ZAMBIA’S JOURNEY TOWARDS TRIPS AND ACCESS TO ESSENTIAL MEDICINES: UN SUPPORT & PERSPECTIVE Francis Mbilima, Programme Analyst – UNJT/UNDP

ZAMBIA’S JOURNEY TOWARDS TRIPS AND ACCESS TO ESSENTIAL MEDICINES: UN PERSPECTIVE Phase 1: Stakeholders Engagement, Situation Analysis and Learning Phase 2: Technical Support and South-South Exchange Phase 3: Development of National IP Policy and Implementation Plan Phase 4: Review of associated IP Statutes Phase 5: Advocacy on enactment of IP Bills Phase 6: Enactment and Awareness Raising Phase 7: Application, Capacity Building, M&E

 Zambia participated in a three-country comparative study on TRIPS and Public Health in relation to essential medicines in 2007:-  Ghana  South Africa  Zambia  The study was followed up by a Pretoria Working Group meeting in November 2007  The Group Meeting revealed that Ghana was TRIPS compliant and well advanced in the implementation process.

 Ghana and Zambia have a lot in common:  both inherited their IP regimes from the British.  Ghana and Zambia are members of ARIPO  have patent administration systems that are very similar.  However, unlike Zambia, Ghana has experience in regional networking, coordination and harmonization of IP rights. i.e. ECOWAS

 Zambia not TRIPS complaint  Had not yet reviewed its national IP statutes to take advantage of the TRIPS flexibilities on Public health and pharmaceutical products.  The Patent Act provides for some flexibilities although it is not exhaustive i.e. in certain parts it falls short of the provisions of the TRIPS Agreement while in other parts it exceeds the recommendations of WTO on TRIPS.

 There were provisions for Compulsory Licensing but the provisions are ambiguous and out dated; provisions are ambiguous and out dated;  The definition of non patentable subject matter has not been properly clarified. properly clarified.  The exhaustion of rights and parallel importation of patentable medicines has not been provided for. medicines has not been provided for.

 The issuance of Compulsory Licenses had not been properly defined i.e. which competent authority must issue the Compulsory Licenses ;  Coordination among stakeholders was inadequate;  There was no provision for regional patents Compulsory Licenses, although the TRIPS Agreement provides for such;  There were inadequate guidelines on the monitoring and enforcement of IP Rights relating to the pharmaceutical products.  There was inadequate guidance on how to conduct clinical trials on pharmaceutical product

The Zambian Delegation poses for a photo with the Deputy Minister of Health, Ghana, in the middle and some of her Team, on far ends. This was after the de-brief on the scope of the Mission. Ghana Study Tour Dissemination and Validation Meeting held on 4 th December 2008 UNDP & NAC-MOH/GRZ: Ghana Study Tour Dissemination and Validation Meeting held on 4 th December 2008

 TRIP constitute one of the biggest challenge for LDCs in amending various pieces of legislation in order to become TRIPS compliant.  Taking full advantage of Paragraph 6 of the Doha Declaration on TRIPS in accessing essential medicines in case of national emergencies is critical to scaling up and sustaining the response to epidemic.  The compelling premise is that:  Zambia is a LDC and not TRIPS compliant.  Zambia does not have sufficient manufacturing capacity of most essential medicines and would therefore greatly benefit from the issuance of Compulsory Licenses and provisions on parallel importation and exhaustion of rights if the provisions of TRIPS were domesticated into the national laws. 9

 The Zambian delegation, led by Officials from the Ministry of Commerce and the Ministry of Health, resolved to constitute a working group on TRIPS and public health with emphasis on essential medicines  It was further resolved to undertake a study tour of Ghana in order to learn from Ghana’s experience in the domestication process and how to become TRIPS compliance. 10

 Selected Institutions for the study tour  Ministry of Health  Food and Drug Board  Ghana National Drug Program  Ghana National Aids Control Program  Ghana National Aids Commission  Ghana National drug Program,  Ministry of Trade and Industry  Ministry of Justice  Registrar General  Cooperating Partners  WHO and  UNDP  Private pharmaceutical company  LaGray, based in Accra. 11

 Full Mission Report and associated Roadmap are available and can be shared upon request:-  Domestication of TRIPS is a mammoth, ongoing task.  The Patent Office in Ghana is under the Office of Registrar General, a department in the Ministry of Justice, The coordination was simplified in that the same ministry that was responsible for protection of IP Rights was also responsible for legislative drafting.  Political will was exhibited from the inception of the process by involving Ministers from all line ministries under the chairmanship of the Vice President.  For Ghana, the process began in 2000 with the drafting of layman’s drafts by Office of the Registrar General and ended in 2003 after parliament passed the bills into law.  Ministry of Finance increased funding to key institutions tasked with responsibility of domestication.  There were a lot conflicts that arose during the domestication process due various interests by line ministries and stakeholders.  It was eventually resolved that the Patent Act be the only guide on the protection and granting of pharmaceutical Patents. 12

 Policy document and implementation plan have been shared widely  Situation in Zambia:  Use of flexibility – limited if any implementation of TRIPS flexibilities  Policy option:  Make full use of flexibility, while:  Engaging in a ‘bottom up’ process of revising domestic legal framework that reflects domestic development policy  And that integrates relevant stakeholder concerns/interests  No protection of pharmaceutical products until

 Current Situation  Pharmaceuticals are not excluded from patent protection in Zambia  Apart from those with ‘known ingredients’ (Art. 18c)  No reference to parallel importation – thus national exhaustion applies  Options or enhancements and implications of current draft IP Bills:  Will be detailed in upcoming presentations: 14

 Need for greater policy coherence:  Current Inter-Ministerial Working Group on TRIPS: o Exchange among different stakeholders to identify appropriate IP systems and coordination mechanisms for Zambia o Involve non-governmental stakeholders i.e CPs, NGOs  PACRO – ZMRA - Ministry of Commerce – Ministry of Health i.e. dealing with patented and none patented drugs o Greater communication needed among the Agencies o To allow for identification of TRIPS flexibilities important for Zambian context o Make use of TRIPS Flexibilities for improved bargaining 15

 More capacity building is needed:  Health and Trade Authorities, Procurement Agents, International Organisations and NGOs  Sensitisation on IPRs and how they affect their work  Make use of flexibilities (including Para 6) to reduce prices  How can they serve as incentive to increase domestic manufacturing  Procurement Agencies  Different regulatory approval processes for different funds  TA is needed to support domestic pharmaceutical and food processing industries in meeting WHO standards  Overall procurement capacity by Government 16

 Eagerly awaited.  Potentially next year given constitutional process  Need to be clear in advance on mechanisms for application/use of flexibilities for the wider public health good  Entails clarity of provisions in the IP Policy and its Implementation Plan  Continual stakeholders engagement in a Standing Committee or Fora co-led by MCTI and MOH, and inclusive of relevant CSOs. 17

 Domestication of TRIPS offers policy space and options for Zambia towards meeting health-related MDGs  Beyond enactment of revised IP Bills, formulate regulations and guidelines will be cardinal.  Various stakeholders, including ZPPA & ZRA must continue to be engaged to take advantage TRIPS provisions on pooled procurement i.e. COMESA, SADC 18

9 August