The fading mirage of a TRIPS waiver

There was barely any excitement when Australia came out in support of a waiver of intellectual property rights (IPR) by the World Trade Organization (WTO) on vaccines, treatments and diagnostic devices needed to fight the novel coronavirus disease (COVID-19) pandemic.

Trade Minister Dan Tehan’s announcement just a couple of weeks before the waiver proposal hit its anniversary — after a dismal year of inaction by WTO even as millions died following the outbreak of SARS-CoV-2 — caused hardly a blip.

The cardiograph charting the waiver proposal’s progress has been flat since it was first proposed by South Africa and India on October 2, 2020, barring the time when the Joe Biden administration caused a sensation — unwarrantedly, this column has argued — with its backing for a limited waiver on vaccines in May this year.

Now Australia has joined over 100 other countries in seeking a limited waiver of IPRS enshrined in the TRIPS agreement of WTO. Does it really matter?

Only a dogged optimist would say it does. For all one knows, it could be just a kite-flying exercise, since Tehan made Canberra’s shift in stance known at a meeting with community organisations. Just a month earlier, Tehan had been singing the usual paeans to the role of IPRS in promoting innovation and had put it on record that the government felt voluntary mechanisms were the best option for increasing access to vaccines.

In a letter written to community organisations, the minister had cited the scarcity of raw materials and the lack of manufacturing capacity as major barriers to increased production of vaccines. It also pointed to the key role of intellectual property protections in encouraging the development of new vaccines and tests and treatments.

Perhaps, the continuing shortage of vaccines for COVID-19 even in Australia has prompted a rethink by the government. And maybe the addition of Australia to the list of countries supporting the proposal could mean that it will get the two-thirds majority needed to pass muster.

According to WTO rules, amendments to the provisions of its agreements should be approved by consensus or by a two-thirds majority. However, in the case of the latter, the amendments would only apply to those WTO members which accept them. It is clear that nothing short of a consensus will work in this case.

What is happening at WTO holds out little hope of securing a consensus. The Biden administration is sitting pretty after making its surprise announcement, waiting on the sidelines while the jousting by the antagonists goes on in various meetings.

A report by news agency Reuters from Geneva indicated the negotiations had hit a cul-de-sac, quoting trade sources who had attended a closed-door TRIPS Council meeting on October 4. The report said Norway’s Dagfinn Sorli, chair of the Council, seemed frustrated on the way forward.

China, it said, had described the discussions as being circular, with no progress achieved. What is apparent is those countries opposed to the waiver, notably the European Union, the United Kingdom, Switzerland and Norway, are succeeding in stalling any meaningful engagement.

Humanitarian organisations like Médecins Sans Frontières (MSF) and Amnesty International might continue to rail against the opposition to the waiver from a small group of rich nations. Civil society organisations might publicise letter after letter written by Nobel laureates, academics and well-meaning public figures pointing to the gross inequity in access to life-saving vaccines and therapies, but all this is of little avail.

The campaign against the TRIPS waiver is as relentless as it is slick and dangerous. It uses scare-mongering as effectively as it deploys “expert opinion” to undermine the logic of those championing a much needed initiative to fight the pandemic.

At a recent panel discussion in Dallas, US, a clutch of lawyers from leading intellectual property (IP) firms raised a different bogey. What if once the limited waiver was approved, the WTO could not rescind it because there was no consensus? Sounds bizarre? Here is what one of the participants said: The waiver is “extraordinarily broad” because it not only seeks a waiver of patents related to the COVID-19 vaccine technology, but all technologies that impact the treatment and care of COVID-19 related illnesses, including vaccines, respirators, software related to contact tracing, etc.

Then came the deadliest punch. Even though the waiver is, on the face of it, intended as a temporary solution, it could have permanent consequences. The danger apparently lies in the revised language which states that “the waiver shall last for a minimum of three years, after which the waiver can be ended by agreement by the WTO”.

This is problematic, according to Andrei Iancu, a former director of the US Patent and Trademark Office who is now partner in a private legal firm, because all 164 members must agree to it. Therefore, it is conceivable “that at least one country would disagree, and thus the revised proposal effectively would make the waiver permanent,” IPWatchdog, which hosted the panel discussion, reported. In sum, changing the US policy on IPRS “after the most successful innovation in human history would be folly”.

Another legal worthy was even more dire in his prognostication. By allowing the waiver, “you are going to take the limited supplies to make this vaccine and spread them out over a less sophisticated supply chain, and you are going to damage the entire system. The limited supply should go to those who are able to produce it safely and effectively.” He was faithfully echoing what leading vaccine makers have been saying since the debate on the waiver became more heated: They have the know-how, manufacturing capacity and ability to produce vaccines safely.

Yet, diehard optimists are hinting at the possibility of a breakthrough at the year-end ministerial meeting of WTO, which is held once every two years. Even if the waiver is by some miracle approved by consensus at the Geneva ministerial, what would change on the ground? Can the companies that are the innovators and manufacturers of the leading vaccines now approved for emergency use by the World Health Organization be forced to part with all kinds of IPRS such as trade secrets, and not just patents?

Trade secrets protect different kinds of crucial information covered by non-disclosure agreements, including data gathered during the regulatory approval process. As yet, no one is clear how pharma companies can be made to cough up their secrets.