3.7.2009

Official Journal of the European Union

C 151/1

COUNCIL RECOMMENDATION

of 9 June 2009

on patient safety, including the prevention and control of healthcare associated infections

2009/C 151/01

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular the second subparagraph of Article 152(4) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Whereas:

(1)	Article 152 of the Treaty provides that Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and eliminating sources of danger to human health.

(2)	It is estimated that in Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare (4).

(3)	The European Centre for Disease Prevention and Control (ECDC) has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the EU, and that 37 000 deaths are caused every year as a result of such infections.

(4)	Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. A large proportion of adverse events, both in the hospital sector and in primary care, are preventable with systemic factors appearing to account for a majority of them.

(5)	This recommendation builds upon, and complements, work on patient safety carried out by the World Health Organisation (WHO) through its World Alliance for Patient Safety, the Council of Europe and the Organisation for Economic Cooperation and Development (OECD).

(6)

The Community, through the seventh framework programme for research and development (5), supports research in health systems, in particular in the quality of healthcare provision under the Health Theme, including a focus on patient safety. The latter is also given particular attention under the Information and Communication Technology Theme.

(7)	The Commission, in its White Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’ of 23 October 2007, identifies patient safety as an area for action.

(8)

Evidence suggests that Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies (6). Therefore, this recommendation intends to create a framework to stimulate policy development and future action in and between Member States to address the key patient safety issues confronting the EU.

(9)	Patients should be informed and empowered by involving them in the patient safety process. They should be informed of patient safety standards, best practices and/or safety measures in place and on how they can find accessible and comprehensible information on complaints and redress systems.

(10)

Member States should set up, maintain or improve comprehensive reporting and learning systems so that the extent and causes of adverse events can be captured in order to develop efficient solutions and interventions. Patient safety should be embedded in the education and training of healthcare workers, as the providers of care.

(11)

Comparable and aggregate data should be collected at Community level to establish efficient and transparent patient safety programmes, structures and policies, and best practices should be disseminated among the Member States. To facilitate mutual learning, a common terminology for patient safety and common indicators need to be developed through cooperation between Member States and the European Commission, taking into account the work of relevant international organisations.

(12)

Information and communication technology tools, such as electronic health records or e-prescriptions, can contribute to improving patient safety, for instance by systematically screening for potential medicinal product interactions or allergies. Information and communication technology tools should also aim to improve the understanding of users of the medical products.

(13)

A national strategy, complementary to strategies targeted towards the prudent use of antimicrobial agents (7), should be developed incorporating prevention and control of healthcare associated infections into national public health objectives and aiming to reduce the risk of healthcare associated infections within healthcare institutions. It is essential that the necessary resources for implementing the components of the national strategy are allocated as part of the core funding for healthcare delivery.

(14)

The prevention and control of healthcare associated infections should be a long-term strategic priority for healthcare institutions. All hierarchical levels and functions should cooperate to achieve result-oriented behaviour and organisational change, by defining responsibilities at all levels, organising support facilities and local technical resources and setting up evaluation procedures.

(15)

Sufficient data on healthcare associated infections are not always available to allow meaningful comparisons between institutions by surveillance networks, to monitor the epidemiology of healthcare associated pathogens and to evaluate and guide policies on the prevention and control of healthcare associated infections. Therefore, surveillance systems should be established or strengthened at the level of healthcare institutions and at regional and national levels.

(16)

Member States should aim to reduce the number of people affected by healthcare associated infections. In order to achieve a reduction in healthcare associated infections, recruitment of health professionals specialising in infection control should be encouraged. Furthermore, Member States and their healthcare institutions should consider the use of link staff to support specialist infection control staff at the clinical level.

(17)	Member States should work closely with the health technology industry to encourage better design for patient safety in order to reduce the occurrence of adverse events in healthcare.

(18)

To achieve the patient safety objectives mentioned above, including the prevention and control of healthcare associated infections, Member States should ensure a fully comprehensive approach while considering the most appropriate elements having a real impact on the prevalence and burden of adverse events.

(19)	Community action in the field of public health should fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care,

HEREBY RECOMMENDS:

Applying the following definitions for the purpose of this recommendation:

‘Adverse event’ means an incident which results in harm to a patient;

‘Harm’ implies impairment of the structure or function of the body and/or any deleterious effect arising therefrom;

‘Healthcare associated infections’ means diseases or pathologies related to the presence of an infectious agent or its products in association with exposure to healthcare facilities or healthcare procedures or treatments;

‘Patient safety’ means freedom, for a patient, from unnecessary harm or potential harm associated with healthcare;

‘Process indicator’ means an indicator referring to the compliance with agreed activities such as hand hygiene, surveillance, standard operating procedures;

‘Structure indicator’ means an indicator referring to any resource, such as staff, an infrastructure or a committee;

THAT MEMBER STATES:

I. RECOMMENDATIONS ON GENERAL PATIENT SAFETY ISSUES

Support the establishment and development of national policies and programmes on patient safety by:

(a)	designating the competent authority or authorities or any other competent body or bodies responsible for patient safety on their territory;

(b)	embedding patient safety as a priority issue in health policies and programmes at national as well as at regional and local levels;

(c)	supporting the development of safer and user-friendly systems, processes and tools, including the use of information and communication technology;

(d)	regularly reviewing and updating safety standards and/or best practices applicable to healthcare provided on their territory;

(e)	encouraging health professional organisations to have an active role in patient safety;

(f)	including a specific approach to promote safe practices to prevent the most commonly occurring adverse events such as medication-related events, healthcare associated infections and complications during or after surgical intervention.

Empower and inform citizens and patients by:

(a)	involving patient organisations and representatives in the development of policies and programmes on patient safety at all appropriate levels;

(b)

disseminating information to patients on:

(i)	patient safety standards which are in place;

(ii)	risk, safety measures which are in place to reduce or prevent errors and harm, including best practices, and the right to informed consent to treatment, to facilitate patient choice and decision-making;

(iii)

complaints procedures and available remedies and redress and the terms and conditions applicable;

(c)	considering the possibilities of development of core competencies in patient safety namely, the core knowledge, attitudes and skills required to achieve safer care, for patients.

Support the establishment or strengthen blame-free reporting and learning systems on adverse events that:

(a)	provide information on the extent, types and causes of errors, adverse events and near misses;

(b)

encourage healthcare workers to actively report through the establishment of a reporting environment which is open, fair and non punitive; this reporting should be differentiated from Member States’ disciplinary systems and procedures for healthcare workers, and, where necessary, the legal issues surrounding the healthcare workers’ liability should be clarified;

(c)	provide, as appropriate, opportunities for patients, their relatives and other informal caregivers to report their experiences;

(d)	complement other safety reporting systems, such as those on pharmacovigilance and medical devices, whilst avoiding multiple reporting where possible.

Promote, at the appropriate level, education and training of healthcare workers on patient safety by:

(a)	encouraging multidisciplinary patient safety education and training of all health professionals, other healthcare workers and relevant management and administrative staff in healthcare settings;

(b)	embedding patient safety in undergraduate and postgraduate education, on-the-job training and the continuing professional development of health professionals;

(c)	considering the development of core competencies in patient safety namely, the core knowledge, attitudes and skills required to achieve safer care, for dissemination to all healthcare workers and relevant management and administrative staff;

(d)	providing and disseminating information to all healthcare workers on patient safety standards, risk and safety measures in place to reduce or prevent errors and harm, including best practices, and promoting their involvement;

(e)

collaborating with organisations involved in professional education in healthcare to ensure that patient safety receives proper attention in the higher education curricula and in the ongoing education and training of health professionals, including the development of the skills needed to manage and deliver the behavioural changes necessary to improve patient safety through system change.

