515 Amendments of Rebecca TAYLOR
Amendment 6 #
2014/2006(INI)
Draft opinion
Recital A
Recital A
A. whereas the 2013 Justice Scoreboard focuses exclusively on civil, commercial and administrative justice, which are of importance for the European Semester as regards boosting competitiveness and growth, but does not cover criminal justice, which has no direct economic impact and is, according to the Treaties, to a much greater extent a national responsibilitymore of a national focus;
Amendment 9 #
2014/2006(INI)
Draft opinion
Recital B
Recital B
B. whereas any evaluation of criminal justice should take account of the prerogatives of the Member States and national law in this area, and remain within the bounds of the Union’s responsibility for coordination only; whereas any value judgment regardjudicial review must be available at the decentralised level of the Union, namely ing national criminal justice systems should be avoidedourts;
Amendment 11 #
2014/2006(INI)
Draft opinion
Recital D
Recital D
D. whereas, in the field of crime prevention, Article 84 TFEU excludes the harmonisation of the laws and regulations of the Member States; whereas it also calls on the EU to promote and support actions by Member States in this field;
Amendment 14 #
2014/2006(INI)
Draft opinion
Paragraph 1
Paragraph 1
Amendment 18 #
2014/2006(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Recalls that the European Commission is in charge of safeguarding the rule of law, which is the basis of all fundamental values which it protects;
Amendment 19 #
2014/2006(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Points outRecalls that the primary body at European level responsible for ensuring respect fordecisions on fundamental rights and the rule of law, including in the area of criminal justice, is the European Court of Human Rights, which already provides an admirable system for the continent-wid framework for the protection of the rights of individuals;
Amendment 21 #
2014/2006(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. BelieveConsiders that the rule of law is a Union-wide concept which requires that the actions of public bodies comply with the legal framework laid down by national constitutions and the laws and regulations deriving therefrom, and should not be reduced to a criminal law issue; takes the view that the assessment of criminal justice systems alone does not permit blanket conclusions to be drawn regarding compliance with the principle of the rule of law; stresses, therefore, that any evaluation of criminal justice should not be connected to a possible new rule- of-law mechanism.
Amendment 4 #
2013/2122(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Encourages the Commission to further reflect on a proposal for an amendment to Directive 2006/114 EC to include a blacklist of practices that are to be considered misleading under all circumstances; believes that this would be preferable todoes not support extending the scope of the Unfair Commercial Practices Directive to B2B practices, as vulnerability and need for protection differ in B2C and B2B relationships;
Amendment 5 #
2013/2122(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers that when the Commission reflects on the question of including a blacklist of practices that are considered to be misleading, to ensure that such a list focuses on certain marketing practices and would not include a list of fraudulent companies;
Amendment 13 #
2013/2117(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission to take into greater consideration and promote the work of the Council of Europe's Commission on the Efficiency of Justice (CEPEJ), as it provides an excellent basis for the exchange of best practices, and duplication needs to be avoided;
Amendment 17 #
2013/2117(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Believes that theany comparison of national justice systems must be based on objective criteria and on evidence which is objectively compiled, compared and analysed; points out the importance of assessing the functioning of the justice system as a whole, without separating it from the constitutional tradition that it stems from; stresses the importance of treating Member States impartially, thus ensuring equality of treatment between all Member States when assessing their justice systems;
Amendment 19 #
2013/2117(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points out that benchmarks must be set before information on national justice systems is gathered in order to develop a common understanding of methodology and indicators; stresses that these benchmarks must take into consideration the differences between national judicial systems, and in particular the differences between civil law and common law systems;
Amendment 28 #
2013/2117(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Member States to examine the results of the 2013 Justice Scoreboard and CEPEJ's 2012 evaluation report on European judicial systems closely and to determine whether any consequences need to be drawn therefrom for the organisation of their respective civil, commercial and administrative justice systems;
Amendment 30 #
2013/2117(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes, however, that many of the questions were not applicable or relevant to all judicial systems, which would explain why data is not complete for all Member States; calls on the Commission to take into greater consideration the differences between national judicial systems in future;
Amendment 1 #
2013/2116(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission to urgently resolve any outstanding issues with regard to the consultations opened in 2011 by either terminating the procedures or by bringing infringement procedures to the European Court of Justice;
Amendment 1 #
2013/2077(INI)
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
- having regard to the opinion of the Committee of the Regions of 30 May 2013),
Amendment 3 #
2013/2077(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that legislation proposed and adopted at the European level should be simple, easy to understand and accessible to allffective and efficient, provide a clear added value, be easy to understand and accessible to all as well as deliver full benefits at minimum costs; recognises that the economic crisis has put increased strain on the resources of national administrations, and believes that a commitment towards producing clear and easily transposable legislation would help alleviate some of this stress;
Amendment 5 #
2013/2077(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Believes that better lawmaking should be pursued in the spirit of multilevel governance, i.e. through coordinated action by the EU, national institutions and local and regional authorities;
Amendment 7 #
2013/2077(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to increase the review of the application of the principle of proportionality, especially with regard to the use of Articles 290 and 291 TFEU on delegated and implementing acts;
Amendment 12 #
2013/2077(INI)
Motion for a resolution
Paragraph 12 – indent 3
Paragraph 12 – indent 3
– complete the Regulatory Fitness and Performance Programme (REFIT) evaluations in key policy areas before the end of the current legislative term; including input from all levels of government in the principal sectors that are of concern to local and regional authorities;
Amendment 13 #
2013/2077(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Emphasises the significance of simplification for streamlining the regulatory environment, especially for local and regional authorities, whose resources for the implementation of legislation are often limited and diminishing;
Amendment 14 #
2013/2077(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14 b. Understand "goldplating" to be the practice whereby Member States, in transposing EU Directives into national law, go beyond the minimum requirements, therefore calls on Member States to specify, in cases where goldplating is undertaken, the reasons for doing so;
Amendment 15 #
2013/2077(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Welcomes the fact that the Commission's impact assessments attempt to cover a wide and comprehensive range of potential impacts, but believes that the system could still be strengthened in a number of ways; such as including the territorial dimension (financial and administrative implications on national, regional and local authorities) in this regard, is encouraged by the Commission's decision to update, consolidate and revise its Impact Assessment Guidelines by June 2014, and reserves the right to make a detailed contribution setting out potential improvements to those guidelines in the coming months;
Amendment 17 #
2013/2077(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to strengthen the role and independence of the Impact Assessment Board, and to involve local and regional authority interest in the deliberations as the level of governance most likely to be involved in the implementation, and in particular only to finalise and present legislative proposals where they have been approved with a favourable opinion by the Impact Assessment Board;
Amendment 18 #
2013/2077(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Welcomes the positive development of the Directorate for Impact Assessment and European Added Value within Parliament; believes that a systematic approach to the consideration of impact assessments should be adopted throughout Parliament; welcomes the preparation by the Impact Assessment Directorate of short summaries of the impact assessments accompanying Commission proposals, and considers that these should form a essential element of committees' consideration of legislative proposals being debated; proposes that the EP's impact assessments should include a territorial dimension when appropriate; requests the Conference of Committee Chairs to consider how best to implement this recommendation;
Amendment 3 #
2013/2063(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Notes the urgent need for a clear and uniform European legislation for cloud computing to ensure a competitive European environment, increasing innovation and boosting growth;
Amendment 7 #
2013/2063(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes the importance of considering the legal framework for cloud computing with the current review of the EU Data Protection rules, ensuring clear rules but more importantly greater confidence for users;
Amendment 9 #
2013/2063(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on the Commission and Member States to continue working closely on the revision of the EU Data Protection rules as these are essential for a secure legal framework, allowing data portability to operate in a highly protected environment resulting in greater data interoperability;
Amendment 24 #
2013/2063(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission to consider further the role of cloud computing for SMEs and to consider an appropriate legal framework to allow SMEs to increase their growth and productivity using cloud computing, as SMEs can benefit from reduced upfront costs and better access to analytics tools, allowing for increase growth and job creation;
Amendment 30 #
2013/2061(INI)
Motion for a resolution
Recital I
Recital I
I. whereas legal and data protection considerations should constitutmust be a priority;
Amendment 38 #
2013/2061(INI)
Motion for a resolution
Recital J
Recital J
J. whereas it is necessary to standardise, or make interoperable, the system technology used in the various Member States, in order to guarantee its effectiveness;
Amendment 44 #
2013/2061(INI)
Motion for a resolution
Recital K
Recital K
K. whereas healthcare professionals should be provided with on-going training, including as part of continuing professional development, in the use of the ICT applied in healthcare systems;
Amendment 49 #
2013/2061(INI)
Motion for a resolution
Recital L
Recital L
L. whereas importance should be attached tothe security of databases and to, where and how they are kept, must be a priority;
Amendment 72 #
2013/2061(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the need for doctors and other healthcare professionals to be provided with special training, which could form part of continuing professional development, in eHealth:
Amendment 96 #
2013/2061(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Urges the Commission to dedicate resources within future research and development framework programmes to e- health;
Amendment 97 #
2013/2061(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Urges the Commission and Member States to work together to develop sustainable funding models for e-health services within national health budgets, and to consult other stakeholders such as health insurance funds, national health institutions, healthcare professionals, and patients organisations when doing so;
Amendment 108 #
2013/2061(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission and the Member States to bring forwardproceed with legislation on the legal and data protection considerations relating to eHealth;
Amendment 2 #
2013/2045(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- Having regard to the European Quality Charter of Internships and Apprenticeships developed by the European Youth Forum together with social partners and other stakeholders
Amendment 66 #
2013/2045(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. Whereas young people have the right to quality-employment according to their skills and that quality-employment is fundamental to the dignity and autonomy of Europe's youth;
Amendment 84 #
2013/2045(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas young people in the EU are being forced to migrate to find a job opportunity: phenomenon that, if not properly guided, risks to lead to brain drain and to increased regional disparities;
Amendment 101 #
2013/2045(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that the policy measures implemented by Member States need to be diversified and should tackle all potential obstacles in young people's pathway to sustainable and decent employment, paying particular attention to vulnerable groups that are more likely to suffer from multiple disadvantages;
Amendment 126 #
2013/2045(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the involvement of all relevant stakeholders, including training and education providers, individual employers, public and private employment services, social partners, third-sector organisations, including youth organizations, and health and other authorities, is essential for the successful implementation and monitoring of a variety of measures fostering youth employment and employability in an integrated fashion; emphasises that measures must be flexible so as to meet the continuously evolving needs on the labour market;
Amendment 163 #
2013/2045(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Welcomes the decision of the EPSCO Council on 28 February 2013 to agree on a Council recommendation on implementing a Youth Guarantee; recommends extending eligibility to graduates aged underp to 30; stresses that the success of this measure will be highly dependent on other factors, e.g. the infrastructure and capacity of public and strengthened private employment services, the availability of student places, the provision of training and, apprentic, including quality apprenticeships and traineeships, and the transferability and implementation of successful experiences from other Member States; stresses that the Youth Guarantee must be integrated within the broader framework of active labour market policies while ensuring high quality standards;
Amendment 175 #
2013/2045(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Encourages the Member States to develop clear quality standards and indicators regarding the development of youth guarantee schemes as well as to boost their support for enterprises, cooperatives and third-sector organisations wishing to participate in Youth Guarantee schemes in close cooperation with public and private employment services, including through tax incentives, subsidies for fixed employment costs, and the possibility of accessing funding for on-site training, which will support enterprises in providing high-quality sustainable employment and training offers, and will represent an investment in young people's potential in an effective and targeted way;
Amendment 228 #
2013/2045(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Member States to support self-employment among young people by creating facilities and preferential conditions for starting up their own businesses, through, e.g., cutting red tape and introducing favourable tax policies as well as easing access to financial credit and efficient counselling and mentoring facilities;
Amendment 260 #
2013/2045(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Member States to ensure high-quality frameworks for traineeships with clear mentions of rights and responsibilities for the interns, backed up by financial support and mandatory monitoring, as well as a common quality standard for traineeships and work placements; stresses that active promotion and awareness-raising in respect of such programmes is needed among entrepreneurs; ; It also calls on Member States to ensure that traineeships are properly remunerated according to collective agreements and minimum wage legislations;
Amendment 268 #
2013/2045(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the European Commission to develop by the end of 2013 a clear proposal for a quality framework for traineeships with precise quality criteria as indicated in the EC proposal setting a Second-stage consultation of the social partners at European level concerning a Quality Framework on Traineeships (COM(2012)0728)
Amendment 287 #
2013/2045(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Encourages the Member States to fosterensure the mobility of young workers by means of further progress towards the mutual recognition of qualifications and skills and enhanced coordination of national social security systems, especially as regards pension systemportability of pension rights and unemployment benefits, as well as by continuing to invest substantially in language learning;
Amendment 292 #
2013/2045(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the need to introduce reforms to EURES with the aim of proactively matching jobseekers and job-changers to existing vacancies, and where necessary, to reform public employment services so as to better target their activities and approaches on young people; stresses thatCalls on Member States to continue in the process of reform and development of effective public employment services so as to better target their activities and approaches on young people as a fundamental component of any youth guarantee strategy; stresses also the need to introduce reforms to EURES with the aim of proactively matching jobseekers and job-changers to existing vacancies as well as raising of awareness of EURES is needed so as to increase its visibility and availability, as a career advice system that supports students in becoming more aware of their aspirations and capabilities, as well as of existing job opportunities;
Amendment 298 #
2013/2045(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. In the absence of specific figures on youth migration flows, calls on Member States to create mechanisms of research, monitoring and evaluation of such mobility that can be transferred to EURES to better address such phenomena;
Amendment 299 #
2013/2045(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Stresses also the importance of sensibilizing more young people on the use of the counselling offered in the framework of the Public employment services, strengthen partnerships with schools and universities as well as to work towards a better integration with the EURES network;
Amendment 325 #
2013/2045(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Stresses the need to invest in the creation of stable and quality greens jobs as the way to allow young people to have a decent life; furthermore it asks the Commission and the Member States to mobilise all available funds to stimulate investments particularly in green jobs with a view to combating the unacceptably high rate of youth unemployment
Amendment 329 #
2013/2045(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Calls on the Commission to consider social parameters in equal footing to economic ones in the context of the European Semester. This is particularly important in the case of youth unemployment which require close monitoring and coordinated actions in all the Member States and at EU level
Amendment 331 #
2013/2045(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
18d. Requests the European Commission, in cooperation with Member States, to investigate the costs of the introduction of youth guarantee schemes at national and regional level. Furthermore requests the European commission to support regions and member states wishing to introduce such framework
Amendment 36 #
2013/2022(INI)
Motion for a resolution
Recital C – footnote 3
Recital C – footnote 3
3. For the purposes of this report, HAI means any infection which occurs during or following the provision of medical services (for diagnostic, therapeutic or preventive purposes) and which was not present or incubating prior to such provision. The infectious micro-organisms (bacteria, fungi, parasites and other transmissible agents) involved in HAI cases may come either from the patient's own organism (intestines, skin, etc.), in which case they are called endogenous infections, or from the patient's environment, in which case they are known as exogenous or cross infections. The term healthcare associated infection covers all infections associated with healthcare systems in general and with individual treatment pathways. These include nosocomial infections (acquired in healthcare establishments, either as an inpatient or an outpatient) and infections acquired during treatment provided outside healthcare establishments, in collective facilities (such as medium- and long-stay facilities, in particular care homes for eolderly dep people) or in the home. (This amendment people) or in the home. applies throughout the text. The term 'elderly' is considered pejorative in the field of ageing policy)
Amendment 43 #
2013/2022(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas reliable information on patient safety and HAIs is subject to limitations, including the ability of healthcare professionals to undertake adverse event reporting candidly and without reservations;
Amendment 47 #
2013/2022(INI)
Motion for a resolution
Recital F
Recital F
F. whereas, furthermore, eolderly patients and patients with immunodeficiencies or chronic diseases, in particular degenerative diseases, are especially vulnerable to healthcare-related adverse events;
Amendment 60 #
2013/2022(INI)
Motion for a resolution
Recital I
Recital I
I. whereas HAIs can occur as a result of time spent in healthcare establishments or during the provision of any healthcare services, including home-based services (in particular as a result of contamination ofthrough medical instruments or, equipment or contact with patients and healthcare professionals);
Amendment 133 #
2013/2022(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Urges the Member States to re- evaluate their adverse event reporting structures, to assess whether such reporting is taking place in a 'no-blame' culture, and that healthcare professionals can come forward with information candidly, without negative consequences for themselves personally;
Amendment 157 #
2013/2022(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Member States to make sufficient human, financial and technological resources available toprioritise effective workforce planning as a means of ensureing that care provided in the home or in hospital is of the highest possible quality, and urges them, staffing levels are adequate to deal with increasing particular, not to cut the budgets allocated to pent throughput and the atitent safety, a key issue for European healthcare systems at a time of global spending reviewdant negative impact on infection control practices;
Amendment 160 #
2013/2022(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Encourages Member States to develop their national practices on the appropriate use of antibiotics in order to limit the spread of antimicrobial resistance and ensure that antibiotic treatment remains effective;
Amendment 165 #
2013/2022(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Urges Member States to provide the Commission with information on vaccination programmes for healthcare professionals including the levels of coverage achieved within healthcare institutions;
Amendment 172 #
2013/2022(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and Member States to use the most advanced technological means available to guarantee optimum patient safety, and, in particular, to introduce across the board electronic health passports containing all relevant information about the patient, including his or her antecedentsdevelop platforms and protocols allowing health data portability, ensuring such activities respect relevant European data protection legislation;
Amendment 177 #
2013/2022(INI)
Motion for a resolution
Paragraph 22 – indent 1
Paragraph 22 – indent 1
– the state of health of patients (particularly eolderly persons and persons with reduced mobility) returning home after a period of hospitalisation must be assessed thoroughly when they leave hospital, with a view, in particular, to evaluating and countering the risk of falls;
Amendment 181 #
2013/2022(INI)
Motion for a resolution
Paragraph 22 – indent 3
Paragraph 22 – indent 3
– the use of throwaway medical equipment must be encouraged as far as possibleequipment used should be disposable or subject to thorough decontamination procedures if reused;
Amendment 185 #
2013/2022(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Member States to carry out specific awareness-raising and training measures concerning HAIs which are aimed not only at healthcare professionals (doctors, nurses, paramedics, etc.), but also, for example, at carerformal and informal carers and hospital volunteers who have contact with patients;
Amendment 201 #
2013/2022(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
Amendment 219 #
2013/2022(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Recommends that regional or local working parties be set up to consider specific issues relating to patient safety; by way of an example, working parties could focus on accident prevention among eolderly people, reducing operation-related risks or reducing the risk of medication- related errors;
Amendment 230 #
2013/2022(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Calls on the Member States to establish a joint database to be used to compilecollaborate in the creation of platforms which allow the sharing of information concerning adverse events in healthcare and to, encourageing the use of all relevant data collection mechanisms (including those based on confidential declar, whilst ensuring such activities respect relevant European data protection legislations);
Amendment 776 #
2013/0309(COD)
Proposal for a regulation
Article 37 – point 3 a (new)
Article 37 – point 3 a (new)
Regulation (EU) No 531/2012
Article 6a
Article 6a
(3a) Article 37 point 4 (new) the following article is inserted: Article 6a Abolition of retail roaming charges With effect from 1 July 2015, roaming providers shall not levy any surcharge in comparison to the charges for mobile communications services at domestic level on roaming customers for any regulated roaming call made or received, for any regulated roaming SMS message sent, for any roaming MMS message sent or for any regulated data roaming services used- or any general charge to enable the terminal equipment or service to be used abroad.
