April 2017—Public Health Law News
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In This Edition
Announcements
Topics: Mosquito Control Law Article, Webinar on Legal Epidemiology, Food Insecurity Article, and more
Webinar — Disaster Preparedness & Response: Here, There & Everywhere. The American Bar Association is hosting a webinar about disaster preparedness and response. This webinar, featuring a speaker from CDC’s Public Health Law Program, will explore all types of unplanned incidents and accidents, the responses to them, and any legal issues that may arise at the federal, state/county, and local levels. This webinar will discuss how healthcare entities, local and state governments, emergency service agencies, community partners, and especially lawyers, need to be alert, informed and prepared all day, every day. This free webinar will take place May 2, 2017, at 1:00–2:00 pm (EDT) and will include a live question and answer session.
Webinar—Legal Epidemiology, Part 1: A Tool for Advancing from Data to Policy. The National Environmental Health Association, in collaboration with CDC’s Public Health Law Program (PHLP), is offering a three-part webinar series about legal epidemiology. The first webinar will feature CDC speakers and serve as an introduction to legal epidemiology. The webinar will examine the relationship between environmental health and policy and describe how legal epidemiology can be used as a tool to advance from data to policy. This free webinar will take place May 10, 2017, at 1:00–2:30 pm (EDT).
Journal Article–Legal Authority for Mosquito Control and Pesticide Use in the United States. This article, published in Public Health Reports, discusses and clarifies the breakdown of the legal authority between federal, state, and local government actors with regard to mosquito control activities, particularly pesticide use.
Journal Article Addressing Food Insecurity and Its Health Implications in Rural Tribal Communities. The article “Food Insecurity and Chronic Diseases Among American Indians in Rural Oklahoma: The THRIVE Study” examines food insecurity and cardiovascular disease-related health outcomes among Native Americans in rural Oklahoma. The article emphasizes the importance of collaborative work between tribal, federal, and state policymakers along with businesses and nonprofits to address the barriers to healthy foods and the underlying causes of food insecurity. [American Journal of Public Health. 2017;107(3):441–6. doi: 10.2105/AJPH.2016.303605].
Legal Tools
Topics: Ambulatory Care Facility Vaccine Laws, Tribal Occupational Safety and Health Laws, and more
State Ambulatory Care Facility Vaccine Laws. PHLP published two menus examining laws related to pneumococcal and influenza vaccine requirements for healthcare workers and patients in state ambulatory care facilities.
Menu of Selected Tribal Laws Related to Occupational Safety and Health. This publication offers examples of selected tribal laws related to occupational safety and health that can be referenced by jurisdictions interested in developing or updating their own occupational safety and health laws. The publication provides examples of occupational safety and health codes, laws specific to certain industries or activities, child labor laws, and workers’ compensation laws.
Behavioral Health Integration in Pediatric Primary Care: Considerations and Opportunities for Policymakers, Planners, and Providers. This Milbank-sponsored report explores the prevalence of childhood behavioral health problems; describes the need for, barriers to, and models of behavioral health integration (BHI) in pediatrics; and offers BHI policy and implementation considerations for policymakers, planners, and providers.
Premiums and Tax Credits Under the Affordable Care Act vs. the American Health Care Act: Interactive Maps. Sponsored by the Kaiser Family Foundation, these interactive maps compare county-level premiums and tax credits between the Affordable Care Act (ACA) in 2020 with those proposed under the American Health Care Act. The comparative information is taken from data made available as of March 21, 2017. For more information about tax credits as applicable to the ACA and the American Health Care Act, refer to How Affordable Care Act Repeal and Replace Plans Might Shift Health Insurance Tax Credits.
Drug Compounding: Survey of State Pharmacy Bodies. The US Government Accountability Office conducted a survey of state pharmacy regulatory bodies in all 50 states, DC, Guam, Puerto Rico, and the US Virgin Islands to collect information about drug compounding; inspections and enforcement actions related to compounding; state laws, regulations, and policies; states’ interaction with the US Food and Drug Administration and other states; and perspectives about the passage of section 503A (establishing requirements for drug compounders that are not outsourcing facilities) and section 503B (added outsourcing facilities) of the Food, Drug, and Cosmetics Act.
