Tissue Engineering

Prepublication version.
See Science as Culture 2008, 17(2) for published article
Tissue-engineered technologies: scientific biomedicine,

frames of risk and regulatory regime-building in Europe
Authors:
Dr Alex Faulkner, Cardiff University, UK
Dr Ingrid Geesink, Cardiff University, UK
Professor Julie Kent, University of West of England, UK
Dr David FitzPatrick, University College Dublin, Ireland
keywords:
tissue engineering; risk; regulatory regime; jurisdiction; technological zone; European
Union
Address for correspondence:
Alex Faulkner
Tel
+44 (0)29 20 874 739
E-mail FaulknerAC@cardiff.ac.uk
Prepublication version. See Science as Culture 2008, 17(2) for published article
Abstract
Tissue engineering is one potential arm of the much-heralded regenerative medicine.
We use the concepts of technological zone, risk framing and regulatory jurisdiction to
analyse what risks are formulated in the zone of tissue engineering and whether
those risks are reflected in emerging regulatory policy in Europe. In the regulatory
jurisdictions of the European Union, public health risks have become increasingly
important. Tissue engineering challenges pre-existing regulatory frameworks.
Scientific-industrial actors formulate the risks of tissue engineering in three primary
frames: technological safety risk; therapeutic efficacy risk, and economic risk. Study
of the prevailing configuration of European Commission institutions and the EU
process of regulatory regime-building for tissue engineering, shows that risk frames
are mobilised selectively. Whilst the technological safety frame and the economic
frame are strongly mobilised, therapeutic efficacy especially comparative efficacy
is not. Additionally the regime avoids any Europe-level position on the so-called
ethics of sourcing and engineering tissues and cells. Efficacy and ethics are defined
as the jurisdiction of national authorities, underpinned by the subsidiarity principle.
Outcomes include the likely banning of certain therapeutic technologies by European
countries that have objections to products deriving from controversial materials and
processes, and the prevention of adoption of products due to efficacy concerns, so
creating new imbalances in the European therapeutic marketplace. Consequently,
the tissue engineered medical products that European societies consume, at least in
the near term, will reflect medically-defined needs of the European population to a
limited and patchy extent.
Introduction
Innovation in medicine is one site of the increased awareness of risk amongst many
sectors of society. Human tissues and cells have been used in transplantation
medicine for many decades, but now there is an increasing global trade and
commercialisation in human tissues and cells, organs and body parts. They are
becoming used in innovative ways as part of the new development of tissue
engineering (TE), aimed at producing medical treatments that typically combine
manufactured biomaterials with viable human tissue and cells.1 Commentators
predict a massive growth in 'regenerative medicine' over the next three decades.
Some TE products using viable human cells are already used in healthcare. These
are mainly skin systems for burns and chronic ulcers, cartilage regeneration for knee
joints, and bone repair. Many further applications are under research and
development.2 Scientists and developers regard tissue engineering as technically
challenging rather than scientifically complex, it does not have obvious defining
features that can be grasped and construed in the public domain. Unlike some other
areas of biotechnology, the existing healthcare applications of TE are relatively
uncontroversial in the public sphere.
The transplantation of human tissues and cells, and engineered therapies using
them, are important and strongly expanding fields of medicine in the view of the
European Commission. These technologies, apart from giving rise to issues of public
health risk and ethical concerns amongst the public, also evoke other sorts of
concerns for governments of advanced industrial societies such as their contribution
to national economies and to healthcare services of the future. Availability of the
existing products in different European countries is very patchy due partly to variation
in national regulatory approaches.
Pharmaceuticals and more recently medical devices have been under EU regulatory
regimes for some time, and now policymakers attention has turned to focus on the
circulation in the European marketplace of human tissues and cells for therapeutic
use. Currently, a myriad of different national legislations applies to TE products,
ranging from medical device, medicinal product and biologics regulations to
unregulated general consumer protection and voluntary codes of practice, where the
lack of unified procedures amounts to a regulatory patchwork (Faulkner et al., 2003).
The existing European-level regulatory regimes are seen by regulators and industry
actors to be challenged by the novel and hybrid character of the material technology
itself and by uncertainties of organisational models and resourcing of the sector.
Stakeholders representing science and industry have thus been active in promoting a
need for new regulation to support the development of the technologies of tissue
engineering and their potential markets. Investment in EU markets3 is perceived by
industry as limited by this absence of clear regulatory controls. As in other sectors,
industrial representatives argue for global harmonisation of regulatory standards. It
has been suggested that in the absence of agreed regulatory controls for TE,
populations in Europe may be denied potential benefits of emerging technology. The
European Union has thus embarked upon a number of regulatory actions in this field.
The political reaction to crises such as BSE and HIV blood contamination suggests
that the European Union is experiencing a shift towards more risk averse and more
stringent regulatory policies in many fields. The domain of public health and safety
has become an important arena for regulatory decision-making for the European
Union. In such an environment, it is important to understand the different framings of
risk in relation to new technologies, the range of stakeholders and viewpoints that
these may represent or exclude, and the pattern and significance of their linkages to
policy as mobilised in regulatory regimes. In this paper, therefore, we ask the
following questions about tissue engineering: How do scientific-industrial actors

elaborate discourses of risk? How are these discourses overlapping or conflicting?
How do those framings relate to recent developments towards a European regulatory
regime for tissue engineering? We identify three primary framings of risk in scientificindustrial actors discourse, and will illustrate how only two of these are strongly
embedded in the organising principles of the emerging regulatory regime.
The paper proceeds with an outline of our conceptual approach, followed by a
detailed analysis of the constructions of risk amongst scientific-industrial actors
involved in TE technologies, illustrated from empirical research. It then moves to a
discussion of the extent to which these constructions of risk are represented in the
emerging configuration of new EU-level regime-building that is shaping human
tissues and TE as regulatable jurisdictions in Europe.
Risk and risk framing in technological zones

Concepts
In order to address the question of how scientific-industrial constituencies construct
tissue engineering as a field in which certain risks are foregrounded, and to assess
the concomitant development of a regulatory regime for the field in the European
Union, we will draw upon theory of the social construction and framing of risk, and
concepts of technological zone and regulatory jurisdiction. These are introduced
below, before we go on to outline and present our empirical case study.
The mushrooming of risk as a pervasive societal experience, and dominant ordering
principle (Stirling et al., 1999, p. 4) is complemented by particular public concerns
with risks to human health. In medical sociology, the generalised anxiety associated
with major collective hazards, it has been argued, leads to a need to develop
improved understandings of how risks are framed and legitimated by scientists and
other social actors (Gabe, 1995, p. 11). Scientists framings of risk, of course, may
not coincide with those promoted by other constituencies.
Framing may be accomplished and contested variously by different social actors or
stakeholders. It is a dynamic feature also of regulatory policy making which makes
issues meaningful in particular ways in governmental activity, leading to pathways of
policy decision-making that mediate societies experience of risks. The notion of
framing offers valuable scope for interpretive analysis of the ways in which policy is
made, and has been used profitably in recent study of the shaping of biotechnology
policy (Jones & Salter, 2003; Jasanoff, 2005). The crucial value of framing as an
analytic tool is that it enables us to see how society and its agents select certain
aspects of an issue for attention and neglect or downplay others. Thus we should
expect to find that different societal groupings differ in their framing of risks (Vaughan
and Seifert, 1992). Conflicting framings of risk may be associated with particular
social constituencies, for example sheep farmers as opposed to a government
department of agriculture (Wynne, 1996); they may concern the evaluative criteria for
appraisal of an issue in terms of its social implications, e.g. commerce or equitable
distribution, gain or loss (Vaughan and Seifert, 1992); or they may primarily concern
the definition of the population that is deemed at risk, for example animal health as
opposed to human health in the case of BSE (Miller, 1999). Perceived salience of
risks is variable and open to alternative constructions of the degree of threat
(Horlick-Jones, 1998, p. 80), as well as its target. A study of risk framing thus
requires us to attend to the actors proposing certain frames, to the social or material
objects that are framed in discursive work, and to the substantial, meaningful
characteristics that are attributed in such framings.
Here, we discuss the framing of risks as occurring in the context of, and as
constituting part of, a potentially emergent technological zone (Barry, 2001) of tissue
engineering. A technological zone is defined by the linked circulation of materials,
knowledge, standards, property and people rather than by given geographical,
political or institutional boundaries Barry gives high energy physics as an example
where activity is both highly concentrated institutionally and highly dispersed
geographically. Whilst we do not attempt a detailed exploration or critique of the
concept here, we adopt it as loosely applicable to tissue engineering, in preference
to, for example, industrial sector which has connotations of multiple technologies,
stable institutional interdependencies and rules of engagement, and product-based
classifications (cf. Malerba, 2004). These connotations are inappropriate in the case
of the emergent and unstable set of activities and actors known as tissue
engineering. Given the well-known analyses of technology in the sociology of
technology and science & technology studies, we take it as read here that a
technological zone is to be understood, broadly, as a sociotechnical phenomenon.
Amongst the participants and would-be participants in a TE technological zone, riskframing takes place in interaction with controversy-strewn discourses of how the
possible rules of engagement in the zone should be constructed, in other words in
interaction with discourses of regulatory regime-building and regulatory policy. An
anthropological theory of science has analysed uncertainties of risk assessment and
risk management strategies in terms of competing groups attempts to establish
authority over regulatory jurisdictions (Hogle, 2002). Regulatory policy indeed can
shape the scope of what products and processes society will recognise as tissue
engineering and which it will not, and what types of institution will legitimately
participate on what terms. An examination of regulatory regime-building can reveal
the types of risks that public policymaking selects and constructs as salient and the
jurisdictions that are construed as regulatable. In such an approach, different
participating actors (stakeholders) constructions of risk become implicated in a
political process of constructing regulation, which we understand here as not only a
safeguarding process, but also an enabling one. In the case of TE, such participating
actors include scientists and engineers, regulators, trade associations and
companies, national governments, EU committees, patient groups, and medical
professionals, amongst others. Regulatory regimes can shape the technologies that
will reach us as patients in the future, and they must therefore embody a vision of
societal benefit. However, like other governance institutions, the European Union
must contend with alternative and possibly competing visions of the social good.
Established jurisdictions such as enterprise, public health, medical device, tissue
bank and pharmaceuticals, as well as a variety of national government institutional
interests, may be threatened by ambiguous technologies such as tissue engineering.
Case study
The paper uses documentary and interview data from research that investigated
relations between industry, regulators, policy makers, scientists, clinicians and
consumers in the EU and in the UK specifically. Between 2002 and 2004 the authors
conducted over 60 in-depth semi-structured interviews with strategically-placed
informants, mostly face to face and some over the phone. We attended many
international conferences in Europe where the science and industry of TE was
discussed and presented by its practitioners, and where regulatory issues were often
debated alongside scientific and commercial issues. Tracking of ongoing regulatory
developments continues via further interviews and documentary analysis. The
discussion illustrates the discourse of members of what we can regard as a looseknit issue network (Rhodes, 1997). Some participants in the network can also be
considered more integral members of a diverse but closer-knit policy-shaping
community. Our focus is, therefore, loosely speaking, the scientific-industrial R&D
community.4 These actors are positioned in the heart of contemporary medical
technological innovation, characterised by close relationships and transactions
between the academic and commercial scientific worlds of biomedicine.
We now turn to the primary empirical focus of this paper, framings of risk analysed
through a detailed consideration of the discursive formulation of TE risk amongst
networks of scientific and industry-based actors who are engaged in the building of a
new zone for tissue-engineered technology in Europe.
Frames of TE risk in a biomedical scientific-industrial network
Uncertainty
The potential risks of tissue engineering technology, and ways to manage or control
these risks, have been the subject of extensive debate in policy-oriented technical
and industrial expert networks in Europe (e.g. Wassenaar et al., 2001; Williams,
2001; EUCOMED, 2003).
The risks might be that it fails, that it doesnt work, safety, disease transfer,
cancer you never know.
(M-EU4, European manufacturer, interview 2003)
Technical uncertainty, as in the quotation above, is highlighted in the framing of TE
risk. It applies to various aspects of the technology such as the understanding of
cells action in the body, and includes unknowable risks, as illustrated by several
participants:
Dealing with biological materials is always much more complicated and
unpredictable than dealing with the types of materials that engineers deal
with.Batch control is difficult itll be a long, long time before you get to
know everything about even fairly purified biological materials.
The type of dangers that they expect, with manipulating cells, you never
know. Cells that you put in the skin and they end up in the kidney for
example... thats also what you see that regulators are afraid of, what
happens with the cells when you put them in a media it might get some kind
of cancer cell afterwards.
I would have no qualms about using tissue engineering myself as a patient
but in three, four years time if youve been a recipient of a tissue engineered
product and a new test comes out which is more accurate, more sensitive to
the material or contaminants that could be in that product then the risk
benefit changes as you go along.
Indeed the innovative material technology of TE and the status of living implanted
tissue is associated with an emergence of new forms of evidence (Hogle, 2005). For
example, it has been argued that animal models have only limited clinical validity for
TE (Tienhoven et al., 2001). Donated cells or tissue can lead to risk of bio-
incompatibility. These TE manufacturers point to risks concerned with safety, the

