WHO Perspective WHO Perspective on Medicine Patents and FTAson Medicine Patents and FTAs

WHO Perspective WHO Perspective on Medicine Patents and FTAson Medicine Patents and FTAs

Asian Regional Workshop on FTAs26-28 August, 2005, Kuala Lumpur, Malaysia

Dr Zafar MirzaDr Zafar MirzaRegional Adviser, Regional Adviser, Essential Drugs & Biologicals

East Mediterranean Regional Office - EgyptWorld Health Organization

Asian Regional Workshop on FTAs26-28 August, 2005, Kuala Lumpur, Malaysia

Dr Zafar MirzaDr Zafar MirzaRegional Adviser, Regional Adviser, Essential Drugs & Biologicals

East Mediterranean Regional Office - EgyptWorld Health Organization

OutlineOutlineOutlineOutline

WHO Perspective on Medicine WHO Perspective on Medicine PatentsPatents

• How we view FTAs in this How we view FTAs in this connection?connection?

• Existing work & plans in this areaExisting work & plans in this area

WHO Perspective on Medicine WHO Perspective on Medicine PatentsPatents

• How we view FTAs in this How we view FTAs in this connection?connection?

• Existing work & plans in this areaExisting work & plans in this area

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsRights based approachRights based approachWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsRights based approachRights based approach

Health is a basic Health is a basic human right and human right and access to medicines is access to medicines is a part of this right.a part of this right.

Health is a basic Health is a basic human right and human right and access to medicines is access to medicines is a part of this right.a part of this right.

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsOur Goal in MedicinesOur Goal in MedicinesWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsOur Goal in MedicinesOur Goal in Medicines

To help save lives and improve health by To help save lives and improve health by ensuring the quality, efficacy, safety and ensuring the quality, efficacy, safety and rational use of medicines, including rational use of medicines, including traditional medicines, and traditional medicines, and by promoting by promoting equitable and sustainable access to equitable and sustainable access to essential medicinesessential medicines, particularly for the , particularly for the poor and disadvantaged poor and disadvantaged

- Up to half of the population in developing - Up to half of the population in developing countries do not have reliable access to countries do not have reliable access to medicines.medicines.

To help save lives and improve health by To help save lives and improve health by ensuring the quality, efficacy, safety and ensuring the quality, efficacy, safety and rational use of medicines, including rational use of medicines, including traditional medicines, and traditional medicines, and by promoting by promoting equitable and sustainable access to equitable and sustainable access to essential medicinesessential medicines, particularly for the , particularly for the poor and disadvantaged poor and disadvantaged

- Up to half of the population in developing - Up to half of the population in developing countries do not have reliable access to countries do not have reliable access to medicines.medicines.

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsThe TragedyThe TragedyWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsThe TragedyThe Tragedy

Citizens continue to Citizens continue to suffer and die for lack suffer and die for lack of access to essential of access to essential medicines.medicines.

Citizens continue to Citizens continue to suffer and die for lack suffer and die for lack of access to essential of access to essential medicines.medicines.

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsThe ChallengeThe ChallengeWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsThe ChallengeThe Challenge

1. Unaffordable medicine prices

2. Irrational Use of medicines

3. Unfair health financing mechanisms

4. Unreliable medicines supply

5. The quality of medicines

6. New medicines are needed

1. Unaffordable medicine prices

2. Irrational Use of medicines

3. Unfair health financing mechanisms

4. Unreliable medicines supply

5. The quality of medicines

6. New medicines are needed

• More than 20 diseases have emerged in last 10 to15 years e.g. ebola virus; new strains of Cholera; SARS etc

• All these new diseases require new treatments to be developed

New drugs for newly emerging diseases

• More effective drugs need to be developed for HIV/AIDS

• TB, Malaria have become drug resistant to existing drugs

• Safer drugs are needed to replace toxic treatments

New drugs to replace ineffective or unsafe drugs

95% investments in R&D are for 20% people

1% drugs in last 25 years for tropical diseases and TB, makes 11% GBD

Vaccines for HIV/AIDS, treatment of hepatitis B, Cystic fibrosis are needed

New drugs for existing neglected diseases

New drugs are to be developed, but even if they are New drugs are to be developed, but even if they are developed would they be accessible to the poor ?developed would they be accessible to the poor ?

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsWHO Perspective on Medicine Patents

• Essential drugs are not simply another commodity.

• Patent protection has been an effective incentive for research and development for new drugs, BUTPatents should be managed in an impartial way, protecting the interests of the patent-holder, as well as safeguarding public health principles.

• Essential drugs are not simply another commodity.

• Patent protection has been an effective incentive for research and development for new drugs, BUTPatents should be managed in an impartial way, protecting the interests of the patent-holder, as well as safeguarding public health principles.

