Sunder on Patents and Access to Medicine

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  ”I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

Sunder acknowledges the importance of patent law to incentivizing the development of new drugs. However, as she wisely notes, one can’t squeeze blood from a stone, however important the “skin in the game” ideology has become to advocates of “free-market” healthcare.  According to Sunder, “creation of generic drug markets for the poor ought not significantly impact the bottom line of Big Pharma, which derives only 5 to 7 percent of its profits from this part of the world.”  It may well be possible to make up for some of that figure by cutting back on promotional budgets in the developed world. It’s also a rather trivial figure compared to tax avoided or evaded on the tens of trillions now hidden away in tax havens.

On the other hand, Big Pharma has a number of justifications and excuses for aggressive assertion of their patents. Spokesmen aver that they are only concerned about what would happen to their profit margins if drugs circulated in an uncontrolled manner. They claim that, if poor countries are permitted to manufacture vast quantities of their drugs, those countries may sell them on the black or grey markets. That, in turn, would reduce the return on such drugs in the developed world, leaving less money for research in the future. Sunder responds that, “The grey-markets concern is a valid one—but . . .the World Trade Organization has begun to craft creative solutions to this problem (requiring generic drugs made for developing world markets to be distinctively labeled, for example).”  As surveillance of both people and goods is better perfected by state security apparatuses and RFID technology, the grey market concern should also become more technologically manageable, enabling finer-grained and more effective price discrimination.

Access to drugs is a key area where ordinary markets simply can’t be expected to achieve humane and rational results.  In 2008, the purchasing power of the average American dog was higher than that of forty percent of the world’s population. Given the extensive extant involvement of the U.S. government both in the domestic pharmaceutical industry and in the international negotiations determining its powers and duties abroad, there is a special moral obligation for U.S. citizens and politicians to assure the widespread and equitable distribution of lifesaving drugs. As Sunder states:

Economists call the millions of people who need a drug but cannot afford it “dead weight loss.” But the millions who die needlessly because of the patent system—a number that some scholars calculate as nine million in the developing world annually—are more than an inefficiency in the system. . . . We must both adopt alternative mechanisms for developing and distributing medicines to the poor (including prizes), and fully support the use of compulsory licenses by developing countries to treat their sick poor. Patent law cannot draw the line at rectifying market failure. Our law must contend with moral failure as well.

Sunder’s eloquent case for access to drugs commends respect and admiration for the Health Impact Fund, Knowledge Ecology International, Medecins sans Frontieres, and other groups for trying to close this gap.

X-Posted at Bill of Health.

Benefit Concert for Africa Surgery in Morristown, NJ

Dicey Riley Band

To present a BENEFIT concert for Surgical Efforts in Sierra Leone, West Africa

Featuring Traditional Irish and Celtic Music and Song, Plus the

Bethel AME and Assumption Children’s Choirs

Singing selected choral works

Refreshments donated by parishioners

Saturday, May 12, 2012, 7:30-9:30 pm

Assumption Church

91 Maple Ave., Morristown, NJ 07960

Suggested donation: $15 per adult, Children Free

All proceeds go directly to procuring badly needed medical care and surgical

Treatment for poor farmers and villagers in Sierra Leone.

For more information call, 973-539-2141

[Ed. Note: I've said it before and I'll say it again: Africa Surgery does God's work. They accomplish a great deal with very little.]

Trip Report, Sierra Leone, Tom Johnson, Jr., Africa Surgery, Inc. (ASI)

[Ed. note: I had the honor of meeting Tom Johnson a few years back, here at Seton Hall Law when I was still a student and he held a fundraiser through the school. AfricaSurgery, Inc. does God's work-- and I'm well pleased to publish his updates here on HRW. With the help of others, he does a lot-- with very little.]

October 27, 2011 – February 15, 2012

Umu Sesay was brought to us by a Catholic missionary priest in 2007.  Her small, seven-year-old spine was so deformed by a tuberculosis infection that I could hardly believe she was still able to stand and to walk around.  We had Umu complete a six-month medical regimen to cure her TB, and we sent her to Ghana in April of 2008 for surgery by a team from the Foundation of Orthopedics and Complex Spine (FOCOS).   Unfortunately, Umu’s chest cavity was so compressed that she was unable to reach the minimum breathing required by the anesthesiologist before she could be cleared for surgery.   But Umu held onto the small plastic device used to measure her inhalation capacity, and she practiced breathing through it after her return to Sierra Leone.  By January, 2010 her persistence had paid off.   She was finally able to make all four of the small plastic balls rise up to the top of a plastic tube, when she inhaled through the testing device.  Umu was one of the four patients ASI sent from Sierra Leone to Ghana for spinal surgery by a FOCOS team in November, 2011.   All four surgeries were successful, and Umu and her three “surgery-mates” are out of pain and the danger of paralysis.  They all can now stand up quite straight.

Umu, whose parents are both deceased, is staying for one month at the ASI base in Freetown where she is receiving nutrient enriched food.  She is being tutored by an ASI helper who is himself a college student and who is a former school teacher.  Umu surprised us with how knowledgeable she is for an 11 year-old girl from a farming village.  Umu will soon be placed with the Cluny Sisters (Catholic missionaries) where she will live at their boarding school for the hearing impaired.  She will attend a primary school for hearing children, until the school year ends in July.  We expect that her spine will have healed by then so that she can be returned to her aunt in their home village.  Umu will no doubt be required to perform many chores, but hopefully she will be able to continue to attend school.

In November, a friend took me to a small village a couple of miles beyond his own to see a six-year-old boy with a “swelling and a sore in his mouth” which turned out to be a fast-growing tumor.  We took little Alimamy Kamara, along with his father, to be seen by the German orthopedic surgeons who were visiting Sierra Leone at that time and who had a reconstructive-plastic surgeon on their team.  The tumor was determined to be inoperable.  The team supplied us with palliative pain medication in the form of suppositories and a liquid formulation that could still be swallowed by the boy whose throat was closing up.   Alimamy died 13 days later. But our visit to his small village turned out to be a blessing for a young man who was also suffering with a painfully swollen face.

Alusine Kamara, age 20, had an abscess in his lower left jaw.  At first reluctant to accept our offer of help, Alusine’s increasing pain eventually forced him to allow us to take him 100 miles down to Freetown.  There the only oral surgeon in the country began what turned out to be a three-month-long process involving admission to the government hospital, heavy doses of intravenous and oral antibiotics and pain meds, and two surgeries.  Two more men completed similar treatments for abscessed jaws while I was in-country, and another man and one woman are to be admitted for oral surgery before the end of this month (Feb. 2012).  This will bring to 18 the number of persons for whom ASI has provided this rather expensive treatment.  The average cost is about $450.  Such abscess can be avoided by simply having decayed teeth pulled in time, saving much pain for the patient, and expense for us.  ASI did have the rotten molars of 55 persons pulled, between March, 2011, and February, 2012, at a cost of about $3.00 each.

