6.12.2014   

EN

Official Journal of the European Union

C 438/1

—

in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32014M7396. EUR-Lex is the online access to European law.

6.12.2014   

EN

Official Journal of the European Union

C 438/1

—

in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32014M7174. EUR-Lex is the online access to the European law.

6.12.2014   

EN

Official Journal of the European Union

C 438/2

—

in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32014M7436. EUR-Lex is the online access to the European law.

6.12.2014   

EN

Official Journal of the European Union

C 438/3

1.

RECALLS that under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Union action, which shall complement national policies, shall cover the fight against the major health scourges by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health. The Union shall encourage cooperation between the Member States and, if necessary, lend support to their action. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.

2.

RECALLS Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (1) (ECDC). The ECDC supports activities for the prevention and control of communicable diseases: epidemiological surveillance, risk assessment training programmes and rapid alert and response mechanisms, and should undertake activities to ensure that Member States regularly exchange good practices and experiences on vaccination programmes.

3.

RECALLS Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013, on serious cross-border threats to health and repealing Decision No 2119/98/EC (2), which provides that Member States shall consult each other in liaison with the Commission through the Health Security Committee with a view to coordinating their response to serious cross-border threats to health, including communicable diseases. It also provides for a possibility to engage in the joint procurement of medical countermeasures on a voluntary basis.

4.

RECALLS the third Programme for the Union action in the field of health (2014-2020) established by Regulation (EU) No 282/2014 of the European Parliament and of the Council (3), aiming to support capacity-building against major cross-border health threats and, to develop preparedness and response planning, taking into account complementarity with the work programme of the ECDC in the fight against communicable diseases.

5.

RECALLS Council Recommendation 2009/1019/EU of 22 December 2009 on seasonal influenza vaccination (4) which encourages the Member States to adopt and implement national, regional or local action plans or policies aimed at improving seasonal influenza vaccination coverage, with the aim of achieving 75 % coverage in the risk groups by 2015.

6.

RECALLS the Council conclusions on childhood immunisation (2011/C 202/02) (5), in which the Member States and the Commission are invited, inter alia, to share experiences and best practices to improve the vaccination coverage of children against vaccine-preventable diseases.

7.

POINTS OUT that vaccines are medicinal products subject to the rules and procedures adopted at Union level, authorised by national authorities or by the Commission on the basis of an assessment carried out by the European Medicines Agency and subject to post-marketing monitoring.

8.

RECALLS the European Region Vaccine Action Plan 2015 to 2020 of the World Health Organisation (WHO), which was approved in response to the Decade of Vaccines, setting a course through a regional vision and goals for immunisation and control of vaccine-preventable diseases from 2015 to 2020 and beyond, by defining priority action areas, indicators and targets, while taking into account the specific needs and challenges of countries in the European region (6).

9.

POINTS OUT that post-marketing studies including those carried out by marketing authorisation holders are important for the evaluation of vaccine products and should be carried out in a transparent way. Studies on the impact of vaccination programmes, carried out independently from commercial interests are equally important. Both kinds of studies can contribute to increasing public trust in immunisation. Member States are encouraged to fund independent studies.

10.

RECOGNISES that communicable diseases, including some re-emerging ones, such as tuberculosis, measles, pertussis and rubella, still present a public health challenge and can cause a high number of infections and deaths, and that the recent emergence and outbreaks of communicable diseases, such as polio, avian influenza H5N1 and H7N9, Middle East respiratory syndrome caused by a coronavirus (MERS) and Ebola virus disease have confirmed that vigilance must remain high also with respect to diseases that are not currently present in the territory of the Union.

11.

RECOGNISES that while vaccination programmes are the responsibility of individual Member States and that various vaccination schemes exist in the EU, efforts to improve vaccination coverage may also benefit from cooperation within the EU and from improved synergies with other EU policy areas, having special regard to the most vulnerable populations identified in the different regions and individual Member States of the Union and to increasing mobility.

12.

OBSERVES that many vaccines used in community vaccination programmes have been able to prevent disease in individuals and at the same time interrupt the circulation of pathogens through the so called ‘herd immunity’ phenomenon, contributing to a healthier global society. Community immunity could thus be considered an objective in national vaccination plans.

13.

CONSIDERS that an evidence-based, cost-effective, safe and efficient immunisation system is an integral part of a well-functioning health system.

14.

POINTS OUT that, given the changes in the demographic structure of the European population, there must be a greater focus on preventing infectious diseases by means of vaccination of all age groups where this improves the epidemiological control of the disease.

15.

RECOGNISES that immunisation programmes require sustainable access to long-term funding and quality supply.

16.

RECOGNISES the importance of the general public understanding the value of vaccinations and NOTES that the occasional lack of awareness of the benefits of some vaccines and the increasing refusal of vaccination in some Member States may lead to under-vaccination in some populations, resulting in public health problems and costly outbreaks.

17.

RECOGNISES that the public should be aware of the value of vaccination and UNDERLINES the crucial role of health care professionals in informing and educating the population about the benefits of vaccination.

18.

RECOGNISES that effective vaccination campaigns are useful in preventing the spread of communicable diseases that may cause permanent health damage or even death, particularly in vulnerable age-groups of the population.

19.

RECOGNISES the positive effect that a reinforced vaccination policy at national level may have on the development of and research in new vaccines in the EU.

20.

POINTS OUT that Member States should, if relevant, inform their citizens travelling abroad about the risk of communicable diseases which are not present in the Union, but may be contracted on international trips outside the Union.

21.

