Kenya generic HIV drugs court ruling sets precedent for Uganda

Henry Zakumumpa

Thousands of people living with HIV and AIDS in East Africa were given new hope last week (25 April 2012), when a High Court judge in Nairobi ruled that Kenya’s anti counterfeit law is unconstitutional in its interpretation of generic HIV drugs as illegal counterfeits.

A generic drug is an identical copy of a brand name, the latter of which are usually manufactured by pharmaceutical giants. Brand drugs such as those manufactured by Pfizer and Norvatis go for prices tailored to Western markets and thus are unaffordable for the majority of patients in sub Saharan Africa. However, many can afford Indian generics, which cost as little as a tenth of the brand price.

Generic drug manufacturers such as CIPLA of India imitate the exact formulas used in brand antiretrovirals (ARVs) drugs through a process called ‘reverse engineering’. The drugs are understood to be as effective as the brand names.

Justice Mumbi Ngugi ruled that intellectual property rights do not override the right to life and health. She found the definition of a ‘counterfeit’ in the Kenya Anti-Counterfeit Act of 2008 to be too broad leading to generic HIV drugs being bundled together with other counterfeits. Justice Mumbi said this vagueness is posing a grave threat to the right to life and health for thousands of Kenyans who depend on life-saving generic ARVs.

The High Court judge has now instructed the Kenyan parliament to review the Anti Counterfeit Act of 2008 and amend the offending articles, which can lead to arbitrary seizures of generic HIV drugs under the pretext that they are ‘counterfeits’, as happened at a Dutch port last year.

Under common law, a high court ruling in Kenya sets a precedent for countries such as Uganda and it is now thought that human rights activists in Uganda and the rest of East Africa will invoke the ruling in any potential suits.

The news will also comes as a welcome development for Ugandan pharmaceutical companies such as the Quality Chemicals Plant in Luzira, most of whose products are generic drugs

While testifying before a Ugandan parliamentary committee last month, Moses Mulumba, a human rights lawyer and intellectual property rights expert, revealed that the Uganda Counterfeit Bill 2010 regards generic AIDS drugs as ‘counterfeits’ and would render 90 % of HIV drugs in Uganda illegal should the bill be passed by parliament and assented to by President Museveni.

With efforts to deepen East African regional integration taking centre stage, the Kenya High Court ruling becomes even more instructive for Uganda and the rest of members of the East African community (EAC).

“A vast majority of people in Kenya rely on quality generic drugs for their daily survival. Through this important ruling, the High Court of Kenya has upheld a fundamental element of the right to health,” said UNAIDS Executive Director Michel Sidibé.

“This decision will set an important precedent for ensuring access to life-saving drugs around the world.”

“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”, Patricia Asero, one of the three petitioners, was quoted as saying.

Last week also marked the successful passage of the East Africa HIV/AIDS Prevention and Management Bill 2012 by the East African Legislative Assembly (EALA), a timely milestone as the assembly’s term of office expires in June this year.

Feature: Maternal health case puts govt on the spot

As Sylvia Nalubowa cried out in agony and begged the nurses to help her, she pledged to give them part of her kibanja (plot of land), hens and pigs if they could save her life.

Only 38, Nalubowa had developed complications after she managed to give birth to one of her twins normally. With the second baby twin still posited in her uterus, Nalubowa’s mother-in-law, Rhoda Kukkirizza, moved her from the government health centre III in Mityana to Mityana district hospital, hoping Nalubowa would get better services there. She did not. An affidavit to a Constitutional Court petition, challenging government to provide better maternal health services, states that Nalubowa died at the hands of negligent and corrupt medical workers.

She became part of the statistics that are Uganda’s maternal mortality rate or MMR (the number of women that die whilst giving birth). Standing at 435 of 100,000 live births, there is general consensus that Uganda’s MMR remains unacceptably high. In 2009, Nalubowa’s tragic tale put a face to the country’s MMR. Her death shook the administration of Mityana district hospital and the ripples spread throughout the nation. It did not take the civil society long to voice its disgust.