While I was in-country, one of my helpers, Foday Tarawalie, brought 38 new patients with eye problems and 21 old cases in need of follow-up medications to the Baptist Eye Hospital in Lunsar.  Nine of the new cases received surgeries to regain their eyesight which was being obstructed by cataracts and/or pterygiums.   The 29 other new cases were medically treated for a variety of conditions including glaucoma and potentially-blinding infections.  ASI is continuing to fund Foday who is continuing to bring old and new patients to the hospital for sight-saving treatments.

Before I arrived in Sierra Leone, 48 surgeries to treat persons with hernias had already been done with funds provided by ASI since February, 2011.   While I was in country 11 more hernia repair surgeries were arranged and funded by ASI, including one for a seven-year-old boy.   Hernias remain a very prevalent health problem in Sierra Leone preventing thousands of men, boys and women from living productive lives.

New Jersey was well represented in Sierra Leone this year.  Dr. Nina Seigelstein returned to the Holy Spirit Hospital with a team including another gynecological surgeon, a scrub nurse, and a midwife.  They preformed 22 major surgeries on women brought to them by ASI, as well as for others who came on their own.   A detailed account can be found at the website: www.oneworldwomenshealth.org.

A member of the ASI board of directors, Sergio Burani, made a nine-day visit to Sierra Leone for the purpose of making a photo documentary of our work.  Sergio fell into stride with the ASI team.  At one point Sergio asked a vendor in an open-air market in the capital city, Freetown, if he could photograph him and his produce.  The man refused but was overheard by the market head-man who, after we explained our mission, insisted that Sergio “snap” away with his camera as much as he wanted to.  All the fuss caught the attention of a passerby who told us of his mother who was in the main government hospital.  Her family could not afford to pay for the medications needed to treat her badly-infected foot which had suffered a wound when a large mortis fell on it.  The young man explained that the entire congregation of their church had decided to pray for his mother to be healed as the only solution at hand.  We paid a visit to the hospital where we heard that the foot might have to be amputated.  We ended up transporting the woman and her daughter 100 miles up-country to our base near the Holy Spirit Hospital.  The woman is being treated as an out-patient for the infection and for a low hemoglobin blood count.  She is scheduled to receive a skin graft by the next reconstructive plastic surgery team that will visit the hospital in early March.  She will not have to lose her foot.

While there, Sergio also instructed six disabled students, three with severe hearing loss, and three post-operative spinal surgery secondary school boys, in the principles of photography and the use of six non-automatic, non-digital cameras which he donated.  One of the hearing-impaired students has already set off on his own, photographing students at their graduation ceremony.   He now is trying to scrape together the money to have his film developed in the hope that he will be able to reap a small profit selling his prints.

On behalf of all of the many Sierra Leoneans whom your generosity is allowing ASI to help, I want to thank you for your support and for your prayers.   I wish to extend special thanks to the Knights of Columbus George Washington Council 359, which gave ASI $3,000 last year.  This more than covered my personal travel and living expenses, enabling all of your donations to go directly to providing medical, surgical, and health care.  We at ASI will continue our work in Sierra Leone to the extent that our funds will allow.  If you are able to join us in this effort, checks can be made out to Africa Surgery, Inc., or to ASI, and mailed to:

Tom Johnson

Africa Surgery, Inc.

70 Macculloch Ave.

Morristown, NJ 07960

You can also donate on line at our website:  www.africasurgery.org

Podcast: Distinguished Guest Practitioner Gian Luca Burci Lectures on the New Field of International Health Law

On Wednesday, February 22, 2012, Distinguished Guest Practitioner Gian Luca Burci, the General Counsel to the World Health Organization (WHO) in Geneva, Switzerland, gave a fascinating talk at Seton Hall Law School on “Navigating the New Field of International Health Law.” The program was sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

Mr. Burci emphasized at the outset that if one defines international health law narrowly, to encompass only international law created “for public health purposes … within a public health environment,” the field is very small indeed.  If one looks more broadly, though, health concerns impact many international law areas, including international environmental law, human rights law, intellectual property law, national security law, and trade law.

The WHO, which is the public health arm of the United Nations, is the source of much or all of what little “hard” international health law there is.  Like other international bodies, the WHO can adopt treaties, but it can also promulgate regulations which do not need to be ratified by its member countries.  Adopted by the WHO’s World Health Assembly, these regulations come into force for all member countries on a specified date.  States that do not wish to be bound by them must affirmatively opt out.

As Mr. Burci put it, the expectation was that the WHO would be a “powerful, normative organization” but “the record is poor, at least in terms of hard law.”  In its 65 years of existence, the WHO has adopted just one treaty, the 2003 Framework Convention on Tobacco Control, and two regulations, the Nomenclature Regulations, which address the classification of, and compilation and publication of statistics on, diseases and causes of death, and the International Health Regulations (IHRs), which aim to limit the international spread of disease.

On the other hand, Mr. Burci explained, the WHO has been “very successful” in introducing rules of a “recommendatory nature,” so-called “soft law.”  The agency is a source of a plethora of technical standards, guidelines, and best practices, including, for example, its non-binding codes on Marketing of Breast-milk Substitutes and on International Recruitment of Health Personnel.

The interplay between soft and hard law is complex and the line between the two can be blurred.  Mr. Burci offered as an example the case of the Codex Alimentarius, which is a collection of non-binding recommendations governing food safety.  If the steps a country takes to protect its food supply conform to the Codex Alimentarius, the country benefits from a presumption that it is in compliance with the General Agreement on Tariffs and Trade (GATT) and the Agreement on the Application of Sanitary and Phytosanitary Measures, both binding treaties. Concomitantly, if a country takes measures that do not comply with the Codex Alimentarius, it exposes itself to the possibility of legal challenge on the grounds that the measures are too trade restrictive.  The ostensibly soft Codex Alimentarius, then, is harder than it seems.

