Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.
Category: Global Health
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
Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS
Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:
Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk
This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.
The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Read More
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. Read More
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. Read More
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.)
Playing the Long Game: Epigenetics and Public Health
By Seán Finan
Good investing takes time, foresight and patience. You have to thoughtfully spend now for a big return in ten years. But when it comes to investments in public health, everybody wants to make a quick and easy buck. I’ve written before about the need for more emphasis on preventive care over “heroic medicine”: it costs less, it’s easier to administer and it leads to better outcomes. But fully realizing the potential of preventive care and public health initiatives takes more than vaccines and check-ups. The government could invest in an unlimited buffet of hospital examinations and laboratory tests for all, but if people can only afford food that leaves them obese and diabetic or if they live in neighborhoods where crack dens and meth labs outnumber the schools, the investment is not going to pay off. Addressing the social determinants of health has incredible potential to improve outcomes on a population level.
Efforts are already being made. The government aims for “Health in All Policies” by promoting holistic education programs for poor youths and funding better food in stores in neglected communities. Other initiatives focus on fighting food insecurity among families or homelessness among pre and post natal mothers. The topic was covered well in this article from the Kaiser Family Foundation. They break the social determinants of health into the broad categories of social, economic and environmental factors. Things like economic stability, neighborhood and physical environment, education, food and social context play a massively underappreciated role in health outcomes. The article contains a graphic on the impact of different factors on the risk of premature death. Apparently, healthcare has the smallest impact at 10%. Individual behaviors carry the biggest single impact at 40%. The social and environmental factors that the article focuses on contribute 20%. The last factor was genetics, at 30%. As I was reading, I remembered seeing this article on epigenetics and it struck me that the separation of genetics from behavior and environmental factors might be a little artificial.
Preventing a post-antibiotic world
Nick Bagley and I have an op-ed in today’s New York Times calling for serious economic incentives for antibiotics, delinking revenues from sales volumes with a $4 billion prize system.
From the piece:
On Friday, the Centers for Disease Control and Prevention released a disturbing report about the death of an elderly woman in Washoe County, Nev. What killed her wasn’t heart disease, cancer or pneumonia. What killed her were bacteria that were resistant to every antibiotic doctors could throw at them.
This anonymous woman is only the latest casualty in a war against antibiotic-resistant bacteria — a war that we are losing. Although most bacteria die when they encounter an antibiotic, a few hardy bugs survive. Through repeated exposure, those tough bacteria proliferate, spreading resistance genes through the bacterial population. That’s the curse of antibiotics: The more they’re used, the worse they get, especially when they’re used carelessly. […]
Read more here.