On 25th April 2013, AIDS Law Project (ALP) organised a workshop in celebration of the World Intellectual Property Week. The workshop featured an interactive key note presentation from the Chief Patent Examiner of the Kenya Industrial Property Institute (KIPI), an inter-universities debating session and an audience discussion. Focus was on Intellectual Property (IP) and access to medicines in developing countries. This was related to the theme for this year’s World IP Day – Creativity: The Next Generation. The event was organised at Strathmore University and hosted by the Center for Intellectual Property and Information Technology (CIPIT).

Dr Isaac Rutenberg, the Director of CIPIT and Jacinta Nyachae of ALP, welcomed the participants to the event. It was their general sentiments that the challenge now lies with the youth to change the status quo. It was noted that the greatest challenge facing IP currently relates to balancing the various competing interests: interests of innovators and creators versus the public interest. On the one hand, IP was identified as an important factor in promoting development, new information, research and development (R&D); protecting innovators, researchers, inventions, among others. On the other hand, IP has had negative consequences especially in the health, agricultural and public sanitation sectors. How to balance these interests was the subject of discussion, especially in relation to access to medicines and promotion of human rights.

Mr David Njuguna, the Chief Patent Examiner at KIPI gave an informative and incisive keynote address. He expressed the opinion that the effect of innovation and technology is evident. He was categorical that the explosion of the knowledge economy has placed young people at an advantaged position in developmental issues. He emphasized the need for continued R&D especially in the medical field. He noted that the resources needed are massive but it would be scary to mankind if there were no medicines. He discussed patenting generally and in relation to public health especially access to medicines and the ongoing debate on generics. He identified some of the challenges facing the IP regime in Kenya as follows: first, that the courts are experiencing problems in dealing with IP related cases; and second, that there was inadequate R&D in Kenya.

The debating session was an intriguing one and centered on the following question: how does the Novartis (India) and the Patricia Osero (Kenya) cases affect public health in developing countries. The moderators were Mr Paul Ogendi, Programme Manager at ALP and Ms Sarah Ochwada, an entertainment and sports lawyer. The teams were composed of four (4) members drawn from various institutions including Mt. Kenya University, Strathmore University, Kenyatta University, and the Kenya School of Law, among others.

The following issues emerged from the debating session:
i) That the determination of the cases was a big win to the right to life, right to highest attainable standard of health and access to medicines. And that an important moral question was factored by the judgments. On the other hand, it was argued that the cases elevated the rights of some parties to the detriment of others; the public versus innovators. For example, that the right to property is ignored. The opposing side thus tied the right to life to the right to property: that one’s right to life is greatly affected by the denial of his/her right to property.
ii) That the strict interpretation of laid down criteria for patentability was plausible, including a strict interpretation of the TRIPs agreement. The “originality” test was considered in the Norvatis case and evergreening rejected. On the other hand, the opposing side was of the strong opinion that such a strict interpretation discourages innovations.
iii) That the Patricia Case breathes life to the 2010 Kenyan Constitution. And that the case upholds the high standard set by the Constitution as regards protection of basic human rights in Kenya.
iv) That the decisions (especially the Norvatis) empower developing countries to protect the interests of their citizens. A question thus arose: between public and commercial interests, which one overrides the other? This was subject of intense debate.
Patricia Asero of the Patricia Asero case, who was present at the debate, expressed the opinion that over 700 people die daily (an equivalent of 13 buses) due to HIV/AIDS and related infections. She urged activists to continue the push for TRIPs flexibilities to be integrated in our national laws.

The debate concluded with participants giving several recommendations aimed at ensuring that access to medicines is enhanced in Kenya. These included: first, that the government plays a greater role in promoting R&D; second, that the TRIPs Agreement flexibilities ought to be integrated in our laws; and third, that a balance should be stuck between commercial and public interests in relation to IP and access to medicines.

