EUROPE! HANDS OFF OUR MEDICINE

Millions of people in developing countries rely on affordable generic medicines to stay alive. More than 80% of the medicines used by MSF to treat AIDS across the developing world are produced in India. But the European Commission is now shutting off the tap of affordable medicines by attacking the production, registration, transportation and exportation of generic medicines. People who need these will be left without a lifeline.

Help Médecins Sans Frontières send a message to the European Commission to keep their HANDS OFF OUR MEDICINE!

India's complaint over in-transit generic seizures dropped?

Phil Taylor
08-Oct-2010
Securing Pharma

Anand Sharma India's commerce and industry minister Anand Sharma says India plans to withdraw its dispute over the seizure of Indian-made generic drugs at EU borders filed with the World Trade Organization (WTO), according to reports in the Indian press.

Several articles suggest that Sharma has decided to draw back from the dispute because of commitments by the EU to revisit its rules covering seizure of goods suspected of infringing intellectual property rights (IPR).

There has however been no official statement from any party involved in the dispute resolution procedure indicating that it has been resolved.

The complaint was filed in the wake of around several seizures by EU customs of generic shipments en route from India to markets in Latin America in 2008 and 2009 - allegedly at the request of pharmaceutical brand owners - on the grounds that they were suspected counterfeits and/or violated IPR.

The problem seemed to reside in the differing interpretation of EU Regulation 1383/2003, which allows seizure by border control agencies of products suspected of IPR infringement, and specifically its tenets on goods in transit. Customs in the Netherlands and France, for example, are said to have taken the position that if such a shipment touched ground in the EU, it is considered subject to standard customs procedures and local IPR laws.

The European Commission's Taxation and Customs Union (TAXUD) ran a public consultation on 1383 between March 25 and June 7, 2010, with a view to updating the regulation if required, but as yet has not published the results of the exercise.

India mostly exports off-patent generic drugs under the umbrella of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which was passed to harmonise IPR standards and enforcement, as well as facilitate access to essential medicines in developing countries.

If the WTO dispute remains unresolved, the next stage would be formation of a WTO panel specifically to look into the complaint.

Meanwhile EU claims the Drug seizure dispute with India not resolved. Apparently there was some progress but negotiations seem to have broken down.

See also "Freer" trade may hurt access to India generic drugs

*UNITAID says 80 percent of its AIDS drugs come from India
________________

Brazil and India have requested WTO consultations on the generic drug seizures issue.

Brazil's request is here. India's request is here.

For background, SpicyIP has a number of posts on the issue here;

Stemming the Brain Drain of Health-Care Workers From Developing Countries

Published on Saturday, May 29, 2010
The Seattle Times


by Amy Hagopian, Eric B. Williams and Emily DeRiel

Last week, international health leaders meeting at the annual World Health Assembly in Geneva made history by endorsing new guidelines to prevent health-worker brain drain from developing countries.

Nations unanimously adopted a voluntary global code that sets ethical principles around the movement of health workers. It was only the second time in the assembly's history that nations agreed to an ethical code.

The Global Code of Practice on the International Recruitment of Health Personnel acknowledges the right of health workers to migrate, while also acknowledging the right to the highest attainable standard of health. It calls on rich nations to meet their own internal demands without taking health workers away from countries that can least afford to lose them.

The critical shortage of health workers in developing countries is staggering. For example, Washington state has 11,000 doctors for its 6.6 million residents; Ethiopia by comparison has 2,000 doctors for its 80 million people. This would be equal to 165 doctors for the entire state of Washington.

Low-income countries invest significant resources to train health workers. Active recruitment of their doctors and nurses systematically deprives communities and entire populations of their right to health.

The loss of these investments equates to a form of reverse foreign aid. Not only is that ethically unacceptable, but speaking strictly parochially, it undermines the efforts of the many Seattle-based organizations working to improve global health. Discovering vaccines does no good if there is no one to administer them.

While the code is welcome news for those of us who work to advance health and human rights, we must admit the final version of the code was weakened in closed-door negotiations. After U.S. lobbying, rich nations reduced their responsibility for tracking the movement of health workers or for providing technical or financial assistance to developing countries.

Nonetheless, important elements of the document were retained and governments must now take steps to implement it.

