1. WHO Perspective on Medicine Patents and FTAs Asian Regional Workshop on FTAs 26-28 August, 2005, Kuala Lumpur, Malaysia Dr Zafar Mirza Regional Adviser, Regional Adviser, Essential Drugs & Biologicals East Mediterranean Regional Office - Egypt World Health Organization Asian Regional Workshop on FTAs 26-28 August, 2005, Kuala Lumpur, Malaysia Dr Zafar Mirza Regional Adviser, Regional Adviser, Essential Drugs & Biologicals East Mediterranean Regional Office - Egypt World Health Organization

2. OutlineOutline  WHO Perspective on Medicine Patents How we view FTAs in this connection?How we view FTAs in this connection? Existing work & plans in this areaExisting work & plans in this area  WHO Perspective on Medicine Patents How we view FTAs in this connection?How we view FTAs in this connection? Existing work & plans in this areaExisting work & plans in this area

3. WHO Perspective on Medicine Patents Rights based approach Health is a basic human right and access to medicines is a part of this right.

4. WHO Perspective on Medicine Patents Our Goal in Medicines To help save lives and improve health by ensuring the quality, efficacy, safety and rational use of medicines, including traditional medicines, and by promoting equitable and sustainable access to essential medicines, particularly for the poor and disadvantaged - Up to half of the population in developing countries do not have reliable access to medicines. - Up to half of the population in developing countries do not have reliable access to medicines. To help save lives and improve health by ensuring the quality, efficacy, safety and rational use of medicines, including traditional medicines, and by promoting equitable and sustainable access to essential medicines, particularly for the poor and disadvantaged - Up to half of the population in developing countries do not have reliable access to medicines. - Up to half of the population in developing countries do not have reliable access to medicines.

5. WHO Perspective on Medicine Patents The Tragedy Citizens continue to suffer and die for lack of access to essential medicines.

6. WHO Perspective on Medicine Patents The 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

7. 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 developed would they be accessible to the poor ?

8. WHO 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, BUT Patents 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, BUT Patents should be managed in an impartial way, protecting the interests of the patent-holder, as well as safeguarding public health principles.

9. WHO 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

10. WHO Perspective on Medicine Patents W 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

11. How we veiw FTAs in this connection? These have a long history which goes much beyond WTO.These have a long history which goes much 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 benefits (not just in economic terms)States have to balance the costs and benefits (not just in economic terms) In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be fully incorporated in FTAs.In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be fully incorporated in FTAs. These have a long history which goes much beyond WTO.These have a long history which goes much 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 benefits (not just in economic terms)States have to balance the costs and benefits (not just in economic terms) In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be fully incorporated in FTAs.In case of IPRs and medicines, we think that not only any TRIPS-plus approach should be avoided but TRIPS flexibilities should be fully incorporated in FTAs.

12. WHO Perspective on Medicine Patents W H A WHO Perspective on Medicine Patents 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

13. What does TRIPS-Plus means in the context of FTAs? Data exclusivityData exclusivity Extension of patent termExtension of patent term Restrictions on use of compulsory licenseRestrictions on use of compulsory license Linking patents with registrationLinking patents with registration Data exclusivityData exclusivity Extension of patent termExtension of patent term Restrictions on use of compulsory licenseRestrictions on use of compulsory license Linking patents with registrationLinking patents with registration

14. Existing Work & Plans1 1. 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. 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.

15. Existing Work & Plans2 2. 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. 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

16. Existing Work & Plans3 3. 3.Impact assessment   Research   Methodologies development   TRIPS Network 3. 3.Impact assessment   Research   Methodologies development   TRIPS Network

17. Existing Work & Plans FTAs   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

18. Countries Support on IPR & Medicine issues more than 60 countries