[Ip-health] WHO Happy With Counterfeit Bill; Activists Not

Riaz Tayob riaz.tayob at gmail.com
Wed Aug 11 03:28:35 PDT 2010

WHO Happy With Counterfeit Bill; Activists Not
By 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.

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. (END)"




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