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Document 52011PC0633

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 medical prescription and as regards pharmacovigilance

/* COM/2011/0633 final - 2008/0256 (COD) */

52011PC0633

/* COM/2011/0633 final - 2008/0256 (COD) */ 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 medical prescription and as regards pharmacovigilance


(...PICT...)

EXPLANATORY MEMORANDUM

The Commission presents an amended proposal for a Directive of the European Parliament and of the Council on information to the general public on medicinal products subject to medical prescription. Incorporated within the amended proposal are amendments proposed by the European Parliament at its first reading which are acceptable to the Commission.

1. Background

On 10 December 2008, the Commission adopted a proposal for a Directive of the European Parliament and of the Council on information to the general public on medicinal products subject to medical prescription. This proposal was forwarded to the European Parliament and the Council on 10 December 2008.

The Economic and Social Committee gave its opinion on 10 June 2009 and the Committee of the Regions, 7 October 2009.

The European Parliament adopted a legislative resolution at its first reading on 24 November 2010.

2. Objective of the Commission's proposal

The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to:

· Provide for a clear framework for provision of information by marketing authorisation holders about their prescription-only medicines to the general public with a view to enhancing the rational use of these medicines, while ensuring that the legislative framework continues to prohibit direct-to-consumer advertising of prescription-only medicines.

This aim shall be achieved by:

· Ensuring the high quality of information provided by coherent application of clearly defined standards across the EU.

· Allowing information to be provided through channels addressing needs and capabilities of different types of patients.

· Allowing marketing authorization holders to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines.

· Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.

This amended proposal is in line with those objectives and further reinforces the rights of patients. In particular, the marketing authorisation holders will have the obligation, and no longer just the possibility, to make available certain information, such as the labelling and the package leaflet.

3. Commission opinion on the amendments adopted by the European Parliament:

On 24 November 2010, the European Parliament adopted 78 amendments on the proposal for a Directive on information to the general public on medicinal products subject to medical prescription. The Commission considers that a majority of the European Parliament's amendments are acceptable in full, in principle, or in part, as they maintain the aims and overall scheme of the proposal.

The Commission therefore accepts in full or in part, the following amendments of the European Parliament:

3.1. Amendments of a general nature

Some of the amendments of the European Parliament, in particular 1, 4 13 and 70, provide for the replacement of the words "disseminate" by "making available" the information. These changes have been incorporated within the whole revised text (recitals and articles) as foreseen by the amendments.

Amendment 2 modifies recital 2 in order to stress that inequalities in accessing information are not acceptable and should be adjust. The Commission introduces these changes within recital 3.

Amendment 3, that the amended proposal incorporates, modifies recital 4 calling for a distinction between advertisement and information in order that all citizens have access to information in all Member States.

Amendments 6 and 7 share the same aim which is to recognise that although some information is made available by national competent authorities and healthcare professionals, marketing authorisation holders may be an additional source of information. The Commission modifies accordingly recital 8.

3.2. Scope of title VIII "Advertising" (Article 86(2))

Article 86(2) of Directive 2001/83/EC, as currently in force, identifies types of information which are not covered by the Directive's title on advertising.

Amendment 20 adds to the list in Article 86(2) correspondence needed to answer a specific question about a medicinal product, and amendment 21 adds some factual, informative announcements. The Commission agrees in principle; however, it is not necessary to specifically mention these aspects as they are already covered by the general indent on "information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which shall comply with the provisions of Title VIIIa".

Amendments 22 and 23 clarify the elements listed in the Commission proposal as not covered by the advertisement title. In particular, amendment 23 adds, to the fact that information to the general public should comply with Title VIIIa, the requirement for such information to be approved by the authorities and to respect quality criteria. As these requirements are included in Title VIIIa, it is not necessary to repeat them.

Amendment 24 adds to the list of elements which should not be covered by the advertisement title, factual, informative announcements for investors and employees on significant business developments provided they are not used to promote the product to the general public. This amendment is incorporated in the amended proposal; it is further specified that, however, if the information concerns individual medicinal products, the conditions of Title VIIIa should apply to ensure that the provisions of information to investors and employees is not used to circumvent the provisions of the Directive.

Amendment 25 clarifies that in cases not covered by the advertising title, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder making available the information should be identified as such. This has been introduced in Article 100a for all activities covered by the Directive's title on information. .

3.3. Exception to advertising (Article 88(4))

Amendment 87 provides conditions that must be fulfilled by industry in order to be authorised to conduct advertising on vaccination campaigns.

Directive 2001/83/EC provides that the prohibition of advertising does not apply to vaccination campaigns carried out by industry and approved by the competent authorities of the Member States. The original proposals extended this exception to public health campaigns in general. Amendment 87 deletes this proposed extension and imposes further requirements on possible vaccination campaigns. The amended proposal incorporates these changes; however the information should refer only to the vaccines and not to the diseases concerned as the scope of Directive 2001/83/EC is limited to medicinal products.

3.4. Advertising to healthcare professionals (Article 94)

Amendment 27 modifies Article 94 which regulates the advertising to healthcare professionals. It specifies that the rules should apply to direct or indirect promotion by marketing authorisation holder or a third party acting on its behalf or following its instructions. The Commission supports this clarification, which should not be restricted to one specific article. It should concern all Articles on advertising. Therefore the change is introduced in Article 86 at the beginning of the Title VIII on advertising.

3.5. Scope of the new title VIIIa "Information to the general public on medicinal products subject to medical prescription" (Article 100a)

Article 100a defines the scope of the title of the Directive on information. Amendment 84, modifying Article 100b on the content of the information, makes the distinction between information that marketing authorisation holders should make available and information that he may make available. By creating this distinction, the European Parliament re-orientates the text from the right of marketing authorisation holders to make available some information to the right of the patients to have information. This re-orientation should also be reflected in Article 100a. Furthermore, requirements added by this amendment regarding identification of the marketing authorisation holder and control mechanisms do not have to be specified in this Article as they are provided for in specific articles.

