The big barriers to global vaccination: patent rights, national self-interest and the wealth gap



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Ilan Noy, Te Herenga Waka — Victoria University of Wellington and Ami Neuberger, Technion – Israel Institute of Technology

We will not be able to put the COVID-19 pandemic behind us until the world’s population is mostly immune through vaccination or previous exposure to the disease.

A truly global vaccination campaign, however, would look very different from what we are seeing now. For example, as of January 20, many more people have been immunised in Israel (with a population less than 10 million) than in Africa and Latin America combined.

Notwithstanding recent questions about the effectiveness of the initial single dose of the vaccine, there is a clear disparity in vaccine rollouts internationally.

That is a problem. As long as there are still existing reservoirs of a propagating virus it will be able to spread again to populations that either cannot or would not vaccinate. It will also be able to mutate to variants that are either more transmissible or more deadly.

Counterintuitively, an increase in transmissibility, such as has been found with the new UK variant, is worse than the same percentage increase in mortality rate. This is because increased transmissibility increases the number of cases (and hence the number of deaths) exponentially, while an increase in mortality rates increases only deaths, and only linearly.

Evolutionary pressure on the virus will inevitably favour mutations that make the disease more transmissible, or the virus itself more vaccine-resistant. It is clear, therefore, that every nation’s interest is in universal vaccination. But this is not the trajectory we are on.

People waiting to be vaccinated in Israel
Fast roll out: a busy coronavirus vaccination station in Israel in mid-January.
GettyImages

Politics and profits

Fortunately, in the countries already vaccinating, the vaccine is (mostly) not allocated by wealth or power, but by prioritising those facing the highest risk. At a country level, however, national wealth is determining vaccine roll out.

Yet in the past we have managed to eradicate diseases worldwide, including small pox, a viral infection with much higher death rates than COVID-19.

There are two barriers that prevent us from rapidly pursuing a similar goal for the current pandemic:

  • big pharma is profit-driven and therefore keeps a tight lid on the intellectual property it is developing in the new vaccines

  • countries find it difficult to see beyond their national interest; not surprisingly, politicians are committed only to their own voters.

At this point, we don’t have a global system to confront either of these problems. Each vaccine’s patent is owned by its developer, and the World Health Organisation (WHO) is too weak to be the world’s Ministry of Health.




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The polio vaccine model

Overcoming big pharma’s profit motive has been achieved before, however.

In 1955, Jonas Salk announced the development of a polio vaccine in the midst of a huge epidemic. The news initially met with scepticism. Even employees of his own laboratory resigned, protesting that he was moving too fast with clinical experimentation.

When a huge placebo–controlled clinical trial involving 1.6 million children proved him right, however, he declared that in order to maximise the global distribution of this lifesaving vaccine his lab would not patent it. Asked who owned the patent, he famously replied:

Well, the people I would say. There is no patent. Could you patent the sun?

In an echo of the current moment, Israel (then a new state) was also experiencing a rapidly spreading polio epidemic. Efforts to purchase vaccines from the US were unsuccessful, as not all American children were yet vaccinated. So a scientist named Natan Goldblum was sent to Salk’s laboratory to learn how to make the new vaccine.

No lawyers were involved and no contracts signed. The young Dr Goldblum spent 1956 setting up manufacturing facilities for Salk’s vaccine in Israel and by early 1957 mass vaccination was underway.

Dr Jonas Salk and a nurse administering a polio vaccine to a girl
Could you patent the sun? Dr Jonas Salk and a nurse administer a polio vaccine in Pennsylvania in the 1950s.
GettyImages

Suspend patent rights

Israel, a small and relatively poor country in the 1950s, became the third country in the world (after the US and Denmark) to produce the vaccine locally and eventually eradicate polio. It took a handful of scientists, a modest budget and, most importantly, no patenting.

Like Salk, Goldblum was aware viruses have complete disregard for political borders. He was also involved in a very successful Palestinian polio vaccination campaign in Gaza.




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More recently, a highly successful international campaign in the early 2000s saw AIDS treatments distributed in poorer countries. Pharmaceutical companies that owned the patented drugs were forced to supply them at cost or for free, not at market prices set in the rich countries. This was achieved through public pressure and the willingness of governments to support the required policies.

A temporary withdrawal of the patenting rights to the successful COVID-19 vaccines, with or without compensation for the developers, seems a small price to pay for an exit strategy from this global and incredibly costly crisis.

Act local, think global

Overcoming national interest is perhaps more complicated. Clearly, countries have an interest in vaccinating their most vulnerable populations first. But at some point, well before everyone is vaccinated, it becomes more efficient for countries to start vaccinating their neighbours (the countries they are most exposed to through movements of people and trade).

Disappointingly, rich countries today behave as though they will reach 100% vaccination rates before they give away a single dose, with many having bought well in excess of what is needed for 100% coverage.




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The COVAX plan to distribute vaccines in poorer countries has so far been an under-funded effort that has not yet delivered a single dose of vaccine. Even if COVAX were to be fully funded, it mostly aims to donate an insufficient number of vaccine doses to the poorest countries, rather than really bring about a universal vaccination programme.

