public-private product development partnerships for global health r&d: issues & challenges

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Public-Private Public-Private Product Development Product Development Partnerships Partnerships for Global Health R&D: for Global Health R&D: Issues & Challenges Issues & Challenges Suerie Moon Suerie Moon Giorgio Ruffolo Doctoral Fellow in Sustainability Science Giorgio Ruffolo Doctoral Fellow in Sustainability Science & Doctoral Candidate in Public Policy & Doctoral Candidate in Public Policy Center for International Development, Harvard Kennedy School of Government Center for International Development, Harvard Kennedy School of Government [email protected] [email protected] Presentation to: Designing Strategies for Neglected Disease Research Presentation to: Designing Strategies for Neglected Disease Research Spring 2009 Spring 2009 UC Berkeley: Law 284.26/Public Policy 290, 190 UC Berkeley: Law 284.26/Public Policy 290, 190 Professors Stephen Maurer & Amy Kapczynski Professors Stephen Maurer & Amy Kapczynski 10 March 2009 10 March 2009

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Public-Private Product Development Partnerships for Global Health R&D: Issues & Challenges. Suerie Moon Giorgio Ruffolo Doctoral Fellow in Sustainability Science & Doctoral Candidate in Public Policy Center for International Development, Harvard Kennedy School of Government - PowerPoint PPT Presentation

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Page 1: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Public-Private Public-Private Product Development Product Development

PartnershipsPartnerships for Global Health R&D:for Global Health R&D:

Issues & ChallengesIssues & Challenges

Suerie MoonSuerie MoonGiorgio Ruffolo Doctoral Fellow in Sustainability Science Giorgio Ruffolo Doctoral Fellow in Sustainability Science

& Doctoral Candidate in Public Policy& Doctoral Candidate in Public PolicyCenter for International Development, Harvard Kennedy School of GovernmentCenter for International Development, Harvard Kennedy School of Government

[email protected][email protected]

Presentation to: Designing Strategies for Neglected Disease Research Presentation to: Designing Strategies for Neglected Disease Research Spring 2009Spring 2009

  UC Berkeley: Law 284.26/Public Policy 290, 190 UC Berkeley: Law 284.26/Public Policy 290, 190 Professors Stephen Maurer & Amy KapczynskiProfessors Stephen Maurer & Amy Kapczynski

10 March 200910 March 2009

Page 2: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational Form, 1. Introduction: History, Organizational Form, and Fundingand Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Targeted Diseases  3. Targeted Diseases  

4. Access Provisions: Policies & IP Management4. Access Provisions: Policies & IP Management

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 3: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1900s-1950s: National R&D efforts led to ‘trickle-down’ approach1900s-1950s: National R&D efforts led to ‘trickle-down’ approach

1960s-80s: International bifurcated public/private system1960s-80s: International bifurcated public/private system Public: e.g. UNICEF-UNDP-World Bank-WHO Special Programme for Public: e.g. UNICEF-UNDP-World Bank-WHO Special Programme for

Research and Training in Tropical Diseases (TDR)Research and Training in Tropical Diseases (TDR) Private: e.g. Industry, globalizing intellectual property rights Private: e.g. Industry, globalizing intellectual property rights

systemsystem

1990s: Global health & neglected diseases1990s: Global health & neglected diseases Linkages: research, health, developmentLinkages: research, health, development Medicines as global public good: access to AIDS treatmentMedicines as global public good: access to AIDS treatment Global health needs: 10/90 Gap and neglected diseasesGlobal health needs: 10/90 Gap and neglected diseases

2000s: Global health for all?2000s: Global health for all? New system for Neglected Diseases (Type III): New system for Neglected Diseases (Type III):

PDPs “a fad and a sacred cow”?PDPs “a fad and a sacred cow”? Trust and networks built; low-hanging fruit harvestedTrust and networks built; low-hanging fruit harvested Honeymoon period over?Honeymoon period over?

