[Cross-Posted at Prawfsblawg]
The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.
Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.
I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.
I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.
by Adriana Benedict
Universities Allied for Essential Medicines (UAEM)
Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies
Thursday, April 25th, 3-5pm
Coffee and refreshments at 2:45pm; reception following the event
Harvard Medical School New Research Building – 77 Avenue Louis Pasteur
Seminar Room 1031
How do innovative medical technologies make their way to a global population, including patients in resource-limited settings? As centers of medical innovation, universities are well-placed to influence the global dissemination of the fruits of biomedical research and enhance access to advances in drug, vaccine, diagnostic and device technologies. In the past five years, several institutions in Boston and beyond have acknowledged this fact and taken bold steps to encourage the transfer of medical technologies to the developing world. Licensing provisions such as tiered, reduced and zero royalties for products sold in developing countries; march-in rights; agreements to agree; agreements not to patent or not to enforce patents in developing countries; and humanitarian licensing exceptions are just some of the strategies used to implement global access licensing of medical technologies. Others can be found in UAEM’s Global Access Licensing Framework, as well as the multi-institution Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.
In this Forum, technology transfer officials and academic research leaders from Harvard, MIT, Tufts, BU, Northeastern, Children’s Hospital and Partners Healthcare (MGH/BWH) will speak to their institutions’ philosophy and experience with global access licensing strategies. In an hour-long Q&A, the audience – including invited experts with significant experience in medical technology development – will contribute to the discussion. The Forum is open to the public; and researchers, entrepreneurs, university leaders and students are highly encouraged to attend.
UAEM is an international interdisciplinary student organization that works with universities to leverage academic research for global health. Since our founding in 2001, we have worked towards illuminating the poorly understood process that brings discoveries from the laboratory to widely accessible products and services meant to improve human health.
Registration through this link is appreciated, but not required.
This event is co-sponsored by grants from the Harvard Global Health Institute (HGHI), the HMS Division of Medical Sciences, and Harvard Law School Advocates for Human Rights.
This is the last in a three-part series (Part I, Part II) of posts I’ve written about the case between Novartis and the Union of India, in which the Supreme Court of India denied Novartis a patent for its anti-cancer drug Glivec. Today I’m continuing the discussion of the practical outcome of the case. What effect is the Glivec patent decision going to have on access to medicines in India and other developing countries?
Beyond issues specific to the transition period, the Supreme Court was considering challenges to Section 3(d) of its patent act, which prohibits patents for a new form of an existing drug without a change in therapeutic efficacy. It is designed to prevent evergreening, a term used to label practices where a small change is made to an existing product and claimed as a new invention. When Section 3(d) was enacted in 2005, it was unique to India—there was no analogous provision in any other country.
Novartis had at one point tried to argue that Section 3(d) was unconstitutional under the Indian constitution and non-compliant with TRIPS, but those arguments were rejected by the High Court at Madras in 2007. Novartis did not appeal those decisions. The High Court rejected the TRIPS claim because in India private plaintiffs may not challenge a national law based on its compatibility with an international agreement. However, the court also referred to the Doha Declaration, which affirms that “the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” This means that WTO members can set their own standards for patent protection within the bounds of TRIPS. Section 3(d) establishes a higher standard for an inventive step, which means that drugs patentable in other countries won’t necessarily be patentable in India.
I wrote earlier this month about the case between Novartis and the Union of India, in which the Supreme Court of India affirmed denying a patent for Novartis’ anti-cancer drug Glivec. Adriana Benedict added an insightful post about the case last week.
In my last post, I talked about the theory behind the decision and what it means for a drug to be therapeutically efficacious. Today and tomorrow, I thought it would be interesting to focus on the practical outcome of the case. In other words, what does this case mean for the access to medicines more generally, both in India and around the world?
Judging by recent public comments, this will be a landmark case. On the Novartis website, where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novaris spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”
Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.
By Adriana Benedict
Last week, Ryan Abbot blogged here about the Novartis case decided last Monday by the Supreme Court of India. Since then, there have been a broad range of reactions to the case, but many of them appear to have left a lurking elephant in the room.
