International Animal Health Industry

Presentation on theme: "International Animal Health Industry"— Presentation transcript:

1 International Animal Health Industry
China 2nd Congress of Veterinary Medicines 第二届中国兽药大会 International Animal Health Industry Overview and Recent challenges 国际动保行业的概况和新近挑战 Barbara Freischem IFAH, Executive Director 国际动保联盟 执行主席 September 2009 2009年9月

2 Presentation overview 演讲概述
About IFAH 国际动保联盟简介 IFAH’s members 国际动保联盟成员 Mission statement 联盟使命 What IFAH does 国际动保联盟做什么 Goals & Objectives 目的和目标 Some Achievements 国际动保联盟的成就 IFAH’s structure 国际动保联盟的结构 Priorities 年的优先事项 International Animal Health Industry overview 国际动保行业概况 Market overview 市场概况 Challenges to industry 行业面临的挑战

3 About IFAH 国际动保联盟简介 International non-profit organisation registered under Belgian law, based in Brussels, Belgium, established in 2002 国际动物保健联盟(简称IFAH)是2002年在比利时注册的非赢利性国际机构，总部位于比利时的布鲁塞尔 The GLOBAL representative body of companies engaged in: 全球代表机构主要从事于： Research 研究 Development 开发 Manufacturing 制造 Commercialization & support 商业化与支持 Represents: 代表： Animal Health companies (11) 家动物保健公司 National/Regional associations (26) 个国家/地区动保协会 Local medium-sized enterprises 本地中型企业 International companies 跨国公司 Veterinary medicines, vaccines and other animal health products 兽药、疫苗和其他动物保健产品

4 Corporate members 合作伙伴
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5 Corporate members 合作伙伴
ALPHARMA 雅来 Bayer Health Care 拜耳 Boehringer Ingelheim 勃林格殷格翰 Elanco 礼来 Intervet Schering-Plough Animal Health 英特威先灵葆雅 Janssen Animal Health 杨森 MERIAL 梅里亚 Novartis Animal Health 诺华 Pfizer 辉瑞 Vetoquinol 威隆（法国） Virbac 维克

6 Member associations 协会会员
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7 Member associations 协会会员
EUROPE 欧洲 Europe 欧洲 IFAH-Europe Belgium 比利时 Pharma.be Denmark 丹麦 VIF France 法国 SIMV Germany 德国 BfT Ireland 爱尔兰 APHA Italy 意大利 AISA Netherlands 荷兰 FIDIN Portugal 葡萄牙 APIFARMA Spain 西班牙 VETERINDUSTRIA Sweden 瑞典 LIF Switzerland 瑞士 SGCI Chemie Pharma Schweiz 瑞士 United Kingdom 英国 NOAH AFRICA非洲 South Africa 南非 SAAHA NORTH AMERICA 北美洲 Canada 加拿大 CAHI Mexico 墨西哥 INFARVET -CANIFARMA United States 美国 AHI CENTRAL & SOUTH AMERICA 中南美洲 Argentina 阿根廷 CAPROVE Brazil 巴西 SINDAN ASIA/PACIFIC 亚洲/太平洋地区 Australia 澳大利亚 The Alliance Indonesia 印度尼西亚 ASOHI Israel 以色列 MAI Japan 日本 JVPA Korea 韩国 KAHPA New Zealand 新西兰 AGCARM South-East Asia 东南亚AAHA 7

8 Mission statement 使命 The mission of IFAH is
to foster a greater understanding of animal health matters and to promote a predictable, science-based regulatory environment that facilitates the supply of innovative and quality animal medicines, vaccines and other animal health products into a competitive market place. These products contribute to the health and welfare of animals and importantly provide a safe food supply for people. The mission of IFAH is to foster a greater understanding of animal health matters and promote a predictable, science-based regulatory environment that facilitates the supply of innovative and quality animal medicines, vaccines and other animal health products into a competitive market place. These products contribute to the health and welfare of animals and importantly provide a safe food supply for people 8 8

9 Mission statement 使命 国际动保联盟的使命是： 1.在全球范围内增进人类对动物保健事业的理解 2.促进科学监管环境的形成，以利于创新型、高品质的动物药品、疫苗及其他动物保健产品进入具有竞争性的市场。 这些产品将有益于动物健康和福利，从而为人类提供安全的食品。

10 IFAHs responsibilities 国际动保联盟的责任
Act as the voice of the industry in dialogue with the major international bodies that have an impact on the animal health industry (FAO, WHO, Codex, OIE, WTO and others); Encourage and assist the development of predictable, science-based regulatory processes and standards; Represent the industry with a unified, global voice in dealings with governments, food industry partners and consumers; Facilitate the international harmonisation of regulatory guidelines governing animal health products.