Amendment 29 provides that healthcare professionals who deliver information on medicinal products during public events should declare their financial interests with marketing authorisation holders. The Commission supports this amendment, which can however only concern medicinal products and not medical devices in view of the scope of the Directive. This amendment is covered by the introduction within the amended proposal of the obligation for any person making available information to the public to declare any financial or other benefits from marketing authorisation holders.

Amendment 31 modifies the list of types of information which should not be covered by the Directive's title on information. The Commission supports this amendment to the extent that it is consistent with Article 100b on the content of information that may be made available.

Amendments 8 and 32 exclude from the scope of the Directive information made available by third parties acting independently from the marketing authorisation holder in order for them to express their views on prescription-only medicinal products. The Commission supports this exclusion. In addition, in order to ensure transparency about information provided by third parties, they should declare their interests when making available information on medicinal products.

3.6. Content of the information (Article 100b)

Amendments 10 and 84 (modifying Article 100b) make the distinction between information that marketing authorisation holders should make available and information that they may make available. Such a distinction was not included in the original proposal, where no mandatory obligations were created. The Commission accepts these amendments.

However, regarding the list of information that can be made available, Directive 2010/84/EU amending Directive 2001/83/EC as regards pharmacovigilance provides within Article 106a requirements applicable to public announcements by marketing authorisation holders relating to information on pharmacovigilance. Therefore, information regarding adverse-reaction warnings should be excluded from the scope of the Directive's Title on information, as it is specifically addressed by the Title on pharmacovigilance.

Lastly, requirements linked to channels of information, persons with disabilities and control (also contained in the amendment) do not have to be specified in this Article as they are provided for in specific Articles.

3.7. Channels of information (Article 100c)

Amendments 12 and 34 delete the possibility to make available information through health-related publications and provide that it cannot be made available through newspapers, magazines and similar publications. However, the amendments introduce the possibility to make available information through printed materials about a medicinal product prepared by marketing authorisation holders upon specific request by a member of the general public. The Commission accepts these changes; however it is the issuing of these printed materials that should be on request, not their drafting.

3.8. Quality criteria and statements (Article 100d)

Amendments 35, 36 and 37 modify some of the quality criteria applicable to the information.

Amendments 39, 40, 41, 42 and 43 modify the statements that must be available with the information and add two others: a statement containing contact information allowing members of the public to contact competent authorities, and a statement containing a reference to the most recent package leaflet or an indication as to where that text can be found. These amendments have been included in Article 100d. The elements of amendment 41 which relate to monitoring are not included in the amended Article 100d, but are added in the specific Article on monitoring. The elements of amendment 43 referring to internet websites are included in Article 100h.

Amendment 44 requires a statement encouraging the report of undesirable effects to doctors, pharmacists, healthcare professionals and competent authorities. Although the Commission supports this proposal, it considers that a specific statement to encourage this reporting of undesirable effects is not necessary. Indeed, Directive 2010/84/EU already introduces such a statement within Article 59 of Directive 2001/83/EC on information to be included within the package leaflet.

Paragraph 3 of Article 100d provides the elements that the information should not include, such as comparisons between medicinal products. Amendment 46 adds the inducement to or the promotion of the consumption of the medicinal product. Although the Commission supports this principle, the text does not need to be modified to reflect this aspect as this follows already from the provisions of the Directive (Article 86). Indeed, all information that can be made available under Title VIIIa should not induce or promote the consumption of medicinal product.

Amendment 48 aligns to the Treaty of Lisbon the granting to the Commission of the power to adopt measures necessary for the implementation of Article 100d. The acts adopted by the Commission should be implementing acts and not delegated acts, as they are limited to the implementation of the quality criteria which are laid down in the proposal.

3.9. Language aspects (Article 100e)

Amendments 49, 50 and 52 refer to Article 100e on languages; however the modifications concern other aspects and therefore have been introduced, if not already provided for, in the corresponding Articles on quality criteria (Article 100d), monitoring (Article 100g), control (Article 100j) and internet websites (Article 100h).

3.10. Persons with disabilities (Article 100f)

Amendment 53 aligns with the Treaty of Lisbon the delegation to the Commission to amend the Article to take account of technical progress.

3.11. Control of the information (Article 100g)

Amendments 9, 11, 56 and 96 provide for the pre-control of the information by competent authorities, including through the marketing authorisation process, and delete the possibility for Member States to opt for voluntary control by self-regulatory or co-regulatory bodies. A derogation from the system of pre-control is foreseen for Member States which have implemented other type of control mechanisms before 31 December 2008.

The Commission accepts this principle of pre-control and the possibility for derogations. For the latter, in addition to the derogation for pre-existing systems foreseen by the amendments, an additional derogation should be included for cases where Member States cannot introduce a system of pre-control for constitutional reasons related to the principles of freedom of expression and of the press. However, the Commission should not be tasked to verify and approve alternative national systems.

As the possibility to opt for voluntary control by self-regulatory or co-regulatory bodies are deleted in the new proposal, the provisions for a code of conduct adopted by the Commission has been deleted, while maintaining provisions for Commission guidelines.

The Commission acknowledges that a number of Member States have expressed concerns in relation to the conformity with their national constitutions. The Commission is prepared to enter into a dialogue with those concerned to find suitable solutions while fully respecting the objectives of this Directive. As regards this Directive, apart from the control mechanism, as some of the provisions introduced by this Directive may interfere with national constitutional rules relating to freedom of the press and freedom of expression in the media, the Commission introduces recital 16 clarifying that this Directive does not prevent Member States from applying these constitutional rules.

3.12. Internet websites (Article 100h)

Article 100h lays down rules for marketing authorisation holders' internet websites making available information on medicinal products under prescription status.