I’d like to attempt to provide some clarity to a question that seems to have created a lot of confusion surrounding the impact of the Novartis decision: If the older alpha crystalline form of imatinib mesylate (generic Glivec) is already available in India, and the newer beta crystalline form is not more therapeutically efficacious, then why does it matter whether or not Novartis can get a patent on the newer version of Glivec? The simple answer is that for the most part, it doesn’t really, in terms of the availability of generic Glivec. At most, it may make a difference for some Indian patients who will do better with the beta crystalline form. And it will make some difference for Novartis, which will now forego a potential market of these Indian patients who would prefer to take (and can afford to pay for) the beta crystalline version. But the alpha crystalline form of imatinib mesylate was already available in generic form in India, and it would have continued to be available in generic form in India regardless of the outcome of this case. So why all the commotion?
First, the Novartis decision means that Indian generic manufacturers can now produce the beta crystalline form of imatinib mesylate with impunity. This means that Novartis is likely to face competition in its production of the beta crystalline form, over which it would otherwise have held a global monopoly. Indian generic manufacturers may now produce and export the beta crystalline form to other countries, which means that many more cancer patients in developing countries will have access to it. Novartis’s markets in these countries may be disrupted through parallel importation of cheaper generics.
By Scott Burris
Stephanie Morain and Michelle Mello’s recent paper in the March issue of Health Affairs is an extremely important contribution. It reports on a survey of American adults investigating their support for a range of current health interventions, and finds – contrary to the myth being propagated in politics and the media – that people strongly support the public health mission and the interventions that accomplish it. There is no better way to celebrate the end of Public Health Week than by sending a pdf to every one you know.
Having praised the piece, though, I want now to disagree with one part of the authors’ analysis. The table below shows the support for a fruit basket of public health interventions.
From this, M&M conclude “that the greater the restraint a legal intervention imposes on individual liberty, the greater public opposition to the intervention is likely to be. There was much support among our respondents for strategies that enable people to exercise healthful choices—for example, menu labeling and improving access to nicotine patches—but little support for more coercive measures, such as insurance premium surcharges.”
I don’t see that in the data.
An important case was decided yesterday that may have a significant impact on access to medicines for patients in developing countries. India’s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its cancer drug Glivec.
The case involved a challenge to Section 3(d) of the Indian Patents Act which was designed to prevent patent holders from extending the duration of their patents by making minor changes to existing formulations—a practice referred to as “evergreening.” Section 3(d) stipulates that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not eligible for patent protection.
The drug Glivec was initially invented and patented as a compound in its free base form. Novartis subsequently obtained a patent in the U.S. and Europe on a beta crystal version of the compound, which was found to possess 30% greater bioavailability. In yesterday’s case, one of the central questions before the court was whether the “new” drug form qualified for a new patent under Section 3(d). The court ruled that it did not.
To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.
On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.
Theoretically, I suspect a more holistic approach is justified.
I am writing my student fellowship paper under the broad topic of health worker “brain drain,” so I have been keeping an eye out for related news stories. Two stories that caught my eye in the past few weeks were about the health worker migration from civil war torn Syria and economic-crisis ridden Sudan. In Syria for example, half the doctors in Homs and all of the country’s nine psychiatrists have recently migrated. In Sudan, 1620 doctors left the country last year compared to 338 in 2008. In countries like these, especially Syria where medical personnel have been targets of violence, solutions to stem the migration or replenish the ranks seem particularly futile. Additionally, these countries’ self-inflicted wounds, including civil wars and poor administration, complicate matters. Not only do these internal struggles diminish the probable efficacy of potential solutions to the brain drain, but they also negate the perceived responsibility of the countries receiving these migrants, diminishing their will to help counteract the deleterious effects of the brain drain.
Civil war stricken countries like Syria present especially difficult cases for developed nation responsibility and intervention. But these news stories led me to think about brain drain and responsibility that results from war, specifically wars waged by developed nations in developing ones. A prime example is the recent war in Iraq. The Brookings Institute estimates that 20,000 of the 34,000 Iraqi doctors in the country in 2003 have migrated, and only 1525 had returned as of 2009. They also cite that 2000 Iraqi physicians have been murdered and 250 have been kidnapped over the same period. 50% of surveyed Iraqi doctors living both in Iraq and abroad said they had been threatened. A recent article in Lancet describes that before 2003 the major problems facing the Iraqi healthcare system stemmed from drug shortages and poverty. These problems have been superseded by violence and failing infrastructure in the intervening years. The brain drain has likely been exacerbated by these new threats.
A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.
No fee. Space limited. Registration required. Please register on our registration website.
by Adriana Benedict
Last week, the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and World Trade Organization (WTO) released a trilateral study on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. According to the official summary of the book, the publication is aimed at policy makers and is divided into four parts:
I. Fundamentals: the background of health policy and medical technology, the work of the three organizations, the burden of disease that challenges health policy, and the factors shaping that policy. Much attention has been paid to diseases such as HIV/AIDS, malaria and tuberculosis, but noncommunicable diseases such as cancer, diabetes and heart diseases are a rising challenge.
