Standard Template for a Candidate Demonstration Project · Standard Template for a Candidate...

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Standard Template for a Candidate Demonstration Project Note: the questions with asterisk should be filled. 1.* Title of the project: ANDI as the regional coordination mechanism for demonstration projects and product R&D in Africa 2.* Submitted by: 3.* Target disease or health condition: (Focus on type II and III diseases and special R&D needs of developing countries in type I diseases where there is an identified health technology gap.) The proposal focuses on the coordination and financing of R&D for types II and III diseases and special R&D needs of developing countries in type I diseases in Africa. 4.* The suggested health technology that project seeks to develop: (e.g. medicine; diagnostic test; medical device; vaccine etc.) The proposal seeks to leverage existing ANDI structure to develop and promote access to medicines, diagnostic tests, medical devices, and other technologies for type II, III and special needs of developing countries in type I diseases, where there is a gap, need and opportunity. In addition, ANDI will use its global network of partners to implement essential technology platforms for R&D, such as the development and access to novel classes of compound library based on traditional medicines and natural products, technology evaluation platforms, open source databases and access to critical R&D facilities and equipment etc. ANDI have relevant

Transcript of Standard Template for a Candidate Demonstration Project · Standard Template for a Candidate...

Standard Template for a Candidate Demonstration Project

Note: the questions with asterisk should be filled.

1.* Title of the project:

ANDI as the regional coordination mechanism for demonstration projects and product

R&D in Africa

2.* Submitted by:

3.* Target disease or health condition:

(Focus on type II and III diseases and special R&D needs of developing countries in type I diseases where there is an identified health technology gap.)

The proposal focuses on the coordination and financing of R&D for types II and III

diseases and special R&D needs of developing countries in type I diseases in Africa.

4.* The suggested health technology that project seeks to develop:

(e.g. medicine; diagnostic test; medical device; vaccine etc.) The proposal seeks to leverage existing ANDI structure to develop and promote access to

medicines, diagnostic tests, medical devices, and other technologies for type II, III and special

needs of developing countries in type I diseases, where there is a gap, need and opportunity. In

addition, ANDI will use its global network of partners to implement essential technology

platforms for R&D, such as the development and access to novel classes of compound library

based on traditional medicines and natural products, technology evaluation platforms, open

source databases and access to critical R&D facilities and equipment etc. ANDI have relevant

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experience and track record in R&D program coordination, pre-competitive project

identification, selection and financing in Africa. It has established a broad network of African

and international institutions (public and private), exemplified by the 38 pan African Centres of

Excellence implemented by ANDI as well as South South and North South partnerships in

various R&D and manufacturing areas.

5.* Project summary:

We propose to leverage the existing ANDI structure as a coordination, financing,

monitoring and evaluation platform for demonstration projects and the sustained implementation

of R&D in Africa. Similar mechanism can be deployed in other regions. This innovative and

sustainable approach will: i) manage and oversee the implementation of demonstration and other

R&D projects that meet the needs of developing countries, ii) fundraise and disburse funds for

projects, iii) implement call for proposal, as required, to ensure optimal portfolio balance and

delivery of milestones, iv) develop and utilize open source and technology platforms in support

of projects, and access to critical equipment, v) coordinate the establishment of local and global

partnerships, networks, technology transfer and capacity building in support of demonstration

projects.

ANDI have a track record in the coordination of health R&D and associated capacity building in

Africa: i) It has implemented the identification and recognition of the first set of 38 pan-African

CoEs (public and private entities) in health innovation based on criteria and an open call for

proposals (1). These CoEs will support implementation of specific R&D and capacity building

activities as well as South South and North South partnerships in Africa; ii) it has successfully

implemented the identification and initiation of viable projects through call for proposals, with

hundreds of proposals received and evaluated. An independent ANDI Scientific and Technical

Advisory Committee (STAC) supports these processes. Some projects selected and funded

include the evaluation and technology transfer of an affordable medical device suite for maternal

and child health in Africa and co-formulation of a combination therapy to treat sickle cell

anemia. Also, a number of network or consortium projects were identified, including a disease

monitoring and surveillance network, diagnostics/medical device networks, and a traditional

medicines and natural products network.

