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Impact of the e-Economy on European enterprises

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Impact of the e-Economy on European enterprises

Outline of the Community (European Union) legislation about Impact of the e-Economy on European enterprises

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Information society > Digital Strategy i2010 Strategy eEurope Action Plan Digital Strategy Programmes

Impact of the e-Economy on European enterprises

This communication analyses the impact of information and communication technologies on European companies and the European market. The objective is to support the full introduction of the e-Economy in Europe.

Document or Iniciative

Communication from the Commission to the Council and the European Parliament – The impact of the e-Economy on European enterprises: economic analysis and policy implications [COM(2001) 711 final – not published in the Official Journal].

Summary

Background

Information and communication technologies (ICT) are having a profound impact on the potential for economic growth and have become one of the main sources of competitiveness and increases in incomes. As a result, they have moved to the centre of the policy debate. When in March 2000, in Lisbon, the European Union (EU) set itself the ambitious target of becoming the world’s “most competitive and dynamic knowledge-based economy” within ten years, it recognised that attaining this goal depended on making the best possible use of ICT. The Lisbon strategy placed greater emphasis on the knowledge-based society within existing policy processes and launched the eEurope 2002 Action Plan as a roadmap to modernise the European economy.

The emergence of the e-Economy: macro and microeconomic issues

It is generally accepted that, atmacroeconomic level, the increased use of ICT leads to productivity gains and hence improves the competitiveness of enterprises and the economy as a whole. ICT-induced productivity gains are also a source of job creation in certain sectors – whereas jobs may be destroyed in others. ICT use does away with repetitive jobs often carried out by workers with low-level skills. The overall dynamism resulting from ICT use leads to job creation in other areas to an extent that more than offsets the losses.

In this context, the matching of skills poses a major challenge for the design and conduct of the labour market. The ICT skills gap is a major risk hampering further growth in Europe. The situation is particularly sensitive in Europe due to declining demographic trends and the decreasing level of interest of young Europeans in scientific studies.

Atmicroeconomic level, the e-Economy is leading to important changes in organisational market structures. The faster pace of technological change is having a major impact on the structure and lifecycle of enterprises. Firstly, ICT reduces the economic impact of distance and the cost of access to information, thus increasing the scope for competition within markets. Secondly, ICT often tends to lower the cost of setting up small enterprises thus, potentially, providing for additional competition. Thirdly, ICT creates the opportunity for new cooperative means of product and service delivery, which can lead to improved quality and cost efficiency. Finally, and perhaps most importantly, ICT gives rise to many new products and services.

The process of creating new enterprises and of adapting or replacing traditional enterprises is indicative of the way the economy adapts to new market conditions. This process has accelerated considerably since the late 1990s. Products are increasingly becoming “extended products” which include an important service component. Internet-oriented enterprises are starting to acquire the characteristics of traditional enterprises, such as warehouses and chains of shops. Conversely, traditional retailers are starting to move part of their activities on-line, adding new distribution channels and new sourcing strategies.

The impact of ICT varies, however, from sector to sector. Information-rich sectors (digital goods, information services, financial and business services, etc.) witness the emergence of new business models and increased market competition. In industries where entry barriers are higher, such as construction and heavy engineering, the impact is likely to be more gradual. Digital interactions between administrations and business are key components of the e-Economy. By offering online access to public services, administrations can add concrete, direct incentives for enterprises to go digital themselves.

One characteristic of the e-Economy is the emergence of new business models. A substantial number of these have failed, along with many “dotcoms”. Others however, have proved to be viable, notably in the business-to-business (B2B) area. Entering the e-Economy at a more mature stage may constitute an opportunity rather than a disadvantage for EU enterprises which have learnt from the mistakes of pioneers. Enterprises can now use tried and tested technologies, as well as viable business models – more specifically B2C (business-to-consumer) whose potential has still to be tapped.

E-Economy enterprises increasingly need to define and manage the risks associated with extended and dynamic enterprise configuration – not just the risks associated with the information infrastructure but also, and especially, those relating to access to adequate financial resources. Although the situation is improving, the EU venture capital market remains only a fraction of that of the US, where pension funds play a major role. Early stage investments in 2000 were five times higher in the US than in Europe. The financial environment in Europe is still insufficiently conducive to innovation, both technological and organisational. In this respect, the European Investment Bank with its “Innovation 2000” initiative and the Commission under the Action Plan on financial services and the multiannual programme for enterprises and entrepreneurship (2001-2006) and the Competitiveness and Innovation Framework Programme (CIP) (2007-2013) have takenn initiatives to contribute to the supply of risk capital for innovative businesses.

Maximising the benefits of the e-Economy: the next steps

This Communication highlights the steps that will have to be taken to maximise the benefits arising to European enterprises from the e-Economy. These steps encompass:

  • the fostering of a culture of entrepreneurship;
  • enhancing the ICT skills levels needed to participate effectively in the e-Economy;
  • raising the ability of European enterprises to compete in a modern global economy;
  • further improving the functioning of the internal market.

Skills underpin entrepreneurship. Both issues are tightly interrelated. The problem of the skills gap (entrepreneurial skills and technical ICT skills) has been addressed through a number of initiatives, notably in the European Employment Strategy and in the eLearning Action Plan (2001-2004). Taking into account these challenges, there is a need to:

  • accelerate the development of focused skills programmes and e-learning solutions;
  • strengthen research efforts not only in the area of technology, but also with regard to related socio-economic issues and to the effects on human resources;
  • strengthen on-going initiatives at all levels to help enterprises, especially small and medium-sized enterprises (SMEs), acquire ICT and e-business skills;
  • monitor the demand for ICT and e-business skills in Europe, benchmark national policies, and strengthen co-operation and co-ordination at the European level;
  • launch focused projects in 2002, in close co-operation with Member States and the private sector, which aim to address the specific needs of enterprises, particularly SMEs.

The simplification and harmonisation activities undertaken at European level up to now should be continued in order to enable rapid development of pan-European businesses and fair trade in both the B2B and B2C environments. On the other hand, it is necessary to continue to review existing product legislation, in particular certification requirements and procedures to ensure that they are neutral between different means of product and service delivery.

Not all problems, however, can be resolved by legislation alone. Self-regulation should play an important role in promoting trust between partners in electronic transactions. Public policy should be aimed at raising credibility for self-regulation and at ensuring that codes of conduct are respected, through the availability, if needs be, of legal remedies.

In Europe, the e-Economy depends to a significant extent on the full participation of SMEs. The eEurope Go Digital initiative provided a first response to this challenge. It aimed to ensure that European enterprises, and in particular SMEs, fully embraced e-business and became active participants in the e-Economy. It is therefore necessary to:

  • foster open standards and certification procedures;
  • reinforce the security of networks and of information;
  • contribute to reinforcing legal certainty for SMEs engaging in cross border e-business;
  • optimise the use of existing resources, such as structural funds and research and technological development (RTD) budgets.