Some countries have already moved to curb their active-recruitment practices. The United Kingdom and Norway have adopted policies to refrain from recruiting health workers from severe-shortage countries. Canada, too, has ramped up training programs so as to create less demand for foreign-trained health workers. The United States should follow suit.

As an initial step, we have to do a better job of tracking health-worker migration to inform policy decisions on increasing our domestic training programs to better meet demand. While we know approximately one in four U.S. physicians and about 220,000 nurses were trained abroad (largely in lower-income countries), those data are hard to come by.

Current information systems are fragmented and privatized. The only national data source on physicians is proprietary and only available for purchase from the American Medical Association. Nurse licensure data are available only on a state-by-state basis.

With 32 million uninsured Americans soon to be eligible for care, it's time to get serious about the fact that the U.S. health work force is too small and unevenly distributed across urban and rural areas. The Council on Graduate Medical Education has predicted the U.S. will be short approximately 85,000 physicians by 2020.

Thirty years ago, the U.S. was the only nation to oppose the World Health Organization's first ethical code, which limited the marketing of infant formula in poor countries because it undermined breast-feeding. This time, the U.S. stood with 192 nations in a show of global solidarity for the health of people in poor countries.

The Code of Practice offers real opportunity. We (and all nations) must now follow through as if we really meant it — because countless lives depend on it.

Fraud in the non-profit sector

Report Sketches Crime Costing Billions: Theft From Charities
By STEPHANIE STROM
New York Times
March 29, 2008

The volunteer treasurer of the Madison County Humane Society in Indiana was charged this month with using $65,000 of the charity’s money to buy jewelry and makeup. In San Francisco, the chief financial officer of the Music Concourse Community Partnership was fired after he was accused of taking $3.6 million of the organization’s money to play the stock market.

Nonprofit leaders tend to shrug off such cases as evidence of “just a few bad apples.” But a new report, trying to identify the scope of such thefts for the first time, suggests otherwise.

The report, by four professors who specialize in nonprofit accounting, found that the typical theft from a charity was committed by a female employee with no criminal record who earned less than $50,000 a year and had worked for the nonprofit at least three years. The amount she stole was less than $40,000.

The most costly cases, the study found, involved male executives earning $100,000 to $149,000 a year. The thieves in such cases had typically been with the organization the longest.

But what is getting the attention of nonprofit leaders is the report’s estimate of the overall cost, which the authors put at $40 billion for 2006, or some 13 percent of the roughly $300 billion given to charity that year.

“It’s a surprisingly large number,” said Paul C. Light, a professor of public service at New York University who does surveys of public confidence in charities. “We really need to take a good hard look at what’s going on in these organizations.”

The new report is based on data from the Association of Certified Fraud Examiners, which, the report said, found that “all organizations,” whether government, for-profit or nonprofit, “lose on average 6 percent of their revenue to fraud every year.” Applying that percentage to nonprofits’ total 2006 revenue of $665 billion — donations, government payments and other income — the authors came up with the $40 billion estimate.

“Determining how much theft and embezzlement takes place has been the holy grail of the sector,” said Jack B. Siegel, a tax lawyer who specializes in nonprofit matters.

If the $40 billion figure is accurate, then the money lost to fraud equaled the combined giving by corporations and foundations in 2006, said Diana Aviv, president and chief executive of the Independent Sector, which represents nonprofit groups.

But Ms. Aviv expressed skepticism about the report, noting that it relied on the fraud examiners association’s estimate of overall fraud across all sectors, including government and corporate.

“They’re lumping all those sectors together, and it could be that the for-profit sector experiences a higher level of fraud, while the nonprofit sector and government experience lower levels,” Ms. Aviv said.

Nonetheless, she said, “even if the figure is $20 billion, that’s still a huge amount and needs to be addressed.”

The report, published in the December 2007 issue of Nonprofit and Voluntary Sector Quarterly, found that losses to fraud among the 58 cases reported to the fraud examiners association in a random survey of nonprofits ranged from $200 to $17 million, with the median fraud costing $100,000.

“Most of these things are not caught by routine audits,” said Gary Snyder, who tracks nonprofit fraud in his newsletter, Nonprofit Imperative. “They’re usually done by someone in the financial area — the treasurer, the bookkeeper, the signer of checks — who knows how to avoid getting caught.”

Almost 95 percent of the reported frauds entailed loss of cash, and a majority of those involved false or inflated invoices, billing for expenses that were never incurred and check tampering.