Amendment 58 clarifies that the information available on these websites shall comply with the requirements of the Directive and that it shall be in accordance with the marketing authorisation of the medicinal product. Although the Commission agrees with this, it is not necessary to specify it, as this already follows from other provisions of the Directive.

Amendment 59 foresees the identification of the marketing authorisation holder in the websites. However this identification is already provided for within Article 100d, paragraph 2.

Amendment 60 provides that any update of the information is subject to the monitoring without leading to a re-registration of the website. It should also be stated that the new information is also subject to the requirement of control provided by Article 100g.

Amendment 61 deals with the possibility of including video content on internet websites. The modification of Article 100d(2) by amendment 84 (allowing still or moving images of technical nature demonstrating the proper way of using the product) is sufficient in this regard.

The Commission agrees to the linkage of marketing authorisation holder websites to EU databases and portals on medicinal products, introduced by amendment 62. However, it is more appropriate to link marketing authorisation holder websites to the EU medicines web-portal established by Regulation (EU) No 1235/2010 than to the EudraPharm database, as that portal is intended to become the central point of access to information on medicines. Furthermore, the identification of marketing authorisation holders providing the information is already required in Article 100d(2); therefore the Commission considers that a reference to this Article is sufficient.

3.13. Penalties (Article 100i)

Article 100i on penalties is modified in order to provide for the possibility to publish the name of marketing authorisation holders who have published information on a medicinal product which is non-compliant with the Directive (amendment 67), to lay down the right of appeal of marketing authorisation holders and to introduce the suspension of the dissemination of the information while the proceedings are on-going (amendment 69).

3.14. Monitoring of the information (Article 100j)

Article 100j refers to marketing authorisation holders' obligations to allow the monitoring of the information provided. Amendment 52, modifying Article 100e, to keep replies available for inspections by national competent authorities, should therefore be introduced within Article 100j.

3.15. Consultation (Article 100ka)

Amendments 16, 90, 92, 93 and 94 refer to the consultation of all relevant stakeholders such as independent patient, health and consumer organisations on issues relating to the implementation of the Directive and its application by the Member States. The consultation of appropriate stakeholders is part of the inter-institutional agreement on better law making (2003/C321/01) and therefore it is not necessary to mention each time examples of these stakeholders, neither to provide for a stand-alone article on that matter.

3.16. Information provided by other sources than the marketing authorisation holder (Articles 21 and 106)

Amendment 79 provides for information about diseases and health conditions and the prevention of such diseases and conditions. The Commission recognises the need for such broader information, however, this cannot be addressed within the Directive which covers medicinal products only.

The part of the amendment intended to task Member States with ensuring that objective, unbiased information is available to general public or members thereof has been introduced in Article 106. This Article following amendment of Directive 2001/83/EC by Directive 2010/84/EU already provides a key tool to fulfil the objective of the amendment (the creation of medicines web portals in every Member States).

3.17. Comitology alignment (Article 100k)

Amendments 15, 75 to 77 are intended to include in Directive 2001/83/EC, in view of the entry into force of the Treaty of Lisbon, general provisions on the granting of delegated powers to the Commission. However, these Articles have been introduced into the Directive by Directive 2010/84/EU. It is only necessary to adapt Article 121a on the exercise of the delegation to include the reference to Article 100f, paragraph 2 which provides for delegated acts.

3.18. Pharmacovigilance

In addition to the changes introduced on the basis of the European Parliament resolution regarding the Commission proposal on information to patients, the Commission considers that certain changes to Directive 2001/83/EC in the area of pharmacovigilance should be introduced.

Directive 2001/83/EC has been recently amended by Directive 2010/84/EU to revise the EU pharmacovigilance system. Directive 2010/84/EU having as legal basis Article 168(4)(c) of TFUE; the amended proposal should also be based on Article 168(4)(c) of TFUE. Directive 2010/84/EU substantially strengthens the legal framework for the surveillance of medicinal products authorised by the Member States, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, in view of recent pharmacovigilance events in the EU, the Commission has detected certain areas where the legislation could be further strengthened. Therefore:

· Articles 107i is modified in order to provide for an automatic procedure at European level in the cases of specific serious safety issues with nationally authorised products, with a view to ensuring that the matter is assessed and addressed in all Member States where the medicinal product is authorised. Articles 31 and 34 are also modified to clarify the respective scopes of this provision and the revised automatic procedure, as well as the links between these procedures and procedures involving medicinal products authorised in accordance with Regulation (EC) No 726/2004.

· Articles 23a and 123 are modified to avoid that the voluntary withdrawal of a marketing authorisation or product by the holder could lead to safety issues not being addressed in the EU, by clarifying information obligations for the marketing authorisation holder.

4. Conclusion

Having regard to Article 293 of the Treaty on the functioning of the European Union, the Commission modifies its proposal as follows:

2008/0256 (COD)

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 medical prescription and as regards pharmacovigilance

(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 168(4)(c) thereof,

Having regard to the proposal from the European Commission [1],

Having regard to the opinion of the European Economic and Social Committee [2],

Acting in accordance with the ordinary legislative procedure [3],

Whereas:

(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [4] 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 health-care professionals) and the 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 the general public, including patients, 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 to the European Parliament and the Council on a "Report on current practices with regard to the provision of information to patients on medicinal products" [5] . 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. 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 certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Union, and that this has also 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 medicinal products. The distinction between advertising and information should be clarified in order to be interpreted uniformly across all Member States so as to ensure patient safety.

(5) Those disparities in the interpretation of the Union rules on advertising, and between national provisions on information have a negative impact on the uniform application of Union rules on advertising, and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the 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 package leaflet) is harmonised at Union level. This includes medicinal products authorised by the Member States under the mutual recognition framework of Chapter IV 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. Patients should have the right to easily access certain information such as the summary of the product characteristics, the package leaflet and the assessment report.

