Regulation For Whom? By Whom? With Whom? for what?

Gregor Wolbring[i]

 

 

The discourse around the regulation of many biotechnology products, goals, processes and applications are perceived by many as highly flawed.

Many feel that the nanotechnology is just developing and the nanotechnology discourse might be able to generate a decent regulation discourse preventing the pitfalls of the biotech regulation discourse. So where are we in the nanotechnology regulation discourse?

The objective of this paper is to address the issues of regulation with whom’, ‘for whom’, ‘by whom’ and ‘for what’ in order to ascertain whether the Nano discourse of today is better than the bio discourse of the past especially in regards to disadvantaged and marginalized social groups especially disabled people.

 

This paper addresses these questions among others by using keyword searches in Google, Google Scholar and different types of academic clusters of databases (results see table),

 

The paper will conclude with an assessment of the state of the nano regulation discourse, the feasibility of the nano regulation discourse ever becoming inclusive and suggestions of tool development needed and attitude change needed to make the nano regulation discourse inclusive.

 

 

 

Nanoregulation for what?

 

An increasing amount of people ask for the regulation of Nanotechnology. However what should be regulated? The safety of nanomaterials, the safety of nanotechnology processes and products? The equitable distribution of nanotechnology products and processes? The governance of nanotechnology?

The proper selection of R&D priorities for a balanced and equitable development of nanotechnology? Should we regulate access issues or privacy issues?

When we chose regulations should they first be related to the needs of the marginalized or the needs of the already powerful social groups? Should they be locally or globally or should the local ones have a global outline? Can the regulatory system of today deal with the increasing speed of inventions and the decreasing time of an invention cycle?

 

It is reaonable to expect that perceptions and social values and the existing hierachy within stakeholders shape what regulation issues are covered with what kind of angles and even how much visibility any given issue receives. Within the biotechnology debate, agriculture biotechnology gained much more visibility and controversy than human ‘health’ biotechnology.  Medical Health safety issues gained much more visibility than social health safety issues such as equity and justice. The same dynamic of medical health safety issues versus social health safety issues appears also within nanotechnology and NBICS. The safety card was played by Bill Joy(1) putting nanobots and nanotech on the agenda and the field of nanotoxicology of nanomaterials becomes increasingly visible. The social issues such as distributive justice, enhancement medicine, transhumanism, concept of health and others are second tier if that. In the moment the Biotechnology hierarchy of issues replays itself within Nanotechnology. The results of the keyword combination search method in Google, Google Scholar, Ovid, Academic Search Premier and Cambridge Scientific Databases (for a description of the academic databases see appendix in (2)) highlight certain characteristics and certain realities.

 

 

 

1)     The Term “Nanotechnology Regulation” receives less or equal hits than Nanotechnology with my name. That is a clear indication of the lack of discourse around Nanotechnology regulation

2)     If one looks at which social groups are mentioned within ‘Nanotechnology Regulation’ one can clearly see a hierarchy with disabled people and indigenous people on the bottom. This is an indication of the prevailing biases within the nanotechnology regulation for whom discourse

3)     The much higher hits with patients versus disabled people indicates a very medical flavor of the nanotechnology regulation discourse

4)     It also allows for the conclusion that terms such as safety and risks are interpreted in certain medical ways 

5)     The keyword combination ‘Nanotechnology and safety’ has Twenty Thousand times more hits than the combination ‘ Nanotechnology and distributive justice

6)     Nanotechnology applications like Energy water and food have only 10% or less hits if combined with the terms law and regulation

7)     Nanotechnology teamed up with human rights has only 20% of the hits of the combination Nanotechnology and weapons and only 1% of  hits of the combination Nanotechnology and health

8)     So far the regulation discourse seems to be much more concerned with medical health safety than social safety

9)     We have not even started the debate around the regulation of nanotechnology and we see already the appearance of synthetic biology which is 1) the design and construction of new biological parts, devices, and systems, and 2) the re-design of existing, natural biological systems for useful purposes which has many envisioned applications (appendix 1) in need of regulation.  The regulatory system of today can not deal with the increasing speed of inventions and the decreasing time of an invention cycle

 

Table 1: Word combination/hits for Google, Google Scholar, Ovid, Academic Search Premier and Cambridge Scientific Databases

SINGLE/COMBINATIONAL KEYWORD/SEARCHTERM

Google

Google Scholar

Ovid

Academic Search Premier

Cambridge Scientific Databases

Nanotechnology

“Nanotechnology regulation”

“Regulation of Nanotechnology”

Nanotechnology+ Regulation

Regulation of Nanotechnology

137,000,000/

928/767

3,370,000

1,170,000

85,700/

10/45/

5,110

3,990

 

