Big pharma is cut out by India's plan to bring medicine to masses

via The Independent, by Nikhil Kumar

India is planning a multibillion-dollar push to bring free medicines to the hundreds of millions of its citizens who, despite the country's economic revival, still languish without access to the very basics of health care.

The $5bn initiative, which is slated to be rolled out by the end of this year, will offer 348 essential drugs to patients across the country. In a blow to the West's big pharmaceutical firms, the planned scheme will largely cut out branded drugs, opting instead for cheaper generic alternatives.

News of the plan comes as the Congress-led administration in Delhi attempts to shore up public support after a raft of corruption scandals and crushing electoral losses in state polls. A recent report confirming a slowdown in economic growth has only served to sharpen criticism of the government.

Now, Delhi is plotting a multi-billion dollar health-care drive, using its network of government-funded hospitals and clinics to deliver free drugs across a country where, despite the much-vaunted boom of recent years, more than two million young children die every year from preventable infections, according to Unicef.

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Improving the Production of Tenofovir

via AllAfrica.com, by Khopotso Bodibe

The national health department has contracted additional pharmaceutical manufacturers to make up the critical shortage of the antiretroviral tenofovir across the country.

HIV clinicians and doctors warned last week that the continued stock out of tenofovir and the failure to advise health workers on how to deal with it was a looming disaster.

Reports of stock outs go as far back as October last year with the explanation given that the drug suppliers Aspen Pharmacare and Sonke Pharmaceuticals were not able to meet the demand once they were awarded the tender.

It emerged this week that the national health department had directed provinces to order tenofovir from two additional suppliers.

Dr Anban Pillay, Cluster Manager for Financial Planning and Health Economics in the national health department, confirmed that Adcock Ingram Pharmaceuticals as well as Cipla Medpro Pharmaceuticals were now also supplying tenofovir to provinces.

"The procurement rules allow that. Obviously, there's a good reason for it. The current suppliers are not able to keep up with the total need. So, for the balance they are allowed to go out and get it from other suppliers," Pillay explained.

Aspen Pharmacare and Sonke Pharmaceuticals were initially contracted to supply tenofovir to the public sector antiretroviral programme, but they have struggled to meet the demand.

"The split between Aspen Pharmacare and Sonke is a 70 30 split, meaning that 70% of the volume goes to Aspen and 30% to Sonke. Unfortunately, Sonke hasn't been able to ramp up its production to the level that is required to meet the demand," said Pillay.

The national health department estimates that tenofovir is dispensed to about 1.2 million patients every month.

Aspen Pharmacare was only able to increase its production to the 70 per cent tender requirement in recent weeks. With Sonke Pharmaceuticals not being able to supply its quota of the tender, the supplies from Aspen Pharmacare were not sufficient to serve all patients on tenofovir, resulting in the shortage.

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Reuters: India Should Tax Air Tickets to Pay for AIDS Drugs - U.N.

via Reuters.com, by Nita Bhalla

Millions of the world's poorest people could have easier access to life-saving drugs if India introduces an air ticket tax to help fund purchases of cheap medicines for HIV/AIDS, malaria and tuberculosis, a senior U.N. official said.

UNITAID, a U.N. agency which negotiates for cheap medicines from pharmaceutical manufacturers to treat deadly diseases, is lobbying countries such as India to join its air ticket levy initiative which began in 2006.

Under the program, countries put a nominal amount on the cost of air tickets which funds UNITAID to buy drugs for patients in the developing world. Ten countries have imposed the levy, generating $200 million annually for cheap medicine.

"What we want in India is a similar system by which a very small contribution which is painless to the traveler can be applied to large numbers of travelers," UNITAID Executive Director Denis Broun told AlertNet in an interview.

"Since air traffic is very high in India, the small amount of levy makes a huge difference to the amount of drugs that we can purchase and the number of poor who can benefit from them."

HIV/AIDS, malaria and tuberculosis kill 4.4 million people each year, UNITAID says. Approximately 14.2 million people are in need of anti-retroviral drugs globally, yet more than half cannot afford them.

India's airlines are reeling under a debt load of $20 billion and lost $2 billion last year, as high fuel prices, a weakening rupee and competition kept fares low and costs high.

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The Impact Generic Drugs Have on the Cost of HIV Treatment

via Huffington Post, by Dean Baker

Drugs are cheap. Patent monopolies are expensive. These are simple facts that everyone should know but for some reason few do.

