News Link n. 22


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 n. 22

Feed the Future Progress Report 2012

A Conversation With: Polio Expert Naveen Thacker

Delivering Medicines in DR Congo: In the Face of Insecurity

Opening Up Microdata Access in Africa

UK Department for International Development: Project Search

WHO’s Global Tuberculosis report 2012

AFGHANISTAN: Winter planning aims to save lives

High Food Prices: Farm Ministers Weigh Options

Arms Trade Treaty negotiations threatened by diplomatic Damocles’ Sword

Pollution as harmful as malaria, TB: study

UK Aid, Imperialism and Child Mortality

Positioning Health in the Post-2015 Development Agenda. WHO discussion paper, October 2012

Future of WHO hangs in the balance

Barack Obama and Mitt Romney on ending poverty, preventable diseases

UN at 67: ‘Solutions for a prosperous world’

Three social enterprises set the pace for global health









News Link n. 21


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 21

-With An Army Of Vaccinators, India Subdues Polio

-Takeaways from this year’s European Development Days

-EDD12: A spotlight on inclusive growth, youth employment

-Relazione tecnica del Governo ( TTF alle pagine 34-35 del documento)

-Rainews tassa sulle transazioni finanziarie:

-New WHO Mechanism Against Poor Quality Medicines To Convene In Buenos Aires

-A closer look at European perception of aid

-Global Fund Nears Selection Of New Director For Transformed Organisation

-Panellists: Global Health Justice Needs Government Commitment, New Innovation Models

-2012 Commitment to Development Index

-Bridging  the gap: why the European Union must address the Global Fund’s funding crisis to tackle the escalating HIV and TB epidemics in eastern Europe and central Asia


The AIDS Story You May Not Have Heard

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.


(News Commentary and Background)

The AIDS Story You May Not Have Heard

William F. Haddad, Chairman/CEO, Biogenerics, Inc.


The United States government, the European Union, multinational pharmaceutical companies and powerful conservative organizations are once again trying to prevent generic companies from providing essential medicines to the poor nations of the world. This time their prime targets are India where recent court decisions may open the door to “€œcompulsory licensing”€ of essential medicines and the Global Fund the major source of financing for AIDS medicines. Also under attack is the World Health Organization’€™s (WHO) pre-qualification system for AIDS and other essential medicines.

India remains the major supplier of generic medicines to Third World nations.

Compulsory licensing can permit competition when a patent is claimed and an essential need identified.

The U.S. team includes former Ambassadors Mark Dybul and William Steiger who helped delay AIDS medicines to millions dying from the illness in poor nations. This was done after the formation of the President’s Emergency Program for AIDS Relief (PEPFAR) in 2003 when they insisted that only products approved by the U.S. Food and Drug Administration (FDA) would qualify for PEPFAR.  They intentionally and deliberately ignored the regulatory requirements created by western and other regulators for the World Health Organization (WHO), a system already in universal use without problems.

The Indian generic companies were excluded until 2007 -€“ 2008 when they received PEPFAR approvals.  During this period only big Pharma benefitted at their high prices while millions died or went untreated. This tragedy can singularly be attributed to the above persons. Their target now appears to be the Global Fund.

India and other nations were required to abandon national laws governing the manufacturing of medicines as a pre-requisite for joining the World Trade Organization (WTO). Uniquely, generic manufacturers in India had developed the strategies and science to clone brand products using methods that often avoided patent protections.  For decades Indian generic pharmaceutical companies have manufactured medicines, including the basic raw materials, that are approved by the U.S. FDA and universally used in the United States.

Poor nations depend on affordable Indian manufactured generics to meet their medical needs.  Branded medicines, often sold at U.S. prices, are simply unaffordable.

The WTO requirement ended that system and obedience to rigid patent laws replaced it in 2005 and was effectively back-dated to 1995. This retroactive action was repressive.

An “€œescape”€ provision in the WTO agreement permits the manufacturing of essential drugs under certain circumstances. In India the unaffordable price for a life saving medicine can qualify for that exemption. However, few of these safeguarding processes work according to their design. Behind the scenes politicians, some hired, some sincere, pulled the strings. In the United States it required thirty years to obtain legislation enabling the routine manufacture and approval for generic medicines.

The burr under the saddle of the multinational pharmaceutical companies (Pharma) is India’€™s apparent refusal to deny patients access to essential medicines because the demanded price is unaffordable. Recently, an Indian court ordered a Pharma company to reduce its price and accept a stipulated royalty for a life saving cancer medicine.

In another, the Indian high court summarily dismissed a challenge from Bayer Inc. claiming a new combination of off-patent medicines constituted a new and patent-protected product. The Court ruled the so-called new medicine was, in effect, “€œevergreening”€ a term used to describe drugs that combine existing medicines with no additional therapeutic impact yet are able to claim and often obtain new patents that can prevent competition for over twenty years although they offered no medical advantage beyond existing patents. These patents have been labeled as “€œfrivolous”€.

