HIV Drug Firm - Call to Pool Patents

posted: 07/09/2009

Leading UK and international organisations have written to Britain's largest drug company urging it to pool its patents on HIV medicines to help save millions of lives in developing countries.

A letter from 15 organisations, including the Stop Aids Campaign, Médecins Sans Frontières, Unicef and Christian Aid, calls on GlaxoSmithKline (GSK) to join a patent pool being put together by UNITAID, which aims to improve access to drugs for HIV, malaria and tuberculosis (TB) in poor countries.

The patent pool would allow cheap copies and combinations of HIV treatments to be made without legal restraint or delays from the manufacturers, whose monopolies are protected for 20 years.

The letter follows Andrew Witty, the chief executive of GlaxoSmithKline, saying that all he knew of UNITAID was what he had read in the papers. UNITAID’s mission is to help increase access to treatment for HIV, malaria and  tuberculosis, for people in poor countries, by getting speedy price cuts for tests and medicines.

On a trip to Katine in northern Uganda, Witty made clear his reservations about a patent pool for HIV drugs, although he said: "I'm not saying no to anything because nobody's actually put in front of me a really concrete proposition." He added that GSK was already doing a lot to help those with HIV in developing countries, including funding research into drugs for children, and he was willing to let generic companies make cheap copies of its HIV drugs under licence.

Witty went to Katine to explain how his own plans to help the developing world would work in one corner of Africa.

He has cut the prices of GSK drugs in poor countries to no more than a quarter of the level in the west and promised to reinvest 20% of profits on those drugs in the developing world. He has also launched a patent pool of his own, with more than 800 compounds and molecules that might be useful to researchers into neglected diseases. HIV, he insists, is not a neglected disease.

Much more still to do

In response, the 15 organisations wrote in their letter: "GSK's insistence that a patent pool for HIV is unnecessary is surprising given the woeful lack of innovation into HIV treatments suitable for children, and the obvious need for new safer and more effective fixed dose combinations for adults." The group also urged Witty to meet UNITAID.

Alan Smith, chair of the Stop Aids Campaign, said: "The UNITAID patent pool is our best hope of increasing access to life-saving medicines on the scale that is needed to achieve universal access.

"It is crucial that Andrew Witty and GSK … engage in an honest and positive manner with the UNITAID taskforce."

A letter from Unitaid to the Guardian on 15 October reinforced the need for a HIV patent pool:

'Unitaid welcomes GlaxoSmithKline's renewed interest in the Unitaid patent pool initiative for HIV/Aids medicines and its openness to taking a flexible approach to managing intellectual property (Letters, 10 September); and GlaxoSmithKline urged to pool its patents on HIV drugs, 7 September). Wherever multiple patents owned by different companies are required to make a product, patent pools may offer a useful solution. Pills that combine three medicines into one tablet to treat HIV/Aids are a good example of such products.

The World Health Organisation recommends the use of such pills because they make it easier for patients to take their treatment and reduces the risk that viral resistance will render the drugs useless. However, patents from two to three different companies are usually required, meaning that single-company initiatives will not do the trick. The Unitaid pool will facilitate the development of combination pills and children's formulations of HIV/Aids medicines for use in developing countries, based on voluntary patent contributions from pharmaceutical companies. Those companies will receive royalty payments for doing so. The pool will also enable robust competition among drug producers to ensure that international resources to fight Aids, currently under severe strain, are spent as efficiently as possible.

The situation is urgent. An estimated 6 million people needing access to Aids treatment, including hundreds of thousands of children, still do not receive it. This number will only grow in the years to come. We ask GSK and other Aids drug patent-owners to work with us to make this initiative a success.' Ellen 't Hoen, Senior adviser IP & medicines patent pool, Unitaid
 

UNITAID

Source

HIV - Decriminalise Drugs Worldwide

posted: 20/04/2009

Michele Kazatchkine's surprise intervention calling for the decriminalisation of drug users was widely welcomed by HIV and drugs campaigners who have also been calling for this. Michele Kaztchkine is head of the influential Global Fund to Fight Aids, Tuberculosis and Malaria and was speaking at the 20th International Harm Reduction conference in Bangkok.

Decriminalising personal drug consumption is highly sensitive and, despite intensive lobbying of governments about the possible advantages for public health, many politicians regard the idea of withdrawing criminal sanctions for drug use as politically toxic.

Sharing drug injection equipment, like needles, almost always leads to the passing on HIV. Even though the Global Fund and others have put a lot of money into drug harm reduction, rates of HIV transmission by sharing drug kit have remained stubbornly high.
That Kazatchkine has chosen to speak out now is not a coincidence. It comes close on the heels of renewed and fiercely fought debate on the issue, when the Vatican in Rome attempted to block UN reform of international drugs policy.

