FDA v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects

Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market.  Opana ER is an extended-release pain reliever often abused by those who take it.  While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or heroin, Opana ER is particularly dangerous because of how people misuse it.  The pill was designed to prevent would-be abusers from crushing and snorting it —  a popular means of ingesting prescription opioids.  Without the ability to crush and snort the drug, however, abusers turned to dissolving the pills and injecting them intravenously, leading to outbreaks of Hepatitis C, HIV, and other blood-borne diseases.  In Indiana’s Scott County, for instance, the prevalence of HIV has skyrocketed since the introduction of Opana ER to the local population, with 190 new cases since 2015.

While this foray into public health is somewhat surprising — given the anti-regulatory stance of the current administration and its billionaire backers — it is precisely the type of initiative the FDA should be taking.  Public health is a central part of the FDA’s mission statement, which notes that the agency “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”  Traditionally, though, the FDA’s efforts to ensure safety and efficacy have been limited to the narrow context of individual patients taking medications as directed under physician supervision.  As the FDA noted in its Opana ER press release, this is the first time it has requested that an opioid be taken off the market as a result of its susceptibility to abuse and the associated public health consequences.

Continue reading

Better Care Act Targets Immigrants

If you need yet another reason to conclude that the Senate Republicans’ proposed health care bill – the so-called Better Care Reconciliation Act (BCRA)– is designed more to appease different parts of the Republican base than improve the health care financing system, look no further than page 2 of the draft. There hiding in plain sight are provisions barring certain classes of documented immigrants from participating in health insurance exchanges. To understand why the bill includes these provisions, and why they make no sense from a health policy perspective, a bit of history is helpful.

As Patricia Illingworth and I document in our recent book, The Health of Newcomers: Immigration, Health Policy, and the Case for Global Solidarity, anti-immigrant sentiment has long distorted health policy. That was the case during the summer of 2009, when opponents of what became the ACA rallied in town hall meetings charging that President Obama wanted to provide coverage to undocumented immigrants. When Obama pledged to a joint session of Congress that undocumented immigrants would not be covered by his plan, Rep. Joe Wilson of South Carolina shouted out “You lie.” Continue reading

Making Health Care Safer: What Good Looks Like

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Continue reading

Housing Equity Week in Review

Our latest round-up of the biggest stories in housing law and equity, for the week of June 12-18, 2017:

  • The Joint Center for Housing Studies of Harvard University released the yearly State of the Nation Housing report. The report encourages a renewed national commitment to expand the range of housing options available.
  • A NY State Appellate Court struck down a chronic nuisance ordinance in Groton, NY, because of provisions that led to the eviction of those who seek emergency services. Story via Ithaca.com
  • The Out of Reach report and tool that was published a couple of weeks ago by the National Low Income Housing Coalition is getting press around the country for showing the gap between current wages and rents in most US cities. This article, from CNBC highlights the lack of affordable housing for minimum wage workers.
  • An opinion piece in The Hill makes, again, the case for investment in housing as an investment in childhood development and health.
  • 79 people are presumed dead in the fire at Grenfell Tower in London. Some argue that the tragedy should be a red light for distressed public housing in the US.
  • The Philadelphia Inquirer posted its second article in its Toxic City series. This most recent article investigates lead-poisoned soil in the city’s River Wards neighborhoods. While lead paint is often considered the biggest danger to children, in these areas and others, the soil may be a great danger.

