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.
George J. Annas, Worst Case Bioethics: Death, Disaster and Public Health, Oxford University Press, 2011, Paperback, 335 pp., £27.50 r.r.p.
In Worst Case Bioethics, George Annas- a respected and well-known professor in health care, human rights and bioethics at Boston University- gives a broad account of the manner in which US public health policy has been and continues to be shaped over time by national responses to doomsday or worst-case scenarios, both real and posited. In doing so he aims to illustrate the manner in which ethically questionable practices and controversial decisions have been excused politically as defences against these often sensationalised eventualities. He also frames his discussion in the context of the American public’s fear of death as a concept, and their apparent unwillingness to accept it as an inexorable eventuality. Continue reading
‘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
If we are autonomous as people, then it follows that we’re going to make what we consider to be ‘good decisions’. We’re going to make those about our daily lives, our actions, and our healthcare. But does a good decision always have to be a rational one?A good decision is the making of a value judgement- the Oxford English Dictionary defines a value judgement to be “an assessment of something as good or bad in terms of one’s standards or priorities”. It stands to reason that the inherent goodness of something can only be judged subjectively, reliant upon what the evaluator considers goodness to be. I would posit that any collective or societal understanding of goodness must be based in generally accepted social mores and principles of behaviour (yeah, it’s one of those posts). For instance, in a medical and health science environment I think I’m safe in suggesting that it would be considered ‘good’, or at least desirable, to follow the principle of beneficence and to work in favour of restoring or improving a patient’s health (unless it has been determined that this is contra to the patient’s best interests, but that’s a very different discussion). However, where you are making a decision for yourself, the subjective nature of goodness dictates that you can only make a truly good decision within your own self-perceived parameters- which is where the concept of rationality becomes vitally important to the equation. Continue reading
The idea that there is a right to refuse to know relevant genetic information about ourselves is one which appears to be broadly recognised in law. The Council of Europe’s Oviedo Convention states that:
“Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.”1
However, I would question whether this is consistent with the principle of autonomy. Given the growing relevance of the field, let’s focus on the idea of genetic information in predictive medicine.
First off, we’re going to need to explore what the concepts at hand actually mean in context.