Top Stories
Topics: Stem Cell Procedure, Tribal Landmark Case
National: Patients lose sight after stem cells are injected into their eyes
New York Times (03/15/2017) Denise Grady
Story Highlights
Stem cells research and procedures have been met with both apprehension and excitement as their capacity to grow new cells and possibly cure diseases like cancer, multiple sclerosis, and age-related macular degeneration (AMD) have been publicized. Federal funding for stem cell research was discontinued in 2001. But even with a steep reduction in funding, the lack of regulation and policy in the field has allowed for continued growth with various stem cell clinics opening across the United States.
On March 16, 2017, the New England Journal of Medicine published an article detailing the activity of one stem cell clinic in Sunrise, Florida that performed procedures resulting in permanent eye damage to three patients. The patients received eye injections of stem cells that were extracted from their own bodies.
The patients underwent the procedure with the impression that it was part of government-approved research. Previously, they had visited and found the name of the clinic providing the procedure, US Stem Cell, on www.clinicaltrials.gov, a government website sponsored by the National Institutes of Health.
While US Stem Cell was listed on the website, it did not receive any federal approval. In fact, because the cells being injected were from the patients’ own bodies—which are not considered a “drug”—the procedure was not subject to US Food and Drug Administration (FDA) approval. The stem cell injection procedure would be considered the same as a skin graft procedure where the patient receives a graft of his or her own skin.
Although these patients had a terrible experience, the chief science officer of US Stem Cell stated that the company treated a variety of other cases without consequence, and these incidents merely reflected “a handful of adverse events.”
Because US Stem Cell and similar clinics are not mandated to report to federal agencies, they operate in unique and vague medical/legal areas. According to current standards, stem cell procedures do not have to be approved as long as they are from the patient and are minimally manipulated. The term “minimally manipulated” has no specific definition and could be understood a variety of different ways.
In response to tragedies like this, the FDA has issued warnings about stem cell treatments. Patients are encouraged to ask their physicians if they have obtained the necessary FDA approval for any stem cell procedures or if the patient will be part of an FDA-regulated clinical study, even if the stem cells being used are the patient’s own.
[Editor’s note: Learn more about stem cells and how they are regulated.]
Canada: Sinixt First Nation wins recognition in Canada decades after ‘extinction’
The Guardian (03/30/2017) Ashifa Kassam
Story Highlights
In 1872, when the border between Canada and United States was established, the territory belonging to the Sinixt First Nation (also known as the Arrow Lakes Tribe) was dramatically altered and divided. With the separation of the land, many members of the tribe moved south to Washington State, leaving few behind in the land located in British Columbia, Canada. When Annie Joseph, the last living tribe member in Canada, died on the Okanagan Reserve in 1953, the country declared the tribe extinct and repossessed the land belonging to the Sinixt. Now, 60 years later, members of that same tribe have won a landmark case that requires Canada to acknowledge their existence and hunting rights.
This decision was based on a case brought to the court by Rick DeSautel, a Sinixt Tribe member and Washington state resident, who was fined by Canadian conservation officers for hunting in what was traditionally Sinixt territory without a license and as a non-resident. DeSautel routinely traveled to Sinixt territorial land to hunt elk and deer to bring to elders on the Colville reservation in Washington and did so based on his ancestral right to the land. However, because Canada had deemed the tribe extinct, they cited their unofficial status as the rationale for the charges. Ultimately Judge Lisa Mrozinski sided with the Sinixt Tribe stating that “the overwhelming historical evidence is that the Sinixt continue to exist today as a group” and that tribe members have the right “to hunt in their traditional territory in what is now British Columbia as they had done for several thousand years before contact.”
This victory for the Sinixt First Nation marks a true success. After years of population decimation, relocation, and invasion, the tribe’s members have been able to reclaim their identity in Canada as a recognized group that will continue their presence in their original territory—not limited by government policy or an international border.
