A safe, proven vaccine for COVID-19 doesn’t yet exist. But the battle for access is heating up.

Even as the world struggles to come up with a viable COVID-19 vaccine as well as new treatments, the debate 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 flashpoint is Geneva’s World Trade Organization – where all eyes are set upon a closed-door meeting of 164 countries and territories, taking place Thursday and Friday.  Members will meet  under  the TRIPS Council, a difficult acronym referring to the powerful WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) protecting patents in international trade.  A treaty few people outside of the circles of patent lawyers and medicines advocates really understand – even though it impacts the daily lives of almost everyone. 

A sweeping proposal by India and South Africa to suspend so-called TRIPS protections of intellectual property (IP) for virtually any health products deemed necessary to fight the pandemic is set to come before the TRIPS Council this week. On Thursday, Kenya and Eswatini were reported to have joined in co-sponsoring the measure, according to an informed source. 

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 WTO charges or penalties 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. 

As per a statement by the Indian government, one of the two leading sponsors of the TRIPS waiver initiative, the existing flexibilities in the TRIPS Agreement are “not adequate to address the fast-changing landscape of COVID19. ”

Of particular concern, it adds, “for countries with insufficient or no manufacturing capacity” is the fact that provisions under which countries can override patents with so-called “compulsory licenses” are limited to pharmaceutical products…. “Medical devices like ventilators, dialysis machines etc. that are crucial for combating the ongoing pandemic, may not be covered” Or to the extent that they are, “Requirements under this System that exporters and importers have to comply with, are extremely onerous and time-consuming, thereby rendering it of no practical utility towards handling the ongoing pandemic.”

While WTO debates are highly technical, the discussion sets the stage for a major public dialogue 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. 

On Thursday, some 370 civil society organizations called on WTO to adopt the proposal, including international groups like Médecins Sans Frontières, Oxfam, and Knowledge Ecology International, as well as dozens of regional and national groups from Europe, Latin America and Africa.

“Many countries, especially developing and least developed countries struggling to contain Covid-19 have experienced and are facing acute shortages of medical products, including access to diagnostic testing” the groups state in their open letter. “Furthermore, wealthy nations representing only 13% of the global population have locked up at least half the doses of the world’s five leading potential vaccines.”

Like a simmering volcano

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

The most memorable eruption was at the peak of the HIV/AIDs epidemic that swept across 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 cheaper and more 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 and sell health products, where and how much they will cost. 

Most countries still adhere to global patent rules, and 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 its trials of a single-dose Covid-19 vaccine – due to an unexplained illness in one trial participant. The vaccine, if proven safe, 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, Eli Lilly suspended a clinical trial for its combination antibody treatment  due to another adverse event – a cocktail similar to the Regeneron brew that President Donald Trump received last week and which he pronounced to be a “virtual cure” – 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 the American people, 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 the rules in emergencies. They can issue their own licenses for generic or biosimilar drug manufacture or imports – under the “TRIPS flexibilities” introduced by the Doha Declaration.  And UN supported mechanisms, such as the Medicines Patent Pool (MPP) have also since emerged. They have wracked up an impressive track record in the negotiation of “voluntary” generic licenses with big pharma 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, while rich countries could afford to buy them, even at premium prices.

But 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. 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, in a recent op-ed. 

Along with the outpouring from civil society, the South African/Indian initiative has recently gained institutional support from the UN-affiliated Unitaid, a group of European Union MPs, and the public-private partnership, Geneva-based Drugs for Neglected Diseases initiative (DNDi): “We strongly support the proposal of South Africa and India,” said DNDi Executive Director Bernard Pecoul on Monday.  “We urge other countries to support this proposal without delay and to make use of TRIPS flexibilities where intellectual property barriers already exist, to ensure that all people – including the poorest, the most vulnerable and those at highest risk – are guaranteed timely and equitable access to the fruits of scientific progress in this pandemic.” 

While not an outright endorsement, a WHO spokesperson also said, “We are aware [of the WTO moves] and WHO of course welcomes any countries’ efforts to expand access in an equitable way, and any effective and practicable initiative that may lead to equitable access.”

Radical TRIPS Council Decision Unlikely

However,  it remains highly unlikely that the TRIPS Council would back the kind of sweeping waiver on patent rules as well as copyrights  – for all drugs, vaccines and technologies –  that the South African and Indian sponsors are proposing. Industrialized countries, including European countries which may even be suffering from shortages, would not go along with such a move, observers say. 

