Biden would lift patents on vaccines: what’s next?

A group of countries led by South Africa and India has proposed to the World Trade Organization that intellectual-property protections on coronavirus vaccines be loosened during the pandemic. 

Even though the USA has been one of the strongest supporters of patents on Covid19 vaccines, the Biden administration released last Wednesday, May 5, its intent to support the temporary waiver on on intellectual property protections. 

As reported by The New York Times, Katherine Tai, the United States trade representative, said in a statement that “This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures”. 

Moreover, “The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines”.

This support from the White House is not a guarantee that a waiver will be adopted. Only one hundred of the WTO's 164 states seems to be in favor with the waiver proposal. 

The decision, in fact, is up to the 164-member World Trade Organization, which administers complex trade rules among nations.The European Union is also hindering the proposal, and changes to international intellectual property rules require unanimous agreement. 

While some pharmaceutical companies are eager not to be seen as profiting from the pandemic, others have strongly opposed such proposals. The reason? In their opinion, it won’t help curb the outbreak any time soon and will hurt innovation.  That's because making vaccines is far more complex than following a recipe, requiring factories with specialized equipment, highly trained workers and stringent quality control. In addition, many raw materials to make the vaccines are in very short supply, which won't change soon.

A waiver could generate short-term health troubles for millions of individuals affected by the COVID-19 pandemic. It could do this by reducing quality-control efforts of new COVID-19 vaccine producers not subject to the oversight of patent holders. 

Absent quality assurance, the incidence of ineffective or harmful vaccine administrations could rise significantly, directly harming individuals and potentially disincentivizing many individuals from obtaining vaccine shots.

Beyond scientific and medical considerations, another reason why the big pharmaceutical industries are opposing this petition is, of course, the financial reward for the research, development, production and sales of the vaccines, money. 

Patents on medicines typically last 20 years from when they are filed. Since it often takes a quite long time to get a drug approved by health authorities, companies typically enjoy little less than 20 years of competition-free sales , due also to recovering time mechanism provided for in most of countries. 

Medicines are incredibly expensive to develop. Most experimental drugs fail -at some point- during the years of laboratory, animal and finally human testing. 

Medicines are incredibly expensive to develop. Most experimental drugs fail -at some point- during the years of laboratory, animal and finally human testing. Some drugmakers, such as the British-Swedish AstraZeneca and the US pharma Johnson & Johnson, have promised to provide their vaccines on a not-for-profit basis until the pandemic comes to an end. They are expecting a revenue of respectively $2-3 billion and up to $10 billion in 2021.

On the contrary Pfitzer, one of the biggest companies engaged in the research and development of the Covid19 vaccine that went for a profit basis, said its vaccine generated US$3.5 billion in revenue in the first three months of this year. 

According to Reuters, the company on Tuesday raised its forecast for 2021 COVID-19 vaccine sales by more than 70% - from $15 billion to $26 billion - and said demand from governments around the world fighting to halt the pandemic could contribute to its growth for years to come. 

The Guardian made a list of companies and their expected revenues, confirming those of Pfitzer/BioNTech between $15 and 30 billion; Moderna expected sales are about $18-20 billion, while other companies (such as Sinovac, Novavac, CureVac) didn’t disclose their expected revenues, even if the potential in the next 12 months is for several billion dollars.