POINTS OUT that some viral agents may also cause chronic pathologies, some of a neoplastic nature, such as cervical cancer, and that vaccinations could contribute to addressing these diseases.

22.

CONSIDERS IT NECESSARY that an analysis and evaluation of the safety, effectiveness and impact of vaccines to prevent distinct communicable diseases, of the risks related to communicable diseases and of the usefulness of vaccinations is periodically carried out in the European Union on the basis of developments in scientific knowledge.

23.

CONSIDERS IT USEFUL that Member States collaborate and exchange best practices concerning the prevention of communicable diseases through vaccination given the fact that communicable diseases cannot be confined to one country either within or outside the European Union, and to do so with the support of the ECDC and the WHO.

24.

CONSIDERS IT NECESSARY that policies to encourage research, including clinical and, post-authorisation studies in the field of vaccination, be supported within the Union, taking into account also the financial constraints, in order to make safer and more effective vaccines available.

25.

OBSERVES that as a result of the success in reducing the spread of a number of serious communicable diseases due to the widespread use of vaccinations, the population may believe that these diseases no longer represent a threat to public health.

26.

CONSIDERS IT APPROPRIATE, especially in order to react to inaccurate information regarding vaccinations in some Member States, that communication campaigns continue to be carried out to educate the public about the risks related to communicable diseases preventable by vaccination.

27.

CONSIDERS IT USEFUL to consult stakeholders including health professionals' organisations, academia, industry and civil society to give them the opportunity to express their positions which could be of use Member States' authorities.

(a)

continue to improve epidemiological surveillance and evaluation of the situation concerning communicable diseases in their territories, including diseases preventable by vaccination;

(b)

continue to improve national vaccination programmes and to strengthen national capacity for carrying out evidence-based, cost-effective vaccination, including the introduction of new vaccines where considered appropriate;

(c)

continue to develop plans and standard operating procedures in collaboration with the ECDC and the WHO to ensure a timely and effective response to vaccine-preventable diseases during outbreaks, humanitarian crises and emergencies;

(d)

continue to develop comprehensive and coordinated approaches within vaccination programmes, following the Health in All Policies approach creating synergies with broader health policies and pro-actively working with other preventive sectors;

(e)

ensure transparency with regard to the post-marketing evaluations of vaccines and of studies on the impact of vaccination programmes in order to provide reliable information for both governments, medicines regulators and manufacturers;

(f)

actively offer appropriate vaccination to population groups considered to be at risk in terms of specific diseases and consider immunisation beyond infancy and early childhood by creating vaccination programmes with life-long approach;

(g)

work with health professionals on risk communication in order to maximise their role in informed decision making;

(h)

further increase activities aimed at expanding, where necessary, the immunology and vaccinology components of the basic medical training curricula for students of medical and health sciences and provide health professionals with relevant in-services training opportunities;

(i)

inform the population in order to raise its trust in vaccination programmes, using appropriate tools and communication campaigns also by engaging opinion leaders, civil society and relevant stakeholders (e.g. academia).

(a)

continue to exchange information and data with the ECDC and the WHO on the risks posed by communicable diseases and on national vaccination policies; in this regard, the communication toolkits developed by the ECDC and made available to the Member States (following the example of the already developed toolkit for influenza) could be taken into consideration;

(b)

continue to exchange data on vaccination coverage for all target risk groups;

(c)

convey informed and clear messages on vaccinations;

(d)

find the best ways to allow stakeholders, including industry and civil society, to express their positions;

(e)

promote activities aimed at engaging with health care professionals more directly and actively on critical vaccination issues, in particular focused on strengthening their role in advocating vaccination;

(f)

share information on cost-effectiveness studies in the EU for the implementation of new vaccines, which would assist the Member States in their national vaccination programmes;

(g)

coordinate activities aimed at advocating and encouraging the use of vaccines included in national vaccination programmes by sharing information on communication plans and campaigns for vaccine introduction;

(h)

further encourage research and innovation aimed at developing new vaccines and demonstrating the benefits of a life course approach, the cost-effectiveness of immunisation and the effectiveness of risk communication, while at all times giving priority to citizens' safety;

(i)

develop joint action programmes co-financed by the Commission and Member States to share best practices on national vaccination policies;

(j)

encourage research activities and continue to exchange information in respect of the monitoring of vaccination impact on disease burden and the development of new vaccines.

(a)

identify and encourage synergy between the promotion of immunisation and the implementation of relevant EU legislation and policies, in particular focusing on the identification and development of integrative and coherent approaches for better preparedness and coordination in health emergencies, while fully respecting national competences;

(b)

ensure that European Union funding is channelled to foster current and future vaccine research, including wide partnership between academia, industry, and public and private funders, and to address and resolve bottlenecks in vaccine development;

(c)

ensure that funding provided by the European Union and other stakeholders, such as academia or public health institutions, and made available by the relevant public health bodies is channelled to support post-marketing studies, including studies on vaccine effectiveness and the impact of immunisation programmes carried out by national public health institutes, academia and other partnerships;

(d)

examine with the ECDC and the EMA and in close cooperation with the WHO, options to:

(e)

assist Member States in making the best use of the technical and scientific expertise of the Union agencies and the Commission's technical committees, in order to respond to questions;

(f)

place technological and IT tools at the disposal of Member States and improve links to existing European portals and tools to support Member States in their efforts to strengthen vaccination as an effective tool in public health.

6.12.2014   

EN

Official Journal of the European Union

C 438/7

1.

