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Trips Waiver and International aspects of Compulsory licensing


Authored By: Krishan Kant Sharma


INTRODUCTION

Covid-19, a situation of the pandemic which began in 2019 blew out like a wildfire over the globe in 2020. The developed and third world countries throughout the globe faced an existential crisis in terms of economy and human life since every country felt hapless to its roots and was busy saving the lives of their people, meanwhile trade and economy took a major setback. At that time there were no medical facilities available to fight but to the palisade, the loss, countries culled for a lockdown which unequivocally sabotaged the worldwide trade. In the meantime, virologists started formulating vaccines but only a few of them were able to attain triumphs such as the USA, Russia, India, and the UK.

Every country kick-started its strategy for jabbing its people with the hope of ascertaining herd immunity. India started the immunization process in different phases.


Front-line workers were among the first to be vaccinated with the highest priority, and the second vaccination drive began, which proved to be difficult because people aged 60 and up are more vulnerable to the virus.


Following the second phase, the Government of India began vaccinating people aged 45-60 in the third phase of the vaccination drive, which began in April 2021.

There was an initial demand of nearly 700 million doses to vaccinate the eligible people after the third phase of vaccination began, but the situation blew out dramatically when vaccination of the age group 18-45 began. The vaccination drive is now open for the most populous bracket, and India needs nearly 2.2 billion vaccines to vaccinate all eligible people; however, this step has resulted in vaccine scarcity. The government devised a policy to vaccinate 300 million people by August 2021, which appears insurmountable because the required dose rate is nearly 3.4 million doses per day, which is unattainable at the current rate of production.

Pharmaceutical manufacturers such as Bharat Biotech and SII have increased production to the maximum extent possible, but this dexterity is insufficient to meet the demand. The Central Government confirmed that SII and Bharat Biotech are producing 85 million doses per month. To reach the goal of vaccinating 300 million people by August 2021, nearly 105 million doses are required each month.


TRIPS AGREEMENT AND DOHA DECLARATION

An ounce of prevention is worth a pound of cure. The ship has sailed for prevention, now only cure could be sought.

Menace created by coronavirus is not only on a national level but all over the world. Waiver of restrictions in the Trips Agreement now seems a plausible solution to India since there couldn’t exist any efficient and effective solution other than using the state-of-the-art infrastructure, innovation, and technology available with the developed countries. Protection of Intellectual Property Rights such as patents and inventions was imposed due to the 1995 negotiation done at WTO which led to the formation of the TRIPS Agreement. This agreement sanctions countries to frame domestic laws to provide for minimal IP protection. Doha Declaration of 2001 was just a clarification to the already existing provisions of the Trips Agreement to establish a clear picture in terms of compulsory licensing on important matters such as public health and safety. Also, as per the special 301 Report of USTR, Doha Declaration highlights that the TRIPS agreement is not an obstruction to promote public health and particularly access to medicine for all.


COMPULSORY LICENSING AND TRIPS WAIVER

India has anticipated at the international level for the waiver of the Trips Agreement and initially, South Africa also buttressed the same. Afterwards, the USA and other WTO members reinforced India in waiver but countries such as Japan and UK are still persistent in not waiving the Trips Agreement. The reason is to protect big pharma companies since the making of a drug requires a huge amount of investment in terms of research, analysis, innovation, and development, and waiving off the patent rights will cause paramount loss to them in the future as the industry flourishes on innovations which require huge investments.

Chief of WTO probed member nations to come up with a proposal on an exigent basis so that the patent could be waived off and the request of India and South Africa could prosper. Meanwhile, International Monetary Fund propounded a plan to inoculate around 60% of the world population by early 2022 at 60 billion dollars.


Compulsory licensing can be granted in situations of national emergency or matters of extreme urgency or for public non-commercial use and the current pandemic is sufficing these criteria. The plausible solution accessible is a waiver of the Trips Agreement which will waive off the intellectual protection to the technologies obligatory for fighting with the covid-19 including the manufacturing of vaccines.


In June 2020, a deal was made between SII and AstraZeneca, a pharma company, and Oxford University to supply 1 billion vaccine doses to low and middle-income countries. Several months later SII was barred from exporting the vaccine to other countries. UNICEF, GAVI (Global Alliance for Vaccine and Immunization) runs an initiative named COVAX along with WTO which delivers vaccines and other allied drugs to poor countries. SII is already under an obligation to source GAVI but recently it halted its supply which may resume once the situation comes under control in India. This international obligation has crippled the situation in India as we are not able to vaccinate our people due to the sharp scarcity of vaccines.


ANTECEDENTS OF GRANTING COMPULSARY LICENSE

Taiwan granted compulsory licensing to Taiwan Pharmaceutical in 2005 for producing Tamiflu during bird flu pandemic when crores of people died and in 2002 Zimbabwe declared emergency and granted a compulsory license to make, use or import generic HIV/AIDS medicines.

In Merck Sharp and Dohme Limited vs. Shionogi (2017), the German Federal Court of Justice granted a compulsory license for HIV pandemic. The current situation of Covid-19 is no less than a pandemic situation and therefore our country should also consider the same.

High, middle and low-income countries such as United States, Malaysia and Mozambique respectively among many others have issued compulsory licensing as per the dire need in times of health emergency.

Israel has already granted a compulsory license along with Thailand and Brazil. Canada, Chile and Ecuador are some of the countries where the groundwork has already started for granting a compulsory license. Covid-19 Emergency Response Act has amended Canadian Patent Act to speed up the process of granting the license. Chile’s lower House of Congress and National Assembly of Ecuador has also passed a resolution in this regard. Developing countries such as India should also work immediately for granting a compulsory license so that covid-19 could be controlled before more damage is done. The fear of trade retaliation may not be allowing India to grant a compulsory license but it is not invincible.


CONCLUSION

Few individuals' commercial rights are not more important than human life. Keeping this in mind, it is past time for the government to grant compulsory licences to pharmaceutical companies by invoking the provisions of the Patents Act, which are required to ensure public health and to protect the people from the inevitable third wave of coronavirus, which is expected to hit in the next 6-8 weeks. Granting a compulsory licence will not only help the country meet its domestic needs, but will also allow it to fulfil its global obligations by providing vaccine to the least developed countries. To effectively immunise the entire country and recover from the pandemic, approximately 70% of the population must be immunised, and only then can protection against mutating coronavirus variants be confirmed. It is necessary to promote innovation through patent protection, but it is also unquestionably necessary to consider public health emergencies. The waiver of the Trips Agreement can serve as a shining knight in shining armour for all those countries that are eagerly anticipating this move because it may be their last chance to save the human race.