In India the multinational pharmaceutical companies often resort to frivolous patenting. They also conduct multiple patenting of the same product in different patent  jurisdictions hoping one of them would be approved.  This undermines the spirit of patenting.

Another shock for Pharma was the recent revoking of Pfizer’€™s patent for its cancer drug Sutent following “€œpost-grant”€ opposition to the patent by Cipla, Ltd.

Dow Jones also noted that Novartis AG has been unable to patent it’€™s cancer drug Glivec in India after its application was rejected in 2006 and that the patent office also rejected an application from Gilead Science for its HIV medicine Viread and noted Roche has been unable to obtain a court order prohibiting the sale of clones of the cancer drug Tarceva.

Conservative associations and their writers perpetuate and promulgate discredited arguments claiming generic medicines, clones of the brand, are “€œless effective”€ and will deny the multinational pharmaceutical companies, often the most profitable segments of any economy, the financing they require to discover new drugs. Although both claims are routinely denounced by the medical community and the FDA, they persist as alibis to deny essential and affordable generics in the poor nations of the world.

Essential AIDS medicines bypassed many of these clichés when WHO with western and other regulators created a “€œone stop”€ universal scientific approval process, “€œpre-qualification”€ accepted by all Third World nations (a first) and by all entities financing their use. Pre-qualification ended nation-by-nation approvals.

It should come as no surprise that pre-qualification is a target of Pharma and others because it deprives Pharma of their ability to use politics and the courts to stretch patents, denying or delaying the use of generic clones.  Many generic companies lack the resources to wage legal battles in each country.

It was this technique that was effectively used to deny AIDS medicines for most of the world. Out of the 36,000,000 afflicted in Africa only 4,000 were in treatment at a prohibitive cost  of $ 12,000 a year.

Pharma now fears a repeat of this defeat will open the market in poor nations to affordable medicines.

To challenge Pharma’€˜s monopoly of essential AIDS medicines, an Indian scientist, Dr. Yusuf Hamied of Cipla Ltd., created Triomune, a unique, regulated combination of the most effective AIDS medicines in one tablet taken twice a day and reduced the cost to a dollar-a-day in 2001. Unfortunately, Triomune, the so-called “€œtriple”€ could not be sold. Thirty-eight Pharma companies sued in a South African court to block the use of generic drugs.  That action effectively prevented the use of generic AIDS medicines.

When Cipla joined forces with Doctors Without Borders (MSF) in 2001 the media exposed Pharma’€™s campaign to deny affordable AIDS medicines from reaching the millions suffering and dying of AIDS. At first there was disbelief. When the reality set it, the intensity and anger of the international condemnation grew. Why would Pharma block the use of a medicine known to prolong lives when it knew few to none in the Third World could afford their prices?  Why would they allow entire families and communities to be destroyed? Editorially, the answer was provided by the media:  Pharma feared price comparisons to their monopoly in western nations, where the cost of a year’€™s treatment was approximately  $12,000 to $15,000 per patient per year, would lead to demands to lower the cost.

Finally, unable to withstand the impact of the truth, the Pharma companies, walked out of court (some wrote “€œwith their tails between their legs”€) and abandoned their legal action. Generic AIDS medicines began to save lives.

This year, UNAIDS and others reported more than 8,000,000 persons were using generic AIDS medicines at a cost of approximately $85  per patient per year.


President Bush in his State of the Union address on 31st January 2003, reacted to the dramatic change in the cost of AIDS medicines and used his State of the Union message to call for the largest contribution of any nation for AIDS treatment.

In an emotional statement, he told the U.S. Congress doctors would no longer be required to tell their patients “…we can’€™t help you. Go home and die….In an age of miraculous medicines no person should have to hear those words…(because)…the cost of these drugs have dropped from $12,000 a year to under $300 a year which places a tremendous possibility within our grasp.”

Congress responded with bi-partisan support and appropriated fifth billion dollars to finance PEPFAR. That donation has now been increased to fifty billion.

Without explanation a tight circle of government executives cooperating with Pharma began an effective campaign to insure only their high priced AIDS medicines would be financed, a goal diametrically opposite to the purpose of the Bush plea and the action of the Congress.

Coordinated Efforts to Deny Financing for Generic AIDS Medicines

As difficult as it is to believe, but after Congress authorized the fifteen billion dollars for PEPFAR, U.S. government officials began to erect roadblocks to prevent the financing of generic medicines. Their first action, without consultation or discussion, was to announce the WHO pre-qualification system, already in widespread use, could not be used to qualify AIDS medicines for PEPFAR funds. No other nation had placed domestic restrictions on their financing for AIDS medicines.

In the United States, the approval of FDA would be required for PEPFAR funds, an expensive and lengthy process. No justification for this action was provided. The worldwide acceptance of pre-qualification was no longer valid. In essence, at its very best, the process would deny generics access to PEPFAR funding undermining the purpose of both the President and the Congress.

