An international legally binding instrument  would be an effective response to address the issues arising in the context of the inequality in rights and obligations that exists  between transnational pharmaceutical corporations and the patients affected by their business policies and practices.  Transnational pharmaceutical corporations and other medical business enterprises, through the global reach of their operational activities, have social and political impacts disproportionate to their legal and social obligations, nationally and internationally.
Medical  Whistleblower Advocacy Network supports the Guiding Principles on Business and Human Rights and their implementation through national action plans and believes that the  Guiding Principles and the mandate of the working group are mutually reinforcing. 
Pharmaceutical transnational corporations have a vast and growing impact on the lives and health of human patients worldwide. There is a critical need to  promote global compliance with a uniform human rights standard to help protect the rights of human subjects and patients.  This is critically important with regard to non-consensual experimentation, or treatment without informed consent with off-label medications.  These medications are sold worldwide. National regulatory lapses and lack of criminal enforcement against pharmaceutical companies, has resulted in an atmosphere of impunity for expansive deceptive marketing programs.  These promotional marketing efforts are designed to disseminate false information in an effort to boost sales to vulnerable patients. Off-label promotion of pharmaceutical drugs is a serious crime, because it undermines the national regulatory agency's role in protecting the public through determination of a drug's safety and effectiveness for a particular use prior to marketing.  Illegal marketing, promotion and misbranding activity increases patients’ costs, threatens their safety, and negatively affects the delivery of healthcare services to patients. 
When the company is facing regulatory actions or criminal sanctions, they often seek to market in another country the medication they can no longer effectively market at home. Pharmaceutical companies frequently repackage medications for a different condition than the one for which the drugs had been tested in clinical trials.  This expands the market for drugs that don’t bring in enough profits when marketed for a particular condition.  When they do this they often do not provide the human consumers of their products with accurate information about the medication's side effects and adverse effects,  Pharmaceutical companies are often deceptive about the drug's effectiveness for the condition for which it was sold.  (for example Eli Lilly's marketing of Strattera in China) 
It is wise to consider why the regulation of pharmaceutical products and their marketing is so crucial to the Right to Health.  A terrible international human rights tragedy was caused by the promotion and sale of the drug, Thalidomide. It was marketed worldwide with little regard to the research findings that the drug could cause severe birth defects in children born to women taking the drug. Thalidomide was synthesized in West Germany in 1954 by the pharmaceutical company Chemie Grünenthal.  It was marketed (available to patients) from October 1, 1957 (West Germany) into the early 1960's. Thalidomide was present in at least 46 countries under many different brand names.  Thalidomide was a morning sickness drug taken by pregnant women. It continued to be sold and assertively marketed to pregnant women, even after it was known by both research findings and clinical experience, that it caused congenital defects. Thalidomide, was promoted and marketed by the pharmaceutical company as a "wonder drug" that provided a "safe, sound sleep".  Thalidomide was a sedative that was found to be effective when given to pregnant women to combat many of the symptoms associated with morning sickness.
Thalidomide was a catastrophic drug with tragic side effects. Initially, it was not realized that thalidomide molecules could cross the placental wall affecting the fetus.  But when the first reports of birth defects became known to the pharmaceutical company, the evidence was suppressed and the company continued to market the drug because it was extremely profitable.  A percentage of the affected patients experience the effects of peripheral neuritis, a devastating and sometimes irreversible side effect.  But thalidomide became notorious as the killer and disabler of thousands of babies. When thalidomide was taken during pregnancy (particularly during a specific window of time in the first trimester), it caused startling birth malformations, and death to babies. Any part of the fetus that was in development at the time of ingestion could be affected.  For those babies who survived, birth defects included: deafness, blindness, disfigurement, cleft palate, many other internal disabilities, and of course the disabilities most associated with thalidomide: phocomelia.  Phocomelia is a condition that involves malformations of the arms and legs. The birth defect results in hands and feet that are attached to abbreviated arms and legs.
The number of thalidomide victims has never been adequately quantified, but it has been estimated that there were between ten and twenty thousand babies born disabled.  Within a few years of the widespread use of thalidomide in Europe, Australia, and Japan, approximately 10,000-20,000 children were born with phocomelia, leading to the ban of thalidomide in most countries in 1961.  There are approximately 5,000 survivors alive today, around the world.  The number of babies miscarried, or stillborn, let alone the number of family members and parents who have suffered over the years will never be known. (Suffer the Children: The Story of Thalidomide, by the Insight team of The Sunday Times of London, The Viking Press, New York)

