By Patralekha Chatterjee for Intellectual Property Watch
India last week saw a landmark public health decision on the evolving role of intellectual property rights in the context of the public interest.
The country’s Intellectual Property Appellate Board (IPAB) revoked a patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a (Pegasys), a medicine used to treat Hepatitis C.
The case has generated significant interest because it breaks ground in two ways: the patent granted to Roche in 2006 was the first product patent on a medicine in India after the country switched to a product patent regime for medicines as mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is also India’s first successful post-grant opposition case.
While welcoming the IPAB’s decision, Eldred Tellis, director of Sankalp Rehabilitation Trust, a nongovernmental organisation which had challenged the patent, told Intellectual Property Watch: “In short term, we will have to look for those interested in producing a biosimilar which will be available at for possibly 8 to 10 times less than Pegasys.” In the long-term, Tellis said he hopes the Indian government will wake up to the seriousness of the problem of Hepatitis C in the country. “There is a need to produce it cheaply, and give it free to those who need it,” he added.
Sankalp works with injecting drug users who often suffer from Hepatitis C. It had filed for a post-grant opposition challenging the patent with help from India’s Lawyers’ Collective HIV and AIDS Unit. India’s Patent Law allows pre-grant and post-grant opposition. In 2009, Sankalp’s post-grant opposition was rejected by the Patent Office. Undeterred, Sankalp filed an appeal before the IPAB challenging the decision.
Whether the IPAB decision will trigger more post-grant oppositions remains to be seen.
By Dr. Cory Couillard:
Annually, 16 million girls aged between 15 and 19 give birth each year. Ninety percent of the births in developing countries occur in adolescent marriages according to World Health Organization (WHO) statistics. In many countries, the risk of maternal death is twice as high for adolescent mothers.
Motherhood is often a fulfilling experience but sadly it is commonly associated with severe health consequences without proper care, education and support. Conditions that are related to pregnancy and childbirth are the second cause of death among women of reproductive age.
Severe bleeding, infections, unsafe abortion and high blood pressure conditions are four of the main killers that cause 70 percent of deaths. In all, over 358,000 women die per year and most of these are preventable.
20 million pregnancy complications
Maternal health simply refers to the overall health of a woman during pregnancy, childbirth and the postpartum period. More than 136 million women give birth per year and about 20 million of them experience pregnancy-related complications. Maternal health or the lack of it is a major public health crisis.
It is important to know that the bleeding after a delivery can kill even a healthy woman if unattended. The risk of death is directly related to the access and availability of proper healthcare services. Generally, access to services is related to the income of the family or individual. Less income generally equates to less access to care and greater risk of death or complication.
Women who are attended by trained healthcare professionals are rarer than you think. Nearly half of all childbirths in developing countries are not attended to properly. Attended childbirths still pose the risk of complications such as infections if cleanliness and hygiene standards are not strictly adhered to.
Unsafe abortion & infant death
There are over 18 million unsafe abortions that are carried out every year that result in over 46,000 deaths. Half of these abortions are considered unsafe.
WHO defines unsafe abortion as a “procedure for terminating a pregnancy that is performed by an individual lacking the necessary skills, or in an environment that does not conform to minimal medical standards, or both.”
It is estimated that three-quarters of newborn deaths could be prevented if women were adequately nourished and received appropriate medical care from early pregnancy through the post-delivery period.
Currently, about four million infants die within their first month. Improved access to medical care and maternal nutrition would significantly reduce stillbirths, which now number 3.3 million worldwide.
Many women in developing countries give birth before the age of 18. Many of these women have been married off as children and lack the education, money, and status to get adequate healthcare services.
Complications run rampant in adolescent pregnancies. Children having children will face substantial risk from having small pelvises that can obstruct labor resulting in long labor times, birth injuries and an increased risk of still born babies.
Education highest priority
Experts at the World Health Organization point to education as the primary way of addressing maternal health in many developing countries. Education can address the root causes — poverty, low status of females and lack of access to healthcare.