[Editor’s note: Read the court’s ruling in Regina v. Richard Lee Desautel [PDF – 5.15MB], Provincial Court of British Columbia, Case No. 23646, Filed Mar. 27, 2017, learn more about
Sinixt tribe and read “The Sad, Strange Saga of the Sinixt People,” published in Indian Country Today, by Jack McNeel (Nov. 9, 2011).]
Briefly Noted
Topics: Fentanyl, Mental Health Insurance Benefits, Education Standards, and more
Florida: Safety net hospitals oppose potential cuts
Health News Florida (04/04/2017) The News Service of Florida
Massachusetts: Fentanyl adds a new terror for people abusing opioids
NPR (04/06/2017) Martha Bebinger
[Editor’s note: Learn more about fentanyl.]
Massachusetts: Pot shops are coming. Where to put them?
Boston Globe (03/17/2017) Johanna Seltz
[Editor’s note: Learn more about marijuana and public health.]
New Hampshire: Needle exchanges one step closer to being in NH
New Hampshire Public Radio (03/23/17) Paige Sutherland
[Editor’s note: Read New Hampshire’s Senate Bill 234-FN.]
New Jersey: Lawsuit blames improper marketing of opioid for woman’s death
STAT (03/24/2017) David Armstrong
Ohio: Drugs are killing so many people in Ohio that cold-storage trailers are being used as morgues
The Washington Post (03/16/2017) Kristine Phillips
Texas: House approves bill focused on mental health insurance benefits
The Texas Tribune (04/04/2017) Marissa Evans
Virginia: Immunization rates plateau in Virginia in recent years
Richmond Times-Dispatch (03/19/2017) Katie Demeria
National: Five pharmacy regulations health execs must keep on their radars in 2017
Modern Healthcare Executive (03/19/2017) Kenneth Maxik
National: Supreme Court sets higher bar for education of students with disabilities
The Washington Post (03/22/2017) Emma Brown and Ann E. Marrimow
[Editor’s note: Read the US Supreme Court decision in Endrew v. Douglas County School District Re-1 [PDF – 122KB], No. 15-827, decided Mar. 22, 2017.]
National: Space tourism companies are going to write their own safety rules because the US government can’t
Quartz (03/20/2017) Tim Fernholz
National: Even for the homeless, no ID means no government aid
Governing (03/14/2017) J.B. Wogan
National: Soda or bear claw? Panera to post added sugar in drinks it sells
New York Times (03/31/2017) Stephanie Storm
Global Public Health Law
Topics: Zika Costs, Food Insecurity, Coca-Cola Boycott, and More
El Salvador: How an innocent man wound up dead in El Salvador’s justice system
The Washington Post (03/16/2017) Sarah Esther Maslin
Japan: UN Report: Sanctions disrupt humanitarian aid to North Korea
US News & World Report (03/23/2017) Eric Talmadge
Latin America: Zika could end up costing Latin America and the Caribbean up to $18 billion, UN report finds
UN News Centre (04/06/2017)
Nigeria: Nigerians boycott Coca-Cola drinks after court rules them ‘poisonous’
CNN (03/28/2017) Paul Adepoju and Kieron Monks
Somalia: The UN is pushing for a dual-track response to the food insecurity crises. Is this feasible?
Devex (04/03/2017) Amy Lieberman
Tanzania: People with HIV are panicking due to Tanzania’s crackdown on gays
NPR (03/15/2017) Amy Fallon
United Kingdom: UN aims to immunize more than 115 million kids
Associated Press (03/23/2017)
Profile in Public Health Law: David Clarke, World Health Organization
Interview with David Clarke
Title: Senior Health System Advisor
Organization: World Health Organization (Geneva, Switzerland)
Education: Bachelor of Laws (LLB), Canterbury University, New Zealand; Master of Laws with honors (LLM), Victoria University of Wellington, New Zealand. Barrister and solicitor of the High Court of New Zealand.
