TropIKA

Draft Summary Minutes and Recommendations
ANDI Launch Meeting
October 6 - 8, Abuja 2008

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Callistus Ikwunze Ewelike/News Agency of Nigeria (NAN)

Callistus Ikwunze Ewelike/News Agency of Nigeria (NAN)

Callistus Ikwunze Ewelike/News Agency of Nigeria (NAN)

Report of the break out session. During the plenary session, the rapporteurs of the respective break our session groups, presented their summary reports on the assigned topics for discussion. The main points are summarized below:

Session 1: Is ANDI needed? Will it fill a gap? What are the challenges? What is needed to make it successful?

Is ANDI Needed?

Yes.  Presently we are suffering from a Poverty of knowledge and an inability to utilize what we already know to benefit our own people. There is an overreliance on the West and a need to harness our use traditional systems for our benefit. ANDI offers such an opportunity.

Yes. Because we need to depart from creating a divide between herbal/traditional medicine and western medicine. ANDI has the potential to provide great public health benefit in Africa by all available means.

May or may not be needed depending on the approach we take. Many other networks already exist, even for very specific diseases, however the impact they have made remains to be seen/validated. ANDI will make itself needed or not depending on the way we choose to operate.

Some were concerned that ANDI is another WHO initiative owned and controlled by WHO, in which case it would not be needed. This was clarified and the focus placed on the fact that ANDI is being created by Africans for Africans only with support (not necessarily financial) from WHO.

ANDI will only become useful/needed when we see ourselves in the right perspective and do not underrate ourselves. We will need to adopt a visionary mentality.

Will ANDI fill a gap?

Gaps do exist but we need to only focus on particular ones and move towards them. Are we going to be funders, virtual organizations etc.

Training is a major gap, including the redistribution of expertise.

There is a gap in identifying already existing centres in country.

A gap in material development.

A management gap that ANDI can fill. Many scientists sometimes work on the same things and do not even know, thus wasting already limited resources. Stand-alone work is becoming outmoded and is not encouraged.

ANDI can fill the gap in the development of both “herbal compounds” and “pure compounds” possibly simultaneously but at least synergistically.

What are the challenges?

The need to structure ANDI and the choice we will make. Funders, virtual and lean etc, and getting past the friction that might develop from the choice we make.

Creation of a system that can make an impact on the global market and health system. Niprisan stood on the shelf for a very long time before an Indian company came by to purchase and market and has now filed with the USA FDA for orphan drug status.

Developing the spirit of entrepreneurship and being willing to take calculated risks.

Having an up to date database which will be updated regularly in order to facilitate networking and discourage duplication and unhealthy competition.

Getting government support for ANDI employing advocacy tools.

Standardization of methods across Africa such that there can be effective exchange of ideas and global
recognition.

Conflicts of interest between individuals and institutions.

Institutional and political commitment.

What do we need to do?

Create an interactive website and database where information and messages can be posted so communication can continue remotely and networking can continue.

Secure funding from African governments and other appropriate sources. We might have to rely on goodwill funds to start with.

Seeking for good legislative policies in Africa as well as health information policies that will promote ANDI’s objectives.

Make use of in-country and expatriate experts, as well as African scientists and other experts in the diasporas to move ANDI forward. We have already started doing this.

Make truth in every form; including honesty and integrity our sunum bonum.

Session 2: What should be the scope (diseases and products)? Is capacity available to initiate and implement agreed activities? What are the low-hanging fruits?

What should be the scope (disease and products)?

ANDI activities should be centered on the development of Traditional, natural, synthetic medicines and diagnostics for the management of communicable and non-communicable diseases in Africa, giving priority attention to prevalent and neglected disease.

Is capacity available to initiate and implement agreed activities?

Some levels of capacity is in certain areas of product development, but there is need for a scientific audit to determine precisely the levels adequacy.

What are the low hanging fruits (examples)?

