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Drug patent plan gets mixed reviews

GlaxoSmithKline's bid to tackle neglected diseases receives a muted response from the rest of the industry.

Proposals to radically change the way the drug industry approaches neglected tropical diseases have prompted intense debate within the sector.

Making plans: Andrew Witty. Credit: T. Melville/Reuters

Andrew Witty, chief executive of GlaxoSmithKline (GSK), outlined the suggestions in a speech on 13 February at Harvard Medical School in Boston, Massachusetts. He committed GSK — the world's second-largest pharmaceutical company by sales — to sharing some of its patents to boost research into neglected diseases, and to making its drugs available more cheaply in the very poorest countries.

He also offered to open up GSK's research centre for neglected diseases at Tres Cantos in Spain to other researchers, companies and governments. The aim would be to foster a global public–private network to supplant the present fragmented research efforts on the most neglected diseases, such as sleeping sickness, visceral leishmaniasis and dengue fever.

Reactions from scientists and public-health experts have ranged from wildly enthusiastic to deeply sceptical. But it is undoubtedly a pioneering move, particularly for a firm that just a decade ago joined 38 other drug companies in suing the South African government to try to stop it making cheap anti-HIV drugs.

"That was the low-water mark for multinationals and global health," says Peter Singer, an expert in public health at the University of Toronto in Canada. "This announcement may not yet be the high-water mark, but it is incontrovertible evidence that the tide has turned. It sends a clear signal that GSK wants to be part of the solution and not part of the problem."

The most innovative aspect of GSK's proposal is the creation of a 'patent pool' for drugs and manufacturing processes related to neglected tropical diseases. Researchers and companies, including manufacturers of generic drugs, would be able to license participants' patents from the pool for free to develop new treatments for neglected diseases in the world's 50 least-developed countries (LDCs).

"A patent pool giving access to molecule libraries and information from different groups is something we have been asking for for years," says Bernard Pécoul, head of the Drugs for Neglected Diseases Initiative based in Geneva, Switzerland. But its success depends on what companies are willing to put in, he adds. "If they put garbage in, we will get garbage out."

Although the pool would be oriented towards drug discovery, it could also provide access to promising drug candidates, existing drugs and formulation technologies for commercialization.

"It's a fantastic step forward," says Mary Moran, director of health policy at the George Institute for International Health in Sydney, Australia. Drug companies usually fight to defend their patent portfolios, she says, refusing to allow their free use for good causes such as tackling neglected diseases. As the patents in this sector have little monetary value, this amounts to "two bald men fighting over a comb", she observes wryly.

Industrial unease

But several other drug companies contacted by Nature were lukewarm about the idea. French firm Sanofi-aventis says that the proposals are "too vague" to comment on, and Swiss-based Novartis "does not consider intellectual property as an obstacle to access to medicines", according to company representatives.

In principle, Bayer in Germany is not against the idea of pooling intellectual property, says the company's spokeswoman, Denise Renn­mann. But it would prefer an industry-wide approach to be agreed multilaterally, she adds — something that the World Health Organization and the International Federation of Pharmaceutical Manufacturers are already discussing. Many companies highlighted their own efforts to improve access to drugs for neglected diseases (see 'Opening access').

The patent-pool proposal has also sparked controversy because it excludes GSK's HIV patents, as the company feels that there is already enough research in this area. That is hotly contested by Michelle Childs, director of policy and advocacy at Médecins Sans Frontières' Campaign for Access to Essential Medicines, who says that there is still a great need for new antiretroviral combinations and formulations for children.

However, GSK's HIV patents could yet dive into a different pool. UNITAID, an international organization that negotiates lower drug prices, hopes to launch a patent pool by the end of this year that would allow companies to license their AIDS drugs in return for royalties. Ellen 't Hoen, UNITAID's senior adviser on intellectual property, says that although no companies have yet signed up, several have expressed interest, including GSK.

There is a sound incentive for companies to join such patent pools. Countries with large populations of sick patients are increasingly likely to use their rights under TRIPS, the World Trade Organization's intellectual-property agreement, to issue compulsory licences, allowing them to produce generic copies of patented drugs at low royalties.

Western drug companies fret that such licences could limit their opportunities in what they see as their biggest future growth markets: the well-off elites in emerging economies such as India, China or Brazil. Preserving these markets may explain why GSK has limited its proposals to the LDCs, says Brook Baker, an expert on health and human rights at Northeastern University in Boston.

Witty also announced that GSK would cut the prices of all its medicines in the LDCs to no more than 25% of their prices in the richest countries. But the focus on the LDCs means that these cuts, and the patent pool, will not benefit the vast number of poverty-stricken people living in middle-income countries, says Baker. According to the World Bank, more people live on less than $2 per day in India than in all of sub-Saharan Africa.

Despite the cuts, GSK's drugs will still be unaffordable to most poor people, he adds. And if generic producers can only use the patent pool to produce drugs for the LDCs, they will not be able to get the economies of scale they need to sell drugs cheaply enough.

"When Glaxo and others announced at the start of the decade that they would cut the cost of HIV drugs by 70%, initially we thought 'this is a big deal'," says Childs. "But they were still unaffordable. It was only when generic manufactures brought prices down 99% that we saw wide access to drugs."

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Additional reporting by Natasha Gilbert

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Related external links

MSF Campaign for Access to Essential Medicines

MSF on patent pools

Drugs for Neglected Diseases Initiative

GSK Access to Medicines site

Institute for OneWorld Health

UNITAID

Knowledge Ecology International

UN Least Developed Countries

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Butler, D. Drug patent plan gets mixed reviews. Nature 457, 1064–1065 (2009). https://doi.org/10.1038/4571064a

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