Biomedical Engineering Reference
In-Depth Information
Herder, 2006). The patent was originally granted but resulted in an
unprecedented community reaction and was later challenged by a
consumer advocate organization on the grounds that the stem cell
technique should be freely available to the community (Plomer et al.,
2008; Murray, 2007). Ultimately the patent was upheld by the US
Patent and Trademark Office (USPTO) (Hayden, 2008).
By contrast, in the European Union, the main focus of the debate
about patenting stem cells revolved around the community's concerns
about the ethics of patenting biological life (Plomer et al., 2008;
Herder, 2006). Under Directive 98/44/EC 'On the Legal Protection of
Biotechnological Inventions', patenting living organisms, or anything
else deemed to be contrary to the moral order, was classified as an
illegal activity within the European Union (Plomer et al., 2008; Herder,
2006). A recent ruling in the European Court of Justice in Luxembourg
on a German patent case has reinforced this position (Connor, 2011).
Different regulations around the world regarding what is appropriate
to patent have somewhat complicated the role of patenting in the
commercialization of biotechnology (Caulfield, 2003).
3.2.6 Consumerprotection
Innovation systems also need to take into account the question of
consumer protection too. The US Food and Drug Administration is
the best known example of the relationship between government
policy and regulation designed for consumer protection. The core
principles that underpin the FDA were established in 1906 with the
passing of the Food and Drugs Act (Swann, 2009). This act was
prompted by concerns that impure drugs and contaminated food
were being misrepresented through advertising and sold to
unsuspecting consumers (Swann, 2009). A number of subsequent
regulatory reforms have culminated in the current shape of the FDA
as it is today (Swann, 2009).
Issuesaroundconsumerprotectioninrelationtonewbiotechnologies
came to the fore in the 1970s with the development of recombinant
DNA technology. A moratorium on certain procedures using
recombinant DNA was put in place in the US in 1974, and the
