1. Innovation and Access: Intersection of Public Health and Intellectual Property EMP - Technical Briefing Seminar 1 November, 2013 WHO HQ, Geneva Zafar Mirza EMP - Technical Briefing Seminar 1 November, 2013 WHO HQ, Geneva Zafar Mirza Public Health, Innovation and Intellectual Property Unit Essential Medicines & Health Products Department Public Health, Innovation and Intellectual Property Unit Essential Medicines & Health Products Department

2. Essential Medicines and Health Products Department (EMP) Office of the Director Policy, Access and Use (PAU) Medicines policy; regional & country collaboration & support Indicators & tools for pharmaceutical sector monitoring & assessment Transparency & good governance in medicines Supply management systems Medicines pricing policies Selection of essential medicines Psychotropics & narcotics, including substance evaluation Access to controlled medicines Rational use and anti-microbial resistance Public Health, Innovation and Intellectual Property (PHI) Global Strategy and Plan of Action PHI Local production Transfer of technology for vaccine production Regulation of Medicines and other Health Technologies (RHT) Norms/standards (including nomenclature) Quality assurance (including blood products) Safety /pharmacovigilance Prequalification of medicines; vaccines, and diagnostics Regulation Technologies Standards and Norms (TSN) Expert Committee Biological Standardization Expert Committee Pharmaceutical preparations INN International Pharmacopeia Reference standards Regulatory Systems Strengthening (RSS) NRA assessment Capacity building Harmonization initiatives ICDRA support Prequalification Team (PQT) Prequalification of medicines, vaccines, Diagnostics, … Dossier assessments Inspection Testing Scientific advice Safety and Vigilance (SAV) Pharmacovigilance Advisory group on PV ATC/DDD committee Vaccine safety initiative Advisory group on vaccine safety SSFFC ( cross cutting)

3. Access and its determinants 1. Rational selection 4. Reliable health and supply systems 2. Affordable prices 3. Sustainable financing ACCESS MEDICAL INNOVATION (R&D)

5. HOW MEDICAL INNOVATION IS DIFFERENT? 1.Sine qua non of health development 2.Public good dimension 3.Discovery is supported by public sector 4.Drug development is long, expensive & risky 5.End products are protected through patents 6.End products are strictly regulated 7.Equitable access to innovations is critical.

7. 7 |7 | Learning Objectives Introduction to the concept of intellectual property protection. To understand the intersection of Intellectual property protection and innovation (R&D) of medical technology. To understand the intersection of Intellectual property protection and access to medical technology. To appreciate WHO response: an introduction to GSPA-PHI. 1 1 2 2 3 3 4 4

8. 8 |8 | What is intellectual property protection (IPP)?  Intellectual property rights are the rights given to people over the creation of their minds inorder to reward them and encourage them to create more.  The legal system for the protection of these rights is called IPP system?  IP rights are private rights.

9. 9 |9 | Types of Intellectual property protection Different types of intellectual property? 1.Copyrights 2.Trademarks 3.Geographical Indications 4.Industrial Designs 5.Patents 6.Layout-Designs (Topographies) of ICs 7.Protection of Undisclosed Information

10. 10 | What are patents and patent protection?  A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor for a limited period of time in exchange for the public disclosure of an invention.  Difference between a "trade secret" and a "patent".  Inventions must be “new” and capable of industrial application.  Process and product patents.

11. 11 | What is the TRIPS Agreement?  Trade Related Aspects of Intellectual Property Rights.  One of the agreements under WTO.  “patents shall be available for any inventions, whether products or processes, in all fields of technology”  The term of protection granted...shall last for at least 20 years from the time of filling of the application for patent protection”

12. 12 | TRIPS Flexibilities Government Use allow government agencies to use an invention, for public, non-commercial purposes. Compulsory License permit 3rd parties to use an invention, without the patent holder's consent on grounds of public interest. Parallel Imports import at a lower price and resale of patented product in another country Exceptions and limitations

13. 13 | Learning Objectives Introduction to the concept of intellectual property protection. To understand the intersection of Intellectual property protection and innovation (R&D) of medical technology. To understand the intersection of Intellectual property protection and access to medical technology. To appreciate WHO response: an introduction to GSPA-PHI. 1 1 2 2 3 3 4 4