ANDI will proactively identify additional partners to support projects and ensure that project

milestones are met and projects are successfully transitioned from one phase to another. An

important part of this project will be the development of ANDI KnowledgeBase to support the

management of demonstration projects and promote information sharing, in manner that adds

value and supports open innovation (Figure 1). This database will also support the proposed

R&D observatory agreed by the World Health Assembly (WHA66.22).

Figure 1: ANDI Knowledge database concept with an open access and closed space.

Another example of an innovative and much needed technology platform that will be

implemented and made available by ANDI is an annotated compound library of traditional

medicines and natural products from African biodiversity that can support screening campaigns

and reverse pharmacological evaluations. ANDI is already discussing with partners in other

regions to establish and use such resource widely. Such resource will support the development of

new medicines for infectious diseases, including those caused by drug resistant bacterial

pathogens that are prevalent in developing countries and for which new drugs are lacking

(example diarrheal, respiratory infections and TB). The resultant leads from the screens for

bacterial pathogens can be developed by ANDI and relevant global partnership. ANDI is also

working with regional and global partners to establish the much needed novel diagnostics

development and evaluation platforms.

Consistent with the vision of ANDI as well as objectives of the GSPoA and demonstration

projects (WHA66.22, 2013), any sustainable solution to the health challenges of developing

countries especially the African continent must strengthen their R&D foundation and capacity

for innovation and entrepreneurship. Through this project, ANDI will work with partners in

Africa and overseas to create sustainable, scalable, and transformative products as measured by:

Access to quality and much needed medicines, diagnostics/medical devices and vaccines.

Training of individuals and institutions to achieve competitiveness.

(Approximately 500 words)

6.* Public health need that the proposed project aims to address:

(Explain the public health need in terms of burden of disease; prevalence; incidence; fatality rate; geographical spread; current interventions and their limitations; and what proposed new technology would change in terms of disease prevention, control, diagnosis, treatment etc. If detailed information is not possible at present then please provide some basic level information)

The African continent, particularly sub-Saharan Africa, bears the greatest burden of types

II and III diseases including the so called neglected diseases, malaria, tuberculosis, HIV/AIDs,

diarrheal and respiratory diseases in the world (2 - 4). While substantial progress has been

achieved in Africa in reducing years of life lost due to premature mortality (YLLs) from

communicable, maternal, neonatal, and nutritional causes, these conditions still account for three

out of four premature deaths (5). In terms of non-fatal health outcomes from diseases and

injuries, the leading causes of years lived with disability (YLDs) in sub-Saharan Africa are

neglected tropical diseases (schistosomiasis, onchocerciasis, African trypanosomiasis, and

hookworm). At the same time, a double burden of communicable and non-communicable disease

now characterizes the health profile in sub-Saharan Africa. However, there are few

mechanisms in place in Africa to ensure sustained access to the tools needed to control,

diagnose or treat these diseases. The over dependence on externally developed and

procured health products is unsustainable and insufficient to meet local needs.

Over the past years, various development agencies in Europe, North America, Japan as well as

philanthropic foundations and international organizations, have supported both capacity-building

and institutional strengthening of clinical laboratories in Africa. Unfortunately, some of these

capacities have not been systematically leveraged to support the health product R&D needs of

Africa in a sustainable way.

A detailed landscape analysis undertaken by ANDI shows that, capacity for innovation exist in

Africa but that the key challenges include lack of coordination of ongoing efforts, lack of

funding and lack of collaboration among African institutions. There is an urgent need for

transformative approaches that address these challenges within Africa, in a manner that

strengthens North South and South South collaboration, and translate stagnating African

discoveries into usable and accessible health tools (4, 6, 7). A recent Lancet article by Pedrique

et al. 2013, show that of the 850 new therapeutic products (drugs, vaccines, biological)

registered from 2000 to 2011, only 4% were indicated for neglected diseases, including

malaria, TB, HIV/AIDS, diarrhea and others. This finding suggests a persistent insufficiency in

drug and vaccine development for Types II and III. Therefore, our proposal addresses a critical

public health need and presents an innovative and coordinated approach to R&D and access to

health interventions in Africa.

Approximately 400 words

7.* Explain which new and innovative approaches and mechanisms to supporting

financing and coordination of R&D this project would demonstrate? (This is a very important part to be filled. The idea of these demonstrations projects is

“to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken” (WHA66.22).

