Regulation

Regulation (209)
Self regulation (13)

Synopsis: Regulation: Regulation:

Methodologies and selected applications Knut Blind Regulation and Innovation Competence Center Fraunhofer Institute for Systems and Innovation research, Germany Berlin University of Technology, Faculty Economics and Management

We follow a rather wide perception of regulation and include standards and standardisation as elements of the regulatory framework.

which enable regulatory bodies to identify future needs for regulations. Finally the usability of the Delphi methodology is discussed

the United kingdom started with some cost-benefit analyses of regulations in the 1980s. Other European countries like Sweden or The netherlands followed in the mid 1990s.

including new regulations. Ex ante impact assessment is required to check all possible impact dimensions and to evaluate the likelihood of their realisation and their strengths.

and not yet widely spread trend is the move toward ex post evaluation of regulations, which is part of the progressive development of regulatory policies,

and monitoring their performance (i e. data gathering and reporting strategies) and practices to review existing regulations.

In order to justify a similar treatment of regulation and standards we have to mention another phenomenon which links standardisation and regulatory policies more strongly at the European level.

The New approach, confirmed by the recent ideas on European governance, requires the standards to be considered which complement or even substitute governmental regulations in comprehensive regulatory impact assessments

The convergence between governmental regulation and private standardisation justifies, and indeed requires, the inclusion of standards in our analysis. 497 K. Blind/Technological forecasting & Social Change 75 (2008) 496 516 Regarding the impact assessment of standards,

The focus of this paper will be neither on ex post impact assessment of regulations and standards nor on ex ante impact assessments of specific options of regulatory instruments.

and have been also be applied to regulation, in order to identify both promising areas for different types of regulation and their possible impacts.

In the following, we report some foresight studies, which focus directly or indirectly on the future need and role of regulations.

The crucial difference of our understanding of regulatory foresight is the main focus on the challenges for the regulatory regimes,

or cover also regulation as a policy instrument, but the main purpose is the reshaping of existing public research and development programmes or launching completely new programmes.

and policy-makers responsible for regulatory regimes but not for science and technology policy in the narrower sense to identify future requirements for regulations

or re-regulations, including formal standards released by standards development organisations not only in existing, but also emerging technologies, sectors or markets in order to shape pro-actively innovation-promoting regulatory framework conditions,

Benchmarking Financing R&d Provision of R&d infrastructure Technology transfer and innovation diffusion Legal frameworks (IPRS, standards and regulation) Integrated projects Networks of excellence Methodology:

we will not discuss all methodologies appropriate for performing ex ante impact assessments of regulations and standards.

and changes in existing regulations or new regulations, on the other hand, underlines that the former can in general be used to determine possible challenges for the regulatory framework in the future.

However, the identification of those regulation-relevant new technologies or new specifications within mature technologies is only just beginning

Within potential technological fields relevant for future regulation, regulation-relevant contents and possible stakeholders have to be identified,

Nevertheless, complementary content and stakeholders analyses allow a further specification of possible fields of future regulation and the identification of stakeholders.

which aim to identify future needs regarding regulations and standards. The following operational steps for the performance of surveys to identify future demand for regulations

and standards have to be distinguished: Elaboration of questionnaire (including the definition of questions on participation in standardisation and involvement in setting up regulatory frameworks, the relevance of regulations, the use of existing standards, the relevance of current regulations, future needs for standards

and regulations and possible impact dimensions; Definition/construction of target population in terms of type of organisation, sectors, size classes,

and regions Collection of survey and preparation of data set; Definition of goal variables of the organisation depending on the possible requirements for regulations and standards;

Construction of an econometric model based on theoretically defined relation of regulations and standards and goal variables;

Statistical or econometric data analysis and interpretation of results. 3. 2. 2. Examples Although we cannot refer to a large number of regulation-and standard-related surveys,

whose data permits the assessment of the future needs for and impacts of regulations and standards.

In a European-wide company survey, companies were asked about the relevance of different types of regulations for the market introduction of new products and services and the various aspects of innovation activities 8. In addition,

Most efficient are assessed the requirement to use plain language when drafting regulations, the harmonisation and coordinnatio of the regulatory policies of different regulation bodies, the instalment of One-Stop Shops responsible for all regulation

-related aspects, the acceleration and reduction of costs of certification and conformity assessments and generally the decrease in the amount of governmental regulations.

the results of the surveys conducted within the framework of the Community Innovation Survey also contain information about regulations and standards as obstacles for innovation and sometimes their role as source for information.

especially regarding quality and compatibility standards. 3. 2. 4. General assessment In general, there is only limited experience in the use of surveys for identifying future needs for standards and regulation.

and regulations differentiated into different types of stakeholder groups, which allows comparative analyses. If surveys address the universe of organisations, e g. firms,

and regulations and their possible future impacts is rather difficult even for experts, because standards and regulations contain technical,

strategic and legal aspects together and most experts in organissation cover just one dimension. This leads to rather moderate and low response rates.

