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Managing Procurement and Logistics of HIV/AIDS Drugs
and Related Supplies
ByYvonne Nkrumah
Legal Counsel, Ghana Food and Drugs Board
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Objectives of The Presentation
To understand the flexibilities of
the TRIPS Agreement
To develop a practical approach to
implementing the TRIPS
Flexibilities
Implementation challenges
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Categories of IPR
Trademark: a right granted to exclude others from the use of a sign that creates confusion in distinguishing the goods or services of one enterprise from those of other enterprises (e.g., Coca-Cola)
Copyright: right granted to author of “expressive” work (e.g., book or song) to prevent others from copying and distributing– No protection for technical information or data– Patient brochures accompanying medicine
(such are not protected
THE TRIPS AGREEMENT CREATES MINIMUM STANDARDS FOR THE PROTECTION OF IPRS
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PATENTS
PatentAn exclusive right granted for the protection of an
invention of a technological product or process that is new, useful and involves an inventive step.
The protection is against unauthorized, making, using, offering for sale or selling or importing the patented item.
Period of protection is 20 years from the date of filing of the application for the patent.
Patent is valid only in the country where protection is granted
NEW IS NOT EQUAL TO PATENT PROTECTION
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Where are we?
Developing countries: Patents should be protected
E.g. Kenya, Zimbabwe, South Africa, Ghana
LDCs: – should not protect patents for pharmaceutical products until 2016 – Zambia, Gambia, Malawi, etc
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TRIPS Flexibilities
Compulsory Licensing -- generics
Voluntary Licensing
Parallel Import – based on the principle of exhaustion of rights
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1. Compulsory License
Enables a government to issue a license to a third party, whether a private company or government agency, to use or exploit a patent without the patent holder’s consent.Government Use Order (for public non
commercial use)Third Party Use (eg. local manufacturers
of ARVS)
Compensation of patent holder through payment of remuneration ( this does not prevent governments from procurement)
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Grounds for CL
Situations of national emergency and extreme urgency
Cases of public non-commercial use
Challenge: issue of countries with insufficient or no manufacturing capacity
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Procurement Checklist
What are you buying????
What is the patent status of what you are buying in the importing country???
Where are we buying from???
What is the patent status of the product in the country of export???
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SCENARIO A
Where the medicine is patented in Ghana and not in the country of export
Based on patent act Payment of compensation by importing country
XNot patented in country of export
Patented in Ghana
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SCENARIO BWhere the medicine is patented in the Namibia and in
India
Compensation to be paid by India
XPatented in
India
Patented in Namibia
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CL and Price of MedicinesTrend in Cost of Therapy Per Patient Per Year
(AZT+3TC+NVP)
$495
$235
2003 2005Year of Procurement
Co
st o
f T
her
apy
(US
D)
Ghana
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2. Voluntary License
South Africa: VL was granted to some
pharmaceutical companies to produce generic
versions of patented ARVs of GSK and BI
Kenya: Cosmos Ltd was granted VL by GSK and
BI for the Eastern African Countries
Ensure economies of scale by negotiating a wider territory
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3. Parallel Importation
Parallel importation involves the import and resale in a country, without the consent of the patent holder, of a patented product that was put on the market of the exporting country by the patent holder.
The Procurement Authority could parallel import medicines by buying the patented version of the medicine at the lowest price available on the world market regardless of where the medicine is placed on the market
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$2
Patent
holder
THAILAND
$6
Kenya
Parallel Importer
$3
Patented Product
Patent holder
PARALLEL IMPORTS
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Parallel Importation
Parallel imports is permissible under
the principle of international
exhaustion of patent rights.
Domestic laws should ensure that
rights are exhausted
internationally and not nationally
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Operationalising the Flexibilities
Developed sensitization strategies for appropriate policy direction
Developed administrative guidelines for maximizing the advantages of the flexibilitiesEg Ghana’s experience
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“Getting the Law right”
Incorporate TRIPs flexibilities to the fullestEmpower state to actStrong government use provisions for state
to discharge its human rights obligationsEmpower third parties to actState may be unwilling/unable to actLimit unnecessary litigationClear, reliable and predictable rulesAvoid expensive to administer system
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Local Production???
Baseline study to determine viabilityWHO Prequalification issuesCapacity to assure to quality????? Changes to WHO treatment guidelines???Procurement of APIs vrs availability of
foreign exchange???Economies of scale????Competitive price????Sustainability????National pride????
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Challenges
Conducting a patent search in AfricaConditionality of some Development
Partners’ funding (U.S )Coordination - engaging collaborating
agencies??? Determining the lead agency????
Lack of political will to take advantage of flexibilities????
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