Around the world, in the late 1960's and into the early 1970's, the victims of the drug thalidomide and their families entered into class action legal suits, or threatened actions, against the various drug companies who manufactured and/or distributed the drug, and they were eventually awarded settlements. In most countries, these settlements included monthly or annual payments based on the level of disability of the individual.  But in some countries, victims of the drug were often forced to face the human tragedy and the legal and medical costs alone, family by family. The victims of this human rights tragedy did not receive adequate redress for their injuries. Often cases never received a trial verdict.  Rather, many families were forced to settle out-of-court with gag orders imposed on them not to discuss the amounts of their settlements. This resulted in wide disparity in the compensation amounts, with settlements for individuals with the same levels of disability varying by hundreds of thousands of dollars. The victims faced the extraordinary medical costs because of their disabilities and now, decades later, any settlement money is long gone. Survivors of the thalidomide tragedy, who are now in their fifties and sixties, are experiencing physical deterioration due to stress placed on their different body structures, further limiting their abilities.  This often results in new disabilities, thus compounding this human rights tragedy. There are many unaddressed needs and overwhelming problems of these victims of a pharmaceutical company. The long term social and medical costs are extensive and borne by the affected individuals themselves, their families, their communities and their home nations.

In the U.S.A. during the 1950's it was legal for U.S. companies to promote drugs for any use.  After the public outcry concerning the thalidomide tragedy, the U.S. Congress banned the practice in 1962.  After 1962, pharmaceutical companies in the U.S.A. were required to prove to the Food and Drug Administration that their drugs were safe and effective for specific uses.  Before that, a drug company could market an approved medicine for any illness.
Thus, the regulatory legislation which legally prohibits the misbranding and deceptive marketing of pharmaceutical products is extremely important in order to prevent another worldwide medical disaster such as thalidomide tragedy.  Nations have the essential need to protect their citizens from off-label promotion and marketing and deceitful misbranding and false and misleading claims about pharmaceutical drugs.
Investor-State Dispute Settlement (ISDS) systems are designed to grant new rights to thousands of multinational corporations to bypass domestic courts and their existing constitutional and human rights protections. The ISDS system enables foreign companies to challenge public health, environmental and social protection laws that harm their profits. The rules of such settlement systems contain conflicts of interest that would be deemed unethical under most legal systems. In the ISDS provisions there is no obligatory code of conduct for arbitrators, to tackle the problem of conflicts of interest or human rights issues. The ISDS system does not provide adequate legal requirements for transparency and accountability for human rights protections and public policy protections for safety and effectiveness of medications. The decisions are not bound by legal precedents or the opinions of governments.  There is no outside appeal to their rulings, even when those rulings may impact the human rights of hundreds of thousands of patients. The ISDS system was designed to give multinational firms the ability to challenge new policies of governments, including social public policy designed to protect the right to health for patients. The investor-state dispute settlement clause, within free trade agreements, is intended to protect foreign investors from discrimination by governments. In practice, it means that companies will have the right to sue foreign governments if they don't like the local legislation. There is little transparency to the process as the cases are heard in private. The nations who face ISDS stand to lose millions of pounds, dollars and euros to private companies when a secret panel of arbitrators decides the national government legislation is not conducive to free trade. In such settlement systems, the safety regulations necessary to promote safe and effective medications are not considered more important than “trade agreement” rights.   In cases involving national social policies regarding the regulation of pharmaceutical products, availability of generic drugs, or the restrictions on the marketing of tobacco to children, full consideration of human rights issues is necessary to protect the human Right to Health. 
The protection of patent rights as it pertains to pharmaceutical drugs is the first step toward off-label marketing of that drug within another nation.  Often with the harmonization of pharmaceutical regulations between countries, a drug legally sold within one nation - like the U.S.A. - gets reciprocal regulatory acceptance and licensing in another country without additional regulatory hurdles prior to marketing.  These reciprocal licensing agreements thus open the door to off-label and misbranded products to be sold in the other country through free trade agreements, as soon as the patent is approved.  Drugs with little evidence of the effectiveness or safety, are thus sold off-label in other countries with less regulatory control over pharmaceutical products.  When faced with public outcry, regulatory control or criminal prosecutions at home, pharmaceutical companies seek to market their products more aggressively in countries with reciprocal licensing agreements and less regulatory control.   In developing countries monitoring is not sufficient to identify all the side-effects and adverse medical events of such medications.  Thus problems with the off-label medications may not be detected immediately and adequate medical response may not be available to affected patients. These same countries have less resources to deal with massive numbers of patients suffering from iatrogenic or medically caused chronic conditions. 

