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Kenya set to repeal controversial anti-counterfeit law

23-Apr-2012
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.

Source: http://www.theeastafrican.co.ke/news/Intellectual+property+Bills+threaten+access+to+medicine/-/2558/1390818/-/f9hlc4/-/

Eala reviews key EAC integration laws

By John Oyuke

East African Legislative Assembly (Eala) has passed two key legislative amendments to strengthen regional integration.

The legislators, whose five-year term ends on June 4, and currently meeting in Nairobi, debated and passed the Customs Management Act (Amendment) Bill 2011, and the Community Emblems Act (Amendment) Bill 2012 on Wednesday.

The Customs Management Act (Amendment) Bill 2011, which sailed through after intense debate modifies the initial Customs Management Act 2004. It comprises a new section providing for the prevention and suppression of money laundering, drugs and arms trafficking and infringement of intellectual property rights.

The Chairperson of the Council of Ministers, Musa Sirma, said the Bill hopes to fill a vacuum left out by the original Bill and proposes joint engagement in fighting transnational crimes in the region. The East African Legislative Assembly Plenary, which started on Monday and runs through to April 26, is also expected to pass several other Bills, including HIV/Aids and conflict resolution before its term expires.

Eala Member Dora Byamukama noted that all partner states had appended their signatures to the international conventions against human trafficking and transnational organised crimes and the Assembly was therefore duty bound to pass the new Bill.

Reacting to the new development, Assistant Minister for Kenya’s East Africa Community ministry, Peter Munya, said the establishment of a single Customs Authority was well underway.

“We do expect the forthcoming Summit of the EAC Heads of State next week shall consider the roadmap and pronounce itself on the matter,” he said.

Members went through the Bill to generate heated discussions as to whether cross-border crimes such as human trafficking were part and parcel of customs issues and if so, the correlation and complementarity with the existing laws and Protocols.

Source: http://www.standardmedia.co.ke/InsidePage.php?id=2000056691&cid=14&j=&m=&d=

Disparities hinder passage of common East African AIDS drugs-access laws

By Zakumumpa Henry

Disparities between the views of East African community (EAC) member countries are complicating efforts to pass a common intellectual property law that would enable access to antiretrovirals to be scaled- up in the area, a regional meeting of East African Health rights NGOs was told last week (12 April 2012).

The three-day meeting held at the Imperial Botanical Beach hotel attracted participants from Kenya, Tanzania, Burundi, Rwanda and Uganda, the countries that make up the EAC.

Moses Mulumba, an intellectual property expert who conducted the study, said there were many disparities between the member states, which is making the passage of a common ‘TRIPS [trade related intellectual property rights] flexibilities’ compliant law difficult.

Currently, Kenya is regarded as a ‘developing’ country while the rest of the East African member states are regarded as ‘least developed countries’ or LDCs.

Mr Mulumba emphasized that this differention is complicating the making of uniform strategies and laws as developing countries are no longer permitted to manufacture generic antiretrovirals drugs whereas LDCs have a grace period running up to 2016 to do just that and also have the opportunity to reform their laws to permit them to continue manufacturing generic antiretrovirals.

In November 1999, the East African Community Treaty was signed by its member states. This means decisions taken at the EAC level, since they are legally-binding on all member states, supersede those taken at individual member country level. Currently, the proposed East African anti-counterfeit bill (2010) looks set to threaten access to essential medicines due to its intellectual property enforcement stance.

Mr Mulumba also revealed there were differences between government sector ministries in East Africa regarding enforcing intellectual property rights, with East African health ministries taking on a public health focus of enabling access to essential medicines while the trade ministries had a bias of enforcing the protection of business interests and private innovation rights.

Further illustrating the disparities, it was revealed that Kenya already has an act on anti counterfeiting while Uganda has a bill before parliament and Tanzania has regulations made under the trade marks law.

At the meeting, it was also revealed that the different East African countries preferred to move at different paces in reforming intellectual property-associated laws, with Tanzania preferring a slower and more cautious approach.

It was noted at the meeting that in regard to laws relating to intellectual property rights, there is widespread, erroneous mixing of the issue of quality and standards on the one hand and enforcing private rights of innovators and inventors on the other.

Jane Nalunga, Country Director of SEATINI-Uganda, an NGO that seeks to strengthen Africa’s world trade position, called on East African countries to negotiate for fairer international trade laws as an East African block as this gave them better leverage than as individual countries.

Ambassador Nathan Irumba of SEATINI said: ‘’Develop intellectual property laws that are based on your current level of development; ones that won’t strangle indigenous efforts. Japan and China did not hurry to enforce intellectual property rights of foreigners until they had reached a certain level of development themselves. How many East Africans have filed applications for patents?’’