66th WHA considered these demonstration projects as part of the efforts to “take forward action in relation to monitoring, coordination and financing for health research and development”. The assembly decided to identify such projects that: “(a) address identified research and development gaps related to discovery, development and/or delivery, including promising product pipelines, for diseases that disproportionally affect developing countries, particularly the poor, and for which immediate action can be taken; (b) utilize collaborative approaches, including open-knowledge approaches, for research and development coordination; (c) promote the de-linkage of the cost of research and development from product price; and (d)

propose and foster financing mechanisms including innovative, sustainable and pooled funding; (2) The demonstration projects should provide evidence for long-term sustainable solutions.”)

This proposal addresses the urgent need for innovative and transformative approaches

for coordination and financing of R&D for diseases that disproportionately affect developing

countries through the use of the African-based network and global North South and South South

partnership. This concept is new, inclusive and can be extended to other regions with close

collaboration with existing initiative, such as TDR, PDPs, EDCTP. The approach is amenable to

global oversight, including through WHO. ANDI brings with it established processes and is best

placed to support the management/coordination function for product R&D projects in Africa.

The immediate benefits of leveraging ANDI as the coordination mechanism are:

(i) ANDI offers a mechanism to develop a long-term and sustainable solution for the support of R&D within Africa.

(ii) ANDI is familiar with identified research and development gaps related to discovery,

development and/or delivery, including promising product pipelines, for diseases that

disproportionally affect developing countries, both in Africa and globally for which

immediate action can be taken;

(iii) ANDI understands and have supported various collaborative approaches, including

open-knowledge and networked approaches for research and development

coordination as well as product development partnerships;

(iv) ANDI has established a mechanism to promote the de-linkage of the cost of R&D

from product price.

As part of the development of the strategic business plan for ANDI, a proposal was made to

establish an African Innovation Fund (AIF) at the African Development Bank (AfDB) to support

health R&D and access in Africa. Although the AIF has not been implemented, the concept is

very relevant to the current discussion on options for financing R&D for diseases that

disproportionately affect developing countries. Such fund can house a pooled or special fund

from taxes for health R&D and access, from which demonstration and future health R&D

projects can be financed. The fund can also be managed through a Trust Fund held by WHO or

other international/regional bodies but fund disbursement to projects can be implemented as part

of the project coordination mechanism. More importantly, such fund can be managed as a self-

sustaining Social Venture Fund that can be divided into two parts: i) a grant making part that

could fund R&D and product registration, e.g. WHO prequalification, and ii) a second portion

with modest loaning modality to support the manufacture and large scale production of products

emanating from these projects. This later part can also support things like technology transfer,

South South or North South partnerships that seek to implement joint venture entities for the

local production and distribution of such products in Africa. This approach will ensure the de-

linkage of cost of R&D from the cost of final product.

A schematic representation of this de-linkage of R&D from the cost of final product is

presented in Fig 2.

(Approximately 400 words)

8.* Evidence of market failure/research landscape:

(Explain why there has been no investment in this technology or why investment has not resulted in access to the health care product.) Market failure for type II and III diseases is well documented (8), and the Global Strategy

and Plan of Action (GSPoA), outlined at the 61st World Health Assembly provides a framework

to drive health product innovation in a sustainable way (9). A key element of this strategy is the

formation of collaborative R&D mechanism in disease endemic countries that ensure that

Figure 2: different mechanisms employed by ANDI for managing and financing upstream R&D, the critical transition from R&D to manufacture and the downstream manufacture/access. Donor funding through grant making is suitable for upstream R&D for diseases that disproportionately affect developing countries but manufacture and access require a mixture of financing mechanism and incentives. Close coordination are required in all cases.

existing capabilities are leveraged, identified gaps are more effectively filled and local priorities

drive the R&D agenda.

An African health R&D landscape analysis undertaken to inform the establishment of ANDI (4,

6) show that there is significant research gap, for example, only few products are being

researched or in clinical trials for the Continent’s most prevalent diseases (Figure 3). Second,

there is a little collaboration between biomedical R&D centers across Africa. Only 5% of peer-

reviewed articles published from 2004-2008 involved institutions in more than one African

country. Thirdly, there is insufficient investment in African R&D with overall yearly R&D spend

of 0.3% of total African GDP, which is about USD 14 billion below the world median (4, 6).

