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HEALTH-UGANDA: EU Supports Law Threatening Access to Medicines

Wambi Michael

KAMPALA, Mar 15 2010 (IPS) - The European Union (EU) is funding the drafting of Uganda’s controversial Counterfeit Goods Bill, a proposed law that has caused an outcry as it threatens access to life-saving generic medicines in this low income East African country. Some 90 percent of medicines used in Uganda’s health-care system are imported, of which about 93 percent are generics.

IPS received information that part of the five million euros that Uganda’s ministry on tourism, trade and industry received from the EU in a financing agreement signed in July 2009 was to finance the drafting of this contentious bill that has consistently been criticised as a threat to treatment.

The financing agreement is aimed at supporting Uganda’s implementation of the economic partnership agreement (EPA) between the EU and East African countries.

Simon Lokodo, Uganda’s state minister for industry, admitted in an interview with IPS that the process of formulating the bill has been funded by the EU.

“We get support from the European Union. With the support we get from them we have managed to employ someone who has helped us to dig into the matter and work with other partners to develop the bill which is before cabinet now,” he said.

Lokodo told IPS that there was nothing peculiar with the EU funding anti-counterfeit policies as part of other support to the trade sector.

“You have seen our markets flooded with counterfeit goods. Those goods are not only impacting our lives but they are killing our industries. I think it is better to work with the EU and other partners to fight those goods,” he said.

But activists have been puzzled by the Ugandan government’s willingness to adopt a law that defines counterfeiting so broadly as to criminalise the production and importation of generic medicines, thereby placing affordable and legitimate medicines outside the reach of millions of people in a country struggling with HIV and AIDS and malaria.

This step has been all the more perplexing since Uganda, as a least developed country, has until 2016 before it is obliged to provide patent protection for pharmaceutical products as per the Trade-Related Aspects of Intellectual Property Rights (TRIPS) regime of the World Trade Organisation.

Harvey Rouse, head of the political and trade section of the EU delegation to Uganda, confirmed to IPS that part of the five million euro financing agreement entered into with Uganda in July 2009 involves developing an anti-counterfeits law.

He said, “we are supporting the ministry of trade … to reform its policy and legal/regulatory regimes, (including on) counterfeits… This support is under the EPA (economic partnership agreement)-related trade and private sector development programme … (implemented over) the next four years.”

In response to further questions about whether the EU delegation was aware of the obstacles to public healthcare that the bill poses, Alex Nakajjo, trade operations officer at the EU delegation in Kampala, pointed out that the bill “targets only people who infringe on protected intellectual property rights … The EU does not support counterfeits trade and counterfeits should not … be confused with generic drugs”.

Moreover, he said, the EU had previously “pushed for a provision to ease access to generic drugs for developing countries under the TRIPS Agreement. The EU as one of the largest donors in the world believes (in) and promotes access to generic drugs for developing countries”.

However, the Ugandan law, like the recently adopted Kenyan law and the pending East African Community law, makes no distinction between legal generic medication and counterfeits, according to the Program on Information Justice and Intellectual Property (PIJIP) at the Washington College of Law in Washington, DC.

PIJIP runs a training programme on the use of intellectual property (IP) flexibilities to ensure access to generic medication.

Activists also point out that, while substandard and fake medicines should not be tolerated, the proposed law will not address the problem of bad quality as it confuses IP rights with quality standards.

Intellectual property rights expert Sisule Musungu pointed to the following that indicate that the draft law is about trade interests and not about safety standards: the channelling of such legislation through trade ministries rather than health ministries which have been working on safety standards for drugs for many years; and the involvement of customs and police rather than health authorities.

Another indication is that the funding of the law comes from money allocated to trade rather than health policy.

Musungu explained the push behind the law as follows: if liberalisation of trade in agricultural and manufactured goods continues, it will eventually mean that the EU and the U.S. will be unable to compete in agriculture with Brazil and in manufactures with China and India.

All that remains for the EU and U.S. in terms of comparative advantage is services and intellectual property rights.

“Intellectual property has become a very important part of the EU’s foreign policy… The big players in the West won’t get very far if they use the standard IP entry point because of the awareness that exists in many developing countries about the effect of IP on access to medicines and other things.

“And so, using the language of counterfeits strategically is basically a strategy to get via another way what you would normally get through IP laws,” he concluded.

IPS has traced the evolution of the law and found that the EU’s association with the drive for anti-counterfeit legislation goes further back. The EU funded the Ugandan trade ministry’s trade sector review conference on Oct 30, 2008 through a programme for the “technical support for the economic partnership agreement finalisation”.

At this conference the first version of the Counterfeit Goods Bill was discussed in a presentation by Private Sector Foundation Uganda (PSFU) chairperson and former Ugandan finance minister Gerald Ssendaula.

The PSFU, which represents 81 business associations and public sector agencies, has been among the primary organisations in Uganda working with other groups in East Africa to push for national and regional anti-counterfeit policies.

At the time Ssendaula identified counterfeits as one of the main challenges in the business environment in Uganda.

He said that, “the private sector notes with concern that the penalty in the draft counterfeits bill is not punitive enough to deter counterfeiting and trademark malpractices. We call upon the government to review the relevant clauses with a view of making them more punitive.”

Ssenduala suggested five-year jail terms for counterfeiters and the establishment of a regional and international link with other bodies to curb importation of fake goods.

The EU delegation’s Rouse told IPS that Uganda lacks adequate legislation and enforcement of IP rights and has weak punitive measures that encourage trade in counterfeits. Uganda also needs a specific institution charged with fighting counterfeits. This position is reflected in the Counterfeit Goods Bill.

Most other countries requires “wilful deception” or piracy “on a commercial scale” for IP infringement to be regarded as counterfeiting. The World Health Organisation also sets the minimum measure of counterfeit to be “deliberate and fraudulent mislabelling” and “misrepresentation of identity or source”.

But in the East African cases, unknowing infringement is made a criminal offence. In the Ugandan case the bill prescribes hefty fines and even prison sentences of up to 20 years. This is in stark contrast to the use of civil remedies that are the internationally accepted legal practice in cases of IP infringement, said Musungu.

Legal experts have argued that Uganda has the necessary laws in place to address the problem of counterfeiting, for example the Copyright Act, Trademarks Act, Patents Act, Trade Secrets Act and sections in the Penal Code which criminalise the sale of counterfeits.

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