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Pfizer says to appeal over India drug patent refusal

US drug giant Pfizer said Friday it will appeal against an Indian ruling overturning a patent for a cancer drug, saying the decision raises questions about intellectual property protection in India.

 

Indian generics heavyweight Cipla opposed the granting of the domestic patent for Prizer’s Sutent, which is used to combat liver and kidney cancer.

The patent office’s decision went to the heart of India’s patent act, which says a patent cannot be granted for a drug unless changes make it significantly more effective and innovative.

“The patentee (Pfizer) has miserably failed to demonstrate any improved activity” warranting a patent, the patent office said in its decision.

“The invention that is claimed in the patent does not involve any inventive step… and hence (is) not patentable,” Nilanjana Mukherjee, senior patent officer, said.

A spokesman for Cipla, which revolutionized AIDS treatment by supplying cut-price drugs to the world’s poor and which has been campaigning to be able offer other low-cost generic medicines, had no immediate comment.

But Pfizer managing director Jazz Tobaccowalla said the company believes the ruling “undermines intellectual property rights in India”.

“We will vigorously defend our basic Sutent patent,” the Pfizer executive said in a statement, adding the company would appeal against the ruling to India’s Intellectual Property Appellate Board.

The patent decision marked another win by Cipla against a global pharmaceutical company.

In September, a court threw out a patent infringement case launched against Cipla by Swiss drug maker F. Hoffmann-La Roche over the Mumbai firm’s version of a lung-cancer drug, ruling it had a different molecular makeup.

The cases have been watched worldwide as they involve interpretation of stricter drug patent protection rules introduced by India in 2005 to comply with World Trade Organization regulations.

India has some of the toughest criteria for drug companies to obtain patents, said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, an industry body.

“These rulings show (foreign) companies need to take into account that India will not permit tweaking of formulations for getting a patent. If they had those expectations, they were unrealistic,” Shah told AFP.

Medical charities have expressed concern compliance with WTO rules could reduce the country’s role as a supplier of low-cost medicines. India is the world’s leading exporter and manufacturer of non-branded medicines.

But Western firms — looking to countries such as India for sales growth — have voiced criticism of brand protection in India.

Earlier this year, an Indian ruling allowed a local firm to produce a vastly cheaper copy of German pharmaceutical giant Bayer’s patented drug Nexavar for liver and kidney cancer.

India’s patents chief ruled the price Bayer charged was “exorbitant” and told the firm to give a “compulsory license” — permitted under WTO rules for public health reasons — to Indian firm Natco Pharma to make a less costly version.

Experts say that ruling could pave the way for a rush of other “compulsory license” applications in India and other poor nations, allowing access to patented life-saving drugs at a fraction of the cost.

Read more: http://india.nydailynews.com/business/678d561f1bf06eab53965176d7bfd4cf/pfizer-to-appeal-over-india-drug-patent-refusal#ixzz28ZbSjQ00

Doctors’ pay raise okay but we need to do more to boost sector service delivery

Media report that the government is to double the salaries of doctors is a positive response to the demand that has taken years. Previously, we had between 10 and 20 per cent increments after strikes by health workers. Therefore, the doubling of doctors’ pay should be the beginning of a wider response in the quest for effective healthcare services.

However, there is need to look beyond the salaries as some factors may still hinder effective service delivery. I have visited some health facilities in Kamwenge District where a health centre IV is the main health facility. Rukunyu Health Centre IV did not have a functional theatre until recently, courtesy of funding by PEPFAR. As a partner, PEPFAR operationalised the theatre by providing equipment. It also supports health workers in the district.

However, the health facility still lacks electricity despite the fact that the power lines cross the compound of the facility. Whatever salary doctors will be paid, a health facility such as Rukunyu, which lacks power, will still struggle to offer effective services. Without electricity, it is not possible to use the ultra sound machines used to ascertain the condition of the baby in the womb. Yet such investigation is necessary for a doctor to make critical decisions regarding the lives of the mother and the unborn baby. Even children born premature cannot receive adequate care because the incubators cannot work.

