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HEALTH: Uganda Bill Shouldn’t Block Generics, Minister Agrees

Wambi Michael

KAMPALA, Apr 28 2010 (IPS) - Uganda’s trade minister is in agreement that his government’s controversial Counterfeit Goods Bill should not restrict the manufacture or import of life-saving generic medicines.

The bill, drafted with funding from the European Union, suggests criminal penalties for counterfeiting.

Counterfeiting is defined expansively as the manufacturing, producing, packaging, re-packaging, labelling or making of any goods which are imitated so as to be substantially similar to the protected goods without the authority of the intellectual property (IP) right owner subsisting in the country or elsewhere.

With reference to the World Trade Organisation’s 2001 Doha Declaration, Gagawala Wambuzi, Uganda’s minister for trade who is spearheading the bill, indicated that his government is aware that the U.S. and the EU have agreed that least developed countries (LDCs) should enjoy greater flexibility with regards IP and medicines.

“Basically the issue of generic drugs for LDCs like Uganda, Tanzania, Rwanda and Burundi is not a big story. They have to allow us to manufacture generics. An LDC must be allowed to do certain things so that we are able to catch up (developmentally) and so that we are able to manufacture generic drugs. That is what it is all about,” Wambuzi acknowledged.

Regarding the civil society campaign about the detrimental consequences of the bill as it currently stands, Wambuzi said, “we cannot make a bill against ourselves. Why would we do it; to favour whom? The bill is for us.”

He added that Uganda’s interest in such a law is to have its industries protected from counterfeiters whom he said are targeting all Ugandan products.

The Uganda Registration Services Bureau, which is charged with the registration of patents, trademarks and copyright, also realises the dangers of the bill in its current form.

Bisereko Kyomuhendo, acting registrar general of the bureau, told IPS that, “we are trying to highlight to the sponsoring ministry that intellectual property issues should not be mixed up with issue to do with enforcement and access to medicine”.

The bureau believes the bill should be redrafted to specifically only fill the gaps in the existing IP legal frameworks in the Copyright Act and Trademarks Act.

Regarding the progress with redrafting, Elizabeth Tamale, the principal commercial officer in the trade ministry, told IPS: “At the moment there are some comments which we have to include into the final document.” These were to be forwarded to the drafters of the bill, she confirmed.

India-based pharmaceutical company Cipla Ltd has partnered with Quality Chemicals in Uganda to locally produce generic antiretroviral (ARVs) and anti-malarial medicines. Similar initiatives, under compulsory licensing arrangements, are happening in Ghana, South Africa, and Mozambique.

Compulsory licensing “is when a government allows someone else to produce the patented product or process without the consent of the patent owner”, according to the World Trade Organisation (WTO) website. The WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement of 1995 allows for this.

Apart from the Ugandan Counterfeit Goods Bill and the Kenyan Anti-Counterfeit Act of 2008, Tanzania also adopted new regulations in 2008, attached to the Merchandise Marks Act, that threaten to have a similar effect on the production of generic medicines as the legislative measures taken by its neighbours.

George Baguma, chief commercial officer with Quality Chemicals, told IPS that, “the anti-counterfeits bills in East Africa should be shelved. I think we are comfortable without them. We still need more pharmaceutical companies in East Africa if we are to provide affordable medicines to our people.

“The effect of these bills is that our plant will close and we shall not produce any more drugs. But what are more important are not even the drugs we are producing now. There are newer drugs which are being produced. We need to access that technology. Basically, if those laws are passed we shall limit our people to old drugs,” he cautioned.

The local production of ARVs by Quality Chemicals will assist Uganda in providing treatment to the projected 263,000 people who will need it by 2012 and the 342,200 people who will require treatment by 2020.

Hakiel Mgonja, assistant registrar at Tanzania’s Business Registration and Licensing Agency, agreed at a recent meeting in Arusha, Tanzania, that it would be a mistake for the region to prevent local production of medicines, given that most people still cannot access essential medicines because of cost.

“In Tanzania we are saying we have the merchandise law and it is working, even for fighting counterfeits. You cannot make a monster and keep it at home because it will eat your children and later on eat you. So we have to create mechanisms for an atmosphere for the pharmaceutical industry if we are to attain universal access,” said Mgonja.

The 2009 World Health Organisation report titled “Towards Universal Access” indicated that 66 percent (or 6,7 million) of eligible people in sub-Saharan Africa are still not receiving ARV treatment. It also indicated that about three million people, who are already on treatment, will need to continue receiving ARVs for the rest of their lives.

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