Public Health Law News (PHLN): What sparked your interest in international public health law?
Clarke: I got into the field by accident. When I was at law school, I wanted to be a litigator like everyone else in my class. When I left law school, I had a choice between a litigation job in a small country town or working at the New Zealand Ministry of Health in Wellington. I chose Wellington. Working at the Ministry of Health opened my eyes to the possibilities of working with health law, the breadth of the field and its complexity, as well as the challenges of working at the intersection between policy, law, rights, and social change.
After the ministry, I started working in health law in many different countries, which added the complexity of navigating different legal systems and the political economy of law reform in these different places. Now, I wouldn’t do anything else; health law is intellectually stimulating work and hugely rewarding.
PHLN: Can you tell us more about your work with the Ministry of Health?
Clarke: When I stared, we were involved in implementing major health sector reforms as part of a wider public sector reform program, so a lot of my early legal work was focused on the reform process, reform legislation, and implementation.
We were a small legal team at the ministry, so I also ended up advising about and working on health policy and legislation development on a broad range of topics, including health privacy, patient rights, health professional regulation, law and mental health, medicines regulation, food law, tobacco control, and public health law.
PHLN: How does law affect health system functions?
Clarke: In the health sector, health law, public health, and health policy are all intertwined. Health policy determines the character and content of laws, and in turn, health laws shape the way that health policy is translated into health programs and services.
Concretely, the law formally expresses and gives effect to fundamental values, principles, and norms, which guide the health work of governments, such as the “right to health” and the “rule of law.” It provides a framework for the day-to-day operation of a health system—most countries belonging to the Organization for Economic Co-operation and Development and many middle income countries have a legal framework for their health systems. Law supports the performance of all the key health system functions and gives legitimacy to and practical means for implementing health policy (through regulation and the creation of institutions and processes).
Critically, law also authorizes the provision of public health goods, such as disease surveillance.
The challenge is making laws work. Many countries have outdated laws that work against a government’s health policies and laws that aren’t implemented or enforced. Understandably, there is a lot of cynicism about the value of law in countries where these situations exist.
PHLN: Before joining the World Health Organization (WHO), you were a consultant to several countries about public health issues. Can you please describe some of those projects?
Clarke: I spent about 10 years working on various projects as a legal consultant in about 40 countries.
The first consulting project I ever had was a project to introduce a legal framework for healthcare standards for Trinidad and Tobago. That involved a lot of technical legal analysis and drafting and a lot of consultation and key informant interviews and policy development work. The last consulting job I had before joining WHO was in Cambodia, working on new laws for regulating health professionals and reforming the way in which Cambodia’s various health professional regulatory bodies are organized and operate.
PHLN: What other public health law issues have you worked on?
Clarke: Much work on public laws (laws affecting population health), so laws about communicable disease control and the International Health Regulations and laws to help curb non communicable diseases (laws relating to tobacco control, alcohol harm, and obesity).
PHLN: What is WHO and what is your role?
Clarke: The United Nations (UN) agency responsible for health.
I work on legal issues about health systems, particularly those focused on universal health coverage. Most of my work is normative, but I also provide direct technical assistance about health law reform to WHO member states and our regional and country offices.
I work in the governance team at WHO headquarters, though I also work across our cluster on legal issues. I work in the health systems and innovation cluster, which is organized along the lines of the various health systems building blocks. Recently, I’ve been working with colleagues on legal issues about health service provision and health worker regulation.
PHLN: What is universal health coverage? Why is it a priority for WHO?
Clarke: All the UN member states have agreed to try to achieve universal health coverage (UHC) by 2030. This includes financial risk protection, access to quality essential health-care services and access to safe, effective, quality, and affordable essential medicines and vaccines for all.
UHC is a health system goal that aims to ensure that all individuals and communities receive the health services they need without suffering financial hardship. It includes the full spectrum of essential, quality health services, from health promotion to prevention, treatment, rehabilitation, and palliative care. UHC is critical for WHO because it is designed to ensure that everyone can access the services that address the most important causes of disease and death. It is also designed to ensure that the quality of those services is good enough to improve the health of the people who receive them.