The point here is simple; the vast majority of drugs are cheap to produce. Chain drug stores sell hundreds of generic drugs for $5-$7 per prescription. They can do this profitably because few drugs require expensive chemicals or manufacturing processes.

However, many brand drugs sell for hundreds or even thousands of dollars per prescription. This is due to the fact that drug companies have patent monopolies on these drugs. The government will arrest anyone who produces these drugs without the permission of the patent holder. Since drugs can be essential for people's health and/or life, if they can find a way to pay any price demanded by the drug companies, they will.

The higher prices due to patent monopolies are the reason that many people have difficulty paying for drugs. If all drugs were sold in a free market as generics, paying for drugs would not be a serious issue except for the very poor.

Of course, patent protection is the way in which drug companies finance their research. It costs a lot of money to research new drugs and then test them to establish their safety and effectiveness and bring them through the Food and Drug Administration's approval process.
However, there are more efficient mechanisms than patent monopolies to finance drug research. Vermont Senator Bernie Sanders is proposing one such mechanism, a prize system, be adopted to support research on AIDS drugs.

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High HIV Prevalence Calls for Stronger Commitment Towards Treatment and Care in Thailand

via Press Tv Bangkok, by Sonia Labboun

The concern is that the disease is increasingly affecting youngsters; about 25% of the total diagnosed patients are in the working group aged between 30-34 years old.

Experts say that schools and universities lack the means to give a proper education about the dangers of HIV and how the disease is transmitted, making this group age an ideal focal for its spread.

In a move to show the government's commitment to combat the disease, the National Health Security Office has announced a subsequent budget of nearly $100 million for HIV care and treatment and is already planning to increase the amount to almost $114 million for 2013.

In a major blow to global pharmaceutical firms, Thailand issued licenses for cheap HIV drugs between 2006 and 2008, a move that has angered industries from the US, Germany and Switzerland who until recently had the monopoly in HIV treatments.

Recently The world bank has pointed out at the fiscal burden of HIV, they say it shouldn't be considered only as a health problem, but also as an economic problem because of the huge costs in treating patients, highlighting as well the importance of effective prevention in order to lessen future costs.

In early 1990s, Thailand has overcome predictions that four million of the 65 million population could become infected by 2000 thanks to successful Aids education and prevention campaign that the current government wishes to revive.

The government is concerned that even though a cheap alternative for HIV treatments is available, the number of new infections is still rising. Experts blame it on poor education at schools and lack of prevention campaign in the media; deficiencies which the current government has promised to take action on."

Check out a video here.

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The Influence of India's New Ruling on HIV/AIDS Pharmaceuticals

via Reuters.com, by Kaustubh Kulkarni and Henry Foy

"India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say."

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.
"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

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Analysis: Legal case in India threatens HIV drug access for poorest

via The Bureau of Investigative Journalism, by Melanie Newman

A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world.

More than 90% of drugs used to treat children with AIDS in Africa come from Indian generic manufacturers, according to the medical NGO Medicins Sans Frontieres. And if the Swiss pharmaceutical giant Novartis wins a case it has brought against the Indian government, MSF fears that supply could dry up.

Novartis is seeking patent protection for its leukaemia drug Glivec, whose patent has expired in India. It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’.

Evergreening is a common method used by drug companies to extend the life of their patents. They make slight alterations to the basis molecule every few years and apply for fresh patents for the amended versions, which then prevents generic copies of the drugs being made.

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A Trade Barrier to Defeating AIDS

Via the New York Times, by Tina Rosenberg.

Earlier this month, [the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries] received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

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ARV Access Fears Across the World

A slew of recent articles have appeared in the news lately which express concern over the availability and accessability of many countries including Swaziland (PlusNews), Indonesia (Jakarta Globe), and middle-income countries around the world (below). This comes on the heels of the Ranbaxy-Gilead deal which has the potential to greatly increase the supply of these life-saving drugs.

Bad News for Drug Prices in Middle-Income Countries

Middle-income countries with large numbers of people living with HIV will no longer benefit from preferential pricing when buying antiretroviral drugs from large pharmaceutical companies, according to the annual Médecins Sans Frontières drug pricing report, Untangling the Web of ARV Price Reductions.

“The main bad news in the study is the fact that a number of pharmaceutical companies will no longer be providing preferential pricing to middle-income countries like Brazil, China, India and Thailand,” Nathan Ford, medical director at MSF’s Campaign for Access to Affordable Medicines, said at the launch of the report at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome.

