Biomedical Engineering Reference
In-Depth Information
innovation process and stimulate the development of therapies for
rare diseases which few people suffer (Amo et al., 1995). In situations
where the potential market is considered too small, too risky because
of the patient populations (for example, children) or will show little
return to justify investment in drug development, under the Orphan
Drug Act, pharmaceutical companies are offered a range of incentives
from the government to overcome these barriers to research and
development (Amo et al., 1995). Incentives include tax breaks,
research grants, direct subsidies and exclusive licensing agreements
(Amo et al., 1995). In some circumstances, the Orphan Drug Act has
been a major boon for stimulating drug development for conditions
largely seen to be unprofitable, yet questions have also been raised
about the pricing of these drugs and the attendant equity issues
associated with expensive drugs (Amo et al., 1995).
The question of where to strike a balance between research
outcomes that will have equitable outcomes for individuals around
the world versus generating a maximum profit is an ongoing one that
is the subject of much debate. While such a topic is a serious concern
for healthcare worldwide, the scope of this topic is too limited to do
it justice properly. The key point that readers might like to bear in
mind though is that estimating the numbers of potential patients that
might use stem cell derived technologies is a core issue for the
commercial prospects of any stem cell application. Given this,
obtaining US Orphan Drug designation for a new product is a
significant motivator for companies bringing new therapies to market.
Yet operating at the interstices between research funding
programmes, traditional pharmaceutical innovation and legislative
incentives like the US Orphan Drug Act is demand from the
community. Patient activists, medical tourists and other 'early
adopters' (Rogers, 1962) of new health biotechnologies have played
a significant role in the current shape of the emerging market for
stem cell therapies. Different individuals and groups have demonstrated
how the expectations (Brown and Michael, 2006) of new
biotechnologies create momentum for the future development of new
markets. Applying what has been called a 'biomedical imagination'
(Waldby, 2006), consumers have created a space where stem cell
therapies are able to move from basic research into applications.
