Plenary Session 1: Moderators: Robert Ridley/Anthony Mbewu

Presentation of the Strategic Business Plan

Anthony Mbewu welcomed Zimbabwe deputy Minister for health Tendai Mombeshora who acknowledged the partnership with WHO to accomplish quite a lot in health related issues such as HIV care, appreciated ANDI as an initiative and pledged financial and political support of his government to ANDI.

Dr Pascal Mocumbi, EDCTP high representative heralded the role of the EDCTP, with its four regional Networks of excellence ready to work with the capacity that ANDI will be developing.

Ambassador Tom Mboya, Chair of the ANDI Task Force made an introductory presentation of the Strategic and Business Plan (SBP) to ANDI Stakeholders and called on the members of the ANDI task force that helped to develop the ANDI SBP to do self introductions. The objectives of the second ANDI meeting were presented and the active participation of all participants was sought to critically review the SBP and bring up any concerns before the SBP is adopted - paving the way for its implementation. Regional mobilization plans to get all the political leaders involved in the ANDI agenda, based on the adopted SBP was announced. He elaborated on the wide nature of the consultations that were involved in the elaboration of this SBP with emphasis on the IPR mechanism laid down by ANDI in this SBP. The issue of advocacy was highlighted to ensure proper transfer of ownership of ANDI and recommended that the SBP be widely distributed to the whole African family interested in addressing the health inequalities that exist in Africa. He brought up issues like the high infant mortality rates and reduced life expectancy in Africa to elaborate on the cases of inequalities in Africa (mboya_andi-meeting-objectives.pdf).

Dr. Tshinko Ilunga, Vice-Chair, ANDI Task Force, presented an update of the ANDI Task Force activities (Post-Abuja), summarized the TOR of the Task Force and potential areas of focus from the activities carried out so far since the creation of this ANDI Task force in Dec 2008 (tshinko_task-force-report_cape-town.pdf).

Dr. Precious Matsoso, WHO/PHI presented the Global Strategy and Plan of Action and the potential engagements with ANDI. A background of the task of the global strategy and plan of action in WHO was presented, and links with the ANDI roadmap was established. Four questions that brought about the creation of the global strategy and plan of action on public health innovation and intellectual property were put up as well as the eight key elements of the May 2008 resolution WHA 61.21 that highlighted the important role of ANDI as another landmark. The ANDI family was called upon not to limit funding mobilization to government but to expand to seek social contract with the private sector, trying to tap from their corporate social responsibilities (matsoso_phi.pdf).

Dr. Solomon Nwaka, WHO/TDR provided an overview of the ANDI SBP (which included the following points) nwaka_sbp.pdf:

 

• Presentation of the ANDI Strategy
• Presentation of the Business Plan (SBP)
• Scope of work
• Organizational Structure
• Implementation Plan

Q&A for Clarification

 

Diaspora (USA): In view of the estimated $1 billion required to bring a drug to market what mechanisms will ANDI put in place to make interventions affordable?

ANDI is clearly aware of this high cost and will engage in cost effective emerging and innovative mechanisms to identify leads so that the cost of the final interventions are affordable for the low income people of Africa.

ISHReCA: Endowment funds could pose particular problems to African governments, the majority of which have a record for failing to maintain contributions.

How will the ANDI fund be any different?

The Task Force will continually remind governments to honour their engagements concerning ANDI and their pledged support.

University of Jos, Nigeria: Can the Task Force assist in identifying country specific plans so that researchers take these priority areas to policy makers. In relation to fundraising - how do we ensure development partners earmark a percentage of their budgets for funds to R&D.

Proper coordination of the regional hubs would be essential and central to understand specific regional needs and potential engagement strategy with countries. However, projects will be highly competitive and specific interest projects will be followed very closely.

CSIR: We have the knowledge, the scientific competence and good will, when will ANDI project funding be available?

After adoption of the SBP the implementation will begin immediately.

