Activities of Bernadette VERGNAUD
Plenary speeches (111)
Electronic communications networks, personal data and the protection of privacy - Electronic communications networks and services - Body of European Regulators for Electronic Communications (BEREC) and the Office - Frequency bands for mobile communications (debate)
Patients' rights in cross-border healthcare (debate)
Explanations of vote
Protection of consumers in respect of certain aspects of timeshares (debate)
Social package (Second part: Cross-border healthcare) (debate)
Electronic communications networks and services - European Electronic Communications Market Authority - Common approach to the use of the spectrum released by the digital switchover - Electronic communications networks and services, protection of privacy and consumer protection (debate)
How marketing and advertising affect equality between women and men (debate)
EU consumer policy strategy 2007-2013 (debate)
Accreditation and market surveillance relating to the marketing of products - Common framework for the marketing of products - Application of certain national technical rules to products lawfully marketed in another Member State - Safety marking on consumer products (debate)
Explanations of vote
Explanations of vote
Dangerous toys manufactured in China (debate)
Explanations of vote
Decision-making in the common European asylum system (debate)
The exclusion of health services from the Services Directive (vote)
The exclusion of health services from the Services Directive (debate)
Explanations of vote
Community action on the provision of cross-border health care (debate)
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Public-private partnerships (debate)
Explanations of vote
Services of general interest (debate)
Forced prostitution during the 2006 football World Cup (debate)
Equal opportunities and equal treatment in employment and occupation (debate)
Explanations of vote
Explanations of vote
Services (continuation of the debate)
The future of the Lisbon strategy from a gender perspective
Equal opportunities in employment and work
Follow-up to the Fourth World Conference on Women Platform for Action (Beijing + 10)
Unfair business-to-consumer commercial practices
European single market for electronic communications - Measures to reduce the cost of deploying high-speed electronic communications networks - Electronic identification and trust services for electronic transactions in the internal market (debate)
Manufacture, presentation and sale of tobacco and related products (A7-0276/2013 - Linda McAvan)
Deployment of the interoperable EU-wide eCall (A7-0482/2013 - Philippe De Backer)
Single European railway area (A7-0037/2014 - Saïd El Khadraoui)
Domestic passenger transport services by rail (A7-0034/2014 - Mathieu Grosch)
Accessibility of public sector bodies' websites (A7-0460/2013 - Jorgo Chatzimarkakis)
Compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights (A7-0020/2014 - Georges Bach)
A 2030 framework for climate and energy policies (A7-0047/2014 - Anne Delvaux, Konrad Szymański)
Compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights (debate)
Homophobia and discrimination on grounds of sexual orientation and gender identity (A7-0009/2014 - Ulrike Lunacek)
Steel industry in Europe (A7-0028/2014 - András Gyürk)
Non-discrimination in the framework of sexual and reproductive health and rights (debate)
Public procurement (A7-0007/2013 - Marc Tarabella)
Access of goods and services to public procurement markets (A7-0454/2013 - Daniel Caspary)
Honey (A7-0440/2013 - Julie Girling)
Food crisis, fraud in the food chain and the control thereof (A7-0434/2013 - Esther de Lange)
Effective labour inspections as a strategy to improve working conditions (A7-0458/2013 - Jutta Steinruck)
Award of concession contracts - Public procurement - Procurement by entities operating in the water, energy, transport and postal services sectors (debate)
North-East Atlantic: deep-sea stocks and fishing in international waters (A7-0395/2013 - Kriton Arsenis)
Recognition of professional qualifications and administrative cooperation through the Internal Market Information System (debate)
Recognition of professional qualifications and administrative cooperation through the Internal Market Information System (debate)
Recognition of professional qualifications and administrative cooperation through the Internal Market Information System (A7-0038/2013 - Bernadette Vergnaud)
Technical requirements and administrative procedures related to air operations (B7-0440/2013)
Manufacture, presentation and sale of tobacco and related products (A7-0276/2013 - Linda McAvan)
Review of the Irish Presidency, including the MFF agreement (B7-0332/2013, RCB7-0334/2013, B7-0334/2013, B7-0335/2013, B7-0339/2013, B7-0340/2013)
Implementing enhanced cooperation in the area of financial transaction tax (A7-0230/2013 - Anni Podimata)
Reforming the structure of the EU banking sector (A7-0231/2013 - Arlene McCarthy)
Roadworthiness tests for motor vehicles and their trailers (A7-0210/2013 - Werner Kuhn)
Situation in Turkey (RCB7-0305/2013, B7-0305/2013, B7-0306/2013, B7-0307/2013, B7-0308/2013, B7-0309/2013, B7-0310/2013, B7-0311/2013)
Appointment of a member of the European Commission - Neven Mimica
Laying down standards for the reception of applicants for international protection (recast) (A7-0214/2013 - Antonio Masip Hidalgo)
Fund for European aid to the most deprived (A7-0183/2013 - Emer Costello)
Temporary reintroduction of border control at internal borders (A7-0200/2012 - Renate Weber)
Amendment of Schengen border code and Convention implementing the Schengen Agreement (A7-0206/2013 - Georgios Papanikolaou)
Motion for a resolution - European Council conclusions of 7-8 February concerning the Multiannual Financial Framework
Decision on the opening of, and mandate for, interinstitutional negotiations on financing, management and monitoring of the CAP - 2011/0288(COD) (B7-0082/2013)
European Semester for economic policy coordination: annual growth survey 2013 (A7-0032/2013 - Elisa Ferreira)
Governance of the single market (A7-0019/2013 - Andreas Schwab)
Transparency of measures regulating the prices of medicinal products for human use (debate)
Explanations of vote
Explanations of vote
Single Market Act II - Concerns of European citizens and business with the functioning of the Single Market (debate)
Implementation of the Single European Sky legislation (short presentation)
Pharmacovigilance (amendment of Directive 2001/83/EC) - Pharmacovigilance (amendment of Regulation (EC) No 726/2004) (debate)
Future of the Single Market Act (debate)
Question Time (Commission)
Question Time (Commission)
Agreement between the EU and Morocco concerning reciprocal liberalisation measures on agricultural products and fishery products (debate)
Conclusions of the informal European Council meeting of 30 January 2012 (debate)
European semester for economic policy coordination (debate)
Implementation of Professional Qualifications Directive (debate)
Modernisation of public procurement (debate)
Explanations of vote
Explanations of vote
Food information to consumers (debate)
Universal service and '112' emergency number (short presentation)
Explanations of vote
Governance and partnership in the Single Market - Single market for Europeans - Single market for enterprises and growth - Public procurement (continuation of debate)
Consumer rights (debate)
Reducing health inequalities (short presentation)
Implementation of the Services Directive (debate)
Patients’ rights in cross-border healthcare (debate)
Explanations of vote
Situation in Western Sahara (debate)
Single Market Act (debate)
Combating late payment in commercial transactions (debate)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Explanations of vote
Effects of the Xynthia storm in Europe (debate)
Internal Market Scoreboard - Consumer protection - SOLVIT (debate)
Mutual recognition of professional qualifications (debate)
Electronic communication networks and services (debate)
Implementation of the Services Directive (debate)
Explanations of vote
Reports (2)
REPORT on the impact and consequences of the exclusion of health services from the Directive on services in the internal market PDF (243 KB) DOC (186 KB)
REPORT proposal for a directive of the European Parliament and of the Council amending Directive 2005/36/EC on the recognition of professional qualifications and Regulation on administrative cooperation through the Internal Market Information System PDF (1011 KB) DOC (1 MB)
Shadow reports (5)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 261/2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights and Regulation (EC) No 2027/97 on air carrier liability in respect of the carriage of passengers and their baggage by air PDF (921 KB) DOC (1 MB)
REPORT on the implementation of the Professional Qualifications Directive (2005/36/EC) PDF (243 KB) DOC (180 KB)
REPORT on modernisation of public procurement PDF (366 KB) DOC (266 KB)
REPORT on a Single Market for Enterprises and Growth PDF (352 KB) DOC (245 KB)
REPORT Report on new developments in public procurement PDF (287 KB) DOC (186 KB)
Opinions (3)
OPINION Proposal for a directive of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare
OPINION Proposal for a regulation of the European Parliament and of the Council on the provision of food information to consumers
OPINION on asylum: practical cooperation and quality of decision-making in the common European asylum system
Shadow opinions (7)
OPINION on the proposal for a regulation of the European Parliament and of the Council laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/EC and Regulations (EC) No 1211/2009 and (EU) No 531/2012
OPINION on an integrated parcel delivery market for the growth of e-commerce in the EU
OPINION The contribution of the EU Institutions to the consolidation and progress of the Bologna Process
OPINION on the proposal for a regulation of the European Parliament and of the Council entrusting the Office for Harmonisation in the Internal Market (Trade Marks and Designs) with certain tasks related to the protection of intellectual property rights, including the assembling of public and private sector representatives as a European Observatory on Counterfeiting and Piracy
OPINION on reducing health inequalities in the EU
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OPINION Proposal for a regulation of the European Parliament and of the Council 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
Amendments (795)
Amendment 3 #
2013/2043(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses the need to maintainonitor compliance with the prescribed driving and resting times and the working hours permitted by law, to reckon all tasks connected with the activity as working time and to monitor compliance with European standards on the protection of health and safety at work, including conditions in vehicles, for all people involved in making deliveries;-{}- irrespective of whether their employment status is self-employed, subcontractor, temporary staff member or contract worker; monitoring should take place by means of digital monitoring devices installed in the vehicle;
Amendment 4 #
2013/2043(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Welcomes the Commission’s commitment to simplifying cross-border parcel delivery for consumers and undertakings by enhancing the transparency of the delivery process, enabling tracking and setting quality standards to create a common European delivery market;
Amendment 5 #
2013/2043(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Considers ensuring reasonable employment conditions in the parcel distribution sector to be a prerequisite for the provision of high-quality delivery services, and essential to the social aspects of an integrated parcel delivery market, and therefore calls on the Member States to guarantee fair and decent working conditions and wages in this sector in order to prevent undeclared work and abuse and hence improve social rights and ensure fair competition between operators;
Amendment 6 #
2013/2043(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Stresses that companies operating in the parcel delivery sector often sub-contract, which can, for no justifiable reason, lead to an increase in competitive pressure, not least by swelling numbers of self-employed workers for cost-cutting motives, to the detriment of safety, social security cover and, ultimately, quality of service;
Amendment 7 #
2013/2043(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Stresses that the parcel delivery sector is one in which working conditions are often typified by precarious contracts, long working hours, excessive workloads and low wages;
Amendment 8 #
2013/2043(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Believes that the development of cross-border online trade also depends on customer confidence, and that the creation of a European network of national problem-solving centres like Solvit would help reassure consumers, as would an alert system like RAPEX, which could warn consumers of sites found to be using fraudulent practices;
Amendment 9 #
2013/2043(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers that the key to appropriate transformation and adaptation measures lies in employee training; regards it as the employer’s task to acquaint employees properly with new technologies such as IT and tracking applications and GPS systems, which can offer support as online delivery becomes more widespread and complex; in the case of temporary contracts, the agency supplying the staff must give them adequate preparation and training;
Amendment 10 #
2013/2043(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Notes the limited cross-border development of e-commerce by SMEs; encourages collaboration between SMEs to introduce shared online platforms and negotiate more advantageous delivery prices;
Amendment 15 #
2013/2043(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that the e-retailer places the order with the deliverer, and should therefore take responsibility for information on the conditions for parcel delivery and their tracea, based on the various options it offers, including as regards price, average delivery times, delivery guarantees and tracking and returns possibilityies;
Amendment 17 #
2013/2043(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Is critical of the extremely high amount of outsourcing which delivery firms undertake outside the regular postal service and the frequently accompanying evasion of legal and remuneration requirements with regard to conditions of work and employment; highlights in this context the long-term social implications of precarious employment for the continued existence of the Member States' health and welfare systems;
Amendment 17 #
2013/2043(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes that consumers like to have a choice between different delivery options, and that online retailers should therefore endeavour to offer a variety of options, including in the case of cross-border sales, and that delivery companies and postal operators should strive to offer as wide as possible a range of services and price rates for deliveries within the EU, including tracking and returns options, and different point of delivery possibilities;
Amendment 18 #
2013/2043(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls as a matter of principle, where parcel service operators deliver parcels themselves, for this to take place in accordance with working conditions agreed by collective bargaining or, where delivery is sub-contracted, in accordance with the principle of equal pay for equal work; calls on the Member States to introduce and strengthen laws on total corporate liability;
Amendment 23 #
2013/2043(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Regrets the fragmentation of the European postal sector into national networks with poor interoperability; calls on the Commission to introduce common labelling and traceability standards; consider drawing up mandates for standardisation, particularly in respect of labelling and traceability, based where appropriate on the work done by the various operators in the sector;
Amendment 24 #
2013/2043(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Stresses also that the slowdown in the growth of cross-border online trading cannot be blamed solely on shortcomings in delivery but is rather the result of uncertainties about consumer rights and rights protection in cross-border online trade; therefore calls on the Commission to take action in the field of consumer protection so as to further facilitate online trade;
Amendment 25 #
2013/2043(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 a. stresses the need to create an European e-Commerce Trustmark ensuring quality, reliability, environmental and social sustainability and adequate working conditions for integrated delivery services that could help improve consumer confidence in e- commerce, stimulate e-retailers and parcel firms to take more responsibility in the delivery chain, boost transparency as well as legal certainty for both consumers and businesses and increase competitive advantage of business, especially SMES, therefore contributing to sound economic growth and employment creation;
Amendment 28 #
2013/2043(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Encourages the development of labels and certificates for delivery services that can be recognised at European level and issued by the competent authorities, thus encouraging companies to improve their performance and giving consumers confidence in the reliabiquality of the services offered, not least as regards their reliability, environmental and social sustainability and the working conditions right along the distribution chain, including among sub-contractors;
Amendment 32 #
2013/2043(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Believes that the development of these labels will increase consumers’ confidence in online commerce, induce them to choose more sustainable methods of delivery and encourage online traders and delivery companies to take a responsible and sustainable approach to their distribution chains, thereby stimulating economic growth and job creation;
Amendment 35 #
2013/2043(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Believes that the relevance of a revision of Directive 2008/6/EC to meet the present challenges can only be assessed after analysis of the evaluation report on its implementation and in light of the efforts made by stakeholders., and calls on the Member States and the Commission to ensure the correct transposition and implementation of the existing regulatory framework, including Community competition law, Directive 2013/11/EU on alternative dispute resolutions and Directive 2011/83/EU on consumer rights;
Amendment 40 #
2013/2043(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Member States to comply with the drivers working times and rest times laid down in law, with the legislation establishing working times in the road haulage sector and with the need to enforce EU standards in the field of health and safety at work, including behind the wheel, for all delivery workers;
Amendment 42 #
2013/2043(INI)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission to hold discussions with the interested parties on the issue of the ‘last mile’ in urban areas, taking into account factors relating to the environment, methods of transport, town planning, quality and choice of services and competition rules.
Amendment 136 #
2013/0309(COD)
Proposal for a regulation
Article 19
Article 19
Amendment 162 #
2013/0309(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
End-users shall be freehave the right to access and distribute information and content, run applications, connect hardware and use services of their choice via their internet access service. Internet service providers may not as a result block, discriminate against or degrade – including through overcharging or preferential treatment – a person’s ability to use a service, gain access to, use, send, post, receive or give any content, application or service of his choosing, whatever its origin or destination.
Amendment 169 #
2013/0309(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Amendment 195 #
2013/0309(COD)
Proposal for a regulation
Article 23 – paragraph 5 – subparagraph 1 – introductory part
Article 23 – paragraph 5 – subparagraph 1 – introductory part
Amendment 289 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 1 c (new)
Article 36 – paragraph 1 – point 1 c (new)
Directive 2002/22/EC
Article 20 – paragraph 1
Article 20 – paragraph 1
Article 20(1)c is amended as follows: "1. Member States shall ensure that, when subscribing to services providing connection to a public communications network and/or publicly available electronic communications services, consumers, and other end-users so requesting, have a right to a contract with an undertaking or undertakings providing such connection and/or services. The contract shall specify in a clear, comprehensive and easily accessible form at least: (a) the identity and, address of the undertaking; (b)and contact information of the undertaking and, if different, the address and contact information for any complaints; (b) the main characteristics of the services provided, including in particular, whether or not access to emergency services and caller location information is being provided, and any limitations on the provision of: – the specific tariff plan or tariff plans to which the contract applies and, for each such tariff plan, the types of services offered, including the volumes of communications; – in the case of tariff plans with a pre-set volume of communications, the possibility for consumers to defer any unused volume from the preceding billing period; – access to emergency services uander Article 26, information on any other conditions limiting access to and/or use of services and applications, where such conditions are permitted under national law in accordance with Community law, — caller location information for all relevant services offered, any limitations on the provision of emergency services under Article 26, and any changes thereto; – the minimum service quality levels offered, namely the time for the initial connection and, where appropriate, other quality of service parameters, as defined by the national regulatory authorities, — information on any procedures put in place by the undertaking to measure; – the types of after-sales services, maintenance service and customer support services provided, the conditions and schape traffic so as to avoid filling or overfilling a network link, and information on how those procedures could impact on service quality, — the types of maintenance service offered and customer support services provided, as well as the means of contacting these services, — any restrictions imposed by the provider on the use of terminal equipment suppliedrges for these services, as well as the means of contacting these services; any restrictions imposed by the provider on the use of terminal equipment supplied, including information on unlocking the terminal equipment and any charges involved if the contract is terminated before the end of the minimum contract period; – on demand, free of charge, and provided that no technical incompatibility has been identified, the technical information necessary for the end-user to ensure the proper functioning of his or her chosen terminal equipment for all the services foreseen in his or her contract; (c) where an obligation exists under Article 25, the subscriber’s options as to whether or not to include his or her personal data in a directory, and the data concerned; (d) details of prices and tariffs, including taxes and additional charges that may possibly be levied, the means by which up- to-date information on all applicable tariffs and maintenance charges may be obtained,; (da) payment methods offered and any differences in costs due to payment method, and available facilities to safeguard bill transparency and monitor the level of consumption; (e) the duration of the contract and the conditions for renewal and termination of services and of the contract, including: – any minimum usage or duration required to benefit from promotional terms; —– any charges related to switching and portability of numbers and other identifiers, —including compensation arrangements for delay or abuse of switching; – any charges due on early termination of the contract, including any cost recovery with respect to terminal equipment, (f) any compensation and the refund arrangements which apply if contracted service quality levels are not met; (g) the means of initiating procedures for the settlement of disputes in accordance with Article 34 (on the basis of customary depreciation methods) and other promotional advantages (on a pro rata temporis basis); (f) any compensation and the refund arrangements, including, where applicable, an explicit reference to statutory rights of the consumer which apply if contracted service quality levels are not met; (g) the means of initiating procedures for the settlement of disputes, including cross- border disputes, in accordance with Article 34; (ga) details on how disabled end-users can obtain information on products and services designed for them; (h) the type of action that might be taken by the provider in reaction to security or integrity incidents or threats and vulnerabilities. Member States may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content, and on the means of protection against risks to personal security, privacy and personal data, referred to in Article 21(4) and relevant to the service provided." lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:337:0011:01:EN:HTML)Or. fr (http://eur-
Amendment 292 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 1 d (new)
Article 36 – paragraph 1 – point 1 d (new)
Directive 2002/22/EC
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
(1d) in Article 20, the following paragraph is inserted: “1 a. In addition to the information referred to in paragraph 1, if the contract includes the provision of internet access and data services, that contract shall also include the following information: (a) details of unit data pricing plans, pricing plans for bulk data and any applicable thresholds. For data volumes above thresholds, unit or bulk pricing on an ad hoc or lasting basis and any data speed limitations that may be applied; (b) the means at the disposal of end-users to follow their level of consumption and to fix any voluntary limits, if these entail additional charges in the case of contracts that include fixed data volumes; (c) for fixed data links, the actual available download and upload data speeds at the location of the end-user; (d) for mobile data, the average estimated download and upload speeds that might be experienced from normal wireless network coverage, and the speed ranges that might be experienced; (e) other quality of service parameters, as defined in Article 24 (2) of Regulation (XXX)*; (f) information on any procedures put in place by the provider to measure and shape traffic, pursuant to Article 23(5) of the Regulation (XXX)*, including an indication of the underlying communication inspection methods used for reasonable traffic management measures and information on how those procedures could impact on service quality, end-users’ privacy and the protection of personal data; and (g) a clear and comprehensible explanation as to how any volume limitation, the actually available speed ranges and other quality of service parameters may practically impact the use of content, applications and services; (h) a clear and comprehensible explanation of the distribution of available bandwidth between the internet access service and specialised services, the consequences that this distribution may have on the use of content, applications and services, with priority being given to internet access, unless the consumer decides otherwise. _________________ * Regulation (EU) No XXX/20XX of the European Parliament and of the Commission of … laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/CE and Regulations (EC) No 1211:/2009 and (EU) No 531/2012 (OJ L XXX, XX.XX.20XX, p. X).”
Amendment 296 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 1 g (new)
Article 36 – paragraph 1 – point 1 g (new)
Directive 2002/22/EC
Article 20 a (new)
Article 20 a (new)
Amendment 303 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 1 k (new)
Article 36 – paragraph 1 – point 1 k (new)
Directive 2002/22/EC
Article 21 – paragraph 3
Article 21 – paragraph 3
(1 k) In Article 21, paragraph 3 is amended as follows: “3. Member States shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and/or publicly available electronic communications services to inter alia: (a) provide applicable tariff information to subscribers regarding any number or service subject to particular pricing conditions; with respect to individual categories of services, national regulatory authorities may require such information to be provided immediately prior to connecting the call; (b) inform subscribers of any change to access to emergency services or caller location information in the service to which they have subscribed; (c) information on any othprovide end-users with access to emergency services and caller location information for all relevant services offered, any limitations on the provision of emergency services under Article 26, and any changes thereto; (da) provide information on internet access services, where offered, specifying the following: (i) for fixed data links, the actual available download and upload data speeds in the end-user’s place of residence, and for mobile data, the average estimated download and upload speeds that might be experienced from normal wireless network coverage, and the speed ranges that might be experienced; (ii) details of unit data pricing plans, pricing plans for bulk data and any applicable thresholds. For data volumes above thresholds, unit or bulk pricing on an ad hoc or lasting basis and any data speed limitations that may be applied; (iii) how end-users conditions limiting access to and/or use of services and applications, where such conditions are permitted under national law in accordance with Community law, (d) provide information on any procedures put in place by the provider to measure and shape traffic so as to avoid filling or overfilling a network link, and on how those procedures could impact on service quality; (e) inform subscribersan monitor the current level of their consumption, and set any voluntary limitations; (iv) a clear and comprehensible explanation as to how any volume limitation, the actually available speed and other quality parameters may practically impact the use of content, applications and services; (v) a clear and comprehensible explanation of the distribution of available bandwidth between the internet access service and specialised services, the consequences that this distribution may have on the use of content, applications and services, with priority being given to internet access, unless the consumer decides otherwise; (vi) information on any procedures put in place by the provider to measure and shape traffic, pursuant to Article 23(5) of the Regulation (XXX)*, including an indication of the underlying communication inspection methods used for reasonable traffic management measures and information on how those procedures could impact on service quality, end-users’ privacy and the protection of personal data; (e) inform consumers, and end-users where applicable, of their right to determine whether or not to include their personal data in a directory, and of the types of data concerned, in accordance with Article 12 of Directive 2002/58/EC (Directive on privacy and electronic communications); and (f) regularly inform disabled subscribersconsumers, and end-users, where applicable, of details of products and services designed for them and the measures taken to ensure equivalence in access. If deemed appropriate, national regulatory authorities may promote self- or co- regulatory measures prior to imposing any obligation.” __________________ * Regulation (EU) No XXX/20XX of the European Parliament and of the Commission of … laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/CE and Regulations (EC) No 1211:/2009 and (EU) No 531/2012 (OJ L XXX, XX.XX.20XX, p. X).” Or. fr (http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:337:0011:01:EN:HTML)
Amendment 310 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 2 Directive 2002/22/EC
Article 36 – paragraph 1 – point 2 Directive 2002/22/EC
(2) Articles 20, 21, 22 and 30 are2 is deleted.
Amendment 312 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 2 a (new)
Article 36 – paragraph 1 – point 2 a (new)
Directive 2002/22/EC
Article 26
Article 26
(2 a) Article 26 is modified as follows: “Article 26 "Article 26 Single European emergency call number 1. Member States shall ensure that, in addition to any other national emergency call numbers specified by the national regulatory authorities, all end-users of publicly available telephone services, including users of public pay telephone all end- users of the service referred to in paragraph 2, including users of public pay telephones and of private telecommunications networks, are able to call the emergency services free of charge and without having to use any means of payment, by using the single European emergency call number “"112”" and any national emergency call number specified by Member States. 2. Member States, in consultation with national regulatory authorities, emergency services and providers, shall ensure that undertakings providing end-users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services. End-users must also be able to reach “112” directly when calling from a private telecommunications network. 3. Member States shall ensure that calls to the single European emergency call number “”112” are appropriately answered and handled in the manner best suited to the national organisation of emergency systems. Such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers, where these continue to be in use. The Commission, having consulted the national regulatory authorities and emergency services, must define the compulsory performance indicators applicable to the Member States. 4. Member States shall ensure that access for disabled end-users to emergency services is equivalent to that enjoyed by other end-users. Measures taken to ensure that disabled end-users are able to access emergency services whilst travelling in other Member States shall be based to the greatest extent possible on European standards or specifications published in accordance with the provisions of Article 17 of Directive 2002/21/EC (Framework Directive), and they shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in this Article. 5. Member States shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority. This shall apply to all calls to the single European emergency call number "112", including calls from private telecommunications networks and roaming calls. Member States may extend this obligation to cover calls to national emergency numbers. Competent regulatory authorities shall lay down criteria for the accuracy and reliability of the caller location information provided. 6. Member States shall ensure that citizens are adequately informed about the existence and use of the single European emergency call number "112", in particular through initiatives specifically targeting persons travelling between Member States. 7. In order to ensure effective access to “112” services in the Member States, the Commission, having consulted BEREC, may adopt technical implementing measures. However, these technical implementing measures shall be adopted without prejudice to, and shall have no impact on, the organisation of emergency services, which remains of the exclusive competence of Member States. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 37(2)." lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:337:0011:01:EN:HTML)By (6 months after the entry into force of the Regulation (XXX)*) at the latest, BEREC, having consulted the stakeholders and in close collaboration with the Commission, shall set the obligatory criteria for the accuracy and reliability of the caller location information to be provided to the emergency services. The Member States must be in compliance with these criteria no later than one year after their publication. The Commission must also guarantee by (18 months following the entry into force of the Regulation (XXX)**) that the levels of accuracy and reliability of caller location information for a call made to “112” from a GNSS-enabled mobile terminal are equivalent to the levels for an eCall call. 6. Member States and the Commission shall ensure that citizens are adequately informed about the existence and use of the single European emergency call number “112”, in particular through initiatives specifically targeting persons travelling between Member States. The Commission shall support and supplement the actions of the Member States. 7. In order to ensure effective access to “112” services in the Member States, the Commission, having consulted BEREC, shall adopt technical implementing measures. These measures must, inter alia, enable the deployment of an interoperable, next generation 112 service, including multimedia applications, no later than (four years following the entry into force of the Regulation (XXX)***. However, these technical implementing measures shall be adopted without prejudice to, and shall have no impact on, the organisation of emergency services, which remains of the exclusive competence of Member States. 7 a. The Commission shall maintain a database of E.164 European emergency service numbers in order to ensure that they can be contacted in one Member State from another. __________________ * Regulation (EU) No XXX/20XX of the European Parliament and of the Commission of … laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/CE and Regulations (EC) No 1211:/2009 and (EU) No 531/2012 (OJ L XXX, XX.XX.20XX, p. X). ** Regulation (EU) No XXX/20XX of the European Parliament and of the Commission of … laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/CE and Regulations (EC) No 1211:/2009 and (EU) No 531/2012 (OJ L XXX, XX.XX.20XX, p. X). *** Regulation (EU) No XXX/20XX of the European Parliament and of the Commission of … laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/CE and Regulations (EC) No 1211:/2009 and (EU) No 531/2012 (OJ L XXX, XX.XX.20XX, p. X).” Or. fr (http://eur-
Amendment 317 #
2013/0309(COD)
Proposal for a regulation
Article 36 – paragraph 1 – point 2 e (new)
Article 36 – paragraph 1 – point 2 e (new)
Directive 2002/22/EC
Article 26 a (new)
Article 26 a (new)
Amendment 24 #
2013/0265(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In order to facilitate cross border acquiring all (cross-border and domestic) 'consumer' debit card transactions and card based payment transaction should have a maximum interchange fee of 0,20% and all (cross-border and domestic)domestic or cross-border, consumer credit card transactions and card based payment transactions based on those should have a maximum interchange fee of 0.30%.
Amendment 50 #
2013/0265(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. With effect from two months after the entry into force of this Regulation, payment services providers shall not offer or request for cross-border debit card transactions a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,23 % of the value of the transaction.
Amendment 51 #
2013/0265(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 60 #
2013/0265(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. With effect from twoone years after the entry into force of this Regulation, payment service providers shall not offer or request a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,23 % of the value of the transaction for any debit card based transactions.
Amendment 62 #
2013/0265(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 77 #
Amendment 79 #
2013/0265(COD)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. Any reduction in interchange fees under Articles 3 and 4 of this Regulation or decided on by the competent authorities referred to under Article 13 must be accompanied by an at least equivalent reduction in merchant service charges payable by recipients to acquiring service payment providers.
Amendment 91 #
2013/0265(COD)
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
One year from the entry into force of this regulation, the Commission shall report to the European Parliament and the Council on the impact on the functioning of the internal market of three party domestic payment fees applying to cross border transactions and, if necessary, draft a legislative proposal seeking to alleviate the negativel effects thereof.
Amendment 149 #
2013/0246(COD)
Proposal for a directive
Article 2 – paragraph 1 – subparagraph 1 (new)
Article 2 – paragraph 1 – subparagraph 1 (new)
Member States may require not only traders, as defined in Article 3(7), but also any not-for-profit organisation that plans and/or sells packages, including on an occasional basis, to meet the obligations laid down in this Directive, with the exception of Article 17.
Amendment 198 #
2013/0246(COD)
Proposal for a directive
Article 3 – point 6
Article 3 – point 6
(6) ‘travellconsumer’ means any person who is seeking to conclude or is entitled to travel on the basis of a contract concluded within the scope of this Directive, including business travellers insofar as they do not travelfor professional (‘business travel’) purposes, provided that the journey is not made on the basis of a framework contract with a trader specialising in the arrangement of business travel;
Amendment 199 #
2013/0246(COD)
Proposal for a directive
Article 3 – point 6 a (new)
Article 3 – point 6 a (new)
(6a) ‘traveller’ means any person who is entitled to travel on the basis of a contract concluded within the scope of this Directive, including for professional purposes, whether or not he/she is the consumer who concluded the contract;
Amendment 289 #
2013/0246(COD)
Proposal for a directive
Article 9 – paragraph 2 – introductory part
Article 9 – paragraph 2 – introductory part
2. If, before the start of the package, the organiser is constrained to alter significantly any of the main characteristics of the travel services as defined in point (a) of Article 4 or special requirements as referred to in point (a) of Article 6(2), the organiser shall without undue delay inform the traveller in a clear and prominent manner on a durable medium and, provided that the consumer has supplied his/her contact details, by any other means of communication of:
Amendment 294 #
2013/0246(COD)
Proposal for a directive
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) the fact that the traveller may terminate the contract without penaltyconsumer must explicitly accept the proposed change within a specified reasonable time-limit and that otherwise the proposed alteration will be considered as accepcontract will be terminated.
Amendment 315 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that the organiser isand/or the retailer party to the contract is/are responsible for the performance of the travel services included in the contract, irrespective of whether those services are to be performed by the organiser or by other service providerand/or the retailer party to the contract or by other service providers and without prejudice to the right of the organiser and/or retailer to pursue those other suppliers of services.
Amendment 333 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 5
Article 11 – paragraph 5
5. As long as it is impossible to ensure the traveller'’s timely return because of unavoidable and extraordinary circumstances, the organiser shall not beacover the cost for the continued stay exceeding EUR 100 per night and three nights per travellerfor no longer than the period required for the traveller’s return to his/her place of departure, provided that such cost is reasonable and having regard in particular to the available accommodation, the category of services and accommodation initially provided for in the contract and any injury sustained by the traveller in respect of which the organiser is responsible under Article 11(1).
Amendment 342 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 6
Article 11 – paragraph 6
6. The limitIn the evaluation of the costs referred to in paragraph 5 shall not apply toaccount must be taken of the needs of persons with reduced mobility, as defined in Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air28, and any person accompanying them, pregnant women and unaccompanied children, as well as persons in need of specific medical assistance, provided the organiser has been notified of their particular needs at least 48 hours before the start of the package. The organiser may not invoke unavoidable and extraordinary circumstances to limit the costs referred to in paragraph 5 if the relevant transport provider may not rely on such circumstances under applicable Union legislation. __________________ 28 OJ L 204, 26.07.06, p. 1 OJ L 204, 26.7.2006, p. 1.
