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ESSENTIALS OF GLOBAL HEALTH Pharmaceutical Companies and Global Health Weng-Foung Huang, Ph.D. Professor, Institute of Health and Welfare Policy National.

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Presentation on theme: "ESSENTIALS OF GLOBAL HEALTH Pharmaceutical Companies and Global Health Weng-Foung Huang, Ph.D. Professor, Institute of Health and Welfare Policy National."— Presentation transcript:

1 ESSENTIALS OF GLOBAL HEALTH Pharmaceutical Companies and Global Health Weng-Foung Huang, Ph.D. Professor, Institute of Health and Welfare Policy National Yang-Ming University 2012/05/18 1YMU/HWF Unless noted, the course materials are licensed under Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Taiwan (CC BY-NC-SA 3.0)Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Taiwan (CC BY-NC-SA 3.0)

2 2 Professional Background Weng-Foung Huang, Ph.D. BS in Pharmacy, National Taiwan University (1972); MS in Pharmacy Administration (1975) and Ph.D. in Social and Administrative Pharmacy, University of Minnesota, USA (1979) Public service career (1980~1994) - Senior official in DOH: (Senior Specialist, Deputy Director General, and Director General of Pharmaceutical Affairs Bureau, Director General of National Laboratories of Foods and Drugs) Architect of Taiwan ’ s drug regulatory reforms (including GMP and clinical trial regulations); Key contributor to Taiwan ’ s NHI pharmaceutical reimbursement system 2012/05/18YMU/HWF

3 3 Professional Background Weng-Foung Huang, Ph.D. Academic career (1994 ~ present): Associate Professor, Director, Professor ; Institute of Health and Welfare Policy, National Yang-Ming University President, Pharmaceutical Society of Taiwan (1995~1997, 2007~2011.1) ; Advisor to Taiwan ’ s DOH(1999 ~ 2000, 2005~2007) ; Chairman of OTC Committee, DOH (1999 ~ 2007) ; Chairman of Pharmacy Service Quality Committee, DOH (2004 ~ 2007) Fields of Specialization: Health Policy Evaluation, Pharmaceutical Pricing and Reimbursement in Health Insurance, Health Technology Assessment (HTA), Development Strategies in Health Care Industry 2012/05/18YMU/HWF

4 Background Significance of Pharmaceuticals in Healthcare Role of Pharmaceutical Industry in International Health Vaccines and International Health Dilemma of Essential Drugs and Choices of Treatment 2012/05/184YMU/HWF

5 Significance of Pharmaceuticals in Healthcare Pharmaceuticals constitute an essential element of healthcare and disease treatment Pharmaceutical industry is a profit-driven industry but pharmaceuticals are also regarded as social goods Intensive R&D and intellectual right protection are core elements in pharmaceuticals innovation and pharmaceutical industry 2012/05/185YMU/HWF

6 Significance of Pharmaceuticals in Healthcare In a national health insurance/service (premium based NHI or tax based NHS), government reimbursement influences the operation of healthcare market. When a national health insurance/insurance is not available, the cost of drugs has been a sensitive issue everywhere. Policy decisions in achieving the balance between industrial goals and social goals are complicate, and sometimes very political. 2012/05/186YMU/HWF

7 International Covenant on Economic, Social and Cultural Rights “The right of everyone to the enjoyment of the highest attainable standard of physical and mental health” (Article 12.1) 2012/05/187YMU/HWF

8 Right to Health  the right to health means: availability, acceptability, accessibility and quality available in sufficient quantities. acceptable, both in terms of their usability and their appropriateness, given cultural and other factors. effective and of good quality. the lowest possible cost to facilitate access. 2012/05/188YMU/HWF

9 2012/05/189YMU/HWF BBC

10 12 Largest Pharmaceutical Companies by revenue as of July 2009 in the Fortune Global /05/18 10 YMU/HWF

11 Top 10 Global Generic Companies, 2008 (Representing 47% of Global Market Share) 2012/05/18 CompanyCountryRevenue (US$100M) Growth Rate Teva Israel % Sandoz Switzerland % MylanU.S.A % Watson U.S.A % Ratiopharm Germany24.45% Stada Germany % Hospira U.S.A.185.6% Actavis Iceland180.6% Ranbaxy India % Dr. Reddy‘s India % Sources: Scrip 、 IT IS/DCB 11 YMU/HWF

