Tomorrow: 3rd Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 7:45 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Should patients be able to limit doctor access to medical records?

by Vadim Shteyler 

The growing accessibility of Electronic Health Records (EHRs) across hospitals and practitioners raises new concerns about patient privacy. Before EHRs, patients had control over how much information they shared with each healthcare provider. Receiving patient information from other practitioners has required a signed consent form specifying the information patients are comfortable sharing (e.g., radiological studies, mental health history, sexual history, etc.). And hospitalists have been expected to request the minimal necessary information to provide good care. With growing networks and increasing compatibility across EHRs, more providers now have access to information without the patients’ express permission or even awareness.

Recent works published in the Journal of General Internal Medicine reported the results of a study that designed and recorded patient and provider experiences with a patient-controlled EHR (in which patients chose which providers could access which data in their medical records). A preliminary survey showed that, before the study, only 10 percent of patients had access to their medical records. Half of surveyed patients did not know what information their EHR contained. However, all patients wanted access to their EHRs. Meanwhile, another study reported that only one-third of physicians thought patients should have EHR access. Continue reading

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

Continue reading

FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.

Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects.  Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines.  Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process.  (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)

But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement.  Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review.  They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs.  But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.

Continue reading

FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation.  And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.

Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion.  Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).

More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw.  I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.

Continue reading

The People of the State of New York v. Actavis: Making a Hard-Switch Procompetitive

Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.

The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.

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European Responses to the Ebola Crisis, Part I: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading

Sloppy Thinking about Genetic Therapy

By David Orentlicher
[Cross-posted at Health Law Profs blog]

As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.

Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.

But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided.  Continue reading

Egg Freezing and Women’s Decision Making

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.

Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing.  Continue reading

Legal Personhood in the New Argentine Civil and Commercial Code

By Martín Hevia

The Argentine Congress has just passed a new and unified Civil and Commercial Code. The new Code will be effective as of January 2016. The Code covers topics from torts and contracts to family law and in vitro fertilization. It is a massive volume of almost 2700 articles – it is, however, shorter than the current Code, which includes almost 4000 articles -.

One of the main issues in the new Code is the definition of legal personhood. Article 19 of the new Code states that “Human personhood starts with conception”. This wording has been strongly critized because “conception” has been frequently defined as “fertilization.” Critics argue that Art. 19 may imply an obstacle for assisted reproductive technologies: in vitro embryos may be considered “legal persons”, comparable to a live human person. Thus, they may be taken to have the same right to life. In fact, this argument has been accepted by some courts. For example, in 2002, the Supreme Court of Argentina prohibited the production, distribution, and commercialization of Imediat, an emergency contraceptive because of its perceived abortive effects it is considered to violate the right to life, which is regarded as an absolute right that preempts any other right.  For the Court, life begins with the union of the gametes, namely, with fertilization and before implantation. A similar line of reasoning was followed by the Ecuadorian Constitutional Court in 2004.

In contrast, defenders of the wording of Article 19 argue that it should be read together with Article 20, which states that “time of conception is that between the maximum and the minimum length of pregnancy”. This may mean that there cannot be conception outside a woman´s body. Thus, conception is to be understood as “implantation.”  Continue reading

Tomorrow: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave.
Cambridge, MA 02138

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Wasserstein Hall, Milstein East B, Harvard Law School, 1585 Massachusetts Ave.

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet ChatI’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.  Continue reading