Graham Dutfield, spécialisé en droit des affaires : « Forcer le partage d’un brevet, c’est du déjà vu » (en Anglais)

Billions of people are waiting for jabs of the Covid-19 vaccines. But these vaccines are the property of a handful of companies that cannot produce enough. In the World Trade Organization, over 100 countries are in favour of a proposal to lift patents that would help combat the pandemic. Investigate Europe spoke with Graham Dutfield, a professor of international governance at the University of Leeds in the UK, specialising in intellectual property and trade law. He speaks about how governments took charge over penicillin patents during World War II, and how, today, some governments seem to wrongly equate the business interests of pharmaceutical companies with their own.

What do you think of the proposal to waive patents and know-how for covid-19 products while the pandemic lasts?

Personally, I support it. We have a shared interest in scaling up production of vaccines. No one is safe until everyone is. Admittedly, advocates like me don’t always pay attention to challenges in production. But we can globalise production if we want to, and we have to think long-term. Even with a time lag between deciding to produce and the final manufacture, any increase of supply would be good.

We have been here before, you say?

Yes. Penicillin was discovered in England in 1940, at the beginning of World War II, but the scientists at Oxford couldn’t find a way to mass-produce it. They went to America, and the US government shared the patents and know-how between companies, universities and other research institutions, and made sure they were available to all. This massively and rapidly increased the production capacity in the US, with Pfizer [being] the biggest single producer. It was a deal imposed by the US government with the UK also involved, so the pharma industry had no choice: there was a war, and the governments did what they had to do. As a result, penicillin became cheap to buy, and widely available.

This approach was hugely successful, also for the industry. Penicillin was the first antibiotic. In the longer term, the US pharmaceutical industry profited from that pooling of know-how and expertise to develop other antibiotics. This helped the American pharma industry become the global leader in the field that it still is.

Why is such government action not happening in today’s emergency?

Perhaps the industry generally sees its mission as different from those days, although it could be ruthless also back then. The economist Milton Friedman famously put forward the view that firms have one mission only: to maximise shareholder value. Industry has become addicted to relentlessly pursuing this objective, which is very much dependent on aggressive intellectual property strategy.

In the past, governments would intervene in emergency situations without necessarily having much regard for intellectual property. Now they are much more reluctant, having largely accepted the ideology which says that for innovation to happen, there must be intellectual property — and if a government intrudes, that is wrong and it is being anti-innovation.

I think “innovation” is an overused and abused word. For me, innovation is when there is a solution to a problem that reaches the public. However, industry today uses innovation in a limited way as if it is something that only they do, and that of course serves their interests.
Governments acted in the case of penicillin, and they can do it again. With penicillin, it was about winning a war. This is also a global emergency, with three million dead and counting. But we human beings find it so hard to treat the other as one of us. Until we act on the belief that all lives matter equally, wherever in the world people live, this is going to happen again and again.

Some opponents of the waiver say it is a distraction.

Some of them point to the importance of know-how, as if patents don’t really matter — at least until you try to take them away! When you think about it, though, dealing with patents is the easy part. Patents are granted by states on behalf of the public, so just as they have the right to give out property, states also have the right to restrict patents in some ways. But know-how is of course needed to produce vaccines, especially when we want them to be produced as soon as possible. Know-how is everything from materials to hands-on knowledge that can only be passed on from one person to another.

It’s often said that you cannot really force industry to share know-how. Voluntary sharing would be ideal and maybe incentives could be provided. But the penicillin example demonstrates that forced sharing has been done before and we can do it again if encouragement doesn’t work.

The waiver proposal is discussed within the TRIPS framework in the World Trade Organization. Some opponents say that TRIPS already has mechanisms that allow countries to produce vaccines they need, through so-called compulsory licenses. Why, then, is this tool not used by those who need it? 

One challenge is politics. Governments who issue compulsory licenses are heavily criticized by the US government. So some are fearful of doing this. Ironically, the US and Canada are the countries who have most used compulsory licensing, albeit mostly in the past. But now it is almost seen as a crime.

Another challenge is that many poor countries don’t have domestic firms or state agencies with the capacity to make vaccines under license. Moreover, any capable alternative local commercial producers without access to the know-how must find the money to invest in generating know-how internally, secure approval, and be able to make a profit at the end. And what if they fail to reverse-engineer the vaccine at all? This is likely because in many countries there are no entities that could do so.

This is about technology transfer, something that has been discussed at the United Nations as early as 1961 and which has gotten nowhere in those 60 years. The various conventions in place that contain technology transfer provisions don’t really force anyone to do anything. Everybody agrees technology transfer is important. But governments will not make a company share know-how if the latter doesn’t want to.

Traditional vaccine production, using cell cultures, is incredibly complex and demanding. The new mRNA vaccines, however, are synthetic and easier to produce. Will know-how be less of an issue with these vaccines?