safety risks of viable biological or cell-based therapies being inherently more complex
than engineering with inert materials, but also show some sign of confidence in an
ability to develop acceptable forms of evidence with which to control risks. This trust
in the ability to develop tests for technological risks is strongly stated by a
representative of one of the trade associations, also emphasizing the link between
risk assessment and new regulation:
... the correct way to do this is to take each product, according to its intended
purpose and intended performance and what its indication is, and then use a
systematic risk management process to identify all the risks, all the hazards.
The number of different types of risks... differ from one product to another,
depending on the degree of manipulation, the degree of handling, what type
of advanced material it may be associated with, with what types of uses put in
the patient. We can see no other way of dealing with this other than to base a
regulation on a risk management type approach.
There is thus some ambivalence within the TE community about the difficulty of
assessing risks of TE technologies. This appears to co-exist with a measure of
confidence, and trust in testing regimes in principle. Aside from this issue of
uncertainty, the TE network identified a number of different substantive aspects of TE
work by which they framed its perceived risks. These are explored below.
Framing TE risk as technological safety risk? Two formulations

TEs scientific practitioners typically distinguish between two main models of tissue
engineering technologies. Autologous applications are those where a patients own
cells are removed, processed (cultured) and re-implanted in the body; allogeneic
products are those where cells or tissues are harvested from another human donor
or donors, may be stored in a tissue bank or as a cultured cell line, and can form the
basis of off-the-shelf products. Both autologous and allogeneic products may be
combined with manufactured biomaterials to form a combination technology. Whilst
R&D in the USA focuses on both types of application, possibly with a bias toward
allogeneic products, in Europe the R&D effort focuses primarily upon autologous,
patient-customised applications (McIntire et al., 2002; Hsing et al., 2003). This
distinction figures large in these actors framings of risk of TE technologies, as we will
see in the analysis below. Underlying the description of these therapies as
technologies, though not a focus of this paper, is the commodity status of human
tissues and cells. This has evolved through recent developments in intellectual
property and the recognition by regulatory agencies internationally of human
materials as commercializable medical therapies.
Self-contained TE risk?
An example of an autologous technology is Carticel, manufactured by Genzyme
Tissue Repair (now Genzyme Biosurgery: www.genzymebiosurgery.com). It employs
a commercial process to expand a patient's own cartilage cells for re-implantation
usually into damaged articular knee cartilage. Extracted cells are grown in culture; a
growth medium consisting of various nutrients to mimic in vivo biology. The
procedure, also provided by other companies and known as autologous cartilage
implantation - ACI has been analysed elsewhere (Kent et al, 2006b). This
technology is used under different regulatory conditions in several academic, clinical
and commercial centres in Europe. For Carticel, the procedure involves exporting
cells to a production facility in the USA and returning cultured cells back to the
originating country and patient.
Members of the TE networks frequently compare autologous and allogeneic
approaches. This scientist saw the use of patients own material as less risky than
using donor cells:
My own feeling is that were going to see advances in tissue engineering for
patients by using the autologous cell routes, using a patients own cells,
treating somewhere, putting them back into their body and there, I think, the
risks probably are less likely than with the other [allogeneic] route.
(S1, UK academic research scientist, interview 2003)
A similar opinion comes from a scientist working for a commercial developer in
Europe:
I would say that our strategy was the use of the cells of the same patients, so
we do not have risks.... so even in some case we are also using the cells of
the people who have infected diseases like, you know, hepatitis, by using
the same cells of the patients you are in the best situation because you
have to return to the patient, his own cells, so without any problems.
(S-EU1, scientist in European tissue engineering company, interview 2003)
... there is no risk and that is why most of these countries look at it as
transplants, because they say there is no foreign material in these products.
(M-EU10, European manufacturer in autologous TE, interview 2003)
The risks of transferring infection and disease were considered lower, and
immunological incompatibility seen as less problematic. But even the autologous
approach requires extensive, careful handling during the processing of cells to
exclude danger from infectious supplements or other contamination. Of course
mixing up cells must be avoided. Generally, at the moment the small scale of the
production process means the chances of mixing them up are almost negligible:
Part of it is logistics... I would like to be able to say that we only ever handle
one lot of cells in the hood at one time. I would love to have more space and
more hoods and to be able to segregate things further than we do. But we
make sure that we only have one operator handling one set of cells, from one
patient, at one time. And then its a case really of maintaining a trail of
labelling that goes all the way through.
(S5, research scientist in clinical setting, interview 2003)
A related safety technological concern lies in the transport of autologous cells. A
company like Genzyme, that offers autologous cultured cartilage on a commercial
basis in several European countries, does not have local production facilities in
Europe. After the cells are harvested from the patient, they are transported to the
USA for culturing, and after a few weeks sent back for implantation in the patient.
The cells are vulnerable though, and their viability is limited. Locally or regionally
based laboratories are seen by some of the scientists as both enhancing safety
controls and being more efficient. Issues of cross-border controls as well as safety
and contamination in handling may be raised. But in terms of individual risk for the
patient the use of autologous tissue is here portrayed as low-risk.
A closer look at the engineering process reveals further issues. Several substances
are typically added to the culture medium, such as growth factors to stimulate cell
growth, antibiotics against infection, and foetal calf serum to support cell growth. As
pointed out in a technical risk assessment study, residues from these components
could remain associated with cells and could induce an unwanted immunogenic or
toxic response after implantation (Tienhoven et al., 2001, p. 14). A major concern
reported was virus transfer caused by the use of bovine material (foetal calf serum) in
this instance in reference to both skin and cartilage technology:
So safety issues are that bovine material might pass on bovine spongiform
encephalopathy (BSE). Depending where you get your material from All of
us culture using foetal calf serum which is bovine Commercially we pay
about four to five times the price if we buy a bottle of serum from New
Zealand than if we get whatevers cheapest from the UK or whatever. What
we are actually paying for is the piece of paper saying that it came from New
Zealand from a herd that is never known to have had BSE.
An alternative is to develop patients own serum technically more difficult but some
manufacturers do use this, or serum free media. However, bovine material may not
be regarded technologically as entirely unacceptable. A European manufacturer
expresses ambivalence on this point:
... If you look at the WHO classifications for health risks, bovine serum [is] one
of the lowest risk bovine products. You have spinal cord and eyes and all that
sort of stuff as being particularly high risk of TSE transmission whereas serum
is pretty low down on the listThe first company who develops a serum free
media will be a very rich company.
Thus the risks to human safety of the use of animal material is contested.6 Different
frames of reference are being drawn upon here. Firstly, some TE actors are
apparently responding to the extreme concern surrounding the public framing of BSE
in the UK, thus drawing upon perceived social values and political concern even in a
causal discourse on safety. But secondly, it is also possible to frame the risk from
animal material in terms of a gradation of high to low risk as expressed in the policy
of an expert public health organisation with high credibility such as the World Health
Organisation.
Thus on the one hand we see autologous TE being framed as essentially risk-free in
terms of the technology and its safety implications for human health. It is portrayed
as a self-contained technology even though it is typically produced in combination
with biomaterials which are foreign to the host patient. In this account a patients cells
are simply removed, multiplied, activated and returned in a self-contained cycle that
avoids the possibility of rejection of foreign material by the patients body. In this
framing the patient is portrayed as receiving implanted material that has the same
identity as that which was removed.7 However, on the other hand we see that this
primary framing of self-containment is troubled by, in particular, xenotransplantation
and logistics. Some TE technologies can, even retrospectively, be classified as
xenotransplant products, raising the spectre of transmissible disease risk with high
public profile, and more regulatory hurdles for manufacturers. These risks are framed
as individual and technical, associated with contamination, virus transfer or
implantation into the wrong patient.
Collective risks of individual therapy?
If you start taking cells from one patient to another, then its a completely
different story. This is difficult, very difficult.