WHO: Global Patient Safety Leadership

By John Tingle

The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:

“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”

Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Continue reading

Vicarious Traumatization in the Wake of Community Violence: Healing the Helpers

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Michelle Bosquet Enlow, PhD

depression_slideWhen a horrific violent event occurs, the community’s thoughts and efforts to help naturally extend out to the injured and traumatized survivors and the loved ones of those killed. However, the effects of such traumatic events ripple out beyond those so directly impacted. According to the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2013), the definition of trauma includes not only direct exposure to actual or threatened death or serious injury, but also witnessing such an event or experiencing repeated or extreme exposure to aversive details of such an event. Under this more comprehensive definition, the circle of affected individuals in the wake of community violence widens to include professionals and community leaders who are tasked with tending to the safety, medical, emotional, instrumental, and spiritual needs of those wounded. These “helpers” include first responders (e.g., police officers, emergency medical technicians), medical and mental health professionals, case workers, and religious leaders. Continue reading

Newtown: A Public Health Law Perspective

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Wendy E. Parmet

No man is an island

Entire of itself,

Every man is a piece of the continent,

A part of the main

—John Donne, 1624

Like John Donne’s famous Meditation XVII, Newtown, Kim Snyder’s documentary about the aftermath of the 2012 massacre at the Sandy Hook elementary school in Connecticut, forces us to reflect on the inter-connectedness of human life. As Newtown shows with power and poignancy, the victims of that awful massacre were not islands. They were a part of a continent comprised of their families, friends, community, and indeed, all who recall the awful day they were killed.

parmet-chartThis inescapable reality, that our lives and deaths can affect and even traumatize others, is perhaps sufficient to proclaim that gun violence is a public health problem. None of the over 30,000 Americans who die each year from gun violence (most by suicide), are islands. Nor are any of the over 78,000 Americans who are injured by firearms. All are part of the continent. Gun violence affects us all.

But gun violence is a public health problem for another, equally important reason. As with other public health problems, from obesity to HIV/AIDS, the risk that individuals face with respect to firearms is influenced significantly by factors that lie outside their own control. This is not simply because the victims of the Sandy Hook massacre did nothing, and could do nothing, to cause their own death. It is also because different populations face different levels of risk. Race, age, income, gender, geography and a host of other variables determine one’s risk of dying or being injured by firearms.  Continue reading

Newtown: A Story of Collective Grief and Trauma

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here

By Kim Snyder, Director and Producer of Newtown

We believe we must be the family of America, recognizing that at the heart of the matter we are bound one to another. – Mario M. Cuomo

newtown_sign_flags_webWhen I first landed in Newtown over four years ago following the horrific tragedy at the Sandy Hook Elementary School, I was drawn first and foremost to a story of collective grief and trauma. Seeing the story in the larger context of commentary on America’s problem with gun violence came later. My producing partner, Maria Cuomo Cole, and I both felt we hadn’t seen a documentary that chronicled the long tail of collective trauma for years out, after the cameras had left. We also hadn’t seen this story told from the perspective of an entire town. It is important to note that Newtown is a community of 28,000 people, and the vision of the film sought to represent a sample of voices from various sub-communities. Over the course of the next three to four years, we built trust with members of the Newtown community and explored the trajectory of collective trauma and resilience as it reverberated throughout Newtown and beyond. Not surprisingly, survival guilt was a pervasive theme that emerged. Through the perspectives of multiple sub-communities of the town—the educators, first responders, medical providers, clergy, neighbors, and youth—we came to observe a journey of fracture, isolation, and repair as this courageous community struggled to survive in the aftermath of the unthinkable.  Continue reading

Healing in the Wake of Community Violence: Lessons from Newtown and Beyond

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Cristine Hutchison-Jones, PhD

Community members gather at a memorial service after the Sandy Hook school shooting. Still from the documentary Newtown.

Community members gather at a memorial service after the Sandy Hook school shooting. Still from the documentary Newtown.

On June 12, 2016, an armed man walked into the Pulse night club—a gay bar in Orlando, Florida, packed with patrons enjoying Latin night—and opened fire. By the time the police shot the gunman three hours later, he had killed 49 people and wounded more than 50 others in the deadliest mass shooting by a single shooter in American history.