The financial resources of huge transnational pharmaceutical companies sometimes dwarf the resources of developing countries that will be facing them legally in an ISDS dispute.  Faced with the prospect of a long drawn out legal dispute and extensive legal costs, countries are pressured into settlements which are not subject to human rights considerations. The ISDS system allows pharmaceutical companies to sue foreign governments if they try to stop off-label promotion of drugs in their countries.  In ISDS proceedings to calculate corporate losses, pharmaceutical companies can utilize marketing profit data from misbranded off-label promotion and marketing in the USA.  This can occur even if those pharmaceutical companies are currently under investigation or prosecution for criminal misbranding and off-label promotion in the U.S.A.

For example, the U.S. pharmaceutical company Pfizer repeatedly criminally marketed drugs for things they knew they couldn’t demonstrate efficacy for.  In 2004, Pfizer agreed to pay $430 million in criminal fines and civil penalties, and assured U.S. prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. But Pfizer managers were off-label marketing in another Pfizer unit, Pharmacia & Upjohn.  In 2009,  Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.  For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states.  The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.

Across the U.S.A., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of kidney and liver failure, diabetes, chest infections, heart attacks, suicidal impulses or death. Doctors influenced by the direct to doctors pharmaceutical promotions, write more than 10 million such prescriptions each year.  This high volume of off-label prescribing is done in the absence of good scientific evidence to support the use of these drugs - especially antidepressants, antipsychotics, and anxiolytic-sedatives. About 15 percent of all drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work. (Randall Stafford, a medical professor at Stanford University in Palo Alto, California.) 

Pharmaceutical companies view the $7 billion paid in penalties for misbranding and off-label promotional marketing criminal fines as just the cost of doing business.  Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.  In  2007, Bristol-Myers paid $515 million — without admitting or denying wrongdoing — to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases. In  2009, Eli Lilly, the largest U.S. psychiatric drug maker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients.  In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia — twice the death rate for those taking a placebo.  These findings were reported in the Journal of the American Medical Association in October 2005. The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.

In 2013 Eli Lilly Corporation used the NAFTA Foreign Investor Privileges to attack Canada's patent policy and demanded $100 million for invalidation of a patent for Strattera.  Eli Lilly sued Canada for violating the North American Free Trade Agreement because Canadian courts had found patents for two of its drugs to be invalid under Canadian law. The Canadian court decisions, Lilly claimed, violated minimum standards of treatment guaranteed to foreign investors under NAFTA and expropriated Lilly’s investment in Strattera, used in the treatment of ADHD, and Zyprexa, used to treat mood conditions including bipolar disorder and depression.  Eli Lilly was demanding to market Strattera in Canada for off-label uses, because sales in the U.S.A. had dropped due to many reports of adverse medical events for individuals using the drug and lack of evidence that it was safe or effective for the purpose it was marketed.  Canada had demanded that Eli Lilly prove that the medication was actually useful (had utility). Eli Lilly claimed that the patent protections in other countries did not need to prove that the drug have utility, therefore Canada was interfering with their right to free trade.  Canada was trying to protect their citizens from the sale of a medication with a proven history of medical problems and no greater effectiveness over generic medications already in use in Canada.   By allowing investors to sue governments for damages, trade agreements with ISDS provisions may be elevating the rights of foreign investors over domestic sovereignty.