(S-EU2, European research scientist, interview 2003)
The distinction between autologous and allogeneic products is drawn primarily in
terms of the different sourcing pathways used for human material and the greater
degree of manipulation of allogeneic technologies. The commercial potential of
allogeneic products may in principle be seen by industry as greater than the
customised treatment, service model of autologous techniques where scaling up is
problematic. Off the shelf TE products use donor tissue, sometimes in combination
with a manufactured scaffold comprising biomaterials and/or growth factors (as do
several autologous products). The main applications currently available are living
skin substitutes for burns patients and diabetic patients with leg and foot ulcers.
These typically use tissue grown from donors (e.g. neonatal foreskin) and are
combined with a bioabsorbable scaffold. Technological safety of allogeneic products
has been given a high profile in debate about TE regulation on the European stage
and is of concern to the scientific, regulatory and industrial communities.
One scientist summarised the issues:
There are a huge number of issues. In terms of cells if you have a product
with cells within them, there are issues about infection transfer, so youre
talking about donation and proof of that. Depending on the source of cells, for
instance if its a xenograft type cell that youre generating this cross species
Theres concern about tumour generation if youre using stem (cell) or a cell
that is highly proliferative. Concerns about migration of cells away from the
site where they were due to act, so a cell that could be very good, if it was
implanted into the brain could be damaging if it went to another part of the
brain or it went to another part of the body Rejection and immune
responses to the cells. It would impose a course of immunosuppressive drugs
on the patient for a long period of time but then theres a whole range of
manufacture issues about how do you quality assure with a product based on
living tissue.
The issues raised are entirely concerned with the technology, its source, its
manufacture and its safety. The range of technical issues is extremely broad and
their uncertainty is emphasized. Scientific commentary from other sources also
highlights this set of issues (Tienhoven et al., 2001; Wassenaar et al., 2001).
The skin product Apligraf, the first human TE product to receive approval from a
national regulatory authority, is made of the cultured cells derived from circumcised
human foreskin and contains nonviable bovine material. Although not given
centralized EU approval, similar allogeneic products are on the EU market and have
included products such as Dermagraft (developed by Advanced Tissue Sciences,
and originally marketed by Smith & Nephew, UK). The manufacturer of Apligraf,
Organogenesis, claims the product has gone through extensive safety testing: the
mothers blood and donors cells are thoroughly screened and found negative for
pathogens and other contaminants (Organogenesis, 2005). Still, these biological
technological risks of cell storage safety and quality of the cell bank are primary
areas of concern for companies and regulators. In addition to virus or disease
transfer and immune rejection, other concerns, as with autologous technology,
include the use of animal materials:
10
In terms of producing scaffolds, only the origin of the scaffold, when there are
animal derived or human derived materials, I think there is always going to be
concern. And this is going to be a hurdle for introduction. ...The risk is very
small when you talk about these scaffolds that are animal derived, that are
carefully handled. But still, if there are alternatives where there is no risk for a
company, if you have a synthetic product, they're not liable for bio
contaminations so the market is wide open... that's the way for success.
(S-EU2, European research scientist, interview 2003)
Donors are screened for infectious diseases including HIV, hepatitis B and C, and
syphilis. There is a suggestion in no risk for a company that the broader framing of
risk as social or ethical concerns about infection in the public sphere is entering into
this construction. As with autologous products, questions of logistics and prevention
of contamination in handling and transport processes figure here too:
It is not known at the present time how to make all the steps in sterile
conditions at low cost. That uncertainty will have to be removed before tissue
engineering becomes more than accessible to just a limited number of
patients.
It can be noted here that practical concerns about the maintenance of quality
assurance risk management practices may themselves constitute a risk to the
commercial exploitation and availability of tissue engineered medical products. The
issue of sterility is formulated as much as an economic issue as a technical issue.
Thus similarities and differences exist in the ways in which autologous and allogeneic
TE technologies are characterised. Allogeneic TE technologies are to be implanted
into individual patients but carry with them greater risks of disease transmission
because the same product may be implanted into larger numbers of people, thus
representing collective or aggregate public health risks. Unlike autologous TE there is
no basic framing of the technology as risk-free; rather there is an emphasis on
uncertainty, on its socially distributed sources and recipients in the population, a
need for future technical advances, and on existing risk-control procedures and
testing. As with the risks of autologous technology, the use of animal materials is
seen as a problematic intrusion in the (as yet ill-formed) public image of tissue
engineering. This highlights its hybrid material technology that cannot be controlled
by attempts to frame some applications as risk-free and self-contained.
The perceived risks discussed above can appropriately be described as comprising a
broadly technological safety frame. This designation is necessarily multidimensional,
including especially components of biological safety and biophysical processes in the
interaction between technology and the human body. Safety as portrayed in this
discourse is intimately tied to the material constitution and technical characteristics of
tissue engineered technologies. The safety risks associated with tissue engineering
technologies, according to these TE actors, range from infectious disease transfer to
issues of immuno-rejection, toxicity, and uncontrolled cell proliferation.
Turning to the relationship between the framing deployed by these scientific actors
and its relationship to the development of regulatory policy, we can note that aspects
of these frames are reflected in the shaping of regulatory jurisdictions produced by
the European Commission. The SANCO (i.e. public health directorate) Directive on
human tissues and cells (2004)8 highlights disease transfer as the prime area of
concern, the Commission stating that:
11
In order to safeguard public health and to prevent the transmission of

infectious diseases by these tissues and cells, all safety measures need to be
taken during their donation, procurement, testing, processing, preservation,
storage, distribution and use (EC DG SANCO, 2004, p. 0048).
But while the primary regulatory effort here is concerned with turning technological
safety risk framing into organising principles for policymaking, frames of other
substantive types of risk have been glimpsed in the analysis above. These include
aspects of clinical efficacy and commercialization of TE production. These framings
also featured significantly in the TE actors accounts and are expanded upon in the
sections below.
Framing TE risk as therapeutic efficacy ?

I think perhaps the biggest risk is, whether they actually work or not, as
opposed to whether theres any risk to the patient.
(S1, UK academic research scientist , interview 2003)
It would be easy to form the impression from the preceding section that scientific and
industrial actors discourse of TE is exclusively preoccupied with biophysical, safety
matters. However, in addition to the framing of technological risks, the effects in
terms of clinical efficacy - does the intervention work? are also to the fore in debate
in the TE networks. There is agreement that there is no long-term clinical evidence
that demonstrates the superiority of tissue engineering products over already existing
and often cheaper treatments. As one scientist with a clinical background suggested:
Risks there are risks in both directionsMost new approaches to therapy
begin with a phase where everyone says theyre going to cure the world and
everyones very excited and then the first results come in and... everyone
says oh god its not going to work at all. (...) and yes, get the right
regulatory framework in place so that it works for us and not against us and
also provides some measure of efficacy as well as safety... Im not that
concerned about safety regulations, they have to be as high as you can make
them within reason and I dont have any problems with that. I have real
problems over the current lack of efficacy outcome data and real problems
with whether a realistic view will be taken on how to acquire that data, and
how to measure it.
(S4, UK academic research scientist in clinical setting, interview 2003)
As the statement suggests, there was also a view amongst scientific actors that the
efficacy of a treatment needed to be assessed against the potential benefits. But
even when the product fails to perform well therapeutically, the risks might be
deemed limited, as a European manufacturer explains, discussing their autologous
knee cartilage technology:
...the risks are minimal or basically theres no risks and it is a very
conservative approach because even in the case that our product would
completely fail, the tissue or the defect - for example the knee or the hip or
the ankle - is in the same situation as before. We havent cut anything away,
we havent put any synthetic materials. So as I said: even if everything would
fail, the patient is in the worst case at the same level as before the surgery.
(M-EU10, European manufacturer in autologous TE, interview 2003)
12
The two preceding statements illustrate different conceptions of the clinical or