Drugs:

• South Africa: TDR15087 UCT
• Nigeria: NICOSAN, NIPRD AM1 IPRD
• Egypt: Schisto products

Diagnostics

• Egypt: Immunodiagnostic kits, Molecular assay of Viral hepatitis, Recombinant therapeutic proteins

Session 3: Who are the key stakeholders? Who will fund? What are the important organizational and funding issues and options that need to be addressed?

Key stakeholders:

African-wide groups

• Local pharmaceutical manufacturers
• Traditional medicine practitioners
• Academic institutions, research institutes
• Drug regulators/associations
• Regional groupings: ECOWAS, SADC, East African
• Continental: African Union, NEPAD
• NGOs

Existing/related initiatives

• GIBEX, SAMI etc
• Strategic partners: existing multinationals (e.g. big pharma)
• Potential consumers/consumer bodies
• IP organizations: ARIPO, OAPI, WIPO, National IP offices

Government Ministries/advocates for policy making/funding

• Health
• Science & Technology
• Finance
• Planning
• International (those interested in empowering Africa)
• WHO, Gates etc

Organizational Structure

• Hub/clearing house
  • Project umbrella
  • Programme umbrella (distributes funds via scientific advisory committee e.g. SAMI model)
  • Diaspora as a hub organized along lines of programme (research, diagnostics, drug discovery etc.)
• Client-server network model
  • ANDI as server, labs of members as clients
  • ANDI as catalyst towards product delivery etc and promote/facilitate collaboration
• Centres of Excellence
• Initial Incubation within WHO/TDR (e.g. MMV etc)

Who will fund ANDI?

• There is a need to define who ANDI wants to be 
• PPP Model
• All funders of PPPs like MMV
• Project funding based on projects or products or patents brought to ANDI by members for development using ANDI consortium expertise
• Commercial Investment strategy
• Industry corporate social responsibility e.g. mining companies
• Governments
• National/regional/continental
• Angel Investors (wealthy individuals give money in exchange for tax breaks etc)
• Wealthy individuals creating scholarships to build capacity by training African students locally and abroad

Plenary session on Next Steps (Chaired by Amb. Dr. Tom Mboya)

• A small working committee (task force) should be urgently established with proper representation of African stakeholders and other partners to collate suggestions and recommendations. The task force will be tasked with specific terms of reference and responsibilities related to providing the draft strategic blueprint for ANDI (policy, strategy, business plan including governance), funding, appropriate R&D model considering existing virtual R&D models. 
• The draft strategic blueprint will be shared with the community as it is developed and will be presented for review at a subsequent meeting of ANDI, with a target date of 4Q 2009.
• Additional mandate for such committee include consideration for a definitive Africa based Secretariat; the idea of a rotational Secretariat to be explored.
• Suggest an interim secretariat that will be hosted by TDR until ANDI agenda is mature
• Others suggested that the blueprint for ANDI be finalized first prior to the selection of the centre to host the Secretariat
• Consideration to be made for the different major languages used in Africa
• Urge government support for R&D of defined priorities and promising deliverables
• Urge government to invest counterpart funding to match external funding
• Establish website and interactive Community of Practice for ANDI

Best Poster Awards. The following were given the Best Poster Awards:

• Chibale K, Ayeni A, Raskin P, Lila M and Dushenkov S. GIBEX-Africa: A unique model for collaborative research in African natural products (Department of Chemistry and Institute of Infectious Disease and Molecular Medicine, University of Cape Town, SOUTH AFRICA).
• Ademowo OG, Okeola V, Nneji CM, Falade CO and Farombi OE. Evaluation of the antimalarial and antioxidant effects of methanolic extract of Nigella sativa in mice infected with Plasmodium yoelii nigeriensis. (Institute for Advance Medical Research and Training, University of Ibadan, NIGERIA).
• Tijani Ao, Okhale SE, Oga E, Tags SZ, Salawu OA and Chindo BA. Anti-emetic activity of Grewia lasiodiscus root extract and fractions. (Department of Pharmacology and Toxicology, National Institute for Pharmaceutical Research and Development, Idu, Abuja, NIGERIA).
• Akanji O. Building capacity for drug discovery, development and manufacturing under cGMP in West Africa. (LaGray Chemical Company, GHANA).