Diseases of global incidence? (Type I)Diseases of global incidence? (Type I)

1.1 Introduction: 1.1 Introduction: History of global health product History of global health product

developmentdevelopment

Page 4: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Source: Ziemba, 2005.

1.2 Introduction: History of PDPs1.2 Introduction: History of PDPs

Page 5: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1.3 Introduction: Definition & Examples of 1.3 Introduction: Definition & Examples of PDPsPDPs

Definition: Definition: Public health driven not-for-profit organisations that drive Public health driven not-for-profit organisations that drive neglected disease drug [product] development in conjunction with industry neglected disease drug [product] development in conjunction with industry

groups groups (Moran et al., 2005)(Moran et al., 2005)

Aeras: Global Tuberculosis Vaccine Aeras: Global Tuberculosis Vaccine FoundationFoundation

BVGH: BIO Ventures for Global HealthBVGH: BIO Ventures for Global Health CONRAD: Contraceptive Research and CONRAD: Contraceptive Research and

Development ProgramDevelopment Program CICCR: Consortium for Industry CICCR: Consortium for Industry

Collaboration in Contraceptive ResearchCollaboration in Contraceptive Research DNDI: Drugs for Neglected Diseases DNDI: Drugs for Neglected Diseases

initiativeinitiative EMVI: European Malaria Vaccine InitiativeEMVI: European Malaria Vaccine Initiative FIND: Foundation for Innovative New FIND: Foundation for Innovative New

DiagnosticsDiagnostics Gates/UNC: Gates Foundation/University Gates/UNC: Gates Foundation/University

of North Carolina Partnership for the of North Carolina Partnership for the Development of New DrugsDevelopment of New Drugs

GMP: Global Microbicide ProjectGMP: Global Microbicide Project HHVI: Human Hookworm Vaccine HHVI: Human Hookworm Vaccine

InitiativeInitiative IAVI: International AIDS Vaccine InitiativeIAVI: International AIDS Vaccine Initiative

IDRI: Infectious Disease Research IDRI: Infectious Disease Research InstituteInstitute

IOWH: Institute for OneWorld HealthIOWH: Institute for OneWorld Health IPM: International Partnership for IPM: International Partnership for

MicrobicidesMicrobicides LAPDAP: LAPDAP Antimalarial Product LAPDAP: LAPDAP Antimalarial Product

DevelopmentDevelopment MDP: Microbicides Development ProgramMDP: Microbicides Development Program MMV: Medicines for Malaria VentureMMV: Medicines for Malaria Venture MVI: Malaria Vaccine Initiative at PATHMVI: Malaria Vaccine Initiative at PATH MVP: Meningitis Vaccine Project at PATH MVP: Meningitis Vaccine Project at PATH

(Program on Technologies for Health)(Program on Technologies for Health) PDVI: Pediatric Dengue Vaccine InitiativePDVI: Pediatric Dengue Vaccine Initiative PneumoADIP: Pneumococcal Vaccines PneumoADIP: Pneumococcal Vaccines

Accelerated Development and Accelerated Development and Introduction PlanIntroduction Plan

RotaADIP: Rotavirus Vaccine ProgramRotaADIP: Rotavirus Vaccine Program SAAVI: South African AIDS Vaccine SAAVI: South African AIDS Vaccine

InitiativeInitiative TB Alliance: Global Alliance for TB Alliance: Global Alliance for

Tuberculosis Drug DevelopmentTuberculosis Drug Development

Source: Ziemba 2005

Page 6: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1.4 Introduction: Basic PDP model1.4 Introduction: Basic PDP model

PDP is a non-profit entity that manages a PDP is a non-profit entity that manages a globally-dispersed portfolio for a disease. globally-dispersed portfolio for a disease.

