by Sisule F. Musungu 

In a landmark Judgement that has been hailed by many in the health community, including UNAIDS, the High Court of Kenya (Honourable Lady Justice Mumbi Ngugi – hereinafter “Justice Ngugi or “ the Judge”) held, in the case of Patricia Asero Ochieng and 2 Others v. the Attorney General & Another, that three sections of the Kenya Anti-Counterfeit Act, 2008 were unconstitutional being a threat to the right to life, dignity and health. Noting that: “There can be no room for ambiguity where the right to health and life of the petitioners and the many other Kenyans who are affected by HIV/AIDS are at stake”, the Judge specifically found that Section 2 (definition of counterfeiting), section 32 (offenses) and Section 34 (Powers of the Commissioner to seize suspected counterfeit Goods) could severely limit or threaten access to affordable and essential drugs including generic medicines for HIV/AIDS and therefore infringed the right to life, dignity and health of the three Petitioners (all people living with HIV/AIDS) under the Constitution of Kenya, 2010.

The 48 page Judgement addressed a range of critical issues, including issues that have animated international intellectual property (IP) discussions in recent years in the context of the World Trade Organization (WTO), the Anti Counterfeit Trade Agreement (ACTA), the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO) Advisory Committee on Enforcement. The Judgement also comes at a time when the East Africa Community (EAC) has been considering an Anti-Counterfeit Bill largely inspired by the Kenya law. Among other issues, the Judge analysed: the real intentions of those behind the law; the role of TRIPS flexibilities in ensuring the fulfilment of fundamental rights; link between the rights of life, health and dignity; and the relationship between fundamental rights and IP rights. She then gave directions on what the Government needs to do.

Caught in a Lie – the Intentions of the Proponents of the Anti-Counterfeit Act

In debates about anti-counterfeiting it has often been argued that these laws are critical to ensure, among others, the health of the population against substandard or other falsified medicines. This was indeed one of the arguments made when the Kenyan law was being discussed in 2008. It is also one of the main arguments advanced by the Attorney General in opposition to the Petition. Justice Ngugi examined this claim and did not mince her words on what she found. At paragraph 82 and 83 she noted inter alia that:

“ Clearly… the tenor and object of the Act is to protect intellectual property rights of individuals… Had the primary intention been to safeguard consumers from counterfeit medicine, then the Act should have laid greater emphasis on standards and quality. 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…Protection of consumers may have been a collateral issue in the minds of the drafters of the Act.”

She went on to hold that the right to life and health cannot be secured by a vague proviso in a situation where those charged with enforcement (customs officials, police etc.,) may not have a clear understanding of the difference between generic and counterfeit medicine.

Indeed, among others, I am on record to have raised this concern and others with the anti-counterfeiting efforts at the Sixth Session of the WIPO Advisory Committee on Enforcement in a paper titled “IP Infringements and Enforcement – Accounting for Socio-Economic, Technical and Development Variables”.

Credit to Parallel Importation

The Judge gave credit to the Kenya Industrial Property Act, 2001 which introduced parallel importation in Kenya for having enabled the widespread use of generic medicines not only for the treatment of HIV/AIDS but also for the treatment of other diseases as well. One of the questions to answer in the case was therefore the impact of the Anti-Counterfeit Act to the flexibility provided under Section 58(2) of the Industrial Property Act. By finding the Anti-Counterfeiting Act as a threat to generic medicines the Judge by implication accepted that the implementation of the Act could roll back the gains made through the implementation of parallel importation provisions in the Industrial Property Act.

Indivisibility and Interdependence of Human Rights

The petitioners had gone to Court fearing the violation of their rights to life, dignity and health. In her analysis, the Judge found that “the right to health, life and human dignity are inextricably bound.” Though not specifically saying so the Judge by her decision affirmed the applicability of the well-recognised principle of indivisibility and interdependence of human rights under Kenyan law.

IP rights and Human Rights

A broader question that came up in this case was whether the enforcement of IP rights could constitute a legitimate limitation to fundamental rights. Accepting the reasoning of the UN Committee on Economic, Social and Cultural Rights inGeneral Comment 17, the Judge held that:

“While… intellectual property rights should be protected, where there is a likelihood, as in this case, that their protection will put in jeopardy fundamental rights such as the right to life of others… they [IP rights] must give way to the fundamental rights of citizens…” 

While the Judgement did not consider the implications of the Constitutional provisions relating to IP it is unlikely that she would have reached a different conclusion if she did.

What Next with Anti-Counterfeiting Law?

Having found that the Anti-Counterfeit Act was unconstitutional as far as generic medicines go the Judge left it to the government to reconsider and appropriately amend section 2 of the Anti-Counterfeit Act in a manner that ensures that the State fulfils its obligations to ensure that Kenyans have access to the highest attainable standard of health.

Importantly, however, the Judge left a more fundamental question open I suspect mainly because the issue was not canvassed before her. The question is whether in the context of Kenya’s existing legal framework as at 2008 the Anti-Counterfeit law was actually necessary? In other words, even with an amendment as foreseen by the Judgement should Kenyan taxpayers be paying for the implementation of this law including sustaining the Anti-Counterfeit Agency?

As the Judge noted (at paragraph 70) it appears that Anti-Counterfeit Act was intended to bolster the protection of IP rights by providing criminal sanctions for infringement. The truth is that, except for severity of penalties, Kenyan law already provided criminal sanctions for certain types of IP infringement as contemplated by the TRIPS Agreement. Some of the existing laws providing such sanctions included the Industrial Property Act, the Copyright Act, the Penal Code, the Standards Act and the Trade Descriptions Act. There is also an elaborate legal framework, backed by criminal sanctions, to ensure the safety of medicines in Kenya. Such laws include the Medical Practioners and Dentists Act, Narcotic Drugs and Psychotropic Substances Act, Pharmacy and Poisons Act, the Public Health Act and the Use of Poisonous Substances Act. Institutions to implement these laws also.

As the Kenyan government and Parliament considers the next steps to bring the Anti-Counterfeit Act in line with the Constitution there will be need to think hard and clearly as to what the objectives are, who is being served and why. The government will also be well advised to seek proper technical expertise. It is sad that both the Office of the Attorney General and the Anti-Counterfeit Agency seemed not to be abreast with critical legal developments in the IP world.

In the end one thing that this Judgement shows is that the Anti-Counterfeit Act, as drafted, is bad both the right to health and for IP rights holders. By conflating issues the Act has succeeded casting doubt on what may be the legitimate interests if IP rights holders.

 

Note: The Author is an Advocate of the High Court of Kenya and practices before the Court in the name and style of Sisule Munyi Kilonzo and Associates, Advocates