RECALLS that under Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, that Union action, which shall complement national policies, shall be directed towards improving public health, that the Union shall encourage cooperation between the Member States in the field of public health and, if necessary, lend support to their action, and fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care;

2.

RECALLS the Council conclusions on common values and principles in European Union Health Systems adopted on 2 June 2006 (1), and particularly the overarching values of universality, access to good quality care, equity and solidarity;

3.

RECALLS that the Annual Growth Survey 2014 highlights the need for the development of active inclusion strategies that include broad access to affordable and high-quality health services, also with regard to achieving the objectives of Europe 2020;

4.

RECALLS the Council Recommendation 2009/C 151/01 of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (2);

5.

RECALLS the Council Recommendation 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (3) and the Commission Action plan against the rising threat from antimicrobial resistance (4);

6.

RECALLS the Council conclusions of 22 June 2012 on the impact of antimicrobial resistance in the human health sector and in the veterinary sector — a ‘One Health’ perspective (5);

7.

RECALLS that antimicrobial resistance and healthcare-associated infections are subject to epidemiological surveillance in accordance with Article 2.1(a)(ii) and Article 2.2 of Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (6);

8.

RECALLS World Health Assembly Resolution WHA67.25 on Antimicrobial Resistance adopted on 24 May 2014;

9.

RECALLS that Recommendation 2009/C 151/01 and Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (7) request that patients receive healthcare in accordance with safety and quality standards and guidelines and clarify the right to receive information, in a clear and transparent way, as regards safety and quality measures in place and complaints procedures and redress mechanisms;

10.

NOTES that policymaking and decision-making processes should be evidence-based, and supported by systematic data collection that uses appropriate health information and communication technology (ICT) tools;

11.

NOTES that the current trend of shifting care from hospitals to outpatient care, including primary care and home care, can result in an increased amount of care provided by non-hospital healthcare workers, social workers and carers, including informal caregivers;

12.

RECOGNISES that education and training on patient safety and infection prevention and control should be embedded in training for health professionals and carers and be included in continuous professional development;

13.

RECOGNISES that just and blame-free reporting and learning systems have proven to be excellent tools to increase patient safety culture;

14.

TAKES NOTE of the conclusions of the two reports (8) from the European Commission on the implementation of Recommendation 2009/C 151/01;

15.

RECOGNISES that the implementation of effective measures to prevent and control healthcare-associated infections at regional and national level is critical in curbing the further spread and rise of antimicrobial resistance and that addressing healthcare-associated infections is one of the cornerstones of the EU Action Plan on combating the rising threat from antimicrobial resistance, adopted in 2011 (9);

16.

RECALLS that approximately 3,2 million patients (10) are estimated to acquire a healthcare-associated infection in the EU every year, with 20-30 % considered to be preventable (11), and that a percentage between 5 % and 10 % of adverse events are expected to occur, with nearly half of these potentially avoidable (12);

17.

TAKES NOTE of the fact that according to the special Eurobarometer survey ‘Patient Safety and Quality of Care’ (13) just over half (53 %) of all EU citizens think that patients could be harmed by hospital care in their country, while half of the respondents think that they can be harmed by non-hospital healthcare and that these percentages have not significantly decreased since 2009;

18.

NOTES WITH CONCERN that according to the most recent data published by the European Centre for Disease Prevention and Control (ECDC) (14), healthcare-associated infections caused by multi-drug resistant microorganisms are on the rise;

19.

TAKES NOTE of the work of WHO and OECD on patient safety and quality of care, which is also supported by the EU;

20.

WELCOMES progress made by the Member States since 2009 in including patient safety in public health policies as specified by Recommendation 2009/C 151/01;

21.

WELCOMES the work of the Patient Safety and Quality of Care Working Group on practical guidelines on education and training and on reporting and learning systems;

22.

NOTES that patient empowerment and involvement are recognised as an essential part of good quality and safety of care and require an effort by Member States to exchange cross-country knowledge and effective tools;

23.

WELCOMES the work of the European Network for Patient Safety and Quality of Care (Joint Action PaSQ) on the implementation of Recommendation 2009/C 151/01 as regards the exchange and implementation of good practices in Member States;

24.

RECOGNISES a need for continued and sustainable collaboration at EU level on patient safety and quality of care;

25.

NOTES that the implementation of the general patient safety provisions of Recommendation 2009/C 151/01 has a positive contribution to the health of the population and the economy of health systems, and that this requires continued attention;

26.

RECALLS that harm associated with adverse events represents an additional cost to health systems;

27.

CONSIDERS that health system performance assessment can contribute to achieving progress in patient safety and quality of care;

(a)

Intensify their efforts in implementing Recommendation 2009/C 151/01, taking into account the priority areas identified in the conclusions of the two Commission implementation reports and the reports on education and training and on reporting and learning systems produced by the Patient Safety and Quality of Care Working Group;

(b)

Identify, if not already done, the authorities in charge of the implementation and monitoring of integrated patient safety strategies, including the prevention, surveillance and control of healthcare associated infections;

(c)

Consider the implementation of guidelines, recommendations and good practices on patient safety, the prevention and control of healthcare-associated infections and antimicrobial resistance, and the use of the WHO taxonomy on patient safety to help improve clinical and organisational performance;

(d)

Promote the education and training of healthcare staff on patient safety and healthcare-associated infections, taking into account the relevant work of the ECDC, including the ECDC's technical document ‘Core competencies on infection control and hospital hygiene professionals in the European Union’ (15), as well as relevant WHO recommendations, with a view to promoting the availability of appropriately trained staff, including specialised infection control staff, in healthcare settings;

(e)