The Centre for Health, Human Rights and Development (CEHURD) did more than voice its disgust. It lodged a constitutional petition, seeking a declaration that government’s failure to provide proper maternal health services to women be deemed a violation of their rights.
Nalubowa’s family, together with that of Jennifer Anguko, another woman who died due to negligence during childbirth in 2010, are among the petitioners seeking justice, not just for their departed relatives, but also for other women who have lost their lives while giving life, as well as others likely to become statistics in Uganda’s grim MMR.

Filed on March 3, 2011, the case kicked off with a very high momentum and attracted ample interest from the media and Ugandans at large. It was supported by affidavits from the families of Nalubowa and Anguko, and from human rights experts like Professor Ben Twinomugisha (Dean, faculty of Law at Makerere University). In their submissions to court, the petitioners argued that the right to health was a human right the government had failed to respect and protect.

The state, however, denied violating women’s right to health, contending that the petition was speculative and without merit. But the petitioners insisted that the maternal deaths were due to government failure to provide basics like razor blades, plastic sheets and other consumables, let alone medicines and medical personnel to attend to pregnant women.

In response, the state reasoned that the government’s meagre resources have to cater for various competing interests that also affect other human rights. And, health aside, the state said the petition raised political rather than legal questions, and objected to court hearing it. The petitioners now await the court’s decision on whether or not it will hear the case.

“We just want court to tell us whether the death of over 16 women due to child birth-related complications is not a violation of human rights. Why is the judiciary dragging its feet?” says David Kabanda, a lawyer for the petitioners.

A letter signed by Deputy Chief Justice Mpagi Bahigeine not only expresses regret at the delay in delivering the ruling, but also promises that everything possible is being done to ensure disposal of the case.

But the petitioners are not convinced. “We do not want regrets,” Kabanda says. “We want a ruling. The judiciary should tell us if they do not have the mandate to decide the case so that we seek other avenues.”

He adds that if the Constitutional Court has expediently disposed of other cases — like the one that challenged the Inspector General of Government’s mandate to prosecute cases of corruption, a case also filed in 2011 — it should be in position to quickly decide on the pertinent issue of women’s lives.

“We understand that there is backlog and the judiciary is understaffed, but priority should go to the rights of pregnant women. Pregnancy will not wait. Every day, 16 women die due to pregnancy-related complications,” Kabanda says.

Judiciary only hope
Uganda’s Constitution has a comprehensive bill of rights, but its rich provisions on human rights have not necessarily translated into respect for human rights in the country. In addition, Uganda is signatory to international human rights instruments such as the Convention on the Elimination of all forms of Discrimination against Women, the International Covenant on Economic, Social and Cultural Rights, the Convention on the Rights of a Child, and the regional African Charter on Human and People’s rights.

All these protect the rights of women and children, and the right to health. On December 15, 2011, Parliament passed a resolution, which, if executed, would come in handy in addressing the issue of maternal mortality. The resolution urges government to expedite the reformation of the midwives’ training curriculum and to recruit a minimum of 2,000 well-trained and well-motivated midwives and other medical personnel.

It further says government should report periodically to Parliament on progress on maternal health. Uganda, as a member of the World Health Organisation’s Safe Motherhood programme, is expected to spend $1.40 per capita on maternal health. It, however, currently spends only $0.50, a mere 36 percent of the required minimum per capita.

The reality is that at the entrance of any government hospital in Uganda, a woman going to give birth is required to present a plastic sheet, razorblade, cotton wool, gauze and other consumables before she can receive any medical attention. Bribes to medical personnel are the norm, and experiences like Nalubowa’s read like a familiar folktale told over and over again. But can a court ruling turn around the tragic scenario where 5,840 women die in child birth each year? Time will tell.

pakumu@observer.ug

Source: http://www.observer.ug/index.php?option=com_content&view=article&id=18444:feature-maternal-health-case-puts-govt-on-the-spot&catid=34:news&Itemid=114

Secret Hoax Campaign Is Another Abortion Wars Tactic

By Leslie Kantor, MPH, vice president of education for Planned Parenthood Federation of America (PPFA) and Dr. Carolyn Westhoff, senior medical advisor for Planned Parenthood Federations of America (PPFA)

In recent weeks people who oppose Planned Parenthood, and our mission to provide high-quality reproductive health care, have been conducting a secret, nationwide hoax campaign in an attempt to undermine women’s access to services.

