Sunder on Patents and Access to Medicine

September 30, 2012 by · Leave a Comment
Filed under: Global Health 

pasquale_frank_lg11Last 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.

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Benefit Concert for Africa Surgery in Morristown, NJ

May 10, 2012 by · Leave a Comment
Filed under: Global Health 

Dicey Riley Band

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

March 13, 2012 by · Leave a Comment
Filed under: Global Health 

[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 is finally able to stand straight thanks to surgery done in November, 2011, by the Foundation of Orthopedics and Complex Spine (FOCOS).

Umu is finally able to stand straight thanks to surgery done in November, 2011, by the Foundation of Orthopedics and Complex Spine (FOCOS).

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, before treatment for an abscess in his lower left jaw.

Alusine Kamara, age 20, before treatment for an abscess in his lower left jaw.

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.

Boi Woody, was despondentbefore we moved her to the Holy Spirit Hospital.  There visiting  teams of reconstructive surgeons from Great Britain will be able to save her from losing her infected foot.

Boi Woody, was despondentbefore we moved her to the Holy Spirit Hospital. There visiting teams of reconstructive surgeons from Great Britain will be able to save her from losing her infected foot.

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

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

February 28, 2012 by · Leave a Comment
Filed under: Global Health, Health Law 

Giana Luca Burci, International Health LawOn 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.

Giana Luca BurciMight 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.

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Introducing Xiao Ma (马潇)

February 17, 2012 by · Leave a Comment
Filed under: Food and Drug Administration (FDA) 

121This 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.

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