Probably. With some sharing of expertise, countries like India and Brazil could do it. Indeed, both are producing the AstraZeneca, one which is of course not an mRNA vaccine. We don’t need vaccine production in every country, but we need regional hubs.

There has been more and more pooling of expertise during the Covid-19 pandemic, just note the scientific articles with numerous authors from around the world, and many journals have made these open access. This means the networks are already largely in place, and institutions are used to working with others from across the world. We do of course need more companies to add their expertise to the pool. These open innovation networks must be a good thing for the next pandemic. But we are in this one now.

Open-source is the tune in computing. Could it become the rule in the pharma industry?

Computing is based largely on copyright law, whereas biotechnology is very patent-centric. There have been attempts to create open-source also for biotechnology. But it has yet to be proven if open source can work in a patent-based industry. Patents have been described by Australian academic Michael Spence as “short, fat rights”— broad in exclusionary power, but for a limited time. By the same measure, copyrights can be seen as “long, thin rights”. That might be part of the reason: fat rights are just too valuable to want to give up or share.

Now more than ever before, companies seek to get as many patents for a product as possible. Each biotechnological product is protected by a large number of patents. The industry is very addicted to this way of doing business. It is hard to wean itself from this established business strategy, and it is certainly not being discouraged by governments in the global North. But it has some very harmful consequences.

Why would anything change — and how?

We have the pharma industry that our regulatory system deserves. This system does not align what we want the industry to do with what it actually does. This industry has made amazing products, such as cancer medicines and cures for previously incurable diseases. But it focusses on making profit, and is very good at managing (some might say ‘gaming’) regulation to suit itself. So we need to look at the whole system. Industry responds to regulation. Regulation forces it to prove that medicines are safe, for instance. We have the power to stop companies from selling dangerous drugs. So we can also do much more with respect to Covid.

Governments must act in the public interest. But we need people of the industry to be part of the conversation. It can be done, but the difficulty is ideological, not just power. A past head of General Motors admitted he had long thought that “what was good for our country was good for General Motors, and vice versa”.  Yet for a long time that assumed symbiotic relationship between leading firms and government has impliedly been accepted by policymakers as self-evident.

It is not that what is good for GM is bad for America, but solutions can only be found when we accept that the interests of leading companies and the public do not necessarily align, but that they should.

With the strong insistence by Western governments and the industry that patents are absolutely vital, we might think this system is very old. You are saying it is not?

Patents on drugs is a relatively new thing in Europe. Until quite recently it was considered as quite unethical to patent medicines. Medication and food were seen as life and death products. The production methods had patents, but the products themselves did not. In Switzerland, this only changed in 1978. Today, Switzerland is an aggressive defender of the interests of international pharma.

The Oxford researchers behind the AstraZeneca vaccine originally wanted to  not patent their vaccine, so that it could be accessible to all — until they partnered up with Astra Zeneca and did it anyway?

Yes, they did apparently make certain undertakings to enhance access. But it does seem they made AstraZeneca promise to make it available on non-profit terms. Sarah Gilbert, who led the team designing the Oxford/Astra Zeneca vaccine, has written a book that comes out in July that may tell the inside story. The UK government seems to have gotten involved and applied certain pressures. In a fit of post-Brexit nationalism, the government needed the vaccine to be a big national success story by associating it with a British (albeit half-Swedish) company.

AstraZeneca has been more altruistic than others, for instance by issuing licenses for India’s Serum Institute and Brazil’s Fiocruz to produce the vaccine. But AstraZeneca is not a charity. I assume that they will benefit financially, although not at the moment.

What will happen with the waiver?

I don’t think it will be adopted in full. But there may be a compromise. Moderna, for instance, has said it won’t sue anyone for patent infringement. The companies know that know-how is currently more valuable than the patents because unlike inventions, they don’t need to reveal it to own it. Ideally, it should become a global public good through non-exclusive and open licensing — preferably both for know-how and patented information. The question is how we can make this happen.

But there is clearly a lot of domestic pressure on the US and European governments plus the European Commission, and that may be more powerful than what the governments of South Africa or Thailand are demanding. This pressure, from activists and organizations demanding that we can do better than this, may have provoked a degree of guilt that may sway governments.

The slogan “no one is safe until everyone is safe” is a very powerful one, nobody can say it is wrong. And in democracies, governments do not always act, but they do listen.

There are media reports that the new US government is considering the merits of the waiver. Can you see any reason why the Biden administration would go along with it?

Yes. Four years of Trump has brought so much shame on the country. Any way the US could assume any sort of global leadership again without the use of military might, would make sense. Going for the waiver would give the US back some sort of moral power. We will see.

Dutfield is the author of the recently-released book, That High Design of Purest Gold: A Critical History of the Pharmaceutical Industry, 1880-2020.