Amendment 35 #
2013/0305(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Where the EMCDDA and Europol, or the Commission, consider that the information shared on a new psychoactive substance notified by severalthree or more Member States gives rise to concerns across the Union because of the health, social and safety risks that the new psychoactive substance may pose, the EMCDDA and Europol shall draw up a joint report on the new psychoactive substance.
Amendment 36 #
2013/0305(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) the chemical and physical identity of the new psychoactive substance, the methods and, if known, the chemical precursors used for its manufacture or extraction, and any other new psychoactive substance or groups of substances with a similar chemical structure that have emerged;
Amendment 44 #
2013/0305(COD)
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1 – point c
Article 10 – paragraph 2 – subparagraph 1 – point c
(c) the risks to public safety, in particular the spread of diseases, including transmission of blood borne viruses, the consequences of physical and mental impairment on the ability to drive, the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment.
Amendment 46 #
2013/0305(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) the risks to public safety are limited, in particular low risk of spread of diseases, including transmission of blood borne viruses, non-existent or low consequences of physical and mental impairment on the ability to drive, and the impact of the manufacture, transport and disposal of the new psychoactive substance and associated waste materials on the environment is low.
Amendment 47 #
2013/0305(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) the risks to public safety are moderate, in particular sporadic spread of diseases, including transmission of blood borne viruses, moderate consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials results in environmental nuisance.
Amendment 48 #
2013/0305(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity, abuse liability and dependence-producing potential, is life threateningsevere and significant, as it generally provokes death or lethal injury, severe disease, and severe physical or mental impairment;
Amendment 49 #
2013/0305(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point c
Article 13 – paragraph 1 – point c
(c) the risks to public safety are severe, in particular significant spread of diseases, including transmission of blood borne viruses, severe consequences of physical and mental impairment on the ability to drive, and the manufacture, transport and disposal of the new psychoactive substance and associated waste materials result in environmental harm.
Amendment 54 #
2013/0305(COD)
Proposal for a regulation
Article -20 (new)
Article -20 (new)
Article -20 National scope Where the EU has not acted, or the Commission has decided not to adopt any restriction measures based on the EMCDDA risk assessment of a new psychoactive substance, individual Member States may maintain or introduce in their territory restrictions on the making available of the new psychoactive substance on the market to consumers, without prejudice to legitimate trade in industry, or to medicinal products or veterinary medicinal products that have obtained a marketing authorisation. Member States shall ensure that such restrictions are immediately communicated to the Commission, the EMCDDA and Europol.
Amendment 55 #
2013/0305(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
The Commission and the Member States shall support the development, sharing and dissemination of information and knowledge on new psychoactive substances. They shall do so by facilitating cooperation between the EMCDDA, other Union agencies, and scientific and research centres, and by regularly providing these bodies with up to date information on such substances wherever possible.
Amendment 56 #
2013/0305(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
The EMCDDA and Europol shall report annually to the Commission and Member States on the implementation of this Regulation, and such reports will be published on a website and made public.
Amendment 12 #
2013/0264(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
22. ‘sStrong customer authentication’ meanis a procedure for the validation of the identification of a natural or legal person basedbased on the use of two or more of the following elements – categorised as knowledge, ownership and inherence: i) something only the user knows, e.g. static password, code, personal identification number; ii) something only the use of two or more elements categorised as knowledge, possession and inherence that arer possesses, e.g. token, smart card, mobile phone; iii) something the user is, e.g. biometric characteristic, such as a fingerprint. In addition, the elements selected must be mutually independent, in that.e. the breach of one does not compromise the reliability of the others and isother(s). At least one of the elements should be non- reusable and non-replicable (except for inherence), and not capable of being surreptitiously stolen via the internet. The strong authentication procedure should be designed in such a way as to protect the confidentiality of the authentication data.
Amendment 17 #
2013/0264(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1
Article 66 – paragraph 1 – subparagraph 1
By way of derogation from Article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions, up to a maximum of EUR 50 or equivalent, resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument.
Amendment 20 #
2013/0264(COD)
Proposal for a directive
Article 90 – paragraph 4
Article 90 – paragraph 4
4. The information referred to in paragraph 21 shall be mentioned in an easily, directly, prominently and permanently accessible way on the website of the payment service provider, where one exists, in the general terms and conditions of the contract between the payment service provider and the payment service user and in invoices and receipts relating to such contracts. It shall specify how further information on the out-of-court redress entity concerned and on the conditions for using it can be accessed clear, comprehensible and easily accessible way on the trader’s website, where one exists and if applicable in the general terms and conditions of sales or service contracts between the trader and a consumer.
Amendment 41 #
2013/0185(COD)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
Amendment 47 #
2013/0185(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Consumers or undertakings to whom actual loss has been passed on have suffered harm that has been caused by an infringement of national or Union competition law. While such harm should be compensated by the infringing undertaking, it may be particularly difficult for consumers or undertakings that did not themselves make any purchase from the infringing undertaking to prove the scope of that harm. It is therefore appropriate to provide that, where the existence of a claim for damages or the amount to be awarded depends on whether or to what degree an overcharge paid by the direct purchaser of the infringing undertaking has been passed on to the indirect purchaser, the latter is regarded as having brought the proof that an overcharge paid by that direct purchaser has been passed on to his level, where he is able to show prima facie that such passing- on has occurred. It is furthermore appropriate to define under what conditions the indirect purchaser is to be regarded as having established such prima facie proof, while also respecting that it is normal business practice to pass on overcharges down the supply chain. As regards the quantification of passing- on, the national court should have the power to estimate which share of the overcharge has been passed on to the level of indirect purchasers in the dispute pending before it. The infringing undertaking should be allowed to bring proof showing that the actual loss has not been passed on or has not been passed on entirely.
Amendment 54 #
2013/0185(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
2. ‘national competition law’ means provisions of national law that predominantly pursue the same objective as Articles 101 and 102 of the Treaty and that are applied to the same case and in parallel to Union competition law pursuant to Article 3(1) of Regulation (EC) No 1/2003; This definition does not apply to national laws which impose criminal sanctions on natural persons except to the extent that such sanctions are the means whereby competition rules applying to undertakings are enforced.
Amendment 78 #
2013/0185(COD)
Proposal for a directive
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Member States shall take the necessary measures to give full effect to legal privileges and other rights not to be compelled to disclose evidence in accordance to national law.
Amendment 81 #
2013/0185(COD)
Proposal for a directive
Article 5 – paragraph 7
Article 5 – paragraph 7
7. Evidence shall include all types of evidence admissible before the national court seiszed, in particular documents and all other objects containing information, irrespective of the medium on which the information is storedwith the exception of leniency corporate statements.
Amendment 101 #
2013/0185(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – introductory part
Article 8 – paragraph 1 – point b – introductory part
(b) the destruction of relevant evidence, provided that, at the time of destruction:;
Amendment 102 #
2013/0185(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – point i
Article 8 – paragraph 1 – point b – point i
Amendment 103 #
2013/0185(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – point ii
Article 8 – paragraph 1 – point b – point ii
Amendment 104 #
2013/0185(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – point iii
Article 8 – paragraph 1 – point b – point iii
Amendment 106 #
2013/0185(COD)
Proposal for a directive
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Member States shall ensure that the limitation period shall not begin to run beforeon the latest date after an injured party knows, or can reasonably be expected to have knowledge of:
Amendment 109 #
2013/0185(COD)
Proposal for a directive
Article 10 – paragraph 2 – point ii
Article 10 – paragraph 2 – point ii
(ii) the qualification of such behaviour as an infringement of Union or national competition law, such as the result of a public action;
Amendment 112 #
2013/0185(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Member States shall ensure that the limitation period for bringing an action for damages is at least fivesix years.
Amendment 114 #
2013/0185(COD)
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Member States shall ensure that the limitation period is suspended if a competition authority takes action for the purpose of the investigation or proceedings in respect of an infringement to which the action for damages relates. The suspension shall end at the earliest one year after the infringement decision has become final, when a case can no longer be appealed or reviewed, or the proceedings are otherwise terminated.
Amendment 118 #
2013/0185(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Member States shall ensure that an undertaking which has been granted immunity from fines by a competition authority under a leniency programme shall be liable to injured parties other than its direct or indirect purchasers or providers only when such injured parties show that they are unait is not reasonably possible to obtain fullappropriate compensation from the other undertakings that were involved in the same infringement of competition law.
Amendment 119 #
2013/0185(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall ensure that the defendant in an action for damages can invoke as a defence against a claim for damages the fact that the claimant passed on the whole or part of the overcharge resulting from the infringement. TWithout prejudice to the commercial presumption that price increases are passed on down the supply chain, the burden of proving that the overcharge was passed on shall rest with the defendant who may reasonably require disclosures from the claimant.
Amendment 121 #
2013/0185(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that, where in an action for damages the existence of a claim for damages or the amount of compensation to be awarded depends on whether - or to what degree - an overcharge was passed on to the claimant, the burden of proving the existence and scope of such pass-on shall rest with the claimin line with the commercial presumption that price increases are passed on down the supply chain, the claimant can benefit from a legal presumption of pass-on under the conditions of paragraph 2. In order to prove these the claimant may reasonably require disclosures from the defendant.
Amendment 123 #
2013/0185(COD)
Proposal for a directive
Article 13 – paragraph 2 – subparagraph 1 – introductory part
Article 13 – paragraph 2 – subparagraph 1 – introductory part
Amendment 131 #
2013/0185(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The rules laid down in this Chapter shall be without prejudice to the right of an injured party to claim compensation for loss of profits, actual loss, and interest from the time the harm occurred until the compensation in respect of that harm has been paid.
Amendment 132 #
2013/0185(COD)
Proposal for a directive
Article 15 – paragraph 1 – point b a (new)
Article 15 – paragraph 1 – point b a (new)
(ba) any relevant results from public competition cases which help to fulfil the criteria in paragraph 2 of Article 13.
Amendment 133 #
2013/0185(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. Member States shall ensure that, in the case of a cartel infringement, it shall be presumed that the infringement caused harm within the market. The infringing undertaking shall have the right to rebut this presumption.
Amendment 134 #
2013/0185(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Member States shall ensure that the burden and the level of proof and of fact- pleading required for the quantification of harm does not render the exercise of the injured party's right to damages practically impossible or excessively difficult. Member States shall provide that the court be granted the power to estimate the amount of harm if the claimant is unable to directly prove the amount of harm suffered.
Amendment 65 #
2013/0110(COD)
Proposal for a directive
Recital 6 c (new)
Recital 6 c (new)
(6c) With regard to environmental matters, the statement should contain, where applicable, details on the current and foreseeable impacts of an undertaking's operations on the environment, health and safety, the use of renewable and non-renewable energy, greenhouse gas emissions, air pollution and water use. As regards social and employee-related matters, the information provided in the statement should concern, in particular, the relationships maintained by the undertaking with its subcontractors, the implementation of fundamental conventions of the International Labour Organisation (ILO), working conditions, social dialogue, health and safety at work and the dialogue with local communities, as well as the actions taken to ensure the protection and the development of those communities. Social matters should also include responsible behaviour on tax planning to ensure that a fair share of tax is paid in the right place and that aggressive tax avoidance is averted. With regard to human rights, anti-corruption and bribery, the non-financial statement should include information on, as a minimum, the prevention of human rights abuses and instruments in place in order to fight corruption and bribery.
Amendment 66 #
2013/0110(COD)
Proposal for a directive
Recital 6 d (new)
Recital 6 d (new)
(6d) Social matters include responsible behaviour on tax planning to ensure that a fair share of tax is paid in the right place and that aggressive tax avoidance is averted.
Amendment 70 #
2013/0110(COD)
Proposal for a directive
Recital 6 h (new)
Recital 6 h (new)
(6h) Undertakings should provide adequate and relevant information in relation to matters that stand out as being most likely to bring about the materialisation of risks of severe impacts, along with those that have already materialised. The severity of such impacts should be judged by their scale and gravity. The risks of adverse impact may stem from the undertaking's own activities or may be linked to its operations, products, services or business relationship such as suppliers, subcontractors and other business partners.
Amendment 72 #
2013/0110(COD)
Proposal for a directive
Recital 7
Recital 7
(7) In providing this information, companies may rely on national frameworks, EU-based frameworks such as the Eco-Management and Audit Scheme (EMAS), andshould rely, as a general rule, on national, EU-based or international normative frameworks such as the United Nations (UN) Global Compact, the Guiding Principles on Business and Human Rights implementing the UN ‘'Protect, Respect and Remedy’' Framework, the Organisation for Economic Co-operation and Development (OECD) Guidelines for Multinational Enterprises. This may also be complemented by other reporting frameworks such as the Eco-Management and Audit Scheme (EMAS), the International Organisation for Standardisation (ISO) 26000, the International Labour Organization (ILO) Tripartite Declaration of principles concerning multinational enterprises and social policy, and the Global Reporting Initiative, the Carbon Disclosure Project (CDP) and the Climate Disclosure Standards Board (CDSB) or other recognised national, EU-based or international Rreporting Initiativeframeworks. In their statement, undertakings should specify which framework(s) they have relied upon.
Amendment 81 #
2013/0110(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
Amendment 98 #
2013/0110(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) The European Council of 22 May 2013 called for the mandatory introduction of country-by-country reporting for all large companies and groups as part of the revision of this Directive. Therefore, in order to provide for enhanced transparency of payments made to governments, large undertakings and public interest entities should disclose material payments made to governments in the countries in which they operate. Such disclosures should be audited.
Amendment 99 #
2013/0110(COD)
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11b) To mitigate aggressive tax planning and avoidance by EU undertakings, Member States should introduce general anti-avoidance rules (GAAR) in line with the European Commission Recommendation on Aggressive Tax Planning on the 12th December 2012 and the OECD Progress Report to the G20 on 5th September 2013. Furthermore, large undertakings in the Union should also make public a report on their aggressive tax planning systems, including other relevant information.
Amendment 107 #
2013/0110(COD)
Proposal for a directive
Recital 16
Recital 16
(16) The obligation to disclose their diversity policies for their administrative, management and supervisory bodies with regard to gender and other aspects such as age, gender, geographical diversitydisability, ethnic or national origin, educational and professional background should only apply to large listed companies. Therefore small and medium-sized companies that may be exempted from certain accounting obligations under article 27 of Directive 78/660/EEC should not be covered to by this obligationundertakings. Disclosure of the diversity policy should be part of the corporate governance statement, as laid down by Article 46a20 of Directive 78/660/EEC. Companie2013/34/EU. Undertakings not having a such a diversity policy should not be obliged to put one in place, but they should clearly explain why this is the case.
Amendment 117 #
2013/0110(COD)
Proposal for a directive
Article 1 – point 1
Article 1 – point 1
Amendment 136 #
2013/0110(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 78/660/EEC
Article 46 – paragraph 1 – point b – subparagraph 2
Article 46 – paragraph 1 – point b – subparagraph 2
Where a company does not pursue policies in relation to one or more of these matters, it shall provide an clear and reasoned explanation for not doing so.
Amendment 150 #
2013/0110(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 78/660/EEC
Article 46 a
Article 46 a
Amendment 154 #
2013/0110(COD)
Proposal for a directive
Article 1 – point 2 – point a
Article 1 – point 2 – point a
Directive 78/660/EEC
Article 46 a – paragraph 1 – point g
Article 46 a – paragraph 1 – point g
(g) a description of the company's diversity policy for its administrative, management and supervisory bodies with regard to gender and other aspects such as age, gender, geographical diversitydisability, ethnic or national origin, educational and professional background, the objectives of this diversity policy, how it has been implemented and the results in the reporting period. If the companyundertaking has no such policy, the statement shall contain a clear and reasoned explanation as to why this is the case.
Amendment 158 #
2013/0110(COD)
Proposal for a directive
Article 2 – point 1 – point a
Article 2 – point 1 – point a
Amendment 176 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point a
Article 2 a (new) – point a
Directive 2013/34/EU
Article 2 – point 16 a (new)
Article 2 – point 16 a (new)
Amendment 179 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point d
Article 2 a (new) – point d
Directive 2013/34/EU
Article 19
Article 19
(d) Article 19 is amended as follows:
Amendment 183 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point d
Article 2 a (new) – point d
Amendment 189 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point e
Article 2 a (new) – point e
Directive 2013/34/EU
Article 20 – paragraph 1 – point c a (new)
Article 20 – paragraph 1 – point c a (new)
(e) In Article 20(1), the following point is inserted: (ca) In order to assess the proportionality of tax reduction methods employed by an undertaking, a description of the undertaking's tax planning arrangements should be specified which at least include: (i) aggressive tax planning arrangements including the general substance of advice received; (ii) transfer pricing arrangements and whether the transfer prices have been agreed by the revenue authorities in each of the countries concerned; (iii) permanent establishment decisions and a list of countries where the undertaking trades without having a permanent establishment; (iv) base erosion methods via interest deduction, royalties and other financial payments, including where brands are developed, where they are paid for by subsidiaries and whether they are owned by the parent company in their main operating base or if not, where domiciled for tax purposes; (v) where research and development takes place and how this is recovered from subsidiaries.
Amendment 193 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point e
Article 2 a (new) – point e
Directive 2013/34/EU
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
(e) In Article 20, the following paragraph 1 a is inserted: 1a. Member States shall require large undertakings and all public-interest entities to publicly disclose annually a country-by-country report on a consolidated basis for the financial year. These obligations shall not apply to any undertaking governed by the law of a Member State which is a subsidiary or parent undertaking, where both of the following conditions are fulfilled: (a) the parent undertaking is subject to the laws of a Member State; and (b) the country-by-country report made by the undertaking are included in the consolidated report on payment to governments drawn up by that parent undertaking in accordance with Article 39. The information referred to in paragraph 1 shall be audited in accordance with Directive 2006/43/EC. The Commission shall conduct a general assessment report as regards potential economic consequences of the public disclosure of the country-by-country report, except those entities which publically disclose in accordance with Article 42, including the impact on competitiveness and investment, and may consider recommending that this information should be available to the competent tax authorities, only in the case of a negative assessment. The Commission shall submit its report to the Council and the European Parliament by 31 December 2015.
Amendment 195 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point e
Article 2 a (new) – point e
Directive 2013/34/EU
Article 20 – paragraph 3
Article 20 – paragraph 3
(e) In Article 20, paragraph 3 is replaced by the following: '3. The statutory auditor or audit firm shall express an opinion in accordance with the second subparagraph of Article 34(1) regarding information prepared under points (c), (ca), (cb) and (d) of paragraph 1 of this Article and shall check that the information referred to in points (a), (b), (e), (f), and (g) of paragraph 1 and paragraph 1a of this Article has been provided.'
Amendment 198 #
2013/0110(COD)
Proposal for a directive
Article 2 a (new) – point f
Article 2 a (new) – point f
Directive 2013/34/EC
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
(f) In Article 29, the following paragraph is inserted: '1a. For the purposes of paragraph 1 of this Article, the review of parent undertakings of a large group whose average number of employees during the financial year exceeds 500 shall also include a non-financial statement containing information relating to, as a minimum, environmental, social and employee matters, respect for human rights, and the fight against corruption and bribery, including: (a) a description of the policies pursued by the undertaking in relation to these matters, (b) the results of those policies; (c) the risks related to matters linked to the undertaking's activities, operations, products and services or through its business relationships which are likely to cause adverse impacts in these areas; (d) how the company manages those risks, including through due diligence processes. Where the group does not pursue policies in relation to one or more of these matters, the review shall provide a reasoned explanation for not doing so. In providing the information required by the first subparagraph, the parent undertaking shall rely on national, EU- based or international frameworks, and if so, the parent undertaking shall specify which frameworks it has relied upon.