Exchanges between business and public administrations are a potentially powerful driving force for the e-Economy. This communication encourages public administrations to be at the leading edge of on-line service delivery, and to provide incentives for enterprises to access such services. Public administrations are also urged to continue these efforts to modernise their internal structure, by fostering, for example, the delivery of online services. The aim is to ensure broad interoperability both across borders and between administrations and business.

Related Acts

Communication from the Commission of 13 March 2001 – eEurope 2002: Impact and Priorities

[COM(2001) 140 final – not published in the Official Journal].

Communication from the Commission of 13 March 2001 – Helping SMEs to “Go Digital” [COM(2001) 136 final – not published in the Official Journal].

Councilof 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) [Official Journal L 333 of 29.12.2000].

 

A single market for 21st century Europe

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A single market for 21st century Europe

Outline of the Community (European Union) legislation about A single market for 21st century Europe

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Research and innovation > Research in support of other policies

A single market for 21st century Europe

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 20 November 2007 entitled: “A single market for 21st century Europe” [COM(2007) 724 final – Not published in the Official Journal].

Summary

The single market is beneficial for consumers and businesses. It has supported job creation and stimulated growth, competitiveness and innovation. The single market has also been essential for the smooth functioning of the economic and monetary policies of the European Union (EU). However, it still has untapped potential.

HARNESSING THE POTENTIAL

The Commission proposes a single market for the 21st century which is strong, innovative and competitive. Building on its existing strong foundations, the single market must concentrate on key areas with potential added value in order to face up to new challenges.

Consumers and businesses

The single market needs to deliver better results and benefits to respond to the expectations and concerns of consumers and businesses. The guarantee of high standards has enabled consumer protection to be ensured in terms of choice and quality of goods, prices, rights, fighting unfair commercial practices and abuse of dominant positions, etc. Nevertheless, the single market can offer more in key sectors of the daily life of consumers, such as energy or telecommunications, and sectors which are fragmented or typified by a lack of effective competition.

The safety and quality of goods and services and market surveillance also need to be strengthened. Food safety, pharmaceuticals and retail financial services are areas in which consumers must be educated and empowered in order to derive full benefit from the single market. In this respect, consumer rights, and especially contractual rights, and redress should be re-examined to move towards a simple, comprehensive protective framework.

In addition, small and medium-sized enterprises (SMEs) are not integrated in the single market in the same way as large enterprises. Their participation is impeded mainly by tax fragmentation and language, cultural and consumer barriers. The initiative of the Small Business Act, based on the principle of “think small first”, and improvement of the tax environment should provide an appropriate response to this problem.

Coping with globalisation

In a constantly changing international context, the single market presents many advantages in terms of innovation, competitiveness and choice, whilst respecting labour, health, safety and environmental standards. Through its nature, it has attracted foreign investments and firms.

The EU must continue this process to cope with globalisation, concentrating on the pillars identified in the Communication “Global Europe competing in the world (BG) (CS) (ET) (GA) (LV) (LT) (HU) (MT) (PL) (RO) (SK) (SL)”, i.e.:

  • the trade and competition policy instruments which guarantee a competitive space by responding to foreign subsidies and other unfair practices;
  • promotion of cooperation on multilateral and bilateral norms. The EU must take inspiration from international standards and its own standards must serve as a world reference, ensuring it a leading role, especially if it speaks with one voice;
  • ensuring that the benefits of market openness reach European citizens, especially in terms of choice and price, but also by following up on trade agreements.

Making knowledge and innovation the “fifth freedom”

The single market, which was originally based on primary products and manufactured goods, has to provide for the greater integration of services, which are assuming a growing role in a knowledge-based economy. In this way, it must tap the potential offered by the new technologies for the benefit of a “fifth freedom”, i.e. free movement of knowledge and innovation.

The Services Directive is the lynchpin of this process. Nevertheless, the removal of barriers and strengthening of competition must be continued to offer more choice at lower prices to consumers and to boost innovation. Initiatives have been taken along these lines, especially with regard to the network industries (energy, postal services, transport, telecommunications, etc.). Information and communication technologies (ICT) are also an asset for the development of interoperable services in the context of the “e-Internal Market” (electronic invoicing, online public procurement and electronic customs), without creating new “e-barriers”.

The mobility of workers, researchers and students must be guaranteed to promote knowledge-sharing. The 7th Framework Research and Development Programme (7th FRDP) and the plan to introduce a “researcher passport” form the foundations of mobility and the development of research networks within the European Research Area (ERA).

Social and environmental dimension

Market opening has social and environmental impacts. The Commission will improve its impact assessments to anticipate market changes more effectively.

The development of the single market goes hand in hand with the European social agenda. Economic and social cohesion, based on the Structural Funds, allows citizens and businesses to be empowered and the benefits of the market to be spread to all regions of the EU. In this respect, the “European Grouping for Territorial Cooperation” (EGTC) offers new possibilities for cross-border cooperation in areas such as health, environment and infrastructures.

Workers’ mobility receives further support under the Job Mobility Action Plan. However, this must respect the fundamental rights of workers, including equal opportunities. The European Works Council will be adapted along these lines.

The development of “eco-industry” (pharmaceuticals or car manufacturing) contributes to the environmental dimension of the single market. Further investments are still needed, especially to contribute to fighting climate change.

DELIVERING RESULTS

An enlarged, diversified EU depends more than ever on the single market working well. The EU must concentrate on the evidence and the impact of the markets, giving priority to where markets do not deliver and where there are maximum chances of improvement. Market monitoring will be stepped up to determine the reasons for market failures and their potential on the basis of competition sector inquiries, lead markets and joint technology initiatives. The consumer scoreboard, which will be integrated into the Single Market Scoreboard from 2009, will provide additional information on the performances of these markets from the point of view of consumers and economic and social requirements.

Simple, appropriate tools will allow the single market to be more targeted and better enforced, without ending up with more regulations. Recourse to existing instruments and procedures under the various policies must be rationalised to achieve an optimum result. This also applies to the tools for the evaluation and implementation of Community legislation. The Commission will reconsider ineffective or superseded Community interventions.

All levels of governance, authorities and stakeholders must be involved on the basis of greater decentralisation, fostering ownership and mutual trust in the context of new working relationships and approaches. The networks, which could be based on “single market centres”, are essential in this respect to ensure enforcement of Community legislation and cooperation, promoting exchanges of experience and good practices.

Communication and access to information form the basis for transparency and knowledge of the Community rules. Member States are responsible for this. Achievement of these objectives will be based on the “single market ambassadors” pilot project (prominent persons in business and trade), a “one-stop shop” for the various services available to citizens and businesses (Europe Direct, Your Europe, SOLVIT, Citizens’ Signpost Service, EURES, the new integrated business support network, etc.), as well as a Single Market Scoreboard adapted to allow better evaluation of performance.

