Global IssuesHEALTH-UGANDA: Problems with Anti-Counterfeit Bill Persist
Health rights activists still insist that, despite some improvements to Uganda’s controversial Anti-Counterfeiting Bill, it will affect the availability of generic medicine if enacted in present form.
The bill has been improved with regard to the functions of different enforcement agencies. In the first draft there was confusion about the roles of various agencies.
The first draft of the bill gave the Uganda National Bureau of Standards (UNBS) the mandate to seize and detain suspected counterfeit goods, a function already fulfilled by the Uganda National Drug Authority (NDA).
The NDA was established under the National Drug Policy and Authority Act of 1993 with a mandate to safeguard the appropriate use of drugs and to regulate the quality of medicines.
Raising concern about the roles of agencies, Dr Sandra Kiapi, executive director at the nongovernmental Action Group for Health, Human Rights and HIV/AIDS (AGHA), said that, 'it is important to regulate the sale of drugs, knowing the danger that fakes pose to people’s lives. But my question is: whose mandate should this be?'
The latest draft addresses this issue by stipulating in clause 20 that any matters relating to the counterfeiting of medicines will be dealt with by the NDA under the National Drug Policy and Authority Act.
But the definition of counterfeiting in the bill remains a problem.
IPS spoke to Raymond Agaba, commissioner for internal trade in the ministry of tourism, trade and industry in Uganda, who said that, 'those fears expressed were originally as a result of the first draft which was more or less like the Kenya model.
'The Kenya model had such problems,' added Agaba, who was referring to neighbouring Kenya’s Anti-Counterfeit Act of 2008, of which the application to medicines has been suspended by that country’s Constitutional Court.
The Kenyan law is the first of a spate of intellectual property (IP) rights laws currently under consideration in several African countries and at the level of the East African Community.
These laws and bills are ostensibly designed to address the problem of counterfeit goods across the board.
But, by conflating quality issues with IP, these laws and bills will in practice block the importation of generic medicines on which most African countries are dependent -- in many cases for up to 90 percent of their healthcare needs.
But Agaba insisted that the second draft of the Ugandan bill 'has taken care of the (issue of) generics and generics are now allowed, and that is of foremost importance.
'That is our key consideration in ensuring that we protect the health of our people. We have consulted and the new draft has taken care of that.
'We have allowed that flexibility,' he added, referring to the IP allowances given to least developed countries (LDCs) in the international trade regime.
The World Health Organisation’s Uganda office has also said that it is satisfied with the second draft of the bill.
However, the clause on medicine that has been added to the definition of counterfeiting in the second draft of the Ugandan bill was copied from the problematic Kenyan law.
It reads that, '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'.
Third World Network (TWN) has previously pointed out the dangers of this definition by noting 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 a counterfeit drug', according to TWN legal advisor Sangeeta Shashikant
'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 issues and not health issues,' she warned.
TWN is an independent, non-profit, international network of organisations and individuals involved in issues relating to development and Third World and North-South affairs.
Moses Mulumba, a Kampala-based health rights activist and IP legal expert, added another issue: 'How does this clause relate to the clause defining counterfeit goods in the bill?
'Because, in defining these goods, the clause makes reference to the trademark and copyright law of the country of importation. In the case of Uganda, these laws already have accepted exceptions which the Anti- Counterfeiting Bill seems to disregard.'
These exceptions are in terms of the flexibilities granted to LDCs in the international trade regime.
Mulumba also added that there is 'an explicit presumption in the bill that quality issues can be dealt with using intellectual property law, which is fundamentally wrong'.
Activists are still concerned that, despite Agaba’s insistence that 'stakeholders' have been consulted about the drafting of the bill, the formulation of the bill is still not transparent.
The ministry of tourism, trade and industry has failed to even share amended versions, Mulumba said.
Civil society organisations suspect that their briefing papers critiquing the bill informed the ministry about the implications of the bill for access to medicines, hence the second draft.
'I am not sure that there is an appreciation of the fact that this bill also has implications for other sectors, such as agriculture and education,' Mulumba warned.
© Inter Press Service (2010) — All Rights ReservedOriginal source: Inter Press Service