Overcoming barriers to the availability of Animal Health products for poor livestock keepers

1. Senegal March 25th – 27th 2008 Steve Sloan CEO GALVmed Overcoming barriers to the availability of Animal Health products for poor livestock keepers

2. A question - What concern is it that poor livestock keepers and animal health pharmaceutical companies have in common?

3. RVF Intervention 2006/7 – Adoption and Acceptance – ILRI 2008 • ..................the uptake of the vaccines provided by the task force was very low; the participants indicated that about 30 % of sheep, 20 % of cattle and 30 % of goats were vaccinated. The reasons given for the low uptake of the vaccines include............. • (ii) lack of pre-vaccination sensitization, so few people were supportive of the program; (iii) side effects leading to mortalities in goats and camels had been observed in the previous vaccinations;............................... • These observations[KRS1]  imply that the success of the interventions provided by the animal and human health delivery systems depends to a large extent on the level of awareness and collaboration received from the livestock owners and other stake-holders in the industry including livestock traders.' • .

4. Barriers to availability of appropriate new products Discovery Research Development Registration Commer- cialisation Sustained Delivery Inconsistent supply Counterfeit products. Lack of patent protection. Poor quality and efficacy. Technical challenges. Lack of appropriate product profiles . Ill-designed proofs-of-concept • Lack of funding for development studies - high risk, • high cost. • Poorly designed, poorly controlled field trials. Lack of market pull-through Poor estimates of need or demand Inappropriate pack-sizes Lack of knowledge or education on proper use • Unclear and varied regulatory requirements. • Lack of QA/QC. • Multiple regulatory authorities.

5. Poor farmers & Animal Health Companies – a shared concern CONFIDENCE For Companies to manufacture and supply and for poor people to adopt

6. GALVmed – The Global Alliance for Livestock Veterinary Medicines A Global Not for Profit established under UK law based in Scotland, we began in November 2005 Following establishment and research phases we have just entered Phase 3 in our development plan – operations Our Mission To make a sustainable difference in the access to medicines by poor livestock keepers (in support of the Millennium Development Goals) To develop, register and launch 4 to 6 vaccine, pharmaceutical or diagnostic products by 2015 that meet the needs of the world’s poorest livestock keepers To work with partner agencies in developing countries to ensure sustainable delivery ( through value chains) of these new products to poor livestock keepers. A passion for and focus on new product delivery

7. GALVmed's role To develop and lead public-private partnerships to break down and overcome the barriers to the sustainable delivery of new AH medicines for poor livestock keepers Technical risks Regulatory risks Financial risks Commercialisation risks Marketing risks Addressing Regulatory risks will require partnerships between AH companies, OIE/FAO/WHO/AU-IBAR, National and International Reg. Auth (EMEA/FDA, PANVAC), private and national vet. agencies and distributors, donors and user groups

8. GALVmed's position on addressing “Confidence” • Confidence is a universal issue, • It begins at the top with a coherent respected and enforced regulatory system • Africa is not alone, there are precedents to build upon • Infrastructure may be an issue but Africa has significant skills, -in our ECF work in Tanzania , Kenya and Uganda, we saw regulatory skills of the highest quality. • Across Africa we observe a debilitating and confidence sapping lack of resources – especially in enforcement • Our programme will support regulation in its observation through our portfolio and by supporting African leadership.

9. Addressing the barriers –in practice ECF-ITM vaccine – creating a robust regulatory dossier (ILRI), defining supply requirements (AU-IBAR, DVS), ensuring robust manufacture and distribution (regional manufacturers and distributors) Thermostable Newcastle Disease vaccine – establishing robust safety and efficacy standards (KARI, Sokaine), agreeing regulatory requirements, identifying manufacture and supply chains Rift Valley Fever vaccines – defining target product profiles, evaluating candidate vaccines, defining regulatory requirements for both an emergency stockpile vaccine for outbreak use and a product for routine use in endemic areas, addressing barriers to farmer adoption Porcine Cystercicosis – evaluating candidate vaccines, defining regional development and regulatory requirements, integrating human and animal components of integrated treatment and control strategy Just the beginning our original portfolio has 13 diseases, there will be more

10. Our focus for the next 3 years Objective 1 Develop data driven decision making tools for socio economic impact and understanding of markets Objective 2 Developing 4 vaccines for 6 animal health diseases critical to poverty reduction Core Objective Leadership, Focus Strategy Partnership Portfolio Development Resourcing Monitoring + Evaluation Objective 3 Addressing Adoption Access Supply, creating value chains, defining sustainability Objective 4 Communicate + network at all levels to gain buy‑in to paradigm change

11. GALVmed – seeking to support systemic strengthening Part of our programme, with the support of our donors, for the next 3 years focuses upon offering support in capacity building to African regulation - under African leadership Rigor, consistency, quality, enforcement The 1st step we believe is to review and assess the baseline and establish the belief that improved systems are possible. Need to focus on Regulation as a Global Issue. e.g. what we can learn from Human Health – Article 58 Harmonising and enabling accelerated registration for pro poor purposes

12. Some questions partners may want to address • What vision do we have for a regulatory system in Africa in say 5 years time? • What should it be achieving? • Who are the critical partners? • What resources will they need and how can we acquire them? • Do we have the will? • Can we afford not to?

13. Thank You Steve Sloan GALVmed www.galvmed.org et en français? sharon.ross@galvmed.org