Panel discussions. Plenary panel discussions were held to address questions on the following topics:

A. Can products be discovered , developed and registered in Africa? Are there examples?
B. What are the needs and opportunities for ANDI? What are the challenges (including IP management)?
C. How can Africans in Diaspora support ANDI
D. How can other African institutions and governments support ANDI?
E. How can ANDI synergize with other product R&D initiatives?

Break Out Sessions. Participants engaged in lively discussions, debates and brainstorming on several topics (see below) during the break out sessions. The topics discussed by the three groups were as follows:

1. Is ANDI needed? Will it fill a gap? What are the challenges? What is needed to make it successful?
2. What should be the scope (diseases and products)? Is capacity available to initiate and implement agreed activities? What are the low hanging fruits?
3. Who are the key stakeholders? Who will fund? What are the important organizational and funding issues, and options that need to be addressed?

Questions/Comments:

1. How could the private sector step up and be involved in this strategy and assist in financing R&D and innovation in Africa?
2. Is there a WHO strategic plan for Africa?
3. What are your recommendations for good intellectual property rights management?
4. Since huge sums of money (US $800 million) are estimated to be required for the development of any one drug, is ANDI a strategy for the future or is there another economically more viable strategy?
5. Due to the issue of drug resistance, what paradigm are we adopting for drug development or health remedies? Since pure molecules readily create resistance, can the traditional model of natural or traditional approach be adopted?
6. Is ANDI going to mobilize funds and make them available to individual researchers or to groups, as in a cooperative?
7. How is ANDI going to prepare for the drying up of generosity from private organizations and agencies in view of current world economic crisis?
8. To what extent is the risk factor of profiteering going to be considered by the investing private sector in the intended PPP?
9. A network like ANDI needs some of the following ingredients to succeed: transparency, peer review, health competition and some cultural evolution.
10. Are there targets to build capacity in areas which Africa currently lacks capacity, such as in genetic issues, single drug design and discovery, etc?

Responses To Questions/Comments

Issues on Funding: Drug discovery may cost $800m in the US, which is more expensive to invest due to the cost of doing business: It is expected to be much cheaper in Africa as a result of lower wages or cost of labour and maybe the raw materials. Also the ANDI concept of networking and taking advantage of synergies among member states or organizations may help in lowering the cost of innovation. The funding has to start from Africans themselves

Many stakeholders are looking at

Current financing

New financing options

Sustainable financing for R&D

IGWG targets for 2010

Dr. Renganathan

Issues on strategy: The WHO is working on a global strategy and there is no specific document known as an African strategy. But ANDI is the contribution from the African region towards the global strategy on better health through R&D and innovation.

Dr. Renganathan

Issues on intellectual property management (IPR): There are a lot of issues and it must be approached at the technical level which also covers biodiversity. You cannot achieve good management by just talking about it. You have to be involved in it through developing innovation and acquiring your own IPR. The issue is not just IPR itself but in doing the deal — the IPR deal.

Dr. Ridley

Traditional approach to innovation: The traditional approach is also scientific and no one is condemning the traditional approach. There has to be dialogue between the traditional approach and the scientific approach to find a common ground or a mid-point.

One of the challenges of the traditional approaches is in dealing with the micro and macro environmental issues in R&D such as the issues of safety and efficacy, quality and standards.

Dr. Ridley

Issues on cost and viability: The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV) have developed 5 different portfolios of drug development costing about US $50million a year. Hence drug discovery is not a cheap venture. But through network and synergies, Africans could develop innovation at lower costs — for instance, using a workforce of high skill at a lower cost.

But the question is not just about cost, but whether you can achieve what you said you were going to achieve. If the big pharmaceutical manufacturers are sure about you achieving your goals they will most likely put their money down, but if not, they just do not want to waste their time, not just their money. Hence you have to be very honest on what you can deliver.

