Profit over public health

(Mains GS 2 : Important International institutions, agencies, their structure and mandates & Issues relating to intellectual property rights)

Context:

• The COVID-19 pandemic has tested the resilience of the global community on various fronts like whether the global community can unite to ensure the availability of COVID-19 medical products for everyone.

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.

Significant climb down:

• The developed world, especially the European Union (EU), consistently opposes the  “waiver proposal”.
• Recently a deal has been brokered between the EU, the U.S., India, and South Africa on the issue of the TRIPS waiver and this deal will now be presented to the entire WTO membership to be accepted at the forthcoming ministerial meeting.
• However, the waiver is a classic case of too little, too late, and represents a significant climb down from the original proposal of India and South Africa.

Waiver for vaccine:

• The draft waiver includes only COVID-19 vaccines and not other COVID-19 medical products shows its major handicappedness as medicines also play an equally important role in combating the pandemic.
• For instance, the World Health Organization (WHO) has recommended baricitinib for treating severe or critical COVID-19 but according to the Médecins Sans Frontières, the generic version of baricitinib is not available in many countries because it is patented.
• This defeats the purpose of the TRIPS waiver, which was to ensure cheaper and faster availability of drugs such as baricitinib.

Old wine in a new bottle:

• The draft waiver proposes to waive only patents and not other IP rights which is against India’s original stand that all IP rights, not just patents, be waived.
• The accessibility of COVID-19 medical products can be held up due to many IP rights like trade secrets.
• The draft waiver appears to be old wine in a new bottle as the draft waiver allows countries to limit the exclusive rights conferred on patent holders under Article 28.1 of the TRIPS agreement through the use of Article 31, which permits the issuance of compulsory licenses but this flexibility is already available under the TRIPS agreement.
• The only waiver is from Article 31(f) which requires countries to ensure that products produced under a compulsory license are predominantly for the domestic market.

Export of vaccines:

• The draft waiver allows countries to export any proportion of vaccines to eligible countries; however, this waiver is subject to several notification requirements.
• Eligible members are obligated to prevent re-exportation of COVID-19 vaccines that they have imported.
• Furthermore, the eligible countries which issue a compulsory license for COVID-19 vaccines have to notify the WTO about the entity that has been authorised to produce the product, the quantities, duration, and the list of countries to which the vaccines are being exported.
• All these procedural requirements will increase the transaction costs and may deter countries from using the system.

New obligation:

• The waiver adds a new TRIPS-plus obligation as Article 31(a) of the TRIPS agreement requires that permission for compulsory licenses shall be considered on a product-by-product basis.
• Concerning Article 31(a), the draft waiver clarifies that a single authorisation may be given to use the subject matter of multiple patents necessary for the production and supply of COVID-19 medicines. 
• However, this entails a new obligation to identify and list all covered patents.

Not universal:

• The draft waiver is not universal. Only those developing countries that exported less than 10% of world exports of COVID-19 vaccine doses in 2021 are covered for exportation and importation and there is no mention of least developed countries.
• Further while the draft waives the obligation of a member to protect undisclosed information submitted before a drug regulator to claim marketing approval in the present context, it is silent on overcoming the challenges posed by protection to other trade secrets covered under Article 39.1 and 39.2 of TRIPS.

History repeats itself:

• In the aftermath of the HIV/AIDS crisis in Africa , the WTO adopted a decision in 2003 waiving certain TRIPS obligations to increase the accessibility of medicines in countries that lacked manufacturing capability. 
• However, this waiver was subject to stringent requirements because of which hardly any country made effective use of this waiver.
• The developed countries serving the interests of their pharmaceutical firms are all set to triumph, once again, over the public health concerns of humanity which will further dent the WTO’s relevance and credibility.

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.