Generalize with great cautionGeneralize with great caution PDPs vary on:PDPs vary on:

One disease or multipleOne disease or multiple Breadth or depth in portfolio managementBreadth or depth in portfolio management External or in-house research & production capacityExternal or in-house research & production capacity Relative emphasis on public vs private sectorRelative emphasis on public vs private sector Level and diversity of funding sourcesLevel and diversity of funding sources Definition of core and secondary missionsDefinition of core and secondary missions Approach to intellectual property managementApproach to intellectual property management Governance structures and stylesGovernance structures and styles Scientific & political challenges facedScientific & political challenges faced

Page 7: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1.5 Introduction: Basic PDP model1.5 Introduction: Basic PDP model

Frequently-conducted functions include:Frequently-conducted functions include: Finances research Finances research ($ to and from private & public sectors)($ to and from private & public sectors) Negotiates access Negotiates access to private sector compounds, experts, to private sector compounds, experts,

labslabs Reduces risk Reduces risk of projectsof projects Offers reputational benefitsOffers reputational benefits, CSR, employee morale, CSR, employee morale Provides access Provides access to research with profitable to research with profitable spillovers spillovers

(Amyris)(Amyris) Liaises with developing countries Liaises with developing countries re: clinical trials & re: clinical trials &

deliverydelivery Helps Helps open open up new up new emerging marketsemerging markets Focuses on adaptedness and affordabilityFocuses on adaptedness and affordability Advocates Advocates for more R&Dfor more R&D

Sometimes:Sometimes: Conducts Conducts in-house in-house researchresearch (Aeras, IAVI) (Aeras, IAVI)

Page 8: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1.6 Introduction: ND R&D Funding to PDPs1.6 Introduction: ND R&D Funding to PDPs

Source: From: Neglected Disease Research and Development: How Much Are We Really Spending? Moran M, Guzman J, Ropars AL, McDonald A, Jameson N, et al. PLoS Medicine Vol. 6, No. 2, e30 doi:10.1371/journal.pmed.1000030

Of $2.5 billion invested in ND R&D in 2007, 23% ($575 mln) routed through PDPs.

Page 9: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Source: Ziemba, 2005.

1994-2004

1.7 Introduction: PDP Funding 1994-2004 1.7 Introduction: PDP Funding 1994-2004

Page 10: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

1.8 Introduction: PDP Funding1.8 Introduction: PDP Funding

Neglected disease research: $2.5 billion in 2007Neglected disease research: $2.5 billion in 2007 Overall global health research: $125 billion/yrOverall global health research: $125 billion/yr Largely financed by bilateral donors and foundations, Gates in Largely financed by bilateral donors and foundations, Gates in

particularparticular Gates is majority funder of many PDPs (Aeras, FIND, IoWH)Gates is majority funder of many PDPs (Aeras, FIND, IoWH) Funding short term & uncertain:Funding short term & uncertain:

Long-term strategic planning difficultLong-term strategic planning difficult Missed opportunities when rapid reaction neededMissed opportunities when rapid reaction needed Weakened negotiating leverage due to riskWeakened negotiating leverage due to risk

Dramatically increased future needs as products move through Dramatically increased future needs as products move through clinical trialsclinical trials

Answers?:Answers?: Profit-making to underwrite research?Profit-making to underwrite research? Auctioning assets e.g. using PRV?Auctioning assets e.g. using PRV? UNITAID-type global tax?UNITAID-type global tax? CGIAR-type donor support?CGIAR-type donor support?

Page 11: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational Form, 1. Introduction: History, Organizational Form, and Fundingand Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Targeted Diseases  3. Targeted Diseases  

4. Access Provisions: Policies & IP Management4. Access Provisions: Policies & IP Management

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 12: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

2.1: Strengths & Weaknesses: 2.1: Strengths & Weaknesses: Challenges for EvaluationChallenges for Evaluation

Evaluating individual PDPs difficult because:

• Varying disease profiles

• Scientific

• Economic

• Political

• Long lead times

• Complex expectations

• Varied approaches

For a full discussion of the challenges of evaluating PDPs, see “Toward a New Approach to Product Development Partnership Performance Measurement,” June 2007, by FSG Social Impact Advisors.

