Counterfeit law will hinder manufacture, access of drugs

Calls to review some of the most defining clauses contained in the proposed counterfeit law has gathered some momentum, with the section of analysts and Civil Society Organisations (CSOs), cautioning the executive arm of government against re-tabling the bill on the floor of parliament in its current form.

The proposed law, titled, the Anti-Counterfeiting Goods Bill, 2015 seeks to prohibit the manufacture and trade in counterfeit goods that infringe upon protected intellectual property rights, something analysts and a range of CSOs describe as “suicidal provision” for the country.

The bill also intends to prohibit release of counterfeit goods in channels of commerce and create offences relating to trade in counterfeit goods.

Speaking yesterday at the stakeholders consultative meeting held in Kampala on “The changes in the Health landscape and implications to the Right to Health in Uganda” Amb. Nathan Irumba, a seasoned trade and investment negotiator and a veteran trade analysts, said: “Agreements related to the protected intellectual property rights are more restrictive.”

He continued: “So the drafters of the proposed law are shooting themselves in the foot because that provision essentially means that Uganda will have no access or even rights to manufacture generic drugs yet it is the most affordable and widely prescribed kind of medicines across the country.”

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their effects are exactly the same as those of their brand-name counterparts.

 Analysts dissects

Weighing in on the matter, Prof. Mwambutsya Ndebesa, a renowned scholar and political, social and economic analyst, said the proposed law currently being reexamined by Cabinet, violates the right to access to drugs/medicine as well as the right to health.

This is because if the bill finds its way to the floor of parliament and somehow get passed in its current form, it will effectively render pharmaceutical industry in the country useless. In addition it will be illegal to manufacture generic drugs here. And those caught doing so (manufacturing drugs) will be held criminally liable. 

In the presentation of the Program Officer, SEATINI-Uganda, Mr Kiiza Africa, it became evident that the definition of counterfeit as contained in the proposed bill is not only problematic but also exposes the country to unnecessary restriction to access of the much-subsidized drugs.

Should the bill make a comeback in parliament and given a nod of approval, it will make it impossible for the majority of the population to access drugs at affordable prices. But to cure this problem, Mr Kiiza seems to suggest that thorough diagnosis of Trade-Related Aspects of Intellectual Property Rights (TRIPS) be conducted.

TRIPS is an international legal agreement between all the member nations of the World Trade Organization (WTO).  It sets down minimum standards for the regulation by national governments of many forms of intellectual property (IP) as applied to nationals of other WTO member nations.

TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO

The Executive Director, HEPS, Mr Kibira Dennis, in his submission said the proposed law will render generic drugs as counterfeit, urging the drafters of the bill to adopt the World Health Organisation definition which clearly distinguishes between counterfeit and falsification of drugs.

However, Dr. David Okello, the Director Non-Communicable Diseases and Health Ageing, wondered how the influx of substandard and fake drugs can be curtailed in the absence of such a law. It emerged that there are already laws in place to deal with such violation although not being properly enforced.          

As a way forward, Amb Irumba advised that Uganda and the Least Developed Countries should continue to take advantage the TRIPS agreement which allows them access to manufacture generic drugs.

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In spite of some strides made in policies and frameworks, the health sector is still confronted with a number of challenges and dynamics which have subsequently made access to health in Uganda a challenge.

These dynamics vary from the New Aid Architecture; Public Private Partnership (PPPs) in Health Sector; Mobility of Health Workers and trade related policies like TRIPS. The purpose of the meeting organized by SEATINI-Uganda was therefore important for the stakeholders including Policy Makers, Human Rights and Health Rights activists to engage with a view of forging a solution forward