Why are some lower-price generics available in the US before they can be sold in Guatemala? Our recent article in Health Affairs analyzes how years of pressure by the pharmaceutical industry and the US government  resulted in intellectual property rules in the Central America Free Trade Agreement (CAFTA-DR) that place desperately needed medicines out of the hands of Guatemalans in violation of the country’s internationally recognized and constitutionally protected right to health.

CAFTA covers the United States and six other countries: the Dominican Republic, Costa Rica, El Salvador, Nicaragua, Honduras, and Guatemala. In 2005, the United States Trade Representative predicted that “[CAFTA] will not affect Guatemala’s ability to take measures necessary to protect public health. . . . Stronger patent and data protection increases the willingness of companies to release innovative drugs in free trade partners’ markets, potentially increasing, rather than decreasing, the availability of medicines.”  However, the Center for Policy Analysis on Trade and Health (CPATH) found that CAFTA in fact increases health risks for patients who need these drugs by increasing the prices of medicines, and CAFTA stifles innovation by undermining Guatemala’s domestic generic drug industry.

CAFTA rules protect the products and processes of brand-name pharmaceutical companies (their intellectual property, or IP) from competition by generic companies — competition that can lower drug prices. These price protections are stronger than existing US law and the World Trade Organization’s (WTO) multilateral Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). The World Health Organization (WHO) and others have expressed concerns that the consequences of these “TRIPS-Plus” rules are particularly serious in lower-income countries, where price is an important factor in access to medicines.

CAFTA also undermines existing mandates to protect public health.  According to the WHO, every country has signed on to at least one treaty that recognizes health as a human right.  Guatemala has signed a number of international conventions advancing public health and explicitly recognizes that health is a human right in its own constitution. However, CAFTA essentially requires Guatemala to continually violate this right, by making it harder for residents to access medications.

For example, Article 10 of the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights (commonly known as the “Protocol of San Salvador”), which Guatemala ratified in 2000, defines the right to health as “the enjoyment of the highest level of physical, mental and social well-being.”  This right includes both access to primary health care and the “prevention and treatment of endemic, occupational and other diseases.”  Yet, as discussed below, CAFTA makes this nearly impossible. It offers patent protections to pharmaceutical companies, which keep drug prices high, excluding invaluable medicines from the very residents who need them the most.

Our recent study measured the effects of two rules: data protection and patents. (There were insufficient data to evaluate the third rule, known as linkage.) Data protection (also referred to as data exclusivity) is a TRIPS-Plus rule that inserts an administrative barrier to the marketing of generic drugs even when there is no patent in place. Brand name drugs must be proven to be safe and effective through clinical studies involving human subjects. Requiring generic companies to repeat these trials would be expensive and unethical. In order to bring their drugs to market, generic drug companies must demonstrate only that their drugs are bioequivalent to brand name drugs — that is, the generic drug and the brand name drug both work the same way in the body. Generic drug companies establish safety and efficacy by referring to the results of the clinical trial data already completed by their brand-name equivalents.

But generic companies are prohibited from using or referring to the originator’s clinical trial data for drugs during the period of time that they are data protected. Under CAFTA and related domestic law, Guatemala authorizes brand-name drugs to be data protected for either 5 or 15 years (the term of data protection depends on whether the drug was listed during the years when the law offered a 15 year term, or in later years when the law offered 5 years). Originator corporations can select which medicines they submit to the Guatemalan drug regulatory agency to be listed as data protected. This is a simpler process for drug companies than getting a patent, and it offers the same monopoly marketing rights, though for a shorter period of time. The result is that generic equivalents of data-protected drugs are effectively barred from entering the market in Guatemala for years.

CPATH found that CAFTA IP protections have caused some generics that were already on the market to be withdrawn. In other cases, new generics were denied the right to register for entry to the market.  Data exclusivity protections affect drugs used to treat the most common health conditions causing death in Guatemala, including hypertension (Ventavis), cancer (Fludara, Aloxi, Emend, Erbitux), pneumonia (Invanz), diabetes (Lantus), and cardiac disease and stroke (Crestor), as well as contraceptives (Yasmin) and antiretroviral medications to treat HIV/AIDS.