Amendment 348 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) any period during which there was lack of conformity contract was not performed or was improperly performed; or
Amendment 352 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 3 – introductory part
Article 12 – paragraph 3 – introductory part
3. The traveller shall not be entitled to price reduction or compensation for damages ifWith regard to entitlement to compensation for damage resulting for the consumer from the failure to perform or the improper performance of the contract, Member States shall take the necessary steps to ensure that the organiser and/or retailer is/are liable unless such failure to perform or improper performance is attributable neither to any fault of theirs nor to that of another supplier of services, because:
Amendment 361 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 3 – point a – point iii
Article 12 – paragraph 3 – point a – point iii
(iii) due to unavoidable and extraordinary circumstancesa case of force majeure, i.e. unusual and unforeseeable circumstances beyond the control of the party by whom it is pleaded, the consequences of which could not have been avoided even if all due care had been exercised, or to an event which the organiser and/or retailer or the supplier of services, even with all due care, could not foresee or forestall or
Amendment 366 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 3 – point b
Article 12 – paragraph 3 – point b
(b) the traveller fails to inform the organiser without undue delay of any lack of conformityexcept in cases of compensation for bodily injury or death, the traveller fails to inform the organiser and/or the retailer, at the earliest possible opportunity, of any lack of performance or improper performance of the services which the traveller perceives on the spot if that information requirement was clearly and explicitly stated in the contract and is reasonable, taking into account the circumstances of the case.
Amendment 370 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 4
Article 12 – paragraph 4
4. IWith regard to damage, other than bodily injury or death, resulting from the failure to perform or the improper performance of the contract, insofar as international conventions binding the Union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package, the same limitations shall apply to the organiser. IExcept in cases of bodily injury or death, insofar as international conventions not binding the Union limit compensation to be paid by a service provider, Member States may limit compensation to be paid by the organiser accordingly. In other casesWith regard to damage, othe contract may limit compensation to be paid by the organiser as long as that limitation does not apply to personal injury and damage caused intentionally or with gross negligence and does not amount to less than three times the total price of the packager than bodily injury or death, resulting from the failure to perform or the improper performance of the contract, Member States may permit a contractual limitation of the compensation, provided it is not unreasonable. Without prejudice to such a limitation, the contract may not provide for the non-application of the provisions of paragraphs 1, 2, 3 or 4.
Amendment 415 #
2013/0246(COD)
Proposal for a directive
Article 17 – paragraph 1 – point b a (new)
Article 17 – paragraph 1 – point b a (new)
(ba) that the consumer will, however, benefit from the rights granted by Directive 2011/83/EU except where this Directive provides otherwise.
Amendment 6 #
2013/0166(COD)
Proposal for a decision
Recital 3
Recital 3
(3) Commission Delegated Regulation (EU) No 305/2013 of 26 November 2012 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the harmonised provision for an interoperable EU-wide eCall21 establishes the specifications for upgrading the Public Safety Answering Point (PSAP) infrastructure required for the proper receipt and handling of eCalls using the 112 number, in order to ensure the compatibility, interoperability and continuity of the harmonised EU-wide eCall service. ______________________________ 21 OJ L 91, 3.4.2013, p. 1. OJ L 91, 3.4.2013, p. 1.
Amendment 7 #
2013/0166(COD)
Proposal for a decision
Recital 3 a (new)
Recital 3 a (new)
(3a) eCall reception centres conforming to standard EN 16102 already exist. Under paragraph (f) of Annex II of Directive 2010/40/EU, the principle of backward compatibility with existing systems must be respected, and it is therefore necessary to take the operation of these centres into account.
Amendment 11 #
2013/0166(COD)
Proposal for a decision
Recital 8 a (new)
Recital 8 a (new)
(8a) To ensure equal access to 112 and emergency services for all citizens, procedures for the location of 112 calls from mobile terminals with GNSS applications should be comparable in terms of accuracy and reliability to eCall location procedures. Article 26 of Directive 2009/136/EC provides that the competent regulatory authorities shall lay down criteria for the accuracy and reliability of caller location information and that the Commission may, after consultation with BEREC, adopt technical implementing measures.
Amendment 16 #
2013/0166(COD)
Member States shall deploy no later than 1 OctoberJune 20156 the necessary eCall PSAP infrastructure required for the proper receipt and handling of all eCalls, if necessary purged of non-emergency calls, on their territory, in accordance with the specifications laid down by Delegated Regulation (EU) No 305/2013, in order to ensure the compatibility, interoperability and continuity of the interoperable EU- wide eCall service. Member States shall also guarantee that procedures for the location of 112 calls from mobile terminals with GNSS applications are equivalent in terms of accuracy and reliability to eCall location procedures. This is without prejudice to the right of each Member State to organise its emergency services in the way most cost effective and appropriate to its needs, including the possibility to filter calls that are not emergency calls and may not be handled by eCall PSAPs, in particular in the case of manually triggered eCalls.
Amendment 17 #
2013/0166(COD)
Proposal for a decision
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
A Member State may choose to outsource all or some 112 eCall services, though public service delegation, to assistance providers recognized by that Member State.
Amendment 381 #
2013/0157(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
This Chapter and the transitional provisions of Article 24 shall notonly apply to cargo handlbunkering services and passenger servicort reception facilities.
Amendment 180 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
Regulation (EC) No 261/2004
Article 1 – paragraph 1
Article 1 – paragraph 1
(-1) Article 1(1) is amended as follows: ‘1. This Regulation establishes, under the conditions specified herein, minimum rights for passengers when: (a) they are denied boarding against their will; (b) their flight is cancelled; (c) the departure of their flight is delayed; (d) their seats are downgraded.’
Amendment 182 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point b a (new)
Article 1 – paragraph 1 – point 1 – point b a (new)
Regulation (EC) No 261/2004
Article 2 – point f
Article 2 – point f
(ba) The following sentence is added to the definition of ‘ticket’ in point (f): ‘with that document constituting the passenger’s contract of carriage and comprising one or more flight coupons corresponding to reservations on one or more flights, which may or may not be connecting flights;’
Amendment 195 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point m
Article 2 – point m
Amendment 220 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point s
Article 2 – point s
Amendment 228 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point y a (new)
Article 2 – point y a (new)
In Article 2, the following point is inserted: ‘(ya) ‘delay in departure’ means the difference between the departure time for the flight indicated on the passenger’s ticket and the time at which the flight actually departs;’
Amendment 229 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point y b (new)
Article 2 – point y b (new)
In Article 2, the following point is inserted: ‘(yb) ‘delay in arrival’ means the difference between the arrival time for the flight indicated on the passenger’s ticket and the time at which the flight actually arrives, or the difference between the time the passenger is due to arrive at his/her destination according to his/her ticket and his/her actual time of arrival;
Amendment 230 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point y c (new)
Article 2 – point y c (new)
In Article 2, the following point is inserted: ‘(yc) ‘travel class’ means a section of the passenger cabin on the aircraft in which a different service is provided from that provided in the other part/s of the passenger cabin;’
Amendment 231 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point y d (new)
Article 2 – point y d (new)
In Article 2, the following point is inserted: ‘(yd) ‘flight concerned’ means the flight on which the passenger has a confirmed reservation, or on which he/she has been rerouted;’
Amendment 232 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point e
Article 1 – paragraph 1 – point 1 – point e
Regulation (EC) No 261/2004
Article 2 – point y e (new)
Article 2 – point y e (new)
In Article 2, the following point is inserted: ‘(ye) ‘rerouting’ means an offer of alternative transport at no additional price that enables the passenger to reach his/her final destination;’
Amendment 233 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 -a (new)
Article 1 – paragraph 1 – point 2 -a (new)
2. (-a) Article 3(1)(b) is amended as follows: ‘(b) to passengers on a flight departing from an airport located in a third country to an airport situated in the territory of a Member State to which the Treaty applies, unless they received benefits : - if the operating air carrier is a Community air carrier; - and if no legal framework compensation and were given assistancevering the incident experienced by the passenger/s exists in thate third country, if the operating air carrier of the flight concerned is a Community carrier. of departure, or if that legal framework is less advantageous for the passenger/s.’
Amendment 238 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 261/2004
Article 3 – paragraph 4
Article 3 – paragraph 4
Without prejudice to Article 8(6), this Regulation shall only apply to passengers transported by motorised fixed wing aircraft. However, where a part of the journey is carried out, in accordance with a single contract of carriage and on the basis of a single reservation, by another mode of transport or by helicopter, this Regulation shall apply for the whole journey and the part of the journey carried out by another mode of transport shall be considered as a connecting flight for the purposes of this Regulation.' The air carrier shall be responsible for ensuring that this Regulation applies for the whole journey.’
Amendment 239 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b a (new)
Article 1 – paragraph 1 – point 2 – point b a (new)
Regulation (EC) No 261/2004
Article 3 – paragraph 5
Article 3 – paragraph 5
2(ba) In Article 3(5) the following sentence is added: ‘Where the passenger travels on the flight of an operating air carrier to which this Regulation does not apply, when the passenger has a contract of carriage with an air carrier to which this Regulation would apply were it to have been the operating air carrier, the operating air carrier shall apply the relevant provisions of this Regulation to the passenger.’
Amendment 267 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 261/2004
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
In Article 4(5), the following paragraph shall be inserted: 5a. At the latest 48 hours prior to departure, passengers shall be able to change the date, time and/or destination of their booking with the air carrier, by paying an additional charge for this purpose where necessary.
Amendment 269 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 b a (new)
Article 1 – paragraph 1 – point 3 b a (new)
Regulation (EC) No 261/2004
Article 4 a (new)
Article 4 a (new)
The following Article 4a shall be inserted: Multiple-leg tickets 1. Where a multiple-leg ticket may be used for successive flights, the air carrier or ticket seller within the meaning of Regulation (EC) No 2111/2005 shall ensure that the passenger was fully aware of the specific conditions on which the fare being offered depends, and shall ask the passenger to contact the carrier, using the contact details provided, in the event that he/she is unable to take one of the flights. 2. Where a passenger has not undertaken his/her outward flight or journey or his/her feeder flight, the carrier shall not cancel the booking for the return flight or journey or subsequent flight. 3. Where the passenger has contacted the carrier before his/her return flight or journey or subsequent flight, he/she may take the flight without any additional charge. 4. In cases other than those covered under paragraph 3, and where the carrier is able to affirm that the provisions of paragraph 1 have been met, the carrier may apply a fare supplement of no more than the difference between the price paid for the flight as specified on the ticket and the price of the flight alone on the date the booking was made.
Amendment 279 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point b
Article 1 – paragraph 1 – point 4 – point b
Regulation (EC) No 261/2004
Article 5 – paragraph 3
Article 5 – paragraph 3
An operating air carrier shall not be obliged to pay compensation in accordance with Article 7 if it can prove that the cancellation is caused by extraordinary circumstances and that the cancellation could not have been avoided even if all reasonable measures had been taken. Such extraordinary circumstances can only be invoked insofar they affect the flight concerned or the previous flighflight immediately preceding it operated by the same aircraft. Where no proof of the existence of extraordinary circumstances is provided, the compensation provided for in Article 7 shall be paid by the air carrier to the passengers.
Amendment 293 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
When an operating air carrier reasonably expects a flight’s departure to be delayed, or an operating carrier postpones the scheduled time of departure, beyond its originally scheduled time of departure, passengers shall be offered by the operating air carrier:
Amendment 295 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 1 – point i
Article 6 – paragraph 1 – point i
when the delay is of at least two hours, the assistanccare specified in Article 9(1)(a) and 9(2); and
Amendment 299 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 1 – point ii
Article 6 – paragraph 1 – point ii
when the delay is of at least five hours and includes one or several nights, the assistanccare specified in Article 9(1)(b) and 9(1)(c); and
Amendment 310 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
Amendment 321 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
Amendment 330 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 261/2004
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
twelven hours or more after the scheduled time of arrival for journeys to/from third countries of 6000 kilometres or morenot covered under points (a) or (b).
Amendment 360 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 261/2004
Article 6 a – paragraph 1 – introductory part
Article 6 a – paragraph 1 – introductory part
Where a passenger misses a connecting flight at an airport located in the area in which the Treaty on European Union applies as a result of a delay or change of schedule to a precedingthe feeder flight, the Community air carrier operating the onward connectingfeeder flight shall offer the passenger:
Amendment 361 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 261/2004
Article 6 a – paragraph 1 – point i
Article 6 a – paragraph 1 – point i
the assistanccare specified in Article 9(1)(a) and 9(2) if the passenger's waiting time for the connection is prolonged by at least two hours; and
Amendment 367 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 261/2004
Article 6 a – paragraph 2
Article 6 a – paragraph 2
Where a passenger misses a connecting flight as a result of a delay to a preceding connecting flight, the passenger shall have a right to compensation by the Community air carrier operating that preceding flight in accordance with Article 6(2). For these purposes, the delay shall be calculated by reference to the scheduled time of arrival at the final destinationt an airport located in the area in which the Treaty on European Union applies as a result of a delay or change of at least 90 minutes to the schedule for the feeder flight at the transfer point, the passenger shall have a right to compensation by the Community air carrier operating that feeder flight under the conditions laid down in Article 7(1)(a), and without prejudice to Article 5(3)(e).
Amendment 402 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 261/2004
Article 8 – paragraph 3
Article 8 – paragraph 3
Amendment 412 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 261/2004
Article 8 – paragraph 6
Article 8 – paragraph 6
Whenever passengers are offered, pursuant to paragraph 1, a total or partial rerouting by another mode of transport, this Regulation shall apply to the transport carried out by that other mode of transport as if it were carried out by fixed wing aircraft. The air carrier shall continue to be responsible for application of this Regulation for the whole of the journey.
Amendment 414 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point a
Article 1 – paragraph 1 – point 9 – point a
Regulation (EC) No 261/2004
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
transport betweenfrom the airport andto the place of accommodation (hotel, place of residence of the passenger or other) and back.
Amendment 421 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point b
Article 1 – paragraph 1 – point 9 – point b
Regulation (EC) No 261/2004
Article 9 – paragraph 4
Article 9 – paragraph 4
If the operating air carrier can prove that the cancellation, delayed departure or change of schedule is caused by extraordinary circumstances and that the cancellation, delayed departure or change of schedule could not have been avoided even if all reasonable measures had been taken, it may limit the total cost oflength of time for which accommodation is provided according to paragraph 1(b) to a maximum of three nights. After three nights, the air carrier may limit the total cost of accommodation to EUR 1080 per night and per passenger and to a maximum of 3. In the event the passenger decides to arrange his own accommodation, the air carrier may limit the costs of the accommodation to EUR 125 per night and to three nights. If the operating air carrier chooses to apply this limitation, it shall nevertheless provide the passengers with information about available accommodation after the three nights, in addition to the continued obligations for information specified in Article 14.
Amendment 436 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 261/2004
Article 11 – paragraph 3
Article 11 – paragraph 3
The operating air carrier shall not apply the limitations set out in Articles 9(4) and 9(5): a) if the passenger is a person with a disability or reduced mobility or any person accompanying him/her, an unaccompanied child, a pregnant woman or a person in need of specific medical assistance, on condition the air carrier or its agent or the organiser has been notified of their particular needs for assistance at least 48 hours before the scheduled time of departure of the flight,. Such notification shall be deemed to cover the entire journey and the return journey if both journeys have been contracted with the same air carrierare shown on the same ticket; b) if the passenger is a pregnant woman or an unaccompanied child. Air carriers shall also endeavour to ensure good care is taken of guide dogs and assistance dogs. Information about assistance and the arrangements available in line with point a) shall be made known through various accessible means of communication.
Amendment 441 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) No 261/2004
Article 13
Article 13
In cases where an operating air carrier pays compensation or meets the other obligations incumbent on it under this Regulation, no provision of this Regulation or of national law may be interpreted as restricting its right to seek compensation for the costs incurred under this Regulation from any third parties which contributed to the event triggeringrom any person, including third parties, in accordance with the law applicable. In particular, this Regulation shall in no way restrict the operating air carrier's right to seek compensation from an organiser or other person with whom the operating air carrier has a contract. Similarly, no provision of this Regulation may be interpreted as restricting the right of a tour operator or a third party, other than a passenger, with whom the operating air carrier has the contract, to seek compensation or ofrom ther obligationperating air carrier in accordance with applicable relevant laws.'
Amendment 481 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EC) No 261/2004
Article 16a – paragraph 1
Article 16a – paragraph 1
At the time of reservation, air carriers or ticket sellers within the meaning of Article 2(d) of Regulation (CE) 2111/2005, shall provide information to passengers on their claim and complaint handling processes in relation to the rights set out in this Regulation and on the relevant contact addresses, to which passengers can submit claims and complaints, including via electronic means of transmission. The air carrier shall also inform passengers of the body or bodies competent for handling passenger complaints.
Amendment 489 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EC) No 261/2004
Article 16a – paragraph 2
Article 16a – paragraph 2
If a passenger wants to make a complaint to the air carrier with regard to his rights under this Regulation, he shall submit it within 36 months from the date on which the flight was performed or was scheduled to be performed. Within 7 days of receiving the complaint, the carrier shall confirm the receipt of the complaint to the passenger. Within two months of receiving the complaint, the carrier shall provide a full answer to the passenger.
Amendment 516 #
2013/0072(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
The Commission shall report to the European Parliament and the Council by 1 January 2017 on the operation and the results of this Regulation, in particular with regard to the impact of the compensation for long delays and the limitation of accommodation in extraordinary circumstances of long duration. The Commission shall also report on the enhanced protection of air passengers on flights from third countries operated by non-Community carriers, in the context of international air transport agreements. The Commission shall also report on the effectiveness of the measures taken and sanctions imposed by the bodies referred to in Article 16 and the possible need for a harmonised approach; the report shall be accompanied, if necessary, by legislative proposals.
Amendment 521 #
2013/0072(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
Regulation (EC) No 2027/97
Article 3 – paragraph 2
Article 3 – paragraph 2
The Community air carrier shall provide a complaint form at the airport situated on the territory where the Treaty on European Union applies and at those situated in third countries served by a Community carrier which allows the passenger to immediately submit such a complaint about damaged or delayed baggage. Such a complaint form, which may take the form of a Property Irregularity Report (PIR), shall be accepted by the air carrier at the airport as a complaint pursuant to Article 31(2) of the Montreal Convention. The complaint form shall also be made available to the passenger at all points of sale of the air carrier, including electronic sites, in respect of all transport operations by Community air carriers and transport to, from and within the European Union with regard to third-country air carriers. This possibility shall not affect the right of the passenger to submit a complaint via other means within the deadlines given by the Montreal Convention.
Amendment 538 #
2013/0072(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Regulation (EC) No 2027/97
Article 6d – paragraph 1
Article 6d – paragraph 1
Whilst air carriers have full commercial freedom to establish the conditions under which they permit baggage to be carried, they shall clearly indicate, at booking and at the check-in desks (including at self- service check-in machines), the maximum baggage allowance passengers are permitted to carry within the cabin and hold of the aircraft on each of the flights included within a passenger's reservation, including any restrictions on the number of items that would be applied within a given maximum baggage allowance. The price of the ticket indicated on booking shall include the carriage of hand luggage, registered luggage and essential items. Where additional charges are applied for the carriage of baggage air carriers shall clearly indicate details of those charges at booking and on request at the airport.
Amendment 119 #
2013/0049(COD)
Proposal for a regulation
Article 2 – paragraph 3 – point c
Article 2 – paragraph 3 – point c
Amendment 147 #
2013/0049(COD)
Proposal for a regulation
Article 5 – point b
Article 5 – point b
(b) in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a), as regards the risks covered by European standards, if it conforms to relevant European standards or parts thereof, the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17, and where appropriate, if it meets the additional health and safety requirements contained in the legislation of the Member State where the product is made available on the market;
Amendment 175 #
2013/0049(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(ba) the essential requirements contained in the standardisation mandates in accordance with Article 16 of this Regulation;
Amendment 222 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2
Article 8 – paragraph 4 – subparagraph 2
Where any of the European standards, health and safety requirements or other aspects referred to in point (c) of the first subparagraph have been only partly applied, the parts which have been applied shall be identified and, where appropriate, details shall be provided on how the risks covered by the parts which have not been applied have been taken into account.
Amendment 230 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 6
Article 8 – paragraph 6
6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product, accompanied in this case by the words 'information to be retained'.
Amendment 242 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 8 a (new)
Article 8 – paragraph 8 a (new)
8a.The instructions and safety information referred to in paragraph 8 shall be conspicuously placed and be readily visible, clearly legible and, where appropriate, indelible. They shall in no way be hidden, obscured, truncated or separated by other written or pictorial or any other matter.
Amendment 322 #
2013/0049(COD)
Proposal for a regulation
Article 14 – paragraph 1 – introductory part
Article 14 – paragraph 1 – introductory part
1. Economic operators shall, on request, identify the following toprovide the market surveillance authorities with the following information:
Amendment 324 #
2013/0049(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point a
Article 14 – paragraph 1 – point a
(a) the identity of any economic operator who has supplied them with the product, and the number of products involved and any complementary traceability information available;
Amendment 326 #
2013/0049(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point b
Article 14 – paragraph 1 – point b
(b) the identity of any economic operator to whom they have supplied the product., and the number of products involved and any complementary traceability information available;
Amendment 163 #
2013/0048(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. Where it is necessary and justified for carrying out their duties, market surveillance authorities may enter the premises of economic operators without prior warning, examine, seize or take copies of any and all documents, gain access to IT systems and take any necessary samples of products.
Amendment 181 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 1 – point c
Article 1 – point 1 – point c
Directive 2012/34/EU
Article 3 – point 31 – sub-point 1 a (new)
Article 3 – point 31 – sub-point 1 a (new)
For the purposes of this paragraph, the railway undertaking or undertakings are users of the infrastructure manager’s infrastructure.
Amendment 310 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 4
Article 1 – point 4
Directive 2012/34/EU
Article 7 b – paragraph 3 – subparagraph 1
Article 7 b – paragraph 3 – subparagraph 1
The infrastructure manager shall have a Ssupervisory Bboard which is composed of representatives of the ultimate owners of the vertically integrated undertaking and, where relevant, representatives of the regional public authorities concerned.
Amendment 386 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 4
Article 1 – point 4
Directive 2012/34/EU
Article 7 d – paragraph 1
Article 7 d – paragraph 1
1. Member States shall ensure that infrastructure managers set up and organise Coordination Committees for each network. Membership of this committee shall be open at least to the infrastructure manager, known applicants in the sense of Article 8(3), where relevant, the regional authorities concerned and, upon their request, potential applicants, their representative organisations, representatives of users of the rail freight and passenger transport services and, where relevant, regional and local authorities. Member State representatives and the regulatory body concerned shall be invited to the meetings of the Coordination Committee as observers.
Amendment 449 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 6 – point a
Article 1 – point 6 – point a
Directive 2012/34/EU
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States may limit the right of access provided for in Article 10(2) to passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route if the exercise of this right would compromise the economic equilibrium of the public service contract or contracts in question. Where a public service contract is awarded by means of a competitive tender procedure, in keeping with Union law, Member States may, in accordance with Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007, limit the right of access provided for in Article 10(2) of this Directive for the duration of the public service contract in question between a place of departure and a destination which are covered by the public service contract. Information concerning the limitation of this right of access shall be made public when the competitive tender procedure for the service contract is launched. The limitations referred to in this paragraph may not have the effect of restricting the right to take on passengers at a station situated on the route of an international service and to set them down at another, including at stations located in the same Member State, unless the exercise of that right is likely to compromise the economic equilibrium and/or the achievement of the service- quality objectives of the public service contract in question.
Amendment 457 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 6 – point b
Article 1 – point 6 – point b
Directive 2012/34/EU
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
In order to determine whether the economic equilibrium of a public service contract would be compromised, the relevant regulatory body or bodies referred to in Article 55 shall make an objective economic analysis and base its decision on pre-determined criteria, taking account of the cumulative effect of the services provided on the basis of free access. They shall determine this after a request from any of the following, submitted within onetwo months from the information on the intended passenger service referred to in Article 38(4):
Amendment 481 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2012/34/EU
Article 13 a – paragraph 1
Article 13 a – paragraph 1
1. Without prejudice to Regulation (EC) No 1371/2007 and Directive 2010/40/EU, Member States mayshall require railway undertakings operating domestic passenger services to participate in a common information andscheme. In addition, Member States may require railway undertakings operating domestic passenger services to participate in a common integrated ticketing scheme for the supply of tickets, through- tickets and reservations or decide to give the power to competent authorities to establish such a scheme. If such a scheme iss are established, Member States shall ensure that ithey does not create market distortion or discriminate between railway undertakings and that it is managed by a public or private legal entity or an association of all railway undertakings operating passenger services.
Amendment 552 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 8 e (new)
Article 1 – point 8 e (new)
Directive 2012/34/EU
Article 59 – paragraph 3 a (new)
Article 59 – paragraph 3 a (new)
In Article 59, the following paragraph 3a is added: 3a. Notwithstanding Article 13(3) of this directive, vertically integrated undertakings managing infrastructures of less than 150 km not connected to the principal network and offering public passenger rail transport services complying with technical specifications diverging substantially from traditional standards shall not be subject to Articles 7 to 7c.
Amendment 116 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Regulation (EC) No. 1370/2007
Article 2 – point c
Article 2 – point c
Amendment 134 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 1 – point b
Article 1 – point 1 – point b
Regulation (EC) No. 1370/2007
Article 2 – point e
Article 2 – point e
"The scope of public service obligations shall exmay include all public transport services that go beyond of what is necessaryhave the potential to reap local, regional or sub-national network effects.
Amendment 218 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 2
Article 1 – point 2
The specifications of public service obligations and the related compensation of the net financial effect of public service obligations shall: achieve the objectives of the public transport plan in the most cost- effective manner and financially sustain the provision of good quality public passenger transport in the long term.
Amendment 221 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 2
Article 1 – point 2
Regulation (EC) No. 1370/2007
Article 2 a (new) – paragraphe 4 – subparagraph 1 – point a
Article 2 a (new) – paragraphe 4 – subparagraph 1 – point a
Amendment 225 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 2
Article 1 – point 2
Regulation (EC) No. 1370/2007
Article 2 a (new) – paragraph 4 – subparagraph 1 – point b
Article 2 a (new) – paragraph 4 – subparagraph 1 – point b
Amendment 269 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 3 – point c
Article 1 – point 3 – point c
Regulation (EC) No. 1370/2007
Article 4 – paragraph 6
Article 4 – paragraph 6
Amendment 308 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 4 – point a
Article 1 – point 4 – point a
Regulation (EC) No. 1370/2007
Article 5 – paragraph 4 – subparagraph 1 - point b
Article 5 – paragraph 4 – subparagraph 1 - point b
where they concern the annual provision of less than 300 000 kilometres of public passenger transport services or less than 1500 000 kilometres in the case of a public service contract including public transport by rail.
Amendment 313 #
2013/0028(COD)
Proposal for a regulation
Article 1 – – point 4 – point a
Article 1 – – point 4 – point a
Regulation (EC) No. 1370/2007
Article 5 – paragraph 4 – subparagraph 1 - point b a (new)
Article 5 – paragraph 4 – subparagraph 1 - point b a (new)
(ba) where the technical specifications for rail systems used in public passenger transport by rail differ considerably from traditional standards and are not connected to the main network.
Amendment 362 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 5
Article 1 – point 5
Regulation (EC) No 1370/2007
Article 5 a (new) – paragraph 2 – subparagraph 2 – introductory part
Article 5 a (new) – paragraph 2 – subparagraph 2 – introductory part
The competent authority may comply with the requirement set out in the first subparagraph in one of the following waysways making for economies of scale, for example:
Amendment 370 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 5
Article 1 – point 5
Regulation (EC) No 1370/2007
Article 5 a (new) – paragraph 2 – subparagraph 2 – point d (new)
Article 5 a (new) – paragraph 2 – subparagraph 2 – point d (new)
(d) by establishing arrangements for cooperation with neighbouring local authorities so as to create a larger pool of rolling stock;
Amendment 373 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 5
Article 1 – point 5
Regulation (EC) No 1370/2007
Article 5 a (new) – paragraph 2 – subparagraph 2 – point c b (new)
Article 5 a (new) – paragraph 2 – subparagraph 2 – point c b (new)
(cb) by seeking a contribution from its Member State towards one of the arrangements for covering the residual value of rolling stock.
Amendment 137 #
2013/0016(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘rail system’ means the conventional and high-speed Union rail system as defined in Article 2 of Directive [xx on interoperability of the rail system];
Amendment 261 #
2013/0016(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. TheBefore any new service gets under way, a single safety certificate shall be granted by the Agency on the basis of the evidence that the railway undertaking has establishedput in place its safety management system in accordance with Article 9 and meets the requirements laid down in TSIs and in other reulevant legislations specific to the system in order to control risks and provide transport services safely on the network.
Amendment 104 #
2013/0015(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) ‘ Union rail system’ means the elements listed inof the conventional and high-speed rail systems listed in points 1 and 2 of Annex I;
Amendment 426 #
2013/0015(COD)
Proposal for a directive
Annex 1 – point 1 – paragraph 1
Annex 1 – point 1 – paragraph 1
For the purposes of this Directive, the Union’s network shall include: – the high- speed network as defined in letters (a), (b) and (c) and the conventional network as defined in letters (d) to (i): (a) specially built high-speed lines equipped for speeds generally equal to or greater than 250 km/h, –(b) specially upgraded high-speed lines equipped for speeds of the order of 200 km/h, –(c) specially upgraded high-speed lines which have special features as a result of topographical, relief or town-planning constraints, to which the speed must be adapted in each case. This category includes interconnecting lines between high-speed and conventional networks, lines through stations, accesses to terminals, depots, etc. travelled at conventional speed by ‘high-speed’ rolling stock. –(d) conventional lines intended for passenger services, –(e) conventional lines intended for mixed traffic (passengers and freight), –(f) conventional lines intended for freight services, –(g) passenger hubs, –(h) freight hubs, including intermodal terminals, –(i) lines connecting the abovementioned elements.
Amendment 430 #
2013/0015(COD)
Proposal for a directive
Annex 1 – point 2 – paragraph 1 – indent 3 a (new)
Annex 1 – point 2 – paragraph 1 – indent 3 a (new)
- high-speed vehicles designed to travel at speeds greater than 250 km/h on specially designed lines which allow for maximum speeds of more than 300 km/h in appropriate circumstances.
Amendment 431 #
2013/0015(COD)
Proposal for a directive
Annex 1 – point 2 – paragraph 1 – indent 3 b (new)
Annex 1 – point 2 – paragraph 1 – indent 3 b (new)
- high-speed vehicles designed to travel at speeds of the order of 200 km/h on specially built or upgraded lines where this is compatible with the performance levels of those lines. In the case of vehicles designed to travel at a maximum speed of less than 200 km/h and which are likely to travel on high-speed lines, the TSIs shall lay down requirements which are such as to guarantee the safe operation of these vehicles on high-speed lines.
Amendment 219 #
2013/0014(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The procedure described in paragraphs 2, 3 and 34 shall apply, mutatis mutandis, in cases where the Agency becomes aware of, or is informed about, any national rule, notified or not, being redundant or in conflict with the CSMs, CSTs, TSIs or any other Union legislation in the railway field or creating an unjustified barrier to the single railway market. In that instance, the time limit laid down in paragraph 1 shall apply.
Amendment 266 #
2013/0014(COD)
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. The Agency shall set up and keepestablish European registers provided for in Article 43, 44 and 45 of Directive … [Interoperability Directive] in a practical, efficient and easy-to-use format so as to meet commercial and operational requirements. The Agency shall act as the system authority for all registers and databases referred to in the Safety, Interoperability and Train Drivers Directives. This shall include, in particular:
Amendment 288 #
2013/0014(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
1. The Agency shall, at the Commission’s request, assist the Commission withmay issue an opinion as regards the implementation of other Union legislation potentially affecting the railway system or aimed at enhancing the level of interoperability of railway systems and at developing a common approach to safety on the European railway system.
Amendment 107 #
2013/0012(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Electricity is a clean fuel particularly attractive for deployment of electric vehicles and electric two-wheelers in urban agglomerations, peripheral population areas and the transport routes connecting them, and which can contribute to improving air quality and reducing noise. Member States should ensure that recharging points for electric vehicles are built up with sufficient coverage, at least twice the number of vehicles, and 10% of them publicly accessible, focussing in particular on urban agglomerations, peripheral population areas and the transport routes connecting them. Private owners of electric vehicles depend to a large extent on access to recharging points in collective parking lots, such as in appartment blocks, office and business locations. Regulatory provisions should be set up by public authorities, assisting citizens by ensuring that the appropriate infrastructure with sufficient electric vehicle recharging points is provided by the site developers and managers.
Amendment 271 #
2013/0012(COD)
Proposal for a directive
Article 4 – paragraph 8
Article 4 – paragraph 8
8. Member States shall not prohibit electric vehicle users from buying electricity from any electricity supplier at home regardless of the Member State in which the supplier is registered. Member States shall ensure that consumers have the right to contract electricity simultaneously with several suppliers so that electricity supply for an electric vehicle can be contracted separatelyThey shall promote the establishment of specific contracts tailored to the home supply of electricity for electric vehicles, possibly, where technically feasible, with a separate supplier from the usual supplier. Member States shall also not prohibit electric vehicle users connecting to a publicly accessible recharging point from concluding a contract with any mobility service operator of their choice, regardless of the Member State in which the operator is domiciled.
Amendment 14 #
2012/2067(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3. Stresses the need for effective implementation and strengthening of legislation on price transparency in order to ensure that all consumers, including persons with reduced mobility and vulnerable consumers, are able to reserve a journey on the basis of the headline price, which must correspond exactly to the final price, including all taxes and supplements;
Amendment 28 #
2012/2067(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Stresses the need to ensure that passengers are informed of these rights before purchasing travel services, and that such information is made available throughout the various stages of travel; calls for action to strengthen the role of consumer centres in resolving consumer problems and disputes, and to ensure that effective mechanisms for alternative dispute resolution and collective redress are available; calls, in this context, for the establishment of a single helpline website, available in all EU official languages, for information on passengers’ rights (www.travel.eu);;
Amendment 339 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique identifier. In order to ensure their integrity, unique identifiers shall be irremovably printed/affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or by the opening of the packetWith a view to enabling effective tracking and tracing, Member States shall require that unique, secure and non- removable identification markings (hereafter called unique identifier), such as codes or stamps, are affixed to or form part of all unit packets and packages and any outside packaging of cigarettes. In relation to products manufactured outside the Union, the obligations laid down in this Article apply only to those destined to or placed on the Union market.