Page 13: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Strengths:Strengths: Renewed ND R&DRenewed ND R&D

From 2000-2005: 0 to 63 drug From 2000-2005: 0 to 63 drug projects = 8 or 9 new drugs projects = 8 or 9 new drugs expected expected

Affordability & adaptedness Affordability & adaptedness as central criteria for new as central criteria for new productsproducts

Harnessing private sector Harnessing private sector capacity for public ends (CSR)capacity for public ends (CSR)

Light networked structureLight networked structure Global coordination of scarce Global coordination of scarce

investmentsinvestments

Weaknesses:Weaknesses: Untested institutional model: Untested institutional model:

will it work?will it work? Financial sustainability unclearFinancial sustainability unclear Governance unclear Governance unclear

(accountability, decision-(accountability, decision-making, transparency)making, transparency)

Developing country Developing country participation is limitedparticipation is limited

Risk that private interests Risk that private interests undermine public goalsundermine public goals

Limited to ND (diseases Limited to ND (diseases without a market)without a market)

Sources: Kettler & Towse (2001), Ziemba (2005), Moran et al. (2005), Widdus (various), Buse (various), Turner & Makgoba (2008), Moon (forthcoming)

2.2: Strengths & Weaknesses: 2.2: Strengths & Weaknesses: What does the literature say?What does the literature say?

Page 14: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

2.3: Strengths & Weaknesses: 2.3: Strengths & Weaknesses: Selected Achievements* Selected Achievements*

New products:New products:1.Paramomycin 1.Paramomycin

(V.leishmaniasis in India)(V.leishmaniasis in India)2.ASAQ (malaria)2.ASAQ (malaria)3.ASMQ (malaria)3.ASMQ (malaria)4.Pediatric AR-LU (Coartem 4.Pediatric AR-LU (Coartem

for for malaria)malaria)

Phase III clinical Phase III clinical trials/equiv:trials/equiv:

1.1. Moxifloxacin (TB)Moxifloxacin (TB)2.2. Pyronaridine+AR (malaria)Pyronaridine+AR (malaria)3.3. Dihydroartemisinin Dihydroartemisinin

(malaria)(malaria)4.4. Paramomycin Paramomycin

(V.leishmaniasis in Africa)(V.leishmaniasis in Africa)

5.5. FastPlaque diagnostic (TB)FastPlaque diagnostic (TB)6.6. LAM-based diagnostic (TB)LAM-based diagnostic (TB)7.7. Synthetic artemisinin Synthetic artemisinin

(malaria)(malaria)

*Based on study of only 8 PDPs – list is non-exhaustive.

Page 15: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

2.4: Strengths & Weaknesses: Open 2.4: Strengths & Weaknesses: Open Questions Questions

• How many PDPs?

• One disease vs. Many?

• Compete vs Collaborate?

• Push vs Pull mechanisms?

• Access/affordability vs. Sustainability?

• Efficiency vs. Capacity building?

• Product development vs Delivery?

Page 16: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational Form, 1. Introduction: History, Organizational Form, and Fundingand Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Target Diseases  3. Target Diseases  

4. Access Provisions: Policies & IP Management4. Access Provisions: Policies & IP Management

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 17: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

3.1: Target Diseases: Overview3.1: Target Diseases: Overview

DengueDengue: PDVI: PDVI Diarrheal DiseaseDiarrheal Disease: IOWH, Rotavirus: RotaADIP: IOWH, Rotavirus: RotaADIP Family PlanningFamily Planning: PATH, CONRAD, CICCR: PATH, CONRAD, CICCR HIVHIV: IAVI, SAAVI: IAVI, SAAVI HookwormHookworm: HHVI: HHVI MalariaMalaria: MMV, EMVI, MVI, IoWH, DNDi, LapDap, FIND: MMV, EMVI, MVI, IoWH, DNDi, LapDap, FIND MeningitisMeningitis: MVP: MVP MicrobicidesMicrobicides (HIV & STIs): IPM, MDP, GMP (HIV & STIs): IPM, MDP, GMP PneumoniaPneumonia: PneumoADIP: PneumoADIP Tropical Neglected Diseases (Multiple):Tropical Neglected Diseases (Multiple): IOWH, DNDi, IOWH, DNDi,

