Under public scrutiny

Under public scrutiny

The pharma and healthcare industry is booming in India, but every good involves some bad. Social activists and NGOs act as watchdogs, keeping the greater common good in mind. Sushmi Dey explores their role

We see them carrying jholas and agitating in the sun, but we never realise that social activists have to do a lot of homework, legwork and research to back their cause. In recent times, the pharma and healthcare industries were kept on alert by these civil society bodies. While the drama on Glivec was on a high, the civil society played a crucial role in safeguarding the interest of the common man, amidst a lot of debate and lobbying. The activists were armed with scientific facts and legal arguments, and this, along with their emotive stand, won them a key victory.

The role

Development and refinement of health in any country is never restricted to just the discovery of treatment for diseases. It has a wider perspective, which involves issues related to cost, availability and accessibility, with an approach to understand the needs of the population. NGOs, health groups and patient groups serve this purpose with a lot of commitment towards keeping a check over the pharma industry. These civil bodies play a very crucial role in the assessment of standardisation of healthcare and socio-economic deprivation of treatment to many patients. Especially, while the pharma industry is booming in India, with a large number of domestic and international players investing in the sector, the cost, availability and accessibility of drugs is a major issue. In other words, civil bodies ensure fairer redistribution of healthcare services and drugs in India, as well as other developing countries. “NGOs and other health groups are very important in this battle between the pharma giants, whose main interest is making profits, and the poor Indian patients, whose need is affordable drugs,” says Y K Sapru, Chairman and Chief Executive Officer, Cancer Patients Aid Association.

Inspite of booming swanky five star hospitals in metropolises, health services in many of India’s villages and small towns are almost not available. The primary health centres or district hospitals have few doctors, almost no diagnostic facilities, and more importantly, no availability of free drugs for poor patients. According to Sapru, this is particularly so because in India, unlike in the developed countries where the state provides social security to meet the health needs of the population, it is only five percent of the population at the outer limit, which is either able to afford treatment at five star hospitals or their bills are picked up by some agency, insurance or company employer. “Government does not even consider it as its responsibility to provide health facilities to its population. In short, the government in India is a silent spectator when it comes to providing health facilities to the Indian population. Out of the total GDP not even one percent of the money is spent on health while in developed countries like USA or Germany, the amount earmarked for health is a double digit figure of the total GDP,” adds Sapru.

“We are guided by the mission. We realised that rights have to be protected if the problem has to be dealt with,” asserts Kajal Bhardwaj, who heads the technical and policy unit for HIV/AIDS in Lawyers Collective. Lawyers Collective, along with other civil society organizations, played a very important role in fighting against Novartis’ Glivec patent application. Chan Park, Senior Technical and Political Advisor in Lawyers Collective, was also amongst the first ones to identify and bring to light plagiarism in the Mashelkar Committee Report on incremental innovations. “NGOs have been doing the work for quite sometime. In fact, many Indian and international NGOs get together and work in collaboration for a better cause. The role of civil bodies is very significant in bringing recognition to human rights,” observes Park.

Médecins Sans Frontières (MSF) is an international humanitarian aid organisation that provides emergency medical assistance to populations in danger in more than 70 countries. The organisation works with an objective of rebuilding health structures to acceptable levels in countries, where health structures are insufficient or even non-existent. MSF collaborates with authorities such as the Ministry of Health to provide assistance. The organisation runs a campaign for access to essential medicines in India.

Cancer Patient Aid Association (CPAA) was formed in 1969 and is committed to total management of patients, and the disease cancer. The organisation also has branches in Delhi, Pune, Bangalore, USA and representative offices in around 35 smaller towns in India. “CPAA’s Bombay branch alone caters to over 1,000 cancer patients per month in terms of free counselling, treatment, surgery, radiation and chemotherapy. We also provide free accommodation, free food, employment opportunities in our rehabilitation centre, free prosthesis in the form limbs, breast prosthesis etc to all who have lost these parts of their bodies due to surgery following cancer,” says Sapru.