Also important is a lack of coordination of ongoing efforts, including fragmented financing in

the continent (1). Pedrique et al. 2013, demonstrated a persistent insufficiency in drug and

vaccine development for Types II and III. There are promising trends that can be harnessed to

address these challenges: there is capacity along the health product R&D value chain across

Africa as evidenced by published articles, patents granted, clinical trial competence and

pharmaceutical manufacturing capacity. These show that what is indeed missing is a coordinated

effort and investment in Africa to overcome the identified challenges. Therefore, our proposal

addresses a critical public health need and presents an innovative approach to R&D in Africa.

Figure 3: Number of research articles and clinical trials

(Approximately 200 words)

9. The scientific and technical feasibility: (Describe the scientific and technical basis for the proposed technology in terms of the state of the art e.g. candidate molecules; biomarkers; pipeline; previous efforts, if any, to develop same or similar technology etc. Include some risk analysis)

This proposal is not focusing on a specific candidate molecule or technology, but it is

seeking to manage and coordinate the development of a pipeline of relevant products and

technologies that emanate from Africa, including approved demonstration projects and to make

these technologies more likely to deliver agreed products. This approach also supports the

development of a diversified portfolio that provides opportunity for cross learning from multiple

projects, diseases and implementing partners. ANDI has the track record and experience in

implementing similar efforts in Africa. It also has the relevance governance and oversight organs

in place to oversee the work, including a Scientific and Technical Advisory committee (STAC).

It should be noted that ANDI governance organs are continually reviewed and there is flexibility

to accommodate any specific need of the demonstration projects in terms of oversight.

The work of ANDI, and other organizations like the European Developing Country Clinical Trial

Partnership (EDCTP) suggest that this proposal is scientifically and technically feasible. It is

important to stress that that the capacity for innovation exists in Africa but what is missing is the

relevant coordination, financing and the political will to support the translation of research into

useful health products in Africa (4, 6, 7, 10, 11). The outcome of the call for proposals by ANDI

presents a direct evidence for the scientific feasibility of this proposal:

i) The identification and recognition of the first set of pan-African CoEs in health innovation

based on criteria and an open call for proposals. The resulting CoEs are now supporting

implementation of specific ANDI activities and will be part of the implementation of this

project and associated capacity building (1).

ii) Successful identification and initiation of projects through transparent call for proposals,

and funding of projects.

Potential risks associated with this proposal and how to mitigate them are as follows:

i) ANDI is presently being transition from WHO/TDR to UNOPS in Addis Ababa, after

initial hosting challenges at the United Nations Economic Commission for Africa

(UNECA). This risk is minimal because the transition of ANDI to UNOPS will be

finalized before the end this year 2013.

ii) Human capacity and funding to support the coordination and funding of

demonstration projects: The hope is that this proposal will be funded to be able

provide coordination and individual funding of the pipeline of demonstration projects.

iii) Lack of partners to support selected demonstration projects: this risk is minimal as

ANDI will seek missing and relevant expertise from around the world to support the

successful implementation of the projects. ANDI is already established key South

South and North South partnerships as part of it ongoing activities and will leverage

these as part of this project.

iv) Regulatory challenges in Africa: ANDI will engage with WHO prequalification,

regulatory harmonization initiatives in Africa and stringent regulatory bodies to

address this challenge. As part of this initiative ANDI will also support training and

capacity building for companies and regulators that will be involved on the project.

(Approximately 500 words)

10. Reasons for proposing:

(Provide details if any priority setting and/or selection criteria that has underpinned the consideration to take up this area of technology for development.)

Our proposal presents a holistic and sustainable approach to the health needs of

developing countries. As indicated earlier, the establishment of ANDI and its objectives are

aligned with the GSPoA and recognized by World Health Assembly through WHA62.16, 2009.

In her address to the 66th World Health Assembly in Geneva in Geneva, the Chairperson of the

African Union (AU), Madam Zuma, highlighted ANDI as very important initiation for Africa

and the entire world. This underscores the leading role that ANDI can in the coordination and

financing of R&D in Africa.