Amendment 84 #
2013/0089(COD)
Proposal for a directive
Article 10 – paragraph 5 – subparagraph 1a (new)
Article 10 – paragraph 5 – subparagraph 1a (new)
Member States shall take appropriate measures with regards to ensuring the smooth transit of generic medicines. Therefore a proprietor of a trade mark shall not have the right to prevent any third parties from bringing goods, in the context of commercial activity, into the customs territory of the Member State based upon similarities, perceived or actual, between the international non- proprietary name (INN) for the active ingredient in the medicines and a registered trademark.
Amendment 121 #
2013/0088(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) No 207/2009
Article 9 – paragraph 5 a (new)
Article 9 – paragraph 5 a (new)
Amendment 33 #
2013/0049(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point d
Article 6 – paragraph 1 – subparagraph 1 – point d
(d) the categories of consumers at risk when using the product, in particular vulnerable consumers, such as children, older people and the disabled;
Amendment 36 #
2013/0049(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied withproduct bears the requirementsd marking set out in Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.
Amendment 37 #
2013/0049(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point c
Article 13 – paragraph 1 – point c
Amendment 39 #
2013/0049(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts may by means of implementing accordance with Article 20ts determininge the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3) does not need to be indicated on the product itself. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 19(2).
Amendment 41 #
2013/0049(COD)
Proposal for a regulation
Article 15 – paragraph 3 – introductory part
Article 15 – paragraph 3 – introductory part
3. The Commission shall be empowered to adopt delegatedadopt implementing acts in accordance with Article 2019(2) in order to:
Amendment 42 #
2013/0049(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point a
Article 15 – paragraph 3 – point a
(a) determininge the products, categories or groups of products susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1;
Amendment 43 #
2013/0049(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point b
Article 15 – paragraph 3 – point b
(b) specifying the data which economic operators shall collect and store by means of the traceability system referred to in paragraph 2.
Amendment 23 #
2013/0025(COD)
Proposal for a directive
Recital 7
Recital 7
(7) Legal professionals, as defined by the Member States, should be subject to the provisions of this Directive when participating in financial or corporate transactions, including providing tax advice, where there is the greatest risk of the services of those legal professionals being misused for the purpose of laundering the proceeds of criminal activity or for the purpose of terrorist financing, terrorist financing, criminal activity as defined in Article 3(4) or aggressive tax avoidance. There should, however, be exemptions from any obligation to report information obtained either before, during or after judicial proceedings, or in the course of ascertaining the legal position of a client. Thus, legal advice should remain subject to the obligation of professional secrecy unless the legal counsellor is taking part in money laundering or, terrorist financing, criminal activity as defined in Article 3(4) or aggressive tax avoidance, the legal advice is provided for money laundering or, terrorist financing purposes, criminal activity as defined in Article 3(4) or aggressive tax avoidance, or the lawyer knows that the client is seeking legal advice for money laundering or, terrorist financing purposes or criminal activity as defined in Article 3 (4) or aggressive tax avoidance.
Amendment 25 #
2013/0025(COD)
Proposal for a directive
Recital 11
Recital 11
(11) The need for accurate and up-to-date information on the beneficial owner is a key factor in tracing criminals who might otherwise hide their identity behind a corporate structure. Member States should therefore ensure that companies retain information on their beneficial ownership, maintain central registers, and make this information available to competent authorities an, obliged entities, and, in the case of listed obliged entities, to the public. In addition, trustees should declare their status to obliged entities.
Amendment 37 #
2013/0025(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point f
Article 2 – paragraph 1 – point 3 – point f
(f) providers of gambling services.casinos;
Amendment 38 #
2013/0025(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point f a (new)
Article 2 – paragraph 1 – point 3 – point f a (new)
(fa) on-line gambling;
Amendment 39 #
2013/0025(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point f b (new)
Article 2 – paragraph 1 – point 3 – point f b (new)
(fb) other providers of gambling services which carry a high risk of being used for money laundering;
Amendment 40 #
2013/0025(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 4 – point e a (new)
Article 3 – paragraph 1 – point 4 – point e a (new)
(ea) tax crimes related to direct taxes and indirect taxes;
Amendment 41 #
2013/0025(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 4 – point f
Article 3 – paragraph 1 – point 4 – point f
(f) all offences, including tax crimes related to direct taxes and indirect taxes, which are punishable by deprivation of liberty or a detention order for a maximum of more than one year or, as regards those States which have a minimum threshold for offences in their legal system, all offences punishable by deprivation of liberty or a detention order for a minimum of more than six months;
Amendment 42 #
2013/0025(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7 – point d – point ii
Article 3 – paragraph 1 – point 7 – point d – point ii
(ii) members of parliaments or other legislative bodies;
Amendment 49 #
2013/0025(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The Commission shall make the opinion publicly available to assist Member States and obliged entities to identify, manage and mitigate the risk of money laundering and terrorist financing.
Amendment 50 #
2013/0025(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Member States shall make the results of their risk assessments publicly available to the other Member States, the Commission, and EBA, EIOPA and ESMA upon request.
Amendment 53 #
2013/0025(COD)
Proposal for a directive
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
(d) for providers of gambling servicecasinos, when carrying out occasional transactions amounting to EUR 2 000 or more, whether the transaction is carried out in a single operation or in several operations which appear to be linked; for on-line gambling when establishing the business relationship; for other providers of gambling services which carry a high risk of being used for money laundering;
Amendment 56 #
2013/0025(COD)
Proposal for a directive
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Member States shall ensure that the information referred to in paragraph 1 of this Article can be accessed in a timely manner by competent authorities and by obliged entitiesand efficient manner by Union and international competent authorities and by obliged entities. Member States shall seek to constructively cooperate whenever possible and should maintain central registries of company beneficial ownership. Information of beneficial ownership of listed companies shall be made public.
Amendment 65 #
2013/0025(COD)
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
Member States shall take all appropriate measures in order to protect employees of the obliged entityensure that the obliged entities prevent their own employees who report suspicions of money laundering or terrorist financing either internally or to the FIU from being exposed to threats or hostile action, including termination of employment, and that these should be provided with adequate legal protection if required.
Amendment 74 #
2013/0025(COD)
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. Member States shall ensure that competent authorities publish any sanction or measure imposed for breach of the national provisions adopted in the implementation of this Directive without undue delay including information on the type and nature of the breach and the identity of persons responsible for it, unless such publication would. Where the publication of this information could cause seriously jeopardisey to the stability of the financial markets. Where publication w, or could cause a disproportionate damage to the parties involved, competent authorities shall publish the sanctMember States may decide to publish the information on an anonymous basis, and if so, shall request for approval of the Commission. Member States shall apply to the Commission for approval of anonymous publication. The application must include detailed economic analysis supporting the Member State's request. The Commission will have 15 working days to refuse the approval request for the information to be published anonymously. If the Commission has not responded within the 15 working days, the request will have be deemed to be accepted, and the Member States shall then publish the sanctions or measures imposed for breach of the national provisions on an anonymous basis.
Amendment 3 #
2012/2322(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that online gambling is a special kind ofn economic activity, to which internal market rules, namely freedom of establishment and freedom to provide services, cannot fully apply; highlights the fact that the Member States have the right to regulate and control their gambling markets in accordance with European internal market legislation;
Amendment 13 #
2012/2322(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Reminds the Commission that, in order to ensure an effective application of European law, strong enforcement is essential and, therefore, effective checks need to be put into place to ensure that national online gambling legislation is compliant with EU law;
Amendment 14 #
2012/2322(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Urges the Commission, therefore, to finalise the numerous infringement procedures and complaints, some of which date back to 2007, before the end of this mandate and to take concrete action where those proceedings breach the Treaty and the case law of the Court of Justice of the European Union;
Amendment 16 #
2012/2322(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recognises that cooperation between Member States is essential but stresses that it is also very important that the expert group on gambling should work in close collaboration with all stakeholders, including both the gambling industry and consumer organisations;
Amendment 17 #
2012/2322(INI)
Draft opinion
Paragraph 6
Paragraph 6
Amendment 19 #
2012/2322(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recognises that match-fixing is a cause for serious concern and is often linked to organised crime, which represents a major threat to the integrity of sports in the European Union; calls on the Commission, therefore, to reinforce cooperation between the main stakeholders, such as police forces, sports bodies and betting operators, in order to enhance the reporting and investigation of suspicious betting patterns;
Amendment 54 #
2012/2258(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Invites the Commission to apply a holistic approach in regard to prevention; points out the systematic correlation between socio-economic status and health outcomes throughout life; invites the Commission and the Member States to tackle structural issues and to eliminateaddress socio-economic inequalities (which lead to health inequalities); further, questions the responsibility and pressure put on individuals to improve their health status, that is, without appropriately tacklingand while accepting that individual responsibility has a role to play in improving health status, requests that the Commission address structural issues, including health illiteracy; therefore, invites the Commission and the Member States to create structural conditions which tackle health inequalities;
Amendment 80 #
2012/2258(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Encourages the Commission's ambition in regard to eHealth, making it a significant and substantial aspect of future care and cure systems; however, points out that the impact of pure technologrecognises that eHealth solutions, whilst beneficial and virtual solutions on overall, may not significantly improve health outcomes will be limited if such solutions are to replace human interaction, that is, as inrather than being integrated with a face- to- face approach between patients and health care professionals;
Amendment 84 #
2012/2258(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Acknowledges the Commission's intention to contribute to making care and cure systems more cost-efficient; however, emphasises that the continuous increase of overall (health) care costs cannot be attributed to population ageing only; furthermore, stresses that the burden of these costs are being put onthat the rise in chronic disease is a key cause of increased healthcare costs and although the risk of developing most chronic diseases increases with age, lifestyle changes can reduce that risk, delay onset or minimise the severity of chronic disease; furthermore, notes that when the burden of healthcare costs is increasingly borne by the individual, increasingly so,t can creatinge a vicious circle in whichwhereby people's health and well-being are being put at risk asby they are compelled to reallocate their often limited resources or when they haveir inability to afford the care they need, leading to postponeing, abandoning or even restrain from treatment,following treatment insufficiently, not requesting necessary assistance and inadequate nutrition; .
Amendment 90 #
2012/2258(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Acknowledges the Commission's objective to deal with legal and regulatory uncertainties and market fragmentation; however,but stresses that in these matters the needs of the population should be prioritised over internal market demandmarket reforms should take into account the importance of keeping health care affordable for citizens, and that the competences of national, regional and local governments in regard to health and social protection should be recognised, respected and complied with;
Amendment 99 #
2012/2258(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Encourages the Commission, in its assessment of Independent Living solutions, to consider the problems presented by the gap that exists in many Member States between average healthy life expectancy and pension age, potentially leaving many people with a period in which they are no longer able to work but are not yet eligible to receive their full pension entitlements;
Amendment 6 #
2012/2101(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
Amendment 7 #
2012/2101(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls, furthermore, on the Commission and the Member States to launch an effective information campaign in order to reach a large number of potential beneficiaries as well as legal practitioners; however recognises the cost implication of large European information campaigns and strongly recommends that the Commission and Member States use a wide range of communication channels including internet based campaigns and the use of interactive platforms as cost effective ways to reach citizens.
Amendment 8 #
2012/2101(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Invites the Commission to make greater use of the EU Judicial platform as mentioned in Article 18 of the Directive; and to work with Member States for a wider promotion of this platform;
Amendment 11 #
2012/2101(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for the Commission to work closely with existing cross-border legal databases such as Find-a-Lawyer launched in 2010 and undertaken by the Council of Bars and Law Societies of Europe and funded by the European Union;
Amendment 14 #
2012/2101(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Suggests that special training schemes to provide legal practitioners with cross- border competency would be desirable,, in particular with a focus on language courses and comparative law, could be developed by Member States with the financial and logistical support of the European Commission;
Amendment 15 #
2012/2101(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Recognises that legal support and training has cost implications for Member States and that in the current economic climate, funding for this may be limited in many Member States; therefore calls on the European Commission to provide funding where possible for Member States to ensure a consistent and high level legal training on cross-border legal aid in civil and commercial matters;
Amendment 17 #
2012/2101(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Invites the Commission to submit a proposal for amendment of the directive along the above lines, possibly in the context of a new Code on Legal Aid;
Amendment 19 #
2012/2101(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Suggest also greater cooperation between the Commission, Member States and professional legal bodies and organisations such as European and national bars and law societies;
Amendment 6 #
2012/2098(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to consider the current discussions taking place with regard to the review of the Accounting and Transparency Directives so that the new proposed CSR strategy would complement the revised Directive;
Amendment 15 #
2012/2098(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Acknowledges the importance of businesses divulging information on sustainability such as social and environmental informationfactors, with a view to identifying sustainability risks and increasing investor and consumer trust; points to the substantial progress made in this respect to date and the EU’s position of global leadership in this area;
Amendment 18 #
2012/2098(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Is closely monitoring the current discussions on the legislative proposal on the transparency of information on sustainability such as the social and environmental inperformationnces, respect of human rights provided by companies; advocates the adoption of an approach ‘comply or explain’ approach which would allowing the greatest possible flexibility of action to be maintained, in order to take account of CSR’s multi- dimensional nature and the diversity of the CSR policies implemented by businesses as well as the need to provide consumers with easy access to information about socially responsible businesses and their products and services;
Amendment 21 #
2012/2098(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Is firmly opposed to the introduction of specific parameters, such as EU-wide performance indicators, which could give rise to unnecessary red tape and inefficient operational strictures; instead, calls on the Commission to provide companies with the choice of internationally accepted framework they would want to rely on when considering their sustainability reporting;
Amendment 25 #
2012/2098(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to ensure that an obligation for systematic reporting on essential information on sustainability does not overburden companies as any new CSR strategy needs to be welcomed by companies; calls on the Commission to allow for a transition period before non- financial reporting on a regular basis comes into force for companies as this transition period would provide companies with the opportunity to first properly implement CSR internally, putting in place an accurate and detailed CSR policy as part of their internal management systems;
Amendment 30 #
2012/2098(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Acknowledges that many SMEs in Europe already undertake CSR policies, such as local employment, community engagement, applying good governance policies with their supply chain etc.; however, most of these SMEs do not know that they are actually putting in practice sustainability, CSR and good corporate governance practices; therefore calls on the Commission to first consider SMEs’ current practices before considering CSR strategies specifically for SMEs;
Amendment 8 #
2012/2097(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Understands that developing CSR will require new skills from businesses and a shift in values and behaviour; is convinced that Member States can play a key role in providing educational institutions with incentives to include CSR, sustainable development and responsible citizenship in the relevant curricula, in both secondary and higher education;
Amendment 10 #
2012/2097(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Acknowledges that within large companies CSR practices and policies are still very much confined to a minority, therefore calls on the Commission to highlight the importance of CSR being included in education and training especially within business and management schools;
Amendment 73 #
2012/2066(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Takes the view that the criteria for defining endocrine disruptors should be based on criteria for defining ‘'adverse effect’' and ‘'endocrine mode of action’'; considers that both these criteria must be weighed up in parallel in order to carry out a comprehensive assessment; considers that proven effects should be assumconsidered to be harmful as long as there is no scientific data to indicate the oppositeat they would come within the WHO "adverse effect" definition; stresses that any possible combination effects should be taken into consideration;
Amendment 134 #
2012/2066(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses that endocrine disruptors should be regarded as substances for which it is not possible to setany new regulatory framework governing endocrine disruptors should take into account the difficulty of setting a limit value at which effects may occur (‘'non- threshold’' substances) and that any low exposure to suchome substances may entail a risk;
Amendment 10 #
2012/2038(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that the art market was valued at USD 10 billion in 2010 and almost USD 12 billion in 2012; believes, as a result, thatconsiders this to be an important market from which artists and their heirs should receive fair compensremuneration;
Amendment 16 #
2012/2038(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Encourages the Commission, in its next assessment report, to reconsider the relevance of applicable rates, the thresholds linked to those rates, and the categories of beneficiaries as specified in the Directive;
Amendment 67 #
2012/0366(COD)
Proposal for a directive
Recital 15
Recital 15
(15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may make tobacco products more palatable, and therefore facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided.
Amendment 73 #
2012/0366(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) The Commission and the Member States should commit themselves to the effective implementation of the FCTC's protocol to eliminate illicit trade in tobacco products. Efforts should be made to prevent and improve the control of illegal trafficking of tobacco products manufactured in third countries.
Amendment 75 #
2012/0366(COD)
Proposal for a directive
Recital 34
Recital 34
(34) 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 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products which claim to have properties beneficial to human health. A significant number of nicotine-containing products werpresenting such claims have already been authorised under this regulatory regime. The authorisation Member Staktes into account the nicotine content of the product in question. Subjecting allare obliged to ensure nicotine- containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilledich do not fall under Directive 2001/83/EC and which are placed on the common market comply with the appropriate legislation listed in [new] Annex IV.
Amendment 76 #
2012/0366(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directivefalling outside of the scope of Directive 2001/83/EC drawing the attention of consumers to potential health risks, and Member States should be obliged to ensure that national age restrictions for buying nicotine containing products are kept in line with those for the sale of tobacco products.
Amendment 96 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Member States shall prohibit the use of characterising flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity. Filters and capsules shall not contain tobacco.
Amendment 105 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover at least 75 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 106 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point g – introductory part
Article 9 – paragraph 1 – point g – introductory part
(g) for unit packets of cigarettes, respect the following dimensions as a minimum:
Amendment 107 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 64 mm;
Amendment 108 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point g – point ii
Article 9 – paragraph 1 – point g – point ii
(ii) width: not less than 55 mm.
Amendment 111 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) promotes a tobacco product by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions;, in particular by suggesting that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural or otherwise positive health effects.
Amendment 112 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
Amendment 117 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of roll-your- own tobacco shall and include at least 20 cigarettes. A unit packet of any other tobacco for smoking shall be packaged in a cuboid or cylindrical composite can or have the form of a pouch, i.e. a rectangular poacket with a flap that covers the opening. The flap of the pouch shall cover at least 70% of the front of the packet. A unit packet of cigarettes shall include at least 20 cigarettes. A unit packet of roll-your-own tobacco, and shall contain tobacco weighing at least 40 g.
Amendment 119 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than thein the form of a flip-top lid. The flip-top lid of a cigarette packet shall be hinged only at the back of the packet..
Amendment 144 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products that are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
Amendment 145 #
2012/0366(COD)
Amendment 146 #
2012/0366(COD)
Amendment 147 #
2012/0366(COD)
Amendment 148 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 149 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 b (new)
Article 18 – paragraph 1 b (new)
1b. For nicotine-containing products where paragraph 1 does not apply, the products may be placed on the market if they comply with this Directive
Amendment 150 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 c (new)
Article 18 – paragraph 1 c (new)
1c. Member States shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
Amendment 151 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 d (new)
Article 18 – paragraph 1 d (new)
1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new] Annex IV as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 152 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 e (new)
Article 18 – paragraph 1 e (new)
1e. Member States shall ensure that nicotine-containing products are not sold to persons below the national legal age for purchasing tobacco products.
Amendment 153 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 f (new)
Article 18 – paragraph 1 f (new)
1f. Where appropriate, Member States may impose marketing restrictions on nicotine-containing products similar to those which apply to the marketing of tobacco products.
Amendment 155 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Commission shall, be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations grantey 1 April 2017, carry out a study on nicotine-containing products in consultation with relevant stakeholders and the Member States. This study will consider whether there is a need for specific legislation in regard to nicotine- containing products pursuant to Directive 2001/83/EC.