And it is also unlikely that the WTO’s new director-general, whose appointment is pending, would openly 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 currently is board chair for Gavi, The Vaccine Alliance, she will not want to burn her bridges too quickly with industry, pundits predict.

“The WTO is highly likely to acquire Okonjo-Iweala — who wants to make the public-private approach work,” said 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 heart, to lungs to brain – that means almost anything.  

A fresh report on the TRIPS agreement and COVID-19 issued Thursday by the WTO Secretariat, also argues that the current IP system can be an enabling factor in facilitating access to existing technologies, as well as supporting the creation of new ones: “The way in which the intellectual property (IP) system is designed — and how effectively it is put to work — can be a significant factor in facilitating access to existing technologies and in supporting the creation, manufacturing and dissemination of new technologies,” states the report’s summary points. 

It states that the TRIPS Agreement “allows compulsory licensing and government use of a patent without the authorization of its owner under a number of conditions aimed at protecting the legitimate interests of the patent holder. All WTO members may grant such licences and government use orders for health technologies, such as medicines, vaccines and diagnostics, as well as any other product or technology needed to address COVID-19. 

Recent initiatives also “have addressed the voluntary sharing and pooling of IP rights (IPRs), thus responding to the spirit of collaboration that is required for any global effort to tackle the COVID-19 pandemic,” the report notes.

Voluntary Patent Pool: A Third Way? 

Indeed, short of a sweeping move by WTO members, almost certain to be dismissed in its current formulation by countries with big pharma interests, the third way, advocates say, is country backing for voluntary measures, such as the WHO co-sponsored Covid-19 Technology Access Pool (C-TAP).  Effectively an expanded version of the successful Medicines Patent Pool model. CTAP is designed to offer a voluntary approach to the pooling or sharing of COVID-19 technologies and related IP.  

But in contrast to the Gavi and WHO co-sponsored vaccine procurement pool, COVAX, which has recruited 180 countries into pre-purchase agreements for expected COVID-19 vaccines, only 41 countries have signed up to the C-TAP pool  – reflecting the lackluster support voluntary approaches to patent sharing have received.  Industry has also repeatedly said that it doesn’t see itself as a player in C-TAP – and without industry the initiative would have no meaning.   

Even Moderna, which recently pledged to “not enforce our patents”  related to its new COVID-19 vaccine candidate, if it is approved, for the duration of the pandemic, has been cool about the C-TAP pool:  

“Our statement speaks to our intentions with respect to intellectual property during the pandemic.  We remain open to dialogue on other approaches to solving important access needs. Moderna understands the important role that multilateral organizations will play in helping to expand access and protect populations around the world,” said a Moderna spokesperson, in response to a Health Policy Watch query about whether the company would offer their product for sale through the WHO co-sponsored COVAX pool.

But with regards to C-Tap, he was much more cool, saying: “We believe it is premature to make commitments to patent pools for emerging technologies such as mRNA.”

WHO, however, is still trying to sound upbeat about the intiative, saying that once more concrete plans are in place, more industryand country support will also follow. 

“As with many new initiatives, the effort requires more dialogue and information exchange,” said a WHO spokesperson.

“We have been finalizing an operational plan for it that maps out much more clearly how different stakeholders (governments, industry, researchers and research funders, civil society, etc.) can contribute, and highlights the benefitst that can be obtained from such an initiative. i.e. faster and more reliable science,” the spokesperson added.  “With that plan, we are reaching out to potential contributors and are alerady in discussions with some potential new countries.”

The Medicines Access Advocates  

Ellen 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 snowballs into a worldwide firestorm. Says t’Hoen in a recent op-ed:

“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 €16 billion. 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,” counters 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 also 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 points out. 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 drama plays out and concludes remains unknown. But one thing is certain. The decisions made behind closed doors in the stone 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 the hospital wards and clinics around the world, where dramas of life and death are being played out for millions of people every day. 

• Updated Thursday 15 October. Originally published in Collaboration with Geneva Solutions, the new Geneva-wide platform for constructive journalism covering International Geneva.  

Image Credits: Keystone/ Hans Pennick, U.S. Army National Guard/Edwin L. Wriston, WTO, European Medicines Agency, Government of Zambia , WTO, WTO, Flickr: SteFou!.