© LIFE COPYRIGHT

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DURATION: 50 min.

India is known as the global medicine production factory. It has a thriving pharmaceutical industry that produces quality medicine at affordable prices.

These are the so called generics, copies of the original drugs produced by the big pharmaceutical companies of the West. They are equally effective, but are sold at incomparably lower prices than the originals. That is why they are of incalculable value to poor people in India and the, so called, developed world.

In the face of competition, the big pharmaceutical companies fight back holding a powerful weapon in their hands, the patents, attempting to strike India’s generic drug industry and consolidate their monopoly worldwide.

It is a real war of interests, where corporate profits are, more literally than ever, juxtaposed to human lives.

The"© Life Copyright” follows the case of the Swiss company Novartis that sued the Indian state, starting thus a landmark legal battle. A battle so important that could threaten the access of billions of poor people around the world to affordable lifesaving drugs.

MAIN CREDITS

 Directed by: Yorgos Avgeropoulos / Written by: Yorgos Avgeropoulos, Georgia Anagnou / Produced by Georgia Anagnou / Director of Photography: Yiannis Avgeropoulos / Production Manager: Anastasia Skoubri / Editing: Vasilis Magos, Anna Prokou / Original Music by: Yiannis Paxevanis / A Small Planet Production for Greek Public Television ΕRΤ © 2013

TECHNICAL DATA

Original Shooting Format: HD 1080/25p / Sound: Dolby Stereo / Languages: English, Hindi, Greek / Subtitles: English / Narration: Greek

 

Mr. Noor Islam Sikh lives in a poor densely populated neighborhood of Mumbai, Bollywood’s capital, which is with 20 million inhabitants India’s modern commercial and industrial center. In the shadow of the city’s skyscrapers and behind the shroud of growth, lies his house, a 5 square meter shack, where he, his wife and seven-year-old daughter are trying to make ends meet.

Amongst all the financial difficulties, their everyday life became even more difficult, when Mr. Noor was diagnosed with leukemia three years ago. Since then, he follows a specific treatment of vital importance to his survival. Every day at noon, he has to take a 400mg pill, which ensures more time and a better quality of life for him.

“Before, my body hurt and when I got up I felt dizzy. I walked a little on the street and was soon after short of breath. Now, I dont have this problem”, he tells us. “With this medicine I feel very good.”

The drug responsible for Mr. Noor’s health improvement is called Veenat and is a generic. It is a copy of Glivec, an original drug introduced in 1992 by the Swiss pharmaceutical Novartis and which is believed to have brought upon a real revolution in the treatment of chronic myelogenous leukemia. “It became known as the magic capsule, as it forever changed the way in which future cancer research will be conducted. The patients, who receive it, have very high survival rates, exceeding the 10 year time frame”, proudly says Ranjit Shahani, Vice Chairman and Managing Director of Novartis India.

Indeed, Glivec, which contains a lifesaving active substance called imatinib, has managed to greatly increase the life expectancy of patients. Since then, generics like Veenat, the drug Mr. Noor takes, contain the exact same active substance.

Both drugs, the original and the copy, have been approved by the appropriate supervisory agencies and have the same therapeutic effect on the patient. But there is also an important difference between them.

 

THE ECONOMIC VALUATION OF HOPE FOR LIFE

The original medicine by Novartis is sold in the Indian market for $2,400 a month, whilst the copy produced by Natco, a large local pharmaceutical company, costs $200.

It has globally been observed that generics are usually 20 to 80% cheaper from the original drugs!

This difference in price is astronomical for India’s poor. “I work in a shop where I polish gold. My wife also works at home, sewing clothes. Our monthly income is 6,000 rupee”, confesses Mr. Noor. With his family income barely reaching 150 euro a month, he is unable to buy even the medicine’s copy, which he receives thanks to a nongovernmental organization, the Cancer Society.

Dr. Dhananjaya Saranath, the organization’s head doctor, notes angrily: “Both drugs have the same effectiveness. So, I think there is no excuse for any company to sell this medicine at a price ten times higher, just because it is the original”.

Dr. Saranath’s anger can be understood ifone considersthat inIndia, 30% of the populationlives below thepoverty line and has to ensureits survivalwith less than$2a day.

