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Archives for : Anand Grover

Access to Medicines in Rajasthan, after Novartis Ruling

In the backdrop of the Supreme Court judgment against Novartis trying to
seek patent on its anticancer drug Gleevec used for treatment of CML and
the granting of license to pharmaceutical company Natco by the Controller
General of Patents India to produce another anti cancer drug Sorafenib used
for treatment of liver and kidney cancers at 98% lesser cost than its
innovator company Bayer under the provisions of Compulsory Licensing, a
workshop for continuing medical education of the clinicians titled *”Making
Essential Medicines Available and Affordable to All Citizens” was jointly
organized by the SMS Medical College Jaipur, Rajasthan Medical Services
Corporation, Prayas and JSA Rajasthan on Saturday, 11th May 2013 in
Jaipur.*The key note address was delivered by Prof. Ranjit Roy
Chaudhury who
currently chairs the expert committee to formulate guidelines and SOPs for
approval of new drugs, clinical trials, banning of drugs and FDCs
constituted by the MOHFW, Govt. of India. Another speaker Mr. Anand Grover,
UN Special Rapporteur on Right to Health and intervening lawyer on behalf
of the Cancer Patients Aid Association in the famous Novartis V/s Union of
India case in the Supreme Court of India spoke about the history of patent
laws and its impact on access to essential medicines in India besides the
developments which led to the Supreme Court rejecting the appeal of
Novartis. Dr. Mira Shiva of AIDAN and IHES spoke on TRIPS, WTO and global
issues relating to access to medicines. Dr. Subhash Nepaliya, Principal SMS
Medical College, Jaipur welcomed the participants. Other speakers were Dr.
Samit Sharma, Managing Director Rajasthan Medical Services Corporation and
Dr. Narendra Gupta of Prayas & JSA Rajasthan. The workshop was attended by
more than 140 persons including Dr. Virendra Singh, Supdt, SMS Hospital
Jaipur, Dr. S.D. Sharma, Supdt. Children’s Hospital, Dr. Pradeep Sharma,
Supdt Mental Hospital attached to SMS Medical College, Jaipur and large
number of other senior faculty members including medical oncologists. There
was very intense question answer session after each presentation. Most
questions raised were relating to the quality, efficacy of generic
medicines and adherence to essential medicines list.

As reported earlier, the Govt. of Rajasthan has included Imatinib Mesylate
under the Free Medicines Scheme of Rajasthan and the innovator company
Novartis had offered to provide 30 capsules of 400 mgm of it sold by it
under the brand name Glivec in Rs. 8000 which it sells in Rs. 1,23,456/- in
the market. This offer came prior to the Supreme Court judgment. But, the
RMSC floated tenders which were opened on the last Friday. Five companies
participated in the tender and offered to provide the medicine in prices as
follows:

1. United Biotech: Rs. 654.84
2. West Coast Pharma : Rs. 883.38
3. Glenmark :Rs.  902.70
4. Naprod Life Science : Rs. 1101.60
5. Cipla : Rs. 2548.62

According to a senior oncologist SMS Medical College Jaipur there are more
than 9,000 patients undergoing treatment for chronic myeloid leukemia in
the state right now and the govt. of Rajasthan is determined to make
Imatinib Mesylate available completely free for all such patients at govt.
health facilities under the Chief Minister Free Medicine Scheme. This would
certainly come as a huge relief to all these patients in terms of the cost
of treatment which they all must be bearing out of their pockets till now.

Prayas, Centre For Health Equity,
URL : www.prayaschittor.org

 

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Novartis case: Supreme Court’s historic decision on Section 3(d) #TRIPS #Patent

A demonstration against Swiss drug manufacturer Novartis in Mumbai, Maharashtra, on Dec. 21, 2012.

Anand Grover | Apr 2, 2013,

After 2005 India started granting product patents on medicines. However, Section S

ection 3(d), one of the safeguards introduced by Parliament, seeks to prevent patenting of new forms of known substances unless they exhibit enhanced efficacy. Were it not for section 3(d), the standards for grant of product patents on medicines in India would be lower, almost identical to the standards in countries such as the United States andEuropean Union, where a large number of patents are granted on minor modifications of a single medicine.