According to the report, pharmaceutical firm ViiV Healthcare – owned by Pfizer and GlaxoSmithKline – no longer offers reduced prices to middle-income countries, even when their programmes are fully funded by the Global Fund to fight HIV, Tuberculosis and Malaria.

Merck has also ceased to offer discounted prices to all lower middle- and upper middle-income countries, proposing instead to negotiate discounts on a case-by-case basis. Previously, Merck offered middle-income countries discounts that were still up to 10 times the price of generic versions. Of particular concern is the price of UN World Health Organization-recommended third-line drug, raltegravir – an integrase inhibitor that blocks retroviral replication – which costs up to US$5,870 per person per year in Brazil, compared with $675 in sub-Saharan Africa.

Janice Lee, pharmacist at MSF’s Campaign for Access to Essential Medicine, noted that drug company discount programmes were not a long-term solution, and governments would have to start using trade-related aspects of intellectual property rights (TRIPS) measures to override patents; in the past, Brazil and Thailand have used compulsory licences – when a government allows someone else to produce the patented product or process without the consent of the patent owner – to lower prices in their countries.

The report notes that Abbott excludes low- and middle-income countries from differential prices for the standalone heat-stable ritonavir 100mg tablet. It blocks the enzyme protease, required by HIV to make new viruses. A spokesman for Abbott said the company’s long-standing pricing policy would protect the poorest people living with HIV.

"Abbott’s preferential pricing policy for ritonavir has been in place, unchanged, for a decade,” Dirk van Eeden, director of HIV communication and policy at Abbott, told IRIN/PlusNews via email. “It includes all African and least developed countries, where the outright majority of patients with HIV live.”

ViiV Healthcare also defended its pricing policy, saying it was committed to ensuring access to its medicines.

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South Africa's Government Mulls State Pharmaceutical Company

Via Mail & Guardian, by Nickolaus Bauer.

The [South African] government was mulling the formation of a state-owned pharmaceutical company, African National Congress (ANC) secretary general Gwede Mantashe said at Luthuli House on Tuesday.

Mantashe was addressing reporters at the ruling party's headquarters in Johannesburg following an ANC lekgotla (meeting) on July 17.

"There is a need and this is in line with our Polokwane resolutions. At the moment South Africa consumes 25% of the world's ARVs [antiretrovirals], and it's with this in mind that we are looking at starting a state-owned pharmaceutical company," Mantashe said.

According to research carried out by the ANC into HIV/Aids infection rates, South Africa has 17% of the world's HIV-positive people.

"We had an idea for a state-owned mine company. That company is now running a coal mine and will open another one soon," he said.

Mantashe assured reporters the company would not threaten the pharmaceutical industry.

"There is a need and this is in line with our Polokwane resolutions. This doesn't mean the pharmaceutical industry will close down. The state-owned pharmaceutical company will operate within the industry," he said.

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Gilead Deal: More AIDS Patients May Get Cheaper Drugs

Ranbaxy Laboratories recently entered into a deal with Gilead Sciences that will allow the Indian pharmaceuticals company to manufacture generic versions of three new HIV medications.

Via Associated Press:

Gilead Sciences Inc. will allow some of its AIDS drugs to be made by generic manufacturers, potentially increasing their availability in poor countries, particularly in Africa, officials said Tuesday.

In the first deal of its kind, the pharmaceutical company has agreed to allow four of its AIDS drugs to be made by generic drug companies at a cheaper cost in return for a small proportion of royalties, United Nations health officials said.

Most of the 33 million people worldwide who have HIV, the virus that causes AIDS, live in Africa. One of the drugs will also be used to treat people with hepatitis.

The deal was negotiated by the Medicines Patent Pool, part of a U.N.-led partnership that raises money for AIDS, tuberculosis and malaria by things like taxing airplane tickets. Among the partnership's 29 member countries, only Chile, France, Korea, Mali and Niger are actually implementing the airline tax.

"We will continue to work with Gilead and others to expand access to all people living with HIV in developing countries," said Ellen 't Hoen, executive director of the Medicines Patent Pool.

Gilead will receive from three to five percent royalties on its four drugs, which will be supplied to about 100 countries.

Until now, its drugs have been mainly sold in rich countries, and profits from the new deal are expected to be a tiny fraction of those Gilead gets from the West.

Typically, patients in poor countries have to wait for years until the patents expire on new drugs before they can be made more cheaply by generic companies.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]