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IMI Joint Undertaking

Outline of the Community (European Union) legislation about IMI Joint Undertaking

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Research and innovation > Research in support of other policies

IMI Joint Undertaking

Document or Iniciative

Council Regulation (EC) No 73/2008 of 20 December 2007 setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines.

Summary

The IMI Joint Undertaking implements the Joint Technology Initiative (JTI) on Innovative Medicines, with a view to the development of a competitive, innovation-based pharmaceuticals sector. This public-private partnership aims to support investments in this field.

The IMI Joint Undertaking is a Community body possessing legal personality. Its headquarters are in Brussels. This undertaking has been set up for a period up to 31 December 2017. Its founding members are the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Any legal entity directly or indirectly supporting research and development in a Member State or in a country associated with the 7th Framework Programme (7^th FP) may become a member of the IMI Joint Undertaking.

Objectives

The Joint Undertaking aims to improve the efficiency and effectiveness of the medicine development process so that the pharmaceutical sector produces safer and more effective innovative treatments. The objectives of the Joint Undertaking are thus to contribute to the implementation of the 7th FP and to support pharmaceutical research and development in the Member States and countries associated with the 7th FP. The participation of small and medium-sized enterprises (SMEs) and cooperation with the private sector and the academic world are encouraged.

In addition, the Joint Undertaking aims to ensure complementarity with other activities of the 7th FP and to establish a public-private partnership with a view to increasing research investment and fostering cooperation between the public and private sectors.

Projects and activities

The IMI Joint Undertaking supports prospective research activities, based on projects selected following open and competitive calls for project proposals, independent evaluation and the conclusion of grant agreements and project agreements.

The participating research-based pharmaceutical companies that are members of EFPIA are not eligible to receive financial support from the IMI Joint Undertaking for any activity.

Operation

The bodies of the IMI Joint Undertaking are as follows:

the Governing Board is composed of representatives of each of the members of the Joint Undertaking. It is responsible for operations and for overseeing the implementation of activities. It meets at least twice a year;
the Executive Director represents the IMI Joint Undertaking from a legal point of view. He or she is also the chief executive responsible for the day-to-day management of the Undertaking in accordance with the decisions taken by the Governing Board;
the Scientific Committee is the advisory body to the Governing Board, with responsibilities including advising on the scientific priorities for the annual implementation plan proposal.

The IMI Joint Undertaking is supported by two external advisory bodies:

the IMI States Representatives Group consists of one representative of each Member State and of each country associated with the Framework Programme. It advises on the annual scientific priorities. Furthermore, it also informs the IMI Joint Undertaking on relevant activities ongoing at national level;
the Stakeholder Forum is convened at least once a year by the Executive Director. It is informed on the activities of the IMI Joint Undertaking and provides comments.

The financial resources of the Joint Undertaking include members’ financial contributions, revenue generated by the IMI Joint Undertaking and any other financial contributions, resources and revenues.

The research activities are funded through non-monetary contributions by the research-based pharmaceutical companies that are members of EFPIA, contributions from members and a Community financial contribution under the 7th FP. This financial commitment on the part of the Community is limited to a maximum of EUR 1 000 million.

Context

Under the 7th Community FP, the EU provides for the establishment of long-term public-private partnerships in the form of JTIs. These JTIs result from the work of European Technology Platforms set up under the 6th FP and implemented through Joint Undertakings.

In addition to the IMI, five other JTIs are planned in the sectors of spaceborne computer systems (ARTEMIS), nanotechnologies (ENIAC), aeronautics and air transport (Clean Sky), hydrogen and fuel cells (FUEL CELL) and Global Monitoring for Environment and Security (GMES).

