ddrg/super_eurlex huggingface dataset:
EN Official Journal of the European Union C 181/202

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance’

COM(2012) 51 final — 2012/0023 (COD)

2012/C 181/38

On 27 February and 16 February 2012 respectively, the Council and the European Parliament decided to consult the European Economic and Social Committee, under Articles 114 and 168 (4)(c) of the Treaty on the Functioning of the European Union, on the

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance.

COM(2012) 51 final — 2012/0023 (COD).

Since the Committee endorses the content of the proposal and has already set out its views on the subject in its earlier opinion CESE 1025/2009, adopted on 10 June 2009 (1), it decided, at its 479th plenary session of 28 and 29 March 2012 (meeting of 28 March), by 157 votes to 1 with 9 abstentions, not to draw up a new opinion on the subject but to refer to the position it had taken in the above-mentioned document.

Brussels, 28 March 2012. The President of the European Economic and Social Committee Staffan NILSSON

(1) OJ C 306, 16.12.2009, p. 33.
EN Official Journal of the European Union C 143/147

Opinion of the European Economic and Social Committee on the ‘Amended Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medicinal prescription and as regards pharmacovigilance’

COM(2011) 633 final — 2008/0256 (COD)

2012/C 143/31

On 28 November 2011, the Council decided to consult the European Economic and Social Committee, under Article 114 and Article 168(2)(c) of the Treaty on the Functioning of the European Union, on the

Amended Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medicinal prescription and as regards pharmacovigilance

COM(2011) 633 final – 2008/0256 (COD).

Since the Committee has already set out its views on the subject of the proposal in question in its opinion CESE 1022/2009, adopted on 10 June 2009 (1), it decided, at its 478th plenary session of 22 and 23 February 2012 (meeting of 22 February), by 135 votes in favour with 7 abstentions, not to draw up a new opinion on the subject, but to refer to the position it had taken in the above-mentioned document.

Brussels, 22 February 2012. The President of the European Economic and Social Committee Staffan NILSSON

(1) OJ C 306, 16.12.2009, p. 18.
EN Official Journal of the European Union C 143/148

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (eighteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)’

COM(2012) 15 final — 2012/0003 (COD)

2012/C 143/32

On 1 February 2012 the Council and on 2 February 2012 European Parliament decided to consult the European Economic and Social Committee, under Article 153 paragraph 2 of the Treaty on the Functioning of the European Union, on the

Proposal for a Directive of the European parliament and of the Council amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (eighteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

COM(2012) 15 final – 2012/0003 (COD).

Since the Committee endorses the content of the proposal and feels that it requires no comment on its part, it decided, at its 478th plenary session of 22 and 23 February 2012 (meeting of 22 February), by 138 votes to 4 with 9 abstentions, to issue an opinion endorsing the proposed text.
EN Official Journal of the European Union C 11/85

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 812/2004 laying down measures concerning incidental catches of cetaceans in fisheries and amending Regulation (EC) No 88/98’

COM(2012) 447 final — 2012/216 (COD)

2013/C 11/19

On 8 August 2012, the European Parliament, and, on 10 September 2012, the Council decided to consult the European Economic and Social Committee, under Article 43 of the Treaty on the Functioning of the European Union, on the

Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 812/2004 laying down measures concerning incidental catches of cetaceans in fisheries and amending Regulation (EC) No 88/98

COM(2012) 447 final — 2012/216 (COD).

Since the Committee endorses the contents of the proposal, it decided at its 484th plenary session of 14 and 15 November 2012 (meeting of 14 November 2012), by 140 votes, with 10 abstentions, to issue an opinion endorsing the proposed text.
EN Official Journal of the European Union C 32/23

Opinion of the European Economic and Social Committee on the proposal for a Regulation of the European Parliament and of the Council applying the arrangements for products originating in certain states which are part of the African, Caribbean and Pacific (ACP) Group of States provided for in agreements establishing, or leading to the establishment of, Economic Partnership Agreements (recast)

(COM(2015) 282 final — 2015/0128 (COD))

(2016/C 032/05)

On 24 June 2015, the European Parliament decided to consult the European Economic and Social Committee, under Article 304 of the Treaty on the Functioning of the European Union, on the:

Proposal for a Regulation of the European Parliament and of the Council applying the arrangements for products originating in certain states which are part of the African, Caribbean and Pacific (ACP) Group of States provided for in agreements establishing, or leading to the establishment of, Economic Partnership Agreements (recast)

(COM(2015) 282 final — 2015/0128 (COD)).