The Results of the intense debate were released at the IP Picnic which was held a day after at the Railways Club in Nairobi.The three best orators some of whom have been offered a one month long internship include the following:

1. Mr. Collins Wanjala
2. Miss Dianah Njeri Mureithi
3. Mr. Mugambi Peter Muhavi

In effect, the decision has given life to section 3(d) of the 1970 Indian Patent Act as amended in 2005 to comply with the Trade Related Intellectual Property Rights (TRIPS) Agreement. Section 3(d) disqualifies as an invention a ‘mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance…’ This means that India will be able to produce generic versions of patented medicines after the expiry of the first patent term which is usually 20years. Any renewal of an existing patent will have to pass a very strict test of enhancing ‘known efficacy’. This requirement will drastically curb the ‘ever-greening’ of patents, a problem that has hindered generic competition in the past. Another outcome of this decision is that pharmaceutical companies will now have to focus their research and development on new medicines as opposed to modifying existing ones.

All in all, this case is bound to affect positively access to essential medicines situation in developing countries. Lastly, it will also challenge the current patent philosophy by encouraging developing countries to adopt a more stringent patentability criteria especially for second or third patents.

For the decision, visit: www.scribd.com/doc/133343411/Novartis-patent-Judgement.

WIPO’s member states designated April 26 as the day in which the WIPO Convention came into force in 1970.The day has since been commemorated as the World IP Day with the aim of increasing a general understanding of IP whilst also encouraging innovation and creativity.

The World IP day continues to offer a unique opportunity each year to join with others around the world to discuss and demonstrate how IP works to contribute to the flourishing of music and the arts and to driving the technological innovation that helps shape our world.

The World IP Day 2013 focused on creativity: The Next Generation. How do you see the future? Who will be the next game-changers?

Find out what the Aids Law Project will be up to;to celebrate this day….more details coming up!!!

1. Consolidate all the laws relating to health in Kenya
2. The Bill also seeks to provide for regulation of health care services and health care service providers
3. Provide for the establishment of national regulatory institutions
4. Consolidate the inter relationship between the national and county health institutions
5. Establish a  coordinating agency of professionals within the health industry and
6. Provide for attainment of the basic right to health

The consolidation of all health laws into one document is an important aspect and has the advantage of certainty and allows for ease of finding provisions relating to health in one Act if the Bill is passed.Nonetheless, this also poses a serious challenge given that issues relating to health are numerous and varied. An attempt to consolidate the law might lead to a very bulky Act which will be rigid and difficult to amend. A risk of omitting certain key provisions remains a very real risk in the endeavor to consolidate the law; leaving such aspects to be covered instead by regulations as opposed to being covered in the Act.

The Aids Law Project in collaboration with various other organizations working in the Health Sector has had several discussions to discuss the proposed Bill. As a result of the said meetings, the Organization has come up with a Memorandum that draws to the attention of the draftsman various provisions in the Bill that are problematic or that may pose a great challenge in the implementation of the same. These include the below:

Clause 57-Procurement and supply of Medicine
This is covered in part 10 of the Bill. Clause 57(4)-states that notwithstanding sub-section (3), counties shall have the right to procure these items incidentally from other sources where the Kenya Medical Supplies Agency is unable to supply them in good time or at a competitive price.

It is our considered view that it is easier and cheaper to monitor and evaluate one procurement agency. Notwithstanding the spirit of the Bill in appreciating devolution, we would much rather that life saving medication such as those used in the treatment of TB, HIV & AIDS, Cancer and Malaria remain centralized at National level while other drugs can be procured at county level. This will ensure that the qualities of medicines available especially to combat the above maladies are standardized.

Clause 23-Kenya Health Service Authority
Part 4 of the Bill makes provisions for the creation of a Kenya Health Service Authority. Clause 23 proposes that the authority shall perform the advisory functions to the national and county governments on issues such as formulation and implementation of necessary policies and measures; development of health regulations, health research, provisions of health care, arbitration in disputes involving institutions within the health sector, human resources among others. The organizational structure of the authority is intergovernmental yet the functions are surprisingly already dominated within the national government. While we appreciate the role the Authority will play, we advocate for the composition of the Authority to comprise of independent experts who have no vested interest whatsoever that may hinder the execution of their duties.