References

Act	Entry into force – Expiry date	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 73/2008	7.2.2008-31.12.2017	–	OJ L 30, 4.2.2008

Galileo Joint Undertaking

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Galileo Joint Undertaking

Outline of the Community (European Union) legislation about Galileo Joint Undertaking

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Other

Galileo Joint Undertaking

GALILEO is the European satellite radio navigation and positioning programme. Launched by the European Commission and developed jointly with the European Space Agency, it will give the European Union an independent technology to compete with the American GPS and Russian GLONASS systems. This Regulation, adopted in 2002, set up a Joint Undertaking to manage the development phase of the GALILEO programme. It was then amended and GALILEO ceased to exist as from 31 December 2006: as the development phase was extended until the end of 2008 the Joint Undertaking’s activities were transferred to the GNSS Supervisory Authority.

Document or Iniciative

Council Regulation (EC) No 876/2002 of 24 May 2002 setting up the Galileo Joint Undertaking [Official Journal L 138, 28.5.2002] [See amending acts].

Summary

Emphasising both the need to give a positive boost to European industries and services and to ensure Europe’s independence in such a vital technology, the GALILEO satellite radio navigation programme has been planned in a number of phases:

the definition phase enabled the basic components of the project to be put in place;
the development phase (initially due to last from 2002 until 2005), aimed at verifying and testing the various components of the system’s architecture; it was in fact extended to last until after 2008;
this phase will be followed by the “deployment phase”, consisting of the production and launching of satellites and the installation of terrestrial stations and equipment;
finally the operational life.

This Regulation lays down the principles and constituent elements of the GALILEO Joint Undertaking. The aim is to have a flexible structure with legal personality that is capable of concluding the contracts needed to establish a European satellite radionavigation system permitting research and technological development. The Joint Undertaking was initially set up to cover the period from 2002 until 2005, until the end of the deployment phase and with the possibility of being extended if necessary. However, given that the development phase will not be completed before the end of 2008, the Union has considered it unnecessary to extend the joint undertaking in 2007, since the GNSS Supervisory Authority, set up in 2004, is capable of performing the necessary tasks.

The Galileo Joint Undertaking therefore ceased to exist as of 31 December 2006.

The two main tasks of the Joint Undertaking were:

implementation of the development phase: to this end, the Joint Undertaking, by agreement, entrusted to the European Space Agency the carrying-out of the activities required during the development phase in the space and associated earth segment;
preparing for the subsequent phases of the programme: the Joint Undertaking mobilised the public and private sector for the funds needed and set up the management structures for the various successive phases of the programme.

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 876/2002	28.5.2002	–	Official Journal L138 of 28.5.2002

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1943/2006	22.12.2006	–	Official Journal L 367 of 22.12.2006

Related Acts

Proposal for a Council Decision on the signing of the Cooperation Agreement on a Civil Global Navigation Satellite System (GNSS) – GALILEO, between the European Community and its Member States and the People’s Republic of China [COM(2003) 578 final – Not published in the Official Journal]

Communication from the Commission to the European Parliament and the Council – Integration of the EGNOS programme in the GALILEO programme [COM(2003)123 final – Not published in the Official Journal].

Communication from the Commission to the European Parliament and the Council – Progress report on the GALILEO research programme as at the beginning of 2004 [COM(2004)0112 final – not published in the Official Journal].

The inventory will be drawn up within six months of the actual establishment of the GALILEO joint undertaking. According to the Commission, 2003 was a decisive year for the programme. The first two experimental satellites were ordered and were due to begin transmitting in 2006 thus securing the frequencies allocated in June 2003 at the World Radiocommunication Conference. International cooperation is in full swing since the interest of non-member countries continues to grow. The European Union concluded an agreement with China in October 2003 and initiatives are under way with the United States (agreement in February 2004), Israel (agreement in March 2004), Russia, Brazil, India, Japan, Canada and South Korea. As regards the transition to the deployment (2006-07) and operating (after 2008) phases (according to the initial schedule), three consortia have expressed their interest in investing in the programme. The undertaking selected will contribute some EUR 1.5 billion.

Communication from the Commission to the European Parliament and the Council of 24 September 2002 on the state of progress of the GALILEO programme [COM(2002) 518 final – not published in the Official Journal].