14. 14 | Medical Innovation 1.Essential for health development 2.Public good dimension 3.Discovery is supported by public sector 4.Drug development is long, expensive & risky 5.Protected through patents 6.End products are strictly regulated 7.Equitable access to innovations is critical

15. MedicineyearImportance Morphine1827 Commercialized by a pharmacy (Merck), pain management (Germany) Aspirin1897Synthetic salicylic acid was commercialized (Germany) Ether1842General anaesthetic, transformed surgery (US) Arsphenamine1910Syphillis Treatment (Hoechst, Germany) Insulin19221st hormone therapy, transformed diabetes management Penicillin1929Transformed the treatment of microbial diseases Chlorpromazine and Haladol 1950 & 1958 Transformed management of psyschosis. (France) (Belgium) Estrogen+ Progestin1961Birth Control Pills, deep social impact (USA) Digoxin1962 Changed treatment of heart failure and hypertension (Germany) (France) Furosemide Loop diuretic, effective treatment of hypertension Atorvastatin1996Cholesterol lowering medicine (USA) HAART1996-7Transforming effect on AIDS patients L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin EVOLUTION OF MEDICAL INNOVATION DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS

16. HOW MEDICAL INNOVATION IS DIFFERENT? 1.Sine qua non of health development 2.Public good dimension 3.Discovery is supported by public sector 4.Drug development is long, expensive & risky 5.End products are protected through patents 6.End products are strictly regulated 7.Equitable access to innovations is critical.

17. 17 | Medical Innovation & IPP  Patent protection  Market based incentive  Return on investment  Time limited monopoly  Market failure  Type III and Type II diseases

18. 18 | Diseases that disproportionately affect developing countries? Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable population in each. Examples of communicable diseases include measles, hepatitis B, and Haemophilus influenzae type b (Hib), and examples of noncommunicable diseases abound (e.g. diabetes, cardiovascular diseases, and tobacco-related illnesses). Type II diseases are incident in both rich and poor countries, but with a substantial proportion of the cases in the poor countries…HIV/AIDS and tuberculosis are examples. Type III diseases are those that are overwhelmingly or exclusively incident in the developing countries - NTDs 1.Dengue 2.Rabies 3.Trachoma 4.Buruli ulcer 5.Endemic treponematoses 6.Leprosy 7.Chagas disease (American trypanosomiasis) 8.Human African trypanosomiasis (sleeping sickness) 9.Leishmaniasis 10.Cysticercosis 11.Dracunculiasis (guinea-worm disease) 12.Echinococcosis 13.Foodborne trematode infections 14.Lymphatic filariasis 15.Onchocerciasis (river blindness) 16.Schistosomiasis (bilharziasis) 17.Soil-transmitted helminthiases

19. 19 | Learning Objectives Introduction to the concept of intellectual property protection. To understand the intersection of Intellectual property protection and innovation (R&D) of medical technology. To understand the intersection of Intellectual property protection and access to medical technology. To appreciate WHO response: an introduction to GSPA-PHI. 1 1 2 2 3 3 4 4

20. ACCESS TO HEALTH TECHNOLOGIES 1. Rational selection 4. Reliable health and supply systems 2. Affordable prices 3. Sustainable financing ACCESS MEDICAL INNOVATION (R&D

21. 21 | Intellectual property protection and access to medicines Potential impact of IPP on access to medicines  Availability Patent protection can encourage companies to invest more on development of new medicines [?]  Affordability During the patent protection period prices of medicines are high and generally unaffordable for patients especially in developing countries.

22. 1.Problems in access to generic medicines health system related issues ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues medicines price surveys data: average availability12 of selected essential medicines was 51.8 per cent in public sector health facilities and 68.5 per cent in the private sector over the period 2007-2011 e.g. in 2000 very few people with HIV/AIDS in developing countries were on treatment, in 2011 6.6 million of them have access to first line ARVs, yet 8 million still wait for the treatment

23. 2.Problems in access to patent protected medicines ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues In March 2012, India granted its first compulsory license, allowing a domestic drug maker to manufacture generic version of Nexavar, a cancer drug by Germany's Bayer. That enabled India's Natco Pharma to sell its generic version of Nexavar at INR 8,800 rupees ($160) per monthly dose, a fraction of the INR 280,000 ($5090) rupees Bayer's version cost.