Roundtable Discussion Focusing on Technical Aspects and how to Implement the Strategic Business Plan

Introduction: Ambassador Tom Mboya made reference to the draft resolution as capturing the spirit of the ANDI strategy and business plan and encouraged participants to study it. Ambassador Mboya also encouraged participants to study the Global Strategy and Plan of Action and its links with ANDI.

Contributions and questions from Participants:

1. The need to ensure that diagnostics are not relegated in favour of drugs during the project selection process was highlighted by participants from Nigeria and Sudan. Dr. Ridley suggested two possible ways of selecting projects; being disease specific or being open and flexible. It is likely that ANDI will pursue an open approach at present so the quality of projects proposed will determine the research that is conducted. However ANDI will ensure that projects that focus on diagnostics are not neglected. Dr. Ochem reminded the gathering that although in the name ANDI drugs are mentioned before diagnostics, it should not in any way be misconstrued to suggest diagnostics were secondary to drugs.
2. A participant from the diaspora was concerned about how the STAC would be formed and how the review process was going to be handled. Dr. Nwaka made reference to page 34 of the SBP. He intimated that measures had been put in place to ensure the transparency of the review process and that well established processes and procedures would be adopted by the board.
3. The issue of already existing strong networks in Africa attracting partnerships from the North and increasing capacity but having financial problems, was raised by a participant from the National Institute of Medical Research in Tanzania. It was suggested that ANDI consider the integration/involvement of already existing networks into the structure of the proposed regional hubs. Dr. Inyang reminded participants that ANDI was not going to compete with already existing networks. The mapping exercise conducted by ANDI last year demonstrated existing capacity but very little coordination or inter-country collaboration. ANDI will synergize existing efforts to create health products.
4. Prof. Addae-Mensah from Ghana cautioned participants not to allow “this unstoppable Tsunami” to turn around and destroy us. He mentioned the existing poor record that African governments have in making promises and failing and encouraged all participants to be advocates for ANDI in their respective countries. Dr. Ilunga of the African Development Bank reinforced the need for all to serve as ambassadors of ANDI in their countries.
5. A participant from the Kenya Medical Research Institute encouraged ANDI to address potential challenges that might result regarding intellectual property and to ensure that Africa does not lose out. Dr. Nwaka indicated that the second mapping which is incorporated into the SBP, took IP issues into consideration and involved WIPO and the WTO (who will also be providing funding). Reference was made to pages 35 and 36 of the SBP which discuss IP issues.
6. A participant from Sudan suggested that an action plan model of operation developed by experts on specific diseases (such as is done by the European COST initiative) could be adopted by ANDI. Dr. Ridley agreed that this was a good idea which could be implemented later in the life of ANDI. This is also dependent on the funds that will be available for research into specific diseases.
7. Concerns about the potential for neglect of basic research and focusing on compound screening were raised by a participant from NIPRD.  An enquiry was also made into how ANDI would create opportunities for PhDs and Post Docs. Prof. Mbewu made reference to page 25 of the SBP in response and said ANDI would leverage local knowledge on the use of Africa’s rich biodiversity with traditional medicines being a particular strength. Capacity building will be in 3 forms. In specific projects; specific platforms; and mapping and interaction with already existing capacity building projects in order to avoid duplication of efforts. Africans in the diaspora will also be able to contribute to the building of capacity.
8. A participant from the diaspora based in Florida, USA inquired on the criteria for success with which ANDI will be measured and also mentioned the need to address the building of skills and human resource. Dr. Bostros indicated that capacity building will be an integral part of ANDI. Dr. Nwaka made reference to page 54 of the SBP which makes mention of the process of transitioning from one point to another including the termination of projects that might not carry much future value which would in itself be an indication of good work. Other indicators for success suggested by participants included an ANDI peer reviewed journal, publications and patents, and eventual improvement in morbidity and mortality from both communicable and non communicable diseases in Africa. A contributor from the TB Alliance mentioned ANDI’s ability to create a detailed portfolio of drugs and diagnostics as a measure of success.
9. Concerns were raised by a participant from Nigeria about how much the African Union has been brought in to the picture regarding ANDI; considering they have a crucial role to play. Dr. Ochem mentioned that the AU is involved in ANDI by default and re-emphasised the crucial role they have to play. He also reiterated the need to keep pressing home requests for support from African governments.
10. A representative from the European Union stressed the need to identify bottle necks in the entire process running from identification of projects to the development and marketing of drugs and diagnostics. He also mentioned the importance of identifying the innovative aspects of projects that are to be funded given that ANDI is to support innovation. ANDI’s ability to utilize already existing funding mechanisms will also be very important.
11. A representative from the African Development Bank noted ANDI’s heavy reliance on the proposed 600 million dollar endowment fund for success. He stressed the need for more detail on how the creation of this endowment fund will be achieved. Dr. Ridley mentioned the existence of potential one-time donors and annual/periodic donors and emphasized the creation of the endowment fund as being critical to the sustainability of ANDI.
12. The need to address safety of bio-resources in Africa (including genetic) was raised by a participant from Nigeria in addition to the need for harmonization of efforts and not to limit work on a particular project to a particular country.
13. Participants from Nigeria reminded the gathering of the desire of the African people to see the products we claim to be developing on the shelves as well as the need for ANDI to collaborate with NGOs. The need for ANDI to support participants in approaching their governments for support was also raised. Drs. Ochem and Ilunga supported the call for ANDI to focus on putting products on the shelf and indicated that NGOs have been considered and have a place on the ANDI board since they can be instrumental in making the products that are developed available to the people.
14. A participant from Cameroon inquired on how good projects with poor proposals could be identified and helped. Drs. Nwaka and Ridley indicated that best practice would be followed and support offered for good ideas to be presented in good proposals.