Since the Committee unreservedly endorses the proposal and feels that it requires no comment on its part, it decided, at its 511th plenary session of 6, 7 and 8 October 2015 (meeting of 8 October 2015), with 70 votes in favour and 6 abstentions, to issue an opinion endorsing the proposed text.
4.19.

In this connection, the Committee also urges the Commission, the Council and the EP to devote greater attention to medium- and longer-term developments that could be positive for consumers, such as the example of electro-mobility. The number of electric cars on the market is expected to increase over the next 20-30 years. An electric car needs approximately 14 kWh per 100 km, equal to EUR 3,50 at 0,25 cents/kWh. A 100 km journey in a car with a combustion engine — with a consumption of 7 l/100 km and at EUR 1,20/litre — costs EUR 8,40. A PV system with approximately six modules is sufficient to produce the amount of electricity required for an electric car to travel 10 000 km; with an investment of around EUR 3 000 it would be possible to power this kind of car (from own production) for 20 years. The financial aspects — both for the public and also potentially for the regions — of the transition to electro-mobility have not been sufficiently discussed to date.
3.4.

In view of the increase in terrorist activities at global level, and in attacks that have led to the loss of lives in a number of Member States, the EESC feels that the rules proposed by the Commission should be approved as a matter of urgency. The introduction of better rules to combat money laundering will eliminate one of the main sources of funding for terrorist organisations. The EESC calls on the Member States to provide the human, financial and logistical resources needed to implement the new rules set out in the package presented by the European Commission as regards combating money laundering. Furthermore, the EESC considers that developing programmes for the exchange of best practice between experts in the Member States’ tax administrations could help achieve better results in the implementation of the new rules.
3.2.

Following an external evaluation (3) and public consultation, the Commission published a report (4) in which it identified the factors that could hinder the efficiency of the Regulation: a) insufficient minimum powers of enforcers to cooperate efficiently and swiftly especially in the digital environment; b) insufficient sharing of market intelligence; c) limitation of the mechanism to address infringements concerning several countries. The national authorities are frequently faced with similar infringements taking place on their markets at the same time. ‘Widespread infringements’ and those of ‘short duration’, but which have harmful effects, should be covered; d) the need to amend the Annex to the Regulation to extend its scope based on the following criteria: i. collective interests of consumers; ii. cross-border relevance; iii. the public enforcement dimension and consistency with sectoral and horizontal legislation listed in the Annex; e) without imposing any additional legal obligations on businesses.
2.19

The EESC supports explicitly inviting judges to consider whether a return order should be provisionally enforceable. Delays after a return decision have a negative impact on parent-child relationships and the best interests of children. The EESC welcomes the fact that the proposal contains a number of clarifications to better implement the current rules. It obliges the Member State where the child was habitually resident immediately before the wrongful removal or retention to conduct a thorough examination of the best interests of the child before a final custody decision, possibly implying return of the child, is given. In this context, when conducting this examination of the best interests of the child, any child who is capable of forming his or her own views has the right to be heard, even if not physically present, using alternative means such as videoconferencing as appropriate.
4.12.

Personal data is the currency of today’s digital market but many consumers seem to be unaware that they trade their personal data in exchange for access to many of the so-called free services and that their data may be sold or shared with third parties. In addition, irrespective of all existing and planned consumer protection measures, using the internet and attaining privacy is, in a technical sense, a contradiction, as there is always the possibility of highly skilled specialists gaining access to practically any data. It is therefore necessary to make all citizens of all ages — among whom the youngest and the oldest are the most vulnerable — also aware of such threats.
4.8.

The EESC views LIFE as a financing facility for implementing EU measures and policies, not as a programme primarily intended for funding projects that are in the national interest. There may well be cases where, for example, LIFE projects proposed by civil society organisations mainly serve the European interest, and the national interest only to a lesser extent. Therefore, co-financing must in future be designed so that such projects do not fail because they are refused national co-financing (the EESC is aware of cases where this has occurred). In addition, the EESC urges the Commission to assess the extent to which even higher co-financing rates could be used, especially for NGOS, for which the own contribution is often a barrier that is difficult to surmount. Moreover, these contributions often come from public budgets and the co-financing providers are evidently pursuing a ‘selection policy’.
12.10.

