HEALTH-UGANDA: WHO Happy With Counterfeit Bill; Activists Not

Rosebell Kagumire

KAMPALA, Aug 10 2010 (IPS) – The Uganda office of the World Health Organisation (WHO) and the country s National Drug Authority are satisfied that the new version of the controversial Counterfeit Goods Bill does not threaten the importation and production of generic drugs by conflating them with fake drugs, as the first draft of the bill did. But health rights activists are not convinced.
The Ugandan government amended the Counterfeit Goods Bill after pressure from civil society organisations about provisions that could restrict access to affordable generic medicines, which currently make up the bulk of drugs used in the East African country s health sector.

The definition of counterfeit goods in the first version of the bill was so wide that it would have criminalised the production and importation of legitimate, effective generic medication.

Joseph Mwoga, essential drugs advisor at the WHO country office in Uganda, told IPS that the revised bill would not affect access to generic medicines. The bill was corrected and the fears that generic drugs would be affected are no more, said Mwoga.

The global debate is that in order for us to improve access to drugs we must have generic versions. If the earlier bill was accepted everything not original would have been affected.

Mwoga said it was important that in a bid to cut down on counterfeit drugs entering the country, Uganda doesn t deny the public access to drugs. About 90 percent of the medicines used in the country are imported.
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The WHO defines counterfeit medicines as being deliberately and fraudulently mislabelled with respect to identity and/or source . The health body asserts that counterfeiting applies to both branded and generic products. Counterfeits may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

The National Drug Authority (NDA), whose job would have been disrupted by the first version of the bill, has expressed their satisfaction with the revised bill. They have put in the bill that issues relating to medicines shall be handled by the NDA, so we think that covers our concerns. Our act (the NDA Act) gives us enough powers to deal with drugs, Apollo Muhairwe, NDA registrar, told IPS.

Muhairwe added that, as much as the NDA is the lead agency in regulating drugs, the Uganda National Bureau of Standards (UNBS) should not be totally removed from the function of regulating counterfeit drugs, a power given to it by the earlier version of the bill.

UNBS is supposed to know about the standards of all goods entering Uganda. As much as the NDA is the lead agency, the law should not totally eliminate the role of UNBS, said Muhairwe.

Sandra Kiapi, a health rights lawyer, said that although the new version of the bill is an improvement on the original one because of the role it gives to the NDA, the bill still needs clearer definitions: This bill excludes medicines from the definition of counterfeit goods but there are certain issues that activists are still raising, especially regarding the WHO definition of what constitutes a counterfeit drug.

Of specific concern to activists is that the government, and therefore the bill, should separate intellectual property issues from the issue of the quality of medicines . Activists will therefore continue lobbying government to clarify the distinction between counterfeit and substandard drugs.

There have also been concerns about the East African Anti Counterfeit Bill 2010 (EAC bill), which will supersede all national legislations. Apart from health rights activists who are monitoring progress with the bill to see if it distinguishes between generic and counterfeit drugs, the NDA is also keeping an eye.

We have communicated to our ministry of health to follow up on the East African law in ensuring that medicines are treated differently to other products. Generic medicines should not be part of efforts to control intellectual property, said Muhairwe.

Health rights proponents are concerned that the EAC bill may undermine the possible gains made with the redrafting of the Ugandan bill. Melody Ginamia, a human rights officer with the Uganda Human Rights Commission, argued that efforts should be put in reforming the regional law. The government of Uganda should consider abandoning the Uganda Counterfeit Goods Bill 2010 as it will be superseded by the EAC bill. Further, the government should push for reform of the EAC bill in a bid to ensure the protection of the right to health through access to generic medicines, she wrote in an opinion piece in the local newspaper the Daily Monitor.

Ginamia urged that Uganda take advantage of the flexibilities provided to least developed countries such as Uganda in the Trade-Related Aspects of Intellectual Property (TRIPS) agreement of the World Trade Organisation (WTO). Uganda only has to implement the provisions of the TRIPS agreement on enforcement of intellectual property rights in 2016.