open Knowledge Innovation

Global Framework

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Since the 2012 CEWG Report…

Nov 2012: Intergovernmental Meeting No treaty…yet Demonstration projects needed May 2013: World Health Assembly Demonstration projects: new incentives, financing, governance Observatory Need evidence for long-term solutions…treaty? Dec 2013: Intergovernmental Meeting May 2014: World Health Assembly May 2016: World Health Assembly

Battles for access to medicines…

• Fought & (largely) Won: – Access to generic HIV medicines – New approaches to R&D for neglected diseases

• Lost: – Revision of TRIPS

• Ongoing: – Middle-income countries – Non-communicable diseases – Formalized access norms: national & international – Equitable (formalized) global framework for R&D – Plurilateral trade negotiations

WHAT CAN WE LEARN ABOUT GLOBAL GOVERNANCE?

Nodal governance

• How do processes of informal norm-building work?

• Nodal governance is an approach to understanding the working of interconnected networks, which operate in a landscape of mixed social interactions and of conflicting or merging cultural and political habits and behaviors.

• Nodal governance in health consists of interfaces between a considerable number of individual nodes.

• Superstructural nodes are clearing-points for discussions and informal negotiations on a more continuous basis.

• Superstructural nodes can develop at important locations (Geneva in GHG) or be linked to specific events at changing locations (Conferences of Parties at the UNFCCC).

„Geneva connection“

Non-state actors in global norm-building

• The impact of framing political issues

• Transnational discourses and the „boomerang effect“

• Transformation of discursive power (normative and expert power) into political/institutional power and economic power

• Open-source anarchy: institutional flexibility vs. blocked decision-making in IGOs.

A path towards transnational democracy ?

• Democratic legitimacy of nodal governance processes (“management of the course of events“ following a „global popular will“?)

• „Access norm“: Implementation of international law through an informal agreement on a secondary norm

• Benefits from nodal governance • Flexibility (subtle changes to adjust and adapt to changing underlying

conditions, power distributions, technological possibilities) • Accessibility for traditionally weak actors (normative, expert power) • Possibly laying the ground for later negotiations on a formal

agreement

• Links between informal norms and formal institutional processes (embedded in prior accepted norms; role of transnational deliberations, road to formal norm-building)

Vielen Dank/Thank you

Comments welcome at: Wolfgang.Hein@giga-hamburg.de

Smoon@hsph.harvard.edu

EXTRA SLIDES

Public-private product development partnerships (PDP)

“PDPs are defined as public health driven, not-for-profit organisations that typically use private sector management practices to drive product development in conjunction with external partners. PDPs tend to focus on one or more neglected diseases and aim to develop products suitable for DC use. While their primary goal is the advancement of public health rather than commercial gain, they generally use industry practices in their R&D activities, for instance portfolio management and industrial project management.” -G-FINDER 2011

Basic PDP model

Frequently-conducted functions include:

Finances research ($ to and from private & public sectors)

Negotiates access to private sector compounds, experts, labs

Reduces risk of projects

Offers reputational benefits, CSR, employee morale

Provides access to research with profitable spillovers (Amyris)

Liaises with developing countries re: clinical trials & delivery

Helps open up new emerging markets

Focuses on adaptedness and affordability

Advocates for more R&D

Sometimes:

Conducts in-house research (Aeras, IAVI)

Traditional Pharma Industry R&D Model

1950s: emergence of modern chemicals-based pharmaceutical industry in a few Western countries

Patent laws (1800s-1900s) pre-date pharma industry, but become key policy tool

Sizeable public investment into biomedical research (earlier stage), few HICs

Sizeable private investment into product devt (later stage), highly concentrated in a few countries. Estimated >$1 billion average R&D costs

Industry priorities driven by potential profitability

Public policies to provide access in HICs; New medicines reached LMICs with significant delays

~$240 billion on health research;

Critiques of traditional R&D business model

Critiques re: innovation:

Markets fail to stimulate sufficient R&D investment for:

Diseases that affect the few (orphan) or

Only the poor (neglected diseases), or

Entail high risks (pediatric, pregnant women, limited basic science)

Monopolies on knowledge deter follow-on innovation

Critiques re: access:

Time-limited monopolies to recoup investments enable high prices that block access

Public-private product development partnerships (PDPs)

Definition: Public health driven not-for-profit organisations that drive neglected disease drug [product] development in conjunction with industry groups (Moran et al., 2005)

IDRI: Infectious Disease Research Institute

IOWH: Institute for OneWorld Health

IPM: International Partnership for Microbicides

LAPDAP: LAPDAP Antimalarial Product Development

MDP: Microbicides Development Program

MMV: Medicines for Malaria Venture

MVI: Malaria Vaccine Initiative

MVP: Meningitis Vaccine Project at PATH

PATH: Program on Technologies for Health

PDVI: Pediatric Dengue Vaccine Initiative

PneumoADIP: Pneumococcal Vaccines Accelerated Development and Introduction Plan

RotaADIP: Rotavirus Vaccine Program

SAAVI: South African AIDS Vaccine Initiative

TB Alliance: Global Alliance for Tuberculosis Drug Development

Aeras: Global Tuberculosis Vaccine Foundation

BVGH: BIO Ventures for Global Health

CONRAD: Contraceptive Research and Development Program

CICCR: Consortium for Industry Collaboration in Contraceptive Research

DNDI: Drugs for Neglected Diseases initiative

EMVI: European Malaria Vaccine Initiative

FIND: Foundation for Innovative New Diagnostics

Gates/UNC: Gates Foundation/University of North Carolina Partnership for the Development of New Drugs

GMP: Global Microbicide Project

HHVI: Human Hookworm Vaccine Initiative

IAVI: International AIDS Vaccine Initiative

Background

Commission on Health Research for Development

(1990)

Commission on Macroeconomics

and Health (2001)

Adapted from JA Rottingen 2012

WHO-UNICEF-UNDP-World Bank Special Programme for Research and Training in Tropical Diseases

(1975)

Longstanding recognition: market-driven global R&D system does not sufficiently meet the needs of majority of the world’s population, 80% of which lives in developing countries

Investing in Health Research

and Development (1996)

2003 2006 2008 2010

WHA56.27

Intellectual property rights, innovation and public health

Public Health, innovation, essential health research and intellectual

property rights: towards a global strategy and plan of action

Global strategy and plan of action on public health,

innovation and intellectual property

Establishment of a consultative expert working group on research and development: financing and

coordination

Commission on Intellectual Property Rights, Innovation and Public Health

Intergovernmental Working Group

Expert Working Group on Research and Development: Financing and Coordination

Consultative Expert Working Group on R&D: Financing and Coordination

A 10-year process 2003-2013

WHA59.24 WHA61.21 WHA63.28