[Ip-health] Open-source model for drug discovery?

[Adrienne.MacDONALD@geneva.msf.org]

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http://economictimes.indiatimes.com/articleshow/msid-2651121,prtpage-1.cms=
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Open-Source Model for Drug Discovery?=0D
The Economic Times, India=0D
26 Dec, 2007, 0338 hrs IST=0D
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 It can help spur basic research on diseases=0D
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 J Chigurupati=0D
 CEO, Zenotech Laboratories=0D
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 Conventional wisdom states that drug development cannot be an open source=
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 activity since no pharma company would invest in drug R&D if competitors=
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 can gain access to the proprietary information generated by the innovator.=
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 But with drug discovery and biotechnology increasingly becoming an=0D
 information science, open source projects have sprung up as the model of=
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 choice for large-scale research enterprises like the Human Genome project=
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 and the Medicines for Malaria Venture. Both projects had significant=0D
 public funding.=0D
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 The idea of doing distributed research by bringing people from diverse=0D
 backgrounds together is appealing. Costs and risks are shared resulting in=
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 increased speed and creativity. It is like immensely expanding the=0D
 employee strength of the research staff in a company, an option that=E2=80=
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 hard to come by for pharmaceutical companies in developing countries.=0D
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 Managing the open source model and defining the scope of the project is=0D
 essential to successful collaboration between academia and industry.=0D
 Focusing on basic research about disease mechanisms and targets for=0D
 diseases that affect the developing world in the open source model will=0D
 enable pharma companies to partner and conduct applied and proprietary=0D
 research for specific drug candidates and for specific diagnostic tools.=
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 In India, several projects involving development of databases of the=0D
 Indian population with respect to their genetic predispositions for=0D
 hypertension, diabetes, cancer or other ailments can be an open source=0D
 project activity. From this databank, if certain diagnostic agents or=0D
 therapeutic candidates are developed for treating Indians using the=0D
 pharmacogenomic approach, it has to be clearly outside the realms of=0D
 open-source and within the confines of proprietary space.=0D
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 Open source approach can provide valuable information at an R&D stage and=
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 the pharmaceutical industry could focus on applied research.=0D
 Pharmaceuticals, unlike software research, are highly regulated. Good=0D
 laboratory and clinical practices are essential for regulatory approval=0D
 and that is a forte of pharmaceutical companies. Significant public=0D
 funding along with the ability for private enterprise to benefit from the=
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 open source approach will result in a strong public-private partnership=0D
 and ensure success of the open source approach.=0D
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 Strong patent protection is harming science=0D
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 Amit Sen Gupta=0D
 General Secretary, AIPSN (All India Peoples Science Network)=0D
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 In 1995 the TRIPS agreement introduced a uniform and higher level of=0D
 patent protection across the globe. The promise that this would lead to=0D
 higher levels of innovation remains a mirage. Globally, the number of new=
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 chemical entities (NCEs) have progressively gone down over the past=0D
 decade. Further, of NCEs approved for marketing, a very small fraction,=0D
 less than 3%, constitute a significant advance over prevailing therapies.=
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 A majority of new products address needs of the wealthy populations in the=
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 global North, while the disease burden is largely in the global South.=0D
 While the industry researches drugs for lifestyle conditions of the=0D
 affluent =E2=80=94 obesity, erectile dysfunction, baldness, etc., =E2=80=
=94 conditions=0D
 like TB, kala azar, sleeping sickness, have to make do with decade-old=0D
 therapies.=0D
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 Clearly, the IPR-based model for innovation is just not working. Strong IP=
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 protection is encouraging protectionism and is harming the way science is=
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 done. Many more patents are taken out to stop others from working than to=
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 protect one=E2=80=99s own research. It is premised on very high costs of=
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 development, that are sought to be recovered through high monopoly pricing=
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 of products.=0D
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 An open-source model to promote innovation is not new and is used=0D
 extensively in the software sector. It organises research around=0D
 researchers across the globe, who draw from a pooled source of information=
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 to which they contribute, and to which they pledge to plough back the new=
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 developments that accrue.=0D
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 Such a model can identify new candidates at a fraction of the cost that=0D
 big pharma claims to spend. It has been argued that the major cost in drug=
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 development relates to clinical trials that need to satisfy drug=0D
 regulatory agencies. Today, big pharma outsources clinical trials to a=0D
 dispersed set of contract research organisations.=0D
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 A collaborative open-source model could use the same route, with the=0D
 difference that the entire endeavour =E2=80=94 from selection of promising=
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 candidates to marketing approval =E2=80=94 is organised and overseen by a=
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 publicly-funded entity or group that promises to place such research in=0D
 the public domain, without insisting on patent monopolies. It is an idea=
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 whose time has come and which has the potential to revolutionise the way=
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 research is done.=0D
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