The Times of India
By Unni Karunakara
Union and its multinational pharmaceutical companies now pressuring
the Indian prime minister's office? In recent months, as negotiators from India and Europe have been thrashing out the details of a free
trade agreement to be signed within months, people living with HIV have been
hitting the streets. From New Delhi
to Nairobi and Brussels
they have been protesting against the very real threat posed to India's ability
to supply life-saving generic medicines to people across the developing world.
both sides have assured that the trade deal will not harm access to the
affordable generic medicines, and have reiterated, as if by rote, the primacy
of people's health over economic interests. But the Indian press now reports
that the PMO, under pressure to conclude the deal, has asked the concerned
government department to reconsider intellectual property (IP) provisions it
had earlier rejected.
What is at stake? India became
the 'pharmacy of the developing world' because its generic manufacturers are
able to produce medicines that are patented elsewhere. This has made it a safe
haven for affordable medicines. Medecins Sans Frontieres now purchases more
than 80% of the medicines it uses to treat 1,60,000 people living with HIV/AIDS
around the world from producers in India. But this safe haven has been
under constant attack.
Six years ago, the first
attack came when India
was obliged under international trade rules to introduce patents on medicines.
Already, patents have been granted on cancer, AIDS and hepatitis medicines. But
parliamentarians sought to balance patents with public health, and designed a
strict patent law that would stand up to trade rules and protect access to
affordable generic medicines.
One core provision of the law
stops pharmaceutical companies from abusing the patents system. Section 3d says
no patent shall be granted for a minor change to an existing medicine, if it
shows no significant therapeutic efficacy over one which already exists. This
prevents "evergreening", when companies seek monopolies to block out
generic competition for as long as possible, simply by making minor changes to
This has irked multinational
pharmaceutical companies, which launched a second attack on the pharmacy of the
developing world. As patent applications for several big-ticket drugs -
oseltamivir for avian and swine flu, imatinib for leukaemia and, very recently,
lopinavir/ritonavir and atazanavir for AIDS - failed to pass the patentability
test in India, companies sought to overturn the law, or empty it of any
notoriously took the government of India to court in 2006, but lost.
Other companies like Bayer
have taken a stab, but have yet to succeed.
Enter the free trade agreement
negotiations, as the European trade agenda becomes the latest mouthpiece for
the multinational pharmaceutical companies. Until now, much of the debate on
generic production in India
has focussed on patents. Now, the EU has changed track and is pushing hard for India to sign
up to another means of blocking off generic production: data exclusivity.
With data exclusivity, India would be
agreeing to grant a period of exclusivity over the clinical trial data
submitted by a pharmaceutical company. This in turn would prevent the Drugs
Controller General of India
- the body responsible for approving medicines for market - from registering a
generic medicine until that time was over. The multinational pharmaceutical
industry has asked for that time to be 10 years.
Data exclusivity is a backdoor
to monopoly protection. It also sweeps away the attempts by India's
parliamentarians to balance health and profits. It makes a mockery of India's patent
offices' work to apply rigorous standards and ensure only innovative medicines
are granted a monopoly. Now, a pharmaceutical company would merely have to
submit clinical trial data to obtain several years of monopoly, whether the
drug was patented or not, whether it was old or new, whether it showed
inventive step or not, or gave added therapeutic benefits or not.
The effect on access to
affordable medicines is clear. India
can learn from the countries that have preceded it down this path. Jordan
brought in data exclusivity as part of a trade deal with the US. A study by
Oxfam found that of 103 medicines registered and launched since 2001 that had
no patent protection in Jordan,
at least 79% had no competition from a generic equivalent as a consequence of
data exclusivity. The study also found that prices of these medicines under
data exclusivity were up to 800% higher than in neighbouring Egypt.
India should not repeat others'
mistakes, or the effect would be felt far beyond India's borders. The country is the
source of the vast majority of drugs used to treat AIDS in developing
countries. Affordable medicines produced in India have played a major part in
reaching the more than five million people receiving HIV/AIDS treatment across
the developing world today.
In 2000, treating one HIV
positive person for a year cost more than Rs 4,00,000. Thanks to competition
among generics from India,
this same treatment today costs Rs 3,000. Any measure in the free trade
agreement that would have the effect of blocking competition would effectively
be turning the clock back on access to medicines. India needs to stand strong and
resist European demands.