Emerging diseases: Preparedness and implementation issues Lyon, France 5 - 8 November 2006 Biological crisis management in human and veterinary medicine – new medicines for animals – a growing global need Comments (with copyright) / Commentaires (soumis au Copyright) : Gideon Brückner Scientific and Technical Department

Established in 1924 – fear of animal pandemic in Europe - rinderpest Intergovernmental organisation – not UN based Five permanent Regional Representations: Bamako, Buenos Aires, Tokyo, Sofia and Beirut Two Sub-regional Offices: Bangkok, Gaborone Five Regional Commissions: Africa, America, Asia-Pacific, Europe and Middle East 167 Member Countries ( 2006)

OIE Objectives World zoosanitary information International solidarity in control of animal diseases Health standards for international trade Provide a better guarantee of the safety of food of animal origin Improve animal health worldwide Go through OIE objectives that are related to the subject of this conference Guarantee the transparancy of the world zoosanitary information To encourage international solidarity in the control of animal diseases : avian influenza does not need a passport To provide healt standards for international trade: to give the CVO’ s recommendations on the trade of animals and animal products in case of an outbreak of one of the listed diseases. This will provide unjustified trade barriers, lead to fairer trade and is of benefit for the developing countries. Provide a better guarantee of the safety of food of animal origin.

Why are we worried about the prevention and control of major animal diseases and zoonosis?

OIE-list of diseases – criteria for listing acknowledge increased importance of human/animal pathogen interface Basic Criteria (always considering “worst case” scenario) Parameters (at least one “yes” answer means that the criterion has been met) International Spread Has international spread been proven on three or more occasions? OR Are more than three countries with populations of susceptible animals free of the disease or facing impending freedom (based on Code provisions, especially Article 3.8.1)? OR Do OIE annual reports indicate that a significant number of countries with susceptible populations have reported absence of the disease for several consecutive years? Significant Spread within Naïve Populations Does the disease exhibit significant mortality at the level of a country or compartment? AND/OR Does the disease exhibit significant morbidity at the level of a country or compartment? Zoonotic Potential Has transmission to humans been proven? (with the exception of artificial circumstances) AND Is human infection associated with severe consequences? (death or prolonged illness) Emerging Diseases (A newly recognised pathogen or known pathogen behaving differently) Is there rapid spread with morbidity/mortality and/or apparent zoonotic properties?

Zoonotic potential of animal pathogens 60% of human pathogens are zoonotic 80% of animal pathogens are multi-host 75% of emerging diseases are zoonotic 80% of agents having a potential bioterrorist use are zoonotic pathogens Nearly all new human diseases originate from animal reservoirs Diseases can now spread faster across the world than the average incubation period of most diseases

(L. King, 2005)

Factors of Emergence and Re-Emergence (L. King, 2005)

General classification of threats related to animal diseases Animal to animal transmission Direct economic impact – agroterrorism Diseases exotic to country Diseases eradicated at high cost Diseases with specific vaccines needed for control Animal to human transmission Diseases with pandemic potential Diseases with high/sudden human mortality Diseases with slow but progressive human illness/mortality Rinderpest

Most common causes of infection Incidental (‘Normal’/expected) External (Uncontrolled/difficult to control) Wild animals, migratory birds Ilegal trade Deliberate spread - Agroterrorism

Minimize threat of emerging animal diseases Early warning Early detection Rapid diagnosis Rapid response Rapid disease containment - vaccination

New Medicines: Global Perspective Global public good to address major animal diseases worldwide: Importance of livestock to developing countries Dual need – protect human/animal health and ensure food security Mandate and obligation of veterinary profession to create immune buffer between human and the animal source of disease – must control disease at animal source Animal diseases have direct and major impacts on food security and poverty alleviation PVS initiative in collaboration with World Bank and other donours ( USA, Canada, Australia, UK, EC) to assist developing and in-transit countries to move towards compliance with OIE standards for disease control

Scenario of total consumption of Livestock products Here you can see in a graph the expected increase in livestock products. Ofcourse there are different scenario’s but all models show a strong increase in the consumption of livestock products.

Trends in growth of global livestock sector Strong increase in global numbers of animals Regional differences in increase of beef, pork and poultry production based on cultural, religious or nutritional preferences Differences between developing and developed countries Strong increase of industrial livestock farming systems Strong increase in consumption will obviously lead to an increase in the numbers of livestock and with the global trade the increase in livestock numbers is mainly expected in the developing countries. All models ofcourse differ slightly but they all predict a strong rise in the numbers of animals Big differences in the different regions, in India more pork and chicken than beef and in Muslim countries an increase in chicken and beef. Many countries worldwide have high numbers of backyard farming, up to 98 % in african countries and for example central asian countries like Afganistan and Kirgistan but with the increase of numbers of livestock it is predicted that the industrial farming also increases which may lead to a difference in disease problems Some practices and by-products of livestock production harm people as we can see for example in the current AI crisis. All people that have got infected so far were in very close intensive contact with poultry, two cases in vietnam of drinking raw duck blood and the cases in Azerbeijdjan because of collecting feathers from infected wild birds. The increase of the global livestock population and the intensification of the holding of the animals may also lead to more emerging zoonotic diseases. Cultural practices may also lead to human infections of animal diseases.

