HealthLawProf Blog

What's at stake for Medicare?

A pointer and a question for Thursday:

1.  Mitt Romney's choice of Paul Ryan for his vice presidential candidate has garnered a lot of speculation as to his design for and potential influence on Medicare's future.  Kaiser Health News has posted a terrific rundown of the issues in video interview form; the clip lasts about 6 minutes, and it is time well spent.  Find it here: http://bcove.me/wnd9f74s or on the KHN website with a transcript (free content, as always).

2.  Do you plan to have your students read all or a portion of NFIB v. Sebelius?  If an abridged reading, how are you selecting the sections of the decision they will read (e.g., the Roberts opinion and Ginsburg opinion but not the joint dissent, only the joint dissent, etc.)?  I am leaning toward having my students read the whole Roberts opinion and the whole Ginsburg opinion but making the joint dissent optional (primarily to reduce the reading but also because Roberts covered their constitutional and statutory points more or less, except for severability, though not quite as broadly).  Thoughts?

[NH]

Medicaid Agonistes

Legal blogs have covered the Medicaid expansion in great detail. Now the law review scholarship is starting to emerge. Here’s one piece sure to make an impact: Nicole Huberfeld, Elizabeth Weeks Leonard, and Kevin Outterson on “Medicaid and Coercion in the Healthcare Cases.” From the abstract:

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes by the joint dissent) decided that the Medicaid expansion created by the ACA was a “new” program to which Congress could not attach the penalty of losing all Medicaid funding for refusing to participate. NFIB signals the Roberts Court’s interest in continuing the Federalism Revolution.

The Court relied on, seemingly modified, and strengthened at least two existing elements of the test for conditional spending articulated in South Dakota v. Dole. Clear notice and germaneness now appear to be folded into the newly fashioned yet undefined coercion doctrine, which relied on quantitative as well as qualitative analysis to determine that the Medicaid expansion was unconstitutionally coercive. The Court is now actively enforcing the Tenth Amendment to protect states from federal spending legislation. NFIB raises many questions regarding implementation of the Medicaid expansion as well as the ACA. The dockets will experience the reverberations of these open questions, as well as the Court’s invitation to explore the coercion doctrine.

For the near future, at least, the authors believe we are “plunged into Justice Cardozo’s ‘endless difficulties.’” For the long term, policymakers may want to take the advice of political science professor Andrea Louise Campbell:

[States are] ill suited to redistributive policy because they [have] an incentive to provide the lowest possible means-tested benefits in order to repel poor people and retain affluent taxpayers. The Great Recession also laid bare the devastating costs of the inability of nearly all states to run budget deficits and to engage in countercyclical spending during economic downturns. For many years, governors have urged the federal government to take on the portion of Medicaid that pays for nursing home stays for the disabled elderly.

Maybe now the time has come to federalize Medicaid altogether. Doing so would remove an enormous burden from state budgets and put an end to variations in state policy toward the poor that can have near-barbaric results. For example, in Texas, one of the states whose government plans to opt out, the working parents of Medicaid-eligible children can only get coverage for themselves if their income is below 26 percent of the federal poverty level. For a family of three, that’s $4,900 in annual income. Constitutionality is no barrier to federalization of Medicaid. The only question is whether it is politically feasible.

Huberfeld comes to a similar conclusion in another paper, arguing that “medicine generally and Medicaid specifically are already on the path to nationalization” and “Medicaid should be nationalized because federalism ideals are generally not served by the current structure.”

[FP]

Health Affairs and Safety Net Providers

Safety-net providers will be among the most significantly affected--for better or for worse--by what happens to Medicaid over the next several years.  Perhaps prescient about the Supreme Court's ACA decision, Health Affairs has devoted its August edition to challenges facing safety net providers. The issue begins with Timothy Jost's discussion of the Court's holding concerning Medicaid and the states and the editor's observation that we may be facing a two-state system:  states that do expand Medicaid and states that do not (or that even cut back). (Here's the issue:  Health Affairs Aug 2012)

The issue is particularly useful for the empirical work it presents about the current state of safety net providers and their patients.  Not surprisingly, nearly a third of providers are unwilling to accept new Medicaid patients at current reimbursement rates, percentages that were higher in smaller practices and in metropolitan areas. Perhaps more surprisingly, safety net hospitals directly governed by elected officials have done reasonably well financially--in part because of subsidies from state and local governments and disproportionate share payments, payments that may erode over the next several years.  These hospitals have faced challenges in implementing new technologies such as electronic health records and may find themselves struggling competitively over the next few years. Efforts to introduce integrated delivery systems, medical homes, and accountable care organizations have met with some success, but the evidence suggests that as funding incentives wane these gains have diminished.