Advocates for reform were outraged when in February the pope issued a statement condemning harm reduction strategies as "anti-life" and, in the kind of language guaranteed to stoke up opposition to wider reform, claimed that assisting addicts to access help without fear of criminal penalty would lead to the "liberalisation of the use of drugs".

If the Vatican's statement was inflammatory, its timing also riled. According to campaigners it torpedoed a crucial UN declaration by exacerbating disagreements between countries about whether to collectively endorse harm reduction strategies such as the provision of the drug substitute, methadone.
 

UN and individual government officials were meeting in February in Vienna as part of the Commission on Narcotic Drugs to work on a new drugs "Declaration of Intent" for the next decade – a significant stage in the evolution of international drugs policy – when the pope's comments were released. The Vatican's action led to Italy withdrawing from a broad EU coalition supporting global harm reduction strategies, weakening the EU in the face of strong opposition from the US, Russia and Japan.
 

The UK-based drugs charity, Release, an organisation at the forefront of campaigns for decriminalisation, said the outcome was a "weak and hugely disappointing" declaration. A spokeswoman said that despite "a wealth of evidence to support its effectiveness", harm reduction had been sacrificed in favour of ineffective criminal sanctions. "Pages and pages of text endorsed the continuation of tackling drug supply and drug use through zero-tolerance criminal sanctions and law enforcement, a policy that has failed the tens of thousands of injecting drug users now infected with HIV."
 

HIV - how many infected through drug use?
Obtaining exact figures for the number of injecting drug users globally or the proportion of users living with HIV is problematic. Robust data is difficult to come by due to a number of factors including the fact that illegality discourages people coming forward. Nevertheless there are some reliable estimates and they help explain the current sense of urgency around rates of HIV infection among IV drug users. There are about 33 million people living with HIV globally according to UNAIDS, which compiles statistics for the organisation. It estimates that in 2007 (the most recent year for which data is available), around 2-3 million of the world's 16 million or so intravenous (IV) drug users were likely to be infected with the HIV virus.
 

Drugs use causes over 80% of all HIV infections in Eastern Europe and central Asia
Illustrating the threat currently presented by HIV infection via IV drug use, a spokeswoman said: "Use of contaminated injection during drug use accounts for more than 80% of all HIV infections in Eastern Europe and central Asia." It is also a "major entry point" for infection in other parts of the world including the Middle East and Latin America. "HIV prevalence among some groups in these regions is estimated at over 40%," she added. In addition – and particularly importantly for those such as Kazatchkine advocating decriminalisation – incarceration for possession of drugs further increases their risk of contracting or transmitting HIV, according to UNAIDS.
 

Harm reduction works – look at Britain
In its latest report on the global HIV epidemic, UNAIDS echoes the concerns of Kazatchkine. "Until sufficient political will exists to address the sources of HIV risk and vulnerability, the epidemic will continue to expand," it concludes. It also highlights that where countries have adopted a "comprehensive approach" to HIV and drug use (it includes Britain on its list), the spread of HIV among those who inject drugs has slowed.
 

Kazatchkine argues that it is ultimately "public health oriented pragmatism" that produces results, not misguided criminalisation. However, if the Vienna conference is anything to go by, the widespread adoption of such an approach is still some way off.
As the Global Fund and other bodies working to fight the spread of HIV scramble for extra money in extremely challenging financial times, Kazatchkine says many are waiting with interest to see what sort of lead the US will take on the issue under Barack Obama. With around half of all people living with HIV in the US coming from the African-American community (despite accounting for just 12% of the population), the pressure will be on Obama to act.
 

"There are strong opponents to harm reduction both among the Republicans and the Democrats," Kazatchkine says. But, he adds, "given the unequal risk for African Americans becoming infected by HIV compared to the white population in the US", the issue is one he would expect the Obama administration to address.
 

The use of illicit drugs must be decriminalised if efforts to halt the spread of HIV are to succeed, one of the world's leading independent authorities on the disease has warned.
 

In an unprecedented attack on global drugs policy, Michele Kazatchkine, head of the influential Global Fund to Fight Aids, Tuberculosis and Malaria, told the Observer that, without a radical overhaul of laws that lead to hundreds of thousands of drug users being imprisoned or denied access to safe treatment, the millions of pounds spent on fighting HIV will be wasted.
 

