News Link n. 58

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 58

Barroso protégé to oversee EU development policy

A new political portfolio for “global issues”?

Health-in-All policies: From rhetoric to seizing opportunities?

Pharma industry downplays lobbyism with patient groups

The BRICS lead by example in global governance reforms

Analysis: The future of food aid

The poorest countries are under renewed threat from WTO rules on access to medicines (and yes, this is 2013) 

How Africa Can Transform Land Tenure, Revolutionize Agriculture, and End Poverty 

African governments still underfunding health  

Development post-2015: What role for African diaspora?

WHO urges governments to act on hepatitis threat

1 million reasons to close the hepatitis policy gap in Asia

WHO Members Meet On Poor Quality Medicines 

OMS in balia dei privati. I timori del non-profit

The Lancet Global Health August 2013 issue

WIPO General Assembly Left To Decide Future Work Of TK Committee

ECOSOC Tackles HIV/AIDS, NCDs, Science & Tech For Development

Concerns Raised Over Potential Threat of Investment Agreements

Se Big Pharma corteggia gli studenti in medicina

Perché Cuba ce la fa

Asia needs to be deeply involved in Africa vision

Intel and Global Fund Start Partnership on AIDS and Malaria Research

German government negotiations with India on future development cooperation

MPP Annual Report 2012 




News Link n. 57

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 57

W.H.O. Recognition Is Boost for New Drugs

Trans-Pacific trade agreement could choke off patient access to affordable generic medicines 

EU publishes initial TTIP Position Papers

As disease rates fall in Africa, EU urged to maintain health aid

Brussels proposes pooling world development aid funding  

Pool development aid to stamp out poverty, says European commission

EU, China officials begin green growth talks in ‘airpocalypse’ smog  

EU’s overseas aid corps faces its own budget hurdle

MEPs deal a blow to crop-based biofuels

The global burden of a poor diet 

Small-scale farmers, The missing element in the WIPO-IGC Draft Articles on Genetic Resources


Brazil develops ‘superfoods’ to combat hidden hunger

The World Bank cuts off funding for coal. How big an impact will that have? 

The World Bank is bringing back big, bad dams

Is there a role for foreign development assistance in middle income Asia?

Protecting Shared and Widely Distributed Traditional Knowledge: Issues, challenges and options 

Save the Children, Merlin merger: Greater reach, impact and value for money 

Mismanaged aid: From an empty building to broken systems

New report shows that a healthier Africa will further boost economic growth on the continent

African Dynamics to Tackle Neglected Diseases

Winning the war against neglected tropical diseases

Winnie Byanyima: Engineering change at Oxfam

Georgia: A Leader in the Global Fight Against Hepatitis C

The Global Commission on Drug Policy: The War on Drugs and the Hidden Hepatitis C Epidemic





News Link n. 56

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 56

EU and US conclude first round of TTIP negotiations in Washington

Oxfam reaction: MEP vote not enough to stop EU biofuel policy fuelling hunger 

WHO Priority Medicines Report: a decline in pharmaceutical research and development productivity?

WHO, WTO, WIPO Heads Call For More Medical Innovation

DNDi & Cipla Advance Development of Paediatric 4-in-1 ARVs to Fulfill New WHO Guidelines 

What Should International Development Look Like After 2015?

Michael Cashman: Take a ‘blitzkrieg’ approach to SRHR

Meet UN Women’s new chief 

The fuss over intensified farming 

Ending Poverty Includes Tackling Climate Change

India will meet poverty reduction target by 2015: UN

Healthcare in Britain – first they came for the immigrants

WTO Aid For Trade Review Looks At LDCs And Value Chains

Mapping the Donor Landscape in Global Health: HIV/AIDS

“Trilateral” Symposium Addresses Topics Of Global Public Health And IP 

Using TRIPS flexibilities to facilitate access to medicines

Progress for Family Planning but 16Million Adolescent Pregnancies Left Behind 

Politica, migrazioni e salute: a farne le spese sono I più piccoli

What is ‘leverage’ (NGO-speak version) and why does it matter?

