Intellectual Property Rights(IPR) and Universal Vaccination – Explained, Pointwise

Introduction

The Covid-19 cases in India are increasing at a very high rate in India. According to the government data, the number of positive cases is increasing at a rate of more than 3 lakh every day since April 21. Now, the only solution suggested by experts around the world is universal vaccination. The government with its new vaccination policy aims to vaccinate people above 18. However, vaccines are not available in sufficient quality to match demand.

One of the hindrances to the wide-scale production of vaccines is Intellectual property rights and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.

Last October, India and South Africa also moved a motion at the WTO. In that motion, they asked the WTO Council on  (TRIPS) to provide a waiver of Intellectual Property Rights for vaccine production. However, the proposal was opposed by the developed countries.

Protection of Intellectual Property Rights under the TRIPS

• TRIPS  is a key legal instrument on intellectual Property Rights. The agreement imposes binding obligations on member countries to ensure a minimum level of protection and enforcement of IP rights in their territories.
• The developed countries especially the US aggressively pushed for the TRIPS agreement.

• Under the TRIPS agreement, the patent holders have the exclusive right to manufacture, sell, and use the vaccine or the drug for the entire term of patent protection. This entire term includes 20 years from the date of the filing of the patent.
• If a country violated the provisions of the agreement then the country has to face the WTO Dispute Settlement Body.
• A country can even file a complaint even when there is an allegation of the violation. This is called a non-violation complaint in WTO.  However, the members of TRIPS  agreed not to use them under the TRIPS Agreement.

Intellectual Property Rights exemptions under WTO and TRIPS:

Both the WTO and the TRIPS Agreement have certain exemptions. Such as,

1. According to the Marrakesh Agreement or WTO agreement, any exceptional circumstances may waive off obligations imposed on a WTO member country. This waiver will include both the WTO Agreement and any other multilateral trade agreement. But to get such a waiver, the request has to receive three-quarters of the member’s support in the WTO Ministerial Conference.
   • Furthermore, the Ministerial Conference can prescribe terms and conditions for such waiver.
   • The Ministerial Conference can also review the waiver annually if the waiver is granted for more than a year.
   • A waiver may be granted to an individual WTO member country or even collectively.
2. If the waiver is requested from any multilateral trade agreements under TRIPS, then the country has to submit the request to the Council of TRIPS. So, the TRIPS Council has jurisdiction over it. The TRIPS council can provide waivers for the Covid-19 vaccine manufacturing, selling, and usage.
3. Articles 31(f) of the TRIPS Agreement: This is one of the important provisions under the TRIPS Agreement. It provides for a compulsory license. Under this, the government can issue a license to make use of a patent without the patent holder’s consent. But, this drug can be used only for the supply of the domestic market. So the government cannot export the patented product.
   • For example, In 2012, India permitted generic production of Bayer Corporation’s Nexavar. This drug was used for the treatment of Liver and Kidney cancer.
   • Similarly, South Africa permitted the generic production of Anti-Retroviral Drugs used in HIV treatment.
4. Apart from these three types, pharma companies also conclude voluntary licensing arrangements between pharmaceutical companies. For example, the licensing agreement between AstraZeneca and Serum Institute of India. Under this, the Serum Institute of India can produce vaccines for both domestic use and export.

Status of vaccine manufacturing

In India:

• The world’s largest vaccine maker, Serum Institute of Technology initially promised to supply 100 million doses of vaccines a month. But in reality, it only provided between 50 million to 60 million doses.
• On the other hand, Bharat Biotech has a planned production capacity of 12.5 million a month. Its current production is somewhere between  1-5 million.
• So, India’s monthly COVID vaccine manufacturing capacity is about 60-65 million doses only.
• The population of India is 1.3 billion. If the Covaxin and Covishield require two doses then India needs 2.6 billion doses. But the present production cannot meet that amount in a short time.

Situation in Europe:

• AstraZeneca’s entered into a contract with the European Union. It committed to supplying an initial 300 million doses of vaccine for distribution among the 27 member countries. Further, it provided an option to order another 100 million doses.
• But it delivered only 30 million doses in the first quarter of 2021. Further, the company also says it can only provide 70 million in the second quarter, rather than the 180 million it had promised.