PHLN: What does law have to do with individuals having access to health care? How does that access relate to public health?
Clarke: Effective legal health coverage is a critical part of UHC. Universal health coverage requires equitable and effective access to at least essential health care as defined at the national level. Law provides the way to formalize health coverage, through entitlements to health prescribed by national law though national health services or national health insurance schemes.
PHLN: Why is it important to have a library of each country’s health laws and universal health coverage status?
Clarke: Because it supports the work of member states on UHC law reform efforts. The website is a quick and easy way to find existing best practice information about law, regulation, and health care, as well as guidance, tools, and best practice guides relevant to law/regulation and UHC. The site is also a continuation of a long-standing practice at WHO to collect and make available information about member state health laws.
PHLN: Why should countries like the United States be interested in global health and global health law?
Clarke: Diseases don’t stop at borders. One important role of public health laws is stopping the spread of disease internationally. Through CDC, the United States has had a very strong leadership role in the global health area.
PHLN: You’re currently working on an initiative that aims to engage countries with the private sector. What might that engagement might look like? Why it is a priority?
Clarke: The reality of many countries’ health systems is that they rely on private health providers, big and small, profit and not-for-profit. The challenge of achieving UHC by 2030 means that governments will need to work with partners, including the private sector. The questions then are when to engage with the private sector, how, and for what purposes. We’re about to launch a project to produce practical guidance for our member states to help them answer these questions.
PHLN: How does your program intersect with other programs at WHO?
Clarke: I collaborate with people across my cluster on health law issues. More informally, I also connect with the lawyers working on health law topics in other clusters. We have plans to build a network in WHO of people who are interested in health law—a bit like the network of public health attorneys and practitioners PHLP supports.
PHLN: What are the greatest challenges of working in a large organization like WHO?
Clarke: Understanding who does what at the headquarters and in the regions and countries. The first thing I printed and pinned to my wall was the WHO organizational chart—even though I have been here for two years now, I still look at it daily.
PHLN: You’ve worked a lot with communicable disease control, alcohol, tobacco, and obesity—how do you feel government policies and laws have affected your ability develop change within these areas?
Clarke: All the countries I’ve worked with in these areas have wanted to reform their laws and policies. The issue is usually the political economy of these changes from groups who oppose change.
PHLN: What other projects are you currently working on?
Clarke: I’m working on a tool for mapping country health laws and assessing their impact on UHC.
PHLN: What would you be doing if you were not working in international public health law?
Clarke: Running a cafe somewhere warm and sunny next to a nice beach.
PHLN: How can people learn more about public health law at WHO?
Clarke: Check out our website or drop us a line at
healthlaws@who.int.
PHLN: Have you read any good books lately?
Clarke: I’ve been reading Homo Deus by Yuval Harari and Umberto Eco’s How to Write a Thesis—in moments of weakness and madness I’m considering starting a PhD program.
PHLN: Do you have any hobbies?
Clarke: Mostly sports—I cycle, kayak, play tennis.
PHLN: Is there anything else you’d like to share?
Clarke: Only that there are many people doing great work in the health law space, and we are very keen to hear from people and organizations willing to help advance the agenda of using laws to improve health systems’ performance.
Public Health Law News Quiz
The first reader to correctly answer the quiz question will be featured in a mini public health law profile in the May 2017 edition of the News. Email your entry to PHLawProgram@cdc.gov with “PHL Quiz” as the subject heading; entries without the heading will not be considered. Good luck!
Public Health Law News Quiz Question: April 2017
For which two diseases did PHLP publish menus of healthcare worker and patient vaccine laws for state ambulatory care facilities in the April 20, 2017, edition of the News?
Public Health Law News Quiz Question March 2017 Winner!
Amy P. Winterfeld
Question: At which conference in Denver, Colorado, did PHLP present a workshop about public health law on March 29, 2017?
Answer: The Society for Public Health Education (SOPHE) Conference.