I commend this rich issue to readers of this blog. The overall conclusion I draw is that if safety net providers are to continue to function for patients, we will need to pay attention not only to which states expand Medicaid or to Medicaid reimbursement rates, but also to support for the infrastructure of safety net providers themselves.

LPF

The Intersection of Immigration Reform and Health Care Reform

On Thursday, August 9, Reuters published an article about one of the hidden effects of the Affordable Care Act on undocumented immigrants that both supporters and opponents of the ACA should think about. Undocumented immigrants are not permitted to purchase private insurance on the heatlh insurance exchanges set up by the ACA, nor are they eligible for Medicaid. Health-care providers that serve this community are concerned that as more low-income citizens and documented immigrants get insurance under the ACA, undocumented immigrants will fail to seek health care because of the fear that they will be easily identified as undocumented due to their uninsured status, and reported to the authorities. Not only will the undocumented immigrants fail to seek health care for themselves, but they may very well fail to seek health care for their U.S.-born children, for fear of being identified, deported, and separated from their children. Despite assurances from health care providers that they don't check immigration status when treating patients, and don't report immigration status to the authorities, many undocumented immigrants have been taught through long experience in their home countries (and here) not to trust any authority, even health care providers. All of this makes the case for a comprehensive review of our laws regarding immigration and the treatment of undocumented immigrants when they are in the country. Having the laws regarding health care and immigration work at cross-purposes is hardly efficient or helpful to any of us.

Comparing our Policy to North Korea and Iran

However, I have little hope that any serious reform efforts to remedy this situation will be forthcoming. I recently saw something circulating on Facebook comparing our immigration policy unfavorably to the actions of North Korea, Afghanistan, and Iran towards those who illegally cross their borders (where you would generally be shot, sentenced to hard labor, or imprisoned for a lengthy period for crossing the border), and insinuating that this is why we are "broke." The absurdity of comparing our policies to those of totalitarian regimes, where people are starving (North Korea) or lacking in freedoms that we consider fundamental to our rights as Americans (Iran), and insinuating that North Korea and Iran have it right, all in an effort to foment baseless hostility towards undocumented immigrants (who have been found to use all social services less than American citizens) as the root of our economic troubles, does not bode well for any reasoned debate about our policy towards immigrants and health care.

A Health Insurance Executive with a Heart

On a more positive note, one of the more surprising statements in the article came from a health insurance executive who spoke anonymously, who expressed frustration with Washington, and stated that "the health system works better when people have access to coverage." The fact that this insurance executive felt the need to speak this simple fact anonymously does not make the the insurance industry look good. Apparently, not everybody in the industry feels the same way, given the history of coverage rescissions, refusals to cover people with pre-existing conditions, and skimpy insurance coverage peddled to many self-employed people. This executive was probably wise to to remain anonymous, if the executive wants to remain employed in the industry.

 [VJW]

Cross-posted on Healthy Interests

Teaching Health Care Reform

With the Supreme Court's mostly green light for implementation of the Affordable Care Act, it will continue to be an important topic in health care law courses. Two years ago, Shelly Kurtz and I organized a colloquium on ACA at the University of Iowa College of Law. We posted a good deal of the materials for the course here.

[DO]

Immigration Laws Affect Health Status

As some of you who attended the panel on immigration and health law issues chaired by Wendy Parmet at which Nathan Cortez, JoNel Neuman and I spoke, one of the serious consequences of law’s like Arizona’s SB 170 is that it discourages people from seeking medical care for themselves and their children for fear of being stopped and asked for immigration papers. This short article in the American Journal of Public Health describes what was essentially an incidental finding in a study of childhood obesity: concern about being stopped by the police has had a negative impact on public health.  The authors write that “Our findings from a study on childhood obesity in Flagstaff suggest that the law changed health-seeking behaviors of residents of a predominantly Latino neighborhood by increasing fear, limiting residents’ mobility, and diminishing trust of officials. These changes could exacerbate barriers to healthy living, limit access to care, and affect the overall safety of the neighborhood.”