Amendment 340 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. For the purposes of effective tracking and tracing, Member States shall ensure that all unit packets of tobacco products, including any outside packaging, shall be marked with a unique, secure and irremovable identifier. In order to ensure their integrity, unique identifiers shall be irremovably printed/affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or by the opening of the packet. In relation to products manufactured outside the Union the obligations laid down in this Article apply only to those destined to or placed on the Union market.
Amendment 347 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point g
Article 14 – paragraph 2 – point g
(g) the intended shipment route, the shipment date, destination, place of departure and recipient;
Amendment 348 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point g
Article 14 – paragraph 2 – point g
(g) the intended shipment route, the shipment date, shipment destination, point of departure and consignee;
Amendment 414 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco product they intend to place on the markets of the Member States concerned, and which could, according to independent and verifiable scientific data, be significantly less harmful than traditional tobacco products. The notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with:
Amendment 420 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 3 a (new)
Article 17 – paragraph 3 a (new)
Amendment 936 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. For the purposes of effective tracking and tracing, Member States shall ensure that all unit packets of tobacco products, including any outside packaging, shall be marked with a unique, secure and irremovable identifier. In order to ensure their integrity, unique identifiers shall be irremovably printed/affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or by the opening of the packet. In relation to products manufactured outside the Union the obligations laid down in this Article apply only to those destined to or placed on the Union market.
Amendment 949 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 – point g
Article 14 – paragraph 2 – point g
(g) the intended shipment route, the shipment date, destination, place of departure and recipient;
Amendment 1123 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco product they intend to place on the markets of the Member States concerned, and which could, according to independent and verifiable scientific data, be significantly less harmful than traditional tobacco products. The notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with:
Amendment 1144 #
2012/0366(COD)
Proposal for a directive
Article 17 – paragraph 3 a (new)
Article 17 – paragraph 3 a (new)
3a. On the basis of independent, reliable and verifiable scientific and technical data, the Commission shall, within two years of the entry into force of this Directive, adopt delegated acts laying down rules governing evaluation, packaging, labelling, ingredients, placing on the market, presentation and sale of, and consumer information about, new tobacco products which are significantly less harmful than traditional tobacco products.
Amendment 55 #
2012/0340(COD)
Proposal for a directive
Title 1
Title 1
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the accessibility of public sector bodies' websites and of general-interest service providers’ websites
Amendment 71 #
2012/0340(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The approximation of national measures at Union level, based on an agreement on accessibility requirements for public sector bodies' websites and of websites of certain general-interest service providers, is necessary in order to put an end to fragmentation. It would reduce uncertainty for web-developers and would foster interoperability. By using accessibility requirements which are technology neutral, innovation will not be hampered and may possibly even be stimulated.
Amendment 79 #
2012/0340(COD)
Proposal for a directive
Recital 19
Recital 19
(19) The Directive should aim at ensuring that certain types of public sector bodies' websites and of websites of certain general-interest service providers that are essential to the public are made accessible according to common requirements. Such types were identified in the 2001 E- government benchmarking exercise and have been used as a basis for the list in the Annex.
Amendment 81 #
2012/0340(COD)
Proposal for a directive
Recital 20
Recital 20
(20) This Directive lays down web- accessibility requirements for certain types of public sector bodies' websites and of websites of certain general-interest service providers. In order to facilitate the conformity of websites concerned with those requirements it is necessary to provide presumption of conformity for the websites concerned that meet harmonised standards that are drawn up and published in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council on European Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Decision 87/95/EEC and Decision No 1673/2006/EC, for the purpose of expressing detailed technical specifications for those requirements. Pursuant to this Regulation, Member States and the European Parliament shall be able to object to the harmonised standards which they consider that do not entirely satisfy the web accessibility requirements laid down in this Directive.
Amendment 85 #
2012/0340(COD)
Proposal for a directive
Recital 24
Recital 24
(24) The conformity with web-accessibility requirements should be continuously monitored from the initial construction of the public sector bodies' website and the website of certain general-interest service providers to all subsequent updates of itstheir content. A harmonised monitoring methodology would cover a way of verifying, on a uniform basis in all Members States, the degree of compliance of the website with the requirements for web-accessibility, the collection of representative samples and the periodicity of the monitoring. Member States should report annually on the outcome of the monitoring and more generally on the list of actions taken in application of this Directive.
Amendment 94 #
2012/0340(COD)
Proposal for a directive
Recital 28
Recital 28
(28) Since the objective of this Directive, namely, the establishment of a harmonised market for the accessibility of public sector bodies' websites and of websites of certain general-interest service providers, cannot be sufficiently achieved by the Member States, because it requires the harmonisation of different rules currently existing in their respective legal systems and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,
Amendment 96 #
2012/0340(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive aims at approximating the laws, regulations and administrative provisions of the Member States related to the accessibility of the content of public sector bodies' websites, and of websites of certain general-interest service providers, to all users, in particular people with functional limitations including persons with disabilities.
Amendment 102 #
2012/0340(COD)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. It lays down the rules according to which Member States shall make accessible the content of websites belonging to public sector bodies, the types of which are specified in the Annex.functionalities and content of:
Amendment 103 #
2012/0340(COD)
Proposal for a directive
Article 1 – paragraph 2 – point a (new)
Article 1 – paragraph 2 – point a (new)
(a) web sites and services of public sector bodies (the types of which are specified in the Annex);
Amendment 104 #
2012/0340(COD)
Proposal for a directive
Article 1 – paragraph 2 – point b (new)
Article 1 – paragraph 2 – point b (new)
(b) web sites and web services of certain general-interest service providers (the types of which are specified in Annex Ia);
Amendment 106 #
2012/0340(COD)
Proposal for a directive
Article 1 – paragraph 3
Article 1 – paragraph 3
3. Member States may extend the application of this Directive to other types of public sector websites (public sector bodies and general-interest service providers) than those referred to in paragraph 2.
Amendment 126 #
2012/0340(COD)
Proposal for a directive
Article 2 – point 8 a (new)
Article 2 – point 8 a (new)
(8a) ‘general-interest service’ means a service which Member States’ public authorities class, at national, regional or local level, as being of general interest and therefore subject to specific public service obligations.
Amendment 133 #
2012/0340(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) in a consistent and adequate way for users' navigation, perception, operation and, understanding, interaction and utilisation, including adaptability of content presentation and interaction, when necessary, providing an accessible electronic alternative;
Amendment 151 #
2012/0340(COD)
Proposal for a directive
Article 6 – paragraph 2 – point a (new)
Article 6 – paragraph 2 – point a (new)
(a) By providing support for establishing or appointing an existing competent public authority to monitor website compliance with the general accessibility requirements laid down in Article 3;
Amendment 152 #
2012/0340(COD)
Proposal for a directive
Article 6 – paragraph 2 – point b (new)
Article 6 – paragraph 2 – point b (new)
(b) Each Member State shall lay down the tasks and powers of the competent authority, including provision for non- governmental associations and organisations representing disabled persons to lodge complaints with it in order to challenge any violation of legislation.
Amendment 168 #
2012/0340(COD)
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6a Complaint procedure (1) Any entity (natural or legal person) considering that this Directive has been infringed may bring the matter to the attention of the owners of the relevant website. (2) Should the entity be unable to obtain satisfaction, a complaint may be lodged with the competent authority appointed in accordance with Article 6(2)(a).
Amendment 197 #
Amendment 208 #
2012/0340(COD)
Proposal for a directive
Annex – point 10 a (new)
Annex – point 10 a (new)
(10a) Entry to civil service competitions
Amendment 209 #
2012/0340(COD)
Proposal for a directive
Annex – point 10 b (new)
Annex – point 10 b (new)
(10b) Entry for final examinations within secondary education
Amendment 240 #
2012/0340(COD)
Proposal for a directive
Annex I a (new)
Annex I a (new)
Types of general-interest service providers’ websites (as referred to in Article 1(2)(b)) (1) Transport services (2) Postal services (3) Information services in connection with electoral processes (4) Energy supply services (5) Communications services (6) Basic banking services (7) Health services
Amendment 56 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – introductory part
Article 2 – paragraph 2 – point 1 – introductory part
(1) ‘Clinical studytrial’: any investigation in relation to humans intended:
Amendment 57 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – point a
Article 2 – paragraph 2 – point 1 – point a
(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; or
Amendment 58 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 2
Article 2 – paragraph 2 – point 2
Amendment 64 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 66 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point c a (new)
Article 2 – paragraph 2 – point 3 – point c a (new)
(ca) the aim of the study is not that of identifying, characterising or quantifying a safety hazard, confirming the efficacy or safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.
Amendment 67 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial;study where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Amendment 68 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4 – indent 1 (new)
Article 2 – paragraph 2 – point 4 – indent 1 (new)
- No payment or other advantage or facilities can be made to healthcare professionals in order to encourage them to prescribe, dispense or use a given medicinal product.
Amendment 69 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’'Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; according to the current reliable scientific evidence; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 73 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘'Substantial modification’': any change to any aspect of the clinical trial, including early termination of the trial, which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely tomay have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;, i.e. change the interpretation of the scientific documents used to support the conduct of the trial, or if the modifications are otherwise significant.
Amendment 76 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘'Sponsor’': an individual, company, institution or organisation which takes responsibility for the initiation and, management and/or financing of the clinical trial;
Amendment 82 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 20
Article 2 – paragraph 2 – point 20
(20) ‘Protocol’: a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments;
Amendment 83 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 30 a (new)
Article 2 – paragraph 2 – point 30 a (new)
(30a) 'Clinical study report' : a report containing the full protocol and its eventual subsequent modifications and dates thereof, a statistical analysis plan, summarised efficacy and safety data on all outcomes, and individual anonymised patient data in the format of tabulations or listings.
Amendment 85 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 2
Article 3 – paragraph 1 – indent 2
– the data generated in the clinical trial are going to be relevant, reliable and robust.
Amendment 87 #
2012/0192(COD)
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Amendment 88 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 90 #
2012/0192(COD)
Proposal for a regulation
Article 4 b (new)
Article 4 b (new)
Article 4b Best current proven intervention The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: (a) the use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or (b) where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of the option set out in point (b) of the first subparagraph.
Amendment 91 #
2012/0192(COD)
Proposal for a regulation
Article 4 c (new)
Article 4 c (new)
Amendment 92 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 77 (hereinafter ‘EU portal’).Within six days following submission of the application dossier, Member States shall collectively appoint a reporting Member State and a co- reporting Member State.
Amendment 93 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 94 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 96 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six days following submission of the application dossier, the proposedappointment of the reporting Member State, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 97 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) whether it is the reporting Member State or which other Member State concerned is the co- reporting Member State;
Amendment 98 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
(da) the clinical trial registration number in the EU portal.
Amendment 99 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 124 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point a
Article 8 – paragraph 2 – subparagraph 2 – point a
(a) significant differences in normal clinical practice between the Member State concerned and the reporting Member State which would lead to a subject receiving an inferior treatmentcare than in normal clinical practice;
Amendment 125 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) Infringement of more comprehensive national provisions for clinical trial subjects' protection than the provisions of this Regulation, in particular as regards vulnerable populations;
Amendment 127 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
(bb) refusal of the Ethics Committee to approve the conduct of the clinical trial in the Member State concerned.
Amendment 131 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Where the Member State concerned disagrees with the conclusion onf the basis of point (a) of the second subparagraph, it shall communicate its disagreement, together with a detailed justification based on scientific and socio-economic arguments, and a summary thereofreporting Member State, it shall communicate its disagreement, through the EU portal to the Commission, to all Member States, and to the sponsor.
Amendment 46 #
2012/0184(COD)
Proposal for a regulation
Recital 4
Recital 4
Amendment 57 #
2012/0184(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Solid investigation results show that 8% of the accidents involving motorcycles are caused or linked to technical defects. Motorcycle riders are the group of road users with the highest safety risk, with rising trend in the number of fatalities. Moped drivers are overrepresented in the number of fatalities, with more than 1,400 drivers killed on the roads in 2008. The scope of vehicles to be tested shall therefore be extended to the highest risk group of road users, the powered two- or three-wheel vehicles.
Amendment 58 #
2012/0184(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In view of the harmonisation of tests and in line with the provisions of Regulation (EU) No 168/20131, no roadworthiness tests on type L vehicles – apart from types L1e and L2e – should affect the compliance of vehicles with the 74kW power limit in the territory of some Member States. __________________ 1 OJ L 60, 2. 3. 2013, p. 52.
Amendment 67 #
2012/0184(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Roadworthiness testing is a sovereign activity and should therefore be done by the Member States or by entrusted bodies under their supervision. Member States should remain responsible for roadworthiness testing in any cases even if the national system allows for authorisation of private bodies, including those involved in performing repairs.
Amendment 75 #
2012/0184(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Frequency of tests should be adapted according to the type of vehicle and to their mileage. Vehicles are more likely to present technical deficiencies when they reach a certain age and, in particular when intensively used, after a certain mileage. It is therefore appropriate to increase the test frequency for older vehicles and for vehicles with high mileage.
Amendment 78 #
2012/0184(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) The holder of the registration of a vehicle subject to a roadworthiness test during which deficiencies are found, in particular those which represent a risk to road safety, should rectify such deficiencies without delay. In case of dangerous deficiencies, the registration of the vehicle should be withdrawnvehicle should not be driven on public roads until those deficiencies are fully rectified.
Amendment 102 #
2012/0184(COD)
Proposal for a regulation
Article 2 – paragraph 1 – indent 5
Article 2 – paragraph 1 – indent 5
– trailers and semi-trailers with a maximum permissible mass not exceedingof between 750 kg and 3 500 kg – vehicle categories O1 andy O2,
Amendment 164 #
2012/0184(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘testing centre’ means public or private bodies or establishments, including those carrying out vehicle repairs, authorised by a Member State to carry out roadworthiness tests;
Amendment 177 #
2012/0184(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Vehicle manufacturers shall provide the testing centres or, when relevant, the competent authority, with access to the technical information necessary for roadworthiness testing, as set out in Annex I. The Commission shall adopt detailed rules concerningThe Commission shall adopt detailed rules concerning the substance of the technical information to be made available by vehicle manufacturers under the provisions of Annex I, as well as the procedures on access to theat technical information set out in Annex I, in accordance with the examination procedure referred to in Article 16(2).
Amendment 180 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. Vehicles in categories L1e, L2e, L3e, L4e, L5e, L6e and L7e which have been registered for use on the road for more than four years shall be required to undergo a roadworthiness test before they may be registered in a new name.
Amendment 187 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 – indent 1
Article 5 – paragraph 1 – indent 1
Amendment 198 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 – indent 2
Article 5 – paragraph 1 – indent 2
– Vehicles of category M1, N1 and O2:N1 four years after the date on which the vehicle was first registered, then and every two years and thereafter annually;
Amendment 211 #
2012/0184(COD)
Proposal for a regulation
Article 5 – paragraph 1 – indent 3 a (new)
Article 5 – paragraph 1 – indent 3 a (new)
- Vehicles of category O2: six years after the date on which the vehicle was first registered and every three years thereafter.
Amendment 248 #
2012/0184(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. Roadworthiness certificates shall be mutually recognised by all Member States for the purpose of re-registration of a vehicle transferred from one Member State to another, provided the relevant certificate is valid in so far as it meets the frequency requirements of the re- registering Member State and complies with the provisions of Article 5(4).
Amendment 254 #
2012/0184(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the case of dangerous deficiencies, the vehicle shall not be used on publicly accessible roads and its registration shall be withdrawn in accordance with Article 3a of Directive XXX of the European Parliament and of the Council amending Council Directive 1999/37/EC on the registration documents for vehicles24 until the deficiencies are rectified and a new roadworthiness certificate is issued testifying that the vehicle is in a roadworthy condition.
Amendment 324 #
2012/0184(COD)
Proposal for a regulation
Annex 7 – part 1 – paragraph 1 – point a – indent 3 a (new)
Annex 7 – part 1 – paragraph 1 – point a – indent 3 a (new)
– verifying strict independence from any automobile workshop.
Amendment 117 #
2012/0180(COD)
Proposal for a directive
Article 5 – paragraph 2 – subparagraph 1 a (new)
Article 5 – paragraph 2 – subparagraph 1 a (new)
Notwithstanding the first subparagraph, Member States may adopt specific provisions for the management of rights in the audiovisual field, authorising collecting societies to ask rightholders to entrust them with the collective management of rights for all modes of exploitation of the work.
Amendment 122 #
2012/0180(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Rightholders shall have the right to terminate the authorisation to manage rights, categories of rights or types of works and other subject matter granted to a collecting society or to withdraw from a collecting society any of the rights or categories of rights or types of works and other subject matter of their choice, for the Member States of their choice, upon serving reasonable notice not exceeding six months. The collecting society may decide that such termination or withdrawal will take effect only at the middle and at the end of the financial year, whichever is sooner after the expiry of the notice perioend of a period not exceeding two years from the date on which the author joined.
Amendment 54 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) ‘reservation concerning access to the market’ means any exception or derogation decided on by a state with which the EU has concluded an international agreement in the field of public procurement or concessions, including commitments concerning market access.
Amendment 56 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Article 2 – paragraph 1 – point g b (new)
(gb) ‘lack of substantial reciprocity’ means any measure restricting access to public procurement markets or the award of concessions which results in repeated, serious discrimination against the EU’s operators, goods and services, in particular by means of discriminatory legislative or administrative provisions or the formal or practical lack of guarantees of equal, transparent treatment.
Amendment 57 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g c (new)
Article 2 – paragraph 1 – point g c (new)
(gc) ‘corrective measures’ means the elimination of restrictive measures targeted by the Commission investigation.
Amendment 124 #
2012/0060(COD)
Proposal for a regulation
Article 20 – title
Article 20 – title
Repealslationships with Directive 2004/17/EC
Amendment 127 #
2012/0060(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 25 #
2012/0035(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Amendment 27 #
2012/0035(COD)
Proposal for a directive
Recital 5
Recital 5
(5) Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products.
Amendment 35 #
2012/0035(COD)
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products, are ascertained in the framework of marketing authorisation procedures. I and may be re-assessed in the framework of pricing and reimbursement procedures, Member States should therefore not re- assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 44 #
2012/0035(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Amendment 44 #
2012/0035(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 a (new)
Article 2 – paragraph 1 – point 3 a (new)
3a. “biosimilar medicinal product” means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC;
Amendment 45 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 49 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 51 #
2012/0035(COD)
Proposal for a directive
Recital 5
Recital 5
(5) Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products.
Amendment 51 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 6
Article 3 – paragraph 6
Amendment 52 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 7
Article 3 – paragraph 7
7. If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 53 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 8
Article 3 – paragraph 8
Amendment 54 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 9
Article 3 – paragraph 9
9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 55 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure that an application to increguarantee that the marketing authorisation holder hase the price of the product can be submitted by the marketing authorisation holder at any point in timeossibility to introduce an application to increase the price of a medicinal product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 56 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.
Amendment 57 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 58 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 59 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 6
Article 4 – paragraph 6
6. If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 61 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
Amendment 62 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application for a derogation. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 63 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 64 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Amendment 66 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure thatguarantee that the marketing authorisation holder has the possibility to introduce an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 68 #
2012/0035(COD)
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re-assess the elements on which the marketing authorisation is based, including the quality,, and Member States should have full access to the data used in the marketing authorisation procedure so that they can assess the relative safety, and efficacy or bioequivalence of the medicinal productf a medicinal product in the context of pricing and reimbursement procedures.
Amendment 69 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision- making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 74 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
Amendment 84 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 85 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.
Amendment 87 #
2012/0035(COD)
Proposal for a directive
Article 2 – point 3 a (new)
Article 2 – point 3 a (new)
3a) ‘biosimilar medicinal product’ means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC;
Amendment 89 #
2012/0035(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 91 #
2012/0035(COD)
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. At the request of the holder of a marketing authorisation whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.
Amendment 94 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in timeguarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 94 #
2012/0035(COD)
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 98 #
2012/0035(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In the framework of pricing and reimbursement decisions, Member States shall notmay re-assess the elements on which the marketing authorisation is based, including the quality, safety, or efficacy or bioequivalence of the medicinal product.
Amendment 102 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 104 #
2012/0035(COD)
Proposal for a directive
Article 16
Article 16
Amendment 121 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 6
Article 3 – paragraph 6
Amendment 122 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 7
Article 3 – paragraph 7
7. If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 123 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 8
Article 3 – paragraph 8
Amendment 125 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 9
Article 3 – paragraph 9
9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 127 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall ensure that an application to increguarantee that the marketing authorisation holder hase the price of the product can be submitted by the marketing authorisation holder at any point in timeossibility to introduce an application to increase the price of a medicinal product. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 135 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.
Amendment 141 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 152 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 153 #
2012/0035(COD)
Proposal for a directive
Article 4 – paragraph 6
Article 4 – paragraph 6
6. If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 154 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
Amendment 157 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in timeguarantee the marketing authorisation holder the right to submit an application for a derogation. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 164 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 166 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Amendment 178 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choicguarantee the marketing authorisation holder the right to submit an application to include a medicinal product in the scope of the public health insurance scheme. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 188 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision- making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 216 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 8
Article 7 – paragraph 8
Amendment 223 #
2012/0035(COD)
Proposal for a directive
Article 8
Article 8
Amendment 225 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
Amendment 227 #
2012/0035(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the productcategory concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.
Amendment 232 #
2012/0035(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 235 #
2012/0035(COD)
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. At the request of the holder of a marketing authorisation whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.
Amendment 240 #
2012/0035(COD)
Proposal for a directive
Article 13 – title
Article 13 – title
Additional proof of quality, safety, efficacy or, bioequivalence or biosimilarity
Amendment 243 #
2012/0035(COD)
Proposal for a directive
Article 13
Article 13
In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elements on which the marketing authorisation is based, including the quality,ssential elements (quality, safety, efficacy or biosimilarity) on which the marketing authorisation is based. Nevertheless, Member States shall have access to all the data used by the authority which granted the marketing authorisation so that they can assess the relative safety, and efficacy or bioequivalence of the medicinal productf a medicinal product in the context of the health insurance system.
Amendment 264 #
2012/0035(COD)
Proposal for a directive
Article 16
Article 16
Amendment 272 #
2012/0035(COD)
Proposal for a directive
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Article 17 – paragraph 1 – subparagraph 1 – introductory part
1. By 31 January of […] [insert a date - the year following the date referred to in the first subparagraph of Article 18(1)], and by 31 January and 1 July of every year thereafter, Member States shall communicate to the Commission and publish in an appropriate publication a detailed report providing the following information:
Amendment 111 #
2012/0011(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) Any processing of personal data should be lawful, fair and transparent in relation to the individuals concerned. In particular, the specific purposes for which the data are processed should be explicit and legitimate and determined at the time of the collection of the data. The data should be adequate, relevant and limited to the minimum necessary for the purposes for which the data are processed; this requires in particular ensuring that the data collected are not excessive and that the period for which the data are stored is limited to a strict minimum. Personal data should only be processed if the purpose of the processing could not be fulfilled by other means. Every reasonable step should be taken to ensure that personal data which are inaccurate are rectified or deleted. In order to ensure that the data are not kept longer than necessary, time limits should be established by the controller for erasure or for a periodic review.
Amendment 125 #
2012/0011(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) The principles of fair and transparent processing require that the data subject should be informed in particular of the existence of the processing operation and its purposes, the criteria and/or legal obligations which may be used as the basis for determining how long the data will be stored, on the existence of the right of access, rectification or erasure and on the right to lodge a complaint. Where the data are collected from the data subject, the data subject should also be informed whether they are obliged to provide the data and of the consequences, in cases they do not provide such data.
Amendment 140 #
2012/0011(COD)
Proposal for a regulation
Recital 97
Recital 97
(97) Where the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union takes place in more than one Member State, one single supervisory authority should be competent for monitoring the processing activities of the controller or processor throughout the Union and taking the related decisions, in order to increase the consistent application, provide legal certainty and reduce administrative burden for such controllers and processors. By way of derogation from Article 51(2), when the processing of personal data is not mainly carried out by the main establishment, but by one of the other establishments of the controller or processor situated in the European Union, the competent supervisory authority for those processing operations shall be that of the Member State where that other establishment is situated. In keeping with the provisions of Chapter VII, this derogation shall be without prejudice to the right of the supervisory authority of the Member State where the main establishment is situated to require an additional declaration.
Amendment 183 #
2012/0011(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
c) adequate, relevant, and limited to the minimum nenot excessaryive in relation to the purposes for which they are processed; they shall only be processed if, and as long as, the purposes could not be fulfilled by processing information that does not involve personal data;
Amendment 192 #
2012/0011(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point f
Article 6 – paragraph 1 – point f
f) processing is necessary for the purposes of the legitimate interests pursued by a controller or by a third party or third parties to whom the data are communicated, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. This shall not apply to processing carried out by public authorities in the performance of their tasks.
Amendment 201 #
2012/0011(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
Amendment 248 #
2012/0011(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point c
Article 14 – paragraph 1 – point c
c) the criteria and/or legal requirements for determining the period for which the personal data will be stored;
Amendment 404 #
2012/0011(COD)
Proposal for a regulation
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2a. By derogation from Article 51(2), when the processing of personal data is not mainly carried out by the main establishment but by one of the other establishments of the controller or processor situated in the European Union, the competent supervisory authority for those processing operations shall be that of the Member State where that other establishment is situated. However, and without prejudice to the provisions of Chapter VII of this Regulation, the main establishment shall make an additional declaration to the competent supervisory authority of the Member State where it is situated, should that authority so require.
Amendment 448 #
2012/0011(COD)
Proposal for a regulation
Article 86 – paragraph 2
Article 86 – paragraph 2
2. The delegation of power referred to in Article 6(5), Article 8(3), Article 9(3), Article 12(5), Article 14(7), Article 15(3), Article 17(9), Article 20(6), Article 22(4), Article 23(3), Article 26(5), Article 28(5), Article 30(3), Article 31(5), Article 32(5), Article 33(6), Article 34(8), Article 35(11), Article 37(2), Article 39(2), Article 43(3), Article 44(7), Article 79(6), Article 81(3), Article 82(3) and Article 83(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 451 #
2012/0011(COD)
Proposal for a regulation
Article 86 – paragraph 3
Article 86 – paragraph 3
3. The delegation of power referred to in Article 6(5), Article 8(3), Article 9(3), Article 12(5), Article 14(7), Article 15(3), Article 17(9), Article 20(6), Article 22(4), Article 23(3), Article 26(5), Article 28(5), Article 30(3), Article 31(5), Article 32(5), Article 33(6), Article 34(8), Article 35(11), Article 37(2), Article 39(2), Article 43(3), Article 44(7), Article 79(6), Article 81(3), Article 82(3) and Article 83(3) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 454 #
2012/0011(COD)
Proposal for a regulation
Article 86 – paragraph 5
Article 86 – paragraph 5
5. A delegated act adopted pursuant to Article 6(5), Article 8(3), Article 9(3), Article 12(5), Article 14(7), Article 15(3), Article 17(9), Article 20(6), Article 22(4), Article 23(3), Article 26(5), Article 28(5), Article 30(3), Article 31(5), Article 32(5), Article 33(6), Article 34(8), Article 35(11), Article 37(2), Article 39(2), Article 43(3), Article 44(7), Article 79(6), Article 81(3), Article 82(3) and Article 83(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
Amendment 22 #
2011/2180(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to support Member States in enhancing the European Credit Transfer and Accumulation System (ECTS) in order to increase transparency so that it can be used as a comparative tool to facilitate the recognition of professional qualifications; takes the view that an approach based on the skills acquired could make such comparisons easier in a large number of areas;
Amendment 24 #
2011/2180(INI)
Draft opinion
Paragraph 6 – subparagraph 1 (new)
Paragraph 6 – subparagraph 1 (new)
Draws attention to the importance of uniform implementation of the ECTS in connection with training geared to the pursuit of professions covered by the principle of automatic recognition laid down in Directive 2005/36/EC;
Amendment 25 #
2011/2180(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to cooperate with Member States and universities in drawing up an indicative comparative table of the number of ECTS credits awarded for courses that are comparable, with a view to ensuring greater harmonisation and thereby facilitating recognition, both in connection with university exchanges and for professional qualifications;
Amendment 29 #
2011/2180(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission and Member States to give wholehearted support to efforts to step up exchanges between universities with a view to improving mutual knowledge and understanding of the various education and training systems;
Amendment 31 #
2011/2180(INI)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on Member States and universities to improve coordination of the modules system, which offers students greater flexibility in their choice of studies while ensuring that a common body of core knowledge and skills is retained; believes that this system could serve as the basis for a partial harmonisation of some diplomas, while allowing national specificities to be preserved;
Amendment 10 #
2011/2150(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out the need for a revision of the Regulations to include the recent case- law1, after evaluation of the probable consequences and benefits for passengers, in order to clarify air passengers’ rights and strengthen enforcement measures; 1 __________________ 1 for example joint cases C 402/07 and C 432/07 Sturgeon
Amendment 32 #
2011/2150(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the need to make passengers more aware of their rights by means of airport information campaigns and the introduction of more stringent obligations for airlines and travel agencies, both in situ and online, particularly with regard to clarity;
Amendment 33 #
2011/2150(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b.Calls on the Commission to introduce a truly multilingual information portal regarding the rights of air passengers, providing easy access to the standard claims form and to the contact points of the national implementing bodies;
Amendment 54 #
2011/2150(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission and Member States to step up cooperation and exchanges of information between national implementing bodies, for example by means of online access modelled on the Solvit network;
Amendment 57 #
2011/2150(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Expresses concern that lengthy and inefficient complaint processing and resolution procedures are a major source of passenger dissatisfaction; takes the view accordingly that the national implementation bodies should be provided with adequate resources and manpower and matching powers to impose penalties;
Amendment 14 #
2011/2107(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of promoting the establishment of public-private partnerships; calls for JTIs to be simplified in order to avoid channelling a large amount of financial resources into just a few projects, and calls for the state aid rules to be simplified by means of mechanisms such as ‘consent by silence’ and block exemptions, so that innovation is not hampered by lengthy processes; (the idea of ‘consent by silence’ lacks clarity and might give rise to legal uncertainty)
Amendment 16 #
2011/2107(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the importance of supporting innovation in public procurement, for example by developing pre-commercial procurement and by ensuring that contracting authorities respect the confidentiality of innovative solutions – especially in terms of know-how – presented by tendering companies; therefore calls for a proactive policy for support and training and for legal certainty for public authorities looking to choose innovative solutions;
Amendment 30 #
2011/2107(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Is of the view that assistance for patenting should be given to innovative young enterprises, particularly with the establishment of the Community Patent;
Amendment 36 #
2011/2107(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Recalls that investment in innovation makes sense only if the solutions and trade marks are properly protected and safeguarded at both intra-Community and extra-Community level; calls therefore for customs cooperation policy and consumer information to be improved and to be given increased human and material resources;
Amendment 4 #
2011/2048(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regard to the WTO Agreement on Government Procurement of 15 April 1994,
Amendment 7 #
2011/2048(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
- having regard to its resolution of 12 May 2011 on equal access to public sector markets in the EU and in third countries,
Amendment 22 #
2011/2048(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Considers that public procurement should be an instrument for promoting research, innovation and environmental policies, and for the creation of high- quality permanent jobs; considers in this respect that compliance with social standards, collective agreements and minimum wages at all stages in the performance of the contract, including the supply chain, should be a compulsory criterion in the award of public contracts;
Amendment 23 #
2011/2048(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. considers that the European market cannot, on a unilateral basis, be open to third-country operators and calls for the Commission to consider the use of a tool to ensure reciprocity vis-à-vis States which do not provide equivalent access to European operators, including those that are signatories to the Agreement on Government Procurement (GPA); points out that the GPA provides for special and differentiated treatment for developing countries;
Amendment 31 #
2011/2048(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that eleven Member States have ratified the ILO’s Convention C94 concerning labour clauses in public contracts and calls on the Commission to encourage all Member States to ratify this Convention in order to limit the undesirable effects of recent ECJ judgments in this field, and to include a reference to this convention in future legislation on public procurement;
Amendment 53 #
2011/2048(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines the exclusion of service concessions from the scope of European procurement rules; notes the Commission’s intention to propose separate legislation on service concessions; takes the view that this should be dealt with in the review of the directives only in order to avoid any further fragmentation of the legislationproposal should basically be a proper clarification of the rules in this field which takes due account of ECJ case law;
Amendment 89 #
2011/2048(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
Amendment 92 #
2011/2048(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Calls for work by the Commission to have the Agreement on Governmental Procurement recognise criteria other than the price criterion, in order to enable the creation of high-quality jobs, promote sustainable development and support European industrial policy;
Amendment 94 #
2011/2048(INI)
Motion for a resolution
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Stresses the importance of supporting innovation in public procurement, for example by developing pre-commercial procurement and by ensuring that contracting authorities respect the confidentiality of innovative solutions – especially in terms of know-how – presented by tendering companies; therefore calls for a proactive policy for support and training and for legal certainty for public authorities looking to choose innovative solutions;
Amendment 131 #
2011/2048(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Considers that the current provisions on subcontracting should be strengthened, as the use of several levels of subcontracting can cause problems in terms of compliance with collective agreements, working conditions and health and safety standards; suggests therefore that the public authorities be informed of all details relating to the use of subcontractors before a contract is concluded, and a chain of responsibility be established which makes contractors liable for any shortcomings by subcontractors in complying with regulations and social, environmental and quality objectives;
Amendment 133 #
2011/2048(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Urges the Commission to exercise caution in promoting public-private partnerships and to look carefully at the many bad examples that have been observed; calls for the development of a European framework for PPPs that provides effective protection for public authorities and ensures the fair distribution of costs, risks and benefits;
Amendment 134 #
2011/2048(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Urges the Commission to clarify the rules concerning the posting of workers in the context of public procurement that should apply equally to contractors and subcontractors, in accordance with the principle of equal pay for equal work performed in the same place;
Amendment 172 #
2011/2048(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Asks the Commission to rewrite the conditions concerning reserved contracts defined in Article 19 of Directive 2004/18/EC, in view of the difficulties involved in interpreting the notion of ‘sheltered workshops’ and the 50% threshold for disabled workers, drawing where appropriate on best practice in some Member States, such as the Italian type B social cooperatives;
Amendment 187 #
2011/2048(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to investigate all the possibilities for encouraging the temporary or permanent grouping of SMEs and small businesses in order to enable them to take part in invitations to tender that are not split into lots without having to operate as subcontractors; takes the view, in particular, that information campaigns and legal and technical training should be organised, where appropriate with national or regional small business and SME organisations;
Amendment 21 #
2011/2024(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Calls on Member States, therefore, to use modern communication technologies, including databases and online registration procedures, in order to ensure that the deadlines set under the general recognition system are met and that significant improvements are made in terms of access to information and transparency of decision-making for professionalknowledge of procedures;
Amendment 22 #
2011/2024(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls for a mandatory obligation for competent authorities to provide up-to- date contact information to all other competent authorities in their given profession;
Amendment 23 #
2011/2024(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Encourages Member States, competent authorities andCalls on the Commission to coordinate and consolidate the various sources of information currently available to professionals - including National Contact Points (NCPs), SOLVIT, and professional bodies - byand to establishing an accessible online portal on the Commission’s website, which would provide relevant and up-to-date information on the recognition process, including administrative information on competent authorities and professional bodies and the documents to be submitted by professionals in order to secure recognition of their qualifications;
Amendment 34 #
2011/2024(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls for further clarification of the concept of temporary and occasional provision of services; argues that competent authorities face difficulties applying the regime and, therefore, calls on the Commission to evaluate the current provisions set out in Article 7 of the directive, specifically those concerning public health and safety, and to present its conclusions to Parliament, while also drawing attention to the importance of the prior declaration system;
Amendment 47 #
2011/2024(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that a vast majority of stakeholders regard the principle of partial access as difficult to monitor in practice; calls for a thorough evaluation of the principle and its consequences;
Amendment 55 #
2011/2024(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to updatereintroduce the mechanisms for dialogue between stakeholders with a view to updating, as regularly as possible and in line with scientific and technical developments, the current classification of economic activities for the automatic recognition systems based on professional experience and minimum training requirements;
Amendment 59 #
2011/2024(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers that dialogue between stakeholders with a view to regularly updating the requirements for initial training, recognition of experience and continuous professional development plays an essential role in the harmonisation of training; considers, moreover, that superimposing a ‘28th regime’ on national systems does not provide a means of resolving in a clear and satisfactory manner the issue of differences in training;
Amendment 68 #
2011/2024(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that Member States shoulde large number of regulated professions in a more proportionate manner, with a view to reducing the total number of regulated professions in the EU, setting aside the healthcare sectorthe European Union, and calls on the Member States to reconsider the justification for the classification of certain professions, bearing in mind that reducing the total number of regulated professions in the EU would facilitate mobility; requests the Commission, therefore, to draw up as complete as possible a comparative overview of the Member States’ regulatory systems; notes that classification is justified, however, on consumer protection grounds, particularly with regard to the medical, legal and technical professions;
Amendment 91 #
2011/2024(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for the establishment, within the framework of the Internal Market Information System (IMI), and for those professions not already covered under the Services Directive, of a proactive alert mechanism, which would make it compulsory to issue an alert to all Member States when a professional has been sanctionedfound guilty of serious professional misconduct which could jeopardise the safety or well- being of his or her clients or patients, with due respect to the rules on the protection of personal data;
Amendment 97 #
2011/2024(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 103 #
2011/2024(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Insists that, for healthcare professionals, the ability to communicate with colleagues and patients is fundamental in order to avoid dangerous or potentially life-threatening situations;
Amendment 113 #
2011/2024(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for the mandatory introduction of the IMI for competent authorities in order to facilitate proactive administrative cooperation and simplify recognition procedures; asks the Commission to put in place accompanying training and technical support measures in order to the ensure full use is made of the potential efficiency gains that system offers;
Amendment 115 #
2011/2024(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on Member States to promote the benefits of the Directive to its citizens and professionals;
Amendment 122 #
2011/2024(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Highlights that the concept of common platforms, as outlined in Article 15 of the directive, has not been successful in that no such platforms currently exist; calls on the Commission to clarifystresses, however, the potential use that could be made of such platforms as a means of facilitating mobility; welcomes the Commission’s desire to improve theis concept in a revised article and to evaluate the proposal to lower the threshold for, primarily by reducing the minimum required level of Member State participation;
Amendment 125 #
2011/2024(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Welcomes recent reforms undertaken as part of the Bologna process and the benefits this process provides to European students in terms of mobility and employability; encourages the European Commission to assist Member States in making the European Credit Transfer Scheme (ECTS) more transparent and comparable in order for ECTS to become an essential tool facilitating the mutual recognition of qualifications and ultimately mobility;
Amendment 133 #
2011/2024(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Considers that the concept of a voluntary Professional Card, which must be linked to an electronic database such as the IMI, could be a useful tool to aid mobility for some professions; stresses that any card introduced must meet specific conditions and that issued by the competent authorities is an essential tool to facilitate mobility for the professions; welcomes the recent concrete proposals for a card of this kind to be used in conjunction with the IMI system; stresses the advantages of the Professional Card system in terms of simplifying administrative procedures for professionals and for the authorities and enhancing patient and consumer safety; stresses the importance of the pilot projects currently in train for the purpose of analysing questions relating to the nsecessary safeguards must be establishedurity and updating of data, to fraud, and to costs;
Amendment 137 #
2011/2024(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
Amendment 811 #
2011/0439(COD)
Proposal for a directive
Article 79 a (new)
Article 79 a (new)
Amendment 814 #
2011/0439(COD)
Proposal for a directive
Article 79 b (new)
Article 79 b (new)
Amendment 865 #
2011/0439(COD)
Proposal for a directive
Article 82 – paragraph 4
Article 82 – paragraph 4
4. Where the value of a modification can be expressed in monetary terms, the modification shall not be considered to be substantial within the meaning of paragraph 1, where its value does not exceed the thresholds set out in Article 12 and where it is below 5% of the price of the initial contract, provided that the modification does not alter the overall nature of the contract. Where several successive modifications are made, the value shall be assessed on the basis of the cumulative value of the successive modifications. When the value of the modification does not exceed half of the thresholds laid down in Article 12 and is equal to or exceeds 5 % of the price of the initial contract, assessment of whether the modification is substantial or not shall be carried out in accordance with the provisions of paragraph 2.
