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GSK puts 800 patents in 'pool', expands trials transparency
  25 March 2009
Having recently proposed a new approach to tackling health problems specific to the developing world, GlaxoSmithKline has announced plans to put 800 of its patents into a pool to stimulate research into neglected tropical diseases.
The company has issued its annual corporate responsibility report, which puts some meat on the commitments made by chief executive Andrew Witty last month in a speech at the Harvard Medical School. GSK says it will place over 500 granted patents and over 300 pending applications in the aforementioned pool and will set out a mechanism "to enable third parties to request access to other intellectual property and know-how about its medicines which may help researchers to develop new treatments for neglected tropical diseases".
GSK also noted that it will reduce prices for patented medicines in the Least Developed Countries (LDCs) so they are no higher than 25% of the developed world price, as long as this covers cost of goods "to ensure this policy is sustainable". The firm is cutting the price on 110 products and formulations across LDCs with an average reduction of 45%, starting April 1.
The company confirmed that it will reinvest 20% of profits made from sales in the LDCs "to support strengthening of healthcare infrastructure". GSK also revealed that it gave 124 million to "charitable initiatives" in 2008, up 13%, and 68 million of that came in product donations.
Key among its charitable programmes has been GSK's efforts to eradicate lymphatic filariasis, also known as elephantiasis. Since 1998, it has donated over one billion albendazole treatments and 570 million people in 48 countries have been treated.
More transparency over clinical research
The company also announced additional steps to increase transparency regarding clinical research and its relationships with healthcare professionals. This includes the expansion of the publication of research of its medicines on GSK's Clinical Study Register, the names of investigators who participate in new trials and financial arrangements with groups that conduct these trials.
Mr Witty said "we recognise that GSK has unique and privileged capabilities. Continually strengthening our contract with society is vitally important and this is why we are fully committed to operating to the highest ethical standards".
UNITAID statement on GSK patent pool for neglected diseases
UNITAID welcomes GlaxoSmithKline's announcement last week that it will tackle neglected diseases in least developed countries and place its patents for the necessary medicines into a pool.

"This is a positive signal from an originator company," said Dr Jorge Bermudez, Executive Secretary of UNITAID, "that industry intends to do more for diseases in poor countries."
The UNITAID Executive Board gave the go-ahead in July 2008 for the establishment of a UNITAID patent pool to expand access to medicines indeveloping countries. The UNITAID pool will start with HIV therapies, which are not included in the GSK announced list of treatments, and will target low- and middle-income countries.
"Patent pools are increasingly seen as a useful tool in tackling barriers to access indeveloping countries," said Dr Philippe Douste-Blazy, Chair of UNITAID's Executive Board. "Sharing knowledge and technologies and putting them at the service of global health is key to truly expanding treatments for all populations."
About six million people who need HIV therapy today are not receiving it due largely to price barriers and the lack of more appropriate treatments for patients in poor countries. For instance, more fixed-dose combinations (several pills in one) are needed to promote patient adherence as well as more affordable second-line treatments for people who have developed resistance to conventional therapies and more child-specific formulations.
The UNITAID patent pool will work with global health authorities to come up with a list of priority medicines. Patent holders will be able to place their patents into the pool voluntarily. The idea is for other companies, including generic manufacturers, to take out licenses on those medicines and produce them in combined or improved form and, ultimately, stimulate competition to bring prices down.
"We also need to make sure that newer, safer and more effective medicines are available to the poor as soon as possible,"said Ellen 't Hoen, UNITAID Senior Advisor on Intellectual Property. "Those newer medicines can sometimes be patent protected for as long as 20 years. People already diagnosed with HIV cannot wait that long."

The UNITAID patent pool aims to become operational towards the end of 2009.
MSF response to GSK patent pool proposal
16 February 2009
A welcome first step - but HIV is also a neglected disease
Statement by Michelle Childs,
Director of Policy and Advocacy, Campaign for Access to Essential Medicines,
Medecins Sans Frontieres
in response to the speech by Andrew Witty, CEO, GlaxoSmithKline (GSK) at Harvard Medical School
Geneva, 16 February 2009 Medecins Sans Frontieres welcomes Mr. Witty's recognition that patents act as a barrier to research and development and that patent pools offer new ways to stimulate research into neglected diseases. Promises now need to be turned into action. The terms of any licences attached to the patent pool will be critical and more detail is needed. Funding sources also need to be identified to develop any products that result from this research.