Refrigerators for storing essential medicines will not be operational hence medicines will rot and sterilizing theatre equipment, a must-do, cannot happen. We have heard stories of health workers improvising lamps or mobile phone to provide light in labour wards as they help mothers to deliver. But such a situation is neither desirable nor sustainable. Fears that the power bills may be high for the health facility to afford cannot be reason enough for not connecting power to it.

However, the bills may not compare with the amount of fuel for ambulance and associated costs that may be required to transport a mother to Ibanda or Fort Portal for emergencies. Beyond, the salaries, urgent steps must be taken to address some of these issues as they have a direct bearing on service delivery.

Even a well-remunerated health worker at a facility that lacks the necessary tools, theatre, gloves, medicines, etc, may find themselves unable to offer effective services.

Paul Mayende Nicodemus, pmayende@baylor-uganda.org

Source: http://www.monitor.co.ug/OpEd/Letters/Doctors++pay+raise+okay+but+we+need+to+do+more+to+boost+sector/-/806314/1520826/-/151y64fz/-/index.html

Call for concepts from University Students

The Center for Health, Human Rights and Development (CEHURD) in Collaboration with the Leaning Network based at the School of Public Health and Family Medicine, University of Cape Town (UCT) and with support from IDRC invites students in Universities in Uganda to submit concept notes for their research to be conducted within the project “Health System Governance: Community Participation as a key strategy for realising the right to health”.

Background
Center for Health Human Rights and Development (CEHURD) in Collaboration with the Leaning Network based at the School of Public Health and Family Medicine, University of Cape Town (UCT) are undertaking an IDRC supported project which entails research on “Health System Governance: Community Participation as a key strategy for realising the Right to Health”. The overall aim of the project is to develop models for community participation in health that advance health equity and strengthen governance systems for health.

The main objective of the project is to explore the hypothesis that building civil society capacity to participate in health care and in services that provide the social determinants of health using a rights-based approach, in the context of interventions to enhance service responsiveness will help to address inequities in health and promote stronger and more sustainable governance systems for health that give voice to the poorest and most marginalized in developing countries.

We welcome approaches from students to conduct research within the broader aims of the project, and invite you to submit a concept note for a study you would like to conduct under the auspices of the project.

Objectives of the call
This project aims to identify, in two sites, one in South Africa and one in Uganda, opportunities for best practice in utilizing community participation as a vehicle for realizing the health rights. As part of the project, we will be developing and testing training materials targeting primary health committees and structures that act as the voice for communities in relation to the health services. In addition, students will play a key role in documenting, describing and evaluating the processes and effectiveness of different strategies of the project.

Research Topics
The research topics should focus on the challenges regarding the sustainability of community participation strategies; effective participation strategies for the right to health ; enhanced responsiveness and better governance of the health system at local level up to the higher levels and how to build stronger conceptual and advocacy links between human rights approaches to health and health equity.

Eligibility
CEHURD and will collaborate with the Universities to select the students that will qualify to undertake research under the project. These students will typically be doing studies in the areas of Public Health, Human Rights, Social Sciences, Law and related areas. The students should be undertaking their research projects within academic year 2012/2013

Support
Students whose projects are approved under this collaboration will receive a student bursary to support their field costs and field work, as long as the project meets a research objective under the broader project aims.

For any inquiries concerning this call, please send an email to info@cehurd.org.

Museveni calls ministers over Health budget deadlock

A deepening budget crisis in Parliament inflamed by a health sector in “shambles”, has forced President Museveni to summon a crisis Cabinet meeting tomorrow to discuss a give-and-take deal that would ease the passing of this year’s budget.

Sources told Sunday Monitor that the discussion in Cabinet will focus on the government option of discussing the politics involved and the implications of rising this year’s Shs11.4 trillion budget by Shs39.2 billion for health sector.

Junior Finance Minister Fred Omach is expected to argue in Cabinet that any attempts to bow to pressure in Parliament would “disorganise” the budget priorities and that this would require the ministry to align the budget afresh, hence delaying its execution.

The Budget Committee of Parliament has since recommended that wasteful areas in some votes be cut by 30 per cent to raise the Shs39.2b needed to motivate and recruit more health workers in the country.

