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Posted on Categories Featured 279 Comments on Kenya set to repeal controversial anti-counterfeit law

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.

Posted on Categories Featured 236 Comments on Intellectual Property Bills threaten Access to Medicines in the region

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/-/

Posted on Categories Featured 147 Comments on Eala reviews key EAC integration laws

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=

Posted on Categories Featured 96 Comments on Disparities hinder passage of common East African AIDS drugs-access laws

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/

Posted on Categories Featured, News 276 Comments on Uganda: Pregnancy and Childbirth Mean Playing Russian Roulette With Women’s Lives

Uganda: Pregnancy and Childbirth Mean Playing Russian Roulette With Women’s Lives

by Jessica Mack

Sylvia Nalubowa’s surviving twin is two-and-a-half; Jennifer Anguko’s baby turned one this past winter. Both of their mothers died giving birth to them – they are orphans of maternal mortality, an epidemic that continues to plague Uganda as it does the rest of the developing world. But these babies are also children of history.

Their mothers have become the face of a landmark case in Uganda that seeks, for the first time, to assign blame to the government for the deaths of women in childbirth. Last March, Ugandan human rights groups joined families of the deceased to file Constitutional Petition 16, alleging that the Ugandan Government failed to protect the women’s constitutional rights to life and health by allowing them to die in ill-equipped and poorly managed public hospitals, or failing to provide them with basic maternal care.

“We are seeking a declaration that maternal deaths happening due to avoidable causes is a violation of the right to health,” said Primah Kwagala, a lawyer for the Centre for Health, Human Rights and Development (CEHURD), a lead petitioner of the case. “The government should own up and increase funding towards maternal Health, and fulfill the Abuja Declaration to give at least 15% of the annual budget to the Health Sector.”

One of the key complaints in the petition is the Government spends just one-quarter on maternal health of what it pledged to spend, per capita.

Each woman died of negligence, essentially, as do 1 in 35 Ugandan women during pregnancy or childbirth. From ill-equipped health workers untrained for obstetric emergencies to inaccessible clinics, birth control stock-outs, and unsafe abortions gone very wrong, women in Uganda are forced to play Russian Roulette with a failing health system.

The petition was filed in March and heard in October, garnering impressive and global attention from advocates and media around the world. It seemed a rare breakthrough in an endless news cycle that treats maternal deaths as sad, but inevitable.

“Maternal health has been overlooked, as people seem to look at it as the daily status quo. People do not know that they have a right to good health service provision; they think it is a privilege,” said Kwagala.

An objection was raised during the petitions hearing which derailed promising momentum, and which must first be ruled upon before the actual petition hearing can move forward. Since then, five months have elapsed and the global media has long since packed up.

This petition was unique from other cases like it worldwide, which have sought retribution for the violation of women’s rights. Other cases before it have centered on unusually cruel and exceptional circumstances – for instance a 17-year old Peruvian woman denied the abortion of her anencephalic fetus, being forced to deliver and breastfeed until it died. Rather, this petition focuses on the mundanity of the status quo, seeking to “make it famous” as an acute abuse of human rights. Given the scale of maternal mortality in the country, the outcome of this petition could potentially put the government on the hook for crimes against humanity.

“Governments have an obligation to take action to prevent maternal deaths, which represent a gross violation of women’s basic human rights,” said Jill Sheffield, President of Women Deliver. “Where human rights have been violated, individuals and organizations must turn to the courts at the national, regional, and UN levels. Health systems that deliver for girls and women, deliver for everyone.”

Women Deliver and the Ugandan group Partners in Population and Development co-hosted a regional consultation on maternal health in the capital city late last month, drawing African maternal health experts from across the continent. The petition didn’t come up explicitly, but experts spouted the same important, but now redundant, points they have for years: women deserve more, and when they get more, we all win.

Maternal health seems to be a chronic back-seat issue, barring a few hopeful moments in history. One of those was 2010, when the Women Deliver conference drew 3,000 maternal health advocates to hear Melinda Gates announce $1.5 billion in new funds for the issue. Soon after, global maternal health data estimates confirmed that progress was underway; the G8 made maternal health its pet issue, and the UN Secretary-General launched a major initiative, the Global Strategy for Women’s and Children’s Health.

That was two years ago. It is too soon to comment on progress, but in many ways outward excitement for this issue has drained. In recent months, it isn’t maternal deaths, but rather the wanted ghost of war criminal Joseph Kony which has catapulted Uganda into the news once again. Love it or hate it, the KONY2012 campaign generated a magnetic force field of global attention toward Uganda. Deft Ugandan advocates parlayed that to leverage new commitments to Nodding Syndrome, a disease overlooked for years. The country’s rising HIV prevalence, has also garnered new focus. Surely this is an opportunity for maternal health advocates to claim their stake once and for all.

“The Government of Uganda talks a good game about its commitment to maternal and reproductive health, but it needs to do more than talk,” says Elisa Slattery, Africa Regional Director for the Center for Reproductive Rights. “It must put money and resources behind efforts that save the lives and health of women.”

What exactly should those efforts look like? That should be up to Ugandan health professional and advocates. Kwagala easily rattles off a list: “recruit more midwives, increase the pay of health workers to motivate them. Amend the constitution to include the right to health. Provide redress measures to patients whose rights have been violated & respect citizen’s rights.” There are other crucial issues to address, like ensuring access to birth control and considering expansions to the country’s abortion law. A recent government estimate suggests it is the cause of 26 percent of maternal deaths in the country.

An even more pragmatic first step might be addressing electricity cuts. “How honestly do you expect a health worker to perform C – Sections on a mother who is suffering obstructed labour if there is no electricity to sterilize instruments, or even light to see if it is in the night,” asks Kwagala. Last week, CEHURD filed a complaint against a major power company, alleging indiscriminate load shedding (rolling blackouts to save money) at hospitals undermined patients right to health.

It’s not for lack of ideas to save them, whether creative or practical, that Ugandan women are dying, but for lack of action. And when it comes to maternal mortality, Uganda is in a unique position: it has neither the best nor the worst death rates in the continent. It was commended by the UN in 2010 for “making progress,” having reduced deaths by 36 percent from 1990 to 2008. Maternal mortality remains a problem of considerable magnitude, but there are potentially enough resources to actually address it.

Last week, CEHURD and their co-petitioners got a break. After constant follow-up and months of waiting, they received a letter from Deputy Chief Justice Alice Mpagi Bahigeine:

“The delay in delivering the ruling is very much regretted. However, it has been brought to the attention of the Hon. Justice responsible and everything possible to ensure speedy disposal of the matter.”

This acknowledgement signals that the government knows the world is watching, and perhaps really is committed to prioritizing this issue. The outcome is still in question, so it is too early to say that the paradigm has shifted but instead we should recognize that it is, indeed, shifting, and we can still do our part to catalyze that.

Source; http://www.rhrealitycheck.org/article/2012/04/02/uganda-womens-rights-maternal-health-fall-to-back-line-once-again

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