The negotiations on India-South Africa proposal for the waiver of certain provisions of the TRIPS Agreement has now turned into a farse. The original waiver proposal sought a targeted and limited duration waiver from the protection and enforcement of certain intellectual property rights under the TRIPS Agreement. The idea was to enhance the policy space of WTO members to take policy measures to address the IP barriers and diversify the production of health products required in the context of COVID 19 pandemic. It is unfortunate that the developed countries like EU, UK, US and Switzerland and the WTO Secretariat worked together to make the waiver proposal limited to vaccines and that too limited to export of vaccine only and that too, unworkable, being loaded with so many conditions. This proposed decision text is not offering any benefit to India or Indian companies producing the vaccine due to the following reasons.
• Proposed decision text waives only the obligation under Article 31 (f) of the TRIPS Agreement. It means under the conditions mentioned in the decision text, predominant part of the vaccines produced under the compulsory license can be exported. Therefore, the decision does not offer any additional freedom for countries like India to issue a compulsory license for its domestic use. Vaccine production requires substantial investment than the medicines and diagnostics; therefore vaccine producers will not come forward to invest only for export purpose.
• Considering the size of the Indian domestic market Indian vaccine producers could export large number of doses to meet the needs of many countries without violating Article 31 (f). Therefore, what is really required is the freedom to ease the TRIPS obligations on compulsory license and trade secret to facilitate statutory or automatic compulsory license for domestic use. The decision text does not offer anything in this direction.
• One of the conditions proposed under Para 6, which is currently within bracket, is to stop the use of compulsory license after the duration of the waiver. It means a company exporting predominant portion of vaccines produced under the waiver decision cannot do so after the end of waiver. Till date, there is no consensus about the duration of waiver. This even means the vaccines produced during the waiver period cannot be exported after the expiry of waiver. This is great disincentive for the investment.
• The scope of decision includes only vaccines and excludes therapeutics and diagnostics. Considering the limitations of the vaccine, i.e. its inability to check the infection, availability, and affordability of medicines (therapeutics) and diagnostics are critical in the fight against COVID19. The current text proposes only a process to decide whether to extend the waiver of Article 31 (f) to cover therapeutics or diagnostics. Anyone who knows about the WTO negotiating process knows that it is a false promise.
• Another stringent condition is the ‘necessary test’ under the decision text. Para 1 of the text raeds: “Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member [1] may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of the subject matter of a patent [2]required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic”. Similarly, there is also necessary test requirement in the definition of subject matter of patent. This means the countries who uses the decision has the burden of proof to show the necessity to invoke the decision. This will be used by the developed countries to invoke dispute settlement mechanism under WTO to challenge the use of the decision. A mere threat can create chilling effect against the use of the mechanism.
In short, the decision is not offering anything new but repackaging of Article 31 (bis) of the TRIPS Agreement, which has proven ineffective and unusable. India should call a spade and reject the adoption of the decision text. Adoption of this text undermines the need of the hour and conveys a message that legitimate needs of developing countries can be ignored for the profit of the transnational corporations. Negotiators from India and other developing countries should ask this question from themselves, do they gain anything from present proposed TRIPS waiver decision?
Ashwani Mahajan 