As we mark today’s anniversary, the news is awash with stories of the way the shooting continues to impact people a year later. Much of the coverage—then and now—has rightfully focused on those most directly affected: the victims and their loved ones, and the LGBTQ and Latinx communities who were targeted and disproportionately impacted by the attack. But amidst the coverage of survivors and their loved ones, some stories are taking a step back to look at the broader impact. This is in keeping with a recent trend to discuss the lasting effects of incidents of mass violence on the wider community. Today’s coverage of the Pulse night club shooting includes stories that focus on the EMTs, police officers, and health care workers who were first on the scene and treated victims in the immediate aftermath of the attack, and on the impact of secondary trauma in their lives. Continue reading

Housing Equity Week in Review

It was a busy week in housing equity and the law! Here’s the news from the week of June 5-11, 2017:

  • The National Low Income Housing Coalition published Out of Reach 2017, a comprehensive report and tool to assess housing affordability in the U.S. The tool assess the rent-wage needed for a two bedroom unit in every county in the United States.
  • The National Fair Housing Alliance, along with other groups, is circulating an open letter the Senate to reject the CHOICE Act that was passed by the House of Representatives last week. The act, which the Alliance refers to as the “Wrong CHOICE Act,” is a deregulation attempt that strips elements of consumer and investor protection from Dodd Frank. These protections, the Alliance argues, had a significant impact mainly on consumers and borrowers of color. Read their statement.
  • Meanwhile, Senate Democrats led by Tim Kaine (D-Va.) introduced the Fair and Equal Housing Act of 2017, which will add sexual orientation and gender identity as protected classes under the Fair Housing Act. The Act will be introduced soon and is accompanied by H.R. 1447: Fair and Equal Housing Act of 2017 that was introduced to the House of Representatives earlier this spring. Coverage via Housing Wire.
  • Mapping Inequality: Redlining in New Deal America is a tool by created by Robert K. Nelson et al. It allows users to explore credit worthiness maps in American cities of 1935-1940.
  • “The Color of Law: A Forgotten History of How Our Government Segregated America” is a new book by Richard Rothstein that explores the role of law in creating and maintaining racial residential segregation. He sat down last week with Ted Shaw at UNC-Chapel Hill and Rep. Gwen Moore (D-Wis.) to discuss his book. Watch a recording of the event here.
  • A report by New Jersey Future assesses changes New Jersey has made to their Low Income Housing Tax Credit Qualified Allocation Plans (QAP). The changes to the QAP are meant to move LIHTC developments away from concentrated poverty areas. The adjustment proved successful in locating LIHTC developments in high opportunity areas. Read more about this from New Jersey Future.

CAVEAT HOSPITIA: Suits Alleging Negligent Credentialing Against Hospitals Get Exemption from Tort Reform

By Alex Stein

Policymakers and scholars interested in medical malpractice and torts generally should read Billeaudeau v. Opelousas General Hospital Authority, — So.3d —-, 2016 WL 6123862 (La. 2016). In this recent and important decision, the Louisiana Supreme Court ruled that suits alleging negligent credentialing against a hospital sound in regular negligence, rather than medical malpractice, and consequently fall outside the purview of the state’s Medical Malpractice Act (MMA) and its limitations on liability. The Court made this decision in connection with the state’s cap on damages recoverable in medical malpractice actions, La. Rev. Stat. § 40:1231.2(B)(1), which limits the total amount that courts can award the victim to $500,000, plus interest and cost, on top of the victim’s future expenditures on medical care and support. For many victims of medical malpractice and their families this cap amount is meager, but the Court nonetheless upheld its constitutionality back in 1992. See Butler v. Flint Goodrich Hosp., 607 So.2d 517 (La. 1992).