24. 24 | Issues in access to patent protected medicines and medical technologies  TRIPS flexibilities, exceptions and limitations should be fully incorporated in the national patent laws  Political issues in the use of TRIPS flexibilities  TRIPS Plus in Free Trade Agreements

25. 25 | DATA EXCLUSIVITY  Test data protection (TRIPS 39.3)  Data exclusivity is independent of patent protection and introduce another kind of monopoly rights with serious implications for access to generic medicines  Patent link… As a part of the US-Jordan FTA, Jordan implemented data exclusivity. A study conducted by Oxfam in 2007 found that of 103 medicines registered and launched since 2001 that had no patent protection in Jordan, at least 79% had no competition from a generic equivalent as a consequence of data exclusivity. The study also found that prices of these medicines under data exclusivity were up to 800% higher than in neighboring Egypt.

26. 26 | Learning Objectives Introduction to the concept of intellectual property protection. To understand the intersection of Intellectual property protection and innovation (R&D) of medical technology. To understand the intersection of Intellectual property protection and access to medical technology. To appreciate WHO response: an introduction to GSPA-PHI. 1 1 2 2 3 3 4 4

27. 27 | WHO & Intellectual Property Protection GSPA-PHI confirms and expands the mandate of WHO in the field of public health & intellectual property: "… the WHO shall play a strategic and central role in the relationship between public health and innovation and intellectual property within its mandates (…), capacities and constitutional objectives, bearing in mind those of other relevant intergovernmental organizations. "

28. 2003 20062008 2010 WHA56.2 7 Intellectual property rights, innovation and public health Public Health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action Global strategy and plan of action on public health, innovation and intellectual property Establishment of a consultative expert working group on research and development: financing and coordination Commission on Intellectual Property Rights, Innovation and Public Health Intergovernmental Working Group Expert Working Group on Research and Development: Financing and Coordination Consultative Expert Working Group on R&D: Financing and Coordination History of debate and developments in WHO WHA59.24 WHA61.2 1 WHA63.2 8

29. 29 | Global Strategy on Public Health, Innovation and Intellectual Property The Aim to promote new thinking on innovation and access to medicines, as well as, […], provide a medium-term framework for securing an enhanced and sustainable basis for needs- driven essential health research and development relevant to diseases which disproportionately affect developing countries,

30. 30 | Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property 2006-09 1. Prioritizing research and development needs. 2. Promoting research and development. 3. Building and improving innovative capacity. 4. Transfer of technology. 5. Application and Management of intellectual property to contribute to innovation and promote public health. 6. Improving delivery and access. 7. Promoting sustainable financing mechanisms for needs driven R&D. 8. Establishing monitoring and reporting systems

31. 31 | Element 5. Application and management of intellectual property to contribute to innovation and promote PH (5.1) supporting information sharing and capacity building in the application and management of intellectual property with respect to health related innovation and the promotion of public health in developing countries (5.2) providing as appropriate, upon request, in collaboration with other competent international organizations technical support, including, where appropriate, to policy processes, to countries that intend to make use of the provisions contained in the TRIPS Agreement, including the flexibilities recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments related to the TRIPS Agreement, in order to promote access to pharmaceutical products (5.3)exploring and, where appropriate, promoting possible incentive schemes for research and development on Type II and Type III diseases and on developing countries’ specific research and development needs in relation to Type I diseases

32. 32 | Learning Objectives Introduction to the concept of intellectual property protection. To understand the intersection of Intellectual property protection and innovation (R&D) of medical technology. To understand the intersection of Intellectual property protection and access to medical technology. To appreciate WHO response: an introduction to GSPA-PHI. 1 1 2 2 3 3 4 4

33. 33 | For more information www.who.int/phi/en/ THANK YOU