Classify and measure patient safety at Community level, by working with each other and with the Commission:

(a)	to develop common definitions and terminology, taking into account international standardisation activities such as the International Classification for Patient Safety being developed by WHO and the Council of Europe's work in this area;

(b)

to develop a set of reliable and comparable indicators, to identify safety problems, to evaluate the effectiveness of interventions aimed at improving safety and to facilitate mutual learning between Member States; account should be taken of the work done at national level and of international activities such as the OECD healthcare quality indicators project and the Community Health Indicators project;

(c)	to gather and share comparable data and information on patient safety outcomes in terms of type and number to facilitate mutual learning and inform priority setting, with a view to helping Member States to share relevant indicators with the public in the future.

Share knowledge, experience and best practice by working with each other and with the Commission and relevant European and international bodies on:

(a)	the establishment of efficient and transparent patient safety programmes, structures and policies, including reporting and learning systems, with a view to addressing adverse events in healthcare;

(b)	the effectiveness of patient safety interventions and solutions at the healthcare setting level and the evaluation of the transferability of these;

(c)	major patient safety alerts in a timely manner.

7.	Develop and promote research on patient safety.

II. ADDITIONAL RECOMMENDATIONS ON PREVENTION AND CONTROL OF HEALTHCARE ASSOCIATED INFECTIONS

Adopt and implement a strategy at the appropriate level for the prevention and control of healthcare associated infections, pursuing the following objectives:

(a)

implement prevention and control measures at national or regional level to support the containment of healthcare associated infections and in particular:

(i)	to implement standard and risk-based infection prevention and control measures in all healthcare settings as appropriate;

(ii)	to promote consistency in, and communication of, infection prevention and control measures between healthcare providers treating or caring for a particular patient;

(iii)

to make guidelines and recommendations available at national level;

(iv)	to encourage the adherence to prevention and control measures by using structure and process indicators, as well as the results of accreditation or certification processes in place;

(b)

enhance infection prevention and control at the level of the healthcare institutions in particular by encouraging healthcare institutions to have in place:

(i)	an infection prevention and control programme addressing aspects such as organisational and structural arrangements, diagnostic and therapeutic procedures (for example antimicrobial stewardship), resource requirements, surveillance objectives, training and information to patients;

(ii)	appropriate organisational governance arrangements for the elaboration and the monitoring of the infection prevention and control programme;

(iii)

appropriate organisational arrangements and qualified personnel with the task of implementing the infection prevention and control programme;

(c)

establish or strengthen active surveillance systems by:

(i)

at national or regional level:

—	organising prevalence surveys at regular intervals, as appropriate;

—	taking into account the importance of surveillance of targeted infection types to establish national reference data, accompanied by process and structure indicators to evaluate the strategy;

—	organising the timely detection and reporting of alert healthcare associated organisms or clusters of healthcare associated infections to the relevant body as per requirements at Member State level;

—	reporting of clusters and infection types of relevance for the Community or international level in accordance with the Community legislation (8) or international regulations in place;

(ii)

at the level of healthcare institutions:

—	encouraging high quality microbiological documentation and patient records;

—	performing the surveillance of the incidence of targeted infection types, accompanied by process and structure indicators to evaluate the implementation of infection control measures;

—	considering the use of surveillance of particular infection types and/or particular strains of healthcare associated pathogens for the timely detection of alert healthcare associated organisms or clusters of healthcare associated infections;

(iii)

using, where appropriate, surveillance methods and indicators as recommended by ECDC and case definitions as agreed upon at Community level in accordance with the provisions of Decision No 2119/98/EC;

(d)

foster education and training of healthcare workers by:

(i)	at national or regional level, defining and implementing specialised infection control training and/or education programmes for infection control staff and strengthening education on the prevention and control of healthcare associated infections for other healthcare workers;

(ii)

at the level of healthcare institutions:

—	providing regular training for all healthcare personnel, including managers, on basic principles of hygiene and infection prevention and control;

—	providing regular advanced training for personnel having particular tasks related to the prevention and control of healthcare associated infections;

(e)

improve the information to the patients by healthcare institutions:

(i)	making available objective and understandable information about the risk of healthcare associated infections, the measures implemented by the healthcare institution to prevent them and on how patients can help to prevent those infections;

(ii)	providing specific information, for example on prevention and control measures, to patients colonised or infected with healthcare associated pathogens;

(f)	support research in fields such as epidemiology, the applications of nanotechnologies and nanomaterials, new preventive and therapeutic technologies and interventions and on the cost-effectiveness of infection prevention and control.

Consider, for the coordinated implementation of the strategy referred to in (8) as well as for the purposes of information exchange and coordination with the Commission, the ECDC, the European Medicines Agency and the other Member States, the establishment, if possible by 9 June 2011, of an inter-sectoral mechanism or equivalent systems corresponding to the infrastructure in each Member State, collaborating with, or integrated into, the existing inter-sectoral mechanism as set up in accordance with Council Recommendation No 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (9).

III. FINAL RECOMMENDATIONS

10.	Disseminate the content of this recommendation to healthcare organisations, professional bodies and educational institutions and encourage them to follow the approaches suggested therein so that its key elements can be put into everyday practice.

11.	Report to the Commission on the progress of the implementation of this recommendation by 9 June 2011 and subsequently on request by the Commission with a view to contributing to the follow-up of this recommendation at Community level,

HEREBY INVITES THE COMMISSION TO:

Produce, by 9 June 2012, an implementation report to the Council assessing impact of this Recommendation, on the basis of the information provided by Member States, to consider the extent to which the proposed measures are working effectively, and to consider the need for further action.

Done at Luxembourg, 8 June 2009.

For the Council

The President

Petr ŠIMERKA

(1) Opinion of 23 April 2009 (not yet published in the Official Journal).

(2) Opinion of 25 March 2009 (not yet published in the Official Journal).

(3) Opinion of 22 April 2009 (not yet published in the Official Journal).

(4) Technical report ‘Improving Patient Safety in the EU’ prepared for the European Commission, published 2008 by the RAND Cooperation.

(5) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the seventh framework programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1).

(6) Safety improvement for Patients in Europe (SIMPATIE) project funded under the Community's Public Health Programme 2003-2008, (http://www.simpatie.org).

(7) For example Council conclusions on antimicrobial resistance adopted on 10 June 2008.

(8) For example Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community and the International Health Regulations (OJ L 268, 3.10.1998, p. 1) and 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 (OJ L 136, 30.4.2004, p. 1).

(9) OJ L 34, 5.2.2002, p. 13.

3.7.2009

Official Journal of the European Union

C 151/7

COUNCIL RECOMMENDATION

of 8 June 2009

on an action in the field of rare diseases

2009/C 151/02

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular the second subparagraph of Article 152(4) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Whereas:

(1)	Rare diseases are a threat to the health of EU citizens insofar as they are life-threatening or chronically debilitating diseases with a low prevalence and a high level of complexity. Despite their rarity, there are so many different types of rare diseases that millions of people are affected.

(2)	The principles and overarching values of universality, access to good quality care, equity and solidarity, as endorsed in the Council conclusions on common values and principles in EU health systems of 2 June 2006, are of paramount importance for patients with rare diseases.

(3)

The Community action programme on rare diseases, including genetic diseases, was adopted for the period 1 January 1999 to 31 December 2003 (3). This programme defined the prevalence for a rare disease as affecting no more than 5 per 10 000 persons in the EU. A more refined definition based on updated scientific review, taking into account both prevalence and incidence, will be developed using the Second Community Health Programme (4) resources.

(4)

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (5) provides that a medicinal product shall be designated as an ‘orphan medicinal product’ when intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10 000 persons in the Community when the application is made.