(8) National competent authorities and health care professionals should remain the main sources of information on medicinal products for the general public. While there is already independent information on medicinal products, for example by national authorities or health care professionals, the situation differs very much between Member States and among medicinal products. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be an additional valuable 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 the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.

(9) Third parties, such as patients and patients' organisations or the press, should be able to express their views on prescription-only medicinal products, and should therefore not be covered by the provisions laid down in this Directive, provided that they are acting independently from the marketing authorisation holder. To ensure transparency as to whether third parties act independently from marketing authorisation holders, when making available information, third parties should declare any financial or other benefits received from marketing authorisation holders.

(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 the general public of medicinal products not subject to prescription, under certain conditions.

(11) Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of medicinal products subject to medical prescription may be made available. 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 the general public on prescription-only medicinal products should comply with a set of quality criteria.

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

(13) Whether obligatory or not, information to the general public on prescription-only medicinal products should only be provided through specific channels of communication, including Internet , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is made available via television, radio or printed media, patients are not protected against such unsolicited information and such channels of information should therefore not be allowed.

(14) 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. Registered websites for objective and non-promotional information are therefore necessary and specific rules on the monitoring of those 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.

(15) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only make available 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. Monitoring should be based on the control of information prior to its being made available, unless the substance of the information has already been agreed by the competent authorities in the course of the marketing authorisation procedures, as it is the case for the summary of the product characteristics, labelling and package leaflet, and the publicly accessible version of the assessment report or any updated versions of these documents.

(16) This Directive enhances compliance with fundamental rights and is fully in line with the principles recognised by the Charter of Fundamental Rights of the European Union, in particular Article 11 thereof. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media.

(17) As this Directive introduces for the first time harmonised rules on the provision of information on medicinal products subject to medical prescription to 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 stakeholders, in the monitoring of information.

(18) Recent pharmacovigilance events in the Union have shown the need for an automatic procedure at Union level in the cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The scope of different Union procedures concerning nationally authorised products should be clarified.

(19) In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to benefits-risks of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provisions should be made for the marketing authorisation holder to inform competent authorities of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.

(20) In order to clarify the information allowed, the power to adopt acts in accordance with Article 290 of the Treaty on the Functionning of the European Union should be delegated to the Commission. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council.

In addition, the Commission should be empowered to adopt implementing measures on the quality criteria to be fulfilled by information by the marketing authorisation holder to the general public on medicinal products subject to prescription.

(21) Since the objective of this Directive 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. 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 this objective.

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

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is amended as follows:

(1) In Article 23a, the second subparagraph is replaced by the following:

"The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The holder shall inform the competent authorities of the reasons for such action in accordance with Article 123."

(2) Article 31 is replaced by the following:

"Article 31

1. The Member States, the Commission, the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Union are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary.

Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) may be applied. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the coordination group, as appropriate, and the procedure laid down in Article 107k shall apply.

However, where one of the criteria listed in Article 107i(1) is met , the procedure laid down in Articles 107i to 107k shall apply.

2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation.

In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter.

Where the scope of the procedure initiated under this Article concerns a range of medicinal products or therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure."

(3) In Article 34(3), the following subparagraph is added:

"Where the scope of the procedure includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall where necessary adopt decisions to vary, suspend, revoke or refuse renewal of the marketing authorisations concerned".

(4) Article 86 is replaced by the following:

"Article 86

1. For the purposes of this Title, 'advertising of medicinal products' shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products by the marketing authorisation holder directly or indirectly through a third party acting on his behalf or following his instructions; it shall include in particular:

(a) the advertising of medicinal products to the general public,

(b) advertising of medicinal products to persons qualified to prescribe or supply them,

(c) visits by medical sales representatives to persons qualified to prescribe medicinal products,

(d) the supply of samples,

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,

(f) sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,

(g) sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.

Any reference to marketing authorisation holders in this Title shall include marketing authorisation holders and third parties acting on their behalf or following their instructions.

:

2. The following are not covered by this Title

(a) the labelling and the accompanying package leaflets, which are subject to the provisions of Title V;

(b) information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;

(c) information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which shall comply with the provisions of Title VIIIa.

(d) information by the marketing authorisation holder to investors and employees on business developments, provided they are not used to promote medicinal products. If announcements concern individual medicinal products, the provisions of Title VIIIa shall apply. "

(5) Article 88(4) is replaced by the following:

"4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

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

(6) The heading “TITLE VIIIa “Information and advertising” is deleted;

(7) Article 88a is deleted;

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

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

Article 100a

1. This Title shall apply to information to the general public or members thereof on authorised medicinal products subject to medical prescription, which is made available by marketing authorisation holders.

Any reference to marketing authorisation holders in this Title shall include marketing authorisation holders and third parties acting on their behalf or following their instructions.

Information which complies with the provisions of this Title shall not be considered advertising for the purposes of the application of Title VIII.

2. This Title shall not cover the following:

(a) public announcements by marketing authorisation holders relating to information on pharmacovigilance concerns, which are subject to Article 106a;

(b) information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;

(c) material provided by the marketing authorisation holder to healthcare professionals for their own use;.

(d) information by marketing authorisation holders to investors and employees on business developments, provided that the information does not concern individual medicinal products and is not used to promote medicinal products.

3. Without prejudice to paragraph 1, when information is made available to the public by persons other than the marketing authorisation holder, any financial or other benefits from marketing authorisation holders shall be declared by the person making the information available.

Article 100b

1. The following information on authorised medicinal products subject to medical prescription shall be made available by the marketing authorisation holder to the general public or members thereof:

(a) the most recent summary of the product characteristics as approved by the competent authorities;

(b) the most recent labelling and package leaflet as approved by the competent authorities;

(c) the most recent publicly accessible version of the assessment report as drawn up by the competent authorities.

