1. Industry: trends, concerns hopes and ideas VICH5 Conference Carel du Marchie Sarvaas, Executive Director October 2015

2. 2 Global representative body of companies and associations R&D, manufacturing and commercialisation Veterinary medicines, vaccines and other animal health products HealthforAnimals was formerly known as IFAH Animal health companies provide value to society: by protecting animals and humans from diseases our products help keep pets and food-producing animals healthy public health benefits we bring include: safer and more secure food supplies more efficient production for increased food supply improved sustainability prevention of the transmission of zoonotic diseases HealthforAnimals VICH5, Tokyo

3. 3 NORTH AMERICA Canada Mexico United States EUROPE and AFRICA Europe Belgium Denmark France Germany Ireland Italy Netherlands Portugal Spain Sweden Switzerland United Kingdom South Africa CENTRAL/SOUTH AMERICA Argentina Brazil Chile Paraguay ASIA/PACIFIC India Australia Indonesia Japan Korea New Zealand South-East Asia Thailand 80+% global animal health sector Top 10 global companies 29 Regional associations The associations also represent hundreds of medium-sized and smaller companies. HealthforAnimals members

4. 4 1.Growing demand for food, changing diets, changing production systems 2.Increasing trade of food = emerging and re-emerging diseases 3.Increasing animal-health and food-safety awareness/standards 4.Increase in vector-borne diseases, climate change 5.Increasing importance of science for productivity increases 6.Increasing number of companion animals Global trends HealthforAnimals VICH5, Tokyo

5. 5 1.More products requiring regulatory assessment 2.More countries putting in place regulatory systems 3.Resource pressure on national regulatory authorities (budget, HR) 4.Increased post-approval surveillance impacting authorities’ resources 5.More willingness for international cooperation 6.Tendency to treat human and veterinary medicines the same - ignoring differences in terms of product requirements and use conditions Regulatory trends HealthforAnimals VICH5, Tokyo

6. 6 Authorisations: time, cost, complexity increase in time and cost to bring products to market increased complexity of regulatory processes need for protection of propriety data consequence: need for global markets = need for harmonisation Challenges with acceptance of new technologies getting approval for new tools - genetics, vaccines, anti-parasitics, biotech lack of expertise with regulators consequence: no harmonisation in requirements = barriers for innovation, availability Responsible use of antibiotics some using irresponsibly - resistance management programmes essential some countries limitations leading to increases in diseases industry position: transparency of use and promotion of responsible use Trade opportunities trade of some products limited = non-scientific, politicised rationales used consequence: less food products traded = impact on prices, availability Concerns HealthforAnimals VICH5, Tokyo

7. 7 1.Global regulatory convergence (e.g. VICH Outreach Forum) 2.Increasing recognition and adoption of VICH guidelines worldwide 3.Regulatory network, sharing best practice (e.g. regulators training regulators) 4.Deepening regional cooperation (ASEAN, West-Africa, East Africa, LATAM) 5.Apply proven successful best practices: innovation fast-track (Brazil) research input tax credits = driver for innovation (Australia) low risk products programme (Canada) joint reviews (Canada-US) consistency and legally set timelines (EU) major positive regulatory reforms (e.g. Japan since 2012) Hopes and ideas HealthforAnimals VICH5, Tokyo

8. 8 Global Benchmarking Survey (GBS) Competitiveness of the animal health industry launch of 5 th GBS in January 2015 (1996, 2001, 2006, 2011, 2015) USA, EU, Japan, China, Brazil, Australia, Canada, 7 national reports + 1 global comparative report -------------------------------------------------------------------------------------------------------- HealthforAnimals VICH5, Tokyo 168 Avenue de Tervueren,1150 Brussels, Belgium carel@healthforanimals.org www.healthforanimals.org twitter! @health4animals twitter! @health4animals

9. 9 www.healthforanimals.org 168 Avenue de Tervueren 1150 Brussels, Belgium carel@healthforanimals.org www.healthforanimals.org twitter! @health4animals twitter! @health4animals