HEARD’s Research Director’s Report: Reflections on AIDS Conference

Why The G8 ‘Commitments’ Lacked Measurable Actions

Creating a Private Sector Development Model for the World to Follow

BRICS and global health: a call for papers

Ensuring food safety and nutrition security to protect consumer health: 50 years of the Codex Alimentarius Commission

Development assistance for health in Africa: are we telling the right story? 








News Link n. 55

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

News Link 55

Untangling the Web of Antiretroviral Price Reductions: 16th Edition

EU aid budget could have been more ambitious — NGOs

FAO testing its budget revolution

SDGs should target ending hunger sustainably by 2025

 One year after: World Bank chief faces challenges 

An alternative guide to the new NHS in England

How the Poor are Saving for Change

AfDB and Global Environment Facility to Strengthen Climate Change Adaptation With Usd 33.58 Million

WIPO Innovation Division On Chopping Block? 

AU: Africa needs energy to be competitive

Questions Arise Over EU Draft Regulation To Implement Nagoya Protocol 

Equal Innovation Seen As Critical To Economic Growth, Achievement Of UN MDGs 

New models of cooperation and partnership for innovation

Medicines Patent Pool Signs Agreement with Shilpa Medicare to Increase Generic Production 

La violenza globale contro le donne

The seven sins and the seven virtues of Universal Health Coverage

ECOSOC Panel: Science, Technology, Innovation Essential For Universal Health Coverage 

Investing in democracy and food security

WHO Issues Guidelines To Push HIV Epidemic Into “Irreversible Decline” The aid transparency ecosystem is growing





Compulsory Licensing of Life-Saving Medicines: “A Story and a History” , “A Problem and a Solution”

The recent internationally reported decision by India’€™s Supreme Court prohibiting increased patent protection for a vital life saving cancer drug, Gleevec, has focused long overdue attention to a “€œtactic”….some call it a bureaucratic “€œtrick”….used and abused by the multinational pharmaceutical companies to increase patent protection from twenty to forty years.


by William F. Haddad

 William F. Haddad, Chairman/CEO, Biogenerics, Inc., has been a pharmaceutical executive since 1986. As Chairman of the generic trade association, he initiated and negotiated Hatch-Waxman, the legislation that opened the door to generics in the United States. He was CEO of a major generic manufacturing company. Earlier he worked with Jack and Robert Kennedy and Senator Estes Kefauver.  He was one of the founders of both the U.S. Peace Corps and the Office of Economic Opportunity (poverty program) and served as the Inspector General or both organizations. As a newsman at the NY Herald Tribune and the NY Post, he won a dozen awards for investigative reporting. He also learned about the wiretapping of Watergate three weeks before the break-in and reported it to the Democratic leadership. He exposed the worldwide tetracycline cartel by locating secret cartel minutes in two Latin American countries, destroying the cartel and leading to a $200,000,000 fine for Pfizer.  He also found the secret minutes of the Uranium cartel that led to Congressional hearings conducted by then Congressman Albert Gore and Haddad. Using New York State’€™s subpoena he uncovered of the role of the New York banks in profiting from the collapse of the City’s financial system; located and exposed secret state police files that contained the names of a million citizens almost all had neither been accused of or committed a crime; he investigated organized crime’€™s role in sports; and he subpoenaed the major television networks to explain covert arrangements with advertisers in advertising to children. As a volunteer, he worked with Cipla to remove the barriers to the use of generic AIDS medicines. He has published several books. He was a merchant marine officer at sea when he was sixteen.


(First of a series)

Compulsory Licensing of Life-Saving Medicines 

“€œA Story and a History”        

“€œA Problem and a Solution”

The recent internationally reported decision by India’€™s Supreme Court prohibiting increased patent protection for a vital life saving cancer drug, Gleevec, has focused long overdue attention to a “€œtactic”…..some call it a bureaucratic “€œtrick”…used and abused by the multinational pharmaceutical companies to increase patent protection from twenty to forty years.

