child getting vaccinated

California Court of Appeal Rejects Challenge to Vaccine Law

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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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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Baby was receiving his scheduled vaccine injection in his right

Childhood Flu Vaccination and Home Rule in the Big Apple

On June 28, the State of New York Court of Appeals upheld a New York City Board of Health requirement that children between the ages of 6 months and 5 years old attending city-regulated child care or school-based programs receive flu vaccinations.

While New York City is no stranger to progressive public health initiatives, this ruling in particular is significant on at least two accounts. First, it strengthens New York City’s ability to confer the public health benefits of flu vaccination to a wider segment of the adolescent population, consistent with current recommendations. Second, it stands as a reminder of the important role that local health authorities, like boards of health, can play in improving population health, if granted sufficient authority under state law.

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a pile of vaccine vials and a needle

Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

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The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium
February 9, 2018, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika.  There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.

Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.

Panelists

  • Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
  • Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
  • Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School

Lunch will be provided. This event is free and open to the public.

Learn more about the Health Policy and Bioethics Consortia.

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. They are organized by the Center for Bioethics at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium
February 9, 2018, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika.  There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.

Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.

Panelists

  • Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
  • Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
  • Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School

Lunch will be provided. This event is free and open to the public.

Learn more about the Health Policy and Bioethics Consortia.

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. They are organized by the Center for Bioethics at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Read More

More on the ECJ Vaccine Liability Decision

By Alex Stein

My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).

To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso. Read More

Vaccine Liability in Europe: A New Development

By Alex Stein

Yesterday, the European Court of Justice has issued an important ruling on vaccine manufacturers liability. N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. This ruling triggered a hailstorm of criticism from different media outlets, including CNN. These outlets, however, have largely misreported the ruling and its underlying reasons, partly because of this misleading Press Release issued on behalf of the Court itself. In this post, I analyze the Court’s actual decision and briefly compare it with the American law.

The case at bar was about an adult patient who developed multiple sclerosis shortly after being vaccinated against Hepatitis B. The vaccination he received was manufactured by Sanofi Pasteur. Following the patient’s death from multiple sclerosis, his family filed a products liability suit against the company. The suit was filed in a French court, whose decision on evidentiary matters triggered a series of appeals that brought the case before the European Court of Justice. The Court was asked to determine whether the French evidentiary rule which allows plaintiffs to prove the vaccine’s defect and causation by “serious, specific and consistent evidence” in the absence of medical research in either direction aligns with the European law of products liability. The Court ruled that it does while making a number of clarifications and setting up conditions for such rules being valid under Article 4 of the European Council Directive 85/374/EEC of 25 July 1985. Read More

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. Read More