(5)

It is estimated that between 5 000 and 8 000 distinct rare diseases exist today, affecting between 6 % and 8 % of the population in the course of their lives. In other words, although rare diseases are characterised by low prevalence for each of them, the total number of people affected by rare diseases in the EU is between 27 and 36 million. Most of them suffer from less frequently occurring diseases affecting one in 100 000 people or less. These patients are particularly isolated and vulnerable.

(6)

Because of their low prevalence, their specificity and the high total number of people affected, rare diseases call for a global approach based on special and combined efforts to prevent significant morbidity or avoidable premature mortality, and to improve the quality of life and socioeconomic potential of affected persons.

(7)

Rare diseases were one of the priorities of the Community's sixth framework programme for research and development (6) and continue to be a priority for action in its seventh framework programme for research and development (7), as developing new diagnostics and treatments for rare disorders, as well as performing epidemiological research on those disorders, require multi-country approaches in order to increase the number of patients for each study.

(8)	The Commission, in its White Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’ of 23 October 2007, which develops the EU Health Strategy, identified rare diseases as a priority for action.

(9)	In order to improve the coordination and coherence of national, regional and local initiatives addressing rare diseases and cooperation between research centres, relevant national actions in the field of rare diseases could be integrated into plans or strategies for rare diseases.

(10)

According to the Orphanet database, of the thousands of known rare diseases for which a clinical identification is possible, only 250 of them have a code in the existing International Classification of Diseases (ICD) (10th version). An appropriate classification and codification of all rare diseases is necessary in order to give them the necessary visibility and recognition in national health systems.

(11)

In 2007 the World Health Organisation (WHO) launched the process of revision of the 10th version of the ICD in order to adopt the new, 11th version of this classification at the World Health Assembly in 2014. The WHO has appointed the Chair of the EU Rare Diseases Task Force as the Chair of the Topic Advisory Group on Rare Diseases in order to contribute to this process of revision, providing proposals for codification and classification of rare diseases.

(12)	The implementation of a common identification of rare diseases by all the Member States would strongly reinforce the contribution of the EU in this topic advisory group and would facilitate cooperation at Community level in the field of rare diseases.

(13)

In July 2004, a Commission High-Level Group on Health Services and Medical Care was established to bring together experts from all Member States to work on practical aspects of collaboration between national health systems in the EU. One of this High-Level Group's working groups is focusing on European Reference Networks (ERNs) for rare diseases. Some criteria and principles for ERNs have been developed, including their role in tackling rare diseases. ERNs could also serve as research and knowledge centres, treating patients from other Member States and ensuring the availability of subsequent treatment facilities where necessary.

(14)

The Community added value of ERNs is particularly high for rare diseases by reason of the rarity of these conditions, which implies both a limited number of patients and a scarcity of expertise within a single country. Gathering expertise at European level is therefore paramount in order to ensure equal access to accurate information, appropriate and timely diagnosis and high quality care for rare disease patients.

(15)

In December 2006 an expert group of the European Union Rare Diseases Task Force issued a report ‘Contribution to policy shaping: for a European collaboration on health services and medical care in the field of rare diseases’ to the High-Level Group on Health Services and Medical Care. The expert group report outlines, inter alia, the importance of identifying centres of expertise and the roles that such centres should fulfil. It is also agreed that, in principle and where possible, expertise should travel rather than patients themselves. Some measures called for in the report are included in this recommendation.

(16)	Cooperation and knowledge sharing between centres of expertise has proven to be a very efficient approach to dealing with rare diseases in Europe.

(17)	The centres of expertise could follow a multidisciplinary approach to care, in order to address the complex and diverse conditions implied by rare diseases.

(18)

The specificities of rare diseases — a limited number of patients and a scarcity of relevant knowledge and expertise — single them out as a unique domain of very high added value of action at Community level. This added value can especially be achieved through gathering national expertise on rare diseases which is scattered throughout the Member States.

(19)

It is of utmost importance to ensure an active contribution of the Member States to the elaboration of some of the common instruments foreseen in the Commission communication on rare diseases: Europe's challenges of 11 November 2008, especially on diagnostics and medical care and European guidelines on population screening. This could be also the case for the assessment reports on the therapeutic added value of orphan medicinal products, which could contribute to accelerating the price negotiation at national level, thereby reducing delays for access to orphan drugs for rare diseases patients.

(20)

The WHO defined empowerment of patients as a ‘pre-requisite for health’ and encouraged a ‘proactive partnership and patient self-care strategy to improve health outcomes and quality of life among the chronically ill’ (8). In this sense, the role of independent patient groups is crucial both in terms of direct support to individuals living with the disease and in terms of the collective work they carry out to improve conditions for the community of rare disease patients as a whole and for the next generations.

(21)	Member States should aim to involve patients and patients′ representatives in the policy process and seek to promote the activities of patient groups.

(22)

The development of research and healthcare infrastructures in the field of rare diseases requires long-lasting projects and therefore an appropriate financial effort to ensure their sustainability in the long term. This effort would notably maximise the synergy with the projects developed under the second community health programme, the seventh framework programme for research and development and the successors of these programmes,

HEREBY RECOMMENDS THAT MEMBER STATES:

I. PLANS AND STRATEGIES IN THE FIELD OF RARE DISEASES

Establish and implement plans or strategies for rare diseases at the appropriate level or explore appropriate measures for rare diseases in other public health strategies, in order to aim to ensure that patients with rare diseases have access to high-quality care, including diagnostics, treatments, habilitation for those living with the disease and, if possible, effective orphan drugs, and in particular:

(a)	elaborate and adopt a plan or strategy as soon as possible, preferably by the end of 2013 at the latest, aimed at guiding and structuring relevant actions in the field of rare diseases within the framework of their health and social systems;

(b)	take action to integrate current and future initiatives at local, regional and national levels into their plans or strategies for a comprehensive approach;

(c)	define a limited number of priority actions within their plans or strategies, with objectives and follow-up mechanisms;

(d)

take note of the development of guidelines and recommendations for the elaboration of national action for rare diseases by relevant authorities at national level in the framework of the ongoing european project for rare diseases national plans development (EUROPLAN) selected for funding over the period 2008-2011 in the first programme of Community action in the field of public health (9).

II. ADEQUATE DEFINITION, CODIFICATION AND INVENTORYING OF RARE DISEASES

2.	Use for the purposes of Community-level policy work a common definition of rare disease as a disease affecting no more than 5 per 10 000 persons.

3.	Aim to ensure that rare diseases are adequately coded and traceable in all health information systems, encouraging an adequate recognition of the disease in the national healthcare and reimbursement systems based on the ICD while respecting national procedures.

4.	Contribute actively to the development of the EU easily accessible and dynamic inventory of rare diseases based on the Orphanet network and other existing networks as referred to in the Commission Communication on rare diseases.

5.	Consider supporting at all appropriate levels, including the Community level, on the one hand, specific disease information networks and, on the other hand, for epidemiological purposes, registries and databases, whilst being aware of an independent governance.

III. RESEARCH ON RARE DISEASES

6.	Identify ongoing research and research resources in the national and Community frameworks in order to establish the state of the art, assess the research landscape in the area of rare diseases, and improve the coordination of Community, national and regional programmes for rare diseases research.

7.	Identify needs and priorities for basic, clinical, translational and social research in the field of rare diseases and modes of fostering them, and promote interdisciplinary cooperative approaches to be complementarily addressed through national and Community programmes.

8.	Foster the participation of national researchers in research projects on rare diseases funded at all appropriate levels, including the Community level.

9.	Include in their plans or strategies provisions aimed at fostering research in the field of rare diseases.

10.	Facilitate, together with the Commission, the development of research cooperation with third countries active in research on rare diseases and more generally with regard to the exchange of information and the sharing of expertise.

IV. CENTRES OF EXPERTISE AND EUROPEAN REFERENCE NETWORKS FOR RARE DISEASES

11.	Identify appropriate centres of expertise throughout their national territory by the end of 2013, and consider supporting their creation.