11 IFAHs responsibilities 国际动保联盟的责任
代表行业发表意见，与主要国际组织对话，如粮农组织，世界卫生组织，食品法典委员会，世界动物卫生组织，世贸组织和其他 鼓励和协助建立可预测的、科学的法规程序和标准 代表行业发表统一的、全面的声音，以处理与各国政府，食品行业的合作伙伴以及消费者的相关事务 促进各国动物保健品管理法规的国际协调与合作。

12 General objectives and goal
To achieve a balanced regulatory and trade framework that fosters innovation while recognising the social and political environment; To encourage constructive dialogue with governments, public policy makers, legislators, regulators, the veterinary profession, the food chain, consumers and other stakeholders; To ensure that the contribution of the animal health industry to health and quality of animal and human life through the advancement of sound science is understood by society at large. 12

13 General objectives and goal 总目标和目的
认可不同的社会和政治制度，创建一个稳定的法规和贸易框架以鼓励创新 旨在同各国政府、国家政策制定机构、立法机构、监管管理机构、兽医行业工作者、产业链中相关行业、消费者和其他利益相关者进行建设性对话 旨在通过向社会大众进行广泛而可靠的科学普及，以保证动物保健行业对人们和动物的生活质量做出突出贡献

14 Recent IFAH achievements
Benchmarking Survey – compelling case for a paradigm shift in dialogue with authorities on impact of regulatory burden Successful global conference – November 2007 FAO world food summit presentation in 2008 Strengthened relationship with OIE (new agreement in 2007); input to: Vaccination guidelines – AI(Avian Influenza), BTV(Bluetongue virus). International standards on antimicrobial resistance Booklet - ‘Human Pharmaceuticals and Veterinary Medicines’ Avian Influenza – reinforced industry role Influenced positive attitude to vaccination Influenced WHO attitude to use of manufacturing facilities Antimicrobials – Risk Analysis Position accepted Human outreach project FAO/IFAH MOU – Trypanocides (quality control in Africa) 14

15 Recent IFAH achievements 近期国际动保联盟的成就
基准统计-在与当局的会谈中有关监管法规问题上，为管理的思维转换提供令人信服的例证。 成功的全球性会议- 2007年11月。 在2008年联合国粮食与农业组织的首脑会议上作报告。 加强与世界动物卫生组织的关系（于2007年达成协议），在以下项目中发挥作用： 1. 疫苗接种指南 -- 禽流感，蓝舌病。 2.抗菌剂耐药性的国际标准 制作宣传册- 《人类用药和动物用药》 禽流感-加强行业职能 1. 对于预防接种形成正面的影响。 2.对世界卫生组织就兽药制造设备的使用态度产生影响 抗菌剂-对风险评估的认可 1. 人类拓展项目（Human outreach project） 粮农组织/ IFAH MOU（Memorandum of Understanding ）国际动保联盟备忘录- Trypanocides杀锥虫药 （非洲质量控制）

16 IFAHs statutory structure 国际动保联盟的法定架构
Governed by IFAH’s Articles of Association 国际动保联盟章程授权 16

17 IFAHs statutory structure (cont)
General Assembly = all full members, meets 1 x year; associate members may attend in consultative capacity Board of Directors CEOs of all IFAH member companies Representatives from associations representing the regions: Australia/New Zealand Europe North America South/Central America South East Asia – Asian Animal Health Association (AAHA) Japan Executive Committee supports the IFAH Board of Directors; it is composed of: 6 company CEOs: President, 4 Vice-Presidents, Treasurer 2 representatives of regions (North America & Europe) Executive Director - appointed by IFAH Board of Directors day-to-day management of the association - attends the meetings of the Board of Directors in a consultative capacity

18 IFAHs statutory structure (cont) 国际动保联盟的法定架构（续）
会员大会=所有正式成员，每年举行1次，准成员允许以顾问身份参加大会。 董事会 - 所有国际动保联盟成员公司的首席执行官们 - 来自各地区协会的代表们： 澳大利亚/新西兰 欧洲 北美洲 南/中美洲 东南亚-亚洲动物健康协会（AAHA） 日本 执行委员会：支持国际动保联盟董事会，它的组成如下： - 六家公司首席执行官：主席，4名副主席，财务主管 - 两个地区的代表（北美和欧洲） 执行董事-由国际动保联盟董事会任命-负责协会的日常管理工作-以咨询的身份出席董事会会议

19 IFAHs statutory structure (cont)
The Board is also supported by: The IFAH Secretariat based in Brussels A number of ‘Core Strategic Teams’ and working groups addressing specific subjects and issues These teams are made up of volunteers for member companies and associations and develop IFAHs view points on the chosen subjects of interest IFAH is funded by contributions from Member Companies (based on sales) Member Associations (based on market size) 19

