Civil Society Appeals for an Extension on Standards for Intellectual Property Rights on Medicines

Uganda –Kampala —Civil society Organizations working on health and access to medicines have today appealed to His Excellence Ambassador Christopher Onyanga Aparr the Permanent Representative to the Permanent Mission of Uganda to the United Nations in Geneva to lead Least developed County (LDC) members of the World Trade Organization (WTO), to act collectively to submit a duly motivated request to the Council on Trade Related Aspects of Intellectual Property (TRIPS) for an indefinite extension of the soon-to-lapse pharmaceutical transition period at the upcoming TRIPS Council meeting on 24th February, 2015.

According to a 2002 WTO TRIPS Council decision, member countries of the WTO considered to be least developed are exempted from enforcing patents and data protections on Pharmaceutical products for until 1st January 2016.

Intellectual properties such as patents raise the costs of medicines because patent holders can eliminate competition which would otherwise lead to cheaper prices. Global studies, including the MSF, Untangling the Web of Antiretroviral Prices routinely show that generic medicines are almost always priced lower than even the discounted prices drug companies sometimes offer to lower-income countries like Uganda.

In a letter dated 16th February, 2014 civil society groups recalled Article 66.1 of the TRIPS Agreement which provides to the effect that the Council for TRIPS “shall, upon duly motivated request by a least-developed country Member, accord extensions”.

In this appeal, the groups are of the view that the extension of the transition period be for as long as an LDC Member State remains a LDC, without conditions, and that it should further motivate waivers of Articles 70.8 and 70.9 to the General Council, also for as long as an LDC Member State remains an LDC. The detailed letter can be accessed here>>

The non film coated tenofovir+lamivudine is a two drug combination used with a third medicine, typically efavirenz or nivirapine.

“Cease Use of Bitter medicines” – CSOs ask of government

PRESS STATEMENT

People living with HIV Call for Urgent Action by Health Ministry to
Cease Use of “Unusable” Medicine
Risk of Chaos in HIV Treatment Undermines the Right to Health

For Immediate Release: September 2 2014
Contact for more information: Kenneth Mwehonge, HEPS Uganda and
Uganda Coalition for Access to Essential Medicines:: 0701182809
Margaret Happy, International Community of Women Living with HIV East
Africa: 0772695133
Read More “Cease Use of Bitter medicines” – CSOs ask of government

More than 500 abortions in Gulu last year, says report

By Cissy Makumbi 

Gulu hospital management has called for government intervention following the release of a report showing an increase in cases of abortion in the district.

The report released on Wednesday shows that up to 568 babies were aborted in the year 2011/2012.

The authorities, who compiled the report, say there is need to save the unborn babies from the practice, common among girls who have unprotected sex for money.

In 2010/2011, about 500 unborn babies were terminated, according to the same report, although it still remains unclear whether the culprits were brought to book, since the practice is a crime under the law.

The director of the hospital, Dr Anthony Onyach, however, attributed the increase in the vice to failure by many mothers to use family planning methods, thus conceiving against their will.

“Most abortions occur among girls who report to the hospital when they are very sick after administering herbs and other drugs on themselves, while others seek help from shrines,” Mr Onyach said.

The same report indicates a drastic decline in the number of mothers seeking family planning services at the health facility. It shows that although in 2010/2011 there were at least 1,239 mothers who visited the hospital’s family planning unit, in 2011/2012, the number reduced to only 770.

Health experts attribute the increasing number of women with cervical cancer to unsafe abortions. Under the law, abortion is illegal and punishable, a situation that sees many women do it undercover with support from ill-equipped health personnel and traditional healers.

The Ministry of Health is considering the recommendations of a report it commissioned into the safety and legality of abortion. The report proposes legalising abortion in specific cases such as rape.

However, the debate on legalising abortion has not been met with open arms, with the proposal opposed by many Ugandans, most arguments based on religious, cultural and moral grounds

Source: http://www.monitor.co.ug/News/National/More+than+500+abortions+in+Gulu+last+year++says+report/-/688334/1506654/-/vx98ym/-/index.html

Indian patent rules infuriate Big Pharma

A CLASH over India’s drug market was inevitable. Foreign drugmakers, facing paltry growth in the West, are eyeing India hungrily. Rising incomes and rates of chronic disease may push sales from $12 billion in 2010 to $74 billion in 2020, according to PwC, a consultancy. But tapping this growth means having patents that protect intellectual property. India is home to a thriving generics industry, whose copycat drugs make up about 90% of the market. India’s drug-patent laws are just seven years old. Its government is keen to encourage generics and keep prices down.

Now India’s patent rules are being put to the test. Novartis, a Swiss giant, is challenging India for denying a patent for Glivec, its blockbuster cancer drug. The fight is due to reach India’s Supreme Court on September 11th. Bayer, a German drugmaker, has a different problem: in March India’s patent controller ordered it to license a drug to a local manufacturer. Its appeal had its first hearing on September 3rd. The cases will help decide how quickly India’s 1.2 billion people get new drugs, and at what price.

India’s drug industry has a unique history. For more than 30 years, the country did not recognise pharmaceutical patents. Domestic firms became masters at copying medicine and making it cheaply. After joining the World Trade Organisation (WTO) in 1995, India had to change its patent policy. But its new system, in place since 2005, includes special protections for both patients and generic manufacturers.

For example, the law bars patents of minor changes to existing drugs, a practice known as “evergreening”. Drug reformulations are often used to extend patents elsewhere; they get no protection in India. The country also has broad criteria for “compulsory licensing”. A WTO agreement allows countries, in some instances, to force a firm to license a patented drug to a generic company. India’s rules give officials broad powers to do this.

Now both provisions are under attack. In 2006 India denied Novartis a patent for Glivec, calling it an unpatentable modification of an existing substance, imatinib. Novartis insists this is nonsense. Only by making it in salt form, imatinib mesylate, did Novartis have a proper drug: the body absorbed the medicine 30% more easily.

Paul Herrling, the chair of Novartis’s Institute for Tropical Diseases, says the case is a test of what is patentable in India. “We are being accused of evergreening,” he says. “Having that concept applied to Glivec, which was one of the major breakthroughs in cancer therapies, is completely ridiculous.” Michelle Childs of Médecins Sans Frontières, a non-profit, retorts that drug firms such as Novartis should not win patents for minor improvements. This would keep generics off the market, driving up prices.

Bayer’s case is equally heated. In 2008 it won an Indian patent for Nexavar, a kidney-cancer drug. But in March India’s patent controller issued the country’s first compulsory licence. He wrote that Bayer had not made Nexavar “reasonably affordable” (Bayer offered it for a whopping $5,000 a month), that the company failed to provide enough of the drug and, in a protectionist nod, reckoned that importing Nexavar further hurt Bayer’s case. The controller ordered an Indian company, Natco, to sell Nexavar for one-thirtieth of Bayer’s price. Bayer will receive a 6% royalty. Meanwhile Bayer is fending off another competitor, Cipla, which has sold generic Nexavar in India for years.

As these cases drag on, India’s government is considering other ways to get cheaper medicine. It plans to offer free generics in public hospitals, which would drive up sales of very cheap copies. It may also set price controls for patented drugs. However, generic companies are not immune to regulatory pressure. Ministers plan to expand price controls for a broader swathe of generics.

Cost versus innovation

 

 

“We realise the industry will take a hit,” explains D.G. Shah of the Indian Pharmaceutical Alliance, which represents big generic companies. “We’re trying to find a solution so that the government’s concerns on access and affordability are addressed without threatening the long-term growth of the pharmaceutical industry.” Nice work, if they can get it.

Source: http://www.economist.com/node/21562226

350,000 abortions in Uganda are induced – experts

Article by Catherine Mwesigwa Kizza ( New Vision)

Infanticide, child abandonment and abuse — the Ugandan media is full of the stories. The missing story though is that the abused and murdered children are most probably survivors of induced abortion.

“There are over two million conceptions in Uganda every year. 200,000 to 300,000 of these miscarry or abort spontaneously but 350,000 abortions in Uganda are induced,” said Dr. Charles Kiggundu an obstetrician and gynecologist at a breakfast meeting convened by the Center for Reproductive Rights and Centre for Human Rights and Development in Kampala Wednesday, to discuss the laws and policies on abortion in Uganda.

“90,000 of the induced abortions end up with severe complications but only a half of them access post abortion services,” he added.

“Only half of the women with complications seek medical care. A few survive but many others die,” he added.

Joy Asaasira of CEHURD said of the 20 women in Uganda who die due to pregnancy and childbirth-related complications every day, four to five of these are due to induced abortion.

Dr. Kiggundu says these are needless deaths. The policy environment allows women to receive healthcare for post- abortion complications, however, studies have shown that when they seek care, it takes about 44 hours for them to get attention compared to 35 to 45 minutes other women spend in hospital before getting a service.

“Health workers do not want to treat women with abortion complications because they do not want to be seen to be accomplices to the termination of pregnancy,” he said.

He also pointed out that phrases on hospital documents like “Police notify” worry health workers and are a deterrent to provision of care for women.

‘Health workers do not want to get involved with police. They want to do their work unencumbered,” he said.

Women induce abortions due to unwanted pregnancies due to wrong timing of pregnancy or economic and social hardships.

“Some men tell their wives to abort because ‘they stopped having children’ and yet did nothing about it,” Dr. Kiggundu said.

Those who survive death end up with chronic pain, anemia, and infertility among other complications.

He said safe abortion services were available but hidden to the poor.

“You must be connected and well-oiled to access the services. Some women fly to South Africa to terminate pregnancies and return,” he revealed.

The consequences for the majority who go to quacks or unskilled medical workers working undercover are dire.

“We recover forks, pens, knitting needles, bed springs, sticks, herbs from women who run to us with botched abortions. Some of these things kill the woman before they even kill the foetus,” he said.

Treatment for those who survive death is expensive. According to CEHURD, sh17.6bn is spent on treating abortion complications.

Not only can this money be saved and spent on worthwhile health causes but women’s lives can be saved as well.

According to Dr. Kiggundu, the Ministry of Health’s comprehensive abortion care includes sexuality education to promote safe sex practices, family planning use including access to emergency contraception, reducing fertility, providing safe abortion services and quality post-abortion care.

Government is also training nurses and giving them skills to perform manual evacuation procedures to attend to women with incomplete abortions.

“There are still many gaps,” said Dr. Kiggundu. “Uganda still produces health workers for export and retains only a few.”

He revealed that only 30% of the vacancies for skilled health personnel required to provide safe motherhood are filled.

It is no wonder that despite government commitments, advocacy efforts, plans and policies to reduce maternal deaths in the country, there has been no progress in this indicator in the past five years.

New data from the Uganda Demographic Health Survey report of 2011 show that the maternal mortality ratio increased from 435 deaths per 100,000 live births in 2006 to 438 deaths, though other international studies show a decline to 310 deaths per 100,000 live births.

“26% of these deaths are due to unsafe abortion,” said Elisa Slattery the Regional Director, Africa Program Center for Reproductive Rights.

Once addressed, reduction in unsafe abortion contributes to reduction in maternal death.

Slattery said studies on the law on abortion in Uganda have found that “abortion is permitted where a mother has severe illnesses threatening her health like cardiac disease, renal disease, eclampsia.”

The Centre for Reproductive Rights study also found that healthcare providers are not required under the Uganda law to consult one or more providers to get their consent before terminating pregnancy as has been previously believed.

The organization is calling on government to broaden access of information among healthcare professionals and the public as a means of stopping the tragedy.

source:http://www.newvision.co.ug/news/634689-350-000-abortions-in-Uganda-are-induced—experts.html