“I gave a talk to a group of nonprofit executives a few weeks ago, and every single one of them had a fraud story to tell,” said one of the report’s authors, Janet S. Greenlee, an associate professor of accounting at the University of Dayton. “This has been going on for years, but there’s a feeling that it shouldn’t be discussed,” because of the effect it might have on donations.

Professor Greenlee — joined in the report by Mary Fischer of the University of Texas at Tyler, Teresa P. Gordon of the University of Idaho and Elizabeth K. Keating of Boston College — said the failure of organizations to punish those who steal from them was perhaps one of the biggest reasons for fraud in the sector. She said she had worked at organizations that refused to dismiss employees caught stealing.

Professor Light, at N.Y.U., said some 70 percent of respondents to a new survey among the general public thought charities wasted “a great deal” or “a fair amount.”

“Donors have already indicated,” he added, “that they don’t have a great deal of faith in the way these groups handle money.”

But it will now be harder for charities to hide fraud, because beginning with tax forms they must file for 2008, the Internal Revenue Service has added a question requiring them to disclose whether they have experienced theft, embezzlement or other fraud during the year.

“Not only will that eventually give us a much better idea of how widespread fraud is with these groups, it also gives them an incentive to have better financial controls,” said Mr. Siegel, the tax lawyer, who is credited with the idea of adding the question to the tax forms.

Mr. Siegel used to track cases of fraud among charities but “got bored,” he said, because there were so many of them.

Newspapers routinely report incidents of nonprofit fraud in their communities, but the amounts tend to be small and thus go unnoticed at a national level.

Mr. Snyder, the tracker of nonprofit fraud in his newsletter, said that through use of databases and other searches, he had stumbled across more than $700 million in fraud already this year among government agencies and nonprofits, including church-related organizations.

Asked about his favorite example of nonprofit fraud, Mr. Snyder was initially stumped.

“There are so many,” he said.

He eventually settled on the embezzlement of some $25 million from Goodwill Industries of Santa Clara County in California.

It started in the 1970s and continued until one of the participants blew the whistle in 1998. Merchandise donated to the organization was sold outside the Goodwill shops by the perpetrators, who kept the proceeds. One of the embezzlers committed suicide before arrest, and six others, all related, pleaded guilty, were fined and, in some cases, were sent to prison.

The thieves had given more than $800,000 to the organization’s president and chief executive, who parked the money in accounts in Switzerland, in Austria and on the Isle of Man and then escaped to Guatemala as investigators closed in, according to the authorities. Guatemala sent him home in 2003, but he ultimately pleaded guilty to only one charge — of tax evasion unrelated to the scandal at Santa Clara Goodwill — and walked out of the courtroom.

“I like that one,” Mr. Snyder said, “because it’s an extreme example of something typical: that no one gets in trouble for this.”

Professor Greenlee said she saw signs that charities were now trying harder to deal with fraud.

“They’re creating audit committees and adopting the provisions of Sarbanes-Oxley as best practices,” she said of the 2002 law that imposed stricter accountability on corporate governing, though not on charities.

“Boards are becoming tougher,” she said, “because they know that as fiduciaries, they are at risk of, at the very least, embarrassment.”

The Drug Industry Cashes In

November 18, 2009
Editorial
New York Times

The drug industry has been ramping up its prices in advance of any health care reforms that might clamp down on its profits. The industry’s rapid price escalation over the past year threatens to make a mockery of its deal with the Senate Finance Committee and the Obama administration to contribute $80 billion over the next decade to help pay for covering tens of millions of uninsured Americans.

The industry’s contribution will consist of drug discounts to certain Medicare beneficiaries, larger rebates on drugs bought for Medicaid beneficiaries and new fees on the industry.

We complained earlier that the industry’s contribution looked small when measured against the $1 trillion needed to cover most of the uninsured or against the $3 trillion likely to be spent on drugs in this country over the next decade. The administration got political benefits from the deal: The drug industry has not opposed health care reform as it did in previous years and has actually run commercials supporting it.

But the deal looks mostly good for the drug companies. They stand to gain tens of millions of newly insured customers who will be able to buy medicines. And the discounts the companies will provide to Medicare beneficiaries who reach a gap in their drug coverage, known as the doughnut hole, will apply only to brand-name drugs, helping the manufacturers to lock in customers that might otherwise turn to cheaper generics.