Amendment 242 #
2011/0438(COD)
Proposal for a directive
Recital 25
Recital 25
(25) Electronic means of communication are particularly well suited to support centralised purchasing practices and tools because of the possibility they offer to re- use and automatically process data and to minimise information and transaction costs. The use of such electronic means of communication should therefore, as a first step, be rendered compulsory for central purchasing bodies, while also facilitating converging practices across the Union. This should be followed by a general obligation to use electronic means of communication in all procurement procedures after a transition period of two years. So as to ensure continued legal certainty, this shall not affect existing arrangements at national level for publishing information on public procurement contracts for amounts below the thresholds set in this directive.
Amendment 436 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 – point d a (new)
Article 10 – paragraph 1 – point d a (new)
(da) transactions carried out by contracting authorities in order to raise money or capital;
Amendment 1300 #
2011/0438(COD)
Proposal for a directive
Article 69 a (new)
Article 69 a (new)
Amendment 1303 #
2011/0438(COD)
Proposal for a directive
Article 69 b (new)
Article 69 b (new)
Article 69b Relations with third countries as regards works, supplies and service contracts 1. Member States shall inform the Commission of any general difficulties, in law or in fact, encountered and reported by their undertakings in securing the award of works, supplies and service contracts in third countries. 2. The Commission shall report to the European Parliament and the Council periodically on the opening up of works, supplies and service contracts in third countries and on progress in negotiations with these countries on this subject, particularly within the framework of the WTO. 3. The Commission shall endeavour, by approaching the third country concerned, to remedy any situation where it finds, on the basis either of the reports referred to in paragraph 2 or of other information, that, in the context of the award of works, supplies and service contracts, a third country: (a) does not grant Union undertakings effective access comparable to that granted by the Union to undertakings from that third country; (b) does not grant Union undertakings national treatment or the same competitive opportunities as are available to national undertakings; or c) grants undertakings from other third countries more favourable treatment than Union undertakings. 4. Member States shall inform the Commission of any difficulties, in law or in fact, encountered and reported by their undertakings and which are due to the non-observance of the international labour law provisions listed in Annex XI when these undertakings have tried to secure the award of works, supplies and service contracts in third countries. 5. In the circumstances referred to in paragraphs 3 and 4, the Commission may at any time propose that the Council decide to suspend or restrict, over a period to be laid down in the decision, the award of works, supplies and service contracts to: (a) undertakings governed by the law of the third country in question; (b) undertakings affiliated to the undertakings specified in point (a) and having their registered office in the Union but having no direct and effective link with the economy of a Member State; (c) undertakings submitting tenders which have as their subject-matter services originating in the third country in question. The Council shall act, by qualified majority, as soon as possible. The Commission may propose these measures on its own initiative or at the request of a Member State. 6. This article shall be without prejudice to the commitments of the Union in relation to third countries ensuing from international agreements on public procurement, particularly within the framework of the WTO.
Amendment 241 #
2011/0437(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 14, Article 53 (1), Article 62 and Article 114 thereof, and Protocol 26 thereto,
Amendment 405 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) a 'public (a) a 'works concession' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of wy means of which one or more contracting authorities or entities award the execution of works for which they are responsible to one or more economic operatorks, where the consideration for the the works to be carried outat award consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment.;
Amendment 406 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b (new)
Article 2 – paragraph 1 – point 2 – point b (new)
(b) a 'services concession' means a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or entities award the performance of services for which they are responsible to one or more economic operators, where the consideration for that award consists either solely in the right to perform the services that are the subject of the contract or in that right together with payment. The right to exploit the works or services shall imply the transfer to the concessionaire of a significant part of the economic risk in exploiting these works or services, defined as the risk of exposure to the vagaries of the market, whether those risks are linked to supply or demand. The concessionaire shall be deemed to assume the substantial operating risk where, under normal conditions of exploitation, it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject of the concession.
Amendment 488 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. This Directive shall not apply to services concessions awarded by a contracting authority or by a contracting entity to an economic operator which is a contracting entity or an association of thereof,concerning the management of network infrastructure related to the activities set out in Annex III or to services concessions for an activity set out in Annex III which, when this Directive enters into force, are the subject of a nationally regulated tariff for vulnerable groups of customers laid down in law or regulation where such concessions are awarded to an economic operator on the basis of an exclusive right that economic operatothe latter enjoys pursuant to applicable and published national law, regulation or administrative provision, and which has been granted in accordance with the Treaty and Union sectoral legislation concerning the management of networks infrastructure related to the activities set out in annex III. By way of derogation from the first subparagraph, where sectoral legislation referred to in the first subparagraph does not provide for sector-specific transparency obligations, the requirements of Article 27 (1) and (3) shall apply.
Amendment 574 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1 – point b
Article 15 – paragraph 1 – subparagraph 1 – point b
(b) at least 90% of the activitiesverage total turnover of that legal person areis generated by means of activities carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity
Amendment 611 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – point b
Article 15 – paragraph 3 – subparagraph 1 – point b
(b) at least 90% of the activitiesverage total turnover of that legal person areis carried out for the controlling contracting authorities or entities as referred to in paragraph 1 subparagraph 1 of Article 4 or other legal persons controlled by the same contracting authority or entity;
Amendment 631 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 2 – point d
Article 15 – paragraph 3 – subparagraph 2 – point d
(d) the controlled legal person does not draw any gains other than the reimbursement of actual costs from the public contracts with the contracting authoritiescouping of the operating and investment costs it incurs in performing the concessions with the contracting authorities or contracting entities, as defined in Article 4(1), point 1.
Amendment 696 #
2011/0437(COD)
Proposal for a directive
Article 18 – paragraph 4
Article 18 – paragraph 4
4. Where contracts have as their object concessions covered by this Directive as well as procurement or other elements not covered by it nor by Directives [replacing 2004/17/EC and Directive 2004/18] or 2009/81/EC, the part of the contract which constitutes a concession covered by this Directive shall be awarded in accordance with this Directive. However, when the different parts of the contract are objectively not separable, the application of this Directive shall be determined on the basis of the main subject of that contract, without prejudice to the provisions of EU law.
Amendment 706 #
2011/0437(COD)
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Where one of the activities for which the concession subject to the provisions of this Directive is intended is listed in Annex III and the other is not listed therein and where it is objectively impossible to determine for which activity the concession is principally intended, the concession shall be awarded in accordance with the provisions applicable to concessions awarded by contracting authorities, without prejudice to the provisions of EU law.
Amendment 732 #
2011/0437(COD)
Proposal for a directive
Article -26 and -26 a (new)
Article -26 and -26 a (new)
Article -26 Freedom of the grantor to organise the procedure The grantor shall have the freedom to organise the procedure leading to the choice of concessionaire subject to compliance with the provisions of this Directive, the only two mandatory stages being the publication of a concession notice at the beginning of the procedure, except in the cases provided for in Article 17 and Article 26(5), and the publication of an award notice at the end of the procedure. Intermediate stages may be provided for during the award procedure by the grantor, such as the sending of an invitation to submit an offer to the candidates who have responded where appropriate to the concession notice. Article - 26a General principles 1. Concessions shall be awarded on the basis of the criteria set out by the grantor in accordance with Article 38a provided that the following cumulative conditions are fulfilled: (a) the tender complies with the requirements, conditions and criteria set out in the concession notice or in the invitation to submit a tender and in the concession documents; (b) the tender comes from a tenderer who (i) is not excluded from participating in the award procedure in accordance with paragraphs 5 and 7 of Article 36, and subject to paragraph 8 of Article 39, and (ii) meets the selection criteria set out by the grantor in accordance with paragraphs 2 and 3 of Article 36. 2. During the concession award procedure, the grantor shall treat economic operators equally and shall act in a transparent and proportionate way. In particular, it shall not provide information in a discriminatory manner which may give some candidates or tenderers an advantage over others. The design of the concession award procedure shall not be made with the objective of excluding it from the scope of this Directive or of artificially narrowing competition. 3. The grantor must ensure that the economic operator complies with obligations relating to social protection and working conditions which apply under the laws and collective agreements in force where the concession is performed, and may set further social and environmental criteria.
Amendment 830 #
2011/0437(COD)
Proposal for a directive
Article 36 – paragraph 6
Article 36 – paragraph 6
6. Any economic operator shall be excluded from participation in a concession where the contracting authority or contracting entity contracting authority or entity may decide to exclude an economic operator from participation in a concession where it is aware of a decision having the force of res judicata establishing that ithe economic operator has not fulfilled obligations relating to the payment of taxes or social security contributions in accord ance with the legal provisions of the country in which it is established or with those of the Member State of the contracting authority or entityy other obligation relating to social and employment conditions, such as health and safety at work, social security and working conditions, as set out in Union and national legislation, including collective agreements applicable in the place where the work or service is performed.
Amendment 844 #
2011/0437(COD)
Proposal for a directive
Article 36 – paragraph 8
Article 36 – paragraph 8
8. Any candidate or tenderer that is in one of the situations referred to in paragraphs 5 to 7 may provide the contracting authority or contracting entity with evidence demonstrating its reliability despite the existence of the relevant ground for exclusion.
Amendment 858 #
2011/0437(COD)
Proposal for a directive
Article 38 a (new)
Article 38 a (new)
Article 38a Award criteria 1. The grantor may hold negotiations with candidates and tenderers. Concessions shall be awarded by the grantor on the basis of objective award criteria complying with the principles referred to in Article 26, subparagraph 2. 2. The subject matter of the concession, the award criteria and the minimum requirements shall not be changed in an arbitrary or discriminatory manner during the course of the negotiations. Any changes shall be immediately brought to the notice of the candidates and tenderers concerned. 3. The award criteria may include environmental, social, cohesion or innovation-related criteria. The grantor shall verify whether tenders properly meet the award criteria.
Amendment 916 #
2011/0437(COD)
Proposal for a directive
Article 42 – paragraph 6 – subparagraph 1 – point a
Article 42 – paragraph 6 – subparagraph 1 – point a
(da) the need for modification has been brought about by circumstances which a diligent contracting authority or entity could not foreseanticipate
Amendment 945 #
2011/0437(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point 2 – paragraph 1
Annex 3 – paragraph 1 – point 2 – paragraph 1
For the purposes of this Directive, supply of electricity includes generation (production) and supply (wholesale of electricityas well as retail sale to end consumers).
Amendment 129 #
2011/0435(COD)
Proposal for a directive
Recital 16
Recital 16
(16) To simplify the system for automatic recognition of all medical and dental, dental, pharmaceutical and veterinary specialities, such specialities should be covered by Directive 2005/36/EC if they are common to at least one third of the Member States.
Amendment 144 #
2011/0435(COD)
Proposal for a directive
Recital 20
Recital 20
(20) Graduates wishing to pursue a remunerated traineeship in another Member State where such traineeship is possible shouldtraineeship which forms part of the training for a regulated profession in another Member State where such traineeship is possible should, irrespective of the level and nature of the remuneration provided, be covered by Directive 2005/36/EC in order to foster their mobility. It is also necessary to provide for the recognition of their traineeship by the home Member State.
Amendment 178 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
2005/36/EC
Article 1 – paragraph 2
Article 1 – paragraph 2
This Directive also establishes rules concerning partial access to acertain regulated professions and access to and recognition of remunerated traineeships which form part of the training for a regulated profession, irrespective of the level and nature of the remuneration provided, pursued in another Member State.
Amendment 187 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive 2005/36/EC
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Directive shall apply to all nationals of a Member State wishing to pursue a regulated profession or a remunerated traineeshiptraineeship which forms part of the training for a regulated profession, irrespective of the level and nature of the remuneration provided, in a Member State, including those belonging to the liberal professions, other than that in which they obtained their professional qualifications, on either a self-employed or employed basis.
Amendment 201 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a – point ii
Article 1 – paragraph 1 – point 3 – point a – point ii
Directive 2005/36/EC
Article 3 – paragraph 1 – point j
Article 3 – paragraph 1 – point j
(j) 'remunerated traineeship': the pursuit of supervised and remunerated activitiestraineeship which forms part of the training for a regulated profession': the pursuit of supervised activities, irrespective of the level and nature of the remuneration provided, with a view to access to a regulated profession granted on the basis of an examination;
Amendment 254 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/CE
Article 4 b – paragraph 3
Article 4 b – paragraph 3
3. The competent authority of the home Member State shall acknowledge receipt of the application and inform the applicant of any missing document without delay fromin three working days of submission of the application. It shall create a file of the application containing all supporting documents, which must be certified as valid, within the Internal Market Information System (IMI) established by Regulation (EU) No […] of the European Parliament and of the Council(*). In case of subsequent applications by the same applicant, the competent authorities of the home or the host Member State may not request the re- submission of documents which are already contained in the IMI file and which are still valid.
Amendment 292 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/CE
Article 4 d – paragraph 3
Article 4 d – paragraph 3
3. In the cases referred to in Articles 7(4) and 14, a host Member State shall decide on whether to recognise the holder's qualifications or to subject him to compensation measures within two montheight weeks from the date of receipt for validation of the European Professional Card transmitted by the home Member State. In case of justified doubts, the host Member State may request additional information from the home Member State. TWhere that request shall not suspend the period of two monthsis justified on practical, technical or organisational grounds, the aforementioned period of eight weeks may be extended by a further two weeks, provided that the professional is duly informed thereof.
Amendment 304 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/CE
Article 4 d – paragraph 5
Article 4 d – paragraph 5
5. The host Member State shall acknowledge receipt of the application for validation of the European Professional Card within a period of five working days. Where the host Member State fails to take a decision within the time limits set out in the paragraphs 2 and 3 or to request additional information within one monthfive weeks from the date of receipt of the European Professional Card by the home Member State, the European Professional Card shall be deemed to be validated by the host Member State and to constitute recognition of the professional qualification to the regulated profession concerned in the host Member State. This tacit recognition of qualifications shall not constitute automatic recognition of the right to practise.
Amendment 321 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/CE
Article 4 e – paragraph 4
Article 4 e – 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, profession, qualifications, applicable regime, competent authorities involved, card number, security features and reference to a valid proof of identity.
Amendment 336 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 (new)
Article 1 – paragraph 1 – point 5 (new)
2005/36/CE
Article 4 f – paragraph 1 – point b (new)
Article 4 f – paragraph 1 – point b (new)
b a) the professional is fully qualified to practise in the home Member State the professional activity for which partial access may be granted in the host Member State;
Amendment 362 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2. Partial access may be rejected if such rejection is justifiedMember States may refuse to apply the principle of partial access to certain professions if they are able to justify this refusal by an overriding reason of general interest, such as public health, it would secure the attainment of the objective pursued and it would not go beyond what is strictly necessary. However, a measure of this kind shall not prevent a competent authority from being able to grant partial access to a professional activity on a case by case basis in specific identified situations.
Amendment 375 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6 – point a
Article 1 – paragraph 1 – point 6 – point a
2005/36/CE
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
b) where the service provider moves, if he has pursued that profession as his main activity or as a regular seasonal activity in one or several Member States for at least two years during the last 10 years preceding the provision of services when the profession is not regulated in the Member State of establishment.
Amendment 383 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6 – point a (new)
Article 1 – paragraph 1 – point 6 – point a (new)
2005/36/CE
Article 5 – paragraph 1 – subparagraph 3 (new)
Article 5 – paragraph 1 – subparagraph 3 (new)
Member States may however retain the requirement concerning pursuit of the profession in the case of certain professions with health or safety implications, if they are able to justify this on grounds of overriding reasons of public interest. Member States shall notify the Commission of the list of professions concerned by (insert the date of entry into force of the directive) at the latest and every two years thereafter.
Amendment 433 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
Directive 2005/36/EC
Article 14 – paragraph 4
Article 14 – paragraph 4
4. For the purposes of paragraphs 1 and 5, ‘substantially different matters’ shall mean matters of which knowledge is essential for pursuing the profession and with regard to which the training received by the migrant shows important differences in terms of duration or content from the training required by the host Member State.
Amendment 435 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point e
Article 1 – paragraph 1 – point 12 – point e
Directive 2005/36/EC
Article 14 – paragraph 6
Article 14 – paragraph 6
(c) explain the substantial differences in terms of content and the implications those differences have for the professional's ability to practise his profession in a satisfactory manner in the host Member State;
Amendment 436 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point e
Article 1 – paragraph 1 – point 12 – point e
Directive 2005/36/EC
Article 14 – paragraph 6 – point d
Article 14 – paragraph 6 – point d
Amendment 441 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14 a (new)
Article 1 – paragraph 1 – point 14 a (new)
Directive 2005/36/EC
Chapter III – heading
Chapter III – heading
(14a) The heading of Chapter III is replaced by the following: Recognition on the basis of a common set of training conditions and levels (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 456 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Directive 2005/36/EC
Article 24 – paragraph 2
Article 24 – paragraph 2
Basic medical training shall comprise a total of at least fivesix years of study, which may also be expressed with the equivalent ECTS credits, and shall consist of at least 5500 hours of theoretical and practical training provided by, or under the supervision of, a university. For persons who began their studies before 1 January 1972, the course of training referred to in the first subparagraph may comprise six months of full-time practical training at university level under the supervision of the competent authorities. By way of derogation from the first paragraph, in exceptional cases Member States may notify, under the procedure provided for in Article 21a, training programmes comprising fewer than six years of study, which may also be expressed with the equivalent ECTS credits, if those programmes consist of at least 5500 hours of theoretical and practical training provided by, or under the supervision of, a university. In such cases, a supplementary assessment carried out by an independent body and confirming that the training programme is of a sufficiently high standard of quality and complies with the requirements of this Directive shall be submitted together with the report provided for in Article 21a(2).
Amendment 497 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 23 – point b a (new)
Article 1 – paragraph 1 – point 23 – point b a (new)
Directive 2005/36/EC
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
(3a) The new provisions of Article 31(1) shall be without prejudice to the acquired rights of nurses responsible for general care who commenced a course of training on the basis of the 10-year general education requirements prior to the date of transposition of this Directive.
Amendment 513 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 26 – point a a (new)
Article 1 – paragraph 1 – point 26 – point a a (new)
Directive 2005/36/EC
Article 38 – paragraph 3
Article 38 – paragraph 3
Amendment 523 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 28
Article 1 – paragraph 1 – point 28
Directive 2005/36/EC
Article 41 – paragraph 1 – point (a)
Article 41 – paragraph 1 – point (a)
(a) full-time training of at least three years as a midwife, consisting of at least 5000 hours of theoretical and practical training, which may also be expressed with the equivalent ECTS credits, with at least one-third of those hours being spent in direct clinical practice;
Amendment 622 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 39 a (new)
Article 1 – paragraph 1 – point 39 a (new)
Directive 2005/36/EC
Article 55 b (new)
Article 55 b (new)
(39a) Civil liability and in-service training requirements 1. This Directive shall be without prejudice to Community and national provisions which enable Member States to require insurance or financial safeguards as such and shall not affect requirements relating to participation in a collective compensation fund, for instance for members of professional bodies or organisations, provided that the provisions in question are non- discriminatory. 2. This Directive shall be without prejudice to national provisions which, for overriding reasons relating to the public interest, make the right to exercise a profession conditional on the regular practice thereof, providing that the provisions in question are non- discriminatory.
Amendment 635 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 39
Article 1 – paragraph 1 – point 39
Directive 2005/36/EC
Article 55 a
Article 55 a
With a view to grant access to a regulated profession, the home Member State shall recognise the remunerated traineeshiptraineeship which forms part of the training for a regulated profession, irrespective of the level or nature of the remuneration provided, pursued in another Member State and certified by a competent authority of that Member State.
Amendment 141 #
2011/0373(COD)
Proposal for a directive
Recital 7
Recital 7
(7) This Directive should apply to complaints linked to contractual disputes betweensubmitted by consumers andgainst traders that are arising from the sale of goods or provision of services in all economic sectors. This should include complaints submitted by consumers aga and from online sales, including the provision of digital content. This Directive should not apply to non- economic services of general interest or to healthcare services provided by traders in order to assess, maintain or restore a patient’s state of health, including the administ traders but alsration and provision of prescription medicinal products and medical devices. It should not apply to complaints submitted by traders against consumers. This Directive should not apply or to disputes between traders; however, it should not prevent Member States from adopting or maintaining in force provisions on procedures for the out- of-court resolution of such disputes.
Amendment 186 #
2011/0373(COD)
Proposal for a directive
Recital 21 a (new)
Recital 21 a (new)
(21a) Where necessary the Commission should divert appropriate funds from the ‘Consumers’ programme for the period 2014-2020 to finance the establishment of new entities and make money available to train mediators or other support staff and provide information and assistance to consumers in particular. Existing resources and contact points should be organised more effectively to make information accessible to the public.
Amendment 201 #
2011/0373(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Member States should involve representatives of business organisations, legal professionals and consumer protection organisations in the work of establishing the ADR system and in the governance system, paying particular attention to the principles of impartiality and independence.
Amendment 208 #
2011/0373(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Close cooperation between the Commission, ADR entities and national authorities entrusted with the enforcement of Union legislation on consumer protection should strengthen the effective application of such Union legislation. The Commission should facilitate administrative cooperation between the Member States, ADR entities and legal professionals by holding regular meetings with the various stakeholders to foster exchanges of best practice and technical expertise between ADR entities and discuss any problems arising from the operation of ADR schemes.
Amendment 273 #
2011/0373(COD)
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
Amendment 52 #
2011/0358(COD)
Proposal for a directive
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
Amendment 60 #
2011/0358(COD)
Proposal for a directive
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 61 #
2011/0358(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 1
Article 24 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of pyrotechnic articles and/or explosive substances which they assess. This shall not preclude the use of pyrotechnic articles and/or explosive substances that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
Amendment 62 #
2011/0358(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 2
Article 24 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those pyrotechnic articles and/or explosive substances, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 63 #
2011/0358(COD)
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 24.
Amendment 64 #
2011/0358(COD)
Proposal for a directive
Article 27 – paragraph 3
Article 27 – paragraph 3
Amendment 65 #
2011/0358(COD)
Proposal for a directive
Article 28 – paragraph 4
Article 28 – paragraph 4
Amendment 66 #
2011/0358(COD)
Proposal for a directive
Article 28 – paragraph 5 – subparagraph 1
Article 28 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 70 #
2011/0358(COD)
Proposal for a directive
Annex II – module C2 – point 3 – paragraph 3
Annex II – module C2 – point 3 – paragraph 3
Amendment 37 #
2011/0356(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 38 #
2011/0356(COD)
Proposal for a directive
Article 21 – paragraph 3 – subparagraph 2
Article 21 – paragraph 3 – subparagraph 2
Amendment 39 #
2011/0356(COD)
Proposal for a directive
Article 21 – paragraph 4 – subparagraph 1
Article 21 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assesscovered by this Directive, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
Amendment 40 #
2011/0356(COD)
Proposal for a directive
Article 21 – paragraph 4 – subparagraph 2
Article 21 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products covered by this Directive, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 41 #
2011/0356(COD)
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 21.
Amendment 42 #
2011/0356(COD)
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3
Amendment 43 #
2011/0356(COD)
Proposal for a directive
Article 25 – paragraph 4
Article 25 – paragraph 4
Amendment 45 #
2011/0356(COD)
Proposal for a directive
Article 25 – paragraph 5 – subparagraph 1
Article 25 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 56 #
2011/0354(COD)
Proposal for a directive
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 57 #
2011/0354(COD)
Proposal for a directive
Article 24 – paragraph 3 – subparagraph 2
Article 24 – paragraph 3 – subparagraph 2
Amendment 58 #
2011/0354(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 1
Article 24 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, purchaser, owner, user or maintainer of safety components for lifts which they assess, nor the authorised representative of any of those parties.
Amendment 59 #
2011/0354(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 2
Article 24 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of lifts which they assess.
Amendment 60 #
2011/0354(COD)
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment procedures for lifts or for safety components for lifts for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 24.
Amendment 61 #
2011/0354(COD)
Proposal for a directive
Article 27 – paragraph 3
Article 27 – paragraph 3
Amendment 62 #
2011/0354(COD)
Proposal for a directive
Article 28 – paragraph 4
Article 28 – paragraph 4
Amendment 63 #
2011/0354(COD)
Proposal for a directive
Article 28 – paragraph 5 – subparagraph 1
Article 28 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 33 #
2011/0353(COD)
Proposal for a directive
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall ensure that the measuring instrument is accompanied by a copy of the EU declaration of conformity and instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end- users, as determined by the Member State concerned.
Amendment 35 #
2011/0353(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Importers shall ensure that the measuring instrument is accompanied by a copy of the EU declaration of conformity and instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end- users, as determined by the Member State concerned.
Amendment 42 #
2011/0353(COD)
Proposal for a directive
Article 23 – paragraph 6 a (new)
Article 23 – paragraph 6 a (new)
6a. The affixing of markings on a measuring instrument that are likely to deceive third parties as to the meaning and/or form of the supplementary metrology marking shall be prohibited. Any other marking may be affixed to a measuring instrument, provided that the visibility and legibility of the supplementary metrology marking is not thereby reduced.
Amendment 44 #
2011/0353(COD)
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 45 #
2011/0353(COD)
Proposal for a directive
Article 28 – paragraph 3 – subparagraph 2
Article 28 – paragraph 3 – subparagraph 2
Amendment 46 #
2011/0353(COD)
Proposal for a directive
Article 28 – paragraph 4 – subparagraph 1
Article 28 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the measuring instruments which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed measuring instruments that are necessary for the operations of the conformity assessment body or the use of such measuring instruments for personal purposes.
Amendment 47 #
2011/0353(COD)
Proposal for a directive
Article 28 – paragraph 4 – subparagraph 2
Article 28 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those measuring instruments, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 48 #
2011/0353(COD)
Proposal for a directive
Article 31 – paragraph 2
Article 31 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the measuring instrument or measuring instruments for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 28.
Amendment 49 #
2011/0353(COD)
Proposal for a directive
Article 31 – paragraph 3
Article 31 – paragraph 3
Amendment 51 #
2011/0353(COD)
Proposal for a directive
Article 32 – paragraph 4
Article 32 – paragraph 4
Amendment 52 #
2011/0353(COD)
Proposal for a directive
Article 32 – paragraph 5 – subparagraph 1
Article 32 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 29 #
2011/0352(COD)
Proposal for a directive
Recital 10
Recital 10
(10) When placing a non-automatic weighing instrument on the market, every importer should indicate on the non- automatic weighing instrument his name and the address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the non-automatic weighing instrument does not allow it. This includes cases where the importer should have to open the packaging to put his name and address on the instrument.
Amendment 32 #
2011/0352(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
1) ‘weighing instrument’ means a measuring instrument serving to determine the mass of a body by using the action of gravity on that body or; a weighing instrument may also servinge to determine other mass-related magnitudes, quantities, parameters or characteristics;
Amendment 35 #
2011/0352(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall take all steps to ensure that instruments continue to conform to the requirements of this Directivebearing the ‘CE’ conformity marking attesting conformity with the requirements of this Directive continue to conform to those requirements.