 

Section 3(d), along with other safeguards such as allowing patent oppositions by public interest groups, has been used as one of the grounds to successfully challenge patents for minor modifications of several antiretroviral (ARV) medicines used to treat people living with HIV.Section 3(d) also became the basis for the refusal of a patent toNovartis for the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer. In 1998, Novartis filed a patent application in India for this medicine. In 2005, the Chennai Patent office heard patent oppositions to this application including one filed by the Cancer Patients Aid Association (CPAA). The CPAA challenge was spurred by great concern over the price Novartis set for its version of the drug (sold as Gleevec) at Rs 1,20,000 ($2,400) per month as against the generic versions that were available at a cost of around Rs 8,000 to Rs 12,000 per month.

In 2006, the Patent Office rejected Novartis’ patent application on several grounds, including section 3(d). Novartis immediately challenged the constitutional validity of Section 3(d) before the Madras High Court arguing that the term “efficacy” was vague. In 2007, dismissing the challenge, the Madras High Court held that the word “efficacy” had a definite meaning in the pharmaceutical field, i.e. therapeutic efficacy. In 2009, the Intellectual Property Appellate Board (IPAB) rejected Novartis appeal against the patent application rejection on the ground that it did not satisfy section 3(d). Novartis then approached the Supreme Court asking for a liberal interpretation of section 3(d) that would allow it to get a patent on imatinib mesylate.

Novartis tried to argue that the physico-chemical properties of the polymorph form of the imatinib molecule, i.e. better flow properties, better thermodynamic stability and lower hygroscopicity, resulted in improved efficacy. The Supreme Court firmly rejected this contention holding that in the case of medicines, efficacy means “therapeutic efficacy” and these properties while they may be beneficial to some patients do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy based on research data in vivo in animals.

Eight years after India’s patent law was amended, the Supreme Court decision has firmly established the legality and validity of Section 3(d) and has lain to rest the controversy raked up around the section by the pharmaceutical industry. The Commerce Minister has said that India’s law is fully in compliance with the TRIPS Agreement. However, on April 15, commerce minister Anand Sharma travels to Brussels to potentially sign the EU-India FTA that threatens to impose on India obligations far in excess of the TRIPS Agreement; obligations known to undermine generic production and access to medicines.

The Indian Parliament has balanced India’s obligations under TRIPS with the right to health through Section 3(d). The Supreme Court has unequivocally interpreted the true intention and spirit of this provision. It behooves the Indian government to respect the Parliament and the Supreme Court and ensure that it does not sign away these hard fought victories by health and public interest groups in trade negotiations.

The author is a senior advocate and director, Lawyers Collective

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#India- SC rejects Novartis’s patent plea for cancer drug Glivec #goodnews

Vidya Krishnan , livemint

Court says Glivec does not meet any standard of ‘novelty or inventiveness’ to qualify for a patent

First Published: Mon, Apr 01 2013.
Shares of Novartis India fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at `577, down 3.64%, at 11:18am.
Shares of Novartis India fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at `577, down 3.64%, at 11:18am.

Updated: Mon, Apr 01 2013. 11 54 AM IST
New Delhi: Swiss drug maker Novartis AG’s seven-year battle to win an Indian patent for its blockbuster anti-cancer drug Glivecended on Monday with the Supreme court dismissing the company’s appeal.
In its ruling, the apex court said that Novartis’s “application for patent on the beta-crystalline salt does not meet any standard of novelty or inventiveness”, and therefore the company cannot be given any patent for this drug.
Shares of Novartis India Ltd fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at Rs.577, down 3.64%, at 11:18am.
The judgement has provided clarity on the so-called evergreening and incremental innovation by pharmaceutical companies in order to retain patents.
Reacting to the ruling, Anand Grover, senior counsel appearing for Cancer Aid Patients Society, said: “It is a very good day for cancer patients. We are very happy. It is a myth spread by the company that judgement will affect research and development expenditures by companies—these companies want to make money without innovation.”
“The court noted that the product—beta crystalline—was known prior to 1995 through an earlier patent Novartis held. The implication of the judgement is that the Indian provision has been completely upheld and patents would be granted only for genuine inventions and litigative patenting will not be allowed,” said Pratibha Singh, an intellectual property lawyer who appeared for Cipla.
The ruling has been keenly followed across the world by pharmaceutical companies, humanitarian aid organizations and generic drug manufacturers as it will have far reaching implications on access to life-saving essential drugs under patents.
After a series of decisions that have gone against the big drug makers with respect to intellectual property rights in the past year, Paul Herrling, Novartis’s head of tropical disease research had said on Wednesday that the company is prepared for a negative response.
The case over patents for Glivec—a blockbuster anti-cancer drug made by Novartis—reached the courts when India denied patent for it in 2006 as the drug wasn’t considered a new molecule, but an altered version of one that had already been in the market for around 15 years. Basel-based Novartis had challenged the rejection of its patent application for Glivec by the Indian patent office and subsequently by the Intellectual Property Appellate Board.
Further, the company had challenged India’s interpretation of section 3 (d), which relates to what constitutes a new molecule, essentially to ensure that companies to not extend patents by simply modifying an already existing drug without any consequent changes in therapeutic effects.

