Step To HIV Patent Pool

posted: 11/02/2011

The determined people campaigning for a patent pool to make HIV drugs available cheaply in developing countries are slowly getting results.
 

Unitaid works to improve access to medicines in developing countries and has set up the Geneva-based Medicines Patent Pool .

Sharing the patents of HIV drugs provides people in the developing world with cheap copies (‘generic’ versions of the drugs, rather than expensive brand name originals). Generic drug manufacturers in countries like India and China can then make legal cheap combinations of some of today's advanced HIV medicines.
 

2nd line generic treatments needed now

The world needs cheap combinations of new generic drugs to keep healthy and well the millions of people already talking treatments in the developing world, as HIV inevitably develops resistance to the basic drugs already being used.
 

Even GSK are now negotiating
But today, two months after sending out letters inviting the major makers of HIV drugs to add their patents on HIV drugs to the patent pool, it was announced that F. Hoffman-La Roche, Gilead Sciences, Sequoia Pharmaceuticals, and ViiV Healthcare (a joint venture of GlaxoSmithKline and Pfizer) are about to start talking business.
 

The big surprise is Viiv Healthcare. GSK has always said it wasn't uninterested in pooling HIV patents. Its chief executive Andrew Witty, said they would do something else instead.
 

Viiv Healthcare has however now taken the first step by saying it is interested in joining the negotiations.

The Medicines Patent Pool has published the responses to the HIV drug patent pool invitation from all the companies, naming and shaming the less than enthusiastic companies with their own letters. They’ll update this every quarter. It will be worth watching to keep drug companies accountable to people with HIV.
 

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HIV Patent Pool Launched

posted: 09/06/2010

The long-awaited patent pool for HIV treatment drugs is now officially approved, and the international drug companies will now be pressed to give up their monopoly rights in July. Last night in Geneva, the final hurdle was crossed and the first-ever patent pool for HIV drugs got the official go-ahead.
 

After months of negotiations and expectations, the board of UNITAID – the international organisation set up by European donor countries to increase the supply of affordable medicines to the developing world - voted to set up the Medicines Patent Pool Foundation and give it $4.4 million in its first year.
 

The newly launched Medicines Patent Pool Foundation is expected to hit the ground running in July, persuading drug companies to hand over the patents they hold on HIV drugs so that cheap generic copies for people in poor countries can be made. The greatest benefits are expected to be in the manufacture of drugs in suitable formulations for children and in combining drugs belonging to a number of different manufacturers.
 

"What this means in practical terms," said Philippe Douste-Blazy, chair of the UNITAID Executive Board, "is that formal negotiations with the patent holders can now begin. We expect the Patent Pool Foundation to have its first licenses within a year."
 

This could be hard work. Not every major drug company is going to want to hand over its monopoly rights in a good cause, particularly when it comes to HIV drugs, for which there is a lucrative market in rich countries.
This is not the first HIV patent pool. British company GlaxoSmithKline recently set up its own, but while it has very creditably put in patents for drugs that could help against neglected diseases, it has excluded its own HIV drugs – and it holds some key HIV treatment patents. But chief executive Andrew Witty has said he will consider a UNITAID patent pool, so we wait to see what GSK will now do.

Meanwhile UNITAID is less than happy with another drug giant, Bristol Myers Squibb (see report yesterday), which is closing the only factory making a cheap generic version of ddl (didanosine) for babies. Up to 7000 babies in the developing world depend on this fall-back treatment option. The new factory is not due to open until next year.

Less than satisfactory answer

The Guardian’s Health Correspondent has managed to get an answer out of the drug company. This was their reply:
“Bristol-Myers Squibb takes the concerns of UNITAID about supply of [ddl] didanosine very seriously and is committed to working with all stakeholders to ensure peadiatric patients remain on treatment.
We informed UNITAID and other procurement agencies that manufacturing of [ddl] didanosine 25mg and 50mg at our plant in France will cease in June of this year. E.U. regulatory approval of the new U.S. manufacturing site is expected in February 2011.

To avoid disruption, we preventively built up inventory to twice the level of 2009 demand. We also took steps to ensure product availability immediately upon regulatory approval of the new manufacturing site. The European regulatory authorities are aware of the urgency of the situation.

A very significant and unforeseeable increase in demand of [ddl] didanosine 25mg and 50mg has however created a supply strain on Bristol-Myers Squibb products only. Supply of [ddl] didanosine 25 mg and 50 mg tablets remains available through multiple generic alternatives.
We are actively working with procurement agencies to provide [ddl] didanosine to patients in need and to ensure minimal disruption.”
 

UNITAID – the problem remains
UNITAID is not impressed "The problem persists," said a spokeswoman. The generic alternatives are not WHO-approved and therefore UNITAID will not buy them because there are not the essential permissions allowing their use. "We would like them to ensure they take all the necessary steps to ensure there isn't an interruption."
 