Amendment 43 #
2011/0352(COD)
Proposal for a directive
Article 6 – paragraph 6
Article 6 – paragraph 6
6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the instrument or, where that is not possible, on its packaging or in a document accompanying the instrument. The address must indicate a single point at which the manufacturer can be contacted.
Amendment 44 #
2011/0352(COD)
Proposal for a directive
Article 6 – paragraph 7
Article 6 – paragraph 7
7. Manufacturers shall ensure that the instrument is accompanied by a copy of the EU declaration of conformity and instructions and information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
Amendment 49 #
2011/0352(COD)
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Importers shall ensure that the instrument is accompanied by a copy of the EU declaration of conformity and instructions and information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
Amendment 57 #
2011/0352(COD)
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 58 #
2011/0352(COD)
Proposal for a directive
Article 22 – paragraph 3 – subparagraph 2
Article 22 – paragraph 3 – subparagraph 2
Amendment 59 #
2011/0352(COD)
Proposal for a directive
Article 22 – paragraph 4 – subparagraph 1
Article 22 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the instruments which they assesscovered by this directive, nor the authorised representative of any of those parties. This shall not preclude the use of assessed instruments that are necessary for the operations of the conformity assessment body or the use of such instruments for personal purposes.
Amendment 60 #
2011/0352(COD)
Proposal for a directive
Article 22 – paragraph 4 – subparagraph 2
Article 22 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those instruments covered by this directive, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 61 #
2011/0352(COD)
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the instrument or instruments for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 22.
Amendment 62 #
2011/0352(COD)
Proposal for a directive
Article 25 – paragraph 3
Article 25 – paragraph 3
Amendment 63 #
2011/0352(COD)
Proposal for a directive
Article 26 – paragraph 4
Article 26 – paragraph 4
Amendment 64 #
2011/0352(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1
Article 26 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 67 #
2011/0352(COD)
Proposal for a directive
Annex II – part 2 – point 2.5 – point 2.5.2 – paragraph 2
Annex II – part 2 – point 2.5 – point 2.5.2 – paragraph 2
A copy of the declaration of conformity shall be made available to the relevant authorities upon requesprovided with each instrument placed on the market.
Amendment 68 #
2011/0352(COD)
Proposal for a directive
Annex II – part 3 – point 3.7 – point 3.7.2 – paragraph 2
Annex II – part 3 – point 3.7 – point 3.7.2 – paragraph 2
A copy of the declaration of conformity shall be made available to the relevant authorities upon requesprovided with each instrument placed on the market.
Amendment 70 #
2011/0352(COD)
Proposal for a directive
Annex II – part 4 – point 4.5 – point 4.5.2 – paragraph 2
Annex II – part 4 – point 4.5 – point 4.5.2 – paragraph 2
A copy of the declaration of conformity shall be made available to the relevant authorities upon requesprovided with each instrument placed on the market.
Amendment 72 #
2011/0352(COD)
Proposal for a directive
Annex II – part 5 – point 5.6 – point 5.6.2 – paragraph 2
Annex II – part 5 – point 5.6 – point 5.6.2 – paragraph 2
A copy of the declaration of conformity shall be made available to the relevant authorities upon requesprovided with each instrument placed on the market.
Amendment 38 #
2011/0351(COD)
Proposal for a directive
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 39 #
2011/0351(COD)
Proposal for a directive
Article 24 – paragraph 3 – subparagraph 2
Article 24 – paragraph 3 – subparagraph 2
Amendment 40 #
2011/0351(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 1
Article 24 – paragraph 4 – subparagraph 1
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the apparatus which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed apparatus that are necessary for the operations of the conformity assessment body or the use of such apparatus for personal purposes.
Amendment 41 #
2011/0351(COD)
Proposal for a directive
Article 24 – paragraph 4 – subparagraph 2
Article 24 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those apparatus, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 42 #
2011/0351(COD)
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the apparatus or apparatuses for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 24.
Amendment 43 #
2011/0351(COD)
Proposal for a directive
Article 27 – paragraph 3
Article 27 – paragraph 3
Amendment 44 #
2011/0351(COD)
Proposal for a directive
Article 28 – paragraph 4
Article 28 – paragraph 4
Amendment 45 #
2011/0351(COD)
Proposal for a directive
Article 28 – paragraph 5 – subparagraph 1
Article 28 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 48 #
2011/0351(COD)
Proposal for a directive
Annex II – point 2 – paragraph 2 – indent 1 a (new)
Annex II – point 2 – paragraph 2 – indent 1 a (new)
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
Amendment 49 #
2011/0351(COD)
Proposal for a directive
Annex II – point 2 – paragraph 2 – indent 1 b (new)
Annex II – point 2 – paragraph 2 – indent 1 b (new)
- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
Amendment 50 #
2011/0351(COD)
Proposal for a directive
Annex III – point 3 – paragraph 2 – point c – point i a (new)
Annex III – point 3 – paragraph 2 – point c – point i a (new)
(ia) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
Amendment 51 #
2011/0351(COD)
Proposal for a directive
Annex III – point 3 – paragraph 2 – point c – point i b (new)
Annex III – point 3 – paragraph 2 – point c – point i b (new)
(ib) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
Amendment 42 #
2011/0350(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 43 #
2011/0350(COD)
Proposal for a directive
Article 21 – paragraph 3 – subparagraph 2
Article 21 – paragraph 3 – subparagraph 2
Amendment 44 #
2011/0350(COD)
Proposal for a directive
Article 21 – paragraph 4 – subparagraph 1
Article 21 – paragraph 4 – subparagraph 1
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the vessels which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed vessels that are necessary for the operations of the conformity assessment body or the use of such vessels for personal purposes.
Amendment 45 #
2011/0350(COD)
Proposal for a directive
Article 21 – paragraph 4 – subparagraph 2
Article 21 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products covered by this Directive, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 46 #
2011/0350(COD)
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3
Amendment 47 #
2011/0350(COD)
Proposal for a directive
Article 25 – paragraph 4
Article 25 – paragraph 4
Amendment 48 #
2011/0350(COD)
Proposal for a directive
Article 25 – paragraph 5 – subparagraph 1
Article 25 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 33 #
2011/0349(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
1) ‘explosives’ means the materials and articles considered to be suchexplosive in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations and which are manufactured with a view to producing a practical effect by explosion or a pyrotechnic effect;
Amendment 34 #
2011/0349(COD)
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 3
Article 6 – paragraph 2 – subparagraph 3
Amendment 35 #
2011/0349(COD)
Proposal for a directive
Article 6 – paragraph 4 – subparagraph 1a (new)
Article 6 – paragraph 4 – subparagraph 1a (new)
When deemed appropriate with regard to the risks presented by an explosive, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of explosives made available on the market, investigate and, if necessary, keep a register of complaints, of non- conforming explosives and of recalls of explosives, and shall keep distributors informed of any such monitoring.
Amendment 36 #
2011/0349(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1a (new)
Article 8 – paragraph 5 – subparagraph 1a (new)
When deemed appropriate with regard to the risks presented by an explosive, importers shall, to protect the health and safety of consumers, carry out sample testing of explosives made available on the market, investigate and, if necessary, keep a register of complaints, of non- conforming explosives and of recalls of explosives, and shall keep distributors informed of any such monitoring.
Amendment 38 #
2011/0349(COD)
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Member States may decide that tThe assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 39 #
2011/0349(COD)
Proposal for a directive
Article 27 – paragraph 3 – subparagraph 2
Article 27 – paragraph 3 – subparagraph 2
Amendment 40 #
2011/0349(COD)
Proposal for a directive
Article 27 – paragraph 4 – subparagraph 1
Article 27 – paragraph 4 – subparagraph 1
Amendment 41 #
2011/0349(COD)
Proposal for a directive
Article 27 – paragraph 4 – subparagraph 2
Article 27 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, marketing , installation, use or maintenance of those explosives or represent the parties engaged in those activities . They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 42 #
2011/0349(COD)
Proposal for a directive
Article 30 – paragraph 2
Article 30 – paragraph 2
2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the explosive or explosives for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 27.
Amendment 43 #
2011/0349(COD)
Proposal for a directive
Article 30 – paragraph 3
Article 30 – paragraph 3
Amendment 44 #
2011/0349(COD)
Proposal for a directive
Article 31 – paragraph 4
Article 31 – paragraph 4
Amendment 45 #
2011/0349(COD)
Proposal for a directive
Article 31 – paragraph 5 – subparagraph 1
Article 31 – paragraph 5 – subparagraph 1
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Amendment 46 #
2011/0349(COD)
Proposal for a directive
Article 40 – paragraph 1 – subparagraph 1a (new)
Article 40 – paragraph 1 – subparagraph 1a (new)
Member States shall also take all appropriate measures to ensure that explosives may be placed on the market only if they are properly stored and used for their intended purpose.
Amendment 48 #
2011/0349(COD)
Proposal for a directive
Annex II – point 2 module C2 – paragraph 7 – subparagraph 3
Annex II – point 2 module C2 – paragraph 7 – subparagraph 3
Amendment 792 #
2011/0294(COD)
Proposal for a regulation
Annex I – Volume 08/33
Annex I – Volume 08/33
Incorporate the Tours-Dijon section into the core network
Amendment 960 #
Amendment 146 #
2011/0187(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
In order to ensure the development of the singletemporary single roaming market, implementation of the technical solutions for the facility of separate sale of roaming services shall take place simultaneously across the Union. and meet the following criteria: (a) any technical solution must be cost- effective; (b) it shall be designed in a customer- friendly way; (c) it shall allow for a maximum degree of interoperability; (d) it shall ensure that the concept of net neutrality is respected for all data use, in particular access to VOIP and other similar services; (e) customers shall be able to easily and quickly switch to an alternative roaming provider or between alternative roaming providers while retaining their mobile number; (f) roaming by Union citizens in third countries shall not be impeded.
Amendment 21 #
2011/0156(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and, on food for special medical purposes and other food intended for special nutritional uses (presented by the Commission pursuant to Article 114 of the Treaty on the Functioning of the European Union) (Text with EEA relevance)
Amendment 25 #
2011/0156(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Directive 2009/39/EC foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses: ‘food intended to meet the expenditure of intense muscular effort, especially for sportsmen’ and ‘food for persons suffering from carbohydrate metabolism disorders (diabetes)’. With regard to food intended to meet the expenditure of intense muscular effort, no successful conclusion could be reached as regards the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation, the number of sub-categories of the food to be included, the criteria for establishing composition require. However, these divergences are giving rise to national measures that are hindering completion of the internal market and for which an appropriate legislative response therefore has to be found. Furthermore, action should be taken to ensure that Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers1 can guarantee a coherent, effective strategy for the protection of sportspeople before the idea of specific legislation is finally abandoned. The particular aim here is to meet the high demand from sportspeople and to clarify the relevant labelling rules. Where foods for sportspeople are concerned, this means that: Regulation (EU) No 1169/2011 needs to be amended; account needs to be taken of the specific nutrient profiles for foods intended for sportspeople whilst establishing the nutrient profiles referred to in Article 4 of Regulation (EC) No 1924/2006 of the European Parliaments and of the potential impact on innovation in product developmentCouncil of 20 December 2006 on nutrition and health claims made on foods2; account needs to be taken of the existence of nutrition claims that are relevant for sportspeople but banned for the general public under Regulation (EC) No 1924/2006 (‘high carbohydrate energy content’ or ‘rich in sodium’, for example); specific conditions need to be established for the use of nutrients and other substances for food intended for sportspeople under Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods3; and there must be a guarantee that there are no ingredients that could be listed as doping substances. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking. ____________________ 1 OJ L 304, 22.11.2011, p. 18. 2 OJ L 404, 30.12.2006, p. 9. 3 OJ L 404, 30.12.2006, p. 26.
Amendment 34 #
2011/0156(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes and foodstuffs for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directives 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/ECnd 1999/21/EC and in Commission Regulation (EC) No 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children and to, food for special medical purposes, and foodstuffs for people intolerant to gluten taking into account Commission Directives 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC2006/125/EC and 1999/21/EC, and Commission Regulation (EC) No 41/2009.
Amendment 40 #
2011/0156(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive s 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC2006/125/EC and 1999/21/EC and in Commission Regulation (EC) No 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal- based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 46 #
2011/0156(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten, taking into account Commission Directives 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC2006/125/EC and 1999/21/EC, and Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 54 #
2011/0156(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of substances, including vitamins, minerals, and amino acids and other substances that may be added, that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and foodstuffs for people intolerant to gluten, taking into account Regulation (EC) No 953/2009 and Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Thoese powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 57 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for special food for normal consumptiopeople intolerant to gluten under the rules specified in CommissionArticle 3 of Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and com. Furthermore, the statement ‘gluten-free’ may be used for food for normal consumption and for foodstuffs suitable for people intolerant to gluten under the rules specified in Article 4 of Regulation (EC) No 41/2009, which does not authorise use of the statement ‘very low gluten’ for these foods. These foodstuffs for special food for people intolerant to gluten should be retained in this regulation, insofar as provision of such safe foodstuffs for people intolerant to gluten and information for peoplye with requirements therein. It is necessary that technical adaptationscoeliac disease on the absence of gluten is essential for management of the disease. This is in accordance with the international standard for foods for special dietary use for puersuant to Regulation (EC) No 1924/2006, incorporatingons intolerant to gluten (CODEX STAN 118-1979 revised in 2008). Thus the nutrcondition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application of this Regulations for using the statement ‘gluten-free’ for food products for normal consumption should be maintained in Regulation (EC) No 41/2009.
Amendment 70 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialised nutrition:
Amendment 79 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foodstuffs for people intolerant to gluten;
Amendment 95 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) ‘foodstuffs for people intolerant to gluten’ means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten.
Amendment 105 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘infant formula’, ‘follow-on formula’, ‘processed cereal-based food’ and ‘baby food’ and, ‘food for special medical purposes’ and ‘foodstuffs for people intolerant to gluten’, taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 132 #
2011/0156(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC and Regulation (EC) No 41/2009 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 141 #
2011/0156(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Provisions for food intended to meet the expenditure of intense muscular effort, especially for sportsmen and women On ...* at the latest, the Commission, after consulting the European Food Safety Authority on the particular nutritional requirements of sportsmen and women with regard to their special physiological condition and the dietary constraints arising from training and competing, shall present to the European Parliament and to the Council a report on the legislative strategy proposed for ‘food intended to meet the expenditure of intense muscular effort, especially for sportsmen and women’ in order to ensure the availability of food with an appropriate nutrient profile, effective implementation of the operators’ responsibility for ensuring the absence of doping substances, the conditions for using nutrients and other substances of interest and preventing any risk in the framework of sporting activities, information on an appropriate and safe use of food for sportsmen and women and claims relevant to sportsmen and women. In the light of this report, the Commission shall: (a) either decide that it is not necessary to adopt specific provisions on the composition and labelling of ‘food intended to meet the expenditure of intense muscular effort, especially for sportsmen and women’, in which case it shall specify the modifications or implementing rules relating to general legislative texts that it thinks necessary to meet the above-mentioned objectives; (b) or, in accordance with the procedure laid down in Article 114 of the Treaty on the Functioning of the European Union, present appropriate proposals with a view to amending this regulation and amending the delegated acts concerned so as to include the relevant specific provisions, in accordance with Article 15 of this regulation. ______________ OJ: please insert date: one year after the entry into force of this Regulation.
Amendment 149 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 132 #
2011/0137(COD)
Proposal for a regulation
Article 2 – point 5 – point 5.1
Article 2 – point 5 – point 5.1
5.1 goods, to include their wrapping, any other trade mark sign (logo, label, sticker, brochure, operating instructions, warranty document bearing the sign in question) even if presented separately, and their packaging which are the subject of an action infringing a trade mark and bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark;
Amendment 23 #
2011/0135(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Office should offer a forum that brings together public authorities and, the private sector and civil society, ensuring the collection, analysis and dissemination of relevant objective, comparable and reliable data regarding the value of intellectual property rights and the infringements of those rights, the development of best practices and strategies to protect intellectual property rights, and raising public awareness of the impacts of intellectual property rights infringements. Furthermore, the Office should fulfil additional tasks, such as to improve the understanding of the value of intellectual property rights, enhance the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures, increase knowledge on techniques to prevent counterfeiting, and improve cooperation with third countries and international organisations.
Amendment 24 #
2011/0135(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) With regard to representatives of the private sector, the Office should involve, when assembling the Observatory in the context of its activities, a representative selection of the economic sectors most concerned by and most experienced in the fight against infringements of intellectual property rights, in particular representatives of right holders and Internet service providerright holders, Internet service providers and consumer associations. Also, a proper representation of consumers and of small and medium sized enterprises should be ensured.
Amendment 29 #
2011/0135(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) enhancing the knowledge on technical tools to prevent and combat counterfeiting and piracy, including tracking and tracing systems; , while respecting basic rights and freedoms in accordance with Article 1(3a) of Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002, on a common regulatory framework for electronic communications networks and services (Framework Directive)1, and Article 1(3) of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002, on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive)2; ____________________ OJ L 108, 24.4.2002, p. 33. OJ L 108, 24.4.2002, p. 51.
Amendment 32 #
2011/0135(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
(d) collecting, analysing and disseminating relevant objective, comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth, welfare, innovation, creativity, cultural diversity, the creation of high quality jobs and the development of high quality products and services within the Union; , and to consumer protection and safety;
Amendment 34 #
2011/0135(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) drawing up reports and publications to raise awareness of the Union's citizens of the impact of infringements of intellectual property rights, and organising conferences, and coordinating on-line and off-line campaigns, events and meetings at European and international levels, while taking into account restrictions in terms of financial and human resources;
Amendment 35 #
2011/0135(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point i
Article 2 – paragraph 2 – point i
(i) organising ad hoc meetings of experts and of representatives of all the relevant stakeholders to support its work under this Regulation;
Amendment 40 #
2011/0135(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Office shall invite to the meetings referred to in point (a) of Article 2(2) representatives from public administrations, bodies and organisations dealing with the protection of intellectual property rights and representatives from the private sector and civil society.
Amendment 41 #
2011/0135(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
Representatives meeting as the Observatory invited from the private sector shall include a broad and representative range of Union and national bodies representing the different economic sectors most concerned by and most experienced in the fight against infringements of intellectual property rights, as well as representatives of civil society including consumer associations.
Amendment 44 #
2011/0135(COD)
Proposal for a regulation
Article 5 – introductory part
Article 5 – introductory part
Without prejudice to law governing the processing of personal data, Member States and private sector representatives of the private sector and civil society meeting as the Observatory shall:
Amendment 32 #
2010/2289(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Welcomes the intention of the Commission to increase consultation and dialogue with civil society, and urges the Commission to launch an information and education campaign on the essence of the single market and the objectives set in order to increase its dynamism while incorporating the dimensions of social and regional cohesion; stresses the need for this communication campaign to favour better participation – and a better ability to participate – by each citizen, worker and consumer in bringing about a competitive, just and balanced market;
Amendment 134 #
2010/2289(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30a. Calls on the Commission to consider extending the Internal Market Information system IMI, the importance of which has been thoroughly demonstrated during the implementation of the Services and Professional Qualifications Directives;
Amendment 22 #
2010/2277(INI)
Motion for a resolution
Recital K
Recital K
K. whereas counterfeiting and piracy reduces business confidence in e-commerce and fuels the fragmentation of intellectual property protection rules which stifles innovation in the Single Market,
Amendment 30 #
2010/2277(INI)
Motion for a resolution
Recital N
Recital N
N. whereas services are accountable for a significant part of our economic growth; whereas the Single Market for services is still underdeveloped due to gaps and late implementation of the Services Directive; whereas the sectors excluded from this directive should be the subject of specific protective legislation that complies with the principles of subsidiarity and proportionality,
Amendment 36 #
2010/2277(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 38 #
2010/2277(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. considers it essential that the Single Market Act include an ambitious agenda for social and consumer protection in the form of the insertion of a social clause in all legislation related to the internal market, legislation on services of general economic interest, a legislative agenda to strengthen workers' rights, an ambitious legislative package for consumer protection that makes a difference to the daily lives of citizens and better tax coordination by means of harmonisation of the corporate tax base and VAT rates;
Amendment 54 #
2010/2277(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Strongly supports the creation of an EU patent and of a unified patent litigation system in order to make the Single Market an innovation-friendly environment; stresses that the cost burden of multilingual patents would hinder innovation in the Single Market, and wants the language problem solved quickly;
Amendment 66 #
2010/2277(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Supports the creation of EUuropean project bonds in order to support long-term innovation in the Single Market and to finance the implementation of major cross-border infrastructure projects, particularly in the areas of energy and transport;
Amendment 75 #
2010/2277(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers that the pooling of European Investment Fund resources with those of national public and private investors would help meet the specific needs of the market and allow more capital to be injected into the venture capital sector, within the context of the need for long-term investment in innovation in order to achieve the ambitious objectives laid down in this field by the EU 2020 Strategy;
Amendment 101 #
2010/2277(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission to take the appropriate measures to enhance the confidence of businesses in e-commerce, namely by harmonizing contract law where possible without jeopardising the consumer acquis and by facilitating cross- border debt recovery;
Amendment 109 #
2010/2277(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 116 #
2010/2277(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the need to create a Single Market for online audiovisual goods by improving the electronic management of copyrights while ensuring that rightholders receive adequate remuneration for their creative works, and with the aim of ensuring that citizens have fair access at a reasonable cost to cultural goods and services;
Amendment 127 #
2010/2277(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Points out the need to strengthen the fight against online piracy in a proportionate manner and with public support by making full use of the available technology while respecting fundamental rightsStresses, with regard to the fight against counterfeiting, that there is a need to align online legislation with existing off-line legislation so that consumers and businesses place more trust in e- commerce;
Amendment 137 #
2010/2277(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to improve SMEs’ access to capital marketsspecific and regulated capital markets by supporting a European network of dedicated stock markets, and also by increasing information available on different EU financing opportunities such as those provided by the Competitiveness and Innovation Programme, the European Investment Bank or the European Investment Fund and by making funding procedures easier, quicker and less bureaucratic;
Amendment 173 #
2010/2277(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to make public procurement procedures more effective to encourage EU firms to participate in cross-border public procurement; stresses that the participation of SMEs in contract award procedures should be further facilitated, whilst endeavouring to uphold their rights and those of their employees when they work as subcontractors;
Amendment 176 #
2010/2277(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Emphasises the importance of ensuring reciprocal access to public contracts with trading partners in the industrialised and major emerging countries;
Amendment 182 #
2010/2277(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission to simplify public procurement procedures in order to reduce the administrative cost and legal uncertainty for contracting authorities; also calls on the Commission to find a clear and appropriate solution for ‘in- house’ contracts in public procurement legislation;
Amendment 187 #
2010/2277(INI)
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
16c. Calls on the Commission to adopt a cautious approach to public-private partnerships, by also taking bad experiences into account, and to propose a clear legislative framework which provides legal certainty and puts bidders and contracting authorities on an equal footing in sharing both the benefits and the risks;
Amendment 188 #
2010/2277(INI)
Motion for a resolution
Paragraph 16 d (new)
Paragraph 16 d (new)
16d. Calls on the Commission to bring legal clarification to public procurement legislation with respect to the inclusion of social and environmental criteria in invitations to tender;
Amendment 190 #
Amendment 195 #
2010/2277(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to present a legislative framework to protect social services of general interest and services of general economic interest, which are at the heart of the European social model, to enable them to fulfil all their tasks, as provided for in the Lisbon Treaty and in accordance with the principles of subsidiarity and proportionality;
Amendment 212 #
2010/2277(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Invites the Commission to propose a legal framework for services concessions that would ensure transparency, effective judicial protection for bidders and legal certaintyConsiders that any legislative proposal on services concessions should provide a legal framework that would ensure transparency, effective judicial protection for bidders and contracting authorities and legal certainty, taking due account of current Court of Justice case law;
Amendment 218 #
2010/2277(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Emphasises the importance of proper implementation of the Professional Qualifications Directive and welcomes the work carried out on its recast; urges the Commission to propose measures for the creation of EU-wide professional cards where appropriate, particularly for the regulated professions or those where the risk of fraud is greatest and most dangerous;
Amendment 223 #
2010/2277(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Highlights the importance of the external dimension of the internal market and in particular of regulatory cooperation with main trading partners with the objective of promoting regulatory convergence, equivalence of third-country regimes and the wider adoption of international standards, particularly on social and environmental matters;
Amendment 225 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Stresses the role of the Services of General Economic Interest and Social Services of General Interest as basic rights for the European citizens, as fundamental pillar of the European social market economy (and as shock absorber for citizens and enterprises during the crisis) and calls for a legislative framework on SGEI - on the basis of art.14 and protocol 26 of TFEU - in order to avoid law uncertainty, to guarantee possibility of public authorities providing, executing and organising these services in a way that meets users needs, to ensure quality and affordable universal services access to public transports, energy, water, housing, banking services; (proposal 25)
Amendment 228 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22b. highlights the importance to review legislation relating to Public procurements and Public and Private partnership with a to foster smart, sustainable and inclusive growth within the Single Market and for local realities; stresses the need for a clear legislation, taking into account the right to impose social and environmental clauses, facilitating access of SMEs to these markets, ensuring legal certainty for contracting authorities, thus respecting the current case law on services concessions; underlines the necessity of a legislative instrument on the implementation of the European Union's commitments relating to international public procurements in order to ensure substantial reciprocity and transparency; stresses that increased competitive pressure among corporations has led to serious abuse of human rights, labour rights and damages to the environment; calls therefore for a Corporate Social Responsibility binding clause to be included in trade agreements; (proposals 17, 24)
Amendment 229 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22c. points out the need to progress towards some tax harmonisation at EU level - thus hindering distorting and unfair tax competition putting at stake social protection and reducing revenues for Member States - with the objective of easing the burden on labour and creating incentives for employment, innovation and long-term investment, notably by harmonising the common consolidated corporate tax base and coordinating VAT rates; (proposal 19)
Amendment 231 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 d (new)
Paragraph 22 d (new)
22d. reminds that financial services are not subjected to VAT; considers that financial services and activities should be subject to an adequate system and level of taxation, therefore asks for the introduction of a Financial Transactions Tax the revenue from which would improve the functioning of the market by reducing speculation and help to finance public goods, long term investment in growth, employment and social inclusion and reduce public deficits in a balanced manner; considers that such a tax ought to be as broadly based as possible or, failing that, that the FTT should be introduced as a first step at EU level by the Commission through a concrete legislative proposal;
Amendment 233 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 e (new)
Paragraph 22 e (new)
22e. highlights the importance of fostering real economy and long term investments conducive to growth and jobs through innovative financing tools, therefore calls for the creation of Euro project bonds to stimulate EU-wide strategic projects, notably on energy, transport, digital and R&D infrastructures, for a European legislation on venture capital funds and long term savings providing capital for innovative and job creating sectors, for facilitating access of SMEs to financing, both by exhorting banks to lend and by putting in place a European network of specific and regulated stock exchange; (proposals 15, 16)
Amendment 234 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 f (new)
Paragraph 22 f (new)
22f. asks for strengthening the fight against counterfeiting, as a major issue for both jobs and growth, and for consumers' safety, by improving the cooperation between customs services, giving appropriate information to consumers, notably on counterfeited goods sold on internet, strengthening the dialogue on these issues with commercial partners, notably China, and "made in" issue; (proposal 3)
Amendment 235 #
2010/2277(INI)
Motion for a resolution
Paragraph 22 g (new)
Paragraph 22 g (new)
22g. calls for the creation of a Single market for online audiovisual goods ensuring an adequate remuneration for right holders thus aiming the broadest access of people to cultural goods; urges specific measures to enhance confidence of businesses and consumers in e- commerce (such as the e-signatures directive...), so to boost the potential of the e-commerce market and to strengthen data and privacy protection on the internet; (proposals 2, 5)
Amendment 11 #
2010/2274(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the Single Market can never be truly considered as complete and should always be reassessed according to social needs and technological developments, social protection guarantees, economic development and growth should always be safeguarded to ensure the Single market brings tangible benefits for citizens, and the Single Digital Market, including for electronic communications, should be enabled and realised without delay, for the benefit of European citizens, consumers and businesses;
Amendment 13 #
2010/2274(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the only number which can be used inEuropean emergency number 112, created in 1991 by a decision of the Council to enable citizens to access all EU Member States to contact emergency services, is the European emergency number ‘112’gency services (fire, police and medical services), is the only emergency number that can be accessed in all the Member States of the European Union, and while a large majority of Europeans is still unaware of it, with no progresses observed since 2000;
Amendment 16 #
2010/2274(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas efforts are still necessary to assess and ensure the quality of service when dialling 112 both on the telecommunications and emergency services coordination aspects, and while a comprehensive and detailed assessment of the real state of implementation of the 112 service in the EU as experienced by citizens, notably evaluating accessibility, interoperability and intervention times, has not been carried out;
Amendment 18 #
2010/2274(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas several recent disasters have shown that early warning and alert of citizens in case of imminent or developing major emergencies and disasters is necessary in view of reducing suffering and the loss of life;
Amendment 30 #
2010/2274(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls for effective transposition of the telecom framework, in particular its net neutrality provisions, in a way that end- users can access the services and content, and run the applications of their choice on the Internet;
Amendment 33 #
2010/2274(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that the Universal service is not a right or the keonly driver for achieving the ‘broadband for all’ objective given the high investment costs required, without necessarily being ableand the insufficient funding granted, thus not being given the opportunity to provide significantly improved services to consumers;
Amendment 44 #
2010/2274(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission to ensure that the next generation broadband networks are rolled out in a way that protects the open and neutral character of the Internet and prevents arbitrary discriminations against end-users’ ability to access the services and content and run the applications of their choice on the Internet;
Amendment 60 #
2010/2274(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission, in close cooperation with Member States, to significantly improve the accuracy and reliability of caller location information under the new EU telecoms rules and upgrade their technology with the ultimate goal of automatic localisation for all 112 calls within few seconds in order to provide accurate and reliable information to dispatchers and therefore prove valuable to citizens;
Amendment 62 #
2010/2274(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
Amendment 63 #
2010/2274(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls on the Commission to support the development of European Next Generation 112 standards and regulations pertaining to caller-location for VoIP calls, considering that these may be initiated through network-independent applications;
Amendment 64 #
2010/2274(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Requests financing to be made available and research projects to be supported to ensure the development of the best possible technologies for identifying of caller location, includnotably by allocating the ICT-PSP funds indicated ing throughe EU Budget 2009, 2010 and 2011 in order to support the testing and implementation of innovative services (based on VoIP, and therefore supports the developmentIP-access to 112) in anticipation of the establishment of a Next Generation 112 system in the EU. The Commission is also invited to examine the implementation of nNext gGeneration standards and regulati112 applications such as texting, video and social networks and how such applications, which are currently available to citizens, can be implemented in emergency communications to improve access to 112 as well as enhance citizen initiated emergency response;
Amendment 68 #
2010/2274(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission, in close cooperation with Member States, to set reliability and quality requirements and establish immediate reaction indicatfor the whole "112" service chain, and to establish performance indicators and guidelines pertaining to the quality of the 112 service as experienced by citizens, taking into account the need fors as performance targetccessibility, for interoperability between emergency services, for multilingualism and for timely and qualitative interventions of emergency services;
Amendment 72 #
2010/2274(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recommends the exchange of best practices particularly on using a single operator to handle a call and the use of interpretation services that could help people who do not speak the language of the country in which they are using the emergency servicCalls on the Commission to support through an action programme the sharing of experiences and the exchange of best practices between EU emergency services by setting-up a network of experts, focusing on regular exchanges of information involving National Regulatory Agencies, emergency services and Civil Society Organisations (CSOs). It should also provide for the support of the deployment of 112 in EU candidate and neighbouring countries;
Amendment 82 #
2010/2274(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to evaluate, by independent bodies and by the end of 2012 at the latest, the real state of implementation of the 112 throughout the EU as experienced by citizens, assessing notably accessibility, interoperability and intervention times. In this respect, the Commission is also invited to provide by the same date an overview of legally binding and practically implemented intervention times in the EU and to extend the impact study prepared in the framework of eCall to the human and financial consequences of the functioning of 112;
Amendment 83 #
2010/2274(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to present a report on the establishment of a "reverse 112 system", i.e. an EU-wide, universal, multilingual, accessible, simplified and efficient interconnected system for warning and alerting citizens in case of imminent or developing natural and/or man-made major emergencies and disasters of any type, considers that such a system should be implemented without hindering privacy and in combination with appropriate information and training campaigns for citizens;
Amendment 84 #
2010/2274(INI)
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22b. Calls on the Commission, in close cooperation with Member States, to assess and consider, as soon as possible, appropriate actions to extend the notion of the Universal Service to include the creation and maintenance of a pan- European, multilingual, accessible to all and efficient «reverse 112» i.e. an early warning system for citizens using telecommunications in case of imminent or developing major emergencies and disasters throughout the EU;
Amendment 26 #
2010/2109(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Urges the Commission and Member States to encourage retail employers and workers representatives to enter in dialogue in order to provide with sector level solutions that favour competition not at the expense of working conditions and jobs; considers that collective bargaining is recognised as a driver for growth and job creation and is protected by the Charter of Fundamental Rights; stresses that, in the absence of social partners or when social dialogue does not function, it is the role of public authorities to protect workers against abuse;
Amendment 83 #
2010/2109(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Believes that fair competition is also guaranteed by a stable working environment as part of the European acquis; asks the Commission to investigate the impact of disproportioned utilisation of fragmented working hours and unlimited shop opening hours on the economic environment, on work-life balance and on employment conditions, and to initiate relevant actions in cooperation with social partners;
Amendment 2 #
2010/2089(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Emphasises the need for a coordinated approach across numerous policy areas to address the underlying socio-economic and geographical causes of health inequalities;
Amendment 9 #
2010/2089(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that health inequalities in the EU represent a substantial burden to Member States and their healthcare systems and that the effective functioning of the internal market and strong and if possible coordinated public policies on prevention can contribute to improvements in this field;
Amendment 11 #
2010/2089(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Encourages Member States to develop partnerships in border regions in order to share costs of infrastructure and personnel, while limiting spatial inequalities with regard to health, particularly for equal access to state-of- the-art equipment;
Amendment 12 #
2010/2089(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that, due to ageing of the population, local social and medical services are needed, and calls on Member States to support such services throughout their territory;
Amendment 16 #
2010/2089(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that within the internal market the accessibility and affordability of pharmaceutical treatments should be consideared a key aspect of health inequality, second only to access to diagnosis, and, in this regard, calls on Member States to ensure that the Transparency Directive (89/105/EEC) is being properly implemented;
Amendment 20 #
2010/2089(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Encourages Member States to increase the use of quality generic medicines, to negotiate as best possible, if appropriate in cooperation between States, the prices of medicines so as to enable the most disadvantaged groups to gain access to quality treatments;
Amendment 24 #
2010/2089(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Considers that the distribution of medicines by qualified healthcare professionals at pharmacies is an essential component of the proper functioning of health systems and ensures that patients receive quality information, particularly in the case of the weakest and least well-informed user groups;
Amendment 33 #
2010/2089(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. RecognisesConsiders that the implementation of the Cross-Border Healthcare Directive 2008/0142 (COD) as a potentially useful tool for addressing health inequalitiesshould be followed by precise impact assessments in order to measure as effectively as possible its consequences – beneficial or otherwise – in combating health inequalities, particularly in terms of the geographical allocation of medical resources, both human and material;
Amendment 37 #
2010/2089(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Regrets that the directive on cross- border health care was not accompanied by a legislative proposal on the mobility of healthcare professionals, taking into account the risk of a ‘brain drain’ within the EU, which would dangerously increase the geographical inequalities in certain Member States, and calls on the Commission to remedy it, possibly in the context of the future revision of the directive on professional qualifications (2005/36/EC);
Amendment 40 #
2010/2089(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Urges Members States to fully implement theStresses that the existing Professional Qualifications Directive (2005/36/EC) and invites the Commissionis not always tailored to further consider whether to make use of the IMI System, and whether an alert mechanism similar to that in opemplexity of medical qualifications in the EU and invites the Commission, in collaboration forwith the Services Directive (2006/123/EC) could be incorporated for the professionscompetent authorities, to continue to develop the IMI System, perhaps by means of an appropriate alert mechanism;
Amendment 48 #
2010/2089(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Argues that open, competitive and well functioning markets may stimulate innovation, investment and research in the healthcare sector and may help in identifying effective healthcare models, but that this must be accompanied by strong financial support for public research in order to guarantee effective healthcare models which can benefit all without any conditions as to resources and while taking the ageing of the population into account;
Amendment 54 #
2010/2089(INI)
Draft opinion
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Takes note that the work already done in the Internal Market and Consumer Protection Committee, in regards to product safety and advertising, among others, has helped to address certain aspects of health inequality in the EU, and in this context stresses the importance of strictly monitoring the information which pharmaceutical firms provide to patients, particularly the most vulnerable and least well informed groups, and the need for an effective and independent system of pharmacovigilance.
