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COVID-19 vaccines: no sharing of know-how

We don’t get to discuss know-how much in our articles. Yet it is, of course, something that falls squarely within the domain of intellectual property law because know-how is often protected by patents.

The issue at hand

On 29 April 2022, the BBC published an article headed “Investors lose vote to share Covid vaccine know-how.” The sub-heading fills in the gaps: “Three of the world’s biggest Covid vaccine makers have seen off attempts to make them share the know-how to make their jabs.”

Moderna, Pfizer and Johnson & Johnson are three of the pharmaceutical giants that make COVID-19 vaccines. Investors in these companies proposed a vaccine know-how share with companies in developing countries in order to ensure that people in the developing world also get vaccinated. In each case, the proposal was rejected. The argument advanced for a know-how share was simple: it will speed up the vaccine rollout. The argument against a know-how share was seemingly something along these lines – we are making vaccines faster than they can be used, so there’s no need for us to share our IP.

Some detail

The head of the WHO, Dr Tedros Ghebreyesus, addressed the Moderna AGM earlier this year. He made the point that more than 11.4-billion doses of the COVID-19 vaccine had been distributed worldwide, yet one-third of the world’s population had not received a single dose. This came on the back of a public statement by Médecins Sans Frontières (“MSF”), in which it called on Moderna to make its COVID-19 vaccine technology available to manufacturers in the developing world. MSF reminded Moderna that it had received some USD10-billion in public funding in order to develop the vaccine.

Yet, only 24% of Moderna’s shareholders backed the proposal that there should be an IP and technical know-how transfer to manufacturers in low and middle-income countries. One small victory was a concession by Moderna to link executive bonuses and the meeting of demand for vaccines in poorer countries.

The shareholders of Pfizer also rejected the idea of a know-how share by a remarkably similar margin, with only 23.7% in favour. Johnson & Johnson did not provide figures.

Reasons advanced by the pharma companies for refusing a know-how share

Moderna’s reason is along the lines of, we’re doing what we can in the context of the constraints facing vaccine delivery in developing countries.

In 2021, the company delivered 807-million doses of vaccine, making a profit of USD12.2-billion. Of these 807-million doses, Moderna claims that more than one quarter went to low or middle-income countries. The company further claims that that share could have been higher if it hadn’t been for issues such as a lack of refrigeration capacity, limited availability of health workers and vaccine hesitancy. The company says that it is looking at increasing its manufacturing capacity in Kenya.

Pfizer defends its refusal to transfer IP on the basis that vaccine production is “extraordinarily complex,” involving as it does “280 ingredients from 86 suppliers in 19 countries”.  Given this complexity, the concern is that a transfer of IP without proper technical implementation may well result in risks to patients. The company claims that it is expanding production to four-billion doses this year, with a quarter going to “less well-off” countries, whereas those with the “lowest incomes” will get vaccines at cost price.

Johnson & Johnson, which has apparently also received millions of dollars from US taxpayers, has indicated that it has provided 900-million doses at not-for-profit prices, and says that it is working on a licensing deal with an African country.

Oxfam’s response

Oxfam USA has shares in all three companies, and in the case of each company, it was Oxfam that submitted the proposal for a know-how share. Oxfam rejects the arguments advanced by the companies for refusing the proposal, claiming that vaccine hesitancy has been exaggerated. It says that “what the donation-based status quo has achieved is 74% vaccination rates in rich countries and 12% vaccination rate in poor countries.” It goes on to say that “lower income countries are saying give us the tools that we need to manufacture our own doses for our own citizens, and that locally based manufacturing will solve many problems.”

So, what does the future hold?

There has, of course, been a great deal of talk about an IP waiver, ever since the issue was raised in discussions involving the EU, USA, India and South Africa. But there has been little real progress. On 6 May 2022, Politico reported that the issue of a waiver had been discussed at the World Trade Organisation, and that following this meeting, the USA had announced that it was still engaged in domestic discussions, whereas China had described the latest text as one that was no more than a basis for further discussions.

As has been pointed out before, there may be more pertinent issues that are stalling access to COVID-19 vaccines in developing countries, such as the cost and availability of raw materials, the capacity and number of vaccine manufacturing facilities capable of producing the quantities of quality vaccine required for the global population, and the logistical complexities of providing vaccines to remote or rural locations, particularly where the vaccine requires a cold chain to remain viable.

Until all of these issues can be addressed, it seems that there will be slow progress for vaccine manufacturing on the African continent, regardless of the willingness of big pharma to share their know-how.

Dr Joanne van Harmelen

IP | Patent Attorney

jvanharmelen@ENSafrica.com