Index 
Texts adopted
Wednesday, 24 November 2010 - StrasbourgFinal edition
Draft amending budget No 8/2010: Section III - Commission - European Solidarity Fund: floods in Ireland - completion of ESF - Objective 1 (2000 to 2006)
 Protocol to the Partnership and Cooperation Agreement between the EC and Moldova ***
 Information on medicinal products (Community code relating to medicinal products) ***I
  Resolution
  Consolidated text
 Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) ***I
  Resolution
  Consolidated text
 Restriction of the use of certain hazardous substances in electrical and electronic equipment ***I
  Resolution
  Consolidated text
  Annex
 Anti-Counterfeiting Trade Agreement (ACTA)

Draft amending budget No 8/2010: Section III - Commission - European Solidarity Fund: floods in Ireland - completion of ESF - Objective 1 (2000 to 2006)
PDF 71k   DOC 33k
European Parliament resolution of 24 November 2010 on Council's position on Draft amending budget No 8/2010 of the European Union for the financial year 2010, Section III – Commission (16722/2010 – C7-0388/2010 – 2010/2217(BUD) )
P7_TA(2010)0427 A7-0327/2010

The European Parliament ,

–   having regard to the Treaty on the Functioning of the European Union and in particular Article 314 thereof, and to the Treaty establishing the European Atomic Energy Community and in particular Article 106a thereof,

–   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities(1) , and particularly Articles 37 and 38 thereof,

–   having regard to the general budget of the European Union for the financial year 2010, as finally adopted on 17 December 2009(2) ,

–   having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management(3) ,

–   having regard to Draft amending budget No 8/2010 of the European Union for the financial year 2010, which the Commission presented on 24 September 2010 (COM(2010)0533 ),

–   having regard to Council's position on Draft amending budget No 8/2010, which the Council established on 22 November 2010 (16722/2010 – C7-0388/2010 ),

–   having regard to Rules 75b and 75e of its Rules of Procedure,

–   having regard to the report of the Committee on Budgets (A7-0327/2010 ),

A.  whereas Draft amending budget No 8/2010 to the general budget 2010 covers the following items:

   mobilisation of the EU Solidarity Fund for an amount of EUR 13 022 500 in commitment and payment appropriations relating to the effects of flooding in Ireland,
   a corresponding reduction in payment appropriations of EUR 13 022 500 from line 04 02 01 - Completion of European Social Fund (ESF) - Objective 1 (2000–2006),

B.   whereas the purpose of Draft amending budget No 8/2010 is to formally enter this budgetary adjustment into the 2010 budget,

1.   Takes note of Draft amending budget No 8/2010;

2.   Approves the Council's position on Draft amending budget No 8/2010 unamended and instructs its President to declare that Amending budget No 7/2010 has been definitively adopted and to arrange for its publication in the Official Journal of the European Union ;

3.   Instructs its President to forward this resolution to the Council and the Commission.

(1) OJ L 248, 16.9.2002, p. 1.
(2) OJ L 64, 12.3.2010.
(3) OJ C 139, 14.6.2006, p. 1.


Protocol to the Partnership and Cooperation Agreement between the EC and Moldova ***
PDF 65k   DOC 32k
European Parliament legislative resolution of 24 November 2010 on the draft Council decision on the conclusion of a Protocol to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Republic of Moldova, of the other part, on a Framework Agreement between the European Union and the Republic of Moldova on the general principles for the participation of the Republic of Moldova in Union programmes (10496/2010 – C7-0330/2010 – 2010/0102(NLE))
P7_TA(2010)0428 A7-0300/2010

(Consent)

The European Parliament ,

–   having regard to the draft Council decision (10496/2010),

–   having regard to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Republic of Moldova, of the other part(1) , concluded on 28 November 1994,

–   having regard to the request for consent submitted by the Council pursuant to Articles 114, 168, 169, 172, 173(3), 188 and 192 and Article 218(6), second subparagraph, point (a), Article 218(7) and the second subparagraph of Article 218(8) of the Treaty on the Functioning of the European Union (C7-0330/2010 ),

–   having regard to Rules 81 and 90(8) of its Rules of Procedure,

–   having regard to the recommendation of the Committee on Foreign Affairs (A7-0300/2010 ),

1.   Consents to conclusion of the Protocol;

2.   Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of the Republic of Moldova.

(1) OJ L 181, 24.6.1998, p. 3.


Information on medicinal products (Community code relating to medicinal products) ***I
PDF 231k   DOC 133k
Resolution
Consolidated text
European Parliament legislative resolution of 24 November 2010 on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0663 – C6-0516/2008 – 2008/0256(COD) )
P7_TA(2010)0429 A7-0290/2010

(Ordinary legislative procedure: first reading)

The European Parliament ,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0663 ),

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0516/2008 ),

–   having regard to the communication from the Commission to the European Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interistitutional decision-making procedures’ (COM(2009)0665 ),

–   having regard to Article 294(3), Article 114 and Article 168(4)c) of the Treaty on the functioning of the European Union,

–   having regard to the opinion of 10 June 2009 of the European Economic and Social Committee(1) ,

–   having regard to the opinion of 7 October 2009 of the Committee of the Regions(2) ,

–   having regard to Rule 55 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0290/2010 ),

1.   Adopts the position at first reading hereinafter set out;

2.   Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.   Instructs its President to forward its position to the Council, to the Commission and to the national parliaments.

Position of the European Parliament adopted at first reading on 24 November 2010 with a view to the adoption of Directive 2011/.../EU of the European Parliament and of the Council amending, as regards information to patients and the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use

P7_TC1-COD(2008)0256


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and Social Committee(3) ,

Having regard to the opinion of the Committee of the Regions(4) ,

Acting in accordance with the ordinary legislative procedure(5) ,

Whereas:

(1)   Directive 2001/83/EC of the European Parliament and of the Council(6) establishes harmonised rules on the advertising of medicinal products for human use. In particular, it prohibits the advertising to the general public of medicinal products subject to medical prescription.

(2)   In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to healthcare professionals) and the patient package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the making available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non-promotional information on medicinal products or on the channels through which this information may be made available .

(3)   On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’. The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information in the patient package leaflet and in the summary of product characteristics . Such unjustifiable inequalities in accessing information that is publicly available in other Member States should be redressed.

