Zeroing In on “Zero Tolerance” School Discipline Laws

By Alexandra Hess

Exclusionary school discipline (ESD) policies, also known as Zero Tolerance policies, enforce disciplinary measures like suspension, expulsion, or law enforcement referral to address particular student behaviors.

Though it began as part of the Gun-Free Schools Act of 1994, which mandated one-year expulsion for possessing a firearm at school, ESD became more widely adopted over time. Now, the policies apply nationwide to a broad range of behaviors — from damaging property and fighting, to possessing a cell phone or tobacco, as well as behaviors described by subjective terms often undefined in the law, like willful defiance, obscenity, or profanity. Read More

Suicide Prevention and Patient Safety

Suicide prevention needs to be taken more seriously globally by governments, health systems as an urgent public health concern.

WHO (World Health Organisation) states that close to 800,000 people die due to suicide every year, which translates to one person dying every 40 seconds. For each adult who died by suicide there may have been more than 20 others attempting suicide. Suicide is the second leading cause of death among 15 to 29-year-olds globally, and occurs throughout the lifespan. Read More

Opportunities and challenges for user-generated licensing models in gene-editing

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

Read More

Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. 

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

 Read the Full post here!

Patient Safety at the Crossroads

By John Tingle

The NHS (National Health Service) in the UK is 70 next year: it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.

What is clear is that ever since 1948 the NHS has been shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near infinite demands is no easy task. Seventy years on, it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS. The issues were recently considered by the National Audit Office (NAO), which found:

  • The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.
  • Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.
  • The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.

Read More

The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

Read More

Factory farming, human health, and the new WHO Director General

By Nir Eyal

Last week, over 200 experts called on the next Director General of the World Health Organization to prioritize factory farming in an open letter. Announced in articles in the New York Times and The Lancet, the letter argues that factory farming is a major barrier to better global health. The letter does not make this argument on animal rights grounds – although this argument is certainly strong – but instead focuses on factory farming’s contribution to antibiotic resistance, climate change, and the rise of chronic diseases. These three issues formed the core of the last Director General’s agenda, although limited attention was paid to factory farming, which the authors argue, “connects the dots among them.”

One of the authors is Scott Weathers, a Global Health and Population MSc student at the Harvard T.H. Chan SPH. The other is Sophie Hermans, a doctoral student from Cambridge U. Their letter received overwhelming response. On twitter, their announcement of the letter was the #1 trending tweet on all relevant hashtags for the recent World Health Assembly.

Congratulations, Scott and Sophie!

(I am among the letter signatories.)

Reflection and Review at The National Health Service Litigation Authority (NHS LA)

By John Tingle

The NHS LA is a pivotal organisations in the NHS whose work has a daily impact on the lives of patients and on all those who work in the health service. The NHS LA  have recently published its new five year strategy which reveals some very interesting and informative data, trends, insights into patient safety and regulation, governance and litigation.

NHS LA functions

If you work as a solicitor, lawyer handling  NHS clinical negligence claims, acting either for an injured patient or a hospital  then the NHS LA will be a daily feature of your professional life. They appoint solicitors to act for the hospital or other NHS organisation which is being sued from an approved panel of law firms and manage the claims process. Read More

Housing Equity Week in Review

We’ve rounded up the latest news from the past week, January 9-15, 2017, for housing law and equity. The HUD confirmation hearing was, of course, the biggest news, but a few other items of note:

Did we miss anything? Let us know!