medical evaluation of effects of therapy. The former reflects the recent turn to
evidence-based medicine and health technology assessment (Faulkner, 1997;
Harrison, 1998) and refers to the availability of statistical population data, whilst the
second reflects a conventional clinical view of the ideal-type individual patient.
Informant S4 expresses the partly ethical concern that data do not currently exist,
making it difficult to create a credible case for innovation, but also the innovators
concern that regulation may make acceptable evidence very difficult to produce. The
framing of TE risk in terms of therapeutic efficacy is drawn into regulatory debate
more explicitly:
Its the worry that regulations set the barrier so high, that efficacy, in that if
it doesnt work, no one is going to buy it. You know, if the efficacy barrier was
somewhat lower. So we showed it did no harm. () The side effects for
tissue engineering seem to be very low.
(M1, UK manufacturer in TE, interview 2003)
The statement explicitly points out that regulation can be seen as impeding
development of the technology. So the risks for this speaker are risks of overregulation or regulatory standards of evidence being set too high. This brings a
further framing of risk into view for technical innovators, the risk of not developing TE
innovations, which itself can be construed as a risk to future public health.
Thus alongside technological safety risk construed by this TE issue network we must
set the risk of a lack of therapeutic efficacy. Clearly visible as informing these
concerns is a version of the fundamental tension of health technology policy, namely
the tension between innovation and commercialization on the one hand, and
regulation and control on the other. Notable also in these actors formulations of risk
is the use of both individual and collective formulations, which produce rather
different assessments of risk one as lack of side-effects or harm, the other, more
uncertain, as lack of evidence of benefit or harm.
The European Commission itself has addressed risks concerning therapeutic
effectiveness in relation to the innovative development of tissue engineered products,
thereby also considering commercial concerns of manufacturers. In this instance,
difficulties companies face in producing evidence of effective products for the
healthcare system are brought into the purview of the EUs aim to enhance
commerce, promoted in the regulatory jurisdiction of the enterprise directorate:
Many of the tissue-engineered products are still in early stages of
development. The small biotech companies involved do not have the
resources for large, long-term clinical trials to provide information on the costeffectiveness of the treatment compared to conventional alternatives. Lack of
cost-effectiveness data is the main reason for which insurance companies are
reluctant to reimburse treatment with tissue-engineered products. (EC DG
Enterprise, 2004)
The reference to conventional alternatives draws our attention to the issue of
comparative efficacy. Trade organisations especially have lobbied for specific
requirements for clinical trials of TE products, separate from guidelines for
pharmaceutical products, to be included in the regulatory framework (EuropaBio and
EUCOMED, 2005). Thus the framing of risk in terms of therapeutic efficacy is an area
of conflict between stakeholders in the tissue engineering zone. As can be seen in
the example above, there is some linkage of framing between therapeutic
effectiveness risk and issues of resourcing for developers. This brings us to the last
13
category of risk framing by TE scientific and industrial actors, namely in terms of

economic and commercial aspects.
Framing TE risk as economic or commercial?

Alongside technological and therapeutic framings of risk, we found that TE actors
also deploy a discourse of what we will term economic risk. This has already been
witnessed for example in statements about the implications for companies of dealing
with the need for sterile production and distribution processes. These TE actors
characterized what we have termed economic risk in a variety of ways:
I cant see any other risks, apart from financial risk. It costs more money
maybe. The end product would cost more than maybe a product already on
the market because tissue engineering costs more than other products.
The risks are perhaps more commercial, that its going to take a lot of money
to get some of these products.
(S1, UK academic research scientist , interview 2003)
Theres issues relating to cost because I suspect the NHS will never be able
to afford the people to be able to have tissue engineering procedures done on
them.
So economic concerns relate to the high cost for commercial ventures of TE products
compared to already existing and more conventional therapies. In fact existing TE
treatments are often not reimbursed currently by national health insurance services.
For developers the high costs and need for reimbursement is a major concern, but
also raised here are issues of access to the technology and its uptake by patients
and national health services, and the potential for social or health inequalities. The
dimensions in which economic risk is constructed thus include both production and
consumption risks.
A commercial concern of another nature is related to the manufacturing process and
commercialisation of TE technologies. A great deal of discussion in TE industry
conferences revolves around possible appropriate business models, including
modes of production. The assumption underlying this discussion is of course that
commercial enterprise is based on a need for economic viability and
competitiveness. The technical distinction between autologous and allogeneic cell
sources is again relevant:
Autologous processes cant be scaled up. So in the case of the cartilage
procedure, its autologous, the patient has to go in, have cells removed, those
cells personally have to be expanded in culture and they have to go back into
that patient its massively labour intensive. If you have a lab that can do 100
of those a year, the only way to double that capacity is to employ twice as
many people and have twice the size of the lab. So the only way were going
to get the scale up is the use of allogeneic made tissue and then you have the
problems of immune rejection of the tissue.
14
The motivation of competitiveness may result in commerce-related risk decisions

affecting the type of TE therapy to be developed. This dilemma may lead to different
responses depending upon the type of organization involved:
theres a number of big commercial failures in the US in tissue
engineering. And its clear its not the science thats failing its the
commercial model cos it cant keep enough money going for enough time
to sustain these small companies. And I think its interesting because
I think what is happening here (UK) and in Europe is that I think there will be
development that goes on that is initially non-commercial and, in other words,
there will be some non-commercial application developed in association
with hospitals as hospital laboratory- almost -based procedures. These may
well be principally autologous with patients cells. So I think there may be
useful progress made by non-commercial developments that work on
smaller problems in terms of the scale that may prove principles that later
lead onto commercial type developments.
(Cl3, UK clinical research scientist, interview 2003)
Thus the commercial risk was seen as stimulating a particular strategy for R&D.
There was some perception (not necessarily wholly generalisable) that the
marketplace was already being structured along such lines:
All of the academic groups I know are doing autologous. All of the commercial
groups I know are doing allogeneic.
In fact as noted above there is an emphasis on autologous TE in Europe compared
to the USA (Bock et al., 2003). We noted that the larger commercial companies tend
to fund both kinds of research activity. Potential profitability of allogeneic products is
one primary motivation in the TE sector in spite of the generally increased perceived
technological safety risks associated with disease transfer. The autologous, service
based model may be seen as commercially weak in the longer term, more suited to
small-scale activity by academics in partnership with clinicians and industry, or
requiring novel approaches to commercialization and a new business model.
Whereas with autologous you tend to be looking at it in say a single hospital
situation. () Its going to be more local probably. I mean, its not, you only
look at the theoretical risk involved. .. But inherently it would be controlled
more in time and location ...in terms of meeting a great demand out there,
autologous treatment is not going to do it.
(M2, scientist and safety manager in multinational company, interview 2003)
However the size of the market is hard to predict, which may be another commercial
challenge, especially when tissue engineered products have to compete with
cheaper alternatives already available.
The current population of patients that require repair of chronic wounds; there
are many hundred thousand patients; one fraction of those could be helped
with a minimally invasive type of treatment? We dont know.
There was, unsurprisingly, a strong perception that an agreed definition of TE
technology itself, linked to a regulated single market in Europe would be beneficial:
15
the difficulty is until they actually say what it is and what the rules and
regulations are governing it, its going to be very difficult, why have we got
different rules and regulations about the products that were using in one
country to another? and I just think harmonisation has to be the way forward,
if were going to work with it and exist within Europe... I dont care what it is,
as long its harmonised
(Cl3 UK clinical scientist, interview 2003).
In summary, commercial or economic risks therefore also include the question of
patients access to the technology (who will be able to afford it or how healthcare
systems might provide access), and an as yet unknown population that would
actually benefit from the treatment. This frame also includes the dimensions of viable,
sterile processing methods, and models of production that might enable the hybrid
form required for mass customization of autologous technologies on an industrial
scale as well as the clearer approaches for donor-based products. There is variation
in the underlying model of the projected patient marketplace, ranging from the
individual self-contained patient to collective patient groups amenable to off-theshelf treatments. The underlying concern with economic viability and
competitiveness in the international marketplace is evident. In fact, in spite of the
reservations illustrated here about the difficulties of scaling-up autologous
applications, there are several Europe-wide, European Commission-funded
collaborative projects aimed at developing technology to make this economically
possible.5
Do scientific-industrial risk frames match regulatory regime configurations?

So far we have considered risk discourses of scientists and industry manufacturers
involved in human tissue commercialisation and tissue engineering in the UK and at
EU level. We have laid out an analysis in terms of a discussion of risk framing. Here
we explore the significance of the frames and dimensions of TE-related risk that
participants in this Europe-wide technological zone have deployed. Firstly we
comment on the three primary frames deployed by TE scientific-industrial actors,
then we illustrate how risk frames match the configuration of emerging European
regulatory regime-building in the negotiation of this potential technological zone.
Finally we comment briefly on ways in which the uncertainty evident in risk framing
that we have described is itself incorporated in the emerging EU regulatory regime.
Framing TE risk discourses
Analytic categorisations of risk can be useful in mapping what might be called the
epistemic range of a world-view. For example a global analytic distinction has been
made between physical, social, economic and environmental risk (Beck, 1992). Here,
in the case of a single field of technology we have analysed in detail the risk issues
formulated in the world-view of a specific network of interested actors. Based on an
empirical case, we have seen a particular set of framings of TE-related risks and
have derived a crude three-way typology of technological (human safety), therapeutic
(efficacy, comparative efficacy) and economic (business viability, competitiveness)
risks. We have illustrated some variability between frames, linkage between them,
and multiple dimensions of meaning in each. We can now review our initial
questions. Who or what is defined to be subject to risk? What is the nature of TE
risks, and what alternative risk-meanings are produced? How are different riskframings related to each other?
16
The constituency of scientists and commercial developers is broad, coming from a

