Innovation and Access: Intersection of Public Health and Intellectual Property

EMP - Technical Briefing Seminar 30 October, 2012

WHO HQ, Geneva

Zafar Mirza

EMP - Technical Briefing Seminar 30 October, 2012

WHO HQ, Geneva

Zafar Mirza Department of Public Health, Innovation and Intellectual PropertyDepartment of Public Health, Innovation and Intellectual Property

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WHO & Intellectual Property ProtectionWHO & 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. "

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Learning ObjectivesLearning 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.

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What is intellectual property protection (IPP)?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.

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Types of Intellectual property protectionTypes of Intellectual property protection

Different types of intellectual property?

1. Copyrights2. Trademarks3. Geographical Indications4. Industrial Designs5. Patents6. Layout-Designs (Topographies) of ICs7. Protection of Undisclosed Information

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What are patents and patent protection?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.

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What is the TRIPS Agreement?What is the TRIPS Agreement?

Trade Related Aspects of Intellectual Property Rights.

One of the agreements under WTO, sets minimum criteria for patent protection

“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”

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TRIPS FlexibilitiesTRIPS Flexibilities

Government Useallow government agencies to use an invention, for public, non-commercial purposes.

Compulsory Licensepermit 3rd parties to use an invention, without the patent holder's consent on grounds of public interest.

Parallel Importsimport at a lower price and resale of patented product in another country

Exceptions and limitations

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Learning ObjectivesLearning 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.

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Medicine year ImportanceMorphine 1827 Commercialized by a pharmacy (Merck), pain management

(Germany) Aspirin 1897 Synthetic salicylic acid was commercialized (Germany)Ether 1842 General anaesthetic, transformed surgery (US)Arsphenamine 1910 Syphillis Treatment (Hoechst, Germany)Insulin 1922 1st hormone therapy, transformed diabetes managementPenicillin 1929 Transformed the treatment of microbial diseasesChlorpromazine and Haladol

1950 & 1958

Transformed management of psyschosis. (France) (Belgium)

Estrogen+ Progestin 1961 Birth Control Pills, deep social impact (USA)Digoxin 1962 Changed treatment of heart failure and hypertension

(Germany) (France)Furosemide Loop diuretic, effective treatment of hypertensionAtorvastatin 1996 Cholesterol lowering medicine (USA)HAART 1996-7 Transforming effect on AIDS patients

L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin

EVOLUTION OF MEDICAL INNOVATION

DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS

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Medical Innovation 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. End products are protected through patents

6. End products are strictly regulated

7. Equitable access to innovations is critical.

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.

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Medical Innovation & IPPMedical Innovation & IPP

Patent protection

Market based incentive Return on investment

Time limited monopoly

Market failure Type III and Type II diseases

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Diseases that disproportionately affect developing countries?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. Rabies3. Trachoma4. Buruli ulcer5. Endemic treponematoses 6. Leprosy7. Chagas disease (American trypanosomiasis)8. Human African trypanosomiasis (sleeping sickness)9. Leishmaniasis10. Cysticercosis 11. Dracunculiasis (guinea-worm disease)12. Echinococcosis13. Foodborne trematode infections14. Lymphatic filariasis15. Onchocerciasis (river blindness)16. Schistosomiasis (bilharziasis)17. Soil-transmitted helminthiases

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Learning ObjectivesLearning 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.

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ACCESS TO MEDICAL TECHNOLOGIES

1. Rational

selection

4. Reliablehealth and

supplysystems

2. Affordable

prices

3. Sustainable

financing

ACCESSMEDICAL

INNOVATION

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Intellectual property protection and access to medicinesIntellectual 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.

1. Problems in access to generic medicines

• health system related issues

ACCESS TO MEDICAL TECHNOLOGIEStwo 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

2. Problems in access to patent protected medicines

ACCESS TO MEDICAL TECHNOLOGIEStwo 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.

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Issues in access to patent protected medicines and medical technologiesIssues 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

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DATA EXCLUSIVITYDATA EXCLUSIVITY

Test data protection (TRIPS 39.3)

Data exclusivity is independent of patent protection and introduce another kind of monopoly rights enforced through NRAs 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.

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Learning ObjectivesLearning 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.

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2003 2006 2008 2010

WHA56.27

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 WHA61.21

WHA63.28

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Global Strategy on Public Health, Innovation and Intellectual PropertyGlobal Strategy on Public Health, Innovation and Intellectual Property

The aim

The global strategy on public health, innovation and intellectual property aims 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, proposing clear objectives and priorities for R&D, and estimating funding needs in this area.

The global strategy is designed to promote innovation, build capacity, improve access and mobilize resources.

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Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property 2006-09

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

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Element 5. Application and management of intellectual property to contribute to innovation and promote PHElement 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

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Learning ObjectivesLearning 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.

11

22

33

44

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For more informationFor more information

www.who.int/phi/en/www.who.int/phi/en/

THANK YOUTHANK YOU