Conclusion: Ambassador Tom Mboya proposed the adoption or otherwise of the SBP by the participants of the 2^nd ANDI stakeholders meeting by popular assent, to which a resounding “aye” was heard in response.

Plenary Session 2: Moderator: Dr. Tshinko Ilunga

Institutional Presentations – R&D Case Studies

Health Product R&D in South Africa and at the MRC: Prof. Anthony Mbewu

Presented an introduction of the health research landscape of the Republic of South Africa with the involvement of about 0.95% of the national GDP spent in research with about half of the actual research spending coming from international funding agencies like the NIH and the Wellcome Trust. An overview of the MRC was presented with key performance indicators like a novel vaccine candidate under phase I trial in the USA and Republic of South Africa and an anti TB drug under development in collaboration with Johnson and Johnson (mbewu.pdf).

Questions:

WHO-AFRO: There is currently a lot of capacity in the Republic of South Africa, how is the Republic of South Africa engaging with other countries in the sub region to develop national priorities?

ICGEB: How would ANDI guarantee continental mobilization of personnel? ANDI intends to engage regional hubs to transform “brain drain” to become “brain gain” within the regions. Databases of human resources personnel would be developed to facilitate networking and build science culture within scientists geared towards improving the quality of life of our people.

Walter Sisulu University RSA: Could ANDI benefit for the MRC’s strategy of engaging weaker institutions with stronger ones within the MRC? Research units within post conflict regions are engaged into programs to bring them up to speed. The EU model could be copied by the AU to fund research.

U Buea: With all the money involved in RSA health research funding, that there are no products on the shelves is quite frightening and discouraging to other African countries, what are the spin off companies marketing? Products have not come to the market because of the general lag in health research due to lack of interest at the later stages of the chain. References will be provide to show how much funding has been provided by the private sector. PPP should be an active part in the implementation of the ANDI SBP to get these private partners to come on board.