So, the Covid-19 Vaccines are already in short supply. In this scenario, protecting the Intellectual Property is not only delay the universal vaccination but also extending the Covid-19 crisis itself.

About removing Intellectual Property Rights for Covid-19 vaccines

• As the Intellectual Property Rights hinder the supply of vaccines, both India and South Africa have proposed to waive off IP rights like patents, copyright, and trademarks for prevention, containment or treatment of Covid-19.
• Other developing countries started to co-sponsor the India and South Africa request. The TRIPS Council also discussed this issue both formally and informally.
• But many developed countries are opposing the move due to their arguments in favour of IP Protection.

Arguments for Intellectual Property Rights laws

The supporters of IP protection mention the below-mentioned points for strengthening IP policies through a network of national and international laws.

• Intellectual Property Rights incentivises innovation. It will provide income to the company invested in its research and capacity. So, the IPR policies will incentivise the companies to perform more research for their incentives.
• Higher cross-border IP protection would bring in greater dividends for their pharmaceutical corporations. The company can expand their operations in other countries and provide solutions to the domestic problem also in future.
• The Exemption clause to provide waiver: The country can get a waiver from the WTO if it wants a waiver for manufacture, sale, and usage. The WTO even provided collective waivers in two instances. Such as
  1.  In 2003 waivers from certain GATT obligations were granted by the WTO to some countries. This is provided after they adopted certain necessary measures to prohibit the export and import of rough diamonds to non-participant countries in the Kimberley Process Certification Scheme
  2. In 2003, the General Council waved off export restriction under the compulsory licence. This is to provide more accessibility of medicines in LDCs and other developing countries that lacked manufacturing ability.

Arguments against Intellectual Property Rights laws

1. Deny Right to health: Intellectual Property Rights especially patents, hinder the introduction of affordable vaccines and drugs in developing countries. Thereby, denying people their right to health.
2. Patents can block the wider accessibility of vaccines and prolong the pandemic. For example, the entire vaccination exercise will end the pandemic not the invention of the vaccine and patenting it. So, the patents are reducing the accessibility of vaccines.
3. Ambiguous definition: the term “exceptional circumstances” mentioned in the WTO Agreement is not mentioned anywhere in the Agreement.
4. Preconditions to waiver: There are certain preconditions attached to the waiver. Such as, the pharmaceutical company must manufacture only the necessary amount to meet the needs of the eligible importing country
5. Conditions in waivers: The waivers from the Intellectual Property Rights has so far come with stricter terms and conditions. For example, in waiving of export restriction on compulsory licence the conditions are,
   • The LDC and other developing countries have to notify the TRIPS Council that they have insufficient or no manufacturing capability to manufacture the drug.
   • They need to specify the required quantity
6. Challenge with the compulsory license: The success of compulsory license depends on every country’s manufacturing capability(As other countries cannot export them). Further, the developed countries will exercise great pressure on countries issuing a compulsory license. For example, In 2012, the US government put great pressure on India for issuing a compulsory licence to the generic version of Bayer’s cancer drug.

Suggestions to improve vaccination

• WTO’s TRIPS Council has to recommend the General Council “a waiver”. This has to include a waiver from the implementation, application, and enforcement of certain provisions of the TRIPS Agreement. These related to waiving IP rights like patents, copyright, and trademarks for prevention, containment or treatment of Covid-19.
• As the Covid-19 pandemic is the worst global health crisis in the last 100 years. So, in this situation, protecting Intellectual Property Rights will aggravate the crisis. The WTO has to permit countries having manufacturing capabilities to manufacture the vaccine and export them globally.
• Many LDC and developing counties lack manufacturing capability in the pharmaceutical sector. But, they need Covid-19 vaccines for their population. So the WTO and developed countries have to look beyond IP Protection.

World Health Organization recently mentioned that “no one is safe unless everyone is safe”. So the vaccine manufacturers have to look beyond profit and try to serve Humanity. Further, the governments are ready to pay for vaccines, the only thing the global community expect from vaccine manufacturers is to set aside Intellectual property Rights during the Covid-19 pandemic alone.