Amendment 157 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 3
Article 18 – paragraph 3
3. Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1which do not fall under the scope of Directive 2001/83/EC shall carry the following health warning: This product contains nicotine which is addictive and canmay damage your health.
Amendment 169 #
2012/0366(COD)
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
Amendment 170 #
2012/0366(COD)
Proposal for a directive
Annex I a (new)
Annex I a (new)
Amendment 199 #
2012/0366(COD)
Proposal for a directive
Recital 34
Recital 34
(34) 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 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products which claim to have properties beneficial to human health. A significant number of nicotine-containing products werpresenting such claims have already been authorised under this regulatory regime. The authorisation Member Staktes into account the nicotine content of the product in question. Subjecting allare obliged to ensure nicotine- containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilledich do not fall under Directive 2001/83/EC and which are placed on the common market comply with the appropriate legislation listed in [new] Annex IV.
Amendment 207 #
2012/0366(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directivefalling outside of the scope of Directive 2001/83/EC drawing the attention of consumers to potential health risks, and Member States should be obliged to ensure that national age restrictions for buying nicotine containing products are kept in line with those for the sale of tobacco products.
Amendment 874 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of roll-your- own tobacco shall and include at least 20 cigarettes. A unit packet of any other tobacco for smoking shall be packaged in a cuboid or cylindrical composite can or have the form of a pouch, i.e. a rectangular poacket with a flap that covers the opening. The flap of the pouch shall cover at least 70% of the front of the packet. A unit packet of cigarettes shall include at least 20 cigarettes. A unit packet of roll-your-own tobacco, and shall contain tobacco weighing at least 40 g.
Amendment 893 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than thein the form of a flip-top lid. The flip-top lid of a cigarette packet shall be hinged only at the back of the packet.
Amendment 1150 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products that are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
Amendment 1162 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 1163 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. Where appropriate, Member States may impose marketing restrictions on nicotine-containing products similar to those which apply to the marketing of tobacco products.
Amendment 1167 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 b (new)
Article 18 – paragraph 1 b (new)
Amendment 1168 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 c (new)
Article 18 – paragraph 1 c (new)
1c. Member States shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
Amendment 1169 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 d (new)
Article 18 – paragraph 1 d (new)
1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new] Annex IV as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 1170 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 e (new)
Article 18 – paragraph 1 e (new)
1e. Member States shall ensure that nicotine-containing products are not sold to persons below the national legal age for purchasing tobacco products.
Amendment 1171 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 1182 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1196 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1218 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Commission shall, be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations grantey 1 April 2017, carry out a study on nicotine-containing products in consultation with relevant stakeholders and the Member States. This study will consider whether there is a need for specific legislation in regard to nicotine- containing products pursuant to Directive 2001/83/EC.
Amendment 1229 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 3 – introductory part
Article 18 – paragraph 3 – introductory part
Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1which do not fall under the scope of Directive 2001/83/EC shall carry the following health warning:
Amendment 1233 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
This product contains nicotine which is addictive and canmay damage your health.
Amendment 1333 #
2012/0366(COD)
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
Amendment 1360 #
2012/0366(COD)
Proposal for a directive
Annex 2 b (new)
Annex 2 b (new)
Amendment 75 #
2012/0360(COD)
Proposal for a regulation
Article 1 – point 23
Article 1 – point 23
Regulation (EC) No 1346/2000
Article 3b – paragraph 2
Article 3b – paragraph 2
2. Where insolvency proceedings are opened in accordance with national law without a decision by a court, the liquidator appointed in such proceedings shall examine whether the Member State in which the proceedings are pending has jurisdiction pursuant to Article 3. Where this is theIn such cases, the liquidator shall specify the grounds on which jurisdiction is based and, in particular, whether jurisdiction is based on Article 3(1) or (2).
Amendment 33 #
2012/0299(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) The EU institutions and agencies should lead by example by improving gender balance. The principles laid down in this Directive should be incorporated into the rules governing the internal staffing procedures of the European Commission, the European Parliament, and all EU-institutions and agencies, including the European Central Bank. More efficient gender policies must be developed in all EU institutions to impact on recruitment to, training in, and the everyday functioning of the different EU institutions. For that purpose the institutions shall ensure that gender balance is achieved in the recruitment of senior management, including Director- Generals, Directors and Heads of Unit.
Amendment 35 #
2012/0299(COD)
Proposal for a directive
Recital 6 c (new)
Recital 6 c (new)
(6c) It is essential that the management of the Commission, the EU's executive body, improves its gender balance to represent better the European citizens. Member States are therefore called upon to nominate both male and female candidates for each position in the college of the Commissioners in order to achieve a gender balance in the Commission college.
Amendment 36 #
2012/0299(COD)
Proposal for a directive
Recital 6 e (new)
Recital 6 e (new)
(6e) The European Central bank (ECB), the European System of Financial Supervision (ESFS) – including the European Systemic Risk Board (ESRB) – and the European Supervisory Authorities (ESAs) should comply with all aspects of equality and non-discrimination on the basis of gender. The Boards of Supervisors of the ESAs should also be encouraged to present a gender-balanced list of candidates for the positions of Chairmen and Executive Directors at the relevant hearing in the European Parliament. The final selection of these positions should be gender balanced. It is also important that the Steering Committee and Advisory Committees of the ESRB are gender balanced.
Amendment 37 #
2012/0299(COD)
Proposal for a directive
Recital 6 f (new)
Recital 6 f (new)
(6f) The supervisory board of the European Central Bank (ECB), including the roles of Chair and Vice Chair, should be balanced from a gender perspective. Whenever a vacancy arises on ECB Executive Board those Member States that have adopted the euro as a currency should be encouraged to nominate two candidates, a male and a female, for the vacant position. The Member States should also be encouraged to appoint women as governors of the national central banks (NCBs) in order to achieve a gender balance in the Governing Council and the General Council of the ECB and on the General Board of the ESRB.
Amendment 52 #
2012/0299(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) It is important to note that the current situation in board recruitment can amount to positive discrimination for men. There are studies showing that male board members are less highly qualified and less experienced than their female counterparts, thus indicating gender discrimination of a positive nature for men and a negative nature for women.
Amendment 54 #
2012/0299(COD)
Proposal for a directive
Recital 10
Recital 10
(10) Despite the existing Union legislation aimed at preventing and combating sex discrimination, the Council recommendations aimed specifically at increasing the presence of women in economic decision-making and Union- level actions encouraging self-regulation, women continue to be strongly outnumbered by men in the highest decision-making bodies of companies throughout the Union. In the private sector and especially in listed companies this gender imbalance is particularly significant and acute, although certain EU institutions and agencies, such as the European Central Bank, also display a deeply problematic gender imbalance. The Commission's key indicator of gender representation on corporate boards shows that the proportion of women involved in top-level business decision- making remains very low. In January 2012, women occupied on average just 13.7 per cent of board seats in the largest publicly listed companies in Member States. Among non- executive directors only 15 per cent were women.
Amendment 61 #
2012/0299(COD)
Proposal for a directive
Recital 12
Recital 12
(12) The scattered and divergent regulation or the absence of regulation at national level as regards the gender balance on boards of listed companies does not only leads to discrepancies in the number of women among non-executive directors and different rates of improvement across Member States, but also poses barriers to the internal market by imposing divergent corporate governance requirements on European listed companies. Those differences in legal and self-regulatory requirements for the composition of corporate boards can lead to practical complications for listed companies operating across borders, notably when establishing subsidiaries or in mergers and acquisitions, as well as for candidates for board positions.
Amendment 62 #
2012/0299(COD)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) Gender imbalances within companies are greater at more senior levels. Furthermore, many of those women who are represented in senior management are to be found in fields such as human resources and communication while men at a senior level are more likely to be employed in general management or "line management" within the company. As the main pool for recruitment to corporate board positions is comprised largely of candidates with senior management experience, it is vital that the number of women advancing to such management positions within companies is increased.
Amendment 64 #
2012/0299(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The current lack of transparency of the selection procedures and qualification criteria for board positions in most Member States represents a significant barrier to more gender diversity among board members and negatively affects both the board candidates' careers and freedom of movement, as well as investor decisions. Such lack of transparency prevents potential candidates for board positions from applying to boards where their qualifications would be most required and from challenging gender-biased appointment decisions, thus restricting their freedom of movement within the internal market. On the other hand, investors have different investment strategies that require information linked also to the expertise and competence of the board members. More transparency in the qualification criteria and the selection procedure for board members enables investors to better assess the company's business strategy and to take informed decisions.
Amendment 69 #
2012/0299(COD)
Proposal for a directive
Recital 14
Recital 14
(14) While this Directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail, the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions forThe introduction of requirements for companies to set individual targets and to develop gender policies in order to improve the gender balance among executive and non- executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability, competence and professional performance is necessary in order to attain gender balance among non- executives directors. Only an EU-level measure can effectively help to ensure a competitive level-playing field throughout the Union and avoid practical complications in business lifeand at all levels of management is necessary to ensure that companies take action on this important matter. The target figures should be ambitious and realistic for the individual company whilst taking into account company-specific and branch- specific characteristics.
Amendment 71 #
2012/0299(COD)
Proposal for a directive
Recital 15
Recital 15
(15) The Europe 2020 Strategy for Smart, Sustainable and Inclusive Growth29 ascertained that increased female labour force participation is a precondition for boosting growth and for tackling demographic challenges in Europe. The Strategy set a headline target of reaching an employment rate of 75 per cent for women and men aged 20-64 by 2020, which can only be reached if there is a clear commitment to gender equality and a reinforced effort to tackle all barriers to women's participation in the labour market. The current economic crisis has magnified Europe's ever-growing need to rely on knowledge, competence and innovation and to make full use of the pool of available talent. Enhancing female participation in economic decision-making, on company boards and at senior management level in particular, is expected to have a positive spill-over effect on female employment in the companies concerned and throughout the whole economy.
Amendment 76 #
2012/0299(COD)
Proposal for a directive
Recital 16
Recital 16
(16) The Union should therefore aim to increase the presence of women on company boards, in order both to boost economic growth and the competitiveness of European companies and to achieve effective gender equality on the labour market. This aim should be pursued through minimum requirements on positive action in the form of binding measures aiming at attaining a quantitative obja "comply or explain" model whereby companies would be required to set targets for the proportion of the underrepresented gender among their executive and non-executive for the gender composition of boards of listed companies, in the view of the fact that Member States and oboard directors and at all levels of management. Furthermore, companies should develop a policy for increasing their gender balance and should report in a transparent manner in their annual report on the gender balance of ther countries which have chosen this or a similar method have achievrporate board and at management levels. If individually- set targets are not reached, the best results in reducing the under-representation of women in economic decision-making positioncompany should be obliged in its annual report to explain the reasons for this failure and to detail the measures planned in order to rectify this.
Amendment 77 #
2012/0299(COD)
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) Listed companies should develop a gender policy in order to attain a more balanced gender representation throughout the company. This policy may include a description of the relevant measures implemented in that company: nominating both a female and male candidate for key positions, mentoring schemes and career development guidance for women, human resource strategies to encourage diverse recruitment. Furthermore, it may include offering flexible working conditions for all employees, for example assistance for parental leave as well as providing assistance for housework and child care. Each company may select the policies best suited to its activities and should take active measures to increase the proportion of the underrepresented gender in the management of the company.
Amendment 89 #
2012/0299(COD)
Proposal for a directive
Recital 20
Recital 20
(20) All board systems distinguish between executive directors, who are involved in the daily management of the company, and non-executive directors who are not involved in the daily management, but do perform a supervisory function. The quantitative objectivobligations relating to individual gender balance targets and gender policies provided for in this Directive should apply only, but not be limited, to the non- executive directors in order to strike the right balance between the need to increase the gender diversity of boards and the need to minimise interference with the day-to- day management of a company. As the non-executive directors perform supervisory tasks, it is also easier to recruit qualified candidates from outside the company and to a large extent also from outside the specific sector in which a company operates – a consideration which is of importance for areas ofGender balance among executive directors and in the overall management of the company is both a goal in itself and a means to enlarge the reconomy where members of a particular sex are especially under-represented in the workforceruitment base for board positions.
Amendment 93 #
2012/0299(COD)
Proposal for a directive
Recital 21
Recital 21
(21) In several Member States, a certain proportion of the non-executive directors can or must be appointed or elected by the company's workforce and/or organisations of workers pursuant to national law or practice. The quantitative objectives provided for in this Directive should apply to all non-executive directors including employee representatives. However, the practical procedures for ensuring that those objectives are attained, taking into account the fact that some non-executive Directors are employee representatives, should be defined by the Member States concerned. Union's nomination of employee representatives to boards should take due regard to gender balance. However, the practical procedures for employee representatives should be defined by the Member States concerned. It is important that employee organisations are involved in the development and implementation of gender policies in the company. Employee representation on the boards of listed companies is also a positive way of enhancing diversity by including key perspectives and genuine knowledge of the internal workings of the company.
Amendment 99 #
2012/0299(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Listed companies in the Union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards. Those listed companies in whose boards members of the under-represented sex hold less than 40 per cent of non- eximplement appropriate and effective measures that ensure that individually set targets regarding the gender composition of their boards are met. The long term objecutive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate, by applying pre-established, clear, neutrally formulated and unambiguous criteria, in order to attain the said percentage at the latest by 1 January 2020. Therefore, the Directive establishes the objective of at least 40 per cent of non-executive directorsof all listed companies should be to reach gender parity, defined as at least 40 per cent of the under-represented sex by that date. This objective in principle only concerns the overall gender diversity among the non-executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case. In particular, it does not exclude any particular candidates for director positions, nor does it impose any individual directors on companies or shareholders. The decision on the appropriate board members thus remains with the companies and shareholdersgender in executive and non-executive directors and at all levels of management.
Amendment 106 #
2012/0299(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Member States exercise a dominant influence over listed companies which are public undertakings within the meaning of Article 2(b) of Commission Directive 2006/111/EC of 16 November 2006 on the transparency of financial relations between Member States and public undertakings, as well as on financial transparency within certain undertakings.32 Due to that dominant influence, they have the instruments at their disposal to bring about the necessary change more rapidly. Therefore, in such companies the objective of least 40 per cent of non- executive directors of the under- represented sex should be set at an earlier date.
Amendment 108 #
2012/0299(COD)
Proposal for a directive
Recital 24
Recital 24
Amendment 113 #
2012/0299(COD)
Proposal for a directive
Recital 26
Recital 26
(26) In line with that case-law, Member States should ensure thatlisted companies should be encouraged to base the selection of the best qualified candidates for non- executive directors is based on a comparative analysis of the qualifications of each candidate on the basis of pre- established, clear, neutrally formulated and unambiguous criteria. Examples of types of selection criteria that companies could apply include professional experience in managerial and/or supervisory tasks, knowledge in specific relevant areas such as finance, controlling or human resources management, leadership and communication skills and networking abilities. Priority shouldmay be given to the candidate of the under-represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability, competence and professional performance, and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex.
Amendment 117 #
2012/0299(COD)
Proposal for a directive
Recital 27
Recital 27
(27) The methods of recruiting and appointing directors differ from one Member State to another and from one company to another. They may involve the pre-selection of candidates to be presented to the shareholders' assembly, for example by a nomination committee, the direct appointment of directors by individual shareholders or a vote in the shareholders' assembly on individual candidates or lists of candidates. The requirements concerning the selection of candidates should be met at the appropriate stage of the selection process in accordance with national law and the articles of association of the listed companies concerned. In this respect, this Directive only establishes a minimum harmonisation of selection procedures, making it possible to apply the conditions provided for by the case- law of the Court of Justice with a view to attainmeasures aimed at meeting the objective of a more balanced gender representation in the boards of listed companies.
Amendment 123 #
2012/0299(COD)
Proposal for a directive
Recital 28
Recital 28
(28) This Directive aims to improve the gender balance among directors of companies listed on stock exchanges and thus to contribute to the realisation of the principle of equal treatment between men and women, recognised as a fundamental right of the Union. Listed companies should therefore be required to disclose, upon the request of an unsuccessful candidate, not only the qualification criteria upon which the selection was based, but also the objective comparative assessment of those criteria and, where relevant, the considerations tilting the balance in favour of a candidate who is not of the under-represented sex . These limitations to the right to respect for private life with regard to the processing of personal data, recognised by the Articles 7 and 8 of the Charter, and the obligation for listed companies to supply that information, upon request, to the unsuccessful candidate, are necessary and, in conformity with the principle of proportionality, genuinely meet recognised objectives of general interest. They are therefore in line with the requirements for such limitations laid down in Article 52(1) of the Charter and with the relevant case-law of the Court of Justice.
Amendment 125 #
2012/0299(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Where an unsuccessful candidate of the under-represented sex establishes the presumption they were equally qualified as the appointed candidate of the other sex, the listed company should be required to demonstrate the correctness of the choiceat his/her failure to be appointed was based solely on his/her gender, the listed company should be required to demonstrate that the appointment was made in line with the applicable national anti-discrimination laws.
Amendment 133 #
2012/0299(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Member States should provide for effective, proportionate and dissuasive administrative sanctions for breaches of this Directive, which could include, inter alia, administrative fines and nul. Sanctions shall be applied in the case of listed companies that do not comply with the procedures for setting targets and developing a gender politcy or annulment declared by a judicial body of the appointment or of the election of non- executive dias laid down in Article 4 (1) or with the disclosure requirements as defined in Article 5 of this Directive. However, the case of companies' failurec tors made contrary to the national provisions adopted pursuant to Article 4(1) reach their individually set targets should not qualify as a breach of this Directive and should not trigger a sanctioning regime.
Amendment 140 #
2012/0299(COD)
Proposal for a directive
Recital 31
Recital 31
Amendment 148 #
2012/0299(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Since listed companies should aim to increase the proportion of the under- represented sex in all decision-making positions, Member States may provide that the objective laid down in this Directive should be considered to be met where listed companies can show that members of the under-represented sex hold at least one third40 per cent of all director positions, irrespective of whether they are executive or non- executive.
Amendment 151 #
2012/0299(COD)
Proposal for a directive
Recital 33
Recital 33
(33) In addition to the measures relating to non-executive directors, and with a view also to improving the gender balance among directors involved in daily management tasks, lListed companies should be required to make individual commitments regarding the representation of both sexes among executive directors, to be achievedand non-executive directors as well at othe latest by 1 January 2020r management levels within the company. These commitments should aim to achieve tangible progress from the individual company's current position towards better gender balance.
Amendment 155 #
2012/0299(COD)
Proposal for a directive
Recital 34
Recital 34
(34) Member States should require listed companies to provide information on the gender composition of their boards as well as information on howon they managedeasures taken to meet the objectives laid down in this Directive, on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors. Such information should be published in the annual report and on the company's website and, where the company in question has not met the objectiveindividually set targets, it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objectiveose targets.
Amendment 160 #
2012/0299(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Member States may have already taken measures providing for means to ensure a more balanced representation of women and men in company boards before the entry into force of this Directive. Such Member States should have an opportunity to apply those measures in place of the procedural requirements relating to appointments where they can demonstrate that the measures taken are of equivalent efficacy in order to attain the long-term objective of a presenceoportion of the under-represented sex of at least 40 per cent among non-executive and executive directors of listed companies at the latest by 1 January 2020 or at the latest by 1 January 2018 in case of listed companies which are public undertakings.
Amendment 164 #
2012/0299(COD)
Proposal for a directive
Recital 38 a (new)
Recital 38 a (new)
(38a) In order to ensure that the gender balance objectives set out in this Directive are fully implemented by the Member States and are integrated into the specific policies of the relevant companies and in order to verify the expected spill-over effects of this Directive, the Commission shall submit to the European Parliament and the Council a report.