By happenstance, the announcement coincided with a worldwide AIDS conference in Paris. There Non-Governmental Organisations (NGOs), Third World nations and the media confronted the U.S. representative, Secretary of Health and Human Services, “€œTommy”€ Thompson asking for an explanation of why the existing WHO system was bypassed?

The media also wanted to know why the expensive and lengthy new tests were required when the approved medicines were readily available and already in use.   Was there a problem with the medicines already pre-qualified by the WHO and universally accepted by all recipient nations?  None had been reported. Wouldn’t the new requirement discourage and delay competition?

Media bureaus around the world reported they could not find reports of failures of the AIDS generic medicines and WHO said had received none.  Was this a manufactured solution to a problem that did not exist?

At first, Secretary Thompson response was hostile refusing to offer an acceptable explanation. But the intensity of the NGO and media questioning continued.

When Secretary Thompson returned home, the FDA requirement was quietly withdrawn. Nations could use WHO’€™s pre-qualification to qualify for PEPFAR funding.

As it turned out, the withdrawal was not a decision, but a tactic. Six months later a lead story in the Sunday New York Times announced the FDA requirement was re-instated.  Again there had been no consultations. The generic companies organized and protested but their arguments were ignored.  Someone, somewhere had made the mysterious decision and it would remain.

Some Pharma executives and a cadre of U.S. officials believed generics either could not, nor would not, submit to the long and expensive FDA process. They were wrong. To their surprise, Cipla submitted to the FDA Triomune, the identical product previously approved by WHO and already recognized as WHO’€™s “€œfirst line treatment”€ for AIDS.

Three years later the FDA approved Triomune without change, opening the door for Africa and the world to purchase generic drugs with PEPFAR funds.

It was estimated one million people might be alive today if use of the generic had not been delayed by politics.

The Bad Guys Return: Déjà  vu All over Again

Two men responsible for delaying universal use of generic AIDS medicines, are no longer in the U.S. government, but are back again, this time their target is the Global Fund where, once again, they are in a position to deny the use of generic AIDS medicines. They are:

Former Ambassador William Steiger

Steiger formerly represented the United States at the Global Fund and WHO and from those positions he threatened that if the Fund financed generics, the United States government would terminate its contribution to the Fund, in effect pulling the financial rug out from under the Fund’s fiscal resources. He enhanced his threat by explicitly warning that he had influence beyond his position. He was, he said, the “€œgodson”€ of the first President Bush (true) implying he could pick up the phone and call the current President if necessary. He also bragged his father had introduced Vice President Cheney to politics (also accurate).

Steiger’€™s threats paralyzed the Fund’€™s operations until a courageous participant in those meetings asked an intermediary to meet him at the Geneva airport where he silently slipped a sealed manila envelope across the table. Inside was confirmation of Steiger’€™s threats. Confidential distribution of the memo ended Steiger’€™s influence and the Fund began to finance generic medicines. Today, as noted, almost all of Fund’€™s monies for AIDS medicines are used to purchase generics.

Unfortunately the story does not end there. Steiger is now back working directly with the Fund and in a position to influence whether brand or generic drugs are used.

When an NGO discovered his involvement, the Fund, at first, denied he was employed but upon reflection admitted “€œyes”€ Steiger had returned but only as a “€œconsultant”€.  Later it was learned his “€œadvise”€ would cover what appears to a revised concept in the purchase of AIDS medicines. A virtually hidden paragraph in the Fund’€™s mission charts a new purchasing policy, opening the door to use of higher priced brand drugs.  That power lies in one sentence consistent with Pharma’€™s age-old arguments against generic drugs. It reads “…the Global Fund procurement policies should not prioritize purchasing on price alone and should place more value on quality.”

Steiger comes to the Fund with renewed authority. He was a principal in a critical review of the Fund that has resulted in changes in the Fund’€™s management personnel.

Steiger working for former HHS Secretary Mike Leavitt helped conduct the review of the Fund following a critical investigative report by the Fund’€™s Inspector General.

Leavitt was recently appointed by former Governor Mitt Romney, now the Republican candidate for President, to manage his “€œtransition team”€ one of the most influential roles in creating an administration if Governor Romney wins the election.

Former Ambassador Mark Dybul

Steiger may be joined at the Fund by former Ambassador Mark Dybul who became the manager of the U.S. AIDS program and was recently summarily discharged from his position by President Barack Obama a day after his re-appointment was announced. It appears he was given a day to leave office but the reasons remain obscure.

Dybul’€™s opposition to generic drugs dates back to a meeting in Botswana organized, in part, to provide the rationale for requiring FDA registrations for generic medicines, a process, participants at the Conference argued, would both delay the urgent need for the medicines and was unnecessary because the medicines had been “€œpre-qualified”€ for use by WHO.