(4)   Experience gained from the application of the current legal framework has also shown that ▌the distinction between the notions of advertising and information is not interpreted consistently across the Union, and that this has given rise to situations where the general public is exposed to disguised advertising . As a result, citizens in certain Member States may be denied the right to have access, in their own language, to high-quality, non-promotional information on medicines. The notions of advertising and information should be defined and interpreted uniformly across all Member States so as to ensure patient safety.

(5)   Those disparities in the interpretation of the Union rules on making available information to patients and the general public , and between national provisions on information, have a negative impact on the uniform application of Union rules on making available information to patients and the general public , and on the effectiveness of provisions on product information contained in the summary of products characteristics and the patient package leaflet . Although those rules are fully harmonised to ensure the same level of protection of public health across the Union, this objective is undermined if widely divergent national rules on the making available of such key information are allowed.

(6)   The different national measures are also likely to have an impact on the proper functioning of the internal market for medicinal products, as the possibility for marketing authorisation holders to make available information on medicinal products is not the same across Member States, while information made available in one Member State is likely to have effects in other Member States. This impact will be greater in the case of medicinal products whose product information (summary of product characteristics and patient package leaflet ) is harmonised at Union level. This includes medicinal products authorised by the Member States under the mutual recognition framework of Chapter 4 of Title III of Directive 2001/83/EC.

(7)   In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the rights and interests of patients . They should have the right to easily access certain information such as a summary of product characteristics and the patient package leaflet in electronic and printed form . Certified and registered websites for independent, objective and non-promotional information are therefore necessary.

(8)   National competent authorities and healthcare professionals should remain the main source of information on medicinal products for the general public. While there is already a lot of independent information on pharmaceuticals, for example information provided by national authorities or healthcare professionals, the situation differs very much between Member States and between the different products available. Member States and the Commission should make much greater efforts to facilitate citizens' access to high-quality information through appropriate channels. ▌

(9)    Without prejudice to the importance of the role played by national competent authorities and healthcare professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to patients and the general public. The ban on advertising to patients and the general public for prescription-only medicinal products should be maintained.

(10)   In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the making available of information on prescription-only medicinal products, as current Union rules allow the advertising to patients and the general public of medicinal products not subject to prescription, under certain conditions. The provisions of this Directive are without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription-only medicinal products, provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of, or in the interest of, the marketing authorisation holder. This Directive requires Member States to permit, via certain channels and subject to appropriate monitoring, the making available by a marketing authorisation holder or a third party acting on its behalf of certain information on authorised medicines subject to prescription to patients and the general public. Communications that do not fall within Title VIIIa of Directive 2001/83/EC are permitted, provided that they do not constitute advertising.

(11)   Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription is accessible . The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to patients or the general public on prescription-only medicinal products should be approved in advance by the competent authorities and should made available only in an approved form .

(12)   In order to further ensure that marketing authorisation holders make available only high-quality information and to distinguish non-promotional information from advertising, the types of information that are made available should be defined. Marketing authorisation holders should make available the approved and most recent contents of summaries of product characteristics, labelling and patient package leaflet and the publicly accessible version of the assessment report. It is appropriate to allow marketing authorisation holders to make available other well-defined medicinal product-related information.

(13)    Approval should be required by the competent authorities, during the course of marketing authorisation, for the summary of product characteristics, labelling and patient package leaflet, and the publicly accessible version of the assessment report or any updated versions of these documents. This information should therefore not be subject to further approval prior to its being made available pursuant to this Directive.

(14)   Information to patients and the general public on prescription-only medicinal products should be provided only through specific channels of communication, including internet ▌, to avoid the effectiveness of the prohibition on advertising being undermined by unsolicited provision of information to patients or the general public. Where information is made available via television, radio, newspapers, magazines and similar publications, patients are not protected against such unsolicited information and the making available of such information should therefore not be allowed.

(15)   The internet is of major importance with regard to the provision of information to patients and its importance is increasing. The internet allows almost unlimited access to information disregarding national boundaries. Specific rules on the monitoring of websites should be established to take account of the cross-border nature of information provided over the internet and to allow cooperation between the Member States.

(16)   Monitoring of information on authorised prescription-only medicinal products under this Directive should ensure that marketing authorisation holders make available only information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. These rules should be harmonised at Union level so as to ensure consistency. In cases of non-compliance, procedures should be put in place for marketing authorisation holders to be represented and heard in the course of the consideration of their case. Monitoring should be based on the control of information prior to its being made available . Only information that has ▌been approved in advance by the competent authorities should be made available and it should be made available in an approved form only .

(17)   As this Directive introduces for the first time harmonised rules on the making available of information on medicinal products subject to medical prescription to patients and the general public, the Commission should assess its operation and the necessity for a review five years after its entry into force. Provision should also be made for the drawing up of guidelines by the Commission based on Member States' experience, in cooperation with all relevant stakeholders, such as patient organisations and healthcare professionals, in the monitoring of information.

(18)    The Commission should consult all relevant stakeholders, such as independent patient, health and consumer organisations and healthcare professionals, on issues relating to the implementation of this Directive and its application by the Member States.

(19)    The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the quality criteria of information made available to patients and the general public and web accessibility guidelines. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(20)   Since the objective of this Directive, namely to harmonise the rules on information on medicinal products subject to prescription across the Union, cannot be sufficiently achieved by the Member States 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 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.

(21)   Directive 2001/83/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments to Directive 2001/83/EC

Directive 2001/83/EC is amended as follows:

(1)    In Article 1, point 26 is replaced by the following: "

   26. Patient package leaflet: A leaflet containing information for the patient which accompanies the medicinal product and which corresponds to patients' real needs.
"

(2)    In Article 59, the following paragraph is added: "

4.    The patient package leaflet shall correspond to patients' real needs. To this end, patient organisations should be involved in developing and reviewing the information on medicinal products by national regulatory authorities and the Agency. The patient package leaflet shall include a short paragraph which sets out the benefits and potential harm of a medicinal product as well as a short description of further information aiming at safe and effective use of a medicinal product.