15258/

0/1

296/

201

16040

10/11

718/718

14790

0/0

177/4

Nanotechnology + Wolbring

840

23

0

7

1

“Nanotechnology regulation”  + women 

252

 

 

 

 

+ “the south”

52

 

 

 

 

+ "indigenous people" 

3

 

 

 

 

 + disabled people/ 

2

 

 

 

 

+ people with disabilities

8

 

 

 

 

+ the poor

88

 

 

 

 

+ patient 

122

 

 

 

 

      + Safety

950

 

 

 

 

 + Risk

1340

 

 

 

 

SINGLE/COMBINATIONAL KEYWORD/SEARCHTERM

Google

Google Scholar

Ovid

Academic Search Premier

Cambridge Scientific Databases

Nanotechnology + Law

14,000,000

9,350

176

1807

184

Nanotechnology +Law + safety

2,340,000

2,090

24

26

18

Nanotechnology +Law + patient/health

430,000/

7,850,000

996/ 3,310

40/60

18

6/41

Nanotechnology +Law + disabled people

32,500

84

2

0

1

Nanotechnology +Law + women

3,790,000

1,430

14

13

16

Nanotechnology +Law +indigenous people

24,500

88

0

0

0

Nanotechnology Law/regulation water

3,220,000/

1,390,000

 

4060/2720

31/41

58/38

23/11

Nanotechnology Law/regulation food

4,570,000/

1,540,000

2170/2150

27/42

40/20

17/28

Nanotechnology Law/regulation energy

6,640,000/

4,000,000

6730/3790

51/48

98/36

52/31

Nanotechnology Law Justice

1,460,000

 

 

 

 

Nanotechnology Law “Distributive Justice”

586/4

 

 

 

 

Nanotechnology Law  Justice Women/disabled people

946,000/16,700

 

 

 

 

SINGLE/COMBINATIONAL KEYWORD/SEARCHTERM

Google

Google Scholar

Ovid

Academic Search Premier

Cambridge Scientific Databases

      Regulation of Nanotechnology

767

45

1

11

0

+ women 

98

 

 

 

 

+ “the south”

40

 

 

 

 

+"indigenous people" 

2

 

 

 

 

+ disabled people/ 

10

 

 

 

 

+ people with disabilities

3

 

 

 

 

+ the poor

88

 

 

 

 

 + patient 

80

 

 

 

 

+ Safety

462

 

 

 

 

+ Risk

400

 

 

 

 

SINGLE/COMBINATIONAL KEYWORD/SEARCHTERM

Google

Google Scholar

Ovid

Academic Search Premier

Cambridge Scientific Databases

Nanotechnology Safety

13,600,000

4,870

395

26

203

Nanotechnology justice

2,720,000

1,350

14

6

29

Nanotechnology distributive justice

664

50

0

0

0

Nanotechnology human rights

415,000

608

9

3

12

Nanotechnology environment

35,200,000

14,400

786

67

669

Nanotechnology health

46,400,000

8,010

835

105

620

Nanotechnology Medicine

31,800,000

7,440

792

51

7266

Nanotechnology Weapons

2,340,000

1,880

36

18

47

Nanotechnology surveillance

853,000

1,320

0

0

34

Nanotechnology security

23,900,000

4,530

79

61

91

Nanotechnology Food

17,700,000

4,950

300

1151

158

Nanotechnology Water

11,600,000

15,800

1692

2604

1135

Nanotechnology Energy

48800,000

25,800

1392

4982

1702

 

 

 

 

 

 

 

 

Nanotechnology Regulation of what? The case of health

 

According to Frost and Sullivann, nanotechnological processes in medicine will obtain a sales volume of about $180 billion until 2015. (3)  According to the Freedonia group,(4) “demand for nanotechnology health care products in the US is projected to increase nearly 50 per cent per year to $6.5 billion in 2009 and by 2020, demand for nanotechnology health care products is projected to exceed $100 billion.”(4)

 

A Nanomedicine taxonomy from 2003 (5) and a 2005 published one(6) give an idea as to what is covered my Nano/NBIC medicine nowadays

 

 

(5)

 

(6)

 

 

A nanoroadmap for Nanomedicine in Europe(3) has the following taxonomy

 

 

 

An interrelationship exist between direction in and governance and regulation of science and technology and the concepts of ‘health’, ‘disease’, ‘wellbeing’, ’disability’, and ‘impairment’. On the one hand technologies such as (a) nanoscience and nanotechnology; (b) biotechnology and biomedicine, including genetic engineering; (c) information technology, including advanced computing and communications; (d) cognitive science (neuro engineering) and e) synthetic biology which is A) the design and construction of new biological parts, devices, and systems, and B) the re-design of existing, natural biological systems for useful purpose,  (‘NBICS’ -nano-bio-info-cogno-synbio) impact on these very concepts. On the other hand these concepts do impact on the direction and governance of research and development of NBICS.