Authorisation and supervision of medicinal products – European Medicines Agency

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Authorisation and supervision of medicinal products – European Medicines Agency

Outline of the Community (European Union) legislation about Authorisation and supervision of medicinal products – European Medicines Agency

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Internal market > Pharmaceutical and cosmetic products

Authorisation and supervision of medicinal products – European Medicines Agency

Document or Iniciative

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [See amending acts].

Summary

With this Regulation, the European Union (EU) develops and improves European procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use. The Regulation also provides the legal basis for the European Medicines Agency, which was established in 1993.

AUTHORISATION OF MEDICINAL PRODUCTS

Scope

No medicinal product appearing in the Annex may be placed on the European market without prior authorisation from the EU. The centralised authorisation procedure will be compulsory for:

  • medicinal products derived from biotechnology;
  • advanced therapy medicinal products;
  • orphan medicinal products;
  • medicinal products containing an entirely new active substance for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes, auto-immune diseases and other immune dysfunctions and viral diseases.

The centralised authorisation procedure will be optional for:

  • other medicinal products containing a new active substance;
  • medicinal products which constitute a therapeutic, scientific or technical innovation or are of interest at Community level.

Immunological veterinary medicinal products for the treatment of animal diseases that are subject to Community prophylactic measures may also be granted such authorisation. Finally, generic medical products of reference medicinal products authorised by the EU may be subject to a decentralised authorisation procedure, provided that the harmonisation achieved at European level is maintained.

Authorisation of medicinal products for human use

The Committee for Medicinal Products for Human Use is part of the European Medicines Agency. It is responsible for drawing up the opinion of the Agency on any matter concerning the evaluation of medicinal products for human use.

Each application for authorisation must be accompanied by the particulars and documents referred to in Directive 2001/83/EC on the Community code relating to medicinal products for human use, and by the fee payable to the Agency. It should also contain a statement to the effect that clinical trials carried out outside the European Union meet the principles of good clinical practice and the ethical requirements of Directive 2001/20/EC on good clinical practice in the conduct of clinical trials on medicinal products for human use.

Each authorisation decision must be taken on the basis of scientific criteria concerning the quality, safety and efficacy of the medicinal product concerned. These three criteria make it possible to assess the risk-benefit balance of all medicinal products. The Committee verifies first of all that conditions for granting a marketing authorisation are satisfied. If this is not the case, the applicant is informed forthwith and he/she may give notice to the Agency within fifteen days that he/she wishes to request a re-examination of the opinion.

In general, the Committee must give its opinion within 210 days after receipt of the application. This analysis may involve a test being conducted on the medicinal product, its starting materials or its intermediate products and a specific inspection of the manufacturing site of the medicinal product concerned.

Within 15 days after receipt of the opinion, the Commission prepares a draft of the decision on the application which may contain the marketing authorisation. If this draft decision is not in accordance with the opinion of the Agency, the Commission annexes an explanation of the reasons for the differences, which is forwarded to Member States and the applicant. The Commission takes a final decision following a procedure of consultation of the Member States (comitology) within 15 days of the end of the procedure.

After verification of the particulars and documents submitted, the marketing authorisation may be refused if:

  • the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;
  • the particulars provided are incorrect.

At the time of authorisation, or once the marketing authorisation has been issued, the Agency may recommend that the Commission impose an obligation to carry out:

  • a post-authorisation safety study;
  • a post-authorisation efficacy study.

These obligations are contained in the authorisation and in the risk management system.

The marketing authorisation is valid for five years and may be renewed. Once it has been renewed, the marketing authorisation is valid for an unlimited period unless the Commission once again opts for a validity of five years.

Authorisation of medicinal products for veterinary use

The Committee for Medicinal Products for Veterinary Use is part of the Agency. It has sole responsibility for preparing the Agency’s opinions on all questions concerning the evaluation of veterinary medicinal products.

Most of the above considerations apply in this field, subject to adjustments relating to certain technical or scientific characteristics.

The marketing authorisation may be refused if:

  • the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;
  • the product is presented for a use prohibited under European law;
  • the health and welfare of animals or consumer safety are not sufficiently taken into account in the case of zootechnical veterinary medicines and performance enhancers;
  • the withdrawal period indicated by the applicant is not long enough to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard for the consumer.

For both categories of medicinal products, if the products marketed are of major therapeutic interest, the applicant can request an accelerated assessment procedure.

The refusal of an EU marketing authorisation constitutes a prohibition on the placing on the market of the medicinal product throughout the EU. Any marketing authorisation which is not followed by the actual placing of the medicinal product on the market for three consecutive years ceases to be valid.

SUPERVISION OF MEDICINAL PRODUCTS (PHARMACOVIGILANCE)

Pharmacovigilance rules are necessary in order to protect public health and to prevent, detect and assess the undesirable effects of medicinal products for human use placed on the EU market, insofar as the safety profile of medicinal products can only be fully appreciated after products have been marketed. In the light of the knowledge obtained and following an assessment by the Commission of the EU pharmacovigilance system, it transpired that measures to improve the European pharmacovigilance system were required.

The Regulation provides for increased market surveillance by reinforcing monitoring procedures. When the medicinal product has been manufactured in the EU, the supervisory authorities are the competent authorities of the Member States which granted the manufacturing authorisation. In the case of medicinal products imported from third countries, the competent authorities are those that granted the import authorisation. These must inform the Committee for Medicinal Products and the Commission of all instances where the manufacturer or importer fails to fulfil the obligations laid down.

The holder of a marketing authorisation for a medicinal product for human or veterinary use is obliged to make any variations that may be required taking account of the manufacturing methods and of technical and scientific progress in accordance with Directives 2001/83/EC and 2001/82/EC.

The holder must also ensure that the medicinal product is manufactured and monitored according to generally accepted scientific methods. He/she must supply to the Agency, to the Commission and to the Member States any new information which might entail the variation of the particulars or documents they have obtained. He/she must also relay any prohibition or restriction imposed in countries in which the medicinal product is marketed, as well as any other information which might influence the evaluation of the benefits and risks of the medicinal product. The holder of the marketing authorisation must also forward the results of clinical trials or other studies. This information must be updated regularly on the basis of recent scientific knowledge.

When there are serious differences of opinion between Member States with respect to whether the holder of a marketing authorisation, a manufacturer or an importer satisfies the requirements set in Directives 2001/83/EC and 2001/82/EC, the Commission may request a new inspection of the marketing authorisation holder, the manufacturer or the importer.

Where urgent action is essential to protect human health or the environment, a Member State may suspend the use in its territory of an authorised medicinal product.

Risk management

The holders of marketing authorisations issued prior to 2 July 2012 are not obliged to implement a risk management system for each medicinal product.

However, the Agency may nevertheless impose upon the holder of a marketing authorisation an obligation to implement such a system if it detects risks that might modify the risk-benefit balance of an authorised medicinal product.

