WTO director-general Ngozi Okonjo-Iweala said on Friday that a full waiver of companies’ Covid-19 vaccine patents under the World Trade Organization’s auspices — sought by many developing countries and supported by President Joe Biden to combat disproportionate access to the therapies — will not be enough to speed up the provision of vaccines to countries where it is lagging.
On that small point, at least, we agree: The nations that spearheaded the petition to waive the patent rights at the WTO, India and South Africa, have been unable to provide any evidence that the international system of respecting intellectual property rights under the law have impeded the development, production or distribution of Covid-19 vaccines and treatments.
May 6, 202110:14
And it is hard to imagine that any such evidence will be forthcoming, as intellectual property is facilitating — not inhibiting — the pharmaceutical industry’s pandemic response.
Normally fierce rival companies have been able to cooperate on vaccine production precisely because inventors know their property rights are — and will remain — secure. For instance, Johnson & Johnson invited Merck to help manufacture its viral-vector vaccine, while Pfizer and BioNTech, which jointly developed their revolutionary mRNA vaccine, are similarly working with French drug giant Sanofi to boost its production.
Suspending intellectual property rights will not get shots in arms any faster at this point and would, in fact, undermine efforts to scale up vaccine production.
And generics manufacturers are already working around the clock on a contract basis with innovator firms to produce vaccines. For instance, India’s largest generics manufacturer, the Serum Institute, is producing billions of doses of the AstraZeneca vaccine for low-income countries, while South Africa’s largest generics firm, Aspen Pharmacare, is producing hundreds of millions of doses of Johnson & Johnson’s vaccine.
India and South Africa’s petition to nullify intellectual property protections, were it to have been in effect, would have made those collaborations impossible.
Suspending intellectual property rights will not get shots in arms any faster at this point and would, in fact, undermine efforts to scale up vaccine production. As Okonjo-Iweala herself pointed out last week, though it will take time to negotiate a wholesale change to WTO treaties, the capacity to manufacture Covid-19 vaccines already exists in Pakistan, Bangladesh, Indonesia, Thailand, Senegal and South Africa but is currently sitting idle despite existing frameworks giving manufacturers in those places the right to start.
The EU, in the meantime, has offered a counterproposal to waive or minimize export restrictions on vaccines and vaccine components, to pledge to supply vaccines to countries with shortages at cost and to allow more countries to take advantage of existing WTO rules that allow countries to license intellectual property without the consent of the patent holders, essentially allowing for an increasing production capacity without waiving the patent rights altogether.
Normally fierce rival companies have been able to cooperate on vaccine production precisely because inventors know their property rights are — and will remain — secure.
So while the appeal of an intellectual property waiver is tempting in the short-run, doing so imperils our ability to develop new medicines and combat future pandemics.
The Biden administration, however, announced its support for such a petition earlier in May and progressive groups cheered, contending that the intellectual property suspension would hasten and make more equitable the global vaccine rollout by enabling more manufacturers to produce the vaccines developed by Western firms.
And, certainly, the rapid and equitable distribution of Covid-19 vaccines is absolutely critical to ending this pandemic. But sacrificing the innovation ecosystem in order to achieve this end would be myopic policy.
There are already very real challenges to inoculating the world, including a widespread lack of proper refrigeration (let alone the ultracold storage required for some vaccines), a shortage of trained professionals to administer them and conduct follow-up evaluations, and a lack of patient compliance with the two-dose regimen for the Pfizer-BioNTech and Moderna jabs.
Plus, there have already been issues with fakes and a lack of trust in the government that have come into play. In Mexico and Poland, authorities have identified counterfeit versions of the Pfizer-BioNTech vaccine. In Malawi, the New York Times reported that “people are asking doctors how to flush the AstraZeneca vaccine from their bodies.”
Leaders in the developed world should focus their efforts on helping other nations overcome challenges, rather than debate the finer points of intellectual property law at the WTO.
Suspending intellectual property rights will not remove any of these roadblocks and would likely exacerbate them. Without certain quality controls implemented by original patent holders, especially in places with existing levels of government or industrial corruption, we could see ineffective vaccines manufactured using substandard processes, and then administered without adequate refrigeration, professional handling or required counseling and follow up.
In this moment, leaders and policymakers in the developed world should focus their efforts on helping other nations overcome these challenges, rather than debating the finer points of intellectual property law at the WTO. The latter is a waste of precious time, especially since without intellectual property protections, there might never have been vaccines to debate — at least not yet.
Take Moderna’s vaccine: A mere two days after Chinese authorities publicly disclosed Covid-19’s genetic sequence in January 2020, Moderna had already sequenced its vaccine candidate, mRNA-1273 — which ultimately proved 94.5 percent effective and became one of the first vaccines approved for emergency use in the United States and the European Union. (By way of comparison, the creation of viable vaccines for smallpox, chickenpox, typhoid fever and polio took decades.)
The explosion of biopharma research — and the number of novel drugs brought to market to combat Covid-19 — are directly linked to a strong system of intellectual property rights.
Moderna’s Covid-19 vaccine was the result of 10 years of work, which took at least $2 billion from investors. Investors were willing to support Moderna for so many years — and potentially lose billions in the process — because they knew both that its technology could revolutionize medicine and that the technology would be protected by intellectual property rules.
Investments in Moderna paid off — but only 12 percent of investigational medicines entering clinical trials are ultimately approved by the U.S. Food and Drug Association. As the average cost of developing a new drug approaches $3 billion, it’s clear that no firm would conduct research and development without the promise of intellectual property rights, which give companies exclusive ownership of their inventions and a chance to recoup the investments that made the drug possible.
Moderna’s success should be a clear lesson for every policymaker: Swift global public health responses to the pandemics of tomorrow are predicated on incentivizing research and clinical development of new drug candidates and clinical pathways today.
The explosion of biopharma research — and the number of novel drugs brought to market to combat Covid-19 — are directly linked to a strong system of intellectual property rights.
The WTO waiver on patent rights for Covid-19 vaccines — let alone requirements for broader technology transfers, which Okonjo-Iweala appeared to call for on Friday — could shatter this system. It is unrealistic to assume groundbreaking innovations will simply appear without solid and reliable protections for those who risk the time and money to develop them.
Source: | This article originally belongs to Nbcnews.com