“We have to talk about the drug’s worth and not its price. What is a mother’s smile worth when her child is saved from a deadly disease? What can be the economic value when you improve life expectancy? I think we should look at those things’ worth and not just do a numerical equation” claims Ranjit Shahani, director of Novartis.

“The company has to consider that disease strikes both the rich and poor alike. Rich people can however, take the medicine and get well. If someone is poor, how can s/he buy such expensive drugs?” says Mr. Noor’s wife with tears in her eyes. “This price is unthinkable to us”.

 

THE POOR MANS PHARMACY

Nowadays, when global commerce is defined by international regulatory rules, it seems difficult for a state to establish politics that will cater to its population’s needs. That is however, what Mahatma Gandhi, independent India’s patriarch, did, highlighting self-sufficiency as a major axisof his politicalphilosophy in thepost-colonialera. He characteristically believed that his country did not need western technology to be independent on clothes, food and medicine.

So since its establishment, the Indian state had formed a patent system, which did not recognize patents in pharmaceutical products. This policy made it possible for the local generics industry to develop and cover the great needs of almost 1.2 billion people.

" Without the benefits of not having patents, India would not have been able to reduce the cost of drugs as much as it already has", says Rajeev Nannapaneni,directorof the IndianpharmaceuticalNatco."If you cannot produce locally to reduce costs and create competition you become confined in monopoly,"explainsin more detailLeena Meghanyby MédecinsSans Frontières.

“What India basically said was that because companies were overpricing medicines, Indian pharmacists would have to build facilities, where they could make their own drugs. Those were public sector facilities that nourished in a way the industry in order to make the medicines we ourselves needed. Of course, once this industry grew other developing countries, as well as UN agencies and the MSF began to buy these drugs from the source itself”, concludes Meghany.

It is estimated that the Indianpharmaceutical industryis currently the thirdlargestin the world.Drugs producedin Indiaare soldin the USA,Europe, SouthAmerica, while at the same time they areused almostexclusively in developingcountriesof Africa.No wonder whyIndia isinternationallyknown asthe pharmacyof the poor.

Thanks to the existenceof generic drugscountries candeviseacomprehensivepolicy to tacklediseases suchas AIDS,which oftenthreaten totakeepidemic proportions.For example, in the 90s before genericdrugs were introduced to the ARV (antiretrovirals) market, AIDS treatmentcost about$10,000a month.Now, it costs less than $250.

The same happens with cancerin India."In our country, we have nearly one million new cases of cancer each year," explainsDr.Lalit Kumar,professor ofoncology at theUniversity Hospital ofAIIMSin New Delhi.
"If we have to use the original drug, the cost will go up three times or more. In this case, I do not know if the government could provide funding for the treatment. If we did not have generic drugs, we most likely could not provide the same services.”

 

THE WAR OF COPYRIGHT

On the other hand, large pharmaceutical companies such asNovartis,arguethattheyshould be rewardedfor their research, since they offersocietyinnovative medicinesto treat deadly diseases.

"The challenge is that research today costs huge amounts of money. If you do not allow a pharmaceutical company to have a fair return, it will just disappear and the shareholders will leave. And this is logical. So the issue is logic and not profit”, says Ranjit Shahaniof Novartisand concludes, almost threateningly: I think we should view it in a logical and not emotional manner. Because ultimately tomorrow you will not have any drugs that you can copy.”

The international legal systemstrongly defendsthe companies’ argument.In 1995,the WorldTrade Organization was founded. Thenewly launchedthen andpowerfulorganization now went on toestablish the famousTRIPS agreement,which determinesthe traderules onintellectual property rights among member countries.

Therefore, under this agreement, every member state of the WTO is obliged to recognize patents on innovative pharmaceutical products. Thus, the companies are provided with the exclusive right to sell the product in the market for a certain period of time, of usually 20 years. In this way, the production of cheaper generics gets postponed for some years and the company is free to set the price of the drug without competition or any other restriction.

"Essentially , the patent is a form of prize given together with the monopoly of the substance for a number of years, in exchange for disclosing later on this patent’s technical details to the public, through the decision-makers", explains thePatent Officeof India.

The Indian state, wishing to also get onthe chariotof neoliberaldevelopment,perhaps even underpressurein ordernot to isolate itself, became from the very beginning a memberof the WTO.After a transitional period, in 2005, for the first time in history, India recognized patents on pharmaceutical products.