Four months on from the entry into force of Regulation (EC) No 876/2002, the Communication reviews the implementation of the GALILEO programme (development phase). The creation of the Joint Undertaking was delayed following problems within the European Space Agency in finalising the respective contributions of the Member States. The Security Board will be set up shortly. The technical document specifying GALILEO’s mission, as well as the range, performance and technical characteristics of the associated services, has been consolidated. The next World Radiocommunication Conference (WRC), in June/July 2003, under the aegis of the UN, should confirm that GALILEO’s access to the frequency spectrum will be flexible enough to provide all the planned services and that GALILEO is compatible with other radio navigation systems (American GPS, the Russian GLONASS, the Chinese systems). Galileo’s worldwide vocation calls for effective cooperation with all third countries.

Communication from the Commission to the European Parliament and the Council – Moving to the deployment and operational phases of the European satellite radionavigation programme [COM(2004) 636 final – Not published in the Official Journal].

European GNSS Agency

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European GNSS Agency

Outline of the Community (European Union) legislation about European GNSS Agency

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Transport > Bodies and objectives

European GNSS Agency

Document or Iniciative

Regulation (EU) No 912/2010 of the European Parliament and of the Council of 22 September 2010 setting up the European GNSS Agency, repealing Council Regulation (EC) No 1321/2004 on the establishment of structures for the management of the European satellite radio navigation programmes.

Summary

This regulation repeals Regulation (EC) No 1321/2004 which had previously established the European Global Navigation Satellite System (GNSS) Supervisory Authority, a Community agency. Regulation (EC) No 683/2008, which defines the new framework for the public governance and funding of the EGNOS and Galileo programmes, sets out the principle of strict division of responsibilities between the Commission, the authority and the European Space Agency (ESA). This regulation grants the Commission certain responsibilities which had previously belonged to the authority, such as the management of the programmes. The authority was renamed the European GNSS Agency. Regulation (EC) No 683/2008 sets out the role and tasks of this agency. The agency is responsible for the following tasks:

ensuring security accreditation;
operating the Galileo security centre;
contributing to the preparation of the commercialisation of the systems;
accomplishing other tasks that may be entrusted to it by the Commission, in accordance with Article 54(2)(b) of the Financial Regulation, addressing specific issues linked to the programmes.

Structure of the agency

The agency is a body of the European Union (EU) with legal personality that is recognised in all EU countries and, as such, can be a party to legal proceedings. The agency has the following bodies: the Administrative Board, the Executive Director, and the Security Accreditation Board for European GNSS systems.

The Administrative Board is composed of one representative from each EU country, five representatives from the Commission and a non-voting representative from the European Parliament. Members are appointed for a term of five years, renewable once. Each representative has one vote, and decisions are taken by a two-thirds majority. The Administrative Board is responsible for ensuring the agency fulfils the tasks entrusted to it in this regulation. With regard to security accreditation matters, the Administrative Board is only responsible for resources and budgetary issues.

The Executive Director manages the agency. S/he is appointed and supervised by the Administrative Board for a term of five years, renewable once. The Executive Director is responsible for managing and representing the agency.

The Security Accreditation Board is composed of one representative from each EU country, one representative each from the Commission and the High Representative for Foreign Affairs and Security Policy. It acts as the security accreditation authority and will need to establish the compliance of the systems with security requirements prior to all major programmatic decisions, such as the approval of the security accreditation strategy, the launch of satellites, the authorisation to operate the systems and ground stations and the manufacture of PRS receivers.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EU) No 912/2010	9.11.2010	–	OJ L 276 of 20.10.2010

Single-member private limited liability companies

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Single-member private limited liability companies

Outline of the Community (European Union) legislation about Single-member private limited liability companies

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Internal market > Businesses in the internal market > Company law

Single-member private limited liability companies

Document or Iniciative

Directive 2009/102/EC of the European Parliament and of the Council of 16 September 2009 in the area of company law on single-member private limited liability companies (Text with EEA relevance).

Summary

This Directive establishes the legal framework applicable to private limited companies.

A company may have a single member by virtue of its being formed, or by virtue of all its shares coming to be held, by a single person (single-member company).