"

(3)   In Article 86, paragraph 2 is replaced by the following:"

2.  The following are not covered by this Title:

   the labelling, which shall always at least specify the International Non-proprietary Name, and the accompanying patient package leaflets , which are subject to the provisions of Title V;
   correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
   factual, informative announcements (including announcements or statements such as those made to media organisations either in response to a direct enquiry or by making them available at conferences or by written releases and announcements or reports to shareholders and/or regulators) and reference material on a medicinal product, relating, for example, to its availability, packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists, reimbursement and information on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any collection system in place, provided that such announcements and reference material include no promotional product claims and that they do not encourage or promote the consumption of the medicinal product ;
   information relating to human health or diseases, provided that there is no reference, even indirectly, to individual medicinal products;
   information ▌on medicinal products subject to medical prescription that meets the quality criteria , that has been approved by the competent authorities in the Member States, that has been made available to patients or the general public in approved form by the marketing authorisation holder and that is subject to the provisions of Title VIIIa;
   factual, informative announcements for investors and employees on significant business developments, provided they are not used to promote the medicinal product to patients or the general public .

3.    When exemptions to advertising referred to in paragraph 2 are granted, the marketing authorisation holder and any third party shall be identified, and any third party acting on behalf of the marketing authorisation holder shall be identified as such.

"

(4)   In Article 88, the following subparagraph is added to paragraph 4 ▌:"

Such campaigns shall be approved by the competent authorities of the Member States only if it is ensured that objective, non-biased information is provided in the frame of the campaign by the industry on the causes of the disease, the efficacy of the vaccine, the adverse reactions and contra-indications of the vaccination.

"

(5)   The heading ‘TITLE VIIIa Information and advertising’ is deleted;

(6)   Article 88a is deleted;

(7)    In Article 94, paragraph 1 is replaced by the following: "

1.    Where medicinal products are being promoted directly or indirectly by a marketing authorisation holder or a third party acting on its behalf or following its instructions to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons.

"

(8)   The following Title is inserted after Article 100:"

Title VIIIa – Information to patients and the general public on medicinal products subject to medical prescription

Article 100a

1.   Without prejudice to the importance of the role that national competent authorities and healthcare professionals play in better informing patients and the general public on authorised medicinal products subject to medical prescription, Member States shall oblige the marketing authorisation holder to make available , either directly or indirectly through a third party acting on behalf of the marketing authorisation holder , information that has been officially approved by national or Union competent authorities to patients or the general public or members thereof on authorised medicinal products subject to medical prescription provided that such information and the manner in which it is made available is in accordance with the provisions of this Title. Such information shall not be considered as advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such.

2.    Healthcare professionals who make available information on medicinal products or medical devices during a public event, in print or broadcast media shall declare publicly their interests, for example any financial ties with marketing authorisation holders or with third parties acting on their behalf. This also covers the making available of information on medicinal products or medicinal devices in the course of consulting services and technical advice.

3.    Information campaigns aimed at raising awareness among patients and the general public and members thereof about the risks of falsified medicinal products should be organised. Such information campaigns may be conducted by national competent authorities in collaboration with industry, healthcare professionals and patient organisations.

4.  This Title shall not cover the following:

   (a) factual, informative announcements (including announcements or statements made to media organisations either in response to a direct enquiry or by making them available at conferences or by written releases and announcements or reports to shareholders and/or regulators) and reference material on a medicinal product relating, for example, to packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists and reimbursement, provided that they do not intend to promote an individual medicinal product ;
   (b) material provided to healthcare professionals for their own use .

5.    The provisions of this Directive shall be without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription-only medicinal products, provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of, or in the interest of, the marketing authorisation holder.

Article 100b

1.    The marketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription, make available to patients and the general public or members thereof the following information :

   (a) the most recent summary of product characteristics, as approved by the competent authorities during the course of marketing authorisation and authorisation renewal ;
   (b) the most recent labelling and patient package leaflet as approved by the competent authorities during the course of marketing authorisation or authorisation variation; and
   ( c) the most recent, publicly accessible version of the assessment report as drawn up by the competent authorities during the course of marketing authorisation and authorisation updates .

The information referred to in points (a), (b) and (c) shall be presented in a format that faithfully represents the officially approved information drawn up by the competent authorities. The information shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.

2.   The marketing authorisation holder may, in respect of authorised medicinal products subject to medical prescription, make available to patients and the general public or members thereof the following information:

   ( a) information on the environmental impact of the medicinal product further to the information provided on the disposal and collection system pursuant to Article 54(j) and made available pursuant to paragraph 1 of this Article.
   (b) information on prices;
   (c) information on packaging changes;
   ( d) adverse-reaction warnings further to the information provided pursuant to Article 59(1)(e) and made available pursuant to paragraph 1 of this Article ;
   (e) instructions for use of the medicinal product, further to the information provided pursuant to Article 59(1)(d) and made available pursuant to paragraph 1 of this Article. This information may be supplemented, where necessary, with still or moving images of a technical nature demonstrating the proper way of using the product;
   (f) the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned presented in factual, non-promotional listings of summary information;
   (g) a summary of the frequently submitted requests for information pursuant to Article 100c(b), and the subsequent answers;
   h) other types of information agreed by the competent authority that are relevant to supporting the appropriate use of the medicinal product.

The information referred to in points (a) to (g) shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.

The information referred to in points (a) to (g) shall be approved by the competent authorities, or in case of Union marketing authorisation, by the Agency, prior to its being made available for the purposes of this Article.

Article 100c

Information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to patients or the general public or members thereof shall not be made available on television or radio or newspapers, magazines and similar publications . It shall be made available only through the following channels:

   (a) internet websites registered and managed in accordance with Article 100h , relating to medicinal products, to the exclusion of unsolicited material actively distributed to patients or the general public or members thereof;
   (b) ▌answers to specific requests for information about a medicinal product of a patient or a member of the general public;
   (c) printed material about a medicinal product prepared by the marketing authorisation holder pursuant to Article 100b upon specific request by a patient or a member of the general public.