Furthermore, a number of international and pan-African reports and resolutions such as the

Commission on Health Research for Development [12], the Accra Plan of Action [13], the Abuja

declaration of 2001 by African leaders [14], and a number of African Ministerial Declarations

[15,16], have stressed the need to support health R&D capacity and coordination for diseases that

are predominant in developing countries especially Africa as well as financing. The resolution

of the World Health Assembly to identify and implement demonstration projects and R&D

observatory presents a real opportunity (WHA66.22). This proposal therefore presents a

unique opportunity for the international community and African government to support the

coordination and financing of R&D and innovation through this critical WHO process.

(Approximately 200 words)

11. Who could potentially develop the technology/carry out the research?

(Provide known details: individual researcher? Group of researchers? Research/coordination organization including PDPs? Group of research organizations working together? Combination of these; What would be the process of selection of developers?) To be successful, a publicly driven product R&D project will require a network or

consortium of partners including public and private agencies, PDPs or individual with

expertise in the various parts of the product R&D value chain, working together to

implement the project. The project will be structured such that transition from one phase

of the value chain to another will be seamless and necessary contractual agreement,

including IP arrangements will be established early in the process to avoid

misunderstanding. ANDI will help in establishing this consortium with necessary

expertise using its network of Centres of Excellence as well as North South and South

South partners. Furthermore, ANDI can also implement new calls to augment

available projects or assuming that no demonstration projects are identified at this

stage. In all cases, ANDI CoEs with relevant expertise will help to fill gaps and

implement R&D.

(Approximately 100 words)

12. Who could potentially manufacture the final product?

Multinational company? Local production? Joint venture? How the decision will be made about the producer?

Transitioning a product from research to manufacture is critical to ensuring access. This is one of

the roles of this coordination effort, which will address issues like downstream manufacturing

partners and the necessary contractual arrangements. Indeed, ANDI is already in discussion with

a number local, regional and multinational companies regarding manufacturing and technology

transfer in Africa. This process will be difficult to handle by individual researchers or

institutions in Africa. ANDI has established a mechanism that supports the managements of this

critical interface in a way that de-links R&D cost from the cost of final products (Fig 2). The

approach considers a granting mechanism for R&D, while the downstream part of

manufacturing, distribution and access requires a mix of grants making, technology transfer,

social and joint venture approaches. This will bring about sustainability and access to final

product while creating opportunity for technology transfer through South South and North South

partnerships. The public procurement incentive will also be used to incentivize the downstream

side of the value chain.

(Approximately 100 words)

13. What could be the role of WHO, if any, in this demonstration project to bring

this venture to fruition? WHO (AFRO and HQ) is a member of the ANDI Board and is represented on the ANDI STAC

as observer. This makes WHO an integral part of the ANDI work. Furthermore, ANDI have

ongoing collaboration with various WHO departments, for example, ANDI was

incubated by TDR, and ANDI will continue to work with TDR, if this proposal if supported.

ANDI can work with WHO/AFRO to establish a joint technical committee made of ANDI

STAC, AFRO ACHR and AU for the purposes of reviewing progress towards the

implementation of the demonstration projects, as needed.

The WHO Essential Medicines department (WHO/EMP), which now houses the Public Health,

Innovation and Intellectual property (PHI) as well as the Prequalification and Regulatory

Strengthening units will be important partners in this project. Indeed, ANDI is already working

with this department at different levels, including through an international consortium of partners

to support the AU in the implementation of the Business Plan for the Pharmaceutical

Manufacturing Plan for Africa (PMPA). Indeed, ANDI, WHO, UNAIDS, UNIDO and AfDB are

members of this consortium established by the AU. Support for the regulatory work on the

demonstration project and the associated capacity building will involve the WHO/EMP.

Furthermore, ANDI will work with the technology transfer WHO as well as the R&D

Observatory being established by WHO. (Approximately 200 words)

14. Please outline a timeframe and projected milestones for the project covering

the first 5 years. This should also highlight the immediate actions that need to be taken?

Assuming the relevant funds are available after World Health Assembly in May 2014, the

timelines and projected milestones for this coordination and financing role over 5 years are as

follows:

1) ANDI will meet with the leaders of the approved demonstration or other R&D projects

from Africa to discuss and clearly define project milestones, timelines, missing expertise

to achieve project objectives, target product profiles and go/no criteria for the projects.

The meeting will also discuss resource needs, review/reporting processes and project

agreement. Timeline for this is June 2014 till October 2014.