Encourage health professional organisations to build an inter-professional patient safety culture which allows integrated and high-quality processes of care;

(f)

Develop measures that allow just and blame-free reporting by health professionals or patients and support blame-free handling of errors and adverse events as well as learning from them;

(g)

Encourage the participation and empowerment of patients, families and their informal caregivers, as well as patient organisations, through evidence-based and unbiased provision of information and education, and promote patients' participation in decision-making in the healthcare process in order to contribute to the prevention of adverse events;

(h)

Consider the opportunity of developing cost-effective evaluation of patient safety programmes, also on the basis of the results of ‘Programme for the Union's action in the field of health (2014-2020)’;

(i)

Reinforce programmes and plans for infection prevention and control throughout the care and cure process, including tailored programmes for nursing homes and long-term care facilities;

(j)

Step up the prevention, diagnosis, monitoring and control of healthcare-associated infections, also by adopting, implementing and monitoring professional guidelines at national level, where appropriate in close cooperation with the ECDC;

(k)

Share experience on strategies to ensure patient safety and quality of care between and across all settings of care;

(l)

Develop professional guidelines on the prudent use of antibiotics, including the monitoring of prescriptions;

(m)

Continue to devote special attention to antimicrobial resistance as stated in the Council Conclusions of 22 June 2012, as well as monitor the consumption of antimicrobial agents and implement the surveillance of antimicrobial resistance, including participation in EU surveillance networks on these issues as coordinated by the European Centre for Disease Prevention and Control and the European Medicines Agency;

(a)

Promote patient safety culture, that comprises just and blame-free reporting on adverse events at healthcare setting level and work towards measuring and improving patient safety culture;

(b)

Regularly review the practical guidelines on the education and training of health professionals and on reporting and learning systems;

(c)

Promote the collection of information on adverse events;

(d)

Promote the uptake of guidelines and evidence-based policy by exchanging best practices on the prevention and control of antimicrobial resistance;

(e)

Develop EU guidance for patient/citizens' involvement in strategies on patient safety, taking into account the work of the World Health Organisation;

(f)

Develop voluntary guidelines on how to establish standards and guidelines on patient safety, taking into account existing methodologies as regards setting standards and guidelines used both by national competent authorities and by health professional and scientific associations;

(g)

Develop further work on the dimensions of quality in healthcare, taking into account existing knowledge, including the work of the ‘Joint Action on patient safety and quality of care’ (PaSQ);

(h)

Finalise by December 2016 a framework for a sustainable EU collaboration on patient safety and quality of care, also taking into account the results of the ‘Joint Action on patient safety and quality of care’ (PaSQ);

(i)

Take into account research results while developing policies and programmes and promoting further research on patient safety and quality of care;

(j)

Work towards a better understanding of the cost-effectiveness of patient safety policies under the principles of efficacy, efficiency, appropriateness, safety and quality of care;

(k)

Further strengthen the cooperation between the human health and the veterinary sectors in order to address the rising threat from antimicrobial resistance;

(l)

Strengthen and coordinate research and innovation efforts to address antimicrobial resistance, in particular by providing support to the Joint Programming Initiative on Antimicrobial Resistance;

(m)

Improve strategies for patient safety based on the outcomes of the Action called ‘Study on costs of unsafe care and cost-effectiveness of patient safety programmes’ launched by the Commission in collaboration with the Patient Safety and Quality of Care Working Group;

(a)

Continue supporting Member States in improving strategies and programmes for patient safety in all settings of care based on the findings of the two Commission implementation reports of Recommendation 2009/C 151/01;

(b)

Ensure coordination of EU activities on patient safety and quality of care, including treatment errors and healthcare-associated infections and antimicrobial resistance with the scientific support of relevant EU agencies, and taking into account the work of international organisations such as WHO and OECD;

(c)

Continue monitoring developments in patient safety and healthcare-associated infections in Member States and at EU level and report its findings on the trends of patient safety policies, the main causes of adverse events and the areas requiring further actions;

(d)

Explore the feasibility to present a proposal for Recommendation on the provision of information to patients on patient safety following Recommendation 2009/C 151/01, and following further preparatory work with the Member States on the dimensions of quality of healthcare;

(e)

Monitor the implementation of the EU case definitions of healthcare-associated infections and participation of Member States in EU surveillance of healthcare-associated infections as coordinated by the ECDC;

(f)

Ensure a continuation of the EU Action Plan on Antimicrobial Resistance post 2017, including an emphasis on the prevention and control of healthcare-associated infections.

6.12.2014   

EN

Official Journal of the European Union

C 438/12

1.

RECALLS that under Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, that Union action, which shall complement national policies, shall be directed towards improving public health, that the Union shall encourage cooperation between the Member States in the field of public health and, if necessary, lend support to their action, and fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care and allocation of the resources to them;

2.

RECOGNISES that innovations in healthcare can contribute to health and well-being of citizens and patients through access to innovative products, services and treatments that have added value with regard to the existing ones and can also lead to more effective ways to organize, manage and monitor work within the health sector as well as to improve the working conditions for healthcare staff;

3.

RECALLS the 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;

4.

RECALLS the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

5.

TAKES NOTE that in order to stimulate development, there is a need to facilitate the translation of scientific advances into innovative medicinal products that meet regulatory standards, accelerate patients’ access to innovative therapies with added value for patients and are affordable to the EU Member States’ health systems;

6.

