Transcript Supporting Zambia to maximize TRIPS flexibilities in patent

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
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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;
 The definition of non patentable subject matter has not been
properly clarified.
 The exhaustion of rights and parallel importation of patentable
medicines has not been provided for.
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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.
UNDP & NAC-MOH/GRZ: Ghana Study Tour Dissemination and Validation
Meeting held on 4th 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.
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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.
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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.
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
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.
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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.
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
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Policy document and implementation plan have
been shared widely
Situation in Zambia:
Use of flexibility – limited if any implementation of TRIPS
flexibilities
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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 2021+
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
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:
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
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
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
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
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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.
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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
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11 April 2016
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