For years opponents of reproductive health and rights have used secret videotaping tactics with fictitious patient scenarios and selective editing to promote falsehoods about Planned Parenthood’s mission, services, and policies. Recently, one group has escalated these hoax visits in many states, apparently using secret recorders while inquiring about sex selection abortions. We anticipate that this group, likely in coordination with a broad range of anti-abortion leaders, will soon launch a propaganda campaign with the goal of discrediting Planned Parenthood, and, ultimately, furthering legislation that blocks access to basic reproductive health care, including birth control.

We can expect this propaganda campaign to further escalate the political battles over access to health care, rather than focus on the best ways to help women and their families get the care they need.

As a nonprofit health care provider with nearly 800 health centers, PlannedParenthood provides access to professional, nonjudgmental, affordable reproductive health care, ensuring nearly three million patients receive preventive and lifesaving care every year. Without Planned Parenthood, many women would have nowhere else to turn for breast and cervical cancer screening, well woman exams, birth control, STD testing and treatment, sex education, and pregnancy options.

As a women’s rights advocate for nearly 100 years, Planned Parenthood finds the concept of sex selection deeply unsettling. Planned Parenthood does not offer sex determination services; our ultrasound services are limited to medical purposes.

Gender bias is contrary to everything our organization works for daily in communities across the country. Planned Parenthood opposes racism and sexism in all forms, and we work to advance equity and human rights in the delivery of healthcare. Planned Parenthood condemns sex selection motivated by gender bias, and urges leaders to challenge the underlying conditions that lead to thesebeliefs and practices, including addressing the social, legal, economic, and political conditions that promote gender bias and lead some to value one gender over the other.

Recent attempts to restrict or deny access to safe abortion under the guise of preventing gender bias is harmful to women’s health, counter to a human rights agenda, and primarily a political tactic of groups who work to make abortion illegal. Planned Parenthood opposes legislation that intrudes on the doctor/patient relationship by requiring doctors to become investigators and patients their suspects, and that strips nonjudgmental, high-quality care from women in need.

The world’s leading women’s health and rights organizations, including the World Health Organization, do not believe that curtailing access to abortion services is a legitimate means of addressing sex selection, and are clear that gender bias can only be resolved by addressing the underlying conditions that lead to it. And we agree. We support efforts that ensure girls and women have access to economic opportunity, including fair wages, basic healthcare, political participation, education, and a life free of violence and discrimination. Planned Parenthood works to ensure women and their familieshave access to high-quality nonjudgmental health services free of coercion,supported by information and counseling.

From the questions that were repeatedly asked in these recent hoax visits, we expect that the materials eventually released will focus on Planned Parenthood’s non-judgmental discussions with the various women who posed aspossible patients. So, we would like to address that subject directly.

Planned Parenthood insists on the highest professional standards, which among other things means we offer nonjudgmental, confidential care in accordance with relevant laws. That doesn’t mean we always agree with the decisions made by people who seek our help, but it does mean that we realize that we can’t know all of the circumstances faced by any patient and that requiring women to justify the care they seek is a dangerous healthcare model for an organization. Four decades ago women in the United States were forced to justify their decision to seek abortion to a panel of doctors, and thankfully we’ve come a long way since then. We provide information that women seek, but ultimately the decision to seek legal abortion is a private one.

Planned Parenthood has extensive guidelines and training requirements for all staff who may encounter difficult or unusual questions, such as those posed by the hoax patients. If a health center learns of an instance where a staff member has not fully followed policies or procedures, swift action is taken to remedy the situation. Our rigorous and ongoing training and quality assurance help identify potential issues, and all health centers respond to any training or personnel needs with professionalism and respect. Planned Parenthood cares about staff, and conducts retraining or other personnel action responsibly.

