Gichinga Ndirangu, HAI Africa

25 January 2012

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 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 living with HIV which required unfettered access to 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 misinterpreted, with a devastating impact on generic medicines which form the backbone of Kenya’s public health 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.

“This is not an academic petition; the risk is real,” warned Steve Luseno, lead counsel for the three petitioners.

Mr Omwanza, representing the interested parties, 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 recognised under Kenyan law.

The UN Special Rapporteur on Health and Human Rights, Anand Grover, 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 March 9. 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.

Gichinga Ndirangu is Regional Coordinator, HAI Africa

By Ellen Hodnett, professor ellen.hodnett@utoronto.ca

Traditional birth attendants, regardless of how well trained or resourced, are commonly thought to be a poor substitute for care by skilled birth attendants (defined as care providers with professional qualifications, such as doctors, midwives, or nurses) in a healthcare facility. In the linked meta-analysis of studies of deliveries assisted by traditional birth attendants, Wilson and colleagues found that offering training, support, and resources—such as clean delivery kits—to traditional birth attendants reduced perinatal and neonatal deaths in low income countries. This study provides compelling evidence that trained and supported traditional birth attendants save babies’ lives.

There are enormous economic and logistical barriers to the provision of skilled birth attendants in many countries, especially where women live in remote areas with inadequate transport to healthcare facilities. “Healthcare facility” is a term that encompasses everything from a stand alone birth centre to a tertiary care hospital. There is little evidence on the relative merits of most types of healthcare facility, although a review concluded that outcomes for healthy childbearing women and their babies are better for hospital based alternative birth settings than for conventional hospital wards. There are also enormous obstacles to changing care givers’ attitudes and behaviours in healthcare facilities. Innovations such as the World Health Organization Reproductive Health Library and the Better Births initiative in South Africa have involved comprehensive strategies to increase the likelihood of humane evidence based care, with modest success.

The authors of the current meta-analysis acknowledge the heterogeneity of interventions in the included studies, but they argue that the consistency of the individual studies’ findings supports the message that traditional birth attendants make a difference. It could be argued that heterogeneity poses a major challenge to successful implementation of interventions, particularly in resource poor countries, because the key components of the intervention under study cannot be definitively identified. However, the notion that the “active ingredients” of a complex intervention can be pinpointed is rooted in an assumption that the various components can be treated as though each is a single intervention and standardised into a one size fits all package. A BMJ editorial challenged this view, arguing that effective complex interventions are based on theory driven principles, which ensure that the process is standardised while the content is tailored to identified community needs.

Over the past six years, despite massive efforts, there has been little progress towards achieving millennium development goal 4 (reducing child mortality) or millennium development goal 5 (improving maternal health), except in a few countries where recent statistics give reason for hope. We know much about what constitutes safe and effective care for most pregnant women. The major research challenges are in the translation of this knowledge—how to effectively implement what is known, and how to influence policy to support the proper delivery of interventions that are known to be effective. With clear evidence that training and support for traditional birth attendants reduces perinatal mortality, WHO is ideally positioned to lead the way in the knowledge translation efforts that are the crucial next steps. But WHO cannot act without the invitation and backing of countries themselves. How can the political will be created, particularly in societies where women and children are at best second class citizens?

At least one country has resorted to legislation. The review of continuous support for women during childbirth was used to persuade the government of Brazil to enact the “Companion Law,” which states that all women have the right to companionship during labour and birth. But surely legislation is not the only, or best, solution to all forms of substandard care. We badly need more effective and flexible means of ensuring knowledge translation.

Trained, supported, and adequately resourced traditional birth attendants save babies’ lives and potentially save their mothers’ lives too. Some countries may welcome communication of this information. For settings in which less positive attitudes to maternal and child health prevail, the urgent research priority is to devise effective knowledge translation strategies that will ensure that the fundamental human rights of women and children are met.