Amendment 195 #
2012/0299(COD)
Proposal for a directive
Article 4 – title
Article 4 – title
Amendment 202 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that listed companies in whose boards members: a) set a target figure for the proportion of the under-represented sex hold less than 40 per cent of the non-executive director positions make the appointments togender among both executive and non-executive directors, and b) set a target figure for those posiroportions onf the basis of a comparative analysis of the qualifications of each candidate, by applying pre-established, clear, neutrally formulated and unambiguous criteria, in order to attain the said percentage at the latest by 1 January 2020 or at the latest by 1 January 2018 in case of listed companies which are public undertakingsunderrepresented gender at other management levels within the company, and c) develop a gender policy to increase the proportion of the underrepresented gender at the management levels of the company.
Amendment 208 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 216 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 3
Article 4 – paragraph 3
3. In order to attain the objective laid down in paragraph 1, Member States shall ensure that, in the selection of non- executive directorsfor listed companies to improve their gender balance, priority shallmay be given to the candidate of the under- represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability, competence and professional performance, unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex.
Amendment 221 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Member States shall ensure that listed companies are obliged to disclose, on the request of an unsuccessful candidate, the qualification criteria upon which the selection was based, the objective comparative assessment of those criteria and, where relevant, the considerations tilting the balance in favour of a candidate of the other sex.
Amendment 229 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 6
Article 4 – paragraph 6
Amendment 239 #
2012/0299(COD)
Proposal for a directive
Article 4 – paragraph 7
Article 4 – paragraph 7
7. Member States may providensure that the objective laid down in paragraph 1 is met where listed companies can show that memberscompanies having reached gender parity, defined as a 40 per cent representation of the under-represented sex hold at least one third of all director positions, irrespective of whegender among executive and non-executive directors, shall not be obliged to draw up a gender balance policy in accordance with Article 4(1) but shall simply state their thkey tare executive or non-executivget figures in their annual report and on their website.
Amendment 242 #
2012/0299(COD)
Proposal for a directive
Article 5 – title
Article 5 – title
Amendment 245 #
2012/0299(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure thatrequire listed companies undertakto provide information on the following in their annual report: a) the percentage of the underrepresented gender among executive iandividual commitments regarding gender-balanced representation of both sexes among executive directors to be achieved at the latest by 1 January 2020, or, in ca non- executive directors, b) the percentage of the underrepresented gender at all levels of management, c) the underrepresented gender as a percentage of the total number of employees, d) whether the target figures set the previous year, in accordance with Article 4(1), have been achieved, e) the gender policy drawn up as referred to in Article 4(1), f) the specific measures, adopted in line with the gender policy drawn up in accordance with Article 4(1), aimed at achieving the targets set out for executive and non-executive directors and other management levels within the company, g) the specific measures intended to be adopted for the following year in line with the gender policy drawn up in accordance with Article 4(1) and aimed at achieving the targets set of listed companies which are public undertakings, by 1 January 2018. ut for executive and non- executive directors and other management levels within the company, h) the status of the company's gender balance and the outlook for the attainment of the long-term goal of gender parity among executive and non- executive directors.
Amendment 248 #
2012/0299(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall require listed companies to provide information to the competent national authorities, once a year as from [two years after adoption], about the gender representation on their boards, distinguishing between non- executive and executive directors and about the measures taken in view of the objectives laid down in Article 4(1) and in paragraph 1 of this Articlereport on their gender balance statistics and on measures taken in accordance with Article 5 (1) to the competent national authorities, once a year as from [two years after adoption], and to publish that information in an appropriate and accessible manner on their website.
Amendment 255 #
2012/0299(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where a listed company does not meet the objectives laid down in Article 4(1) or its own individual commitments taken pursuant to paragraph 1 of thisreach its own individual target figures as set in accordance with Article 4(1), the information referred to in paragraph 2 of this Article shall include the reasons for not reaching the objectives or commitmenttarget figures and a description of the measures which the company has adopted or intends to adopt in order to meet the objectives or commitmenttarget figures.
Amendment 274 #
2012/0299(COD)
Proposal for a directive
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. Sanctions shall be imposed on companies for infringing the procedure of setting target figures, of drawing up a gender policy and of disclosing the relevant information in accordance with Articles 4(1) and 5(1) of this Directive. The sanctions must be effective, proportionate and dissuasive and may include the following measures:
Amendment 285 #
2012/0299(COD)
Proposal for a directive
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
Amendment 298 #
2012/0299(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 1
Article 8 – paragraph 3 – subparagraph 1
Amendment 302 #
2012/0299(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall communicate to the Commission by 1 January 2017 at the latest and every two years thereafter a report on the implementation of this Directive. These reports shall include, amongst others, comprehensive information about the measures taken with a view to attaining the objectives laid down in Article 4(1), information provided in accordance with information about individual commitments taken by listed companies pursuant to Article 5(24(1) and the information about individual commitments taken by listed companies pursuant todisclosed by the listed companies in accordance with Article 5(1) and (2).
Amendment 303 #
2012/0299(COD)
Proposal for a directive
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1a. The Commission shall submit an evaluation report by 1 July 2017 on the implementation of the requirements for listed companies referred to in Articles 4 (1), 5(1) and (2),on the basis of the reports submitted by the Member States pursuant to paragraph 1. In addition, the Commission report shall include the gender-balance situation at board-level and at management level of non-listed companies that are above the SME threshold as defined in Article 2.
Amendment 307 #
2012/0299(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1
Article 9 – paragraph 2 – subparagraph 1
Member States having suspended pursuant to Article 8(3) the application of the procedural requirements relating to appointments contained in Article 4(1), (3), and (4) and (5Article 5(1) shall include information in the reports mentioned in paragraph 1 demonstrating the concrete results obtained by the national measures referred to in Article 8(3). The Commission shall then issue a specific report ascertaining whether those measures effectively enable members of the under-represented sex to hold at least 40 per cent of the non-executive director positions by 1 January 2018 for listed companies which are public undertakings, and by 1 January 2020 for listed companies which are not public undertakingsof listed companies by 1 January 2020. The first such report shall be issued by the Commission by 1 July 2017, and subsequent reports shall be issued within six months after notification of the respective national reports under paragraph 1.
Amendment 310 #
2012/0299(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Member States in question shall ensure that listed companies, which by applying the national measures referred to in Article 8(3) have not appointed or elected members of the under-represented sex for at least 40 per cent of the non-executive director positions of their boards by 1 January 2018, where they are public undertakings, or by 1 January 2020, where they are not public undertakings,20 apply the procedural requirements relating to appointments contained in Article 4(1), (3), (4) and (5Article 5(1) with effect respectively from thoseat dates.
Amendment 83 #
2012/0267(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In the case of urgent or unmet medical needs for patients, such as emerging pathogens and rare diseases, single health institutions should have the possibility to manufacture, modify and use devices in-house and therefore address, within a non-commercial and flexible framework, specific needs which can not be met by an available CE- marked device.
Amendment 89 #
2012/0267(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) Eudamed’s electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical performance studies should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public
Amendment 102 #
2012/0267(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level, using harmonised formats, and guaranteeing anonymity, where appropriate. The national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 112 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
– diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Amendment 138 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution’s single quality management system, and the health institution is compliant withaccredited to standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 141 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply withbe exempt from the requirements of this Regulation. However, the provis, with the exception of Article 59(4), where the following conditions aregarding met; (a) the recipient patient or patient group’s specific needs can not be met by an available CE -marking set out in Article 16 and the obligationsed device; (b) the health institution is accredited to EN ISO standard 15189 quality management system, or any other equivalent recognised standard; (c) the health institution provides their competent authority referred to in Articles 21 to 25 shall not apply to those devices6 with a list of such devices, which shall include a justification of their manufacturing or modification, in particular, where similar devices have been made available on the market. This information shall be updated yearly, and shall be made public.
Amendment 142 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. Member States shall retain the right to restrict the in-house manufacture and use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation, and may also make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 187 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 2 – point e – point i
Article 22 – paragraph 2 – point e – point i
(i) to operate its system for the assignment of UDIs for the period to be determined in the designation which shall at least be threfive years after its designation;
Amendment 194 #
2012/0267(COD)
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
The Commission shall develop and manage the European databank on medical devices (Eudamed) in accordance with the conditions and modalities established by Article 27 of Regulation (EU) [Ref. of future Regulation on medical devices]. The Commission shall consult patients groups and healthcare professionals when developing the European Databank
Amendment 224 #
2012/0267(COD)
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – paragraph 2 – subparagraph 1
Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A sSuspension shall not exceed a period of one year, renewable once for the same periodapply until a decision to annul the suspension has been reached by the MDCG, which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 30(3) and (4). Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification.
Amendment 228 #
2012/0267(COD)
Proposal for a regulation
Article 35 – paragraph 3 – subparagraph 1
Article 35 – paragraph 3 – subparagraph 1
3. Where the Commission ascertain, in consultation with the Medical Devices Coordination Group, decides that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification, if necessary, in line with Article 34(2).
Amendment 229 #
2012/0267(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
The Commission, in consultation with the Medical Devices Coordination Group, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices].
Amendment 231 #
2012/0267(COD)
Proposal for a regulation
Article 37 – paragraph 2 a (new)
Article 37 – paragraph 2 a (new)
The group shall meet, at the least, every 6 months
Amendment 232 #
2012/0267(COD)
Proposal for a regulation
Article 37 – paragraph 2 b (new)
Article 37 – paragraph 2 b (new)
The Commission or the MDCG may request the participation of any notified body.
Amendment 233 #
2012/0267(COD)
Proposal for a regulation
Article 37 – paragraph 2 c (new)
Article 37 – paragraph 2 c (new)
The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Amendment 294 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point c a (new)
Article 51 – paragraph 1 – point c a (new)
(c a) the clinical performance study reports submitted by sponsors in Article 56(5);
Amendment 302 #
2012/0267(COD)
Proposal for a regulation
Article 55 – paragraph 3
Article 55 – paragraph 3
3. Within one year from the end of the clinical performance study, the sponsor shall submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in Section 2.3.3 of Part A of Annex XII. Where, for scientific reasons, it is not possible to submit the clinical performance study report within one year, it shall be submitted as soon as it is available. In this case, the clinical performance study protocol referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of the clinical performance study are going to be submitted, together with an explanation.
Amendment 310 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1 a (new)
Article 59 – paragraph 3 – subparagraph 1 a (new)
The reporting of suspected serious incidents shall take into account whether parts or components have been replaced, as specified in Article 19.
Amendment 312 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point f a (new)
Article 60 – paragraph 1 – point f a (new)
(f a) the reports by competent authorities on serious incidents and field safety corrective actions taken within Health Institutions involving devices referred to in Article 4(4)
Amendment 313 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 25.
Amendment 317 #
2012/0267(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 25.
Amendment 321 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point a a (new)
Article 77 – paragraph 1 – point a a (new)
(aa) to oversee the coordination group of Notified Bodies as specified in Article 39;
Amendment 324 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point b a (new)
Article 77 – paragraph 1 – point b a (new)
(ba) to act as an arbitration forum for disputes concerning Chapter IV on the competences of Notified Bodies.
Amendment 326 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point d a (new)
Article 77 – paragraph 1 – point d a (new)
(da) to assist the Commission in providing an overview of vigilance data and market surveillance activities, including any preventive health protection measures taken, on a 6-monthly basis. This information shall be accessible through the European databank in Article 75;
Amendment 356 #
2012/0267(COD)
Proposal for a regulation
Annex 2 – point 6 – paragraph 2 – point 6.1 – point 6.2 – paragraph 2
Annex 2 – point 6 – paragraph 2 – point 6.1 – point 6.2 – paragraph 2
The clinical evidence report referred to in Section 3 of Annex XII shall be included and/or fully referenced in the technical documentation.
Amendment 182 #
2012/0266(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical investigations should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public
Amendment 204 #
2012/0266(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats and guaranteeing anonymity, where appropriate. The national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 277 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State or on its own initiative, and following consultation with the MDCG, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 387 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.comply with guidelines to be set out by the Commission by means of implementing acts, to ensure the safety of the reprocessing
Amendment 442 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 2 – point e – point i
Article 24 – paragraph 2 – point e – point i
(i) to operate its system for the assignment of UDIs for the period to be determined in the designation which shall at least be threfive years after its designation;
Amendment 470 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point c
Article 27 – paragraph 1 – point c
(c) to enable the public to be adequately informed about clinical investigations, for healthcare professionals to have adequate access to the results of clinical investigations, and to enable sponsors of clinical investigations to be conducted in more than one Member State to comply with information obligations under Articles 50 to 60;
Amendment 471 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point c a (new)
Article 27 – paragraph 1 – point c a (new)
(ca) to enable the public and healthcare professionals to have an overview of vigilance data and market surveillance activities
Amendment 479 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 4 a (new)
Article 27 – paragraph 4 a (new)
4a. The information contained in the European Databank shall be robust, transparent and user-friendly, enabling the public and healthcare professionals to compare information on registered devices, economic operators, clinical investigations, vigilance data and market- surveillance activities
Amendment 480 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 4 b (new)
Article 27 – paragraph 4 b (new)
4b. The Commission shall consult patients groups and healthcare professionals when developing the European Databank.
Amendment 520 #
2012/0266(COD)
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 1
Article 36 – paragraph 2 – subparagraph 1
Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A sSuspension shall not exceed a period of one year, renewable once for the same periodapply until a decision to annul the suspension has been reached by the MDCG, which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 30(3) and (4). Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification.
Amendment 526 #
2012/0266(COD)
Proposal for a regulation
Article 37 – paragraph 3 – subparagraph 1
Article 37 – paragraph 3 – subparagraph 1
Where the Commission ascertain, in consultation with the Medical Devices Coordination Group, decides that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification, if necessary. n line with Article 36(2).
Amendment 528 #
2012/0266(COD)
Proposal for a regulation
Article 39 – paragraph 1
Article 39 – paragraph 1
The Commission, in consultation with the Medical Devices Coordination Group, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices.
Amendment 529 #
2012/0266(COD)
Proposal for a regulation
Article 39 – paragraph 2 a (new)
Article 39 – paragraph 2 a (new)
The group shall meet every 6 months
Amendment 530 #
2012/0266(COD)
Proposal for a regulation
Article 39 – paragraph 2 b (new)
Article 39 – paragraph 2 b (new)
Amendment 531 #
2012/0266(COD)
Proposal for a regulation
Article 39 – paragraph 2 c (new)
Article 39 – paragraph 2 c (new)
The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Amendment 624 #
2012/0266(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point c a (new)
Article 53 – paragraph 1 – point c a (new)
(c a) the clinical investigation reports submitted by sponsors in Article 58(5)
Amendment 628 #
2012/0266(COD)
Proposal for a regulation
Article 57 – paragraph 3
Article 57 – paragraph 3
3. Within one year from the end of the clinical investigation, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV. Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation.
Amendment 645 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 27
Amendment 680 #
2012/0266(COD)
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 27
Amendment 705 #
2012/0266(COD)
Proposal for a regulation
Article 78 – paragraph 5 a (new)
Article 78 – paragraph 5 a (new)
5 a. The MDCG shall oversee the coordination group of Notified Bodies as specified in Article 39
Amendment 709 #
2012/0266(COD)
Proposal for a regulation
Article 78 – paragraph 7 a (new)
Article 78 – paragraph 7 a (new)
7 a. The MDCG shall support the Commission in providing an overview of vigilance data and market surveillance activities, including any preventive health protection measures taken, on a 6- monthly basis. This information shall be accessible through the European databank in Article 27.
Amendment 710 #
2012/0266(COD)
Proposal for a regulation
Article 78 – paragraph 7 b (new)
Article 78 – paragraph 7 b (new)
7 b. The MDCG shall acts as an arbitration forum for disputes concerning Chapter IV on the competences of Notified Bodies.
Amendment 102 #
2012/0192(COD)
Proposal for a regulation
Recital 9 b
Recital 9 b
(9b) The concept of 'Normal Clinical Practice' is of vital importance in determining whether an application is authorised as a 'low intervention clinical trial'. The definition of 'Normal Clinical Practice' should be clarified by the Commission in guidelines.
Amendment 110 #
2012/0192(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (‘'relevance’)'), and the risk and inconveniences for the subject. Regarding the relevance, numerous aspects should be taken into account, including; in later trial phases this should include whether the trial subjects are representative of the population for whom the medicinal product is targeted, and whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products.
Amendment 175 #
2012/0192(COD)
Proposal for a regulation
Recital 62 a (new)
Recital 62 a (new)
(62a) According to the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era-Putting Competitiveness and Sustainability at Centre Stage", systematic evaluation of legislation should become an integral part of smart regulation. To ensure that this Regulation keeps pace with scientific, technological and medical progress with regard to the organization and conduct of clinical trials and that it interfaces with other legal provisions, the Commission should periodically report on the experience with and functioning of the Regulation, and present its conclusions to the Parliament and Council.
Amendment 220 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
Amendment 291 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 2
Article 6 – paragraph 1 – point a – point i – indent 2
– the relevance of the clinical trial, ensuring that the trial participants are representative of the target population for the medicinal product, taking account of the current state of scientific knowledge, and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products;
Amendment 316 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
Amendment 361 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Where, regarding Part I of the assessment report, the clinical trial is acceptable or acceptable subject to conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report. The Member State concerned shall submit both Part I and Part II of the assessment report, including their conclusions, to the sponsor.
Amendment 399 #
2012/0192(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point c
Article 14 – paragraph 3 – point c
Amendment 538 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a (new)
Article 34 – paragraph 3 – subparagraph 2 a (new)
In the event of non-compliance by the sponsor with the obligation referred to in paragraph 3, financial penalties shall be imposed by the Member State concerned. The Commission shall produce guidelines for Member States on the consistent application of such financial penalties.
Amendment 603 #
2012/0192(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least fivetwenty years after the end ofconcluding the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation. If the sponsor is unable to archive the master file, it may be archived with the Agency.
Amendment 56 #
2012/0146(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 79 #
2012/0146(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point c
Article 6 – paragraph 1 – point c
(c) the notifying Member State ensures that the person identification data are attributed unambiguouslyto a sufficiently high level for the identity assurance level in question to the natural or legal person referred to in Article 3 point 1;
Amendment 81 #
2012/0146(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point c a (new)
Article 6 – paragraph 1 – point c a (new)
(ca) the party issuing the electronic identification means ensures that the person identification data referred to in point (c) are attributed to a sufficiently high level for the identity assurance level in question in relation to the electronic identification means at the time of the issuance of the electronic identification means;
Amendment 85 #
2012/0146(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point e
Article 6 – paragraph 1 – point e
Amendment 87 #
2012/0146(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Point (ec) and (d) of paragraph 1 is without prejudice to the liability of parties to a transaction in which electronic identification means falling under the notified scheme are used.
Amendment 143 #
2012/0146(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Trust service providers shall, without undue delay and where feasible not later than 24 hours after havingas soon as it becomes aware of it, notify the competent supervisory body, the competent national body for information security and other relevant third parties such as data protection authorities of any breach of security or loss of integrity that has a significant impact on the trust service provided and on the personal data maintained therein.