wide variety of contributory disciplines. They have formulated TE risk drawing upon
discourses interpretable in three broad frames. As one might predict, to the fore is
technological risk highlighting biological pathways relevant to human safety and
public health issues, but we note also, contrary perhaps to some expectations, that
other interrelated framings of risks are strongly articulated by these strategically
placed actors. This is probably testimony to the strategic alliances that they have
developed with commercial and clinical collaborators, or indeed their individual hybrid
roles and careers. Risks are defined to concern both individual and public health,
commercial enterprise and competitiveness, and the effectiveness and efficiency of
therapy in the context of healthcare services.
As noted in our introductory review, risk framing may alter the perceived salience of
certain risk issues while others are downplayed in the selective, discursive, framing
process. Most notably, in the case of TE the use of the term autologous in the
framings of risk that we have described is a typification that acts in this way. In
particular, it has been used in a manner that emphasizes matters of sourcing of
material and purity of process, rather than use of hybrid materials or culturing
processes in which foreign, non-human matter might be introduced. The greater,
multi-dimensional, technical and social safety of self-contained TE is thus, even in
the discourses of TE insiders, not unproblematic. That reusing a patients own cells
is preferable rests in part on the tacit belief that the patients bodily integrity and
identity is maintained (Kent et al., 2006b). In contrast, the framing of the technologybased riskiness of allogeneic products is drawn in terms of a need to find suitable
donors who are screened for disease, virus and other unwanted characteristics. The
incorporation of viable human (or animal) tissue or cells into medical technologies
raises the possibility of large scale transmissible disease and contamination. It is no
coincidence that autologous processes are favoured in Europe (Bock et al, 2003),
where the major public controversy and EU activity about BSE and other forms of
collective, trans-national contamination have occurred.
However, together with technological safety risk, we have also seen that these TE
actors frame TE risks in discourses of therapeutic efficacy and of economics. What
are the relationships between these different frames? It is clear that in some
instances they are closely aligned and really only analytically distinguishable from
each other. For example, the issue of scale-up illustrates the close link between the
technological frame that distinguishes TE applications on the basis of cell source and
the economic frame of commercial risk. On the other hand, the frames cannot be
regarded as of equal salience, or as functioning free of the context of their use. Thus
in some circumstances the therapeutic risk of lack of effectiveness is given more
weight than the technological frame of biophysical safety the former might be the
biggest risk as one interviewee put it, implicitly comparing risks which in this
discourse are separate and of a qualitatively different order. The dimensions within
these frames such as the greater or lesser safety risk attributed to different types of
animal material and the equation of autologous with self-contained technology
might therefore be regarded as exhibiting the interpretative flexiblility that has been
noted about the design of artefacts in the sociology of technological innovation (Bijker
et al, 1987)
Summarising, therefore, we note that this set of actors deploys the three framings of
risk in flexible ways. Sometimes frames are aligned and overlapping, and sometimes
they are held separate. Furthermore, multiple, alternative discursive meanings can
be constructed from the base material of tissue engineering representations.
Risk and regulatory jurisdictions
17
Actors in regulatory arenas typically negotiate jurisdictions in which authority and

expertise can be claimed (Hogle, 2002), as noted in the conceptual introduction to
this paper. The jurisdictions of public health and of enterprise have been referred to
in our analysis of risk frames above. The framing of risk issues by the constituencies
attempting to define the boundaries and organising principles of a new technological
zone is a demonstration of expertise and embodies claims to participate in and
construct the zone of TE in particular ways its dominant types of technology,
business models, technical standards, forms of evidence, national or transnational
institutions, local or global markets, central or devolved regulatory institutions. In the
context of the European regulatory state (Majone, 1994), we would expect the most
powerful actors to include regulatory policymakers and industrial actors. In the TE
zone, indeed, there are conspicuously contested boundaries between, for example,
medical device and pharmaceutical industrial sectors, between hospital/tissue bank
and commercial sectors, and between national and European-level regulators
jurisdictions. Our research shows that the construction and representation of risk is a
key discourse in TE, and that many, though not all, risk issues conceived by
scientific-industrial participants are also regulatory issues.
We now discuss evidence of the European institutions selection and framing of risks
in the configuration of their regulatory policy, and how the TE actors discourses of
risk might be reflected in the jurisdictional claims evident in the emerging regulatory
policy. Our ambition here is the modest one of analysing the apparent fit or match
between the framings of risk that we have illustrated and the configuration of the
template for regulatory policy that is emerging for a TE zone in the European Union
we do not attempt here to spell out specific mechanisms or pathways (such as
political lobbying, participation in Council of Europe working groups, or routing of
legislation through alternate European Commission administrative units) by which
any parallels or divergences might be produced. The detailed substantive issues
involved in moving toward new regulation for TE technologies have been described
elsewhere (Kent et al., 2006a; Faulkner et al., 2006). Here, we confine ourselves to
noting the key regulatory movements, their institutional underpinnings, and their
defining points that highlight (to date) the European institutions jurisdictional regimebuilding discourse in this technology.
The European Commission, as the main legislative body, has a variety of
institutionalised structures and functions that include promoting economic growth and
stimulating innovation, whilst simultaneously acting as regulator of consumer safety
in this complex domain (Geesink, 2006). There have been two major regulatory
policy movements that shape human tissue and TE as regulatable jurisdictions over
the last decade, devoted firstly to the sourcing and circulation of human tissues and
cells and secondly (and still evolving at the time of writing) to engineered products.
The first of these8 as noted at the end of our discussion of technological safety risk
frames, was proposed and promoted under the auspices of the European
Commissions Directorate-General SANCO, i.e. the public health directorate, whilst
the second was under the authority of DG Enterprise & Industry, whose remit is to
protect and enhance free trade within the European area and the international
competitiveness of its industries. Each is also underpinned by a different Article in
the terms of the Treaty of Rome which lays down the legal principles for the
operation of the European Union. Thus the jurisdictions of the two were defined very
differently from the outset. However, a regulatory approach that was not based upon
this boundary-defining distinction is certainly imaginable. The aims and
infrastructures of expertise and authority associated with the two jurisdictions often
find themselves in tension, and it is clear that the emerging zone of TE is no
exception. In the case of the SANCO Directive, as noted in the extract at the end of
18
the section above illustrating technological risk, the primary framing was clearly
focused on human safety in relation to disease transmission, echoing the
technological safety frame deployed by the scientists/industrial actors that we have
described. On the other hand, the Regulation for entry to the marketplace of TE
products, we suggest, combines two frames, namely the technological safety and
economic frames. Evidence for this comes, for example, from the introductory
organising principles of the European Commissions proposal document for this
Regulation, presented as a proposal for advanced therapies 9 that include tissue
engineering. It lays out several key aims and risk-framing assumptions. These
principles frame risks in ways that we can recognise from our discussion of the
technological frame concerned with safety and the economic frame concerned inter
alia with the viability of alternative organisational models for producing TE products:
Traceability from the donor to the patient, long-term patient followup and a thorough post-authorisation risk management strategy are
crucial aspects to be addressed when evaluating advanced therapies.
Advanced therapy products are usually developed by innovative
small and medium-sized enterprises, highly-specialised divisions of
larger operators in the Life Science sector hospitals or tissue
banks (EC DG Enterprise & Industry, 2005, p2)
Similarly, the Director of DG Enterprise and Industry summarised the main aims of
this Regulation as being to Guarantee a high level of health protection; Harmonise
and facilitate market access; Foster competitiveness; and Provide overall legal
certainty (Lalis, 2006). The proposed advanced therapies regime includes some
market approval fee reductions for small companies attempting to bring new products
to the marketplace through an EU-centralised regulatory agency an explicit
measure to support the zone and to foster competitiveness of a European presence
in a developing global sector. None of the core organising principles refers to matters
of therapeutic risk or comparative effectiveness of alternative therapies in healthcare
delivery. It is notable, therefore, that in this instance the technological and economic
frames appear to be more firmly embedded in the European institutions and their
construction of regulatory jurisdictions than does the clinical therapeutic risk frame.
This accords with the relatively weak organisation of healthcare at the transnational
level and the strong position of national healthcare systems, which in the regulatory
field uphold the European principle of subsidiarity of nation states. Such a conclusion
would be familiar to analysts of the regulation of other innovative medical technology
such as pharmaceuticals in the EU (Abraham and Lewis, 2000).
Earlier consultation on the regime for TE products had produced a proposal
(superseded by the Advanced Therapy proposal noted above) that autologous TE
applications, framed as less technically risky, could be controlled by national
authorities under a form of negotiated subsidiarity, whilst allogeneic technologies
should be assessed by an EC centralised body (EC DG Enterprise, 2004). However,
the widespread framing of autologous TE technological safety risk as low began to
be challenged even on technical grounds: it appeared that this framing was based
mainly around existing products, namely some skin systems and cartilage
regeneration processes relatively uncontroversial and low profile therapies. When
more high profile self-contained potential therapies were contemplated, for example
heart muscle regeneration for patients who have suffered heart attack, in which the
risk to health could be much higher, then one of the rationales for subsidiarity to a
national jurisdiction was undermined. This may be one reason why the later proposal
for an Advanced Therapy regulation is for an EC-centralised jurisdiction for most TE
products and potential applications.
19
The scientific-industrial TE actors discussed here referred to a very limited extent to

