Tag Archives: regulation

Morality in pharmaceutical regulation

29 Jan
There’s been a lot of questions recently about NICE’s approval procedures for new drugs. My own familiarity with the process is only related to the ethics committees’ role, so I wouldn’t try to offer any kind of solution- let’s face it theres going to be enough of those thrown out half-cocked in the coming months. What I do want to talk about, though, is the morals which underly the process, or at least that should. Normally, I’d rail against the idea that societal morality makes sense, but here, it really serves a purpose.

Moral criticisms often get thrown at big pharma, for reasons I don’t really need to go through here. The same can be said for the regulatory procedures governing what drugs make it to market, and who gets them. Things aren’t necessarily so simple as is often made out, though- it just doesn’t come down to blindly following rules and disregarding compassion, as so many commenters blithely shout. So, what I’m gonna do is attempt to demonstrate that while both policy and morality are essential for regulating pharmaceuticals, the latter is determinative of the fundamental nature of regulation; and that without morals it would be impossible to interpret standards set to maintain successful governance of the industry. Big talk, for sure.

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How can we govern new life forms?

12 Nov

Synthetic biology’ is an emergent scientific field with enormous potential for development and technological advancement. However, it also carries an equal capacity for risk and for harmful results to derive from the advancement of the science. Consequently, it is widely recognised in academic papers, political documents, and public discourse as requiring regulation on national and global levels, on both an ethical plane and as a safeguard.

Synthetic biology as a realised or projected field of research has existed for at least a hundred years.[ii] Today, we could attempt to define the science as “focus[sing] on the design and synthesis of artificial genes and complete biological systems, and on changing existing organisms, aimed at acquiring useful functions.”[iii] The advent of the technologies of DNA sequencing in the latter part of the 20th century and more recently of DNA synthesis[iv] have thrown the field into the spotlight as a major and realistic growth area, and have highlighted the absence of a cohesive regulatory methodology to unite the various disciplines involved.[v] Also noted to be absent is an intellectual property model pertaining to organisms or technologies arising from the field.[vi] Continue reading