Kazatchkine used his keynote speech at the 20th International Harm Reduction Association conference today in Bangkok to expose the failures of policies which treat addiction as a crime. He accused governments of using what he calls "repressive" measures that deny addicts human rights rather than putting public health needs first.
 

Harm reduction works
He argued that governments should fully commit to the widespread provision of harm reduction strategies aimed at intravenous drug users, such as free needle exchanges and providing substitutes to illicit drugs, such as methadone.
 

Drugs law and policing cause health harm
"A repressive way of dealing with drug users is a way of facilitating the spread of the [HIV/Aids] epidemic," Kazatchkine said. "If you know you will be arrested, you will not go for treatment. I say drug use must not be criminalised. Criminalise trafficking, not users. From a scientific perspective, I cannot understand the repressive policy perspective."
 

He condemns policymakers who argue that, because drug users frequently turn to crime to fund their habit, it justifies making it a criminal justice issue. Harm reduction both helps the addict and wider society and reduces the need to commit crime, he said. All of the groups affected by HIV, (for example heterosexual and gay African people, gay men, children infected by mothers) have seen great reductions in death rates, apart from one – injecting drug users.
 

"The one population where [HIV] mortality has been untouched - and in fact has worsened - has been IV [intravenous] drug users. It's amazing, because what we call harm reduction, such as exchanging needles, has been scientifically proven as the most effective.
 

"This is why I started my speech in Bangkok by mentioning the contrast between major progress achieved in decreasing mortality from HIV in the poorest countries of the world versus the total lack of progress for what is the main route of transmission in most parts of the world outside Africa."
 

Fears of criticism
Kazatchkine suggested that politicians feared that the public would label them soft on drugs. A doctor and respected HIV expert with 20 years in the field, he has in his two years at the helm of the Global Fund overseen some of the most dramatic improvements in treatment and prevention of HIV globally.
 

Since it was established in 2001, the fund has received $21bn in contributions from the world's wealthiest nations and used it to play a significant part in reducing rates of new HIV infections. It has also contributed to the distribution of much needed life-preserving anti-retroviral drugs to millions of people already diagnosed.
 

Alex Stevens, a senior research fellow specialising in drugs and criminalisation at the University of Kent, said the speech highlights many of the troubling consequences of criminal justice approaches to drugs policy.
 

"In many countries, serious human rights infringements are committed in the name of fighting drugs," he said. "These include the use of the death penalty for drug offences, compulsory treatment regimes that include methods (such as physical beatings) that are akin to torture, and, for example in the USA, depriving convicted drug law offenders of the right to vote."
Stevens said that, while the UK was ahead of many other countries on harm reduction, its tendency to criminalise drug users undermine its efforts.
 

Total global rethink on drugs needed

What is needed, Kazatchkine argues, is a total rethink of world drugs policies. "What I'm saying is that government's function is to protect their citizens. This is why harm reduction should be supported by all governments everywhere."
 

Source

earlier report

Drug Firms Merge HIV Arms

posted: 17/04/2009

Glaxo-SmithKline (GSK) and Pfizer are to merge the HIV arms of both these international drug companies, in a move to better develop and market HIV drugs. This follows an announcement in February that GSK was going to reduce the prices of its drugs, including those for HIV, across the developing world.

Britain's biggest drugs company, GlaxoSmithKline, is to pool resources for treating HIV with its USA rival Pfizer, in a bid to reinvigorate financial returns from tackling the global epidemic.

GSK and Pfizer announced that they intend to create a new company, headquartered in London but as yet unnamed, to manage their HIV operations with initial working capital of £250m.

The lion's share of the business will be owned by GSK, which will take 85% to reflect its portfolio of big-selling HIV drugs such as Combivir and Kivexa. The other 15% will go to Pfizer, which will contribute potentially promising new treatments.

Delivering new drugs

GSK's chief executive, Andrew Witty, said the "clear focus" of the joint venture would be in delivering new drugs to build on what he described as the drugs industry's remarkable success in tackling HIV over the last two decades.

Witty recalled that as recently as 1990, it was extremely difficult to conduct clinical trials in HIV because people rarely lived long enough to complete studies. He said: "I think it's one of the finest performances of the pharmaceuticals industry to have transformed an incredibly frightening infectious disease into something more manageable."

The new company will have 11 drugs on the market and a further six in clinical development. It will have a market share of 19% and annual sales of £1.6bn.

Once the global leader in HIV drugs, GSK has slipped to second place behind a USA rival, Gilead, and has seen sales stutter. Revenue from GSK's HIV treatments fell by 5% to £1.5bn last year, while sales of the company's entire pharmaceuticals portfolio slipped 3% to £20.3bn. It has few new HIV drugs in the pipeline, but Pfizer has several.