TAKES NOTE that the EU pharmaceutical legislation already provides regulatory tools for the authorisation of medicinal products in order to meet unmet medical needs and facilitate timely access of patients to innovative treatments under certain circumstances and subject to certain conditions. Such mechanisms include ‘conditional’ marketing authorisation, authorisation under ‘exceptional circumstances’, accelerated scientific review and compassionate-use programmes.

7.

RECALLS that Regulation (EC) No 141/2000 on orphan medicinal products provides incentives for the development of medicinal products for rare diseases and resulted so far in the authorisation of a great number of such medicinal products and an equally important number of orphan designations.

8.

RECALLS THAT the new Clinical Trials Regulation (EU) No 536/2014 aims to increase the EU’s competitiveness in clinical research and the development of new and innovative treatments.

9.

NOTES THAT the Paediatric Regulation (EC) No 1901/2006 has contributed to better and safer research and more medicines for children on the EU market.

10.

RECOGNISES that the development of innovative medicinal products is costly and time-consuming and includes risks; this may result in insufficient investment in research and development, thereby making it particularly difficult for smaller companies to bring innovative products onto the market;

11.

RECOGNISES that early dialogue between technology developers, regulatory, health technology assessment (HTA) and, where relevant, pricing bodies may promote innovation and quicker access to medicines at affordable prices, to the benefit of patients;

12.

RECALLS that Regulation (EC) No 1394/2007 on advanced therapy medicinal products is intended to ensure the protection of public health, the free movement of advanced therapies and the effective operation of the internal market in the biotechnology sector, whilst being innovation-friendly, proportionate and adapted to scientific progress;

13.

TAKES NOTE of the ongoing European Medicines Agency’s ‘Pilot project on adaptive licensing’;

14.

TAKES NOTE of the Report from the Commission to the European Parliament and the Council in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (1);

15.

RECALLS the Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, the Directive 93/42/EEC concerning medical devices and Directive 98/79/EC on in vitro diagnostic medical devices;

16.

RECALLS the Council conclusions on innovation in the medical device sector, adopted in 6 June 2011 (2);

17.

RECALLS the Council conclusions on the ‘Reflection process on modern, responsive and sustainable health systems’, adopted on 10 December 2013 (3), and the Council conclusions on the economic crisis and healthcare, adopted on 20 June 2014 (4), which advocate the need for cooperation, while fully respecting areas of Member States’ competence, on strategies to effectively manage expenditure on pharmaceuticals and medical devices, while ensuring equitable access to effective medicines within sustainable national healthcare systems;

18.

NOTES WITH CONCERN that due to the very high prices of some innovative medicinal products in relation to their benefit to patients and to the public health expenditure capacities of some Member States, patients do not always have access to innovative treatments;

19.

TAKES NOTE of the cooperation within the Network of Competent Authorities for Pricing and Reimbursement as well as the initiatives (5) for exchange of information and collaboration in the field of pricing and reimbursement facilitated by the European Commission between the competent national authorities and all relevant stakeholders, which may facilitate, inter alia, cost-containment, pharmaceutical innovation and patients’ access to medicines;

20.

TAKES NOTE that the European Union has supported cooperation on HTA since the late 1990s by co-funding projects and two Joint Actions (EUnetHTA I and II);

21.

RECALLS that, while respecting the competencies of Member States, European cooperation on HTA can promote more consistent approaches to HTA as a health policy tool to support evidence-based, sustainable and equitable choices in healthcare and health technologies for the benefit of patients;

22.

RECALLS that the objectives of the HTA Network (6) shall be to: i) support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short and long-term effectiveness, when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies; ii) support the analysis of the nature and type of information to be exchanged, and iii) avoid duplication of assessments;

23.

UNDERLINES the importance of the strategy adopted by the HTA Network on 29 October 2014 (7);

24.

RECALLS the discussion in the Working Party on Public Health at Senior Level on cost effective use of medicines as part of the Reflection Process on modern, responsive and sustainable health systems.

25.

RECALLS the discussion at the Informal Meeting of Ministers of Health in Milan on 22-23 September 2014 on ‘innovation in health care for the benefit of patients’, which highlighted the need to support innovation for the benefit of patients with better use of the existing regulatory tools for marketing authorisation procedures and which highlighted the potential risks to the sustainability of some national health systems linked to very high cost pressures arising from some innovative products.

26.

RECOGNISES that while these Conclusions mainly refer to medicinal products, given the specific nature of the sector, the same considerations regarding research and development and HTA are also applicable to medical devices, which play an equally important part in innovation for the benefit of patients.

27.

Explore opportunities for cooperation on exchange of information between competent bodies in relation to a ‘life cycle approach’ for innovative medicinal products, including, where appropriate:

28.

Implement the HTA strategy adopted by the HTA Network, taking into account national circumstances.

29.

Increase the effective sharing of information on prices of and expenditure on medicinal products, including innovative medicinal products;

30.

Continue to discuss and work further on innovations for the benefit of patients within the Working Party on Public Health at Senior Level, while recognising that a discussion on the relationship between the current legal framework for medicinal products and timely patient access to medicinal products has already started in the Pharmaceutical Committee.

31.

Exchange views on how to make effective use of the existing EU regulatory tools of accelerated assessment, conditional marketing authorisation and authorisation in exceptional circumstances and on the effectiveness and impact of these tools while ensuring the high level of patient safety;

32.

Discuss national initiatives for early patient access to innovative medicines and the possibility of increased information-sharing and cooperation in relation to compassionate use, so as to maximise the opportunities of patients across the EU to be supplied with innovative medicines;

33.

Further enhance joint work on HTA;

34.