2) In parallel with action 1, ANDI will initiate the recruitment of relevant staff to support

the implementation of the pipeline of projects, including the establishment of relevant

partnerships. Timeline for this will be June 2014 – December 2014.

3) Project and partnerships agreement in place. Timeline: September 2014 – February 2015.

4) Implementation kick off meeting: this will be a collective meeting of all demonstration

projects to discuss the pipeline of projects or portfolio. All relevant partners will be

invited to this meeting including WHO and other interested parties. Timeline for this will

be March 2015.

5) Ongoing annual STAC meeting to review progress starting December 2014 till 2018,

followed by governance meetings.

6) Targeted call for proposal to strengthen and achieve optimal portfolio of projects for

delivery of the objectives of demonstration projects, if required after STAC reviews.

Timeline January 2015 - 2018.

7) Ongoing field Monitoring and Evaluation of projects by secretariat staff, consultants etc:

Timeline March 2015 – 2018

8) Ongoing report to World Health Assembly through WHO. Timeline January 2015 - 2018

9) Ongoing capacity building activities linked to demonstration projects including

regulatory support. Timeline March 2015 – December 2018

10) Ongoing development of critical and shared technologies such as new compound

collection and screens. Timeline March 2015 – December 2018

11) Registration of a product by December 2018 from demonstration projects

12) Over 100 Africans will be trained and 5 institutions (public and private sectors)

strengthened based on concrete projects in various parts of the R&D value chain,

portfolio management, project and finance management.

(Approximately 200 words)

15. What is the intellectual property (IP) landscape relative to this project? Is there any IP, e.g. patents that need to be licensed in to be able to develop and market the product in developing countries? How would IP and related intellectual assets, including knowhow, proposed to be managed in this project?

IP management and licensing issues are important parts of the coordination. Experience

shows that every product R&D project will have unique characteristics regarding IP

employed in the development of the product, as well as partnership arrangements. ANDI has

developed a draft IP strategy with the support of WIPO and UNDP which will be ratified by

the Board in due course. The basic premise of this strategy is that ANDI will use IP, where

appropriate, to support the advancement of products for public health access in developing

countries. IP will typical reside with the institutions or agency that developed them but ANDI

will seek appropriate licence to enable continued and unhindered development and public

health access for the product in developing countries. ANDI will also facilitate the

development of IP or patents, in instances where it will advance access to products for

diseases that disproportionately affect developing countries. ANDI will also promote the use

of TRIPS flexibilities to support access to products.

(Approximately 400 words)

16.* What would be the strategy to ensure access to the product once it is developed? (Access is an important dimension of these demonstration projects, it is important for

the projects to begin with the end in mind, explain how this project would deliver the technologies to the needy patients i.e. price and affordability; modes of supply; storage; prescription; dispensing; and compliance; WHO will develop guiding principles for ensuring access to any products coming out of the demonstration projects)

ANDI will adhere to any WHO guiding principles for ensuring access to any product

coming out of this process. In addition, the following modalities will be considered as

part of the project agreements to ensure access: i) In addition, ANDI will engage with

African governments, development agencies, international organizations, NGOs and

Foundations to secure procurement of the products resulting from this project for the

poor populations of Africa; ii) ANDI will also ensure that appropriate pricing for the

products that result from this process are agreed ahead of time and that products sold

through the public and private sector market meet these pricing guidelines; iii) as part

of the work of ANDI, appropriate training and partnership concerning supply chain

management and delivery will be implemented in preparation for the arrival of new

product.

(Approximately 400 words)

17. How could the project be financed paying particular attention to the need to

demonstrate new and innovative forms of financing? Also provide an estimated cost of the project.

This proposal assumes that a certain level of financial commitment will be provided by

WHO through its member states to kick-start the implementation of selected demonstration

projects. As indicated above, this commitment can be operationalized through the

establishment of pooled financing mechanism where countries can contribute into or through

special airline or tobacco taxes. These funds can be hosted and managed regionally and/or

globally in a professional and self-sustaining manner. From these funds, regional R&D

activities can be financed through an appropriate coordinating body. Regional development

banks such as the African Development Bank or an appropriate WHO or UN Trust Fund can

be established for such funds, from which specific project funds can be disbursed at the

request of the coordinating body. The fund can provide grant money for the R&D part of the

demonstration projects and also promote various venture approaches or guaranteed loan for

manufacturing and access. In addition, government or international guarantee for

procurement of finished product would be helpful, assuming all conditions are met. This

approach will promote technology transfer, South South and North South collaboration to

support sustained local production and access of finished product.