The article calls for more research into this phenomena (hint for those considering applying for funding to study law & public health issues).  The same week it decided the Affordable Care Act case, the Supreme Court also upheld provisions of SB 170 which allow local and state law enforcement to check the immigration status of individuals who they are questioning for other reasons, it is likely that other states will soon adopt similar laws. This is a good example of a direct link between a law which has nothing to do with financing health care and a change in the health status of those affected.

JSB

Mental Health, Accommodation, and Understanding

One of the great challenges of both disability law and institutional governance is to determine how to fairly and empathically respond to the physical and emotional challenges of workers and clients.  Gregory Duhl's review of Margaret Price’s Mad at School: Rhetorics of Mental Disability in Academic Life should be of great interest to those grappling with these difficult issues. 

[FP]

Meaningful Adoption: What We Know or Think We Know About the Financing, Effectiveness, Quality, and Safety of Electronic Medical Records

I've posted a new article, here, that takes a critical look at the "Meaningful Use" subsidy program for Electronic Medical Records.

As ONC is working hard to draft the final regulations for Stage 2 of Meaningful Use (MU), its policy teams are working on the framework for Stage 3. Although the stimulus program has several more years to run early adopters who sought to maximize their receipt of federal funding will soon be reaching the mid-point of their journey. As a result data points are now emerging for some of the more important features of the program’s implementation. These data points can be compared to expectations set both in 2009 and earlier. This article reviews the history of MU and examines the level of current and projected implementation. It challenges the basis for some of the positive cheerleading surrounding the subsidy program and questions the quality of the installed base of EMRs. The critical analysis then extends outside of compliance with the quality and effectiveness requirements of MU to safety externalities and their regulatory and liability implications.

[NPT]

Worth Reading This Week

Ezekiel Emanuel et al, A Systemic Approach to Containing Health Care Spending, NEJM

Gil Siegal et al, Personalized Disclosure by Information-on-Demand: Attending to Patients’ Needs in the Informed Consent Process, SSRN

Jordan Paradise, Regulating Electronic Cigarettes: How the FDA Can Effectively Utilize the Tobacco Control Act to Protect Public Health, SSRN

Charles Roehrig et al, When the Cost Curve Bent — Pre-Recession Moderation in Health Care Spending, NEJM

[NPT]

 

The trope of flexibility

On Monday, Cindy Mann, Director of the Center for Medicaid and CHIP at CMS, spoke to the National Conference of State Legislators and assured them of CMS's permissive approach to participation in the Medicaid expansion.  Her statements were striking for their willingess to allow states flexibility in joining, participating in, and dropping the new expansion population.  Mann indicated this was CMS's interpretation of the Court's decision in NFIB, but CMS is offering much more flexibility than the Court required.  

Why would CMS read NFIB so broadly when it appears to limit HHS authority, or at least devolve a great amount of authority to the states?  One word: coverage.  If the agency's goal is to get as many lives as possible enrolled in Medicaid, then presenting the states with flexibility is probably the way to do it, at least in the current political environment.  But, Republican Governors have scoffed at Mann's offer of total flexibility.  It is hard to imagine any level of flexibility that would satisfy them beyond block grants with no conditions attached.

This drive for coverage should be balanced with the reality of payment sufficiency; will CMS be ‘flexible’ about what states pay the providers for the Medicaid expansion too?  CMS faces perverse incentives in its enforcement of the Medicaid Act - the federal government saves money if the states pay less for Medicaid services, even though the Act demands sufficient payment to ensure equal access to medical care in a geographic region.  If the states underpay their providers, the expansion population will have a very hard time accessing medical care.  Until now, CMS has been notoriously lax in enforcing the Equal Access provision, but it is in the process of writing final regulations to explain how that requirement should work.  CMS should ensure that the Equal Access regulations achieve the goals of Medicaid expansion rather than continue the old patterns of nonenforcement.  Otherwise, the "flexibility" offered to the states for enrollment of the newly eligible will only provide a veneer of coverage.

