WTO enters Covid pandemic fray with dispute over patent rights

Even as the world struggles to come up with a viable Covid-19 vaccine as well as new treatments, the fight over how to ensure that people around the world can get access to whatever products are available, now or in the future, is heating up significantly this week.

The most immediate flashpoint is Geneva’s World Trade Organization – where all eyes are set upon a closed-door meeting of 164 countries and regions, taking place over the next two days. Members will meet under the TRIPS Council, a difficult acronym referring to a powerful WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) protecting patents in international trade.

This international treaty is one that few people outside of the circles of patent lawyers and medicines advocates know about – or understand – even though it impacts the daily lives of almost everyone.

Why is this important? A sweeping proposal by India and South Africa to suspend so-called TRIPS protections of intellectual property (IP) for virtually any health product deemed necessary to fight the Covid-19 pandemic is set to come before the TRIPS Council this week.

The proposal would allow countries to waiver patents, copyrights and other IP not only for the products themselves but also for their underlying technologies – without facing charges or penalties at the WTO for violation of international trade rules. And the proposal also casts a very broad net; almost any medical product necessary to test, treat or prevent Covid-19 could be eligible for such a waiver.

While highly technical, the discussion sets the stage for a major public debate over the growing clamour in low- and middle-income countries to wipe the slate clean of any patent protections on Covid-related drugs, tests, protective gear or hospital equipment for as long as the pandemic lasts.

The debate over access to medicines that is bubbling up now is reminiscent of a simmering volcano that occasionally erupts.

The most memorable eruption was at the peak of the HIV/AIDs epidemic that swept Africa around the turn of the millennium when countries like South Africa forced major changes in the rules of the patent game. That paved the way for the WTO Doha Declaration on TRIPS and Public Health in 2001, which introduced so-called “TRIPS flexibilities” opening up new channels for countries to permit the generic manufacture and importation of otherwise costly therapies during health emergencies. This along with national legal precedents, and new precedent-setting agreements with industry, helped make antiretrovirals (ARVs) for treating HIV cheap and accessible across Africa and the world.

WTO as gatekeeper. Despite those historic revisions. WTO has for the past two decades retained its role through TRIPS as the global gatekeeper of world trade rules related to patents on vaccines, drugs and other health products. And that, in turn, is one of the things – although certainly not the only one – that continues to affect who can manufacture these products, where and how much they will cost.

Most countries still adhere to global patent rules, and even poor countries make use of the “TRIPS flexibilities” very judiciously because they can face claims at WTO – or other kinds of pressure and reprisals from countries hosting the pharma firms who hold the original patents. As a result, WTO continues to hold the wheel on when, and to what extent, IP protections are enforced – or overlooked.

Still early days. But could the status quo change even more dramatically now? Keep in mind that we are still in the early days of this debate – partly because there are still no approved vaccines, or many treatments, available. Just this week, big pharma companies registered some major setbacks in both arenas.

Those included Monday’s announcement by Johnson & Johnson that it was temporarily suspending trials of a single-dose Covid-19 vaccine – due to an unexplained illness in one trial participant. The vaccine would be particularly suited to low and middle-income settings because not only is it just one dose (others are two) but it does not require extreme cold storage.

On Tuesday, due to another adverse event, Eli Lilly suspended a clinical trial for its combination antibody treatment – a cocktail similar to the Regeneron brew that President Donald Trump received last week and which he pronounced to be a “virtual cure”. He was, of course, disregarding the obvious scientific principle that an experiment involving only one individual – even the President – is not proof of widespread efficacy or even safety.

But hopefully, innovation will do its thing and eventually treatments – and a vaccine – will emerge. What can we expect then? Will someone promise, as President Trump spontaneously did, to make the drugs that he got ‘free for everyone’, and really mean it?

Another watershed moment? Since the HIV crisis of the 1990s, countries are allowed to suspend TRIPS rules in emergencies. They can issue their own licenses for generic or biosimilar drug manufacture or imports under the provision of the Doha Declaration, which introduced certain “TRIPS flexibilities”.

In addition, UN-supported mechanisms, such as the Medicines for Patents Initiative (MPP) have since emerged. They have wracked up a track record in the negotiation of “voluntary” licenses with big pharma for the manufacture of generic drugs for urgently needed drugs, including new generation hepatitis cures.

Most of the time, it has been poor countries that have issued waivers or licensing to manufacture generic versions of a patented drug. Rich countries could afford to buy the latest brands, even at premium prices, until the patents expired.

Now, pressures are growing in rich countries, as well. Countries in high-income Europe have struggled with shortfalls or high prices for the few Covid therapies already available. For instance, a shortage of Remdesivir is making headlines in the Netherlands, observes Ellen ‘t Hoen, who heads the Dutch-based non-profit advocacy group, Medicines, Law & Policy.

Meanwhile, the South African and Indian initiative for suspending the usual IP rules of play during the pandemic has recently gained support from the UN-affiliated Unitaid, a group of European Union MPs, Doctors Without Borders, and other advocacy groups including Geneva-based Drugs for Neglected Diseases initiative (DNDi).