Surveys are probably not the best tool to collect information about the future needs for standards and regulations.

Although Delphi studies are also capable of identifying promising fields or future needs for regulation, the issue of regulation was taken only into account in the large national Delphi exercises in Japan 43,

which was applied in Germany 44. Regulation was included in a set of possible obstacles, like lack of capital or human resources, for the development of science and technology.

In the following Sixth Japanese and Second German Delphi studies 45,46, all obstacle categories were changed into policy measures

and the obstacles regulations were transformed into changes in regulations. The survey results could be used to identify those areas which are hampered

either by regulation or which can be promoted by adjustments of the regulatory framework. In the first German Delphi survey, the field communication was characterised by the most negative values regarding the impact of the regulatory framework3 because of the former monopolistic structures in the telecommunication markets and the massive public intervention in the radio

However, regulations still enjoy a rather high importance in the information and communication fields. From these experiences, it can also be derived that the Delphi methodology can be used to set priorities in regulation

and to assess the future impacts of regulations in rather future sciences and technologies. However, surveying the activities in the last years,

we can only list some exercises, like surveys and trend workshops, which tried to identify future needs in regulation in already existing

or emerging markets. 3. 3. 3. A Delphi survey among telecommunication experts Whereas in most of the previous selected examples of Delphi studies regulation was a side aspect of secondary relevance,

or establishing regulations); deregulation (relaxing or abolishing related regulations), and standardisation within formal standards development organisations for the implementation of these visions.

Table 2 presents the assessment of the 21 telecommunication-related technologies expected to diffuse mostly within the next ten years.

which are characterised by a high relevance of regulations as obstacles or as required policy measure. Based on this information

NO-REST ITU Survey Fraunhofer ISI 2005)( 1=low importance to 5=high importance) Year Importance R&d Regulation Deregulation Standardisation Widespread use

& Social Change 75 (2008) 496 516 pushed by adequate regulations, whereas again standardisation is assessed to be limited of effectiveness for achieving

There are obvious different impacts of governmental regulations and standardisation as an important form of self regulation with the former type being more effective for achieving health, safety and environmental aspects,

we still find a positive correlation between regulation and standardisation, whereas regulation and deregulation correlate negatively.

In addition, both regulation and self regulation loose significantly in importance the more in the future a new technology might be realised.

Finally the assessment of R&d support and standardisation as a more diffusion oriented policy instrument correlate very high,

whereas the statistical connection between R&d support and regulation is rather vague. 3. 3. 4. General assessment In general,

we could identify only very few and not very systematic foresight exercises regarding future priorities for regulations and standards.

However, the sound experiences of the Japanese and German Delphi studies underline that foresight methodologies can be applied for the identification and setting priorities of future areas of regulation and therefore also of standardisation

but also for the ex ante assessment of the impacts of regulations standards. Furthermore, the small-scale Delphi survey focusing on the future demand for standards in the ICT area confirmed the general applicability of this approach,

but even regulations and standards not yet existing. The classical foresight methodologies enjoy a high acceptance, if they are performed in an adequate way.

The application of the Delphi method to the issue of regulations and standards requires the development of questionnaires,

and areas requiring different types of new regulations or an adjustment of existing regulations in the future.

which are the criteria for setting priorities in the possible regulatory instruments, like safety regulations or standards.

and marketing issues, have to be involved as well as those ministries responsible for general regulatory issues and the officers in regulatory bodies taking care of the implementation of regulations.

which is required to detect fields where regulations can help to increase the acceptance of future technologies and innovative products.