12.	Foster the participation of centres of expertise in European reference networks respecting the national competences and rules with regard to their authorisation or recognition.

13.	Organise healthcare pathways for patients suffering from rare diseases through the establishment of cooperation with relevant experts and exchange of professionals and expertise within the country or from abroad when necessary.

14.	Support the use of information and communication technologies such as telemedicine where it is necessary to ensure distant access to the specific healthcare needed.

15.	Include, in their plans or strategies, the necessary conditions for the diffusion and mobility of expertise and knowledge in order to facilitate the treatment of patients in their proximity.

16.	Encourage centres of expertise to be based on a multidisciplinary approach to care when addressing rare diseases.

V. GATHERING THE EXPERTISE ON RARE DISEASES AT EUROPEAN LEVEL

17.

Gather national expertise on rare diseases and support the pooling of that expertise with European counterparts in order to support:

(a)	the sharing of best practices on diagnostic tools and medical care as well as education and social care in the field of rare diseases;

(b)	adequate education and training for all health professionals to make them aware of the existence of these diseases and of resources available for their care;

(c)	the development of medical training in fields relevant to the diagnosis and management of rare diseases, such as genetics, immunology, neurology, oncology or paediatrics;

(d)	the development of European guidelines on diagnostic tests or population screening, while respecting national decisions and competences;

(e)	the sharing Member States′ assessment reports on the therapeutic or clinical added value of orphan drugs at Community level where the relevant knowledge and expertise is gathered, in order to minimise delays in access to orphan drugs for rare disease patients.

VI. EMPOWERMENT OF PATIENT ORGANISATIONS

18.	Consult patients and patients′ representatives on the policies in the field of rare diseases and facilitate patient access to updated information on rare diseases.

19.	Promote the activities performed by patient organisations, such as awareness-raising, capacity-building and training, exchange of information and best practices, networking and outreach to very isolated patients.

VII. SUSTAINABILITY

20.	Together with the Commission, aim to ensure, through appropriate funding and cooperation mechanisms, the long-term sustainability of infrastructures developed in the field of information, research and healthcare for rare diseases.

HEREBY INVITES THE COMMISSION:

To produce, by the end of 2013 and in order to allow proposals in any possible future programme of Community action in the field of health, an implementation report on this recommendation addressed to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions and based on the information provided by the Member States, which should consider the extent to which the proposed measures are working effectively and the need for further action to improve the lives of patients affected by rare diseases and those of their families.

2.	To inform the Council of the follow-up to the Commission Communication on rare diseases on a regular basis.

Done at Luxembourg, 8 June 2009.

For the Council

The President

Petr ŠIMERKA

(1) Legislative resolution of 23 April 2009 (not yet published in the Official Journal).

(2) Opinion of 25 February 2009 (not yet published in the Official Journal).

(3) Decision No 1295/1999/EC of the European Parliament and of the Council of 29 April 1999 adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003) (OJ L 155, 22.6.1999, p. 1). Decision repealed by Decision No 1786/2002/EC (OJ L 271, 9.10.2002, p. 1).

(4) Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-2013) (OJ L 301, 20.11.2007, p. 3).

(5) OJ L 18, 22.1.2000, p. 1.

(6) Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning the sixth framework programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002 to 2006) (OJ L 232, 29.8.2002, p. 1).

(7) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1).

(8) http://www.euro.who.int/Document/E88086.pdf

(9) Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (OJ L 271, 9.10.2002, p. 1).

3.7.2009

Official Journal of the European Union

C 151/11

Opinion of the European Data Protection Supervisor on the Proposal for a Council Regulation establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy

2009/C 151/03

THE EUROPEAN DATA PROTECTION SUPERVISOR,

Having regard to the Treaty establishing the European Community, and in particular its Article 286,

Having regard to the Charter of Fundamental Rights of the European Union, and in particular its Article 8,

Having regard to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data,

Having regard to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, and in particular its Article 41,

Having regard to the request for an opinion in accordance with Article 28(2) of Regulation (EC) No 45/2001 sent to the EDPS on 14 November 2008,

HAS ADOPTED THE FOLLOWING OPINION:

I. INTRODUCTORY OBSERVATIONS

On 14 November 2008, the Commission adopted a Proposal for a Council Regulation establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (hereinafter: ‘the proposal’). The proposal was sent by the Commission to the EDPS for consultation, in accordance with Article 28(2) of Regulation (EC) No 45/2001 (1).

On the same day, the Commission adopted two other instruments as part of the fisheries package. First, the Commission adopted a Communication on the proposal for a Council Regulation establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy. Second, it also adopted a Commission staff working document (Impact Assessment) accompanying the Proposal for a Council Regulation establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy. Those two documents formed, together with the proposal, the package sent to the EDPS for consultation.

The objective of the Common Fisheries Policy, as set out in Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of resources under the Common Fisheries Policy (2), is to ensure exploitation of living aquatic resources in such a way that ensures sustainable economic, environmental and social conditions.

4.	The proposal establishes a Community system for control, monitoring, surveillance, inspection and enforcement of the rules of the Common Fisheries Policy.

5.	The EDPS welcomes the fact that he is consulted on this issue and that reference to this consultation is made in the preamble of the proposal, in a similar way to a number of other legislative texts on which the EDPS has been consulted, in accordance with Regulation (EC) No 45/2001.

The EDPS recalls that he provided informal comments on 3 October 2008 on a draft proposal. In these comments, he underlined that the data protection legal framework has to be considered not only in respect of the transfer and exchange of personal data but also in respect of the collection of these data.

7.	Finally, the EDPS emphasises that this opinion addresses only a few provisions of the proposal, namely Recitals 36 to 38 and Articles 102 to 108.

II. BACKGROUND AND CONTEXT

There are different reasons why data protection provisions in the context of this proposal are relevant. First, the proposal foresees the processing of various data, which in certain cases, can be considered as personal data. For instance, when a vessel's identification is required, it will normally contain a reference to the master of the vessel or his representative. In certain provisions, the proposal also clearly underlines the need to communicate the name of the vessel's owner or master. In such cases, the data not only relate to the vessel, but also to identifiable individuals who play a role in the way in which that vessel is used and compliance with the rules of the Common Fisheries Policy is ensured. Moreover, the proposal also foresees transfers of these data and exchanges of information, both between Member States and with the Commission or the Community Fisheries Control Agency. The EDPS also notes that the proposal foresees the use of aggregated data in certain circumstances. All these aspects require respecting the data protection legal framework.

The EDPS is glad to see that the proposal clearly specifies that the European legal framework relating to the protection of personal data (Directive 95/46/EC (3) and Regulation (EC) No 45/2001) shall apply to the processing of personal data carried out in the application of the Regulation, whether by Member States or by the Commission. These principles are contained both in Recitals 36 to 38 and in Articles 104 and 105.

10.

Without doubt, and as specified in the recitals, clear rules for the processing of personal data are needed for reasons of legal certainty and transparency, and to ensure the protection of fundamental rights, and in particular, the right to the protection of the private life and the personal data of individuals.

III. PROTECTION OF PERSONAL DATA AND CONFIDENTIALITY OF DATA

11.

Article 104 of the proposal concerns specifically the protection of personal data, while Article 105 deals with confidentiality, professional and commercial secrecy. The former Article deals with the general principles established in Directive 95/46/EC and Regulation (EC) No 45/2001, while the latter further develops specific aspects relating to the confidentiality of the processed data.

12.	The EDPS welcomes the limitations and references made in both Articles as to the use and transmission of the data of natural persons with respect for Directive 95/46/EC and Regulation (EC) No 45/2001.

13.