Source: BJM (Helping doctors make better decisions)

http://www.bmj.com/content/344/bmj.e365

In a perfect world, maternity care would be at a similarly excellent level for all moms and babies around the world, but the fact is that some countries just seem to do better than others. Government programs, medical culture, and other factors that support maternal health and finances for new families can make a big difference for moms. In this list, we’ll show you 10 countries that are clearly doing things right, where moms (and often, dads) enjoy maternity and newborn perks like house calls, baby bonuses, 100% free health care, and amazingly low rates of maternal and infant death. We’ve listed these mother-loving countries in no particular rank because we believe they’re all excellent. So read on to find out about the 10 countries that know how to treat moms right.

France
Mothers in France enjoy a multitude of maternity benefits, ranging from generous paid time off to extended time in the hospital. One mom, Bindi Dupouy, enjoyed five full days of resting at her local hospital after a normal vaginal delivery, and enjoyed the entire experience. Dupouy shared, “They treat expecting mums like treasures here. They take really good care of you. The health care system is just amazing.” After leaving the hospital, Dupouy was able to take five months paid maternity leave from her job as a lawyer, and on top of that, can opt to take an additional seven months unpaid without any job disruption. With a full year available after birth, Dupouy and other French mothers certainly have the opportunity to bond and enjoy their children while they’re still small.

The benefits for families continue well after infanthood, as well. France offers subsidized daycare before age three, childcare allowances, and stipends for in-home nannies, as well as universal full time preschool beginning at the age of three. Statistically, France does well for moms, with 99% of women receiving at least one pre-natal visit and delivery care coverage from a skilled attendant. The risk of maternal death is low, at 1 in 6,600, as well as an under-5 mortality rate of four. These facts are not lost on French families, who are propelling France’s “robust reproduction rate” past other European countries that are suffering from a decline in births.

Sweden
Sweden is easily one of the best places in the world to have a baby, and it shows: the country has one of the highest birth rates in Europe, just edging out France’s rate of 1.8 with 1.9 children per mom. That’s largely thanks to generous parental leave laws, which allow Swedish women to easily juggle work and family. Together, Swedish couples enjoy 13 months paid leave, plus another three months at a fixed rate. Most of that time is available to be split between the two parents, so families can decide which parent would be better at home. Swedish mom Anna Eriksson enjoys this system, pointing out that it “means there’s no financial hardship, and your job is still waiting for you afterward,” thanks to a law that requires employers to hold a mother’s job during her maternity leave. Eriksson spent seven months at home with her son before her partner, Henrik Eriksson took over to become a stay at home dad. The situation works so well for the Erikssons, that they decided to have another baby shortly after their son’s birth. Perhaps even more impressive, the Erikssons are able to enjoy these benefits even though they are an unmarried couple. Health-wise, Swedish families do very well, with a maternal mortality ratio of 1 in 11,400 and a very low under-5 mortality rate.

Norway
Norway is another top contender for a great place to have a baby, with excellent medical care, generous maternity leave, and low mortality rates for both mother and child. Norwegian women enjoy medical professionals present at almost all of their births, and there is only a 1 in 175 chance of losing a child before the age of five. Norway’s c-section rate is low, with just 16% of births from 2005 to 2009 delivered via c-section. Norway also enjoys a maternal mortality ratio that’s on par with other developed countries at a rate of 1 in 7,600, as well as an under-5 mortality rate of three. But perhaps the most impressive part of giving birth in Norway is that it’s 100% free, from the first check up to the delivery, due to universal health care in the country. The international organization Save the Children praised Norway for these marks, as well as “one of the most generous maternity leave policies in the developed world,” a full year of paid leave for parents to spend with their infant. Norway’s clear advantage in these departments earned them number 1 in their 2011 Top Ten Places to Be a Mother report.

Australia
Australian moms don’t do too shabby either, with Australia coming in at number two according to Save the Children. The rankings were a result of figures including maternal death, access to medical resources, and the economic and political status of women. For most women, maternity care through Medicare is nearly free, with some only responsible for small co-pay amounts for doctor visits and no charge at all for hospital care. It’s not at all surprising to find out that Australian women take full advantage of this care, with statistics reporting that 100% of Australian moms have at least one pre-natal visit, and 100% have a skilled attendant at birth. C-section rates are fairly high at 30%, but that is still lower than the United States’ 31%, and the maternal mortality ratio is a reasonably low 1 in 7,400. Women, and mothers in particular, are well supported in Australia, with up to a year of shared maternity and paternity leave for parents. Previously, this was on an unpaid basis, but now, both mother and father receive 18 weeks of paid leave at federal minimum wage. For families who opt not to take part in parental leave pay, a baby bonus is available, with monthly installments paid out over the first year of the baby’s life to offset the additional costs of having a new child. The cost of having a child is further discounted through Australia’s child care benefit, which offers assistance with high day care costs.