"After they began to grant patents, how many drugs have been researched, how many innovative medicines have been released in the market?" asks Vikas Ahuja, from theOrganization Delhi Network of Positive People (DNP +)."If you look at the data, you will see that there used to be more innovative medicines coming on the market than they do now." Vikasspeaksangrily, considering that the availability ofgenericdrugsiscritical to thesurvivabilityof thousands of peoplesufferingwith AIDS,as he does. And now patentsare threateningto blocktheir production for several years.

"We should not play with human lives. These drugs are a necessary resource for life, such as water or air. If someone starts to make a profit from such a necessary commodity, it will make the lives of ordinary people more difficult”, he says.

"They say we should stop having patents? This is absolutely absurd," replies the spokesman of Novartis.

 

EVERGREENING – A NICE WORD FOR A BAD PRACTICE

Patient and activist organizations accuse large pharmaceutical companies of abusing the privilege accorded to them by the patent system. Using a common practice,called evergreening, they attempt to extend the monopoly of certain products in the market.

"If you ask me what it means in two lines, you take the same drug and you patent it again and again and again, in different forms," says Leena Menghaney of MSF. “You don’t present any innovation. You just take the same drug and change its standardization. For example you take a pill for adults and put it in children’s syrup. And that may become a completely different patent. Thus, they can continuously increase their profit from the same innovation. That is the meaning of evergreening. It is an operational technique to maximize profits. It may not serve the public interest, but this is what companies do. Why invest in a new drug when they can expand their profits patenting the same drug again and again?

Although the Indian state adopted the system of patents, at the same time it raised a strong shield against this abusive practice.

Section 3d, is the article in the Indian legal framework that sets strict conditions for maintaining innovation, when granting  apatent on a medicinal product. Having that as their guideline the officials of the Indian Patent Office rejected Novartis’s patent application noting that it contained elements of evergreening, something the company denies. So, the company sued the Indian state in 2006, starting a long legal battle, the last chapter of which was played out in the country’s Supreme Court from September 2012 until April 2013.

 

THE POOR PATIENTS’ VICTORY

"Glivec has been patented in 40 countries we have applied to", says Ranjit Shahani, director of Novartis India Ltd. "In India a patent application was filed, but got rejected. Novartis was naturally keen to guarantee, wanted to see how innovation is valued in India and that is why we fight here for the patent to be acknowledged”, he says, unable to hide his irritation about this conflict.

It does not deserve a patent recognition , because there is no originality”, answered the Patent Office of India. Some compounds already known in 1993 cannot be patented . There is no novelty .”

" When they got the patent in the U.S., they were given a monopoly for 20 years. At that time, it was indeed a new compound. But during that time India did not participate in the patent system. We cannot go back 10 years, and give a patent on a molecule of 1992”, adds Leena Menghaney of MSF.

80% of the medicines used by the MSF in their mission to provide life for patients around the world are generic drugs from India. That is why the organizationis one of the Swiss company’s most ardent opponents in this case, as it believes that any vindication of Novartis would open Pandora's Box, prompting other companies to follow the same practice, with painful consequences.

It's not that drugs will disappear tomorrow from MSF clinics. But in 10 years will we be able to cure cancer, cure hepatitis, tuberculosis, HIV? The answer is no. In 10 years, without generics the MSF will not be able to provide their services in the same way we have done for example in sub-Saharan Africa, Central Asia or Latin America.

Novartis claims that the case is not related to monopoly or skyrocketing prices”, answers Vikas Ahujaandthe Organization Delhi Network of Positive People (DNP +) that also highlights the immediate threat.“If this is not the reason, then why take legal action? If this is not the reason, return to your office and start working for the best interests of society, instead of spending your time at the courts. If the patent has nothing to do with profits, then why go to court to address this issue?”

India has become a “brazen” competitor”, says Rajeev Nannapaneni, director of Indian Natco.“If India has become the key supplier of these goods, then the rest of the planet can do so as well. I think that ' s the issue .”

On 1 April 2013, the Supreme Court of India issued its final decision, at last putting the issue to rest after 7 years. It dismissed Novartis’s appeal, on the grounds that the renewed synthesis of Glivec does not meet the "innovation orcreativity" criteria required by law.

The news went around the world and scattered relief to millions of poor patients.

The great interest sat stake do not leave much hope that something similar will not be attempted again in the future.

But this important battle was finally won.

 



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