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HIV Drugs Patent Pool

posted: 18/12/2009

An international agreement to pool drug patents for HIV treatments has just been launched, putting even more pressure on drug companies to give up their monopoly rights to HIV drugs. The idea is to make low cost treatment far more widely available in poorer countries.
 

Unitaid, an international drug purchasing facility, voted for the pool in Geneva this week. It was welcomed by campaigners and the British government, which has strongly backed the idea.
 

Campaigners say millions of lives could be saved by drug companies giving up their patent rights to allow anti-HIV drugs to be produced cheaply by generic manufacturers. It would also allow different companies' drugs to be combined in simple-to-take multi-drug combination pills for people in the developing world.
 

The rich multi-national patent-holding drug companies would get a royalty in exchange while keeping their exclusive 20-year patent rights in wealthy countries.
 

'Victory' for developing world
"The Unitaid decision is a huge victory for those in need of HIV treatment around the world," Diarmaid McDonald, the co-ordinator of the umbrella group Stop Aids, said. "It will help to break down the patent barriers which stop people getting the drugs they need to stay alive. Unitaid and the UK government should be commended for their leadership on this." McDonald said the focus "now shifts to the big drug companies", adding: "It will test the sincerity of their rhetoric on helping the most vulnerable in our world."
 

People Campaigning

A grass roots campaign is asking people to email the ten leading drug multi-nationals with HIV patents to ask them to take the patent pool plunge.

Drug companies divided
"Companies like Gilead and Merck showed real leadership within the industry by speaking positively of the patent pool – they must now go beyond words and contribute their patents to the pool. The pressure will be on others within the industry to follow or to explain why they are willing to turn their backs on an initiative with such huge potential to save lives."
 

A small number of companies have so far shown a willingness to discuss flexibility over their patents, but the British firm GlaxoSmithKline (GSK) – a leading manufacturer of HIV drugs – is not interested.
Andrew Witty, GSK’s chief executive, said this summer that he had reservations and believed the company's price cuts and other initiatives would produce better results.
 

GSK under more pressure
McDonald said there had been meetings with GSK, but stressed that the company was a long way from committing to any involvement. "They have come up with lengthy questions and hesitations and concerns about the patent pool and have been less than co-operative in how they have engaged with the Unitaid task force," he added. "The pressure is going to increase on GSK to justify their rationale for walking away from an initiative which could save millions of lives."

Treatment at the crossroads
The international development minister, Mike Foster, applauded the board's decision. "The international community is at a crossroads in meeting the demand for HIV treatment," he said. "Last year, 2.7 million people were newly infected with HIV and 2 million people died from Aids – the need to make effective HIV medicines affordable for developing countries has never been greater. The Unitaid patent pool could be a key means of addressing the treatment crisis."
 

The UK is a founder member of Unitaid, along with Chile, Brazil, Norway and France. Much of its funding comes from a tax on airlines.
 

Michelle Childs, the policy director at Médecins Sans Frontières, the volunteer doctors organisation that pioneered the use of HIV drugs in the developing world, said the pool would be judged by its outcome. "We've been encouraged by the positive responses from a number of companies to our campaign in support of the pool," she said.
 

"Now that the pool has been given a green light, patent holders need to move from expressions of general support to firm and formal license commitments. We urge them to do so. This needs to happen fast as the clock is ticking for millions of patients."
 

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Unitaid report

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

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Pool HIV Patents

posted: 17/04/2009

The UK Minister for International Development has challenged drug companies to help the developing world by giving up their patent rights to compounds that could be used in cures for neglected diseases and medicines for children with HIV.

Ivan Lewis, the minister for international development, said it was reasonable to expect the drug giants to do more. "Now is the time for industry to step up to the mark," he said. We're all concerned about the economic circumstances we're living in and the danger that that will push an increasing number of people into poverty," he added. "Challenging pharma to do their bit ... is entirely legitimate."

Pool Patents

Lewis will meet executives of leading drug companies to ask them to join two patent pools. He wants to know whether they will respond to the invitation of GlaxoSmithKline, which a few weeks ago said it would put all relevant patents into a pool designed to facilitate research into drugs for neglected diseases, and invited other companies to do the same.

Lewis will also ask whether they will support a patent pool for HIV medicines being designed by Unitaid, an international organisation launched by France, Brazil, Chile, Norway and the UK that buys medicines for the developing world.

"There's never been a better time for other companies to make their position known," he said.

Faster child-friendly treatments

The minister also intends to press Unitaid to move faster. He will write to the agency "urging them to speed up their work specifically on the question of child-friendly HIV treatments".

New medicines for TB are among those needed as the global epidemic grows, fuelled by HIV and complicated by resistance to old drugs. On World TB Day, Lewis announced £18m research funding for the TB Alliance to develop a shorter course of treatment. The UK is making the grant against a background of concern that recession may cause donors to cut back on funding for poor countries.
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