Article 100d

1.  The content and presentation of information, on authorised medicinal products subject to medical prescription, made available by the marketing authorisation holder to a patient or the general public or members thereof shall fulfil the following conditions:

   (a) it must be objective and unbiased, and, in this regard, if the information refers to the benefits of a medicinal product, its risks shall also be stated;
   (b) it must be patient oriented to better meet patients“ needs ▌;
   (c) it must be based on evidence, be verifiable and include a statement on the level of evidence;
   (d) it must be up to date and include the date of publication or last revision of the information;
   (e) it must be reliable, factually correct and not misleading;
   (f) it must be understandable and perfectly legible for a patient and the general public and members thereof, paying particular attention to elderly people ;
   (g) it must clearly state the source of the information indicating its author and giving references to any documentation that the information is based on;
   (h) it must not contradict the summary of product characteristics, labelling and patient package leaflet of the medicinal product, as approved by the competent authorities.

2.    By ... (7) , the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the patient package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. The Commission shall, if appropriate, and on the basis of the report, and after consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.

3.  Any information shall include:

   (a) a statement that the medicinal product concerned is available on prescription only and that instructions for use appear on the patient package leaflet or on the outer packaging, as the case may be;
   (b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and healthcare professionals and that a healthcare professional should be contacted if the patient requires clarification or further information on the information provided;
   (c) a statement indicating that the information is made available by, or on behalf of, a named marketing authorisation holder;
   (d) a postal address or e-mail address allowing patients and members of the general public to send comments to, or requests for further information from, the marketing authorisation holder. Comments sent by private individuals and the replies from marketing authorisation holders shall be duly recorded and monitored;
   (e) a postal address or e-mail address allowing patients and members of the general public to send comments to the national competent authorities;
   (f) the text of the current patient package leaflet or an indication as to where that text may be found. In the case of internet websites under the control of marketing authorisation holders that are directed specifically at citizens of one or more Member States, they shall contain the summary of product characteristics and the patient package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised if the information on medicinal products is available in those languages;
   (g) a statement indicating that patients and members of the general public are encouraged to report all suspected adverse reactions of medicinal products to their doctor, pharmacist, healthcare professional, or to the national competent authority, and indicating the name and web-address, postal address and/or telephone number of that national competent authority .

4.  The information shall not include:

  (a) comparisons between medicinal products regarding their quality, safety and efficiency, if the information is made available by marketing authorisation holders except where those comparisons are:
   included in officially approved documents, such as the summary of product characteristics ;
   based on comparative scientific studies published by the relevant national authorities or the Agency;
   contained in the summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004, which will list the other available therapeutic options and whether the new medicinal product brings about a therapeutic value;
   (b) any inducement to, or promotion of, the consumption of the medicinal product;
   (c) any of the material referred to in Article 90;
   (d) information on other medicinal products for which the pharmaceutical company is not the marketing authorisation holder .

5.   In order to ensure the quality of information made available to patients or the general public or members thereof, the Commission shall adopt, by means of delegated acts in accordance with Article 100n, and subject to the conditions of Articles 100n and 100o, the measures necessary for the application of paragraphs 1, 2, 3 and 4.

Article 100e

1.   Member States shall ensure that marketing authorisation holders' internet websites reproduce the last updated version as approved by the competent authorities of ▌the summary of product characteristics and of the patient package leaflet of the medicinal products subject to medical prescription that they market in the official languages of the Member States in which they are authorised.

2.    Member States shall ensure that each webpage from a marketing authorisation holder's website referring to a medicinal product subject to medical prescription includes a link to the corresponding webpage of the Union database (hereinafter the “EudraPharm database”) referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004, and the national medicines web-portals referred to in Article 106 of this Directive or the European medicines web-portal referred to in Article 26 of Regulation (EC) No 726/2004.

3.    The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall be hyperlinked with the corresponding studies in the European database on information about clinical trials (the “EudraCT database”) provided for in Article 11 of Directive 2001/20/EC.

4.   Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a patient or a member of the general public may be drafted in any of the official languages of the Union which are official languages in the Member States in which the medicinal product is authorised. The reply shall be drafted in the language of the request. The replies shall be kept available for inspection by national competent authorities.

Article 100f

1.   Member States shall, without creating a disproportionate burden for the marketing authorisation holder, ensure that marketing authorisation holders make information provided in accordance with this Title accessible to persons with disabilities.

2.   To ensure accessibility of information on a medicinal product provided by marketing authorisation holders through the internet, the websites concerned shall conform to the World Wide Web Consortium's (W3C) Web Content Accessibility Guidelines version 1.0, Level A. The Commission shall make those guidelines publicly available.

In order to take account of technical progress, the Commission may adopt, by means of delegated acts in accordance with Article 100m, and subject to the conditions of Articles 100n and 100o, measures necessary for the application of this paragraph .

Article 100g

1.   Member States shall ensure that ▌misuse ▌is avoided by ensuring that only the marketing authorisation holder supplies information, and that he supplies only such information as has been approved by the competent authorities about approved medicinal products subject to medical prescription, and that it is supplied in the form that has been approved for the making available to patients and the general public or members thereof. By way of derogation, Member States may continue those types of control mechanism which they implemented before 31 December 2008 not excluding enhancements to such control mechanisms. The Commission shall verify and approve such mechanisms and their enhancements, taking advice from the competent authorities.

Such mechanisms shall be based on the control of information prior to its being made available , unless:

   the content of the information has already been approved by the competent authorities; or
   an equivalent level of adequate and effective monitoring is ensured through a different mechanism.

2.   After consulting the Member States and all relevant stakeholders, such as patient organisations and healthcare professionals , the Commission shall draw up guidelines concerning information allowed under this Title and containing a code of conduct for marketing authorisation holders providing information to patients and the general public or members thereof on authorised medicinal products subject to medical prescription. The guidelines shall contain provisions to ensure that patients and members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information. The Commission shall draw up these guidelines by ... (8) and update them regularly on the basis of the experience gained.

Article 100h

1.   Member States shall ensure that marketing authorisation holders register internet websites under their control that are directed specifically at citizens of one or more Member States and that contain authority-approved information on prescription-only medicinal products covered by this Title , prior to making it available to patients or the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration. This information shall comply with the requirements laid down in this Directive and shall be in accordance with the registration dossier for the medicinal product.

After registration of the internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other internet websites registered by the marketing authorisation holder in accordance with the provisions of the first subparagraph throughout the Union if the contents are identical. Such websites shall clearly identify the marketing authorisation holder.

After registration of the internet website, any amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 4. Such changes shall not require re-registration of the website.

2.    Each Member State shall draw up and update a list of registered internet websites. Those lists shall be made available to consumers.