Amendment 16 #
2010/2053(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that most of the Member States have favoured transposition through ‘horizontal’ legislation; observes, however, that the method of transposition depends on the specific nature of the internal organisation of Member States; calls but regrets the lack of transparency onf the Member States to ensure that the transposition process isprocess in some Member States, in particular those which did not opt for horizontal transposition; calls, accordingly, on the Member States concerned to ensure greater transparentcy, particularly by improving the involvement of the national parliaments in the production of correlation tables;
Amendment 29 #
2010/2053(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines the difficulties encountered with recognising professional qualifications, in particular in the medical sector; points out that the Services Directive cannot apply to provisions already covered by the sectoral directives; asks the Commission to clarify this situation as part of a review of the directive on professional qualifications;
Amendment 76 #
2010/2053(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Notes the difficulties encountered in some Member States with precisely defining the scope of the exclusions provided for by the Directive, particularly concerning social services and health services; points out that such services were excluded because of their specific nature and that they require a sectoral Community legislative framework, such as a framework directive on services of general economic interest;
Amendment 22 #
2010/2051(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses, however, that these principles are not in themselves sufficient to ensure that small and medium-sized enterprises and societal stakeholders – in particular those representing health and safety, consumer and environmental interests – are adequately represented in the standardisation process; considers, therefore, that a vital element is the addition of the principle of ‘balanced and appropriate representation’, given that it is of the utmost importance, whenever the public interest is concerned, to incorporate all stakeholder positions in a balanced manner as regards participation by societal stakeholders and SMEs in NSBs, but also by ensuring appropriate representation within ESOs, especially in the development of standards intenddesigned to support EU legislation and policies;
Amendment 31 #
2010/2051(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Supporggests, therefore,at the Commission’s intention to include encourage participants to develop service standards within the legal framework of European standardisation, as this will not only organisations (ESOs) – namely CEN, CENELEC and the European Telecom Standards Institute (ETSI) – in order to ensure the notification of all national service standards that could potentially constitute technical barriers to trade in the internal market, but also prov and ultimately to avoide a proper legal basis on which the Commission can request the European standardisation organisations (ESOs) – namely CEN, CENELEC and the European Telecom Standards Institute (ETSI) –s much as possible this fragmentation between different national standards; calls on the Commission to include service standards in the legal framework of European standardisation if the results obtained by ESOs on a voluntary basis prove to be insufficient, thus providing a legal basis that allows the Commission to ask ESOs to develop standards in the services sector;
Amendment 69 #
2010/2051(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. WelRecommesnds that ESOs observe and, where necessary, take into account recent developments in the International Organisation for Standardisation (ISO), in particular the model used to develop the ISO 26000 standard on social responsibility, in which national standards bodies were entitled to nominate to the respective working group only one representative from each of six stakeholder categories (industry, consumers, government, labour, NGO, SSRO (service, support, research and others)) that were identified, ensuring, where necessary, appropriate representation for weaker stakeholders, and taking care to avoid the unnecessary duplication of work already carried out at international level;
Amendment 84 #
2010/2051(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Urges Member States to ensure effective representation of all relevant stakeholders on national technical committees by establishing monitoring and reporting mechanisms and, where necessary, providing training and financial support to weaker societal stakeholders, including SMEs, in order to facilitate their participation;
Amendment 117 #
2010/2051(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Emphasises the need to safeguard and enhance Europe’sthe position of Europe and all its Member States in the international standardisation environment in order to promote the development of international standards with genuine global relevance, facilitate trade and increase European competitiveness;
Amendment 93 #
2010/2012(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission to begin formulating European standards to facilitate cross-border e-commerce, to bridge variations between the laws in force within the various Member States and to remove the obligation within a selective distribution network of having an off-line shop prior to selling on-line, as both prevent where it is shown that such an obligation is not justified by the nature of the goods and services sold, thus enabling consumers and small and medium- sized enterprises fromto fully exploiting the internal market's potential in the electronic environment;
Amendment 106 #
2010/2012(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the need to reviewmonitor the application of recently adopted rules on exclusive and selective distribution which are based on market information from the parties concerned and the national competition authorities, and to review such rules where necessary in order to reduce barriers to online sales;
Amendment 124 #
2010/2012(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Considers that users (consumers and undertakings) need legal certainty when operating online, and welcomes the Commission’s proposal which, in the context of the digital agenda, envisages updating certain provisions – including those on limited liability for information society services in the field of e-commerce – in line with technical progress;
Amendment 38 #
2010/0252(COD)
Proposal for a decision
Recital 13
Recital 13
(13) The 800 MHz band is optimauseful for the coverage of large areas by wireless broadband services. Building on the harmonisation of technical conditions under Decision 2010/267/EU, and on Commission Recommendation of 28 October 2009 calling for analogue broadcasting to be switched off by 1 January 2012, and given rapid national regulatory developments, this band should in principle be made available for electronic communications in the Union by 2013. In the longer term, additional spectrum below 790 MHz could also be envisaged, depending onconsideration could also be given to the possibility of using additional spectrum in the UHF band, depending on actual market demand, social and cultural objectives, experience and the lack of spectrum in other bands adequate for coverage. Considering the capacity of the 800 MHz band to transmit over large areas, coverage obligations should be attached to rights.
Amendment 87 #
2010/0252(COD)
Proposal for a decision
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Member States shall, by 1 January 2013 make the 800 MHz band available for electronic communications services in line with the harmonised technical conditions laid down pursuant to the Decision No 676/2002/EC. In Member States where exceptional national or local circumstances would prevent the availability of the band, the Commission may authorise specific derogations until 2015. In accordance with Article 9 of Directive 2002/21/EC , the Commission, in cooperation with the Member States, shall keep under review the use of the spectrum below 1GHzUHF band as a whole and assess whether additional spectrum could be freed and made available for new applications.
Amendment 5 #
2009/2175(INI)
Motion for a resolution
Citation 10 a (new)
Citation 10 a (new)
- having regard to the opinion of the Committee of the Regions of 10 February 2010 on ‘contributing to Sustainable Development: the role of Fair Trade and non-governmental trade-related sustainability assurance schemes’ (RELEX-IV-026),
Amendment 6 #
2009/2175(INI)
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
- having regard to its resolution of 6 June 2006 on Fair Trade and Development (2005/2245 (INI)),
Amendment 18 #
Amendment 19 #
2009/2175(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Deplores the fact that the aims of the 2004 revision of the public procurement directives have not yet been achieved particularly with regard to the simplification of the procurement rules as well as the creation of more legal certainty; expresses the hope, however, that the most recent judgments handed down by the CJEU will help to resolve the outstanding legal issues and that the number of appeal procedures will fall;
Amendment 25 #
2009/2175(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Deplores, further, the fact that, in particular as a result of the interaction between European, national and regional law, as well as the plethora of soft law proposals put forward by the Commission and Commission departments and of the interpretation of the relevant legal provisions by European courts, the interaction between European, national and regional lawand National courts, has given rise to a complicated and confusing set of rules which is creating, in particular for smaller local authorities and for small and medium-sized undertakings, serious legal problems which they can no longer overcome without incurring substantial administrative costs or seeking external legal advice; urges the Commission to remedy this situation and, as part of the Better Lawmaking initiative, to examine the impact of soft law proposals, to restrict them to the essential and assess them in the light of the principles of subsidiarity and proportionality;
Amendment 28 #
2009/2175(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Points out that as a result of this development, the public procurer often has to prioritize legal certainty above policy needs, and given the pressure on public budgets, frequently has to award the contract or service to the cheapest offer, rather than to the most economically advantageous tender. Is afraid that this will weaken the EU’s innovative base and global competitiveness; Urges the Commission to remedy this situation and to develop strategic measures to encourage, empowering public procurers to give contracts to the most economical and best quality offers;
Amendment 31 #
2009/2175(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Urges the Commission to remedy this situation and to develop strategic measures to encourage and empower contracting authorities to give preference to the economically and qualitatively most advantageous offer, thereby contributing to the Union’s policy objectives, in particular the objectives of innovative and socially and environmentally responsible growth which lie at the heart of the Europe 2020 strategy;
Amendment 33 #
2009/2175(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Criticises the lack of transparency regarding the composition and results of the work of the internal Commission advisory committee on public procurement (ACPP) or the role and competencies of the advisory Committee on the Opening up of Public Procurement (CCO) and calls on the Commission to take steps to ensure that both this committee and the planned new advisory committee on public-private partnerships have a balanced composition and work in a transparent manner; demands that the European Parliaments is properly informed and is provided with all the information available;
Amendment 37 #
2009/2175(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Takes the view that as public contracts concern public funds, they should be transparent and open for public scrutiny; asks the Commission for clarification to ensure that local and other public authorities have legal certainty and can inform their citizens of their contractual obligations;
Amendment 38 #
2009/2175(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission, when reviewing the public procurement directives, to take account of the opinions expressed in this report; expects that review to be carried out with the full involvement of all stakeholders, but warns that it regards a revision of the directives at this juncture as premature; when such a revision is carried out at a later date, however, advocates that it shoul and in close cooperation with the European Parliament; advocates that a revision should take into account the whole framework and also encompass the directive on review procedures concerning public contracts, in order to prevent any further fragmentation of public procurement law; takes the view that the practical impact of that directive cannot yet be assessed, as it has not been transposed in all the Member States;
Amendment 42 #
2009/2175(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission, when reviewing the public procurement directives, to take account of the opinions expressed in this report; expects that review to be carried out with the full involvement of all stakeholders, but warns that it regards a revision of the directives at this juncture as prematureand in close collaboration with the European Parliament; when such a revision is carried out at a later date, however, advocates that it should also encompass the directive on review procedures concerning public contracts, and a specific legislative framework for service concessions, in order to prevent any further fragmentation of public procurement law; takes the view that a coherent legal framework for public contracts requires a framework directive on services of general economic interest; takes the view that the practical impact of that directive cannot yet be assessed, as it has not been transposed in all the Member States;
Amendment 46 #
Amendment 48 #
2009/2175(INI)
Motion for a resolution
Paragraph 6 – indent 1
Paragraph 6 – indent 1
- the purpose of the partnership is the joint provision of a public-service task conferred on all local authorities,
Amendment 61 #
2009/2175(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Points out that in its judgment of 10 September 2009 in Case C-573/07 the CJEU found that the mere possibility of the opening-up of the capital of a previously publicly-owned company to private investors may not be taken into consideration as a factor making competitive tendering a requirement unless there exists, at the time the contract is awarded, a real prospect in the short term of such an opening-up; notes that the law in this area is now sufficiently clear;welcomes the recent judgments handed down by the Court in this area; therefore calls on the Commission and the Member States to providmake widely available information about the legal implications of these judgments and expects that in future no further appeal procedures will be brought in these areas;
Amendment 66 #
Amendment 73 #
2009/2175(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes the Commission Communication of 19 November 2009 on the development of public-private partnerships and awaits the relevant impact assessment with great interest; emphasises that due account must be taken of both the complexity of the procedures and the differences in legal culture and practice between the Member States with regard to service concessions, and doubts, thereforetakes the view that, when ther a proposal for a legal act dealing with public procurement directives are revised in future, service concessions wshould have any added value; takes the view that withbe the subject of specific legislation based on their definition and their status as laid down in the 2004 public procurement directives and the supplementaryed by the case- law of the CJEU the process of defining the term ‘service concession’ and establishing the legal framework governing such concessions has been completed;
Amendment 77 #
Amendment 78 #
2009/2175(INI)
Motion for a resolution
Paragraph 10 – indent 1
Paragraph 10 – indent 1
- the private participant must be selected by means of a public procedure,transparent procedure, with publication in advance of the contract following a review of the financial, technical, operational and administrative requirements and the characteristics of the tender in the light of the particular service to be provided;
Amendment 80 #
2009/2175(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Invites the Commission, having regard to its communication of 19 November 2009, to advocate a more nuanced approach to the use of public- private partnerships, also taking into account the difficulties sometimes encountered; takes the view, however, that public-private partnerships can provide a solution in particular in the case of major infrastructure works, provided the balance is respected between cost and the quality of the service provided for users, on the one hand, and annuity profits awarded to undertakings, on the other; invites the Community to conduct a study of the real long-term economic benefit to public authorities and States of such partnerships in the different relevant sectors;
Amendment 82 #
Amendment 83 #
2009/2175(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Looks forward with great interest to the CJEU judgment in Case C-451/08 and hopes that it will clarify the issues still under dispute in the area of town planning; endorses the opinion delivered by the Advocate-General of the CJEU in this case on 17 November 2009 to the effecttakes the view that ‘the broad and ambitious aims of the directive must be borne in mind when interpreting the Directive but it should not be assumed that, by appealing to the purpose of the measure, its scope can be extended indefinitely’ (point 35); otherwise there would be a danger that ‘all town planning activities would be subject to the Directive since, by definition, provisions on the possible execution of building works substantially alter the value of the land in question’ (point 36);
Amendment 85 #
Amendment 86 #
2009/2175(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Points out that the European Parliament it is a party to the action Germany v Commission brought before the CJEU against the Commission interpretative communication of 1 August 2006 on the Community law applicable to contract awards not or not fully subject to the provisions of the Public Procurement Directives and expects a prompt ruling;
Amendment 87 #
2009/2175(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
Micro, small and medium-sized enterprises 12a. Asks the Commission to evaluate the impact of the public procurement directives on micro, small and medium- sized enterprises especially in their role as sub-contractor and to assess for a future review of the directives if we need further rules for the award of sub-contracts to avoid specifically that SMEs as subcontractors get worse conditions than the main contractor of the public contract;
Amendment 93 #
Amendment 94 #
2009/2175(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Draws attention to the great importance of public procurement for climate and environmental protection, energy efficiency, the environment and innovation and reiterates that public authorities should be encouraged and put in a position to base public procurement on ecological, social and other criteria; welcomes the practical assistance given to public authorities and other public bodies in connection with sustainable procurement and urges the Commission and the Member States to organise training courses and campaigns to raise awareness of this issue; supports the idea of a transparent process, involving the Member States, to develop the relevant criteria further; points out that in the area of social criteria in particular such a process offers good prospects for improvements;
Amendment 109 #
2009/2175(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for the development of a database so that the criteria on which the various labels are based can be used for public procurement purposes; calls on the Commission to put forward initiatives at European and international level with a view to the gradual harmonisation of labels and the criteria on which they are based; expects the Member States and all stakeholders to be fully involved in this process; furthermore draws attention, at the same time, to the negative impact which a market fragmented by the existence of so manynumerous varying regional, national, European and international labels has on innovation and research;
Amendment 113 #
2009/2175(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. EDraws attention to the great importance of public procurement for the achievement of EU social objectives and the advancement of sustainable development; emphasises the lack of clarity in the area of socially responsible public procurement and calls on the Commission to provide assistance in the form of manuals and to publish without delay a guide on the integration of social considerations in procurement; in that connection, draws attention to the changes in the legal framework brought about by the Lisbon Reform Treaty and the Charter of Fundamental Rights and looks to the Commission to implement the relevant provisions in an appropriate manner; considers that the new EU legal framework strengthens the legitimacy of ILO Convention 94 on labour clauses in public contracts and that Member States who have not yet ratified the Convention should be encouraged to do so; emphasises the underlying problem that social criteria relate to the manufacturing process, so that their impact is generally indiscernible in the final product, and that globalised production systems and complex supply chains make compliance with the criteria difficult to monitor; expects, therefore, precise, verifiable criteria and a database containing product- specific criteria to be developed for the area of socially responsible public procurement as well; draws attention to the problems contracting authorities have, and the costs they incur, in verifying compliance with criteria and calls on the Commission to offer suitable assistance and to promote instruments which can be used to certify the reliability of supply chains;
Amendment 121 #
2009/2175(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Practical Help: Database and training courses Calls for the development of a frequently updated database so that the criteria on which the various labels or sustainability assurance schemes are based can be used for public procurement purposes and so that public authorities can verify the compliance with the criteria demanded; Urges the Commission and the Member States to organise training courses and campaigns to raise awareness for local authorities and political decision-maker and to include other stakeholders, in particularly providers of social services;
Amendment 128 #
2009/2175(INI)
Motion for a resolution
Paragraph 15 h (new)
Paragraph 15 h (new)
15h. Social services of general interest Draws attention to the difficulties in transposing the Services Directive of 12 December 2006 in many Member States, in particular as regards the specific nature of social services of general interest; emphasises that the way in which procurement operates in the field of social services through calls for tenders has a detrimental effect on quality and therefore on the service provided to users, because quality criteria are too often neglected; takes the view that the public procurement directives do not provide an appropriate framework for contracts connected with social services of general interest; therefore calls on the Commission to put forward, as soon as possible, specific legislation to provide a framework for social services of general interest;
Amendment 46 #
2009/0054(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Late payment is particularly regrettable if it occurs despite the debtor’s solvency. Surveys show that public authorities often pay invoices very late after expiration of the applicable payment period. Public authorities, even though they may face lighter financing constraints because theyand may benefit from more secure, predictable and continuous revenue streams than private undertakings. It is therefore appropriate to introduce correspondingly higher dissuasive compensation in case of late payment by public authoritieHowever, unlike private undertakings, public authorities are not motivated by profit but pursue objectives in the general interest. It would not therefore seem desirable to introduce higher dissuasive compensation for public authorities than for private undertakings.
Amendment 86 #
2009/0054(COD)
Proposal for a directive
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. Member States shall ensure that in commercial transactions between private undertakings, the creditor is entitled to inter or those leading to the delivery of goods or the provision of servicest for late payment without the necessity of a reminderremuneration to public authorities, the creditor is entitled, without the necessity of a reminder, to interest for late payment equal to statutory interest if the following conditions are satisfied:
Amendment 98 #
2009/0054(COD)
Proposal for a directive
Article 3 – paragraphs 2 and 3
Article 3 – paragraphs 2 and 3
2. Where the conditions set out in paragraph 1 are fulfilled, Member States shall ensure the following: (a) interest for late payment shall become payable from the day following the date or the end of the period for payment fixed in the contract; (b) if the date or period for payment is not fixed in the contract, interest for late payment shall become payable automatically within any of the following time limits: (i) 30 days following the date of receipt by the debtor of the invoice or an equivalent request for payment; (ii) if the debtor receives the invoice or the equivalent request for payment earlier than the goods or the services, 30 days after the receipt of the goods or services; (iii) if a procedure of acceptance or verification, by which the conformity of the goods or services with the contract is to be ascertained, is provided for by statute or in the contract and if the debtor receives the invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place, 30 days after that date. For hospital structures, however, the time limits referred to in points( i), (ii), and (iii) are sixty days. 2a. Member States shall ensure that the maximum duration of the procedure of acceptance or verification referred to in paragraph 2(b)(iii) shall not exceed 30 days, unless otherwise specified and duly justified in the tender documents and/or the contract. 2b. Member States shall ensure that the period for payment fixed in the contract shall not exceed the time limits provided for in paragraph 2(b), unless it is specifically agreed between the debtor and the creditor and is duly justified in the light of particular circumstances such as an objective need to schedule payment over a longer period.
Amendment 133 #
2009/0054(COD)
Proposal for a directive
Article 4 a (new)
Article 4 a (new)
Article 4a Lump-sum compensation 1. Member States shall ensure that, when interest for late payment becomes payable, the creditor is entitled to obtain from the debtor any of the following amounts: (a) compensation equal to 3% of the amount due after 60 days from the date when interest becomes payable. (b) compensation equal to 5% of the amount due after 90 days from the date when interest becomes payable. 2. The compensation referred to in paragraph 1 shall be additional to the interest for late payment and to the compensation for recovery costs. 3. The amount of the compensation referred to in paragraph 1 shall not exceed EUR 50 000.
Amendment 135 #
2009/0054(COD)
Proposal for a directive
Article 5
Article 5
Amendment 22 #
2008/2038(INI)
Motion for a resolution
Recital F
Recital F
F. whereas gender stereotyping in advertising straitjackets women, men, girls and boys by restricting individuals to predetermined and artificial roles that are often degrading, humiliating and dumbed down for both sexes; whereas advertising often shows women in situations that are violent and liable to be detrimental to human dignity; whereas the nature of advertising also reinforces this negative impact as the message is constantly reiterated and reproduced,
Amendment 34 #
2008/2038(INI)
Motion for a resolution
Recital H
Recital H
H. whereas gender stereotyping in advertising not only restricts individuals to playing various predetermined roles, but also excludes individuals who do not fit the norm, such as men and women with disabilities and non-heterosexuals,
Amendment 47 #
2008/2038(INI)
Motion for a resolution
Recital J
Recital J
J. whereas gender stereotyping is instrumental in segregating and differentiating between the sexes from a very young age; whereas this segregation/differentiation sets the tone forreinforces any lifelong discrimination between the sexes,
Amendment 52 #
2008/2038(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the whole of society has to be involved in efforts to avoid the reproduction of gender stereotyping; whereas the responsibility for doing so should be shared by all parties from the cradle to the grave,
Amendment 60 #
2008/2038(INI)
Motion for a resolution
Recital N
Recital N
N. whereas children are a particularly vulnerable group that places its trust not just in authority but also in characters from myths, TV programmes, picture-books, TV games, toy advertising, etc.; whereas children learn by imitation and mimicking what they have just experienced; whereas gender stereotyping in advertising is for that reason not just a restraint oninfluences individual development but also one of the direct causes of an individual being implicated from an early age in lifelong discrimination in whichand accentuates the fact that a person's gender dictates what is possible and what is not,
Amendment 61 #
2008/2038(INI)
Motion for a resolution
Recital O
Recital O
O. whereas TV advertising is omnipresent in our daily lives; whereas, regardless of our age and gender, we are exposed to commercial breaks in daily TV programmes; whereas the law of many Member States is inadequate and national codes of ethics applicable to advertising are not respected or in some cases do not even exist; whereas it is of particular importance that TV advertising be subject to ethically and/or legally binding rules to prevent adverts communicating gender stereotypes,
Amendment 78 #
2008/2038(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. RemindsCalls on the EU institutions and Member States of the commitments made andto adhere to the guidelines adopted through various Community programmes and policy documents/, such as EQUAL, and guidelines focussing on gender equality;
Amendment 83 #
2008/2038(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes the need for measures of an educational nature (such as already exist in some Member States) from an early age to eliminate male and female stereotypes and develop the critical faculties as from adolescence;
Amendment 101 #
2008/2038(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of the role played by the media in creating and perpetuating gender stereotypes and calls on the EU institutions and Member States to comply with and/or establish ethical codes and/or legal rules on how persons of both sexes can and should be presented in advertisingapplicable to creators and distributors of advertising concerning the concepts of discriminatory advertising and demanding respect for values of human dignity;
Amendment 103 #
2008/2038(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes the need to conduct training and awareness training accontinuous training actions for media professionals and in collaborations with media professionals on the harmful effects of gender stereotypes and good practice in this areathem and awareness training actions for society on the negative effects of gender stereotypes;
Amendment 104 #
2008/2038(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Emphasises the importance of supporting the education, training and employment of women to promote and ensure that they have equal access to all areas and levels of the media, supporting research into all aspects of women and the media, encouraging and recognising women’s media networks, and developing regulatory mechanisms, including voluntary ones, that promote balanced and diverse portrayals of women by the media and international communications systems;
Amendment 115 #
2008/2038(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
Amendment 121 #
2008/2038(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Emphasises the need for good examples from a gender perspective in the media and advertising world in order to show that change is possible and desirable; considers that all Member States should, like Spain, which has established a prize for 'creating equality', make official the award of a prize by advertisers to members of their own industry, and a prize awarded by the public, to reward advertising which best breaks with gender stereotypes and presents a positive or status-enhancing image of women, men or relations between them;
Amendment 124 #
2008/2038(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 27 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 12
Recital 12
(12) In order to ensure close cooperation between the Member States in the area of pharmacovigilance, the mandate of the coordination group set up by Article 27 of Directive 2001/83/EC should be enlarged to include the examination of based on the expertise of the pharmacovigilance systems of the Member States, a new coordination group should be set up with specific responsibility for these pharmacovigilance issues, to examine questions related to the pharmacovigilance of all medicinal products authorised by the Member States. In order to fulfil its new tasks, the new coordination group should be further strengthened through the adoption of clear rules as regards the expertise required, the adoption of opinions, transparency, independence and professional secrecy of its members, and the need for cooperation between Community and national bodies.
Amendment 29 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 17
Recital 17
(17) To further increase the coordination of resources between the Member Statespharmacovigilance expertise at Community level, Member States should be authorised to delegate certain pharmacovigilance tasks tohave the option of arranging for their teams to be trained by the specialist teams of another Member State.
Amendment 30 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 5
Recital 5
Amendment 31 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 28
Recital 28
(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of feesThe indirect collection of additional resources should be possible for this purpose. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.
Amendment 36 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21 a – introductory part
Article 21 a – introductory part
Amendment 37 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 22 – paragraph 3
Article 22 – paragraph 3
Continuation of the authorisation shall be linked to the annual reassessment of these conditions. The list of these conditions shall be made accessible to the public without delay, together with deadlines and dates of fulfilment.
Amendment 38 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 10
Article 1 – point 10
Directive 2001/83/EC
Article 22 a (new)
Article 22 a (new)
1. After the granting of a marketing authorisation, the national competent authority may require a marketing authorisation holder to conduct a post- authorisation safety study if there are concerns about the risks of an authorised medicinal product. The requirement shall be made in writing, provide a detailed justification and include the objectives and timeframe for submission and conduct of the study. It shall be made public without delay. 2. The national competent authority shall provide the marketing authorisation holder with an opportunity to present explanations on the requirement within a time limit which it shall specify, if the marketing authorisation holder requests this, in writing and with a detailed justification, within 30- days of receipt of the written requirement. Such requests shall be made public without delay. 3. On the basis of explanations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the requirement. That decision shall be made public without delay. Where the national competent authority confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Amendment 39 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point a
Article 1 – point 14 – point a
Directive 2001/83/EC
Article 27 – paragraph 1
Article 27 – paragraph 1
“1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures, responsible for the following purposetasks: (ai) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the pharmacovigilance of medicinal products authorisvariations to the terms of marketing authorisations granted by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (c) 35(1), with the examinaception of all questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)ing to pharmacovigilance. The Agency shall provide the secretariat of this coordination group. For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committefor mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Amendment 40 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point a
Article 1 – point 14 – point a
Directive 2001/83/EC
Article 27 – paragraph 1 – point a a (new)
Article 27 – paragraph 1 – point a a (new)
(aa) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (ii) the examination of questions relating to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), for all questions relating to pharmacovigilance. The Agency shall provide the secretariat of this coordination group.
Amendment 42 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point b
Article 1 – point 14 – point b
Directive 2001/83/EC
Article 27 – paragraph 2
Article 27 – paragraph 2
“Members of the coordination groups and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national marketing authorisation bodiesbodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts. Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of its membertheir members. Their members may be members only of one coordination group at a time. The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.”
Amendment 43 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 4
Article 27 – paragraph 4
“4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination groups.
Amendment 44 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 5
Article 27 – paragraph 5
5. The members of the coordination groups shall ensure that there is appropriate coordination between the tasks of thateir group and the work of national competent authorities, including, respectively, the consultative bodies concerned with the marketing authorisation and those concerned with the surveillance of medicinal products.
Amendment 45 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 6
Article 27 – paragraph 6
6. Save where otherwise provided for in this Directive, the coordination groups shall use itstheir best endeavours to take decisions by consensus. If such a consensus cannot be reached, the position of the majority of members shall prevail.
Amendment 46 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 7
Article 27 – paragraph 7
7. MemberDetailed agendas of the coordination group shall be required, even after their dmeetings shall be made public at the latest the day before the meeting concerned. Detailed minuties have ceased, not to disclose informof coordination group meetings, containing the decisions taken, details of votes and explanations of the kind covered by the obligation of professional secrecyvotes, including minority opinions, shall be made public in the month following the meeting.”
Amendment 53 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103
Article 103
A Member State may not delegate any of the tasks entrusted to it under this Title to. It may request training and assistance from another Member State, subject to athe written agreement of the latter. The delegarequesting Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that informatand the training Member State shall submit a detailed and budgeted training and assistance plan to the Commission and the Agency, which shall finance it from the Union’s public funds.
Amendment 54 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105
Article 105
Amendment 74 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
11) adverse reaction: a response to a medicinal product which is noxious and Uunintended, and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Amendment 95 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d
Article 1 – point 1 – point d
Directive 2001/83/EC
Article 1 – point 28c
Article 1 – point 28c
(28c) Pharmacovigilance system: a system utilized bywhich marketing authorisation holders and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monis it possible: (a) to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including in cases of misuse, medication abuse or medication error; (b) to assess this information scientifically in order to detect any change tor the safetyrisk- benefit balance of authorised medicinal products and detect any change to their risk-benefit balance. ; (c) for marketing authorisation holders and for Member States to fulfil the tasks and responsibilities listed in Title IX
Amendment 97 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – points 32 a, 32 b and 32 c (new)
Article 1 – points 32 a, 32 b and 32 c (new)
(da) The following point 32a is inserted: “(32a) Medication error: a non- intentional omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient. By definition, medication error is avoidable because it indicates what should have been done but was not done during the medical treatment of the patient. Medication error can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions.”
Amendment 98 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 b (new)
Article 1 – point 32 b (new)
(da) The following point 32b is inserted: “(32b) Medication misuse: use of a medicinal product not in compliance with the recommendations in the summary of the product characteristics (SPC).”
Amendment 99 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 c (new)
Article 1 – point 32 c (new)
(da) The following point 32c is inserted: “(32c) Medically justified use outside the approved indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the SPC but based on the assessment data.”
Amendment 100 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 d (new)
Article 1 – point 32 d (new)
(da) The following point 32d is inserted: “(32d) Commercially confidential information: parts of documents, data or information are regarded as being commercially confidential, for a determined period which must be specified, if it is shown that divulging them is likely to cause disproportionate harm to the commercial interests of a marketing authorisation holder, except in cases in which, notwithstanding this damage, there is a major public-interest justification for divulgation. Information about public health, especially pre- clinical, clinical and pharmacovigilance data, can never be regarded as commercially confidential information. Data about sales volumes should also be made public as they are scientific data that make it possible to assess the level of exposure of the population to adverse reactions to a given medicinal product.”
Amendment 126 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a - introduction
Article 21a - introduction
Amendment 131 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – paragraph 8
Article 1 – paragraph 8
Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2
Article 21a – point 4 – subparagraph 2
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary.