One example of the problems that such IP protections cause is seen in the case of insulin. In 2007, insulin made by Sanofi Aventis (US; brand named Lantus) cost $50.31 per 100 mL, while a therapeutically equivalent generic insulin made by Drogueria Pisa de Guatemala cost $5.95 per 100 mL.  Yet, as Lantus is protected by data exclusivity until 2016, Guatemalans will pay 846% more for insulin than they would pay for its locally manufactured equivalent.

A number of the protected drugs will become open for generic competition in the United States, where they were first launched, before generic versions will be legally available in Guatemala. For example, clopidogrel bisulfate (Plavix), used to treat myocardial infarction, both is patented and has fifteen-year data exclusivity in Guatemala. Four drug companies that formerly sold registered generic versions of clopidogrel bisulfate in Guatemala have had that registration revoked. The result is reduced competition.

Because CAFTA has shifted power to the drug industry, the cost of managing HIV/AIDS has also gone up, and local health care facilities are unable to provide adequate treatment.  According to the Guatemalan advocacy group Mujeres Positiva, in 2009 the Guatemalan government discontinued purchasing several antiretrovirals from donor organizations like the Pan American Health Organization and the Clinton Fund.  Instead, the government shifted purchases to the brand-name companies, increasing the cost of a year’s supply of Abacavir from $350,000 to $5.5 million and of Kaletra from $1 million to $5.4 million. As a result, clinics are reducing the supply of drugs provided at each visit, are requiring multiple visits that are impossible for many, and are discontinuing the lab tests necessary to calibrate doses.

In 2007, the US Congress removed a similar data-exclusivity provision from the pending Peru Trade Promotion Agreement, recognizing the life-threatening consequences such provisions have on lower-income countries.  As we debate health care reform in the United States, it is important to recognize the impact that trade policy has on health worldwide. CPATH urges the Obama Administration to work with Central American governments to suspend these provisions and to promote policies that further public health, advancing human rights worldwide. The President and his Trade Representative should take their lead from the World Health Organization (WHO), which has proposed a comprehensive framework for trade that balances the need for pharmaceutical innovation with the needs of developing countries to access affordable medicines.

For more information:

WTO: Intellectual Property (TRIPS) – gateway

Globalization and Health: TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines?

Photo © 2008 Fred Abrahams/HRW

The recent humanitarian release of Libyan citizen Abdalbaset al-Megrahi from prison in Greenock, Scotland, because of his poor health, and his subsequent “hero’s welcome” in Libya is strikingly incongruous when compared with the tragic fate of Fathi al-Jahmi, a Libyan prisoner who also suffered from poor health, including coronary artery disease, congestive heart failure, hypertension, and diabetes.

Libyan authorities held Mr. al-Jahmi prisoner in Tripoli on two occasions for a total of six and a half years. His “crime”? The peaceful exercise of his fundamental rights of freedom of expression and association. He advocated for democratic reforms and free elections, as have many other Libyan citizens whose outspoken opinions have led to their imprisonment. Additionally, Mr. al-Jahmi had the audacity to directly criticize the Libyan government and its leader of 40 years, Colonel Mu’ammar al-Quaddafi.

Mr. al-Jahmi’s second arrest took place in March 2004. In February 2005, a medical doctor representing Physicians for Human Rights (PHR) visited him in a special detention facility and reported that he suffered from diabetes, hypertension, and heart disease. PHR “called for al-Jahmi’s unconditional release and access to medical care.”

However, following a secret trial in May 2006 that failed to meet fundamental fair-trial standards, the court ruled that Mr. al-Jahmi was mentally unfit to stand trial. Confinement in a psychiatric hospital, for an entire year, followed this ruling. He was denied both medical care and family visits. In mid-2007, after a diagnosis of congestive heart failure, the Libyan authorities granted Mr. al-Jahmi a transfer to Tripoli Medical Center and later claimed he was a free man.