3.   Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph. Those websites shall identify the competent authority which granted the marketing authorisation and its website address.

Internet websites registered in accordance with paragraph 1 shall not allow the identification of patients or members of the general public which have access to those websites without their explicit prior consent, or the appearance therein of unsolicited content distributed to patients or the general public or members thereof. Internet websites may provide video content if it is useful for supporting the safe and effective use of the medicine .

Registered websites shall display a notification at the top of each webpage informing patients and the general public that the information contained therein is developed by a named marketing authorisation holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.

4.   The Member State in which the internet website has been registered shall be responsible for the monitoring of the contents relating to medicinal products subject to medical prescription made available on that website.

5.  A Member State shall not adopt any measure with regard to the content of an internet website which reproduces an internet website registered with the national competent authorities of another Member State, except on the following grounds:

   (a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide a certified translation of the authority-approved information made available on the internet website registered with the national competent authority of another Member State.
   (b) If a Member State has reasons for doubts as to whether the authority-approved information made available on an internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee referred to in Article 84. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.

6.   Member States shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 5 to include a message at the top of each webpage informing patients and the general public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription-only medicinal products . The message shall clearly identify the national competent authority monitoring the website concerned and the marketing authorisation holder responsible for the website . It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval and shall include a link to the EudraPharm database specifying that validated information is available there .

7.    The Commission shall establish, by means of delegated acts in accordance with Article 100m and subject to the conditions of Articles 100n and 100o, the detailed rules and conditions for registration and monitoring of internet websites referred to in this Title and of information provided therein, with a view to guaranteeing the reliability of the data presented and their compliance with the authorisation and registration of the medicinal products concerned so as to provide a guarantee for consumers that the website or information concerned is accurate and based on facts. Those rules and conditions shall include certification or qualification criteria to be applied with respect to registered websites.

Article 100i

1.  Member States shall take appropriate measures to ensure that the provisions of this Title are applied and that adequate and effective measures are adopted to sanction non-compliance with those provisions. Such measures shall include the following:

   (a) the determination of the penalties which are to be imposed should the provisions adopted for the implementation of this Title be infringed; those penalties shall be effective, proportionate and dissuasive;
   (b) the obligation to sanction cases of non-compliance;
   (c) the conferment of powers on the courts or administrative authorities enabling them to order the cessation of the making available of information that does not comply with this Title or, if such information has not been made available but will be imminently, to prohibit the making available of such information.

Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for making available non-compliant information on a medicinal product.

2.   Member States shall make provision for the measures referred to in paragraph 1 to be taken under an accelerated procedure either with interim effect or with definitive effect.

3.    Member States shall ensure that marketing authorisation holders are represented and heard in any consideration of a case in which they are accused of non-compliance with the provisions set out in this Title. The marketing authorisation holders shall have the right to appeal to a judicial or other body against any decision. During the appeal procedure the making available of information shall be suspended until a contrary decision is taken by the responsible body.

Article 100j

Member States shall ensure that marketing authorisation holders, through the scientific service referred to in Article 98(1):

   (a) keep available, for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance , a sample of all information made available in accordance with this Title and information on its volume of provision , together with a statement indicating the persons to whom it is addressed, the method of making it available and the date on which it was first made available ;
   (b) ensure that information on medicinal products by their undertaking complies with the requirements of this Title;
   (c) provide the authorities or bodies responsible for monitoring information on medicinal products with the information, the financial resources and assistance they require to carry out their responsibilities;
   (d) ensure that the decisions taken by the authorities or bodies responsible for monitoring information on medicinal products are immediately and fully complied with.

Article 100k

Information on homeopathic medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title. The same shall apply to information on herbal medicinal products or any other compounds or therapies that have been classified as prescription-only medicinal products.

Article 100l

1.    Notwithstanding the provisions of this Title on information by the marketing authorisation holder, each Member State shall ensure that objective, unbiased information is available to patients and the general public or members thereof on:

   (a) medicinal products placed on the market on its territory. Such information shall include, but shall not be limited to, the most recent summary of product characteristics and labelling and patient package leaflet of the medicinal product as approved by the competent authorities during the course of marketing authorisation and its renewal, and the most recent, publicly accessible version of the assessment report as drawn up by the competent authorities, and updates thereof;
   (b) the diseases and health conditions which are to be treated with medicinal products placed on the market on its territory; and
   (c) the prevention of such diseases and conditions.

2.    The information referred to in paragraph 1 shall be made available both in electronic and printed form and in a format accessible for people with disabilities. The information shall be made available through the following channels:

   (a) dedicated websites set up by the Member State or by a body assigned by the Member State, and monitored by the competent national authority or by a body assigned by the competent national authority;
   (b) printed materials made available to patients and the general public;
   (c) written answers to requests for information of patients and members of the general public.

3.    The Commission shall facilitate the sharing of best practices between Member States and shall adopt guidelines.

4.    By ... (9) the Commission shall present a report to the European Parliament and the Council on the progress made by the Member States in applying this Article.

Article 100m

1.    The power to adopt delegated acts referred to in Articles 100d(5), 100f(2) and 100h(7) shall be conferred on the Commission for a period of five years from ... (10) *. The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the five- year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament and the Council revoke it in accordance with Article 100n.

2.    As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

3.    The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 100n and 100o.

Article 100n

1.    The delegation of power referred to in Articles 100d(5), 100f(2) and 100h(7) may be revoked at any time by the European Parliament or by the Council.

2.    The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.

3.    The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 100o

1.    The European Parliament or the Council may object to a delegated act within a period of three months from the date of notification.

At the initiative of the European Parliament or the Council that period shall be extended by one month.

2.    If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.

The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

3.    If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

Article 100p

   By ... (11) , the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting all relevant stakeholders, such as independent patient, health and consumer organisations and the members of healthcare professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.
"

(9)    The words ‘package leaflet’ and ‘package leaflets’ shall be replaced by ‘patient package leaflet’ and ‘patient package leaflets’ throughout the text.

Article 2

Consultation of stakeholders

The Commission shall consult all relevant stakeholders, such as independent patient, health and consumer organisations on issues relating to the implementation of this Directive and its application by the Member States.

Article 3

Transposition

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (12) . They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 5

Addressees

This Directive is addressed to the Member States.

