- Intellectual property rights give manufacturers the right to sue someone who makes a generic version of its product (such as a COVID vaccine) without permission.
- If a proposal at the World Trade Organisation is accepted, such rights could be suspended for three years, making vaccines and other COVID treatments easier for poorer countries to access.
- The waiver and the specific wording it uses must ideally be accepted by all 164 nations, and so far the most powerful governments are resisting.
Sparks were expected to fly at the 12th ministerial meeting of the World Trade Organisation (WTO), which was due to start today, as the trade organisation’s top decision-making body would have debated who has the right to manufacture COVID-related health products. But things petered out when the WTO general council decided late on Friday to postpone the meeting because of the new Omicron variant that has been detected in several southern African, European and Middle Eastern countries, as well as the United States (US) and the United Kingdom (UK) and Australia. The World Health Organisation (WHO) has classified Omicron as a variant of concern. European countries have implemented travel bans against southern African countries, including South Africa, which will prevent them from travelling to Geneva, where the meeting would have been held.
Powerful governments, including the European Union (EU), the UK, Switzerland and Norway, are resisting a proposed WTO waiver for COVID-related intellectual property (IP) rights that, if implemented, will enable companies in less developed countries to temporarily manufacture COVID products developed by large pharmaceutical companies.
IP rights protect an inventor’s designs, trade secrets, such as methods and processes, and trademarks. Essentially, IP rights allow developers to make and sell products exclusively for a certain period. Only, this can block competition and equitable access. In the case of COVID vaccines, for instance, poorer countries have had significantly less access to these products – at least in part because they’re not able to manufacture the vaccines themselves.
The biennial ministerial meeting, which is attended by trade ministers and senior officials of WTO member countries, was due to negotiate text around the proposal, which was tabled by SA and India in October 2020. But more than 130 civil society groups, mainly from developing countries, have called on governments to instead immediately agree to the waiver. They say a ministerial meeting is not necessary in this instance, “as waivers have been agreed by meetings of the general council of the WTO”.
Some groups have also written to US President Joe Biden, requesting his “personal engagement” in delivering a temporary waiver “so that countries can remove IP barriers that are limiting the supplies of COVID-19 vaccines, treatments and diagnostic tests necessary to end the pandemic”.
In May, the US expressed its support for a temporary waiver, but activists are unhappy that the country supports only part of the proposal, not the waiving of IP rights for all COVID-related technologies.
There has, however, been a lot of shuffling about since the initial proposal was put on the table. After meeting upon meeting, a revised version of the proposal was submitted in May. It was adapted to deal, in part, with concerns that the phrasing was too broad, and to make the timeframe more specific (a waiver of at least three years). Then came a counter proposal by the EU. And eventually an announcement in June that WTO members, including the US, have agreed to start text-based negotiations.
By November there was still no clear decision about which proposal to negotiate. And now there’s been an indefinite postponement of the ministerial conference – albeit with an open-ended comment that this “does not mean negotiations should stop”.
So, is all the huffing and puffing just bluffing? How do text-based negotiations work and how close is the world to reaching a definitive, fair agreement about IP rights for COVID-19 technologies? We asked experts to break it down. Here are 10 things you should know.
1. What are text-based negotiations?
They’re a normal part of talks among WTO members to hash out the conditions of trade agreements. Representatives of member countries typically signal that they want to negotiate the wording in a draft agreement by adding square brackets to a piece of text.
2. Why are negotiations around COVID-19 technologies necessary?
The proposal currently on the table asks WTO member countries to suspend some of the IP rights, including patents, that apply to “health products and technologies” for the “prevention, treatment or containment” of COVID-19 for “at least three years”.
Doctors Without Borders’ global IP adviser Leena Menghaney explains that IP rights can give a patent holder – a pharmaceutical company, for example – the power to sue someone who makes a generic version of its product without permission. This can block competition, which would lower prices. In a global pandemic, and especially in developing countries, enforcing IP rights on COVID-related products won’t work, she says, “because we cannot wait for years for alternative supply”.
Given the protection IP rights offer product developers, it’s not unexpected that a proposal to waive these rights – or even just some of them – would get push-back. In fact, the EU’s counter proposal makes the case for using existing provisions in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to govern the trade in COVID-19 technologies.
3. Why is the proposed waiver contentious?
The proposal is about more than vaccines, and this is a sticking point. When the US announced in May that it was willing to participate in text-based negotiations, it said it supported waiving IP protections specifically for COVID vaccines.
Menghaney gives the US trade representative credit for “backing off from being Big Pharma’s ally, and saying: ‘Let’s negotiate’”.
But, she says, a vaccines-only waiver, which excludes other COVID treatments, health products and technologies, is not acceptable. “The waiver is also about getting the newer drugs that are in the pipeline to people when they need [them] most,” she says. “As treatment activists, we believe that the right way of dealing with a pandemic is to save people who are dying and to prevent them from getting very sick and overwhelming healthcare systems.”
Fatima Hassan, founder of the Health Justice Initiative and an advocate for the waiver, agrees. “The issue that we’re trying to address is how IP affects the ability of the world to have immediate, and obviously more affordable and sustainable, supplies of multiple life-saving interventions, including vaccines,” she says.
4. What is discussed during text-based negotiations?
The talks could be based on one text or “several bits of text,” says South African trade official Mustaqeem de Gama.