20 IFAHs statutory structure (cont) 国际动保联盟的法定架构（续）
董事会支持单位还有： －位于布鲁塞尔国际动保联盟的秘书处； －设定若干“核心战略小组‘和工作组，以解决具体的科目和事务； －这些小组是由成员公司和协会的自愿者所构成，旨在对关注的选定主题各抒己见。 国际动保联盟由以下成员资助： －成员公司（基于销售额） －成员协会（基于市场规模）

21 Strategic Goals 2009 – 2011 2009-2011年的战略目标
Leadership: Maximize the effectiveness of IFAH at global, regional and national levels in established and emerging markets to achieve its mission IFAH Leadership Team carries out work Value to society: Continuously illustrate to stakeholders and the public the value and contribution of animal health to society to build trust and acceptance of existing and new technologies IFAH Value Team carries out work Regulatory: Foster a favourable regulatory environment that supports the needs of animal health industry and society IFAH Regulatory Strategy Team, supported by sub- groups, carries out work A Communication stream underlies all 3 goals Leadership Objectives: Prioritisation process Resource plan Defining roles and responsibilities of member associations at global, regional & national level IFAH Leadership Team will manage these tasks and ensure liaison with IFAH board members. Value to society - Objectives: Effective short term management of emerging issues Establish a longer term outreach capability to proactively engage with key opinion leaders and appropriate experts with the aim of optimising societal acceptance of new and existing technologies for veterinary medicines, implement for two topics. IFAH Value Team will lead this field. Regulatory Strategy Objectives: Strive to decrease both the time and cost of product development Strive to increase market access Increase the acceptance and scope of data protection (DP) and data exclusivity (DE) to ensure market access and protect company investment. IFAH Regulatory Strategy Team gives strategic direction on regulatory activities and to other working groups/teams on specific issues. 21

22 Strategic Goals 2009 – 2011 2009-2011年的战略目标
领导力：最大化国际动保联盟在全球、区域和国家层面上的成熟和新兴市场影响力，以实现其使命， 国际动保联盟的领导小组负责开展此项工作 对社会的价值：持续不断的向利益相关者和公众普及动物保健对于社会的价值和做出的贡献，以建立信任，以及提高对于现有技术和新技术的可接受度。 国际动保联盟的价值小组负责开展此项工作 法规管理：培养良好的监管环境，旨在支持动物保健行业和社会发展的需要 国际动保联盟的管理战略小组，由分小组负责开展工作 沟通是实现这三项目标的基础。

23 IFAHs functional structure 2009 – 2011 2009-2011年 国际动保联盟的职能架构
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24 International Animal Health Industry – overview 国际动物保健行业—概述
Information commercially available from Vetnosis, IFAHs trusted source of market research data ( 信息来源于Vetnosis。 Vetnosis Limited Abbey House 83 Princes Street Edinburgh EH2 2ER United Kingdom T: +44 (0) F: +44 (0) E: 24

25 Market evolution 1998-2008 市场演变图表1998-2008
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26 Company 2008 Sales & Growth 2008 各公司的销售增长
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27 Company reported sales & growth 各公司公布的销售额和增长
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28 Animal Health market 2008 by product group 2008年 动物保健品市场图表（按产品种类划分）
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29 Animal Health market 2008 by region 2008年 动物保健品市场图表（按照地域划分）
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30 Animal Health market 2008 by animal species 2008年 动物保健市场图表（按照动物种类划分）
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31 Challenges for the International Animal Health Industry [1]
Research &Development costs background facts (2006): R&D investment: EU & US: ≈ 10% of annual turnover Defensive R&D costs: EU: ≈ 35% of annual R & D budget US: ≈ 15% of annual R & D budget Impact of regulatory factors on average development cost (changes in real terms over last 5 years) Europe USA Canada Australia Japan Major Livestock Species + 25% + 32% +10% + 36% + 15% Companion Animal Species + 23% + 37% + 10% + 26% + 7% Minor Species + 28% + 1% + 22% + 8%

32 国际动物保健行业面临的挑战 研究开发费用（2006年）： 家畜 + 25% + 32% +10% + 36% + 15% 宠物 + 23%
研发投入: 欧盟 & 美国: ≈ 10%的年营业额 防御性的研发成本:欧盟: ≈ 35%的年度研发预算 美国: ≈ 15% 的年度研发预算 管理因素在平均研发成本的影响(过去五年中的实际变化) 欧洲 美国 加拿大 澳大利亚 日本 家畜 + 25% + 32% +10% + 36% + 15% 宠物 + 23% + 37% + 10% + 26% + 7% 其他品种 + 28% + 1% + 22% + 8%

