Recurring debate

Proposed trade pact clause on intellectual property could endanger India's TB programme

A draft of the Regional Comprehensive Economic Partnership agreement reveals three clauses that could potentially hurt production of important generic drugs.

The latest round of the Regional Comprehensive Economic Partnership or RCEP that concluded in Japan in early March did not yield any major decisions. The stalemate is largely due to the continued insistence of developed countries to include provisions that will adversely impact generic production of cheaper medicines. If such provisions are passed, India’s tuberculosis control programme might be among the worst affected.

The RCEP is a mega trade deal being negotiated between 10 ASEAN countries and their six partners, namely India, China, Australia, South Korea, New Zealand and Japan. The negotiations have been difficult because of developed countries pushing for intellectual property protections that will hamper the production of cheaper generic medicines in developing countries.

“Developed countries are pushing the most for the clause related to data exclusivity,” said one delegate at the negotiations, who did not wish to be identified. “Australia, New Zealand, Malaysia and South Korea already have data exclusivity in their countries. The pressure is on other countries including India.”

Data exclusivity disallows clinical trial data generated by one company to be used by another company to get approvals to market generic versions of the drug for which the trial was conducted. This will make producing cheap generic medicines almost impossible because companies making generics will have to repeat these clinical trials at high costs.

ASEAN countries and India have so far resisted the demand for data exclusivity but there are indications that the ASEAN countries might buckle under pressure. “If ASEAN nations relent to the data exclusivity clause, then India will be left alone in the fight,” said the delegate. India’s stand is important because as the major source of affordable generic medicines for middle and low income countries, policy changes that affect India have a global impact.

“Medicines by big pharma companies will be costly and generic companies won’t be able to produce inexpensive ones,” said Swarnim Shrivastava, lawyer who works on free trade agreements. “Recently TRIPS was amended to promote production of generic medicines to export to least developing countries. RCEP provisions are in contradiction to it and go against international consensus on public health.”

The Trade-Related Aspects of Intellectual Property Rights or TRIPS is an international agreement on intellectual property between member countries of the World Trade Organisation. The agreement earlier allowed which produced under compulsory licences to be sold only in the country of their production. A compulsory licence allows the authorities to grant a license to a generic manufacturer even if the company that first made the drug holds a patent.

In January 2017, member countries approved the first-ever amendment to TRIPS since it came into force in 1994, according to which medicines made under compulsory licences can be exported to least-developing countries that lack manufacturing capacity themselves. This amendment emerged only after consistent pressure from middle- and low-income countries to safeguard their public health concerns.

Damaging proposals

The draft intellectual property chapter from the current draft of the RCEP had many damaging clauses apart from data exclusivity. RCEP represents 45% of the world population and 40% of global trade. Negotiations started in 2012 and have been held behind closed doors. The leaked text of the RCEP revealed that provisions backed by Japan and South Korea can block access to low cost medicines from India.

“These provisions are pushed mainly by Japan and South Korea,” said Shailly Gupta from international humanitarian organisation Medecins Sans Frontiers. “The intellectual property chapter of RCEP looks exactly like the one from Trans-Pacific Partnership, which is now dead. MSF had called the Trans-Pacific Partnership’s intellectual property chapter the worst deal for affordable medicines.”

The Trans-Pacific Partnership was the mega-trade deal negotiated between the United States and 11 Pacific nations, which is now in cold storage after US President Donald Trump withdrew from it.

Health activists find two more provisions of the RCEP’s intellectual property chapter particularly worrying. According to TRIPS, a new medicine can be patented for 20 years but the RCEP could extend this to 25 years. Another clause allows pharmaceutical companies to sue governments under a investor-state dispute settlement or ISDS mechanism by which companies can seek huge financial compensation and destroy any competition in the market.

Ukrainian law allows for data exclusivity and the government was recently sued by Gilead, pharmaceutical company in the United States, for allowing the sale of sofosbuvir that is used to treat hepatitis C. Gilead sued Ukraine for $4 million and forced the generic version of the drug manufactured by Egyptian company Pharco Pharmaceuticals out of the market. According to World Health Organisation statistics, more than 13,00,000 people are infected with hepatitis C in Ukraine. The state hepatitis treatment programme covers only about 2,000 people while more than 44,000 Ukrainian citizens urgently need treatment.

“Competition is crucially important for affordable prices on medicines while creation of monopoly regarding sofosbuvir may lead to increase or freeze its price for many years,” said Sergiy Kondratyuk, a legal specialist on intellectual property with the All-Ukrainian Network of People Living with HIV/AIDS.

Can these provisions on data exclusivity interfere with the process of issuing complusory licences?

“The patent climate has to be conducive for compulsory licences,” said Shrivastava. “India should not accept the current RCEP provisions because they are in contradiction to our stated positions like compulsory licencing.”

Impact on TB treatment

All these provisions, if passed in the RCEP deal, will mean that new medicines will remain expensive for longer periods of time. India’s Revised National Tuberculosis Control Programme could be hit badly.

After forty years, two new TB drugs – Bedaquiline and Delamanid – have been discovered. They are effective in treatment of drug-resistant TB, which is emerging as a major public health issue in India and other developing nations. The Global TB Report 2016 by World Health Organisation showed that India has 2.8 million TB cases of which 79,000 are of drug-resistant TB. According to WHO guidelines, all extremely drug resistant or XDR TB patients and pre-XDR patients should be given the new drugs.

A tuberculosis patient is categorised as XDR when he is found to be resistant to isoniazid, rifampicin, fluoroquinolone and second-line injectables. A patient is called pre-XDR if he is resistant to the first two drugs and any one of the latter two. If a pre-XDR patient is not treated with correct medication, he have a high chance of turning XDR. About 10% of all DR-TB patients have XDR TB. Thus, in India nearly 8,000 XDR TB patients will need these medicines to survive and many more pre-XDR TB patients will need the drugs as well. Pre-XDR-TB is defined as TB with resistance to isoniazid and rifampicin and either a FQ or a second-line injectable agent but not both

Both Bedaquiline and Delamanid are patented drugs. If the national TB programme wants to scale up treatment for drug-resistant TB, the government will have to buy the new drugs. Without the new drugs, the current cost of DR-TB treatment is between Rs 60,000 and Rs 2,70,000, depending on the patient’s regimen. Bedaquiline costs about Rs 60,000 per course and Delamanid around Rs 1,02,000. Thus, the total cost for an effective treatment will be approximately between Rs 2,22,000 and 4,32,000.

The United Nations Programme on HIV/AIDS has donated 600 courses of Bedaquiline to India. Once the donation is over, the Indian government will have to start buying its own medicines. Delamanid, produced by Japanese company Otsuka, is expected to be registered in India within four to five months. For the past eight years Otsuka has held the patent for the medicine without registering it in India, ensuring that there is no competition through generic production. No Indian company can apply for a manufacturing licence for an unregistered drug. If a clause such as data exclusivity comes into force, then it will be the death knell for production of any cheaper version of the medicine. In effect, the tuberculosis programme will have to buy both Bedaquiline and Delamanid at high prices from the big pharmaceutical companies.

“The RNTCP is facing a major fund crunch,” said Ketho Angami, member of international coalition of TB experts and activists, TB-community advisory board. “Unless the new medicines are available at cheaper price, there is no way that DR-TB patients will be able to receive them. The RCEP agreement needs to be in line with the provision of making drugs easily accessible for all.”

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Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

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This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.