REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

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Privacy and Confidentiality: Bill of Health at Five Years and Beyond

In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information.  The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection and use of health information for public health and research, commercialization and monetization of information, whether and why we care about health privacy, and much more.  Interestingly, Bill of Health has no categorizations for core concepts in this area:  privacy, confidentiality, security, health data, HIPAA, health information technology—the closest is a symposium on the re-identification of information, held in 2013.  Yet arguably these issues may have a significant impact on patients’ willingness to access care, risks they may face from data theft or misuse, assessment of the quality of care they receive, and the ability of public health to detect emergencies.

Over the past five years, Bill of Health has kept up a steady stream of commentary on privacy and privacy-related topics.  Here, I note just a few of the highlights (with apologies to those I might have missed—there were a lot!) There have been important symposia:  a 2016 set of critical commentaries on the proposed revisions of the Common Rule governing research ethics and a 2013 symposium on re-identification attacks.  There have been reports on the privacy implications of recent or proposed legislation: the 21st Century Cures Act, the 2015 proposal for a Consumer Privacy Bill of Rights, and the proposed Workplace Wellness Bill’s implications for genetic information privacy.  Many comments have addressed big data in health care and the possible implications for privacy.  Other comments have been highly speculative, such as scoping out the territory of what it might mean for Amazon to get into the health care business. There have also been reports of research about privacy attitudes, such as the survey of participants in instruments for sharing genomic data online.  But there have been major gaps, too, such as a dearth of writing about the potential privacy implications of the precision medicine and million lives initiative and only a couple of short pieces about the problem of data security.

Here are a few quick sketches of the major current themes in health privacy and data use, that I hope writers and readers and researchers and most importantly policy makers will continue to monitor over the next five years (spoiler alert: I plan to keep writing about lots of them, and I hope others will too): Read More

Orphan Drugs Designations and Approvals have Something to Say about Risks

This brief essay examines data from the U.S. Orphan Drug Act, including specifically the FDA designations of an indication for a drug to treat an orphan disease, and the likelihood that once the designation is made, the FDA will approve the drug for that indication. This is one empirical measure of the risks associated with the development of new drugs to treat U.S. defined orphan diseases.  Note that 75 percent of all novel cancer drugs approved in the United States from 2010 to 2016 qualified as orphan products.    The essay also reports the average time between the FDA designation and the FDA approval for orphan indications.

The main findings are that since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.

The essay concludes with a comparison to other studies of the risks of drug development.


On January 5, 1983, the U.S. Orphan Drug Act became law as Public Law 97-414. Over the past 34 years the Act has been amended numerous times, often extending or expanding the benefits, which currently include a 50 percent tax credit for qualifying clinical trials, exemptions or discounts on prescription drug user fees, an easier and faster path to FDA approval, and seven years of marketing exclusivity for an approved orphan indication. Read More

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School 

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

Read More

Be Very, Very Concerned About What Allergan Just Did

Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back to Allergan, in exchange for tens of millions of dollars in both licensing and royalty fees. Although it may not sound like it, this transfer is potentially huge news in the drug pricing world. It is also extremely complex, and its full implications have yet to be determined.

Enormous caveat before we begin: I am by no means an expert on tribal sovereign immunity. I may well be wrong here. (In fact, I would very much like to be wrong here.) There is little (any?) case law on sovereign immunity’s impact in the Hatch-Waxman area, and much of what follows is extrapolated from case law on tribal sovereign immunity both in IP and in other contexts, state sovereign immunity in the IP area, and discussions with other law professors. Please let me know if this is your area of expertise and you believe I’ve gotten the analysis wrong!

In short, if repeated and taken to its logical conclusion, this transfer has the potential to prevent most invalidity challenges to drug patents. Would-be generic competitors could not seek to initiate inter partes review (IPR) actions before the Patent and Trademark Office (PTO). They could not bring declaratory judgment actions in federal court. And – both most importantly and most unclear – they could not bring Paragraph IV invalidity counterclaims under Hatch-Waxman, preventing generic companies from independently challenging patents’ invalidity and potentially requiring us all to wait until the very end of patent expiration to experience generic competition.

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First, Do No Harm: NGOs and Corporate Donations

By Clíodhna Ní Chéileachair

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.

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Innovation and the Firm: Vertical Integration in Patent-Intensive Industries – Seminar 9/8 at the University of Copenhagen

Looking forward to hear Professor Peter Lee’s (UC Davis) talk on “Innovation and the Firm: Vertical Integration in Patent-Intensive Industries” at the University of Copenhagen on Friday, Friday, September 8th 2017 from 10:00 – 12:00. If you are interested to join, please register here.

Abstract of Professor Lee’s talk:

Recent scholarship has highlighted the prevalence of vertical disintegration in high-technology industries, whereby distinct, specialized entities along a value chain transfer intellectual assets between them. Patents play an important role in vertical disintegration, for they lower the cost of technology transactions between upstream suppliers and downstream users.

This presentation, however, draws on empirical accounts to explore the peculiar persistence of vertical integration in patent-intensive fields. In biopharmaceuticals, agricultural biotechnology, and information technology, firms are increasingly acquiring technology providers rather than simply licensing their patents. This dynamic is even evident to a certain extent in university-industry technology transfer, where universities and commercializing firms frequently engage in institutional meshing to transfer patented technologies. Read More

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Read More