The Committee would highlight the fact that the report provides a great deal of information collected from many players, but does regret the fact that this transparency, both on prices and on costs, is not reaching households: for renewables, network costs can make up 50 % of the price (Report from the Centre d’analyse stratégique, 2012, France). Sound statistics, as the proposal for a Commission regulation (referred to in footnote 1) is proposing to collate, are necessary for consumers to be able to make choices and decisions. They should include the cost of damage to the environment and be easily accessible to those for whom these measures are being taken and who wish to understand why and how they obtain energy and pay for it.
4.6.

The EESC notes that according to the proposed legislation, the Commission may prepare and issue reports describing the specific circumstances of the market in any given country or sector. These reports and the evidence on which they are based would become part of any anti-dumping investigation into that country or sector, and would be publicly available. EU industry could also use information from these reports when lodging a complaint or a request for review. However, the EESC is worried that no provisions for enlarging the actual number of staff dealing with trade defence instruments are included in the European Commission proposal. It also notes that the legal status of those reports is not defined and it is not clear how the reports can be used in case of a legal challenge to the reports by the country concerned. There is also no mention of how often the reports will be updated and how they will be adapted to sector-specific challenges.
4.9

When it comes to another carbon intensive sector, transport, the EESC supports the Commission’s objectives, but wonders about some aspects: — It is indeed essential to further electromobility by producing battery cells in Europe and making storage part of electricity systems, but the EESC wonders about the communication’s lack of regulatory or financial arrangements for developing electric charging stations on the Union’s roads and motorways, despite the fact that these are needed to ensure the promotion of electric vehicles. — In order to complement the measures on technological innovation to decarbonise the transport sector, the EESC calls on the Commission to investigate road haulage, promoting intermodal systems by developing road-rail transport and freight on inland waterways. The modal shift from private cars to public transport should also be encouraged.
4.1.

The EESC welcomes the fact that the Commission has taken the initiative of clarifying the regulatory framework on the road transport market and ensuring better enforcement, while improving working conditions and combating social dumping in order to ensure a well-functioning internal market in the sector. The proposed changes address access to the profession, market access — including cabotage — and working conditions, such as driving and rest time and specific rules on the posting of workers in road transport. However, the EESC thinks that the proposed changes in legislation, despite showing an ambition to make regulations easily enforceable and guarantee fair competition, mostly fail to effectively resolve the problems they address, including those that have emerged when implementing the current framework. The EESC notes that the initiative has generated diverging points of view among Member States, social partners and operators. It maintains that the only sustainable way forward is through clear and easily enforceable legislation that delivers legal security regarding market access and adequate protection of social rights. The EESC also stresses the need to use modern IT (tachographs etc.) and efficient infrastructure (secure parking spaces) to help implementation and enforcement. A surprising feature of the communication is that combined transport is addressed not as a market access issue, but only as a matter of optimising sustainability. (For details of the EESC positions on these proposals, see the separate opinions adopted.)
6.3.

The EESC supports separate financing for the two windows — EU financing for the research window and Member States’ budgets for the capabilities window. The EESC has already given its view that ‘as long as the Union does not have its own variable income, the procurement of the military capabilities of the armed forces remains the responsibility of the Member States. […] The EESC underlines that in accordance with Article 41 TEU, the EU budget cannot be used to finance military operations. Departing from this principle would also conflict with the specific character of the security and defence policy of particular Member States (Article 42(1) TEU)’ (8).
5.13.

The EESC endorses the Commission’s decision to develop the external dimension of the digital single market strategy, but feels that so far very little has been done in this sector. It would particularly like to see action taken on two levels: — a definition of new relationships with digital competitors. The EU must protect digital rights, combat digital protectionism and be at the forefront of a global alliance to promote cybersecurity. This process will play a key role in the definition of new global governance; — promotion of digital development. Digitisation can be an important driver of growth capable of combating the causes of war, poverty and migration. The EESC also considers that meeting most of the UN sustainable development goals requires full-scale and widespread use of digitisation that actively involves countries and individuals, and not only the richest and most advanced. Reducing the technology gap, therefore, must be a priority for the EU at global level and not just in terms of cross-border cooperation.
3.4.

