Why a vaccine patent waiver is a contentious idea

Since Joe Biden unexpectedly set the cat among the pigeons by backing a temporary waiver of COVID-19 vaccine patents, citing the old adage "extraordinary times call for extraordinary measures", there has been much discussion of the pros and cons of such an extraordinary move. India, South Africa and up to a hundred other medium- to low-income countries have been calling for a suspension of patents rules since last October, and the World Health Organization strongly supports the idea. But many higher income countries (including Canada) have been prevaricating and avoiding a definitive decision.

It sounds, at first blush, like a no-brainer. This is a global health crisis like no other. We are "all in it together" and "nobody is protected until we are all protected", and all that). So, in the interests of global equity and the common good, what could possibly be wrong with allowing poorer countries to produce their own vaccines if they can't afford the products being offered by Big Pharma, or can't get hold of them because of the prior claims of rich countries?

Well, a few things, apparently.

For one thing, coronavirus vaccines (particularly mRNA vaccines like Pfizer and Moderna's, but also the adenovirus products of AstraZeneca and Johnson & Johnson) are complex technical products. They are biological agents, rather than just chemical compounds that can be easily reverse-engineered. To replicate these kinds of vaccines requires access to the developer's "soft" intellectual property (the proprietary recipe, cell lines, manufacturing processes, etc). Developing, testing and quality-controlling such a product would take many months, if not years, for a country without (or even with) a high-level pharmaceutical and research base, and may not even be practical at all. For this reason, it is unlikely to be of much help in the short term.

In addition, potential manufacturers would need certain raw materials and other materials, like glass vials, bioreactor bags, and filtration equipment, which are already in short supply due to the overwhelming global demand, not to mention disruptive export restrictions.

Vaccine producers, and some countries that are against waiving patents, like Germany, argue that the price of the vaccines is not the main sticking point constraining vaccination in developing countries. It is true that the developers, while still making profits in some cases at least (AstraZeneca is being distributed on a not-for-profit basis), are not gouging as much as Big Pharma is often accused of, and have constrained their prices, especially given the billions of dollars in development fees they have swallowed, even after handsome government contributions.

Another issue is the potentially dangerous precedent that such a move creates. If patents can be waived at will, then much of the financial basis of the pharmaceutical industry starts to crumble. Will firms and individuals invest in vaccine projects in the future if there is no guarantee of profits? The reason patents were established in the first place was to provide incentives of short term monopolistic/oligopolistic profits as a recompense for research, innovation and technical progress. As Germany contends,"the protection of intellectual property is a source of innovation and must remain so". Now, I am not a big fan of Big Pharma, but it has to be admitted that the current system did yield several excellent vaccines in record time.

So, it's not as simple as it might appear at first sight. How do these arguments stack up against the bare fact that, as of April 9th, the 67 poorest countries in the world had received just 0.2% of the world's vaccines? Hard to say. Even if the moral argument supports a patent waiver, the fact remains that such a move would have little or no practical effect in the short term, and that's the term we need to focus on right now.

The debate rages on. Some countries like America, France and New Zealand, that were originally against patent waivers, have come around to the idea. The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement requires a consensus, though, and many countries remain on the fence, and some - notably Germany - strongly against it.

Some people think that voluntary licensing would be a better solution than an outright waiver of patent rights. This would entail the developers entering into binding contractual agreements with generic producers, which would receive the necessary permission, know-how and assistance from the patent-holder to produce a vaccine for sale in a certain market. The patent-holder can ensure quality, and would receive royalties  in return, usually off less than 10% (as compared to the 25-30% profit margin companies like Pfizer are currently earning). AstraZeneca and Novavax have already entered into such agreements with India, Japan and South Korea. New agreements, it is argued, could be fostered, or even forced on the current patent-holders.