Guest post by Daphne Zohar, the founder and CEO of PureTech Health, a Boston-based biopharma that is advancing 26 therapeutics and therapeutic candidates through its internal pipeline and its Founded Entities, including two that have received FDA clearance and European marketing authorization.
The news ricocheted through the bio innovation community, sparking alarm and frustration.
Innovators and entrepreneurs, scientists and CEOs reacted with deep concern to the Biden administration’s decision this week to support temporarily waiving intellectual property rights for COVID-19 vaccines.
This was the third time in just the past few months that politicians sought to intervene in the biopharma industry with policy proposals that betrayed a deep misunderstanding of the complex engine driving the discovery and development of life-saving – and, in this case, pandemic-ending – medicines.
First, Rep. Katie Porter (D-CA) released a report blasting mergers and acquisitions (M&A) in the biopharma industry. This report painted a false picture of M&A as a destructive force that supposedly squashes innovation and kills jobs. The Federal Trade Commission then announced an investigation of M&A’s impact on competition in the industry, spurring an investor sell-off. Actually, M&A is the lifeblood of innovation, funding startups and supporting job creation and development of new cures and bringing them to patients.
Next, members of Congress renewed a vocal push for legislation to control drug pricing. One proposal would authorize the federal government to impose a tax of up to 95% on the revenue from certain drugs if pharma companies refused to “negotiate” lower prices. This concept is ill informed and would severely limit the ability of biotech companies to attract the funding needed to advance new cures. While there are absolutely some unjustified price hikes, in many cases, costs to patients are artificially driven up by middlemen. There are much better ideas for reducing the burden of out of pocket costs on patients and their families, including insurance and rebate reform, value based pricing models, and incentives to offset costs for loss-making biotechs.
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Then this past week, we have the spectacle of policy makers grabbing headlines with cries to cancel vaccine patents. It’s a soundbite “solution” that would do nothing to address supply bottlenecks or speed near-term production. Instead, it could help our geopolitical rivals steal US technology – and make it less likely that industry will jump in to save us from the next pandemic. Without protection for intellectual property, investors won’t put up the huge sums, often billions, needed to take a potential cure from initial concept to proven therapy. That means no more vaccines, no more gene therapies for rare disease, no more novel treatments for cancer, Alzheimer’s disease and other devastating conditions.
The common thread in all these proposals is a rush to act – well meaning, perhaps, but coupled with a catastrophic failure to understand the thriving ecosystem put at risk by these policies.
It’s as if, having been stung by a bee at a picnic, you hired a squadron of exterminators to destroy every honeybee in the state. You wouldn’t fix the problem. You would, however, disrupt a delicate ecosystem in which honeybees play a pivotal role. And the downstream consequences to the environment would be disastrous.
To be clear, I’m not arguing that politicians must steer clear of any issue involving biopharma. These are the right problems to focus on and I support smart regulation and sound policy, as does most everyone I know in the industry. But it’s imperative that lawmakers listen.
Listen to the academic scientists who ask bold questions and run painstaking experiments that sometimes lead to discoveries which reshape our understanding of human biology.
Listen to entrepreneurs like myself who pour everything we have into shepherding those breakthrough discoveries from the lab into a medicine that will make a difference in patients’ lives, whether that be a novel cancer immunotherapy or a therapy that could potentially address the lung scarring of Long COVID.
Listen to the investors who risk huge sums to back audacious visions: Gene editing to conquer heart disease, mRNA vaccines, or “living biotherapeutics” to tackle autoimmune diseases. These are technologies you don’t know about until they make it through decades of discovery, research, and clinical development. Then you can’t imagine modern medicine without them.
Listen, above all, to the patients and their families, many of them living in pain and fear, waiting and praying for new therapies to reach them.
While I’m proud to be a biopharma CEO, I’ll be the first to say that the industry isn’t perfect. That’s why we need smart regulation. But like good medicines, smart policies require a deep understanding of the ecosystem you’re trying to modulate.
There are many of us on the frontlines of drug discovery and bio-entrepreneurship who would be happy to work together on smart policies. We’ll explain the challenges we face and the benefits that flow from our unique ecosystem which nurtures innovation, promotes growth, supports millions of jobs – and brings life-saving medicines to market.
Don’t let policy-by-soundbite kill the engine that brought you COVID vaccines with 95% efficacy, cures for hepatitis C, and hope for people living with cancer and rare diseases. The world depends on the innovation we nurture. Don’t act until you understand it.