A realistic budget for this proposal will be defined once the number and types of

demonstration project that will be supported under this coordination mechanism is

established. In the time, considering that ANDI has a very slim structure, the possible

cost of coordination without direct funding for project can range from USD1 to 2 Million

per annum over five years.

(Approximately 200 words)

18. How could the project be governed and coordinated paying particular

attention to the need to demonstrate better way of coordination? This proposal is focusing on governance, coordination and financing of demonstration and R&D

projects in Africa through the use of existing ANDI structure (Fig 4) consisting of Board,

Secretariat, STAC and host agency .

ANDI Board: The Board is a ministerial level board and currently consists of 12 members from

among its key stakeholders including representatives of ministries of health, science and

technology and finance from the five regions of Africa.

ANDI Secretariat: The Secretariat includes the central office of ANDI, its sub-regional hubs

and staff responsible for the implementation of all ANDI activities under the leadership of an

Executive Director.

Host agency in Africa: United Nations Office for Project Services (UNOPS) has been selected

by the ANDI Board as the new host agency for ANDI and contractual arrangement between

WHO and UNOPS is being finalised to this effect

STAC: The STAC is comprised of experts with a track record in various aspects of health

product innovation and the R&D value chain. STAC members are independent experts acting in

an individual and personal capacity. They provide technical advice to the ANDI Board and the

ANDI Secretariat.

Figure 4: Governance structure of ANDI

(Approximately 200 words)

19. Have any donor agencies/governments already indicated interest in supporting the project?

The work of ANDI is presently supported with funding from the European Union,

WHO/TDR, Nigeria, the African Development Bank including through Trust Funds from

South Korea and Brasil.

(Approximately 200 words)

References:

1) Nwaka et al. Analysis of pan-African Centres of excellence in health innovation

highlights opportunities and challenges for local innovation and financing in the continent. BMC International Health and Human Rights 2012, 12:11 Page 2 of 15

2) World Health Organization: World Health Report 2004. Geneva: 2004. http://www.who.int/whr/2004/en/report04_en.pdf.

3) Murray CJ, Lopez AD: Mortality by cause for eight regions of the world:Global Burden of Disease Study. Lancet 1997, 349:1269–1276.

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4) Strategic Business Plan for ANDI: (http://www.andi-africa.org/images/stories/docs/Business%20Plan.pdf)

5) http://blogs.worldbank.org/africacan/how-does-africa-fare-findings-from-the-global-

burden-of-disease-study 6) Nwaka S. et al. (2010) Developing ANDI: A Novel Approach to Health Product R&D in

Africa. PLoS Med 7(6): e1000293. doi:10.1371/journal.pmed.1000293% 7) Simiyu K, Daar AS, Singer PA: Global health. Stagnant health technologies in Africa.

Science 2010, 330:1483–1484. 8) Trouiller P et al. (2002) Drug development for neglected diseases: a deficient market and

a public-health policy failure. Lancet. 2002 Jun 22;359(9324):2188-94. 9) WHO WHA 61.21 2008 http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf) 10) Irikefe V et al: The view from the front line - Africa’s nations are achieving some success

in building their science capacity, but the foundations remain unsteady. Nature 2011, 474:556–559.

11) NEPAD and COHRED: Strengthening Pharmaceutical innovation in Africa. 2010. 12) Commission on Health Research for Development: Health research. New York: Essential

Link to Equity in Development. Oxford University Press; 1990. 13) OECD: The Paris Declaration on Aid Effectiveness and the Accra Agenda for Action

2005/2008. Accra; 2008. 14) United Nation: Abuja declaration on HIV/AIDS. Tuberculosis and other related

infectious diseases, OAU/SPS/ABUJA/3. Abuja:; 2001. 15) African Ministerial Council on Science & Technology: Resolutions f The Second African

Ministerial Conference On Science And Technology. Dakar: 2005. 16) World Health Organization Regional Office for Africa: The Algiers Declaration. Algiers:

Ministerial Conference on Research for Health in the African Region; 2008.