The meeting was hosted by SEATINI-Uganda in partnership with Center for Health, Human Rights and Development (CEHURD) and HAI –Africa with funding from the Open Society Foundation.

Source: http://www.keycorrespondents.org/2012/04/16/disparities-hinder-passage-of-common-east-african-aids-drugs-access-laws/

GMO foods should be labelled

Now, I may not be smart enough to understand the argument, but why hide from the consumers how the food product you are peddling is really made, refusing to name precisely what is in it? So far, as I understand it, that is the logic of US-based agriculture giant Monsanto which has threatened to sue the State of Vermont for crafting a law that would require all foods to be clearly labelled.

The agri-business multinational let it be known that it will fight the proposed bill known as H-722 (the “VT Right to Know Genetically Engineered Food Act”) because it discriminates against genetically modified food. The bill still in the initial stages of formulation would require food producers to label their food products, a move that would compel Monsanto to slap the GMO label on all its food products.

The problem for me is two fold. On the one hand, Monsanto which has cornered the market on genetically produced food seem to be saying, “Look here, GMO foods are safe, nutritious and wholesome and you should eat them”.

On this basis alone, one would expect the agri-business giant to embrace food labelling in order to effectively market its food product. If, as Monsanto argues, genetically modified food is the way of the future, the salvation for humankind, then it makes sense that it should be called by its name so that eager consumers will line up for it.

On the other hand, even as it proclaims from the rooftop the safety aspects of GMO foods, Monsanto is slyly shying away from the spotlight, indeed, aggressively ensuring that GMO foods are never labelled.

This contradictory action has two implications, one being that consumers must trust Monsanto when it says that genetically made food is safe, nutritious and healthy. Secondly, Monsanto is also saying that consumers should never be trusted to make choices based on transparent information. The average person, in Monsanto’s warped thinking, is probably an idiot who, given the freedom of choice through food labelling, will always make the wrong choice.

Now I have maintained in many of my previous writings that it is unthinkable that just one or two multinational companies could soon control food production. But is precisely what Monsanto is aiming to do—control food production and corner the market. It goes without saying that whoever controls food production will control human behaviour for eternity, dictating who will survive and who will die, who will reproduce children and who will not because food, after all, is life.

But scratching deeper, the threat to sue a whole state planning to create a law to protect consumers has more immediate implication for Monsanto which is keenly aware that its genetically produced food is contaminating natural food supplies.

There are organic farmers who have begun to sue Monsanto for these contaminations, but by not labelling foods, Monsanto believes there will be a time when all the natural food supplies will be so contaminated that such lawsuits will become meaningless anyway. In the meantime, it is Monsanto that is suing, mostly successfully, farmers whose fields are contaminated by genetically modified varieties, claiming that the farmers in effect stole the GMO patent.

The case is still fresh of the Canadian farmer whose crops was contaminated by Monsanto’s genetically modified crops and, to add salt to injury, was sued by Monsanto for patent infringement. The Supreme Court of Canada agreed with Monsanto that the farmer indeed infringed on Monsanto’s patent rights.

It is like the cow rancher who cries foul when one of his bulls jumps the fence, mate with one of your thoroughbred cows, impregnates it and produces a mixed breed calf of indeterminate quality. Even though you are the victim, the rancher neighbour yammers loudly for compensation and, worse, the court agrees with him.

For me, genetically modified food remains an undetermined food with many long term ill consequences for consumers.

And although proponents of GMO like to point out that these products are now consumed widely, my rejoinder is simply that GMO is very young when considered in the context of human food production. Fifty years from now, what will be discover in GMO foods that we are currently blind to?

The history of science, after all, is filled with thousands of victims who suffered serious health consequences after being reassured that certain drugs were safe. We still all remember Thalidomide, the wonder drug that was introduced by a German drug maker in 1957 as a treatment for morning sickness in pregnant women. By the time it was withdrawn from the market, over 10,000 deformed children were born, many without limbs.

By threatening to sue the State of Vermont, Monsanto essentially wants to have its cake and eat it too. If it is peddling genetically modified food as good, safe and healthy products then it must also allow them to be labelled as such.

I, as a consumer, must know what I am buying from the grocery store. There is no way I can surrender my rights to know what goes in my stomach just so that a corporate giant can have its profits.

No way.

Opiyo.oloya@sympatico.ca
Twitter: @OpiyoOloya

Source: http://www.newvision.co.ug/news/107-blog-gmo-foods-should-be-labelled.aspx