BVGH, FIND, Gates/UNC, IDRIBVGH, FIND, Gates/UNC, IDRI TBTB: Aeras, FIND, GATB: Aeras, FIND, GATB

Page 18: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

3.2 Target Diseases:3.2 Target Diseases:Priority-SettingPriority-Setting

Among diseases: no norms for how to measure Among diseases: no norms for how to measure needs and translate into investments needs and translate into investments

Within diseases: PDP Scientific Advisory bodiesWithin diseases: PDP Scientific Advisory bodies

Page 19: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational 1. Introduction: History, Organizational Form, and FundingForm, and Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Target Diseases  3. Target Diseases  

4. Access Provisions4. Access Provisions

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 20: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

4.1: Access provisions: Affordability4.1: Access provisions: Affordability

Affordability a central part of the mission:Affordability a central part of the mission: But, most access provisions confidential But, most access provisions confidential

(“trust me” approach): why?(“trust me” approach): why? Fear of loss of competitive advantage among Fear of loss of competitive advantage among

firmsfirms Loss of negotiating leverage for PDPLoss of negotiating leverage for PDP Compromised patent application for firmsCompromised patent application for firms Lack of detailed information on compound in Lack of detailed information on compound in

early stagesearly stages

Page 21: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

4.2: Access provisions: Strategies4.2: Access provisions: Strategies

Limited ExperienceLimited Experience Access strategies include:Access strategies include:

Global market segmentation (tiered pricing)Global market segmentation (tiered pricing) Country categories often undefinedCountry categories often undefined Challenge: Middle income countriesChallenge: Middle income countries Public sector vs private markets in LMICs Public sector vs private markets in LMICs

e.g. TB drugs in Indiae.g. TB drugs in India Exclusive licensingExclusive licensing Cost auditsCost audits Target pricesTarget prices Open access (no patent or multiple licenses)Open access (no patent or multiple licenses)

DNDiDNDi

Page 22: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

2.3: Strengths & Weaknesses: 2.3: Strengths & Weaknesses: Selected Achievements* Selected Achievements*

New products:New products:1.Paramomycin 1.Paramomycin

(V.leishmaniasis in India)(V.leishmaniasis in India)2.ASAQ (malaria)2.ASAQ (malaria)3.ASMQ (malaria)3.ASMQ (malaria)4.Pediatric AR-LU (Coartem 4.Pediatric AR-LU (Coartem

for for malaria)malaria)

Phase III clinical Phase III clinical trials/equiv:trials/equiv:

1.1. Moxifloxacin (TB)Moxifloxacin (TB)2.2. Pyronaridine+AR (malaria)Pyronaridine+AR (malaria)3.3. Dihydroartemisinin Dihydroartemisinin

(malaria)(malaria)4.4. Paramomycin Paramomycin

(V.leishmaniasis in Africa)(V.leishmaniasis in Africa)

5.5. FastPlaque diagnostic (TB)FastPlaque diagnostic (TB)6.6. LAM-based diagnostic (TB)LAM-based diagnostic (TB)7.7. Synthetic artemisinin Synthetic artemisinin

(malaria)(malaria)

*Based on study of only 8 PDPs – list is non-exhaustive.

Page 23: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

4.3: Access provisions:4.3: Access provisions:Intellectual Property ManagementIntellectual Property Management

Ideally PDPs get access to desired compounds & technologies Ideally PDPs get access to desired compounds & technologies and maximize control over IP. and maximize control over IP.

Practically, will depend on negotiating leverage: Practically, will depend on negotiating leverage: Size of firm, Size of firm, Stage of development, Stage of development, Disease area, Disease area, PDPPDP Who paid?Who paid?How to strengthen leverage:How to strengthen leverage: Priority review voucher?Priority review voucher? Mandatory donor access provisions?Mandatory donor access provisions? Reliable, plentiful funding?Reliable, plentiful funding?

