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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.
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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)
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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.
sushmi.dey@expressindia.com
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