Might we see more hard law from the WHO?  Mr. Burci noted that there has been a strong call for a convention on alcohol control, but opined that such a convention is unlikely to be adopted.  Tobacco, he explained, is different from alcohol in that there is no level of use that is harmless.  Mr. Burci suggested that the problems of illicit trade in medicines and of counterfeit medicines might be amenable to a hard law solution, as might the failure of the market to produce medicines for certain diseases.  With regard to the latter, Seton Hall Law Professor Carl Coleman notes here that a WHO working group recently recommended “the adoption of a binding international convention to promote research and development related to diseases predominantly affecting developing countries.  The proposal is expected to be on the agenda for the May 2012 meeting of the World Health Assembly…, where it is likely to generate significant discussion.”

Listen to Gian Luca Burci’s lecture by clicking on the radio.

Introducing Xiao Ma (马潇)

This semester, Health Reform Watch will be hosting a series of blog posts on Chinese regulation of pharmaceuticals by Xiao Ma. Xiao is an LL.M. student at Seton Hall Law who has worked in both the medical and legal systems in China. Xiao graduated from SiChuan University in 2009 with a Medical Science and a Law degree.

Xiao has served as Associate Counsel at Si Chuan Yuanda Shuyang Pharmaceutical Co. He was an Intern Official at Chengdu Wuhou District Center for Disease Control and Prevention, and an Intern Physician at Sichuan Academy of Medical Science & Sichuan Provincial People’s Hospital. He brings a unique set of skills and perspectives on ongoing legal developments in clinical trials, drug research and development, and international trade. Having taught Xiao in my seminar on Health Information, Privacy, and Innovation, I’m very glad he’ll be sharing his perspectives on Health Reform Watch.

Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO

This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m.  There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at sara.simon@shu.edu or call 973-642-8190.

Update Report, Africa Surgery, Inc., Tom Johnson, Jr., Sierra Leone, December, 2011.

[Ed. note: I had the honor of meeting Tom Johnson a few years back, here at Seton Hall Law when I was still a student and he held a fundraiser through the school. AfricaSurgery, Inc. does God's work-- and I'm well pleased to publish his updates here on HRW. With the help of others, he does a lot-- with very little.]

Because they had intestinal worms and the hemoglobin level of their blood was low, two of the four children we wanted to send from Sierra Leone to Ghana for spinal surgery had to be held back.   I learned of this shortly before I was to depart for Sierra Leone myself on October 25.  I was able to replace one child with an eight-year-old girl in danger of paralysis just in time for her to join the other two patients, a boy and a girl, and two escorts as they left for Ghana on October 28.  I was able to fill the other slot with a young man who was also in danger of paralysis due to the deterioration of some vertebrae by an infection.  We sent him alone on a plane to Ghana in time for surgical treatment by the team from the Foundation of Orthopedics and Complex Spine (FOCOS) in November.  The fifth surgical candidate, a young woman with a severe scoliosis, decided not to have surgery and so was not sent at that time.  The two boys who were held back have had their worms treated and are currently being built up with medications and a nutrient-rich dietary supplement so that they might be able to go for surgery in February, if funds will be available.

All four patients who were operated on are now out of pain and the danger of paralysis.  They are all reported to be walking although one is still having some difficulty moving one leg; hopefully this will clear up with time and physical therapy.

While I was in New Jersey this past year, Foday, one of my Sierra Leonean counterparts, continued to bring people suffering with eye ailments to the Baptist Eye Hospital.  Six of these patients received cataract surgeries which preserved and in some cases restored their vision.  Others were treated medically for infections or as a routine after-surgery follow-up.  Foday and I have so far brought 13 new cases to the eye hospital.  Six of these have undergone surgeries for cataracts, two of these were also surgically treated for pturygiums, a growth-like condition that causes the outside of the eye to be slowly covered with a mesh of over-grown blood vessels which block the vision.  The other five patients are being treated for eye infections.  Two of these, a man 26 years old, and a boy 12 years old, have already lost one eye each to infection.  The goal now is to protect their remaining eyes.

We brought Zinab Sherif, a girl age six, to be seen by Dr. Fritjof, an orthopedic surgeon, and his team who were in Sierra Leone in November on a working visit from Germany.  A bone in Zinab’s right forearm was infected, causing puss to drain out through orifices that would open up after painful periods of swelling.  Needless to say Zinab was making little use of the arm.   Dr. Fritjof cleaned out the infected bone twice and the wound was closed up by a plastic surgeon member of his team.  Zinab was discharged from the hospital on November 28 and her prognosis is good.

A team of plastic surgeons were here at the Holy Spirit Hospital-Catholic Mission in late November.  In five days they preformed 32 procedures.  Because the team included two surgeons who are members of the British Society for Surgery of the Hand (BSSH),  we provided them with: a young boy whose fingers on his left hand are restricted with scar tissue from an accidental scalding, a three-year-old girl with the toes of her right foot contracted due to a burn by fire ashes, and a girl, age six, whose head, face, arms, hands, and one ankle were burnt when a mosquito net caught fire and fell upon her.   We also brought to the team a woman and a young man, both having deep ulcerated sores on their lower legs that required skin grafts.  All five of these cases are still having their dressings changed by nurses at the hospital.  Two will require some physical therapy.

Yabu Kanu, the girl who suffered the multiple burns, and her mother are staying with us at our two houses in Masongbo village because they are from a distant village and are very poor.  There are now 21 spinal surgery children also staying with us at Mansongbo.  We have almost finished the Christmas shopping for them.  They will each be getting a new set of used clothes and new shoes and some items I brought over or had shipped from America including coloring books, used crayons, and drawing paper.  They will each get a pen, a pencil, a note book, and a few hard candies.   There will be dolls for the younger girls costing about $2.00 each, and used toy cars for the younger boys each costing about 45 cents.  There will be a couple soccer balls to be shared by the middle and older boys.  My used National Geographic magazines will go to those not physically able to play ball and for the older girl who is quite bright.  The girls will get little sewing kits and some finger nail sticker-art donated by a friend in New Jersey.  I keep telling them all that “Christmas no go day for bad pikin dem.” (there will be no Christmas for naughty children).   Their behavior has been pretty good lately.

Thank you for all of your help with this work. We have a new website that you might want to visit: www.africasurgery.org.  May you and yours all have a Merry Christmas and a Blessed New Year.

Tom

For Vietnam, Sharp Increase in Infant Fatalities by Hand, Foot, and Mouth Disease

[Ed. Note: We are pleased to welcome Clarissa Gomez to HRW. She is a first year student at Seton Hall University School of Law and graduated in December, 2010 from The College of New Jersey with a B.A. in English and Women and Gender Studies, and a minor in Law, Philosophy and Politics. While she is fairly new to the world of health law, she is currently a representative for the SHU Health Law Forum. Being well-traveled and witnessing the healthcare disparities throughout the world, she has high interest in international healthcare regarding access to treatment and disease prevention, as well as those issues regarding womens' health.]

