Biomedical Engineering Reference
In-Depth Information
addressed. It could be argued that hESC research will be a long-term
goal of twenty-first-century biomedicine. Continuing debate over
ethical quandaries regarding the use of embryos in research, the use
of public funding for hESC research, how hESC research should be
regulated and the patentability of stem cell applications are key
factors that will shape the future of the field.
While the early days of hESC research were marked by widespread
public discussion of the ethical issues associated with the use of human
embryos in research, should the current clinical trials prove successful
it might be anticipated that these concerns will lesson in their impact
on the field. The blastomere method of deriving stem cells from
early-stage human embryos developed and patented by Advanced Cell
Technology is another potential means of resolving the impasse over
the links between human embryos and abortion politics. Likewise, to
be discussed in more detail in the next chapter, the use of induced
pluripotent stem cells is thought to be the most obvious option for
overcoming the ethical barriers to the progress of stem cell research.
Ongoing patent disputes are increasingly being resolved, but at
much time and cost to the parties involved in litigation. As the trials
developed by Geron and Advanced Cell Technology demonstrate,
patent protection is the core commercial strategy shaping current
developments in the field. Without adequate patent protection, it
might be argued, the incentive for developing any new product,
taking it through closely scrutinized clinical trials and negotiating all
the regulatory hurdles that accompany this process would hardly be
justified. Concerns about broad patent applications and the creation
of patent thickets in the industry are potential hurdles to competitors
looking to enter the market, but they will allow early developers
significant market protection and incentive for developing new
products.
The gradual shifts in regulatory arrangements governing the
conduct of hESC research worldwide could ultimately lead to the
destigmatization and decriminalization of research involving human
embryos, resulting in more projects being developed, more funding
being channelled into hESC research and more young scientists
entering into careers in this area. Uneven regulatory arrangements
around the world, however, have not only created high levels of