However, it remains highly unlikely that the TRIPS Council would back such a sweeping waiver for all drugs, vaccines and technologies as the South African and Indian sponsors are proposing. Industrialized countries, including European countries, would generally not go along with such a move, even if some are suffering, observers say.

And it is also unlikely that the WTO’s new director-general, whose appointment is pending, would take sides. Among the two final candidates left in that race, Nigeria’s Ngozi Okonjo-Iweala is considered to be the front-runner, ahead of Republic of Korea’s Yoo Myung-hee. Despite Okonjo-Iweala’s sensitivity to global health issues- she is currently the board chair of Gavi, The Vaccine Alliance, she will not want to burn her bridges too quickly with industry, pundits say.

“The WTO is highly likely to acquire Okonjo-Iweala — who wants to make the public-private approach work,” said The Financial Times’s world trade editor, Alan Beattie, in a recent piece. “She told us in an interview in July: ‘We’re saying we need to get these vaccines to everyone at affordable prices [but] how do we protect intellectual property, because without that you will not have the innovation, and the research?’ Conversations between Okonjo-Iweala and India/South Africa might get a bit spicy.”

He and others also point out that in the case of vaccines which are complex and sensitive to manufacture, “IP is not the gating factor”. These require a complex set of technologies that can take years for a country to develop. However, the sweeping nature of the South African and Indian waiver proposal also means that if it were approved, then patents on almost any other technology associated with Covid treatment could effectively be put on pause. And since Covid can involve so many organs of the body, from the heart to the lungs to the brain – that means almost anything.

A third way. Short of a major WTO move, almost certain to be dismissed in its current formulation by countries with big pharma interests, the third way, advocates say, is country backing for the WHO-sponsored Covid-19 Technology Access Pool (C-TAP). An expanded version of the MPP, the C-TAP pool is designed to offer country and industry a voluntary approach to COVID-19 technology sharing.

But so far only 41 countries have signed up to C-TAP, reflecting the lacklustre support voluntary approaches have received. The industry has also repeatedly said that it doesn’t see itself as a player in C-Tap – and without industry, the initiative would have almost no meaning.

The medicines access advocates. ‘t Hoen, is one among a growing chorus of advocates who say that countries need to be considering right now how the rules of the game can and should be changed proactively – before the various national crises over access to different drugs and treatments snowball into a worldwide firestorm:

“The success of C-TAP will depend on the political support it will receive…. But persuasion will need to come from governments and institutions that spend public resources on the development of new drugs and vaccines by demanding from their recipients that they share the IP and know-how they create with those public funds, with the WHO C-TAP.

“Unfortunately, despite the lofty promises of the vaccine as a global public good, wealthy nations are not making such demands. It is therefore understandable that developing countries are also looking at non-voluntary measures such as the proposal for a temporary waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of Covid-19. No doubt this will be met with opposition from wealthy countries and drug companies.

“But those countries and companies who refuse to make the WHO C-TAP a success while telling developing countries they are not entitled to take measures to protect public health in the midst of a global health crisis are not credible.”

She also points out that in the Covid research race, “countries have coughed up unprecedented sums of public money to conduct research – meaning that they should also own more of the associated knowledge. At the same time, due to the complexity of vaccine manufacture, countries will not anyway begin to manufacture, helter-skelter, the most cutting edge products.”

“Governments around the globe are carrying the financial risk of developing new health technologies and in particular vaccines by pouring billions of public monies into research and development. The EU tracker of pledged resources for access to tests, treatments and vaccines today stands at €16bn. Therefore, the often-heard argument that monopoly rights are needed to allow the inventor to recoup his or her investment does not seem to apply.”

Industry begs to differ. “Intellectual property is not a hindrance but a help to end Covid-19; indeed the current level of risk-taking would be impossible without a flourishing innovation ecosystem built on strong IP incentives,” said Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

“For this reason, the TRIPS Council proposal by South Africa and India is incorrect in portraying intellectual property as a barrier to the collaboration and manufacturing of COVID-19 technologies. It does not correspond with our experience.

“On the contrary, it is IP that has enabled collaboration between bio-pharmaceutical innovators and governments, universities and other research partners to speed up progress on our most pressing unmet medical needs, including hundreds of potential Covid-19 treatments and vaccines for patients around the world.

Cueni goes on to say that the pandemic moment is not the ideal time to stir the simmering lava-pot of IP disputes.

Suspending key protections of the TRIPS agreement would send the wrong message to industry investors that have “taken huge risks”, he argues. And this:

“At a time when unprecedented efforts across the board are being made to control and hopefully end this pandemic and prepare for any future health crisis, we need innovation and science more than ever.”

How the political drama plays out and concludes with respect to the current pandemic remains unknown. But one thing is certain. The decisions made behind closed doors in the fortress-like WTO headquarters on the tranquil shores of Geneva’s Lake Leman, by a council of countries operating under the acronym of TRIPS, will echo back to hospital wards and clinics around the globe, where dramas of life and death are being played out for millions of people every day.