[NH]

 

 

Backing off on Pollution from Animal Feed Lots

In June, the DC Court of Appeals upheld the  Environmental Protection Agency’s authority to regulate greenhouse gas emissions (i.e. from cars and power plants), declaring in its opinion that the EPA was “unambiguously correct” that the Clean Air Act requires the EPA to impose limits once it has determined that emissions are causing harm. The EPA is clearly committed to going forward on health threats in the air.

However, the Administration seems less committed on water pollution threats. As Pew Charitable Trusts accurately reported, the EPA has just abandoned its proposed rule that would collect information about concentrated animal feeding operations (CAFOs). These lots often confine thousands of animals and generate massive quantities of waste, often containing heavy metals, hormones, antibiotic residues, and nutrients such as nitrogen and phosphorus. Many US drinking water sources are at risk from these discharges, but there is not much information collected about them.

On July 31, the North Carolina Environmental Justice Network and two other groups filed a lawsuit alleging a hog farm in North Carolina is illegally discharging animal waste into creeks, rivers, ditches and lands surrounding the facility. The groups measured unacceptably high levels of nitrogen, phosphorus, and fecal coliform in the waters. Examples like this abound, and illustrate the need for collecting this discharge information.

[MM]

A Tale of Two Conferences

 

During the past two weeks, Washington DC has been the site for two conferences of note to those interested in health law.  One was a conference of optimism and excitement, the other a conference of empiricism and concern.

The 19th International AIDS Conference was held July 22-27. The DC location was itself grounds for optimism:  the lifting in 2010 of the US restrictions on entry by persons living with HIV meant that the conference could once again be held in the US. Information about the conference--including rapporteurs notes about sessions as they are posted--can be found at http://www.aids2012.org/. There are also many wonderful blogs about the conference, including the National Latino AIDS Action Network, http://nlaan.org/main/, and the blog*AIDS*gov with conversations from AIDS 2012, http://blog.aids.gov/2012/07/conversations-from-aids-2012-ron-valdiserri-and-terrance-moore-on-addressing-hiv-disparities-among-black-gay-bisexual-men.html. The conference was addressed by a glittering list of political, entertainment, and philanthropic superstars. The theme of the Conference was "Turning the Tide Together" and the official press release billed it as beginning "the march toward the end of the AIDS epidemic."  Coinciding with the opening day of the conference were local Washington events, including a "keep the promise" march and performance by Wyclef Jean.  Here's Victoria Pickering (my sister)'s photo of the march: 

 flickr user vpickering

Far more sober was the second conference, the National Conference on Health Statistics, http://www.cdc.gov/nchs/events/2012nchs/  There was no address by Secretary Sebelius or Bill Clinton or Bill Gates. There were no parties or receptions--not even the potato chip gathering that used to serve (I am told) as a way for health statistics folks to schmooze.  Instead, there was an opening session devoted to the tremendous economic importance of good public health statistics overshadowed by the deep fear that government cutbacks are gutting this essential resource.  There were many wonderful sessions about the data that are increasingly being made available, about data standards and usability, and about the health progress that is made through good data. All slides from the conference will be available on the web site relatively soon.  My own hope is that public policy makers recognize the importance of these public resources before they starve.

[LPF]

Tax Credits, Federal Exchanges, and Misplaced Blame

It appears that congressional opponents of the Affordable Care Act will stop at nothing to derail it, even if it means that their own constituents would suffer.  Recently, House Republicans on the Oversight and Government Reform Committee questioned the Internal Revenue Service's ability to apply tax credits to the purchase of health insurance in federal insurance exchanges that will be set up by the federal government in states that refuse to set up their own insurance exchanges.  These tax credits are designed to make private insurance affordable for moderate-income consumers who want or need to purchase insurance on these exchanges.  So if the the law is not interpreted to allow the IRS to apply the tax credits in states that refuse to set up health insurance exchanges, consumers in those states will be forced to either purchase insurance they cannot afford, or pay the tax due for failure to purchase health insurance.  Even though the non-partisan Congressional Budget Office and the congressional Joint Committee on Taxation agree with the IRS, these sage representatives apparently know better.

