1. DOMESTICATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION FOR STRENGTHENING ACCESS TO MEDICINES IN ZAMBIA Anthony Bwembya, Registrar & CEO 2 nd October2013 www.pacra.org.zm The Patents and Companies Registration Agency

2. Outline of Presentation Development of IP Policy Development of IP Policy Implementation Plan Implementation Plan Status of IP Policy Status of IP Policy IP Legislation IP Legislation

3. Development of IP Policy National IP Policy drafted between 2008 and 2009, and adopted in 2010 National IP Policy drafted between 2008 and 2009, and adopted in 2010 The Policy was developed after analyzing the IP Audit report which revealed that the IP portfolio in Zambia was fragmented due to lack of National IP Policy. The Policy was developed after analyzing the IP Audit report which revealed that the IP portfolio in Zambia was fragmented due to lack of National IP Policy. PACRA was mandated by government to coordinate with key stakeholders and develop the National IP Policy PACRA was mandated by government to coordinate with key stakeholders and develop the National IP Policy

4. Implementation Plan After the drafting of the IP Policy, it was subjected to stakeholder workshops e.g. WIPO, ARIPO, WTO, UNDP, Government Ministries, National Aids Council (NAC), Zambia Medicines Regulatory Authority (ZMRA), Civil Society, etc. After the drafting of the IP Policy, it was subjected to stakeholder workshops e.g. WIPO, ARIPO, WTO, UNDP, Government Ministries, National Aids Council (NAC), Zambia Medicines Regulatory Authority (ZMRA), Civil Society, etc. After its adoption, the Implementation Plan was developed based on concrete areas of work to be undertaken by key stakeholders After its adoption, the Implementation Plan was developed based on concrete areas of work to be undertaken by key stakeholders Key institutions, namely, Ministry of Commerce through PACRA, Ministry of Health through NAC and ZMRA, Ministry of Information and Broadcasting Services, UNDP, Ministry of Agriculture, Ministry of Science and Technology to mention but a few developed the matrix to operationalise the implementation plan Key institutions, namely, Ministry of Commerce through PACRA, Ministry of Health through NAC and ZMRA, Ministry of Information and Broadcasting Services, UNDP, Ministry of Agriculture, Ministry of Science and Technology to mention but a few developed the matrix to operationalise the implementation plan

5. Status of IP Policy The IP Audit report done by Prof. Kanyanga revealed: - that most of the IP piecies of Legislation were not TRIPS compliant. Most of them did not domesticate the international instruments to which the country had acceded. Consequently, the National IP Policy outlined key institutions that needed to review or enact new laws Various international treaties or instruments that needed to be taken on board Introduction of IP in schools and creation of awareness on IP related issues

6. IP Policy Status – Cont’d The following stakeholders were mandated to come up with interventions that will promote innovations and creativity: PACRA was tasked to develop a Technolgy and Innovation Support Center (TISC) - Implemented Ministry of Science and Technolgy was to create a Science and Technolgy Innovation Youth Fund (STIYF) - Implemented Ministry of Education, through UNZA, to develop a National Technology Business Centre (NTBC) based at Government complex- Implemented

7. IP Legislation The following key stakeholders, namely, PACRA, ZARI, MIBS were identified with a view of reveiwing their legislation or enacting new ones: PACRA drafted following Bills: Patents and Utility Model Act Incorporates TRIPS flexibilities on nutrition and essential medicines International exhausion rights Limitations on use of patents for research and education purposes Trademark and Geographical Indications Act Incorporates the Madrid Protocol The Singapore Trade Mark Law Treaty The Registered Designs Act The Interated Circuits Act The Traditional Knowledge and Genetic Resources Act Recognises tradtional medicines Prevents un-athourised use of genetic resources

8. IP Legislation – Cont’d IP Legislation – Cont’d Zambia Agricultural Research Institute (ZARI) has developed the initial institutional IP Policy which will eventually guide the enactment of a new act safeguards the interests of peasant farmers Incoporates the International Convention for the Protection of New Varieties of Plants (UPOV Treaty) Ministry of Information and Broadcasting Services (MIBS) MIBS enacted Copyright Act in 2010 making it TRIPS compliant Incorporates the Berne Convention and WIPO Producers WIPO Copyright Treaty (WCT) and Phonograms Treaty (WPPT)

9. Thank You 9