Obligations incumbent upon holders of marketing authorisations, Member States, the Agency and the Commission apply to safety notices concerning medicinal products for human use.

The Agency must draw up and update a list of medicinal products that are to be the subject of further monitoring. This list must give:

  • the name of and active substances contained in medicinal products authorised in the EU if such medicinal products contain a new active substance which, until 1 January 2011, was not contained in any medicinal product authorised in the Union;
  • the name of and active substances contained in any biological medicinal product authorised after 1 January 2011.

EudraVigilance database

The Agency has set up the EudraVigilance database, the aim of which is to collate pharmacovigilance information relating to medicinal products authorised in the EU and to make such information accessible to the competent authorities.

EudraVigilance collects information relating to the undesirable effects on humans arising following use, whether compliant or not, of medicinal products, or those which come to light during post-authorisation studies. On the basis of this information, the Agency prepares an annual report which is sent to the Commission, the European Parliament and the Council.

The Agency takes the following measures concerning medicinal products for human use that have been authorised by means of the centralised procedure:

  • monitoring the results of measures to minimise the risks outlined in risk management plans;
  • assessment of updates to risk management systems;
  • monitoring information contained in the EudraVigilance database.

Cooperation

The Agency collaborates with the World Health Organization (WHO) as regards pharmacovigilance, as well as with the European Monitoring Centre for Drugs and Drug Addiction.

It collaborates with the Member States on the international harmonisation and standardisation of technical measures related to pharmacovigilance.

PROVISIONS CONCERNING THE EUROPEAN MEDICINES AGENCY

The European Medicines Agency is made up of different committees, including the Committee for Medicinal Products for Human Use, the Pharmacovigilance Risk Assessment Advisory Committee, the Paediatric Committee, the Committee on Herbal Medicinal Products, the Committee for Advanced Therapies, a secretariat and a Management Board. Each Member State appoints one member and one alternate of the Management Board and one member and one alternate to the Committees. The members of each Committee may be accompanied by experts in specific scientific or technical fields.

The Agency is specifically responsible for:

  • providing the Member States and the EU institutions with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which are referred to it;
  • coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to European marketing authorisation procedures and the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products;
  • coordinating the supervision of medicinal products for human use which have been authorised in the EU;
  • keeping, and transmitting on request, assessment reports and information on authorised medicinal products;
  • collecting and disseminating information on potential adverse reactions to medicinal products for human use authorised in the EU, by means of a database permanently accessible to all Member States;
  • assisting Member States with the rapid communication of information to health-care professionals;
  • creating a database on medicinal products which is accessible to the general public;
  • advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin.

Each committee establishes a standing working party with the sole remit of providing scientific advice to businesses, particularly small and medium-sized enterprises (SMEs), during the research stage and when developing new therapies. The objective is to stimulate pharmaceutical research in Europe, and thus allow patients to benefit earlier from more effective medicinal products.

The Agency’s revenue consists of a contribution from the EU and fees paid by undertakings for obtaining and maintaining EU marketing authorisations and for other services provided by the Agency. SMEs may pay reduced fees, defer payment of the fee, or receive administrative assistance under certain conditions.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 726/2004

20.5.2004

–

OJ L 136, 30.4.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1901/2006

26.1.2007

–

OJ L 378, 27.12.2006

Regulation (EC) No 1394/2007

3.12.2007

–

OJ L 324, 10.12.2007

Regulation (EC) No 219/2009

20.4.2009

–

OJ L 87, 31.3.2009

Regulation (EC) No 470/2009

6.7.2009

–

OJ L 152, 16.6.2009

Regulation (EU) No 1235/2010

1.1.2011 (applicable from 2.7.2012)

–

OJ L 348, 31.12.2010

Subsequent amendments and corrections to Regulation (EC) No 726/2004 have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council [Official Journal L 155 of 15 June 2007].

This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations who infringe certain obligations. It provides for two types of financial penalties: fines and periodic penalty payments.

Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council [Official Journal L 92 of 30 March 2006].

Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises [Official Journal L 329 of 16 December 2005].

Executive Agency for Competitiveness and Innovation

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Executive Agency for Competitiveness and Innovation

Outline of the Community (European Union) legislation about Executive Agency for Competitiveness and Innovation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The institutions bodies and agencies of the union

Executive Agency for Competitiveness and Innovation (EACI)

Document or Iniciative

Commission Decision 2004/20/EC of 23 December 2003 setting up an executive agency, the “Intelligent Energy Executive Agency”, to manage Community action in the field of energy in application of Council Regulation (EC) No 58/2003 [See amending acts].

Summary

This Decision established the Executive Agency for Competitiveness and Innovation (EACI), previously the Intelligent Energy Executive Agency, for the period 1 January 2004 – 31 December 2015. Governed by Council Regulation (EC) No 58/2003, the EACI is responsible for managing Community action in the fields of energy, entrepreneurship and innovation, as well as sustainable freight transport. It is located in Brussels.

The EACI implements tasks under the Competitiveness and Innovation Framework Programme (CIP) 2007-13 and the second Marco Polo Programme 2007-13. The tasks consist of the following:

  • management of specific projects within the Entrepreneurship and Innovation as well as the Intelligent Energy – Europe Programmes;
  • adoption of budget implementation instruments and management of implementing measures for contracts and grants;
  • collection, analysis and communication of the information required for implementing the Programmes.

The Agency is also responsible for managing the implementing measures of the Intelligent Energy – Europe 2003-06 and the Marco Polo 2003-06 Programmes. In addition, the EACI may be given responsibility for executing other similar tasks under the CIP or other Community programmes. In such an event, this Decision will be amended to take into account the supplementary tasks.

The EACI is managed by a Steering Committee and a Director. Both are appointed by the Commission, the first for three and the latter for five years.

The Agency is financed from the funds of the CIP and the second Marco Polo Programme. Any supplementary tasks will be financed from the funds of the relevant Community programmes. Its administrative budget is implemented on the basis of Commission Regulation (EC) No 1653/2004.

The Commission holds supervisory authority over the Agency, which must regularly report back on the progress it has achieved in implementing its Programmes.

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 2004/20/EC 23.12.2003 – 31.12.2015 – OJ L 5 of 9.1.2004
Amending act(s) Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 2007/372/EC 31.5.2007 – 31.12.2015 – OJ L 140 of 1.6.2007

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

The Community Lisbon Programme: proposal for 2008–2010

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The Community Lisbon Programme: proposal for 2008–2010

Outline of the Community (European Union) legislation about The Community Lisbon Programme: proposal for 2008–2010

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Employment and social policy > European Strategy for Growth > Growth and jobs

The Community Lisbon Programme: proposal for 2008–2010

The Commission intends to strengthen the Community Lisbon Programme (CLP) and is proposing ten objectives for the period 2008-2010. In order to ensure optimum implementation of the CLP, it is counting on effective collaboration between the various European institutions, and on close monitoring.