Where a company becomes a single-member company because all its shares have come to be held by a single person, that fact, together with the identity of the single member, must either be entered in a register kept by the company and accessible to the public or be recorded in the file or entered in the central register or the register of companies.

The single member exercises the powers of a general meeting of the company. Decisions taken by the single member and contracts between him and his company as represented by him must be recorded in minutes or drawn up in writing.

Where a Member State allows single-member companies in the case of public limited companies as well, the provisions of this Directive shall apply.

This Directive repeals Directive 89/667/EEC.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2009/102/EC	21.10.2009	–	OJ L 258, 1.10.2009

The formation of public limited liability companies and the maintenance and alteration of their capital

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The formation of public limited liability companies and the maintenance and alteration of their capital

Outline of the Community (European Union) legislation about The formation of public limited liability companies and the maintenance and alteration of their capital

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Internal market > Businesses in the internal market > Company law

The formation of public limited liability companies and the maintenance and alteration of their capital

Document or Iniciative

Second Council Directive 77/91/EECof 13 December 1976 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent [See amending acts].

Summary

This Directive establishes provisions which aim to protect shareholders and creditors of public limited liability companies by coordinating national provisions relating to the formation of companies and the maintenance, increase or reduction of their capital.

The Directive lays down minimum requirements in terms of information. The statutes or instrument of instruction of a public limited liability company should contain the following information:

the type and name of the company;
the objects of the company;
the amount of capital;
the rules governing appointing members responsible for the management, administration and supervision of the company.

Further information must be published in the statutes, the instrument of incorporation or in a separate document, including:

the registered office;
the value, number and form of the subscribed shares;
the amount of subscribed capital;
the identity of the signatories of the instrument of incorporation or the statutes.

In addition the Directive lays down the rules applicable:

to the value of the minimum capital;
to the issuing and acquisition of shares;
to the distribution of dividends;
to the financial aid accorded by companies for the acquisition of their shares;
to the increases and reductions in capital;
to the dissolution of public limited liability companies.

With regard to these increases and reductions of capital, the Directive aims in particular to ensure that the Member States’ legislation ensures equal treatment to all shareholders who are in the same position, as well as protecting creditors.

This Directive limits the possibility for a public limited liability company to acquire its own shares. In order to prevent circumvention, Directive 92/101/CEE extends this rule to all capital companies covered by Directive 68/151/CEE in which the company indirectly holds a majority of the voting rights or on which it can exercise a dominant influence either directly or indirectly, even if the other company is governed by the law of a third country on the condition that it has a comparable legal forms.

Context

This Directive forms part of the Community’s harmonisation of company law and company governance process, an essential condition in realising the internal market.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 77/91/EEC	16.12.1976	17.12.1978 17.12.1979 17.12.1980	OJ L 26, 31.1.1977

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 92/101/EEC	4.12.1992	1.1.1994	OJ L 347, 28.11.1992
Directive 2006/68/EC	15.10.2006	15.4.2008	OJ L 264, 25.9.2006
Directive 2009/109/EC	2.10.2009	30.6.2011	OJ L 259, 2.10.2009

The successive amendments and corrections to Directive 77/91/EEC have been integrated in to the original text. This consolidated version is of documentary value only.

The European Ombudsman

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The European Ombudsman

Outline of the Community (European Union) legislation about The European Ombudsman

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Justice freedom and security > Citizenship of the Union

The European Ombudsman

Document or Iniciative

European Parliament Decision 94/262/ECSC, EC, Euratom of 9 March 1994 on the regulations and general conditions governing the performance of the Ombudsman’s duties [See amending acts].

Summary

This European Parliament Decision establishes the position of the European Ombudsman and the conditions under which he works.

Combating maladministration

The main role of the European Ombudsman is to investigate cases of maladministration by Community bodies and institutions. To this end, these bodies and institutions must provide the Ombudsman with all the information he requires and indicate if any of this information is classified. If so, access to the information is regulated by the security rules of the body or institution in question, as provided by Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents. Member States may also be required to provide information to the Ombudsman. However, if this information is covered by laws on secrecy, the Ombudsman must not divulge it further. If the requested assistance is not provided, the Ombudsman informs the European Parliament, which then takes the necessary steps.