Support collaboration between national regulators, HTA bodies, the European Medicines Agency and the HTA Network throughout the life cycle of the products, without compromising the independence and respective prerogatives of regulatory and HTA processes;

35.

Use existing relevant fora to reflect on:

36.

Continue the dialogue between stakeholders and competent authorities, including pricing and reimbursement authorities, and examine opportunities for potential cooperation on a voluntary basis in the field of pricing and reimbursement and facilitate the launching of pilot projects in that field;

37.

Consider possible changes to the Regulation (EC) No 1394/2007 with a view to analysing and if necessary reducing regulatory burdens to increase incentives for SMEs and academia, while maintaining the principle of marketing authorisation based on quality, efficacy and safety;

38.

Support the cooperation between Member States to implement the HTA strategy through a Joint Action under the third Programme for the Union’s action in the field of health (2014-2020), while exploring options for continued and sustainable financing;

39.

Propose measures to ensure the long-term sustainability of work on HTA, fully exploring all potential options, including considerations on how to make the best use of existing bodies which could facilitate cooperation, efficiency gains and scientific synergies;

40.

While fully respecting the Member States’ competencies, support the exchange of information between Member States on prices, pricing policies and economic factors determining the availability of medicinal products as well as, where appropriate, medical devices, with particular attention being paid to orphan medicinal products and small markets as they are particularly vulnerable to deferred or missed market launches, supply shortages and obstacles to achieving affordable prices of medicinal products;

41.

Continue to support research and information tools that aim to provide a better understanding of how pharmaceutical pricing may be applied to maximise benefits for patients and Member States’ health systems and, where relevant, to minimise possible unintended negative effects on patient access and health budgets.

6.12.2014   

EN

Official Journal of the European Union

C 438/16

6.12.2014   

EN

Official Journal of the European Union

C 438/17

1.

The Advisory Committee agrees with the Commission that the proposed transaction constitutes a concentration within the meaning of the Council Regulation (EC) No 139/2004 (the ‘Merger Regulation’).

2.

The Advisory Committee agrees with the Commission that following a referral request made by Spain the proposed transaction has a Union dimension within the meaning of the Merger Regulation.

3.

The Advisory Committee agrees with the Commission that, for the purpose of assessing the present operation, the definitions of the relevant product markets are:

4.

The Advisory Committee agrees with the Commission that, for the purpose of assessing the present operation, the definitions of the relevant geographic markets are:

5.

The Advisory Committee agrees with the Commission that the proposed concentration is unlikely to significantly impede effective competition due to non-coordinated effects in the following markets:

6.

The Advisory Committee agrees with the Commission that the proposed concentration is unlikely to significantly impede effective competition due to coordinated effects in all markets for grey cement in the Centre region.

A minority disagrees and a minority abstains.

7.

The Advisory Committee agrees with the Commission that the notified transaction must be declared compatible with the internal market and the functioning of the EEA Agreement.

A minority disagrees and minority abstains.

6.12.2014   

EN

Official Journal of the European Union

C 438/19

1.

On 28 February 2014, the European Commission (the ‘Commission’) received a notification of a proposed transaction by which Cemex España, SA (‘Cemex España’ or the ‘Notifying Party’) will acquire sole control over the production and distribution assets of Holcim España, SA (‘Holcim Assets’) in cement, ready-mix concrete, aggregates and mortar in Spain (the ‘Transaction’) (2). The Holcim Assets are fully controlled by Holcim Ltd (‘Holcim’).

2.

The Transaction does not have an EU dimension within the meaning of Article 1 of the Merger Regulation (3). The Transaction was notified to the Commission following a referral request by the Spanish Competition Authority under Article 22(1) of the Merger Regulation on 12 September 2013. The Commission accepted the referral request by decision of 18 October 2013 (4).

3.

On 23 April 2014, the Commission found that the Transaction raised serious doubts as to its compatibility with the internal market and the EEA Agreement and adopted a decision to initiate proceedings pursuant to Article 6(1)(c) of the Merger Regulation. The Notifying Party submitted written comments on 6 May 2014.

4.

On 3 July 2014, the Commission adopted a Statement of Objections (‘SO’) addressed to the Notifying Party, in which it took the preliminary view that the Transaction was incompatible, within the meaning of Article 2(3) of the Merger Regulation, with the internal market and the EEA Agreement.

5.

The Notifying Party replied on 17 July 2014 and requested the opportunity to develop its arguments at a formal oral hearing. Holcim was also informed of the objections and submitted written observations on 17 July 2014.

6.

The Notifying Party received access to the file via CD-ROM on 4 July 2014 and on 22 July 2014.

7.

Pursuant to Article 10(3) of the Merger Regulation, the Commission extended the time limit to review the Transaction by five working days on 28 July 2014.

8.

The representatives of the employees at the works council of Holcim (‘Forum Européen’) demonstrated sufficient interest within the meaning of Article 18(4) of the Merger Regulation and were thus recognised as interested third persons. They received information of the nature and subject matter of the procedure and were given the opportunity to make known their views.

9.

The oral hearing was held on 23 July 2014. It was attended by representatives of Cemex España and Holcim as well as their external legal and economic advisers; the relevant Commission services; and representatives of the competition authorities of four Member States. At its request, the Notifying Party presented its economic assessment of the case in a closed session.

10.

The draft decision provides for an unconditional clearance of the proposed Transaction. Pursuant to Article 16 of Decision 2011/695/EU, I have examined whether the draft decision deals only with objections in respect of which the parties have been afforded the opportunity of making known their views, and I have come to a positive conclusion. Overall, I conclude that all parties have been able to effectively exercise their procedural rights in this case.