 

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#Mumbai- Women Hunted at workplace , Hounded for Protest #Vaw #Womensday

HUNTED AT WORKPLACE, HOUNDED FOR PROTEST

In a city where everyone strives to find their place under the sun, women face a double challenge — to excel in their professions and also fight off strong gender bias

Swati Deshpande | TNN

even in a big city like Mumbai, not many women, in fact very few women, actually report sexual harassment at work,’’ says Flavia Agnes, a leading women’s activist and lawyer who began Majlis, an organization that takes up women’s rights issues.
The much-awaited Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Bill is expected to become a law soon, yet activists are sceptical. “The passing of the Bill will enable victims to fight but its implementation has to be seen,” says Flavia. For 16 years, the Supreme Court’s directives in the landmark Vishakha case were the only guidelines. It called for committees to include women members and from NGOs, the new law will do the same. The law, in fact sets a 90-day deadline for in-house committees to dispose of harassment complaints and failure to do so attracts a penalty of Rs 50,000.
In the US in 2010, there were almost 12,000 sexual harassment cases. The data, compiled by the US Equal Employment Opportunity Commission notes “only 5-15% of victims report harassment”. There are no specific figures for India, but across corporate cubicles, public sector corridors and unorganized employment platforms, cases of sexual harassment in the workplace have risen, say experts. And predatory bosses often target “vulnerable women’’ Agnes says, especially those who need the job and suffer silently.
But women in senior positions have also reported harassment. In 2007, a former director of a multinational firm alleged her male colleagues had shown her semi-nude photographs of a woman stripper in 2005 and that a colleague said he could arrange for a male stripper at a discount. She filed an FIR against several colleagues, four of whom got relief from the Bombay HC a year later. Last year, at a meeting held by the Maharashtra state commission for women on sexual harassment, Thansky Thekkekara, additional chief secretary said, “From personal experience, I can say we are all exposed to
sexual harassment
at the workplace.’’ She said the state sometimes takes the issue “lightly’’. Vandana Krishna, principal secretary, state women and child development admits “sexual harassment at work is one of the most difficult subjects to handle.”
Agrees advocate and human rights activist Mihir Desai who has been on various committees set up under the SC judgment. “Often, the woman who complains of sexual harassment becomes a victim and the fight then becomes one of trying to save her job,” he says. Desai says harassment is often verbal, with insinuations. Advocate Rina Pujara at the Bombay high court says, “Companies are not happy to receive sexual harassment complaints. Women are made to feel they may be making much ado about nothing. Some are even told a pretty woman is likely to face harassment so she must learn how to deal with it.’’ Adds advocate Anand Grover, “Though sexual harassment at the workplace is pervasive, few report it as they don’t want to be seen as troublemakers or undergo the humiliation of crossexamination.”
A professor at a Mumbai college c o m p l a i n e d a g ainst her head of department for repeated suggestive remarks and denying her a promotion after she rebuffed him. The case is now before the HC. “Often women end up fighting not just the man but also the institution. The woman has to suffer not just indignity but also huge legal expenses,” she says. The tendency to malign women who do speak out must change, say activists. NGO members on committees in several MNCs say complaints sent to global head offices always elicit quicker and pro-active responses.
A senior government official says, “The least we can do when such cases come to our notice is to support the woman mentally, encourage her to come out and complain. The woman shouldn’t look back after years and feel it was the most traumatic experience of her life.’’
KNOW YOUR RIGHTS
Sexual harassment is a form of abuse. At the workplace, it is also about power play of a bully over a vulnerable individual, regardless of age, race, class, religion or sex. It impinges on the fundamental right to earn a livelihood by making it difficult to work
Sexual harassment includes unwelcome acts or behaviour like physical contact and advances, a demand or request for sexual favours or making sexually coloured remarks or showing pornography, other unwelcome physical, verbal or non-verbal conduct of sexual nature whether direct or by implication
THE PROPOSED LEGISLATION
Parliament on February 27, 2013, passed the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Bill. It provides for protection of women, including domestic helps and agricultural labourers, against sexual harassment at the workplace
The Bill makes it mandatory for all workplaces including homes, universities, hospitals, government and non-government offices, factories, other formal and informal workplaces to have an internal redressal mechanism for complaints related to sexual harassment
The in-house committee has to dispose of a complaint within 90 days
There will also be a safeguard against against false or malicious charges. If a woman is found to have filed a complaint with mala-fide intentions, she can be punished. Failure to prove charges, however, will not be construed as mala-fide intention

