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.
 

Source

EU Blocking Cheap HIV Drugs

posted: 08/10/2010

The EC is pushing for a trade agreement with India which will restrict companies from making cheap copycat drugs for poor countries, says MSF. In 2001, when the Doha declaration was signed, it was widely thought that the battle for cheap drugs for developing countries had been won.

The declaration created a helpful loophole in the medicine patent rules. Indian companies and those in other countries would be licensed to make cheap copies of patented HIV and other drugs for poor countries.
 

Fight-back against drug company and EU
Now Médecins Sans Frontières, is accusing the European Commission of aggressively pushing policies - including a trade agreement with India - that will dry up the flow of cheap drugs to those who badly need them in poor countries.
 

Europe! HANDS OFF our medicine
A three-month campaign, called "Europe! HANDS OFF our medicine", launched today, invites people to let the EC know they object by an easy email system. The emails go to the Trade Commissioner, Karel De Gucht. "If you continue to pursue your actions, people who rely on these medicines to stay alive will be left without a lifeline and many are likely to die," it says.
 

Send an email today

Tough language, but MSF believes the stakes are high and argues that the EC has been doing the bidding of the multinational drug companies (who want to protect their drug monopolies) for some time and in a number of ways. This is what Dr Unni Karunakara, president of MSF's international council says:
'We depend on access to affordable medicines like those produced in India to treat all kinds of diseases. We buy 80% of our AIDS medicines from India - medicines that keep 160,000 people alive today. On their behalf, we cannot remain silent as Europe works to close the door on every aspect of drug supply - the production of a generic medicine, its registration, and its transportation to patients in other parts of the world. So today we are launching a campaign demanding 'Europe! HANDS OFF our medicine.'

Tougher patent rules
There are several issues. The free trade agreement is seeking tougher patent rules than the existing World Trade Organisation agreement requires, says MSF. The EC wants to introduce "data exclusivity", which would stop a generic company registering a copy of a drug without running its own expensive and lengthy clinical trials. This would seriously delay the supply of generic versions.
One example is nevirapine syrup for children with HIV. It does not have a patent from the Indian patent office, which means generics companies could copy it. If there was data exclusivity, children in Africa would have had to wait for years.
 

Generic HIV drugs seized at ports
But the campaigners also take issue with the EC over a number of seizures of generic drugs that have taken place in European ports since 2008. AIDS drugs intended for Nigeria, bought by the European-funded access to medicines organisation UNITAID, were seized in the Netherlands.

EU pawn of drug companies
Michelle Childs, policy advisor for MSF's access campaign, says the EC is doing the pharmaceutical's industry bidding. "The IFPMA [the trade body] has said they want data exclusivity. They have repeatedly asked for this. It's been a long-standing aim of the pharmaceutical companies to introduce this because it gives them the extra period of time."
The Office of the EU Trade Commissioner denied it was impeding access to medicines for the poor. This was what its spokesman told the BBC:
‘The EU has never and will never stand in the way of the production of legitimate generic medicines. The EU is in favour of providing access to medicines to people in need and these negotiations with India do not stand in the way of this. Patents are important, they need to be protected. The European pharmaceutical companies say that the patents need to be protected otherwise the production of new drugs will be seriously in peril.’
MSF simply points out that the issue is not about patents.

Europe! HANDS OFF our medicine

Source
 

End to Cheap HIV Drugs?

posted: 15/09/2010

A new report shows that the vast majority of HIV drugs keeping people alive in developing countries are made by Indian generics companies, but new trade rules may prevent them making cheap copies in the future.
Several million people are alive today - and fit and active and looking after their children - who would be dead, had it not been for the roll-out of antiretroviral drugs to treat people with HIV. This is a spectacular success story - even though less than half (4 million out of 9.5 million) people who need HIV drugs are so far on treatment.
 

But will the cheap generic drugs continue to be provided? Much may depend on the cost of the drugs.
 

Cheap generics

The three-drug antiretroviral combinations now in use in the developing world are cheap - really cheap. The prices came down from over $10,000 a year per person to under $100, because Indian generic drug manufacturers make cheap but effective versions, which are approved for quality by the World Health Organisation.
 

Just how much that price plunge mattered is made clear in a report from Brenda Waning and colleagues, available free online, published in the Journal of the International Aids Society today.  Their research shows that the vast bulk of these HIV drugs - up to 87% by 2008 - were supplied by the Indian generics companies.
 

Almost all the rest that are used in poor countries are not first-line combinations, but second or even third-line treatments, for use when the first combination won’t work. HIV is adept at developing resistance to the drugs used against it - it also happens across Europe and the USA.
 