Amendment 174 #
2012/0146(COD)
Proposal for a regulation
Article 20 – paragraph 6
Article 20 – paragraph 6
Amendment 175 #
2012/0146(COD)
Proposal for a regulation
Article 28 – paragraph 6
Article 28 – paragraph 6
Amendment 46 #
2012/0060(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Goods or services originating in least- developed countries listed in Annex I to Regulation (EC) No 732/2008the following classifications of third countries shall be treated as covered goods and services.:
Amendment 47 #
2012/0060(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point a (new)
Article 4 – paragraph 2 – point a (new)
(a) least-developed countries listed in Annex I to Regulation (EC) No 732/2008;
Amendment 48 #
2012/0060(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point b (new)
Article 4 – paragraph 2 – point b (new)
(b) countries that have been classified by the World Bank as a low-income country during three consecutive years.
Amendment 49 #
2012/0060(COD)
Proposal for a regulation
Article 5
Article 5
Amendment 50 #
2012/0060(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5a Rules of access for non-covered goods and services 1. Member States or their contracting authorities/entities shall not restrict the access of non-covered goods or services to their tendering procedures by any measure other than those provided for in this Regulation. 2. Non-covered goods and services may be subject to restrictive measures taken by the Commission according to the rules set out in Articles 10 and 11.
Amendment 51 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
Amendment 52 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
Where contracting authorities/entities intend to request the exclusionare obliged to exclude tenders in accordance with paragraph 1 from procedures for the award of contracts on the basis of paragraph 1 they shall indicate this in the contract notice they publish pursuant to Article 35 of Directive 2004/18/EC or pursuant to Article 42 of Directive 2004/17/EC or Article 26 of the Directive on the award of concession contracts.
Amendment 53 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 3
Article 6 – paragraph 2 – subparagraph 3
Where contracting authorities/entities receive tenders that meet the conditions of paragraph 1 for which they intend to request the exclusionde for that reason, they shall notify the Commission. During the notification procedure the contracting authority/entity may continue its analysis of the tenders.
Amendment 54 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 6
Article 6 – paragraph 2 – subparagraph 6
That information shall be provided within eight working days, commencing on the first working day following the date on which it receives the request for additional information. If the Commission receives no information within this period the period established in paragraph 3 shall be suspended, until the Commission receives the requested information.
Amendment 55 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 56 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
Amendment 57 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
Amendment 58 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 3
Article 6 – paragraph 4 – subparagraph 3
Amendment 59 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
Amendment 60 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
Amendment 61 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 62 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Amendment 63 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. TWhen pursuing an investigation referred to in paragraph 1 is conducted on the basis of the criteria laid down in Article 6.under paragraph 1, the Commission shall examine the following:
Amendment 64 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point a (new)
Article 8 – paragraph 2 – point a (new)
(a) if a third country has concluded an agreement listed in Annex I, whether the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the Union and the third country concerned where there are explicit market access reservations taken by the Union;
Amendment 65 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point b (new)
Article 8 – paragraph 2 – point b (new)
(b) if an agreement referred to in Annex I does not exist, whether the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the Union and the third country concerned.
Amendment 66 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 (new)
Article 8 – paragraph 2 – subparagraph 1 (new)
A lack of substantial reciprocity is presumed where restrictive procurement measures result in serious and recurring discriminations of Union economic operators, goods and services.
Amendment 67 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. TWhen assessment by the Commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and Member States and/or facts collected by the Commission during its investigation, and shall be concluded within a period of nine months after the initiation of the investigation. In duly justified cases this period may be extended by three months.ing whether a lack of substantial reciprocity exists, the Commission shall examine the following:
Amendment 68 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a (new)
Article 8 – paragraph 3 – point a (new)
(a) to what degree public procurement laws of the country concerned ensure transparency in line with international standards in the field of public procurement and preclude any discrimination against Union goods, services and economic operators;
Amendment 69 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b (new)
Article 8 – paragraph 3 – point b (new)
(b) to what degree public authorities and/or individual procuring entities maintain or adopt discriminatory practices against Union goods, services and economic operators.
Amendment 70 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
Amendment 71 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
The assessment by the Commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and Member States and/or facts collected by the Commission during its investigation, and shall be concluded within a period of six months after the initiation of the investigation. In duly justified cases this period may be extended by two months.
Amendment 72 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 4 b (new)
Article 8 – paragraph 4 b (new)
When the Commission concludes as a result of the external procurement investigation that the alleged restrictive procurement measures are not maintained by the third country concerned, the Commission shall adopt a decision terminating the investigation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17 (2).
Amendment 73 #
2012/0060(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Where it is found in an investigation pursuant to Article 8, and after following the procedure foreseen in Article 9, that restrictive procurement measures adopted or maintained by that third country leads to an lack of substantial reciprocity in market opening between the Union and the third country as referred to in Article 68, the Commission may adopt implementing acts to temporarily limit the access of non- covered goods and services originating in a third country for up to five years. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2).
Amendment 74 #
2012/0060(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point a
Article 10 – paragraph 2 – point a
(a) in accordance with Article 6, the exclusion of tenders of which more than 750 % of the total value is made up of non- covered goods or services originating in the country adopting or maintaining a restrictive procurement practice; and/or
Amendment 75 #
2012/0060(COD)
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
The Commission shall not approve an intended exclusion where it would violate market access commitments entered into by the Union in its international agreements.
Amendment 76 #
2012/0060(COD)
Proposal for a regulation
Article 11 – title
Article 11 – title
Amendment 77 #
2012/0060(COD)
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
Pursuant to its decision in Article 10(1), the Commission shall regularly monitor the situation in the third country concerned and report annually to the European Parliament and the Council on whether remedial/corrective measures have been taken.
Amendment 78 #
2012/0060(COD)
Proposal for a regulation
Article 11 – paragraph 1 b (new)
Article 11 – paragraph 1 b (new)
Where the Commission considers that the reasons justifying the measures adopted pursuant to Article 9(4) and 10 still apply upon the end of the temporary period under Article 10(1), the Commission may adopt an implementing act to renew the measures for a further period of up to five years and renewed every five years thereafter.
Amendment 76 #
2012/0011(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The main establishment of a controller and/or a processor in the Union should be determinsignated according to objective criteria and should imply the effective and real exercise of managementdata activities determining the main decisions as to the purposes, conditions and means of processing through stable arrangements. This criterion shall apply both to data controllers and data processors and should not depend on whether the processing of personal data is actually carried out at that location; t. The presence and use of technical means and technologies for processing personal data or processing activities do not, in themselves, constitute such main establishment and are therefore no determining criteria for a main establishment. The main establishment of the processor should be the place of its central administration in the Union.
Amendment 85 #
2012/0011(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) Any person should have the right to have personal data concerning them rectified and a ‘right to be forgotten’ where the retention of such data is not in compliance with this Regulation. In particular, data subjects should have the right that their personal data are erased and no longer processed, where the data are no longer necessary in relation to the purposes for which the data are collected or otherwise processed, where data subjects have withdrawn their consent for processing or where they object to the processing of personal data concerning them or where the processing of their personal data otherwise does not comply with this Regulation. This right is particularly relevant, when the data subject has given their consent as a child, when not being fully aware of the risks involved by the processing, and later wants to remove such personal data especially on the Internet. However, the further retention of the data should be allowed where it is necessary for historical, statistical, aggregated and scientific research purposes, for reasons of public interest in the area of public health, for the purpose of processing health data for healthcare purposes, for exercising the right of freedom of expression, when required by law or where there is a reason to restrict the processing of the data instead of erasing them.
Amendment 89 #
2012/0011(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) Every ndatural persona subject should have the right not to be subject to a measure which is based on profiling by means of automated processing and which produces adverse legal effects concerning the fundamental rights and freedoms of this natural person or affects the data subject in a significantly negative manner. However, such measure should be allowed when expressly authorised by law, carried out in the course of entering or performance of a contract, or when the data subject has given his consent. In any case, such processing should be subject to suitable safeguards, including specific information of the data subject and the right to obtain human intervention and that such measure should not concern a child.
Amendment 96 #
2012/0011(COD)
Proposal for a regulation
Recital 121 a (new)
Recital 121 a (new)
(121a) This Regulation allows the principle of public access to official documents to be taken into account when applying the provisions set out in this Regulation. Personal data in documents held by a public authority or a public body may be disclosed by this authority or body in accordance with Member State legislation to which the public authority or public body is subject. Such legislation shall reconcile the right to the protection of personal data with the principle of public access to official documents.
Amendment 117 #
2012/0011(COD)
Proposal for a regulation
Article 4 – point 10
Article 4 – point 10
(10) ‘genetic data’ means all data, of whatever type, concerning the characteristics of an individual which are inherited or acquired during early prenatal developmentinformation on the hereditary characteristics, or alteration thereof, of an identified or identifiable person, obtained through nucleid acid analysis;
Amendment 121 #
2012/0011(COD)
Proposal for a regulation
Article 4 – point 13
Article 4 – point 13
(13) ‘main establishment’ means as regards the controller, the place of its establishmentthe place of establishment of the controller, the processor or group of companies in the Union where the main decisions as to the purposes, conditions and means of the processing of personal data are taken; if no decisions as to the purposes, conditions and means of the processing of personal data are taken in the Union,. The controller, processor or group of companies shall designate the main establishment isfor the place where the main processing activities in the context of the activities of an establishment of a controller in the Union take place. As regards the processor, ‘main establishment’ means the place of its central administration in the Union;urpose of data protection compliance and shall notify this to the relevant national supervisory authority. The national supervisory authority can in cases of disagreement on the designation of the main establishment request the opinion and guidance of the European Data Protection Board.
Amendment 131 #
2012/0011(COD)
Proposal for a regulation
Article 5 – point e
Article 5 – point e
(e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the data will be processed solely for historical, statistical, aggregated or scientific research purposes in accordance with the rules and conditions of Articles 81 and 83 and if a periodic review is carried out to assess the necessity to continue the storage;
Amendment 153 #
2012/0011(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Consent shall not provide a legal basis for the processing, where there is a significant, imbalance between the position of the data subject and the controller, which results in a lack of freedom in the provision of consent.
Amendment 156 #
2012/0011(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of this Regulation, in relation to the offering of information society services directly to a child, the processing of personal data of a child below the age of 13 years shall only be lawful if and to the extentwould normally require that consent is given or authorised by the child's parent or custodian. The appropriate form for obtaining consent should be based on any risk posed to the child by the amount of data, its type and the nature of the processing. The controller shall make reasonable efforts to obtain verifiable consent, taking into consideration available technology.
Amendment 159 #
2012/0011(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. Paragraphs 1, 2 and 3 shall not apply where the processing of personal data of a child concerns health data and where the Member State law in the field of health and social care prioritises the maturity and competence of an individual over physical age.
Amendment 170 #
2012/0011(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The controller shall inform the data subject without delay and, at the latest within one month40 calendar days of receipt of the request, whether or not any action has been taken pursuant to Article 13 and Articles 15 to 19 and shall provide the requested information. This period may be prolonged for a further monthurther, if several data subjects exercise their rights resulting in a large and exceptional number of requests and their cooperation is necessary to a reasonable extent to prevent an unnecessary and disproportionate effort on the part of the controller. The information shall be given in writingHowever, the controller must comply with the requests as soon as practicable and, if requested, should justify this extension to the supervisory authority. The information shall be given in writing or, where feasible, the data controller may provide access to a secure online platform which would provide the data subject with direct access their personal data. Where the data subject makes the request in electronic form, the information shall be provided in electronic form, unless otherwise requested by the data subject or not available in that format.
Amendment 205 #
2012/0011(COD)
Proposal for a regulation
Article 17 – paragraph 3 – point a
Article 17 – paragraph 3 – point a
(a) for exercising the right of freedom of expression in accordance with Article 80; or when providing an information society service to facilitate the accessing of such expression.
Amendment 206 #
2012/0011(COD)
Proposal for a regulation
Article 17 – paragraph 3 – point b
Article 17 – paragraph 3 – point b
(b) for healthcare purposes or for reasons of public interest in the area of public health in accordance with Article 81;
Amendment 220 #
2012/0011(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Every ndatural persona subject shall have the right not to be subject to a measuredecision which produces legal effects concerning this ndatural person or significanta subject or negatively affects this ndatural persona subject, and which is based solely on automated processing intended to evaluate certain personal aspects relating to this ndatural persona subject or to analyse or predict in particular the natural person's performance at work, economic situation, location, health, personal preferences, reliability or behaviour.
Amendment 241 #
2012/0011(COD)
Proposal for a regulation
Article 22 – paragraph 2 – introductory wording
Article 22 – paragraph 2 – introductory wording
2. The measures provided for in paragraph 1 shallcould in particular include:
Amendment 268 #
2012/0011(COD)
Proposal for a regulation
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. The obligation provided for in paragraph 1 shall not apply to SMEs who process data only as an activity ancillary to the sale of goods and services.
Amendment 308 #
2012/0011(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
Amendment 313 #
2012/0011(COD)
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
1a. SME controllers and processors shall designate a data protection officer only where the SMEs' core activities consist of data processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects.
Amendment 386 #
2012/0011(COD)
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. Without prejudice to any other administrative or judicial remedy, every data subject shall have the right to lodge a complaint with athe supervisory authority in any Member Statethe Member State of his habitual residence or in the Member State where the data controller has its main establishment; if they consider that the processing of personal data relating to them does not comply with this Regulation.
Amendment 434 #
2012/0011(COD)
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
1. Member States shall provide for exemptions or derogations from the provisions on the general principles in Chapter II, the rights of the data subject in Chapter III, on controller and processor in Chapter IV, on the transfer of personal data to third countries and international organisations in Chapter V, the independent supervisory authorities in Chapter VI and on co-operation and consistency in Chapter VII for the processing of personal data carried out solely for journalistic purposes or the purpose of artistic or literary expression in order to reconcile the right to the protection of personal data with the rules governing freedom of expression.
Amendment 438 #
2012/0011(COD)
Proposal for a regulation
Article 80 a (new)
Article 80 a (new)
Article 80a Processing of personal data and the principle of public access to official documents Personal data in documents held by a public authority or a public body may be disclosed by this authority or body in accordance with Member State legislation regarding public access to official documents, which reconciles the right to the protection of personal data with the principle of public access to official documents.
Amendment 444 #
2012/0011(COD)
Proposal for a regulation
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) these purposes cannot be otherwise fulfilled by processing data which does not permit or not any longer permit the identification of the data subject data subject has given consent, subject to the conditions laid down in Article 7;
Amendment 445 #
2012/0011(COD)
Proposal for a regulation
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) data enabling the dattribution of information to an identified or identifiable data subject is kept separately from the other information as long as these purposes can be fulfilled in this mannera has been rendered sufficiently anonymous.
Amendment 447 #
2012/0011(COD)
Proposal for a regulation
Article 83 – paragraph 2 – introductory wording
Article 83 – paragraph 2 – introductory wording
2. Bodies conducting historical, statistical, aggregated or scientific research may publish or otherwise publicly disclose personal data only if:
Amendment 448 #
2012/0011(COD)
Proposal for a regulation
Article 83 – paragraph 2 a (new)
Article 83 – paragraph 2 a (new)
2a. Within the limits of this Regulation, where the purposes of historical, statistical, aggregated or scientific research cannot be fulfilled by the disclosure of data which is rendered sufficiently anonymous and consent for disclosure has not been obtained from data subjects then approval for disclosure must be granted by an independent and competent body which has had its authority conferred by legal provision.
Amendment 130 #
2012/0010(COD)
Proposal for a directive
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
Amendment 131 #
2012/0010(COD)
Proposal for a directive
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Directive applies to the processing of personal data wholly or partly by automated means, and to the processing other than by automated means of personal data which form part of a filing system or are intended to form part of a filing system. This Directive applies equally to personal data stored electronically and in paper form.
Amendment 168 #
2012/0010(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a (new)
Article 12 – paragraph 1 – point a (new)
(a) all personal data undergoing processing and any available information as to their source
Amendment 169 #
2012/0010(COD)
Proposal for a directive
Article 12 – paragraph 1 – point g
Article 12 – paragraph 1 – point g
Amendment 174 #
2012/0010(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. When the right referred to in paragraph 1 is exercised, the supervisory authority shall inform the data subject at least that all necessary verifications by the supervisory authority have taken place, and of the result as regards the lawfulness of the processing in question. Member States shall lay down whether the data subject may assert this right directly against the controller or through the intermediary of the competent national supervisory authority.
Amendment 187 #
2012/0010(COD)
Proposal for a directive
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Member States shall provide that in the case of a personal data breach, the controller notifies, without undue delay and, where feasible, not later than 24 hours after having become aware of it, the personal data breach to the supervisory authority. The controller shall provide, on request, to the supervisory authority a reasoned justification in cases where the notification is not made within 24 hoursFor the most serious breaches, Member States shall provide that the controller notifies the breach to the supervisory authority not later than 24 hours after having become aware of it.
Amendment 205 #
2012/0010(COD)
Proposal for a directive
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Member States shall provide that any person who has suffered damage as a result of an unlawful processing operation or of an action incompatible with the provisions adopted pursuant to this Directive shall have the right to receive compensation from the controller or the processor for the damage suffered in line with national law.
Amendment 57 #
2011/0461(COD)
Proposal for a decision
Recital 14 a (new)
Recital 14 a (new)
(14a) For capacities maintained outside of the European Emergency Response Capacity, Member States are encouraged to develop a regional approach. Cooperation between regional and local governments should facilitate effective preparation and response, ensuring that scarce resources are used efficiently, utilising, inter alia, published records of capacities held at each level of government and voluntary pooled resources. Where Member States choose to adopt this approach, the Commission should be available to provide assistance and support.
Amendment 137 #
2011/0461(COD)
Proposal for a decision
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. Where Member States have a vast number of existing risk management plans at devolved levels of government, the minimum requirement of information to be submitted to the Commission shall be a collation of the information within these plans, including but not limited to; possible risks, capacities available, and contingency plans in place. The submission of original versions of regional risk management plans shall be encouraged, along with any relevant data.
Amendment 171 #
2011/0461(COD)
Proposal for a decision
Article 10 – paragraph 1 – point b a (new)
Article 10 – paragraph 1 – point b a (new)
(ba) the Commission shall establish contact with interested non-governmental civil protection actors and, where possible, record what capacities they can make available for operations under the Mechanism.
Amendment 180 #
2011/0461(COD)
Proposal for a decision
Article 11 – paragraph 6
Article 11 – paragraph 6
6. The capacities registered in the European Emergency Response Capacity shall be available for emergency response operations under the Mechanism at the request of the Commission through the ERC. Member States shall inform the Commission as soon as possible of any compelling reasons that prevent them from making these capacities available in a specific emergency. Member States shall provide the Commission with a brief description of these compelling reasons.
Amendment 190 #
2011/0461(COD)
Proposal for a decision
Article 12 – paragraph 4 a (new)
Article 12 – paragraph 4 a (new)
4a. Outside of the ERC framework, Member States shall be encouraged to adopt a regional approach where practicable, utilising voluntary pools of resources within their territory, to maximise the efficient use of scarce resources. On request, the Commission shall provide information, expertise and technology to facilitate this approach.
Amendment 231 #
2011/0461(COD)
Proposal for a decision
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
Amendment 78 #
2011/0439(COD)
Proposal for a directive
Article 81 – paragraph 2
Article 81 – paragraph 2
2. Member States may provide that, at theif request ofed by the subcontractor and where the nature of the contract so allows, the contracting entity shall transfer due payments directly to the subcontractor for services, supplies or works provided to the main contractor. In such case, Member States shall put in place appropriate mechanisms permitting the main contractor to object to undue payments. The arrangements concerning that mode of payment shall be set out in the procurement documents.