After seven years of persistent deliberations  and the personal courage of a small cadre of determined voices, India’€™s Supreme Court opened the door to a long overdue discussion of the practical solution for a responsible, legal way to provide affordable life-saving medicines for the millions currently sick or dying in the poor nations of the world.

The Indian Court’€™s ruling was the second citing misuse of a patent by a multinational pharmaceutical company. For the multinational pharmaceutical companies the ruling and the worldwide reporting of the decision was regarded as “handwriting on the wall” of things to come.

The multinationals began their counter-offensive by organizing attacks on India itself, a tactic they have previously avoided preferring to work within the small circle of political influence. Those actions may have been a serious mistake.

Both rulings highlighted publically what many in positions of influence around the world already knew:

The price of medicines was often beyond the means of a developing nation or its citizens to pay.  For lack of available medicines, people continued to suffer, and millions died.

For the multinationals private access to prominent public officials was their preferred forum to lobby for continued monopoly control, often by using arguments not viable in public forums.

Now, rather unexpectedly, India’€™s highest courts are engaged, spotlighting how competition was side-tracked. Their rulings stirred and renewed worldwide attention and threatened to open up both the tactics and the success of how a handful of  multinational pharmaceutical companies were, in the words of an observer, “€œdigging the graves”€ of poor people around the world.

If continuous pandemics had occurred in western nations, or in China or Russia, and medicines to control or cure the diseases were available there is little doubt these nations would use existing international law to acquire or manufacture them.

When a potential medical crisis developed in the United States ….mail containing anthrax, a deadly poison, was sent to Members of Congress and the media….. it was revealed the life-saving remedy, the medicine, Cipro, was unaffordable.

 Offshore generic companies offered to immediately provide the medically approved Cipro clone at one-fiftieth the price the original multinational pharmaceutical company offered.

Although the multinational pharmaceutical companies often use the U.S. government to argue their case for patents, or to condemn nations that provide affordable medicines without regard to patents, in the anthrax crisis the U.S. government said it was considering bypassing Bayer’€™s patent to insure affordable  medicines were available to prevent a potential national tragedy. Eventually, Bayer marginally reduced its price to block competition.

The multinational did the same some years later as regards Tamiflu made by Roche. In both these cases of Anthrax and Bird flu, the Indian generic company Cipla came forward and offered the approved generic to the United States government. The only way the government could purchase generics during the life of a patent was by compulsory licensing, which the United States government was reluctant to do. Should the destiny of the United States or other countries be controlled by a private company?  Such is the power of monopoly.

The Legal Right to Provide Medicines

Currently Third World nations have the legal right to produce or purchase medicines to insure they are available and affordable. This right, €œcompulsory licensing”€ of a medicine, is guaranteed by  binding international agreements: the Trade-Related Aspects of Intellectual Property (TRIPS) of the World Trade Organization (WTO). Those rights allow a nation to either manufacture or import medicines.

Why, then, aren’€™t those rights used by Third World nations to provide the affordable medicines they need?

The answer is not a secret. Nations who need affordable medicines are often intimidated by the “€œbehind-the-scenes”€ influence of the multination pharmaceutical companies, the brand companies, and their political allies, western nations, who often use public and private threats to discourage competition. Their tactics, fear and retaliation, successfully prevent Third World nations from using that right.  

When western nations finally acknowledged the right to compulsory licensing was binding, the multinationals went, as Americans say, “€œaround the barn”€ to “€œconvince” forty nations to publically pledge not to exercise that right.  Almost all Third World nations refused to join the boycott.  It does not require a sophisticated knowledge of politics to imagine what took place behind those closed doors to convince nations to abandon a right they might need to provide their citizens with affordable medicines.

Clearly, the multinationals fear an affordable price for identical medicines in Third World nations will be contrasted to the high prices they demand in developed nations where they maintain a twenty year monopoly.