Product R&D in East Africa, Kenya and KEMRI: Dr. Jennifer Orwa

Presented the mandate of the KEMRI and main research areas. Though no lead compounds have been developed, traditional medicines for malaria are under development. No patent developed but researchers are called to collaborate more while their IP rights are protected. A herbal preparation for Herpes simplex virus is under development. There are quite a lot of challenges for which the KEMRI is looking up to ANDI for strengthening to further develop the unique opportunities the KEMRI offers.

Such as provision of funds for traditional medicine product development, and support for the different stages of the development of products within the KEMRI and establish synergy with the rest of Kenya (mpoke.pdf).

Questions:

Promising herbal preparation for HSP with whole extract, what is the normal way to proceed to the use of this extract in humans?

KEMRI does separations and follows the standardization process. Studies are just to confirm the merits of the traditional medicines. Compounds are developed to be used as markers for laboratory testing.

Addis Ababa University, Ethiopia: in collaboration with DNDI what challenges for leishmaniasis trial in KEMRI. Based on the request from ANDI these questions have been raised not because of much expectation from ANDI but as sign of a home work well done.

NIPRD: How will the existence of ANDI guarantee success of an initiative such as KAVI?

Social scientists and marketers should be in research institutes to be more aggressive.

Collaboration is very difficult within researchers and ANDI should help to forge much collaboration so that ANDI does not fall short of expectations.

How are standards in KEMRI formulated? How can ANDI incorporate standards?

ANDI will engage in best quality standards and practices. Work with WHO and NEPAD to harmonize and set up regulatory agencies for drugs together with partners such as DNDI, NEPAD and the Gates foundation.

R&D Case studies Egypt and North Africa: Prof Maged Al-Sherbiny

With the belief that science and technology is important, harmonizing with the different groups and ministries involved is important.

A newly created Higher Council for Science and Technology composed of 9 ministries chaired by the Prime minister coordinates all research in Egypt. Sets the priorities and structures that are needed for the country’s research as well as remove the barriers for researchers to have their job to be done. A science and development fund ensures that there is funding for research. The Higher Council coordinates the over 360 research centers in Egypt.

With all the technology in Egypt, the country is willing to work carefully with ANDI. Hepatitis C, identified as a priority in Egypt brought about the call from the EU specifically for Hepatitis C. SESAME success was presented as a potential model for ANDI. Challenges include lack of sustained funding, coordination trust in own capacity, module, unorganized access to traditional medicine products. Proposals for how these challenges could be addressed were made and key future directions were provided based on specific country needs (al_sherbiny.pdf).

Questions:

What is the level of resistance to praziquantel . No evidence of praziquantel and Ivermectin resistance, however there is potential for resistance to both drugs.

Hepasa developed in Cameroon and another product developed in Tanzania could be explored by Egypt in collaboration since the burden of hepatitis C is huge and Egypt is very willing to do so.

Drug Discovery in West Africa: The NIPRD Experience: Prof Uford Inyang

Reiterated the poor coordination of R&D within West Africa and poor advocacy for research results. Potential development of home made artemisinin based drugs utilizing extracts from plants grown in Nigeria. Main challenge is power supply and finite resources in R&D with heavy dependency on external funding (inyang.pdf).

Questions: 

National Biotechnology agency, Nigeria: Diagnostics were left out in the presentation and called on ANDI to engage in diagnostics, prevention and drugs.

ISHReCA: Publications in local journals should be encouraged and evaluation of scientist who engage in networking instead of knowledge generation should be encouraged so that more researchers would be willing to engage in this part of science. Mechanisms to position pharmaceutical products and the improvement of the  poor participation of industry in phyto products that will result from ANDI efforts would be enhanced.

NIPRD is collaborating with agronomists to find the most appropriate area in Nigeria to cultivate Artemisia annua. Intellectual Property should be paid attention to when dealing with external collaborators.

Biotechnology in South Africa (Department of Science & Technology). Dr. Theresa Smit:

The National biotechnology strategy was presented with the various institutions involved.