Amendment 84 #
2011/0439(COD)
Proposal for a directive
Article 93 – paragraph 1 – subparagraph 1 a (new)
Article 93 – paragraph 1 – subparagraph 1 a (new)
Member States that have particular constitutional arrangements which would prevent them from establishing a single independent body, and already have in place a structure of several administrative bodies can retain these arrangements, as long at the bodies concerned fulfill all responsibilities as stated below.
Amendment 19 #
2011/0438(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Other categories of services continue by their very nature to have a limited cross- border dimension, namely what are known as services to the person, such as certain social, health and educational services. These services are provided within a particular context that varies widely amongst Member States, due to different cultural traditions. A specific regime should therefore be established for public contracts for these services, with a higher threshold of EUR 51 000 000. Services to the person with values below this threshold will typically not be of interest to providers from other Member States, unless there are concrete indications to the contrary, such as Union financing for transborder projects. Contracts for services to the person above this threshold should be subject to Union-wide transparency. Given the importance of the cultural context and the sensitivity of these services, Member States should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate. The rules of this directive take account of that imperative, imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities are able to apply specific quality criteria for the choice of service providers, such as the criteria set out in the voluntary European Quality Framework for Social Services of the European Union's Social Protection Committee. Member States and/or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of public contracts, for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority, without any limits or quotas, provided such a system ensures sufficient advertising and complies with the principles of transparency and non-discrimination.
Amendment 22 #
2011/0438(COD)
Proposal for a directive
Recital 18
Recital 18
(18) In view of the detrimental effects on competition, negotiated procedures without prior publication of a contract notice should only be used in very exceptional circumstances and under the threshold as set out in Article 4 and with adequate justification. This exception should be limited to cases where publication is either not possible, for reasons of force majeure in line with the standing case-law of the Court of Justice of the European Union, or where it is clear from the outset that publication would not trigger more competition, not least because there is objectively only one economic operator that can perform the contract. Only situations of objective exclusivity can justify the use of the negotiated procedure without publication, where the situation of exclusivity has not been created by the contracting authority itself with a view to the future procurement procedure, and where there are no adequate substitutes, the availability of which should be assessed thoroughly.
Amendment 36 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) EUR 58 000 000 for public works contracts;
Amendment 38 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) EUR 13200 000 for public supply and service contracts awarded by central government authorities and design contests organised by such authorities; where public supply contracts are awarded by contracting authorities operating in the field of defence, that threshold shall apply only to contracts concerning products covered by Annex III;
Amendment 40 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) EUR 2300 000 for public supply and service contracts awarded by sub-central contracting authorities and design contests organised by such authorities.
Amendment 41 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) EUR 5800 000 for public contracts for social and other specific services listed in Annex XVI.
Amendment 107 #
2011/0438(COD)
Proposal for a directive
Article 71 – paragraph 2
Article 71 – paragraph 2
2. Member States may provide that at the, if request ofed by the subcontractor and where the nature of the contract so allows, the contracting authority shall transfer due payments directly to the subcontractor for services, supplies or works provided to the main contractor. In such case, Member States shall put in place appropriate mechanisms permitting the main contractor to object to undue payments. The arrangements concerning that mode of payment shall be set out in the procurement documents.
Amendment 120 #
2011/0438(COD)
Proposal for a directive
Article 84 – paragraph 1 – subparagraph 1 a (new)
Article 84 – paragraph 1 – subparagraph 1 a (new)
Member States that have particular constitutional arrangements which would prevent them from establishing a single independent body, and already have in place a structure of several administrative bodies can retain these arrangements, as long at the bodies concerned fulfill all responsibilities as stated below.
Amendment 70 #
2011/0435(COD)
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) The mobility of healthcare professionals should also be considered within the broader context of the European workforce for health which should be addressed through a specific strategy at European level and in coordination with Member States, in order to guarantee the highest level of patients and consumers protection while maintaining the financial and organisational sustainability of national healthcare systems.
Amendment 73 #
2011/0435(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Directive 2005/36/EC already provides for clear obligations for professionals to have the necessary language skills. The review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients' safety. Language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host Member Statecertain professions with health, patient and consumer safety implications but should not constitute grounds for refusal to recognise a professional qualification.
Amendment 76 #
2011/0435(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Whilst the Directive already provides for detailed obligations for Member States to exchange information, such obligations should be reinforced. Member States should not only react to request for information but also alert other Member States in a proactive manner. Such alert system should be similar to that of Directive 2006/123/EC. A specific alert mechanism is however necessary for health professionals benefiting from automatic recognition under Directive 2005/36/EC. This should also apply to veterinary surgeons unless the Member States have already triggered the alert mechanism provided for in Directive 2006/123/EC. All Member States should be alerted if a professional due to a disciplinary action, legal sanction or criminal conviction is no longer entitled to move to another Member Statepractice the profession, or when a professional has used fraudulent or false qualifications or supporting information when applying for recognition. This alert should be activated through the IMI regardless of whether the professional has exercised any of the rights under Directive 2005/36/EC or of whether he has applied for recognition of his professional qualifications through the issuance of a European Professional Card or through any other method provided for by that Directive. The alert procedure should comply with Union law on the protection of personal data and other fundamental rights.
Amendment 78 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2005/36/EC
Article 1 – paragraph 3 (new)
Article 1 – paragraph 3 (new)
(1a) In Article 1, the following third paragraph is added: "This Directive shall apply without prejudice to measures necessary to ensure a high level of health and consumer protection.".
Amendment 104 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2005/36/EC
Article 4e – paragraph 4
Article 4e – paragraph 4
4. The information included in the European Professional Card shall be limited to the information that is necessary to ascertain its holder's right to exercise the profession for which it has been issued, in particular name, surname, date and place of birth, professiontype of qualification and profession, nationality at the point of recognition, current registration status, applicable regime, competent authorities involved, card number, security features and reference to a valid proof of identity.
Amendment 111 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 15 a (new)
Article 1 – point 15 a (new)
Directive 2005/36/EC
Article 21 – paragraph 7 a (new)
Article 21 – paragraph 7 a (new)
(15a) In Article 21, the following paragraph is added: "7a. Member States may require that professionals possessing evidence of formal qualifications listed in Annex V, points 5.1.1, 5.1.2, 5.1.4, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2, 5.6.2 and 5.7.1 shall only benefit from the provisions in paragraph 1 if they have qualified within the preceding 3 years or can demonstrate through an attestation from a competent authority or other relevant organisation, that they have effectively and lawfully been engaged in the activities in question for at least three consecutive years during the five years prior to the date of issue of the attestation. Where this is not provided, Member States may assess a professional's qualification either under the provisions outlined in Title III, Chapter I or grant limited access to the profession according to national law.".
Amendment 43 #
2011/0429(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. It would be appropriate to take a consistent policy approach regarding pharmaceutical substances, taking into consideration the full societal and medical implications, in full consultation with all relevant stakeholders. To this end, the Commission will produce a report with possible legislative proposals on the environmental effects of pharmaceutical substances for human use in waters and soils, under Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use1 and Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products2. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice to the application of the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. _______________ 1 OJ L 348, 31.12.2010, p. 74 2 OJ L 348, 31.12.2010, p. 1
Amendment 62 #
2011/0429(COD)
Proposal for a directive
Recital 17
Recital 17
(17) A new mechanism is needed to provide the Commission with targeted high-quality monitoring information on the concentration of substances in the aquatic environment, with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment. The new mechanism should facilitate the gathering of that information across Union river basins. In order to maintain the monitoring costs at reasonable levels, the mechanism should focus on a limited number of substances, included temporarily in a watch list, and a limited number of monitoring sites, but deliver representative data that are fit for the purpose of the Union prioritisation process. The list should be dynamic, to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary. Given the concerns raised in relation to Diclofenac, 17beta-estradiol and 17alpha-ethinylestradiol, the Commission is asked to prioritise undertaking scientific assessment of these three substances with a view to including them in a watch list, should that assessment justify inclusion. Any assessment of these three substances should include the potential economic and societal impact of their monitoring and restriction.
Amendment 128 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 2 a (new)
Article 8 b – paragraph 2 a (new)
2 a. The Commission, within 12 months of the adoption of this directive, shall undertake scientific assessment of the following substances, to evaluate their suitability for inclusion in a watch list: i) Diclofenac ii) 17beta-estradiol iii) 17alpha-ethinylestradiol The Commission shall be assisted by the Committee established by Article 21(1) of Directive 2000/60/EC.
Amendment 135 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 1
Article 8 b – paragraph 4 – subparagraph 1
4. Member States shall monitor each substance in the watch list at selected representative monitoring stations over at least a 124-month period commencing within 36 months of its inclusion in the watch list.
Amendment 144 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 3
Article 8 b – paragraph 4 – subparagraph 3
In selecting the representative stations, the monitoring frequency and timing for each substance, Member States shall take into account the use patterns of the substance. The frequency of monitoring shall not be less than once pbe every 9 months to cover ysearsonal fluctuations.
Amendment 171 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 46
Annex I – table – row 46
Directive 2000/60/EC
Annex X – table – row 46
Annex X – table – row 46
Amendment 178 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 47
Annex I – table – row 47
Directive 2000/60/EC
Annex X – table – row 47
Annex X – table – row 47
Amendment 185 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 48
Annex I – table – row 48
Directive 2000/60/EC
Annex X – table – row 48
Annex X – table – row 48
Amendment 205 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 46
Annex II – table – row 46
Directive 2008/105/EC
Annex I – table – row 46
Annex I – table – row 46
Amendment 210 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 47
Annex II – table – row 47
Amendment 215 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 48
Annex II – table – row 48
Directive 2008/105/EC
Annex I – table – row 48
Annex I – table – row 48
Amendment 38 #
2011/0421(COD)
Proposal for a decision
Recital 10
Recital 10
(10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure would increase the availis undertaken with the aim of enability of those products and ensure fairer access to them among Member States participating in the joint procurementng more equitable access to vaccines for the Member States involved, to help them better meet the vaccination needs of their citizens, in line with national vaccination policies.
Amendment 45 #
2011/0421(COD)
Proposal for a decision
Recital 17
Recital 17
(17) The applicability of some specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, depends on the recognition at Union level in the framework of Decision 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza. Those provisions allow for the accelerated marketing of certain medicinal products in case of urgent needs, by means, respectively, of a conditional marketing authorisation and of the temporary possibility to grant a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non- clinical or clinical data are missing. However, in spite of the utility of such provisions in the event of a crisis, there is to date no specific procedure for issuing such recognitions at Union level. It is therefore appropriate to provide for such a procedure as part of the standards of quality and safety for medicinal products. The declaration of an emergency situation at Union level should be without prejudice to the effects of a decision taken by the World Health Organisation to trigger the production of vaccines from seasonal to pandemic
Amendment 70 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 2 – point iii a (new)
Article 4 – paragraph 2 – point iii a (new)
(iiia) specific mechanisms to monitor and report on vaccines coverage in respect of those listed in the Annex to Decision 2119/98/EC.
Amendment 80 #
2011/0421(COD)
Proposal for a decision
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. The actors in the Early Warning and Response System shall perform their duties independently and in the public interest. Prior to taking up their duties, they shall make available a declaration of interests, setting out any activities or roles which may compromise their integrity. Those declarations should be updated when significant changes occur, or at least once a year
Amendment 91 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c a (new)
Article 10 – paragraph 2 – point c a (new)
(ca) on the assessment of the World Health Organisation, when provided, in the case of an international public health emergency.
Amendment 24 #
2011/0387(COD)
Proposal for a decision
Annex – part 1 – point 1.1 – paragraph 11
Annex – part 1 – point 1.1 – paragraph 11
The set-up of the KICs as single legal entities led by a Chief Executive Officer (CEO) provides a clear departure from a traditional multi-beneficiaries approach. Moreover, all KICs follow business logic for the strategic planning of their activities, and all KICs have implemented the co- location concept: bringing diverse teams together in one physical place, acting as a clearing house for many KIC activities, and combining competences and skills developed in different areas of specialisation at pan-European level. KICs should be able to mobilise investments and long term commitments from the private, public and third sectors.
Amendment 28 #
2011/0387(COD)
Proposal for a decision
Annex – part 1 – point 1.3 – paragraph 2
Annex – part 1 – point 1.3 – paragraph 2
The EIT will strongly contribute to the objectives set out in Horizon 2020, in particular by addressing societal challenges in a complementary way to other initiatives in these areas. Within Horizon 2020, the EIT will be part of the ‘tackling societal challenges’ objective but following the approach of seamless interaction across objectives, it will also contribute to ‘industrial leadership and competitive frameworks’ by stimulating results-driven research and fostering the creation of high growth innovative SMEs. Finally, it will contribute to the creation of an ‘excellent science base’ by fostering mobility across boundaries – of disciplines, sectors and countries – and by embedding entrepreneurship and a risk-taking culture in innovative post-graduates degrees. The EIT will thereby significantly contribute to promoting the framework conditions that are needed to realise the innovative potential of EU research and to promote the completion of the European Research Area (ERA). A coordination mechanism between the EIT and the other activities under Horizon 2020 shall be proposed by the European Commission in consultation with the EIT, to be implemented by the EIT.
Amendment 31 #
2011/0387(COD)
Proposal for a decision
Annex – part 2 – point 2.1 – paragraph 4
Annex – part 2 – point 2.1 – paragraph 4
The ‘EIT investor’ approach stands for a focus on identifying best strategic opportunities and selecting a portfolio of world-class partnerships – the KICs – to deliver on these. As part of this approach, the EIT awards the annual grants to the KICs based on their past performance and proposed activities in their business plan in a clear and transparent procedure. The assessment of the business plans will be supported by external, independent experts. In this perspective, the EIT should not only set out broad directions and visions, but needs to provide KICs with an appropriate level of support and monitor their performanceand report about their performance in a clear and transparent way. At the same time, KICs are given a substantial degree of leeway to define their internal strategies and organisation as well as to deliver their activities and mobilise the talent and resources needed.
Amendment 32 #
2011/0387(COD)
Proposal for a decision
Annex – part 2 – point 2.2 – paragraph 1
Annex – part 2 – point 2.2 – paragraph 1
In the initial period, the EIT has mainly focused its efforts on establishing the KICs. While it isIt must be a clear goal for the EIT to strengthen existing centres of excellence, twith a wide participation of Member States, where they can add value. The EIT will need to ensure that it also delivers benefits to areas of the Union which are not directly participating in KICs. It is therefore mission critical for the EIT to actively promote the dissemination of good practices for the integration of the knowledge triangle in order to develop a common innovation and knowledge sharing culture.
Amendment 33 #
2011/0387(COD)
Proposal for a decision
Annex – part 2 – point 2.2 – paragraph 1 a (new)
Annex – part 2 – point 2.2 – paragraph 1 a (new)
The EIT will have a role in supporting the development of innovative IPR policy and practices that can answer the needs and interests of the involved stakeholders across Europe, in particular SMEs.
Amendment 37 #
2011/0387(COD)
Proposal for a decision
Annex – part 2 – point 2.2 – paragraph 9 – indent 4 a (new)
Annex – part 2 – point 2.2 – paragraph 9 – indent 4 a (new)
- Have a role in supporting the development of innovative IPR policy and practices that can answer the needs and interests of the involved stakeholders across Europe, in particular SMEs.
Amendment 38 #
2011/0387(COD)
Proposal for a decision
Annex – part 3 – point 3.2 – paragraph 1
Annex – part 3 – point 3.2 – paragraph 1
Interactions between the EIT and the KICs not only provide the framework for KICs to operate successfully, but are also at the core of the mutual learning process enabling the EIT to play its role as a test bed for new innovation models. In order to provide KICs with appropriate framework conditions, clear and coherent guidance must be given by the EIT at all stages of the process without at the same time being overly prescriptive. Interactions between EIT headquarters and the KICs need to be systematic and regular as well as clear, open, transparent and trust-based in order to achieve maximum efficiency. Both the contractual relations between the EIT and the KICs as well as the organisational arrangements of the EIT headquarters should contribute thereto.
Amendment 40 #
2011/0387(COD)
Proposal for a decision
Annex – part 3 – point 3.3 – paragraph 3
Annex – part 3 – point 3.3 – paragraph 3
Moreover, active consultation with other EU institutions, in particular with relevant services of the Commission, from early on in the process will help to maximise synergies and mutual learning with other EU initiatives. The EIT will engage in a regular dialogue with the relevant services of the European Commission and with the European Parliament.
Amendment 13 #
2011/0384(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The rules concerning the management of intellectual property rights are defined in the Rules for Participation and must ensure the right balance between right holders and users. The European Commission, in consultation with the EIT, should provide guidance on innovative intellectual property rights models promoting knowledge transfer and dissemination, both within the context of the KICs and more widely across the EU.
Amendment 15 #
2011/0384(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The scope of the EIT contribution to the Knowledge and Innovation Communities (hereinafter referred to as KICs) should be defined and the origins of KICs' financial resources clarified. In particular, EU funding should be considered as leverage to encourage KICs to pursue other sources of private or public funding, and a review of the use of EU funding as leverage should be considered in future by EU institutions.
Amendment 16 #
2011/0384(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The composition of the EIT bodies should be simplified. The functioning of the EIT Governing Board should be streamlined and the respective roles and tasks of the Governing Board and the Director should be further clarified. The Governing Board and the Director must act in the interests of the EIT in an independent, impartial and transparent way.
Amendment 17 #
2011/0384(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The EIT Triennial Work Programme should take into account the Commission's opinionopinions of the Commission, the European Parliament and the Council concerning the EIT's specific objectives, as defined in Horizon 2020, and its complementarities with European Union policies and instruments. These three EU institutions should be adequately involved when this programme is established.
Amendment 23 #
2011/0384(COD)
Proposal for a regulation
Article 1 – point 12
Article 1 – point 12
Regulation (EC) No 294/2008
Article 15 – subparagraph a
Article 15 – subparagraph a
(a) a rolling triennial work programme, based on the SIA, once it is adopted, containing a statement of the major priorities and planned initiatives of the EIT and the KICs, including an estimate of financing needs and sources, and a review of the financial viability of each KICs. It shall also contain appropriate indicators for monitoring the KICs and EIT activities. The preliminary rolling triennial work programme shall be submitted by the EIT to the Commission by 31 December each N-2. The Commission shall deliver an opinion within three months with regard to EIT specific objectives as defined in Horizon 2020 and its complementarities with Union policies and instruments. The EIT shall take a due account of the Commission opinion, and in case of disagreement justify its position. The final work programme shall be transmitted by the EIT to the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Committee of the Regions for information;
Amendment 25 #
2011/0384(COD)
Proposal for a regulation
Annex – section 2 – paragraph 1 – point p
Annex – section 2 – paragraph 1 – point p
(p) promote the EIT globally, so as to raise its scientific, academic and business attractiveness and make it a world-class body for excellence in higher education, research and innovation.
Amendment 205 #
2011/0359(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The provision of services other than statutory audit to audited entities by statutory auditors, audit firms or members of their networks may compromise their independence. Therefore, it is appropriate to require the statutory auditor, the audit firm and the members of their network not to provide non-audit services to their audited entities. The provision ofsafeguards in the form of a prohibition of certain non- audit services by an audit firm to a company would prevent that audit firm from carrying out statutory audit of that company, thus resulting in a reduction of the audit firms available to provide statutory audit, in particular with regard to the audit of large public-interest entities where the market is concentrated. Asthe statutory auditor cannot perform to their audited entities, as well as result, in order to secure that a minimum number of audit firms is able to provide audit services to large public-interest entities, it is appropriate to request that audit firms of significant dimension focus their professional activity on the carrying out of statutory audit and are not allowed to undertake other services unconnected to their statutory audit function such as consultancy or advisory services- tendering, at the behest of the audit committee, of any non-audit service and financial audit related services above a 30% threshold.