 

Regulating health applications is not as simple as it might seems.

 

 

 

Relationship between health and wellbeing:(2)

 

Two contradictory models exist concerning the relationship between "health" and "wellbeing".

The World Health Organization (WHO) model considers different domains of well-being as determinants of the umbrella term “health” which is reflected in the WHO definition of health, wherein health is defined as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” (7). This model through different wellbeing determinants combines the areas of “medical health” and “social health” under the term “health”.

 

However  increasingly the discourse seems to move away from the WHO definition of health  treating especially social wellbeing less and less as a determinant of health(8-10)  but interpreting the term “health” to mean “medical health”/ “medical illness”.  “Health” is used today to cover the domain of "medical" determinants of "wellbeing." “Social health” is not covered anymore under the term “health.”

 

Determinants and models of health(2)

 

Two models of health are dominant. 

 

Medical model of health and disease

 

Within the medical model of health and disease, health is limited to cover “medical health” and is characterized as the normative functioning of biological systems whereas disease/ illness is defined as the sub-normative functioning of biological systems.

 

Locating the cause of and solution for “ill medical health” comes in two flavors.

 

Medical determinants of medical health place the cause of sub-normative functioning within the individual’s biological system leading to medical interventions towards the species typical norm on the level of the individuals (medical, individualistic cures). (2)  

 

Social determinants of medical health identify external factors as the cause for the “ill medical health” the sub-normative functioning of the individual and tries to fix the external factors. This includes, for example, contaminated water that leads to bacterial or parasitic infections, or job insecurity that contributes to stress and heart disease. (2)

 

This version of the medical model is often misleadingly referred to as the "social model of health" or as the "social determinants of health". It is misleading in my eyes because the model addresses only “ill medical health”/"medical illness". The "social determinants" relating to the social wellbeing the “social health” of a person are rarely addressed. (2) Furthermore even if the social well being is addressed it is addressed within the framework of the social well being of a medically ill person.

 

Extension One needed: Real Social model of health(2)

 

A real social model of health is needed which would examine how social determinants influence "physical, mental, and social wellbeing" and would not be limited to look at how social determinants influence and worsen “medical health”. It would also look at the social well being of a person in general not just a ‘medically ill person’. One does not have to be identified as a “patient” or “patient to be”, as a person in “ill medical health” or in danger of gaining ill/bad medical health in order to be covered and investigated under the social model of health.

 

 

Models of “disability/impairment” (2) 

 

 

The Basics: Medical Model of “Disability/Impairment”

 

Within the medical model of ‘disability/impairment’,  disability/impairment’ is viewed as a defect, a problem inherent to the person, directly caused by disease, trauma or other ‘medical health conditions’ and a deviation from certain norms. The person obtains the label ‘patient’ with subnormative functioning.

 

 

The solution for the “disability/impairment” of the person or person-to-be is mostly focusing on cure, prevention of birth, deselection on the embryo level, or normative adaptation. Medical individualistic care and prevention (in the case of the fetus/embryo) and individualistic normative rehabilitation are viewed as the primary endpoint and at the political level the principal response is to make curative and preventive medicine more efficient.

 

Extension One needed: Medical model/social determinants  of “disability/impairment”

 

Rarely does one employ the concept of “social determinants of health” within the medical model of ‘disability/impairment’ to investigate how external factors further already existing “ill medical health” and negatively affect the social wellbeing of the ‘patient’ the person with a disability/impairment’. 

 

Extension Two needed: Medical model/social determinants/social well being  of “disability/impairment”

Even rarer does one seek modifications of social determinants to make them instrumental in diminishing the ill/bad “social health” and in increasing the social wellbeing of the ‘patient,’ despite this necessity for the ‘disabled/impaired’ person/patient. (2)

 

 

Extension Three Needed: Social Model of Disability(2)

 

The social model moves beyond the medical model, social determinants/social wellbeing combination by linking the usage of social determinants to social wellbeing and by uncoupling social determinants from the prerequisite of one being or becoming medically ill. The biological reality of disabled people is seen as a variation of being not in need of fixing but in need of having the physical environment, the interaction with the physical environment, and the societal climate changed to accommodate their biological reality. It does see disability mainly as a socially created problem, and as a matter of the full integration of individuals with different biological realities and abilities into society. Disability is not seen as an attribute or defect of an individual, but as caused by the reaction of society towards the biological reality of the individual.