The education of girls and young women does a lot more than just improving the lives of mothers; it protects children’s health, facilitates healthy families, creates less of a burden on healthcare delivery systems and overall improves society.
Dr. Cory Couillard is an international healthcare speaker and columnist for numerous newspapers, magazines, websites and publications throughout the world. He works in collaboration with the World Health Organization’s goals of disease prevention and global healthcare education. Views do not necessarily reflect endorsement.
Nakaibale with her triplets at home in Bukwaya-Inuula, Bugyenda district
Annet Nakaibale, a mother of eight, knew she was carrying more than one baby, but did not expect triplets. As fate would have it, labour pains struck when she was by herself in a grass-thatched hut.
The 35-year-old narrowly survived death. She recently successfully delivered triplets without anyone’s help.
The resident of Bukwaya-Inuula in Bugaya subcounty, Buyende district, says the labour pains began at about 7:50am when all her children had gone to school and the neighbours to their gardens.
“The pains started abruptly but I did not have the energy to walk to my neighbours, who were tending to their gardens,” she says.
Nakaibale delivered the first child, but hardly had she reached for the razor blade to cut the umbilical cord, when the second baby came. “After cutting the second cord, I thought it was over, but fresh pains erupted and the third baby came.”
As Nakaibale lay in a pool of blood wondering what to do, she heard someone walking past her hut and she made an alarm.
“Help, I have delivered triplets, but I am desperate,” Medi Kabolu, the passerby, narrates. “The triplets were crying helplessly, lying bare on the ground.” He did not know what to do, so he also raised an alarm. Sympathisers gathered around her and mobilised a motorcycle that transported her to Bugaya Health Centre III, 15km away.
The babies’ weight had not been established, but they were healthy, according to medical workers at the health centre. Unfortunately, Nakaibale’s husband, David Kaduku, left four months ago to burn charcoal in Kiboga Forest, so he was not at home to welcome the bundles of joy.
“I am happy that I survived because I would have bled to death. I thank my fellow residents for their support” Nakaibale, says.
She says four months ago, the attendants of a nearby drug shop had examined Nakaibale and revealed that she was carrying more than one baby, but did not divulge more details.
On why she did not consult the experts, Nakaibale says she could not afford sh10,000 to hire a boda boda to Bugaya Health Centre III.
Challenge of health facilities in Bugaya
Charles Musasizi, the district health inspector for Buyende, says Inuula parish comprises 14 villages with only one health facility, Bugaya Health Centre III.
He adds most maternal deaths result from failure of mothers to make it to the health centre because they cannot afford the transport costs. Musasizi says there is also shortage of medical workers. The people manning the drug shops usually double as midwives.
According to Dr. Thomas Suubi of Suubi Medical Clinic-Mateete, Sembabule district, an expectant mother must be put under surveillance to minimise pre-and post-delivery complications.
Recently, Sarah Naigaga, a resident of Buseete, Buyende district in eastern Uganda, also delivered a baby in Buyende livestock market. Such occurrences are common, since the Melinda Gates Foundation that used to transport pregnant mothers in Buyende and Pallisa districts phased out the project in 2010.
Understanding the risks involved
Any pregnancy is challenging, but for a multiple pregnancy, the experience is more demanding and the risks, high
If you are expecting more than one child, you are at a greater risk of pre-eclampsia, a life-threatening condition that occurs during pregnancy and/or immediately after giving birth.
The condition is characterised by a rapid rise in blood pressure that can lead to seizures, stroke, multiple organ failure and death of the mother and/or baby. One, therefore, has to understand and appropriately respond to the warning signs of preeclampsia before the condition gets out of hand.
Multiple pregnancies are high risk and an obstetrician must watch the pregnancy closely because it can result in pre-term birth. A pre-term birth is when a baby arrives before 37 weeks of pregnancy.