The EDPS would like to comment on Article 104, paragraph 2, further to which ‘the names of natural persons shall not be communicated to the Commission or to another Member State except in the case where such communication is expressly provided for in this Regulation or if it is necessary for the purposes of preventing or pursuing infringements or the verification of apparent infringements. The data referred to in paragraph 1 shall not be transmitted unless they are aggregated with other data in a form, which does not permit the direct or indirect identification of natural persons’. First, the EDPS considers that the current drafting of Article 104, paragraph 2, unduly restricts the scope of the protection. The text should make clear that the protection does not cover only the transfer of the names of natural persons but also other personal data (4). He therefore asks a revision of the wording so as to reflect this aspect. Moreover, the EDPS would also suggest amending the second sentence of the paragraph, so that it reads: ‘The data referred to in this Article…’ to be more consistent, as paragraph 1 is mainly a reference to the Community legal framework for the protection of personal data.

14.

Article 105 deals with confidentiality and professional and commercial secrecy. This provision applies, regardless of whether data can be considered as personal data or not. Paragraphs 1 to 3 apparently aim to set out the general principles of confidentiality, whereas paragraph 4 is designed to give additional protection in certain cases, although the object of this paragraph is not entirely clear. The EDPS found a great similarity between Article 105, paragraph 4(a) of the proposal and Article 4, paragraph 1(b) of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents, which the EDPS has thoroughly analysed (5). Article 4(1)(b) of this Regulation was widely criticized as being ambiguous about the precise relation between access to documents and the rights to privacy and the protection of personal data. The Article was also disputed before the Court of First Instance (6). An appeal on grounds of law is now pending before the Court of Justice (7). The EDPS invites the Community legislator to clarify Article 105, paragraph 4 of the proposal as to the harms envisaged, which would undermine the protection of personal data in the context of the Common fisheries policy and on the consequences in terms of public access or other relevant situations covered by this provision.

15.

The EDPS suggests that the Community legislator also clarifies the relations between Article 105, paragraph 4 and Article 105, paragraph 6. Although one seems to relate to public access and its possible limitations and the other relates to further legal actions and proceedings, the distinction is not clear from the wording used. Further clarification should be made.

16.

Without prejudice to the applicability of Directive 95/46/EC and Regulation (EC) No 45/2001, the EDPS acknowledges that exemptions and restrictions to the protection of personal data may be applied in line with Article 13 of Directive 95/46/EC (8). However, the EDPS would like the Community legislator to mention the specific cases in which such exemptions may take place and to clarify the situations in which such use of data may take place, if this could be relevant in the present context.

IV. NATIONAL ELECTRONIC DATABASE

17.

Article 102, paragraph 3 of the proposal states: ‘Member States shall set up a computerized database for the purpose of the validation system referred to in paragraph 1, having regard to the data quality principle applicable to computerized databases’ (9). The EDPS is pleased to see that Article 102 of the proposal implements the data quality principle (10) when Member States shall set up a computerised database which allows the identification of fishing vessels or operators for which inconsistencies of data were repeatedly found, and permits the correction of incorrect data entries.

18.

A first example of the implementation of the data quality principle consists of the necessary features of the computerised system. According to Article 102, paragraph 1, the computerised system shall include: procedures for checking the quality of all data recorded in accordance with the Regulation; cross-checks, analysis and verification of all data recorded in accordance with the Regulation; procedures for checking compliance with deadlines for the submission of all data recorded in accordance with the Regulation. As another example of the implementation of the data quality principle, Article 102, paragraph 2, specifies that the validation system shall allow the immediate identification of inconsistencies of related data and their consequent follow-up. The EDPS considers that a consequent follow-up would consist of the deletion of inconsistencies and outdated data. Therefore, some automated check of the duration of storage of the data should be implemented to ensure that inconsistencies do not remain in the system.

19.

Another reason to insist on the respect of the data quality principle can be found in Article 103, which deals with the communication of the data from the computerised database. This article foresees that the Commission has direct real time access at any time without prior notice, to the computerised database of each Member State. The purpose of Commission access is precisely to enable the Commission to control the quality of the data.

20.

However, Article 103 also states that the Commission shall be given the possibility to download these data for any period or number of vessels. In this respect, the EDPS invites the Community legislator to consider introducing additional rules regarding the control over the information downloaded by Commission officials, which will be in compliance with the specified purpose of the Regulation. Such access to the information should respect the limitations of the Regulation itself.

21.

One additional element which should be taken into consideration in this context relates to the fact that there is currently no mention of a specific storage period of the data contained in the computerised database. However, Article 108 of the proposal foresees that the computerised database is part of the databases which are accessible in the secure part of national websites. For this secure part, a retention period is foreseen (minimum three years). Taking into consideration the comments made below about the retention period of data on the secure part of national websites (chapter V below), the Community legislator should also foresee rules regarding the time of storage of data at the national level which should only be stored as long as necessary for the purpose of this Regulation and then deleted. This provision would be compliant with Article 6(e) of Directive 95/46/EC and Article 4(e) or Regulation (EC) No 45/2001.

22.

Moreover, in cases like the present one, the Commission would be processing data (and sometimes personal data) which would trigger the applicability of Regulation (EC) No 45/2001 to such processing operations. The control of the Commission on the use of these data by its services may lead to the need of prior-checking by the EDPS on the basis of Article 27 of Regulation (EC) No 45/2001. (11) The EDPS invites the Commission to consider the possible need for notification of the system for prior checking.

V. NATIONAL WEBSITES

23.

Article 106 deals with the setting up by each Member State of an official website accessible via Internet and composed of a publicly accessible part and a secure part. Regarding the secure part of the website, Article 108 of the proposal establishes the principles relating to: the lists and databases it contains (paragraph 1); the direct exchange of information with other Member States, the Commission or the body designated by it (paragraph 2); the remote access which is provided to the Commission or body designated by it (paragraph 3); the recipients in the Member States or in the Commission or the body designated by it to which the data are made available (paragraph 4) and the storage period (minimum of three years) of the data (paragraph 5).

24.

The EDPS would like to draw the attention of the Community legislator to Articles 25 and 26 of Directive 95/46/EC which concern the transfer of personal data to third countries′ authorities. Paragraph 2 of Article 108 of the proposal foresees that each Member State shall establish, on the secure part of its website, a national fisheries related information system, which allows for the direct electronic exchange of information with other Member States, the Commission or the body designated by it as referred to in Article 109. However, Article 109 does not refer to a list of designated recipients but stresses that the authorities responsible for the implementation of this Regulation in the Member States shall cooperate with each other, with authorities of third countries, with the Commission and the body designated by it in order to ensure compliance with this Regulation.

25.

The EDPS considers that there is some discrepancy between the content of Article 108, paragraph 2, and Article 109, as regards third countries′ authorities. First, authorities of third countries are said to cooperate with Member States, but no reference in Article 108 is made to them. Second, the EDPS would like to underline that if transfers to third countries are envisaged through this cooperation, Articles 25 and 26 of Directive 95/46/EC will have to be respected, especially the requirement that the third country ensures an adequate level of protection.

26.	As regards the remote access (paragraph 3) provided by the Member State to Commission officials, the EDPS welcomes that it is based on electronic certificates generated by the Commission or the body designated by it.

27.

The EDPS welcomes that paragraph 4 specifies that the recipients of the data shall be bound by the purpose limitation principle and the rules of confidentiality. This is done by allowing access to the data only for specific users authorised to that effect and by limiting access to the data they need in order to carry out their tasks and activities of ensuring compliance with the rules of the Common Fisheries Policy.

28.

The EDPS considers that the storage period (paragraph 5) should be established more precisely by setting a maximum period of retention (instead of only a minimum). Moreover, the Community legislator could also consider establishing a minimum set of rules in view of ensuring the interoperability and other security aspects of the system, possibly under the mechanisms provided by the proposal (Article 111). This comment is also linked to point 21 of this Opinion, regarding the storage within the computerised database (see above).