33 Challenges for the International Animal Health Industry [2] 国际动保行业面临的挑战（2）
Regulatory environment: IFAH member companies develop products for global sale, making best use of company resources and providing product of the same quality standard world-wide Differing, often conflicting regulatory requirements in different countries are a major cost factor in product development and limit product availability IFAH actively supports a science-based regulatory environment that ensures high-quality, efficacious medicines. Important initiatives are VICH – harmonizing data requirements Codex Alimentarius – safe standards for residues, science-based approaches to regulatory decision making Benchmarking survey of regulatory systems world-wide 33

34 Challenges for the International Animal Health Industry [2] 国际动保行业面临的挑战（2）
监管环境： 国际动保联盟的会员单位，充分利用公司资源，开发并将同样质量标准的产品销往世界各地。 不同的是，不同国家管理机构的要求存在差异，成为产品开发的主要成本因素和产品供应的限制因素。 国际动保联盟积极支持以科学为基础的监管环境，以确保生产质量高，疗效优的药品。重要举措有： VICH —— 统一数据的要求 食品法典委员会 —— 药物残留的安全标准，科学为基础的管理决策方法 世界范围内监管系统的基准统计

35 Benefit to countries of striving for international regulatory standards 造福于致力建立国际监管标准的国家
From the industry experience: 从行业经验： Transparent science-based decision making supports consumer confidence 以科学为基础的决策过程，透明的决策环境，会增加消费者信任 High quality, efficacious animal health products for high quality animal produce for the own market 品质高、疗效优的动物保健品为本国市场提供了高品质的动物制品 Compliance with international standards for export of animal produce 符合动物制品出口的国际标准 Enforceable, time-saving quality standards for animal health products 坚决贯彻执行省时省力的动物保健品的质量标准

36 Challenges for the International Animal Health Industry [3] 国际动保行业面临的挑战（3）
Intellectual property / data protection: 知识产权/数据保护 The animal health market is driven by research based companies, who heavily invest in Research & Development to ensure efficacious, high quality animal health products Company survival depends on the ability to recuperate R&D investments with the few products that successfully reach the market IFAH actively promotes data protection to ensure an environment that makes development economically viable IFAH members are also active supporters of this aspect 36

37 Challenges for the International Animal Health Industry [3] 国际动保行业面临的挑战（3）
动物保健品市场主要是由以科学研究为基础的公司所引领，这些公司大量投入科学研究，以确保生产有效地、高品质的动物保健产品。 企业的生存能力取决于对研发投入的回报，而企业研发往往只有少数几个产品进入市场。 国际动保联盟积极推动数据保护行动，以确保建立一个经济可持续性发展的环境。 国际动保联盟的成员们同样是这方面的积极支持者。

38 Challenges for the International Animal Health Industry [4] 国际动保行业面临的挑战（4）
Societal concerns and perception of the animal health industry: Socio-economic value of animal health products largely not well understood by the general public Sound scientific debate (e.g. on antimicrobial products, and potential impact of veterinary use on human health) influenced by goals of specific interest groups => loss of scientific basis of decision making IFAH gearing up to effectively address consumer concerns to illustrate the contribution of the animal health industry

39 Challenges for the International Animal Health Industry [4] 国际动保行业面临的挑战（4）
社会对于动物保健行业的关注和看法： 动物保健产品的社会经济价值很大程度上没有很好的得到广大公众的理解 合理而科学的辩论（如抗菌剂作为兽用对人类健康的潜在影响）受到特定的利益群体目标的影响=>缺乏科学依据的决策过程 国际动保联盟正做好准备，高效地向消费者宣传和展示动物保健行业所做出的贡献

40 Challenges for the International Animal Health Industry [5]
One world – one health; initiative of OIE, FAO, WHO, World Bank, UNICEF and UN Systems Influenza Coordination: Recognition of interlinked nature of health and environment of humans, domestic animals and wildlife, and need to act together to control emerging diseases IFAH member companies develop products that can assist in controlling emerging diseases and pandemics IFAH member companies invest in research and experts from IFAH members can offer specialist knowledge to help fight against global animal pandemics IFAH actively participates in the development of a mechanisms to implement the above concept 40

41 Challenges for the International Animal Health Industry [5] 国际动保行业面临的挑战（5）
同一个世界，同一种健康;由世界动物卫生组织、粮农组织、世界卫生组织、世界银行、联合国儿童基金会（UNICEF）和联合国系统流感问题协调处共同发起： 1. 认识人类的健康与环境、家畜与野生动物的相互联系，需要共同行动控制突发疾病 2. 国际动保联盟的成员单位研发的产品可以帮助控制突发疾病和流行病 3. 国际动保联盟的成员单位在研发和科研专家的投入，能够提供专业知识，帮助对抗全球动物流行疾病 4. 国际动保联盟积极参与并落实有关以上概念的机制发展

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