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28th April 2021 by Joe Zammit-Lucia

This article was also published in the Times of Malta

Every epidemic generates the same call from the same groups of people – suspend intellectual property rights on new medicines or vaccines so that they can be made freely available to everyone across the globe.

Such calls are understandable. As more people become ill and the death toll rises, the imperative to do more is strong. Overriding patents and opening innovation to all seems like a good idea to bring benefit to billions of people. The reality is, as always, not quite so simple.

The pharmaceutical industry obviously resists such moves tooth and nail. It is easily painted as an industry that puts profits before people’s health and well-being. Such sound bites gain strong political traction. It has been reported that the US administration is now considering whether a waiver of intellectual property rights for covid-19 vaccines is the way to go – a big shift for a US that has traditionally been a strong defender of intellectual property rights.

As always, things are not quite so simple. The trade-offs to be made are difficult.

First of all, modern medicines are complicated, high tech products. Vaccines maybe even more so than other types of medication. What prevents rapid expansion of production facilities is the lack of widespread know-how in how to scale up complex manufacturing processes to produce billions of doses to the right quality. Over-riding patents is only one step. Companies that have discovered and are producing these vaccines would need to transfer their manufacturing know-how and work closely with any producers to make sure of the quality and reliability necessary to produce the right product.

The challenges associated with such a process have recently been laid bare in a sophisticated US manufacturing plant that was producing both the J&J and the AstraZeneca vaccine. Quality control issues arose resulting in the disposal of millions of defective doses and the plant being then dedicated to the sole production of the J&J vaccine. Production of two vaccines side by side proved too complex.

The same question around suspension of IP rights arose during the HIV epidemic in Africa. The pharmaceutical industry came under severe pressure to suspend its patents. What became clear was that the main blocks in the system were developing country health care systems that did not have the resources to deliver and oversee a highly complex, multi-drug regime that needed constant medical monitoring. People with HIV sometimes had to walk for days to access heath care facilities. There was no way they could come in for the necessary regular blood tests and other monitoring.

There was also a thriving black market for ‘medicines’ – any medicines. Rather than use them, patients given a supply of medicines would go out and sell them to anyone who was willing to pay real money for some shiny new tablets.

True, neither of these issues apply in the same way to vaccines. Just to say that delivering any medicine involves effectiveness across the whole value chain from production to administration and monitoring. Issues are not resolved by focusing solely on one part of the chain

Then there is the issue of counterfeit medicines. Pharmaceutical products are of high value. They are easily transported in bulk. Producing and distributing counterfeit medicines is a highly lucrative criminal activity. Reports of counterfeit covid-19 vaccines have already started to emerge. One can only imagine that such activity would proliferate if production were open to all and sundry. The consequences for public health of large numbers of people being vaccinated with ineffective counterfeit vaccines would be devastating.

Finally, intellectual property rights are not absolute. All countries have the option of forcing companies to issue compulsory licences to local manufacturers in cases of public health need and lack of supply. That none have yet used this option suggests that it’s not the easy solution it might seem.

There is no doubt that ways need to be found to accelerate production, distribution and use of covid-19 vaccines across the world, and particularly in developing countries. It is far from clear that suspension of IP rights is an effective way to achieve that aim in spite of the idea having irresistible sound bite appeal. Much more than that is needed to produce at vast scale products that are complex to make, that must be quality tested at each step, that can be distributed widely, and that less developed health care systems can actually reliably get into people’s arms.

It is also worth bearing in mind that new variants are arising all the time. Our global battle against the virus will likely need a continued multi-year effort by pharmaceutical companies to keep developing new vaccines that are effective against new strains as they emerge. We should approach with caution any public policy action that could blunt the incentives for them to do that.


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