 I assume that the overall strategy here is to ensure that people in these states get so upset by the unaffordability of insurance on the exchanges (due to the lack of tax credits available to them) that they blame the supporters of the law for this debacle, rather than the politicians who are apparently willing to sacrifice their own constituents' well-being and pocketbooks in favor of their agenda.  This reminds me of the ACA Supreme Court dissenters' concerns that the Medicaid expansion in the ACA could confuse voters by blurring the lines of political accountability between the federal government and the states.  The argument is that voters who are upset by the expansion of Medicaid and the bureaucracy needed to achieve the expansion would blame the states, rather than the federal government, for the expansion, and that this poses a danger to our federalist system.  Apparently, the opponents of the ACA do not share this concern of misplaced blame when it comes to playing politics in Congress.

I quote the late Telly Savalas as Kojak: "Who (really) loves ya, baby?

 [VJW]

Cross-Posted on Healthy Interests

RomneyCare Part 2

The Massachusetts Health Care Cost Containment Bill may have been long on rhetoric and short on enforcement mechanisms, here, but today it became law, here. Will we look back on this as the beginning of the end for fee for services? [NPT]

Information Technology’s Failure to Disrupt Healthcare

I've posted a new piece, Information Technology’s Failure to Disrupt Healthcare, here.

Information Technology (IT) surrounds us every day. IT products and services from smart phones and search engines to online banking and stock trading have been transformative. However, IT has made only modest and less than disruptive inroads into healthcare. This article explores the economic and technological relationships between healthcare and healthcare information technologies (HIT), asks (leveraging the work of Clayton Christensen) whether current conceptions of HIT are disruptive or merely sustaining, and canvasses various explanations for HIT’s failure to disrupt healthcare. The conclusion is that contemporary HIT is only a sustaining rather than disruptive technology. Notwithstanding that we live in a world of disruption, healthcare is more akin to the stubborn television domain, where similarly complex relationships and market concentrations have impeded the forces of disruption. There are three potential exceptions to this pessimistic conclusion. First, because advanced HIT is not a good fit for episodic healthcare delivery, we may be experiencing a holding pattern while healthcare rights itself with the introduction of process-centric care models. Second, the 2010 PCAST report was correct, the healthcare data model is broken. If Stage 3 of the MU subsidy program or some other initiative can fundamentally rethink interoperability (and we can fix the privacy issues) investment and innovation will migrate to data services built on top of shareable data. The final and potentially most interesting exception may be Mobile Medical Apps; products that are built on hugely disruptive platforms and championed by some of our most disruptive companies. Leveraging the growing computing power of smartphones and linkable biometric sensors, these apps hold the promise for “healthcare everywhere” and may be where the real disruption of healthcare will begin.

Comments gratefully received. [NPT]

 

Misguided Genetic Exceptionalism

While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media.

A genetic cancer test. In a fascinating series on genetics in medicine, Gina Kolata reported in the New York Times on a genetic test for ocular melanoma. The test distinguishes between curable and fatal forms of the melanoma, yet some physicians do not offer the test to their patients (though they disclose the availability of the test).

Of course, some patients may choose not to know which type of melanoma they have. Both curable and lethal types are treated in the same way--surgical removal--and knowing that death is certain may be too unsettling for a number of patients with the fatal form.

But to not even offer patients the chance to know seems odd. If the diagnostic test were not a genetic one, I suspect the physicians would act differently. For example, if doctors were able to distinguish between curable and fatal forms of ocular melanoma when tumor cells were sent to the pathology lab for standard cellular analysis, there would not be the same reluctance to offer patients the opportunity to find out which kind of tumor they had.

To be sure, the fact that a particular medical test is genetic may increase the potential for concerns with the test. But many genetic tests do not pose any special problems. Physicians should not let a genetic label mislead them.

Fighting dengue fever. A second example of problematic thinking about genetics appeared in the New Yorker in an article by Michael Specter about genetic modification of the Aedes aegypti mosquito to eliminate dengue fever. If the mosquito can be eradicated, so can the dengue fever virus, which kills many and for which there is no vaccine or antiviral therapy.