Delhi Network of Positive People (DNP+) was founded in 1999 as a support group for people suffering from AIDS. The group has grown to be the official voice of HIV+ people in India. The organisation actively lobbies for treatment access for HIV+ people and also provides services such as counselling and support services to the community.

Lawyers Collective HIV/AIDS Unit was set up in 1998 based on a realisation that law, policy and judicial action that upheld the human rights framework, had a central role to play in effectively containing the HIV epidemic. The organisation works with a mission to protect and promote the rights of people, through law forum, legal aid and allied services of advocacy, training and research. “Our mission directs our work, which is premised on human rights,” says Bhardwaj.

Facing Challenges

The role is significant and challenges are many. The civil society is not just disturbed with the not-so-concerned attitude of the government, but also because of the unsystematic functioning of government bodies. While patent scrutiny is stuck in groove with an absolute absence of operational manuals to guide examiners, civil society organisations complain that there is also a huge backlog that is taking a toll. The number of drug patent applications is also large. Especially, after India introduced product patents in 2005 across all categories, there is a sudden rush of drug patent applications. “Approximately 11,000 drug patent application are their in the mail box and they are in sheer volumes,” says Park.

However, civil bodies assert that the patent office is not user friendly and it is very difficult and tedious to get information on these applications. “The weekly patent journal does not give clear details about the drug patent applications. Finding particular information and scrutinising it is too time consuming. They also do not have any user friendly data base. The patent office publishes a 5,000 word pdf journal on weekly basis and it is extremely difficult to understand the complete data and find out the exact abstract. In fact, at times there is everything but the actual direct information, often they don’t even mention it,” adds Park. Bhardwaj agrees with this observation, “The drug patent applications are ridiculously vague. The number of genuine applications is very less, majority are likely to be for new forms or new uses.”

According to Loon Gangte, President, DNP+, finding data about drugs which are filed for patent is a Herculean job. “There are lots of technicalities involved,” says Gangte. “A lot of legal and technical research has to be done. For the civil society, who might not necessarily be people with science background, understanding this data is a challenging job. However, we go to researchers and people with similar background for consultation and then do our legal research,” explains Bhardwaj.

The colour of money

Besides technical challenges, the civil society also faces challenges in terms of money and power, says Sapru. “The main challenge is to fight the money power of the huge MNCs, who on many occasions are able to influence the political big wigs with the use of their money power,” reveals Sapru. Keeping a check over the pricing of the drug is another challenge for these civil society bodies. While the health needs of the common man in India are not yet clearly met, there is a sheer lack of well equipped hospitals with specialised treatment facilities. There is also a non-availability of drugs, which can be given free of cost to poor patients, who cannot afford to buy them on their own. “This is particularly hurting and coming in the way of treatment when the drugs prescribed or needed are like Glivec, which costs Rs 1,20,000 for one month’s treatment and needs to be taken for longer periods of time. There are several examples like Glivec in the treatment of several life saving drugs where the prices are so high that the patient has to go without them,” says Sapru.

However, the civil society feels that although the government is not as proactive as it should be, it has been open to hear their views and arguments. “In the case of data exclusivity, the government took a lot of interest, but not so in case of patents. We want them to be far more proactive,” opines Bhardwaj. Civil bodies also feel that the pro-industry attitude of government is, at times, influenced by the foreign investment involved in the business. The next important suggestion in line is for government offices to gear up. “The Indian patent offices need to be more proactive with better infrastructure and data base. There has to be more transparency. The transparency one finds in US and Europe is nowhere to be seen here,” says Park.

The case: On 18 May 2007, the Sankalp Rehabilitation Trust, an organisation that provides treatment and rehabilitation support for intravenous drug users, filed a post-grant opposition against Roche’s patent for the hepatitis-C drug peg, interferon á2a, marketed by Roche as Pegasys. The drug is available only from Roche at the price of Rs 2.25 lakh ($ 5,625) for a six month course. In the hope that an absence of patent protection will spur generic competition, and bring down the price of this much needed drug, Sankalp decided to file an opposition against Pegasys.

