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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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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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

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

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.

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

An Outlook on What to Expect for the Future of HIV Treatment

via TheBody.com, by By Joel Gallant

2012 promises a number of changes and advances in the way we treat and prevent HIV infection. There is growing enthusiasm for widespread use of antiretroviral therapy (ART), regardless of CD4 count, both for treatment and prevention. New drugs and co-formulations are coming this year that will expand treatment options and simplify drug regimens, especially for initial therapy. At the same time, political and economic realities may prevent us from being able to implement broad-scale treatment and prevention efforts, and the coming of generic drugs, while cost-saving, may put limits on our choices of antiretroviral drugs.

When to Start

 San Francisco and New York City now recommend ART for everyone with HIV, regardless of CD4 count and viral load. Current U.S. treatment guidelines already come close to that aggressive standard. They recommend ART for anyone with a CD4 count below 500, and say that everyone else should consider treatment. Treatment is also recommended at any CD4 count for people with additional conditions, including pregnancy, HIV-associated nephropathy (HIVAN), hepatitis B or C, older age, high viral load, rapid CD4 decline, and high risk for heart disease.

In the minds of many HIV experts, ART is now the "default" -- recommended unless there's a good reason not to treat. Reasons why not to treat? People who aren't ready or willing to start should wait until they are. Some people have no way to pay for treatment, an increasingly common scenario even in the United States. We don't know what to do with "elite controllers" -- people whose viral loads are already undetectable without therapy. Assuming normal and stable CD4 counts, it would be hard to show a benefit to starting ART in those individuals.

How did we get to this point, where ART is recommended for virtually everyone else? First, we're recognizing that HIV isn't just a disease of immunosuppression due to CD4 decline. Untreated HIV has consequences even for people with high CD4 counts, due to the inflammation and immune activation caused by ongoing replication of the virus. Shutting off viral replication may help to reduce the long-term risk of conditions such as heart disease, cognitive decline, loss of bone density, and malignancies by reducing HIV-associated inflammation.

We also know that treating people with HIV lowers their risk of infecting others. In fact, the HPTN 052
study demonstrated that ART was 96% effective at preventing transmission to negative partners, a far greater efficacy than we've seen with any other form of prevention so far, including condoms, circumcision, microbicides, vaccines -- probably even "abstinence." Put simply, if everyone with HIV were on treatment with an undetectable viral load, we would see virtually no new cases.

Evidence of the benefit of early ART is clear, but the decision to treat early must also consider the cost of therapy, in order to weigh the costs against the benefits. Once-daily regimens are now the norm; a growing number of single-tablet regimens (STRs) are becoming available; tolerability and safety are high. Weighing the financial cost against the benefits is more complicated, since it involves economics and politics rather than science. This is where the prevention benefits of ART become so important. Some people may be unwilling to pay for universal ART for individuals, but if universal treatment can slow or even stop the epidemic, perhaps they'll see it as money well spent. (At least, that's what they should be thinking!)

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

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

Activists Urge a Change in Patent Laws in South Africa

via PlusNews Global

Ten years ago, the Doha Declaration allowed countries to circumvent patent rights to access life-saving medicines, particularly those used to treat HIV/AIDS, tuberculosis and malaria. However, the South African government has failed to take advantage of these provisions, and increasingly important TB medication and second- and third-line antiretrovirals (ARVs) remain out of reach, activists warn.

"Pre-Doha, treating [HIV] without generics... meant HIV was a death sentence," said Gilles van Cutsem, medical coordinator for Médecins Sans Frontières (MSF).

In South Africa, with the world's highest HIV infection rate, the availability of generic first-line ARVs meant a drop from an annual cost of more than US$10,000 per patient to $60. Now, with more than one million people on treatment, the country will need to put more HIV-positive people on second- and third-line regimens.

Right to health

The Doha Declaration, or the Declaration on the TRIPS Agreement (Agreement on Trade-related Aspects of Intellectual Property Rights), was signed by members of the World Trade Organization (WTO) in response to concerns that patent protection granted by the TRIPS Agreement would undermine the ability of countries to protect their right to health and access to medicines.

The 1995 TRIPS Agreement made all WTO members beholden to a pharmaceutical patent period of 20 years, during which time no generic could be produced. Before TRIPS, countries such as Brazil and India did not respect patent periods at all, and many other nations observed shorter time-spans (16 years in South Africa).

With the 2001 Doha Declaration, provisions within the TRIPS agreement to protect public health were reaffirmed, as were the rights of member countries to "use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose".

This included the granting of compulsory licences, which allow a government to formulate or import generic versions of medicines essential to public health but still under the 20-year patent period.

To take advantage of public health flexibilities such as compulsory licensing, however, it must be enacted into national legislation. Unfortunately, few countries, including South Africa, have taken advantage of their rights.

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