Iceland
Iceland is another country that takes good care of its moms, with extensive pre-natal care offered for free to legal residents of more than six months. Icelandic moms enjoy about ten visits before the birth of their first child, including care from both midwives and doctors, ultrasounds, and general medical examinations. The hospital birth experience is also free, with a “lying-in” period that varies from one day to several days, depending on the circumstances of the birth. Icelandic births are very safe, with just a 17% c-section rate and a 1 in 9,400 maternal mortality ratio. Iceland also provides for a midwife home birth option for mothers with favorable conditions. After delivery, nurses will actually do a home visit for the the new mother and child, helping them to get settled into their new lives together, eliminating the stress and risk of infection associated with newborn doctor office visits. Working moms and dads in Iceland are cared for financially, with 90 days at 80% of their salary for both parents, plus 90 days to be shared between the parents. This time can be taken at any point during the first 18 months of their baby’s life. Iceland also provides for quarterly child benefits, paid at a fixed amount for each child under seven years of age, and disbursed based on family size and income through 18 years of age. There is one strange drawback to having a baby in Iceland, however: you must pick your baby’s name from the National Register of Persons, otherwise, you have to appeal for a new name to be added to the list, which must not be embarrassing, and conform to the Icelandic language and customs.

Germany
German moms are well cared for, with plenty of maternity benefits, and even special benefits for nursing mothers. After delivery, families are welcome to stay for what seems like a luxurious visit: 7 days for a vaginal delivery, and 7 to 14 days for a cesarean section. During this stay, moms can benefit from exercise classes to get back into shape, as well as therapeutic measures like sitting baths and sunlamps. Both pregnant and nursing mothers have extensive protection in the German workplace, and can not be scheduled to work on Sundays, or holidays, take on overtime or be required to more than 8 1/2 hours of work each day. Pregnant mothers are not expected to work during the last six weeks of their pregnancy in Germany, and new mothers are not allowed to return to work until their child is eight weeks old. Germany has strict rules about the hazardous exposures that pregnant and nursing mothers are open to, providing for adequate breaks and a ban on heavy, physical labor, as well as a ban on any conditions that might be hazardous to their health. German moms benefit from four months maternity leave, and employers are required to provide for at least three months of pay. Statistics back up Germany’s excellent policies, with an outstanding 1 in 11,100 maternal mortality ratio, and under-5 mortality rate of four.

Switzerland
Women in Switzerland enjoy a wealth of choices in childbirth. Births may take place in a hospital, after which moms and babies return home in the care of a midwife if they are both well. Mothers also have the choice to have a home birth, or go to a birth house where the environment is more home-like with little to no medical interventions, attended by midwives. Maternity benefits are great, with basic birth costs covered for Swiss women. Working Swiss mothers are eligible for 14 weeks paid maternity leave, and are forbidden from working for the first eight weeks following birth. Weeks nine through 16 are optional. Maternal mortality in Switzerland is low at 1 in 7,600, and the under-5 mortality rate is 4, both of which are on par with other industrialized countries.

Japan
Japanese families benefit from a similar situation to the Swiss. Moms in Japan can choose from hospitals, the most popular choice, midwife clinics with a home-like atmosphere, or a home birth. Two prenatal checkups are provided free of charge, and there are free childbirth classes available. Drawbacks do exist, however. Some women feel it is a bit over-medicalized, with too many tests, but most doctors are happy to scale it back on request. There are also some unusual restrictions for pregnancy that women in other parts of the world might not understand, like keeping your feet warm, wrapping your belly to keep it warm, and not driving after the eighth month of pregnancy. But for most women, these quirks are worth enduring for the world class medical care available. Japan’s maternal mortality ratio is among the best in the world at 1 in 12,200, and 100% of births have a skilled attendant of some kind present. Japan’s postnatal care is excellent, and most hospitals expect new families to stay about a week, however, families can leave earlier if they feel they are up to it. Families are expected to pay for their own medical costs, but after the birth will receive a standard payout, presumably to apply to medical bills. Financial support after the birth is reasonable, with moms receiving 60% of their usual pay for 14 weeks. Moms and dads can both take up to a year off for parental leave, offering Japanese families plenty of time to bond and adjust to their new lives together.

