Tuesday, November 2, 2021

Opinion | The Risk in Suspending Vaccine Patent Rules


Companies can afford to license patents for free, or sell drugs at cost, precisely because they know that their intellectual property will be protected. That’s not a flaw in the system; it’s how the system ensures that pharmaceutical research will continue to be funded.

Eroding patent protections has far-reaching consequences.

Take “messenger RNA,” the technology platform that supports the vaccines from Pfizer/BioNTech and Moderna. Ozlem Tureci and Ugur Sahin, the wife-and-husband team at the helm of BioNTech, began exploring the use of mRNA more than 25 years ago and founded their company in 2008. Theoretically, mRNA can instruct the body to engineer proteins, including ones that increase immunity against infectious pathogens, cancers and rare genetic conditions. But the Covid-19 vaccines are the first truly successful applications of this technology. Scientists eager to explore future uses of mRNA will struggle to find investment if intellectual property protections are snatched away when others deem it necessary.

Critics of intellectual property rights cite public investment in research as a reason to waive patent protections. They correctly point out that governments bankroll important, early-stage research across the sciences. It’s true that without public funds from agencies like the U.S. Biomedical Advanced Research and Development Authority or the German Federal Ministry of Education and Research, global drug companies might not have developed Covid-19 vaccines so quickly. But here, the funding principally helped reduce risk and accelerate production timelines — the research and development were still driven by scientists in the private sector. Further, governments have neither the money nor the risk tolerance to take over the role of businesses in developing pharmacy-ready medicines.

There is no available substitute for private funding in bringing new medicines to market. Directing government labs to manufacture medicines, for example, would politicize drug development, empowering politicians and their appointees to decide which research lines were worth funding.

There is also no reason to fear a Covid-19 vaccine monopoly. According to the World Health Organization, there are 214 Covid-19 vaccine projects around the world; 52 are in clinical trials, with 13 in the most advanced phase of testing. Seven have been approved for emergency or limited use in various countries. In short, we are rapidly headed for a competitive marketplace, the opposite of a monopoly.

There are, to be sure, serious obstacles to distributing Covid-19 vaccines quickly and fairly around the world. But they have nothing to do with intellectual property. The challenge, rather, is speedy manufacturing. A study from the U.S. Defense Department estimated that it would cost $1.56 billion over 25 years to build and operate a facility producing three vaccines. Facilities cost less in developing countries like India, but only marginally. The equipment required to manufacture vaccines — bioreactors, centrifuges, cold storage and the like — is expensive everywhere. That’s why Covid-19 vaccine production is taking place almost exclusively in existing facilities.

Dismantling patent protection would do nothing to expand access to vaccines or to boost global manufacturing capacity. Research scientists develop vaccines in record time because they have the security and resources that come with a robust system of protection for their intellectual property. That system is crucial to allowing companies to create the vaccines we need for wide distribution.

Thomas Cueni is director-general of the International Federation of Pharmaceutical Manufacturers and Associations.

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