The Court has now decided that suits alleging negligent credentialing against hospitals are not subject to this cap and that successful plaintiffs consequently will recover full compensation for any proven damage. Continue reading

ERISA: A Bipartisan Problem for the ACA and the AHCA

By Allison K. Hoffman

On Monday, the Supreme Court decided another case that enhances ERISA’s deregulatory impact, Advocate Health Care Network v. Stapleton (holding that pension plans maintained by church-affiliated organizations, including hospitals, are exempt from ERISA’s pension protections as “church plans.”). Justice Sotomayor joined the majority opinion but wrote a concurring opinion lamenting its outcome and suggesting that Congress rethink ERISA — a suggestion Justices Thomas and Ginsburg have also made in the past. Abbe Gluck, Peter Jacobson, and I wrote the following on ERISA’s increasingly outsized influence and how it poses an impediment to health reform in the Health Affairs Blog on June 2, 2017.

From our post:

The Supreme Court has once again been called on to mediate the boundaries of a far-reaching, infamously complex, federal employee benefits law. And once again this law may have an important and unanticipated effect on health care.

The main goal of this law, the Employee Retirement Income Security Act of 1974 (ERISA), was to provide uniform, federal regulation of pensions and employee benefit plans (including health care). But the law has had a far more dramatic impact on health policy beyond what Congress ever contemplated. Because ERISA pushes aside state regulation of these plans, it has impeded the states’ ability to partner with the federal government to achieve key health policy goals. ERISA has also stymied some of Congress’s goals under the Affordable Care Act, and may prove an even greater obstacle to Republican efforts to return more authority over health policy to the states. Continue reading

Housing Equity Week in Review

Affordable housing was the biggest topic of conversation last week, May 29-June 4. Here’s the week in review for housing equity and the law:

  • Vox published an interactive tool with “Everything you need to know about the affordable housing debate.” It covers issues from “What is affordable housing?” to gentrification, section 8, and zoning.
  • California’s State Senate and Assembly passed multiple laws to tackle the affordability crisis in California cities. Laws include more funding and relaxed regulation to build affordable housing units. Coverage via KQED.
  • Last week, HUD secretary Ben Carson said that, to a large extent, “poverty is a state of mind.” Today, Carson clarified that “state of mind” is just one component. Affordable housing advocates like Diane Yentel, of the National Coalition of Low Income Housing, responded that housing poverty is due in large to HUDs budget, not state of mind. Coverage via NPR.
  • The mortgage interest tax deduction is a controversial program that many critique as being beneficial mainly to the rich. Eliminating the mortgage interest tax deduction could make houses much more affordable. CityLab offers a way to make homes 10 percent more afforable.
  • Five hundred people lined up to try to get an apartment in a 88 unit development in Philadelphia, shedding light on the city’s affordability and homelessness crisis. Coverage via Philly.com.

The Global Virome Project: Understanding Our Viral Enemies to Create a Safer World

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

By Ana S. Ayala

There is no doubt that viruses, emerging and re-emerging, have become an imminent global health threat. Starting in 2014, we saw the decimation of West African countries as a result of the Ebola epidemic. Soon after came the Zika outbreak that continues to pose a threat to countries in the Americas and around the world. Since December 2016, Brazil has been experiencing a rise in yellow fever cases , and deaths, among humans and monkeys alike. Colombia and Peru have already reported probable cases. As a response to rising human cases of the H7N9 bird flu, China just ordered the closure of all poultry markets in the eastern province of Zhejiang to stop the trade of live poultry.

Experts warn that the question is not whether but when a pandemic will hit. Unknown or little-known viruses currently looming in animal populations undetected pose a especially dangerous risk–we have little to no experience with them, we do not know whether or when they will spill over to humans, and we do not know where they will emerge next. Continue reading

Newtown: A Public Health Law Perspective

This post stems for the “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Film Screening and Panel Discussion,” held at Harvard Law School on April 24, 2017. 

By Wendy E. Parmet

No man is an island
Entire of itself,
Every man is a piece of the continent,
A part of the main

                John Donne, 1624

Like John Donne’s famous Meditation XVII, Newtown, Kim Snyder’s documentary about the aftermath of the 2012 massacre at the Sandy Hook elementary school in Connecticut, forces us to reflect on the inter-connectedness of human life.  As Newtown shows with power and poignancy, the victims of that awful massacre were not islands. They were a part of a continent comprised of their families, friends, community, and indeed, all who recall the awful day they were killed.