 

 

 

Extensions Happening to the models driven by NBICS(2)

 

Moving from Species-typical functioning to Beyond species-typical functioning

 

Advances in and converging of NBIC allow for a new model of health which takes into account the increased ability of science and technology products to modify the appearance of the human body and it’s functioning  (2)  beyond existing norms and species-typical boundaries.

 

The new kid on the block: the transhumanist/enhancement model of health (2)

 

What is a non-disabled person?

 

So far a non-disabled person was someone whose body functioning was seen as performing within species typical acceptable parameters (medically healthy). The term non-disabled was used as a counterpart to the medical/patient type understanding of disabled people.

However this is changing.

 

Within the transhumanist/enhancement model of health, the concept of health no longer has the endpoint that someone is “healthy” if the biological systems function within species-typical, normative frameworks. Within the transhumanist/enhancement model all Homo sapiens bodies – no matter how conventionally “medically healthy” – are defined as limited and defective in need of constant improvement made possible by new technologies appearing on the horizon (a little bit like the constant software upgrades we do on our computers). Health in this model is the concept of having obtained maximum (at any given time) enhancement (improvement) of one’s abilities, functioning and body structure. Disease, in this case, is identified in accordance with a negative self-perception of ones non-enhanced body (i.e., “I feel un-well because I feel confined to the normal human body and I want to add capabilities to the body as soon as it is possible”).  It also links social wellbeing and “social health” to the availability of enhancement procedures. 

 

What is a disabled person?

 

 

 

The pure transhumanist/enhancement model of “disability/impairment”

 

The transhumanist model of health sees every Homo sapiens body as defective in need of improvement (above species-typical boundaries). Every Homo sapiens is by definition, “disabled” in the impairment /medical/patient sense.

Within the transhumanist model of “disability/impairment”, disabled people are those who are not able to improve themselves beyond Homo sapiens normative functioning. (techno poor disabled)

The transhumanist/enhancement model is a variation of the medical, individualistic, deficiency model using transhumanist determinants. These transhumanist determinants are in fact medical determinants that include enhancement, augmentative medicine.

Under this model, technologies which add new abilities to the human body are seen as the remedy for ill medical/transhumanist health and wellbeing. Enhancement medicine is the new field providing the remedy through surgery, pharmaceuticals, implants and other means. 

 The transhumanist model of "disability" views science and technology including NBICS as having the potential to free everyone the now "all disabled people" from the "confinement of their genes" (genomic freedom) and the "confinement of their biological bodies" (morphological freedom).  It seems to fit well with the existing dynamic of the medicalization of the human body where more and more variations of human body structure and functioning are labelled as deviations as diseases and with the phenomenon that more and more ‘healthy’ people feel ‘unhealthy, feel bad about their bodily structure and functioning’ (2).

 

Realization of the transhumanist/enhancement model

Step 1: Make “healthy” people feel bad about themselves:

 

The very meaning of health and disease is, today, highly contested. As a result of the dynamics of medicalization more and more variations of human body structure and functioning are being labelled as deviations and disease. A growing number of medical technologies are being employed to improve the looks, performance, and psychological well-being of people who are healthy. The traditional medical model of health is increasingly used to artificially assigns a subnormal label toward natural variations of human characteristics (shyness). More and more variations of natural characteristics of the human body are being labelled as defective and in need of fixing. Perfectly healthy persons are made to feel badly about their appearances or functioning.  It sells to healthy people the idea that they are sick.  Disease-mongering is a term some people use (11-14)

 

 

 

The reality of medicalizationis acknowledged by many”(2)

 

An editorial in the British Medical Journal,(15) which rephrased an editorial of Amartya Sen in the same issue,(16) stated:

“Amartya Sen, an even more distinguished economist, discusses the paradox that people in America feel much less well than those in Bihar, India, though their life expectancy is much better.”(16)(p.860)

 

In an issue of the Seattle Times one reads:

 

“The number of people with at least one of four major medical conditions has increased dramatically in the past decade because of changes in the definitions of disease. ‘The new definitions ultimately label 75 percent of the adult U.S. population as diseased,’ according to calculations by two Dartmouth Medical School researchers.” (17)

 

 

Step 2: Add enhancement to the mix

 

 

The transhumanist/enhancement model of health, ability and disease elevates the medicalization dynamic to its ultimate endpoint, namely, to see the enhancement beyond species-typical body structures and functioning as a therapeutic intervention (transhumanization of medicalization).

It also leads to a new social group the techno poor disabled.

Within the transhumanist/enhancement model of health and disability, disabled people are those who cannot afford or who are unwilling to improve themselves beyond human species normative functioning. They are the new techno-poor disabled

 

 

It is important to scrutinize more closely the societal dynamics around the redefinition of health, disease, disability/impairment in general and the move towards a transhumanist/enhancement model in particular and its impact on what is in need of regulation

 

 

In the last part I outlined a variety of options you can chose from in regards to health and disability.

