IP rights have nothing to do with slow global rollout of vaccines

In the face of a Covid-19 pandemic that has caused 2.6-million fatalities worldwide, life sciences companies have raced to bring forward a wide range of life-saving innovations, including novel diagnostic tests such as that of LumiraDx, which can detect the virus within minutes; therapeutics, such as Gilead Science's remdesivir; and highly effective vaccines such as those from Moderna, Pfizer-BioNTech, and Johnson & Johnson.

More than 600 novel Covid-19 treatments are under development, including 130 vaccines in global clinical trials and 176 in pre-clinical trials.

Yet, amid this unprecedented pace of innovation, some 90 developing nations, led by India and SA, have petitioned the World Trade Organization's (WTO) trade-related aspects of intellectual property rights council calling for a waiver to suspend all intellectual property (IP) rights associated with Covid-19 innovations, again asserting the false narrative that IP rights inhibit access to medicines.

The waiver petition itself suggests the various fallacies underlying the request. First, the waiver (initially submitted on October 2 2020) acknowledges that, "to date, there is no vaccine or medicine to effectively prevent or treat Covid-19". This admission immediately confirms that IP rights are not and have never been the challenge in the Covid-19 pandemic.

Rather, the challenge initially was the very lack of IP; we had to, and did, discover and invent the scientific and technical knowledge necessary to understand the operation of the virus and how to defeat it with novel vaccines and therapeutics. Much of this involved new-to-the world technologies such as mRNA-based vaccines.

Far from being an inhibitor of this process, the robust IP regimes in place in many nations contributed to a body of biomedical knowledge and technologies that provided a crucial platform for the innovation of Covid-19 solutions.

Second, the waiver petition vaguely references "several reports about IP rights hindering or potentially hindering timely provisioning of affordable medical products to the patients".

The first of two cited instances pertained to Labrador Diagnostic, a patent-licensing firm which — although it did file a suit against a French firm, bioMérieux, developing coronavirus tests, to ensure its IP was not infringed — has actually committed to offering its patents royalty-free to any company developing coronavirus tests. The second instance referenced Kentucky governor Andy Beshear's call for 3M to release a patent on N95 respirators [a type of mask].

But that was it; on those two incredibly thin reeds, with nary any serious evidence whatsoever that IP rights were inhibiting access to Covid-19 treatments, let alone that no Covid-19 vaccines existed at the time, the petitioners took the radical step of calling for a suspension of all IP rights pertinent to Covid-19 technologies throughout the duration of the pandemic.

And while petitioners made this call on the alleged grounds of ensuring sufficient access to needed vaccines and therapeutics, their call for the suspension of every facet of IP rights on every conceivable coronavirus-related technology — even such as for copyrights and industrial designs — betrays the reality that the petitioners' core goal isn’t really about access, but about undermining the global IP rights system.

To be sure, the developed world needs to be fully committed to ensuring that the world's citizens receive the Covid-19 vaccines and therapeutics they need. But this can be accomplished through structures such as licensing and product development partnerships, without requiring an abrogation of IP rights.

For instance, in February 2021, the Biden administration announced it would contribute up to $4bn to Covax, the vaccine alliance seeking to distribute Covid-19 vaccines to 92 low- and middle-income countries. Covax aims to deliver at least 2-billion vaccine doses by the end of 2021, covering at least 20% of the most vulnerable citizens in these countries.

Innovative life sciences companies have entered into a number of licensing agreements to facilitate dramatically expanded manufacturing of Covid-19 vaccines and therapeutics. For instance, Gilead has licensed its therapeutic, remdesivir, royalty-free to nine generic drug manufacturers in Egypt, India and Pakistan. AstraZeneca reached a licensing and technology transfer agreement enabling the Serum Institute of India (SII) to manufacture 1-billion vaccine doses for low- and middle-income countries.

The SII has further entered into manufacturing licences with a number of developers of yet-to-be approved vaccines, as have several other Indian vaccine manufacturers. J&J has announced plans to allocate up to 500-million vaccine doses to lower-income countries, with delivery starting by mid-2021. Companies such as J&J are making the vast majority of these vaccine doses available on a not-for-profit basis.

Thus, the fundamental problem isn't high prices due to IP rights; it's dramatically scaling up manufacturing capacity. It takes 60 to 110 days to produce one batch of Covid-19 vaccine. When SII CEO Adar Poonawalla was asked if vaccine rollout was slowed because vaccine patent-holders were licensing too few manufacturers to make them, he responded, "No. There are enough manufacturers, it just takes time to scale up. And by the way, I have been blown away by the co-operation between the public and private sectors in the last year, in developing these vaccines."

Poonawalla actually cited the lack of global regulatory harmonisation as a far greater cause of delays in the vaccine rollout. Even Médecins Sans Frontières's Rose Scourze acknowledged (in a January 20 2021 BBC interview) that suspending patent rights "wouldn't produce millions of more vaccines".

Instead of forcing the disclosure of IP, policy-makers should encourage the use of voluntary licensing agreements to expand production of the needed Covid-19 vaccines and therapeutics. One reason this critically matters is to ensure consistency and safety in the production of these treatments. The mRNA-based vaccines developed by Moderna and Pfizer-BioNTech are incredibly complex, biologic products that require specialised experience, expertise and equipment to manufacture.

For example, mRNA vaccines require a complicated technique known as "bio-process" that requires speciality bio-reactors to first manufacture DNA that codes for the desired mRNA sequence, then uses a second bio-process to create billions of identical mRNA segments. These are then wrapped in a nano-lipid wrapper using yet another very specialised fluidics and mixing process and there are only three facilities in the world that can execute the step of creating the liquid capsule around the RNA.

Instead of simply being forced to divulge their IP or see it be compulsorily licensed to other manufacturers, in light of the extreme complexity of manufacturing Covid-19 vaccines and therapeutics companies should have the right to evaluate potential licence partners and ensure they can meet the production standards required to safely and reliably produce Covid-19 vaccines or treatments before entering into licence arrangements with them.

Indeed, this is critical, for it would be disastrous if defective vaccines or therapeutics were produced at facilities not properly equipped to produce such complex treatments.

As Phil Stevens and Mark Schultz have written, there's simply no evidence that invalidating IP rights would achieve more than the licensing agreements being forged between innovators and reputable vaccine manufacturers in countries such as India and Brazil.

Instead of rolling back IP rights, policy-makers in developed and developing nations alike should focus on mechanisms to scale up production of vaccines and make them affordably available to citizens in developing countries.

This article was first published on BusinessDay on 17 March 2021.

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