This inescapable reality, that our lives and deaths can affect and even traumatize others, is perhaps sufficient to proclaim that gun violence is a “public health problem. None of the over 30,000 Americans who die each year from gun violence (most by suicide), are islands. Nor are any of the over 78,000 Americans who are injured by firearms. All are part of the continent. Gun violence affects us all. Continue reading

Emergency Preparedness: Is Quarantine All We Have to Offer?

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy K. Mariner

On August 1, 2014, while Ebola raged in Guinea, Liberia, and Sierra Leone, Donald Trump tweeted: “The U.S. cannot allow Ebola infected people back! People that go to faraway places to help out are great-but must suffer the consequences.”  Most experts agree that epidemics are best avoided where the population is educated, well-nourished, and resilient, with access to effective medical and public health resources. Yet, too often, the first response to the threat of an epidemic is to keep people out of the country or quarantine them. It is worth considering why this is so, and how we can do better.

A New Foreign and Interstate Quarantine Rule

On January 19, 2017, the day before Trump’s inauguration as President, the Centers for Disease Control and Prevention (CDC) issued final regulations for detaining individuals suspected of harboring a “quarantinable” communicable disease (QCD). Why would the Obama Administration issue new rules? The explanation in the Federal Register offers 2 reasons: (1) responding to the Ebola epidemic and outbreaks like MERS and measles; and (2) clarifying and codifying “current practice” “to make the public aware of their use.” Continue reading

When a Nurse Needs an Attorney: US Quarantine Policy

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Kaci Hickox, MPH, MSN, RN

As new cases of Ebola in the Democratic Republic of Congo (DRC) are announced, I am reminded of the importance of applying lessons learned from U.S. quarantine policies during the 2014 West Africa Ebola outbreak. I watched the suffering of entire families and communities facing the largest Ebola outbreak in history. During my Ebola training in Brussels, I will never forget hearing an Ebola expert explain, “Remember to have compassion because this disease turns peoples’ loved ones into a biological hazard.” I remember the moment I understood Ebola with my heart, not merely my head, when a young woman admitted to the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Treatment Unit in Bo, Sierra Leone, explained, “Nineteen of my family members have died of Ebola.”

Yet, in the midst of extreme fear and suffering, I also witnessed the profound courage of the staff responding to stop the outbreak. On my last day in the unit we had celebrated the discharge of 39 Ebola survivors. Offering isolation, testing, and treatment for persons who developed symptoms of Ebola was necessary to stop disease transmission and finally, after two years of response, the outbreak was declared over in December 2015! In this globalized world, we must be prepared to react not only to Ebola, but to any infectious disease threat with courage instead of fear, science instead of politics.

How do we ensure courageous responses to infectious disease threats? Continue reading

New Blog Symposium: Between Complacency and Panic – Legal, Ethical and Policy Responses to Emerging Infectious Diseases

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy E. Parmet and Jennifer L. Huer

Public health is often invisible. In contrast to health services, public health interventions usually operate behind the scenes, reducing risks to broad populations. No one can say who was saved, what deaths were prevented.

For public health, this invisibility presents political and budgetary challenges. Without clear beneficiaries, public health has lacked the political support and dollars allocated to health services. This challenge may be even more formidable today as the Trump Administration seeks enormous cuts to public health programs, while questioning settled public health science.

In the face of such challenges, it may be tempting for public health advocates to emphasize the dangers of emerging infectious diseases. Over the last forty years, a multitude of new or previously tamed infectious diseases such as HIV/AIDS, SARS, Ebola, and Zika have emerged, wrecking morbidity and mortality, and causing panic around the globe. During these outbreaks, public health’s importance becomes, at least briefly, all-too-apparent. Continue reading

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.)

Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Continue reading