Dr. Ridley

Ingredient for successful R&D/innovation: It takes a good and experienced researcher to know the ingredient as itemized by the speaker. A good innovation drive requires transparency, healthy competition, drive for openness, etc.

Dr. Ridley

Building capacity: The issues raised on building R&D capacity in genetic issues, etc, clearly shows that there are capacity gaps in the continent. The South African government recently started to develop a diagnostic facility on a particular disease but soon discovered that there were no adequate samples for it. In other words, the centre has excess capacity and the challenges soon became getting enough capacity for the center to be sustainable. Hence the network of ANDI is expected to bring together areas of limited capacity and merge with areas of excess capacity in order to forge ahead.

Dr. Ridley

Rapporteurs

1. Dr. Alex U. Akpa
2. Mr. Egharevba H.O.

6th October 2008

(By Dr. E. Renganathan, Executive Secretary on Public Health, Innovation and Intellectual Property (IGWG); WHO, Geneva)

Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)

Background

WHO Commission on Intellectual Property Rights, Innovation and Public Health established 2004.

WHO Commission’s report was published in April, 2006.

The World Health Assembly (WHA) in May 2006 adopted resolution WHA59.24 requesting the DG to establish an Intergovernmental Working Group (IGWG).

IGWG to draw up a global strategy and plan of action that aims at inter-alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries

IGWG Process

First session of the IGWG held in December, 2006.

Second session of the IGWG held in November, 2007 and resumed in April, 2008.

Follow-up drafting group to finalize strategy at the WHA 61 in May 2008.

Other Related Activities

Member States had additional opportunities to provide further inputs to the negotiating text during the process.

Web-based public-hearings held in November, 2006 and August to September, 2007.

Regional Consultations held in all regions from August to October, 2007.

Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property

The global strategy is designed to promote innovation, build capacity, improve access and mobilize resources.

Eight elements of the plan of action:

Prioritizing research and development needs

Promoting research and development

Building and improving innovative capacity

Transfer of technology

Application and management of intellectual property (IP)

Improving delivery and access

Ensuring sustainable financing mechanisms

Establishing monitoring and reporting systems.

At the 61st World Health Assembly

Member States adopted the global strategy and the agreed parts of the plan of action on public health, innovation and intellectual property (Resolution WHA 61.21)

The strategy proposes that WHO play a strategic and central role in the relationship between public health and innovation and IP within its mandates, capacities and constitutional objectives.

Member States were urged to adopt and support actively the wider implementation of the global strategy, in particular through providing adequate resources to enhance and implement the specific actions recommended in the global strategy on public health, innovation and intellectual property.

Relevant international organizations and other relevant stakeholders were called upon to give priority within their respective mandates and programmes to implementing the global strategy and plan of action on public health, innovation and intellectual property.

Recommended expected outcomes for ANDI

Equitable access to good quality, affordable medicines.

Commitment and engagement of governments and other stakeholders.

Promotion and sustainability of African led R&D innovation through discovery, development and delivery of affordable new tools, as well as supporting capacity and infrastructure development.

Leverage and building of existing activities in Africa.

Leadership by African scientists and institutions with clear political support, ownership and involvement of African countries and regional networks.

(By Dr. R. Ridley, Director, Special Programme for Research and Training in Tropical Diseases (TDR); Geneva)

Innovation is the act of bringing about an improvement by introducing something new, such as an idea, product or process. It is applicable to business and technology as well as all areas of life.

Distinction between invention and innovation.

Invention is the first occurrence of an idea for a new product or process

Innovation includes carrying it out into practice

Diffusion of innovations is in two folds which include:

Cultural diffusion more like geographical diffusion

Process of adaptation and improvement

Innovation for health — can occur at any stage along the value chain of capacity building and knowledge management which may include the following:

New knowledge/discoveries

New and improved tools

New and improved interventions

New and improved strategies

Although ANDI focuses on technological innovation, the whole value chain remains important.

Some examples of innovation for health

Fleming’s discovery of penicillin and its development, production and widespread distribution as a drug.