12 2005 我國藥品市場銷售額前 20 大藥廠 2012/05/18 12 YMU/HWF 排行廠商排行廠商 1Pfizer11Eli Lilly and CO 2Sanofi-Aventis12 中國化學 3GlaxoSmithkine13Bristol-Myers Squibb 4Novartis Group14Johnson & Johnson 5Merck & Co15Abbott Laboratories 6Roche Group16 生達 7AstraZeneca17 信東 8Bayer18Takeda Pharmaceutical 9 永信 19 東洋 10Wyeth20 百靈佳殷格翰 source :吳孟欣 2006<< 台灣製藥業優勢發展策略之探討 -以五大本土藥廠為例 >> 逢甲大學經營管理碩士在職專班 碩士論文。王啟秀等,台灣發展製藥產業競爭分析。

13 Market Values of Big Pharmaceutical Companies and GDP of Selected Countries 2012/05/1813YMU/HWF

14 2012/05/1814 YMU/HWFPublic Citizen’s Congress Watch

15 2012/05/1815 YMU/HWF Public Citizen’s Congress Watch

16 16 Pharmaceutical Market Structure in Taiwan  Hospital segment the major market (78%) , Drugstores the next (14%), the rest are clinics (8%)  Foreign companies: local companies by values - 7:3 。  Foreign companies: local companies by quantity - 3:7 Year Local companies24,86626,92327,85527,00925,561 MNC/Imported69,68076,22976,46981,02884,141 Total94,546103,152104,324108,037109,702 Market share of local companies 26.3%26.1%26.7%25.0%23.3% Unit: NT$1M 2007 Market StructureUnit:NT$1M Source : 2008 Biomedical industry Almanac 2012/05/18 YMU/HWF

17 Four Elements in Access to Essential Medicines 1. Rational Selection 4. Reliable Health and Supply System 2. Affordable Price 3. Sustainable Financing Access 2012/05/18 17YMU/HWF

18 1. Rational Selection 4. Reliable Health and Supply System 2. Affordable Price 3. Sustainable Financing Access Four Elements in Access to Essential Medicines 2012/05/18YMU/HWF18

19 WHO: Progress of WHO Member in Developing National Drug Policies and in Revising Essential Drugs Lists Geneva: World Health Organization, /05/18YMU/HWF19 WHO

20 Structure of Pharmaceutical Industry Multinational Companies (MNCs): Aggressive professional marketing, huge and continuous investment in R&D, Highly profitable industry, Political-economic complex in capital market, Production facilities and network, Intellectual Property Right Protection under WTO framework 。 Containment of MNCs’ influence in developing countries: Import control, essential drug list, incentives for local production and export, national pharmaceutical companies 2012/05/1820YMU/HWF

21 Issues Related to Pharmaceutical Industry Over-use and misuse Illegal or hazardous distribution: Illicit trade of heroin, cocaine, amphetamine ; dumping of counterfeit drugs, diversion of philanthropic drugs 。 Role of government (public sector and private sector in production and distribution): manufacture of narcotic drugs, national pharmaceutical companies, protection of domestic manufacturers, restricting operation of foreign investment companies Drug pricing (including international price transfer) Equity, availability and accessibility R&D and profitability Harmonization of regulatory requirements and market approvals TRIPS/WTO 。 2012/05/1821YMU/HWF

22 2012/05/18YMU/HWF22 Oxfam International & Health Action International

23 Oxfam’s Criticism on EU IP Measures 1. Introducing TRIPS ‐ plus rules (IP rules that exceed obligations under WTO rules) through agreements, especially free trade agreements (FTAs) with developing countries. 2. Exerting bilateral pressure upon developing countries to prevent the use of TRIPS public health safeguards to reduce medicine prices. 3. Leading on a new global framework to enforce IP rules, within which elements of European legislation are resulting in the seizure of generic medicines in transit, intended for developing countries. 2012/05/18YMU/HWF23