Italy
If you’re strictly concerned with maternal health, Italy is the place to be. In 2010, the country was rated the safest place to have a baby, with just 4 maternal deaths per 100,000 births. Amazingly, this incredibly safe maternity environment is completely free, in a system where families do not have to pay for prenatal visits or the hospital birth. Moms also benefit from 22 weeks of leave paid at 80% of their salary, and 2 weeks to relax and prepare for birth. And to encourage more children in the country, Italy has begun to offer a 1,000 Euro baby bonus to families with newborns. However, despite Italy’s benefits and safe delivery environment, it does have a high rate of c-sections: 40%. This may not necessarily be a reflection of poor care however, as many Italian women wait until they are older to have children, and advanced maternal age can come with higher risks for birth that may lead to c-section. The high rate of c-sections may also be tied to the excellent safety rating of the maternal health system, in which doctors do not hesitate to take drastic measures (as in a necessary c-section) to protect the lives of Italian mothers.

The Netherlands
Women who are interested in natural childbirth just might want to head to the Netherlands. The Dutch believe in keeping it natural, avoiding treating pregnant women as patients with a medical condition. That is not to say that they aren’t taken care of, though. Moms in the Netherlands do have excellent support, with 100% of births taking place with a skilled attendant present, which can mean either an OB-GYN or midwife. Home births are common, with 30% of births in the Netherlands taking place at home, the highest rate of home births in the world. Women are safe giving birth in the Netherlands with a low maternal mortality ratio (1 in 7,100). Just 10% of women in the Netherlands use pain relief, and no traditional pain relief is available at Dutch home births. Instead, moms are taught natural methods of pain management in prenatal classes, including yoga techniques. Moms who deliver in hospitals are typically home within hours, sent with a maternity care assistant to stay for at least a week to help out and support the family. This assistant is known as a kraamzorg, and offers an amazing amount of help to new moms with guidance on breastfeeding, baby care, as well as duties including light cleaning and babysitting older children. The help continues, as Dutch moms get 16 weeks maternity leave paid at 100% of their salary. Fathers only get two days leave paid at 100%, but both parents have up to 26 weeks available to take unpaid from employers, and through tax breaks, receive 50% of the national minimum wage.

We’re sure you’re wondering why the US is not a part of this list. In a recent ranking by Save the Children, the US came in at #31 on the Mothers’ Index, and it’s not difficult to see why. Safety for infants is an issue, with an under-5 mortality rate of 8, compared with the 4 or fewer seen in most other industrialized countries. The maternal mortality rate is similarly disturbing, with a ratio of 1 in 2,100 versus a typical 1 in about 7,500 often found in other industrialized countries. The US has a high c-section rate of 31%, double the World Health Organization’s recommendation of 15%. But beyond medical care, American moms still get the short end of the stick, with no paid maternity leave, a benefit that even moms in Afghanistan enjoy (90 days at 100%), the country rated the absolute worst for mothers at #164. In fact, the US is the only country in the developed world without a mandatory paid maternity leave. While it isn’t the worst place in the world to give birth, the US is a long way from making our top 10 list.

Source: http://www.medicalbillingandcoding.org/blog/the-10-best-countries-for-maternity-care/comment-page-1/#comment-2619

TO: Major General Kahinda Otafiire
Minister of Justice & Constitutional Affairs

RE: Revision and re-introduction the Industrial Property Bill for consideration in Parliament ahead of 2013

Dear Sir,
We (the undersigned) are writing this Letter as Civil Society Organisations in Uganda working in areas of Intellectual Property and access to Medicines.

The purpose of this letter is to express our concerns about the delay to review and re-introduction of the Industrial Properties Bill to Parliament for debate. This Bill was read to the eighth Parliament as Bill no.5 of the year 2009. However, there were concerns that were raised on provisions of the Bill which threaten access to medicines and since then the Bill has been shelved and it lapsed with the eighth parliament.