The Eli Lilly case centered around the “promise doctrine,” which has played a prominent role in Canadian patent law since 2005. Canada is the sole developed nation that requires applicants to demonstrate the “utility” of an invention at the time of application.  Under this doctrine, Canadian courts have reviewed patent specifications to determine whether the inventor had made an express promise concerning the invention’s utility at the time the patent application was made, and whether the patent data fulfilled that promise. Canadian regulators realized the threat of unregulated off-label promotion of Eli Lilly's products.   Canada had the scientific and legal means to counter the legal challenge, but many developing countries do not have the scientific medical patent expertise or legal resources to effectively protect their home country from such legal challenges presented outside their own nation's court system.  In the final decision, the NAFTA tribunal  refused to question Canadian judicial interpretations of domestic patent law and Eli Lilly lost the case. 

But the ISDS clauses have been rewritten and redefined in newer trade agreements to better protect the profit interests of transnational corporations and businesses, with little consideration of the human rights issues involved.  The Trans-Pacific Partnership (TPP) – a trade agreement which was under negotiation between the United States and ten Pacific Rim countries – planned to expand on the ISDS provisions that provide the basis for such challenges to countries’ patent policies.  

Historically pharmaceutical companies have shown little willingness to abide by human rights principles and have done human rights abuses especially in regards to the use of human subjects for non-consensual experimentation in pharmaceutical research.  These corporations actively promote deceptive marketing practices that impede the patient's right to the knowledge necessary to give informed consent prior to treatment. There is a huge disparity between the political power and financial power of transnational pharmaceutical corporations and the victims of their business related human rights abuses. Through the global reach of these corporations, the violations of human rights by such entities disproportionately affect marginalized and impoverished groups and exacerbate existing human rights concerns.  It is essential to find effective means of preventing and redressing human rights abuses related to transnational pharmaceutical corporations and of ensuring greater accountability and access to remedy for victims.  Much more remains to be done to prevent abuses in connection with activities by transnational pharmaceutical corporations and other medical business enterprises and to enable victims to have meaningful  access to remedy when abuses occurred.   

The Australian Government is opposed to signing up to international agreements that would restrict Australia’s capacity to govern in the public interest — including in areas such as public health or the environment, especially in the wake of a complaint by Philip Morris about Canada's requirements for health warnings on cigarette packets. Brazil continues to receive lots of foreign investment, despite its long-standing refusal to sign any treaty with an ISDS mechanism.  South Africa, Indonesia, India and Ecuador are  terminating or renegotiating their treaties with ISDS provisions. Venezuela and Bolivia have already done so.

But in the past few years, the number of such investor-state attacks has surged. From the 1950s – when this system was first established – until 2000, only 50 cases were initiated.  In the past 5 years, more than 50 cases have been filed each year, for a total of 760 cases. A whole industry of third-party financing and specialized law firms has sprung up to help multinational corporations extract taxpayer dollars and roll back key public interest policies using the ISDS system.

Multinational pharmaceutical companies also use their huge financial and political influence to  expand the length and scope of monopoly patent rights, which can limit consumers' access to cheaper generic drugs.  This causes higher prices and restricts access to necessary medications for cancer, HIV/AIDS, and tuberculosis, for patients in developing countries.  Pharmaceutical companies also utilize their enormous financial and political influence to affect national legislation which limits and controls the ability of social programs to pay for medications and limits public policies which negotiate prices.  Higher prices means rationing of medications to needy patients.

The widespread off-label promotion of drugs which have not been proven safe and effective, is an indication of a health-care system that has become dysfunctional.  When the public health dollar is spent on ineffective and sometimes very dangerous drugs, that money is not spent on effective and safe necessary health care.  In developing countries struggling to provide even effective, safe therapies for their populations, this can severely decrease the ability to provide citizens the right to health.

Medical Whistleblower Advocacy Network supports the drafting of a  legally binding human rights instrument to redress the current imbalance between the human right to health, and the clinical research and marketing opportunities offered to pharmaceutical transnational corporations.  Without corresponding obligations for corporations to be required to respect human rights, the human rights of patients will be undermined.