Moreover, the EESC considers that the amended proposal should: (a) include rules allowing the consumer to initiate legal proceedings directly against the producer in the event of lack of conformity between the goods and the contract, as required by numerous national laws; (b) include the durability requirement in its provisions, as the EESC has called for on several occasions in its opinions (9); (c) establish a maximum time period for repair (10) in accordance with good professional practice; (d) require producers to maintain an adequate stock of spare parts for the average lifetime of goods, as is the case in several national laws (11); (e) include other guarantees offered by the seller (brand/producer/equipment insurance, etc.) for goods and services; (f) include in the mandatory content of the guarantee statement detailed information on whether or not cost is involved, charges and the form of payment; (g) specify that where ownership of the goods or service is transferred and under normal conditions of use, the rights deriving from the guarantee are also transferred in full; (h) provide for the direct joint and several liability of producer and seller with regard to the consumer in cases where the consumer chooses to repair or replace the goods, without prejudice to the right of redress laid down in Article 16 and of prior contacting of the seller; (i) provide for the joint and several liability of online platforms, while excluding mere intermediaries, where consumers have purchased goods through an online marketplace, without prejudice to the right of redress.
3.11.

The EESC believes that priority in structural reforms should go to those reforms that enhance productivity growth but also strengthen job security and the social protection system within the framework of appropriate business conditions. No euro area country can compete in the modern world on the basis of low wages and casual employment. The emphasis should be on reforms that combine negotiated flexibility with security so as to enhance, and create incentives for enhancing, skills and innovation. Labour market reforms should promote greater stability in employment, which will help improve both the supply and the demand side of the euro area economy, even in the short term. They should also help to boost collective bargaining, based on the independence of the social partners, and social dialogue.
2.4.

In February 2017, three Member States — France, Germany, and Italy — called on the European Commission to review the rules for foreign direct investment into the European Union. This call was prompted by concern about technological expertise being lost to other countries, as a growing number of non-EU investors are purchasing EU technologies to promote these countries’ strategic aims while EU investors are often confronted with obstacles to investment in other countries. The three Member States pointed out that the principle of reciprocity should be upheld if EU investors are given only limited access to markets outside the EU. The three Member States called on the European Commission to develop a European instrument to ‘prevent any damage … through one-sided, strategic direct investment made by foreign buyers in areas sensitive to security or industrial policy, and to ensure reciprocity. The state instruments that are currently available at the level of EU Member States are not sufficient to guarantee protection of this kind.’
5.3.

In order to address employers’ concerns about an additional administrative burden, suitable accompanying measures for businesses should be introduced. Both trade unions and employers are responsible for equal pay. Of course, initiatives to promote equality must be set up in education, the labour market, childcare, etc. Nevertheless, pay transparency is also a solution, because transparency and pay audits all have their part to play in the process. Companies are starting to commit to combating all forms of discrimination in the workplace and are already dealing with these problems in order to ensure that pay systems are gender-neutral, and reflect the diversity of national industrial relations systems. It is important that all stakeholders play their role in closing the gender pay gap and explain the real causes, ensure a more coherent and evidence-based approach and clarify any possible misconceptions.
3.5.6.

The EESC also warns that it is important to have systems in place to prevent abuse of the court system. This should be kept in mind when granting free access to justice to civil society organisations. However, the EESC stresses the advantages of granting them access to justice, as it would enable them to protect consumers, health and the environment for the benefit of society as a whole. As a result, the provisions aimed at preventing abusive actions should be specific and targeted, so that they do not hamper the vital work carried out by civil society organisations in helping to implement the legislation.
2.14.1.

Since it is they who rally the local players concerned, civil society organisations are particularly well placed to pinpoint local problems and formulate proposals. As a consequence, the EESC believes that their participation takes on particular importance and it advocates harnessing their expertise and capacity for coordination (by, for example, making use of the inter-regional indicators of chambers of commerce or cooperation which already exists between trade unions or organisations of various interests). The Committee deems it to be equally important to take account of the work of regional and national economic and social councils.
5.5.

Because of the high numbers of vehicles manufactured in Britain and exported within the EU, the EESC is particularly concerned that any exclusion of the UK from this market will negatively affect overall competitiveness, which in turn will increase costs to all sections of the economy as well as consumers. Therefore, the Commission’s proposal, which advocates that all of these interests are protected, must ensure that there is ongoing commitment to this and it must be enshrined in future agreements.