Suspend international IP, patent obligations on Covid-19 vaccines
Although strenuous efforts are on across the globe to develop vaccines and drugs to fight Covid-19, the issue of their equitable access remains a major challenge. A formidable barrier to ensuring timely access to vaccines and drugs could be patents or other intellectual property (IP) rights. Médecins Sans Frontières (MSF), in a 2017 report, documents how patents have hindered the introduction of affordable vaccines in developing countries. The rights of the inventor should be protected through IP laws. Arguably, such protection spurs innovation, overcoming the social costs imposed on the public through limited accessibility of the product. However, in a world living through the worst pandemic in a century, there is a strong case for the collective interests of humanity to trump the individual interests of the inventor.
India’s recent proposal at the World Trade Organization (WTO), jointly with South Africa, asking for a temporary waiver of the application of certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on Covid-19 vaccines and drugs must be seen in this light. If the waiver is granted, WTO member- countries will not be under obligation, for a temporary period, to either grant or enforce patents and other IP-related rights to Covid-19 drugs, vaccines,ventilators, masks and other related items. This will help them devise plans for vaccinating their populations without worrying about legal suits. While many developing countries have endorsed India’s proposal, countries such as the United States have opposed the move.
Articles IX.3 and IX.4 of the WTO agreement empowers the ministerial conference to grant such a waiver. The ministerial conference should state the exceptional circumstances justifying the decision, the terms and conditions governing the working of the waiver, and the date on which the waiver shall end. Thus, the WTO can temporarily suspend the application of the IP-related provisions for a certain period to address the issue of accessibility of vaccines and drugs. There are several instances where WTO has adopted such waivers in the past.
Arguably, there is no need to suspend the application of the TRIPS agreement because countries can make use of its flexibilities such as the issuance of compulsory licences. But, working out of some of these flexibilities involves onerous procedural requirements. For instance, while Article 31 bis of the TRIPS agreement allows countries with insufficient manufacturing ability to benefit from the issuance of compulsory licences, the procedural requirement of packaging and labelling is cumbersome. It can lead to delays in supplying vaccines or drugs. Thus, a temporary waiver will be more effective than relying on flexibilities.
However, the concern regarding IP rights becoming a barrier in speedily distributing Covid-19 vaccines and drugs is germane not just for WTO law but also vis-à-vis bilateral investment treaties (BITs). Several BITs recognise IP rights as part of foreign investment. Consequently, State regulatory measures that impact the investments of transnational pharmaceutical corporations could be challenged as potential breaches of BITs. This could have a chilling effect on State regulation aimed at ensuring accessibility of Covid-19 drugs and vaccines. Globally, pharma companies have, in the past, used BITs to challenge State regulations on IP rights. Thus, India and other countries must also secure a waiver from the application of BITs to Covid-19 vaccines, drugs, and diagnostics. Countries can do this by adopting a binding declaration to that effect either bilaterally or multilaterally.
Some pharmaceutical companies have voluntarily offered that they would not enforce their Covid-19 vaccine patents. However, given the real dangers of “vaccine nationalism” — as per Oxfam’s report, a small group of rich countries has already purchased more than 50% of the future supply of Covid-19 vaccines — voluntary efforts may not be enough. Coordinated State action at the global level that temporarily suspends the application of relevant international law to Covid-19 vaccines and drugs will be an important step in fighting the pandemic.
URL:https://www.hindustantimes.com/analysis/suspend-international-ip-patent-obligations-on-covid-19-vaccines/story-C8KL9pTmRcvaxvMOXhZcYN.html
India’s recent proposal at the World Trade Organization (WTO), jointly with South Africa, asking for a temporary waiver of the application of certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on Covid-19 vaccines and drugs must be seen in this light. If the waiver is granted, WTO member- countries will not be under obligation, for a temporary period, to either grant or enforce patents and other IP-related rights to Covid-19 drugs, vaccines,ventilators, masks and other related items. This will help them devise plans for vaccinating their populations without worrying about legal suits. While many developing countries have endorsed India’s proposal, countries such as the United States have opposed the move.
Articles IX.3 and IX.4 of the WTO agreement empowers the ministerial conference to grant such a waiver. The ministerial conference should state the exceptional circumstances justifying the decision, the terms and conditions governing the working of the waiver, and the date on which the waiver shall end. Thus, the WTO can temporarily suspend the application of the IP-related provisions for a certain period to address the issue of accessibility of vaccines and drugs. There are several instances where WTO has adopted such waivers in the past.
Arguably, there is no need to suspend the application of the TRIPS agreement because countries can make use of its flexibilities such as the issuance of compulsory licences. But, working out of some of these flexibilities involves onerous procedural requirements. For instance, while Article 31 bis of the TRIPS agreement allows countries with insufficient manufacturing ability to benefit from the issuance of compulsory licences, the procedural requirement of packaging and labelling is cumbersome. It can lead to delays in supplying vaccines or drugs. Thus, a temporary waiver will be more effective than relying on flexibilities.
However, the concern regarding IP rights becoming a barrier in speedily distributing Covid-19 vaccines and drugs is germane not just for WTO law but also vis-à-vis bilateral investment treaties (BITs). Several BITs recognise IP rights as part of foreign investment. Consequently, State regulatory measures that impact the investments of transnational pharmaceutical corporations could be challenged as potential breaches of BITs. This could have a chilling effect on State regulation aimed at ensuring accessibility of Covid-19 drugs and vaccines. Globally, pharma companies have, in the past, used BITs to challenge State regulations on IP rights. Thus, India and other countries must also secure a waiver from the application of BITs to Covid-19 vaccines, drugs, and diagnostics. Countries can do this by adopting a binding declaration to that effect either bilaterally or multilaterally.
Some pharmaceutical companies have voluntarily offered that they would not enforce their Covid-19 vaccine patents. However, given the real dangers of “vaccine nationalism” — as per Oxfam’s report, a small group of rich countries has already purchased more than 50% of the future supply of Covid-19 vaccines — voluntary efforts may not be enough. Coordinated State action at the global level that temporarily suspends the application of relevant international law to Covid-19 vaccines and drugs will be an important step in fighting the pandemic.
URL:https://www.hindustantimes.com/analysis/suspend-international-ip-patent-obligations-on-covid-19-vaccines/story-C8KL9pTmRcvaxvMOXhZcYN.html
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