Clause 63(1)-Traditional and Complementary Medicine
Part 13 of the Bill makes provisions on traditional and complementary medicine in Kenya. This is an attempt to recognize the value of such medicine and how they can play a role in the wider medical scheme. As much as we are elated that this is a first attempt by government to regulate this sector, we deem it fit that Kenya should come up with a comprehensive separate legislation on traditional and complementary medicine as has been demonstrated to be quite effective in countries such as South Africa and Zimbabwe to effectively regulate the sector.
The power of the National Minister for Health to identify and document issues appertaining to traditional medicine is an extremely weak provision that needs to be beefed up by the formation of a fully fledged authority or regulatory agency.

Clause 102-Regulations and Access to Medicine
The clause empowers the cabinet secretary to make regulations generally for the better carrying out of the proposed law. The clause needs to be strengthened to allow the cabinet secretary to have powers to issue compulsory licenses and/or grant them powers to allow for parallel importation of medicine. In the event that this is not agreeable, we further recommended that the cabinet minister for health be allowed to initiate the process of compulsory licensing with the cabinet minister for trade.

Intellectual Property Issues
The Bill fails to make any provision on generic medicine. We recommend that the Bill should not leave such vital provision to be dealt with by other statues. The same should be addressed in the proposed law.

Kenya Judiciary building by Wing

AIDS Law Project applauds land mark Judgment on access to quality generic medicines.

The long awaited judgment was finally delivered on 20th April 2012 by Lady Justice Mumbi Ngugi: The case was filed by three petitioners (Patricia Asero, Maurine Atieno and Joseph Munyi), AIDS Law Project was enjoined as an interested party; and the UN special Rapportuer on the right to health joined as Amicus Curiae:

The Judge ruled that sections 3, 32 and 34 of the Anti counterfeit Act of 2008 were unconstitutional being a threat to the right to life, dignity and health. she noted 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 and AIDS are at stake”, the Judge found that these three sections 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.

She also noted that there appears to be a conflict between the intellectual property rights and the rights of the people living with HIV and AIDS and in such an instance the lives of citizens’ who form a large constituency must be given priority. On this 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 …”

Lastly she pointed out that Kenya has ratified the various international treaties and conventions and as a result those same conventions are applicable law in Kenya. Seeing that majority of the international treaties do protect the right to health, and specifically with regard to against scientific invention and trade, therefore the right to health has to be upheld, her noted that “The parties have referred the court to various decisions in which the High Court has applied international law and urged the court to be guided by those decisions. However, Article 2 of the Constitution now makes it clear that all international treaties to which Kenya is a party are now part of the laws of Kenya. I am therefore bound by the Constitution to have regard to these treaties.”

Effect of this judgment: this judgment means that the said sections 2, 32 and 34 of the anti counterfeit act have been declared unconstitutional and therefore cannot be enforced.

Way forward: the minister concerned upon advice for the Attorney general will be required to amend the said sections to reflect the spirit of the judgment and by extension the constitution.

AIDS Law Project acknowledges with thanks the support of Open Society Initiative for East Africa (OSIEA) and Akiba Uhaki foundation.

• Download Press Statement: Health activists welcome High Court judgment on anti-counterfeit law [pdf 42 kb]
• Download the judgement here [pdf 1.1 mb]

Image of Kenya Judicary building By Wing (Own work) used by permission CC-BY-SA-3.0

After three years of waiting, health activists today welcomed a decision by the High court that the Kenya Anti-Counterfeit Act 2008 was vague and could undermine access to affordable generic medicines. High Court Judge Mumbi Ngugi, found that the Act had failed to clearly distinguish between counterfeit and generic medicines.

Justice Mumbi’s ruling affirmed a conservatory order issued on April 23, 2010 by Justice Roseline Wendoh which stopped the government from implementing the Anti-Counterfeit Act with respect to generic medicines until the case was determined.

“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”, said Patricia Asero, one of the three petitioners.