In this part I am outlining some of the consequences.

 

 

A transhumanized version of ableism:

 

Ableism is a network of beliefs, processes and practices that produce a particular kind of self, body and abilities which are projected as the perfect and essential while at the same time labeling deviation (real or perceived) from this essential self, body and abilities as a diminished state.

 

 

Ableism has been long-used to justify hierarchies and the exclusion of people not classified as ‘disabled people’.  Advances in science and technology are increasingly enabling science and technology R&D products to modify the appearance and functioning of the human body beyond existing norms and species-typical boundaries. The direction and governance of science and technology and the concept of ability are inter-related. On the one hand, technologies such as NBICS have an impact on the very concept of ability and how we judge and deal with abilities. On the other hand how we judge and deal with abilities influences the direction and governance of NBICS processes, products and research and development.

A new transhumanized form of ableism is appearing that takes into account the increased ability of science and technology R&D products for body modification and is “a network of beliefs, processes and practices that perceives the improvement of human body and functioning beyond species-typical boundaries as the norm, as essential and judges a non-enhanced human body as a diminished state of existence”.[1] Transhumanism “is a way of thinking about the future that is based on the premise that the human species in its current form does not represent the end of our development but rather a comparatively early phase”(18).

 

The Techno Poor Disabled and the Ability divide

 

As more powerful, less invasive and more sophisticated enhancements become available the market share and acceptance of enhancement products will grow. This could very likely develop into a situation where those who do not have or do not want certain enhancements (the techno poor disabled) will be discriminated against, given negative labels and suffer difficult consequences (transhumanism of ableism). For any given enhancement product there will not be a bell curve distribution, but rather a distribution jump from the “have nots” to the “haves” which will lead directly to an ability divide. What will change– depending on the social reality such as GDP of the economy, income levels and other parameters – is how many people end up as ‘haves’ or ‘non haves’ (techno poor disabled). The ability divide will be bigger between low and high income countries than it will be within any give low middle and rich countries and the ability divide will develop between the poor and rich within every country.  Not everyone can afford the enhancement of ones body. And no society can afford to enhance everyone’s body if everyone so wishes.  Those deemed healthy by most people today, but who cannot afford or don’t want the technological enhancements, will became the new class of 'techno-poor disabled.' Billions of people that today are seen as healthy will become disabled not because their bodies have changed, but precisely because they have not changed their bodies in accordance with the transhumanist norm.

The transhumanization of ableism is a logical extension of the ableism the social justice type of disabled people is facing. Therefore it is of importance how much of this type of ableism is visible, investigated and rejected or supported. 

 

 

A transhumanized version of the DALY

The Disability Adjusted Life Years (DALY)(19-29) is a measure developed in the 1990s and refined ever since was explicitly developed to "curtail allocative inefficiency" in the usage of health budget dollars according to Murray, who was hired by the World Bank and the World Health Organization to develop the DALYs (24). However what does that mean under a transhumanist version of health?

To quote Murray and Acharaya (24)

 

“… individuals prefer, after appropriate deliberation, to extend the life of healthy individuals rather than those in a health state worse than perfect health”

 

The spirit of this quote allows for the justification of a hierarchy of treatment of people with ill medical health whereby the ones which are deviating the least from a “species typical medical health state are treated first. 

It furthermore allows for the following interpretation

 

“ individuals prefer, after appropriate deliberation, to ENHANCE the life of healthy individuals rather than those in a health state worse than perfect health.”

 

which allows for the justification of a societal development where one favors ‘enhancement medicine over ‘curative medicine’ seeing pure curative medicine as futile and waste of health care dollars.(2) This shift might also be lucrative from another economic standpoint as enhancement medicine provides the remedy through surgery, pharmaceuticals, implants and other means and could become the number one cash cow for many hospitals and medical practitioners such as ‘body engineers’, ‘body designers’ and body techno-maintenance crews. (2)

 

Transhumanized version of burden of disease

 

It prepares the groundwork for the acceptance of a   transhumanist/ enhancement burden of disease which links the burden of disease not to a deviation from Homo sapiens-typical functioning but to the lack of enhanced functionalities and life extension and productivity modification of sentient beings.

 

 

Scientific and techno solutions for social well being?

 

One can envision that access to technology external or internal related to the body might increasingly be seen as the solution to bad social well being. One might see a shift away from societal changes to promote social well being to science and techno solutions like pills to achieve the goal that the person feels well socially and otherwise.  

 

Do we develop regulations for or against the different transhumanized versions outlined above?