Pfizer has a relatively newly launched HIV drug, Selzentry, and is working on several more in trials.

"Both companies are facing some pressures in the HIV area," said Damien Conover, an analyst at the Chicago research firm Morningstar. "Selzentry is not doing as well as it probably could if it had more resources behind it."

Cautious welcome

Charities supporting people living with HIV greeted the tie-up with cautious optimism. Sir Nick Partridge, chief executive of the Terrence Higgins Trust, said his organisation "welcomes any move which will strengthen HIV research and development and benefit people living with HIV".

Partridge said that 33 million people lived with HIV worldwide: "We need to be making constant advances to stay one step ahead of the virus."

The new company will be run by Dominique Limet, a former head of GSK's French operation who presently runs the group's personalised medicine strategy.

Under the arrangement, either GSK or Pfizer could be rewarded with a greater ownership stake depending on whose laboratories come up with promising treatments in the future.

GSK's chief executive Witty, who is sceptical about multimillion-dollar mergers among drugs firms, suggested that this tie-up could be an example of how collaboration could be made to work elsewhere in future. "It's not necessarily a template but it will apply elsewhere," he said. "This structure is a good example of the way we want to create value and generate efficiency in our business."

He pledged that the new company would adopt "enlightened mindsets" towards the pricing and availability of HIV drugs in sub-Saharan Africa and other developing countries.
 

Source

Obama - Drugs Harm Reduction

posted: 17/03/2009

The Obama administration signalled today that it was ready to repudiate the prohibition and "war on drugs" approach of previous presidents, and steer policy towards prevention and "harm reduction" strategies favoured by Europe.

David Johnson, an assistant secretary of state, said the new administration would embrace policies supporting federally funded needle exchanges. The aim, he said, was to establish a policy based on public health needs. "This will result in a policy that is broader and stronger than the one we had in the past," Johnson said on the sidelines of a UN drug strategy conference in Vienna.

Last minute change for UN drugs conference

The UN international drug strategy conference meets every ten years to agree the international drugs strategy. It has been deadlocked. Europe is leading calls for harm reduction measures, such as needle exchanges and methadone, to help manage injecting drug use and reduce the risk of HIV and hepatitis C tranmsission, while the USA has stuck with the former USA "war on drugs" rhetoric and outright hostility to the pragmatic harm reduction approach. Now the USA seems to be swinging towards European policy, at the last minute.

His words come days after his nomination of the Seattle police chief, Gil Kerlikowske, to the post of director of the Office of National Drug Control Policy, the nation's drug czar. Kerlikowske has built a reputation in Seattle for pursuing drug policies based on harm reduction. The state has an established needle exchange programme, has legalised marijuana for medicinal purposes and has made marijuana among the lowest priorities for law enforcement.

Congress calls for drugs policy change

In a further sign of a new approach in Washington, congressional committee hearings last week heard lawmakers argue for a shift in national drug policy, largely in response to the rising drug-related violence seeping into the US from Mexico.

Those hearings followed a report by the former presidents of Mexico, Colombia and Brazil, which dubbed the war on drugs a "complete failure". Ernesto Zedillo, César Gaviria and Henrique Cardoso, all conservative politicians, blamed the US emphasis on criminalisation for the continuing toll caused by drug trafficking, and called for an approach based on public health, including the legalisation of marijuana.

Change came the top

Johnson said the latest shift came as a result of a direct instruction from the new administration. "There was very much an official directive from Washington," he told Reuters. "There was no confusion whatsoever. The [switch on] needle exchange was the clear signal of that."

Ethan Nadelmann, the executive director of the Drugs Policy Alliance, which lobbies for alternatives to the war on drugs, welcomed the change.

Public health comes before politics

"These statements really indicate a significant shift," he said. "It's not just a repudiation of the Bush administration, it's a repudiation of the Clinton administration. This signals a new direction in US drug policy. This is about all the leading scientists and all the public health people pushing in the same direction and Obama saying he's putting science above politics."

In a statement last week announcing the nomination of the new drug czar, Obama said: "With escalating violence along our Southwest border and far too many suffering from addiction here at home, never has it been more important to have a national drug control strategy guided by sound principles of public safety and public health."