Veterinary Vaccine Market Market is as big as human market - but much more diverse (160 versus 30 vaccines) Market is heterogenous Countries Species conditions R&D costs increased over the years We all know the stories of the use of material from infected animals to vaccinate healthy animals. With the increased knowledge on the infectious agents, receptors, immunology etc and the introduction of the biotechnology and the genomics we have been able move from trial and error to rationale vaccine development The market is very big but more divers as we deal with more animal species and more disesases for which we vaccinate. This market will certainly grow due to the developments in the livestock sector but I did not even talk about the pet animals, a market that is also still growing. The market is very heterogenous in the different countries, dependent on the species, the incomes, the pet animals, the disease situation in that country, political aspects etc In some countries the logistical aspects are still very difficult…storage and transport of vaccines is not always easy.

Vaccine sales per region 30 25 20 15 10 5 Here you can see that the market will grow very much in the regions where the increase of the livestock is expected, Asia, Latin America and also East Europe. The increase in livestock population is not so much expected at this moment in Africa but when incomes would increase there there will also be a growth in the numbers of vaccines sold North West Far East Latin East Rest of America Europe America Europe world

A survey of Vaccines for listed diseases in OIE member Countries Variety of vaccines for FMD, CSF, NDV, bacterial diseases Limited number of vaccines for AHS, Bluetongue, CBPP, HPAI, LSD, PPR, RVF, RP, S/G Pox, SVD and VD An outbreak of any of these diseases will have very serious consequences Increased need for inactivated vs attenuated vaccines

International standards, guidelines and recommendations Terrestrial Animal Health Code Aquatic Animal Health Code Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Manual of Diagnostic Tests for Aquatic Animals

What is International Public Good? Animal health Veterinary Services Animal Disease Zoonosis Human health Poverty Food security Lack of trade

Where does vaccination fit in? Animal health Vaccination Creating the buffer Animal Disease Zoonosis Human health Poverty Food security Lack of trade

Time & financial constraints What does the OIE accept and acknowledge about the current situation relative to needs? Restraints of pharmaceutical industry (pressure, fear of exposure, demands) Time & financial constraints Increased public sensitivity on human/animal pathogen interface -> demands on vaccine manufacturers Changes in policy on disease control strategies and effect of that on vaccine industry – e.g. vaccination vs mass culling; need for marker vaccines Needs and constraints of developing countries Food chain sensitivity

Realisation of the OIE on some general barriers in vaccine, pharmaceuticals and diagnostic development More basic research necessary to be innovative Non-vaccination policy in Europe Development of new medicines is very expensive Maintenance of patent rights Pressure to be ready but without a guaranteed market Return on investment: big market is essential Reluctance in development / use of recombinant medicines

What do we need now - compared to 5 to 10 years ago? – view of OIE Public resistance against mass culling Less sensitivity in trade in animals and animal products on vaccination Need vaccines that would not require a long post-vaccination period before movement Need to distinguish between vaccinated and infected animals Need vaccines that do not require a second booster within short time

What do we need now - compared to 5 to 10 years ago? – view of OIE Need vaccines that can be administered with a reasonable guaranteed immune response in adverse conditions (cold chain friendly vaccines) Need multiple disease combination and multistrain vaccines (AI, BT, FMD, NCD) Need to match vaccine strains with epidemiological need – rapid vaccine development response Need to rapidly introduce new master seed strains Vaccine banks – emergency response

Desired Developments Develop partnerships public – private Networks human animal interface Stimulate innovation (harmonise guidelines for GMO’S) Make new vaccines widely available - also developing countries More basic research: from trial and error to rational vaccine design Build a robust but accommodating regulatory process also with regard to emerging diseases. Further expansion of the current PVS initiative of the OIE to elicit donour support for the evaluation of developing and in-transit countries to identify shortcomings to comply with and maintain OIE standards for disease control

Conclusion … Vaccination will become the choice alternative for disease control – provided the vaccines available do not pose a risk for international spread of disease

Thank you very much! World Organisation for Animal Health 12 rue de Prony 75017 Paris, France Tel: 33 (0)1 44 15 18 88 – Fax: 33 (0)1 42 67 09 87 Email: oie@oie.int http://www.oie.int