II. The Policy Context: the international framework, linking health policy, intellectual property and trade, the contributions of economic analysis, and the use of traditional medical knowledge in research.
III. Innovation in Greater Detail: the evolution of research and development, alternative ways of promoting innovation for neglected diseases, the role of intellectual property rights, with examples.
IV. Access: how to ensure pharmaceuticals and other medical technology reach the people who need them: pricing policies, taxes and import duties, procurement, regulation, technology transfer, local production, patents, compulsory and voluntary licences, trade agreements, and competition policies, etc.
In her remarks at the launch of the publication, WHO Director-General Dr. Margaret Chan emphasized the importance of the public interest not only in public health, but also intellectual property and trade policy. Importantly, Dr. Chan noted that it “is worth considering” an extension of the TRIPS Agreement (WTO Agreement on Trade-Related Aspects of Intellectual Property) transition deadline (currently set to July 1, 2013) for least-developed countries (LDCs) to implement the agreement’s provisions.
Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.” You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:
- “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.” Note that this doesn’t say anything about the injury being study-related.
- If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
- If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
- Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence. But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”. Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
by Adriana Benedict
In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries. In recent years, open access issues have taken on an increasingly important role in global health discussions. In 2009, the Institute for Information Law and Policy, the Justice Action Center and Health Information for All 2015 made the case for a rights-based approach to the issue in a report called Access to Health Information under International Human Rights Law. In 2011, a medical student in the Right to Research Coalition explained 6 Reasons Open Access Matters to the Medical Community. And the 2012 WHO CEWG Report recommending a binding treaty on Research and Development to Meet the Needs of Developing Countries includes as one of its proposals “open approaches to research and development and innovation which include precompetitive research and development platforms, open source and open access schemes.”
In response to the increasing demand for open access to biomedical research, PLOS Medicine partnered with WHO to issue a call for papers “intended to culminate in an open-access collection of original research and commentary articles to coincide with the launch … [of] World Health Report 2012: No Health without Research.” However, the 2012 World Health Report was unexpectedly called off to be replaced by a 2013 report on “contributions to research to universal health coverage,” a far less politically polarizing topic. In its editorial response to the cancellation of the 2012 Report, PLOS Medicine noted that “The reasons for these delays and for the changes in scope of WHO’s flagship publication, are unclear,” not in the least because “Previous World Health Reports … have represented bold political statements.”
Friday Jan 25th @ BU Law. Focusing on current constitutional and treaty-based challenges (WTO, First Amendment, BITs, TRIPS). Details here.
Governance of Tobacco in the 21st Century:
Strengthening National and International Policy for Global Health and Development
February 26-27, 2013
Harvard University, Cambridge, MA, USA
|Dr. Nkosazana Dlamini-Zuma
Chairperson, African Union Commission
|Dr. Margaret Chan
Director-General, World Health Organization
How do international laws and institutions regarding tobacco, trade, investment, agriculture and economic development intersect? What are the implications for global tobacco control efforts? How should public health concerns be taken into account in international economic policymaking? What is the proper balance between a government’s obligations to protect the health of its citizens and other international agreements to which it has subscribed? What are the broader implications for global governance and for global health?
This conference will bring together representatives from governments, intergovernmental organizations, civil society, business, and academia to explore these questions with the objective of:
- Enhancing knowledge, information-sharing, network-building and learning across countries, contexts and policymaking arenas
- Identifying strategies to strengthen the governance of tobacco at national and international levels;
- Fostering greater policy coherence among actors working in health, trade and investment to ensure the protection of global health
The conference is being hosted by the Harvard School of Public Health’s Center for Global Tobacco Control and the Harvard Global Health Institute’s Forum on Global Governance for Health, with advice and support from the World Health Organization’s Tobacco-Free Initiative.
Additional support is provided by: American Legacy Foundation; American Cancer Society; the International Development Research Centre Canada; Campaign for Tobacco-free Kids; Harvard Law School; Framework Convention Alliance; O’Neill Institute for National and Global Health Law, Georgetown University; Institute for Global Tobacco Control, Johns Hopkins University; International Tobacco Control Policy Evaluation Project, University of Waterloo, Canada; Southeast Asia Tobacco Control Alliance (SEATCA).