2. The following information on authorised medicinal products subject to medical prescription may be made available by the marketing authorisation holder to the general public or members thereof:

(a) information on the environmental impact of the medicinal product further to the information on the disposal and collection system contained in the documents referred to in paragraph 1,

(b) information on prices;

( c) information on pack changes

(d) information on the instructions for use of the medicinal product, further to the information contained in the documents referred to in paragraph 1;

(e) information on the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned;

(f) a summary of frequently submitted requests for information pursuant to Article 100c(c), and the answers to such requests;

(g) other types of information approved by competent authorities that are relevant to support the proper use of the medicinal product.

The information referred to in point (d) of the first paragraph may be completed, where necessary, with still or moving images of a technical nature demonstrating the proper way of using the product.

Article 100c

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

(a) printed materials about a medicinal product prepared by the marketing authorisation holder made available to the general public or member thereof on request or through healthcare professionals;

(b) internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;

(c) written answers to specific requests for information about a medicinal product of 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 the general public or members thereof shall fulfil the following conditions:

(a) it shall be objective and unbiased; in this regard, if the information refers to the benefits of a medicinal product, its risks shall also be stated;

(b) it shall be patient-oriented to adequately meet the needs and expectations of patients;

(c) it shall be based on evidence, be verifiable and include a statement on the level of evidence;

(d) it shall be up-to-date and include the date of publication or last revision of the information;

(e) it shall be reliable, factually correct and not misleading;

(f) it shall be understandable and legible for the general public or members thereof;

(g) it shall clearly state the source of the information indicating its author and giving references to any documentation that the information is based on;

(h) it shall not contradict the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities.

2. 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 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 health professionals and that a health professional should be contacted if the patient requires clarification on the information provided or further information;

(c) a statement indicating that the information is made available by or on behalf of or following instructions of a named marketing authorisation holder;

(d) a postal address or e-mail address allowing members of the general public to send comments to, or requests for further information from, the marketing authorisation holder;

(e) a postal address or e-mail address allowing members of the general public to contact the competent authorities which have authorised the medicinal product;

(f) the text of the most recent package leaflet or an indication as to where that text may be found.

3. The information shall not include:

(a) comparisons between medicinal products;

(b) any of the material referred to in Article 90.

4. In order to ensure the quality of information made available to the general public and members thereof, the Commission shall adopt, by means of implementing acts, the measures necessary for the implementation of paragraphs 1, 2 and 3. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).

Article 100e

1. Member States shall ensure that marketing authorisation holders' Internet websites on which information on medicinal products subject to medical prescription are making available reproduce the documents referred to in Article 100b (1).

2. Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by 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 where the medicinal product is authorised. The reply shall be drafted in the language of the request.

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 2.0, Level A. The Commission shall make those guidelines publicly available.

The Commission shall be empowered to adopt delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c to amend this paragraph to take account of technical progress

Article 100g

1. Member States shall ensure that information on authorised medicinal products subject to medical prescription is made available by the marketing authorisation holder to the general public or members thereof after it has been approved by the competent authorities.

However, the documents referred to in Article 100b(1) shall not require further approval before they are made available to the general public or members thereof in addition to their approval in the context of a marketing authorisation procedure.

2. By way of derogation from paragraph 1, Member States may rely on other mechanisms for the control of information after it has been made available, on any of the following grounds:

(a) such mechanisms already existed on 31 December 2008,

(b) a system of control of information before it is made available is not compatible with the constitutional rules of the Member State concerned.

Such mechanisms shall ensure

a level of adequate and effective control equivalent to the approval referred to in paragraph 1 .

3. After consulting the Member States and stakeholders, the Commission shall draw up guidelines concerning information allowed under this Title The Commission shall draw up these guidelines on the entry into force of this directive 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 containing information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to 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.

After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holders on other of their Internet websites containing information on medicinal products throughout the Union if the contents are identical.

2. 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 members of the general public which have access to those websites or the appearance therein of unsolicited content actively distributed to the general public or members thereof.

3. The Member State where the Internet website has been registered shall be responsible for the control of the information made available at the time of registration and of subsequent information in accordance with Article 100g and for the monitoring of such information, in accordance with Article 100j

4. 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 the Member State of registration monitors the information after it has been made available in accordance with Article 100g(2), a Member State may require that the information is approved by the competent authorities before it is reproduced on a website in that Member State;

(b) 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 for a certified translation of the information made available on the Internet website registered with the national competent authority of another Member State.

(c) If a Member State has reasons for doubts as to whether the 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 set up by Decision 75/320/EEC. 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.

5. Member States shall require marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include the following therein:

(a) in addition to the statements listed in Article 100d(2), a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. In cases where the information is not subject to approval prior to its being made available pursuant to Article 100g(2), Iit shall also specify that the fact that the website is registered and monitored does not necessarily mean that all the information on the website has been subject to prior approval.

(b) a link to the European medicines web portal referred to in Article 26 of Regulation (EC) No 726/2004.

6. Member States shall ensure that information on medicinal products authorised in accordance with Regulation (EC) No 726/2004 is not made available on Internet websites that they have registered until the information has been approved by the Agency in accordance with Articles 20b and 20c of that Regulation.

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 shall be imposed should the provisions adopted for the implementation of this Title be infringed;

(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 making available information that does not comply with this Title or, if such information has not been made available but this is imminent, to prohibit the making available of such information ;

(d) the possibility to publish the name of marketing authorisation holders responsible for making available information not compliant with this Title.

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 any decision to a judicial or other body. During the appeal procedure the making available of information shall be suspended until a decision to the contrary 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 responsible for monitoring information on medicinal products, a sample of all information made available in accordance with this Title and information on its volume , together with a statement indicating the persons to whom it is addressed, the method of communication and the date on which the information was first made available,

(b) keep available for the competent authorities responsible for monitoring information on medicinal products, the replies made in accordance with this Title together with a statement indicating the persons to whom they are addressed,

(c) ensure that information on medicinal products by their undertaking complies with the requirements of this Title;

(d) supply the authorities responsible for monitoring information on medicinal products with the information and assistance they require to carry out their responsibilities;

(e) ensure that the decisions taken by the authorities 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.