Employment organization and job title: Tri-County Health Department—Chronic Disease Prevention Policy Specialist; Colorado Public Health Association—Public Health Policy Director (volunteer)
A brief explanation of your job: In my day job, I work for a local public health agency that serves three counties that ring the northern, eastern, and southern sides of the Denver metropolitan area and the 26 municipalities in that area. I’m part of a team that helps municipalities enact and implement policies for tobacco prevention and control. I also work with colleagues across the agency and around the state on a variety of other public health policy matters. Separately, I volunteer as public health policy director for the Colorado Public Health Association, where we’re currently preparing to observe National Public Health Week, including a Public Health Day at the Colorado capitol.
Education:
Bachelor of arts, with honors in history—Brown University
Juris doctor—University of Colorado School of Law
Favorite section of the News: Briefly Noted. I like this section because it provides quick summaries of public health policy innovations, news stories, and court decisions from all around the nation.
Why are you interested in public health law? Public health laws and policies can bring about improvements in the health of entire populations, at the community, state, national, and global levels.
What’s your favorite hobby? I have an assortment of pastimes—walking, theater, reading, cooking.
Court Opinions
Topics: EMTLA, Untaxed Cigarettes from Reservation, Aboriginal Hunting Rights, and more
Maine: Summary judgement denied—hospital may be found liable for violating stipulations established in the Emergency Medical Treatment and Labor Act’s screening and stabilization requirement, because patient’s symptoms may have qualified him as needing “emergency medical condition.”
Michaud v. Calais Regional Hospital
United States District Court for the District for Maine
Case No. 1:15-cv-359-NT
Filed 03/07/2017
Opinion by Judge Nancy Torresen
Federal: Court holds UPS liable for transporting untaxed cigarettes from Indian reservations in New York.
State of New York v. United Parcel Service, Inc. [PDF – 779KB]
United States District Court for the Southern District of New York
Case No. 15-cv-1136 (KBF)
Filed 03/24/2017
Opinion by District Judge Catherine B. Forrest
British Columbia (Canada): British Columbia court affirms aboriginal hunting and fishing rights in favor of Sinixt People.
Regina v. Richard Lee Desautel [PDF – 5.16MB]
Provincial Court of British Columbia
Case No. 23646
Filed 03/27/2017
Opinion by Judge L. Mronzink
Quote of the Month
James Farrell, Virginia Department of Health Vaccination Director
“We are suffering from our own success. We’ve had parents who never had communicable diseases because the vaccines have been so effective. Vaccines are the greatest public health success story there is,” said Dr. James Farrell of Virginia’s stagnant vaccine rates.
Editor’s note: This quote is from Immunization rates plateau in Virginia in recent years, Richmond Times-Dispatch, 03/19/2017, by Katie Demeria.
About Public Health Law News
The Public Health Law News is published the third Thursday of each month except holidays, plus special issues when warranted. It is distributed only in electronic form and is free of charge.
The News is published by the Public Health Law Program in the Office for State, Tribal, Local and Territorial Support.
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News content is selected solely on the basis of newsworthiness and potential interest to readers. CDC and HHS assume no responsibility for the factual accuracy of the items presented from other sources. The selection, omission, or content of items does not imply any endorsement or other position taken by CDC or HHS. Opinions expressed by the original authors of items included in the News, or persons quoted therein, are strictly their own and are in no way meant to represent the opinion or views of CDC or HHS. References to products, trade names, publications, news sources, and non-CDC Web sites are provided solely for informational purposes and do not imply endorsement by CDC or HHS. Legal cases are presented for educational purposes only, and are not meant to represent the current state of the law. The findings and conclusions reported in this document are those of the author(s) and do not necessarily represent the views of CDC or HHS. The News is in the public domain and may be freely forwarded and reproduced without permission. The original news sources and the Public Health Law News should be cited as sources. Readers should contact the cited news sources for the full text of the articles.
- Page last reviewed: April 20, 2017
- Page last updated: April 20, 2017
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