 

 

Interpretation of international Documents:

 

It is evident that the different understanding of ‘health’, ‘disease’ and ‘disability/impairment’ has a great impact on the interpretation of international documents  i.e. “Bangkok Charter for Health Promotion in a globalized world”(30) the Universal Declaration of Human Rights(31) and the International Classification on Functioning Disability and Health (ICF)(32) and the to come Universal Convention on the rights of people with Disabilities(33). To give some quotes.

 

ICF definition of disability and impairment.

 

Disability is defined as "the outcome or result of a complex relationship between an individual’s health condition and personal factors, and of the external factors that represent the circumstances in which the individual lives." Impairments are defined as "problems in body function or structure such as a significant deviation or loss.", http://www3.who.int/icf/intros/ICF-Eng-Intro.pdf

 

In the 2005 Bangkok Charter for Health Promotion in a globalized  world one finds the following wordings

” The United Nations recognize that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without discrimination;”

“Regulate and legislate to ensure a high level of protection from harm and enable equal opportunity for health and well being for all people;” “Government and international bodies must act to close the gap in health between rich and poor”; “healthier world”; “Health promotion has an established repertoire of proven effective strategies which need to be fully utilised”; “advocate for health based on human rights and solidarity”; “commitments to health for all”; “Make the promotion of health central to the global development agenda”; “Health promotion must become an integral part of domestic and foreign policy and international relations, including in situations of war and conflict”; “Health determines socio-economic and political development”; and whole sections such as  “Make the promotion of health a key focus of communities and civil society”; and “Make the promotion of health a requirement for good corporate practices.” 

 

These quotes beg a few questions.

What does “equal opportunity for health and well-being” mean?  Does the quote mean medical health and mental and spiritual well-being?  Or which well-being does the Bangkok charter have in mind? Does the quote “must act to close the gap in health between rich and poor” mean that we just close the “medical health gap”?  Where does that leave the people who are already “medically unhealthy”?  Does one just focus on trying to fix their “medical problem,” ignoring their social well-being problems?  Does that quote include making “medical information” accessible to disabled people?

 

The Universal Declaration of Human Rights  Article 25-1 states: “Everyone has the right to a standard of living adequate for the health and well-being of himself.”

 

The UNESCO Declaration on Bioethics and Human Rights states

 

“Recognizing that health does not depend solely on scientific and technological research developments but also on psycho-social and cultural factors.

Considering the desirability of developing new approaches to social responsibility to ensure that progress in science and technology contributes to justice, equity and to the interest of humanity.

Considering the desirability of developing new approaches to social responsibility to ensure that progress in science and technology contributes to justice, equity and to the interest of humanity.

Stressing the need to reinforce international cooperation in the field of bioethics, taking into account in particular the special needs of developing countries, indigenous communities and vulnerable populations.

Article 10 – Equality, Justice and Equity - The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.

Article 11 – Non-Discrimination and Non-Stigmatization - No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms.

Article 14 – Social Responsibility and Health

a)       The promotion of health and social development for their people is a central purpose of governments, that all sectors of society share.

b(iv) Elimination of the marginalization and the exclusion of persons on the basis of any grounds.”

 

 

Depending which models and determinants one follows in regards to health, wellbeing and disability the above quotes demand and justify totally different actions and regulation efforts. All the quotes from different documents obtain different meanings depending which models and determinants of health (medical, social, and transhumanist) one follows and whether one perceives health to mean ‘medical health’ and to be a determinant of wellbeing or wellbeing  including social well being to be a determinant of health leading to different  expected actions, and mandates. All of the quotes also lead to certain expectations as to the usage of Nanotechnology and NBICS and to certain expectations as the technology is used in relation to disabled people.

 

 

 

 

Conclusion:

 

So far the discourse around regulation hardly exists and the existing one is biased towards certain interests and certain worldviews. It’s a long way to go to make the regulation discourse useful to the global majority. To change the regulation discourse deficit it has to start to involve marginalized populations and it has to take into account social safety issues not just medical health/environmental safety issues.

 

Appendix 1: 

 

Synthetic biology applications(taken from http://syntheticbiology.org/Applications.html):

Areas Of Interest

·         Fabrication: Synthesis and Assembly

·         Computation & Signal Processing:

·         Energy Management:

·         Materials Processing: 

·         I/O And Sensing: MAS (chemical and E/B fields)

·         Mechanics

·         Replication And Evolution: 

Energy Production And Storage

Summary

·         Humans that photosynthesize

·         Photosynthetic oil factories

·         Power supply

·         Convert light to chemical or electrical energy

·         Superefficient agriculture via altered nutrient uptake (nitrogen fixing plants, etc)

·         Mechanical energy storage, in bio-molecular springs.