Article 100l

By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title, after consultation of stakeholders, 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) In Article 121a(1), the words "Article 22b, 47, 52b and 54a" are replaced by "Articles 22b, 47, 52b, 54a and 100f (2)".

(10) In Article 121b(1), the words "Articles 22b, 47, 52b and 54a" are replaced by " Articles 22b, 47, 52b, 54a and 100f(2)".

(11) In Article 106, the following first sub-paragraph is inserted:

"Each Member States shall ensure that objective, unbiased information is made available to general public or members thereof on medicinal products placed on the market on its territory".

(12) Article 107i(1) is replaced by the following:

"1. A Member State or the Commission, as appropriate, shall initiate the procedure provided for in this section, by informing the other Member States, the Agency and the Commission , in any of the following cases:

(a) it considers suspending or revoking a marketing authorisation;

(b) it considers prohibiting the supply of a medicinal product;

(c) it considers refusing the renewal of a marketing authorisation;

(d) it is informed by the marketing authorisation holder that, on the basis of safety concerns, he has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or that he intends to do so, or has not applied for the renewal of a marketing authorisation;

(e) it considers that a new contraindication, a reduction in the recommended dose, or a restriction to the indications is necessary.

The Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.

Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make information that the procedure has been initiated available to marketing authorisation holders."

(13) Article 123(2) is replaced by the following:

"2. The marketing authorization holder shall be obliged to notify Member States forthwith of any action taken by him to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is linked to any of the grounds set out in Articles 116 and 117. In such case, Member States shall ensure that this information is brought to the attention of the Agency."

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [12 months after publication in the Official Journal; exact date inserted at time of publication] at the latest. 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 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative:

1.2. Policy area(s) concerned in the ABM/ABB structure

1.3. Nature of the proposal/initiative

1.4. Objective(s)

1.5. Grounds for the proposal/initiative

1.6. Duration and financial impact

1.7. Management method(s) envisaged

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

2.2. Management and control system

2.3. Measures to prevent fraud and irregularities

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected

3.2. Estimated impact on expenditure

3.2.1. Summary of estimated impact on expenditure

3.2.2. Estimated impact on operational appropriations

3.2.3. Estimated impact on appropriations of an administrative nature

3.2.4. Compatibility with the current multiannual financial framework

3.2.5. Third-party participation in financing

3.3. Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

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 medical products for human use subject to medical prescription and as regards pharmacovigilance

Amended proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004, as regards information to the general public on medical products for human use subject to medical prescription and as regards pharmacovigilance

This Legislative Financial Statement covers the two above-mentioned legal proposals

1.2. Policy area(s) concerned in the ABM/ABB structure [6]

Public Health

1.3. Nature of the proposal/initiative

x The proposal/initiative relates to a new action

The proposal/initiative relates to a new action following a pilot project/preparatory action [7]

The proposal/initiative relates to the extension of an existing action

The proposal/initiative relates to an action redirected towards a new action

1.4. Objectives

1.4.1. The Commission's multiannual strategic objective(s) targeted by the proposal/initiative

Within heading 1A, Competitiveness for Growth and Employment, the proposal aims to promote public health across the EU through providing for harmonized rules on information on medicinal products subject to medical prescription

Supporting the achievement of the internal market in the pharmaceutical sector.

1.4.2. Specific objective(s) and ABM/ABB activity(ies) concerned

Specific objective No..

Pre-control of the information for centrally authorised medicinal products.

ABM/ABB activity(ies) concerned

Public Health

1.4.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

The high level objective of the proposal is to improve the protection of health of EU citizens and to ensure the proper functioning of the internal market for medicinal products for human use. Following this line, the proposal aims specifically to:

Provide for a clear framework for provision on information by marketing authorisation holders about their prescription-only medicines to the general public with a view to enhancing the rational use of these medicines, while ensuring that the legislative framework continues to prohibit direct-to-consumer advertising of prescription-only medicines.

This aim shall be achieved by:

- Ensuring the high quality of information provided by coherent application of clearly defined standards across the EU.

- Allowing information to be provided through channels addressing needs and capabilities of different types of patients.

- Not inappropriately restricting the ability of marketing authorization holders to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines.

- Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.

1.4.4. Indicators of results and impact

Specify the indicators for monitoring implementation of the proposal/initiative.

The Commission has established mechanisms for working with the Member States to monitor transposition and in the pharmaceutical sector the Commission's Pharmaceutical Committee is a key forum for exchanging information in this regard.

The EMA should contribute to the implementation, although no scientific assessment of information will be necessary.

With regard to ex-post evaluation of the operational objectives, these can be evaluated by:

- Extent of compliance with rules,

- Information provision by industry,

- Indicators of use of this information,

- Patient awareness of this information,

- Measuring the effect of information on patient behaviour and on health outcomes.

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term

Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union.

Patients have become more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments. While Directive 2001/83/EC provides for a harmonised framework on advertising of medicines at EU level , the application of which remains a responsibility of Member States, neither Directive 2001/83/EC nor Regulation (EC) No 726/2004 include detailed provisions on information on medicinal products. Therefore, EU legislation does not prevent Member States from establishing their own approaches.

Divergent interpretations of EU rules and different national rules and practices on information are creating obstacles to patients' access to high quality information and to the operation of the internal market.

1.5.2. Added value of EU involvement

Considering the existing harmonised EU legislation on the authorisation and supervision of medicinal products a common approach on information provision has to be taken. Harmonised provisions would allow that citizens in all Member States have access to the same type of information. If this matter continues to be left for national rules, it will almost inevitably lead to the adoption of national rules running counter to the spirit of the existing pharmaceutical legislation.