Done at

For the European Parliament For the Council

The President The President

(1) OJ C 306, 16.12.2009, p. 18.
(2) OJ C 79, 27.3.2010, p. 50.
(3) OJ C 306, 16.12.2009, p. 18.
(4) OJ C 79, 27.3.2010, p. 50.
(5) Position of the European Parliament of 24 November 2010.
(6) OJ L 311, 28.11.2001, p. 67.
(7)* 24 months after the entry into force of this Directive.
(8)* The entry into force of this Directive.
(9)* Three years from the entry into force of this Directive.
(10)** The entry into force of this Directive.
(11)* Five years from the entry into force of this Directive.
(12)* One year after the entry into force of this Directive.


Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) ***I
PDF 126k   DOC 55k
Resolution
Consolidated text
European Parliament legislative resolution of 24 November 2010 on the proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, 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 (COM(2008)0662 – C6-0517/2008 – 2008/0255(COD) )
P7_TA(2010)0430 A7-0289/2010

(Ordinary legislative procedure: first reading)

The European Parliament ,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0662 ),

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0517/2008 ),

–   having regard to the communication from the Commission to the European Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665 ),

–   having regard to Article 294(3), Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union,

–   having regard to the opinion of 10 June 2009 of the European Economic and Social Committee(1) ,

–   having regard to the opinion of 7 October 2009 of the Committee of the Regions(2) ,

–   having regard to Rule 55 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0289/2010 ),

1.   Adopts the position at first reading hereinafter set out;

2.   Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.   Instructs its President to forward its position to the Council, to the Commission and to the national parliaments.

Position of the European Parliament adopted at first reading on 24 November 2010 with a view to the adoption of Regulation (EU) No .../2011 of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, 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

P7_TC1-COD(2008)0255


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and Social Committee(3) ,

Having regard to the opinion of the Committee of the Regions(4) ,

Acting in accordance with the ordinary legislative procedure(5) ,

Whereas:

(1)   On 20 December 2007, the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’. The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Experience gained from the application of the current legal framework has also shown disparities in the interpretation of Union rules on advertising, and between national provisions on information, highlighting the urgent need for a more precise distinction between advertising and information .

(2)   The introduction of a new Title VIIIa in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use(6) addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription and to place emphasis on the rights and interests of patients .

(3)   Disparities in the provision of information on medicinal products for human use are not justified in the case of medicinal products authorised pursuant to Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council(7) for which a single summary of the products characteristics and package leaflet are approved for the whole Union. Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products.

(4)   Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to being made available . In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter the ‘Agency’), and for the Agency to monitor the measures to be taken by the manufacturer and to monitor the updating of the literature following the reporting of adverse reactions .

(5)   To ensure the adequate funding of these activities related to information, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.

(6)    In the event that the additional costs incurred by the Agency as a result of its preliminary checking of certain types of information pursuant to this Regulation are not covered by the fees payable by the marketing authorisation holders for this purpose, the amount of the Union's contribution to the Agency's budget should be reviewed. Accordingly, efforts should be initiated at Member State level with a view to the possible amendment of the Union's contribution to the Agency.

(7)   Since the objective of this Regulation, namely to provide for specific rules on information on medicinal products for human use subject to prescription authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by Member States 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 European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(8)   Regulation (EC) No 726/2004 should be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 726/2004

Regulation (EC) No 726/2004 is amended as follows:

(1)    In Article 9(4), the following point is added: "

   (f) the summary of the European Public Assessment Report referred to in Article 13(3).
"

(2)   The following Articles are inserted:"

Article 20a

1.   Title VIIIa of Directive 2001/83/EC shall apply to medicinal products which are authorised under this Title and are subject to medical prescription.

Article 20b

1.   By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its being made available, unless this information appears on a website, the responsibility for monitoring the content of which rests with a Member State in accordance with Article 100h of Directive 2001/83/EC .

2.   For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be made available .

3.   The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 90 days after receipt of the notification. If the Agency does not object within 90 days , the information shall be deemed accepted and may be published. The marketing authorisation holder shall remain fully liable and responsible for the information provided in all cases.

4.    If the Agency asks for changes to be made to information submitted by the marketing authorisation holder, and if the latter resubmits an improved mock-up of the information within 30 working days, the Agency shall communicate its response to the new proposal within 60 working days.

The Agency shall charge the marketing authorisation holder an additional fee for this assessment.

5.   The submission of information to the Agency in accordance with paragraphs 1, 2, 3 and 4 shall be subject to a fee payable in accordance with Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products*.

__________________

* OJ L 35, 15.2.1995, p. 1.

"

(3)   Article 57 is amended as follows:

   (a) paragraph 1 is amended as follows:
"
   (i) point (l) is replaced by the following: "
   ( l) creating a database on medicinal products, to be accessible to the general public, in all official languages of the Union, and ensuring that it is updated and managed independently of the commercial interests of pharmaceutical companies. The database shall facilitate the search for information already authorised for package leaflets, it shall include a section on medicinal products authorised for the treatment of children, and the information provided to the public shall be worded in an appropriate and comprehensible manner designed for non-experts;
"
   (ii) the following points are added:"
   (u) delivering opinions on information to the general public on medicinal products for human use subject to medical prescription;
   ( v) promoting existing sources of independent reliable health information.
  (b) paragraph 2 is amended as follows:
   (i) The first subparagraph is replaced by the following: "
2.    The database provided for in point (l) of paragraph 1 shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and Chapter 4 of Title III of Directive 2001/82/EC. The database shall subsequently be extended to include any medicinal product placed on the market within the Union. That database shall be actively promoted to EU citizens. "
   (ii) A fourth subparagraph is added: "
The information submitted by marketing authorisation holders and approved by the national authorities shall be sent to the Agency by those authorities and included in the database referred to in the first subparagraph, which shall be available to the public. "

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at

For the European Parliament For the Council

The President The President

(1) OJ C 306, 16.12.2009, p. 33.
(2) OJ C 79, 27.3.2010, p. 50.
(3) OJ C 306, 16.12.2009, p. 33.
(4) OJ C 79, 27.3.2010, p. 50.
(5) Position of the European Parliament of 24 November 2010.
(6) OJ L 311, 28.11.2001, p. 67.
(7) OJ L 136, 30.4.2004, p. 1.


