By Leah Pierson
Academia often treats all areas of research as important, and two projects that will publish equally well as equally worthy of exploring. This, I believe, is misguided.
Instead, we should strive to create an academic culture where researchers consider and discuss a project’s likely impact on the world when deciding what to work on.
By Jorge L. Contreras
The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).
The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.
By Mason Marks
On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.
Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.
I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.
By Matthew Bauer
How should scientists, policy makers, and governments balance efforts to address the current pandemic with initiatives to prevent the next one?
We have seen this play out before during the 2003 SARS crisis. A burst of research funding and resources were thrown at tackling the health emergency that spread to 29 different countries. Ultimately, enormous efforts across the globe were able to halt the crisis, but as scientific research continued post-outbreak, it became difficult to sustain funding.
By Matt Bauer
In academia, many of the scientists who are recognized as inventors on patents see little economic gain from these agreements.
Instead, royalties are primarily assigned toward their home institutions.
The scientists who drive discoveries within the walls of academia are not receiving an equitable share of the benefits of their innovations. Despite being the source of these discoveries, students and postdoctoral researchers don’t see the financial upside of the commercialization of their inventions.
By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.
By Leah Pierson
The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.
The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.
Join the author today for the 2021 CeBIL Symposium. Register here!
By Sarah Rickwood
The 2020s are the age of orphan medicines.
Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.
Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).
Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!
By Sven Bostyn
The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).
But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.
Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!
By Jakob Wested and John Liddicoat
In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.
The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?
Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.