advances in biological and medical research and their translation into diagnostic , prognostic and therapeutic tools are relying increasingly on partnerships between the academic ( government and university ) and industrial ( biotechnology , pharmacy and technology ) sectors , with essential participation and support from patient organizations and charities . despite these concerted efforts and the promises of genomics and systems biology , over the past two decades
the cost of research and development has continuously escalated , while the number of truly novel drugs coming to market has constantly declined . to a large extent , this has been addressed in the private sector through mergers and outsourcing , with downsizing of the research and development workforce .
these trends can not be sustained further as they threaten the economic viability of the healthcare system worldwide . at a time of a global crisis , it is crucial to identify how we can overcome these hurdles .
i argue here that we should look again at how knowledge can be shared between all the stakeholders , redefining the frontier between what can be the subject matter of valuable intellectual property rights and what is the basic knowledge that should be made freely available to all .
it was hotly debated at the beginning of the human genome project ( hgp ) , and for its entire duration in relation to competition between the public and private sectors .
i suggested early on that the nucleic acid sequences collected on a genome scale should be considered as elements of description insufficient to warrant property rights by themselves in the absence of a genuine invention and should thus be placed in the public domain .
a similar attitude was taken by the participants of the hgp in 1996 , as expressed in the ' bermuda rules ' , with the result that the openly accessible reference human genome sequence is now the common basis for current research .
these proposals contributed to the ' universal declaration on the human genome and human rights ' adopted by the united nations and its educational , scientific and cultural organization ( unesco ) in 1997 - 1998 , which stated about the human genome : " in a symbolic sense , it is the heritage of humanity " , and " the human genome in its natural state shall not give rise to financial gains . "
the issue was , and remains to a large extent , how best to balance general and particular interests to sustain basic research while promoting efficient healthcare product development .
this has been discussed extensively on ethical , legal and social grounds , and the counterproductive underuse of scarce resources when they are protected by excessive intellectual property rights ( the tragedy of the ' anticommons ' ) has been pointed out ; these discussions have led to proposals to establish patent pools to facilitate development of diagnostic tests .
the recent advent and rapid development of new generations of very - high - throughput dna sequencing methods makes it now possible to foresee that in the next few years the sequencing and assembly of thousands of human genomes ( and transcriptomes ) will be achievable at a cost of $ 1,000 each or less , which is a projected decrease of almost a million - fold in less than ten years . without the availability of the reference sequence ,
run delivering information on the scale of the entire genbank , it is clear that data quality assessment and analysis are becoming the limiting steps , beyond the capability of single individuals or groups .
similar trends can be anticipated for proteins and metabolites when reference proteomes and metabolomes also become available in the coming years .
public electronic repositories for these large - scale datasets , together with standards and open access publications for their description , have been important developments in the past decade for ensuring that they become available for further studies .
however , despite requirements by prominent journals and funding agencies for submission of primary data as a condition for publication and financial support , recent surveys indicate variable compliance with these rules in both academia and industry .
there is clearly room for significant improvements in this area if researchers are to take the best advantage of the large datasets produced .
the same issues of data quality and availability are becoming prominent in the assembly of ever - increasing patient cohorts for the purpose of clinical trials and genome - wide genetic association studies , now often reaching tens of thousand of samples .
great efforts have been made , initially in developed countries , to establish standards of good practice for informed consent , clinical trial registration and sample collection and storage in biobanks , and these are now being enforced in newly industrialized countries such as china and india .
although these are welcome developments , much also remains to be done to ensure that these essential resources are used to the best advantage of the patients themselves , and to use genomics and bioinformatics to sustain the development of systems biology and medicine .
the issues are many and complex , given the sensitive status of human material with respect to legal rules and practices that can vary substantially from country to country .
international harmonization of health regulations and intellectual property rights is ongoing ; this is necessary but insufficient to overcome the major bottlenecks in the development of healthcare products , and it will take time to mature and adapt to the rapid pace of technology development .
all stakeholders should work together to identify topics and areas in which joint actions would improve the situation significantly in the short term .
i would like to suggest that one such topic is the status and availability of large amounts of underexploited experimental and clinical data in public and private laboratories .
in many cases , these existing databases have been developed for a specific purpose , with a focus on a small number of biological elements . with the shift from targeted to global analyses ,
most of the data collected are not exploited at all , although they could be relevant in another context .
it must be recognized that the high potential value of these datasets relies to a large extent on the quality of the biological and clinical annotations , which becomes significant only if the experimental data are properly collected and described .
when that is the case , the added value will come from provision of the combined data for further analysis by other experts addressing related and complementary questions . recognizing this as a topic for sharing of knowledge between academic and industrial partners and establishing data warehouses with agreed open access rules would be a significant step in this direction .
 to help overcome the bottlenecks that limit the development of diagnostic and therapeutic products , academic and industrial researchers , patient organizations and charities , and regulatory and funding institutions should redefine the basis for sharing the knowledge collected in large - scale clinical and experimental studies . 