On 11 March 2020, the World Health Organization (WHO) declared the escalating coronavirus crisis to be a pandemic. Fast forward 12 months, and eight Covid-19 vaccines are approved for use in various countries across the world. These include mRNA vaccines made by Moderna, as well as partners Pfizer and BioNTech, and adenovirus candidates produced by Johnson & Johnson (J&J), AstraZeneca alongside the University of Oxford and Russia’s Gamelya Institute.
Although it is a tremendous achievement to have any, let alone so many vaccines approved within a year of the pandemic’s outbreak, new challenges have emerged, most notably surrounding distribution and access to these vaccines.
As the developed world has made huge strides with its vaccination programmes, much of the developing world has been left behind struggling to get access to Covid-19 vaccines. This is of little surprise to many given that even while the vaccines were in development, various developed countries were signing bilateral deals with leading manufacturers to secure millions of doses in advance.
In October, South Africa and India decided to try and tackle this inequitable situation at the World Trade Organization (WTO). Their representatives asked the WTO to allow member countries to waive intellectual property (IP) rights, including patents, related to Covid-19 vaccines and other technologies for the duration of the pandemic. They submitted their request to the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and asked for the waiver to remain in place until most of the world has been vaccinated against Covid-19.
Opposition by pharma companies and developed countries
Although over the past few months, the proposal has garnered significant support from the developing world – as can be visualised in this map developed by Médecins Sans Frontières (MSF) – the US, the UK and the European Union (EU), among other richer countries, have been vocal opponents of the IP waiver proposal.
Unsurprisingly, pharmaceutical industry trade associations have also vocalised their opposition to the idea. In December, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) noted in a release that “diluting national and international IP frameworks during this pandemic is counterproductive… IP enables research and development and ensures that the next generation of inventors and investors will remain engaged.”
IFPMA director-general Thomas Cueni said: “At a time when the focus should be on science and innovation, undoing the very system that supports it is dangerous and counterintuitive.”
The US Chamber of Commerce agreed; its Global Innovation Policy Center senior vice-president Patrick Kilbride wrote in a statement: “Proposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world’s citizens.
“Diminishing intellectual property rights would make it more difficult to quickly develop and distribute vaccines or treatments in the future pandemics the world will face.”
Axinn partner and patent attorney David Silverstein unpacks this further, explaining: “Large amounts of capital [is] required to develop these kinds of products; often the capital has to be secured from outside investors. The concern is if they can’t reliably forecast the return on that investment, might they have trouble securing similar investments in the future for other projects?”
Will a WTO IP waiver resolve Covid-19 vaccine access issues?
The arguments made by the representatives from South Africa and India at the WTO stated: “Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights…. do not create barriers to the timely access to affordable medical products including vaccines. There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients.”
MSF supports this argument. MSF international president Christos Christou said in a release: “The waiver proposal offers all governments opportunities to take action for better collaboration in development, production and supply of Covid-19 medical tools without being restricted by private industry’s interests and actions, and crucially would give governments all available tools to ensure global access.”
Although Silverstein notes that an IP waiver may help to improve access, he emphasised that is not “the silver bullet that it is generally regarded as”.
“It is not so much the blueprints for these vaccines that is the real barrier here; there are many more barriers” to access, says Silverstein.
This is because these are complicated products to manufacture and so the IP waiver wouldn’t just “flip a switch” to allow manufacturers across the world to start producing the vaccines, explains Silverstein.
He makes an analogy with Elon Musk’s Space X rockets. The patents Elon Musk has regarding his spaceships “are not what is keeping me as an individual or my firm from making rockets. We need specialised equipment; we need trained personnel and we need the infrastructure to support it.”
What are the alternatives?
Instead, Silverstein argues there is a need for companies to partner up to maximise their manufacturing capacity. This IP waiver threat is “further motivation to do everything in their power to partner with competitors to invest in increased infrastructure and manufacturing” capacity. This approach is more appealing to companies than unilateral stripping of their IP.
They should be supported in doing this by governments, according to Silverstein. He cites the example of the US Government’s move to get Merck and J&J to the negotiating table regarding vaccine manufacturing.
At a Chatham House conference, IFPMA and another industry association, the Biotechnology Innovation Organization (BIO), among other stakeholders, agreed there was a need to increase manufacturing through technology transfer and partnerships between various companies.
Cueni noted: “This year for Covid-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10bn, doubling world vaccine capacity of what is a very complex process in a matter of months, thanks to unprecedented industry commitment and collaboration.
“During the summit discussions there was a clear desire to leave no stone untouched to address inefficiencies and increase manufacturing capacities. I’m confident we will see new players coming in with their manufacturing know-how and capacities.”
BIO president and CEO Dr Michelle McMurry-Heath added: “The technical and logistical complexities of the task before us will require vaccine manufacturers, suppliers, governments, multilateral organisations and non-governmental organisations to work together in new and creative ways to find solutions to our shared challenges. We must invest across all of the ecosystem to ensure that there is not only manufacturing capacity but also increasing amounts of the vital production supplies needed for that capacity.”
The need to increase capacity was emphasised by the incoming WTO director-general Ngozi Okonjo-Iweala at a March meeting to discuss the IP waiver proposal. In a speech, she talked about the ‘third way’ to broaden access through encouraging licensing agreements between companies, and particularly generics manufacturers.
She explained that this would immediately help the poor countries who are yet to vaccinate a single individual. However, as Health Policy Watch reported, Iweala noted that a more long-term solution regarding IP may ultimately be required to tackle inequitable access to vaccines.
Stopping export barriers
Finally, Silverstein says it is crucial that countries do not impose export barriers on Covid-19 vaccines.
There has been significant controversy surrounding export barriers. For example, in light of shortages of AstraZeneca/Oxford Covid-19 vaccine supplies in the EU, its executive body the European Commission introduced a temporary export mechanism for vaccines. Italy became the first country to implement this mechanism in early March when it blocked the export of more than 250,000 AstraZeneca/Oxford vaccine doses to Australia.
The EU has also accused the UK and the US of banning the export of Covid-19 vaccines or vaccine components. The UK has strongly denied this accusation.
Although Silverstein notes he understands that governments have obligations to their own population, they need “to keep in mind that this is a global pandemic”.
“If we are short-sighted and only eradicate the spread of the virus domestically, [because of] international travel and commerce, it will make its way back to our shores.”
Another related issue with not vaccinating the entire world is that it encourages the evolution of the virus and the emergence of variants. “If we hoard all the vaccines in the US or the UK [for example], there is a chance the virus will mutate by the time it makes its way back to our shores,” concludes Silverstein.
All inequitable access to vaccines has achieved, therefore, is to prolong the pandemic and its disastrous impact on individuals’ lives and countries’ economies.