The World Health Organization (WHO) recently reported information regarding the current outbreak of Hand, Foot and Mouth Disease (HFMD) in Vietnam. While Avian influenza and Severe Acute Respiratory Syndrome (SARS) have been the two leading outbreak diseases in Vietnam over the past eight years, HFMD is the topic of the country’s current health concerns.  Traditionally, HFMD has been common in Vietnam and there have been reports of larger-scale outbreaks from time to time, but so far this year the infection and death toll statistics are already significantly higher than usual. More than 42,000 individuals have been sickened this year, a vast increase from the 10,000 to 15,000 cases that have been reported on average per year since 2008. The main targets of HFMD have been children three years old or younger, and so far 98 children have died from the disease– that is already about triple the  average annual number of chidren’s deaths.

Earlier this year I had the privilege of traveling the dusty, motorcycle-infested streets of Vietnam. After witnessing first-hand the severe lack of sanitary rules to govern sidewalk phở eateries and other food vendors, along with the knowledge that HFMD is most often spread from person to person through contact with virus-contaminated surfaces like unwashed hands, the recent report by WHO is not shocking. The virus can survive for a long period of time in the environment or sewage, which adds to the difficulty in preventing and controlling its spread. Children have the highest risk for infection since they lack the protection of antibodies that are developed within a person’s body with age. While no vaccine or specific treatment exists, the disease has generally been described as mild and quickly recoverable. So, then, what is surprising is the drastic increase in deaths from previous years; it is unclear what may account for this, and the Vietnamese Ministry of Health further warns that the number of cases will likely increase even more in the coming months as children most at risk resume preschool and kindergarten.

I had quite the experience traveling on the train called the “Reunification Express”;  it allows one to travel from north to south Vietnam and vice versa. I was told, and to my surprise, that the train had been modernized and had seen many improvements over the past few years. Suffice it to say, it was no Amtrak. The bathroom consisted of a toilet bowl with a hole that led directly to the train tracks and ground. I could only imagine where the goods of those who used it for relief ended up. Issues of personal hygiene and sanitary practices are at the forefront of the outbreak of HFMD, which is why I mention the train facilities above. The WHO report attributed the spread of HMFD to contact with fluid in blisters or infected feces. As disgusting as it sounds, encountering bodily waste on the street is not a terribly rare or shocking event in rural Vietnam. Perhaps it is a lack of — or disregard for– these everyday public health lifestyle practices that can, and most likely does, account for the statistics being reported by WHO.

Fortunately, the Ministry of Health is closely monitoring the situation and precautionary measures have already been implemented throughout the country in order to reduce further spread of the disease. All health care facilities have received guidelines for surveillance, prevention and treatment of the disease; training courses are being conducted for preventive medicine staff as well as pre-school teachers, and a nation-wide public awareness campaign on television and other means of media are relaying preventative measures to the citizens.

Increased standards of both personal hygiene and environmental care are crucial to the prevention of HFMD, as there is no specific medication administered to combat the disease. It is hopeful, then, that the campaign for heightened awareness will not only prevent the further spread of the virus and lessen the number of casualties due to HFMD, but that Vietnam as a country will benefit as well. Despite the numerous public health issues I encountered, it is, among the countries I’ve visited, one of my favorites.  And since my most recent trip, I hold Ho Chi Minh and Hanoi as two must go-to cities that I desire to travel back to in the future…but I just may not plan my trip between the months of March to May and September to December. Why? Southern Ho Chi Minh city has been one of the hardest hit by HFMD and these months are when the rates of infection are highest.

As tourism accounts for a relatively small but steadily increasing and significant portion of Viet Nam’s economy, it is not hard to believe that the institution of increased sanitary and public health measures, which one might presume will lessen the occurrence and spread of infectious diseases, will ultimately help Viet Nam from both a substantive health and an economic perspective.

Photo Credit: 1, by anjči via Flickr; 2 & 3, Clarissa Gomez

AfricaSurgery, Inc., Update Report, Tom Johnson, Jr., July, 2011

[Ed. note: I had the honor of meeting Tom Johnson a few years back, here at Seton Hall Law when I was still a student and he held a fundraiser through the school. AfricaSurgery, Inc. does God's work-- and I'm well pleased to publish his updates here on HRW. With the help of others, he does a lot-- with very little.]

Dear Friends,

After a baby was born with a hydrocephalous head, the unknown mother kept the boy for about one year before abandoning him in the bushes near the latrine at a hospital-clinic in Sierra Leone.  A nurse named Adema found the child and, despite his deformity, took him in as her own.  She named him Samuel, and gave him her-and-her-husband’s family name of Sesay.  We sent Samuel and Adema to Ghana on March 3, 2011.  Dr. Akoto, a neural surgeon from FOCOS, implanted a shunt in Samuel that will allow excess fluids to drain from his brain into his abdomen.  Samuel is already developmentally and cognitively impaired, but the shunt will prevent water pressure from causing any further damage to Samuel’s brain and will allow him to advance to his greatest level.

In January, 2010 we sent Abdul Kamara from Sierra Leone to Ghana, where Dr. Akoto removed the very large tumor which had displaced up to one-third of his brain.  Abdul recovered and showed no signs of any damage to his brain.  Sadly, however, this past April Abdul passed away unexpectedly after a-day-and-a-night of headache.  We can take some comfort in the knowledge that, after his surgery, Abdul enjoyed 15 months of normal life.

On November 1, 2010 Wusum Koroma, age 28, came to us because he had a hard, bony bump on his head that had started out small but was continuing to grow.  It had already become about the size of a grade-A-jumbo egg.   I feared that this kind of a tumor would eventually bore through Wusum’s skull and invade his brain, as the one had done with Abdul Kamara.  On May 31, 2011 we sent Wusum Koroma to Ghana where he underwent surgery by Dr. Akoto to remove the bone tumor.  Fortunately, the tumor had not yet entered into Wusum’s skull cavity, and he returned to Sierra Leone on July 3.  His prognosis is very good.