24 Oxfam’s Recommendations 1. The European Commission and EU Member States should honor commitments under the MDGs, the Doha Declaration on TRIPS and Public Health, and relevant World Health Assembly (WHA) resolutions on innovation and access to medicines, including full implementation of the WHO ‘Global Strategy and Plan of Action’. 2. The EU should ensure its trade policy is in line with its development objectives, including specifically enhancing access to health care and access to medicines. This includes ensuring that trade rules, whether multi ‐ lateral, regional, or bilateral, exclude essential public services such as education, health, and water and sanitation from liberalization commitments. 19 EU Member States must act to hold the EC accountable when the EC fails to uphold these principles. 2012/05/18YMU/HWF24

25 With respect to IP 3. With respect to IP: The EU and Member States should not misuse FTAs to introduce TRIPS ‐ plus IP rules in developing countries to extend monopoly protection and introduce new enforcement measures, which limit access to medicines. The European Commission should stop exerting pressure on governments that attempt to introduce safeguards and flexibilities to protect and promote public health. The European Commission should amend its counterfeiting regulation to ensure it does not have a detrimental impact on developing countries, by excluding border measures for violations of pharmaceutical patents, especially for medicines in transit. 2012/05/18YMU/HWF25

26 With respect to IP The EU should ensure that the Anti ‐ Counterfeiting Trade Agreement (ACTA) does not set a new global standard for intellectual property rules (IPR) that impedes access to medicines in developing countries. Therefore, the EU should ensure that patents are excluded from any agreed framework. The European Commission and Member States should identify and support other measures to improve access to generic medicines in developing countries, including the UNITAID patent pool for HIV and AIDS medicines. 2012/05/18YMU/HWF26

27 With respect to IP European donors, including the Commission, should scale up financial contributions to R&D to address diseases that disproportionately affect people living in developing countries, especially through alternative funding mechanisms that promote therapeutic innovation. The EU should also support Product Development Partnerships (PDPs) that are designed to deliver affordable and effective new products, and it should continue building R&D capacity in developing countries. 2012/05/18YMU/HWF27

28 With Respect to R&D 4. With Respect to R&D The EU should support the implementation of the World Health Organization’s Global Strategy and Plan of Action (GSPA) on Public Health, Innovation and Intellectual Property, and support the Expert Working Group in its efforts to explore new models of innovation that increase both innovation and access. The European Commission should take appropriate measures to ensure that specific initiatives such as the Innovative Medicines Initiative (IMI) meet real health needs, and that both the IMI and the EUs regulation on children’s medicines can also be to the benefit of developing countries. 2012/05/18YMU/HWF28

29 2012/05/18YMU/HWF29 Oxfam International & Health Action International

30 2012/05/1830YMU/HWF

31 TRIPS and Pharmaceuticals  The rules To Create a harmonized global system under which inventors are granted exclusive marketing rights for a minimum of 20 years for ‘new and inventive’ products. Enforcement of a country’s compliance with TRIPS is ensured through the WTO dispute procedure, which places the burden of proof on the defendant. 2012/05/1831YMU/HWF

32 TRIPS and Pharmaceuticals Countries failing to meet their obligations can be subjected to trade sanctions. Fully integrates sectors such as biotechnology and pharmaceuticals into the global regime. Prior to TRIPS, approximately 50 developing countries and several developed countries either excluded medicines from being patented, or provided patents only for production processes rather than products. 2012/05/1832YMU/HWF

33 What is ‘TRIPS plus‘? The US government policy to push developing countries into passing 'TRIPS plus' national legislation. These are laws based on the most restrictive interpretation of TRIPS, purged of the original safeguards, and containing levels of IP protection that go well beyond anything mandated by TRIPS. The aim of the US government is to provide the longest possible period of effective protection for its corporations. 2012/05/1833YMU/HWF

34 What is ‘TRIPS plus‘? The threat to developing countries is unilateral trade sanctions, which can be authorised either by Section 301 of the US Trade Act, or by a WTO Dispute Settlement panel in the event of a TRIPS violation. The US government also uses bilateral and regional trade agreements to induce countries into accepting the patent rules sought by US companies, and then binds them into those commitments. 2012/05/1834YMU/HWF

35 How the US TRIPS strategy works  The US strategy employs three mutually reinforcing instruments: unilateral US investigation and sanction under Section 301 of the US Trade Act bilateral IP treaties, and bilateral and regional trade instruments containing IP provisions which specify in detail what national laws should be TRIPS, backed by the WTO enforcement mechanisms 2012/05/1835YMU/HWF