Their fear is justified.

The multinationals have learned the competitive and licensed generic industry is able to quickly end monopolies both as regards the active pharmaceutical ingredients (API’€™s) and drug formulations by providing regulated and affordable clones of a branded product on the very day monopoly patent protection ends. Generic companies routinely clone patented medicines and subject them to regulatory authorities long before a patent expires.

After decades of denial, the AIDS crisis finally exposed the consequences of the multinational pharmaceutical companies callous attitude towards Third World nations. Those who lived in western nations with AIDS could survive using available medicines and those who lived in the poor nations of the world, would die. Some labeled the intransigence of the multinational companies as “€œa death sentence”€.

Around 2001, in Africa, of the estimated 36 million suffering from AIDS, only 4,000 could afford treatment of the ARV drugs made by multinational companies costing US$ 12,000 per patient per year and approximately 8000 were dying per day. The results were not only traumatic but tragic. When, as often happened, husband and wife died a slow and painful death from AIDS, they often left behind generations of children forced to return to live with grandparents in the villages their parents left in search of education or opportunity.

These undisputed facts could have and should have forced a vigorous public or political response but most nations and too many institutions sat hopelessly on the sidelines. The western nations argued they were bound by patent laws and the poor nations said they feared legal actions if they used their international rights.

Not everyone accepted “€œthe stand down”€ attitude.

Multinationals Face Unexpected Challenge 

The AIDS crisis unexpectedly opened the door enabling Third World countries to legally provide the medicines now denied them. In one sense, it was the needed harbinger for compulsory licensing.

Cipla, a leading generic company in India, refused to stand down and openly challenged the right of the multinational pharmaceutical corporations to deny affordable medicines to Third World nations, including India. The steps they took were totally legal and within the framework of India and Africa traditions.

The company developed an affordable AIDS medicine that, in one tablet, taken twice a day, ended a complicated daily regime of medicines from three brand companies, and reduced the cost of the “€œcocktail triple”€ from $12,000 per patient per year, to  $ 300 a year.

Today, similar “€œtriples”€ is recommended as “€œfirst line treatment”€ for AIDS by WHO and is manufactured by a dozen or more generic companies in several countries.

UNAIDS recently reported the wide usage of generic AIDS medicines. Today these are extensively used to sustain life by around nine million people at a cost of under US$100 per patient per year.  Almost all the patients in the Third World countries and particularly in Sub-Saharan Africa are treated and maintained on generic drugs..

Fearful of the spread of  generic competition in Africa and with an affordable AIDS drugs cocktail  on the horizon, thirty-eight brand companies in 2001 sued in a South African court to stop competition from affordable medicines manufactured by generic companies. Several western nations, including the United States, wrote to the Court supporting this legal action.

Subsequently, the United States, after domestic protests, withdrew its support and the brand companies later withdrew their opposition.  

In January, 2000,  presiding as the rotating Chairperson of the United Nations Security Council, American Ambassador Holbrooke took the unprecedented action to emotionally and forcefully focus the world’€™s attention on the AIDS pandemic, the first time the U.N. Security Council focused on a health emergency.  His plea won worldwide support, but when the excitement died, the multinational pharmaceutical Companies continued with their unaffordable pricing making it impossible to tackle the AIDS problem in a sincere and realistic way.    

Years later when the impact of the AIDS crisis again made headlines,  the U.N. called for a meeting of the multinational pharmaceutical companies to discuss the problem.

Inexplicably, only the multinational pharmaceutical companies were invited. Generic companies were specifically told they could not attend. At one point, annoyed by the repeated request to offer alternative pricing, a generic company’’s supporter was told “€œdon’€™t bother us again.”

With that attitude, the results of the U.N. meeting were not difficult to predict. Nothing resulted from the meeting. The high prices remained intact.

The World Trade Organization, Barrier to Competition 

The World Trade Organization, created to regulate trade between nations, specifically authorizes the right of any nation to obtain medicines without regard to patents.