The High court ruling means that parliament will now have to review the Act and amend sections that confuse generic medicines with counterfeits and remove ambiguities that may result in arbitrary seizures of generic medicines under the guise of fighting counterfeits. Health activists have vowed to press for those changes to protect access to generic medicines. “This was a poorly drafted law from the outset that must be urgently reviewed to avoid threatening public health programmes such as the national treatment programme on HIV which is predominantly dependent on access to generic anti-retrovirals”, warned Jacinta Nyachae, executive director, AIDS Law Project.

The activists also predict this will set a positive precedent for the entire East Africa region as other countries in this region and the East African Community are considering anti-counterfeiting laws that may threaten generics. “Kenya is leading the way in protecting access to medicines and public health and we are watching the actions of the East Africa Community member states to see if they follow suit,” she added.

Contact AIDS Law Project at infoaidslawproject.org /+254 786 318627 for more details on the judgment.

• Download this press release here [pdf 42 kb]
• Download the judgement here [pdf 1.1 mb]

Download the judgement here [pdf 1.1 mb].

• Lady Justice Ngugi – presiding Judge
• Mr. Luseno for the petitioners
• Mr. Omwanza for the interested party (AIDS Law Project) and amicus curiae ( UN Special Rapportuer on right to Health )
• Ms Kimani for the respondents

After almost three years of waiting since three petitioners living with HIV filed a constitutional petition challenging the implementation of a law on anti-counterfeiting, the Kenyan High court is due to deliver a verdict on March 9.

The court will rule on whether, the Kenya Anti-Counterfeit Act of 2008 which was enacted by the national parliament infringes on the right to access more affordable medicines especially for treatment of HIV and other public health challenges. Depending on the decision, it is widely expected that this case, the first legal challenge in Africa against a new push for anti-counterfeit legislation, could have significant implications on other countries preparing similar laws.

On April 23, 2010 Kenyan High Court Judge, Roseline Wendoh issued a conservatory order stopping the government from implementing the Anti-Counterfeit Act with respect to generic medicines until the case heard and determined.

The three petitioners in the case have argued that the Kenyan law should be declared unconstitutional on the grounds that it infringes on their right to health by giving a broad definition and interpretation on what constitutes counterfeit medicines in a manner that affects access to more affordable generic medicines.

On January 24, 2012 the lawyers representing the petitioners and interested parties made oral submissions to the trial judge to which the Attorney-General, as legal representative of the government, was invited to respond.

The petitioners argued that the government was obliged to secure the right to treatment of all persons infected with HIV which required unfettered access to affordable medicines. The Kenyan law contained ambiguities, which if misinterpreted or abused would be detrimental to the government’s ongoing efforts to ensure access to essential medicines for all Kenyans.

The court was invited to address these ambiguities to safeguard any discrimination against more affordable generic medicines. It was argued that the definition of ‘counterfeiting’ could easily be taken to cover generic medicines with devastating impact on generic medicines which form the backbone public health treatment programmes.

The power of seizure conferred on the police could be abused to affect imports of generic medicines because there were no clear guidelines to safeguard the rights of importers and patients. This would result in derogation from constitutional rights and freedoms regarding unfettered access to treatment. The court was invited to take cognizance of seizures of generic medicines by customs officials in various transit points like Holland in the recent past. .

Mr Omwanza, representing the interested parties AIDS Law Project warned that the Kenyan law went beyond the country’s obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) by seeking extra-territorial enforcement of Intellectual Property Rights not recognized under Kenyan law.

The UN Special Rappoteur on health, Anand Groover, who was represented by Mr. Omwanza, invited the court to consider that access to medicines is key to the progressive realisation of the right to health and that the Kenyan law undermined this right.

In his response, the Attorney-General contested that the Act limited or threatened access to generic medicines. The AG argued that generic medicines were distinct from counterfeit medicines and argued the need to check on counterfeits because of the risk to health. It was argued that the Kenyan Act was necessary to regulate counterfeit medicines.

The High court is set to make a ruling on 9th March 2012. If declared unconstitutional, the Kenyan parliament will be expected to review the Act to safeguard the right to access treatment and address the ambiguity over counterfeit and generic medicines.