This proposal was rejected by the President after Parliament recommended that defence budget be cut by Shs15 billion. The President on Monday reportedly stormed out of the NRM caucus meeting at State House after he was heckled by defiant NRM members. Trouble started after the President said he couldn’t “sacrifice the defence budget for anything”.

The President has proposed that the budget be approved and the government brings a supplementary request at a later date to address the challenges in the health sector. The president also said government would recruit 1,000 midwives this year and that the health sector will be prioritised next financial year.

“If they don’t listen to us, we are going to pass the budget as recommended by the Budget Committee, but not as Executive wants it,” Wilfred Niwagaba (NRM, Ndorwa East) said, adding: “For us to delay the process, we are only helping the government to see sense in helping the people who are dying in hospitals without doctors and drugs.”

Sunday Monitor understands that there will be an NRM caucus tomorrow to discuss the Cabinet position on the standoff holding the approval of this year’s budget.

The NRM Caucus on Thursday had tasked Ministry of Finance to work with Ministry of Health with a view of finding the required funds through re-allocations within the budget or a supplementary.

On Wednesday President Museveni summoned Speaker Rebecca Kadaga to State House where the President reportedly demanded to know why Parliament was holding the passing of the budget. But Ms Kadaga explained that she had asked the budget committee to harmonise the budget figures with the Executive after members vetoed a budget without the money for health sector.

The budget deadlock has increased the pressure on government to fix a “dilapidated” healthcare system and wobbled the centre of power in a rising political contest that has unsettled the relationship between Legislature and Executive.

The government failure to provide Shs260b to health sector has infuriated lawmakers who are now accusing the government of being “insensitive” to health of Ugandans. The government has blocked the proposed Budget Committee recommendations to cut Shs39.2b from wasteful expenditures.
Asked what will happen in the event that the government refuses to adjust the Shs11.4 trillion budget to take care of health sector, the former Shadow Finance Minister, Mr Oduman Okello, said the government would operate without a budget.

“The budget will not be passed and the service delivery will definitely be curtailed, but who is to blame?”

Nicholas Opio, an independent legal analyst, said the power of Parliament is admittedly limited to approval.

It is useful to distinguish between approval and allocation. The duty of allocation is the preserve of the Executive but the allocation is subject to the approval of Parliament.

In arriving at approvals, Article 155 (4) requires that an appropriate committee of the house provides recommendations to parliament – the recommendation then provides a basis for approval or non-approval of the budget by the house.

Source: http://www.monitor.co.ug/News/National/Museveni+calls+ministers+over+budget+deadlock/-/688334/1514638/-/8v8dyb/-/index.html

Uganda: The Deadly Hours for Women to Give Birth

BY CAROL NATUKUNDA

Woe unto a mother who goes to deliver in Mulago hospital at night or early morning. Chances are she could die.

A new report shows that the highest number of maternal deaths (14.2%) occurs between 9 am- 10am. Other “deadly” hours to be admitted are 7-8pm, 1-2am and 9-10pm.

In other regional referral hospitals combined, the highest number of deaths (13.2%) occurred between 7-10pm, followed by the 5-6am and 1-2pm.

The revelations are contained in a report titled “maternal mortality reviews in three referral hospitals in Uganda” 2009-2011. About 300 deaths of mothers were reviewed in Fort portal, Masaka and Mulago referral Hospitals.

According to the report, these time periods, in which mothers died relate to health worker fatigue and the periods of changeover of the medical staff.

Although 42% mothers died within 24 hours of admission, 20% died in the first six hours of admission. These were considered as the “walk in” dead, which suggested that they came to hospital when it was a little too late and nothing little could be done for them.

The report is the first of its kind and was carried out by the Association of Gynecologist and Obstetrics in Uganda, to explore why women continue to die in labour. An estimated 6,000 women die every year due to birth related problems.

Months of death

Overall, many mothers admitted at Mulago Hospital died in January and in July. These two months a number of changes on the calendar- the university examinations and holidays for the lecturers and some medical students, as well as recruitment of new interns.