6.12.2014   

EN

Official Journal of the European Union

C 438/21

(1)

Cemex España, SA (‘Cemex España’, Spain) is controlled by Cemex, S.A.B. de C.V., which is headquartered in Mexico and, along with the rest of the Cemex companies, constitutes the Cemex Group. All companies of the Cemex Group are hereinafter referred to as ‘Cemex’.

(2)

Cemex is a global building materials company active in cement, ready-mix concrete (‘RMX’), aggregates and related building materials. It has operations in Africa, the Americas, Asia, Europe and the Middle East. In Spain, Cemex undertakes its activities through Cemex España, which is the sole holding company of Cemex España Operaciones S.L.U. (‘Cemex España Operaciones’, Spain), which owns Cemex’s cement, mortar, concrete plants and aggregate quarries in Spain.

(3)

Holcim España, SA (‘Holcim España’, Spain) owns plants and quarries dedicated to the production and supply of cement, aggregates, RMX and mortar in Spain (‘Holcim Assets’, Spain). The Holcim Assets are currently controlled by Holcim Ltd (‘Holcim’), a joint stock company established under Swiss law, which is the ultimate parent company of the Holcim Group. All companies of the Holcim Group are hereinafter referred to as ‘Holcim’.

(4)

Holcim is a global supplier of cement, aggregates, mortar, RMX, asphalt, cementitious materials and related building materials with operations in more than 70 countries.

(5)

On 28 February 2014, the European Commission received a notification of a proposed transaction by which Cemex intends to acquire sole control over the Holcim Assets.

(6)

The proposed transaction does not meet the turnover thresholds of Article 1(2) or Article 1(3) of Regulation (EC) No 139/2004. It does therefore not have a Union dimension. The Commission decided, however, to examine the proposed transaction by adopting a decision on 18 October 2013 pursuant to Article 22(3) of Regulation (EC) No 139/2004. That decision followed a request from Spain of 12 September 2013 pursuant to Article 22(1) of the aforementioned Regulation.

(7)

The transaction was notified to the Commission on 28 February 2014. On 23 April 2014, the Commission found that the proposed transaction raised serious doubts as to its compatibility with the internal market and with the EEA Agreement, and initiated proceedings pursuant to Article 6(1)(c) of the Merger Regulation.

(8)

The in-depth investigation allowed dispelling the competition concerns preliminarily identified.

(9)

The draft Decision was discussed with the Member States during the Advisory Committee on Concentrations on 26 August 2014, which provided a favourable opinion. The Hearing Officer provided its favourable opinion on the proceedings in his report which was submitted on 29 August 2014.

(10)

The transaction concerns the building materials industry and notably cement, aggregates RMX, mortar and clinker.

(11)

In the decision opening proceedings the Commission raised serious doubts as to the compatibility of the transaction with the internal market and with the EEA Agreement in relation to the market for grey cement due to: (i) non-coordinated effects; and (ii) coordinated effects.

(12)

The Commission did not raise serious doubts as to the compatibility of the transaction with the internal market and with the EEA Agreement in relation to the other products.

(13)

The market investigation in the present case has supported the Commission’s earlier findings that the two main types of cement (white and grey) constitute separate product markets.

(14)

The Commission also investigated whether grey cement should be further segmented according to different presentations (bulk versus bagged) and different types of classes.

(15)

The Commission concludes that, for the assessment of the effects of the proposed transaction, the relevant product market is the overall market for grey cement. However the exact market definition can be left open.

(16)

The Commission considers in the circumstances of the present case that the relevant geographic markets should be defined as circular areas around the relevant cement plants, in line with the previous practice of the Commission as regards grey cement.

(17)

The Commission concludes that in light of the existing and potential demand and supply patterns and the views of market participants, it is most appropriate in this case to assess the competitive effects of the proposed transaction on different geographic markets on the basis of radii of 150 km around the Parties’ plants.

(18)

Both Parties are active in the production and supply of grey cement. Cemex operates five integrated plants in Spain: one in Buñol (province of Valencia), one in Alicante, one in Alcanar (province of Tarragona), one in Morata (province of Zaragoza) and one in Lloseta (Balearic Islands). In addition it operates one grinding mill in Castillejo (province of Toledo) and a number of terminals. Holcim owns three integrated plants in southern Spain: two of the plants (Gador and Carboneras) are located in the province of Almeria and one in Jerez (province of Cadiz). In addition it operates one grinding mill in Yeles (province of Toledo) and a number of terminals.

(19)

The Commission has analysed potential non-coordinated effects of the proposed transaction on the various clusters defined by circles with radii of 150 km drawn around the Parties’ cement production facilities in Spain.

(20)

In the Gador-Carboneras cluster, the Parties’ combined 2013 market share was (40-50) %, with an overlap of (10-20) %. The competitive landscape in the Gador-Carboneras cluster is fragmented. In terms of market share, the Parties’ nearest competitors are the grinding mills Cementos La Unión (CLU) and Cementos La Cruz (CLC), Financiera y Minera (FYM) and Votorantim (all with (5-10) %).

(21)

In the Alicante cluster, the Parties’ combined market share in 2013 was approximately (30-40) %, with an overlap of (10-20) %. The rest of the market in the Alicante cluster is also fragmented. In terms of market share, the Parties’ nearest competitors are CLU ((10-20) %) and CLC ((10-20) %) followed by Lafarge ((5-10) %).