New Devices And Assembly

·         Plastic production with precise monomer order

·         Carbon nanotube building/binding

·         Collagen protein construction of molecular assemblies

·         assemble small things

·         Nanofabrication of micro and macro materials

·         New biological pathways

·         template independent DNA synthesis

·         Biologically compatible miniature cameras

Molecular Medical Devices

·         Medical Applications

·         Reversal of Aging

·         Disease Fighting

·         Implantable living battery for medical device. out of electric eel cells.

·         beneficial bacterial infections programmed to augment immunity, provide needed vitamins, etc.

·         cells that circulate in the body (extension of immune system)

[edit]

Story

The number of bacterial cells in your body at this very moment is equivalent to the total population of your own cells. For the most part they are beneficial, preventing infection, aiding digestion, and perhaps even producing useful chemicals. These commensals, as they are called, have evolved with humans in a strongly symbiotic relationship. Clearly, our body is already conditioned to hold a vast army of prokaryotes to do its bidding. How can synthetic biology harness this potential?

Imagine a time in the not-too distant future. Elliott wakes up in the morning to get ready for work. After taking a shower, he examines his clean, clear face in the mirror, deciding that he can probably wait another month before re-applying the bio-spray that keeps his skin pores clean and renders shaving unnecessary. The spray contains skin surface bacteria engineered to eat dirt, oil, and dead skin, as well as dissolve the keratin in facial hair, while keeping the skin intact. They also prevent colonization by foreign bacteria that can cause infection of pores in skin, preventing acne. He looks at his old toothbrush in the medicine cabinet, and decides to throw it away. Ever since the dentist gave him the oral wash earlier in the year, he has had no use for it. The wash contained a population of bacterial cells programmed to vigorously eat and break down any stains or food residue, and dissolve plaque buildup. They also created a special biofilm which prevents other bacteria from colonizing, eliminating halitosis and gingivitis. Elliott decided to change his breath scent, and picked up a small pen light which he set to yellow and flashed in his mouth. A few minutes later he checked his breath. Faintly sweet and citrusy, very pleasant. The bacteria had been programmed to produce different aromatic compounds depending on the detection of specific pulses of light; the type Elliott had washed with gave him 7 popular scents to choose from.

Elliott walked downstairs to the table for breakfast. He had a bowl of cereal and milk, along with a spicy southwest omelette and some sausages. Eating was always an enjoyable experience. Elliott used to be wary of many foods, as he was prone to frequent indigestion, especially from spicy foods or dairy products. But since his visit to the dietician earlier this year, those problems were a thing of the past. After analyzing his symptoms, the doctor selected a digestive commensal from the Biobricks 3000 catalog which had been programmed for his needs. Now lactose and the irritating chemicals in most spicy foods were broken down with ease in his stomach, before they could cause any distress . An added benefit was that he no longer had to worry about food poisoning. The new commensals specifically targeted and killed any pathogens from a long list of possible food contaminants, and could even neutralize the toxins these bacteria produced. Elliott relished his new state of permanent gastrointestinal bliss.

Elliott then left for his exciting job at the screw factory. Little did he know that the PDKLHS (People's Democratic Republic for Lefthanded Screws) had sinister plans this very day. (to be continued)

What we need to do

Such consumer product applications require a significant amount of metabolic engineering, combined with tightly restricted control systems. The chassis for these systems are already in existance, as harmless commensal bacterial species already inhabit these areas of our bodies. Taking these as a starting point, we need to design metabolic pathways and physiology which defines a solution-specific molecular input/output. for example, the toothpaste bacteria must have a metabolism which is geared toward the "food" we designate; in this case, plaque or materials that can cause cavities. These metabolic systems need to be tightly controlled by regulatory and logic systems that allow for feasability; i.e., sufficient energy and nutrients must exist and be managed in the pathway for the bacteria to happily make its living, without the buildup of harmful intermediates or any other metabolic "dead ends". Finally, the system must be designed so that waste products are optimal for function. For example, sweet smelling molecules for fresh breath, or other harmless outputs. The thermodynamics and molecular economy of the cell will have to be tightly constrained to accomplish this.

Potential Problems

Replication is one problem that will need to be overcome. How to keep the number of organisms at an optimum, so as not to elicit immune response or get any "buildup", while still reaping the benefits? one possible solution would be incorporating quorom sensing. Other problems involve restriction of growth. You do not want an anti-shaving bacteria to start munching on your eyebrows. Therefore somehow spacial control must be strictly maintained, and I am unsure how this would be accomplished.