People rely on Planned Parenthood for accessible and affordable quality care; that’s why one in five women have turned to us at some time in their lives for professional, nonjudgmental, and confidential care, and we value the trust they put in us.

###
Planned Parenthood is the nation’s leading sexual and reproductive health care provider and advocate. We believe that everyone has the right to choose when or whether to have a child, and that every child should be wanted and loved. Planned Parenthood affiliates operate nearly 800 health centers nationwide, providing medical services and sexuality education for millions of women, men, and teenagers each year. We also work with allies worldwide to ensure that all women and men have the right and the means to meet their sexual and reproductive health care needs.

Source: plannedparenthood.org

Is Criminalization of HIV Transmission Effective? Swedish Case Reveals Why the Answer Is No

By Marianne Mollmann

Earlier this month, a 31-year-old woman in Sweden was sentenced to one and a half years in prison for having unprotected sex without disclosing to her partner beforehand that she is living with HIV.

Even a perfunctory news search reveals that this is not the first time the Swedish justice system has applied criminal sanctions to potential HIV-transmission. In January, a 20-year-old man was sentenced to eight months in prison for having unprotected sex without disclosing his status. In December 2006, a 34-year-old woman got two months, and in January 2003, a 32-year-old woman one year. All of these sentences also required the person living with HIV to pay monetary damages to their former sex-partners.

For anyone who cares about human rights from a health and discrimination angle, these cases raise multiple red flags.

For starters, consensual sex between consenting adults should, in principle, never be subject to government control or regulation. Moreover, the criminalization of HIV transmission has multiple negative outcomes. It leads to distrust in the health and justice systems; it can discourage people from seeking to know their HIV status; it adds to the stigmatization of those living with HIV; and it is ineffective in bringing down HIV transmission.

In fact, UNAIDS (the Joint UN Programme on HIV/AIDS) recommends that governments limit criminal sanctions for HIV transmission to cases where all of three conditions are met: the person charged 1) knows he or she is living with HIV; 2) acts with the intention of transmitting the virus; and 3) actually transmits it. UNAIDS also recommends that cases of such intentional HIV-transmission should be tried under generic criminal provisions for bodily harm or assault, and not under HIV-specific provisions.

Public health and human rights activists are clear on this. That is why the Swedish Embassy in France was defiled with paint-filled condoms in protest against the 2003 ruling. And that is also why my own reaction to the ruling was to declare it “bad” over twitter, a statement that was re-tweeted several times.

A closer read of the cases highlighted in the Swedish media, however, leads me to reconsider, at least in part.

If the media-accounts are accurate, the Swedish government has, in fact, partially followed UNAIDS recommendations. The convicted individuals all knew their HIV status and the cases were brought under general criminal law provisions on grave assault, physical abuse and attempt to cause physical harm. So far so good.

The two remaining questions — intent and actual transmission — are more difficult to gauge.

Consider this.

In most of the cases, the convicted person either has multiple convictions over several years for the same thing, or the conviction is based on multiple unprotected sexual interactions with different partners without disclosure. It is perhaps valid for prosecutors to ask if, absent proof of intent which is hard to produce, the fact that an individual living with HIV repeatedly and knowingly exposes someone else to a deadly virus shouldn’t count for something.

Further, actual HIV transmission may not be the only harm caused. The 20-year-old convicted man was charged with having unprotected sex with eight women, none of whom ultimately ended up HIV-positive, though they all claimed to have suffered severe emotional trauma as a result of the experience. In cases of domestic violence we often ask prosecutors to consider emotional distress as real harm, so why require actual transmission in order to prove harm in this case?

Then again, consider this.

The 20-year-old man was born HIV-positive and is being charged as an adult also for those unprotected sexual encounters that occurred when he was a teenager. He was initially placed in solitary confinement, seemingly because of his HIV status.