Restriction of the use of certain hazardous substances in electrical and electronic equipment ***I
PDF 98k   DOC 61k
Resolution
Consolidated text
Annex
European Parliament legislative resolution of 24 November 2010 on the proposal for a directive of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (COM(2008)0809 – C6-0471/2008 – 2008/0240(COD) )
P7_TA(2010)0431 A7-0196/2010

(Ordinary legislative procedure: first reading - recast)

The European Parliament ,

–   having regard to the Commission proposal to Parliament and the Council (COM(2008)0809 ),

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0471/2008 ),

–   having regard to the Commission communication to Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665 ),

–   having regard to Article 294(3) and Article 114 of the Treaty on the Functioning of the European Union,

–   having regard to the opinion of the European Economic and Social Committee of 10 June 2009(1) ,

–   having regard to the opinion of the Committee of the Regions of 4 December 2009(2) ,

–   having regard to the undertaking given by the Council representative by letter of 12 November 2010 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–   having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(3) ,

–   having regard to the letter of 11 November 2009 from the Committee on Legal Affairs to the Committee on the Environment, Public Health and Food Safety in accordance with Rule 87(3) of its Rules of Procedure,

–   having regard to Rules 87 and 55 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0196/2010 ),

A.   whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance,

1.   Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2.   Approves its statement annexed to this resolution;

3.   Takes note of the Commission statements annexed to this resolution;

4.   Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

5.   Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 24 November 2010 with a view to the adoption of Directive 2011/.../EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)

P7_TC1-COD(2008)0240


(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2011/65/EU).

ANNEX

Statements

Statement by the European Parliament

The European Parliament regrets that the Council was not prepared to accept the mandatory publication of correlation tables in the context of the recast of Directive 2002/95/EC. With a view to advancing a horizontal and inter-institutional solution of this matter, the European Parliament calls on the European Commission to make a report within six months after adoption of this agreement in plenary on the practice of Member States to draw up correlation tables in the field of EU environmental legislation and to make them public, including an assessment of how current practice affects the Commission's role of ‘guardian of the Treaty’ in controlling correct transposition of EU directives into national legislation in the field of environment protection.

Commission statement on the scope (Article 2(2))

The Commission interprets Article 2(2) that electrical and electronic equipment that was outside the scope of Directive 2002/95/EC, but which would be covered by the new Directive, does not need to comply with the requirements of this Directive during a transitional period of eight years.

EEE which was outside of the scope of Directive 2002/95/EC, but which would be covered by the new Directive, includes amongst others EEE covered by:

   the new category 11 in Annex I;
   the new definition of ‘dependent’ of Article 3(2);
   ‘cables’ mentioned in article 4 and the related definition in Article 3(5);
   two-wheel vehicles which are not type-approved (Article 2(4)(f)).

During the transitional period of eight years, in the Commission's interpretation, it follows from Article 2(2) that Member States are obliged to allow electrical and electronic equipment that was outside the scope of Directive 2002/95/EC, but which would be covered by the new Directive, to continue to be made available on their market.

Commission statement on the review (Article 24)

Pursuant to Article 24, the Commission intends to undertake, no later than three years after the entry into force of this Directive, an impact assessment (review) on Article 2 focussing on the changes in scope of this Directive compared to Directive 2002/95/EC which have not yet been impact- assessed.

This review, followed by a report to the Council and the European Parliament, may be accompanied by a legislative proposal, if the Commission deems appropriate. The extent of the review and of the legislative proposal remains to be determined by the Commission in accordance with its right of legislative initiative, in line with the Treaties.

Commission statement on nano-materials (recital 16 and Article 6)

The Commission notes that work towards a common definition on nanomaterials is still on-going and intends to adopt a Commission Recommendation on a common definition for all legislative sectors in the near future. The Commission considers that the RoHS provisions cover different forms (including nanoforms) of the substances which are currently banned and those which will be in the future subject to a priority review under RoHS.

Commission statement on correlation tables

The Commissions recalls its commitment towards ensuring that Member States establish correlation tables linking the transposition measures they adopt with the EU directive and communicate them to the Commission in the framework of transposing EU legislation, in the interest of citizens, better-law making and increasing legal transparency and to assist the examination of the conformity of national rules with EU provisions.

The Commission regrets the lack of support for the provision included in the 2008 Commission proposal on the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast), which aimed at rendering the establishment of correlation tables obligatory.

The Commission, in a spirit of compromise and in order to ensure the immediate adoption of that proposal, can accept the substitution of the obligatory provision on correlation tables included in the text with a relevant recital encouraging Member States to follow this practice.

However, the position followed by the Commission in this file shall not be considered as a precedent. The Commission will continue its efforts with a view to finding, together with the European Parliament and the Council, an appropriate solution to this horizontal institutional issue.

(1) OJ C 306, 16.12.2009, p. 36.
(2) OJ C 141, 29.5.2010, p. 55.
(3) OJ C 77, 28.3.2002, p. 1.


Anti-Counterfeiting Trade Agreement (ACTA)
PDF 84k   DOC 40k
European Parliament resolution of 24 November 2010 on the Anti-Counterfeiting Trade Agreement (ACTA)
P7_TA(2010)0432 B7-0618/2010

The European Parliament ,

–   having regard to having regard to Articles 207 and 218 of the Treaty on the Functioning of the European Union (TFEU),

–   having regard to the Charter of Fundamental Rights of the European Union,

–   having regard to its resolution of 10 March 2010 on the transparency and state of play of the ACTA [Anti-Counterfeiting Trade Agreement] negotiations,

–   having regard to its decision of 20 October 2010 on the revision of the framework agreement on relations between the European Parliament and the European Commission,

–   having regard to the plenary debate of 20 October 2010 on the Anti-Counterfeiting Trade Agreement,

–   having regard to the 2 October 2010 draft of the Anti-Counterfeiting Trade Agreement,

–   having regard to the European Ombudsman's decision on complaint 90/2009/(JD)OV relating to access to ACTA documents,

–   having regard to Council Regulation (EC) No 1383/2003,

–   having regard to the Inter-Institutional Agreement on Better Law-Making between Parliament, the Council and the Commission (2003/C 321/01),

