Government and big pharma face clash on Covid-19 vaccine patent waiver

The Government could be on a collision course with the State’s powerful pharmaceutical industry over support for US backing of a move to lift patent protection on Covid-19 vaccines.

The Biden administration has thrown its support behind the move that would allow other companies to make the jabs but reduce the profits of the pharmaceutical giants behind the vaccines.

US trade representative Katherine Tai said that it would support the waiver of intellectual property protections on vaccines "to help end the pandemic" and that the US would participate in negotiations on the move at the World Trade Organisation, which sets the rules for global trade.

“Extraordinary times call for extraordinary measures,” said Ms Tai.

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The slow pace of the rollout of the vaccines and shortages in the global supply have put pressure on governments to look to new measures as some countries face new surges in infections.

Intellectual property is the valuable creative asset behind the development of innovative medicines. Patents protect the creators of those assets by giving them the benefit of a short-term monopoly on the sale of the vaccines to cover the cost of the development and to encourage further investment.

Supporters of the patent waiver argue that it would allow the manufacturing of vaccines to be increased dramatically and provide more affordable supplies to less wealthy countries.

Political

Minister for Foreign Affairs Simon Coveney described the announcement by the US trade representative and the Biden administration as "very significant".

“It won’t solve all Covid vaccine manufacturing and supply issues, but it is a step and the right decision in response to a global demand emergency,” he tweeted.

Minister for Health Stephen Donnelly retweeted Ms Tai's tweet about the US move, describing it as a "hugely positive development."

Tánaiste and Minister for Enterprise, Trade and Employment Leo Varadkar said the decision of the US administration to support a waiver “is very significant and should cause the EU and other developed countries to reassess their position”.

Urging caution however, he said in the Dáil that “our strong view is that Covax is the best way to do this, the international partnership”.

Mr Varadkar said “very few countries in the global south have the infrastructural know-how or the materials to make those vaccines and there’s no point in giving somebody a recipe if they don’t have the kitchen or the cooking skills or the ingredients.”

The Trips (trade-related intellectual property rights) waiver “is definitely an option”, he told Social Democrats TD Jennifer Whitmore and People Before Profit TD Paul Murphy.

But “what we want to do is take actions that do good, not just actions that look good or make us feel good. And we think the best way to do that is to involve the pharmaceutical companies, the scientists and universities in the solution, a solution that will actually allow more vaccines to be made particularly in the global south.”

World Health Organisation director-general Tedros Adhanom Ghebreyesus described the Biden administration’s backing as “a monumental moment in the fight against Covid-19.”

He said it was a “powerful example” of the US leadership to address global health challenges.

European Commission President Ursula von der Leyen has said that the bloc is "ready to discuss any proposals that address the crisis in an effective and pragmatic manner."

French president Emmanuel Macron said that he was "absolutely in favour" of the plan.

India and South Africa are leading a group of countries that have, for several months, been pushing for patents on vaccines to be set aside in a move they argue would increase vaccine production around the world. More than 100 countries support the proposal.

Pharma opposition

Critics of the waiver argue that sharing details around the creative process behind the vaccines would result in large pharmaceutical companies giving up valuable trade secrets and serve as a disincentive for companies to develop medicines and vaccines in response to other health crises.

The share prices of vaccine manufacturers, including Pfizer and Moderna, fell in response to the US government's support for the patent waiver.

The Irish Pharmaceutical Healthcare Association, a representative body for the pharmaceutical industry in Ireland, said that a waiver on the vaccines would not boost production capacity for the jabs but would instead set back "the medicines innovation agenda."

“It is a short-sighted and ineffectual decision that puts at risk the hard-won progress in fighting Covid-19,” said Oliver O’Connor, the chief executive of the IPHA.

“We are urging the Government to oppose the waiver and to continue to back intellectual property as the formula for the invention of new vaccines, medicines and technologies.”

Mr O’Connor said that a waiver would risk “diverting raw materials and supplies away from well-established, effective supply chains to less efficient manufacturing sites where productivity and quality may be an issue” and “risks the entry of counterfeit vaccines” into global supplies.

The industry has argued that it is pushing for an increase in vaccine production instead through licensing partnerships between vaccine creators and manufacturers.

"Intellectual property is an important strategic area for the industry because it allows the industry to invest in research and commercialise products," said Matt Moran, chief executive of BiopharmaChem, part of the business representative and lobby group, Ibec.

“It underpins the research that led to the discovery of the vaccines that are being used and allowed companies to form partnerships on the basis that IP was going to be respected.”

Mr Moran said that “any move to weaken” intellectual property would be a concern to the industry as it could disrupt supply chains and lead to low-quality products being made.

The pharmaceutical industry is a key sector for the Government, employing about 25,000 people directly and about the same number who provide services to the industry.

In 2019, the industry accounted for €140 billion in annual exports, or 32 per cent of the Irish gross domestic product, the value of goods and services produced in the State.