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Kenya generic HIV drugs court ruling sets precedent for Uganda

Henry Zakumumpa

Thousands of people living with HIV and AIDS in East Africa were given new hope last week (25 April 2012), when a High Court judge in Nairobi ruled that Kenya’s anti counterfeit law is unconstitutional in its interpretation of generic HIV drugs as illegal counterfeits.

A generic drug is an identical copy of a brand name, the latter of which are usually manufactured by pharmaceutical giants. Brand drugs such as those manufactured by Pfizer and Norvatis go for prices tailored to Western markets and thus are unaffordable for the majority of patients in sub Saharan Africa. However, many can afford Indian generics, which cost as little as a tenth of the brand price.

Generic drug manufacturers such as CIPLA of India imitate the exact formulas used in brand antiretrovirals (ARVs) drugs through a process called ‘reverse engineering’. The drugs are understood to be as effective as the brand names.

Justice Mumbi Ngugi ruled that intellectual property rights do not override the right to life and health. She found the definition of a ‘counterfeit’ in the Kenya Anti-Counterfeit Act of 2008 to be too broad leading to generic HIV drugs being bundled together with other counterfeits. Justice Mumbi said this vagueness is posing a grave threat to the right to life and health for thousands of Kenyans who depend on life-saving generic ARVs.

The High Court judge has now instructed the Kenyan parliament to review the Anti Counterfeit Act of 2008 and amend the offending articles, which can lead to arbitrary seizures of generic HIV drugs under the pretext that they are ‘counterfeits’, as happened at a Dutch port last year.

Under common law, a high court ruling in Kenya sets a precedent for countries such as Uganda and it is now thought that human rights activists in Uganda and the rest of East Africa will invoke the ruling in any potential suits.

The news will also comes as a welcome development for Ugandan pharmaceutical companies such as the Quality Chemicals Plant in Luzira, most of whose products are generic drugs

While testifying before a Ugandan parliamentary committee last month, Moses Mulumba, a human rights lawyer and intellectual property rights expert, revealed that the Uganda Counterfeit Bill 2010 regards generic AIDS drugs as ‘counterfeits’ and would render 90 % of HIV drugs in Uganda illegal should the bill be passed by parliament and assented to by President Museveni.

With efforts to deepen East African regional integration taking centre stage, the Kenya High Court ruling becomes even more instructive for Uganda and the rest of members of the East African community (EAC).

“A vast majority of people in Kenya rely on quality generic drugs for their daily survival. Through this important ruling, the High Court of Kenya has upheld a fundamental element of the right to health,” said UNAIDS Executive Director Michel Sidibé.

“This decision will set an important precedent for ensuring access to life-saving drugs around the world.”

“The court has correctly interpreted the Constitution and guaranteed the right to health. This ruling speaks against any ambiguity that serves to undermine access to generic medicines and puts the lives of people before profit”, Patricia Asero, one of the three petitioners, was quoted as saying.

Last week also marked the successful passage of the East Africa HIV/AIDS Prevention and Management Bill 2012 by the East African Legislative Assembly (EALA), a timely milestone as the assembly’s term of office expires in June this year.

Kamuli girl who walked 12km for ARVs dead

By Tom Gwebayanga

Rachel Namulondo, the 17-year-old girl who has been trekking for 12 kilometers for five months to pick her ARV’s from Kamuli Main Hospital in Kamuli district, has died.

Namulondo, whose plight ran in New Vision, died in her 85-year-old grandfather’s hut in Gwozira zone in Nabwigulu sub-countyTuesday night.
The teen has been a common sight along Nabirumba -Kamuli road en route to pick her ARV’s from the hospital and back to her home.

Her father, Amuza Lugandha abandoned her, saying he could not waste his money on an AIDS victim.

According to Stephen Namayo, the Community Based Facilitator (CBF) under Plan-Kamuli, Namulondo died when her grandfather, Nasani Musengawe was asleep.

She developed a high temperature and started vomiting after supper which briefly stopped after midnight

Her grandfather, thinking the girl was a bit okay, retired to his bed as the girl battled for her life but died. Mzee Musengawe woke up at about 6.30 am only to find his granddaughter lifeless.

