Do Not Label Generic Medicines As Counterfeit

Close to the heels of the Indian Patent Controller order granting a compulsory license to an Indian company to produce and market a generic version of a patented cancer drug, (thus bringing down its cost by 97%, from US$5600 to US$176 per month) we have another landmark judgement delivered by the Kenyan High Court, with a view to safeguard the interests of people living with HIV (PLHIV) in accessing low cost generic HIV drugs.
In a judgement, delivered recently, the High Court of Kenya at Nairobi has held three Sections (2, 32 and 34) of the Kenya Anti-Counterfeit Act, 2008 as unconstitutional and infringing the petitioners’ right to life, dignity and health. The judgement says that, “It is incumbent on the state (Kenyan Government) to reconsider the provisions of Section 2 of the Anti-Counterfeit Act alongside its constitutional obligation to ensure that its citizens have access to the highest attainable standard of health and make appropriate amendments to ensure that the rights of petitioners and others dependent on generic medicines are not put in jeopardy.

The Kenyan Anti-Counterfeit Act adopted in December 2008 contained a broad definition of what constitutes a 'counterfeit' product that had the potential to include legally-manufactured generics. As such, legally manufactured and/or imported generic medicines of approved quality may be erroneously interpreted as 'counterfeits' because of the provisions of this Act.

In 2009, three HIV+ citizens of Kenya filed a constitutional challenge in the High Court of Nairobi that their fundamental right to life, human dignity and health are threatened by the enactment of the Anti-Counterfeit Act, 2008, whose provisions (specifically sections 2, 32 and 34) would affect their access to affordable and essential drugs and medicines, including generic drugs and medicines, thereby infringing their fundamental right to life, human dignity and health as protected by Articles 26(1), 28 and 43 of the Constitution of Kenya. On 8th March 2010, the Aids Law Project, a non-governmental organisation registered in Kenya, joined as an Interested Party to the proceedings. On 17th January, 2011, Mr. Anand Grover, the United Nations Special Rapporteur for Health, also joined as an Interested Party. 

All the three petitioners (Patricia Asero Ochieng, Maurine Atieno and Joseph Munyi) are unemployed and have been living with HIV for periods ranging between 8 and 19 years. They are all getting free of charge ARV medication through projects funded by the government and Medicins Sans Frontieres (MSF). None of them are in a position to afford any of the HIV/AIDS medication if required to purchase the drugs from the market. 

By their Amended Petition dated 3rd November 2010, the petitioners sought:- 

(a) A declaration that the fundamental right to life, human dignity and health as protected and envisaged by Articles 26(1), 28 and 43 of the Constitution encompasses access to affordable and essential drugs and medicines including generic drugs and medicines. 

(b) A declaration that in so far as the Anti Counterfeit Act, 2008 severely limits access to affordable and essential drugs and medicines including generic medicines for HIV and AIDS, it infringes on petitioners right to life, human dignity and health guaranteed under Articles 26(1), 28 and 43 of the Constitution. 

(c) A declaration that enforcement of the Anti Counterfeit Act, 2008 in so far as it affects access to affordable and essential drugs and medication particularly generic drugs is a breach of the petitioner’s right to life, human dignity and health guaranteed under the Constitution. 

While delivering the judgement, Judge Mumbi Ngugi, said-- I find that Sections 2, 32 and 34 of the Anti Counterfeit Act threaten to violate the right to life of the petitioners (as protected by Article 26), the right to human dignity (guaranteed under Article 28) and the right to the highest attainable standard of health (guaranteed under Article 43), and grant the declarations sought as follows: 

(a) The fundamental right to life, human dignity and health as protected and envisaged by Articles 26(1), 28 and 43(1) of the Constitution encompasses access to affordable and essential drugs and medicines including generic drugs and medicines. 

(b) In so far as the Anti Counterfeit Act, 2008 severely limits or threatens to limit access to affordable and essential drugs and medicines including generic medicines for HIV and AIDS, it infringes on the petitioners’ right to life, human dignity and health guaranteed under Articles 26(1), 28 and 43(1) of the Constitution.  

(c) Enforcement of the Anti Counterfeit Act, 2008 in so far as it affects access to affordable and essential drugs and medication particularly generic drugs is a breach of the petitioners’ right to life, human dignity and health guaranteed under the Constitution. 

On the definition of counterfeit the judge observed that "In my view, the definition of 'counterfeit' in Section 2 of the Act is likely to be read as including generic medication. I would therefore agree with the Amicus that the definition 'would encompass generic medicines produced in Kenya and elsewhere and thus is likely to adversely affect the manufacture, sale, and distribution of generic equivalents of patented drugs. This would affect the availability of the generic drugs and thus pose a real threat to the petitioners' right to life, dignity and health under the Constitution. Enforcement of the Anti Counterfeit Act, 2008 in so far as it affects access to affordable and essential drugs and medication particularly generic drugs is a breach of the petitioners’ right to life, human dignity and health guaranteed under the Constitution."

The decision highlights that the anti- counterfeiting law does not only pose a threat for access to generic medicines, but also diverts attention and resources from where action is most needed to ensure that patients receive quality drugs. According to the Judge - "The Anti-Counterfeit Act has, in my view, prioritised enforcement of Intellectual Property Rights in dealing with the problem of counterfeit medicine. It has not taken an approach focused on quality and standards which would achieve what is the purpose behind the Act: the protection of the petitioners in particular and the general public from substandard medicine. 

The decision is also important on the broader question of whether the enforcement of Intellectual Property Rights can constitute a legitimate limitation to fundamental rights. In the coming years, the decision will be an important legal precedent in developing countries as the court has clearly ruled that, "While such Intellectual Property Rights should be protected, where there is the likelihood, as in this case, that their protection will put in jeopardy fundamental rights such as the right to life of others, I take the view that they must give way to the fundamental rights of citizens.”

Shobha Shukla - CNS
(The author is the Managing Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. She also co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: shobha@citizen-news.org, website: http://www.citizen-news.org) 


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