ASI field agent Foday Tarawalie has been chartering taxies to take the 18 persons already diagnosed with cataracts to the Baptist Eye Hospital in Lunsar, Sierra Leone, where three of them have already had surgeries to save their vision.  Four others, whose cataracts have matured, are scheduled to be surgically treated during July.  Foday has also been bringing patients who have already had eye surgeries back for check-ups and follow-up treatment with medications.   He reports that more people whose vision is lost or fading from what might be cataracts have approached him.  He has told them to wait until he has finished with our current list and to hope that we can get the funding needed to help them.  A cataract surgery now costs about $85 per eye.  Foday has even more work to do now.  I have just released funds for him to bring to the hospital six more men who have come to him because they are in dire need of hernia surgeries.

Over the past two years, ASI has had nine persons with serious abscess infections of their jaws surgically treated by Dr. Davies, the only oral surgeon in Sierra Leone.  All had hugely swollen faces.  One of these, a young man named Santigi Sesay, had both sides of his lower jaw infected.  Two of the patients had large portions of their lower jaws protruding through an orifice in the sides of their faces where their bodies were dispelling the infected bone material.  All of them were admitted into the government hospital in Freetown for two-to-four months where strong antibiotics were administered before-and-during treatment.  Dr. Davies is now having Foday bring each of these patients back so that he can examine them and treat any who might need further care.

Seven-year old Mahawa Timbo Kamara underwent spinal surgery by a FOCOS team in Ghana in May, 2010 because her small spine was already fractured as a result of a tuberculosis infection, a painful condition known as Pott’s disease.  In December, 2010, Mahawa’s mother passed away, and Mahawa was sent to live with her grandmother in a remote village.  In January, 2011 we brought Mahawa in to stay with us because she had developed on her incision line a small, oozing sore which we began to have treated with antibiotics and topical meds at the Holy Spirit Hospital.  In February, Dr. Harry Akoto, the neural surgeon who was visiting Sierra Leone with two other FOCOS team members to examine patients, determined that Mahawa’s infection was deep.  We sent Mahawa along with another girl, Kadiatu Bangura, age 12, whose implants were working lose from her spine, back to Ghana on March 3.  Mahawa had a procedure known as a “wash out.”  Kadiatu had a revision surgery to remove the detaching portion of implants which were no longer needed because her spine had healed since her first surgery in November, 2009.  Both girls are now back in Sierra Leone and are recovering well.  They have joined the 17 other spinal surgery children living with ASI field agent Foday Tarawalie and his family in a village about four miles from the Holy Spirit Hospital.   Mahawa’s destitute father has asked us to keep his daughter indefinitely because he cannot care for her properly nor provide for her education.  Kadiatu will be returned to her family once we determine that her revision-spinal surgery has completely healed.  Until then, we are keeping her in the vicinity of the hospital where doctors, X-ray and ultra-sound equipment are available.

When Alimamy Sesay was brought to us in December, 2008, he was nine-years old and was in great pain because a tuberculosis infection had caused his spine to fracture.  His father carried him on his back because Alimamy’s legs were paralyzed.   We started Alimamy on anti-TB medications and secured a wheelchair for him.  When I visited Alimamy’s village about one year later, I found that he had recovered much use of his legs.  He was using the wheelchair as a walker and seemed to be out of pain as he visited some neighbors.   But his condition is still serious.  Alimamy’s fractured spine is still exerting pressure on his spinal cord, causing his legs to be spastic.  He could become paralyzed again.  Alimamy is one of the 16 patients now being considered by FOCOS for surgery in Ghana this November.  He is one of the ten of these who have just gotten cat scans this month in the capital city, Freetown.   The scans are expensive, but they will help Dr. Boachie, the head surgeon of FOCOS, determine which candidates need surgery the soonest.

Kadiatu Kanu was six-years old when I was brought to see her on November 26, 2008.  Her spine was fractured from a tuberculosis infection, and her legs were becoming paralyzed.  She was started on a six-month regimen of anti-TB medications which eventually cured her of the tuberculosis.  As the pressure on her spinal cord was relieved, she gradually regained the use of her legs.  But this respite was not permanent; and as her spine continues to collapse, Kadiatu is again becoming paralyzed.  A spine surgeon visiting Sierra Leone from Germany, Dr. Zsolt Fekete, has seen Kadiatu and her X-rays.  As soon as he can work out the details, Dr. Fekete wants us to get Kadiatu to Switzerland to receive emergency treatment, by a specialist in pediatric spinal surgery.  Dr. Fekete is also working out the details for the required hospitalization.  Meanwhile, one of ASI’s helpers in Freetown has gotten Kadiatu a passport and is working on getting her a visa.

On behalf of all of the many Sierra Leoneans whom your generosity is enabling ASI to help — including: 62 who have had successful spinal surgeries; well over 300 men, boys, and some women, treated for debilitating hernias; 52 women surgically treated for various gynecological conditions; over 60 people who have had their sight saved or restored through cataract and other eye surgeries and treatments (one of these was a woman who had been blind for 13 years); eight children who have had clubfeet made straight; the 13 people have had severe abscesses of their jaws drained and surgically treated; and over 100 recipients of reconstructive plastic surgeries for such conditions as cleft lips and cleft pallets, burns and burn-scar contractures, tumors and growths, over 50 children being sponsored for their schooling, and more — I want to thank you for your support and for your prayers.  We at ASI are resolved to continue our work in Sierra Leone to the extent that our funds will allow.

If you are able to join us in this effort at this time (or anytime), checks can be made out to Africa Surgery, Inc., or to ASI, and mailed to me at our new address:

ASI

c/o Tom Johnson

70 Macculloch Ave.

Morristown, NJ 07960

You can also donate on-line at our website:  africasurgery.org (no www. in front).

Whether you can donate at this time or not, please remember our work and our patients in your prayers.

Tom

Contractual Liability and Clinical Trial Reimbursement in Italy

Contractual Liability and Clinical Trial Reimbursement in Italy

By: Christopher J. Asakiewicz, Esq. and Anna Pinkhas, Esq. [1]

In the Italian Ministerial Decree of July 14, 2009 (the “Decree”) the Ministry of Labour, Health and Social Policy sets forth a number of statutory requirements relating to insurance in human clinical trials conducted in Italy. In order to safeguard the clinical participants the Decree expanded on and formulized into law a requirement previously established by the European Union, which provides that a clinical trial can be initiated in the Member States only when provisions have been made for insurance or indemnity to cover the liability of the investigator and sponsor towards clinical trials subjects. [2] However prudent and protective of clinical participants the Decree is, its implementation into Italian law has led to significant delays in the negotiation of the indemnification clauses in clinical trial agreements because of improper interpretation, an interpretation that delays the introduction of possible life saving medicines into the country and the European marketplace.