Discovery of the value of oral rehydration therapy and its scaled-up production and availability in endemic and epidemic situations.

Concept of community-directed interventions for delivery of ivermectin for river blindness and its validation by experimentation and scaled up implementation.

The new TDR Vision is to foster an effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role. However, for disease endemic countries to play a pivotal role, they must be involved in generating innovation of their own as well as testing the innovations of others.

Countries engaging and succeeding in innovation-driven development include South Korea and Singapore while India, China, Brazil, South Africa and the Gulf states are also making progress. Brazil in the 1990s invested only in R&D with no economic growth. It has recently adopted the two pronged approach of R&D and innovation, and they are beginning to experience some measure of economic growth.

For health, it has to be shown that R&D is not just for discovery but for wealth creation. Innovation has to take into account the different fields of human endeavour and not just any singular discipline in order to succeed. The countries of the north see the cost of innovation as not just a cost but an investment for economic growth.

Some activities and behaviours associated with innovation include:

Experimentation

Research and development

– The EU Lisbon Strategy has set as a goal that their average expenditure on R&D should be 3 % of GNP

Entrepreneurship

Risk taking

Persistence

Managing innovation is often complex and reasons for innovation failure are:

External causes

Idea proven invalid or unworkable

Change (reduction) in demand and need for the innovation and/or inability to obtain resources for development

Superior (competing) innovation developed

Internal causes include poor

Organisation and leadership

Goal definition

Participation in teams

Monitoring of results

Knowledge management

Common to both — poor communication

Some observations

Organisation and management can be as important as the idea
Organisational structures can in themselves be innovative
Borrow from others what works well and adapt it to your needs
ANDI concept can lead to innovation ‘potentially’

Some strategic considerations or questions for ANDI are:

Why ANDI now?

What ‘cost-effective’ practices can be used?

Are there opportunities for African innovation to be competitive?

Why ANDI now? Environmental considerations.

There is a new international movement for the initiative through frequent meetings on R&D and innovation. Hence there is a growing international and governmental interest e.g.

There is a growing recognition that capacity for innovation is a pre-requisite for sustainable economic development

The capacity and critical mass for R & D is now present in many countries to provide a platform for innovation to move forward.

Cost consideration: some proven practices with low start-up costs are

Public-private partnerships

Virtual product discovery and development

Venture capital support for biotech start-ups

Technology transfer

Networks — through network, you can access ’scarce’ expertise and build capacities as well as utilise new information technologies. Hence there is no need for reinventing the will.

Opportunities –- There are opportunities that could help drive innovation in Africa and make African R&D and innovation competitive. For example:

New technologies allow for innovative organizations and networking, e.g. mobile phones; internet.

The fact that there are different regional disease burdens and needs of users of innovations. Africans are better placed to develop appropriate tools for African innovation.

Markets that are small in the context of developed countries could be meaningful in developing countries.

Indigenous knowledge is available and may be useful.

NOTES

1. Africa could skip a generation of innovation methodologies by building upon networks as they did in communication technology.
2. Regional variation in disease burden calls for regionally driven solutions.
3. Leading causes of death in Africa are infectious diseases, which account for about 60%.
4. There is a vast array of literature on networking for ANDI to take advantage of and break the cycle of poverty and diseases.
5. There is the need for leadership in quality management of research, network and training at the national, institutional and individual level.
6. ANDI provides an opportunity to:

– Address regional poverty — associated health issues through innovation
– Build regional capabilities critical for economic development through network

Abuja, Nigeria — African-based researchers and institutions have the capacity to develop new drugs and diagnostic tools for diseases affecting Africans, but are hampered by a lack of coordination and funding to the continent. At the conclusion of the first meeting of the new African Network for Drugs and Diagnostics Innovation (ANDI) in Abuja, Nigeria, participants from 21 countries committed to a network approach to increase the ability of African countries to bring forward new medicines and diagnostics.