issues concerning perceived public controversy about the source of tissues and cells
from which TE therapies might be developed. In fact, although the process itself is
not discussed here, this was a major issue in the political debate about the new
Regulation in the European Parliament and Council. However, the conclusion was
that ethical issues would be excluded from the new Europe-wide regulatory
jurisdiction. This can be illustrated from remarks made by the representative of the
then German Presidency of the Council at the time the Commission proposal and
some proposed ethical amendments from Members of the European Parliament
were considered (Council of the European Union, 2007):
Speaking for the Council Presidency, Minister Schrder: recalled that already,
since the adoption of the Human Tissues and Cells Directive, there is an
agreement to the effect that ethical matters in this field are dealt with in
accordance with the subsidiarity principle and that they remain an area of
national competence; ... stressed the fact that the subsidiarity principle ensures
that national legislation - for example, on stem cells - will not be affected by the
proposed Regulation. (This position was subsequently adopted in a vote).
Thus within Europe the developing harmonised regulatory framework constitutes a
jurisdiction for the tissue engineering zone that is anomalous from the viewpoint of
free trade within Europe. This is because the subsidiarity principle allows Member
States to vary their regulation of particular sources of cells and engineering
procedures for TE products. It is likely, therefore, that some countries will ban
products derived from processes using human embryonic stem cells and humananimal hybrids, and national healthcare system gatekeepers will vary in their
appraisals of the efficacy of new TE technologies. The strong EU regulatory
presence in this technological zone does construct risk and its regulatory
management at a transnational level, especially in technological and economic
frames. These framings emphasise collective technological safety and a desire to
stabilise a competitive TE industrial zone. National jurisdictions, however, are
regulated to be in tension with the EU supranational regime. This cannot but extend
imbalances of access to therapies across the populations of the EU.
Circumscribing uncertainties in risk regulation
TE presents scientific and engineering challenges and as one would expect,
uncertainty marks many aspects of the science itself. Equally unclear are the viability
of different production and business models for commercialization of the technology
and evidential criteria for assessing performance of TE technologies. We have
observed scientific uncertainty informing formulations of TE risk. This applied both to
biological and engineering sciences, and to the healthcare sciences of patients
outcome measurement associated with evidence-based medicine. Scientific
uncertainty also plays an important part in the negotiable construction of regulatory
jurisdictions and standards of control.
A prominent scientist in the TE issue network, involved in advising EC regulators, has
argued that TE is one of the technologies, together with for example gene therapy
and xenotransplantation, that is altering the way in which what we would describe
here as technological risks can be assessed (Williams, 2001). TE technological risks
are seen as more difficult to assess and risk management strategies therefore more
difficult to develop. Turning to how discourse of uncertainty of technological risk is
construed within regulatory policy, we can draw attention to the extensive recourse to
technical guidelines in the latest formal regulatory proposals. These proposals
20
enable emerging issues deemed to be technological to be dealt with outside the

realms of European Parliament debate, via comitology the use of closed expert
technical committees (EC DG Enterprise & Industry, 2005).10 But whilst the
comitology procedure has been developed as a tool to manage complexity and
uncertain risks projected as technological or technical (EU insiders often refer to
them informally as technical committees), which became especially relevant in the
post-BSE era, this same procedure raises questions about the legitimacy of the
current regulatory system in the EU. This is sometimes explicitly discussed in EU
parliamentary committee debate in terms of technocratic versus democratic
principles, and in terms of the difficulties in drawing boundaries between matters of
technical innovation and broader socio-political concerns. The comitology process
itself, therefore, is controversial amongst some EU parliamentarians. Some of these
parliamentarians, indeed, in the case of the TE negotiations have sought to introduce
into the regulatory framework an increased parliamentary review of decisions that
would otherwise remain the province of technical committee working. It is clear that
use of the comitology process is an attempt to draw and maintain boundaries
between jurisdictions deemed in terms of current EU governance process to be
technical versus political. But some parliamentarians, as ourselves, believe that
such boundaries are contentious and difficult to maintain.
Conclusion: regulation, risk and social need for tissue-engineered

technologies in Europe
The concepts of risk frames, technological zone and regulatory jurisdiction have been
used to develop this analysis. We have shown how a range of experts risk frames in
the unstable zone of TE are being selectively embedded in the emerging institutional
template of EU-level and national regulatory jurisdictions. We identified three
framings of risk. We have argued that TE risks are framed strongly by participating
scientific-industrial actors in what we have called (1) a technological safety frame, but
these are combined with (2) therapeutic efficacy, and (3) economic risk frames. The
TE actors combine or separate frames flexibly in their repertoires of risk discourse.
The three frames can thus be regarded as closely interlocking in their world view.
The reach of the three different frames, arguably, in itself points to the heuristic value
of hybrid concepts such as biomedical technoscience (cf. Clarke et al, 2003) and
entrepreneurial science (Etzkowitz, 1998) for understanding the contemporary
knowledge economy, concepts which recognise a convergence of medical, scientific
and technological arenas, academic and commercial.
Frames of risk, we have demonstrated, are interlinked with the building of regulatory
jurisdictions. We showed that only two of the risk frames (technological safety and
economic) have been taken up in building a new regulatory jurisdiction for TE
products in Europe. Risk framings contribute to constituting human tissues and TE
as a zone that may have a distinct identity and contribution to make in the emerging
medico-industrial fields of regenerative medicine. Conceptualisations of TE risks
have been taken up in political attempts to create risk management jurisdictions and
standards for a stabilised European TE zone which attempt to negotiate nationaltransnational dimensions and which are still evolving. The social management of
identified risks depends in part upon the risks that societies select for assessment
and the forms that those assessments take. The fit or match between the definition
and assessment of risks and their institutionalised management has been stated to
be dynamic and of varying effectiveness in different policy fields (e.g. Brown and
Michael, 2004; Brown et al., 2006). In the case of TE we do not yet know how
effective the regulatory regime might be, in terms of avoiding safety risks, enabling
more effective therapy to enter healthcare practice, or in stimulating competitiveness
and business viability. Indeed, our analysis suggests that scientific and regulatory
21
actors will not always share definitions of criteria for a regimes effectiveness, as
shown in the principle of therapeutic efficacy identified here. Our analysis shows that
in order to assess the configuration of an emerging regulatory jurisdiction for
biomedicine it is useful to understand the range of frames deployed by scientificindustrial actors who have insight into the scientific, industrial and clinical issues
which confront regulators and their institutions. Our analysis has enabled tensions
between the range of risk assessments and the institutionalisation of regulatory
jurisdictions to be assessed.
As we have seen in examining the emerging EU regulatory template for human
tissues and TE, each frame formulated by the scientific-industrial actors finds some
expression but the institutional basis, and the regulatory regime that embeds
technological safety and economic risk (and benefit) at supranational level is stronger
than that for therapeutic efficacy risk framing. As indicated above, regulatory regimes
can shape the technologies that will reach patients and in this field the ways in which
the multidimensional riskiness of TE technologies is built in to the regulatable
jurisdiction may be expected to influence the kinds of products that enter the market.
The European Commission strategy-makers and EU politicians believe that Europe
needs new therapeutic technologies, but such need must be negotiated in the
context of existing therapeutic options for many medical conditions. Whilst political
commitment to assessing and acting on the efficacy of new medical technologies,
and especially comparative efficacy in relation to existing technologies, is growing (as
instanced for example by the health technology assessment work of the National
Institute of Health and Clinical Excellence (NICE) in the UK), it is still relatively weak.
Arguably, the growth and strengthening of pan-European technological and
economic regulation of biomedical technology generally over the last decade has
been paralleled by the growth of national health technology assessment efforts, to
identify the most efficacious technologies for given medical conditions in given
national healthcare systems. Thus we can note that the risk frames that we have
discussed as being strongly inscribed in the EUs regulatory jurisdictions do not
support a concept of societal therapeutic need for efficacious TE or other
technologies at the level of healthcare systems. This would require analysis of
comparative efficacy of competitor technologies alongside epidemiological and other
analysis. Such work is left to national jurisdictions. In practice then, supply and
demand for TE products will be influenced by decisions at this national level. As we
noted at the beginning of this paper, there is a boundary between the jurisdiction of
public health (safety from disease transmission, cross-national) which is increasingly
Europeanised, and health care (therapeutic service delivery, national) which is
primarily a national matter. Our analysis shows that in the TE zone this boundary is
being reproduced, and we argue that this explains why, despite the interlocking
nature of the frames employed by scientific-industrial actors, matters of comparative
therapeutic efficacy are neglected at the European level.
The technological zone of European TE is constructed here as an economic zone
(echoing the concept of techno-economic network (Callon, 2004)). European
regime-building embeds transnational technological safety standards and a
framework for supporting economic viability and competitiveness. As Barry
suggested, making a technical practice more social or cultural may serve to
restrict its movement (Barry, 2001, p38-9). In the matching between scientificindustrial TE risk frames and the template for an EU regulatory jurisdiction, matters of
comparative therapeutic efficacy in healthcare delivery, and matters of ethics of
tissue and cell materials, through the subsidiarity principle, are in effect deemed to be
local national and cultural matters. They are thus restricted to being outside the
rules of engagement of a TE medical technology zone on the European Union stage.
22
This is likely to have practical consequences in influencing the trading and availability
of TE therapies across the countries of Europe, in spite of shared technical
standards, safety procedures and centralised market approval decisions.
23
Notes
Applications of tissue engineering technology already exist in fields such as skin

systems for wound care (burns and diabetic and venous ulcers e.g. Epicel,
Dermagraft, Apligraf); cartilage repair (e.g. Carticel, MACI, Hyalograft C); and bone
regeneration (e.g. BioSeed). In the pipeline are other applications, including (cardio-)
vascular prostheses and pancreatic, bladder and corneal repair, and optimistic future
scenarios envisage organ-assist devices for the liver and kidney, whole organ
replacement, repair to neurological tissues, and the application of stem cell therapies
(Lang, 2003).
2
Some major multinational pharmaceutical and medical device companies are

involved in the development of tissue engineering, together with many smaller
biotechnology companies and academic scientific centres. Transnational alliances
mark many of the research and development efforts. While the market for tissuebased products is expanding globally, in comparison to pharmaceuticals it remains
small. The emerging sector attracted massive venture capital during the late1990s,
especially in the USA, but few products reached the healthcare system. Investor
confidence then dipped (capital valuation of publicly traded TE companies was
estimated at $2.5 billion in 2000, dropping to $0.4 billion by the end of 2002
Lysaght & Hazlehurst, 2004). Since 2004-5 private investment appears to be
increasing again. TE is a major area for public investment, with programmes of
government-sponsored support for research evident in the United States and Europe
as well as Asian countries. At EU level, framework programmes and project grants
dedicated to the promotion of biotechnology and life sciences provide a supportive
environment for R&D in tissue engineering.
3
The size of markets for TE technologies is difficult to estimate. A survey of

regulatory authorities of European member states, conducted as part of the research
discussed here, found that most were unable to list all products currently available in
their countries (see Kent et al, 2006a). In a market overview carried out for the
European Commission some 113 TE companies were identified in Europe, mostly
small and medium-sized enterprises (SMEs). In 2003 about 35 commercial products
were on the European market, mostly autologous technologies and mainly for skin
and cartilage repair, followed by some bone applications. According to this study
(Hsing et al, 2003), European TE markets are fragmented and localised, with
companies targeting different national markets but with no single product available in
all EU Member States. Whereas allogeneic products generally reach a broader
market, the trend of European manufacturers to focus primarily on autologous
applications is not expected to change over the next few years (Bock et al., 2005).
Although the European Union market has been estimated in the region of 50 to 100
million euros (Schutte, 2003), also more modest figures have been reported, in the
order of only several million a year (Bock et al., 2003; Hsing et al., 2003).
4
Interview extracts are coded anonymously; M referring to individuals we classified

as manufacturers, S for scientists. The EU suffix denotes participants active at EU
level, while those without a suffix were involved in national UK activities.
5
Such initiatives include the 25 million STEPS programme (Systems Approach to