At the Conference Dybul and the others were confronted by a woman who managed a Catholic AIDS program in Africa. Reflecting the attitude of the NGOs  at the meeting she said the delay in PEPFAR funding for generic drugs would force her to treat one rather than four patients, a reminder of the days before generic AIDS medicines became available.  The official U.S. delegation that co-sponsored the meeting did not respond but her remarks lit a fuse and others sharply questioned the reason behind abandoning pre-qualification.

At this writing (October, 2012) it is reliably reported Dybul is on the short list for Executive Director of the Global Fund.

U.S. Official Warns India, But Gets Her Facts Wrong

Undersecretary of Commerce, Ms. Teresa Stanek Rea, who also serves as the Deputy Director of the Patent and Trademark Office recently told Congress of the efforts of the United States government to stop compulsory licensing  in several countries inaccurately claiming compulsory licensing was illegal under WTO’s TRIPS (Trade Aspects of Intellectual Property Rights). She said she was particularly outraged when an Indian Court awarded a compulsory license for a life saving cancer drug , Nexavar, to Natco to manufacture. The drug was not widely used in India because of its patent protected price of $5,500 a month. As a result of the pricing, only two percent of those needing the medicine could afford that price because India’€™s per capita yearly income is approximately $ 3,693.00.

The case was a classic example of a nation that could not afford to buy the medicine but its pharmaceutical companies, capable of manufacturing the medicine to western standards, were prevented from manufacturing and selling it at an affordable price. The proven and irrational result was sickness and death.

Fortunately, Ms. Rea had her facts wrong.

Article 31 of the TRIPS agreement expressively permits compulsory licensing, the result of long and hard fought discussions and compromises within WTO for the right to remove patent protection for an essential medicine sold at a price beyond the ability of a patient to purchase it.  Many nations demanded that right as a condition of joining WTO.

Anand Grover, the United Nations Rappoteur on the Right to Health and Senior Advocate for the Indian Supreme Court said “€œsetting an exorbitant price which makes the drug unavailable to those who need it…(is) grounds for the issuance of a compulsory license.”

Peter Maybarduk, Director of Public Citizens Access to Medicines added: “€œcompulsory licensing is a sovereign right to protect health and other interests. It has been around as long as patents have been around.”

Ms. Rea also argued: “€œwe are doing everything to respect the rights of U.S. innovators.”

She was wrong again.  Bayer, the company involved, is a German company.

She also said she was working hard to stem the tide of compulsory licenses and said her targets were foreign officials and judges.

Facing the factual challenges, Ms. Rea finally admitted she was wrong, yet she remains in office and the media has shown very little interest in pursuing her story although her behavior undermines years-long struggles by nations to provide access to essential medicines at affordable prices with “€œcompulsory”€ licensing as the right of a nation to protect its citizens.

Due to pressures, public and secret, only four nations have used compulsory licensing to lower the cost of essential medicines even as the AIDS pandemic devastated their nations.

Roger  Bate, the Generic Headhunter, Returns

Roger Bate, closely affiliated with the powerful and well financed American Enterprise Institute (AEI), has returned to once again harass generics. His was an important, skillful anti-generic voice and his access to the media was impressive.

Bate skillfully used that access and his affiliation with the AEI to advance what was/is recognized as an anti-generic agenda. Now, he is back and very dangerous.  It appears his new target is WHO’€™s pre-qualification program.  He recently promulgated an “€œacademic”€ study that implied approved malaria medicines were sub-standard.

The Bate conclusions are now the subject of an independent review to determine if conclusions of the study meet scientific requirements.

One early theory for his recent outrage may be that for the first time, FDA has delegated to WHO pre-qualification the right to certify malaria medicines but it now appears his target may have been the widely acclaimed October announcement that a jointly developed fixed dose malaria medicine, Mefliam Plus had obtained WHO pre-qualification making it eligible to bid on tenders that receive funding from international procurement agencies including UNICEF and the Global Fund.

Bernard Pecoul, executive director of the prestigious non-profit organization DNDi (Drugs for Neglected Diseases initiative) said the new drug (a combination of artesunate and mefloquine) meets an important public health need and forms a part of a malaria treatment necessary to control the disease.  The combination was originally developed by DNDi and  Brazilian government-owned pharmaceutical firm, Farmanguinhos and a technical transfer between Farmanguinhos and  Cipla achieved in 2010. WHO’€™s pre-clearance opens the door to delivery of an important new malaria drug to poor nations without the necessity to seek approval nation-by-nation.

But Bate’€™s return to the fray signals that the team of “€œhired hands”€ from conservative associations may be preparing to renew their attacks on generic medicines and pre-qualification that remains a target of Pharma companies.

The European Union’€™s Anti-Counterfeiting Campaign

Quite suddenly, the European Union began to remove generic cargoes touching European ports based on claims from multinational pharmaceutical companies that the medicines were “€œcounterfeits”€.   After several cargoes had been removed, it was revealed “€œcounterfeiting” was a merely a claim by Pharma companies that a generic cargo was destined for a location where the multinational corporations claimed patent rights might be violated.  The vague charge was sufficient to cause a ship to unload the medicines before it could continue on its voyage.