The Vice-President of Nigeria, Dr. Goodluck Jonathan, stated that “Nigeria is in full support for ANDI. We understand the pivotal role of R&D to national development”. Nigeria’s minister of health, the chair of the Nigerian senate committee for health, and the minister of state for the federal capital territory of Nigeria, attended.

Communicable diseases such as tuberculosis, HIV and malaria account for about 60% of the mortality and morbidity in Africa. There are pockets of product discovery and development activities in Africa, but no one African country or institution has demonstrated the capacity to move from basic research to the commercialization of a new drug.

His Excellency Tom Mboya-Okeyo, Ambassador of Kenya in Geneva, who led the concluding session, said, “ANDI is a valuable niche in the global strategy”. He was referring to the efforts by the World Health Organization to develop a plan to increase R&D and intellectual property management across the globe.

A new study mapping the R&D capacity and gaps was released at the meeting. Conducted by the Special Programme for Research and Training in Tropical Diseases (TDR), in collaboration with African institutions, it concluded that there is enough capacity on the continent to build from, with significant potential for increasing the number and quality of new tools developed, as well as providing economic development to the countries. It also highlighted the need for a systematic evaluation and validation of the biological activities of traditional medicines.

This initial report of the 4 UN organizations sponsoring TDR (UNICEF, UNDP, the World Bank and WHO), along with the commitment from the African countries, will be used to build support and collaboration with health experts, high level national officials, business leaders, international organizations, donors and policy makers. The goal is to develop locally sustainable health research and development, coordinated through an African-based and led organization. TDR Director Robert Ridley said, “ANDI will help connect people and give African scientists the opportunities to lead and manage this research and development. We believe that this approach will lead to long-term sustainability and success”.

The full report and more detailed coverage on the meeting is available online at www.who.int/tdr/svc/research/lead-discovery-drugs.

1. ANDi Health Innovation for Development. Nwaka, Solomon - WHO-TDR, Geneva, SWITZERLAND

2. Innovation: Challenges and Opportunities for its Delivery. Ridley, Robert - Director, WHO-TDR, Geneva, SWITZERLAND

3. The Global Strategy on Public Health, Innovation and Intellectual Property. Renganathan, Elil - WHO, Geneva, SWITZERLAND

4. Theodor Bilharz Research Institute Research & Development. Botros, Sanaa - Theodor Bilharz Research Institute, Cairo, EGYPT

5. IP and benefit-sharing arrangements in the development of drugs based on traditional knowledge. von der Ropp, Anja - World Intellectual Property Organization, Geneva, SWITZERLAND

6. Discovery of An Orally Active Antimalarial Lead through a WHO/TDR Network of Partnerships. Chibale, Kelly - Dept of Chemistry & Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, SOUTH AFRICA

7. Antiretroviral efficacy, tolerability and safety of irab in the treatment of HIV infection. Chijioke, Chioli - Dept of pharmacology & Therapeutics, College of Medicine, University of Nigeria Teaching Hospital, Enugu State, NIGERIA

8. Research and Development of Phytopharmaceuticals at the National Institute for Pharmaceutical Research and Development. Inyang, Uford - National Institute for Pharmaceutical Research and Development, Abuja, NIGERIA

9. Developing Herbal Medicines and New Chemical Entities from African Traditional Medicines: Applying new technologies to ancient knowledge. Meoni, Paolo - Council for Scientific and Industrial Development, Pretoria, SOUTH AFRICA

10. Plants-based drug discovery in Madagascar: Achievements, challenges and new directions. Rasoanaivo, Philippe - Institut Malgache de Recherches Appliquees, MADAGASCAR

11. Research & Development Innovation in East Africa: The case of Kenya Medical Research Institute. Ronoh, Wesley - Office of Marketing, IP and Technology Transfer, Kenya Medical Research Institute, Nairobi, KENYA

12. Opportunities for Diagnostics and Entrepreneurship: US and Africa. Sia, Samuel - Columbia University, New York, USA
13. Compounding Factors to Collaborative Product Research and Development in Africa. Walubo Andrew & GM Matsabisa - University of the Free State, Cape Town, SOUTH AFRICA