Managing Procurement and Logistics of HIV/AIDS Drugs and Related Supplies By Yvonne 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  Patent  An 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 X Not patented in country of export Patented in Ghana

SCENARIO B  Where the medicine is patented in the Namibia and in India  Compensation to be paid by India X Patented in India Patented in Namibia

CL and Price of Medicines 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 flexibilities Eg Ghana’s experience

“Getting the Law right”  Incorporate TRIPs flexibilities to the fullest  Empower state to act  Strong government use provisions for state to discharge its human rights obligations  Empower third parties to act  State may be unwilling/unable to act  Limit unnecessary litigation  Clear, reliable and predictable rules  Avoid expensive to administer system

Local Production???  Baseline study to determine viability  WHO Prequalification issues  Capacity 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 Africa  Conditionality of some Development Partners’ funding (U.S )  Coordination - engaging collaborating agencies??? Determining the lead agency????  Lack of political will to take advantage of flexibilities????