US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 woman holding newborn

By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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California Court of Appeal Rejects Challenge to Vaccine Law

Vaccines are now mandatory for school age children in California.

By Dorit Reiss

The Second Appellate District’s Court of Appeal upheld the California law that removed California’s Personal Belief Exemption (PBE) from school immunization requirements earlier this month.

The decision is a strong endorsement of immunization mandates and is binding on all state courts until another appellate decision is handed down, or the Supreme Court of California addresses the question.

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Ontario’s Sex-Ed Curriculum: A Step Back for Health and Safety

Teens in Ontatio, Canada could be put at risk by a change in the public school sex-ed curriculum that omits LGBT relationships.

By Gali Katznelson

Come September, it seems Ontario students in grades 1-8 will follow the same sexual education curriculum that was taught in schools in 1998.tse

Days after the Progressive Conservative Party’s win in Ontario, premier Doug Ford has announced that he will scrap the province’s elementary school sex-ed curriculum and replace it with one that is twenty years old.

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Cottage Food and Food Freedom Laws – New LawAtlas data

The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.

Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.

These laws are quickly becoming an increasing area of debate at the state level.  Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to.  At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.

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Are we speaking the same language? An alphabet soup of acronyms in the opioid epidemic

By Stephen Wood

Medication Replacement Therapy (MRT), Medication Assisted Therapy (MAT). Opioid Substitution Treatment (OST). Opioid Replacement Therapy (ORT). Opioid Agonist Therapy (OAT). This confusing array of acronyms are all terms that have made their way into the dictum of patients, healthcare providers, policy leaders, politicians and journalists —and new ones pop up every day.

Buprenorphine Enabled Recovery Pathway (BERP) is one I just came up with but could just as easily make its way into the menagerie of acceptable buzzwords for using an agonist-antagonist (or other drug) for the treatment of substance use disorder.

It doesn’t stop there.

Safe Consumption Facilities (SCF), Safer Injection Facilities (SIF), another SIF in Supervised Injection Facilities, Supervised Injection Sites (SIS), Medically Supervised Injection Sites (MSIS), and Drug Consumption Sites (DCS) only begin to round out the list of areas that people who use intravenous drugs can go to use in a safe, clean and supported environment.

We see these terms bantered about in the media, among healthcare providers, legislators and policy makers. We hear them from patients with SUD, their families as well as advocate organizations. These terms are in published research reports and clinical studies. To even the savviest person though, it is a confusing alphabet soup of acronyms that are all trying to describe an array of programs, possibly something similar or maybe even the same.

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After Julie Eldred, Considering Addiction as Disease or Choice

The Massachusetts Supreme Judicial Court ruled that relapse could be a violation of parole.

By Chris Hutchison-Jones

Is substance addiction a choice or a disease?

In the recent ruling by the Massachusetts Supreme Court in the case of the Commonwealth vs. Julie A Eldred judges had to consider this question.

But they came to the wrong conclusion.

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Introduction to “Diseases of Despair: The Role of Policy and Law”

By Wendy E. Parmet and Jennifer Lea Huer

We are pleased to host this symposium featuring commentary from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series will be available here.

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Promoting Health Equity Through Health in all Policies Programs: A Health Law Perspective

Scholars and public health advocates are optimistic about Health in All Policies initiatives.

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Peter D. Jacobson

Scholars and public health advocates have expressed optimism about the potential for Health in All Policies (HiAP) initiatives to improve both health equity and population health. HiAP is a collaborative approach across all sectors, involving both public and private decision-makers, to integrate health and equity during the development, implementation, and evaluation of policies and services. Braveman and colleagues define health equity to mean that “that everyone has a fair and just opportunity to be as healthy as possible.”

I suspect the vast majority of health law scholars support the concept of health equity. But what does the concept mean in practice and how can it be implemented? From a public health law perspective, does implementation require a legal imprimatur or can it be effectively designed and implemented absent some sort of legal mandate?

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Global Patient Safety and Health Quality

By John Tingle

The WHO (World Health Organization), the World Bank Group and OECD (Organization for Economic Co-operation and Development) have jointly produced a report which states that poor quality health services are holding back progress on improving health in countries at all income levels.

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The Healing Potential of Medical-Legal Partnerships

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Tamar Ezer

As we grapple with today’s social ills and Diseases of Despair such as the opioid crisis, violence and suicide, medical-legal partnerships (MLPs), can potentially provide a powerful healing combination.

MLPs, which integrate legal services into health care, have several important strengths.

They embrace a holistic approach to health, addressing not just biological factors, but also social determinants, such as access to housing or freedom from violence. They bring access to justice to communities. People need not go out to seek legal support, but can find services at a one-stop shop for multiple, intersecting needs. MLPs help address legal issues early, preventing problems and intervening before there is an eviction or utilities are shut off.

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Resiliency as Prevention against Diseases of Despair and Structural Violence

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By JoHanna Flacks

If despair is the disease, what is the remedy? I was privileged to participate in a panel with colleagues from the medical-legal partnership (MLP) movement at a Diseases of Despair conference convened by Northeastern University’s School of Law in April. We were invited to share how MLP approaches can answer this question broadly by helping to identify and implement interventions that show promise as despair antidotes or – better yet – antibodies that can prevent despair’s onset.