Now come the price increases. As Duff Wilson reported in The Times on Monday, the industry has raised the wholesale prices of prescription drugs by about 9 percent in the past year. That appears to be the highest annual increase since 1992.

The industry contends that it must raise prices to finance research on new drugs, and that may hold some truth given the dearth of promising new drugs in the pipelines of major manufacturers. But the increases also look designed to establish a higher price base before reform bills, if passed, try to reduce drug spending.

The industry’s maneuver suggests that the Senate’s deal with the industry should be abandoned in favor of the much tougher demands in the reform bill passed by the House. The House bill requires rebates and discounts from drug makers that may save the government about $150 billion over 10 years, according to the chief actuary for the Center for Medicare and Medicaid Services. The House bill also authorizes the secretary of health and human services to negotiate with the companies to obtain lower prices for drugs sold to Medicare beneficiaries and to a new public plan if one is approved.

The government needs every penny it can get to help cover the uninsured. Given the industry’s last-minute price increases, it seems prudent to ignore the supposed deal and demand a greater contribution.

Cancer cures in the Amazon?

In Amazon, a frustrated search for cancer cures
By Stuart Grudgings Stuart Grudgings Tue Nov 17, 2:11 pm ET

SAO SEBASTIAO DE CUIEIRAS, Brazil (Reuters) – The task of harvesting the secrets of Brazil's vast Amazon rain forest that could help in the battle against cancer largely falls to Osmar Barbosa Ferreira and a big pair of clippers.

In jungle so dense it all but blocks out the sun, the lithe 46-year-old shimmies up a thin tree helped by a harness, a strap between his feet, and the expertise gained from a lifetime laboring in the forest.

A few well-placed snips later, branches cascade to a small band of researchers and a doctor who faithfully make a long monthly trip to the Cuieiras river in Amazonas state in the belief that the forest's staggeringly rich plant life can unlock new treatments for cancer.

They may be right.

About 70 percent of current cancer drugs are either natural products or derived from natural compounds, and the world's largest rain forest is a great cauldron of biodiversity that has already produced medicine for diseases such as malaria.

But finding the right material is no easy task in a forest that can have up to 400 species of trees and many more plants in a 2.5-acre (1-hectare) area, and in a country where suspicion of outside involvement in the Amazon runs strong.

"If we had very clear rules, we could attract scientists from all over the world," said the doctor, Drauzio Varella, with a mix of enthusiasm and frustration. "We could transform a big part of the Amazon into an enormous laboratory."

As it stands, though, foreigners are barred from helping oncologist Varella and the researchers from Sao Paulo's Paulista University, who are among a tiny handful of Brazilian groups licensed to study samples from the Amazon.

Varella, 66, believes his high profile has helped. He is a well-known writer and television personality who shot to fame in 1999 with a book and subsequent hit movie based on his work as a doctor in a brutal Sao Paulo prison called Carandiru.

But a move by his team in the 1990s to partner with the U.S. National Cancer Institute produced a storm of accusations of "bio-piracy" and for years it has been blocked from the international cooperation and funding that could increase the chances of finding the Holy Grail of a cancer cure.

Their work has also been regularly delayed by bureaucratic demands, once stopping their collections for two years.

In more than a decade of searching, the group has brought back 2,200 samples from this tributary of the mighty, tea-dark Rio Negro (Black River) to its laboratory in Sao Paulo, of which about 70 have shown some effect against tumors. Just those samples have given the team enough analysis work for 20 years, said Varella, a lanky marathon runner whose younger brother died of cancer.

"If we can find 70, imagine what a big university with international resources could do -- they could screen for an absurd amount of diseases," said Varella, who still spends part of his time treating prisoners in Sao Paulo.

"As well as the impact this could have on human health, it could bring resources for preservation and to improve the quality of life of people who live here."

Ironically, it was a foreigner who inspired Varella to begin his search. Robert Gallo, a U.S. researcher and leading AIDS expert who co-discovered the HIV virus, asked Varella during a trip to the Amazon in the early 1990s if anyone was researching the medical potential of the forest.

JIGSAW PUZZLE

Among the natural products being used to fight cancer today is Taxol, a chemotherapy drug that comes from the bark of the Pacific yew tree.

