PATENTS AND HEALTH. A CASE STUDY OF THE UGANDAN CONTEXT. (PHA3 JULY 7 TH 2012 –CAPE TOWN, SOUTH AFRICA) MS. MARIAM AKIROR LLB (HONS) / DIP. SW / CPC. PROG. OFF. RESEARCH & MONITORING (HEALTH & HUMAN RIGHTS). HEPS – UGANDA.

WHAT IS A PATENT? Is an exclusive right awarded to an inventor to prevent others from making, selling, distributing, importing or using their invention, without license or authorisation from the patent holder for a fixed period of time (TRIPS Agreement stipulates at least 20 years of protection).

WHAT IS HEALTH? “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” (1946 WHO CONST’N)

REQUIREMENTS FOR PATENTABILITY OF AN INVENTION 1.Novelty- New characteristics which are not “prior art”. 2.An Inventive Step – Not obvious to one skilled in the field. 3.Industrial Applicability.

WHAT IS THE IMPLICATION OF PATENTS ON HEALTH? 1.Patent Rights on Medicines lead to Monopoly Pricing, Affordable only to the Rich. E.G, a 20 year Patent for an Essential Medicine will mean that only the Patent holder can produce it for that period, before Competitors can be permitted to produce it. And during the 20 years, the Patent holder can most likely produce less than the required quantities and sell at high prices.

IMPLICATION OF PATENTS ON HEALTH CONTINUED The above can mean that many people, particularly in poor countries like Uganda, would die due to inability to afford the Medicine. This can be worse in the case of dynamic diseases like HIV/AIDS, where new Medicines are being continuously developed to keep pace with the changing nature of the HIV virus. Long Patents for such Medicines may deny poor people access forever!

IMPLICATION OF PATENT ON HEALTH CONTINUED 2. A Patent gives the holder the Right to exclude Competition. 3. Right to set prices at what the Market will bear. E.G, “Research Based” Pharmaceutical Companies (Basically Multinational Cos) use the protection & enforcement of Patents & Test Data to gain monopoly rights which then allows them to charge very high prices & obtain profitability.

IMPLICATION OF PATENT ON HEALTH CONTINUED E.G, in 2000, the price of HAART in Kampala & Durban S.A was the same as in NY City- $ 10,439 per patient per year. However, today due to the entry of Generic Drugs from India that had no Patent protection for Pharmaceutical products & thus was able to manufacture Generic versions of patented products; prices have reduced dramatically to less than 150$ per person per year- 6.6 Million people in low-income countries now have access to ARVs.

CHALLENGE TO HEALTH BY OTHER UGANDAN IPR PROPOSED LEGISLATION INDUSTRIAL PROPERTY BILL,2009; Doesn’t provide for any extension period; Bolar provisions only allow Scientific Research; it excludes Drug Testing, approval & registration which may delay post-patent competition; on Compulsory license, unnecessary barriers have been proposed by requiring applicants to go through lengthy court procedures. ANTI-COUNTERFEIT GOODS BILL NO.22 /2012; Risk of wrongful Border seizures still high. Both Bills still have TRIPS-Plus provisions; Industrial Property Bill has not fully utilised TRIPS Flexibilities that protect & promote public health particularly access to medicines.

CONCLUSION In designing Intellectual Property Laws that affect Public Health for example Patents, there is need to retain maximum Policy space for Generic competition by utilising the Flexibilities / safeguards provided by the TRIPS Agreement. It is worth recalling the WTO’s Doha Declaration on the TRIPS Agreement & Public Health that confirm the right of WTO Members to implement the TRIPS obligations in a manner that ensures the protection of Public Health particularly Access to Medicines by all. We call upon all LDCs to support the push for a Transition Period to either 2025 OR 2030 to be TRIPS compliant; our technology & Pharmaceutical Industry is still wanting; E.G, 90% of Uganda’s Medicines are imports from India; we have only one Pharmaceutical Industry (QCIL) manufacturing ARVs of a Generic Version.

THANK YOU FOR LISTENING, PLIZ!!!