The opposition: Roche’s patent for Pegasys involves combining interferon—a naturally occurring protein with antiviral effects that has been known for years—with a structure called polyethelyene glycol (PEG), an inert substance that helps to prevent the interferon from being broken down by the body, thus allowing it to remain in the bloodstream longer. This technology of combining interferon and other biologically active proteins with PEG had also been known for years prior to this patent. In fact, the technology embodied in Roche’s patent is essentially identical to that disclosed in an academic paper that was published a year prior to the filing of Roche’s patent application.

The reasoning: The opposition to the patent for Pegasys was based on these grounds—Patent protection is only granted to inventions that are new and involve an inventive step. Sankalp has argued in its opposition that the patent was wrongly granted, because given the state of the existing knowledge at the time of the grant of patent, the ‘invention’ that Roche was claiming was neither new nor inventive. Rather, Sankalp has argued, the patent is an attempt to obtain a monopoly over technology that existed in the public domain.
Sankalp has also invoked some legal provisions that are unique to Indian patent law, including the assertion that Roche’s alleged ‘invention’ is at most a ‘mere admixture’ of known substances and is unpatentable under section 3(e) of the Patents Act, and that it is just a ‘new form of a known substance’ and not patentable under section 3(d) of the Act.

(Source: Lawyers Collective HIV/AIDS Unit)

Together we work

Civil society organisations vary in their mechanisms, but they work together with a common objective of keeping a check over the pharma companies. “Civil bodies work very differently so it’s hard to generalise. There are NGOs working on every aspect of people’s health,” says Achal Prabhala, who is an intellectual property researcher. The People’s Health Movement works on broad ethical and access issues in the third world, Medecins Sans Frontieres (MSF) works primarily on providing medical treatment, but is increasingly and successfully moving into advocacy. However, the Lawyers Collective HIV/AIDS Unit works on research and public policy. There are other patients’ groups all over India like the Cancer Patients Aid Association, Indian Network of Positive People, which work on furthering every aspect of treatment and care of the patients they are constituted by.

These organisations work on their individual level, as well as collectively in developing healthy relationships with the public, in order to bring everyone together and fight collectively for a cause. A lot of advocacy initiatives are undertaken by these civil society organisations to make people understand the complicated legal and technical aspects related to their rights. “Public is very proactive. On our advocacy front we try to make the legal matters simpler and bring everyone together to fight for a cause. In the Glivec case, people and other civil society groups worked in close partnership with us and that is the reason that the debate is out in the open,” opines Bhardwaj. The advocacy initiatives include training, workshops, seminars and meetings. The organisations also hold agitations, dharnas, and signature campaigns against any frivolous attempts to exploit the human right to treatment or medicines.

According to Sapru, attempts are also made by civil society to educate the legislators at both central and state levels so that provisions in the laws that are made, like frivolous patenting or misuse of the patent act, is not possible. Besides, a lot of technical and legal research is done by civil society before making any opposition. The oppositions are based on technical grounds and meet with the legal requirements.

The last word

Presently, the main issue in front of the pharma industry is how to remain profitable, and yet provide drugs, particularly the life saving ones, at affordable prices. According to Sapru, this can happen only if there is a policy of dual pricing with respect to drugs in India. Many civil society organisations are seeking to force pharma manufacturers to sell a portion of their production at subsidised rates and this could be routed for treatment of the poorer section of the Indian population through public or free private hospitals.

India’s pharma industry plays a very important role when it comes to global healthcare, as it supplies affordable medicines to many developing countries. “India is in a viable position. It is not just a major supplier of generic drugs, but also of many life saving medicines,” says Gangte. “What is interesting in India is the international dimension of anything that happens to our patent law or domestic pharmaceutical industry. Its not just Indians who care about the Glivec case—it is patients and public health activists from all over the world,” agrees Prabhala. Hence, civil society has a major role to play.

However, experts feel that there is a need for more such organisations in India. “We need more NGOs and more people involved in these movements if we need to produce effective results in terms of superior health facilities for all in our country. If the disparity between the facilities for the few very rich and the large population of poor keeps on increasing in all areas including health care, there will surely be large scale unrest and turmoil in the society,” asserts Sapru.