National rules and practices on information may lead to restrictions to the free movement of goods in violation of Art 34 EU, impacting negatively on the completion of a single market in pharmaceuticals which the harmonised legal framework on medicinal products tries to achieve.

1.5.3. Lessons learned from similar experiences in the past

N/A

1.5.4. Coherence and possible synergy with other relevant instruments

N/A

1.6. Duration and financial impact

Proposal/initiative of limited duration

– Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

– Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited duration

– Implementation with a start-up period from 2016 to 2021,

– followed by full-scale operation.

1.7. Management mode(s) envisaged [8]

Centralised direct management by the Commission

X Centralised indirect management with the delegation of implementation tasks to:

– executive agencies

– X bodies set up by the Communities [9] : European Medicines Agency

– national public-sector bodies/bodies with public-service mission

– persons entrusted with the implementation of specific actions pursuant to Title V of the Treaty on European Union and identified in the relevant basic act within the meaning of Article 49 of the Financial Regulation

Shared management with the Member States

Decentralised management with third countries

Joint management with international organisations (to be specified)

If more than one management mode is indicated, please provide details in the "Comments" section.

Comments

The EU system for regulating medicinal products operates as a network between the Commission, the European Medicines Agency (EMA) and the National competent authorities for medicinal products. Responsibilities are frequently shared with the exact split depending on whether a medicine is centrally authorised (with the Commission as competent authority) or nationally authorised (with the Member States providing the competent authorities).

Considering the existing harmonised EU legislation on the authorisation and supervision of medicinal products a common approach on information provision has to be taken. Harmonised provisions would allow that citizens in all Member States have access to the same type of information. If this matter continues to be left for national rules, it will almost inevitably lead to the adoption of national rules running counter to the spirit of the existing pharmaceutical legislation.

National rules and practices on information may lead to restrictions to the free movement of goods in violation of Art 34 EU, impacting negatively on the completion of a single market in pharmaceuticals which the harmonised legal framework on medicinal products tries to achieve.

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

Specify frequency and conditions.

The Commission has established mechanisms for working with the Member States to monitor transposition and in the pharmaceutical sector the Commission's Pharmaceutical Committee is a key forum for exchanging information in this regard.

EMA should contribute to the implementation, although no scientific assessment of information will be necessary.

With regard to ex-post evaluation of the operational objectives, these can be evaluated by:

- Extent of compliance with rules

- Information provision by industry

- Indicators of use of this information

- Patient awareness of this information

- Measuring the effect of information on patient behaviour and on health outcomes.

2.2. Management and control system

2.2.1. Risk(s) identified

Main risk is the incorrect or incomplete transposition of EU legislation by the Member States.

2.2.2. Control method(s) envisaged

The Commission has established the Pharmaceutical Committee which allows for the exchange of information between Member States and the Commission on the state-of play- of implementation of EU legislation

2.3. Measures to prevent fraud and irregularities

Specify existing or envisaged prevention and protection measures.

The European Medicines Agency has specific budgetary control mechanisms and procedures. The Management Board, which comprises representatives of the Member States, the Commission and the European Parliament, adopts the budget, as well as the internal financial provisions. The European Court of Auditors examines the execution of the budget each year.

Regarding fraud, corruption and other unlawful activities, the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) apply to the EMA without restriction. Besides, a decision concerning co-operation with the OLAF was already adopted on 1 June 1999 (EMEA/D/15007/99).

Finally, the Quality Management System applied by the Agency supports a continuous review. Several internal audits are undertaken each year as part of this process.

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In order of multiannual financial framework headings and budget lines.

· New budget lines requested

In order of multiannual financial framework headings and budget lines.

Heading of multiannual financial framework | Budget line | Type of expenditure | Contribution |

| Number [Heading……………………………………..] | Diff./non-diff. | from EFTA countries | from candidate countries | from third countries | within the meaning of Article 18(1)(aa) of the Financial Regulation |

| [XX.YY.YY.YY] | | YES/NO | YES/NO | YES/NO | YES/NO |

3.2. Estimated impact on expenditure

3.2.1. Summary of estimated impact on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: | Number | [.] |

DG: <> | | | Year 2016 [10] | Year 2017 | Year 2018 | Year 2019 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |

Operational appropriations | | | | | | | | |

Number of budget line – 17.031001 | Commitments | (1) | | | | | | | | |

| Payments | (2) | | | | | | | | |

Number of budget line – 17.031002 | Commitments | (1a) | | | | | | | | |

| Payments | (2a) | | | | | | | | |

Appropriations of an administrative nature financed from the envelop of specific programs [11] | | | | | | | | |

Number of budget line | | (3) | | | | | | | | |

TOTAL appropriations for DG <.> | Commitments | =1+1a +3 | | | | | | | | |

| Payments | =2+2a+3 | | | | | | | | |

TOTAL operational appropriations | Commitments | (4) | | | | | | | | |

| Payments | (5) | | | | | | | | |

TOTAL appropriations of an administrative nature financed from the envelop of specific programs | (6) | | | | | | | | |

TOTAL appropriations under HEADING <1A.> of the multiannual financial framework | Commitments | =4+ 6 | | | | | | | | |

| Payments | =5+ 6 | | | | | | | | |

If more than one heading is affected by the proposal / initiative:

TOTAL operational appropriations | Commitments | (4) | | | | | | | | |

| Payments | (5) | | | | | | | | |

TOTAL appropriations of an administrative nature financed from the envelop of specific programs | (6) | | | | | | | | |

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) | Commitments | =4+ 6 | | | | | | | | |

| Payments | =5+ 6 | | | | | | | | |

Heading of multiannual financial framework: | 5 | " Administrative expenditure " |

EUR million (to 3 decimal places)

| | | Year 2016 | Year 2017 | Year 2018 | Year 2019 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |

DG: <…….> |

Human resources | | | | | | | | |

Other administrative expenditure | | | | | | | | |

TOTAL DG <…….> | Appropriations | | | | | | | | |

TOTAL appropriations under HEADING 5 of the multiannual financial framework | (Total commitments = Total payments) | | | | | | | | |