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 11 December 2007 – Proposal for a Community Lisbon Programme 2008–2010 [COM(2007) 804 final – Not published in the Official Journal].

Summary

The Lisbon Strategy has proved its worth. Since its relaunch in 2005, more than 6.5 million jobs have been created in Europe and unemployment has fallen to its lowest level for 25 years. Growth has also been sustained.
However, given that Europe is now confronted by a worldwide economic slowdown and must face unprecedented long-term challenges (ageing of the population, globalisation, climate change, dependence on energy imports, etc.), the second phase (2008-2010) of the Community Lisbon Programme (CLP) would appear to be crucial.
Against this backdrop, the Commission means to draw lessons from the 2005-2008 phase, particularly as regards the implementation of the strategy.

Strengthening and renewing the CLP

In order to complement the CLP, the Commission is pinpointing ten objectives which offer either genuine Community-level added value or show significant impacts on growth and jobs within the European Union (EU). The selection of the objectives is on the basis of sound economic analyses and policy priorities.

These objectives are based on the integrated guidelines and rest fully on the four priority areas of the Lisbon strategy, namely:

  • investing in people and modernising labour markets;
  • energy and climate change;
  • strengthening economic competitiveness;
  • promoting knowledge and innovation.

Investing in people and modernising labour markets

Human resources which are better adapted to the needs of labour markets are both the key to European competitiveness worldwide and the basis for more independent living. This will require:

  • a renewal of the Social Agenda;
  • improved coordination of instruments to better anticipate EU-wide labour market developments and needs;
  • greater comparability and recognition of qualifications;
  • development of a common policy on immigration, with the introduction of a “blue card” scheme for highly qualified migrants representing a first step in this direction.

Unlocking business potential, especially of SMEs

Small and medium-sized enterprises (SMEs) make up more than 99% of all businesses and employ 67% of the EU’s total workforce. The potential for growth and jobs in SMEs is still not being fully exploited. In order to support SMEs throughout their life-cycle, the Commission plans to:

  • adopt a European Small Business Act for the benefit of small-scale enterprises;
  • undertake a specific screening of the acquis communautaire from an SME perspective and introduce exemptions from administrative requirements of EU legislation wherever possible;
  • ensure the implementation of the various European programmes to reduce administrative burdens, with the aim of a 25% reduction by 2012.

The Commission is also proposing new measures for the financial services market. In particular, it plans to implement the services Directive and, more specifically, to establish the Single Euro Payments Area. SMEs will be the first to benefit from this removal of barriers to market access, for example by being allowed to choose an EU-wide tax base.

Investing in knowledge and innovation

The Commission is introducing a new dimension: the creation of a fifth freedom on the single market – based on the three components of the knowledge triangle, i.e. research, innovation and education – for the purpose of setting up a European research area. This will require a concentration and a more effective use of R&D resources and common calls for projects. Finally, it is crucial that the European Institute of Innovation and Technology (EIT) be made operational.

The Commission is also proposing to create more favourable conditions for the financing of innovation and to improve SMEs’ access to finance for new technologies. In this connection, the creation of a Community patent would not only improve the current patent litigation system but would also increase legal certainty, leading to a greater investment readiness among SMEs.

Energy and climate change

Among the objectives identified by the Commission, Nos 8 and 9 are concerned with energy policy and climate change in the context of the Community Lisbon Programme. The internal market for electricity and gas must be completed by introducing an emissions trading scheme. It is therefore crucial that legislation be passed in order to meet the EU’s targets of achieving at least a 20% reduction in greenhouse gas emissions and a 20% renewable energy share by 2020.

In addition, industrial policy must be geared to sustainable consumption. The Commission is thus proposing to establish an internal market for environmental technologies and promote the development of European lead markets for energy-efficient technologies. To this end, Community funds must be used to develop a market in low-carbon products and technologies. The Commission also plans to review the energy taxation Directive in order that other fiscal instruments can be used to promote low-energy products.

As regards the external agenda, where the opening-up of Europe and the defence of its legitimate interests go hand in hand, bilateral negotiations with the main trading partners are the main concern of the foreign-policy element of the Community Lisbon Programme.

The Commission should also work to conclude the Doha multilateral trade negotiations. In order to make for a more coordinated approach by the EU, the Commission is proposing to introduce annual reports on countries and sectors in which barriers to trade still exist. Improving the framework for the enforcement of intellectual property rights against counterfeiting is also a priority which can be achieved through more effective cooperation between customs authorities.

Implementation of the CLP

The ten priority objectives need to be closely monitored by means of annual reports. This would allow a systematic assessment of progress made, which would form the basis for the Commission’s annual autumn reports. The Spring European Council must take stock and provide further direction as part of its annual overall assessment of the Lisbon Strategy on Growth and Jobs. The programme will also be subject to a mid-term review to enable any adjustments to be made to the ten priority objectives.

The Community’s financial resources for improving growth and economic adjustment derive from cohesion policy programmes of the European Agricultural Fund for Rural Development (EAFRD), the Lifelong Learning Programme and the European Globalisation Adjustment Fund. It is estimated that two million additional jobs will be generated by these funds by 2015. The Communication also proposes that a close follow-up be undertaken by each of the institutions and all the Member States in order to achieve the ten objectives.

Related Acts

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 16 December 2008 – Implementation Report for the Community Lisbon Programme 2008 – 2010 [COM(2008) 881 final – Not published in the Official Journal].
The Commission presented the first annual report on the outcomes of the Community Lisbon Programme 2008 – 2010. This report evaluates the outcomes of the first year the programme has been implemented. It proposes new objectives in-line with the priorities of the European Economic Recovery Plan and complementing the reforms being carried out by Member States.

Thus it concerns:

  • improving the skills of workers, modernising the labour market and social protection systems, according to the terms of the renewed Social Agenda. Further efforts are needed to assess the needs of the labour market, as well as to remove the regulatory constraints which act as a barrier to mobility, recognition of qualifications and access to pension and social protection systems. The Commission will make proposals for an immigration strategy, aimed at placing value on the abilities of migrants;
  • increasing the development potential of enterprises, in particular small and medium-sized enterprises (SMEs). The EU shall guarantee SMEs have access to finance and shall reduce Community administrative burdens by 25% by 2012. Enterprises will benefit from the strengthening of the single market for financial services;
  • making Europe a leading knowledge and innovation economy and society through the creation of the European Research Area, open and competitive on an international level. Also by improving conditions for innovation (finance, investment and legal certainty);
  • finalising the energy market and combating climate change. With the aim of making the energy supply secure, the EU has committed to reducing greenhouse gas emissions by 20% by 2020. Industrial production must be aimed at achieving objectives related to energy efficiency and sustainability;
  • opening up new opportunities for trade, market access and international investment. The Community is working to conclude the Doha negotiations under the framework of the WHO, and to lead bilateral negotiations with its commercial partners. The Community promotes the improvement of international standards and regulatory cooperation, particularly with regard to combating counterfeiting.

