Andrea Silenzi, MD, MPH, PhD

Highlights
The International Federation of Medical Students’ Association (IFMSA), representing more than a million medical students worldwide, strongly condemns the drug company Novartis’ suit against the Indian government for producing cost effective generic drugs. IFMSA expresses its deepest concern that the pharmaceutical industry is suing national states for their attempt to protect its citizens and promote greater access to health. IFMSA believes that the current unequal distribution of essential medicines is unacceptable, and that the human right to health care is unattainable without affordable access to essential medicines.

Main text
India is considered as the pharmacy of the world. Health care systems in low- and middle income-countries and NGO’s are dependent on India’s production of cheaper cost effective, generic drugs. India has been able to be a key manufacturer and supplier for medicines around the globe due to a strong constitution protecting intellectual properties surrounding health and public health.

In 2005 India started granting patents according to the World Trade Organization (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This led to drug companies being able to patent drugs in India. However, the Indian Patents Act states that only true medical innovations will be granted patents. Section 3(d) further states that if a drug is based on an already existing compound it has to show an improved effect over the existing ones to grant a patent. This is to avoid ever-greening, a process in which drug companies extend the 20-year patent by making minor alterations and re-brand a drug. Backed by Section 3(d) in the Indian Patents Act, Novartis was denied patent for the leukemia drug imatinib mesylate (marketed as Gleevec) in 2006. Thus, Novartis filled legal claims to the Madras High court, one to appeal the rejection on the patent and secondly to have Section 3(d) declared contrary to the TRIPS agreement and to the Indian Constitution. Both claims failed.

In August 2009, Novartis approached the Supreme Court of India with a new case, to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices. The final arguments are due to start before the Supreme Court of March 28th, 2012.

The IFMSA thinks that the outcome of this case will have a pivotal impact on the availability of drugs not only in India, but also in the world. As the one of the globe’s leading generic manufacturers, India is largely understood as the pharmacy of the developing world, and the legal decision taken in this case will have an enormous impact on the ease with which pharmaceutical companies can obtain patents in India. The Novartis case will also serve as critical precedent for other nations in their decisions regarding the implementation of their TRIPS obligations in context of concerns about access to medicines. The affordability and therefore accessibility of many life-saving medications hinges on the outcome of this case.

IFMSA is also deeply concerned that private industry can go to such an extent and sue a sovereign national state for trying to protect the health of its inhabitants. The precedence being set in the aftermath of this case can alter the power distribution between strong corporates and national states, either by stating that economical interests for a company is more important than human safety and health or that the health of the worlds’ population weights heavier than the interests of private companies.

We in IFMSA strongly believe that human health and safety have to be prioritized. Generic production of affordable drugs is crucial for maintaining a minimum of health care service for the worlds’ poorest and thus most vulnerable populations. In our commitment to increasing access to cost effective generic drugs, IFMSA has adopted a Policy on Access to Essential Medicines.

Novartis drop the case (IFMSA)

As future doctors and health care leaders, IFMSA asks Novartis to reconsider the possible impact of this decision to global health and thus request they drop their claim against the Government of India.

IFMSA’s position on Essential Medicines
We believe that access to essential medicines is challenged by factors like inadequate infrastructure, lack of primary care which can provide universal health coverage and the lack of skilled workforce in many low- and middle-income countries. Nevertheless, public policies on intellectual property rights and the lack of research on tropical diseases have significant impact on access to medicines, and the IFMSA calls for increased attention towards the actions and considerations which can be taken in order to improve the global access to medicines.

The lack of access to essential medicines calls for a substantial and long-term response. A well-defined needs-driven research and development agenda is needed to assist policy makers, funding agencies and the research community in setting priorities.

The IFMSA, representing 1.2 million medical students worldwide, believes that the current unequal distribution of essential medicines is unacceptable, and that the human right to health care is unattainable without affordable access to essential medicines.

Written by: Roopa Dhatt (IFMSA VPE), Usman Mushtaq (IFMSA LO WHO), Johanne Iversen (NMSA-Norway), Lukas Sveikata (IFMSA LOSO) and Joško Mise (IFMSA SCORA-D)

References:
1. International Federation of Medical Students’ Associations, Policy Statement on Access to Essential Medicines, Adopted: Montreal, Canada, August 2010.

