managing procurement and logistics of hiv/aids drugs and related supplies by yvonne nkrumah legal...

Managing Procurement and Logistics of HIV/AIDS Drugs

and Related Supplies

ByYvonne Nkrumah

Legal Counsel, Ghana Food and Drugs Board

Objectives of The Presentation

To understand the flexibilities of

the TRIPS Agreement

To develop a practical approach to

implementing the TRIPS

Flexibilities

Implementation challenges

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

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

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

TRIPS Flexibilities

Compulsory Licensing -- generics

Voluntary Licensing

Parallel Import – based on the principle of exhaustion of rights

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)

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

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???

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

SCENARIO BWhere the medicine is patented in the Namibia and in

India

Compensation to be paid by India

XPatented in

India

Patented in Namibia

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

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

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

$2

Patent

holder

THAILAND

$6

Kenya

Parallel Importer

$3

Patented Product

Patent holder

PARALLEL IMPORTS

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

Operationalising the Flexibilities

Developed sensitization strategies for appropriate policy direction

Developed administrative guidelines for maximizing the advantages of the flexibilitiesEg Ghana’s experience

“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

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????

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????