Amendment 212 #
2011/0359(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Audit committees, or bodies performing an equivalent function within the audited entity, have a decisive role in contributing to high-quality statutory audit. It is particularly important to reinforce the independence and technical competence of the audit committee by requiring that a majority of its members is independent and that at least one member of the committee has competence in auditing and another one in auditing and/or accounting. Members of the audit committee should take part in skill enhancement programmes to ensure an appropriate level of technical knowledge to fulfil their roles. The Commission Recommendation of 15 February 2005 on the role of non- executive or supervisory directors of listed companies and on the committees of the (supervisory) board26 sets out how audit committees should be established and function. Considering, however, the dimension of boards in companies with reduced market capitalisation and in small and medium-sized public-interest entities, it would be appropriate that the functions assigned to the audit committee for those entities, or to a body performing equivalent functions within the audited entity, may be performed by the administrative or supervisory body as a whole. Public- interest entities which are UCITS or alternative investment funds should also be exempted from the obligation to have an audit committee. This exemption takes into account the fact that where those funds function merely for the purpose of pooling assets, the employment of an audit committee is not appropriate. UCITS and alternative investments funds, as well as their management companies, operate in a strictly defined regulatory environment and are subject to specific governance mechanisms such as controls exercised by their depositary.
Amendment 227 #
2011/0359(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to address the familiarity threat and therefore reinforce the independence of auditors and audit firms, it is important to establish a maximum duration of the audit engagement of a statutory auditor or audit firm in a particular audited entity. AFurthermore, a comprehensive, transparent and independent evaluation of audit quality should be regularly and appropriately documented. This comprehensive assessment should form the basis for the annual auditor selection by the general assembly. The purpose of mandatory tendering for the audit engagement is to not only evaluate the incumbent provider's performance but also the requirements of the audited entity. Furthermore, an appropriate gradual rotation mechanism should also be established with regard to the most senior personnel involved in the statutory audit, including the key audit partners carrying out the statutory audit on behalf of the audit firm. It is also important to provide for an appropriate period within which such statutory auditor or audit firm may not carry out the statutory audit of the same entity. In order to ensure a smooth transition, the former auditor should transfer a handover file with relevant information to the incoming auditor.
Amendment 234 #
2011/0359(COD)
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36a) The Proposal for a Regulation of the European Parliament and of the Council on specific requirements regarding statutory audit of public- interest entities envisages that the EU- wide cooperation between competent authorities in respect of the activities of statutory auditors and audit firms that audit the financial statements of public- interest entities would take place within ESMA. ESMA would thus take over the EU-wide cooperation mechanism that currently takes place under the aegis of the European Group of Auditors' Oversight Bodies (EGAOB), an expert group established and chaired by the European Commission. ESMA should create a standing committee composed of the competent authorities and supervisors of auditors. However, auditor public oversight would continue to be carried out at national level. ESMA would be best placed to fulfil the new tasks according to this Regulation in order to ensure an effective and operational cooperation at EU level. An EU-wide cooperation on auditor supervision within ESMA would benefit from the experience and resources of ESMA, as they are already working in the field of auditing regarding public-interest entities under the auspices of the Corporate Reporting Standing Committee. Under this new structure within ESMA, Member States will be sufficiently represented and will be an integral part of the decision-making process. The Commission, shall after a transitional period, report back to the European Parliament and the Council with a report on the function of ESMA regarding coordination of European audit supervision and their future role in this regard. The Commission shall evaluate ESMA has enough resources to fulfil its tasks laid down in this Regulation and propose budget increases if necessary.
Amendment 294 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point e a (new)
Article 10 – paragraph 2 – point e a (new)
(ea) auditing technology systems and risk management procedures related to the preparation and/or control of financial information included in the financial statements and advice on risk;
Amendment 296 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point e b (new)
Article 10 – paragraph 2 – point e b (new)
(eb) audit of occupational pension schemes and pension obligations;
Amendment 299 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point f
Article 10 – paragraph 2 – point f
(f) any other statutory duty related to audit work imposed by Union legislaw or regulation to the statutory auditor or audit firm.
Amendment 308 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 1
Article 10 – paragraph 3 – subparagraph 1
A statutory auditor or an audit firm carrying out statutory audit of public- interest entities shall not directly or indirectly provide to the audited entity, to its parent undertaking and to its controlled undertakings prohibited non-audit services.
Amendment 312 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 2
Article 10 – paragraph 3 – subparagraph 2
Where the statutory auditor belongs to a network, no member of such network shall provide to the audited entity, to its parent undertaking and to its controlled undertakings within the Union any prohibited non- audit services.
Amendment 316 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – introductory part
Article 10 – paragraph 3 – subparagraph 3 – introductory part
For the purposes of this Article, prohibited non-audit services shall mean:
Amendment 321 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point ii
Article 10 – paragraph 3 – subparagraph 3 – point a – point ii
(ii) bookkeeping services including the calculations of current and deferred taxes and preparing accounting records and financial statements as well as financial information;
Amendment 323 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point iii
Article 10 – paragraph 3 – subparagraph 3 – point a – point iii
(iii) designing andor implementing internal control or, risk management procedureor financial information technology systems related to the preparation and/or control of financingal information included in the financial statements and advice on risk;
Amendment 328 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point iv
Article 10 – paragraph 3 – subparagraph 3 – point a – point iv
(iv) valuation services, providing fairness opinions or contribution-in-kind reports;
Amendment 330 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point iv a (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point iv a (new)
(iva) generate information that is significant to the accounting records or financial statements that are subject to the statutory audit;
Amendment 332 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point vi
Article 10 – paragraph 3 – subparagraph 3 – point a – point vi
Amendment 338 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point vii a (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point vii a (new)
(viia) payroll services;
Amendment 343 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii a (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii a (new)
(viiia) human resources and/or recruitment services, including searching for and seeking out candidates for personnel positions within the audited entity;
Amendment 347 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii b (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii b (new)
(viiib) legal and tax services that go beyond the presentation of alternatives; tax services for natural persons with a significant role in the financial reporting of the audited entity and the marketing of tax planning concepts;
Amendment 350 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii c (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii c (new)
(viiic) promoting, dealing in, or underwriting client shares;
Amendment 352 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii d (new)
Article 10 – paragraph 3 – subparagraph 3 – point a – point viii d (new)
(viiid) providing comfort letters for investors in the context of the issuance of an undertaking's securities;
Amendment 354 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3 – point b
Article 10 – paragraph 3 – subparagraph 3 – point b
Amendment 373 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 4
Article 10 – paragraph 3 – subparagraph 4
Amendment 380 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 5
Article 10 – paragraph 3 – subparagraph 5
Amendment 397 #
2011/0359(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 413 #
2011/0359(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Tender of non-audit services 1. Related financial audit services enumerated in Article 10 (2) that would increase the ratio of non-audit to audit fees to more than 30% and non-audit related services must be subject to an open and transparent tendering procedure, if the designated audit committee feels it is necessary. If the audit committee does not feel it is necessary, it should explain why to the competent authority. 2. The tendering procedure referred to in Paragraph 1 shall be designed by the audit committee and approved by the competent authority. When designing their non-audit service policies, audit committees must: (a) aim for the greatest possible transparency; (b) give due consideration to small and medium-sized service providers; (c) ensure involvement of shareholders in the provision of non-audit services, in particular the audit committee shall receive an annual approval of the audited entities policy for non-audit services. 3. The selection procedure for those non- audit services referred to in paragraph 1 shall respect the following criteria: (a) the audit committee shall be free to invite any statutory auditors, audit firms or non-audit service providers to submit proposals for the provision of non-audit services; (b) tender documents shall be prepared by the audit committee, which should contain transparent and non- discriminatory selection criteria that shall be used to evaluate the proposals made by statutory auditor(s), audit firm(s), or non- audit service provider(s); (c) where, in accordance with national Union law, the competent authorities referred to in Article 35, require statutory auditors, audit firms and non-audit service providers should comply with certain quality standards, those standards shall be included in the tender documents; (d) the audit committee shall evaluate the proposals made by the statutory auditors, audit firms or non-audit service providers in accordance with the selection criteria predefined in the tender documents; (e) the audit committee shall be able to demonstrate to the competent authority referred to in Article 35 that the selection procedure was conducted in a fair manner.
Amendment 456 #
2011/0359(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 476 #
2011/0359(COD)
Proposal for a regulation
Article 23 – paragraph 2 – point e
Article 23 – paragraph 2 – point e
(e) describe the distribution of tasks among the statutory auditor(s)s and/or the audit firm(s) and include a description of the scope and timing of the audit and significant findings from the statutory audit conducted. This should include any significant deficiencies in the internal control system of the audited entity; how they addressed significant difficulties encountered during the audit and other matters arising from the statutory audit that in the statutory auditor's or audit firm's professional judgment are significant to the financial reporting process;
Amendment 520 #
2011/0359(COD)
Proposal for a regulation
Article 31 – paragraph 1 – subparagraph 3 a (new)
Article 31 – paragraph 1 – subparagraph 3 a (new)
Members of the audit committee shall take part in skill enhancement programmes in order to ensure an adequate technical knowledge level to fulfil their tasks.
Amendment 536 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – introductory part
Article 32 – paragraph 3 – subparagraph 1 – introductory part
Amendment 539 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – point a
Article 32 – paragraph 3 – subparagraph 1 – point a
(a) the audited entity shall be free to invite any statutory auditors or audit firms is free to submit proposals for the provision of the statutory audit service on the condition that Article 33(2) is respected and that at least one of the invited auditors or firms is not one who received more than 15% of the total audit fees from large public-interest entities in the Member State concerned in the previous calendar year;
Amendment 543 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – point c
Article 32 – paragraph 3 – subparagraph 1 – point c
(c) the audited entity committee shall prepare tender documents to the intention of the invited statutory auditor(s) or audit firm(s). Those tender documents shall allow the audit firm to understand the business of the audited entity and the type of statutory audit that is to be carried out. The tender documents shall contain transparent and non- discriminatory selection criteria that shall be used by the audited entity committee to evaluate the proposals made by statutory auditors or audit firms;
Amendment 544 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – point d
Article 32 – paragraph 3 – subparagraph 1 – point d
(d) the audited entity committee shall be free to define the selection procedure and may conduct direct negotiations with interested tenderers in the course of the procedure;
Amendment 545 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – point f
Article 32 – paragraph 3 – subparagraph 1 – point f
(f) the audit committeed entity shall evaluateperform a comprehensive assessment of the proposals made by the statutory auditors or audit firms in accordance with the selection criteria predefined in the tender documents. The audited entity shall prepare a report on the conclusions of the selection procedure, which shall be validated by the audit committee. The audited entity and the audit committee shall take into consideration any inspection report on the applicant statutory auditor or audit firm referred to in Article 40(6) and published by the competent authority pursuant to Article 44(d);
Amendment 546 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 1 – point g
Article 32 – paragraph 3 – subparagraph 1 – point g
(g) the audited entity committee shall be able to demonstrate to the competent authority referred to in Article 35 that the selection procedure was conducted in a fair manner.
Amendment 547 #
2011/0359(COD)
Proposal for a regulation
Article 32 – paragraph 3 – subparagraph 2
Article 32 – paragraph 3 – subparagraph 2
Amendment 572 #
2011/0359(COD)
Proposal for a regulation
Article 33 – paragraph 1 – subparagraph 2
Article 33 – paragraph 1 – subparagraph 2
The public-interest entity may renew thise audit engagement only once, provided this is based on a proposal of the audit committee after a re-tendering process has taken place. Shareholders at the annual general meeting shall formally approve the statutory auditor(s) engagement.
Amendment 585 #
2011/0359(COD)
Proposal for a regulation
Article 33 – paragraph 1 – subparagraph 3
Article 33 – paragraph 1 – subparagraph 3
The maximum duration of the combined two engagements shall not exceed 614 years. At least one re-rendering process shall take place during this 14 year period.
Amendment 592 #
2011/0359(COD)
Proposal for a regulation
Article 33 – paragraph 1 – subparagraph 4
Article 33 – paragraph 1 – subparagraph 4
Amendment 614 #
2011/0359(COD)
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
Amendment 105 #
2011/0308(COD)
Proposal for a directive
Recital 32
Recital 32
(32) In order to provide for enhanced transparency of payments made to governments, large undertakings and public interest entities which are active in the extractive industry or logging of primary forests should disclose in a separate report on an annual basisshould disclose, as part of their annual financial statements, material payments made to governments in the countries in which they operate. Such undertakings which are active in countries rich in natural resources, in particular minerals, oil, natural gas as well as primary forests. The report should include in their annual financial statements types of payments comparable to those disclosed by an undertaking participating in the Extractive Industries Transparency Initiative (EITI). The initiative is also complementary to the EU FLEGT Action Plan (Forest Law Enforcement, Governance and Trade) and the Timber Regulation which require traders of timber products to exercise due diligence in order to prevent illegal wood from entering into the EU market.
Amendment 111 #
2011/0308(COD)
Proposal for a directive
Recital 33
Recital 33
(33) The reportdisclosures should serve to facilitate governments of resource-rich countries in implementing the EITI Principles and Criteria, amongst other voluntary reporting standards, and account to their citizens for payments such governments receive from undertakings active in the extractive industry or loggers of primary forests operating within their jurisdiction. The report should incorporate disclosures on aoperating within their jurisdiction. The disclosures should be on a country-by- country and project-by-project basis, where a project is considered as the lowest level of operational reporting unit at which the undertaking prepares regular internal management reports, such as a concession, geographical basin, etc and where payments have been attributed to such projects. In the light of the overall objective of promoting good governance in these countries, the materiality of payments to be reported should be assessed in relation to the recipient government. Various criteria on materiality could be envisaged such as payments of an absolute amount, or a percentage threshold (such as payments in excess of a percentage of a country's GDP) and these can be defined through a delegated act, such as a contract, license, lease or other legal agreement under which an undertaking operates, which give rise to specific liabilities and where payments have been attributed to such projects, if any one payment or set of payments of the same type amount to more than 100 000 EUR. The reporting regime should be subject to a review and a report by the Commission within fivthree years of the entry into force of the Directive. The review should consider the effectiveness of the regime and take into account international developments including issues of competitiveness and energy security. The review should also take into account the experience of preparers and users of the payments information and consider whether it would be appropriate to include additional paymentfinancial information such as effective tax rates and recipient details, such as bank account information.
Amendment 115 #
2011/0308(COD)
Proposal for a directive
Recital 35
Recital 35
(35) In order to take account of future changes to the laws of the Member States and in the legislation of the Union concerning company types, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of updating the lists of undertakings contained in Annexes I and II. The use of delegated acts is also necessary to adapt the undertaking size criteria, as with the passage of time inflation will erode their real value. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. In order to ensure a relevant and appropriate level of disclosure of payments to governments by the extractive industry and loggers of primary forests and to ensure uniform application of this Directive, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of the specification of the concept of materiality of payments.
Amendment 166 #
2011/0308(COD)
Proposal for a directive
Article 36 – paragraph 1
Article 36 – paragraph 1
Amendment 170 #
2011/0308(COD)
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
Amendment 186 #
2011/0308(COD)
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
1. Member States shall require large undertakings and all public interest entities active in the extractive industry or the logging of primary forests to prepare and make public a report on payments made to governments on an annual basias part of their annual financial statements.
Amendment 217 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – introductory part
Article 38 – paragraph 2 – introductory part
2. The following types of payments and information shall be reported:
Amendment 218 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point b
Article 38 – paragraph 2 – point b
(b) taxes on profits, levies and administrative fees, as well as the effective rate applied;
Amendment 221 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point b a (new)
Article 38 – paragraph 2 – point b a (new)
(ba) profit before tax;
Amendment 223 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point c a (new)
Article 38 – paragraph 2 – point c a (new)
(ca) quantities produced;
Amendment 224 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point e a (new)
Article 38 – paragraph 2 – point e a (new)
(ea) total number of people employed;
Amendment 225 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point e b (new)
Article 38 – paragraph 2 – point e b (new)
(eb) employees aggregate remuneration;
Amendment 227 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point f a (new)
Article 38 – paragraph 2 – point f a (new)
(fa) payments for having broken the law, such as environmental and remediation liabilities;
Amendment 230 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point f b (new)
Article 38 – paragraph 2 – point f b (new)
(fb) payments to government security forces;
Amendment 232 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 2 – point f c (new)
Article 38 – paragraph 2 – point f c (new)
(fc) expenditure on fixed asset investment;
Amendment 241 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 3 a (new)
Article 38 – paragraph 3 a (new)
3a. Payments shall be disclosed if any one payment or set of payments of the same type amount to more than EUR 100 000.
Amendment 243 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
Amendment 253 #
2011/0308(COD)
Proposal for a directive
Article 38 – paragraph 5
Article 38 – paragraph 5
Amendment 257 #
2011/0308(COD)
Proposal for a directive
Article 39 – paragraph 1
Article 39 – paragraph 1
1. A Member State shall require any large undertaking or any public interest entity active in the extractive industry or the logging of primary forests and governed by its national law to draw up a consolidated report on payments to governments in accordance with Articles 37 and 38 if that parent undertaking is under the obligation to prepare consolidated financial statements as laid down in Article 23(1) to 23(6) of this Directive.
Amendment 25 #
2011/0307(COD)
Proposal for a directive
Recital 7
Recital 7
(7) In order to provide for enhanced transparency of payments made to governments, issuers whose securities are admitted to trading on a regulated market and which have activities in the extractive or logging of primary forest industries should disclose in a separate report on an annual basis payments made to governments in the countries in which they operate. The reportshould disclose as part of their annual financial statements payments made to governments in the countries in which they operate. In the case of issuers engaged in activities related to extractive or forest industries, disclosures should include types of payments comparable to those disclosed under the Extractive Industries Transparency Initiative (EITI), and provide civil society with information to hold governments of resource-rich countries tomongst other reporting standards. For all issuers, disclosures should be on ac count for their receipts from the exploitation of natural resources. The initiative is also complementary to the EU FLEGT Action Plan (Forest Law Enforcement, Governance and Trade) and the Timber Regulation, which require traders of timberry-by- country and project-by-project basis, where a project means a contract, licence, lease or other legal agreement under which an undertaking operates, which gives rise to specific revenue liabilities and where payments have been attributed to such produjects to exercise due diligence in order to prevent illegal wood from entering into the EU market, if any one payment or set of payments of the same type amount to more than EUR 100 000. The detailed requirements are defined in Chapter 9 of Directive 2011/.../EU of the European Parliament and of the Council.
Amendment 29 #
2011/0307(COD)
Proposal for a directive
Recital 10
Recital 10
(10) A harmonised regime for notification of major holdings of voting rights, especially regarding aggregation of holdings of shares with holdings of financial instruments, should improve legal certainty, enhance transparency and reduce administrative burden for cross-border investors. Member States should therefore not be allowed to adopt stricter or divergent rules in that area than those provided in Directive 2004/109/EC. However, taking into account the existing differences in ownership concentration in the Union, Member States should continue to be allowed to set lower thresholds for notification of holdings of voting rights; nevertheless, measures to incentivise long term investment should be considered and also a requirement for full transparency of voting for any borrowed shares.
Amendment 45 #
2011/0307(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Member States shall require all issuers active in the extractive or logging of primary forest industries, as defined in […] to prepare, in accordance with Chapter 9 of Directive 2011/.../EU of the European Parliament and of the Council, a reportdisclosure onf payments made to governments on an annual basias part of their annual financial statements. The report shall be made public at the latest six months after the end of each financial year and shall remain publicly available for at least five years. Payments to governments shall be reported at consolidated level.