Tissue Engineering Processes and Products), a 25-partner 13-country consortium
24
addressing manufacturing and production issues and led by the University of

Liverpool, UK, and Fidia, one of Italys leading TE companies.
6
See Brown et al. (2006) for a detailed exploration of the relationship between tissue
engineering and xenotransplantation and their regulation.
See Kent et al, 2006b.
In April 2006 the so-called Tissues and Cells Directive (EC DG SANCO,
2004/23/EC) became effective in Member States of the EU, establishing a general
regulatory framework for the safety and quality of these human substances. The
legislation was adopted after years of preparation and deliberation by DG SANCO
(2002), the Commission unit responsible for consumer and health protection, and
under pressure of different interested parties, in order to accommodate the urgent
need to regulate the conditions under which human tissues circulate within the
European Market (EGE, 1998). Based on the public health article in the Amsterdam
Treaty, the Tissues and Cells Directive contains harmonised safety and quality
standards for the ways in which tissue establishments deal with human tissues and
cells, including their donation, procurement, distribution and use. It contains detailed
guidelines for registered tissue establishments covering implementation of a quality
system, accreditation, organisation of control and inspection within Member States,
data protection and confidentiality, assurance of traceability of donors and the design
of a single European coding system for the main characteristics and properties of
tissues and cells. This Directive is supplemented by more detailed guidelines for the
implementation, including Directive 2006/17/EC on technical requirements for the
donation, procurement and testing of human tissues and cells, and a second stage
covering processing, preservation, storage and distribution, which was adopted in
October 2006.
9
A Regulation on Advanced Therapies was proposed by DG Enterprise & Industry

(2005). Advanced therapies comprise gene and cell therapy (already subject to
regulation via an annex revising the EU medicines legislation (EC, 2003) and most
notably TE. In order to secure a single European market and foster competitiveness,
this Regulation aims to harmonise and ease the marketing authorisation of TE
products in Europe by providing a centralised structure for approval, based on the
model for medicinal products. In the proposed Regulation the European Medicines
Agency (EMEA) plays a dominant role in assessing these advanced therapies via a
new, dedicated committee, and providing scientific advice, with strengthened
requirements for risk management and traceability. The proposal defines many TE
products as unconventional medicines. It includes a number of special measures
such as fee reductions to facilitate small and medium-sized companies (SMEs)
(compared to large pharmaceutical companies) bringing new products for
assessment and marketing approval. In principle the scope of TE in this Regulation
includes both xenogeneic products and those based on human embryonic stem cell
research, the latter having given rise to major political controversy in the European
Parliament.
10
Comitology-based committees presume the existence of technical jurisdictions. In