Indemnification is a critical part of the clinical trial agreements between clinical trial sponsors, investigational sites and, sometimes, the principal investigator. Generally, indemnification language in any agreement seeks to impute liability to a contractual party for acts or omissions and to defend, hold harmless and compensate the other party for any loss that such party may suffer during the performance of the contract that results from said acts or omissions. Indemnification provisions in a clinical trial agreement differ among varying sponsors and investigational sites. Generally, the provisions are mutual. A mutual indemnification provision will have the sponsor indemnify for personal injury or illness to study patients that relates to the study or the study drug, and likewise, the other party will indemnify the sponsor for any negligence or willful misconduct for which it is responsible.

Drafting and negotiating an indemnification clause can be both difficult and tedious, as the clause’s meaning is particularly important during litigation. Frequent confusion, however, between indemnification and study subject reimbursement further complicates and delays negotiations. A clinical trial agreement generally also includes a provision where the sponsor agrees to reimburse the institution for any reasonable and necessary medical expenses incurred by the investigational site for the treatment of patients’ illness or injuries related to the study or the study drug.  The purpose of such subject injury language is to address reimbursement of expenses incurred to treat an adverse event. [3] This reimbursement language is meant to swiftly compensate such injuries without regard for party fault so the patient can receive care immediately or continue to receive the highest standard of care.

Indemnification, on the other hand, is to assume responsibility and the costs incurred in litigation or from claims that resulted from the fault attributable to the wrongdoing of the indemnifying party. Although these two scenarios are clearly distinguishable, confusion arises over the Italian regulation because of misunderstanding about the nuances of indemnification as compared to subject injury reimbursement. The Decree states that the promoter, or the sponsor, of the clinical trial shall provide insurance to cover “any civil liability of investigator and promotor of the clinical trial, without excluding any damage which may be unintentionally caused by accident e/o be attributed to negligence, imprudence or inexperience.” [4] In other words, the clinical trial sponsor is required by the Decree to be insured to sufficient limits for not only willful or reckless conduct, but also for negligent unintentional acts or omissions. [5] Many Italian sites interpret this language to mean they are not responsible for their own negligence and therefore remove their indemnification obligation of the sponsor, the promotor, from the clinical trial agreements. However, the Decree only governs reimbursement to study subjects by the insured in the event of injuries, and does not limit contribution as well as the investigational site’s indemnity of the sponsor for those third party claims which fault is attributable to either it or its actors.

Article 1 states: “The insurance policy is to grant specific cover in connection with the reimbursement of damages caused to the subjects by the clinical trial activities throughout the entire duration thereof.”

[6] The Decree’s purpose is therefore not to forgive or excuse liability, but only to safeguard participants by ensuring that a damaged party obtains reimbursement immediately. It is incorrect to interpret the legislation’s purpose as being a limit on the scope of the Institution’s liability with respect to its own actions, as the Decree further states “[t]his restriction shall not in any event impair the right of the damaged party to seek reimbursement of damages from the person liable therefor.” [7] Exclusion language which relates to negligence, imprudence or inexperience of the investigator serves to make the insurance policy a no-fault policy, assuring participants appropriate compensation and reimbursement for their injuries or illness without having to litigate the cause of the injury or prove fault. [8]

The patient’s clinical trial injury and treatment expenses will be immediately reimbursed by the policy. But, as the Decree does not limit the remedies at law, and corresponding insurance policy’s only purpose is to compensate the participant immediately, the site can still be held liable by a court for its actions. In the situation, when the sponsor was required to compensate, but is not the determined cause, the sponsor is entitled seek contribution or indemnity for such actions’ expenses from those actors responsible. The Italian Civil Code also supports the notion that the site can still be held liable, as Article 2053 provides that any willful or negligent conduct, causing an unjust harm to third parties, obliges the tortfeasor to compensate the damages. [9]

To resolve this confusion between indemnification and clinical trial injury reimbursement, the authors recommend that a sponsor with sites operating in Italy, (i) obtain an insurance policy covering all treatment expenses incurred by patients and associated with injuries related to the study drug or protocol procedures, and (ii) ensure that any indemnification provision in the clinical trial site’s contract does not exclude the institution or the investigators from liability. The Italian Civil Code and Decree are both in agreement that those persons liable for causing harm to a third party are obligated to compensate for those damages. The sponsor through clinical trial insurance can therefore immediately reimburse the patient’s costs, then, in accordance with the mutual indemnification, the sponsor or the insurer may seek to subrogate or recoup through contribution such expenses which are attributable to the investigational site or investigator and outside the sponsor’s control. [10]

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[1] DISCLAIMER: Both authors are admitted to practice law in the state of New Jersey and draft and negotiate international clinical agreements as well as counsel on patient disclosures for pharmaceutical companies. The views and opinions expressed are solely those of the authors and shall not be attributed to any other party, company or entity. The expressed opinions are for informational purposes only, and not meant to nor intended to be an advertisement, solicitation, legal advice, authority nor services of any kind to any Client, including any person or entity in any state, country or sovereign nation. Such information is not meant to create an attorney-client relationship. the reader must not act nor rely upon these materials without seeking professional legal counsel.

[2] See Art. 3(2)(f) Directive 2001/20, of the European Parliament and of the Council of  4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, 2001 O.J. (L 121) 34, 37 ( “provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor. “); See also Art. 3(1)(f) Decreto Legislativo, 24 June 2003, n. 211, G.U. 09 Aug 2003 (It.) (“provision has been made by the trial sponsor for insurance to cover the third-party liability of the investigator and the sponsors in the event of claims for damages by trial subjects.”).

[3] “adverse event” means any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

[4] Art. 1(2) Decreto Ministeriale 14 July 2009, n. 213, G.U. 14 September 2009 (It.) (Italian Ministerial Decree, Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products.).

[5] See Art. 2(2) D.M. n. 213/2009 (It.) (“Insurance shall provide for an insured limit for the reimbursement of damages not lower than Euro 1 million per participant, although the following minimum limits for each individual protocol are required, not less than: a) Euro 5 million if trial participants are less than or equal to 50; b) Euro 7 million five hundred thousand if the trial participants are more than 50 but less than 200; c) Euro 10 million if the trial participants are more than 200.”).

[6] Art. 1(2) D.M. n. 213/2009 (It.) (emphasis added).

[7] Art. 1(6) D.M. n. 213/2009 (It.) (emphasis added).

[8] “no-fault insurance” is any type of insurance contract under which insured’s are compensated for losses, regardless of fault in the incident generating said losses.

[9] Art. 2043 Codice civile [C.c.] (It.) (Italian Civil Code).

