Current Federal Law and Policy 
43 
searchers (nor is it clear that all of them will ever be available 
for widespread use.) Indeed, a point critical to understanding 
the current situation is that as of the autumn of 2003 only 
twelve lines are available for use,^^ while most of the other 
lines are not yet adequately characterized or developed (some 
exist only as frozen stocks) and so have at least not yet be- 
come available. The process of establishing a human embry- 
onic stem cell line, turning the originally extracted cells into 
stable cultured populations suitable for distribution to re- 
searchers, involves an often lengthy process of grov\rth, charac- 
terization, quality control and assurance, development, and 
distribution. In addition, the process of making lines available 
to federally funded researchers involves negotiating a contrac- 
tual agreement (a “materials transfer agreement”) with the 
companies or institutions owning the cell lines, establishing 
guidelines for payment, intellectual property rights over result- 
ing techniques or treatments, and other essential legal assur- 
ances between the provider and the recipient. 
The entire process — scientific and legal — has tended to 
take at least a year for each cell line. Thus, determining which 
of the 78 eligible lines are in sufficiently good condition, char- 
acterizing and developing those lines, and establishing the 
arrangements necessary to make them available has been a 
demanding task. By September of 2003, slightly over two years 
after the enactment of the funding policy, twelve of the eligible 
lines had become available to federally funded researchers.* 
The NIH has made available “infrastructure award” funds 
(totaling just over $6 million to date) to a number of the institu- 
tions that possess eligible cell-lines, to enable them to more 
quickly and effectively develop more lines to distribution qual- 
ity. As a result, while the number of available lines (only one in 
the summer of 2002 but risen to twelve in the autumn of 2003) 
is expected to continue to grow with time, it is unclear how 
many of the 78 lines will finally prove accessible and useful. 
According to the NIH, as of the autumn of 2003, the owners of 
these 12 available lines have distributed over 300 shipments of 
lines to researchers. No information is presently available on 
* Readers may keep abreast of the current number and availability of embry- 
onic stem cell lines eligible for funding at the NIH Stem Cell Registry web- 
site, stemcells.nih.gov 
PRE-PUBLICATION VERSION 