–   having regard to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS),

–   having regard to Rules 115(5) and 110(2) of its Rules of Procedure,

A.   whereas the fight against counterfeiting represents a key element in the EU political strategy with a view to ensuring justice, a level playing field for our producers, the maintenance of employment for citizens and respect for the rule of law,

B.   whereas, in order to be more effective, the fight against counterfeiting – which is a worldwide phenomenon – requires stronger international cooperation among the major world players,

C.   whereas, despite several attempts to achieve a multilateral approach – which remains the main goal in the EU strategy – this could not be pursued because of resistance and opposition from other global players, and whereas the plurilateral agreement therefore seems to be the best way of addressing specific concerns at an international level,

D.   whereas, as the Commission has repeatedly stated, ACTA is concerned solely with enforcement measures and does not include provisions modifying the substantive intellectual property rights (IPR) law of the EU or the other ACTA parties, but rather establishes, for the first time, a comprehensive international framework to assist the parties in their efforts to combat IPR infringements effectively, and it does not therefore imply any change to the acquis communautaire ,

E.   whereas, in many areas, including provisions for the digital sector and the scope of compulsory border measures, ACTA goes beyond the scope of TRIPS and therefore affords right-holders better protection,

F.   whereas, after strong representations by Parliament, the level of transparency of the ACTA negotiations was fundamentally improved and, since the negotiating round in New Zealand, Parliament has been fully informed of the course of the negotiations; and whereas it took cognisance of the negotiated text one week after the conclusion of the last round in Japan,

G.   whereas the negotiated text reflects the main concerns expressed by Parliament over recent months, including on issues such as the observance of fundamental rights, privacy and data protection, respect for the important role of free Internet, the importance of safeguarding the role of service providers, and the need to safeguard access to medicines – a reference to the Doha Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001, having been incorporated into the preamble to the agreement,

H.   whereas the Commission has repeatedly affirmed the importance of enforcing the protection of geographical indications (GIs); whereas it has been agreed by parties to the agreement that ACTA will provide for the enforcement of GIs,

I.   whereas the Commission, as guardian of the Treaties, is obliged to uphold the acquis communautaire when negotiating international agreements affecting legislation in the EU, and whereas the Commission has committed itself to providing immediate and full information to Parliament at every stage of negotiations on international agreements,

J.   whereas it is crucial to ensure that the development of IPR enforcement measures is accomplished in a manner that does not impede innovation or competition, undermine IPR limitations and personal data protection, restrict the free flow of information or unduly burden legitimate trade,

K.   whereas any agreement reached by the EU on ACTA must comply fully with the acquis communautaire, and this relates particularly to legal obligations imposed on the EU with respect to privacy and data protection, notably as provided for in Directive 95/46/EC, Directive 2002/58/EC and the case law of the European Court of Human Rights and the Court of Justice,

L.   whereas, as a result of the entry into force of the Lisbon Treaty in December 2009, Parliament will have to give consent to the ACTA text prior to the agreement's entry into force in the EU,

1.   Welcomes the release of the 2 October 2010 draft of the Anti-Counterfeiting Trade Agreement following the Tokyo negotiating round and expects the Commission to release to Parliament and the public the finalised ACTA text following the technical negotiation meeting in Sydney from 30 November to 3 December 2010;

2.   Reiterates that combating counterfeiting is a priority in its internal and international political strategy and that international cooperation is a key issue in the attainment of this goal;

3.   Is fully aware that the agreement negotiated will not solve the complex and multi-dimensional problem of counterfeiting; considers, however, that it is a step in the right direction;

4.   Welcomes the Commission's repeated statements that enforcement of the ACTA provisions – especially those on copyright enforcement procedures in the digital environment – will be fully in line with the acquis communautaire and that neither personal searches nor the so-called ‘three strikes’ procedure will be introduced by this agreement; points out that no ACTA signatory, and particularly not the EU, may be mandated by the agreement to introduce a ‘three strikes’ or similar regime;

5.   Welcomes the fact that the deliberative draft text of 2 October 2010 confirms, in its preamble, ACTA's aim of providing effective and appropriate means of IPR enforcement, complementing the TRIPS agreement and taking into account differences in the respective legal systems and practices of the ACTA parties; and insists on the fact that the principles set out in the Doha Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 by the WTO at its Fourth Ministerial Conference, held in Doha, Qatar, are the building blocks underpinning the ACTA deliberative draft text of 2 October 2010 and that, therefore, any enforcement of ACTA should comply with these principles;

6.   Emphasises that ACTA will not change the EU acquis in terms of IPR enforcement, because EU law is already considerably more advanced than the current international standards, and that it therefore represents an opportunity to share best practices and guidelines in this area;

7.   Considers ACTA as a tool for making the existing standards more effective, thus benefiting EU exports and protecting right-holders when they operate in the global market, where they currently suffer systematic and widespread infringement of their copyrights, trademarks, patents, designs and GIs;

8.   Stresses the importance, for European companies and employment in the EU, of protecting GIs; acknowledges the efforts made by the Commission to include the protection of GIs within the scope of ACTA;

9.   Finds it regrettable that, in its Article 1.X, the agreement does not define ‘counterfeit geographical indications’, as this omission could create confusion or at least complicate the tasks of administrative and judicial authorities in the interpretation and enforcement of ACTA;

10.   Welcomes the inclusion of the word ‘may’ in Article 2.14.3 (‘Each party may provide criminal procedures and penalties [...]’);

11.   Welcomes the fact that the parties agreed, following EU insistence, that the criminalisation of ‘camcording’ should be merely optional (Articles 2.14.3 and 2.15);

12.   Welcomes the fact that ACTA membership is not exclusive and that additional developing and emerging countries may join, thus promoting widespread IPR protection and enhancing the fight against counterfeiting worldwide; considers that, in the future, ACTA could potentially attain a multilateral level;

13.   Emphasises that any decision taken by the Commission as part of the ACTA Committee must lie within the scope of the acquis and may not unilaterally change the content of ACTA; considers therefore that any proposed change to ACTA would need to be adopted by Parliament and the Council in accordance with Article 207 and 218, TFEU;

14.   Calls on the Commission to confirm that ACTA's implementation will have no impact on fundamental rights and data protection, on the ongoing EU efforts to harmonise IPR enforcement measures, or on e-commerce;

15.   Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the states parties to the ACTA negotiations.

Last updated: 28 February 2012Legal notice