Page 24: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Source: Giorgio Roscigno, “Revolutionizing disease control with innovation in new diagnostics.” June 2006. Available at: http://www.finddiagnostics.org/about/innov_new_diag_for_disease_control_june2006.pdf

Page 25: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

4.4: Access provisions:4.4: Access provisions:IP Management (cont’d)IP Management (cont’d)

Generic Competition & Affordability: Factors to Generic Competition & Affordability: Factors to considerconsider

Non-patent barriers to entry: eg technology transferNon-patent barriers to entry: eg technology transfer Economies of scale & competitor’s cost auditsEconomies of scale & competitor’s cost audits License to multiple producers when significant License to multiple producers when significant

benefits expectedbenefits expectedFollow-on innovation:Follow-on innovation: No norm (yet) of open access No norm (yet) of open access Information sharing across PDPsInformation sharing across PDPs ““Giant sucking sound”:Unequal contributions by Giant sucking sound”:Unequal contributions by

PDPs & private actors?PDPs & private actors?

Page 26: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational Form, 1. Introduction: History, Organizational Form, and Fundingand Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Targeted Diseases  3. Targeted Diseases  

4. Access Provisions: Policies & IP Management4. Access Provisions: Policies & IP Management

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 27: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

5.1 PDPs in the R&D Ecosystem5.1 PDPs in the R&D Ecosystem

Delicate balance: charitable vs profitable enterprise

Effects of new market-based incentives? (AMC, PRV): Firms may seek market-value remuneration if available Small firms may enter disease areas and reduce PDPs’

ability to build portfolios and synergies across firms/research groups;

Priorities of PDPs may shift toward products that can generate revenue to keep an organization running;

PDPs may have stronger leverage with PRV PDPs may be reluctant to share information with each

other if competing for the same valuable reward (e.g. PRV).

Page 28: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

5.2 R&D Ecosystem: Unintended 5.2 R&D Ecosystem: Unintended Consequences Consequences

of Market-based Incentivesof Market-based Incentives““We note that commercialising low-value neglected disease We note that commercialising low-value neglected disease

markets, for example, through the use of advance purchase markets, for example, through the use of advance purchase commitments or roaming patent extensions, is likely to commitments or roaming patent extensions, is likely to increase industry activity (particularly by small companies), increase industry activity (particularly by small companies), but at the cost of curtailing these positive behaviours and but at the cost of curtailing these positive behaviours and returning R&D to the more secretive and nonreturning R&D to the more secretive and non--collaborative collaborative approaches that are characteristic of commercial R&D.” approaches that are characteristic of commercial R&D.” (Moran et al., 2005)(Moran et al., 2005)

Prizes, AMC, PRV could make a big difference, but…Prizes, AMC, PRV could make a big difference, but… Careful attention to system-wide effects of new incentivesCareful attention to system-wide effects of new incentives

Page 29: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

OverviewOverview

1. Introduction: History, Organizational Form, 1. Introduction: History, Organizational Form, and Fundingand Funding

2. Strengths and Weaknesses2. Strengths and Weaknesses

3. Targeted Diseases  3. Targeted Diseases  

4. Access Provisions: Policies & IP Management4. Access Provisions: Policies & IP Management

5. PDPs in the broader R&D Ecosystem5. PDPs in the broader R&D Ecosystem

6. Governance Issues6. Governance Issues

7. Conclusions7. Conclusions

Page 30: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

6.1 Governance: Transparency6.1 Governance: Transparency

Transparent re:Transparent re: Composition of Board, Scientific Advisory, Stakeholders, Composition of Board, Scientific Advisory, Stakeholders,

Staff, Staff, Limited transparency re:Limited transparency re: Funding sourcesFunding sources Budgets & SpendingBudgets & SpendingVery little transparency re:Very little transparency re: Decision-making proceduresDecision-making procedures Agreements between PDPs and industryAgreements between PDPs and industry Cost of R&DCost of R&D

How much transparency should we expect or demand from a How much transparency should we expect or demand from a hybrid public-private entity? From a non-profit hybrid public-private entity? From a non-profit organization?organization?

