Linked Life Data

19702185

Source:http://linkedlifedata.com/resource/pubmed/id/19702185

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2009-8-25
pubmed:abstractText
Decisions such as KSR illustrate that Canadian firms and inventors do not operate within a purely local sphere, but rather are embedded within a complex domestic network of scientific, legal, regulatory, economic and political actors enfolded within a still larger global innovation ecology. It was reasoned that a system of this nature has many of the hallmark characteristics of an open and continually evolving complex adaptive system. A complex systems approach to innovation privileges the interrelationships among actors and institutions and their interdependence in maximizing system fitness--in this case innovation in the medical sciences and enhancing national productivity and prosperity. Of importance from a health law and policy perspective, a systems approach is conducive to accomplishing these goals in a manner that respects many of the fundamental distributive and egalitarian considerations embedded within the democratic state, common law, Rule of Law and entrenched human rights. That the goal of a robust complex adaptive system is not optimization but operational efficiency from the perspective of the whole, underscores the importance of maximizing social efficiencies and minimizing social inefficiencies. When drafting law and policy with the goal of respecting the characteristics of a complex system, it is therefore important to balance accommodation and cooperation with competition among system elements so as to maximize the flexibility and responsiveness of the system to changing conditions. As discussed in the context of pharmaceutical innovation, placing too much emphasis on controlling or regulating an inherently indeterminate and emergent system without paying sufficient attention to states of criticality and phase transitions can lead to inefficient behaviors of a system that contradict its stated policy objective. Over-regulation of innovation by excessive or narrowly circumscribed IPR rights may allow for escape of creative energy away from the desired policy goal towards less innovative, less resource heavy yet more constrained pathways that benefit discrete actors and institutions rather than the system. A highly constraining IPR rights regime not only has the potential to skew the benefits of innovation towards discrete modules (corporations, individuals), but also to skew function of the system more broadly by influencing the general pattern and scope of innovative activity by persons skilled in the art as well as the manner in which newly synthesized scientific knowledge is used by legal, regulatory, economic and political actors. The ironic result of this is that innovation can be stifled by the very policies meant to stimulate it. Indeed, in its leading patent jurisprudence, SCOTUS, from Hotchkiss through Graham and KSR, has maintained the position that the grant of patents for non-inventive products and processes inhibits rather than stimulates innovation and competition. There is some evidence to suggest that a conceptual model of innovation as a global systems ecology may have particular resonance for Canada, as well as other nations seeking to leverage their national S&T base in the medical sciences, in light of several signs signifying Canada is nearing a major phase transition in its system of public health. These include: (a) the CIHR moving from a system of medical research focused on accrual of new knowledge by university-based researchers to one which underscores the importance of translating knowledge into marketable products through public-private partnerships; (b) attempts by the CIHR and other national and provincial funding agencies to emulate the successes of the United States in commercializing university-based medical research through accumulation of IPR rights; (c) the TPD positioning Canada as one of the first jurisdictions in the world to transition from a regime of drug approval and regulation based on the precautionary principle to a corporate-based risk management style regime; (d) the move by Health Canada generally away from a traditional political "gatekeeper" role in protecting public health to a hybrid position where government is equally responsible for public health and ensuring a high return on investment on medical research; (e) the move by the Government of Canada towards both deregulation and regulatory harmony with other federal agencies funding medical research and regulating the products of that research; (f) the possibility of a two-tiered medical system following Chaoulli; and (g) the Government of Canada's avowed purpose in engaging in many of these activities to succeed not only domestically, but globally, in order to enhance national productivity and prosperity on the back of "leading edge" medical research. The observation in an array of natural, biological and technological complex adaptive systems that newer systems are more labile and uncertain than older established systems suggests a certain degree of prudence in ilishilig for such a large scale transition. Several considerations support a tote of caution, including the possibility that a large Iraction of the physical mci economic risks ol a new public health system wood be shifted away [mm govemnutent and corporatiorts and onto the pnhlic. and the willingness shown by the government to enter into public-private partnerships with increasing trequency over the development of policy, legislation and regulations pertaining to a variety ol public healilt issues. This is not to say the government should rely ott older back-loaded models ol policy development and regrmlation instead of newer organizational models. Rather, in order to grapple with partictmlarly "sticky' or wicked" policy problems. such considerations tmnderscore the neeti for just such novel models and therefore the need to thoroughly explore evolving conceptual and technological models of complex adaptive systems. By taking an approach that respects rather than avoids the complex nattire and inherent uncertainties of global innovation and product development, nations entering large-scale phase transitions related to medical research can avoid both the Ilaws inherent to organizational strategies based on deterministic, linear and ctinnstrained cnncepttmal models and the moral and physical dangers of their improper application in a ptmblic health context. One of the major leverage poimtts of complex adaptive systems. and other systems-based approaches, is the acceptance of tomtcertainty as an inherent. unavoidable and positive force, rather than something to be restrained and constrained at all costs. This has some fairly straight forward implications for innovation, in the medical sciences or otherwise. This is because the sine qua non of innovatmon is tnventitmrm, which is at heart a highly serendipitous process rather than one that can be qtmantified by narrowly circumscribed or measurable IPR rights-intensive S&T policies. This is particularly true where, as in the present imistance, the concepttmal models for obtaining, synthesizing and exulicatine new forms ot knowledge are themselves new and evolving.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
H
pubmed:status
MEDLINE
pubmed:issn
1192-8336
pubmed:author
pubmed:issnType
Print
pubmed:volume
15
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
247-94
pubmed:meshHeading
pubmed:year
2007
pubmed:articleTitle
KSR v. Teleflex. Part 2: Impact of U.S Supreme Court Patent Law on Canadian and global systems-based innovation ecologies.
pubmed:affiliation
Faculty of Law Health Law Institute, University of Alberta, Edmonton, Alberta.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't