“These personnel changes, impacted on the quality of services, provided at these hospitals,” the report states.

Furthermore, June and July was cited as the end of the financial year, and the hospitals were generally faced with challenges in procurement of essential supplies.

Causes of death

Presenting the findings at a conference on Thursday, Dr. Jolly Beyeza, a senior gynecologist and obstetrician said heavy bleeding ranked the highest cause of mortality at these hospitals, which often resulted from complications in labor, and delivery.

Other top complications, according to Beyeza were abortion, infections, and hypertentive disease in pregnancy. “Among mothers who died from abortion and ectopic related conditions had never had any antenatal care,” said Dr. Beyeza. Among the mothers whose mode of delivery was recorded, 11% died undelivered. Seven mothers were brought in hospitals when they were already dead, while the majority of mothers who came in with abortion or after delivery were critically ill.

Should abortion be legalized?

During the conference, participants debated on whether to legalise abortion or not.

Joy Asasira, a lawyer with the Center for Women’s Rights and Development said a lot of women are unnecessarily dying from crude methods of abortion.

“If a woman wants to have an abortion, it does not matter what the law says. She’ll have it anyway,” Asasira said.

“Many people don’t want to talk about it, but it happens. If you don’t talk about abortion, yet we want to achieve the Millennium Development Goal of improving maternal health, we are deceiving ourselves,” she added.

Asasira argued that the government was spending sh7.5billion every year to treat complications resulting from unsafe abortions. The World Health Organization estimates that in Uganda, about 300,000 abortions are carried out every year.

Statistics show that the use of contraceptives is still low in Uganda. About 26% of women in Uganda are using modern contraception methods, while about 16 women die every day due to maternal health problems, including abortion.

Asasira stressed that nearly all unsafe abortions are because of unwanted pregnancies.

She also acknowledged that while the law in Uganda does not criminalize abortion, terminating a pregnancy had to be done within constraints of the law.

Quoting Section 224 of the Penal Code Act, Asasira said: “The law doesn’t prohibit abortion absolutely. It has a provision that acknowledges that to save the life of a mother, in case of a severe illness, that is threatening the life of a mother; a safe abortion should be carried out. But most people are not aware of this fact.”

However, doctors were skeptic, arguing that if safe abortion is readily available, women might choose to use it as a form of family planning, rather than an emergency solution to an unwanted pregnancy.

“The best thing is preventing pregnancy itself. You cannot start solving a problem from the bottom of it. Even if you made removal of pregnancy available, women will decide to use abortion as a family planning method,” argued Prof Donald Amoko, a Ugandan gynecologist based in South Africa.

Dr, James Batwala, a senior consultant obstetrician and gynecology was also pessimistic. “I am sure as we talk now; abortion is going on either legally or illegally. When you think about it, a woman has a right [to abort]. But what about the child? Don’t they have a right to life? We need to draw a line. What is more important right now is that abortion is a killer,” Batwala said.

Reacting to the concerns, Asasira, argued: “As a lawyer, rights begin at birth. I am a woman, I love babies, but there are some issues beyond the woman.”

What mothers say

The median age at death was 25 years. According to the study, only 57% of women in Uganda deliver in a health facility. “We are wondering. Where do the rest go?” asked Beyeza.

Many mothers cite lack of transport from home to the health facilities in time, staff lacking expertise and shortage of doctors among others. But doctors also complained that patients came to hospital when it was way too late. They also lacked essential facilities in health centers to carry out emergencies.

Way forward

Participants noted that most the complications were treatable. Dr. Florence Mirembe, a gynecologist said involving men in the maternal health fight would make a difference. “The men need to walk with us,” she said.

The ministry of health permanent sectary Dr. Asuman Lukwago said the government was committed to give more resources to the sector. He also announced that a women’s hospital at Mulago Hospital would be ready within two years, and called for the need for training of more gynecologists and obstetricians to work at the center.

Frank Tumwebaze, the incoming minister of presidency said the government would look into recruitment of midwives. He also called on parliament to advocate aggressively for the increase of doctors and nurses salaries, saying it would make them motivated.

Source: http://allafrica.com/stories/201209220493.html