The Ombudsman may act either on his own initiative or following a complaint. The complainant may refer a matter to the Ombudsman via a Member of the European Parliament, but this is not obligatory.

The Court of Justice and the Court of First Instance, in the exercise of their judicial function, are excluded from the scope of the Ombudsman’s powers. The Ombudsman is not empowered to investigate cases of maladministration by national, regional or local governments in the Member States. Neither can he intervene in a case already brought before a court, nor question the validity of a court decision.

Taking a complaint to the European Ombudsman

Persons wishing to submit a complaint to the European Ombudsman must meet certain eligibility conditions:

The complainant: any European citizen, or other natural or legal person residing or having a registered office in one of the Member States of the Union, may submit a complaint. The complainant does not have to be affected directly by the case of maladministration.
The subject of the complaint: the complaint must relate solely to a case of maladministration on the part of a Community body or institution. “Maladministration” means, for example, an abuse of power, administrative irregularities, discrimination, etc.
The deadline: a complaint regarding a case of maladministration must be lodged within two years of the date on which the facts were brought to the citizen’s attention. It should be noted that the submission of a complaint to the Ombudsman does not affect the deadlines set in any other legal or administrative procedures.
The last resort principle: before submitting a complaint, the complainant must take the relevant administrative steps with the institution(s) concerned.

After the initial investigations, if the Ombudsman finds that a complaint is eligible, he informs the institution concerned and asks it to submit a detailed opinion within three months. Following this, the Ombudsman will send a report, with possible recommendations, to both the European Parliament and the institution concerned. The complainant will then be given the results of the Ombudsman’s inquiries, and possible recommendations, as well as the opinion of the institution concerned. The complainant has one month to submit any comments.

If the Ombudsman finds evidence of any criminal wrongdoing, he must immediately inform the national authorities, the Community institution responsible for fighting fraud, or the Community institution for which the official or agent in question works.

The Ombudsman may cooperate, under certain circumstances, with similar national authorities in order to enhance its investigations and to better protect the rights of the complainants. Likewise, the Ombudsman may also cooperate with national institutions responsible for protecting and promoting fundamental rights.

Appointment of the Ombudsman

The European Ombudsman is elected by the European Parliament for the Parliament’s term of office (five years), with the possibility of reappointment. He is chosen among those citizens of the Union who are in full possession of their civil and political rights and who are not subject to any conflict of interest. The person chosen must be capable of exercising a senior legal function or have a demonstrated ability to accomplish the tasks of the Ombudsman.

10 The Ombudsman acts independently and accepts no instructions from any government or other organisation. During the term of his mandate, he may not exercise any other political or administrative function or occupation, paid or unpaid. He is assisted by a secretariat.

An Ombudsman who no longer meets these conditions or who has committed a grave error may be dismissed by the Court of Justice of the European Communities, at the request of the European Parliament.

Origins

The position of Ombudsman was established by the Treaty on European Union (TEU, 1992).

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 94/262/ECSC, EC, Euratom	4.5.1994	–	OJ L 113 of 4.5.1994

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 2002/262/EC, ECSC, Euratom	9.4.2002 Applicable with effect: 1.1.2000	–	OJ L 92 of 9.4.2002
Decision 2008/587/EC, Euratom	31.7.2008		OJ L 189 of 17.7.2008

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

A simplified business environment

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A simplified business environment

Outline of the Community (European Union) legislation about A simplified business environment

Topics

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

Internal market > Businesses in the internal market > Company law

A simplified business environment

Document or Iniciative

Communication from the Commission dated 10 July 2007 on a simplifed business environment for companies in the area of company law, accounting and auditing [COM (2007) 394 final – Official Journal C191 dated 15.8.2007].