For each scenario, the respective relevance and impacts of the selected regulation have to be determined.

but also possible impacts of regulations and standards. Delphi surveys require the identification of a sufficient number of experts dealing with regulatory issues

or influence future regulations. 4. Comparison and assessment of methodologies Although we cannot refer to a broad sample of regulatory foresights,

and to conduct several studies trying to determine the future needs for regulations and standards,

and a need to look for further methodological improvements towards regulatory foresights focusing on future strategies and actions concerning regulation and the special needs of regulatory bodies.

and fields of regulations is developed not yet. Simple quantitative approaches are not sufficient. However, the databases provide further information about 512 K. Blind/Technological forecasting & Social Change 75 (2008) 496 516 regulation-relevant contents, like health,

environmental and safety aspects addressed in scientific publications or patents, and even the identification of stakeholders, especially companies,

countries and over time Little information about possible types of regulation Detailed analysis allows the identification of specific regulation-relevant content

and the organisation Detect insights of specific needs for future regulation High cost and time-consuming Qualitative Assessment of future relevance of regulation,

but also actual relevance of existing regulation Findings from the surveyed sample can be generalised to the universe Processing and analysis of data requires large human resources Identification of adequate samples Some types of information are difficult to obtain (answers to counterfactual questions

Analysis of Regulations Shaping New Markets, European commission DG Enterprise (ed.),Luxembourg,(2004. 9 B. R. Martin, Foresight in science and technology, Technol.

Labour Market Institutions, Product Market Regulation, and Innovation: Cross country Evidence, ECO/WKP (2002) 2, OECD (ed.),Paris. 29 U. Blum, A. Töpfer, G. Eickhoff,

50 S. Kuhlmann, C. Bättig, K. Cuhls, V. Peter, Regulation und künftige Technikentwicklung, Technik, Wirtschaft und Politik.

In addition he is head of the competence center Regulation and Innovation of the Fraunhofer Institute for Systems and Innovation research.

To the extent that this path would also comprise benevolent regulation and S&t policies, what we show here as the possible future path/paradigm at the level of an application area (drug discovery) may also be called an innovation system.

and regulations may give rise to a number of future trends, some of which are briefly summarised below. 1. Intensifying international mobility of postgraduate students and researchers.

i) a conscious strategic choice to use available funds and other policy tools (e g. regulation) exclusively or excessively for boosting competitiveness,

i) the context conditions are less stable and predictable due to increasing changes on the demand side and changing regulations,

Firstly, uncertainty in context conditions has been increasing substantially due to changing regulations, rapid urbanization and shrinking rural regions as well as market liberalization 3. Secondly

context factors like economic, demographic and settlement development, future political culture and environmental regulations. They select the most influencing

On the other hand, new water regulations require the removal of micro pollutants. III) The top/flop scenario describes a downturn of industrial activity in the region.

JRC (2002) and compilation by OECD. Area/name of composite indicator Economy Composite of Leading indicators (OECD) OECD International Regulation Database (OECD) Economic Freedom of the World

different ex-ante evaluations procedures have been integrated into one regulatory policy appraisal approach to improve the quality of regulation,

Ministries can be obliged by regulation, cabinet decision or voluntary agreement, for example, to undertake scenario planning regularly

Much of this interaction concerns the current drive toward regulation and codification of the research and technological development needed for the creation of desirable artifacts.

Of course the technology options themselves may shape the landscapes that they encounter could initiate a change in industrial sectors, in regulation etc.

and the various environments (industrial, market, society, regulation, research, etc.).5 To this end it was necessary to create a scenario method

The key point here is that novelties do not traverse a static landscape made up of various selection environments (such as regulations, markets, policy etc.

but by the end of 2007 they were solidifying into policy and regulation. Thus, there was an occasion to launch a technology assessment exercise,

whilst in the meantime proposals for regulation were being formulated and various NGOS were taking positions, often advocating a precautionary approach (cf.

because existing law and regulation is sufficient, at least for the time being. Thus codes are on the agenda,

may remove the pressure to develop regulation. 10 I have placed innovation journeys at the micro-level, technology developer coordination attempts at the meso-level and selector coordination and control at the macro-level.

SME's, already severely hampered by lack of public financing (linked with university ties) can't cope on own with voluntary regulations,

providing some guidelines for nano alongside existing regulation of medical devices and so self regulation of new nano-enabling components can continue.

Gaps in regulation widen as nanotechnologies become increasingly more complex existing laws which could be applied to products (medical devices) are equipped less to oversee products and processes such as active nanostructures

there is no new nano specific regulation so soft law is taken as a solution. This was one vision of the future proposed by a number of codes of conduct tabled in the December 2007 EU meeting.

this element linked up with the difference between two regulation reviews in the UK during 2006.

HSE executive saying current regulation was enough. DEFRA saying there are gaps 37..Industrial consortia and research networks develop agreed best practices,

providing some guidelines for nano alongside existing regulation of medical devices (such as ISO 14971 for Medical Devices),

Codes are intended not to supplant regulation but in practice reduce pressure on regulators causing delays in regulatory mechanics.

but the major emphasis lies on the fact that nano regulation is difficult due to increasing complexity law is equipped less to oversee products and processes such as active nanostructures

The lack of nano specific regulation allowed innovations to proliferate but transition into the clinic became fraught with many other challenges related to user needs and user practices.