The further on into your pregnancy you are, the more likely it is that your baby will do well. This is because his organs will be more mature, his lungs will be better prepared for breathing and he will have more strength for sucking and feeding.
You may face physical complications from the added strain of carrying additional weight for a longer period of time, and you might feel some extra psychological stress over wondering how you will feed and care the babies
Sometimes one baby will get more than its share of oxygen and nutrition at the expense of the other. This puts both in grave danger, as the overload on the larger twin can be just as lethal as the deprivation to the smaller one.
Regular ultrasounds are, therefore, needed to make sure the babies are growing at roughly the same rate.
Delivery poses dangers as well. Breech babies are frequent. This is where the baby’s buttocks and/or feet will be positioned. This makes C-section the safest way to deliver.
The Population Secretariat (POPSEC) has started campaigning for maternal health as a human right. The project, launched on Thursday at Hotel Africana, Kampala, changes strategy from merely advocating for maternal health to creating massive awareness that it is a human right.
Dr. Betty Kyadondo, the Head of Family Health Department at POPSEC said they hope this will empower all women with knowledge regarding their rights to health. This will exert pressure on the government to respond accordingly.
According to the Uganda Demographic and Health Survey 2011, 438 mothers out of every 100,000 live births, die while giving birth. The figure has risen three points from 435 deaths in 2006.
Presenting a report by POPSEC, Kyadondo called it developing the capacity of duty bearers, the government, to meet their obligations and encourage rights’ holders, the community, to claim their rights.
“A woman in the village does not know that health is her right,” she said. “Once they do, and start demanding for them, then the government will shift priority. When the community gets empowered, then the voice will be even stronger.”
States are obliged, under international human rights law, to respect, protect and fulfill the human rights related to pregnancy and child birth, for example, ensuring women’s access to a wide range of sexual reproductive information and health services, including family planning, antenatal care, skilled delivery and post natal care.
Through the Partners in Population and Development Africa Region, POPSEC was commissioned by the World Bank to implement the project. Dr. Jotham Musinguzi, the Regional Director of Partners in Population and Development Africa Region, noted that mothers were dying from preventable and treatable diseases, and such approaches are needed to scale the numbers down.
The chief guest, Hon Gabriel Aridru Ajedra, the MP of Arua Municipality, also minister designate for investment, described the intervention as unique
Expectant mothers who had been admitted to the maternity ward last week after the hospital had run out of blood. PHOTO BY SAM LAWIN
Gulu
Gulu Regional Referral Hospital has received a new consignment of blood after suffering shortage for nearly a week.
This led to the death of two newborn babies in the maternity department after their mothers, because of delayed delivery, caused their exhaustion due to lack of blood.
Last week, several patients, who were either lined up for surgical operations or needed blood transfusion, opted to go to nearby private hospitals.
Feeling the pinch
A caretaker at the hospital, who requested anonymity, said: “I brought my sister all the way from Lalogi Sub-county, about 70 kilometres away, to have safe delivery here but we had to move to St. Mary’s Hospital Lacor where it is offered at a fee.”
Many expectant mothers, after the death of the two babies, reportedly abandoned the maternity ward fearing that they could be forced to undergo caesarean operation that would require blood transfusion.
But the hospital principal administrator, Mr Muhammad Mubiru, said the management was relieved at the weekend after several units of blood were brought from Kampala. He could not give the exact amount of the units received.
“We had to keep other patients on oxygen and other mechanisms while those with minor operations were advised to wait as the hospital tried to get screened blood,” Mr Mubiru said, adding that the shortage was caused by lack of a blood screening machine after one at the hospital broke down.
The hospital, with a capacity of about 500 beds, receives more than 400 outpatients in a day, Shortage of blood, drugs and other medical supplies has become the norm in many government hospitals and smaller health units.The Ministry of Health has always blamed the National Medical Stores, the distributing agency, and the districts for poor planning, leading to delayed delivery