Amendment 170 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage doctorpatients, doctors, hospitals, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;
Amendment 204 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105
Article 105
Amendment 9 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 7
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk Assessment Advisory Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit.
Amendment 10 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 9
Recital 9
Amendment 13 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 1
Article 1 — point 1
Regulation (EC) No 726/2004
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 15 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients. All citizens of the Member States of the Union shall have the option of submitting online declarations in their mother tongue. The Agency shall also make available to the public any other means for patients to report undesirable effects, such as a dedicated telephone number or special email address.
Amendment 26 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 3
Article 28 – paragraph 3
3. The European Pharmacovigilance Risk Assessment Advisory Committee shall assess the periodic safety update reports. It shall prepare an assessment reporCommittee shall assess scientifically the risk-benefit balance of the medicinal product on the basis of all the information available, including periodic safety update reports and data entered in the Eudravigilance database. It shall prepare a scientific report on the risk-benefit balance of the medicinal product within 90 days of receipt of the periodic safety update report and send it to the marketing authorisation holder and the pharmacovigilance risk assessment coordination group. Within 30 days of receipt of the assessment report, the marketing authorisation holder may submit comments to the Agencyand the pharmacovigilance risk assessment coordination group may submit comments to the European Pharmacovigilance Committee. At its next meeting following the end of the period for comments by the marketing authorisation holder, and the Ppharmacovigilance Rrisk Aassessment Advisorycoordination group, the European Pharmacovigilance Committee shall adopt the assessment report with or without changes, taking into account any comments submitted by the marketing authorisation holder. With effect from [indicate precise date, namely 18 months after the date referred to in Article 3], the assessment report shall be published immediately on the European medicines safety web-portal.
Amendment 27 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 4 – subparagraph 1
Article 28 – paragraph 4 – subparagraph 1
4. Within 30 days of receiptadoption of the report by, the European Pharmacovigilance Risk Assessment Advisory Committee, the Committee for Medicinal Products for Human Use shall consider the report andCommittee shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Amendment 28 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 6
Article 28 – paragraph 6
6. The assessment reports, opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web- portal referred to in Article 26.
Amendment 29 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 12
Article 1 — point 12
Regulation (EC) No 726/2004
Article 56 – paragraph 1 – point aa
Article 56 – paragraph 1 – point aa
“(aa) the Pharmacovigilance Risk Assessment Advisory Committee, which shall be responsible for providing advice to the Committee for Mthe pharmacovigilance assessment, after marketing authorisation has been granted, of medicinal Pproducts for Human Use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human usplaced on the market in accordance with the centralised procedure;”
Amendment 30 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 1
Article 61a – paragraph 1
1. The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following: a) twenty-seven members and twenty-seven alternates appointed by the Management Board, on the basis of proposals by the national competent authorities; b) five members and five alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament. The alternates shall represent and vote for the members in their absence. The Commission may adapt the nincluding at least one healthcare professional representative, at least one patient representative and at least one consumber of members and alternates in the light of technical and scientific needs. Those measurepresentative, on the basis of a public call for expressions of interest, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a)after consulting the European Parliament. The alternates shall represent and vote for the members in their absence.
Amendment 31 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 2
Article 61a – paragraph 2
2. The members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee shall be appointed on the basis of their relevant expertise in pharmacovigilance and risk assessment of medicinal products for human use, in such a way as to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. They shall not be subject to the authority of national marketing authorisation bodies and of the Committee for Medicinal Products for Human Use. For this purpose, the Executive Director of the Agency shall assist the Management Board and the Commission in order to ensure that the final composition of the Committee covers the scientific areas relevant to its tasks.
Amendment 32 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 3
Article 61a – paragraph 3
3. The members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee shall be appointed for a term of three years, which may be prolonged once. The Committee shall elect its Chairman among its members for a term of three years, which may be prolonged once.
Amendment 33 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 4
Article 61a – paragraph 4
4. Paragraphs (3), (4), (7)3, 4, 7 and (8)8 of Article 61 shall apply to the Pharmacovigilance Risk Assessment Advisory Committee.
Amendment 34 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 5
Article 61a – paragraph 5
5. Members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee may not seek or take instructions from any national competent authority, organisation or person. They shall carry out the duties assigned to them objectively and impartially.
Amendment 35 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 6
Article 61a – paragraph 6
Amendment 36 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 18 – subpoint b
Article 1 – point 18 – subpoint b
Regulation (EC) No 726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
“4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency, and receive public funding commensurate with the scale of the tasks assigned. This shall not preclude the indirect collection of fees to be paid by marketing authorisation holders for theadditional funding to enable the Agency to carrying out of theose activities by the Agency, provided that its independence is strictly guaranteed.”
Amendment 81 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Regulation EC/726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency and shall receive public financing commensurate with the tasks set. This shall not preclude the indirect collection of fees to be paid by marketing authorisation holderadditional resources for the carrying out of these activities by the Agency, on condition that its independence is strictly guaranteed.
Amendment 540 #
Amendment 545 #
2008/0196(COD)
Proposal for a directive
Article 4 – paragraph 1 and paragraph 1 a (new)
Article 4 – paragraph 1 and paragraph 1 a (new)
1. Member States may not maintain or introduce, in their national laws, provisions diverging from those laid down in this Directive, including more or less stringent provisions to ensure a different level of as long as they guarantee a higher degree of consumer protection. 1a. The rights resulting from this Directive shall be exercised without prejudice to the provisions of another Community act governing consumer protection.
Amendment 1328 #
2008/0196(COD)
Proposal for a directive
Article 28 – paragraph 1
Article 28 – paragraph 1
1. The trader shall be held liable under Article 25 where the lack of conformity becomes apparent within twoone years as from the timeday the risk passed to the consumerconsumer became aware of the lack of conformity.
Amendment 1334 #
2008/0196(COD)
Proposal for a directive
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. The Member States shall establish the deadline by which the rights conferred on the consumer by virtue of Article 25 become void.
Amendment 34 #
2008/0142(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty establishing the European Community, and in particular Article 95s 16, 95, 137 and 152 thereof,
Amendment 39 #
2008/0142(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Given that that the conditions for recourse to Article 95 of the Treaty as a legal basis are fulfilled, the Community legislature shall relyWhilst Article 95 of the Treaty may be justified as the legal basis for a directive concerning cross-border healthcare services, because onf this legal basis even when public health protection is a decisive factor in the choe omission of healthcare services from the Services Directive, the specific nature of these services requires account to be taken of Articles made; in this respect Article 95(3) of the Treaty explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts16, 137 and 152 which underline the place occupied by services of general economic interest, which guarantee a high level of protection of citizens’ health, in the framework of national social protection systems, for which the Commission aims only to introduce a supplementary cooperation and coordination measure.
Amendment 61 #
2008/0142(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Health and health systems in the Member States are a matter of general interest. The health systems of the CommunityMember States are a central component of Europe’s high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development. They are alsoAlthough their specific nature should be noted, at the same time they are part of the wider framework of services of general interest.
Amendment 72 #
2008/0142(COD)
Proposal for a directive
Recital 8
Recital 8
(8) This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensurepermit patients’ mobility under certain conditions and freedom to provide healthcare and high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness. (The third modificationalready uses the terms in the FTrench original does not apply to the English version whichaty.)
Amendment 75 #
2008/0142(COD)
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movementindividual patients who decide to seek treatment in a Member State other than the Member State of affiliation; it may therefore apply to all types of healthcare. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionals.
Amendment 106 #
2008/0142(COD)
Council position
Recital 18
Recital 18
(18) In order to enable patients to make an informed choice when they seek to receive healthcare in another Member State, the Member State of treatment should ensure that patients from other Member States receive on request the relevant information on safety and quality standards enforced on its territory as well as on which healthcare providers are subject to these standards. Furthermore, healthcare providers should provide patients on request with information on specific aspects of the healthcare services they offer. To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on those specific aspects, this Directive should not oblige healthcare providers to provide more extensive information to patients from other Member States. Nothing should prevent the Member State of treatment from also obliging other actors than the healthcare providers, such as insurance providers or public authorities, to provide the information on specific aspects of the healthcare services offered, if that would be more appropriate with regard to the organisation of its healthcare system. All such information should also be made available in formats accessible to persons with disabilities.
Amendment 131 #
2008/0142(COD)
Council position
Recital 50
Recital 50
(50) The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States. Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoid duplication of effort, and provide a better basis of evidence for optimal use of new technologies to ensure safe, high- quality and efficient healthcare. Such cooperation requires sustained structures involving all the relevaHowever, the assessment of health technologies and the possible restriction of access to new technologies by certain decisions by administrative bodies raise a number of fundamental social issues which require contributions from a wide range of stakeholders and the establishment of a viable governance model. Accordingly any cooperation should involve not only the competent authorities of all the Member States, building on existing pilot projects. This Directive should therefore provide a basis for continued Union support for such cooperation. t also all the stakeholders concerned, including health professionals and representatives of patients. Moreover, this cooperation should be based on viable principles of good governance such as transparency, openness, objectivity and the impartiality of procedures.
Amendment 138 #
2008/0142(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Any healthcare which is not regarded as hospital care according to the provisions of this Directive and the law of the Member State of affiliation should be considered as non-hospital care. In the light of the case- law of the Court of Justice on the free movement of services, it is appropriate not to set a requirement of prior authorisation for reimbursement by the statutory social security system of a Member State of affiliation for non- hospital care provided in another Member State. In so far as the reimbursement of such care remains within the limits of the cover guaranteed by the sickness insurance scheme of the Member State of affiliation, the absence of a prior authorisation requirement will not undermine the financial equilibrium of social security systemsHowever, the provision of non- hospital care in another Member State requires the patient to notify the social security administration of the Member State of affiliation about it, this notification being accompanied by a statement that the patient has received all the necessary information before his departure to the other Member State where the care is to be provided. This stipulation does not call into question the principle of automatic authorisation in the case of non-hospital care.
Amendment 140 #
2008/0142(COD)
Proposal for a directive
Recital 30
Recital 30
(30) There is no general definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Communitygeneral definitions of hospital care and specialised care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may beis also appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost- intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedurEach Member State of affiliation should draw up a list of such treatments which will be paid for by its social security system. This list must be published and should not constitute a disproportionate obstacle.
Amendment 151 #
2008/0142(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should therefore provide for a system of prior authorisation for assumption of costs for hospital and specialised care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8.
Amendment 159 #
2008/0142(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely manner and with due care and regard for both those overall principles and the individual circumstances of each case, the period being reduced where the state of health of the patient and the urgency of the treatment so warrant. This applies also to the actual reimbursement of costs of healthcare incurred in another Member State after the patient's return. It is appropriate that patients should normally have a decision regarding the cross-border healthcare within fifteen calendar days. However, that period should be shorter where warranted by the urgency of the treatment in question. In any event, recognition procedures and rules on the provision of services as provided for by Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications should not be affected by these general rules.
Amendment 164 #
2008/0142(COD)
Proposal for a directive
Recital 37
Recital 37
(37) Realising the potential of the internal market for cross-border healthcare requires cooperationCooperation is required between providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high quality and efficient care across borders. This is particularly the case for cooperation in border regions, where cross- border provision of services may be the most efficient way of organising health services for the local populations, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States. Such cooperation may concern joint planning, mutual recognition or adaptation of procedures or standards, interoperability of respective national information and communication technology systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Directive 2005/36/EC on the recognition of professional qualifications stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to those provisions of Directive 2005/36/EC.
Amendment 167 #
2008/0142(COD)
Council position
Article 7 – paragraph 1 – subparagraph 1 a (new)
Article 7 – paragraph 1 – subparagraph 1 a (new)
After obtaining authorisation on the basis of an objective clinical examination, which procedure should be subject to appeal in the event of authorisation being refused, patients affected by rare diseases shall have the right to access healthcare in another Member State and to receive reimbursement, even if the treatment in question is not among the benefits provided for by the legislation, administrative regulations, guidelines and codes of conduct of the medical professions of the Member State of affiliation. However, the Member State of affiliation may require the treatment to be recognised by the European reference networks or, failing that, by international medical science.
Amendment 167 #
2008/0142(COD)
Proposal for a directive
Recital 37 a (new)
Recital 37 a (new)
(37a) Directive 2005/36/EC stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State should not, subject to specific provisions of Community law, be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to the provisions of Directive 2005/36/EC. However, Directive 2005/36/EC takes account only very imperfectly of the specific details of health care qualifications, to the detriment of patients' safety. Appropriate procedures for the recognition of qualifications should therefore be established either as part of the revision of Directive 2005/36/EC or in a specific legislative instrument.
Amendment 177 #
2008/0142(COD)
Council position
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Healthcare that may be subject to prior authorisation shall be set out in a list by the Member State of affiliation, to be transmitted to the Commission. It shall be limited to healthcare which:
Amendment 183 #
2008/0142(COD)
Council position
Article 8 – paragraph 5 – introductory part
Article 8 – paragraph 5 – introductory part
5. The Member State of affiliation may refuse to grant prior authorisation for reasons including, but not limited to, the following reasons:
Amendment 185 #
2008/0142(COD)
Council position
Article 8 – paragraph 5 – point b
Article 8 – paragraph 5 – point b
b) if this healthcare can be provided on its territory within a time-limit which is medically justifiable, taking into account the current state of healthacceptable on the basis of an objective medical assessment of the clinical needs of the person concerned in the light of all of the factors characterising his medical condition and the probable course of the illness ofat the person concernedtime when the request for authorisation is made;
Amendment 197 #
2008/0142(COD)
Proposal for a directive
Article 1
Article 1
Amendment 209 #
2008/0142(COD)
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or privatcross-border healthcare and to individual patients who independently choose to seek healthcare abroad. This Directive shall not serve to encourage the provision of cross-border healthcare or the referral of patients by the social security scheme of a Member State to the healthcare system of another Member State in order to receive treatment there.
Amendment 220 #
2008/0142(COD)
Council position
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary. For this purpose, the Commission shall, in consultation with the European Parliament, facilitate the establishment of a network connecting the national authorities or bodies responsible for health technology assessment designated by the Member States. The members of the network shall participate in, and contribute to, the network's activiat network shall be based on the principles of good governance, including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant groups, including - but not limited to - health professionals, patients' representatives in accordance with the legislation of the Member State where, social partners and scientists, whilst respecting Member States' competence in they are establisheda of health technology assessment.
Amendment 223 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 1 - point (f)
Article 3 - paragraph 1 - point (f)
(f) Regulations on coordination of social security schemes, in particular Article 22 of Regulation (EC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community and Council Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems and their implementing regulations;
Amendment 224 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 1 - points (g a) and (g b) (new)
Article 3 - paragraph 1 - points (g a) and (g b) (new)
(ga) Directive 2005/36/EC on the recognition of professional qualifications; (gb) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market.
Amendment 229 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 2
Article 3 - paragraph 2
Amendment 239 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 3
Article 3 - paragraph 3
Amendment 242 #
2008/0142(COD)
Proposal for a directive
Article 3 - paragraph 4
Article 3 - paragraph 4
Amendment 244 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) ‘healthcare’ means a health service provided by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is publics and products provided or prescribed by a health professional to patients with a view to assessing, maintaining or restoring their state of health or preventing the appearance orf privateathologies;
Amendment 296 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) ‘harm’ means adverse health outcomes or injuries stemming from the provision of healthcare where these outcomes or injuries can be linked only to the best- endeavours obligation which requires health professionals to do everything in their power to restore a patient’s state of health.
Amendment 319 #
2008/0142(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member Sta. This information shall include in particular: - a list of the healthcare covered by the health system of the Member State of affiliation and the rates of reimbursement or coverage; - the quality and safety standards applicable in the Member State of treatment; - the availability, prices, quality certification and risks inherent in the healthcare provided, and details of the insurance cover or other means of personal or collective protection with regard to professional liability of the healthcare providers in the Member State of treatment; - a list of the healthcare providers recognised by the competent authorities of the Member State of treatment; - patients' entitlements, procedures for accessing those entitlements and systems of appeal and redress, if patients are deprived of such entitlements; - the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. The Member States of affiliation shall ensure that the information provided to patients complies with public health considerations and is impartial, comparative and complete.
Amendment 337 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on their contract status, availability, prices and outcomes of the healthcare providedreimbursement levels and procedures, quality indices and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 392 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided.
Amendment 426 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed, by the Member State of affiliation, access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.
Amendment 437 #
2008/0142(COD)
Proposal for a directive
Article 7
Article 7
The Member State of affiliation shall not make the reimbursement of the costs of non-hospital care provided in another Member State subject to prior authorisation, where the cost of that care, if it had been provided in its territory, would have been paid for by its social security system. . Any patients who receive non-hospital care in another Member State shall notify this care to the social security scheme of their Member State of affiliation before they leave to receive the care They shall also declare that they have received information concerning the care, in accordance with Article 10 of this Directive. If such a declaration is not sent with the notification of non-hospital care in another Member State, the social security scheme of the Member State of affiliation shall ascertain from the patients that they have taken steps prior to their departure to receive all the necessary information relating to this non-hospital care in another Member State.
Amendment 443 #
2008/0142(COD)
Proposal for a directive
Article 8
Article 8
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care and specialised care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night; (b) healthcare, included in a specific list, that does noas defined in the legislation of the Member State of affiliation, which shall be subject to planning if it requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that or requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcare involvinges treatments presenting a particular risk for the patient or the population. 23. This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).3. 3. The Member State of affiliation may provide for a system ofe Member State of affiliation shall submit for prior authorisation fthe payment or reimbursement by its social security system of the cost of hospital or specialised care provided in another Member State where the following conditions are met : (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriousl, as defined by the Member State of affiliation in accordance with Paragraph 1. 4. The refusal of prior authorisation shall be limited to what is necessary uandermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. 4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination proportionate and shall not constitute a means of arbitrary discrimination. 4a. The authorisation required under Paragraph 1 may be refused if it is established that a move may compromise the patient's state of health or the provision of medical treatment. 5. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.
Amendment 508 #
2008/0142(COD)
Proposal for a directive
Article 9
Article 9
1. The Member State of affiliation shall ensure that administrative procedures regarding the use of healthcare in another Member State related to any prior authorisation referred to in Article 8(32), reimbursement of costs of healthcare incurred in another Member State and other conditions and formalities referred to in Article 6(3), are based on objective, non- discriminatory criteria which are published in advance, and which are necessary and proportionate to the objective to be achieved. In any event, an insured person shall always be granted the authorisation pursuant to Regulations on coordination of social security referred to in Art. 3.1 f) whenever the conditions of Art.22.1 c) and Art. 22.2 of Regulation 1408/71 are met. 2. Any such procedural systems shall be easily accessible and capable of ensuring that requests are dealt with objectively and impartially within time limits set out and made public in advance by the Member States. 3. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(32). 4. Member States shall, when setting out the time limits within which requests for the use of healthcare in another Member State must be dealt with, and when considering these requests, take into account: (a) the specific medical condition, (b) the patient's degree of pain, (c) the nature of the patient's disability, and (d) the patient's ability to carry out a professional activity. 5. Member States shall ensure that any administrative or medical decisions regarding the use of healthcare in another Member State are subject to administrative review, possibly on the basis of a medical opinion, and also capable of being challenged in judicial proceedings, which include provision for interim measures.
Amendment 545 #
2008/0142(COD)
Proposal for a directive
Article 10
Article 10
1. The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received. In particular, the information shall contain: • a list of the healthcare covered by the health system of the Member State of affiliation and the rates of reimbursement or coverage; • the quality and safety standards applicable in another Member State. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall include information on of treatment; • the availability, prices, quality certifications and risks inherent in the healthcare provided, and details of the insurance cover or other means of personal or collective protection with regard to professional liability of the healthcare providers in the Member State of treatment; • a list of the healthcare providers recognised by the competent authorities of the Member State of treatment; • patients' entitlements, on procedures for accessing those entitlements and on systems of appeal and redress if the patient is deprived of such entitlementsredress if patients are deprived of such entitlements; • the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. The Member States shall ensure that this information complies with public health considerations, and is impartial, comparative, unbiased and complete. 2. The information referred to in paragraph 1 shall be made easily accessible, including by electronic means, and shall be gathered in accordance with the cooperation mechanism described at Article 13. 3. The Commission may, in accordance with the procedure referred to in Article 19(2), develop a standard Community format for the prior information referred to in paragraph 1.
Amendment 611 #
2008/0142(COD)
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. Member States shall exchange information on disciplinary and criminal law proceedings taken on their territory against health professionals.
Amendment 703 #
2008/0142(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
The Commission shall within fivthree years after the date referred to in Article 22(1) draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council, and thereafter at least every five years. That report shall pay particular attention to the effects of the application of this Directive on access to healthcare and health services from a financial and geographical viewpoint, and on the mobility of patients and of all the actors in the Member States’ health systems. It shall involve all stakeholders and all actors, infrastructures and health systems in the Member States, including hospitals and payer organisations. If necessary, the Commission shall enclose proposals for legal amendments with the report.
Amendment 215 #
2008/0028(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) It is also important to provide consumers with information on the other alcoholic beverages. Specific Community rules already exist on the labelling of wine. Council Regulation (EC) No 1493/1999 of 17 May 1999479/2008 of 29 April 2008 on the common organisation of the market in wine and Council Regulation (EC) No 1601/1991 of 10 June 1991 provides an exhaustive set of technical standards which fully cover all oenological practices, manufacturing methods and means ofr presentation and labelling of wines and wine products, thus ensuring that all stages in the chain are covered and that consumers are protected and properly informed. In particular, this legislation describes in a precise and exhaustive manner the substances likely to be used in the production process, together with the conditions for their use via a positive list of oenological practices and treatments; any practice not included in this list is prohibited. Therefore, it is appropriate to exempt wine at this stage from the obligation to list the ingredients and to provide for a nutrition declaration. As regards beer and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 and any alcoholic beverage containing more than 1.2% alcohol by volume, and in order to ensure a consistent approach and coherence with the conditions established for wine, the same kind of exemptions shall apply. However, the Commission will produce a report after fivthree years ofrom the entry into force of this Regulation and may propose, if necessary, specific requirements in the context of this Regulation.
Amendment 237 #
2008/0028(COD)
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) In order to allow for additional ways of presenting nutrition information, which will enable consumers to make healthier choices, the mandatory nutrition declaration may be expressed as percentages of recommended daily intakes. These recommended daily intakes must be based on reliable scientific findings. For this purpose, EFSA has issued a scientific opinion, which is the basis for the reference values.
Amendment 323 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in characters of a font size of at least 3 mm and shall be presented in a way so as to ensure a significant contrast between the print and backgrounda legible font consistent with the following size criteria, taking the letter 'x' as the standard: - at least 1 mm for packages or containers the largest printable surface or label of which has an area of between 25 and 75 cm2; - at least 1.4 mm for packages or containers the largest printable surface or label of which has an area of more than 75 cm2.
Amendment 331 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. The mandatory particulars listed in Article 9(1) shall be presented in such a way as to guarantee a significant degree of contrast between print and background and to be easily visible, clearly legible and indelible.
Amendment 333 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The particulars listed in Article 9(1) (a), (e) and (k) on the one hand, and in Article 9(1)(c), (f), (g) and (j) on the other, shall appear in the same field of vision.
Amendment 337 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The minimum font size referred to in paragraph 1 shall not apply in case of packaging or containers the largest printable surface of which has an area of less than 1025 cm2. Specific national provisions may be introduced for such packaging or containers by Member States which have more than one official language.
Amendment 355 #
2008/0028(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. IWithout prejudice to the provisions of Article 14(4), in the case of packaging or containers the largest surface of which has an area of less than 1025 cm2 only the particulars listed in Article 9(1) (a),(b), (c), (e) and (f) shall be mandatory on the package or on the label. To deal with any legibility problems, the particulars referred to in Article 9(1)(b) shall also be provided through other means or shall be available at the request of the consumer.
Amendment 368 #
2008/0028(COD)
Proposal for a regulation
Article 20 – point e
Article 20 – point e
e) wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labellbeverages containing more than 1.2% alcohol by volume. By ...* at the latest, the Commission shall produce a report concerning the application of Article 19 on these products and may accompany this report by specific measures determining the rules for labelling ingredients. Those measures designed to amend non-essential elements of this Regulation, by supplementing it shall be adopted, as appropriate, in accordance with the following procedures: (i) for the products referred to in Article 1(2) of Regulation (EC) No 479/2008 of 29 April 2008 on the common organisation of the market in wine, ing and the protection of geographical indications of spirit drinks and repealingccordance with the procedure laid down in Article 113(1) of that Regulation; (ii) for the products referred to in Article 2(1) of Council Regulation (EEC) No 1576/89. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of601/1991 of 10 June 1991, laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails, in accordance with the procedure laid down in Article 193 onf that Regulation; (iii) for these products and may accompany this report by specific measures determining the rules for labelling ingredients. Those measures designed to amend non-essential elements of this Regulation, by supplementing it shall be adoptedreferred to in Regulation (EC) 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/1989, in accordance with the procedure laid down in Article 25(2) of that Regulation; (iv) for other products, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3); . ___________ *OJ: Three years from the date of entry into force of this regulation.
Amendment 370 #
2008/0028(COD)
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. Any ingredient listed in Annex II or any substance originating from an ingredient listed in that Annex, subject to the exceptions thereof provided for in that Annex, shall be indicated on the label with a precise reference to the name of the ingredient or the substance causing allergies or intolerances.
Amendment 383 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – points a, b and b a (new)
Article 29 – paragraph 1 – points a, b and b a (new)
a) energy value (calorific value), b) the amounts of fat, saturates, carbohydrates with specific reference to sugars, and salt. ba) the amount of saturates and transfats, sugar, fibre and protein.
Amendment 397 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
Article 29 – paragraph 1 – subparagraph 2
This paragraph shall not apply to wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealingbeverages containing more than 1.2% alcohol by volume. The Commission shall produce a report by …* concerning the application of this paragraph to these products and may accompany this report by specific measures determining the rules for a mandatory nutrition declaration for these products. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted, as appropriate, in accordance with the following procedures: (i) for the products referred to in Article ... of Council Regulation (EEC) No 1576/89. T479/2008 of 29 April 2008 on the Ccommission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of this paragraph to these products and may accompany this report by specific measures determining the rules for a mandatory nutrition declarationon organisation of the market in wine, in accordance with the procedure laid down in Article 113(1) of that Regulation; (ii) for the products referred to in Article 2(1) of Council Regulation (EC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails, in accordance with the procedure laid down in Article 13 of that Regulation; (iii) for these products. Those measures designed to amend non- essential elements of this Regulation, by supplementing it shall be adopted referred to in Council Regulation (EC) No 110 /2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89, in accordance with the procedure laid down in Article 25(2)X of that Regulation; (iv) for other products, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
Amendment 405 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. The nutrition declaration may also include the amounts of one or more of the following: a) trans fats, b) mono-unsaturates, c) polyunsaturates, d) polyols, e) starch, f) fibre, g) protein, ea) cholesterol, h) any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI. , ha) other substances as defined in Regulation (EC) No 1925/2006.
Amendment 424 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), per portion.
Amendment 426 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. In addition to the nutrition declaration per 100g or per 100ml referred to in Article 31(2), the information may be expressed per portion as quantified on the label, provided that the number of portions contained in the package is stated and the portions are all identical. The mandatory nutrition declaration in the main field of vision of the elements referred to in Article 29(1)(a) and (b) may be expressed on a per portion basis alone if the food is prepacked as an individual portion and the portions are all identical. The expression in the main field of vision of the elements referred to in Article 29(1)(a) and (b) on a per portion basis alone for foods not referred to in paragraph 2 shall be established by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3) by the end of the transition period.
Amendment 453 #
2008/0028(COD)
Proposal for a regulation
Article 33
Article 33
Amendment 457 #
2008/0028(COD)
Proposal for a regulation
Article 34
Article 34
1. The particulars referred to Article 31(2) and (2a) related to the mandatory nutrition declaration shall be included in the principal field of vision. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and salt. 21a. The nutrition declaration in relation to the nutrients referred to in Article 29(2) shall appear together in onparticulars referred to in paragraph 1 should appear in the bottom right-hand corner of the front of the place and, as appropriate, in the order of presentation provided in Part C of Annex XIII. Whenkaging, in a font size of 1.5 mm, surrounded by a border, and in a graphical form showing thise nutrition declaration does notvalues as ap pear in the principal field of vision, it shall be rcentage of the reference intakes laid down in Annex XI, part B, expresentsed in tabular fkcal per 100g/ml orm , with the numbers aligned if space permits. Where space does not permit, the declaration shall appear in linear formhere appropriate, per portion. This graphical representation should not apply to foods where the largest surface of the packaging or container has an area of less than 80 cm². 32. If tThe mandatory nutrition declaration appears together with the declaration on nutrind the declaration in relation to the elements referred to in Article 29(2) shall appear together in one place and, as appropriate, relating to the elements referred to in Article 29(2), in the order of presentation of the energy and nutrients included in the declaration shall be, as appropriate, in the order provided in Part C of Annex XIII. provided in Part C of Annex XIII. This nutrition declaration shall be presented in tabular form, with the numbers aligned if space permits. Where space does not permit, the declaration shall appear in linear form. 4. In cases where the amount of energy or nutrient(s) in a product is negligible, the nutrition declaration on those elements may be replaced by a statement such as ‘Contains negligible amounts of …’ in close proximity to the nutrition declaration when present. 5. Graphical forms or symbols for the presentation of the nutrition declaration may be used under a national scheme referred to in Article 44 provided the following essential requirements are met: a) such forms of presentation shall not mislead the consumer; and b) there shall be evidence of understanding of such forms of presentation by the average consumer. In cases where the amount of energy or nutrient(s) in a product is equal to zero, the nutrition declaration for those elements may be replaced by the indication ‘contains no …’ in close proximity to the nutrition declaration when present. 6. Rules relating to other aspects of presentation of nutrition declaration, other than those referred to inparticularly those relating to paragraph 5, may1a, should be established by the Commission. Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
Amendment 1 #
2007/2285(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas particular attention must be given to obesity among children and adolescents, with a view to providing early treatment, and to those belonging to the least favoured socioeconomic categories, who are in a more vulnerable situation because of healthcare and social inequalities which frequently undermine the quality and balance of their diets,
Amendment 3 #
2007/2285(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the Commission's approach followed in its White Paper on nutrition, overweight and obesity related health issues,1 offering industry the possibility, through self-regulatory initiatives, ofnevertheless calls on industry to contributinge to reducing ill health due to overweight and obesity, giving consumers the option of a healthy lifestyle and increasing their access to quality products at affordable prices; calls, however, on the Commission to closely monitor and encourage industry's initiatives aiming to advertise responsibly through the European Food Safety Authority and to reduce levels of salt, fat and sugar in foodstuffs, with a view to a revision of the current situation by 2010; 1 COM(2007)0279.09; calls on the Member States to undertake to protect their citizens from media advertising for foods with a high fat and sugar content, introduce ethical codes of conduct regarding programmes for children in particular and verify compliance by the media; Or. fr
Amendment 4 #
2007/2285(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the recently adopted Commission proposal for a regulation on the provision of food information to consumers, since consumers needmust be given clear nutritional information in the form of simple and, understandable and legible on- pack labelling in order to make healthy and well-informed choices regarding nutrition;
Amendment 6 #
2007/2285(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Acknowledges that consumers, in particular the most vulnerable categories, may be confused about what constitutes a healthy diet; calls, therefore, on the Member States, in cooperation with the industry and consumer associations, to use innovative information and government-led marketing campaigns in order to motivate consumers to make healthy food choices; in particular, encourages the Member States to draw up food education programmes for nursery and primary schools, taking account of the good practices developed within the ENHPS (European Network for Health Promoting Schools);
Amendment 7 #
2007/2285(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Notes with concern that obesity is a cross-border phenomenon affecting all Member States, with obesity rates increasingly rapidly in the new Member States; calls, therefore, on the Commission to consider public health as a priority objective through its various policies, in particular education, youth, culture, sport and agriculture, giving particular attention to the social dimension of the problem; also calls on the Commission to define common projects to promote better nutrition and healthy living and to establish an EU health monitoring system; calls also on the Member States, in cooperation with the Commission, to promote the exchange of best practices and experiences, in particular, through the development of networks of reference centres and through cooperation between all stakeholders at local, regional and national level to encourage people to lead active social lives and engage in a physical activity;
Amendment 62 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 4 b (new)
Recital 4 b (new)
(4b) Member States should introduce measures to promote the creation of a market for widely available products and services incorporating facilities for disabled users. One way among others of achieving this is with reference to European standards, introducing electronic accessibility (eAccessibility) requirements for public procurement procedures and tendering services, in accordance with legislation upholding the rights of the disabled.
Amendment 64 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Definitions need to be adjusted so as to conform to the principle of technology neutrality and to keep pace with technological development. In particular, conditions for the provision of a service should be separated from the actual definitional elements of a publicly available telephone service, i.e. an electronic communications service available to the public for originating and receiving, directly or indirectly via carrier selection or pre-selection or resale, national and/or international calls through a number or numbers in a national or international telephone numbering planand means of communication specifically intended for disabled users using text relay or total conversation services through a number or numbers in a national or international telephone numbering plan, whether such a service is based on circuit switching or packet switching technology. It is the nature of such a service that it is bidirectional enabling both the parties to communicate. A service which does not fulfil all these conditions is not a publicly available telephone service.
Amendment 66 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 12
Recital 12
(12) Providers of electronic communications services should ensure that their customers are adequately informed as to wthether or not level of reliability they are able to ensure regarding access to emergency services is provided,n the light of current technology and existing standards and are given clear and transparent information in the initial customer contract and at regular intervals thereafter, for example in customer billing information. Customers should also be kept well informed of possible actions that the provider of electronic communications service may take to address security threats or in response to a security or integrity incident, since such actions could have a direct or indirect impact on the customer’s data, privacy or other aspects of the service provided.