Few 2nd and 3rd line generics

Generic versions of the newer, second and third combination drugs needed to deal with this resistance are not widely available.

Alarm bells TRIP for cheap new generics

Today's report raises the alarming possibility that they may not be made widely available.
Generic companies in India were able to make the basic HIV drugs because India did not recognise the patents on those drugs. But now everything is changing. Since 2005, a global trade agreement called TRIPS (trade-related aspects of intellectual property), has begun to have an impact, restricting the copying of new drugs. Negotiations on further trade agreements are ongoing.
 

The report’s author Waning works for UNITAID, an organisation dedicated to obtaining greater access to HIV medicines for poor countries. This is what UNITAID's executive secretary Jorge Bermudez had to say about the report:
“The findings of this study raise grave concerns for us because UNITAID relies heavily on Indian generic manufacturers to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50 countries. What we need today is a more flexible approach to scale up treatment and not the opposite.”

If Indian manufacturers cannot meet these demands, a lot of the progress we have made in the last seven years against HIV in the developing world will be reversed.
 

Source The Guardian
 

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."
 

Source

Drug Firm's Bold Promise

posted: 16/02/2009

The new chief executive of pharmaceutical giant GlaxoSmithKline (GSK) says the company will cut prices for its drugs in the developing world.

Andrew Witty said GSK would cut the cost of drugs in the 50 poorest nations to 25% of price in the UK and US. He also said the firm would share knowledge of patents and reinvest profits in local clinics.

Charities have long campaigned for such a policy as patents prevent cheaper generic versions of drugs.

Mr Witty told the Guardian newspaper drugs companies had a duty to help the poor. He said: "We work like crazy to come up with the next great medicine, knowing that it's likely to get used an awful lot in developed countries, but we could do something for developing countries.

"Are we working as hard on that? I want to be able to say yes we are, and that's what this is all about - trying to make sure we are even-handed in terms of our efforts to find solutions not just for developed but for developing countries."

Formulas and processes owned by GSK under patent will be shared with researchers and 20% of the firm's profits in the developing world will be reinvested in hospitals and clinics there.

Move welcomed by HIV and health campaigners

Health campaigners have said more still needs to be done but they welcomed the initiative. Oxfam said affordable HIV treatment, for instance, could stop 6,000 people dying every day in countries affected by the HIV/Aids epidemic.

Charity World Vision's director of advocacy Mike French said: "Slashing drug prices is good. But without the necessary health infrastructure many won't be able to access those drugs. Therefore, investment by GSK, along with the knowledge pooling, make this a landmark announcement.

"This is a gutsy move in a commercial world. Witty has demonstrated a willingness to make saving lives a business goal along with making money."

George House Trust Chief Executive Michele Reid responded, saying:
"Andrew Witty has taken a bold first step in the right direction. We hope that other international drug companies will soon match and then outbid GSK's move. They can and need to do more if we are to see real change in the developing world for people living with HIV."

"In the future, rather than selling their own HIV drugs to the developing world for a bit less, we'd like to see the pharmacos allowing the generic companies to produce drugs more cheaply."

"We also need Witty's "patent pooling" idea to include HIV drugs, so we can have faster development of new HIV treatments. This is a good start, but let's hope it leads to saving lives on the ground, which should be everyone's driving ambition in the HIV drugs marketplace."
 

Could do better - check the small print

Critics of the drug companies acknowledged yesterday that GSK was making strides, but said it could go further. It's proposal to give away 20% of profits in the 60 least developed countries is not what it seems - GSK currently has operations in only 18 of them and earns around £30 million a year from them.

"I recognise the fact that GSK is seeking to meet concerns," said Michelle Childs, director of policy and advocacy at Médecins sans Frontières, who welcomed the move to open to pool patents on chemical compounds that could help the development of treatments for neglected diseases. But, she said, she would challenge GSK to go further.

Need for HIV patent pool and cheaper drugs from generic manufacturers

"He is saying there is no need for a patent pool for HIV. Our position is that there is an urgent need for a patent pool for HIV because of the rising prices of new first and second line drugs for patients who develop resistance."

Buying cut-price drugs from GSK would not necessarily be the best move for the poorest countries, she added.

Generic companies were capable of producing drugs at lower prices than big pharma could manage, because of the lower costs of manufacture. GSK's combination HIV drug Combivir had been reduced from $730 (£506) in 2001 per patient per year and now sells at $197 in the least developed countries.

source 1

source 2

source 3

letters from Stop Aids Campaign and others in response