Upon investigation it was revealed the seized cargo contained AIDS medicines destined to the American Embassy in Nigeria.

Mistakes were admitted, but the so-called “€œcounterfeit”€ law remains in force although seizure may now require more proof than a claim by a competitor.  If truth be told, it is the branded product that is most often counterfeited because it can command a higher price. There is little doubt that “€œreal” counterfeit medicines are delivered and sold and generic companies cooperate with government officials to locate their source.

International Trade Agreements

Hidden clauses in international agreements have consistently included exclusive and often unwarranted protection of brand products and are often demanded by western nations.  The United States recently admitted it was pressuring Pacific nations to “€œsign off”€ on a new treaty many NGOs and generic companies believe will use “€œpatent claims”€ to prevent sale of generic medicines.  Most often these treaties that are negotiated in secret, contain measures that fly a “€œpatent flag”€™ but are blunt attempts to restrict generic competition.


The situations discussed in this document are accurately reported and only focus on recent activities. For decades similar anti-generic strategies were used, many with the cooperation of western officials.

The success with providing AIDS medicines at affordable prices has heightened the fear of Pharma companies and has only increased their political activities around the world. Compulsory licensing is perhaps the only remedy that will curb that influence.

Thank you for taking the time to read this document.


News Link n. 20


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 20

– Tobin tax, finalmente

– Tanzania probes fake HIV drugs

– GlaxoSmithKline opens door on data in bid to aid discovery of medicines

– UPDATE 2-GlaxoSmithKline to reveal more drug secrets     

– Indonesia in bold move to obtain cheap drugs for HIV 

– UN High-Level Meeting In India On Biodiversity Sees Need For Capacity-Building On Access And Benefit-Sharing

– ‘It is time for us to become a solutions bank’

– TRIPS-Related Patent Flexibilities and Food Security: Options for Developing Countries

– Africa Seen at Risk of Social Unrest From Food Shortages

– A good support system?

– ‘One Billion Hungry’ Peak Missing From New FAO Numbers

– IMF, World Bank must support poor countries facing food price volatility, Euro crisis…

– Al Ansari Exchange and Bill & Melinda Gates Foundation sign Memorandum of Understanding on collaboration for global health

– Justine Greening eyes new approach for UK aid

– India: Toilets versus temples

– Changing the world on the quiet 

– U.N. Rapporteurs Call For Creation Of Global Fund As Social Safety Net For Vulnerable Populations…

– An invisible issue: The presidential campaign and HIV/AIDS…

– Innovative funding model allows urban poor to determine their own future

– At WHO, Pharma Suggests Payment Plan For Influenza Virus Use






Interview: Yusuf Khwaja Hamied, Cipla Ltd., India

By Daniele Dionisio, GESPAM Head

Interview: Yusuf  Khwaja  Hamied, Chairman and Managing Director, Cipla Ltd., India

GESPAM had the pleasure to interview Dr. Yusuf Khwaja Hamied as the Chairman and Managing Director of pharmaceutical  Indian company Cipla Limited.   

Cipla is renowed both locally and internationally for its high standards, quality, efficacy and affordability of medicines.

Born in 1936, Dr. Hamied obtained Ph.D in Organic Chemistry from Cambridge University. In the same year, he joined Cipla as a Research Officer. He was appointed as its Managing Director in 1976 and as Chairman in the year 1989.

Dr. Hamied has introduced over 30 new drugs to India and is marketing as cost-effective options to 180 countries worldwide. Under his guidance Cipla is now ranked as a leader in the domestic pharmaceutical industry and Cipla’s manufacturing facilities have been approved by various international regulatory authorities including the Food and Drug Administration (FDA)-USA, Medicines and Healthcare products Regulatory Agency (MHRA)-UK, Therapeutic Goods Administration (TGA)-Australia, Medicines Control Council (MCC)-South Africa, National Institute of Pharmacy (NIP)-Hungary, Pharmaceutical Inspection Convention (PIC)-Germany, World Health Organisation (WHO), Department of Health-Canada, State Institute for the Control of Drugs-Slovak Republic, ANVISA-Brazil

In numerous public dialogues Dr. Hamied has sought to make patient welfare the priority for multinational pharmaceutical companies and the World Trade Organization, rather than concerns about profitability, patents and economic returns.

Dr. Hamied’€™s vision is that every citizen in India should have full access to vital medicines and healthcare at affordable prices. Coherently, he has been at the forefront of the movement to break big pharma’€™s global monopoly over lifesaving drugs. And he got his latest success on 7 September 2012 when the Delhi High Court ruled that Cipla can sell its own generic version of the Roche cancer drug erlotinib, at a third of the proprietary version price. 