PHR and Human Rights Watch representatives, including PHR advisor Dr. Scott Allen, visited Mr. al-Jahmi at the Tripoli Medical Center in mid-March 2008 — a repeat visit facilitated by the Quaddafi Foundation, which is headed by Col. Quaddafi’s son, Saif al-Islam. They found that Mr. al-Jahmi’s health had improved with better medical care and that he was not “mentally disturbed.” However, his health was still substantially worse than at the time of his arrest, and he remained very ill, so much so that the PHR doctor recommended immediate invasive testing and suggested possible angioplasty or bypass surgery. Because Mr. al-Jahmi did not trust the Libyan authorities, the PHR doctor said that it could prove necessary to perform such follow-up procedures abroad.

When the two rights organizations’ representatives asked Mr. al-Jahmi if he was free to leave the medical center, he said no. When they asked him if he wanted to go home, he said yes. They also reported that security officers controlled access to visitors and that neither Mr. al-Jahmi nor his family could “freely make decisions about his medical care, due to real or perceived pressure from the government.”

Mr. al-Jahmi’s family subsequently reported that he was denied regular nursing care and critical medical treatment. Guards flanked his door and confined him to his room, which they locked from the outside. During the family’s daily visits, limited to two hours, his wife and children brought him food and did what they could to make him comfortable. But they also watched his health steadily deteriorate, and by early 2009, they said he was no longer able to move, eat, or drink without assistance and could speak only with great difficulty. In early April 2009, Mr. al-Jahmi’s family requested his transfer to the intensive care unit, but this request was not granted until, on May 3, he lapsed into coma.

The International Human Rights Network of Academies and Scholarly Societies, of which I am executive director, and many other concerned groups, sent repeated and urgent appeals for Mr. al-Jahmi’s release on humanitarian grounds for health reasons to Col. Quaddafi and Libyan government authorities. We did not receive a single direct reply to our pleas. Only through an international organization, acting as an intermediary in a private process between our group of national academies and the Libyan government, did we learn that the Libyan authorities claimed, contrary to information we deemed reliable, that Mr. al-Jahmi was a free man, in the hospital of his own choice, and receiving appropriate medical treatment.

Subsequently, we learned from Mr. al-Jahmi’s brother that on May 5 of this year the apparently frantic Libyan authorities had Mr. al-Jahmi flown to the Arab Medical Center in Jordan, presumably to avoid the accusations and humiliation that would follow if they allowed him to die in a Libyan prison, as rights organizations and others had feared they would do. Mr. al-Jahmi was taken out of the country, still in a coma, and in the company of security guards who did not take along any of his essential medical records. Only his son was permitted to accompany him. Mr. al-Jahmi reportedly never regained consciousness. He was 68 years old and an internationally recognized democracy advocate and prisoner of conscience when he died on May 20, far away from his home and family, with Libyan security guards looking on.

The Libyan authorities callously denied Mr. al-Jahmi the medical treatment he required during much of his imprisonment and the last months of his life. Then, when clearly on his death bed, in an apparent attempt to avoid embarrassment, they took him away from his home and family to die in Jordan. Thus, it was a cruel and deeply offensive irony when, just four months later, another seriously ill internationally known Libyan prisoner was flown by Libyan authorities, in the company of Col. Quaddafi’s son, to a “hero’s welcome” in Tripoli. That man was Abdalbaset al-Megrahi, a convicted mass murderer, known to the world as the Lockerbie bomber.

The authorities in Edinburgh, Scotland, said they had released Mr. al-Megrahi because he was dying of prostate cancer and should be permitted to spend what time he had left at home, in the company of his family. Col. Quaddafi’s son reportedly said he was deeply grateful “to the Scottish government for taking this brave decision [Megrahi’s release] and for taking into account the special humanitarian circumstances.”

If the Libyan authorities had shown any semblance of courage or understanding or compassion toward Mr. al-Jahmi, their own citizen and a truly courageous and selfless human being, and had responded to the many repeated and urgent appeals from around the world for his humanitarian release, surely this brave and clearly innocent man would be alive today. Instead, the Lockerbie bomber is now at home among his family and friends, benefiting from the kind of medical care that could have saved Mr. al-Jahmi — a man who never got the hero’s welcome he so deserved.

This blog post was endorsed by the Executive Committee of the International Human Rights Network of Academies and Scholarly Societies.

Below is one PHR-Israel case study representing a current trend in the provision of exit permits to Gazans for medical reasons. Case studies such as this one have been provided by PHR-Israel to raise awareness about border restrictions in Gaza that prevent Gazan patients from receiving critical health care. Full names are withheld for reasons of medical confidentiality and can only be released for purposes of access to medical care.