David Newman, head of the Natural Products Branch of the U.S. National Cancer Institute, said several promising cancer drugs derived from natural sources as varied as a deep-water sponges and microbes are currently going through clinical trials. Often the natural compounds are tweaked or mimicked to better fight cancer cells.

"It's a detective story and a jigsaw puzzle, but you don't know how many pieces there are or what the picture looks like," he said. "In one teaspoon of soil from the Amazon, you find over a thousand microbes that have never been isolated."

Out of an estimated 80,000 species of flower-bearing plants in the Amazon, only about a fifth have been identified.

Newman said progress in Brazil has been greatly hampered by the inability of companies to patent a natural product under legislation passed in the 1990s, leaving no incentive to invest in research.

He cited the example of a Brazilian viper snake whose venom proved vital to the development of blood pressure drug captopril in the 1970s, a find that might not have happened under today's laws.

Further analysis of the promising compounds found by Varella's team has been held up while the university waits for access to a nuclear-magnetic resonance machine that can isolate the active elements.

"We're still a long way from discovering an actual medicine that could cure a type of cancer but we have strong signs that some plants have substances that inhibit the growth of tumors," said Mateus Paciencia, a bearded 34-year-old botanist.

Their main hope is that growing concern over the environment and increasing government efforts to slow the destruction of the Amazon by ranchers and loggers will turn the tide in favor of sustainable forest industries, of which they say their work is a prime example.

"There is nothing more sustainable than this," said Paciencia. "We take a kilogram worth of samples from a tree that weighs a ton and get an extract that lasts 10 years."

As he hung from a tree trunk, Ferreira said his relationship with the forest had been transformed by his job. He used to cut down trees with a chainsaw and sell the lumber in the city of Manaus, about 80 km (50 miles) down river from the research site.

"I think we'll find a medicine, and it won't take too long," he said. "If I deforest, I'm killing not just one plant but destroying a lot of other plants as well. So the job we're doing here is much better."

'Made in India' dominates US AIDS scheme

P B Jayakumar / Mumbai October 16, 2009,
Business Standard (India)


Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief (Pepfar).


Out of the 100 approvals by the US drug regulator Food and Drug Administration (FDA) so far, close to 95 per cent are for Indian companies.

Aurobindo leads the list with 34 approvals, followed by Cipla and US-based Mylan Laboratories' Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme.

The Pepfar programme, started in 2003, aimed at the prevention, treatment, and care of people infected with HIV/AIDS worldwide.

On October 6, the FDA approved the 100th anti-retroviral drug under the Pepfar programme.

"It is a service to the society and we are happy to be the leader in supplying anti-retrovirals, at one-third of the prices of original drugs under the programme," said K Nityananda Reddy, managing director of Hyderabad-based Aurobindo.

The service to society makes business sense, too, for the drug companies. Pepfar is the largest commitment ever by any nation for an international health initiative dedicated to a single disease and is focused on 15 of the hardest-hit countries in Africa, Asia, and the Caribbean.

These countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia. In May 2007, then US President George W Bush reauthorised the programme by increasing procurement of generic drugs and offered another $30 billion, in addition to the initial $15 billion commitment made in 2003.

“On average, we have earned $20 million to $25 million (Rs 92 crore to Rs 115 crore) annually in the last few years from Pepfar supplies. I anticipate a slight plus or minus revenue to this figure in the coming years from this programme,” said Amar Lulla, joint managing director of Mumbai-based Cipla, another major supplier.

As on September 30, 2008, the most recent figure available, Pepfar supported life-saving antiretroviral treatment for more than 2.1 million living with HIV/AIDS. In 2008, it provided nearly $1.6 billion in support of treatment programmes, including antiretroviral drugs and services.

“There is no separate data on the spend for drug procurement under the programme. Companies involved in the programme do not reveal their revenues separately. Supplies are staggered and procurement takes months or quarters later from the date the orders are placed,” said Ranjit Kapadia, vice president, institutional research with HDFC Securities.

"It is estimated that FDA’s actions are allowing Pepfar to spend $150 million (Rs 690 crore) more each year on patient access to care,” US FDA Commissioner Margaret A. Hamburg said in a statement.

The approval process for drugs is rapid. Even patent-protected drugs are procured for supply with a tentative approval in the countries covered under the programme.

The goal of the programme is to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, Pepfar will support training for at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.