Under Dr. Hamied’€™s leadership, Cipla was the first to offer the HIV triple drug cocktail, Triomune, which can transform the life of an HIV positive patient at a fraction of the international cost.

Dr. Hamied  has also established the Cipla Palliative Care Centre in India, and the Hamied Institute for Education and Research into Palliative Care, at a time when Cipla continues its ongoing support of education and community welfare both directly and through charitable trusts.

Thanks to Dr. Hamied, Cipla has launched breakthrough medicines including one in cancer chemotherapy, a once-daily novel 4 drug kit Qvir for HIV, and an innovative ‘€œMother-Baby Pack’€ for preventing mother-to-child transmission of HIV. And, as part of a  partnership with Drugs for Neglected Diseases Initiative (DNDi), Cipla just announced the prequalification of the fixed dose combination (FDC) of Artesunate (AS) and Mefloquine (MQ) -€“ ASMQ FDC -€“ by the WHO. This Cipla-manufactured ASMQ FDC is the first artesunate-mefloquine FDC to be prequalified by WHO and is recommended for the treatment of malaria. 

Meanwhile, DNDi and Cipla are committed to develop a 4-in-1 new formulation to fill the gap in appropriate HIV medicines for infants and young children.

Dr. Hamied’€™s contributions as a scientist, a business man and a humanitarian personality have been recognized by a number of awards to the company and himself.


GESPAM: Dr. Hamied, India’s obligations to the World Trade Organization (WTO) prevent local companies from making generics for medicines introduced since 2005. These developments threaten the supply of generic medicines from India that serve as a lifeline to resource-limited countries. What about India’€™s relevant patent law?


Yusuf Hamied: India changed its patent laws in 1972, exactly 40 years ago. Prior to this India followed the British Patent Law of 1911. The 1972 law abolished product patent for drugs, but retained process patent. The effect of this was that the indigenous drug industries in India made enormous strides and is today regarded as the pharmacy capital of the world. In 2005, India changed its patent laws and reintroduced product patents back-dating the cut-off date to January 1995.


GESPAM: Under Section 3(d) of its 2005 Amended Patents Act, India is free to reject frivolous patent applications to any new forms of old medicines unless therapeutic efficacy has increased significantly. And earlier from 1 January 1995, a mailbox facility was put in place in India to receive product patent applications. In cases where Indian companies were already rolling out these products before 1 January 2005, they can continue to produce under Section 11A(7), against ‘€œreasonable royalty’€.  

Bearing these safeguards in mind, do you think India’€™s patent law amendment in 2005 was a fair process?


Yusuf Hamied: This was totally unfair. The government passed the 2005 patent bill without a debate and only on show of hands on an issue affecting the lives of millions of Indians. The problem is that after 2015 India will enter into a system of monopoly. We are against monopoly, not against valid patents. Today drug patents are being filed in India frivolously with no real novelty. Also same patents are being filed in multiple locations e.g. Mumbai, Chennai, Delhi, etc. so that they are approved somewhere.


GESPAM: In this connection, which is your fight today?


Yusuf Hamied: Our fight today is against frivolous patenting in India. Our fight also is that as WTO’€™s TRIPS rules allow a compulsory licensing system*, India should adopt this immediately for all drugs .  This was mandated in the Doha Declaration and was a system followed by Canada from 1969 to 1992 under the Canadian Bill S-91. In our opinion, this is the best legal way possible for India.


*Compulsory license (WTO rule): when a resource-limited country’s government allows the manufacture domestically or importing of copies of patented drugs at prices much cheaper than those imposed by the patent holder and without his consent. Both importing and exporting countries need to have enabling legislation in place (a corresponding compulsory license for export has to be issued by the exporting country)


GESPAM: In other terms?


Yusuf Hamied: India on intellectual property must decide its own destiny and not follow the dictates of the EU or the USA. India will want like minded countries to follow its example.


GESPAM: Thank you Dr. Hamied for your upfront vision.

News Link n. 19


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 19

-India Ratifies Nagoya Protocol On Biodiversity Access And Benefit-Sharing…

-ONG: la cooperazione è una priorità…

-Calls for adoption of Financial Transaction Tax as way forward for global development…

-A $400,000 Drug and Why It Matters for Global Health

-South-South Cooperation Comes to WIPO

-BANGLADESH: Urbanization strains health care

-US department of Commerce heavily redacts FOIA request regarding Thailand compulsory license

-General Statement of India to the WIPO General Assembly 2012 (raises concerns on public health and green technology)

-Land grabs Q&A | Oxfam International

-Video of the Week: Turning the Tide on Global Hunger…

-What the World’s Hungry Would Have Liked to Hear Last Night…

-Nature Examines Future Of AMFm

-Europe and global health: looking for a leader…  

-MSF Launches Patent Opposition Database

-External Financial Aid to Blood Transfusion Services in Sub-Saharan Africa: A Need for Reflection