State aid for SMEs in the fisheries sector

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State aid for SMEs in the fisheries sector

Outline of the Community (European Union) legislation about State aid for SMEs in the fisheries sector

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Competition > Rules applicable to specific sectors > Competition in agriculture and fisheries

State aid for SMEs in the fisheries sector

Document or Iniciative

Commission Regulation (EC) No 736/2008 of 22 July 2008 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production, processing and marketing of fisheries products.

Summary

This Regulation applies to aid granted to small and medium-sized enterprises (SMEs) in the fisheries sector. This aid is exempt from a case-by-case assessment on the condition that it complies with the previsions of the European Fisheries Fund (EFF) and the fisheries guidelines .

The categories of aid exempted pursuant to this Regulation are:

  • aid for cessation of fishing activities;
  • aid for financing socioeconomic measures;
  • aid for productive investments in aquaculture;
  • aid for aqua-environmental measures;
  • aid for public health and animal health measures;
  • aid for inland fishing;
  • aid for processing and marketing fisheries products and aquaculture;
  • aid for collective actions. This aid is for the financing of measures of common interest which are supported by operators, producer organisations or other organisations recognised by the Member States.
  • aid for measures intended to protect and develop aquatic fauna and flora;
  • aid for investments in fishing ports, landing sites and shelters;
  • aid for development of new markets and promotional campaigns;
  • aid for pilot projects;
  • aid for modification for reassignment of fishing vessels;
  • aid for technial assistance.

This Regulation does not cover:

  • aid the amount of which is fixed on the basis of price or quantity of products put on the market;
  • aid to export-related activities;
  • aid favouring domestic products over imported products;
  • aid granted to undertakings in difficulty to rescue and restructure them;
  • aid granted to an undertaking which is subject to an outstanding recovery order following a decision by the Commission declaring an aid illegal and incompatible with the common market.

Member States must ensure that the aid it wishes to grant does not affect trading conditions in a way contrary to the general interest. Aid granted is not subject to the notification requirement of Article 88, paragraph 3 of the Treaty establishing the European Community (EC Treaty). However, Member States must send a form of summary information detailed in Annex I of this Regulation in electronic format to the Commission for publication in the Official Journal of the European Union.

The amount of aid cannot exceed a maximum of EUR 1 million per beneficiary, per year or EUR 2 million per eligible project.

Cumulation of exempted aid under this Regulation with other aid of the same type is possible if the cumulated aid concerns different eligible costs within the maximum amounts detailed above.

Only aid with an incentive effect will benefit from the exemption of the aforementioned Regulation. Aid has an incentive effect when it enables beneficiaries to carry out activities or projects which they would not have undertaken under normal market conditions. For the incentive effect to be recognised, the beneficiary must submit an application for aid before the launch of the project or activities start.

Each year Member States must send a report in electronic format to the Commission. The information submitted must enable the Commission to verify that the exempted aid complies with transparency and exemption criteria.

References

Act

Entry into force – expiry date

Deadline for transposition into the Member States

Official Journal

Regulation (EC) No 736/2008

18.8.2008 – 31.12.2013

–

OJ L 201 of 30.7.2008

Innovation Union

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Innovation Union

Outline of the Community (European Union) legislation about Innovation Union

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Research and innovation > General framework

Innovation Union

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 6 October 2010 Europe 2020 Flagship Initiative: Innovation Union [COM(2010) 546 final – Not published in the Official Journal].

Summary

The European Union (EU) prepares a new research and innovation policy as part of the Europe 2020 strategy. This new approach aims in particular at supporting innovation in fields that represent challenges for European society, such as climate change, energy efficiency, food safety, health and the ageing population.

In this regard, as one of the objectives to be reached in 2020, 3 % of the EU’s gross domestic product is to be invested in research and development.

Developing knowledge and skills

Education and training systems must be modernised, particularly to promote science teaching, interdisciplinary university programmes and e-skills.

In addition, the European Research Area should be established before 2014, facilitating researchers’ mobility and cooperation. The EU and the Member States must also work together to build priority European research infrastructures, and on international scientific and technological cooperation.

Encouraging innovative companies

Innovative companies must have better access to markets and finance. They should therefore be offered diversified sources of funding, in particular by the establishment of a European risk capital fund. Furthermore, their cross-border activities should not be hindered by tax barriers.

Companies’ activities in the internal market are to be facilitated, particularly by the introduction of a European patent and a unified system of dispute settlement, but also by improving the interoperability of products and innovative systems.

Promoting creativity

The Innovation Union encourages joint research initiatives and technology transfers between Member States. Intellectual property rights and free access to the results of public research should also promote creativity.

Increasing social and territorial cohesion

Current and future financing granted by structural funds should be used to promote innovation. In particular, it should be used to finance national innovation systems, smart specialisation strategies, cross-border projects and social innovation.

Establishing partnerships for innovation

The Innovation Union promotes a new approach based on partnerships between the regional, national and European stakeholders involved throughout the chain of research and innovation.

Such partnerships are aimed at areas for which government intervention is clearly justified and stakeholders’ cooperation is more effective. The Commission has selected a series of interdependent conditions for partnerships’ success. They must:

  • focus on a challenge that is shared across Europe, with clear and measurable goals;
  • mobilise the stakeholders involved over a long period of time;
  • be more efficient since action is at European level;
  • be result-oriented in line with defined targets;
  • benefit from adequate financial support.

Leveraging external policies

The EU must become attractive to academia, researchers and highly skilled third country nationals. In addition, European external policy should promote scientific cooperation and international research strategies.

Regional Policy serving innovation

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Regional Policy serving innovation

Outline of the Community (European Union) legislation about Regional Policy serving innovation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Regional policy > Review and the future of regional policy

Regional Policy serving innovation

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, of 6 October 2010, Regional Policy contributing to smart growth in Europe 2020 [COM(2010) 553 final – Not published in the Official Journal].

Summary

European Regional Policy can make a substantial contribution to the objectives of the Europe 2020 strategy, particularly regarding the flagship initiative Innovation Union. Regional Policy and its funding can be used to promote research and development, education, entrepreneurship or information and communication technologies.

Encouraging regional innovation potential

The regions of Europe have different levels of development and innovation potential. Public intervention must therefore be adapted to these diverse situations. Regional Policy thus supports both the performance of the most advanced regions and redirects the regions that are lagging behind towards the most competitive activities.

Regional Policy funding is coordinated with the Competitiveness and Innovation Framework Programme (CIP) and the 7th
Framework Programme for Research and Development.