Case Study 3

(Provided by PHR-Israel)

August: Diplomatic pressure fails to reverse a prohibition on medical access from Gaza
Yousef I.A.L, male, 41, is a father to six children from the Jabalia refugee camp in the Gaza Strip. In 2005, Yousef underwent surgery replacing a mitral valve and also removing a cancerous tumor from his heart. He currently suffers from chronic renal failure and is awaiting a kidney transplant. He also suffers from recurrent venous and arterial thrombosis, including pulmonary embolism and critical ischemia in the legs and hip, from diabetes, high blood pressure, and nerve atrophy which began in childhood. Over the past three months, Yousef has lost over 30kg of his body weight and together with the overall deterioration in his physical condition there is a concern for the recurrence of cancer in his body.

On May 13, 2009, Yousef was referred by the Palestinian Health Ministry for treatment at Al Makassed Hospital in East Jerusalem after the hospitals in Gaza could not provide him with the required care. The patient was since invited five times by Al Makassed Hospital, three times by the Department of Cardiology (June 21, July 1, and July 19) and the other two by the Department of General & Vascular Surgery (June 3 and June 18). Yet Yousef was not able to attend any of these appointments. The Israeli secret police (ISA/GSS/Shin Bet) rejected three applications that Yousef had submitted to the Israeli authorities at Erez, based on a “security prohibition” against him. In addition, an application to exit Gaza submitted by the Palestinian coordinating mechanism in May 2009 did not receive any response from the Israeli army. Only after PHR-Israel contacted the army in July 2009 it was told that the application had been denied by the secret police. Applications submitted by PHR-Israel on behalf of the patient on July 21 and August 12 were also denied on the same grounds.

To assess the patient’s medical condition, PHR-Israel consulted with two of its volunteer Israeli medical doctors who are experts in the fields of Yousef’s condition. These physicians were provided with his medical files. Professor Raphael Walden, an expert on vascular medicine and Deputy Director at Sheba Medical Center in Tel Hashomer, wrote that “treating the patient in Gaza is impossible and his life is in danger….” Prof. Dina Ben Yehuda, Head of the Hematological Department at the Hadassah Medical Center in Jerusalem, wrote that “the patient requires evaluation in a tertiary hospital to find the reason for his thrombosis as well as for the possibility of performing surgery on his ischemia.” Despite the fact that this information was brought to the attention of the Israeli military authorities and secret police, Yousef’s applications were denied. It is worth mentioning that Yousef entered Israel and East Jerusalem at least seven times in the past to receive treatment. On August 19 PHR-Israel applied to the embassy of the EU presidency (Sweden) in Tel Aviv as well as the Norwegian embassy, to members of Knesset and to well known public personages in Israel to apply pressure on the Israeli authorities to enable access to lifesaving care to this patient. One week later, the Israeli coordinator of operations in the OPT (COGAT), Mr. Uri Singer, informed the embassy representatives by telephone that their response to this request was negative. The patient remains in Gaza in imminent danger of his life.

Below is one PHR-Israel case study representing a current trend in the provision of exit permits to Gazans for medical reasons. Case studies such as this one have been provided by PHR-Israel to raise awareness about border restrictions in Gaza that prevent Gazan patients from receiving critical health care. Full names are withheld for reasons of medical confidentiality and can only be released for purposes of access to medical care.

Case Study 2

(Provided by PHR-Israel)

July: Diplomatic and public pressure reverse “security” considerations regarding medical access from Gaza.

Ahmad A.B., male, 28, resident of Gaza, was diagnosed in August 2008 as suffering from a Hodgkin’s lymphoma type cancer. He underwent seven series of chemotherapy in Gaza but did not respond to it. A CT scan performed in May 2009 showed a tumor in the chest and enlarged lymph nodes. On May 7 he was urgently referred for care to the Augusta Victoria hospital in East Jerusalem, which has advanced care facilities for cancer patients, for lifesaving care. Ahmad was given an appointment for June 23, but his request for an exit permit from Gaza — submitted via the Palestinian coordinating mechanism to the Israeli authorities — was rejected by the Israeli secret police (ISA/GSS/Shin Bet) on the grounds of a “security prohibition.” The patient then applied to PHR-Israel for assistance, who transferred his medical documents to their Israeli expert volunteer Prof. Dina Ben Yehuda, head of the Hematology Department at Hadassah hospital in Jerusalem. Prof. Ben Yehuda provided a medical opinion according to which, since the patient was not responsive to ABVD therapy received in Gaza, he must urgently arrive at the Jerusalem hospital to receive combined care including aggressive chemotherapy, radiotherapy and other care.