-Who Sets the Global Health Research Agenda? The Challenge of Multi-Bi Financing

-Scientists Debate Climate Change Impacts on Tropical Diseases…

-Missing in Africa: How Obama Failed to Engage an Increasingly Important Continent

-Increased Cases Of Polio Reported In Nigeria

-UGANDA: Concern over allegations of misuse of Global Fund money…

-On TPP Secrecy, US And Five Others Decline To Answer UN

-‘Some progress, but aid is still not transparent’

-A new entity for the negotiation of public procurement prices for  patented medicines in Mexico

-Public health round-up

-World Bank brass heads to Tokyo

-Jim Yong Kim wants a more efficient, flexible World Bank

-WHO Prequalifies A New Artemisinin-Based Combination Treatment (ACT) for Malaria. Artesunate-Mefloquine Fixed-Dose Combination (ASMQ FDC) to be rolled out throughout Asia

-EU seeks a new focus on resilience building



Fondo Globale: più performance dalla ristrutturazione

Il Fondo Globale per la Lotta all’AIDS, Tubercolosi e Malaria (GF) è un partenariato fra governi, società civile, settore privato  e comunità afferenti, quale finanziatore internazionale di programmi per la prevenzione e terapia di HIV/AIDS, tubercolosi (TB) e malaria

Spinto da un deficit finanziario, il Fondo ha avviato  un processo di ristrutturazione per  migliorare efficienza e prestazioni, fondato sulla ridistribuzione dello staff, su modelli flessibili di business e  allocazione delle risorse, e su nuovi approcci per semplificare e accelerare l’erogazione dei  â€œgrants”, incrementare le donazioni e perfezionare la capacità previsionale.




Daniele Dionisio*


Dal suo inizio nel 2002, il GF è ormai il principale finanziatore di iniziative di lotta ad AIDS, TB e malaria, con 23 miliardi di dollari disponibili per oltre 1.000 programmi  in 151 paesi. In risposta ad articolati programmi nazionali, il GF elargisce fondi vincolati all’impegno di risultati documentabili.

Oggi, i programmi sostenuti dal GF assicurano terapie per  HIV e TB a 3.6 milioni e 9.3 milioni di persone rispettivamente (incrementi del 21% dalla fine del 2010), e 270 milioni di zanzariere impregnate di insetticida per la prevenzione della malaria

E, grazie ai programmi sostenuti dal GF, il numero dei casi di malaria in trattamento è aumentato a  260 milioni mentre I servizi per TB/HIV sono più che raddoppiati, le sedute di testing e  counselling per HIV sono salite a 210 milioni (una crescita del 43%), e il numero delle gravide con HIV sottoposte a ciclo completo di terapia antiretrovirale ha toccato il milione e mezzo  http:/ /

Complessivamente, mentre quasi 9 milioni di vite sono state risparmiate grazie ai programmi del GF, l’istituzione punta oggi a destinare almeno 8 miliardi di dollari in “grants” per la lotta ad HIV, TB e malaria durante i prossimi 20 mesi, di cui 5 miliardi per la sola Africa


Drastica ristrutturazione

Ma queste prospettive potrebbero rivelarsi vuote ora che il GF è stretto da una crisi di bilancio per  rallentate o congelate donazioni in conseguenza della crisi economica globale…  

Urgono misure per mantenere il GF all’altezza del compito e delle attese, tanto più necessarie oggi che i donatori premono per migliore performance e maggiori ritorni dai loro investimenti. 

Coerentemente, il 23 Novembre 2011, il Board del GF decise di rifiutare nuove richieste di “grants” almeno sino al 2014, di finanziare solo programmi correnti a termine entro il 2014, e di ridurre ulteriormente il supporto economico ad alcuni paesi con più alto medio reddito. Il Board decise inoltre la nomina di un General Manager incaricato di traghettare il GF, attraverso una drastica ristrutturazione, verso migliori prestazioni 

Così, sin dalla nomina di Gabriel Jaramillo lo scorso Febbraio, il GF si è lanciato in una “rivoluzione” interna per la gestione ottimizzata dei “grants”, l’aumento delle donazioni, e il rafforzamento delle capacità previsionali…  

Il ridisegno include un approccio perfezionato alla gestione del rischio frode Paese, mediante stretta attenzione ai risultati delle investigazioni condotte dall’Ufficio dell’Ispettore Generale nel periodo 2005-2012……

Queste indagini hanno rivelato che almeno il  3% dei sovvenzionamenti sono stati spesi male o inappropriatamente, o rendicontati insufficientemente.  

Non stupiscono, perciò, le profonde modifiche associate alla globale ristrutturazione in corso al GF:

• taglio del 40% nel settore burocratico con riconversione del 75% dello staff alla gestione dei “grants”.

• implementazione delle raccomandazioni espresse da un panel per la supervisione dei controlli finanziari attuati dal GF e delle modalità di spesa dei fondi.