Contributing to the Europe 2020 strategy

In order to support the objectives of the Europe 2020 strategy, Regional Policy must in particular enable:

  • a region’s competitiveness to be strengthened by targeting resources to high value-added activities, by supporting skills, education and infrastructures;
  • smart specialisation strategies to be developed, in conjunction with other EU policies;
  • certain business sectors to be fostered;
  • multi-level governance to be developed;
  • links to be created between policy domains and between regions.

In addition, Regional Policy encourages cooperation between enterprises, research centres and universities, to define specialisation strategies that are adapted to their regional situation and investment capacity.

Such specialisation strategies should encourage:

  • the forming of innovation clusters of companies, so as to share services and infrastructures;
  • favourable conditions for the innovation of SMEs, that have a key role to play in growth, employment, innovation and cohesion in the EU;
  • education and lifelong learning in research and innovation, in partnership with universities and local enterprises;
  • regional research infrastructures, including the creation of infrastructure networks in the regions requiring more support, by making more extensive of use of information and communication technologies;
  • creativity and cultural industries;
  • the Digital Agenda, based on fast internet applications;
  • the use of public procurement co-financed by the European Regional Development Fund (ERDF) to accelerate the marketing of innovations;
  • Innovation Partnerships as part of the Europe 2020 strategy, particularly in areas of common interest (such as climate change, energy and resource efficiency, demographic ageing, etc.).

Creating synergies

Synergies must be established between European policies which support research and innovation. In order to do this, the Commission needs to simplify and harmonise the rules relating to the use of programmes so as to foster cooperation between innovation stakeholders.

It is also necessary to create synergies between and group together regional stakeholders in order to foster innovation. In the context, Regional Policy supports the development of trans-national and inter-regional cooperation programmes. It also supports, in particular, the forming of science and technology parks or business incubators.

Context

After 2013, innovation, research and development must be key priorities for EU cohesion and budget policy. Nevertheless, during the current programming period for structural funds, the EU Member States and their regions must start re-orienting their practices so as to broaden their innovation potential.

Competitiveness and Innovation Framework Programme

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Competitiveness and Innovation Framework Programme

Outline of the Community (European Union) legislation about Competitiveness and Innovation Framework Programme

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Research and innovation > Research in support of other policies

Competitiveness and Innovation Framework Programme (CIP) (2007-2013)

Document or Iniciative

Decision 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007-2013) [See amending act(s)].

Summary

The Competitiveness and Innovation Framework Programme (CIP) proposes a coherent framework to improve competitiveness * and innovation capacity * in the European Union (EU). The actions it supports encourage the development of a knowledge society and sustainable development based on balanced economic growth.

The framework programme incorporates specific Community support programmes, new actions and synergies with other programmes, thus meeting the objectives of the renewed Lisbon Strategy for simpler, more visible and better targeted Community action.

Specific programmes

To take account of the diversity of its objectives and ensure that these are visible, the CIP is made up of three specific subprogrammes. The interests of small and medium-sized enterprises (SMEs) and eco-innovation are cross-cutting priorities reflected throughout the framework programme.

  • The Entrepreneurship and Innovation Programme brings together activities to promote entrepreneurship, industrial competitiveness and innovation. It specifically targets SMEs *, from hi-tech “gazelles” (companies with high growth potential) to the traditional micro-businesses and family firms which make up a large majority of European enterprises. It facilitates SMEs’ access to finance and investment during their start-up and growth phase. It also gives businesses access to information and advice on the functioning and opportunities of the internal market, as well as to information on Community legislation applying to them and on future legislation so that they can prepare to adapt in a cost-effective way. In this context, the Enterprise Europe Network plays an important role. The programme also makes provision for the exchange of best practices between Member States in order to create a better regulatory and administrative environment for business and innovation. Finally, it backs the promotion of eco-innovation * by encouraging efforts to tap the full potential of environmental technologies.
  • The objective of the ICT Policy Support Programme is to promote the adoption and use of information and communication technologies (ICT), the backbone of the knowledge economy. The uptake of ICTs by both the private and public sectors helps to stimulate European innovation performance and competitiveness. The programme forms part of the Digital Agenda for Europe and incorporates the instruments previously financed by the eTen, eContent and Modinis programmes.
  • The Intelligent Energy – Europe Programme helps speed up efforts to achieve the objectives in the field of sustainable energy. It supports improvements in energy efficiency, the adoption of new and renewable energy sources, greater market penetration for these energy sources, energy and fuel diversification, an increase in the share of renewable energy (the EU has set itself the objective of raising the share of renewable energy in gross domestic consumption to 12 % by 2010) and a reduction in final energy consumption. Particular attention is paid in this context to the transport sector. The programme follows up the Intelligent Energy – Europe (2003-2006) programme, which expired on 31 December 2006.

Implementation

Implementation of the CIP relies on several instruments (financial instruments, projects, networks, analyses, etc.), which can be applied in each of the specific programmes. This common “toolbox” for the different programmes helps to simplify the way the framework programme works for its users. The CIP is not just based on tried and tested measures, but also introduces new instruments.

Several Community financial instruments are involved in business support. The High Growth and Innovative SME Facility (GIF) promotes the supply of seed and early-stage capital for SMEs for their start-up, and a new feature introduced by the CIP is the provision of “follow-on” capital during their growth phase. The SME Guarantee Facility, for its part, facilitates access for SMEs to financing (loans or leasing), microcredit and equity or quasi-equity. This facility also includes a new securitisation instrument for bank loan portfolios to help mobilise additional loan financing for SMEs.

The CIP strengthens and develops business and innovation support services which disseminate information to businesses on Community policies, legislation and programmes, particularly concerning the internal market and framework research programmes. These services also offer businesses information on innovation, technology and knowledge transfer and provide feedback from them for impact assessments and policy development.

A new mechanism fosters cooperation among national and regional programmes to promote business innovation, thus providing businesses with other ways of benefiting from ideas, know-how and market opportunities in other European regions.

The framework programme also supports pilot market replication projects. These aim to promote the effective marketing and economic exploitation of innovative or eco-innovative technologies and products which have already been technically demonstrated with success but have not yet penetrated the market to a significant extent. These projects are implemented through public-private partnerships.

The Intelligent Energy Executive Agency is responsible for the implementation of action under the “Intelligent Energy – Europe” programme and action under the “Enterprise and Innovation” programme.

In order to optimise the flow of knowledge and ideas, the strategic development of Community policies must continue on the basis of the open method of coordination and be backed up by new twinning actions to help Member States and regions exploit examples of best practice.

Consistency with other Community policies

The CIP links up with other key Community initiatives. Their different activities are implemented in parallel and complement each other. The framework programme is thus involved in achieving Community objectives in the fields of research, cohesion, the environment, education and training.

The CIP thus facilitates access to finance for businesses whose activities relate to innovation, research and development. It also helps businesses get involved in theFramework Programme for Research and Technological Development (FP7-RTD).

Budget

The framework programme will run for seven years, from 1 January 2007 to 31 December 2013. It has been allocated a budget of €3.621 billion for that period.