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsWHO Perspective on Medicine Patents

• Introduction of a public health perspective into the intellectual property protection regime

• Use of the flexibility permitted by the Agreement in the revision of national laws and regulations (e.g. Bolar provision, compulsory licensing, exceptions to exclusive rights, extension of the transitional period)

• Implementation of the Doha Declaration• Caution with "TRIPS-plus" provisions• Monitoring of the health impact of new trade

agreements

• Introduction of a public health perspective into the intellectual property protection regime

• Use of the flexibility permitted by the Agreement in the revision of national laws and regulations (e.g. Bolar provision, compulsory licensing, exceptions to exclusive rights, extension of the transitional period)

• Implementation of the Doha Declaration• Caution with "TRIPS-plus" provisions• Monitoring of the health impact of new trade

agreements

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsW H A ResolutionsW H A ResolutionsWHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsW H A ResolutionsW H A Resolutions

WHA52.19 May 1999 … monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, … to maximise the positive and mitigate the negative impact of those agreements …

WHA55.14, 2002 … ensure that WHO's Medicines Strategy address … the impact of international trade agreements on access to Medicines

WHA56.27, 2003 … to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the TRIPS Agreement

WHA52.19 May 1999 … monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, … to maximise the positive and mitigate the negative impact of those agreements …

WHA55.14, 2002 … ensure that WHO's Medicines Strategy address … the impact of international trade agreements on access to Medicines

WHA56.27, 2003 … to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the TRIPS Agreement

How we veiw FTAs in this How we veiw FTAs in this connection? connection? How we veiw FTAs in this How we veiw FTAs in this connection? connection?

• These have a long history which goes much These have a long history which goes much beyond WTO.beyond WTO.

• It is a sovereign right of the countries.It is a sovereign right of the countries.

• States have to balance the costs and States have to balance the costs and benefits (not just in economic terms)benefits (not just in economic terms)

• In case of IPRs and medicines, we think that In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be avoided but TRIPS flexibilities should be fully incorporated in FTAs.fully incorporated in FTAs.

• These have a long history which goes much These have a long history which goes much beyond WTO.beyond WTO.

• It is a sovereign right of the countries.It is a sovereign right of the countries.

• States have to balance the costs and States have to balance the costs and benefits (not just in economic terms)benefits (not just in economic terms)

• In case of IPRs and medicines, we think that In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be avoided but TRIPS flexibilities should be fully incorporated in FTAs.fully incorporated in FTAs.

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsW H A W H A 57.14 (22 May 2004)Scaling up treatment and care within coordinated and comprehensive response to HIV/AIDS

WHO Perspective on Medicine PatentsWHO Perspective on Medicine PatentsW H A W H A 57.14 (22 May 2004)Scaling up treatment and care within coordinated and comprehensive response to HIV/AIDS

Urges Member States, as a matter of proiority

…to encourage that bilateral trade

agreements take into account the flexibilities contained in the WTO TRIPS Agreement and recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health

Urges Member States, as a matter of proiority

…to encourage that bilateral trade

agreements take into account the flexibilities contained in the WTO TRIPS Agreement and recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health

What does TRIPS-Plus means in the What does TRIPS-Plus means in the context of FTAs?context of FTAs?What does TRIPS-Plus means in the What does TRIPS-Plus means in the context of FTAs?context of FTAs?

• Data exclusivityData exclusivity

• Extension of patent termExtension of patent term

• Restrictions on use of compulsory Restrictions on use of compulsory licenselicense

• Linking patents with registrationLinking patents with registration

• Data exclusivityData exclusivity

• Extension of patent termExtension of patent term

• Restrictions on use of compulsory Restrictions on use of compulsory licenselicense

• Linking patents with registrationLinking patents with registration

Existing Work & PlansExisting Work & Plans 11Existing Work & PlansExisting Work & Plans 11

1. Policy development Globalization, Trade & Health WTO Agreements and Public Health IPRs and Access to Medicines Commission on Intellectual Property

Rights, Innovation and Public Health Publications; briefs; representations;

meetings etc.

1. Policy development Globalization, Trade & Health WTO Agreements and Public Health IPRs and Access to Medicines Commission on Intellectual Property

Rights, Innovation and Public Health Publications; briefs; representations;

meetings etc.

Existing Work & PlansExisting Work & Plans 22Existing Work & PlansExisting Work & Plans 22

2. Technical assistance in implementation Transitional periods Accession process TRIPS compliance Legal reviews and amendments Assistance in use of TRIPS

flexibilities and safeguards Inter-agency work

2. Technical assistance in implementation Transitional periods Accession process TRIPS compliance Legal reviews and amendments Assistance in use of TRIPS

flexibilities and safeguards Inter-agency work

Existing Work & PlansExisting Work & Plans 33Existing Work & PlansExisting Work & Plans 33

3. Impact assessment Research Methodologies development TRIPS Network

3. Impact assessment Research Methodologies development TRIPS Network

Existing Work & PlansExisting Work & Plans

FTAsFTAs

Existing Work & PlansExisting Work & Plans

FTAsFTAs

Technical Assistance during FTA negotiations – e.g. Andean countries

Case-study development Policy Guide development

Technical Assistance during FTA negotiations – e.g. Andean countries

Case-study development Policy Guide development

Countries Support on IPR & Medicine Countries Support on IPR & Medicine issuesissues

more than 60 countriesmore than 60 countries

Countries Support on IPR & Medicine Countries Support on IPR & Medicine issuesissues

more than 60 countriesmore than 60 countries