There is a belief that women somehow provoke sexual harassment. Be it at the workplace, on the sidewalk or otherwise. Women have become perpetrators to that toxic thought process by not protesting the very first time they are victimised. We have to encourage a culture of airing our grief and shaming our tormentors. If you look at what constitutes sexual harassment, then ALL women have been victims of the same at some point of their life
Pooja Bhatt
ACTOR, FILMMAKER
Pay disparity between men and women in a profession is unfortunate, but this has been the truth since cinema started in our country. But today female actors do have a much stronger monetary command than they ever did earlier, especially actors like Sridevi, Madhuri, Kareena & Priyanka Madhur Bhandarkar FILMMAKER
I took a break from work to take care of something more important at that point of time and which will always be a priority. I did not miss on anything, rather experienced the joy of motherhood. It has always been a nice feeling to be there with your family, to watch your kids grow. Making a comeback was not difficult but it was important to do something worthy after so many years. Once I decided to do E n g l i s h V i n g l i s h, there was no worry of acceptance. I am also privileged to have a family that supported me and helped me make a comeback
Sridevi
ACTOR

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Your chance to influence UN Special Rapporteur’s report on access to medicines and the right to health –


Add your voice today!
We would like to encourage you to add your voices to the UN Special Rapporteur‘s report on access to medicines and the right to health. Your voices will significantly contribute to integrating women’s human rights and a feminist perspective to the mandate of the Special Rapporteur on the right to health.

Background Information

Pursuant the Human Rights Council resolution 17/14, Anand Grover, the UN Special Rapporteur on the right to health, is working on a study on existing challenges with regard to access to medicines in the context of the right to health, ways to overcome them and good practices, to be presented to the Council at its twenty-third session in June 2013.

Add Your Voice

In preparation for this study, the questionnaire has been prepared by the UN Special Rapporteur to seek the views of relevant stakeholders on this important subject. It is an important opportunity for women in the Asia Pacific to critically inform the Special Rapporteur on the situation of access to medicines and the right to health in the region. Your contribution in sharing issues, persistent structural challenges, promising practices and innovative strategies will be crucial in informing the report.

To add your voice, please complete the questionnaire (click here to download) and submit it electronically to [email protected] by Friday, 12 October 2012.

 

For more information,http://www.ohchr.org/EN/Issues/Health/Pages/AccessToMedicines.aspx

Consultation on access to medicines and the right to health

The Special Rapporteur on the right to health, Anand Grover invites all relevant stakeholders (States, UN agencies, national human rights institutions, civil society and community groups) to participate in the consultation on access to medicines and the right to health.

The objective of this consultation is to enable interested parties to submit information and comments to the Special Rapporteur, who was mandated by the Human Rights Council (resolution 17/14, para 11) to prepare a study on existing challenges with regard to access to medicines in the context of the right to health, ways to overcome them and good practices, to be presented to the Council at its twenty-third session in June 2013.

Your information will substantively inform the forthcoming study on access to medicines and the right to health.

Please make your submissions (in English, French or Spanish) by completing the relevant questionnaire below (in Word) and emailing it to the Office of the High Commissioner for Human Rights on [email protected].

You can read the overview of the Special Rapporteur’s study on access to medicines here

Thank you for your submissions.

The closing date for all Government submissions is Friday, 14 September 2012.

Questionnaires for Governments: English – French – Spanish

The closing date for all submissions from pharmaceutical companies is Friday, 28 September 2012.

Questionnaires for pharmaceutical companies: English only.

The closing date for all submissions from international civil society organizations is Friday, 12 October 2012.

Questionnaires for international civil society organizations: English only.

 

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