While hope is despair’s antonym in common usage, the idea of “resiliency” has taken root among healthcare and human service teams as a key quality to cultivate among, for example, survivors of adverse childhood experiences (ACES) who are at risk of poorer health and well-being in the absence of buffers from the toxic stress of these traumas.

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Many State Laws Undermine Harm Reduction Strategies in the Opioid Crisis

A protest sign seen at an ACT UP demonstration. Syringe exchange programs are a harm reduction policy that could have an impact on the opioid crisis. (Photo by riekhavoc/flickr)

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Aila Hoss

Despite the increase in rates of opioid overdose death since 1999, the Opioid Use Disorder crisis shows little signs of abating. Recent reports from the Centers for Disease Control and Prevention indicate that overdose death rates have continued to climb in recent years. These sobering reports, along with others highlighting the impact of the crisis on children and families, the increase in methamphetamine and cocaine use, and the economic costs to businesses, communities and our healthcare system remind us that “opioid addiction isn’t the disease; it’s the symptom.”

There is “no easy fix” to the social and economic determinants of health, such as poverty and housing insecurity, that are fueling this crisis. However, there are actionable, discrete, evidence-based policy measures that can be taken to reduce the rates of overdose deaths via harm reduction strategies.

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Reports on the Opioid Crisis are Full of Misidentified Problems and Poorly Calibrated Solutions

Photo by striatic/flickr

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Nicolas Terry

The epidemic associated with Opioid Use Disorder (OUD) has birthed a proliferation of reports, many with notable provenance. They include the Surgeon General’s Report (2016), the President’s Commission on Combating Drug Addiction and the Opioid Crisis (2017),  and the National Governors Association Recommendations for Federal Action to End the Nation’s Opioid Crisis (2018). We can add innumerable regional and state reports to that list.

Placed next to each other, their recommendations are broadly similar. While they may differ somewhat to the extent that they emphasize criminalization versus medicalization, overall, they tend to coalesce around harm reduction (such as broad naloxone availability and syringe exchanges), upstream opioid reduction strategies (such as prescription limits and prescription drug monitoring programs), and increased public health surveillance based on improved data collection and analysis.

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Physicians and Firearms: Finding a Duty to Talk to Patients About Guns

Sixty-one percent of gun deaths in 2015 were suicides. Physicians should be empowered to speak to patients about guns.

By Elisabeth J. Ryan

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

Florida enacted a statute in 2011 entitled the “Firearms Owners’ Privacy Act,” which quickly became known nationwide as simply the “Docs v. Glocks” law.

This law essentially forbade doctors from asking their patients about gun ownership, recording information about guns in the home, and “unnecessarily harassing” patients for being gun owners. The penalty was potential medical license sanctions and a fine up to $10,000.

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Meditation? There’s an (almost FDA-approved) app for that

By Gali Katznelson

Headspace is paving the way for the first FDA-approved prescription meditation app.

Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can help treat 12 mental and physical conditions.

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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.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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CMS Abandonment of Outcomes-Based Payment Deal with Novartis is a Missed Opportunity

The Centers for Medicare and Medicaid Services have cancelled an outcomes-based price plan with drug maker Novartis. (Wikimedia Commons)

By Rachel Sachs

Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement.

The Food and Drug Administration’s approval of Kymriah in August of last year was accompanied by the announcement of a novel outcomes-based agreement with CMS, in which CMS would pay for Kymriah only if patients had responded to it by the end of the first month. Now, CMS has quietly backed away from that agreement. What does the deal – and its subsequent abandonment – tell us about CMS’ involvement in outcomes-based contracts going forward?

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Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy.

In two high profile cases in 2011 and 2015, Kavanaugh upheld key parts of the Affordable Care Act (ACA). But these cases, taken out of context, are misleading. They should not distract anyone evaluating his long record, nor overly inform how he might decide in future cases when it comes to health care.

Besides his record on reproductive health — which is controversial and is already creating significant opposition to his confirmation — Kavanaugh has exhibited strongly-held ideas about the relationship of the courts to government agencies and bureaucracies that carry out most of American public policy, also known as “the administrative state.”

Read more at WBUR’s Cognoscenti

How the New York Court of Appeals Applied the Soda Cap Criteria to Vaccines

By Dorit Reiss

(Photo by pahowho/Flickr)

New York’s Court of Appeals reversed an Appellate Division decision and reinstated New York City’s influenza mandate for city daycares in Garcia v. New York City Department of Health and Mental Hygiene in June. Applying the same criteria the court used in 2014 to overturn the city’s controversial Soda Cap, the court found that the rules are well within the Board’s authority.

We can suspect that the recent influenza season influenced the decision, but it was also based on a more explicit delegation of authority, and a history of vaccination programs by the Board.

Also, it’s likely good news for at least some of New York’s youngest, who will be better protected from a dangerous disease, and for the public.

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