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Civil Society Appeals for an Extension on Standards for Intellectual Property Rights on Medicines

Uganda –Kampala —Civil society Organizations working on health and access to medicines have today appealed to His Excellence Ambassador Christopher Onyanga Aparr the Permanent Representative to the Permanent Mission of Uganda to the United Nations in Geneva to lead Least developed County (LDC) members of the World Trade Organization (WTO), to act collectively to submit a duly motivated request to the Council on Trade Related Aspects of Intellectual Property (TRIPS) for an indefinite extension of the soon-to-lapse pharmaceutical transition period at the upcoming TRIPS Council meeting on 24th February, 2015.

According to a 2002 WTO TRIPS Council decision, member countries of the WTO considered to be least developed are exempted from enforcing patents and data protections on Pharmaceutical products for until 1st January 2016.

Intellectual properties such as patents raise the costs of medicines because patent holders can eliminate competition which would otherwise lead to cheaper prices. Global studies, including the MSF, Untangling the Web of Antiretroviral Prices routinely show that generic medicines are almost always priced lower than even the discounted prices drug companies sometimes offer to lower-income countries like Uganda.

In a letter dated 16th February, 2014 civil society groups recalled Article 66.1 of the TRIPS Agreement which provides to the effect that the Council for TRIPS “shall, upon duly motivated request by a least-developed country Member, accord extensions”.

In this appeal, the groups are of the view that the extension of the transition period be for as long as an LDC Member State remains a LDC, without conditions, and that it should further motivate waivers of Articles 70.8 and 70.9 to the General Council, also for as long as an LDC Member State remains an LDC. The detailed letter can be accessed here>>

Sections of the Kenya Anti Counterfeiting Act Struck Down as a Threat to Fundamental Human Rights

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

Kenya set to repeal controversial anti-counterfeit law

Kenya’s High Court has ordererd a review of a controversial anti-counterfeit law enacted in 2008 on the grounds that it could interfere with the supply of legitimate generic medicines to patients.

The 2008 Anti-Counterfeiting Act has been under fire since before it was passed with critics claiming that it was too much of a blunt instrument to handle the complexities of the counterfeit and substandard medicines trade, and set too much store by intellectual property rights.

The Act defined counterfeiting as an intellectual property breach of a protected good, which can include “the manufacture, production, packaging, re-packaging, labelling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods.”

In theory, this could encompass legitimate generic copies of drugs that are on-patent anywhere overseas. Given that the vast majority of drug patents are not registered in developing countries like Kenya, there had been fears that enforcement of the ACT could reduce the range of generic medicines available to doctors and their patients.

That was acknowledged by the High Court, with Judge Mumbi Ngugi saying in her ruling that “the Act is vague and could undermine access to affordable generic medicines since [it] failed to clearly distinguish between counterfeit and generic medicines.”

The High Court has called on Kenya’s Parliament to review the Act and remove ambiguities that could result in arbitrary seizures of generic medicines under the pretext of fighting counterfeit drugs. The judgment also stated that IP rights should not override the right to life and health.

The judgment comes at a time when the World Health Organisation (WHO) is also struggling to contend with the controversy about the conflation of IP and public health issues in the area of what it refers to as substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFCs).

The High Court ruling has been immediately welcomed by UNAIDS, whose executive director Michel Sidibe said: “This decision will set an important precedent for ensuring access to life-saving drugs around the world.”

UNAIDS notes that at the end of 2011 about 1.6m people in Kenya were living with HIV, with more than half a million on antiretroviral therapy provided in large part by generic drugs from generic manufacturers in India and elsewhere.

Intellectual Property Bills threaten Access to Medicines in the region

By Flavia Lanyero
A draft Bill seeking to protect the region from counterfeit products could deny millions of people living with HIV/Aids access to life-saving generic anti-retroviral drugs if passed, a new report says.

Civil society activists and intellectual property experts warn that generic medicines have wrongly been labelled “fake” and “counterfeit” under the EAC Anti-Counterfeit Bill, which will block the production and importation of generic drugs into East Africa.

(Read: EAC to harmonise medicine registration)

If passed, the Bill could see the region lose recent gains made in improving access to healthcare, especially for people living with HIV/Aids, and would significantly undermine the region’s progress in attaining Millennium Development Goal 6, which calls on countries to halt the spread of HIV and Aids by 2015 and achieve universal access to treatment for HIV and Aids by 2010. It also aims at halting and reversing the spread of malaria and tuberculosis by 2015.

“This policy, in its current form, would not in any way address the question of quality of medicines but instead has the potential to negatively affect both regional and national initiatives in EAC partner states to protect the right to health and life as well as improve public health,” the report by Southern and Eastern African Trade Information and Negotiations Institute (SEATINI) notes.

The report investigating patents, laws, policies and institutions related to access to medicine in the EAC indicates that the Anti-Counterfeiting Policy does not provide for the use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities as the World Intellectual Property Organisation recommends.

These flexibilities would allow trade in generic medicines as long as they are not counterfeit, experts say. Instead, the Bill makes recommendations for seizure and detention of all suspected counterfeit goods, under which generic drugs have now been categorised, affecting the cross-border flow of generics.

“Let’s harmonise laws according to our needs; we need to be proactive and negotiate to change these agreements and take advantage of the flexibilities where we think it will help,” said Nathan Irumba, chief executive officer of SEATINI.

(Read: Kenyan court strikes out law against generic drugs)
The survey conducted in March by SEATINI and Centre for Health, Human Rights and Development and Health Action International notes that while intellectual property holders view IP enforcement as a critical tool for their business, some health groups, consumer groups and other stakeholders have expressed concerns over possible abuse such as preventing market entry by competitors and compromising efforts of technology transfer.

“Generally on the East African level, they are mixing up intellectual property and quality issues. We need to make sure that mistakes made at national level do not escalate to the East African level first,” Melba Kitindi of Kenya Legal and Ethical Issues Network observed.

According to Mr Kitindi, the civil society has to understand the operation of the East African Community and inform the people so that they can have a say on what is going on.

This is a view shared by a lawyer with the Centre or Health Human Rights and Development, Moses Mulumba.

“The operation of the EAC is confusing on the one hand they suggest utilising TRIPS flexibilities under the [World Trade Organisation] Protocol and on the other, they take away the flexibilities under the proposed anti-counterfeiting Bill and Policy,” he said.

Mr Mulumba blamed policymakers for “signing agreements before understanding what they are signing” leaving little room to mitigate what they have already done.

However, Uganda Ministry of East African Community Affairs commissioner Ronah Serwanda defended the EAC arguing, “The EAC recognises those issues and has a policy, legal and institutional framework to handle that. We are looking into how we can form partnerships between government and civil society so as to form strong laws which do not infringe on access to medicine.