• costituzione di 3 unità per il controllo di 20 Paesi espressivi di oltre il 70% del carico globale di HIV, TB e malaria: due unità sono devolute all’Africa ed una all’Asia.

• “country-teams” per la gestione dei “grants” formati da membri  di differenti dipartimenti posti a  lavorare insieme.   

• apertura ai partners nelle commissioni del GF, per aumentare confronto e condivisione sugli investimenti da decidere. Oltre ai Paesi donatori, i partners includono, tra gli altri, la società civile, il settore privato, e istituzioni quali PEPFAR (U.S. President’s Emergency Plan to Fund AIDS Relief), PMI (President’s Malaria Initiative), RBM (Rollback Malaria), Stop TB.   

• riforma delle commissioni per HIV, TB e malaria per verificare mensilmente il progresso delle operazioni e correggere il tiro. 

• rafforzamento delle iniziative di prevenzione.

• sostituzione del “rounds-based grant system” con un nuovo modello di finanziamento mirato a interventi, Paesi e popolazioni più bisognosi e alla semplificazione e sveltimento del processo di erogazione  In termini generali:

-I fondi saranno canalizzati a specifici gruppi di Paesi e ulteriormente suddivisi per ciascun Paese del gruppo in funzione delle criticità e priorità per la salute. 

– I richiedenti sottoporranno una nota di concetto più breve e snella di quanto sinora previsto e riceveranno sollecito feedback su eventuali modifiche utili al rapido conseguimento del “grant”.

-le richieste di “grant” non saranno più presentate a scadenze fisse, ma secondo tempistiche “nazionali”.

Perfezionamenti sono attesi al prossimo meeting del Board GF in novembre. In ogni caso:

• il GF continuerà a focalizzare sui Paesi a basso e a basso-medio reddito, e ad implementare circa il 40% dei “grants” tramite la società civile per il massimo effetto  in aree remote e nelle fasce a maggior rischio. Al riguardo, i Country Coordinating Mechanisms (CCMs) manterranno il ruolo di entità primaria responsabile in ciascun Paese della formulazione delle richieste e della sorveglianza sui “grants”. E ogni CCM embricherà con tutti gli addetti, società civile inclusa, per la produzione di robuste richieste al GF.

• il GF continuerà ad incoraggiare I percettori dei “grants” ad applicare le flessibilità previste dall’ Accordo TRIPS dell’ Organizzazione Mondiale del Commercio per consentire il più basso prezzo per farmaci di certificata  qualità   .

• il GF implementerà la collaborazione con i ministeri per la salute allo scopo di rafforzare I sistemi nazionali, migliorare trasparenza e responsabilità, dare impulso ai canali locali di fornitura e approvvigionamento di farmaci, e supportare la formazione dei quadri medici e paramedici.


Di nuovo in business?

Dopo tutte le modifiche fatte o in divenire, è il GF pronto a riguadagnare business? Probabilmente sì se lo scorso Maggio il Board ha previsto la disponibilità di 1.6 miliardi di dollari per il periodo 2012-14 grazie a nuove donazioni, accelerati esborsi e rinuncia di alcuni governi a parte dei finanziamenti a favore delle nazioni a basso reddito…

 Infatti, Paesi come India, Russia e Cina giocano oggi parti importanti sia come donatori al GF sia come beneficiari di “grants”.  

Purtroppo, il passo corrente difficilmente permetterà il conseguimento entro il 2015 degli obiettivi del Millennio per la salute. E appena il 41% dei Paesi sostenuti dal GF raggiungeranno il traguardo del taglio alla mortalità infantile e quelli connessi alla lotta ad AIDS, malaria e altre infezioni…

Ecco perchè il GF instancabilmente persegue opera di persuasione affinchè  Paesi a rapida crescita come Cina, India, Brasile, Indonesia, Messico, Corea del sud, Arabia Saudita e Turchia (accanto a donatori principali quali Francia, Giappone, Stati Uniti, Inghilterra Germania, e la Fondazione Gates) donino e incrementino considerevolmente i loro contributi…

Ma, sono i Paesi avanzati pronti ad abbracciare oggi gli appelli del GF come un’opportunità di sicurezza nazionale e vantaggioso ritorno sui loro versamenti, piuttosto che come un pesante fardello in tempi di recessione economica? Questo farebbe davvero la differenza.


*Daniele Dionisio è membro del Gruppo di Lavoro del Parlamento Europeo per Innovazione, Accesso ai Farmaci e Malattie della Povertà. E’ consigliere “Medicine per I Paesi in via di Sviluppo” per la Società Italiana di Malattie Infettive e Tropicali (SIMIT), e già direttore della Divisione di Malattie Infettive dell’Ospedale di Pistoia. Dal febbraio 2012, Dionisio è responsabile del progetto di ricerca  Geopolitics, Public Health and Access to Medicines (GESPAM).