On June 30 PHR-Israel applied in Ahmad’s name to the Israeli military authorities at Erez Crossing asking that he be urgently transferred to East Jerusalem for medical care. On July 2 the Israeli authorities answered that the request had been rejected by the secret police. PHR-Israel then referred the case to members of Knesset, to PHR-Israel’s members and to the embassies of the EU presidency (Sweden) and of Norway in Tel Aviv, asking that pressure be exerted on the Israeli military to enable the exit of this patient. Several days later, following multiple queries to the military authorities and to the Israeli Foreign Ministry, the military authorities reversed the patient’s “security prohibition” and the patient was allowed to access the hospital.

The Israeli-imposed border restrictions in Gaza continue to choke off needed medical assistance for Gazan patients. Humanitarian and medical aid can barely squeeze into the blighted region, and sick Gazans with referrals for medical treatment outside of Gaza may not be granted permission to exit.

Additionally, the Gaza War earlier this year triggered major setbacks in health sector operations, according to data published by the World Health Organization in July 2009. Bureaucratic complications and political disputes led to delays in processing applications, culminating with the closure the Referral Abroad Department from March 22 to April 27. The report indicates that in the six months following the war, only half of the applications to exit Gaza via Erez Crossing for medical reasons were approved. The only other way out — the Rafah Crossing leading into Egypt — is open infrequently and only for short periods of time.

Physicians for Human Rights-Israel, a Jaffa-based Israeli organization, has been documenting these permit constraints in order to advocate for patients in tremendous need of care outside of Gaza. According to PHR-Israel, more than 100 Gazan patients apply to PHR-Israel for assistance in medical access from Gaza every month.

Below is one PHR-Israel case study representing a current trend in the provision of permits. Case studies such as this one have been provided by PHR-Israel to raise awareness about border restrictions in Gaza that prevent Gazan patients from receiving critical health care. Full names are withheld for reasons of medical confidentiality and can only be released for purposes of access to medical care.

Case Study 1

(Provided by PHR-Israel)

May and June: Bureaucratic hurdles decreased medical access at Erez Crossing. These months were characterized by severe delays in the handling of Palestinian patients’ requests for permission to exit Gaza for medical care.

Issam Z, male, 44, a resident of Gaza, suffered from severe ischemic heart disease. He was referred for open heart surgery – unavailable in Gaza – in Al Takhasussi hospital in Nablus, West Bank. However, although he had all necessary documents by February 2009 (referral letters from both hospitals and a financial undertaking from the PA to cover the costs of the procedure), he did not succeed in coordinating his exit from Gaza.  Since the Palestinian coordinating mechanism for medical permits was not functioning throughout March and April, his request was not forwarded to the Israeli side, while at the same time, the Israelis were refusing to process applications direct from the patients.

In late April Issam applied to PHR-Israel for assistance, who appealed to the Israeli coordinating authority at Erez Crossing, on April 27, 2009, asking for a speedy processing of the patient’s request to exit Gaza, in the light of his condition and the lack of a Palestinian go-between. On May 5 the Israeli authorities informed PHR-Israel that the Palestinian coordinating mechanism had returned to functioning and therefore they were stopping their handling of his application. They demanded that Issam re-apply via the Palestinian side. On May 14 the Israeli army informed PHR-Israel that the application for exit from Gaza had been approved, only to reverse this decision without explanation several days later. On June 3, after several vain attempts by the patient to re-apply for exit, PHR-Israel demanded of the Israeli army that they expedite the process of dozens of cases that had been delayed in this way since May, including that of Issam. On June 7 the patient’s family informed PHR-Israel that Issam had died of his illness at his home in Gaza.