The Finnish case sparks of a chain of enquiries into nano-regulation, and a number of lines of R&d grind to a halt pending further investigation Finnish case triggers a temporary moratorium:

and lack of 13 REACH regulations Registration, Evaluation, Authorisation and Restriction of Chemical substances (EC 1907/2006) which entered into force on 1 june 2007.

'since future investments in research infrastructures or future changes in policies/regulations, for example, can make a significant difference to a country's ability to exploit a particular S&t thematic area.

which was renamed subsequently Regulation of Chronic, Degenerative and Infectious diseases. 15. At the same time, however, overwhelming participants with large amounts of generic datawould have lead to confusion and frustration.

as for example within the areas of environmental regulation or energy conservation. In the Norwegian municipal visioning project stakeholder participation was socially and politically legitimised by the municipal government and the municipal employees responsible for the project.

which everybody can agree upon. 22 These universal values are being included in laws and regulations on planning procedures with no further reflections upon

The co-evolution trajectories are determined partly by characteristics of National innovation systems such as regulation and cultural context 10.

in putting in place its instruments and regulations, its broad objectives and budget; it involves Government and Parliament.

and strong industrial push on the one hand and sceptical citizens and consumers and strict regulation on the other.

The commercial environment is constantly evolving through the interactions of thousands of variables from market-driven pricing processes to government regulations, from consumer opinion to market competition,

and the use of procurement or regulation to stimulate innovation is dependent upon the formation of a common vision between the supply

new demand-side innovation policies such as the use of innovative public procurement and regulation to pull through innovations requires a shared vision on the part of purchasers and suppliers.

By contrast demand-side measures seek to use instruments such as public procurement, standards and regulation to pull-through innovations.

More recently prominent demand-side policies include use of regulation and standards to stimulate innovation.

but also opportunities for regulation to foster the development of new markets 37. A series of methodological options, including scientometric indicators,

and other factors such as regulation and competition are favourable. Put simply, a lead market provides a launch platform for innovations

and the implications for regulation towards an approach for the information society, COM/97/623, December 1997.17 Nordic ICT foresight, available at:

The paper concludes with those issues in which the FTA COMMUNITY is starting to devote attention to as well as those it still ought to consider. 2. History Governance is an outcome of the continual battle between risk and regulation.

Risk and perceptions of it are closely related to fear making the proper understanding of the real physical nature of risk of prime importance to framing regulations where the politics of fear may intrude irrationally.

Regulations are framed to attempt to calm the perceptions of risk and to control or reduce fear

and implements regulations in ways that are a political art as much as a science, underlain by the question of equity:

and glocalisation and to the need to anticipate the future needs to manage risk and regulation.

which is threatened through risk, regulation and governance. The relationship between advances in technology and human social development was established during the Enlightenment well before the notion of‘economics'was born as a cultural invention, rather than as a pseudo-objective science.

and others 5 7. The nuclear threat was seed the for the current call for new forms of governance to cope with the regulation of S&t that is now embedded in the combined phenomena of globalisation and glocalisation of business, with effects on every aspect of modern

regulation and public policy 8. The shift from technocratic decision making towards more democratic processes can be captured in the concept of governance.

Governance and regulatory concepts imply a modified description of what regulation is and how it works, where the regulatory limits of state authority and the potential of society to influence

and their implementation are done in a manner that follows rules and regulations. It also means that information is freely available in easily understandable forms

and beyond regulation to balance the needs of stakeholders with the need to make a profit 24.

Regulation brings with it predictability and in many cases, innovation, such as standards which can be improved continuously through a combination of both research and legislation 24.5.3.

and regulations are embedded in globalisation and glocalisation. Similarly, innovations in international agreements on trade, standards of all kinds, intellectual property rights, environmental matters, health and safety and human rights are involved all, often interactively,

) In this entire context, standardisation in regulation is one of the fundamental concepts of governance.

This kind of‘private'regulation is named‘self regulation 'and has become part of the standardisation and regulation process in a number of areas including food safety and environmental standards.

and regulations embodied in governance. The move towards a new mantra for FTA is shyly

Concluding, the expectations on the societal level show a contradiction in the sense that on the one hand nanotubes are used without regulation

and on the other hand there is a public call (from various groups) that regulation is needed. However, the fact that nanotubes offer great promises for various industries is acknowledged. 3. 1. 2. Technological field After the discovery of the single-walled nanotube in 1993,

which are covered not by current regulation. Second, at the level of the EU, a 6th framework programme has been approved.