principle they assist the European Commission in working out the technical details for
implementation of new legislation, thus providing flexibility in regulatory approach, as
new insights can in principle be included in implementation measures via these
committees. For example, requirements for new safety tests that are developed can
be incorporated more easily in risk management approaches, without recourse to full
parliamentary discussion and procedure.
25
Acknowledgments
The authors are grateful for funding support from the United Kingdom ESRC/MRC
programme on Innovative Health Technologies (IHT) 2002-04, award number
L218252058, and ESRC grant RES-000-22-1814. Early versions of this paper were
presented by IG during the 2003 conference of the European Sociological
Association (SSTNET) in Murcia, Spain, and the 2003 BSA Risk & Society Study
Group Conference in Plymouth, UK. The authors thank participants at these
conferences for their critical comments and support, and all interviewees for their
participation in this research. Les Levidow and two anonymous reviewers provided
valuable comments, for which the authors are grateful.
26
References
Abraham, J. and Lewis, G. (2000) Regulating medicines in Europe: Competition,
expertise and public health (London: Routledge).
Barry, A. (2001). Political machines: governing a technological society (London:
Athlone Press).
Beck, U. (1992) Risk Society: Towards a New Modernity (London: SAGE).
Bijker, W.E. Hughes, T.P., Pinch, T.J. (eds.) (1987) The Social Construction of
Technological Systems: New Directions in the Sociology and History of
Technology (Cambridge, MA: MIT Press).
Bock, A.-K., Rodriguez-Cerezo, E., Husing, B., Buhrlen, B. and Nusser, M. (2005)
Human tissue-engineered products: Potential socio-economic impacts of a
new European regulatory framework for authorisation, supervision and
vigilance. Technical Report EUR 21838 EN. European Commission's Joint
Research Centre (Institute for Prospective Technological Studies). Brussels,
November 2005. ftp://ftp.jrc.es/pub/EURdoc/eur21838en.pdf [last accessed:
Dec 2006].
Bock, A. K., Ibarreta, D. and Rodriguez-Cerezo, E. (2003), Human tissue-engineered
products: today's market and future prospects. Synthesis report EUR 21000
EN. Institute for Prospective Technological Studies IPTS and Joint Research
Centre EC, pp. 1-55.
Brown, N., Faulkner, A., Kent, J. and Michael, M. (2006) Regulating Hybrids
cleaning up and making a mess in tissue engineering and transpecies
transplantation, Social Theory and Health 4(1), pp. 1-24.
Brown, N. and Michael, M. (2004) Risky Creatures: institutional species boundary
change in biotechnology regulation, Health, Risk and Society, 6 (3), pp. 207222.
Brown, P., Dombal, G., Dornbusch, D. Elsami, B. et al (2001) Human cell- and
tissue-based products: progress, promise and regulatory issues, Journal of
Commercial Biotechnology, 7 (4), pp. 287-298.
Callon, M. (2004), Europe wrestling with technology, Economy and Society, 33, 1,
121-134.
Clarke, A. E., Shim, J. K., Mamo, L., Fosket, J. R. and Fishman, J. R. (2003)
Biomedicalization: Technoscientific transformations of health, illness, and
U.S. biomedicine, American Sociological Review, 68 (2), pp. 161-194.
Council of the European Union. (2007). Proposal for a Regulation of the European
Parliament and of the Council on advanced therapy medicinal products and
amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Outcome of the European Parliament's first reading. 8719/07. 8 May 2007,
Brussels.
EC (2003). Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of
the European Parliament and of the Council on the Community code relating
to medicinal products for human use. Official Journal L 159, 27/06/2003 P.
00460094.
EC DG Enterprise (2004) Proposal for a harmonised regulatory framework on human
tissue engineered products: DG Enterprise consultation paper.
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm [last
accessed: Dec 2006]
EC DG Enterprise and Industry (2005). Proposal for a Regulation of the European
Parliament and of the Council on advanced therapy medicinal products and
amending Directive 2001/83/EC and Regulation (EC) No 726/2004
{SEC(2005) 1444}. COM(2005) 567 final 2005/0227 (COD). Presented by the
Commission, adoption of the Commission proposal on 16 November 2005.
27
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm [last
accessed: Dec 2006]
EC DG SANCO (2002) Proposal for a Directive of the European Parliament and of
the Council on setting standards of quality and safety for the donation,
procurement, testing, processing, storage, and distribution of human tissues
and cells (2002/C 227 E/28) COM(2002) 319 final 2002/0128(COD)
(Submitted by the Commission on 19 June 2002). Health and Consumer
Protection, European Commission (EC), Official Journal of the European
Communities, C 227 E/505-521.
EC DG SANCO (2004) Directive 2004/23/EC of the European Parliament and of the
Council of 31 March 2004 on setting standards of quality and safety for the
donation, procurement, testing, processing, preservation, storage and
distribution of human tissues and cells. Health and Consumer Protection,
European Commission (EC), Official Journal of the European Union, L
102/148-158.
EGE (1998) Ethical aspects of human tissue banking. Opinion no. 11 of the
European Group on Ethics in science and new technologies to the European
Commission, 21 July 1998.
EUCOMED (2003) Quality and safety of human tissues and cells: Eucomed Position
Paper on the Commission report to the Council and Parliament on Medical
Devices. 14 October 2003.
Etzkowitz, H. (1998) The norms of entrepreneurial science: cognitive effects of the
new universityindustry linkages. Research Policy, 27, pp823833.
EuropaBio and EUCOMED (2005) Why human cell & tissue-engineered products
(hTEPs) need a specific and separate Regulation. Joint industry statement,
Brussels 29 March 2005. Online at:
http://www.europabio.org/documents/Ebio-Eucomedhteps.pdf [last accessed:
Dec 2006].
Faulkner, A. (1997) Strange bedfellows in the laboratory of the NHS? An analysis of
the new science of health technology assessment in the United Kingdom. In:
Elston, M. A. (ed.), The sociology of medical science and technology.
Sociology of Health and Illness Monograph (3), pp. 197-223 (Oxford:
Blackwell).
Faulkner, A., Geesink, I., Kent, J. and FitzPatrick, D. (2003) Human tissue
engineered products--drugs or devices? British Medical Journal, 326 (7400),
pp. 1159-1160.
Faulkner, A., Kent, J., Geesink, I. and FitzPatrick, D. (2006) Purity and the dangers of
regenerative medicine: Regulatory innovation of human tissue-engineered
technology, Social Science & Medicine 63 (2006), pp. 2277-2288.
Gabe, J. (1995) Health, medicine and risk: The need for a sociological approach, in
Gabe, J. (ed.), Health, medicine and risk: sociological approaches, pp. 1-17
(Oxford: Blackwells).
Geesink, I. (2006) Risk regulation of tissue engineering in the EU; a political
economy of medicine. PhD thesis. Cardiff: Cardiff University.
Harrison, S. (1998) The politics of evidence-based medicine in the United Kingdom,
Policy & Politics, 26 (1), pp. 15-31.
Hogle, L. F. (2002) Introduction: jurisdictions of authority and expertise in science
and medicine, Med Anthropol, 21 (3-4), pp. 231-246.
Hogle, L. F. (2005) Emerging forms of evidence in regenerative medicine,
Presentation to Innovative Health Technologies Workshop at Health
Technology Assessment International (HTAi) Annual Conference, Rome, 2022 June 2005.
Horlick-Jones, T. (1998) Meaning and contextualisation in risk assessment,
Reliability Engineering & System Safety, 59 (1), pp. 79-89.
28
Hsing, B., Bhrlen, B. and Gaisser, S. (2003), Human Tissue Engineered Products
Todays Markets and Future Prospects. Final Report for Work Package 1:
Analysis of the actual market situation Mapping of industry and products,
Karlsruhe, Germany: Fraunhofer Institute for Systems and Innovation
Research, pp. 1-122.
Jasanoff, S. (2005) Designs on nature. Science and Democracy in Europe and the
United states (Princeton, NJ: Princeton University Press).
Jones, M. and Salter, B. (2003) The governance of human genetics: policy discourse
and constructions of public trust, New Genetics and Society, 22 (1), pp. 2142.
Kent, J., Faulkner, A., Geesink, I. and FitzPatrick, D. (2006a) Towards Governance
of Human Tissue Engineered Technologies in Europe Framing the case for a
new regulatory regime, Technological Forecasting and Social Change, 73, pp.
41-60.
Kent, J., Faulkner, A., Geesink, I. and FitzPatrick, D. (2006b) Culturing cells,
reproducing and regulating the self: autologous applications of tissue
engineering, Body & Society 12 (2), pp. 1-23.
Lalis, G. (2006). Genes, Cells and Tissues: Commission proposal on Advanced
Therapies. Presentation to BIO (Biotechnology Industry Organization)
International Convention, Chicago, April 2006. Available at:
http://www.europabio.be/AdvancedTherapies.htm (Accessed April 2007).
Lang, J. C. T. (2003), Presentation at public hearing Quality and safety of human
tissue and cells, European Parliament Brussels, 29 Jan 2003. Online via:
http://www.eutop.de/de/iv_hearings/humantc_download.htm [last accessed:
Dec 2006].
Lysaght MJ, Hazlehurst A. (2004). Tissue Engineering: the end of the beginning.
Tissue Engineering, 10, pp. 309-320.
Majone G. (1994). The European Community as a Regulatory State. European
Community Law, 1, 321-419.
Malerba, F. (2004). Sectoral systems of innovation: basic concepts. In: Malerba, F.
(ed.) Sectoral systems of innovation: concepts, issues and analyses of six
major sectors in Europe. (Cambridge: Cambridge University Press), pp.9-41.
McIntire, L. V., Greisler, H. P., Griffith, L., Johnson, P. C., Mooney, D. J., Mrksich, M.,
Parenteau, N. and Smith, D. (2002), WTEC Panel Report on Tissue
Engineering Research. (Maryland: International Technology Research
Institute, WTEC Division).
Miller, D. (1999) Risk, science and policy: BSE, definitional struggles, information
management, and the media, Social Science and Medicine, 49 (9), pp. 12391255.
Organogenesis (2005). Apligraf website. http://www.apligraf.com/ Accessed 12/2005.
Rhodes, R. A. W. (1997) Understanding Governance: Policy Networks, Governance,
Reflexivity and Accountability (Buckingham: Open University Press).
Schutte, E. (2003) Industry Position on Proposed Directive (representing Eucomed),
Presentation at public hearing Quality and safety of human tissue and cells,
European Parliament Brussels, 29 Jan 2003. Online via:
http://www.eutop.de/de/iv_hearings/humantc_download.htm [accessed: Dec
2006].
Stirling, A., Renn, O., Klinke, A., Rip, A. and Salo, A. (1999) On Science and
Precaution In the Management of Technological Risk: An ESTO Project
Report, ftp://ftp.jrc.es/pub/EURdoc/eur19056en.pdf [last accessed: Dec
2006].
Tienhoven, E. A. E. van, Geertsma, R. E., Wassenaar, C. and Jong, W. H. de (2001),
Pre-clinical safety assessment of Tissue Engineering Medical Products
(TEMPs) - an investigation on assays and guidelines for biocompatibility
testing, Bilthoven: RIVM report 640080 002/2001, pp. 1-33.
29
Vaughan, E. and Seifert, M. (1992) Variability in the framing of risk issues, Journal of
Social Issues, 48 (4), pp. 119-135.
Wassenaar, C., Geertsma, R. and Kallewaard, M. (2001), Tissue Engineered Medical
Products (TEMPs): A prelude to risk management, Bilthoven, the
Netherlands: RIVM National Institute of Public Health and the Environment
Williams, D. (2001) Clarity and Risk: The Challenges of the New Technologies,
Medical Device Technology, 12 (9), pp. 12-14.
Wynne, B. (1996) May the sheep safely graze? A reflexive view of the expert-lay
knowledge divide, in Lash, S., Szerszynski, B. and Wynne, B. (eds.) Risk,
Environment and Modernity: Towards a New Ecology (London: Sage).
Biographical note for the 'Contributors' section

Alex Faulkner (faulknerac@cf.ac.uk)
Dr Alex Faulkner is Senior Research Fellow at the Cardiff Institute of Society, Health
and Ethics in the School of Social Sciences, Cardiff University. He leads a research
programme on the societal management, regulation and governance of
developments in biomedicine and their healthcare impact. Technologies include
those classed as medical devices, human implant technologies, tissue- and cellbased therapies, and technology-assisted self-care.
David FitzPatrick (david.fitzpatrick@ucd.ie)
Dr David FitzPatrick is a Senior Lecturer and Head of the School of Engineering:
Electrical, Electronic & Mechanical at University College Dublin (UCD), Ireland. He is
also Visiting Senior Lecturer in Bioengineering at Trinity College Dublin (TCD).
Ingrid Geesink (Geesinki@cf.ac.uk)
Dr Ingrid Geesink is a sociologist of science interested in innovative health
technologies. Her PhD research at Cardiff University focused on socio-political,
ethical and economic aspects of tissue engineering regulation in the EU. She
currently holds an ESRC/MRC postdoctoral fellowship at the Centre for Economic
and Social Aspects of Genomics (CESAGen) in Cardiff, Wales.
Julie Kent (Julie.Kent@uwe.ac.uk)
Julie Kent is Professor of Sociology of Health Technology at the University of the
West of England (UWE) in Bristol. Her recent research has focused on the regulation
and governance of medical devices and tissue engineering in the UK and Europe.
She currently works on a UK ESRC project grant under the Stem Cell Programme
which looks at developing a socio-cultural analysis of the use of fetal stem cells.
30

Tissue Engineering

Transféré par

Informations du document

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

Tissue Engineering

Transféré par

Droits d'auteur :

Formats disponibles

Prepublication version.

See Science as Culture 2008, 17(2) for published article

Tissue-engineered technologies: scientific biomedicine,

Address for correspondence:

following questions about tissue engineering: How do scientific-industrial actors

Risk and risk framing in technological zones

incompatibility. These TE manufacturers point to risks concerned with safety, the

Framing TE risk as technological safety risk? Two formulations

Collective risks of individual therapy?

In order to safeguard public health and to prevent the transmission of

Framing TE risk as therapeutic efficacy ?

The two preceding statements illustrate different conceptions of the clinical or

category of risk framing by TE scientific and industrial actors, namely in terms of

Framing TE risk as economic or commercial?

The motivation of competitiveness may result in commerce-related risk decisions

Do scientific-industrial risk frames match regulatory regime configurations?

The constituency of scientists and commercial developers is broad, coming from a

Actors in regulatory arenas typically negotiate jurisdictions in which authority and

The scientific-industrial TE actors discussed here referred to a very limited extent to

enable emerging issues deemed to be technological to be dealt with outside the

Conclusion: regulation, risk and social need for tissue-engineered

Applications of tissue engineering technology already exist in fields such as skin

Some major multinational pharmaceutical and medical device companies are

The size of markets for TE technologies is difficult to estimate. A survey of

Interview extracts are coded anonymously; M referring to individuals we classified

Such initiatives include the 25 million STEPS programme (Systems Approach to

addressing manufacturing and production issues and led by the University of

See Kent et al, 2006b.

A Regulation on Advanced Therapies was proposed by DG Enterprise & Industry

Comitology-based committees presume the existence of technical jurisdictions. In

Biographical note for the 'Contributors' section

Vous aimerez peut-être aussi