(22)

In the Buñol cluster, the Parties’ combined market share in 2013 was (20-30) %, with an overlap of (10-20) %. The competitive landscape in the Buñol cluster is similar to that prevailing in the Alicante cluster. In terms of market share, the Parties’ nearest competitors are CLU ((10-20) %) and CLC ((10-20) %). These grinding mills are followed by the integrated player Lafarge ((5-10) %) and the grinding mill Cementval ((5-10) %).

(23)

The Commission considers that in Gador-Carboneras cluster, Alicante cluster and Buñol cluster (‘the Levante region clusters’) there are several competitors that can be considered as equally close or even closer alternatives for Holcim’s customers than Cemex. Likewise, some Levante region clusters rivals can be considered as closer or equally close alternatives for Cemex’s customers than Holcim.

(24)

Second, the Commission considers that the Parties’ competitors (grinding mills and integrated players) in the Levante region clusters have both the ability and incentive to increase supply if the merged entity were to increase prices as: (i) grinding mills in particular are not limited by their need to source clinker since they have the possibility to buy it from the integrated players in the region or from overseas; and (ii) the high level of spare capacity held by the Parties’ main competitors in the Levante region clusters is enough to make any unilateral attempt to increase prices by the merged entity unprofitable.

(25)

Regarding the Yeles and Castillejo clusters (‘the Centre region clusters’), the Parties’ combined market shares in 2013 were below (20-30) % and slightly above (20-30) % respectively. There are two competitors of comparable size to the Parties, namely CPV ((20-30) %) and Lafarge ((20-30) %). There are also other competitors with market shares in excess of (5-10) %, namely Balboa (above (10-20) % in both clusters) and Votorantim (above (5-10) % in the Yeles cluster). Moreover, the high level of spare capacity held by the Parties’ main competitors in the Centre region clusters is enough to make any unilateral attempt to increase prices by the merged entity unprofitable.

(26)

In the clusters of Alcanar, Lloseta, Morata and Jerez the increment brought about by the transaction is less than (0-5) %.

(27)

The Commission therefore concludes that the proposed transaction is unlikely to significantly impede effective competition in the markets for grey cement within the 150 km clusters around the Parties’ plants due to non-coordinated effects.

(28)

The Commission has analysed potential coordinated effects on the various clusters defined by circles with radii of 150 km drawn around the Parties’ cement production facilities in Spain.

(29)

The Commission considers that the most likely coordination scheme in the grey cement markets under investigation is customer allocation whereby competitors refrain from approaching rivals’ customers with low prices. Under such a coordination scenario, the sizable transport costs for cement would lead to a general allocation of customers based on their proximity to a given plant.

(30)

The Commission has thus investigated whether cement competitors might face limited incentives to attract new customers aggressively. Under such a scenario, competitors would benefit from a coordination scheme through increased margins and therefore profits.

(31)

The Commission considers that there are number features of the grey cement markets under investigation indicating that market interactions are not delivering competitive outcomes. For instance, the Parties’ and their main competitors achieve positive average gross margins in the Centre region clusters despite the availability of considerable spare capacity. However, on balance, all factors considered are insufficient to conclude that market outcomes can be associated with the existence of current coordination.

(32)

There are also elements speaking against any potential coordination. In particular, the role of independent distributors in the Centre region clusters has the potential to undermine the sustainability of a coordination scheme based on customer allocation.

(33)

As regards merger-specific effects, in the current case, given that the evidence is insufficient to conclude that existing market outcomes can be associated with the existence of current coordination, the Commission does not have to conclude on whether the changes that this merger brings about would make coordination easier, more stable or more effective.

(34)

On balance, there is insufficient evidence to establish that the current market outcomes are determined by the existence of customer allocation amongst the four major cement producers (namely the Parties, Lafarge and CPV). Therefore, the Commission concludes that it is unlikely that the proposed transaction will make coordination easier, more stable or more effective to a degree that could be considered to constitute a significant impediment to effective competition.

(35)

For similar reasons, the Commission also concludes that it is unlikely that competitors that were previously not coordinating are significantly more likely to engage in coordination as a result of the proposed transaction.

(36)

It is therefore considered that the proposed transaction is unlikely to significantly impede effective competition in the markets for grey cement within the 150 km around the Parties’ plants due to coordinated effects.

(37)

For the reasons mentioned above, the Commission concludes that the proposed concentration will not significantly impede effective competition in the Internal Market or in a substantial part of it.

(38)

The notified operation is therefore declared compatible with the Internal Market and the functioning of the EEA Agreement, in accordance with Article 2(2) and Article 8(1) of the Merger Regulation and Article 57 of the EEA Agreement.

6.12.2014   

EN

Official Journal of the European Union

C 438/25

6.12.2014   

EN

Official Journal of the European Union

C 438/27

6.12.2014   

EN

Official Journal of the European Union

C 438/29

1.

On 28 November 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertakings PRS for Music Limited (‘PRSfM’, United Kingdom), Föreningen Svenska Tonsättares Internationella Musikbyrå u.p.a. (‘STIM’, Sweden), and Gesellschaft für musikalische Aufführungs- und mechanische Vervielfältigungsrechte (‘GEMA’, Germany) (together: ‘the Parties’) acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control by way of purchase of shares in a newly created joint venture.

2.

The business activities of the undertakings concerned are:

—   for the Parties: collective rights management of copyrights of authors in musical works;

—   for the joint venture: multi-territorial multi-repertoire licensing activities for mechanical and performing rights of authors in musical works for online and mobile exploitation; copyright database management and online licences processing.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.6800 — PRSfM/STIM/GEMA/JV, to the following address: