• Report a rights violation:
  • 0800 300 044
  • info@cehurd.org
Search
Close this search box.
UCHD2023
Posted on Categories Featured 234 Comments on Brand-name drug makers counter that compulsory licensing makes it difficult for them to invest millions of dollars in researching and developing new drugs.

Brand-name drug makers counter that compulsory licensing makes it difficult for them to invest millions of dollars in researching and developing new drugs.

The world’s brand-name drug makers have long viewed India as their problem child for delaying compliance with international property rights law while serving as the developing world’s pharmacy for generic drugs.

Although India eventually agreed to comply with the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), it made it clear that it fully intended to use a provision of international law that allows for the so-called “compulsory licensing” of generic drugs that are the therapeutic equivalents of their patented counterparts in the interests of ensuring the poor and disadvantaged have access to drugs (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-3898).

That day has come as India has issued its first patent compulsory licensing order, for the kidney/liver cancer drug sorafenib, and started a deep ripple in the global pharmaceutical pond. China, the target market of many brand-name drug makers, quickly amended its intellectual property law to allow for the compulsory licensing of generic drugs “for reasons of public health.” Argentina and the Philippines have indicated they’ll soon do the same, while in other nations, such as Malaysia, local groups are pressing the government to grant a compulsory licence to a second-line antiretroviral used in the treatment of HIV/AIDS.

India’s first post-TRIPs compulsory licence, issued in March, allowed NATCO Pharma Limited to produce a generic version of sorafenib, the patent for which is held by German drug giant Bayer AG, on the grounds that the brand-name version was not “reasonably affordable.” The licence entitles NATCO to sell the drug at about 3% of Bayer’s price. That substantially reduces the cost of a monthly, 120-tablet dose of the drug to 8880 rupees (roughly $180) from 280 428 rupees (about $5500) (http://pib.nic.in/newsite/erelease.aspx?relid=82984). The license requires NATCO to pay Bayer a royalty of “6% of the net sales of the drug” and to supply the drug free of cost to at least 600 “needy and deserving” patients annually.

There’s no question that the licence was justified on public health grounds, argues Dr. Kunal Saha, president of the nongovernmental advocacy group People for Better Treatment. “In a country like India, where a large fraction of the population is still in the lower rungs of the economic ladder with very little money to spend on health care, there can be nothing wrong with the fundamental reason for the compulsory licence order issued recently by the Indian patent office because, in simple terms, it will reduce the price of many drugs that have been monopolized by few selective and wealthy drug companies,” says Saha.

Compulsory licensing will increasingly be a necessity for many nations, argues Dr. P. Khadgapathi, chairman of the industrial pharmaceutical division of the Indian Pharmaceutical Association. The association “supports the move of compulsory licensing and feels that it is a must for not only developing and underdeveloped nations but also developed nations,” he says. “The decision of compulsory licensing is based on the health needs of a nation and various other factors, like availability, affordability of drugs, etc. Previously, other nations, like USA [United States] too, have adopted similar moves during the anthrax scare.”

Brand-name drug makers counter that compulsory licensing makes it difficult for them to invest millions of dollars in researching and developing new drugs. Bayer has already appealed the compulsory licensing order with the Intellectual Property Appellate Board in a bid to defend “intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” Mandira Viegas, a spokesman for the Bayer Group in India writes in an email. “The order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research. The limited period of marketing exclusivity made possible by patents ensures that the costs associated with the research and development of innovative medicines can be recovered.”

But some analysts say that this argument is based on a faulty premise. “For years, advocates questioning the high prices of new drugs have heard the familiar threat from the drug manufacturers that reducing prices will mean less money for research,” says Musa Mayer, a patient advocate in the US and a consultant with the US Food and Drug Administration’s Cancer Drug Development Program. “I believe the picture is far more complex than that, and that this is merely a tactic.”

The government of India, meanwhile, has indicated that its long-term plans include greater use of compulsory licences. “In consultation with concerned Ministries, local production of bulk drugs and vaccines should be encouraged to build “drug security” in the country. The MoHFW [Ministry of Health & Family Welfare] should identify and get compulsory license issued for patented expensive drugs required for public health programmes, and encourage their manufacture in the country,” the government’s Health Division Planning Commission states in the Report of the Steering Committee on Health for the 12th Five-Year Plan (http://planningcommission.nic.in/aboutus/committee/strgrp12/str_health0203.pdf).

Somewhat surprisingly, compulsory licensing also appears to have had an effect on the price of other cancer drugs. The Indian pharmaceutical giant Cipla Ltd., for example, announced that it was slashing the price of three anticancer drugs by 59%–75% (www.cipla.com/whatsnew/news.htm#03may12).

Mayer is hopeful that the long-term consequences for consumers will be lower prices but frets that patients in developed countries will have to pay higher prices to offset reduced industry profits in the developing world.

“Clearly this kind of inequity in pricing cannot continue indefinitely,” she notes. “The whole house of cards that is drug pricing worldwide could be threatened by what is occurring in India and elsewhere. That might be a good thing. Perhaps the free-market economists should put their money where their mouths are and actually let the market work and see what the real value of these cancer drugs actually is to patients — what is known as ‘value pricing’. I think we would all be shocked.”

Source: http://www.cmaj.ca/site/earlyreleases/18july12_from-outlier-to-trendsetter.xhtml

Posted on Categories Featured 57 Comments on ACTA may be dead… but not yet buried

ACTA may be dead… but not yet buried

Raphael Vassallo
Opponents of the controversial ACTA legislation were in full celebration mode this week, following what many believe was a definitive rejection of the law by the European Parliament.

The EP rejected the controversial Anti-Counterfeiting Trade Agreement (ACTA) on Thursday, in a 478 to 39 vote with 165 abstentions: after the European People’s Party (EPP) unsuccessfully attempted to delay the decision.

The EPP’s proposed postponement was rejected in a 420 to 255 vote, with nine abstentions.

But while activists loudly proclaimed the resulting ‘death’ of ACTA, newswires were considerably more prudent in reporting the event. ACTA, we were told, was not quite ‘dead’, but rather on ‘life support’. For while the EP has now rejected the law in its present form, the European Commission is still awaiting a ‘verdict’ from the European Court of Justice regarding the legality of the law itself – suggesting that the final act in the ACTA saga may not be over yet.

Earlier this year the Commission had referred ACTA to the ECJ, with a view to determining ACTA was incompatible “in any way – with the EU’s fundamental rights and freedoms, such as freedom of expression and information or data protection and the right to property in case of intellectual property”.

EC representative to Malta, Martin Bugelli, confirmed this week that the Commission is still awaiting the results of the Court’s inquiry: “Citizens and the Parliament have raised concerns over the potential impact of intellectual property rights on other fundamental rights,” Bugelli told MaltaToday. “This is why the Commission will continue to wait for the opinion of the European Court of Justice and study it closely. The Commission would also discuss the outcome of the Court referral with other signatories of ACTA and would then consider further steps to take.”

However, critics of ACTA have all along argued that the reason for the original referral to the ECJ was to sidestep the European Parliament.

European Commissioner for Trade De Gucht had even hinted that the Commission’s referral was intended as a insurance policy against possible rejection by the EP: according to minutes of a Heads of Cabinet meeting in February 2012 (made public by European Digital Rights, an NGO aiming to protect freedom of expression in the internet) the European Commission was profoundly impressed by popular opposition to ACTA, and described the “strong mobilisation” against the agreement by “certain NGOs and movements active on the internet” as a “problem” for the European Commission.

EDRi reported that “the increasing opposition to ACTA on the streets and among Member States created a very real possibility that the European Parliament would vote ‘no’ to ACTA in June, effectively killing it”.

The Commission’s referral to the ECJ was interpreted as a pretext to keep alive the possibility of a revised version of ACTA, in case the Parliament went on the reject the law: as in fact happened this week.

But why is the Commission so keen to keep ACTA alive in the face of such overwhelming opposition by European citizens? Leaving aside conspiracy theories along the lines that that the EC is in collusion with major corporations to maximise profits – or, more sinister still, that it has an interest in curtailing internet freedom in a bid to exert more control over the masses – the ‘official’ reason for Europe’s insistence on an international anti-counterfeiting agreement has much more to do with safeguarding European businesses against unfair competition.

The controversy itself may have revolved mainly around privacy and personal liberty issues: but lurking in the background was concern with competition from China: namely, to protect Europe’s prime resource – its intellectual property – from being eroded by counterfeit products flooding European markets.

Bugelli admits that this was and remains a primary concern for the Commission. “Seeking protection for European creators and enterprises, and pursuing a more level playing field with other global players, was indeed one of the main aims of the proposed Agreement. That was precisely why it was important to have non-EU partners around the same table to play by the same rules.”

He also concedes that the vote against ACTA will be “a setback for the protection of our intellectual property rights around the world.

“As the Trade Commissioner De Gucht said in Parliament this week, other countries may read in this rejection as a reduced commitment by the EU to protect intellectual property rights and to enforce the rights of its industries and artists around the world.”

Bugelli adds that efforts to stave off illegal competition to the detriment of European resources will not be completely sidetracked by the defeat of ACTA in the EP.

“European competitiveness on the global stage remains on top of the agenda of the European Commission, and it will continue to seek ways to enhance it.”

Source: http://www.maltatoday.com.mt/en/newsdetails/news/national/ACTA-may-be-dead-but-not-yet-buried-20120709

Posted on Categories Featured, News

Abortion complications still robbing young lives in Uganda

Experts blame the high levels of abortions to lack of comprehensive contraception, sex education, safer abortion measures, and safe and quality post abortion measures

SPECIAL REPORT BY XINHUA CORRESPONDENT Ronald Ssekandi

KAMPALA (Xinhua) — Uganda spends 7.5 billion shillings (3.1 million U.S. dollars) annually treating complications resulting from unsafe abortion, a new study reveals.

The World Health Organization guidance on abortion-related services reveals that in Uganda, about 300,000 abortions are carried out every year and in Africa an estimated 68,000 girls die from unsafe abortion and many more are injured, some permanently.

While speaking at a national conference on reducing maternal mortality from unsafe abortion, Florence Mirembe, an associate professor at the department of obstetrics and gynaecology at Mulago hospital last week said abortion related complications are one of the leading causes of admissions to gynecological wards in hospitals across the country.

Charles Kiggundu, a consultant gynecologist and obstetrician says many women, especially youth die from complications of unsafe abortion in the East African country.

“There is evidence that whatever the law or restrictions attached to abortion, the practice only goes underground and kills more women,” he said.

Experts like Kiggundu blame the high levels of abortions in the country to lack of comprehensive contraception, sex education, safer abortion measures, and safe and quality post abortion measures for those that must have the abortions.

According to The State of Uganda’s Population Report, about 755, 000 women get unintended pregnancies each year and many end up having unsafe abortions.

In Ugandan law, abortion is illegal. Any person who, with intent, procures an abortion is subjected to imprisonment for 14 years.

The law, however, provides for exceptions for this violation in situations when a pregnancy endangers the life of the mother and in some cases where rape has been proved.

Most women choosing abortion are doing so because of unplanned pregnancies, rape, incest and poor marital relationships.

Experts say that more than half of all abortions are believed to be carried out by individuals equipped with the knowledge and tact. These include doctors, nurses and midwives.

The remaining procedures are performed by non-professionals, including pharmacists, traditional providers and women, according to Guttmacher Institute, a non-profit organization advancing sexual and reproductive health worldwide.

WHO places the number of women who die from complications resulting from abortions performed by unskilled practitioners every year at 67,000.

According to the global health body, unsafe abortions are characterized by the provider’s inadequate skills; unsanitary facilities and use of hazardous techniques.

Health risks at the time of an unsafe abortion include infection, hemorrhage, septic shock and abdominal injury.

In the long run, chronic problems such as pelvic infection, ectopic pregnancy and infertility can occur.

State owned New Vision daily in November last year published a story of Kansiime a 14 year old girl who was forced to abort by her 20 year old boyfriend.

“I got pregnant in June, and when I found out in July and told Adolf about it, he said I must abort because the Police would arrest him for defilement,” Kansiime said.

“Although I was not ready for pregnancy, I never wanted to abort. I wanted to have my baby but Adolf took me into a clinic. The “doctor” told me to lie on a bed and said he was going to terminate the pregnancy,” she said.

After the abortion, the doctor instructed her to leave and did not give her any medication, despite the tremendous pain and over- bleeding.

“I was told to come back the next day to remove the cotton wool that he had inserted in my private parts. By the time I came out, Adolf was nowhere to be seen. I had to walk 1km back home. My condition worsened at night,” Kansiime narrates.

Uganda ’s contraceptive use stands at 24 percent which is less than projected target of 50 percent by 2050.

The 2011/2012 national budget Uganda allocated 8 billion shillings (3.3 million U.S. dollars) for family planning.

Activists argue that for Uganda to reduce on the abortion levels which arise mainly because of unwanted pregnancies government must invest adequately in maternal health and family planning.

According to the United Nations Population Fund Uganda has one of the highest maternal mortality rates in the world standing at 435 deaths per 100,000 births while unsafe abortion causes up to 26 percent of the maternal deaths.

According to the UN population agency although more women in Uganda are now able to practice family planning, majority still lack full access to reproductive health services, including quality contraceptive services.

Reproductive Health Uganda , a local nongovernmental organization has embarked on a massive distribution of condoms and contraceptives in order to prevent unwanted pregnancies and HIV/ AIDS.

The organization is using university students to reach their peers educating them on using contraceptives

Posted on Categories Featured, News 99 Comments on Living positively behind bars

Living positively behind bars

By Petride Mudoola: Robert Sebunya, who is serving a 45-year jail term for murder in Luzira Maximum Prison, is HIV-positive. His life in jail has been one hell of a nightmare. “Its double tragedy living positively behind bars,” he says.


Sebunya is in bad shape and is required to use Antiretroviral (ARVS) drugs which he is able to get but finds it difficult to take.

“I cannot swallow them on an empty stomach. I end up throwing them away,” he says.

For a man whose state of health requires constant and proper feeding, Sebunya is in danger of experiencing more serious complications.
He says that even though inmates receive the required medication, there is need for authorities to consider supplementary diet for HIVpositive inmates.

The prisons lack the necessary nutrition to cater for HIV-positive inmates, yet those on ARVs are meant to take a balanced diet. Gabriel Mugaga, another inmate living with HIV, says many of his colleagues fear to take ARVs due to the bad feeding in the prison.

“We throw away the ARVs because we cannot swallow them on empty stomachs.” Mugaga wishes to have healthy meals from his family in Kibaale, but they are far away and cannot bring food for him.

Poor feeding is one of the major challenges that HIVpositive prisoners in Uganda face. This has made the already appalling conditions of HIVpositive prisoners even worse.

Frank Baine, the prison’s publicist, observes that while the prison is supposed to cater for HIV-positive inmates, its budget is too small to do.

“We have no specific budget for feeding inmates on ARVs,” he said. He adds that those on treatment are sometimes provided with vegetables and eggs from prison farms.”

Baine says as a prerequisite, prisoners are subjected to an HIV test upon being imprisoned.

Those found to be positive are referred to the inmate’s health facility for treatment and restricted from engaging in hard labour. But there is little support in curbing the spread of the virus among the inmates, he adds.

The HIV prevalence among inmates has also been heightened by the increased sharing of sharp objects among prisoners.

HIV challenges in Ugandan Prisons

According to the prisons department, Uganda’s prisons has over 2,000 HIV-positive prisoners. Three hundred and fifty inmates living with HIV are in Luzira Maximum Security Prison. Only 178 of them have access to ARVs on a regular basis.

During celebrations to mark World AIDS Day at Luzira Prison, Dr. Joseph Andama, the medical superintendent Murchison Bay Hospital, said HIV prevalence among inmates was higher than the national average. He urged the Government to invest in the management of HIV/AIDS and Tuberculosis (TB) in prisons to reduce more infections.

“This investment should consider timely diagnosis, early treatment, observing the dosage strategy, ensuring that HIV inmates are screened for TB and those with latent TB receive isoniazid treatment so that they don’t develop fullblown TB,”Andama explained.

Andama said prisoners’ misuse of sharp objects has worsened the situation. And due to shortage of counsellors, many inmates find it hard to cope with their condition.

Johnson Wavamuno, an inmate in charge of prisoners living with HIV in Luzira Upper Prison, says the limited number of counsellors due to understaffing leaves inmates unable to deal with the consequences of HIV.

He says more trained counsellors should be attached to the detention facility.

HIV at a glance

According to AVERT-An international HIV/AIDS charity, the number of people living with HIV globally rose from around eight million in 1990 to 34 million by 2010.

The World Health Organisation (WHO) statistics for 2010 corroborate this figure. WHO adds that 17% of people living with HIV by 2010 were women.

The overall spread of the epidemic, according to AVERT, has stabilised in recent years. The number of AIDS-related deaths has also declined “due to the significant increase in people receiving antiretroviral therapy.”

Since the beginning of the epidemic, nearly 30 million people have died from AIDS-related causes.

In 2010 there were an estimated 23 million people living with HIV in Sub- Saharan Africa.

This has increased since 2009, when an estimated 23 million people were living with HIV, including 2.3 million children.

In Uganda, incidence rates have stalled at 6.4%. According to the Uganda AIDS Commission (UAC), close to 128,980 people acquired HIV/AIDS last year up from 124,261 in 2009.
UAC estimates that 64,016 people die in Uganda from HIV/AIDS per year.

Source; http://www.newvision.co.ug/news/632631-living-positively-behind-bars.html

Posted on Categories Featured 97 Comments on The Copyright (Amendment) Bill 2012: The right of artistes

The Copyright (Amendment) Bill 2012: The right of artistes

The revamped Bill offers artistes different rights for different media

Not very long ago, issues like patents, trademarks, copyright, etc, collectively called intellectual property rights (IPRs), were sort of alien subjects relating mainly to foreign companies and some large Indian companies. However, people have become more conscious of their rights regarding their creations. The past few years have seen the emergence of a strong campaign by some leading film personalities for protecting the rights of writers, singers, lyricists, etc. The Indian Copyright Act, 1957 (the Act) governs the law applicable to copyright, modelled along the British laws. The Copyright Act of 1914 was, in turn, based on the British Copyright Act, 1911. Similarly, the Copyright Act, 1957 borrowed extensively from the Copyright Act of the United Kingdom of 1956.

According to Wikipedia, “Copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. In fact, it is a bundle of rights including, inter alia, rights of reproduction, communication to the public, adaptation and translation of the work. There could be slight variations in the composition of the rights depending on the work.” The Oxford English Dictionary defines copyright as: “The exclusive right given by law for a certain term of years to an author, composer, etc (or his assignee), to print, publish and sell copies of his original work.”

The Act has served well but, in recent years, there was a demand for effecting changes in the Act to protect the interest of persons who have not been protected under the Act for no fault of theirs, mainly singers, lyrists, writers, etc. The Copyright Amendment Bill, 2012 (the Bill) incorporates the desired changes in the law. The Bill has been approved by both the houses of Parliament.

A major challenge before the lawmakers was about the fact that changes in technology could play havoc with the rights of a person, unless there is adequate protection in law; a case in point being the change in the way films, songs, etc, are produced and broadcast. A few decades back, there were not many modes or options available to producers of cinema to exploit their product, but the last decade and a half has changed the landscape dramatically. Today, producers of cinema have several avenues to exhibit their product and generate revenues for themselves and this includes the use of songs and music as well.
However, a problem arose when producers refused to share the additional spoils with the original creators/ singers on the ground that all the rights were with the producers as they had already paid for them. They refused to take cognisance of the fact that new technologies have provided hitherto non-existent avenues / mediums for exploiting different aspects of cinema and its music. The Bill attempts to redress this grievance of artistes of different genres who can assign different rights in respect of their creations.

A very important change in favour of the creators is that any such assignment will not be applicable to any medium or mode of exploitation of the work which did not exist or was not in commercial use at the time when the assignment was made. In other words, unless the assignment specifically referred to such medium or mode of exploitation of the work, it will not be automatically valid. The effect of the change will be that, in future, with the advent of new technologies and opening up of new avenues of revenue generation, the interest of assignees will be protected and they would be entitled to a share in the earnings generated by the new income streams.

The Bill has also attempted to streamline the functioning of the Copyrights Board by effecting important changes in its constitution and management. Hopefully, these changes will make the Copyrights Board nimble-footed to meet the demands of a dynamic situation where change will be the only constant.

Source: http://www.moneylife.in/article/the-copyright-amendment-bill-2012-the-right-of-artistes/26764.html

1 … 24 25 26 27 28 … 34
Close