Klietmann: With one move, president threatens medical progress – Boston Herald

With a single remark, President Joe Biden did more to undermine progress in medical science than any president in recent memory. While speaking to reporters, Biden expressed his support for an effort at the World Trade Organization to cancel intellectual property protections on COVID-19 vaccines.

The mere suggestion of such a policy by the leader of the free world was enough to shake confidence in the ecosystem that enables biomedical innovation. If the effort succeeds, it wont be large drug companies who are most harmed. It will be the small start-ups working on tomorrows medicines for patients across the world.

We must hope that the president rethinks his support for this proposal.

Small companies are responsible for the vast majority of new medicines invented each year. And the WTO proposal poses a threat to their very survival.

The central assumption behind the WTO waiver proposal is that IP protections are keeping poorer countries from accessing COVID-19 vaccines by restricting manufacturing. By stripping biotech firms of their IP rights, the thinking goes, policymakers can empower more generics factories to meet vaccine demand.

This justification doesnt withstand scrutiny.

Production is limited because there arent enough qualified manufacturers capable of producing these vaccines and there arent enough raw materials. This is why Modernas decision to temporarily waive the patents on its revolutionary vaccine hasnt done anything to increase the supply of its shots.

Further, global production is on overdrive thanks to intellectual property protections. Merck is helping produce Johnson & Johnsons vaccine, Sanofi is helping produce the Pfizer-BioNTech vaccine, and generic producers in India, South Africa and elsewhere are producing the vaccines from Johnson & Johnson and AstraZeneca as quickly as they safely can. These partnerships exist because the innovator companies know their proprietary data and research is protected by IP rules.

As ineffective as an IP waiver might be in expanding access, it would still do irreparable damage to the industry thats helping to end this crisis. So it could stymie medical progress for years to come.

Inventing a new medicine is extraordinarily risky. Of the medicines that enter clinical trials, just 12% are ultimately approved by the FDA. And that figure doesnt include the countless drug candidates that are abandoned in the lab.

Innovation is also massively expensive. A Tufts University study estimates that the creation of a single successful drug costs just shy of $3 billion, on average.

Attracting investment for these high-risk projects requires the promise of a reward should a medicine succeed. By enabling firms to sell their inventions exclusively for the few years following a drugs approval, IP protections give companies and investors the assurance that they might turn a profit.

If investors arent confident in IP rules, this system breaks down. Yet by backing the WTO waiver, Biden has vastly undermined confidence in IP protections.

Thats why this move could curtail if not decimate research at small start-ups. Small biotechs are responsible for nearly two in three new medicines and depend on regular influxes of cash from private investors to stay in business. As Albert Bourla, CEO of Pfizer, recently put it, Bidens support for waiving patents (could discourage) the thousands of small biotech innovators that are totally dependent on accessing capital from investors who invest only on the premise that their intellectual property will be protected.

Funding for new research will dry up quickly if the WTO waiver succeeds. Indeed, Bidens support for the effort has already sapped investors confidence, resulting in double-digit drops in the share prices for vaccine-makers Moderna, BioNTech and Novavax.

Some argue that if the biotech industry collapses, the task of developing new medicines can be left to universities. But this is a fantasy. Even academic institutions like Harvard Medical School, where I taught, is ill-equipped for the kind of aggressive investment and risk-taking that biotech innovation demands. High-stakes research and development can only occur in the private sector.

The small companies that create life-saving therapies and vaccines already face impossibly long odds. Now, at a moment in which the industrys value to the world has never been more apparent, Biden has added to the burdens these start-ups face, threatening the very existence of the companies that drive medical science forward.

Dr. Wolfgang Klietmann is a former clinical pathologist and medical microbiologist at HarvardMedical School.

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Klietmann: With one move, president threatens medical progress - Boston Herald