Guest post from Daphne Zohar, Founder and CEO of PureTech Health, a Boston-based biopharmacy that advances 26 therapeutics and drug candidates through its internal pipeline and founded entities, including two that have received FDA clearance and European marketing authorization.
The news ricocheted through the bio-innovation community, raising alarm and frustration.
Innovators and entrepreneurs, scientists and CEOs have reacted with deep concern to the Biden administration’s decision this week to support temporary waiver intellectual property rights for COVID-19 vaccines.
It was the third time in just a few months that politicians had sought to intervene in the biopharmaceutical industry with policy proposals that betrayed a deep misunderstanding of the complex engine leading to the discovery and development of survival – and, in this case, of the pandemic – end – drugs.
First, Representative Katie Porter (D-CA) released a report on mergers and acquisitions (M&A) in the biopharmaceutical industry. This report misrepresents mergers and acquisitions as a destructive force that is supposed to crush innovation and kill jobs. The Federal Trade Commission then announced investigation the impact of mergers and acquisitions on competition in the industry, resulting in liquidation of investors. In fact, mergers and acquisitions are the cornerstone of innovation, funding startups, and supporting job creation and the development of new remedies and their benefit to patients.
Then the members of Congress renewed a vocal push for legislation to control the price of drugs. A proposal would allow the federal government to impose a tax of up to 95% on the revenues of certain drugs if drug companies refuse to “negotiate” lower prices. This concept is misinformed and would severely limit the ability of biotech companies to attract the funding needed to advance new remedies. While there are absolutely unjustified price increases, in many cases the costs to patients are artificially increased by intermediaries. There are much better ideas for reduce the burden of personal expenses on patients and their families, including insurance reform and discounts, value-based pricing models and incentives to offset the costs of deficit biotechnology.
Then last week we got the spectacle of policymakers making the headlines screaming to overturn vaccine patents. It is a “solution” of sound expressions which would do nothing to address supply bottlenecks or speed up production in the short term. Instead, it could help our geopolitical rivals steal American technology – and reduce the likelihood of industry stepping in to save us from the next pandemic. Without intellectual property protection, investors will not put in huge sums, often billions, necessary to take a potential remedy from initial concept to proven therapy. This means more vaccines, more gene therapies for rare diseases, more new treatments for cancer, Alzheimer’s disease and other devastating conditions.
The common thread running through all of these proposals is the rush to act – well-intentioned, perhaps, but coupled with a catastrophic inability to understand the thriving ecosystem endangered by these policies.
It’s as if, after being stung by a bee during a picnic, you hire a squadron of exterminators to destroy all the bees in the state. You wouldn’t solve the problem. You would, however, disrupt a delicate ecosystem in which bees play a central role. And the downstream consequences on the environment would be disastrous.
To be clear, I am not saying that politicians should avoid any problem involving biopharmacy. These are the right issues to focus on and I support smart regulation and good policy, like most people I know in the industry. But it is imperative that lawmakers listen.
Hear from academic scientists who ask bold questions and conduct painstaking experiments that sometimes lead to discoveries that reshape our understanding of human biology.
Hear from entrepreneurs like me who are investing all we have to guide these groundbreaking lab discoveries in a drug that will make a difference in the lives of patients, whether it’s new cancer immunotherapy or therapy that could potentially treat Long’s lung scars. COVID.
Hear from investors risking huge sums to support bold visions: beat heart disease, MRNA vaccinesor “live biotherapeutics” to fight against autoimmune diseases. These are technologies you don’t know until they’ve gone through decades of discovery, research, and clinical development. So you can’t imagine modern medicine without them.
Above all, listen to patients and their families, many of whom live in pain and fear, waiting and praying for new therapies to reach them.
While I am proud to be CEO of biopharmacy, I will be the first to say that the industry is not perfect. That is why we need smart regulation. But like good drugs, smart policies require a deep understanding of the ecosystem you are trying to modulate.
Many of us are at the forefront of drug discovery and bio-entrepreneurship that would be happy to work together on smart policies. We will explain the challenges we face and the benefits that flow from our unique ecosystem that fosters innovation, fosters growth, supports millions of jobs and brings life-saving medicines to market.
Don’t let soundbite politics kill the engine that brought you COVID vaccines with 95% effectiveness, hepatitis C cures, and hope for people with cancer and rare diseases. The world depends on the innovation we cultivate. Don’t act until you understand it.