Amendment 77 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 15
Recital 15
(15) The availability of transparent, up-to- date and comparable tariffs is a key element for consumers in competitive markets with several providers offering services. Consumers of electronic communications services should be able to easily compare prices of various services offered on the market based on tariff information published in an easily accessible form. In order to allow them to make price comparisons easily, national regulatory authorities should have powers to require from operators better tariff transparency and to ensure that third parties have the right to use without charge publicly available tariffs published by undertakings providing electronic communications services. They should also make price guides available where the market has not provided them. Operators should not be entitled to any remuneration for such use of tariffs which had already been published and thus belong to the public domain. In addition, users should be adequately informed of the price involved or the type of service offered before they purchase a service, in particular if a freephone number is subject to any additional charges. The Commission should be able to adopt technical implementing measures to ensure that end- users benefit from a consistent approach to tariff transparency in the Community, particularly through the introduction of a standard form for use by all operators in harmonising the presentation of bills, thereby facilitating a direct comparison of tariffs and services.
Amendment 78 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 15 a (new)
Recital 15 a (new)
Amendment 79 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 15 b (new)
Recital 15 b (new)
(15b) The Member States shall introduce single information points for all user queries. These information points, which could be administered by the national regulatory authorities together with consumer associations, shall also be able to provide legal assistance in case of disputes with operators. Access to these information points must be free of charge and users must be informed of their existence by regular information campaigns through a reference thereto in the charter of rights of electronic telecommunications services users.
Amendment 85 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 19
Recital 19
(19) End-users should be able to call and access the emergency services provided using any telephone service capable of originating voctronice calls through a number or numbers in the national or international telephone numbering plansommunications service. Emergency authorities should be able to handle and answer calls to the number “112” at least as expeditiously and effectively as calls to other national emergency numbers. It is important to increase awareness of “112” in order to improve the level of protection and security of citizens travelling in the European Union. To this end, citizens should be made fully aware that “112” can be used as a single emergency number when travelling in any Member States, in particular through information provided in international bus terminals, train stations, ports or airports and in telephone directories, payphone kiosks, subscriber and billing material. The obligation to provide caller location information should be strengthened so as to increase the protection of citizens of the European Union. In particular, operators should provide caller location information to emergency services in a “push” mode. In order to respond to technological developments, including those leading to increasingly precise accuracy of location information, the Commission should be able to adopt technical implementing measures in order to ensure the effective implementation of “112” in the Community for the benefit of citizens of the European Union.
Amendment 87 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 22
Recital 22
(22) A single market implies that end-users are able to access all numbers included in the national numbering plans of other Member States, and to access services, including Information Society services, using non-geographic numbers within the Community, including among others freephone and premium rate numbers. End- users should also be able to access numbers from the European Telephone Numbering Space (ETNS) and universal international freephone numbers (UIFN). Cross-border access to numbering resources and to the associated service should not be prevented except in objectively justified cases, such as when this is necessary to combat fraud, and abuse e.g. in connection with certain premium-rate services, or when the number is defined as having a national scope only (e.g. national short code). Users should be fully informed in advance in a clear manner of any charges applicable to freephone numbers, such as international call charges for numbers accessible through standard international dialling codes. In order to ensure that end-users have effective access to numbers and services in the Community, the Commission should be able to adopt implementing measures. End users should also be able to connect to any other end user (especially via IP numbers) in order to exchange data, regardless of the operator they choose.
Amendment 92 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 24
Recital 24
(24) A television broadcast is a linearLegal “must-carry” obligations may be applied to specified radio and audiovisual media services as dend ancillary services supplied by a specifined in themedia service provider. Audiovisual Mmedia Sservices Directiveare defined in Directive 2007/65/EC of the European Parliament and of the Council of [….] 2007, which is provided by11 December 2007 a mendia service provider for simultaneous viewing of programmes on the basis of a programme schedule; a media service provider may provide a number of audng Council Directive 89/552/EEC on the coordination of certain provisions laid down by law, regulation or audio visual programme schedules (channels). Legal “must-carry” obligations may be applied, but only to specified broadcast channels supplied by a specified media service providerdministrative action in the Member States concerning the pursuit of television broadcasting activities1. Member States should provide a clear justification for the “must carry” obligations in their national law so as to ensure that such obligations are transparent, proportionate and properly defined. In that regard, “must carry” rules should be designed in a way which provides sufficient incentives for efficient investment in infrastructure. “Must carry” rules should be periodically reviewed in order to keep them up-to-date with technological and market evolution in order to ensure that they continue to be proportionate to the objectives to be achieved. Given the rapid change in technology and market conditions such a full review would need to be carried out at least every three years and would require a public consultation of all stakeholders. One or more broadcast channels may be complemented byAncillary services include services to improve accessibility for users with disabilities, such as a videotext service, subtitling service, an audio description or sign language. _________ 1 OJ L 332, 18.12.2007, p. 27.
Amendment 107 #
2007/0248(COD)
Recital 22
(22) End-users should decide what content they want to be able to send and receive, and which services, applications, hardware and software they want to use for such purposes, without prejudice to the need to preserve the integrity and security of networks and services. A competitive market with transparent offerings as provided for in Directive 2002/22/EC should ensure that end-users are able to access and distribute any content and to use any applications and/or services of their choice, as stated in Article 8 of Directive 2002/21/EC. Given the increasing importance of electronic communications for consumers and businesses, users should be fully informed of the traffic management policies of, and subsequent possible limitations of access to applications or services imposed by, the service and/or network provider with which they conclude the contract. Where there is a lack of effective competition, national regulatory authorities should use the remedies available to them under Directive 2002/19/EC (Access Directive) to ensure that users’ access to particular types of content or application is not unreasonably restricted.
Amendment 107 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 2 – point b
Article 1 – point 2 – point b
Directive 2002/22/EC
Article 2 – point (c)
Article 2 – point (c)
(c) “publicly available telephone service” means a service available to the public for originating and receiving, directly or indirectly via carrier selection or pre- selection or resale, national and/or international calls and means of communication specifically intended for disabled users utilising text relay or total conversation services through a number or numbers in a national or international telephone numbering plan;
Amendment 114 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2002/22/EC
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that all reasonable requests for connection at a fixed location to a public communications network or connection to a cellular network are met by at least one undertaking.
Amendment 119 #
2007/0248(COD)
Recital 30
(30) Directory enquiry services should be, and frequently are, provided underin competitive market conditionson, pursuant to Article 5 of Commission Directive 2002/77/EC of 16 September 2002 on competition in the markets for electronic communications networks and services. MWholesale measures concernensuring the inclusion of end-– user data (held by undertakings that assign telephone numbers to subscribersboth fixed and mobile) in databases should comply with the safeguards for the protection of personal data, including Article 12 of Directive 2002/58/EC (Directive on privacy and electronic communications). The cost-–oriented supply of that data for the purposes of publicly available directory and directory enquiry servicesto service providers, with the possibility for Member States to establish a centralised mechanism for providing comprehensive aggregated information to directory providers, and the provision of network access in reasonable and transparent conditions, should be in place in order to ensure that end- users benefit fully from competition, with the ultimate aim of enabling the removal of retail regulation from these services and the provision of offers of directory services under reasonable and transparent competitive conditions.
Amendment 119 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2002/22/EC
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The connection provided shall be capable of supporting voice, facsimile and data communications, at data rates that are sufficient to permit functional Internet access, taking into account prevailing technologies used by the majority of subscribers and technological feasibility.
Amendment 120 #
2007/0248(COD)
Recital 32
(32) Member States should ensure that undertakings providing end- users with an electronic communications service designed for originating calls through a number or numbers in a national telephone numbering plan provide reliable and accurate access to emergency services with such accuracy and reliability as is technically feasible for that electronic communications service, taking into account possible lack of access in areas not covered by mobile networks. Network- independent service providerundertakings may not have control over networks and may not be able to ensure that the emergency calls made through their service are routed with the same reliability as traditional integrated telephone service providers, as they may not be able to guarantee service availability, given that problems related to the infrastructure are not under their direct control of these undertakings. Once internationally-recogniszed standards ensuring accurate and, reliable routing and connection to the emergency services are in place, all network-independent service providers should also fulfil the obligations related to access to emergency services at a level comparable to that required of other undertakings.
Amendment 121 #
2007/0248(COD)
Recital 38
(38) Legal ‘must-carry’ obligations may be applied to specified radio and television broadcast channelaudiovisual media services and complementary services supplied by a specified media service provider. Audiovisual media services are defined in Directive 2007/65/EC of the European Parliament and of the Council of 11 December 2007 amending Council Directive 89/552/EEC on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities. Member States should provide a clear justification for the ‘must carry’ obligations in their national law so as to ensure that such obligations are transparent, proportionate and properly defined. In that regard, ‘must carry’ rules should be designed in a way which provides sufficient incentives for efficient investment in infrastructure. ‘Must carry’ rules should be periodically reviewed in order to keep them up-to-date with technological and market evolution and in order to ensure that they continue to be proportionate to the objectives to be achieved. Complementary services include, but are not limited to, services designed to improve accessibility for end-users with disabilities, such as videotext, subtitling, audio description and sign language.
Amendment 122 #
2007/0248(COD)
Article 1 – point 1
Directive 2002/22/EC
Article 1 – paragraph 1
Article 1 – paragraph 1
1. Within the framework of Directive 2002/21/EC (Framework Directive), this Directive concerns the provision of electronic communications networks and services to end-users. The aim is to ensure the availability throughout the Community of good- quality publicly available services through effective competition and choice and to deal with circumstances in which the needs of end- users are not satisfactorily met by the market. Theis Directive also includes provisions concerning certain aspects ofonsumer premises terminal equipment intended to facilitate access for disabled end-users, with particular attention being given to terminal equipment for users with special needs, including the disabled and the elderly.
Amendment 123 #
2007/0248(COD)
Article 1 – point 2 – point (b)
Directive 2002/22/EC
Article 2 – point (c)
Article 2 – point (c)
(c) ‘publicly available telephone service’ means a service made available to the public for originating and/or receiving, directly or indirectly, national or national and international calland/or international calls and other means of communication specifically intended for disabled users using text relay or total conversation services through a number or numbers in a national or international telephone numbering plan;
Amendment 125 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2002/22/EC
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall ensure that all reasonable requests for provision of a telephone and data communication service over the network connection referred to in paragraph 1, allowing originating and receiving of national and international calls and data and calls to emergency services via the number “112”, are met by at least one undertaking.
Amendment 127 #
2007/0248(COD)
Article 1 – point 13
Directive 2002/22/EC
Article 20 – paragraph 1 – point (b)
Article 20 – paragraph 1 – point (b)
(b) the services provided, including in particular, - information on the provider’s traffic management policies- whether or not reliable and accurate access to emergency services and caller location information is being provided and/or any limitations for provision of emergency services under Article 26 and/or the possible lack of access in areas not covered by mobile networks, - information on any limitations regarding access to and/or use of services and applications, including information on any traffic management policies which are essential to prevent degradation of service or slowing of traffic over networks and on how these may impact on the delivery of the service, - the minimum service quality levels offered, namely the time for the initial connection and, where appropriate, other quality of service parameters, as defined by the national regulatory authorities, - the types of maintenance service offered and customer support services provided, as well as the means of contacting these services, - any restrictions imposed by the provider on the use of terminal equipment supplied;
Amendment 128 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2002/22/EC
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall take specific measures, in the light of national conditions,all appropriate measures to ensure that disabled end- users can also take advantage of the choice of undertakings and service providers available to the majority of end-users.
Amendment 129 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2002/22/EC
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2a. In taking the measures referred to above, Member States shall encourage compliance with the relevant standards or specifications published in accordance with the provisions of Article s 17, 18 and 19 of Directive 2002/21/EC.
Amendment 130 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2002/22/EC
Article 7 – paragraph 2 b (new)
Article 7 – paragraph 2 b (new)
2b. In order to be able to adopt and implement specific arrangements for disabled users, Member States shall encourage the production and availability of terminal equipment offering the necessary services and functions.
Amendment 133 #
2007/0248(COD)
Article 1 – point 13
Directive 2002/22/EC
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Member States shall ensure that national regulatory authorities are able to oblige undertakings providing connection to a public electronic communications network and/or electronic communications services to inter alia: (a) provide applicable tariff information to subscribers regarding any number or service subject to particular pricing conditions; with respect to individual categories of services, national regulatory authorities may require such information to be provided immediately prior to connecting the call; (aa) regularly remind subscribers of any lack of reliable access to emergency services or caller location information in the service to which they have subscribed; (b) inform subscribers of any relevant change to the provider’s traffic management policies and subsequent possible limitations of access to applications or services; (c) inform subscribers of their right to determine whether or not to include their personal data in a directory, and of the types of data concerned, in accordance with Article 12 of Directive 2002/58/EC (Directive on privacy and electronic communications); and (d) regularly inform disabled subscribers of details of products and services designed for them. If deemed appropriate, national regulatory authorities may promote self- or co- regulatory measures prior to imposing any obligation.
Amendment 139 #
2007/0248(COD)
Article 1 – point 13
Directive 2002/22/EC
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3a. To ensure quality of services, operators may use traffic management policies, namely the procedures put in place by the provider in order to measure and control traffic on a network link so as to avoid filling the link to capacity or overfilling the link, which would result in network congestion and poor performance.
Amendment 141 #
2007/0248(COD)
Article 1 – point 13
Directive 2002/22/EC
Article 22 – paragraph 3 b (new)
Article 22 – paragraph 3 b (new)
3b. Traffic management policies are deemed appropriate and reasonable as long as it can be proved that they are not anti-competitive or do not give preferential treatment to the services or applications of the network operators or their commercial partners over the services and applications of other providers.
Amendment 143 #
2007/0248(COD)
Article 1 – point 15 – point c
Directive 2002/22/EC
Article 25 – paragraph 3
Article 25 – paragraph 3
3. Member States shall ensure that all end- users provided with a publicly available telephone service can access directory enquiry services. National regulatory authorities shall be able to impose obligations and conditions on undertakings that control access of end-users for the provision of directory enquiry services in accordance with the provisions of Article 5 of Directive 2002/19/EC (Access Directive). Such obligations and conditions shall be objective, proportionat and that operators controlling access to such services provide it on terms which are fair, reasonable, objective, non-discriminatory and transparent.
Amendment 144 #
2007/0248(COD)
Article 1 – point 16
Directive 2002/22/EC
Article 26 – paragraph 5
Article 26 – paragraph 5
5. Member States shall ensure that, to the extent technically feasible, undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority. This applies to all calls to the single European emergency call number ‘112’. Member States may extend this obligation to cover calls to national emergency numbers. Where undertakings referred to in paragraph 2 wish to claim that providing caller location information is not technically feasible, they shall bear the burden of proving this.
Amendment 144 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 12
Article 1 – point 12
Directive 2002/22/EC
Article 20 – paragraph 2 – subparagraph 1 – point (b)
Article 20 – paragraph 2 – subparagraph 1 – point (b)
(b) the services provided, the service quality levels offered, as well as the time for the initial connectionincluding in particular: - the level of reliability with which the operator can provide access to emergency services in the light of current technology and existing standards, - information on the inclusion of subscriber information in directories, - the service quality levels and types of maintenance services offered, - the time for the initial connection, and - any restrictions on the use of terminal equipment imposed by the provider;
Amendment 145 #
2007/0248(COD)
Article 1 – point 21
Directive 2002/22/EC
Article 31 – paragraph 1 – subparagraph 1
Article 31 – paragraph 1 – subparagraph 1
1. Member States may impose reasonable ‘must carry’ obligations, for the transmission of specified radio and television broadcast channelaudiovisual media services and complementary services, particularly accessibility services to enable appropriate access for disabled end-users, on undertakings under their jurisdiction providing electronic communications networks used for the distribution of radio or television broadcast channelaudiovisual media services to the public where a significant number of end- users of such networks use them as their principal means to receive radio and television broadcast channelaudiovisual media services. Such obligations shall only be imposed where they are necessary to meet general interest objectives as clearly and specifically defined by each Member State and shall be proportionate and transparent.
Amendment 154 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 12
Article 1 – point 12
Directive 2002/22/EC
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Member States shall ensure that where contracts are concluded between subscribers and undertakings providing electronic communications services that allow voice communication, subscribers are clearly informed whether or not access to emergency services is providedas to the level of reliability with which the operator can provide access to emergency services in the light of current technology and existing standards. Providers of electronic communications services shall ensure that customers are clearly informed as tof the lackevel of reliability of access to emergency services in advance of the conclusion of a contract and regularly thereafter.
Amendment 170 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 12
Article 1 – point 12
Directive 2002/22/EC
Article 20 – paragraph 6 a (new)
Article 20 – paragraph 6 a (new)
6a. Member States are required to ensure that the duration of contracts concluded between users and undertakings providing electronic communications services does not exceed 24 months. They shall also ensure that the possibility for users to subscribe to a contract with a maximum duration of 12 months is guaranteed for all types of service and equipment.
Amendment 192 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 12
Article 1 – point 12
Directive 2002/22/EC
Article 21 – paragraph 5
Article 21 – paragraph 5
5. Member States shall ensure that national regulatory authorities are able to oblige undertakings providing electronic communications services and/or networks to provide information required in accordance with Article 20(5) and (6) to customers on a regular basis and in a clear, comprehensive and easily accessible form. National regulatory authorities shall ensure in particular that undertakings providing electronic communications services and/or networks provide regular information to their subscribers on: (a) the unlawful use of electronic communications services, particularly where it may prejudice respect for the rights and freedoms of others, and (b) the means of protection and limitations concerning personal data and privacy in the use of electronic communications services.
Amendment 213 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2002/22/EC
Article 26 – paragraph 1
Article 26 – paragraph 1
1. Member States shall ensure that, in addition to any other national emergency call numbers specified by the national regulatory authorities, all end-users of services referred to in paragraph 2, including users of public pay telephones and disabled users, are able to callontact the emergency services free of charge and without having to use any means of payment, by using the single European emergency call number “112”.
Amendment 214 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2002/22/EC
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Member States shall ensure that undertakings providing a, in cooperation with the regulatory authorities, emergency service fs, network originating national and/or international calls through a numberperators and providers who are independent orf numbers in a national or international telephone numbering plan provide access to emergency serviceetworks, shall ensure that all undertakings providing electronic communications services are able to provide reliable access to emergency services, whatever technology is used, in particular by establishing secure standards.
Amendment 230 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2002/22/EC
Article 28 – paragraph 1 – subparagraph 1 – point (b)
Article 28 – paragraph 1 – subparagraph 1 – point (b)
(b) end-users are able to access all numbers provided in the Community, whatever technological devices are used by the operator, including those in the national numbering plans of Member States, those from the European Telephone Numbering Space and Universal International Freephone Numbers.
Amendment 248 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 19
Article 1 – point 19
Directive 2002/22/EC
Article 31 – paragraph 1 – subparagraph 1
Article 31 – paragraph 1 – subparagraph 1
Member States may impose reasonable “must carry” obligations, for the transmission of specified radio and television broadcast channels andaudiovisual media services and complementary services, particularly accessibility services, on undertakings under their jurisdiction providing electronic communications networks used for the distribution of radio or television broadcastaudiovisual media services to the public where a significant number of end-users of such networks use them as their principal means to receive radio and television broadcastaudiovisual media services. Such obligations shall only be imposed where they are necessary to meet general interest objectives as clearly and specifically defined by each Member State in its national law and shall be proportionate and transparent.
Amendment 267 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2002/22/EC
Article 34 – paragraph 1
Article 34 – paragraph 1
1. Member States shall ensure that transparent, simple and inexpensive procedures, including out-of- court procedures and collective redress mechanisms, are available for dealing with unresolved disputes between consumers and undertakings providing electronic communications networks and/or services, relating to the contractual conditions and/or performance of contracts concerning supply of such networks or services. Member States shall adopt measures to ensure that such procedures enable disputes to be settled fairly and promptly and may, where warranted, adopt a system of reimbursement and/or compensation. Member States may extend these obligations to cover disputes involving other end-users. Member States shall ensure that bodies in charge of dealing with such disputes, which can be single points of contact, provide relevant information for statistical purposes to the Commission and the Authorityies.
Amendment 273 #
2007/0248(COD)
Proposal for a directive – amending act
Annex I – Part A – point e b (new)
Annex I – Part A – point e b (new)
Directive 2002/22/EC
Annex I – Part A – point e b (new)
Annex I – Part A – point e b (new)
(eb) Cost control Member States shall ensure that national regulatory authorities ensure that undertakings providing electronic communications services provide tools enabling users to control the costs of the communications services they use. Such tools may take the form of warnings, free of charge, of abnormally high consumption, and a comprehensive, precise statement of annual consumption, based on the average unit cost.
Amendment 277 #
2007/0248(COD)
Proposal for a directive – amending act
Annex I – Part B – point b a (new)
Annex I – Part B – point b a (new)
Directive 2002/22/EC
Annex I – Part B – point b a (new)
Annex I – Part B – point b a (new)
(ba) Services in the event of theft Member States shall ensure that a freephone number common to all mobile telephony service providers is set up for reporting the theft of a terminal and immediately suspending the services associated with the subscription. It must also be possible for disabled users to access this service. Users must be regularly informed of the existence of this number, which must be easy to remember.
Amendment 278 #
2007/0248(COD)
Proposal for a directive– amending act
Annex I – Part B – point b b (new)
Annex I – Part B – point b b (new)
Directive 2002/22/EC
Annex I – Part B – point b b (new)
Annex I – Part B – point b b (new)
(bb) Protection software Member States shall ensure that national regulatory authorities are able to require operators to make available free of charge to their subscribers reliable and easy-to- use protection and/or filtering software to control access by children or vulnerable people to unlawful or dangerous content.
Amendment 44 #
2007/0196(COD)
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2003/55/EC
Article 3 – paragraph 2
Article 3 – paragraph 2
1a) Article 3(2) is amended as follows: "2. Having full regard to the relevant provisions of the Treaty, in particular Article 86 thereof, Member States may impose on undertakings operating in the gas sector, in the general economic interest, public service obligations which may relate to security, including security of supply, regularity, quality and price of supplies and environmental protection, including energy efficiency and climate protection. Such obligations shall be clearly defined, transparent, non-discriminatory, verifiable and shall guarantee equality of access for EU gas companies to national consumers. These obligations may, for example, take the form of price regulation, including the fixing of a ceiling price for gas supplies to final users. In relation to security of supply, energy efficiency/demand-side management and for the fulfilment of environmental goals, as referred to in this paragraph, Member States may introduce the implementation of long- term planning, taking into account the possibility of third parties seeking access to the system."
Amendment 59 #
2007/0196(COD)
Proposal for a directive – amending act
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
Directive 2003/55/EC
Article 6 a (new)
Article 6 a (new)
(3a) The following article shall be inserted after Article 6: "6a. In order to ensure the independence of transmission system operators Member States shall ensure that as from [date of transposition plus one year] vertically integrated undertakings have to comply either with the provisions of points (a) – (d) of Article 7 on ownership unbundling or with the following provisions of Article 9a on effective and efficient unbundling (“EEU”)."
Amendment 63 #
2007/0196(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/55/EC
Article 9
Article 9
Amendment 64 #
2007/0196(COD)
Proposal for a directive – amending act
Article 1 – point 8 a (new)
Article 1 – point 8 a (new)
Directive 2003/55/EC
Article 9 (aa) (new)
Article 9 (aa) (new)
Amendment 19 #
2007/0195(COD)
Proposal for a directive – amending act
Recital 21 d (new)
Recital 21 d (new)
(21 d) Energy poverty is a growing problem within the Community. Member States must develop national plans of action to underpin measures to combat energy poverty and guarantee not only affordable prices for all but also specific arrangements – payment facilities - for vulnerable consumers.
Amendment 25 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point b b (new)
Article 1 – point 1 – point b b (new)
Directive 2003/54/EC
Article 2 – point 34 b (new)
Article 2 – point 34 b (new)
(b b) The following point is added: (34b.) 'energy poverty' means a situation in which a domestic user cannot afford to heat his home to an acceptable level. This level shall be evaluated in accordance with the recommendations of the World Health Organisation, that is to say at least 18°C in all living areas when occupied, up to 22°C depending on the function of the room. This requirement shall also be evaluated in the light of the scope for customers to purchase other energy services for their homes at a reasonable price. A domestic user is poor in energy terms if energy expenditure as a percentage of total household expenditure exceeds twice the national average energy expenditure.
Amendment 27 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point b d (new)
Article 1 – point 1 – point b d (new)
Directive 2003/54/EC
Article 2 – point 34 d (new)
Article 2 – point 34 d (new)
(b d) The following point is added: (34 d) 'affordable price': a price defined at national level by the Member States in consultation with national regulators, the social partners and other stakeholders, taking account of energy poverty as defined by this Directive.
Amendment 29 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2003/54/EC
Article 3 – paragraph 2
Article 3 – paragraph 2
(1a) Article 3(2) is amended as follows: '2. Having full regard to the relevant provisions of the Treaty, in particular Article 86 thereof, Member States may impose on undertakings operating in the electricity sector in the general economic interest of the public and universal obligations which […] relate to security, including security of supply, regularity, quality and fairer price of supplies and environmental protection including energy efficiency and climate protection. Concerning energy efficiency, an integrated approach is necessary in terms of home improvements – and high quality environmental standards. Such obligations shall be clearly defined, transparent, non-discriminatory, verifiable and shall guarantee equality of access for EU electricity companies to national consumers, including the most vulnerable consumers. In relation to security of supply, energy efficiency/demand-side management and for the fulfilment of environmental goals as referred to in this paragraph, Member States may introduce the implementation of long-term planning, taking into account the possibility of third parties seeking access to the system.
Amendment 31 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2003/54/EC
Article 3 – paragraph 2
Article 3 – paragraph 2
(1a) Article 3(2) is amended as follows: '2. Having full regard to the relevant provisions of the Treaty, in particular Article 86 thereof, Member States may impose on undertakings operating in the electricity sector, in the general economic interest, public service obligations which may relate to security, including security of supply, regularity, quality and price of supplies and environmental protection, including energy efficiency and climate protection. Such obligations shall be clearly defined, transparent, non discriminatory, verifiable and shall guarantee equality of access for EU electricity companies to national consumers. These obligations may, for example, take the form of price regulation, including the fixing of a ceiling price for electricity supplies to final users. In relation to security of supply, energy efficiency/demand-side management and for the fulfilment of environmental goals, as referred to in this paragraph, Member States may introduce the implementation of long term planning, taking into account the possibility of third parties seeking access to the system.
Amendment 56 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2003/54/EC
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. In order to ensure the independence of transmission system operators, Member States shall ensure that as from [date of transposition plus one year]:, vertically integrated undertakings have to comply: – either with the provisions of Articles 8 and 8a – or with the provisions of Articles 8a, 8b and 8c.
Amendment 57 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 5 – introductory part
Article 1 – point 5 – introductory part
The following Articles 8a, 8b and 8bc are inserted:
Amendment 58 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2003/54/EC
Article 8 (ba) (new)
Article 8 (ba) (new)
Amendment 60 #
2007/0195(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/54/EC
Article 10
Article 10
Amendment 93 #
2007/0113(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In order to enhance legal certainty and fully achieve the benefits of the internal market for consumers and businesses, the relevant laws of the Member States need to be approximated further. However,A system for the certain aspects Member States should be able to continue to apply stricter rulesification of traders should be created at European level, alongside a mutual warning system between Member States so that complaints may be brought against infringements potentially warranting the withdrawal of certification and information disseminated to consumers. However, Member States may adopt or maintain more favourable consumer protection rules in the fields governed by this directive, without prejudice to their obligations under the Treaty.
Amendment 102 #
2007/0113(COD)
Proposal for a directive
Recital 7
Recital 7
(7) In order to give the consumer the possibility to fully understand what his obligations and rights are under the contract he should be allowed a period during which he may withdraw from the contract without having to justify it, and a cooling-off period before the conclusion of the contract. Currently the length of thisese periods varies between Member States, and experience shows that the length prescribed in Directive 94/47/EC is not sufficiently long. The periods should therefore be extended and harmonised and calculated in working days.
Amendment 105 #
2007/0113(COD)
Proposal for a directive
Recital 11
Recital 11
(11) It is necessary that Member States lay downdetermine the system of sanctions applicable, including criminal law penalties, and that these sanctions should be effective, proportionate and dissuasive sanctions for infringements of this Directive.
Amendment 115 #
2007/0113(COD)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. Member States may continue to applyadopt or maintain national provisions in the field approximated by this Directive which are more stringent to ensure a higher level of consumer protection, and which relate to a) the starting point for the right of withdrawal; b) the modalities of exercising the right of withdrawal; c) the effects of exercising the right of withdrawalfavourable to consumer protection in the areas governed by this Directive, without prejudice to their obligations under the Treaty.
Amendment 132 #
2007/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point (g)
Article 2 – paragraph 1 – point (g)
g) 'ancillary contract' means any contract which is subordinatedcomplementary to another contract.
Amendment 133 #
2007/0113(COD)
Proposal for a directive
Article 2 – paragraph 1 – point (ga) (new)
Article 2 – paragraph 1 – point (ga) (new)
(g a) ‘aggressive commercial practice’ means a practice which, in its factual context, taking account of all its features and circumstances, by harassment, coercion or undue influence, significantly impairs or is likely to significantly impair the average consumer’s freedom of choice or conduct with regard to the product and thereby causes him or is likely to cause him to take a transactional decision that he would not have taken otherwise.
Amendment 140 #
2007/0113(COD)
Proposal for a directive
Article 3 – paragraph 2 – introductory part
Article 3 – paragraph 2 – introductory part
The trader shall provide a consumer requesting information with written information which, in addition to a general description of the product, shall provide at least brief and accurate information on the following items, where applicable:
Amendment 147 #
2007/0113(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall ensure that the contract is in writing and drawn up in one of the official languages of the Community, as chosen by the consumer, in easily legible characters, and drawn up in the language or one of the languages of Member State in which the consumer is resident or in the language or one of the languages of the Member State of which he is a national which shall be an official language or official languages of the Community, at the consumer’s option. The Member State in which the consumer is resident may, however, require that the contract be drawn up in all cases in at least its language or languages – which must be an official language or official languages of the Community – and that the trader provide the consumer with a certified translation of the contract in the language or one of the languages of the Member State in which the immovable property is situated which shall be an official language or official languages of the Community.
Amendment 155 #
2007/0113(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
2. The written information referred to in Article 3(2) shall form an integral part of the contract and shall not be altered unless the parties expressly agree otherwise or the changes result from circumstances beyond the trader’s control.
Amendment 159 #
2007/0113(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
3. Before the signing of the contract, the trader shall explicitly draw the consumer’s attention to the existence of the right of withdrawal and the length of the cooling- off and withdrawal periods referred to in Article 5 and the ban on advance payment during the withdrawal period referred to in Article 6.
Amendment 169 #
2007/0113(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that, before the contract is entered into, the consumer is allowed a cooling-off period of seven working days, and that, after entering into a contract, the consumer has the right to withdraw, without giving any reason, within fourteen working days of both parties' signing the contract or of both parties' signing a binding prelimthe finaryl contract. If the fourteenth day is a public holiday, the period shall be extended to the first working day thereafter. , including in cases where such contract has been preceded by a binding preliminary contract.
Amendment 183 #
2007/0113(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. If the consumer intends to exercise the right of withdrawal he shall, before the expiry of the deadline, and in a manner susceptible of proof under national legislation, notify the person whose name and address appear in the contract for that purpose pursuant to point (p) of Annex I. The deadline shall be deemed to have been observed if the notification, if it is in writing, is dispatched before the deadline expires.
Amendment 186 #
2007/0113(COD)
Proposal for a directive
Article 5 – paragraph 5
Article 5 – paragraph 5
Amendment 207 #
2007/0113(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall provide for appropriate sanctionsdetermine the system of sanctions applicable, including criminal law penalties, in the event of the failure of the trader to comply with the national provisions adopted pursuant to this Directive.
Amendment 246 #
2007/0113(COD)
Proposal for a directive
Annex I – point (m)
Annex I – point (m)
m) information on the right to withdraw from the contract and the consequences of withdrawing from the contract, including a precise indication of the nature and amount of the costs which the consumer will be required to reimburse pursuant to Article 5 (5) if he exercises his right to withdraw; where appropriate, information on the arrangements for the termination of the credit agreement and the ancillary contract linked to the contract in the event of withdrawal from the contract; information about the consequences of such withdrawal;
Amendment 267 #
2007/0113(COD)
Proposal for a directive
Annex III – point (g)
Annex III – point (g)
g) information on the right to withdraw from the contract and the consequences of withdrawing from the contract, including a precise indication of the nature and amount of the costs which the consumer will be required to reimburse pursuant to Article 5 (5) if he exercises his right to withdraw; where appropriate, information on the arrangements for the termination of the credit agreement and the ancillary contract linked to the contract in the event of withdrawal from the contract; information about the consequences of such withdrawal;
Amendment 289 #
2007/0113(COD)
Proposal for a directive
Annex IV – point (e)
Annex IV – point (e)
e) information on the right to withdraw from the contract and the consequences of withdrawing from the contract, including a precise indication of the nature and amount of the costs which the consumer will be required to reimburse pursuant to Article 5 (5) if he exercises his right to withdraw;
Amendment 316 #
2007/0113(COD)
Proposal for a directive
Annex V – point (i)
Annex V – point (i)
i) information on the right to withdraw from the contract and the consequences of withdrawing from the contract, including a precise indication of the nature and amount of the costs which the consumer will be required to reimburse pursuant to Article 5 (5) if he exercises his right to withdraw; where appropriate, information on the arrangements for the termination of the credit agreement and the ancillary contract linked to the contract in the event of withdrawal from the contract; information about the consequences of such withdrawal;