[Ip-health] Global pharma ’s stand on India considering permits for generic production of patented drugs is flawed

[Ellen T HOEN]

http://www.livemint.com/2008/04/21225354/A-lifeline-for-millions.html


A lifeline for millions
Global pharma’s stand on India considering permits for generic production
of patented drugs is flawed
Johannes van de Weerd and Leena Menghaney

Last year, when Thailand issued compulsory licences to overcome patent
barriers that stood in the way of providing affordable medicines to treat
patients, people and public interest groups stood up and cheered. When the
European Commission, the United States Trade Representative and the drug
companies retaliated by threatening to impose trade sanctions or to
withdraw any new medicines from Thailand, people across the world were up
in arms.

Now, it’s India that may draw the ire of the pharma industry and its
protectors in the US and EU. Three years after India revised its 1970
Patents Act, patent offices have granted product patents on several drugs,
including medicines for HIV/AIDS, hepatitis C, chronic kidney disease and
cancer. The patented drugs are prohibitively expensive and, in the absence
of generic competitors, will remain out of reach of patients. Faced with
the impact of its decisions on public health and patients’ lives, India’s
patent office is at a point where it must consider compulsory licensing to
authorize generics competition in the event that patent holders fail to
fulfil their duty to make patented medicines available and affordable.
Before even one licence has been issued, rumbles of discontent are already
being heard from pharma multinational companies (MNCs).
In India, the importance of generics production in fostering competition
and reducing prices was first recognized by lawmakers in the Patents Act of
1970. In the following decades, India was not only successful in making
drugs affordable, but also significantly increased availability by building
its capacity to produce essential and life-saving drugs, diagnostics and
vaccines for its people. It also went on to become the “pharmacy of the
developing world” supplying medicines to other countries that lacked the
capacity and resources to produce the drugs themselves and pay the prices
demanded by pharma MNCs.
AIDS treatment is one of the most important illustrations of the benefits
of encouraging generics competition. It was only with the arrival of
competitor generic antiretrovirals on the market in 2001 that prices
started to decline significantly from $14,349 to $350 for first-line AIDS
treatment. Originator drug companies, too, agreed to a reduction in prices.
Today, first-line AIDS treatment is available for as little as $99 per
patient per year—140 times lower than the price charged by pharma MNCs in
2001. This price cut saved millions of lives of people living with
HIV/AIDS.
The Novartis contention that a compulsory licence is reserved for an
emergency is inaccurate
Patents have a major impact on the prices of drugs, by preventing
competition. Following the implementation of the TRIPS agreement in India
as of April 2005, Indian generic companies may no longer be able to provide
the competition that drives prices down. From 2005 onwards, new drugs may
be subject to at least 20 years of patent protection in India. The major
consequence is that new drugs will be expensive and out of reach for the
majority of Indians and those living in developing countries—even though
the drugs may be needed urgently. Patients needing to switch to newer
treatment will bear the brunt of unaffordable pricing. This is all the more
significant as resistance to current HIV/AIDS and tuberculosis treatment is
a growing problem across the world.
A 4 February story in Mint had quoted the Swiss pharma company Novartis as
saying that the move (compulsory licensing) was unjustified in the absence
of an emergency for which compulsory licensing is designed. This is an
incorrect reading of India’s patent law and certainly not a requirement of
international trade agreements. The Indian Parliament, in the revised
Patents Act, included progressive and comprehensive provisions authorizing
generics production despite the fact that a patent has been issued on a
particular drug.
Compulsory licences can be issued to generic producers if patented drugs
are not available or affordable or if countries that lack production
capacity order drugs from India. The government can equally notify drugs on
which compulsory licences need to be issued for public non-commercial use
and government use. And, of course, they can be issued in situations of
national emergency or extreme urgency. The Novartis contention that a
compulsory licence is reserved for an emergency is thus inaccurate, and
certainly not required by domestic or international trade law.
Besides, the assessment of whether a compulsory licence is needed or not,
should be made by the Indian Patent Office in consultation with patient
groups, public health experts and the health ministry.
Circumstances requiring the issuance of compulsory licences in India and
other developing countries may vary, ranging from well-recognized public
health crises of HIV/AIDS and tuberculosis to widespread chronic illnesses
such as cancer, heart disease, diabetes and asthma. Without discrimination,
compulsory licensing can address problems of access to affordable quality
drugs, diagnostics and vaccines for a range of illnesses.
It is, therefore, evident that access to essential medicines for millions
of people in India and abroad in the coming years will depend on the Indian
government’s decisions. India through its legislation is in a unique
position of global responsibility. It can make affordable generic medicines
available to the world in the event that patent holders choose profits over
patients.
For that the government should look beyond the false perspective that
compulsory licensing is only for extraordinary emergencies, and instead do
more in overcoming availability shortfalls and pricing barriers by
encouraging generics production. India’s Patents Act allows it to implement
a progressive compulsory licensing policy in full accordance with
international trade rules.
Public interest groups, other developing countries and, most importantly,
people across the world will applaud India’s decision to continue its
long-standing tradition of placing patients before patents.

Johannes van de Weerd is director of MSF–Campaign for Access to Essential
Medicines and Leena Menghaney is a lawyer working with it. Comments are
welcome at theirview@livemint.com