Kerlikowske faces bruising confirmation hearings in the Senate. After his name was floated for the position, it emerged his stepson has been arrested several times on drug-related charges. Kerlikowske alluded to this at the announcement of his nomination. "Our nation's drug problem is one of human suffering," he said, "and as a police officer, but also in my own family, I have experienced the effects that drugs can have on our youth, our families and our communities."
 

source

UN Drugs - No Harm Reduction

posted: 11/03/2009

IAS, the International Aids Society and other international organisations, are insisting that countries must reject the new draft 10 year UN drug policy, because it does not include harm reduction - the supply of clean needles and syringes to prevent the spread of HIV and hepatitis. And it lacks key human rights protections.
 

Lacks critical HIV prevention points

The new UN Political Declaration on Drugs, designed to guide drug policy for the next 10 years, lacks critically important measures for treating and stemming the spread of HIV, Human Rights Watch, the International AIDS Society, and the International Harm Reduction Association said today.

The groups said that respect for human rights and HIV prevention should be at the heart of the policy, but that critical elements had been stripped from the final declaration. They called on member governments to refuse to support the declaration, which is being considered at the high-level segment of the Commission on Narcotic Drugs (CND) this week in Vienna .

Weak declaration "undermines fundamental health and human rights obligations"

"Government delegations could have used this process to take stock of what has failed in the last decade in drug-control efforts, and to craft a new international drug policy that reflects current realities and challenges," said Prof. Gerry Stimson, executive director of the International Harm Reduction Association. "Instead, they produced a declaration that is not only weak - it actually undermines fundamental health and human rights obligations."

Harm reduction services left out

What is at issue is a series of measures known collectively as "harm reduction services," which have been endorsed by UN health and drug-control agencies, including the UN Office on Drugs and Crime, UNAIDS and the World Health Organization. However the draft declaration excludes these. These measures include needle and syringe exchange and medication-assisted therapy (for example, with methadone), both inside and outside prisons, as essential to address HIV among people who use drugs. The groups noted that a wealth of evidence proves harm reduction is essential to HIV prevention for people who use drugs. The action was taken against the direct advice of UNAIDS, the Global Fund to fight AIDS, Tuberculosis and Malaria, and the UN special rapporteurs on health and on torture.

Harm reduction ommission is "unacceptable and unconscionable"

Up to 30 percent of all HIV infections outside of sub-Saharan Africa occur via unsafe injecting drug use. The groups said there is clear evidence that harm reduction interventions can halt or even reverse HIV epidemics among people who inject drugs.

"This political declaration fails public health," said Craig McClure, executive director of the International AIDS Society. "Coming less than 12 months after UN member states convened a high level meeting in New York to restate the international commitment to fight HIV, the denial of any reference in the declaration to life-saving harm reduction programs is unacceptable and unconscionable."

Human Rights failings

The political declaration also fails human rights. In country after country around the world, abusive law enforcement practices conducted under the banner of the 'war on drugs' result in extensive, and often horrific, human rights violations. In addition, overly restrictive interpretations of the international drug-control treaties at national level result in the denial of access to essential pain medications to tens of millions of people worldwide.

Both of these issues were raised by the UN special rapporteur on health and the UN special rapporteur on torture, who wrote to the CND to urge explicit support for human rights within the political declaration. All member states of the UN have ratified at least one of the core UN human rights treaties, and the UN General Assembly has consistently stated that drug enforcement must be carried out in a manner consistent with respect for human rights.

"Given the widespread human rights abuses around the world directly resulting from drug enforcement, human rights must be placed at the heart of UN drug policy," said Joseph Amon, director of Human Rights Watch's health and human rights division. "But the political declaration makes scant reference to the legal obligations of member states under international human rights treaties, nor does it insist on respect for human rights in drug policy."

Failure to be followed by Failure?

The past 10 years international drugs policy was under the banner of "a drug-free world." It's been a conspicuous failure. Continuing to exclude harm reduction from international drugs policy is not likely to reverse the failings of the past ten years. 

The international community should recognize that the current approach to international drug policy has failed, the organisations said. Concrete steps should be taken to set forth a drug policy framework incorporating evidence-based measures to address drug-related harm and the human rights obligations of states, and of the UN as an international organization, at its heart.

This means supporting harm reduction measures. It means acknowledging that punitive drug policies don't work, and have taken a serious toll on the lives and health of millions of people. It also means acknowledging that we need a new way forward.

The groups called on member states not to lend their names to a political declaration that does not sufficiently prioritise the centrality of harm reduction and human rights within the global response to drugs, and join the call from other civil society organizations for further efforts across the UN system to find a more effective, coherent, and relevant response to drugs.

The January 2009 overview document by the International Harm Reduction Association and Human Rights Watch, International Support for Harm Reduction.
 

More on Human Rights Watch's work on drug policy.