New Product Liability Regime for Stem Cell Products?

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By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More

The Supply of American Doctors

The Petrie-Flom Center Staff Leave a comment

Following up on his post on Australia, Al Roth notes that American medicine is a market with tightly restricted entry, at all levels. Proposed legislation offers a glimpse: Bill Would Create More Medical-Residency Slots, Potentially Easing Physician Shortage

Legislation introduced in Congress on Monday would expand the number of Medicare-sponsored training slots for new doctors by 15,000, a step that two medical-education groups said would go a long way toward easing a projected shortage of physicians. The bill, the Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act (HR 6352), is sponsored by Rep. Aaron Schock, an Illinois Republican, and Rep. Allyson Schwartz, a Pennsylvania Democrat. Medical schools have been expanding their enrollments and new schools have been opening up as concerns have grown about a shortage that could reach more than 90,000 physicians by 2020, according to the Association of American Medical Colleges. Those worries have intensified with passage of the Affordable Care Act, which will greatly increase the number of people seeking medical care by providing insurance coverage to 32 million more people. But while more students are making their way through the medical-school pipeline, they’re likely to run into bottlenecks because of a cap on the number of Medicare-supported residency training slots that Congress imposed in 1997.

[cross-posted on Market Design]

Is the USTR Trading Away Doctors’ Rights to Freely Perform Medical Procedures?

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By Adriana Lee Benedict 

The 14th round of negotiations for the Trans-Pacific Partnership Agreement (TPPA, a multilateral trade agreement currently being negotiated by the USTR and 10 other countries) is currently underway in Leesburg, VA.  Last month, KEI posted a brief video blog about an interesting provision (Article 8.2) of the TTPA’s leaked draft IP chapter calling for patentability of diagnostic, therapeutic and surgical methods.  Critically, KEI pointed out that current US law (35 U.S.C. 287(c))—which was amended after widespread concern from physicians’ associations regarding the adverse public health effects of medical method patent liability were brought to light with Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt. 1995)—immunizes medical practitioners from patent infringement suits concerning medical methods, although the draft TPPA provision makes no such exception.  The proposed provision is also contrary to Article 27(3) of TRIPS and Article 1709(3)(a) of NAFTA, all of which allow countries to exclude such medical methods from patentability, as well as Rule 39.1 of the 1970 PCT, which exempts International Searching Authorities from having to conduct patent searches relating to medical methods.

Medical professional societies, including the WMA, AMA, AAOS, ACOG and ASRC, have also opposed medical procedure patents on ethical grounds.  The WMA has explained that patents are not necessary to incentivize innovation in medical procedures: “Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills… physicians already have both obligations to engage in these professional activities as well as rewards for doing so.”  The WMA has also noted a number of adverse effects on access to medical care resulting from medical procedure patents, including higher costs, fewer physicians available and/or willing to perform patented procedure, and less innovation in medical procedures.

So what does this mean for the TPPA negotiating parties? Read More

Yale’s Friday Newsletter

The Petrie-Flom Center Staff Leave a comment

So…it’s a bit late today, but each Friday we’ll be posting some highlights from the Yale Interdisciplinary Center for Bioethics newsletter (AKA “Frimail”), a really fantastic resource for those of us interested in what’s been going on in the bioethics world each week (both in the popular media and in the journals). They also have job and conference announcements, etc. Enjoy!

Read More

Market Design Flaw in Australia

The Petrie-Flom Center Staff Leave a comment

Al Roth has come across a troubling phenomenon in Australia, where medical internships are in short supply.

Medical students languish in a critical condition

The Australian Medical Students’ Association estimates almost 500 students will miss out on an internship next year because of insufficient places. Under the internship system students must work for a year under supervision in a hospital before they can work as doctors. … Australian Medical Association president Steve Hambleton points to the curious situation where the nation has a shortage of doctors, yet there are too few internships.  … The placement system has fallen apart, he says, because the federal government regulates the number of students universities can enrol while its state counterparts oversee the provision of internships. 

[cross-posted on Market Design]

 

Worth Reading This Week

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By Nicolas Terry

FDA Law: More Statutes Than Regulations?

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By Katie Booth

The FDA Law Blog has just published a semi-serious study by Kurt Karst on the growth of Title 21 of the United States Code (“USC”) compared to Title 21 of the Code of Federal Regulations (“CFR”) over the past twelve years. Title 21 governs food and drug law. Karst used the PDFs of the USC and CFR available on the Government Printing Office website to compare the number of pages in the USC and CFR from year-to-year. A graph of his results is available on Karst’s post, “The Obesity Epidemic: FDA’s Growing Waistline!”

Unsurprisingly, Title 21 of both the USC and the CFR grew in length between 1999 and 2011. More interestingly, however, the USC grew by 50% while the CFR grew by only 10%. If the purpose of regulations is to interpret and flesh out statutes, common sense would suggest that food and drug regulations would grow at a greater rate than food and drug laws (or at least at the same rate). Karst’s explanation for his findings is that the “FDA has been issuing far fewer regulations, and instead, has been implementing the law through guidance and other policy documents.”

Read More

The Evolution of Public Health Law Research

Temple University Center for Public Health Law Research Leave a comment

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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Discrimination in the Doctor-Patient Relationship

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By Holly Fernandez Lynch

Nir Eyal’s post below has teed up the issue of doctors refusing to accept patients for reasons that seem to be pretty questionable.  The latest example has to do with obesity, but there are plenty of others having to do with vaccination status, sexual orientation, and the like.  Sometimes these refusals can be clearly categorized as conscientious objections (religious or otherwise).  And other times they are  a bit fuzzier, such as when the refusals are rooted in attempts to drive changes in behavior  (e.g., “get vaccinated or you can’t be my patient”) or when they stem from having inadequate staffing or equipment.  But for the patient, all of these refusals can feel discriminatory.   And that raises the obvious question: can doctors legally discriminate against patients?  The answer: it depends.  Sometimes yes, and sometimes no.

First, bear with me while I make the obligatory pitch for my book, Conflicts of Conscience in Health Care, which is now a few years old, but the issues are still very much live.  In that book, I delve deeply into the question of how to balance provider conscience and patient access.  In general, I argue that it is important to protect provider conscience, to a point (or points) – and those points have to do with burden on the patient and avoidance of invidious discrimination.   Read More

Conference Announcement: Connected Health Symposium 2012

The Petrie-Flom Center Staff Leave a comment

We got an email today announcing the Connected Health Symposium in Boston this October 25-26.  Check out the agenda here.  Elliott Fisher, Professor at The Dartmouth Institute and one of the architects of the concept of “accountable care organizations,” will be discussing why the principles underlying accountable care should help to address the problems confronting US health care.