VI. COMITOLOGY PROCEDURE

29.

Several Articles of the proposal refer to its Article 111, which implements a Committee procedure (through the Committee for fisheries and aquaculture - comitology procedure). Although several of the references to Article 111 made throughout the proposal refer to technical aspects, some refer to data protection aspects. For instance:

—

Article 103 on the communication of data foresees that Member States shall ensure that the Commission has direct real time access at any time without prior notice, to the computerised database referred to in Article 102. The Commission shall be given the possibility to download these data for any period or for any number of vessels. The detailed rules for the application of these articles, in particular for establishing a standardised format for the download of data referred to in Article 102, shall be adopted in accordance with the comitology procedure,

—	Article 109 foresees that administrative cooperation of Member States (among them and in relation with the Commission) shall be adopted following this comitology procedure,

—	Another reference to the comitology procedure is found in Article 70 dealing with the list of Community inspectors which shall be established by the Commission.

30.

The EDPS understands that the implementation of these Articles will depend on the adoption of specific rules following the procedure foreseen in Article 111 of the proposal. Given the impact that these detailed rules may have on data protection, the EDPS expects to be consulted before these detailed rules are adopted.

VII. CONCLUSIONS

31.	The EDPS has noted the initiative of establishing a Community system for control, monitoring, surveillance, inspection, and enforcement of the rules of the Common Fisheries Policy.

32.

The EDPS welcomes that reference to privacy and data protection is made within the current proposal. However, some amendments are needed, as explained above, in order to provide clear requirements, both for the Member States and for the Commission to address the data protection aspects of the system.

33.

The observations of this opinion, which should be taken into account, include:

—	the review of Article 104, paragraph 2, in order to cover any personal data and not only names of natural persons,

—	the review of Article 105, paragraphs 4 and 6, on confidentiality, professional and commercial secrecy, so as to clarify the specific cases in which these paragraphs shall apply,

—	the introduction in Article 103 of additional rules regarding the control over the information downloaded by Commission officials,

—	the establishment of a specific storage period of data on national electronic databases and on national websites,

—	the respect of procedures on transfers of personal data to third countries,

—	the consultation of the EDPS when the procedure of Article 111 is used.

Done in Brussels, 4 March 2009.

Peter HUSTINX

European Data Protection Supervisor

(1) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

(2) OJ L 358, 31.12.2002, p. 59.

(3) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

(4) In Article 2(a) of Directive 95/46/EC defined as ‘any information relating to an identified or identifiable natural person’. This also includes e.g. information on an individual's behaviour and any measures taken in relation to an individual.

(5) See for instance Opinion of the European Data Protection Supervisor on the Proposal for a Regulation of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents, 30 June 2008, available on the EDPS website.

(6) Judgement of 8 November 2007, Bavarian Lager v Commission, T-194/04. Two other still pending cases concern the same issue.

(7) Pending Case C-28/08 P, Commission v Bavarian Lager, OJ C 79, 29.3.2008, p. 21.

(8) See also Article 20 of Regulation (EC) No 45/2001.

(9) Text corrected for an apparent mistake (‘… is applicable’).

(10) See more in general Article 6 of Directive 95/46/EC.

(11) Article 27(1) of Regulation (EC) No 45/2001 provides for prior checking of ‘processing operations likely to present specific risks to the rights and freedoms of data subjects by virtue of their nature, their scope or their purpose’. Article 27(2) specifies a number of situations, including (a) processing of data relating to suspected offences, and (b) processing operations intended to evaluate personal conduct.

3.7.2009

Official Journal of the European Union

C 151/16

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(Text with EEA relevance)

2009/C 151/04

Date of adoption of the decision	1.4.2009
Reference number of State Aid	N 356/08
Member State	Denmark
Region	—
Title (and/or name of the beneficiary)	Forhøjelse af støtte til elektricitet fremstillet ved biogas
Legal basis	Lov om elforsyning, jf. lovbekendtgørelse nr. 1115 af 8. november 2006. Ændringerne, som anmeldes, fremgår af lov nr. 505 af 17. juni 2008.
Type of measure	Aid scheme
Objective	Environmental protection, Energy saving
Form of aid	Direct grant
Budget	Annual budget: DKK 150 million; Overall budget: DKK 3 000 million
Intensity	53 %
Duration (period)	2008-2028
Economic sectors	Energy
Name and address of the granting authority	Energinet.dk (statsejet transmissionoperatør)
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision

20.5.2009

Reference number of State Aid

NN 23/09

Member State

Denmark

Region

—

Title (and/or name of the beneficiary)

Redningsstøtte til Fionia Bank

Legal basis

Lov nr. 1003 af 10/10/2008

Rammeaftale mellem afviklingsselskabet og Fionia Bank af 22/2/2009

Type of measure

Individual aid

Objective

Aid to remedy serious disturbances in the economy

Form of aid

Soft loan, Other forms of equity intervention

Budget

Overall budget: DKK 6 100 million

Intensity

—

Duration (period)

15.4.2009-14.10.2009

Economic sectors

Financial intermediation

Name and address of the granting authority

Afviklingsselskabet til sikring af finansiel stabilitet A/S Dronningens Tværgade 4,1

1302 Copenhagen

DANMARK

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	25.5.2009
Reference number of State Aid	N 185/09
Member State	Italy
Region	—
Title (and/or name of the beneficiary)	Regime per il salvataggio e la ristrutturazione delle medie imprese in difficoltà
Legal basis	Delibera del Comitato Interministeriale per la Programmazione Economica n. 296 del 18/12/2008, Criteri e modalità di funzionamento del Fondo per il finanziamento degli interventi consentiti dagli Orientamenti U.E. sugli aiuti di Stato per il salvataggio e la ristrutturazione delle imprese in difficoltà.
Type of measure	Aid scheme
Objective	Restructuring of firms in difficulty
Form of aid	Guarantee
Budget	Annual budget: EUR 35 million; Overall budget: EUR 500 million
Intensity	100 %
Duration (period)	until 31.12.2013
Economic sectors	All sectors
Name and address of the granting authority	Ministero dello Sviluppo Economico
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	25.5.2009
Reference number of State Aid	N 187/09
Member State	Italy
Region	—
Title (and/or name of the beneficiary)	Regime per il salvataggio e la ristrutturazione delle medie imprese in difficoltà
Legal basis	Delibera del Comitato Interministeriale per la Programmazione Economica n. 296 del 18/12/2008, Criteri e modalità di funzionamento del Fondo per il finanziamento degli interventi consentiti dagli Orientamenti U.E. sugli aiuti di Stato per il salvataggio e la ristrutturazione delle imprese in difficoltà.
Type of measure	Aid scheme
Objective	Rescue of firms in difficulty
Form of aid	Guarantee
Budget	Annual budget: EUR 35 million; Overall budget: EUR 500 million
Intensity	100 %
Duration (period)	until 31.12.2013
Economic sectors	All sectors
Name and address of the granting authority	Ministero dello Sviluppo Economico
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

3.7.2009

Official Journal of the European Union

C 151/19

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(Text with EEA relevance)

