This is the first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
Category: Health Law Policy
Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy
By Jorge L. Contreras, JD
The U.S. patent system gives inventors a 20-year exclusive right to their inventions to incentivize the creation of new technologies.
But what if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable? Conversely, should the U.S. Patent and Trademark Office (PTO) grant patents covering imaginary, fraudulent and otherwise non-existent inventions? Probably not, but it happens with alarming frequency, and it is causing serious problems.
Introducing New Contributor Jorge Contreras
Jorge Contreras is joining Bill of Health as a regular contributor.
Jorge L. Contreras is a Presidential Scholar and Professor of Law at the University of Utah with an adjunct appointment in the Department of Human Genetics. His research focuses on intellectual property, technical standards and science policy, and he is one of the co-founders of the Open COVID Pledge, a framework for contributing intellectual property to the COVID-19 response. Professor Contreras is the editor of six books and the author of more than 100 scholarly articles and chapters appearing in scientific, legal and policy journals including Science, Nature, Georgetown Law Journal, NYU Law Review, Iowa Law Review, Harvard Journal of Law and Technology and Antitrust Law Journal. He has served as a member of the National Institutes of Health (NIH) Council of Councils, the Advisory Councils of the National Human Genome Research Institute (NHGRI) and the National Center for Advancing Translational Sciences (NCATS), and as the Co-Chair of the National Conference of Lawyers and Scientists. He is a graduate of Harvard Law School (JD) and Rice University (BSEE, BA).
A New Litigation Crisis on the Horizon: Negligent Delays for Non-COVID-19 Patients
By John Tingle
As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.
Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.
To Address COVID-19 Disparities, 340B Hospitals Need More Flexibility
By Sravya Chary
Many racial minorities and low-income individuals rely on 340B hospitals and associated child sites for access to discounted drugs and charity care.
In 1992, Congress enacted the 340B program as an avenue of access to prescription medication for “the nation’s most vulnerable patient populations.” Hospital savings incurred from purchasing 340B drugs at a steep discount are invested in charity care programs to enhance patient services and access to care.
The 340B program is an essential component of the COVID-19 response. Increased flexibility for 340B covered entities is necessary to address disparities faced by marginalized communities.
Racial Disparities Persist in Human Subjects Research
By Beatrice Brown
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.
One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 pharmaceutical law and policy.
Below are links to the papers identified from the month of May. The selections feature topics ranging from the association between clinical benefit of approved cancer drugs and their prices in the U.S. and Europe, to an assessment of how commercial health plans cover biosimilars relative to their reference products, to a commentary on how children should be included in clinical trials evaluating COVID-19 therapies. A full posting of abstracts/summaries of these articles can be found on our website.
What the Supreme Court’s LGBT Discrimination Decision Means for Health Care
On Monday, the Supreme Court held in Bostock v. Clayton County that LGBT discrimination is sex discrimination under Title VII, the federal workplace protection of the Civil Rights Act of 1964.
The ruling comes in stark contrast to a recent action taken by the Department of Health and Human Services (HHS). Just last Friday, HHS issued a new rule interpreting Section 1557 of the Affordable Care Act so as to strip LGBT people of rights to nondiscrimination.
Since it was enacted in 2010, Section 1557 of the Affordable Care Act has prohibited federally funded health programs, including insurers and health care providers, from discriminating based on the sex of patients. In 2016, the Obama Administration issued a rule making clear that transgender people and, to a lesser extent, LGB people were protected.
But under the Agency’s new interpretation, discrimination based on gender identity or sexual orientation is not sex discrimination.
In light of Monday’s Supreme Court decision, many are now wondering whether—and how—the new HHS rule interpreting Section 1557 of the ACA might be affected.
COVID-19 Clinical Negligence and Patient Safety Update
By John Tingle
Health care law is evolving particularly rapidly during the COVID-19 pandemic.
For example, as the COVID-19 pandemic continues, families in England who have lost loved ones to the virus are considering filing clinical negligence claims. And there have even been calls in some quarters to bring global lawsuits against China for breaches of international health regulations over its handling of COVID 19.
How Do We Arrive at Fair Pricing for COVID-19 Therapies?
By Padmashree Gehl Sampath
As the search for COVID-19 treatments and vaccines continues, questions of pricing and access are beginning to emerge.
How can pharmaceutical companies determine fair prices for these therapies? And how can they ensure that all those who need these treatments are able to access them? These are valid concerns in the current global pharmaceutical landscape, where in recent years, soaring drug prices have been an issue for almost all governments.
