Global connections concept illustration.

21st Century Lawmaking in an Interdependent World

By Caroline E. Foster

A new pandemic instrument should explicitly embrace the three emerging global regulatory standards of due diligence, due regard, and regulatory coherence.

These standards sit at the interface between national and international law to help functionally align the two in ways that will protect and advance shared and competing interests in an interdependent world.

The standards require nations to exercise their regulatory power in certain ways, including demonstrating (i) due regard for the international legal rights and interests of others, (ii) due diligence in the prevention of harm to other States, and (iii) regulatory coherence between governmental measures and their objectives. These international law standards are already implicit in and given effect by the operation of WHO’s current International Health Regulations (IHR) of 2005.

As we develop new pandemic instruments, their presence should be made increasingly explicit. Giving a stronger profile to the standards will help generate new political impetus and new legal bases for implementation of world health law, and fit it to 21st century application.

Read More

Gloved hands hold medical face mask with WHO (World Health Organization) flag.

Strengthening International Legal Authorities to Advance Global Health Security

By Lawrence O. Gostin

The COVID-19 pandemic has exposed marked limitations in the International Health Regulations (IHR) and constrained authorities of the World Health Organization (WHO). With a rising imperative to advance pandemic preparedness and response, more than twenty heads of government proposed a new pandemic treaty. This prospective pandemic treaty offers a pathway to develop innovative international legal obligations, strengthening core capacities, good governance, and compliance mechanisms to prepare for novel outbreaks with pandemic potential.

Read More

international connections concept art.

Moving Beyond a State-Centric Pandemic Preparedness Paradigm: A Call for Action

By Tsung-Ling Lee

Despite the World Health Organization’s (WHO) recent efforts to broaden participation, the international infectious disease control regime remains state-centric.

As such, the state-centric infectious disease regime violates the fundamental principle of how contagious diseases spread within and across countries — the virus recognizes no national borders, nor does the virus discriminate. The longstanding global health mantra — no country is safe until all countries are safe; no one is safe until everyone is safe — should guide global pandemic preparedness.

Read More

Minneapolis, MN / USA - May 26 2020: Black Lives Matter, "I Can't Breathe" Protest for George Floyd.

Expendable Lives and COVID-19

By Matiangai Sirleaf

Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).

“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.

Read More

Road sign that reads "Attention Ebola"

Ebola… again: What have we learned?

By Alicia Ely Yamin

As Susan Sontag eloquently noted decades ago, illness conjures metaphors that reveal a great deal about how we think about, and, in turn, address them. None more so than the lethal Ebola, which monstrously disfigures bodies before killing the infected person and spreading rapidly through the routines of everyday life.

In the West, Ebola evokes images of illness as a deadly foreign invasion, while in the West African pandemic we know that first those who were afflicted—and later those who survived—were stigmatized as possessing demons.

The growing outbreak in the DRC has produced calls for greater physical and financial involvement from the US government by a number of health law scholars, citing the potential for exponential spread if it reaches highly populated areas, and underscoring it as a global health security issue.  Thus far, WHO’s Director General has not declared it a “Public Health Emergency of International Concern” (PHEIC), which triggers consideration of both trade and travel restrictions, as well as international assistance and under the International Health Regulations. Read More

Innovation Gaps on Life Science Frontiers

Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The  Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).

Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.

Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)

Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K

More information on  speakers, agenda and registration is available here and here.

Extended background:

Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.

To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.

This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.

 

.

 

Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

By Timo Minssen

As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of Law and Business about the failures of the patent system to support new therapeutics. The text is below:

Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine

Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Read More

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

By Timo Minssen

Dear readers and colleagues,

I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016.

Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, living in Sweden and commuting every week over the bridge to Copenhagen in Denmark – most recently with thousands of terrified refugees and border controls on the way back to Sweden – this year has left me with much astonishment and concern about the state of the European Union and our global situation. It appears to me as if the EU and other global leaders have focused far too much on tiny technicalities, while leaving the bigger issues untouched and disregarding crucial lessons of history. There are so many things that we must learn from 2015’s terrible events and alarming decisions, but also from the hope-giving agreements, incidents and initiatives. For me one of the most important take-aways is that everything is connected and that sustainable, realistic solutions not only require immediate actions. In my view, we need to think about long-term strategies both in more detail and from a bigger perspective. Due to the complexity of our most pressing problems this is a colossal task. It demands more knowledge, better communications, more collaboration and a more effective coordination of  the considerable skills and different competences that are already out there.

Returning to the actual topic of this blog, it becomes evident that this is also very much true for the health sector and the bio-pharmaceutical area. Not only the Ebola outbreakglobal health crises, IPR debates, dreadful business models and controversial FTA negotiations, but also scientific break troughs, new therapies, legislative action and novel US and EU approaches demonstrate very clearly how this area is left with many challenges and opportunities. The recently approved US 21st Century Cures Act and the new EU Clinical Trials Regulation, for example, show how legislative activities pursuing laudable goals might lead to unwanted adverse effects if they are not carefully enough considered. Read More

Classifying Ebola as a National Security Threat

At yesterday’s Third Annual Health Law Year in P/Review event hosted by the Petrie-Flom Center, George Annas, William Fairfield Warren Distinguished Professor of Health Law, Bioethics, and Human Rights at Boston University School of Public Health, discussed the legal and public health response to Ebola. One issue that he raised was that in response to the outbreak in West Africa, President Obama classified the situation as a matter of national security rather than a public health issue. It is not clear to me that these categories need be mutually exclusive. (To be clear, Annas did not assert that they were.) Regardless, retrospectively the decision to frame Ebola as a threat to national security appears to have allowed bi-partisan support for a large scale humanitarian aid project, in a way that alternative framing of the problem may not have. It is interesting to note that the President actively encouraged the Ebola outbreak to be perceived as a “biological danger,” a “national security threat,” and “not just a humanitarian or economic concern.” However, framing the Ebola outbreak in West Africa as a national security issue did not only come with the positive externality of increased support for foreign aid. Once a domestic issue, there was some confusion as to who was “in charge” of the handful of Ebola-related issues that arose–with the President appointing an Ebloa Czar, Gov. Christie issuing quarantine notice for Kaci Hickox, and the response of the CDC blaming the nurses for breaking protocol the Dallas hospital case, serving just a few main examples.

Although framing Ebola as a national security issue may have allowed for increased support for the United States’ role internationally, it is unclear whether the domestic response to Ebola could have been more coordinated had this initially been framed as a public health issue.

Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

By Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen

This new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen appears on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.