2009/C 151/05

Date of adoption of the decision	28.5.2009
Reference number of State Aid	N 248/09
Member State	Italy
Region	—
Title (and/or name of the beneficiary)	Limited amounts of compatible aid under the Temporary Framework
Legal basis	Modalità di applicazione della comunicazione della Commissione europea — Quadro di riferimento temporaneo comunitario per le misure di aiuto di Stato a sostegno dell’accesso al finanziamento nell’attuale situazione di crisi finanziaria ed economica (Articoli da 1 a 3 e da 8 a 10)
Type of measure	Aid scheme
Objective	Aid to remedy serious disturbances in the economy
Form of aid	Direct grant, guarantee, debt write-off
Budget	—
Intensity	—
Duration (period)	until 31.12.2010
Economic sectors	All sectors
Name and address of the granting authority	All competent granting authorities in Italy
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	28.5.2009
Reference number of State Aid	N 266/09
Member State	Italy
Region	—
Title (and/or name of the beneficiary)	Temporary aid scheme for granting aid in the form of guarantees
Legal basis	Modalità di applicazione della comunicazione della Commissione europea — Quadro di riferimento temporaneo comunitario per le misure di aiuto di Stato a sostegno dell’accesso al finanziamento nell’attuale situazione di crisi finanziaria ed economica (Articoli da 1,2,4,8,9,10)
Type of measure	Aid scheme
Objective	Aid to remedy serious disturbances in the economy
Form of aid	Guarantee
Budget	—
Intensity	—
Duration (period)	until 31.12.2010
Economic sectors	All sectors
Name and address of the granting authority	All competent granting authorities in Italy
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	29.5.2009
Reference number of State Aid	N 268/09
Member State	Italy
Region	—
Title (and/or name of the beneficiary)	Temporary aid scheme for granting aid in the form of loans with subsidised interest rate
Legal basis	Modalità di applicazione della comunicazione della Commissione europea — Quadro di riferimento temporaneo comunitario per le misure di aiuto di Stato a sostegno dell’accesso al finanziamento nell’attuale situazione di crisi finanziaria ed economica (Articoli da 1,2,5,8,9,10)
Type of measure	Aid scheme
Objective	Aid to remedy serious disturbances in the economy
Form of aid	Interest subsidy
Budget	—
Intensity	—
Duration (period)	until 31.12.2010
Economic sectors	All sectors
Name and address of the granting authority	All competent granting authorities in Italy
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	3.6.2009
Reference number of State Aid	N 308/09
Member State	Greece
Region	—
Title (and/or name of the beneficiary)	Greek temporary Scheme for loan guarantees
Legal basis	The legal basis for the scheme are the following legal acts: Draft Ministerial Decision — TEMPORARY FRAMEWORK to support access to finance during the current financial and economic crisis in accordance with the Commission Communication of 22.1.2009, in order to release bank lending in Greece and facilitate access of companies to finance in response to the financial and economic crisis that led to insufficient provision of funding by the financial institutions and resulted in a serious disturbance of the entire economy in Greece. The legal basis for the Minister to adopt such Ministerial Decisions is Greek Law 2322/1995.
Type of measure	Aid scheme
Objective	Aid to remedy serious disturbances in the economy
Form of aid	Guarantee
Budget	Overall budget: EUR 2 000 (in combination with N 309/09) million
Intensity	—
Duration (period)	until 31.12.2010
Economic sectors	All sectors
Name and address of the granting authority	Ministry of Economy and Finance
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

Date of adoption of the decision	3.6.2009
Reference number of State Aid	N 309/09
Member State	Greece
Region	—
Title (and/or name of the beneficiary)	‘Greek temporary scheme for subsidised interest rate’
Legal basis	Draft Ministerial Decision — TEMPORARY FRAMEWORK to support access to finance during the current financial and economic crisis in accordance with the Commission Communication of 22.1.2009, in order to release bank lending in Greece and facilitate access of companies to finance in response to the financial and economic crisis that led to insufficient provision of funding by the financial institutions and resulted in a serious disturbance of the entire economy in Greece. The legal basis for the Minister to adopt such Ministerial Decisions is Greek Law 2322/1995.
Type of measure	Aid scheme
Objective	Aid to remedy serious disturbances in the economy
Form of aid	Interest subsidy
Budget	Overall budget: EUR 2 000 (in combination with N 308/09) million
Intensity	—
Duration (period)	until 31.12.2010
Economic sectors	All sectors
Name and address of the granting authority	Ministry of Economy and Finance
Other information	—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/index.htm

3.7.2009

Official Journal of the European Union

C 151/23

Euro exchange rates (1)

2 July 2009

2009/C 151/06

1 euro =

	Currency	Exchange rate
USD	US dollar	1,4049
JPY	Japanese yen	135,95
DKK	Danish krone	7,4460
GBP	Pound sterling	0,85730
SEK	Swedish krona	10,8400
CHF	Swiss franc	1,5235
ISK	Iceland króna
NOK	Norwegian krone	8,9375
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	25,755
EEK	Estonian kroon	15,6466
HUF	Hungarian forint	268,45
LTL	Lithuanian litas	3,4528
LVL	Latvian lats	0,7005
PLN	Polish zloty	4,3543
RON	Romanian leu	4,2062
TRY	Turkish lira	2,1489
AUD	Australian dollar	1,7525
CAD	Canadian dollar	1,6201
HKD	Hong Kong dollar	10,8879
NZD	New Zealand dollar	2,2168
SGD	Singapore dollar	2,0377
KRW	South Korean won	1 783,80
ZAR	South African rand	10,9708
CNY	Chinese yuan renminbi	9,5974
HRK	Croatian kuna	7,2992
IDR	Indonesian rupiah	14 374,42
MYR	Malaysian ringgit	4,9452
PHP	Philippine peso	67,569
RUB	Russian rouble	43,8009
THB	Thai baht	47,900
BRL	Brazilian real	2,7222
MXN	Mexican peso	18,4393
INR	Indian rupee	67,3580

(1) Source: reference exchange rate published by the ECB.

3.7.2009

Official Journal of the European Union

C 151/25

Call for proposals — Culture Programme (2007-2013)

Implementation of the programme actions: multiannual cooperation projects; cooperation measures; special action (third countries); and support for bodies active at European level in the field of culture

2009/C 151/08

INTRODUCTION

This call for proposals is based on Decision No 1855/2006/EC (1) of the European Parliament and of the Council of 12 December 2006, establishing the Culture Programme (2007-2013), hereinafter referred to as the ‘Culture Programme’. the detailed conditions of this call for proposals can be found in the programme guide for the Culture programme (2007-2013) published on the Europa website (see point VIII). The programme guide constitutes an integral part of this call for proposals.

I. Objectives

The Culture programme has been established to enhance the cultural area shared by Europeans, which is based on a common cultural heritage, through the development of cooperation activities among cultural operators from eligible countries (2), with a view to encouraging the emergence of European citizenship.

The programme is aimed at three specific objectives:

—	promotion of the transnational mobility of people working in the cultural sector;

—	support for the transnational circulation of cultural and artistic works and products;

—	promotion of intercultural dialogue.

The programme has a flexible, interdisciplinary approach and is focused on the needs expressed by cultural operators during the public consultations leading up to its design.

II. Strands

This call covers the following strands of the Culture programme:

1. Support for cultural projects (strand 1)

Cultural organisations are given support for projects to work together across borders and to create and implement cultural and artistic activities.

The thrust of this strand is to help organisations, such as theatres, museums, professional associations, research centres, universities, cultural institutes and public authorities from different countries participating in the Culture programme to cooperate so that different sectors can work together and extend their cultural and artistic reach across borders.

This strand is divided into four categories, which are detailed below.

Strand 1.1: Multiannual Cooperation Projects (lasting from three to five years)

The first category seeks to foster multiannual, transnational cultural links by encouraging a minimum of six cultural operators from at least six eligible countries to cooperate and work within and across sectors to develop joint cultural activities over a period of three to five years. Funds of between a minimum of EUR 200 000 and a maximum of EUR 500 000 per year are available, but EU support is limited to a maximum of 50 % of the total eligible cost. The funding is intended to help set up or extend the geographical reach of a project and make it sustainable beyond the funding period.