The Harvard University Program in Ethics and Health announces its annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, to be held in Boston on April 18-19, 2013.
Until very recently, universal coverage (“UC”) has been achieved in the health systems primarily in the wealthiest countries. Though there have been notable exceptions, including Cuba, it has been assumed that most of the world’s peoples would have to wait until economic development in their countries lifted them into the world’s upper class. The successful UC initiatives of middle-income countries such as Mexico, Thailand, and Taiwan demonstrated that UC was achievable without very high national GDP.
Can Universal Coverage be achieved in even the world’s lowest-income countries? China’s recent health reform, which in three years has extended health coverage to 95% of Chinese citizens, including innovative financing initiatives in some of the poorest provinces, has focused the attention of governments of low-income countries on UC. The World Health Organization’s annual report of 2010, Health Systems Financing: The Path to Universal Coverage, identified the prospects for UC in even the least-developed countries and sparked an international effort to pursue this once-elusive goal.
While maintaining a constructive and optimistic frame of mind is essential for progress toward UC, it is necessary also to identify the key ethical dilemmas arising in trying to extend the health system to all with so few resources. The choices are unavoidable:
- Between goals of UC (including financial protection against catastrophic medical expenses; health; and personal and national overall wellbeing);
- Between dimensions of UC (who is covered; what is covered; what share of costs are covered); and
- Trade-offs within and between each of these
Each country will resolve these dilemmas in its own way. Our hope is that this conference will enhance their capacity for ethical deliberation in UC, so that the ethical choices can be made responsibly and thoughtfully.
Dates and Times
Dates: Thursday and Friday, April 18-19, 2013
Times: 8:00 AM – 6:00 PM Each Day
The Inn at Longwood Medical (Best Western Boston)
Longwood Hall, 342 Longwood Avenue, Boston, Massachusetts
No fee. Space limited. Registration required. Please register on our registration website.
By Scott Burris
In a well-known exchange, Richard Epstein argued that modern public health had strayed far outside its traditional and proper work of preventing epidemics and injuries into a realm of social engineering in which it lacked both competence and legitimacy. William Novak, the historian, disagreed, emphasizing the continuity of our public quest for well-ordered, salubrious (and virtuous) communities. Deciding whether public health is winning or losing in the legal arena – and figuring out how we win more often — depends to some degree on what game it is we think we are playing – that is, on whether Epstein or Novak is right.
I think they both are, and it is worth considering how. I suspect that most of us think, without going too deeply, that we’re doing pretty much the same thing that Lemuel Shattuck was doing at the dawn of modern American public health: marshaling collective resources to use data to diagnose, treat and prevent harm to public health. And if that’s what you think you’re doing, his report is still an excellent guide to making the case for legal action: evidence shows that we can prevent morbidity and mortality in a cost-effective way that does not significantly interfere with anyone’s rights and makes our society stronger and more competitive.
But law, at least, is a very good area for asking whether we are doing something quite different than our grandmother’s public health. The use of law as a tool of intervention in public health – as a way of creating safer products and environments and incentivizing healthier behavior — has exploded since the 1960s. Yes, you can find public health law at work in the early 17th century, but when I was born in 1956, there was no OSHA, no EPA, no NHTSA. No warning labels on dangerous products. No safety belt standards or laws. Minimal limits on drinking and driving. No federal clean water or air standards. An unrecognizable FDA. And so on it goes. In the great Novak-Epstein debate, Novak is right that we have a rich tradition of public health regulation, and plenty of paternalism and interference with individual rights based on epidemiological evidence of preventable harms. This is public health as sic utere, then and now largely a matter of showing how someone is doing something that demonstrably imposes costs on others. That’s why the debate Shattuck was waging sounds so familiar to contemporary ears. (And, by the way, that extends to the moralism implicit in our “scientific” recommendations about healthy lifestyles.)
But Epstein is right, too, I think, to observe that something is different. Public health is now a pillar of the regulatory state and the risk society, deeply enmeshed in the project of defining and minimizing risks great and, let’s face it, small. We deploy complex regulatory systems, some of which work and some of which we continue to defend anyway, in spite of our own commitments to evidence. As matters like obesity and inequality take intervention further and further from proximate to distal links in the causal chain, our ability to back our proposals with evidence, and evidence that speaks to an everyday sense of causality, becomes severely attenuated. Much of what we propose rests on a vision of the good – salus populi – that is as much a matter of values as it is of evidence. Failing to own that, we fool ourselves without winning over our audience.
By Nir Eyal