The LC1 Chairman, James Balukube said Namulondo, whose mother, Monica Nakamya, , died four years ago, got infected with HIV a decade ago as she attended to her aunt, Monique Naggita, who was an HIV/AIDS victim.

She tested HIV positive in 2004 and has been struggling to live single-handedly, picking her ARV’s on foot for the last five months of her life, until Tuesday night.


NGOs give EU commission a beating over anti-counterfeit pact


BRUSSELS – Amnesty Intentional, Oxfam, Reporters without Borders as well as internet rights groups and the Council of Europe all spoke out against the Anti-Counterfeiting Trade Agreement (Acta) at a European Parliament hearing on Wednesday (11 April).

“The vision set out by the Universal Declaration of Human Rights is at stake,” warned Marianne Mollmann, senior policy advisor of the London-based organisation human rights group Amnesty International.

Mollmann said the trade agreement threatens the right to the freedom of expression, the right to health, the right to due process and fair trial, and the right of an author to benefit from the protection of moral and material interests resulting from any scientific and literary production.

“These are all human rights that need to be balanced [in Acta], and they are not,” said Mollmann, adding that the trade agreement shifts liability of copyright infringement onto service providers and encourages private entities to enforce and police its users.

The NGOs raised a number of issues surrounding the controversial agreement, qualifying it as dangerous for promoting over-policing, unreasonable levels of surveillance, risks to privacy, and even development.

None of the NGOs present at the hearing had been invited and asked to provide input during the treaty’s negotiation, creating a cloak of secrecy that some believe has further undermined its legitimacy.

As an international trade agreement, Acta is supposed to help countries work together to tackle large-scale intellectual property rights violations, according to the European Commission. It also targets counterfeit goods and generic medicines.

But mounting public pressure and protests from around Europe may derail its ratification by the European Parliament, scheduled for either June or July.

EU trade commissioner Karel de Gucht last week requested the parliament refrain from any ratification until the treaty has been scrutinised by the European Court of Justice (ECJ), a process that could take months.

The European Parliament’s international trade committee, however, voted on 29 March not to send the treaty to the ECJ.

NGOs refute Commission’s claims on Acta
The commission claims the agreement is in line with European fundamental rights such as the freedom of expression and information or data protection and the right to property including that of intellectual property.

But experts at Wednesday’s parliament hearing, organised by Dutch Liberal MEP Marietje Schaake and Bulgarian Socialist MEP Ivailo Kalfin, all refuted the commission’s claims, arguing instead that there is a clear imbalance in the favour of intellectual property rights rather than natural rights.

The treaty mentions intellectual property rights 43 times. Fundamental rights are not mentioned at all, while freedom of expression is mentioned twice as a principle rather than as a right, said Gabrielle Guillemin, a legal officer at the London-based NGO Article 19.

“The criminal provisions under Acta lack the legal certainty required under international law, under article 10 of the European Convention on Human Rights as well as article 52 of the EU Charter of fundamental rights,” she explained.

The commission also says the treaty would safeguard European businesses, promote growth, stimulate innovation and create and protect millions of jobs. Again, experts at the hearing refuted the claims.

Sebastiano Toffaleti of the Pan European ICT & eBusiness Network for small businesses (PIN-SME), which represents some 50,000 small-ish IT companies, said the treaty would instead undermine European enterprise and innovation.

“Acta would hamper innovation and growth of SMEs that develop content and market it online,” said Toffaleti.

According to Toffaleti, criminal liability threats in the treaty would deter internet service providers (ISPs) from hosting products developed by SMEs irrespective whether the claims are legitimate or not.

Meanwhile, a US-based study, entitled The Sky is Rising , concluded that the entertainment industry grew by 50 percent in the last decade. The overall industry, including books, music, video games and films, grew from €341 billion in 1995 to €567 billion in 2010.

The study infers that the commission’s argument that Acta is needed to safeguard and promote such sectors is not based on fact.

“More content is being produced than ever before,” said Mike Masnick, who conducted the study. “More content is available to the public than ever before. In short, we found that the overall industry is thriving.”