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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Removing the layers of complexity that weigh down mental health in rural India

Patients in rural areas of the country face several obstacles to get to treatment.

Two individuals, with sombre faces, are immersed in conversation in a sunlit classroom. This image is the theme across WHO’s 2017 campaign ‘Depression: let’s talk’ that aims to encourage people suffering from depression or anxiety to seek help and get assistance. The fact that depression is the theme of World Health Day 2017 indicates the growing global awareness of mental health. This intensification of the discourse on mental health unfortunately coincides with the global rise in mental illness. According to the latest estimates from WHO, more than 300 million people across the globe are suffering from depression, an increase of 18% between 2005 and 2015.

In India, the National Mental Health Survey of India, 2015-16, conducted by the National Institute of Mental Health and Neurosciences (NIMHANS) revealed the prevalence of mental disorders in 13.7% of the surveyed population. The survey also highlighted that common mental disorders including depression, anxiety disorders and substance use disorders affect nearly 10% of the population, with 1 in 20 people in India suffering from depression. Perhaps the most crucial finding from this survey is the disclosure of a huge treatment gap that remains very high in our country and even worse in rural areas.

According to the National Mental Health Programme, basic psychiatric care is mandated to be provided in every primary health centre – the state run rural healthcare clinics that are the most basic units of India’s public health system. The government provides basic training for all primary health centre doctors, and pays for psychiatric medication to be stocked and available to patients. Despite this mandate, the implementation of mental health services in rural parts of the country continues to be riddled with difficulties:

Attitudinal barriers

In some rural parts of the country, a heavy social stigma exists against mental illness – this has been documented in many studies including the NIMHANS study mentioned earlier. Mental illness is considered to be the “possession of an evil spirit in an individual”. To rid the individual of this evil spirit, patients or family members rely on traditional healers or religious practitioners. Lack of awareness on mental disorders has led to further strengthening of this stigma. Most families refuse to acknowledge the presence of a mental disorder to save themselves from the discrimination in the community.

Lack of healthcare services

The average national deficit of trained psychiatrists in India is estimated to be 77% (0.2 psychiatrists per 1,00,000 population) – this shows the scale of the problem across rural and urban India. The absence of mental healthcare infrastructure compounds the public health problem as many individuals living with mental disorders remain untreated.

Economic burden

The scarcity of healthcare services also means that poor families have to travel great distances to get good mental healthcare. They are often unable to afford the cost of transportation to medical centres that provide treatment.

After focussed efforts towards awareness building on mental health in India, The Live Love Laugh Foundation (TLLLF), founded by Deepika Padukone, is steering its cause towards understanding mental health of rural India. TLLLF has joined forces with The Association of People with Disability (APD), a non-governmental organisation working in the field of disability for the last 57 years to work towards ensuring quality treatment for the rural population living with mental disorders.

APD’s intervention strategy starts with surveys to identify individuals suffering from mental illnesses. The identified individuals and families are then directed to the local Primary Healthcare Centres. In the background, APD capacity building programs work simultaneously to create awareness about mental illnesses amongst community workers (ASHA workers, Village Rehabilitation Workers and General Physicians) in the area. The whole complex process involves creating the social acceptance of mental health conditions and motivating them to approach healthcare specialists.

Participants of the program.
Participants of the program.

When mental health patients are finally free of social barriers and seeking help, APD also mobilises its network to make treatments accessible and affordable. The organisation coordinates psychiatrists’ visits to camps and local healthcare centres and ensures that the necessary medicines are well stocked and free medicines are available to the patients.

We spent a lot of money for treatment and travel. We visited Shivamogha Manasa and Dharwad Hospital for getting treatment. We were not able to continue the treatment for long as we are poor. We suffered economic burden because of the long- distance travel required for the treatment. Now we are getting quality psychiatric service near our village. We are getting free medication in taluk and Primary Healthcare Centres resulting in less economic stress.

— A parent's experience at an APD treatment camp.

In the two years TLLLF has partnered with APD, 892 and individuals with mental health concerns have been treated in the districts of Kolar, Davangere, Chikkaballapur and Bijapur in Karnataka. Over 4620 students participated in awareness building sessions. TLLLF and APD have also secured the participation of 810 community health workers including ASHA workers in the mental health awareness projects - a crucial victory as these workers play an important role in spreading awareness about health. Post treatment, 155 patients have resumed their previous occupations.

To mark World Mental Health Day, 2017, a team from TLLLF lead by Deepika Padukone visited program participants in the Davengere district.

Sessions on World Mental Health Day, 2017.
Sessions on World Mental Health Day, 2017.

In the face of a mental health crisis, it is essential to overcome the treatment gap present across the country, rural and urban. While awareness campaigns attempt to destigmatise mental disorders, policymakers need to make treatment accessible and cost effective. Until then, organisations like TLLLF and APD are doing what they can to create an environment that acknowledges and supports people who live with mental disorders. To know more, see here.

This article was produced by the Scroll marketing team on behalf of The Live Love Laugh Foundation and not by the Scroll editorial team.