MSF calls on all other pharmaceutical companies to lift patent barriers and make their molecule compounds and processes available to help develop treatments for neglected diseases and open up their compound libraries to researchers.
But GSK must extend this thinking to include HIV: HIV is also a neglected disease Mr. Witty claims that a patent pool is meant to focus on diseases with a severe lack of treatments and that there is sufficient innovation for HIV.
He is wrong. In the field of HIV/AIDS treatment, the gap between what is needed and what is available is large. A patent pool can help address that gap and encourage innovation in areas where it's not happening today.
- We need new fixed-dose combinations: We desperately need new fixed-dose combination drugs that combine multiple compounds into one pill, especially those including newer drugs. But today, patents on individual compounds can stand in the way of the development of fixed-dose combinations..
- We need new paediatric formulations and accelerated paediatric studies.. With 90% of HIV-positive children living in sub-Saharan Africa, paediatric studies and formulations are not a priority for pharmaceutical companies: of the 22 antiretrovirals approved by the U.S. Food and Drug Administration, eight are not approved for use in children and nine do not come in any kind of paediatric formulations. And when versions for children do exist, they are often not adapted for use in resource-limited settings (e.g. they need refrigeration or access to safe drinking water or are difficult for caregivers to administer in correct doses). Generic companies have expressed the interest and will to develop AIDS medicines in tablet formulations more suitable for children. But again patent barriers can currently prevent them from doing so, particularly for newer drugs.
Innovation is meaningless if there is no access
Research alone will not ensure that people living in poor countries will receive new treatments. In order to ensure access to the fruits of innovation, the resulting products must be affordable. Yet MSF, along with others providing HIV/AIDS treatment in developing countries, continues to struggle with the affordability of antiretrovirals.
Mr. Witty's prescription is to offer discounts of at least 75% on drug prices. While any lowering of prices is welcome, this is by no means a panacea. Experience has shown that competition among multiple generic producers is the tried and tested way to drive prices down - by between 95 and 98% since 2000 for the first generation of antiretrovirals.
The limitations of company discounts are particularly evident when they are restricted to least-developed countries only, and exclude middle-income countries - countries such as China, where in the absence of competition GSK charges over US$3,000 for the antiretroviral lamivudine; or Thailand, where Abbott refused to drop the price of heat-stable lopinavir/ritonavir, and it is only after the country issued a compulsory licence that the price fell from close to $3000 to around $500 today.
MSF is thus concerned to see that Mr. Witty appears to be separating out middle-income countries, offering little more than a promise of ill-defined pricing flexibility for these countries.
The price crisis in AIDS medicines is set to return.
Yet as more and more newer drugs are being patented in key generic producing countries, generic competition will no longer be able to act as the catalyst for price reductions as it did in the recent past.
HIV/AIDS is a disease that requires life-long treatment and people need access to newer more potent, and less toxic drugs when they experience side effects, or when they develop drug resistance.
The improved WHO-recommended regimen for first-line AIDS treatment costs, at best, between $613 and $1,033 using originator products. This is a seven to twelve-fold increase compared to older first-line treatments - which thanks to the effects of generic competition, are now available for $87 for one patient's yearly treatment. For second-line treatments, the prices are, at best, up to 17 times more expensive, in countries that cannot access generic versions because of patent protection.
New ways to keep medicines affordable must thus be set in motion. Increased competition is the best way to do that. This can either happen through compulsory licences, by countries following Thailand's lead. Or it can happen without the need for confrontation and litigation, through a patent pool, such as the recent proposal by the drug purchasing facility UNITAID to establish a voluntary patent pool for HIV medicines for use in lower and middle income countries.
MSF calls on GSK to collaborate with the UNITAID and make relevant intellectual property available through a voluntary patent pool for AIDS medicines.
For press enquiries please contact Guillaume Bonnet, MSF Press Officer on +41 79 203 13 02
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