Few nations could refrain from joining an organization established to create the rules and regulations for world trade but Third World nations seeking membership were required to abandon their pharmaceutical laws designed to provide affordable medicines and accept, over time, western patent laws. 

One WTO concession, however, authorized a nation to manufacture or import medicines without regard for patent limitations, opening the door to potential competition. (Doha Declaration)

To safeguard against change, a unanimous vote was required to change WTO rulings, a right used by some western nations to deny WTO had authorized the importation or manufacture of medicines without regard to patents. The veto or threat of its use prevented clarification of the right of a nation to manufacture or import medicines without regard to patents.

Eventually, pressures built and the U.S. suddenly decided it would not use its veto to prevent a clear interpretation of a nation’€™s right to manufacture or import products. A Committee was established to determine how the right to manufacture or import could be used. The Committee decided to meet secretly in Geneva.

During the negotiations it was “€œleaked”€ that the Committee was using a basic document prepared by Pfizer, one of the largest of the multinationals, to determine how that right was to be used.  Years earlier Pfizer, after the New York Herald Tribune exposed the Pfizer cartel, the company was fined $200,000,000 for controlling the  price of tetracycline worldwide. At the time, tetracycline was the “€œmiracle”€ drug but Pfizer set prices virtually unaffordable in poor nations.

It was not long before the Third World nations realized they may have won the WTO battle, but they had lost the war.

To date, only two nations, Brazil and Thailand have exercised their WTO rights.  Another seven cited the WTO stipulation to manufacture or import AIDS medicines.

For all practical purposes the rights affirmed by WTO have been quietly and effectively swept into a dark corner never to be heard from again.

The multinational pharmaceutical companies and their entrenched political allies could, with immunity, continue to “bully” nations into submitting to their prices.

Compulsory Licensing 

Simply stated, compulsory licensing of a patent is the key to providing affordable medicines and as noted that right is specifically authorized in two binding compacts signed by all WTO Member states.   It legalizes and authorizes a nation to manufacture a medicine by paying a perpetual dividend on sales, usually three to five percent.

Multinational pharmaceutical companies have and do routinely negotiate and award the exclusive right to manufacture and market their products in exchange for a suitable royalty on sales.  

Canada’€™s Compulsory Licensing Law (Bill S-91 valid from 1969 to 1992)

Compulsory licensing is not a new or unique concept.  For decades, compulsory licensing of medicines was the law in Canada.

After a short period of exclusivity, the patent owner was required to license competition allowing generic companies to clone and market the product often at a dramatically lower price than the branded product.

The spread of compulsory licensing, in the words of one brand manufacturer, “€œwas a nightmare”€. 

The multinationals feared Canada’€™s solution to affordable prices would spread to other nations, not only Third World, but western nations.

What they lacked at the time was a serious sponsor who would could undermine or change Canada’€™s compulsory licensing system. 

Eventually, the multinationals and their corporate allies convinced President Ronald Reagan to offer Canada financial assistance if they abandoned their Bill S-91 and accepted patent protection as in the United States. NAFTA was created in 1992, a three country agreement between Canada, USA and Mexico. This necessitated Canada giving up their Bill S-91.

Although Canadians opposed the change, the government approved it and quickly both patent law and high prices were and remain the Canadian norm. The multinationals had ended their “€œnightmare”€.

Now Is the Time for Compulsory Licensing

Cloned (and simplified) AIDS medicines became the high visibility example of what can happen when Third World nations remove imposed barriers to providing affordable medicines for their populations. Cipla achieved its results by creating an AIDS drugs combination and its availability eventually opened doors to wide usage in Africa.

Creating clones of medicines is now routine. The staggering price difference between brand and generic medicines is well documented. The Third World has the unquestioned authority and the opportunity to cure or control chronic diseases and confront epidemics.

The obvious question is “€œwhy hasn’€™t this happened”€?