Also, one of the convicted women alleged she had been raped. The male partner produced evidence to the contrary and she later withdrew the allegation. Nevertheless, coercion and fear are highly relevant when it comes to decisions about how and when to disclose HIV status. Research indicates that many women, in fact, are reluctant to disclose their HIV status because they quite legitimately fear abuse.

And with regard to actual harm caused, it is at least possible that the ramped-up attention to the cases have contributed in some part to the severity of the emotional distress of the sex partners.

It is, of course, reckless to knowingly expose anyone to real danger, also through potential HIV-transmission, even if the danger ultimately does not materialize. This is a notion the UNAIDS recommendations to a large extent fail to acknowledge.

But the highly publicized use of the criminal law in Sweden to punish those living with HIV for being timid about their health status does not make it easier for anyone to disclose. So perhaps the real question with regard to any government’s approach to HIV transmission should not be whether it follows UNAIDS recommendations, but rather if it is effective.

An educated guess says not so much.

This article was first published on RHRealityCheck.

Source: http://www.huffingtonpost.com/marianne-mollmann/is-criminalization-of-hiv-effective_b_1445385.html

Kenya: Access to Generic Drugs Prevails in High Court Ruling on Anti-Counterfeit Law

In a landmark decision last Friday, Kenya’s High Court ruled that the country’s anti-counterfeiting legislation could potentially undermine access to life-saving generic medicines. Lawmakers will now have to reconsider the relevant sections of the bill to eliminate ambiguities between generic and counterfeit drugs.

The 2008 Anti-Counterfeit Act was approved by the Kenyan Parliament with the intent of prohibiting trade in counterfeit goods and establishing an Anti-Counterfeiting Agency. (See Bridges Review, June 2009) The legal challenge to the act began in 2009 with a lawsuit filed by three petitioners with HIV/AIDS.

High Court Judge Mumbi Ngugi found that the act fails to clearly distinguish between counterfeited drugs and generic medicines. The ruling affirms that this legislative misstep may lead to confusion, which in turn could hinder access to life-saving medicines, particularly for people living with HIV.

“The right to life, dignity, and health of people like the petitioners who are infected with the HIV virus cannot be secured by a vague provison in a situation where those charged with the responsibility of enforcement of the law may not have a clear understanding of the difference between generic and counterfeit medicine,” Judge Mumbi Ngugi stated in the ruling.

“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 which would achieve … the protection of the petitioners in particular and the general public from substandard medicine,” Ngugi added.

Following doubts in July 2010 over the act’s consistency with the Kenyan Constitution on the right to life and the right to the highest standard of health, the High Court suspended implementation of the act’s provisions on counterfeited drugs until a decision on the case could be taken.

Last Friday’s ruling reaffirmed the suspension, underscoring 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.”
Health activists welcome decision

After the ruling, UNAIDS Executive Director Michel Sidibé declared that “the High Court of Kenya has upheld a fundamental element of the right to health.”

According to UNAIDS, 1.6 million people in Kenya live with HIV/AIDS; an estimated 743,000 Kenyans are eligible for antiretroviral treatment, of whom 539,000 are currently receiving it. Generic drugs are the most widely used medicines in Kenya.

“We must have both generic drugs and strong anti-counterfeit laws. Generic drugs give more people access to life-saving treatment – while anti-counterfeit laws keep people safe,” Sidibé added.

Several health advocacy groups similarly applauded the decision. AIDS Law Project Executive Director Jacinta Nyachae – in a joint statement issued by Médecins Sans Frontières, Health Action International Africa, and the Kenya Ethical and Legal Issues Network on HIV and AIDS – welcomed the High Court ruling and underlined the possible ripple effect the decision could have on Kenya’s neighbours.

“Kenya is leading the way in protecting access to medicines and public health and we are watching the actions of the East African Community member states to see if they follow suit,” Nyachae concluded.

ICTSD reporting; “Kenyan court ruling upholds access to generic drugs,” REUTERS AFRICA, 20 April 2012.

source: http://ictsd.org/i/news/bridgesweekly/131980/