global strategy and plan of action on public health ... ridley... · igpa, montreal, october 1st,...

1IGPA, Montreal, October 1st, 2009

Global Strategy and Plan of Action on

Public Health, Innovation and

Intellectual Property

Robert Ridley

Director, TDR

Special Programme for Research and Training in Tropical Diseases


Health problems affecting the poor


Gross Domestic Product vs.

Gross National malaria Prevalence

GDP GNmP


General Background

International debate on IP rights, innovation and public health

limited innovation for diseases where limited market

limited availability / access to drugs in developing countries

price issues e.g. HIV drugs

quality and counterfeiting issues

weak health systems

Poverty reduction and health a major focus of development

MDG 6 – combating HIV, TB, malaria and other diseases

Access to medicines for poverty linked diseases a priority

Global Fund to fight AIDS, TB and malaria

UNITAID (financed by tax on airline tickets)


Background to GSPOA

WHO Commission on Intellectual Property Rights, Innovation and Public

Health established 2004, published 2006

Intergovernmental Working Group (IGWG) established in 2006:

– to secure an enhanced and sustainable basis for needs-driven, essential

health R&D relevant to diseases that disproportionately affect

developing countries

– @150 countries negotiated over two years regionally and in Geneva

Global Strategy and Plan of Action developed (www.who.int/phi)

– WHA 61.21 (2008)

– WHA 62.16 (2009)


The Global Strategy and Plan of Action on

Public Health, Innovation and Intellectual Property

Global strategy designed to promote innovation, build capacity, improve

access and mobilize resources

Eight elements :

1. prioritizing research and development needs

2. promoting research and development

3. building and improving innovative capacity

4. transfer of technology

5. application and management of intellectual property

6. improving delivery and access

7. ensuring sustainable financing mechanisms

8. establishing monitoring and reporting systems


Many constituencies must contribute

National OECD

National MIC

National

LIC

WHO

Health Related

Industries

Foundations

NGO / Civil Society

Intl. Agencies

$147 billion price tag

2009-2015

How can value

be added by WHO?


Elements 1 to 3 focus on research

1. prioritizing research and development needs

2. promoting research and development

3. building and improving innovative capacity

4. transfer of technology

5. application and management of intellectual property

6. improving delivery and access

7. ensuring sustainable financing mechanisms

8. establishing monitoring and reporting systems


TDR Vision can harmonise with GSPOA

To foster:

An effective global research effort on

infectious diseases of poverty in which

disease endemic countries play a

pivotal role


Track record

• Supported >10,000 projects;

trained >1,500 PhD scientists

• Five of 10 tropical diseases

targeted for global / regional

elimination

• Tools for malaria control

• Incubation and spin-off of

product development

organizations

•MMV, DNDi, FIND

TDR mission

• To develop new and

improved tools for

tropical disease control

• To strengthen the

research capability of

the disease endemic

countries (DECs)

TDR was established as a special programme 30 years ago

Key strengths

• Co-sponsored and

representative governance

• UN’s convening power

• Location in WHO and links to

ministries and control

• Partner network and brokering

capabilities

• Long-standing DEC

relationships


Element 1: Priority Setting

Biennial reports on 'status of research on infectious diseases of poverty' –

first in early 2011 – stakeholder driven in regions and countries


Drug Reg Indication Partners

Praziquantel 1976 Schistosomiasis Bayer / TDR

Benznidazole 1978 Chagas disease Hoffman La Roche

Multi-drug therapy 1980 Leprosy Ciba-Geigy / TDR

Albendazole 1981 Intestinal parasites, LF Smith Kline Beecham

Mefloquine 1984 Malaria Roche, WRAIR / TDR

Ivermectin 1987 Onchocerciasis Merck / TDR

Halofantrine 1988 Malaria Smith Kline Beecham, WRAIR

Eflornithine 1991 African Trypanosomiasis Marion Merrel Dow / TDR

Liposomal amphotericin B 1994 Leishmaniasis (Kala azar) NeXstar / TDR

Artemether 1997 Malaria Rhone Poulenc , Kunming /TDR

Artemether-lumefantrine 1999 Malaria Novartis / Chinese governemnt

Atovaquone+proguanil 2000 Malaria Glaxo Wellcome

Artemotil (beta-arteether) 2000 Malaria Artecef, WRAIR / TDR

Miltefosine 2002 Leishmaniasis (Kala azar) Zentaris, Indian CMR / TDR

Paromomycin 2006 Leishmaniasis (Kala azar) IOWH (TDR)

Artesunate-Amodiaquine 2007 Malaria Sanofi-Aventis/DNDi (TDR)

Artesunate - Mefloquine 2008 Malaria Farmanguinhos/DNDi (TDR)

Element 2: Promoting R&D – medicines


Criteria and evaluation methodology developed for 'Point of Care' tests

Commercial tests accessed from companies and assessed

– agreement that data will be made public

Successful tests go on to WHO procurement list

– 2003 syphilis (6 tests)

– 2005 visceral leishmaniasis (1 test)

– chlamydia and gonnorea (0 tests)

– TB (0 tests)

– 2009 malaria (40 tests evaluated informing pre-qualification )

Country-based capabilities developed

Element 2: Promoting R&D – diagnostics


Growth of PPP's

Private Sector

Preferential Pricing

Public Sector

Reduction of Cost

and Risk

Private Sector

Preferential Pricing

Public Sector

Reduction of Cost

and Risk


Beyond PPP's

Promoting innovation through networks

Sources: TDR, MMV, DNDi, TB Alliance, etc.