Literally, life and death depend on the answer. We know an epidemic will raise the question again…and again…but the multinational companies appear secure in their belief they can continue to hide behind western nations and pull the strings of their puppets and avoid serious challenge to their monopolies.

The multinationals have learned from long experience that their backdoor success works, but they also understand  continued  success depends on casting doubt on the existing right of nations to exercise that right to lower the cost of medicines.  They realize change will only result from sustained public protest, based on public knowledge and political courage, both now suppressed, develops.  

Some multinationals fear such awareness is on the horizon but unless it becomes visible and an informed public understands what is happening, it may take another worldwide pandemic to end the practice of refusing to provide affordable medicine when it is available elsewhere.

Literally,  public records reveal that unique profits from sales in western nations more than compensate for the artificial estimates of the cost of creating …..not often finding …a new medicine.

Also to be faced are the other ways to extend patent life.

Tricks of the Trade 

Over the years, the multinationals have found ingenious, sometimes, illegal, ways to extend patents.  Sometimes they are caught, most times not. Nations are just beginning to realize what they lost, and the cost, of expanding patent life from seventeen to twenty years with little opposition. The promise of a burst of new medicines was never realized. The extra years have only strengthened the status quo worldwide.

One trick used to extend the monopoly on a product for an additional twenty years is to add a new component to the existing medicine, often without an acknowledged medical improvement. By “€œcoincidence”€ these alleged “€œdiscoveries”€ occur just as the existing patent is expiring.

The “€œnew and improved”€ medicine is the old medicine in “€œdisguise” ….sometimes the view of regulators and medical authorities…. but it is patented and marketed as a new medicine usually at an increased price. Its reality, its purpose is to avoid competition. Unfortunately, it is often successful.

Where Do We Go From Here?

India and China have indicated they are capable of exercising their right to compulsory licensing, but, judging from the public response of the multinationals and their allies, India remains the primary target.

The recent Indian Supreme Court decisions have blocked a legal pathway to extend patent life.  The multinationals remain uneasy but their preference, it would appear, is not primarily directed at the Supreme Court decisions that may be the harbinger of what is to come. Instead, they are seeking and finding allies to attack India itself.  How far the United States is prepared to wage that attack with them, or to open up the doors for them, is unclear. But, for all practical purposes, the battle is joined and how many live and how many die as a result of their tactics, remains unresolved.

India and China, if they use its yet-to-be-tested right to compulsory licensing law, are capable of opening a door to compulsory licensing that the multinationals may find difficult to close even with the support of western nations. Too many people, young and old, are dying for a business decision to close the doors to life. 

The discussion of compulsory licensing is urgent.  Cipla, the company that first enabled AIDS drugs to be available and affordable and the other Indian companies now manufacturing AIDS medicines may be prevented from challenging the next generation of AIDS medicines.

The newer AIDS drugs now covered under patent in India cannot be manufactured and marketed by them. This will return the supply of AIDS medicines to the very high pricing that prevailed prior to 2001.

India itself will be denied the life-saving medicines it has provided over the years. In answer to a request from media about providing life-saving medicines at affordable prices and controlling of disease, it was suggested “€œwhat is best for India is to have an easy to operate pragmatic compulsory licensing system.”

€œWith a population of over 1.3 billion, India provides an example of why a monopoly in healthcare cannot be tolerated.  The country’€™s disease profile is alarming:  110 million mental patients, 60 million diabetics, 60 million asthmatics, 50 hepatitis cases, etc.  Apart from this there is a high prevalence of T.B., malaria and AIDS and other diseases.

“€œIndia must not get swayed by the developed countries because the country has become the battleground on which access to medicines may be fought.”€

No nation should deny its citizen’€™s access to medicines especially when that right is specifically permitted under WTO’€™s TRIPS regulations.

The forum for this important discussion should begin without delay at WTO.  It is time that WTO takes the next logical step by opening the door to compulsory licensing to be enforced in a rational and timely manner in the third world and the developing countries.

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