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Thursday, October 28, 2021
KAMPALA, May 6 2010 (IPS) - The Ugandan government’s controversial Anti-Counterfeiting Bill has been amended after civil society organisations campaigned against provisions in the bill that may restrict access to generic medicines, which form the bulk of medicines used in the East African country.
Organisations such as Health Action International Africa (HAI Africa) and the Coalition for Health Promotion and Social Development (HEPS Uganda) pointed out that the definition of counterfeit goods in the first version of the bill was so wide as to criminalise the production and importation of legitimate, effective generic medication.
IPS has obtained the latest version of the bill in which the definition of counterfeiting and counterfeit goods is restricted to copyright and trademarks and excludes patents.
Furthermore, a specific clause on medicines has been inserted that reads: “in the case of medicines, (counterfeiting) includes the deliberate and fraudulent mislabelling of medicines with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging”.
Paul Asiimwe, a lawyer with Kampala-based Sipi Law Associates specialising in IP law, told IPS that the latest version of the bill has improved the clauses which may have an effect on access to medicines.
He believes that the new version creates clarity about the definition of counterfeits with the previous more expansive definition that included patents having been dropped.
The definition was originally developed at a 1992 workshop of the World Health Organisation and the International Federation of Pharmaceutical Manufacturers and Associations. The latter is a global non-profit nongovernmental organisation that represents large multinational pharmaceutical companies and national and regional associations.
Sangeeta Shashikant, legal advisor at Third World Network (TWN) in Geneva, pointed out the dangers of this definition previously when she wrote that, “the terms ‘identity’ and ‘source’ are not explained (therefore) ‘identity’ could also refer to (the) trademark or the trade name of the drug, which means that a drug of good quality but having a close similarity with another trademark or trade name can be termed as a counterfeit drug.”
She added that, “the term ‘source’ could be interpreted to mean the patent holder of that product or the chemical entity. In both cases the definition would address IP (intellectual property) issues and not health issues.”
TWN is an “independent, non-profit, international network of organisations and individuals involved in issues relating to development, Third World and North-South affairs”.
Asiimwe also pointed out that the latest version of the bill gives the National Drug Authority express jurisdiction to handle matters where medicines are involved.
This, Asiimwe believes, should allay the fears of those who felt that the Uganda National Bureau of Standards, which was previously tasked with fighting counterfeits, was not competent to deal with or distinguish counterfeits from generic drugs.
The Anti-Counterfeiting Bill has been in the making for two years. It is currently being discussed at cabinet level and is expected to become law later this year.
Ugandan president Yoweri Museveni had in the past called for tougher laws against counterfeiters. He had suggested that counterfeiters should be “hanged”.
Uganda is a least developed country (LDC) which, under the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, does not have to protect intellectual property rights until July 2013.
Regarding pharmaceuticals, Uganda does not have to put in place IP protections until 2016.
Civil society organisations are concerned that the passing of the bill would trade away the flexibilities which the WTO had extended to LDCs under the TRIPS agreement and that allow them take advantage of technological advancements and gain the capacity to produce their own drugs.
They had warned the Ugandan government against following the dangerous path to impose an IP-based framework that hinders access to generic medicines.
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