[10] See Blacks Law Dictionary (9^th ed. 2009) (1) (SUBROGATION “1. The substitution of one party for another whose debt the party pays, entitling the paying party to rights, remedies, or securities that would otherwise belong to the debtor.”).

The Right to Life, Liberty… and the Internet?

This month, the United Nations (UN) Human Rights Council recognized access to the Internet as a human right. The report was written by UN Special Rapporteur on the Promotion and Protection of the Right to Freedom of Opinion and Expression, Frank La Rue, and it separately considers access to Internet content and access to the infrastructure required for Internet access. The report cites over 2 billion Internet users worldwide and notes that the Internet has becomes a key means through which individuals can exercise their right to freedom of opinion and expression. La Rue concludes that “there should be as little restriction as possible to the flow of information via the Internet, except in few, exceptional, and limited circumstances prescribed by international human rights law.”

The report seems motivated by recent episodes of political unrest such as the Arab Spring uprisings. La Rue states that the Internet is “one of the most powerful instruments of the 21st century for increasing transparency in the conduct of the powerful, access to information, and for facilitating active citizen participation in building democratic societies.” He notes that countries have been increasingly censoring online information through 1) arbitrary blocking or filtering of content, 2) criminalization of legitimate expression, 3) imposition of intermediary liability, 4) disconnecting users from Internet access, and 5) inadequate protection of the right to privacy and data protection. La Rue recognizes some legitimate reasons to restrict Internet access, like in the case of cyber- attacks, but focuses on how countries often abuse their power and infringe on the rights of their citizens:

In many instances, States restrict, control, manipulate and censor content disseminated via the Internet without any legal basis, or on the basis of broad and ambiguous laws, without justifying the purpose of such actions… Such actions are clearly incompatible with States’ obligations under international human rights law, and often create a broader “chilling effect” on the right to freedom of opinion and expression.

La Rue specifically notes his concern with the “three- strikes-law” in France and the UK’s Digital Economy Act of 2010. Both of these proposals are anti-piracy measures that would impose penalties against Internet users for illegal file sharing and violation of intellectual property rights. The end result could be suspension of Internet service if copyright infringers disregard warnings. La Rue considers that

Cutting off users from Internet access, regardless of the justification provided, including on the grounds of violating intellectual property rights law, to be disproportionate and thus a violation of article 19, paragraph 3, of the International Covenant on Civil and Political Rights.

Article 19 of the ICCPR concerns the right to freedom of expression.

The fundamental human rights doctrine, the Universal Declaration of Human Rights (UDHR), was penned in 1948 just after the end of WWII. In part based on Franklin Delano Roosevelt’s Four Freedoms, the document was largely a response to the atrocities seen in the war. Article 19 of the UDHR states that

“Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.”

The drafters left the definition of ‘media’ open in anticipation of new technologies, and the Internet and its extraordinary proliferation in recent years is the most relevant form of media in our time.

La Rue, however, does not just depend on this as a basis for his claim that removing Internet access is a deprivation of the basic human right of freedom of expression. He elaborates on how the Internet facilitates the realization of other human rights-

The right to freedom of opinion and expression is as much a fundamental right on its own accord as it is an “enabler” of other rights, including economic, social and cultural rights, such as the right to education and the right to take part in cultural life and to enjoy the benefits of scientific progress and its applications, as well as civil and political rights, such as the rights to freedom of association and assembly. Thus, by acting as a catalyst for individuals to exercise their right to freedom of opinion and expression, the Internet also facilitates the realization of a range of other human rights.

But even if Internet access constitutes a human right, many countries lack access to basic commodities such as electricity, let alone the necessary infrastructure and technologies to access the Internet. La Rue rests on the positive obligation of countries to work towards promoting or facilitating freedom of expression. He encourages countries to develop a “concrete and effective policy… to make the Internet widely available, accessible and affordable to all segments of population.”

La Rue’s report remains the first recommendation in a series of negotiations on how to adopt access to the Internet as a fundamental right. As La Rue concludes, “given that the Internet has become an indispensable tool for realizing a range of human rights, combating inequality, and accelerating development and human progress, ensuring universal access to the Internet should be a priority for all States.”

La Rue is right to understand the internet as a means to effectuate development. The implications for healthcare can, of course, be staggering. An internet connection is no substitute for bread or medicine but that connection  makes widely available medical techniques and public health information and makes “remoteness” a somewhat antiquated concept. If global health is to substantially  improve, internet access will ultimately be key.

Review of Reconsidering Law and Policy Debates: A Public Health Perspective

Reconsidering Law and Policy Debates: A Public Health Perspective, edited by John Culhane, is a superb collection of thought-provoking essays which features some of the most well-regarded health law scholars in the US. It also includes contributors from schools of public health, public affairs, and public administration. The chapters are uniformly well-written and instructive. Though I cannot in this brief review give consideration to all of the essays, I will try to highlight contributions related to some of my own areas of interest in the intersection between public health and medico-legal research.

Several authors focus on the difficult questions raised by extreme inequality. For example, Vernellia R. Randall’s Dying While Black in America reflects on the disturbing disparity between white and black death rates in the US. A black American male can expect to live seven years less than a white American male, and black women face a four-year gap. Randall explores a number of potential explanations, including discriminatory policies and practices, lack of language and culturally competent care, inadequate inclusion in healthcare research, and hidden discrimination in rationing mechanisms. Randall argues that these disparities will never be addressed effectively until the legal system develops doctrines that can deter not only intentional discrimination, but also “negligent discrimination in healthcare:”

Negligent discrimination in healthcare would occur when healthcare providers failed to take reasonable steps to avoid discrimination based on race when they knew or should have known that their actions would result in discrimination. An example of this would be decisions to close inner-city hospitals and move them to the suburbs. (86)

Randall expertly characterizes race as a key “social determinant of health” in the United States. Countering the many current legal doctrines that promote the legitimation of discrimination, Randall envisions the type of guarantees of equality that will be necessary to realize the antisubordination and antisubjugation principles that animate the 14th Amendment properly understood.

Diane E. Hoffman also addresses stunning inequalities, this time on a global level. Hoffman’s long engagement with end-of-life care informs a consistently sensitive and insightful public health perspective. Considering the situation in the United States, Hoffman concludes that “it is not as all clear that we would want to give the state a public health justification for taking on end-of-life care,” because “we might have trouble reining in the government and preventing it from implementing increasingly more coercive measures” (59). This judgment is particularly pertinent in a political environment where extreme inequality and ever-lower taxes on the wealthiest have imperiled many important health programs for the aged.