36 Section requires the USTR annually to identify countries that deny adequate IP protection to US firms and, depending on the perceived severity, to warn those countries to shape up, to present them a plan for progress, or to apply trade sanctions. In the case of medicines, the office of the USTR bases its assessment and grading on information supplied by PhRMA. Section 301 also allows the USTR to act against countries opposing the IP policies of the US government in multilateral organisations. 2012/05/1836YMU/HWF

37 2012/05/18YMU/HWF37 * Prospective impacts of the EU– Peru FTA, employing the same methodology, are similar to findings in Colombia. These studies were commissioned during the EU–Andean community trade negotiations. After objections by an alliance of Latin American and European civil society, 69 and the countries in question, TRIPS-plus rules have been modified to reduce public health impacts on negotiating partners. Oxfam International & Health Action International

38 2012/05/18YMU/HWF38 Oxfam International & Health Action International

39 2012/05/18YMU/HWF39 Oxfam International & Health Action International

40 Issues in Pharmaceutical Innovation Economic/industrial development Intellectual property protection Regulatory requirement and approval Pricing and reimbursement in health insurance Public assess to pharmaceutical innovation — availability, acceptability, accessibility and quality 2012/05/1840YMU/HWF

41 Stakeholders Biotechnology sector Generic drugs industry Civil society groups, A group of developing countries Universities Governments Non-profit foundations and/or organizations 2012/05/1841YMU/HWF

42 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (DOHA DECLARATION) Adopted on 14 November We recognize the gravity of the public health problems afflicting many developing and least developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. 2.We stress the need for the WTO Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address these problems. 3. We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices. 2012/05/1842YMU/HWF

43 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (DOHA DECLARATION) Adopted on 14 November 2001 “.. the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. …… the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” “..the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” 2012/05/1843YMU/HWF

44 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (DOHA DECLARATION) Adopted on 14 November 2001 These flexibilities include: a) ….each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. b) Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted. 2012/05/1844YMU/HWF

45 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (DOHA DECLARATION) Adopted on 14 November 2001 c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. d) The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and /05/1845YMU/HWF

46 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (DOHA DECLARATION) Adopted on 14 November 2001 We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of ….the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January /05/1846YMU/HWF

47 Public health, Innovation and Intellectual Property Rights REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH 4/25/2006 WHO 2012/05/1847YMU/HWF

48 2012/05/1848YMU/HWF WHO

49 Thank you for your attention 2012/05/1849YMU/HWF

50 COPYRIGHT DECLARATION 2012/05/18YMU/HWF50 PAGEWORKLICENSEAUTHOR/SOURCE 9 BBC 10 Wiki List of pharmaceutical companies es Visited 2012/07/ This work is from "Drug Industry Most Profitable Again" Public Citizen’s Congress Watch April 11, 2001, p4 This work is used subject to the fair use doctrine of Article 52, 65 Taiwan Copyright Act by GET. 15 This work is from "Drug Industry Most Profitable Again" Public Citizen’s Congress Watch April 11, 2001, p5 This work is used subject to the fair use doctrine of Article 52, 65 Taiwan Copyright Act by GET.

51 2012/05/18YMU/HWF51 PAGEWORKLICENSEAUTHOR/SOURCE 16 NTU Weng-Foung Huang 17 NTU Weng-Foung Huang 18 NTU Weng-Foung Huang 19 WHO p9 This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 22 Oxfam International & Health Action International This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 29 Oxfam International & Health Action International This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 30 NTU Weng-Foung Huang COPYRIGHT DECLARATION

52 2012/05/18YMU/HWF52 PAGEWORKLICENSEAUTHOR/SOURCE 37 Oxfam International & Health Action International This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 38 Oxfam International & Health Action International This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 39 Oxfam International & Health Action International This work is used subject to the fair use doctrine of Article 46, 50, 52, 65 Taiwan Copyright Act by GET. 48 WHO This work is licensed by WHO for the use of “Essentials of Global Health” ONLY. The copyright belongs to the above mentioned creator(s) and GET does not have the authorization right.


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