Jayant Dasgupta, former Indian ambassador to the WTO (2010–2014), adds that during these negotiations “either alternative language has to be suggested and accepted by everybody or [part of the text] just drops because the country that suggested it initially could be persuaded [to drop it]”.
- READ MORE: Why South Africa stopped making vaccines
The initial waiver proposal asked the WTO to lift the regulations that protect copyright, industrial designs, patents and undisclosed information for any products used in the fight against COVID-19 for an undefined period. This scope was considered uncomfortably broad by some member countries, so after discussions the wording was adapted. The language in the revised version, which is currently up for discussion, therefore specifies what type of COVID-related health products and technologies should be exempted from IP rights (namely diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and the methods for their manufacture) and for how long (at least three years).
5. How long do these negotiations take?
Really long. In some cases, they can go on for years.
For one, members might not agree on the text that should form the basis of negotiations, as is the case at present.
De Gama explains: “A member will [typically] put in a text reflecting its expectations and its solution. And several members probably will come over time and add either a sliver or a big piece of text, or have a standalone text, or they could all add to the text that’s already there, for example, that the proponents have put on the table.”
Once the text flagged for negotiation is finalised during these drawn-out discussions – and depending on the timing – De Gama says it would go to the WTO’s general council or ministerial conference, which makes decisions on trade agreements.
To get a sense of how slow the process can be, consider negotiations around aspects of fisheries subsidies, which could lead to overfishing and the depletion of natural stocks. These negotiations were announced in 2001; two decades later, they’re still ongoing.
But, says De Gama, it’s important to distinguish between examples such as these and the COVID proposal, “which is driven by an externality [the pandemic] that requires a little bit more urgency”.
Dasgupta adds that target dates are usually set for completing text-based negotiations “to inject momentum in the negotiations and lead to some outcome”. The next ministerial conference is typically a good target, he says. Which is where the process was last week.
6. How does a text get approved?
The WTO favours decision-making by consensus, which means all 164 member governments have to agree to the text. This can be a hurdle for the TRIPS waiver proposal, because some high-income countries – most notably Germany – have been fiercely opposed to it. In fact, a German government representative said at a press conference in May that IP should be protected to ensure continued future innovation.
If consensus can’t be reached, the WTO can, in certain instances, take the matter to a vote. For the TRIPS waiver to be accepted, it would need the support of 75% of member countries.
De Gama, who has been involved in the waiver discussions, says its supporters are aiming for consensus, but if “consensus cannot be reached and the situation requires us to go to a vote, we will not shy away from using that”. Yet a Geneva-based trade official says it’s unlikely a vote will take place, because all member governments would have to agree to proceed to a vote in the first place.
Hassan worries that countries that oppose the TRIPS waiver are going to “drag it out”. “Because, you know, the entire model of the WTO is about consensus-building. You have to negotiate the text, but people are waiting for vaccines. So this is why we say it’s absurd to rely on a trade body to get you out of a pandemic, because now we sit in Geneva at the WTO and negotiate with diplomats who don’t understand public health.”
7. What if a text doesn’t get approved?
The talks continue. De Gama says it is not uncommon, in text-based negotiations, that agreement is not reached by the deadline. “There are 15 items that I can refer to – fisheries subsidies would be one of them – where there should have been an outcome already at previous ministerial [conferences]. So it failed at that point; members got back and they picked up the pieces and they continue to negotiate.”
8. What would it mean if the waiver is accepted?
If the waiver is approved, WTO member countries would be able to suspend COVID-related IP rights without being in violation of international rules, says Roshan Joseph, trade and IP analyst for Doctors Without Borders’ access campaign.
But it would be up to individual countries to decide whether they go this route. But if they do go ahead, it essentially means that:
- they would be able to ramp up the supply of COVID-19 test kits, treatments, vaccines, medical devices, personal protective equipment and other health products and technologies, because they don’t have to fear (possibly expensive, drawn-out) legal action for infringing IP rights.
- WTO member countries would not have to fear a trade dispute being lodged by another member country.
- a patent-holding company would not be able to block the manufacture of COVID-19 technologies in a country where the waiver is implemented.
- a company would not be obliged to share its know-how or other undisclosed information with competitors (but it would be possible for a third party, such as a regulator, to share information submitted to it).
9. Why are existing local laws not used to overcome IP hurdles during the pandemic?
South Africa law does make it possible for a court to issue a compulsory licence that allows someone other than the patent holder to use a patent. But it’s not easy.
The problem, says Yousuf Vawda, a senior research associate at the University of KwaZulu-Natal’s law school, is that the grounds for such an application in terms of the Patent Act are “very few” and the process is “onerous, time consuming and expensive” – which means small, generic manufacturers are unlikely to proceed.
Another complication is that many patents could apply to a single product. “There might be a patent on the active ingredient [of a drug, for example], on the method of manufacture, and so forth. There may be dozens of patents. You have to know what all those patents are, and you have to apply for a compulsory licence against all of those patents. And that’s a very difficult thing to do,” says Vawda.
10. What’s next?
If the waiver is approved, it would mean the relevant IP rights would not apply for at least three years in countries that adopt it. In theory, this could help them ramp up their production of COVID-19 technologies. But producing a market-ready product such as a vaccine without having the actual method is tricky and time consuming, as the partners of the WHO’s first mRNA vaccine tech transfer hub are finding out.
The waiver alone will not be the answer. But as things stand now, we don’t even know whether we’ll have an answer about it any time soon. Which leaves poorer countries – still – on the back foot in confronting the pandemic.