INNOVATION GAP

100.0

30.0

19.5

10.7

5.8 4.01.9 1.3 1.3

Attrition Rates and Current Neglected Disease Pipelines

UW

NPIMR

LSHTM

LMPH-UA

STI

TBRI

U.Buea

CDRI

Vitro/Vivo Screening Network Target Portfolio Network/HTS

UW

BIOTEC

UPenn

UCSF

NEB

Pfizer

Inpharmatica

SangerCent.

WEHI

MedChem/DMPK Network

Pfizer

MerckSerono

Chemtura

Pharmacopeia

U-Nebraska

Ohio State

St Judes

Dundee

Cape Town

AiBST

Monash

Fellows

Brazil

Cameroon

Zambia

S. Africa

India

China

Russia

EU

USA

Nwaka & Ramirez - unpublished

Open source information

(link to patent pooling)

Innovation gap also addressed

by developing countries


Element 3: Building Capacity

Need to move beyond North-South


Promoting Regional Networks

African Network for Drugs and Diagnostics Innovation

Lancet 2009, 373, 1507-1508

Goal:

$600M Fund, Formal organization by 2010

Business Plan developed

To be presented Cape Town Oct. 5-7

Potential for Initiatives in other regions

Partners

African Development Bank, WIPO, WHO, other


Impact of Public – Private Partnership and

Networks

Cost and time-effective product development (and delivery?) where limited markets

– impact on market

– impact on health and health equity

Opportunity for (developing country generic) manufacturers to extend expertise upstream. Several examples of collaborations with 'generic' companies

– process R&D

– formulations

– development


(4.1) promoting transfer of technology and the production of health

products in developing countries

(4.2) improved collaboration and coordination of technology transfer

– TRIPS article 66.2

(4.3) new mechanisms to promote transfer of and access to key health-related technologies

– patent pooling?

– TRIPS instruments?

Opportunities to partner / license for manufacturing in developing countries

Element 4. Transfer of technology


(5.1) supporting information sharing and capacity building in the application

and management of intellectual property

(5.2) providing technical support …. to countries that intend to make use of

the provisions contained in the [TRIPS] Agreement ….

(5.3) incentive schemes for research and development ….on developing

countries’ specific research and development needs …

Collaboration between WTO, WIPO and WHO

Element 5. Application and management

of intellectual property


Element 6. Improving delivery and

access

(6.1) encouraging increased investment in the health-delivery infrastructure and financing

of health products …

– international aid, (US Govt: PEPFAR, President's Malaria Initiative)

– Global Fund for AIDS, TB and Malaria

– Global Alliance for Vaccines and Immunization

(6.2) establishing and strengthening mechanisms to improve ethical review and regulate

the quality, safety and efficacy of health products and medical devices

– WHO working with partners to support regulatory agency capabilities

– concept of African sub-regional regulatory agencies

– Asian and Pacific Network for Ethical review (FERCAP)

(6.3) promoting competition to improve availability and affordability of health products

consistent with public health policies and needs

– UNITAID (established by airline ticket tax) focus on niche indications


Element 7. Promoting sustainable

financing mechanisms

(7.1) endeavouring to secure adequate and sustainable financing for

research and development, and improve coordination of its use …..

(7.2) facilitating the maximum use of ….. existing financing, including that

through public-private and product development partnerships

WHO Expert Working Group established and due to report 2010


Element 8. Establishing monitoring and

reporting systems

(8.1) measuring performance and progress towards objectives contained in the strategy and plan of action

Regular reporting back on progress to World Health Assembly

against defined indicators


Challenges

Maintenance (and enhancement) of gains made in past decade

Coherence in a competitive, modified-market, environment

– priority setting, policy guidance and technical support

– pre-competitive innovation networks / patent pooling

– quality assurance (regulatory, WHO pre-qualification …)

Engagement of developing countries

– as generators of innovation as well as users of innovation

– as manufacturers

Access / Delivery ……

– importance of policy dimension in non-market environment or where

public sector drives the market


Research, Market and Public Policy – linking for impact


Roles for Governments and Industry

The pharmaceutical industry and governments in developed countries, notably USA and Canada, can play an important role

– $$$$; in-kind resources; win-win deals

Economic and pharmaceutical growth across developing world

– China, India, Brazil, South Africa, …….

– but also in many low income countries including in sub-Saharan Africa

Opportunities for technology transfer and joint ventures

– opportunities for public sector and industry to work together to develop innovative approaches

– link Trade, Aid and Development

– supported by WHO, WTO, WIPO, other UN agencies ……


Thank You

For further information on Global Strategy and Plan of

Action

www.who.int/phi

For further information on TDR

www.who.int/tdr

*

http://www.who.int/phi

http://www.who.int/tdr

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global strategy and plan of action on public health ... ridley... · igpa, montreal, october 1st,...

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