DOMESTICATION OF TRIPS FLEXIBILITIES IN ZIMBABWE

A presentation by Moses NkomoIntellectual Property Attorney and

ConsultantNational Workshop on TRIPS and access to medicines in Zimbabwe

Holiday Inn, Harare, Zimbabwe22 January 2014

Presentation outline

Definition of TRIPS Flexibilities Nature and Scope of TRIPS Flexibilities Overview of TRIPS Flexibilities

incorporated into the Zimbabwean Patents Act

Challenges and opportunities for effective utilisation of TRIPS Flexibilities

Observations from utilisation of Flexibilities

Recommendations

Definition of TRIPS Flexibilities

TRIPS flexibilities” is a term that is used to describe those provisions of the TRIPS Agreement which give member states latitude or flexibility to formulate domestic legislation in a way that balances their international obligations with their national interests.

-mechanisms in the TRIPS Agreement which enable members States to use TRIPS compatible norms in a manner that allows them to pursue their own public policies either in specific fields like access to pharmaceutical products

Flexibilities available under the TRIPS Agreement:

1) Transition periods 2) Compulsory licensing 3) Public, non-commercial use of patents 4) Parallel importation 5) Exceptions e.g. research 6) Exclusion from patentability, including

exclusion of new uses of known drugs; and

7) Limits on data protection.

Flexibilities incorporated into the Patents Act of Zimbabwe

Exclusion from Patentable subject matter –Section 2A

International Exhaustion (Parallel importation) – Section 24A

Test batches (Bolar Exception) – Section 24B

Compulsory licences – Section 30A and 31 Anti-competitive behaviour – Section 31(6a) Government use - Sections 34 -36

Zimbabwe and government use orders

According to Section 35(1) of Zimbabwean Patents Act:“During any period of emergency the powers… in relation to an invention by a department of the State shall include the power to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient - for the maintenance of supplies and services essential to the life of the community; or for securing a sufficiency of supplies and services essential to the well-being of the community”

General notice 240 of 2002 declared a period of emergency due to HIV/AIDS pandemic valid for 6 months

This allowed a person authorized by government to:

a) Make or use any patented drug including ARVs; andb) To import any generic drug used in the treatment of HIV/AIDS Lowered price of AZT/3TC from US$30 per month

to US$15 a month

How the government use was done

Act Number 9 of 2002 amended Patents Act Declaration of Period of Emergency

(HIV/AIDS) Notice 2002, General Notice 240 of 2002 – 6 months.

Statutory Instrument 32 of 2003 extended period of emergency for a further 6 years from January 2003 to December 2008.

Declaration of Period of Emergency on (HIV/AIDS) Notice, 2009: General Notice Number 49 of 2009 extended period to 2019.