Continue reading

Worth Reading This Week

Mary Crossley, Tax-Exempt Hospitals, Community Health Needs and Addressing Disparities, SSRN/Howard LJ

Rodney Kristopher Miller, Sacrificial Lambs: Compensating First Subscribers to FDA-Approved Medications for Postmarketing Injuries Resulting from Unlabeled Adverse Events, SSRN/Catholic University L Rev

Sara Rosenbaum & Timothy Westmoreland, Shaky Assumptions Underlie New ACA Scoring, Health Affairs

[NPT]

 

Legal Barriers to Effective Pain Control (Part One)

 

The under-treatment of pain continues to be a significant public health problem in the United States.  According to a 2008 article in the Annals of Oncology, “Nearly one of two patients with cancer pain is undertreated. “   Moreover, according to a report issued by the Institute of Medicine in in June 2011, “the medical costs of pain care and the economic costs related to disability days and lost wages and productivity amount to at least $560 billion to $635 billion annually.  Because the range does not include costs associated with pain in children or military personnel, it is a conservative estimate.”  Unfortunately, even as both acute and chronic pain is under-treated, opiods continue to be abused.  According to FDA Commissioner Margaret A. Hamburg, MD, ““Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” 

Although the actual treatment of pain is a medical issue,  the law plays a significant role.  The FDA’s recent announcement of a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications” highlights the problem.     The initiative “calls on 20 companies that manufacture painkillers to fund training courses for doctors that will be taught by medical education companies. The goal is to reduce the risk of addiction and other health problems associated with opioids, while ensuring access to the drugs for patients in pain.”   These guidelines are, however, voluntary which is just fine with the American Academy of Family Physicians (AAFP) which rejects “mandatory “continuing medical education in pain control.   But it doesn’t go far enough according to “a coalition of doctors and public health officials” which is “petitioning the Food and Drug Administration” to go beyond education and actually “change the prescription guidelines for opioid medicines” to make it much more difficult for doctors to prescribe  “narcotic painkillers …in inappropriate cases.   “The petitioners say the prescribing of opioids has increased over the past 15 years, in response to a campaign by Purdue Pharma and other pharmaceutical companies that exaggerated the benefits of painkillers, while minimizing the risk of their long term use.”  The petition notes that, “Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain,” the petition says. “These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids.”

The many conflicts of interest between the companies which manufacture these drugs, the doctors who want broad authority to use them, and the patients in need of pain control represent a serious problem and, I suggest, yet another example of the difficulty of providing wide-scale, quality care absent any ability to directly regulate the health care system.

 JSB

 

 

Brustle: In the EU, it's immoral to patent stem cells obtained from destroying an embryo

Last fall, the European Court of Justice (Grand Chamber) interpreted Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions to exclude from patentability stem cells obtained from the destruction of human embryos. The case was brought by Greenpeace and sought annulment of Oliver Brustle's patent on neural precursor cells and processes for their production. The German Bundesgerichtshof (Federal Court of Justice) referred the case to the ECJ for interpretation of Directive 98/44/EC. The ruling reasoned that embryos are not patentable and thus materials obtained through embryo destruction are not patentable. Brustle v. Greenpeace (18 October 2011), http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d0f130d5d4216b78fe284603bff3d470bbb043f5.e34KaxiLc3eQc40LaxqMbN4Oa3iSe0?text=&docid=111402&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=30577.

In the legal background of the decision is the TRIPS agreement provision that members may exclude from patentability inventions when their commercial exploitation would threaten public policy or morality. Article 53 of the Convention on the Grant of European Patents excludes from patentability inventions "the commercial exploitation of which would be contrary to 'ordre public' or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting States." Directive 98/44/EC likewise emphasizes the non-patentability of inventions where commercial exploitation offends ordre public or morality. Article 6 of the Directive specifies that use of human embryos for industrial or commercial purposes violates ordre public or morality. Several assumptions were key to the ECJ ruling. The ECJ judged that the EU required a common standard for the definition of human embryo. The definition should be framed broadly rather than narrowly, to avoid encouraging a race to seek patents in the least restrictive jurisdictions. Patentability most be excluded whenever respect for human dignity could be affected. And dignity is affected by the treatment of any entity that could become a human being, including: "any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis." The ECJ left up to the referring court whether in light of current science stem cells themselves could become a human being and thus should be included within the ban.

Not surprisingly, the decision has generated significant controversy in the EU. Some see it as reflecting the influence of conservatives and the Catholic church, a potential harbinger of anti-abortion rulings to come. Others see it as likely to hamstring stemcell research within the EU. Still others see it as an important step in fighting unjustifiable commodification of human beings, a genuine achievement for human dignity.

Although the decision came down last fall, it has not yet been noted in this blog. I've used this post to call it to readers' attention as another illustration of the significant differences between EU and US approaches to the relationship between economic gain and research.

[LPF]