Against the equitable access to essential medicines

(Mains GS 2 & 3 : Effect of policies and politics of developed and developing countries on India’s interests, Indian diaspora. Important International institutions, agencies, their structure and mandates & Issues relating to intellectual property rights)

Context:

• Since the onset of COVID-19, the world has seen a reaffirmation of intellectual property rules that have served as a lethal barrier to the right to access healthcare over the last few decades.

Taken a firm position:

• On October 2, 2020, India and South Africa submitted a joint petition to the World Trade Organization (WTO), requesting a temporary suspension of rules under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
• Their contention was that the application and enforcement of intellectual property rights (IPRs) were “hindering or potentially hindering timely provisioning of affordable medical products to the patients”.
• India and South Africa, therefore, argued that “rapid scaling up of manufacturing globally” was “an obvious crucial solution to address the timely availability and affordability of medical products to all countries in need”, and for doing so, IPRs must be waived for at least three years.
• By submitting their proposal, India and South Africa had, thus, taken a firm position that when lives are at stake, these products should be treated as global public goods.

Strong warning:

• Nearly 18 months later, 164 members of the WTO could not find common ground on the “waiver proposal” even as 63 developing countries have become co-sponsors of the proposal and another 44 countries lent support from the floor.
• Initially, all advanced countries opposed the proposal, but after the Biden Administration took office, the United States (U.S.) backed the waiver, but only for vaccines.
• The stance of the advanced countries is hardly surprising as they have always put the interests of pharmaceutical companies ahead of the lives of the ordinary citizens in many countries who are yet to be fully vaccinated.
• As of today, only 14% of people in low-income countries have received at least one vaccine dose; thus, the recent surge of infections in China is a strong warning to the global community that the threat from COVID-19 still remains.

Differences resolved:

• In this complex situation, one of the consistent opponents of the “waiver proposal”, namely, the European Union (EU), announces that the differences over the proposal had been resolved.
• But when going into the details it is revealed that India and South Africa, the movers of the “waiver proposal”, are among the four countries that found a “compromise outcome”.
• The EU, which has unveiled the “solution”, states that this is a “compromise outcome” that will now be “put forward for [WTO] members’ consideration”.
• Interestingly, the “compromise outcome” adopts the approach that the EU has been proposing all along namely, granting compulsory licences to enhance vaccine production.

The “Quad” solution:

• Generally, patent laws, including that of India’s, allow for the grant of compulsory licences if patent holders charge high prices on the proprietary medicines in exercise of their monopoly rights. 
• Moreover, such licences can usually be granted if efforts in obtaining voluntary licences from the patent holders have failed. 
• The “Quad” proposal states that in case of a medical urgency, there is no requirement to make efforts to obtain voluntary licences with the patent holders before granting compulsory licences on the patented products. 
• The “Quad” solution also provides that WTO members would be able to issue compulsory licences even if they do not currently have the provisions to issue them under their national patent laws. 

Considerable details:

• The compulsory licensing system that the “Quad” has proposed contains considerable details, the implications of which need to be understood.
• The “Quad” solution can be used only by an “eligible member”, defined as a “developing country member” of the WTO that “had exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021”. 
• The eligibility criteria, therefore, implies that the least developed countries are excluded which means that Bangladesh, which is still a least developed country, but has a growing pharmaceutical industry, is also excluded.

Stringent export restriction:

• While introducing the export restriction, the “Quad” solution proposes to waive the obligation under Article 31(f) of the TRIPS Agreement.
• Article 31(f) provides that the compulsory licences issued by any WTO member must be used “predominantly for the supply of the domestic market”.
• The “Quad” solution states that the export restriction in 31(f) was removed as there was a “long standing request from the waiver proponents that want to be free to export any proportion of the COVID-19 vaccine”. 
• But while they have proposed removal of Article 31(f), the “Quad” solution includes a more stringent export restriction in the form of the eligibility criteria.

Mandatory notification:

• Further, the “Quad” has introduced additional conditions to using the compulsory licences, some of which are well beyond the developing country obligations under the TRIPS Agreement.
• For instance, the proposed condition of listing all patents covered under the compulsory licences is not a requirement under the TRIPS Agreement.
•  Similarly, there is no obligation to notify the details of licensee, the quantity and export destination under the TRIPS provisions, but the Quad text proposes mandatory notification.

Conclusion:

• By accepting the “compromise outcome”, India and South Africa could jeopardise their high moral ground which they had gained through their attempt to make medicines and medical products necessary for COVID-19 treatment or containment as global public goods.