Highlights
The International Federation of Medical Students’ Association (IFMSA), representing more than a million medical students worldwide, strongly condemns the drug company Novartis’ suit against the Indian government for producing cost effective generic drugs. IFMSA expresses its deepest concern that the pharmaceutical industry is suing national states for their attempt to protect its citizens and promote greater access to health. IFMSA believes that the current unequal distribution of essential medicines is unacceptable, and that the human right to health care is unattainable without affordable access to essential medicines.

Main text
India is considered as the pharmacy of the world. Health care systems in low- and middle income-countries and NGO’s are dependent on India’s production of cheaper cost effective, generic drugs. India has been able to be a key manufacturer and supplier for medicines around the globe due to a strong constitution protecting intellectual properties surrounding health and public health.

In 2005 India started granting patents according to the World Trade Organization (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This led to drug companies being able to patent drugs in India. However, the Indian Patents Act states that only true medical innovations will be granted patents. Section 3(d) further states that if a drug is based on an already existing compound it has to show an improved effect over the existing ones to grant a patent. This is to avoid ever-greening, a process in which drug companies extend the 20-year patent by making minor alterations and re-brand a drug. Backed by Section 3(d) in the Indian Patents Act, Novartis was denied patent for the leukemia drug imatinib mesylate (marketed as Gleevec) in 2006. Thus, Novartis filled legal claims to the Madras High court, one to appeal the rejection on the patent and secondly to have Section 3(d) declared contrary to the TRIPS agreement and to the Indian Constitution. Both claims failed.

In August 2009, Novartis approached the Supreme Court of India with a new case, to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices. The final arguments are due to start before the Supreme Court of March 28th, 2012.

The IFMSA thinks that the outcome of this case will have a pivotal impact on the availability of drugs not only in India, but also in the world. As the one of the globe’s leading generic manufacturers, India is largely understood as the pharmacy of the developing world, and the legal decision taken in this case will have an enormous impact on the ease with which pharmaceutical companies can obtain patents in India. The Novartis case will also serve as critical precedent for other nations in their decisions regarding the implementation of their TRIPS obligations in context of concerns about access to medicines. The affordability and therefore accessibility of many life-saving medications hinges on the outcome of this case.

IFMSA is also deeply concerned that private industry can go to such an extent and sue a sovereign national state for trying to protect the health of its inhabitants. The precedence being set in the aftermath of this case can alter the power distribution between strong corporates and national states, either by stating that economical interests for a company is more important than human safety and health or that the health of the worlds’ population weights heavier than the interests of private companies.

We in IFMSA strongly believe that human health and safety have to be prioritized. Generic production of affordable drugs is crucial for maintaining a minimum of health care service for the worlds’ poorest and thus most vulnerable populations. In our commitment to increasing access to cost effective generic drugs, IFMSA has adopted a Policy on Access to Essential Medicines.

Novartis drop the case (IFMSA)

As future doctors and health care leaders, IFMSA asks Novartis to reconsider the possible impact of this decision to global health and thus request they drop their claim against the Government of India.

IFMSA’s position on Essential Medicines
We believe that access to essential medicines is challenged by factors like inadequate infrastructure, lack of primary care which can provide universal health coverage and the lack of skilled workforce in many low- and middle-income countries. Nevertheless, public policies on intellectual property rights and the lack of research on tropical diseases have significant impact on access to medicines, and the IFMSA calls for increased attention towards the actions and considerations which can be taken in order to improve the global access to medicines.

The lack of access to essential medicines calls for a substantial and long-term response. A well-defined needs-driven research and development agenda is needed to assist policy makers, funding agencies and the research community in setting priorities.

The IFMSA, representing 1.2 million medical students worldwide, believes that the current unequal distribution of essential medicines is unacceptable, and that the human right to health care is unattainable without affordable access to essential medicines.

Written by: Roopa Dhatt (IFMSA VPE), Usman Mushtaq (IFMSA LO WHO), Johanne Iversen (NMSA-Norway), Lukas Sveikata (IFMSA LOSO) and Joško Mise (IFMSA SCORA-D)

References:
1. International Federation of Medical Students’ Associations, Policy Statement on Access to Essential Medicines, Adopted: Montreal, Canada, August 2010.