Summary

High administrative costs resulting from EU legislation restrict the competitiveness of European companies. Furthermore, legislation relating to company law, accounting and auditing has not developed in line with the business environment. The Commission proposes to re-examine EU directives in this area and their relevance. These proposals are subject to discussion with Member States, European Parliament and stakeholders with the aim of arriving at a consensus and submitting legislative proposals.

Company law

Member States need to be able to provide rapid and flexible responses appropriate to the constantly developing business environment. In this situation, a harmonised European framework promotes a climate of confidence that is required for the smooth running of the single market, but it also represents a restraint on innovation and imposes additional administrative burdens on companies.

An initial option consists in considering the relevance of directives and their complete or partial repeal where they do not regulate cross-border issues. This affects the following:

Domestic mergers and divisions (Third and Sixth Directives);
Rules on the capital of public limited companies (Second Directive);
Rules on single-member private limited liability companies (Twelfth Directive).

A second option consists of considering simplifying legislation if repeal is too far-reaching. This is aimed at giving Member States a wider margin for manoeuvre in mergers and divisions, regarding:

The choice between extending directors’ responsibility and the provision of specific financial data to reduce the burdens resulting from information (reports) to be compiled;
General meeting approval of the company acquiring another company and cases where this is necessary. In return, the protection of creditors needs to be ensured; Directive 2006/68/EC amending legislation relating to the formation of public limited liability companies and the maintenance and alteration of their capital may be used as a reference basis.

Specific simplification measures are also proposed in order to reduce unnecessary burdens and costs resulting from other legislative obligations for companies and their branches. These measures apply to:

Publicity. The duty to publish certain information in the national gazettes in compliance with the First Company Law Directive may be abolished. In fact, this information has already been published in national registers, since 2007 in electronic format, and is accessible to all Member States. For this reason, a simple registration service would be sufficient. Furthermore, publicity obligations for branches in the establishment’s Member State could also be simplified as regards the certified translation of certain documents and the Member State of the branch could have the certified translation prepared in another Member State. In both cases, the European Business Register (EBR) is an appropriate interface to access information taking full advantage of electronic registers;
The European Company Statute, particularly the requirements regarding the registered office which should be reviewed in the light of case law at the European Court of Justice. The report scheduled for 2009 on the European Company Statute will provide an opportunity to re-examine legislation.

Accounting and auditing for SMEs

The directives which ensure the quality of financial information and auditing in the EU impose a high administrative burden on companies, especially on small and medium-sized companies (SMEs).

The Commission proposes to introduce the idea of a micro entity, already considered by certain Member States, and to exclude it from the scope of the Fourth Directive on annual accounts. The micro entity could satisfy the following criteria: fewer than 10 employees, balance sheet total less than €500,000 and turnover less than €1,000,000.

As regards SMEs, various additional measures are proposed, namely:

To exempt small companies from the obligation to publish their accounts;
To extend the exemptions reserved for small entities when managers of the medium-sized entity are also owners of the small entity or when these companies have unlimited liability;
To realign periods of transition (from two years to five years when the threshold is exceeded and from two years to one year in the event of any movement in the opposite direction) and to review the procedure for adapting thresholds.

Additional measures may also be considered for SMEs, such as regular updating of thresholds, amendment of requirements in the area of consolidation (especially for small and medium-sized subsidiaries), revision of the need for accounting for deferred taxes and to remove certain disclosure requirements (on start-up costs and on breakdown of turnover).

Background

Reducing administrative burdens for companies boosts the European economy. Initiated by the Commission in 2006, the updated simplification programme, completed with an action programme, following on from the European Council of 8 and 9 March 2007 (FR ) (pdf). Company law, accounting and auditing had been identified there as three priority action areas.

Associated Acts

December 2007 summary on reactions to the Communication from the Commission on a simplified business environment in the area of company law, accounting and auditing (COM (2007) 394) (pdf ).
Following the Communication from the Commission dated 10 July 2007, the Council invited the Commission to examine responses generated by the Communication on a simplified business environment and, if necessary, to submit new proposals. As a result of the summary of these reactions, there is a clear preference for the solution involving simplifying existing legislation (second option proposed by the Commission in its Communication).