We are aware that Uganda is party to the World Trade Organisation’s agreement on Trade Related Aspects of Intellectual Property (TRIPS). The TRIPs agreement seeks to bring strong enforcement of intellectual property even on essential goods such as medicines. It however, has flexibilities which apply to least Developed Countries like Uganda before the expirely of the transitional period in 2013 for general provisions and 2016 for pharmaceutical products’ patents.

Ten years ago on the 14th of November while at Doha, member states to the WTO agreed that the TRIPS Agreement does not and SHOULD NOT prevent Members from taking measures to protect public health. The Doha declaration is a reaffirmation of members’ rights to exploit the flexibilities as provided under the TRIPS agreement. Uganda is a least developed country with very limited technological capacity to support the pharmaceutical needs of its population. It should be noted that almost 90% of drugs in Uganda are imports of which most are generic versions which need protection from patent owners who may want to stop their sale in a bid to get market for their expensive brand name drugs; this would be a disadvantage to Ugandans as they will not be able to access cheap drugs.

It is for this reason that we seek your attention to ensure that the Industrial Properties Bill takes maximum advantage of the flexibilities detailed under the TRIPS Agreement and as provided by the Doha Declaration. We for these reasons call upon government under the leadership of your ministry to ensure that:
• The Bill should expressly provide under section 8 (3) that pharmaceutical products are excluded from patent protection until 1st January 2016 or such other date as may be extended in the future;
• The Bill should under section 28 (13) & (14) indicate that applications for pharmaceutical products should only be filed after 1st January 2016 or such other date as may be extended in the future;
• The government should enhance the effectiveness of third party patent oppositions under section 28 (7) through providing the necessary technical capacity to Registrar General’s office to enable them examine the substance of the opposition;
• The Bill should be amended under section 8 to exclude natural substances from patentability;
• The Bill should properly define the public emergency provision and indicate that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency;
• The bill (section 66(3)) should be brought in line with the minimum standards under article 31(h) of the TRIPS Agreement by 1 July 2013;
• Section 61(2)(e) of the Industrial Property Bill should be amended to provide that when using the draft article 31bis TRIPS system as an importing country, the patent holder in Uganda does not need to be remunerated, to the extent that adequate remuneration has already been paid to the patent holder in the exporting country;
• Section 61(1) of the Industrial Property Bill should be amended to include the possibility of administrative (as opposed to judicial) grants of compulsory licences for private third parties acting on their own behalf and account. The ministry of health should be authorized to issue the compulsory licence in the area of pharmaceuticals;
• On re-exportations of pharmaceuticals produced under compulsory licence under the WTO 30 August 2003 Waiver Decision, section 102(8) should not only refer to COMESA, but also to the partner States of the EAC;
• Section 60(1) (a) should be amended to include a reference to a maximum period of negotiations with the right holder before granting a compulsory licence;
• As regards parallel importations, the reference to “importation into Uganda” of patented products under section 43(2) should be deleted to provide for a rule of international patent exhaustion;
• The Bill should introduce a provision enabling Uganda to take advantage of August 30th Decision

As currently drafted, the Bill does not make full and maximum use of the TRIPS flexibilities and as such impedes access to medicines initiatives of Ugandans. It is important that the laws of our country aim at putting the citizenry’s priorities into perspective in order to promote public health for all. We therefore strongly urge you to consider review and subsequent tabling of this Bill soon, as in its proposed form; it would destroy the traditional balance between intellectual property protection and public access, a balance that is essential to our nation’s economic growth and competitiveness.

We are looking forward to working with you to address our Concerns in this Bill.
Sincerely,

1. The center for Health Human rights and development (cehurd)
2. SEATINI Uganda
3. The International HIV/AIDS Alliance in Uganda
4. Open Society Innitiative for Eastern Africa (OSIEA)
5. KIOS

CC: Mr. Frederic Ruhindi
State Minister for Justice & Constitutional Affairs
CC: Hon. Amelia Kyambadde
Minister of Trade, Industry and cooperatives
CC: Uganda Law Reform Commission