According to an indicative breakdown, 60 % of the overall budget (€2.170 billion) is allocated to the Entrepreneurship and Innovation Programme. One fifth of this (€430 million) is earmarked for promoting eco-innovation. 20 % of the overall budget (€730 million) has been allocated to the ICT Policy Support Programme, and the last 20 % (€730 million) is for the Intelligent Energy – Europe Programme.

Costs that are eligible under several instruments cannot be funded twice.

Monitoring and assessment

The Commission carries out regular monitoring of the implementation of the framework-programme and the specific programmes which come under it. Each year it drafts a report to provide an update of the activities supported using indicators concerning the financial implementation, the results achieved and, where possible, the impact of the actions implemented.

The framework-programme and the specific programmes which come under it are subject to an intermediary assessment and a final assessment. These assessments examine aspects such as the relevance, the coherence and synergies, effectiveness, the efficient use of resources, and the sustainability, etc. of the actions. Furthermore, the final assessment verifies to what extent the framework-programme as a whole, and each of its specific individual programmes, have achieved their objectives.

Context

The Lisbon Process, whose objective is to make Europe the most competitive and dynamic knowledge-based economy in the world, has naturally made competitiveness one of the EU’s key political concerns. In order to ensure greater coherence between the different programmes involved in the Community’s efforts to enhance competitiveness, and in response to the objectives set by the renewed Lisbon Strategy, the European Commission is proposing a framework programme for innovation and competitiveness.

Key terms used in the act
  • Small and medium-sized enterprises (SMEs): enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding €50 million, and/or an annual balance sheet total not exceeding €43 million (Recommendation 2003/361/EC).
  • Competitiveness: the capacity of enterprises to adapt quickly to change, exploit their innovation potential and develop high-quality products.
  • Innovation: renewal and extension of the range of products and services, introduction of new design, production, supply and distribution methods, introduction of changes to management methods, work organisation and employees’ terms and conditions of employment and qualifications.
  • Eco-innovation: any form of innovation intended to achieve the objective of sustainable environmentally-friendly development by reducing the impact on the environment or by using natural resources, especially energy, in a more efficient and responsible manner.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Decision 1639/2006/EC

29.11.2006

–

OJ L 310 of 9.11.2006
Amending Act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EU) No. 670/2012

18.8.2012

–

OJ L 204 of 31.7.2012

Successive amendments and corrections to Decision 1639/2006/EC have been incorporated in the basic text. This consolidated versionis for reference purpose only.

Related Acts

Proposal for a Regulation of the European Parliament and of the Council establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (2014 – 2020) [COM(2011) 834 final – Not published in the Official Journal].
Codecision procedure (2011/0394/COD)

Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Evaluations of the Competitiveness and Innovation Framework Programme [COM(2013) 2 final – Not published in the Official Journal].

A modern policy for SMEs

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A modern policy for SMEs

Outline of the Community (European Union) legislation about A modern policy for SMEs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Enterprise > Business environment

A modern policy for SMEs

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions of 10 November 2005, entitled “Implementing the Community Lisbon programme – Modern SME policy for growth and employment” [COM (2005) 551 final – Not published in thOfficial Journal].

Summary

Small and medium-sized enterprises (SMEs) make a major contribution to growth and job creation in the European Union (EU). This is why the new policy on small and medium-sized enterprises (SMEs) creates a more coherent, pragmatic and horizontal framework for these enterprises. Promoting entrepreneurship and developing an environment favourable to SMEs will allow them to become more competitive.

SMEs are very diverse, and consequently have different needs. Some of them are start-ups, while others are rapidly growing “gazelles”. Some are active in vast markets, others in local or regional markets. If by definition all SMEs have fewer than 250 employees, some are micro-enterprises, others are family SMEs. In order to unlock the growth potential of SMEs as a whole, policies and action to support them need to reflect this diversity.

The success of this new policy will depend on the effective involvement of all SME stakeholders, national, regional and European, public and private.

Specific action is proposed in five key areas:

  • Promoting entrepreneurship and skills. Promoting entrepreneurship, reducing the burden of risk linked to setting up and running a business, eliminating the negative effects linked to business failure, and providing support for the successful transfer of businesses are all elements that contribute to a better exploitation of Europe’s entrepreneurial potential. Special attention will be paid to promoting entrepreneurial skills, reducing the skills gaps and providing support to particular categories of entrepreneurs (women, young people, old people, and people from ethnic minorities).
  • Improving SMEs’ access to markets. Better access to tenders on the public market, greater participation in the standardisation process, increased awareness of intellectual property rights, and support for inter-enterprise cooperation, particularly in border regions, will help SMEs to take full advantage of the opportunities provided by the internal market. SME access to international markets will also be facilitated.
  • Cutting red tape. It is vital to simplify the regulatory and administrative constraints weighing on SMEs. The principle of giving priority to small enterprises (“Think Small First”) will be integrated across all EU policies. The interests of SMEs will systematically be taken into consideration when assessing the impact of Community legislation and when preparing forthcoming legislation. Derogations for SMEs can be developed for this purpose. Special attention will be given to the rules concerning state aid, SME involvement in Community programmes, value-added tax (VAT) and, at national level, direct taxation.
  • Improving SMEs’ growth potential. Improving SMEs’ access to finance, research, innovation and information and communication technologies (ICT) will contribute directly to unlocking their potential for growth. Financial support, initially provided at Community level by the Multiannual Programme for Enterprises and Entrepreneurship (2001-2006), has now been increased by the Competitiveness and Innovation Framework Programme (CIP) (2007-2013). It is also vital to strengthen SMEs’ capacities for research and innovation, as continued innovation is essential for the sustainable development of SMEs. SME involvement in the 7th Research Framework Programme will thus be facilitated.
  • Strengthening dialogue and consultation with SME stakeholders. Enterprises, in particular SMEs, and the European Institutions suffer from a lack of information exchange. More systematic cooperation and consultation with stakeholders is an essential guideline of the new SME policy. When policies are being developed, SMEs will be consulted by the Commission’s SME Envoy or the “SME Panel”, a new quick-and-easy mechanism for consultation via the Enterprise Europe Network. In addition, as from the end of 2005, “European Enterprise Awards” will reward measures that have proved to be effective in promoting entrepreneurship and thus contributed to the exchange of best practices. The Community business support networks will, for their part, continue to play an essential role in spreading information on the EU to businesses, particularly SMEs.

Background

SMEs make up a large part of Europe’s economy and industry. The EU’s 23 million SMEs account for 99 % of all businesses and contribute up to 80 % of employment in some industrial sectors, such as textiles. European SMEs are thus an essential source of growth, employment, entrepreneurial skills, innovation and economic and social cohesion. It is therefore essential to unlock the potential of SMEs and improve the environment they operate in by promoting entrepreneurship.