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I.P. protection vital for innovation

Clinical trials have demonstrated the efficacy of three vaccines to conquer the Covid-19 pandemic and another dozen or more could be ready within months.

As this hopeful news has emerged, so, too, has concern surrounding fair distribution of the vaccines.

To preempt this concern, India and South Africa — joined by Bolivia, Eswatini, Kenya, Mozambique and Pakistan — petitioned the World Trade Organisation (WTO), which governs trade rules among its 164 members, to suspend intellectual property (IP) protections on all Covid-19 technologies.

This would apply to medical equipment like ventilators, masks and protective gear, as well as Covid-19 vaccines and treatments. These governments claim they're driven by a desire to protect the disadvantaged and jump-start necessary reform of the IP system for this and future pandemics.

But their diagnosis and prescription are wrong. There is no sign that patents will impede access to Covid-19 vaccines. And gutting IP protections will decimate the development of new medicines. Singapore, however, recognises that IP protections underpin the entire innovation ecosystem and dissented from the WTO proposal.

After all, embarking on the development of a new medicine is a challenging, expensive venture. It typically takes 10 years and costs more than US$1 billion to bring a single new medicine to market. Those who fund scientific research are only willing to assume this risk because they know their inventions will be protected. So if a new medicine is successful, they'll have the chance to earn a return.

The development of breakthrough medicines only seems routine because the system works so well. The rapid development of Covid-19 vaccines proves this. That's why the WTO petition is so jarring. There's no evidence that patents are preventing Covid-19 vaccines from reaching patients.

Consider, first, the enormous task of vaccine production. Vaccines are biologic agents, so each one requires its own dedicated production line. In fact, each manufacturing step requires about 450 quality checks. The cost of regulatory compliance is, understandably, very high.

Building and staffing new facilities in the next few months just isn't realistic. Seizing intellectual property incentives will do nothing to help today's vaccine makers ramp up production and distribution capacity. It is more likely to slow things down, as companies could cease risking money on not-yet-approved vaccines.

John-Arne Røttingen, appointed as Norway's Global Health Ambassador, recently stated in The Lancet that, "if you want to establish a biological production line, you need a lot of additional information, expertise, processes, and biological samples, cell lines, or bacteria" to be able to document to regulatory agencies that you have an identical product.

Vaccine makers have announced that they will offer their vaccines at cost or very close to it. Four large pharmaceutical companies are pledging three billion vaccine doses for developing countries.

And thanks to a licensing agreement with the Serum Institute of India, AstraZeneca plans to provide 400 million vaccine doses to low- and middle-income countries and eventually raise that number to one billion. South Africa's Aspen Pharmacare announced it entered into a preliminary agreement with Johnson & Johnson for the technical transfer and proposed commercial manufacture of its Covid-19 vaccine candidate.

Other research-based biopharmaceutical firms have promised to deploy vaccines on a not-for-profit basis or employ socially responsible pricing. The industry is truly walking the walk.

The private sector's well-documented commitment to ensuring access to Covid-19 technologies makes it stranger that the World Health Organisation (WHO) is asking them to forfeit their IP protections. WHO is urging biopharmaceutical firms to donate the IP behind of their latest Covid-19 innovations to the Covid-19 Technology Access Pool to boost manufacturing of these worldwide.

Both the WHO and WTO are expected to discuss their IP proposals this month. Biopharmaceutical companies have already committed to making their discoveries available worldwide. Forcing them to waive their IP rights would set a dangerous precedent that will discourage future innovation and effect research in development not just in this sector.

Intellectual property is at the foundation of medical innovation. Without them, the world would be defenceless against future pandemics. Facts easily counter the dogmatic posturing from India and South Africa. At the WTO, let us hope that facts prevail.

The writer is director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)


The views expressed in this article are the author's own and do not necessarily reflect those of the New Straits Times

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