Nevertheless, overcoming the profit-maximising interest of big pharma and the national focus of governments is not a pipe dream. The world has done it before.The Conversation

Ilan Noy, Professor and Chair in the Economics of Disasters and Climate Change, Te Herenga Waka — Victoria University of Wellington and Ami Neuberger, Clinical Assistant Professor, Technion – Israel Institute of Technology

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use it



LINEAR CLINICAL RESEARCH/PR handout

Natalie Stoianoff, University of Technology Sydney

With research laboratories around the world racing to develop a coronavirus vaccine, a unique challenge has emerged: how to balance intellectual property rights with serving the public good.

Questions of patent protection and access to those patents has prompted an international group of scientists and lawyers to establish the Open COVID Pledge.

This movement calls on organisations to freely make available their existing patents and copyrights associated with vaccine research to create an open patent pool to solve a global problem.

The EU is leading the charge to create such a pool by drafting a resolution at the World Health Organisation. The US, UK and a few others have been opposed to this idea.




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For now, however, there are very few pharmaceutical and biotechnology corporations participating in the pledge, raising questions over whether the initiative will work.

Instead, universities, publicly funded research institutes and pharmaceutical and biotechnology corporations are working on vaccine research through international consortia or public-private partnerships.

If one group does develop a viable vaccine, this raises other questions that will soon need to be addressed:

  • who is funding the research, and who has the rights to any patents coming out of it?

  • can governments compel the owners of those patents to license other manufacturers to make the vaccines or medicines?

What are patent rights and why are they important?

Patent rights are a form of intellectual property rights. They provide creators of new inventions, like novel vaccines and medicines, with a limited-term monopoly over those inventions in the marketplace to help recover the costs of research and development.

In other words, patents are an incentive to invent or innovate.

Patents are granted by individual nations, but don’t apply across borders. To gain global protection, an inventor needs to apply for patents in every country – something that could be critical when it comes to vaccines. The Patent Cooperation Treaty helps to streamline the process, but it is still expensive and time-consuming.




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The limited-term monopoly on the market is balanced by the requirement that patent holders share information about their inventions in a register to make it available for anyone to use after the patent protection expires. The term of a standard patent is usually 20 years.

During the patent period, patent holders have exclusive rights to manufacture and sell their inventions. Or, they can choose to license the technology to others to manufacture and sell to the public.

Such licences include a specified time limit and geographical area to exploit the patent. In return, the patent holder receives royalties or licence fees, or both.

So, the race to develop a vaccine for COVID-19 is not just about saving lives during a pandemic, it’s also about owning the patent rights. This gives the owner control over the manufacturing and distribution of the vaccine in the countries where the patent rights are granted.

Who is currently researching a coronavirus vaccine?

The race currently includes universities, publicly funded research institutes and pharmaceutical and biotechnology companies, some working in partnership with government institutions.

The company that just announced early positive results on a vaccine is Moderna, a biotech company based in the US, which is working with the National Institutes of Health. A number of other developers are also doing human trials globally, including many in China.

When private companies and government institutions partner on developing a vaccine, it may result in joint ownership of a patent. This gives each owner the right to manufacture the vaccine, but only together they can license the manufacturing to third parties.

What about the rights of nations?

Even if patent ownership is in the hands of private companies, the state may still have the right to use them for its own purposes or in the case of emergencies. Many countries have specific laws to facilitate these arrangements.

In the US, the Bayh-Dole Act 1980 ensures the government retains sufficient rights to use patents resulting from federally supported research.

Under these rights, the government can be granted a free license to use the patent itself or the right to arrange for a third party to use the patent on its behalf.




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In cases where the patent holder of a publicly funded invention refuses to licence it to third parties, the Bayh-Dole Act gives the government “march-in” rights.

Under specific guidelines, this means a forced licence can be granted to a third party on reasonable terms. This includes in cases when the “action is necessary to alleviate health or safety needs” or to ensure the patented invention is actually manufactured within a reasonable time.

In the case of COVID-19 research, this means the US government could order a corporation or university that invents a vaccine with federal funding to license the patent to others to make it.

In Australia, the government can exploit the patented inventions of others under right of “crown use”. In these cases, the patent holder is entitled to financial compensation from the government.

Like most other members of the World Trade Organisation, Australia also has compulsory licensing rules in its patent law that force inventors to license their patents to third parties on reasonable terms in specific circumstances.

In reality, though, such compulsory licences are under-utilised in countries like Australia, New Zealand, the UK and Japan, and rarely granted, if at all.

Working together for the common good

This brings us to the Open COVID Pledge, which is designed to make the relevant intellectual property freely available under an open licence.

Such open-access licensing has been used in the publishing industry for years, for example with Creative Commons publications online, and in the technology industry through open-source licences.

If more of the public-private partnerships working on a coronavirus vaccine do sign up to the pledge, perhaps it will be one of the positives to come out of the pandemic. It could allow open-access licences for lifesaving technologies to become accepted practice.The Conversation

Natalie Stoianoff, Professor, Faculty of Law, University of Technology Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.