When the global community is wrecked by unprecedented corona virus, only solace
can be expected out of the well guided labor of pharmaceutical sector. The
manufacturing of vaccines following research and development, succor human
beings in fighting against deadly corona virus. Pharma giants shoulders major
responsibility in fortifying human lives.
However, the water tight compartment
of Intellectual Property Rights (IPR) does not allow procurement of vaccines,
unless hefty amounts are paid in proportion to investment. Accordingly,
stringent IPR (patent) regime is erecting walls for the developing economies, as
far as lifesaving medicine procurement is concerned. This has sparked the debate
over loosening up robust IPR regime to protect indefeasible Right to Life. The
Pharma sector is expected to come forward and waive patent protection for the
noble cause of saving human lives. Preservation of human lives is the need of
hour, rather earning profits out of sweat of brow.
Article 3 of the Universal Declaration of Human Rights (UDHR) and Article 6 of
the International Covenant on Civil and Political Rights (ICCPR) guarantees
Right to Life. Moreover, Article IX (clause 3 and clause 4) of Marrakesh
agreement pitches for waving off patent in certain circumstances of exceptional
nature. Therefore, pharma companies are expected to work in nexus with their
government, in strict observance of these international instruments, in their
According to Wall Street Journal, United States will support waiver of
Intellectual Property Rights.[i] Ostensibly, this decision has been taken in the
wake of allowing developing countries to augment COVID immunization program.
This is a welcome step to cap the exorbitant prices charged over patented
vaccine, especially in the benefit of Nations like India. However, the problem
does not end here.
Even when the United States has agreed to lift their IPR
cover on vaccines, as discussed above, still developing economies lacks ability
to come up with vaccines in reasonable time, since the scarcity of raw material
is of major concern. Also, it has been claimed that they
lack manufacturing capabilities to snowball production of vaccines.[ii]
Over the couple of months, India has witnessed record corona cases amidst high
demand for getting inoculated. It is expediting its vaccination program in order
to prevent billion plus population. Article 21 of the Indian Constitution
encompasses Right to Life within its sweep. Therefore, State is acting under
legitimate expectation to safeguard its population interest. The collective
effort of legislative will and judicial wisdom is going to ensure win over this
seemingly insurmountable disease.
Still, we need to overcome some impediments,
where we are lacking. Indian Government should mull granting compulsory licenses
over its patented medicines/vaccines immediately. Recently, Hon’ble Supreme
Court In Re: Distribution Of Essential Supplies And Services During Pandemic
pitched for allowing compulsory license.
It observed that:
According to the 2001 Doha Declaration, TRIPS should be interpreted in a manner
supportive of the right of members to protect public health and to promote
access to medicines. It recognizes the right of WTO members to use the full
extent of the TRIPS flexibilities to secure this objective. Para 5(b) of the
Doha Declaration provides the freedom to each member to grant compulsory
licenses and to determine the grounds on which the licenses are granted.
Para 5(c) leaves it up to each nation to determine what constitutes a national
emergency or extreme urgency. In the context of the COVID-19 pandemic, we note
that several countries such as Canada and Germany have relaxed the legal regimes
governing the grant of compulsory licenses.
Certainly, this initiative of Indian judiciary will inspire patent controller to
consider conferring compulsory license. Section 92 of The Patent Act, 1970 is an
enabling provision, which allows any interested manufacturer, to seek compulsory
license over patented product, so as to develop vaccine required to satisfy
public health emergency. Recently, Natco has filed compulsory license
application before Patent Controller of Mumbai, to manufacture Baricitinib (used
for COVID19 treatment).[iii]
Hence, the patent controller should accede to this,
to ensure its affordability and wide distribution in India. Recently,
our commerce secretary has announced that we can expect soon decision on waiver
of IP cover, inclusive of waiver on domestically made Covaxin. [iv] This will
certainly bring satisfaction to the masses in India, who are expecting first and
second jab of vaccines, within reasonable time.
Profits can be generated later as well, but the existing situation demands
flexibility in the applicability of IPR rules and regulations. In the existing
state of affairs, the Indian government is justified in offering
medicines/vaccines at subsidized rate, at the touchstone of right to life.
People are gasping for life and therefore government is ensuring instantaneous
availability of essential medicines. No matter, how much difficult the task is
but State machinery will toil hard, in keeping with, indispensable Right to
(Views expressed are personal)