[Ip-health] Doctors Without Borders Congressional Testimony on India Patent Law & Global Health

Judit Rius Judit.Rius at newyork.msf.org
Tue Jul 2 11:32:43 PDT 2013


Dear Colleagues,

I would like to share with you witness testimony of Rohit Malpani, 
director of policy and analysis for the Medecins Sans Frontieres/ Doctors 
Without Borders (MSF) Access Campaign, which he provided last Thursday 
during a U.S. Congressional hearing on India's trade policies organized by 
the Subcommittee on Commerce, Manufacturing, and Trade of the U.S. House 
Energy and Commerce Committee. 

In his oral and more detailed written testimony Rohit explains India's 
critical role as pharmacy of the developing world and as a producer of 
quality generic drugs for many global health programs, including many 
supported by U.S. taxpayers. Rohit also explained how India's actions in 
restricting abusive patent practices with the recent Novartis Supreme 
Court decision and in issuing its first compulsory license for a highly 
priced cancer drug, are not only completely in line with existing 
international trade law but are in fact essential to promote a balance 
between intellectual property and public health. 

You may view the oral testimony online  or read it below. You can also 
find the more detailed written testimony here: 
http://docs.house.gov/meetings/IF/IF17/20130627/101056/HHRG-113-IF17-Wstate-MalpaniR-20130627.pdf 
 

Sincerely,

Judit
Judit Rius Sanjuan
U.S. Manager of the Access Campaign
Medecins Sans Frontieres/ Doctors Without Borders (MSF)
333 Seventh Ave, 2nd Floor
New York, NY 10001 USA
Office: +1 212 655 3762 // Mobile: +1 917 331 9077
Email: judit.rius at newyork.msf.org

MSF Oral Testimony at US Congressional Hearing: “A Tangle of Trade 
Barriers: How India’s Industrial Policy is Hurting U.S. Companies”

Speaker: Rohit Malpani - Director, Policy & Analysis, MSF Access Campaign

Washington, DC - June 27, 2013 

Good morning. My name is Rohit Malpani and I am the Director of Policy and 
Analysis at Doctors Without Borders, or Médecins Sans Frontières. MSF is 
an international medical humanitarian organization which provides 
impartial medical assistance to those affected by armed conflict, 
epidemics, exclusion from health care, or natural disasters. Today, MSF 
carries out this work in more than 70 countries worldwide, while raising 
awareness on neglected crises and advocating for improved medical tools 
and protocols.

MSF has been invited to provide testimony on India’s intellectual property 
laws. As a medical treatment provider, MSF is able to speak about the 
relationship between intellectual property rules and access to medicines, 
and about the role India has played in enabling millions access to 
life-saving medicines. 

In 2001, MSF faced what seemed like insurmountable barriers in meeting 
critical health needs and saving the lives of our patients. In particular, 
we faced an astronomical 10,000-dollar per-person per-year price-tag for 
life-saving HIV medicines which barred treatment for millions and 
prevented us from being able to reach more than a very limited number of 
patients.

But a solution was found in India. The country, free from having to grant 
patents on medicines until 2005, was able to manufacture low-cost, quality 
generic medicines for a fraction of the existing price. Literally 
overnight, the cost to treat someone with HIV fell by over 96 percent, to 
360 dollars per person per year. Generic competition has seen the cost 
fall even further.

As a result, more than nine million people worldwide now receive treatment 
for HIV, many of those from PEPFAR-funded programs. India’s role in this 
treatment scale up has been – and continues to be – a critical one. As the 
‘pharmacy to the developing world’, and the biggest source of quality 
generic medicines, governments and donors such as the United States rely 
heavily on Indian generic medicines. 98 percent of the medicines used in 
American-taxpayer funded treatment programs rely on low-cost generic 
medicines manufactured in India.

Today, India is a full member of the World Trade Organization, providing 
patent protection for medicines. Between 2005 and 2008, India granted over 
2000 patents for medicines, and continues to grant patents today. These 
patents delay generic competition, which keep costs high and places an 
enormous burden on treatment providers such as MSF, Ministries of Health 
in low-income countries and donor governments, including the US. 

While India does reward genuine innovation with 20 year patents, it 
manages to strike a balance between providing intellectual property 
protection and having the flexibility to protect public health. This 
balance is possible as both the TRIPS Agreement and the 2001 WTO Doha 
Declaration on TRIPS and Public Health enshrines the right of WTO members 
to implement safeguards and flexibilities.  

One safeguard under TRIPS is the right of governments to define strict 
patentability criteria. Governments have the right to define ‘scope of 
patentability’ in a way that addresses the needs of their own citizens, as 
long as they abide by international agreements. The US recently 
contributed to its own definition when the Supreme Court reaffirmed strict 
patentability criteria for gene patents.

India has adopted a standard of pharmaceutical patenting that is stricter 
than that in the U.S. or the EU, but which is in line with international 
trade rules. In rejecting one patent application by Novartis on a salt 
form of an already known substance, the Indian Supreme Court was legally 
validating a choice by the Indian government that patents should only be 
granted when those products represent a genuine advance over older 
versions of medicines.

By contrast, the US has decided to approve secondary patents for very 
obvious modifications of existing medicines which often delays generic 
competition and keeps prices high. This is a practice commonly called 
ever-greening by which the pharmaceutical industry extend their monopoly 
on drugs beyond the original patent’s 20 years. Allowing companies to 
extend patent protection and keep prices high is expensive for U.S. 
consumers and the U.S. government.

A second legally recognized safeguard to overcome barriers of affordable 
access is the right to issue compulsory licenses. The U.S. government used 
compulsory licenses for medicines in the past to meet public health needs, 
and stated that it would look to use them in the future if necessary.

In India, a compulsory license was granted in the interest of public 
health when the country was faced with a price-tag for a cancer drug which 
kept it out of reach of 98 percent of those eligible for treatment. 
Granting the compulsory license reduced the price by 97 percent, whilst 
recognizing the innovation behind the drug through the payment of a 7 
percent royalty. 

The U.S. government continues to make adjustments to its patent system to 
achieve a better balance between rewarding innovation and providing for 
public health needs. It should allow other governments, like India, to do 
the same. The measures taken by the Indian government do not undermine 
innovation, but rather curtail the worst excesses of the patent system and 
ensure that companies focus their energies on scientific, and not legal, 
innovation.

Governments around the world and US assistance programs are straining 
under high costs for new medicines. In times of economic austerity, we 
should remember that high medicine prices are an issue of life and death 
for millions of people.  Ensuring that balanced innovation systems make 
these medicines available to those who need them most is imperative.

Thank you again for the opportunity to provide testimony on this important 
topic. 


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