Genetic DNA technology to test phytocompounds is available in RSA. RSA is using genetically modified plants.

Training is needed in areas where capacity is needed. Researchers in RSA are in most parts of Africa and more interaction and engagement is going on with other countries. Biosafety and benefit sharing act is under development (smit.pdf).

Plenary Session 3: Moderator: Prof. Anthony Mbewu

Presentation of the strategic and business plan to African Ministers and Round table discussion focusing on political aspects and how to implement the SBP

Introduction: Dr. Solomon Nwaka presented a brief summary of the SBP to the four ministers gathered.

Short Comments from the Ministers gathered:

Assistant Deputy Minister for Science and Higher Education, Egypt:

• All must work with the vision of ANDI being established in the next year. AMCOST can provide political coverage for ANDI activities.
• ANDI needs to attract the interest of the relevant ministries in African countries.
• The issues surrounding ANDI’s legal status should be looked at closely and addressed.
• Financing: Proposed starting with small fees/levies from countries and later soliciting for monies from donor agencies before moving to the endowment fund.

Minister for Science and Technology, Zambia:

• ANDI is ambitions and needs to be followed expeditiously.
• Need to engage political leadership.
• Science and research is often neglected because of its inherent inability to produce short term results that generate popular support translating into votes.
• Regional blocks e.g. SADEC, ECOWAS, COMESA, OCEAC to appreciate what ANDI is trying to do. Also include the AU in all discussions.
• Appreciated problems of research and science when he was moved to Science and technology ministry.

Minister of State for Health, Uganda:

• Very impressed and will take story of ANDI to Uganda.
• Gave example of the Ugandan President having supported research and innovation by funding a local scientist to extract a molluscicide from a local plant.
• Many resolutions have been signed in the past but little follow-up.
• Africa must adopt a do-it-yourself attitude to certain problems that are unique to the continent.
• Encouraged “any politician worth his name” to take up the mantle and push ANDI.
• Encouraged African governments to take the lead in financing ANDI.
• Suggested ministers of health, technology and finance to meet and discuss these issues especially to harmonize thinking and allow for the release of funds.

Deputy Minister of Health, Zimbabwe:

• Pointed out that every country seems to have some R&D going on, this underlines a fundamental appreciation of the importance of research in Africa.
• Decisions are normally taken by cabinet and thus role of ANDI must be clearly defined to them.
• Advocated for greater inter-ministry communication in country to foster support for ANDI.
• Need to convince universities, NGOs etc so they are aware of the ANDI SBP.
• ANDI to be adopted at the regional level (SADEC, ECOWAS, COMESA) and to be adopted at country level by parliament.
• Need to improve links between researchers and traditional medicine practitioners and ensure that IP is protected.

Comments from participants:

• CSIR, South Africa: More than just money required, but need for peaceful and stable environments to work.
• Olabisi Onabanjo University, Nigeria: ANDI to serve as an annual forum for scientists to voice their concerns and to share ideas.
• WHO representative, South Africa: Need for people in-country to appreciate the importance of research and so be empowered to demand R&D for health just as they do roads etc.
• University of Nigeria: Need for ANDI to acquire political clout through the AU in order to mandate the politicians to act in support of ANDI and health R&D in general.
• NIPRD, Nigeria: Need to have pressure groups to influence politicians such as the American Association for the Advancement of Science.
• TBRI, Egypt: The need to work ANDI into the already existing meetings for ministers of health/science.
• NIPRD, Nigeria: Need to have African governments making contributions to enhance a sense of African ownership.
• TBRI, Egypt: To have the ministers present to serve as advocates in their various regions by providing them with advocacy letters to be written by the Task Force.
• Diaspora: To get the ministers and politicians to view the issues to be addressed by ANDI as national security issues.

Conclusion: Prof. Mbewu closed the day’s session and commended the gathering on their enthusiasm and contribution to the discussions

Rapporteurs: Foluke Fakorede, Palmer Netongo and John Amuasi