Page 31: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

6.2 Governance:6.2 Governance:Endemic country involvementEndemic country involvement

Clinical trialsClinical trials ResearchResearch ProductionProduction Governance Governance BRICS vs LDCs?BRICS vs LDCs?

Page 32: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Source: Ziemba, 2005.

Page 33: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

6.3 Governance: Sustainability6.3 Governance: Sustainability

Scientific: need to invest in capacity of Scientific: need to invest in capacity of more countries to contributemore countries to contribute

Financial: need innovative financing modelFinancial: need innovative financing model Political: need broader base of supportPolitical: need broader base of support How do PDPs fit into a rapidly changing How do PDPs fit into a rapidly changing

institutional landscape?institutional landscape?

Page 34: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

6.4 Governance: Accountability6.4 Governance: Accountability

Accountable to: mechanismAccountable to: mechanism Donors: future fundingDonors: future funding Partner firms: future partnersPartner firms: future partners Patients: reputationPatients: reputation Public (as taxpayers and potential beneficiaries): Public (as taxpayers and potential beneficiaries):

reputationreputation

Hybrid structure = unclear expectations of Hybrid structure = unclear expectations of accountabilityaccountabilityExample: FDA Priority Review VouchersExample: FDA Priority Review Vouchers

New neglected disease product gets tradable voucher for New neglected disease product gets tradable voucher for accelerated FDA reviewaccelerated FDA review

Worth up to ~300 million USDWorth up to ~300 million USD Who decides how to spend, how to invest, how to ensure Who decides how to spend, how to invest, how to ensure

public interest?public interest?

Page 35: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

6.5 Governance:6.5 Governance:Public goals and private partnersPublic goals and private partners

Tension between public & private objectives:Tension between public & private objectives: Impacts governance (secrecy)Impacts governance (secrecy) Impacts innovation (secrecy, patent applications, Impacts innovation (secrecy, patent applications,

competitiveness, delays [moxifloxacin])competitiveness, delays [moxifloxacin]) Impacts affordability (price discrimination)Impacts affordability (price discrimination) Impacts financial position: direct tradeoff between Impacts financial position: direct tradeoff between

control over end-user access and PDP investmentcontrol over end-user access and PDP investment Impacts public trust: public money to private sectorImpacts public trust: public money to private sector Private free-riding on PDP knowledge-generationPrivate free-riding on PDP knowledge-generation Unintended consequences of private incentives on Unintended consequences of private incentives on

public-private cooperation?public-private cooperation?

Page 36: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

7. Conclusions7. Conclusions

Advances of PDPs over old pure public or private R&D:Advances of PDPs over old pure public or private R&D:• Increased resources for R&D dedicated to diseases affecting Increased resources for R&D dedicated to diseases affecting

world’s poorestworld’s poorest• Improved emphasis on access & adaptednessImproved emphasis on access & adaptedness• Increased transparency (compared to private)Increased transparency (compared to private)

Key questions re: PDP model:Key questions re: PDP model:• Financing: how to sustain?Financing: how to sustain?• Governance: Who sets the agenda? How is IP managed? Governance: Who sets the agenda? How is IP managed?

Transparency? Public accountability?Transparency? Public accountability?• Sustainable: how to achieve scientific, financial, political Sustainable: how to achieve scientific, financial, political

sustainability of global public goods provision?sustainability of global public goods provision?• How do we manage the tensions inherent in harnessing How do we manage the tensions inherent in harnessing

private actors for public ends? What expectations should we private actors for public ends? What expectations should we have?have?

Page 37: Public-Private  Product Development Partnerships for Global Health R&D: Issues & Challenges

Thank youThank you

Questions to: Questions to: [email protected][email protected]