However, Hoffman comes to a different conclusion in the case of many developing countries, where the question is less one of rationing access to life extending technologies than it is one of extending access to basic treatments for pain. In a sobering series of statistics, Hoffman presents a tragic panorama of human suffering. In India, only 1% of the 1.6 million people enduring cancer pain each year are likely to receive any type of pain medication. Morphine dispensaries are rare; Calcutta, with 14 million residents, has only one. Though nearly half its population is extremely poor, India is not an outlier. While developing countries account for 80% of world population, they use only 6% of the morphine consumed each year. Sometimes, shortages of medical personnel help explain the problem: for example, in Sierra Leone, there is only one doctor for every 54,000 people (as opposed to a 1:350 ratio in the US). But Hoffman gives several examples of easily preventable policies and business practices that keep painkillers out of the hands of the world’s poorest individuals. This is a truly neglected global crisis, generating levels of suffering that are rarely encountered or even imagined in the developed world.

Returning to the US, the last two chapters in the book are very interesting contributions to ongoing debates about the nature and role of tort doctrine. Elizabeth Weeks Leonard expertly deconstructs the usual dichotomy between tort law’s individualism and the population focus of public health. As she notes, cases involving asbestos, lead paint, silicone breast implants, the Dalkon shield, hazardous autos, tobacco, firearms, Phen-Fen, OxyContin, and Vioxx have all combined efforts by individuals to secure compensation for injuries with broader strikes against destructive products and practices. Weeks succeeds in demonstrating the “counterintuitive fit between tort law and public health law” (189), arguing that each “offers approaches to addressing inevitable conflicts in organized society between individual interests and community needs.”

Jean Macchiaroli Eggen tries to make the fit better by focusing on punitive damages. Toward the end of her chapter, she proposes that states solve the “plaintiff windfall problem” in punitive damages by requiring that “the portion of the punitive award the plaintiff does not receive [due to split-recovery statutes and other measures] be allocated to a state or private program that will enhance the deterrence of the conduct that gave rise to the warden the particular case.” The contributions of both Weeks Leonard and Macchiaroli Eggen would be of great interest to tort classes and seminars considering the difficult issues raised by judicial efforts to address public health concerns.

John Culhane is to be commended for bringing together such an illustrious group of contributors to address public health, an issue that has been neglected in law schools. Knowing full well that factors like income, race, pollution, and even commute length may have a far greater impact on health than, say, dispute resolution methods used by insurance companies, law professors nevertheless tend to focus on purely legal topics. (I am as guilty of this as anyone, and credit this book (and many interventions by Daniel Goldberg) for pushing me to do more to consider the social determinants of health in my own work.) Well after the sturm und drang surrounding the constitutionality of the ACA has dissolved, we will still face problems of balancing liberty, equality, and welfare that this book’s thoughtful contributors address. Their voices deserve to be heard in those future, more substantive, debates.

Hans Rosling, Stats Guru: Income/Health in 200 Countries Over 200 Years in 4 Amazing Minutes

Just too good to pass up: via TPM and the BBC, Hans Rosling, Professor of International Health at Karolinska Institute and Director of the Gapminder Foundation, looks at the relationship between income and health in 200 countries over a span of 200 years– in a few clear and amazingly animated minutes.

Secretary of State Hillary Clinton on the Global Health Initiative

This C-SPAN report is worth considering: “Secretary of State Hillary Clinton spoke at Johns Hopkins University’s School of Advanced International Studies on the Obama Administration’s Global Health Initiative. She discussed the six-year, $63 billion investment that focuses on improving the health of women, children and newborns throughout the world.”

You can see the video (or the transcript) by clicking on the picture.

Recommended Reading: Recent Legal Scholarship on Issues in Global Public Health

Redressing the Unconscionable Health Gap: A Global Plan for Justice (published in the Harvard Law & Policy Review). In this article Lawrence Gostin brings a big picture issue — the vast global health gap between rich and poor — into perfect focus. Professor Gostin reminds us of an “uncomfortable truth” — “that closing the health gap is well within the means of the international community” — and he proposes a simple (in concept if not execution) plan to do just that.  No international treaty would be required; Professor Gostin’s Global Plan for Justice would take the form of a World Health Assembly resolution.  No new organization or governance structure would be required either; rather, the World Health Organization would “assume its place as the global health leader.”  States would be asked to contribute a small percentage — Professor Gostin suggests 0.25% — of their Gross National Income each year to a Global Health Fund.  The WHO would then allocate the Fund’s resources based on “the health needs of developing countries measured by poverty, morbidity, and premature mortality.”  Professor Gostin suggests that the mission of the Fund be threefold: “(1) ensure the fair allocation of essential vaccines and medicines, with particular attention to low- and middle-income countries in a public health emergency; (2) meet basic survival needs [e.g. food, water, sanitation, and vector controls] and create the conditions in which people can be healthy; and (3) help countries that will suffer most to adapt to the health impacts of climate change.”  Existing efforts, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, demonstrate the power of voluntary collective action; unlike the proposed Global Health Fund, however, they are too narrowly-targeted and inconsistent to close the global health gap.  Professor Gostin’s article is short (it’s based on the text of a speech), straightforward, and provocative in the best sense of the word.  I highly recommend it.

I also highly recommend Kevin Outterson’s The Legal Ecology of Resistance: The Role of Antibiotic Resistance in Pharmaceutical Innovation (published in the Cardozo Law Review) in which he uses proprietary sales and volume data for the important hospital antibiotic vancomycin to test a number of widely-propounded theories about the interplay between antibiotic resistance and intellectual property law.  The vancomycin case study fails to support the hypothesis that a patent holder is likely to zealously market an antibiotic with an eye to the drug’s dwindling patent term, without regard for the risk that increased uptake could accelerate the evolution of antibiotic-resistant bacteria.  It also fails to support the hypothesis that if patent terms for antibiotics were extended, patent holders would better manage the sales and use of their drugs to forestall the development of resistance.  By contrast, the story of vancomycin is consistent with the hypothesis that antibiotic resistance stimulates innovation — as bacteria evolve that are resistant to an existing antibiotic a market for a new antibiotic arises.  All of this suggests that “tinker[ing] with the patent system” is unnecessary and could even backfire.  Professor Outterson concludes that a more direct and potentially more effective approach to preserving the antibacterial effectiveness of our antibiotics would be to fix our broken health care reimbursement system, under which infection control is an unreimbursed cost and “hospitals and doctors have generally gained revenues from additional infections[.]“

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