Strand 1.2.1: Cooperation Projects (lasting up to 24 months)

The second category concerns actions shared by at least three cultural operators, working within and across sectors, from at least three eligible countries over a maximum period of two years. Actions that explore means of long-term cooperation are especially targeted. Funds of between EUR 50 000 and EUR 200 000 are available, but EU support is limited to a maximum of 50 % of the total eligible cost.

Strand 1.2.2: Literary Translation Projects (lasting up to 24 months)

The third category concerns support for translation projects. EU support for literary translation is aimed at enhancing knowledge of the literature and literary heritage of fellow Europeans by way of promoting the circulation of literary works between countries. Publishing houses can be awarded grants for translations and publication of works of fiction from one European language into another European language. Funds of between EUR 2 000 and EUR 60 000 are available, but EU support is limited to a maximum of 50 % of the total eligible cost.

Strand 1.3: Cooperation projects with third countries (lasting up to 24 months)

The fourth category seeks to support cultural cooperation projects aimed at cultural exchanges between the countries taking part in the programme and third countries, which have concluded association or cooperation agreements with the EU, provided that the latter contain cultural clauses. Every year one or more third country(ies) is/are selected for that particular year. The country(ies) is/are indicated each year on the website of the Executive Agency in due course before the deadline for submission.

The action must generate a concrete international cooperation dimension. The cooperation projects involve at least three cultural operators, from at least three eligible countries and cultural cooperation with at least one organisation from the selected third country and/or involve cultural activities carried out in the selected third country. Funds of between EUR 50 000 and maximum EUR 200 000 are available, but EU support is limited to maximum 50 % of the total eligible cost.

2. Support for organisations active at European level in the field of culture (Strand 2)

Cultural organisations working, or wanting to work, at European level in the field of culture can receive support for their operating costs. This strand targets organisations that promote a sense of shared cultural experience with a truly European dimension.

The grant awarded under this strand is a support to operating costs incurred for the permanent activities of beneficiary organisations. This profoundly differs from any other grants, which may be awarded under the other strands of the programme.

Four categories of organisations are eligible under this strand:

(a)	Ambassadors

(b)	Advocacy networks

(c)

Festivals

(d)

Policy support structures for the Culture agenda, further divided into two subcategories:

(i)	Structured dialogue platforms

(ii)	Policy analysis groupings.

Maximum funds are available, depending on the category applied for, but EU support is limited to maximum 80 % of the total eligible costs.

III. Eligible actions and applicants

The Culture programme supports projects, organisations, promotional activities and research in all branches of culture, except the audiovisual branch for which there is a separate programme named MEDIA (3). Cultural operators, including cultural enterprises, can participate in the Culture programme as long as they are acting in a non-profit-making cultural capacity.

Eligible applicants must:

—	be a public (4) or private organisation with legal status, whose principal activity is in the cultural sphere (cultural and creative sectors); and

—	have their registered legal seat in one of the eligible countries.

Natural persons are not eligible to apply for a grant under this programme.

IV. Eligible countries

Countries eligible under this programme are:

—	EU Member States (5);

—	EEA (6) countries (Iceland, Liechtenstein, Norway);

—	Countries candidate to EU membership (Croatia, Turkey and former Yugoslav Republic of Macedonia) plus Serbia.

The countries of the western Balkans (Albania, Bosnia-Herzegovina and Montenegro) could become eligible in the future, subject to the conclusion of a Memorandum of Understanding concerning the participation of each of those countries in the Programme (7).

V. Award criteria

1.	the extent to which the project can generate real European added value;

2.	the relevance of the activities to the specific objectives of the programme;

3.	the extent to which the activities proposed are designed and can be carried out successfully with a high level of excellence;

4.	the quality of partnership (only for strand 1.1, 1.2.1, and 1.3) (0-5 total pts);

5.	the extent to which the activities can produce outputs which achieve the objectives of the Programme;

6.	the extent to which the results of activities proposed will be appropriately communicated and promoted;

7.	the long-term impact — sustainability (not for strand 1.2.2);

8.	the International Cooperation Dimension (only for strand 1.3: Cultural cooperation projects with third countries).

VI. Budget

The programme has a total budget of EUR 400 million (8) for the 2007-2013 period.

Total yearly appropriations, including for those actions that do not form part of the Programme Guide, may vary from around EUR 43 million to about EUR 58 million, depending on the year.

On a proposal by the Commission the annual budget breakdown per strand (in line with the approximations indicated hereafter) is approved by the programme committee.

Foreseen budget 2010 for the following strands

Strand 1.1	Multiannual cooperation projects	EUR 18 140 264
Strand 1.2.1	Cooperation projects	EUR 17 900 000
Strand 1.2.2	Literary translation projects	EUR 2 700 000
Strand 1.3	Cooperation projects with third countries	EUR 2 650 000
Strand 2	Support for organisations active at European level in the field of culture	EUR 7 700 000

VII. Deadlines for applications

Strands		Deadline for submission
Strand 1	Support for cultural projects
Strand 1.1	Multi-annual cooperation projects	1 October 2009
Strand 1.2.1	Cooperation projects	1 October 2009
Strand 1.2.2	Literary translation projects	1 February 2010
Strand 1.3	Cultural cooperation projects with third countries	1 May 2010
Strand 2	Support for organisations active at European level in the field of culture	1 November 2009

If the deadline for submission falls on a weekend or public holiday in the applicant's country no extension will be granted and applicants must take this into account when planning their submission.

The deadlines for submission of applications for the following years under the Culture programme will be on the same calendar dates as indicated in the programme guide.

VIII. Further information

The detailed conditions for application can be found in the Culture programme guide on the following websites:

Directorate-General for Education and Culture

http://ec.europa.eu/culture/index_en.htm

Education, Audiovisual and Culture Executive Agency

http://eacea.ec.europa.eu/culture/index_en.htm

(1) OJ L 372, 27.12.2006, p. 1.

(2) See point IV.

(3) http://eacea.eu.europa.eu/media/index_en.htm

(4) Public organisation is considered as any organisation, any part of whose costs are financed from the State budget as of right, either by central, regional or local government. That is, these costs are financed from public sector funds raised through taxation or fines or fees regulated by law, without going through an application process which might result in their being unsuccessful in obtaining funds. Organisations that depend on state funding for their existence and receive grants year after year, but for which there exists at least the theoretical possibility that they may fail to receive money in a given year are considered to be private organisations.

(5) The 27 EU Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

(6) European Economic Area.

(7) Further information on developments concerning these third countries will be announced on the website of the Executive Agency: http://eacea.ec.europa.eu

(8) Non-EU eligible countries also contribute to the programme's budget.

		ISSN 1725-2423 doi:10.3000/17252423.C_2009.151.eng
Official Journal of the European Union		C 151

English edition	Information and Notices	Volume 52 3 July 2009

Notice No	Contents	page
	I Resolutions, recommendations and opinions
	RECOMMENDATIONS
	Council
2009/C 151/01	Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections	1

2009/C 151/02	Council Recommendation of 8 June 2009 on an action in the field of rare diseases	7

	OPINIONS
	European Data Protection Supervisor
2009/C 151/03	Opinion of the European Data Protection Supervisor on the Proposal for a Council Regulation establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy	11

	II Information
	INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2009/C 151/04	Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections ( 1 )	16

2009/C 151/05	Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections ( 1 )	19

	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2009/C 151/06	Euro exchange rates	23

	NOTICES FROM MEMBER STATES
2009/C 151/07	Notification on the minimum height for the operation of mobile communication services on aircraft (MCA services) above parts of Austrian national territory, provided by Austria in accordance with Article 4 of Commission Decision 2008/294/EC	24

	V Announcements
	ADMINISTRATIVE PROCEDURES
	Commission
2009/C 151/08	Call for proposals — Culture Programme (2007-2013) — Implementation of the programme actions: multiannual cooperation projects; cooperation measures; special action (third countries); and support for bodies active at European level in the field of culture	25