Bioreactors

·         Make intelligent chemical or bioreactors

·         Dust eaters

·         Total Material recycling to ideal output (controlled bioreactor)

·         bacteria which break down waste and use it to create useful products

·         break down of toxic chemicals to nontoxic components

·         custom drugs

·         in vivo drug regulated production

Biofilm Scrubbers

Many bacteria grow into colonies which form surfaces with specific properties, called biofilms. These films themselves can be viewed as dynamic materials which can be designed for various functions. One possible function that has been suggested is to generate a biofilm that forms an airtight sphere. The bacteria in this spherical biofilm matrix would secrete hydrogen gas into the sphere, producing a "balloon" which could float. I suggest that such free-floating biofilm spheres would be the perfect cleaners for air pollution. In highly polluted environments, the bacteria would scavenge the particulate sulfur, nitrogen, and carbon compounds out of the air, using them for energy and growth. Waste products would include hydrogen gas, which would be excreted to the inside of the sphere, keeping it afloat.

Life cycle:

These structures would start as a typical bacterial mat-like structure. As hydrogen is generated and secreted in between the layers, it will begin to swell until bouyancy takes over, and the mat floats away as a sphere. Questions:

How big will the biofilm structure have to be? it is biologically realistic? How will the spheres replicate? Is there enough energy and materials present in pollutants to power a Hydrogen producing metabolism, or will photosynthesis be required? Can a biofilm be engineered that can prevent the escape of hydrogen?

Programmable Devices And Control Logic

·         Control cells

·         build a molecular Turing machine

·         create D/B and B/D converters (is this digital/bio?)

·         signal propagation across cells

·         programmable biological computers

You Me Genics

·         Human debugger (read/write)

·         body as edit surface

·         cybernetics

·         self repair bodies

·         external human processing

How do we get there?

·         Need to understand human genome extremely well

o        How to build using compatible materials?

·         What would the interface look like?

o        Need a way to have inputs and outputs on cellular level

o        Can we make cells that passively detect signals (like action potentials) without disturbing it?

·         How do we get away from all the bad notions associated with eugenics?

o        Need safeguards to prevent misuse

Programmed Organisms

·         Controlled crop maturing (count days)

·         chemically controlled pets

·         changing behavior

·         programmable pets

·         biological robots

·         syntho-eukaryotic cell

·         consumer products

Smart Materials

·         Smart paint

·         living self-repairing materials (inhabited by colony of engineered cells)

·         make materials (e.g. table top) that change shape on command

Sensors

·         smart sensors

·         noise detection and manipulation

·         use cells to read, process, output information

·         detect arbitary substances

·         self-reproducing chemical/radioactivity sensors

·         detect biotoxins and encapsulate. flash when it does.

·         responsive materials. oil lubricants by design/need

·         specific detection of chemicals by proteins

·         tools to measure concentration of protein in cell

·         ecosystem debugger (read/write)

·         single event/interaction detection (visualization)

·         Intelligent Biosensors

Complex Assembly

·         grow a house

·         grow chairs like we grow corn (do we really want chairs?)

·         build toys

 

 

 

 

 

 

 

 

 

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[1] Wolbring, G. Science and Public Policy, submitted; Wolbring (2006) "KEY TERMINOLOGIES IN THE FIELD OF DISABILITY: Impact on data, rehabilitation ‘health services’ and disabled people" for World Health Organization meeting on disability data and terminology on 27 and 28 July 2006  convened by the disability and rehabilitation unit of the WHO. .



[i] Dr Wolbring is based at the University of Calgary. He is a health researcher, a ability/disability studies scholar, a governance of science and technology researcher, a bioethicist, and a biochemist. He is a Biochemist at the Dept. of Biochemistry and Molecular Biology Faculty of Medicine University of Calgary, Canada, Adjunct Assistant Professor at the Dept. of Community Health, Faculty of Medicine, University of Calgary, Canada, Adjunct Assistant Professor at the Dept. of Community Rehabilitation and Disability Studies Faculty of Education University of Calgary, Canada; Fellow, Institute for Population Health University of Ottawa; Founding member and distinguished fellow Center for Nanotechnology and Society at Arizona State University, USA; Chair: Disabled People's International Bioethics Taskforce; Adjunct Assistant Professor at the John Dossetor Center for Health Ethics, University of Alberta, Canada; Founder and Executive director of the International Center for Bioethics, Culture and Disability Founder and Coordinator of the International Network on Bioethics and Disability. He is a member CAC/ISO - Canadian Advisory Committees for the International  Organization for Standardization  section TC229 Nanotechnologies and a  member of the Executive of the Canadian Commission for UNESCO. His webpage is www.bioethicsanddisability.org/start.hml . His biweekly column “The Choice is Yours” can be found here http://www.innovationwatch.com/commentary_choiceisyours.htm