Municipal policies are implemented strictly through norms and regulations. In this context, the planning value chain is fragmented very much

Clear and strict regulations are established to force companies and public bodies to internalise their environmental costs. 4. 3 Step 3:

as well as the performance of ex post evaluation of regulations (which is part of the progress development of regulatory policies,

and monitoring their performance (i e. data gathering and reporting strategies) and practices to review existing regulations (Blind, 2006).

and prioritizing the future areas of regulation. 6. These were the cases of the future-oriented technology assessment exercises conducted during the period 1974-1995 by the US Office of Technology assessment (OTA).

which concerns the task of governmental authorities to develop policy instruments and regulations;(ii) the arena of research performance:

The market is a distinct selection environment, next to institutional (regulations), cultural or political selection environments.

such as national regulations or exchange rates, and market issues, such as moves by suppliers and established competitors.

middle classes Uncertain results for banking regulation A challenge to liberal democracy models Conflict follows geopolitical shifts Terrorism continues to pose a threat to security A multi-polar governance system Religion

investment Smart travel Carbon taxes Transport market liberalisation versus environmental regulation Education and skills The knowledge economy ICT in education Social mobility and higher education Social

changes in regulation, changing/stronger ethical concerns, scarcity of natural resources, environmental issues, etc. as well as due to new combinations of existing and/or emerging technologies.

, fluctuations in demand, regulations, ethical or environmental concerns. In addition, one would want to address the potential unintended, indirect,

However, the next strategic document, the Action Plan Nanotechnology 2015 refers to only some initiatives of other ministries and agencies (mainly with regard to regulation,

First, regulations and specifications imprinted by the parent organization and frequent reporting duties equal to those of significantly larger projects subsidized in the European Framework Programs (FPS) not only significantly slow down the network's activities,

a prospective study dealing with the future evolution of the creative content industtries She has worked also for many years in the field of electronic communications policy and regulation at Europeea level.

In 1982, to fit the new‘Good Manufacturing Practice'regulations announced by the government, the manufacturing facilities of local SMES were upgraded (Zheng 2001:

all the companies producing Chinese herbal medicines followed the regulations of the US Food and Drug Administration (FDA).

To comply with the US FDA regulations, each new herbaceeou medicine was made by a single composition extraacte from a particular herb.

Due to the regulations concerning academics, 7 interactions between universities and pharmaceutical firms were forbidden. In fact, the main occasion for academics to practice their knowledge was to support the government in drawing up regulations in order to control the qualities of the pharmaceutiicals For example

some scientists of Chinese herbal medicines were funded by the government to survey the herbs of Taiwan.

in order to comply with the Good Manufacturing Practice regulations. But until the late 1990s, there was no institution

Thus regulation and FDI policies were very important. After 1982 as policies graduaall turned to encouraging innovation in the pharmaceuticca sector,

and remained the most important regulation controlling the manufacture of medicines until 2000. The Good Manufacturing Practice regulations were launched in 1982 to force the local SMES to upgrade their manufacturing capabilities.

In 1950, the government launched the‘Statute for Encouraging Foreign Direct Investment'(abolished in 1990)

Nevertheless, because of the Taiwanese government regulations, even though the GM papayas were developed successfully, they were allowed not to be cultivated in the normal farms (Science and Technology research and Information Center, 2005:

8 Another important agricultural policy promoted by the government was agricultural regulation. Before the 1980s, there was no policy regulating the innovation of seeds.

Moreover, until 2000, there was no regulation for non-edible GMOS. Therefore, non-edible GMOS, such as GM ornamental fish, could be traded in the domestic market without permission.

Because of the regulation of human resources in universities the networks between universities and pharmaceuttica companies were established not clearly.

The policies directed towards the pharmaceutical biotechnology system were regulations, FDI and R&d. Before the 1980s,

the main policies were regulation and FDI, which aimed to control the manufacturing facilities and the quality of the medicines.

many of them defined differently in different national spaces, e g. through regulations, financiia incentives, consumer preferences etc.

business routines as well as organisational and institutional patterns and infrastrucctures finance available (including foreign direct investment), public procurement, standards, intellectual property rights, regulations etc.

and regulations) and soft institutions (e g. social norms and values) that can enable or hinder innovation.

various visions and expectations, regulations and policies, and the activities of lead users. As such, guidance can be considered to be an interactive and cumulative process of exchanging ideas between technology producers, users and many other actors..

particularly for radical innovatiions The innovation system therefore needs to create spaces, for example, through procurement policies, standards or regulations that nurture demand for innovations..

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