EUR million (to 3 decimal places)

| | | Year 2016 [12] | Year 2017 | Year 2018 | Year 2019 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework | Commitments | | | | | | | | |

| Payments | | | | | | | | |

3.2.2. Estimated impact on operational appropriations

– The proposal/initiative does not require the use of operational appropriations

– x The proposal/initiative requires the use of operational appropriations, as explained below:

Commitment appropriations in EUR million (to 3 decimal places)

Indicate objectives and outputs | | | Year 2016 | Year 2017 | Year 2018 | Year 2019 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |

| OUTPUTS |

| Type of output [13] | Average cost of the ouput | Number of ouputs | Cost | Number of ouputs | Cost | Number of ouputs | Cost | Number of ouputs | Cost | Number of ouputs | Cost | Number of ouputs | Cost | Number of ouputs | Cost | Total number of ouputs | Total cost |

SPECIFIC OBJECTIVE No 1 [14]… | | | | | | | | | | | | | | | | |

- Output | | | | | | | | | | | | | | | | | | |

- Output | | | | | | | | | | | | | | | | | | |

- Output | | | | | | | | | | | | | | | | | | |

Sub-total for specific objective N°1 | | | | | | | | | | | | | | | | |

SPECIFIC OBJECTIVE No 2… | | | | | | | | | | | | | | | | |

- Output | | | | | | | | | | | | | | | | | | |

Sub-total for specific objective N°2 | | | | | | | | | | | | | | | | |

TOTAL COST | | | | | | | | | | | | | | | | |

Impact on EMA budget

The Legislative Financial Statement is proposed based on the fact that the legislative proposal foresees that specific information activities of marketing authorization holders for centrally authorized medicinal products subject to medical prescription will be subject to fees charged by the European Medicines Agency (EMA).

The Legislative Financial Statement and the calculations demonstrate that costs relating to activities resulting from the legislative proposal will be recuperated through fees. On this basis, the calculation leads to the conclusion that the proposals on information to the general public on medicinal products subject to medical prescription would not have a financial impact on the Union budget.

The EMA budget is €208,9 million in 2011. The EU contribution has increased from €15,3 million in 2000 to € 38,4 million in 2011. The remainder of the increase of the budget over time has been covered by fees charged by the EMA to the pharmaceutical industry (estimated at 85% of total income in 2011 and based on Council Regulation (EC) No 297/95 as amended by Commission Regulation No 312/2008 of 3 April 2008). Fee revenues are anticipated to further increase in the coming years. It should be noted that based on fee income the EMA budget has run at a surplus in recent years and use has been made of the carry-over facility. Indeed, in 2010 the surplus was superior to €10 million.

The legislative proposal foresees that the EMA shall be charged with the pre-control of the information for centrally authorised medicinal products.

The request for pre-control shall be subject to a fee payable in accordance with Regulation (EC) No 297/95. The assessment of the information submitted shall be fully conducted by EMA staff. Due to the fact that EMA activities will only concern pre-control of the information and that subsequent monitoring will be undertaken by Member States, administrative procedures within the Agency will not be burdensome. However, as some of the information will not have been already assessed by EMA in the context of the marketing authorisation process, for example information on the disposal and collection system of the product as well as information on prices which is under the exclusive competence of the Member States, this pre-control will demand coordination with the Member States and the impact of this work should be considered.

Furthermore, applications might be submitted in other languages than EN, the usual working language of the Agency. Therefore either translations will need to be done or Staff Members will have to be able to work in several EU languages.

The average cost of 1 full time equivalent (FTE) AD Staff Member for the EMA in London has been provided by the EMA (beginning 2011) as: Salary €161 708/year for AD and €90 091/year for AST, these are the staff costs used for the calculations below.

Fees charged by the EMA to the pharmaceutical industry

Regarding EMA fees, the following estimates can be made:

At the moment 566 centrally authorised medicinal products exist. As per the EMA annual report 2009, there were 2577 variations, 708 out of them referred to type II clinical variations, which implied a substantial change in the product information. These procedures to change the initial marketing authorisation will also lead to new information on medicinal products to be pre-controlled. It can be estimated that during the first year of application of the proposed regulation approximately 700 submissions of information to be disseminated to the general public will be submitted to the Agency for a pre-control. For the following years, an increase in submissions to the Agency can be expected. The average estimated fee charged to the pharmaceutical industry is € 3 650.

Cost to the EMA

As explained above, it can be estimated that 700 submissions about information to patients on centrally authorised products will need to be checked by the Agency in the first years (2016-2021). An increase of this number is to be expected to 800 submissions once pharmaceutical companies have got familiar with the new procedure (as from 2019).

It can be estimated that total costs for EMA is made up by:

1. the annual salary of the staff, comprising the following tasks:

– checking the information on the basis of the documentation that has been provided by the pharmaceutical company and on the basis of other scientific information,

– contacts with pharmaceutical companies if there is a need for extra information,

– contacts with Member States in order to have information which is under their competence and to ensure consistency, in particular with regard to information on clinical trials;

– internal discussions,

– administrative processing of the submission (incl. drafting of the conclusion)

There will be no extra costs for literature screening by EMA, because the information to patients shall be based on the documentation that the pharmaceutical companies provide in their application.

2. translations: applications might be submitted in other languages than EN, the usual working language of the Agency. Therefore the application will have to be translated into EN in order to be checked by EMA and then its assessment will have to be translated back into the language of the applicant.

3. IT: the pharmaceutical industry will provide information through channels addressing needs and capabilities of different types of patients. This will include video, audio and written materials. In order to review, track and store this variety of communication media, the EMA will need to put in place appropriate infrastructure with compatible IT software. EMA foresees the development of the IT tool over 12 months for a total cost of €1,5 million. Maintenance of the IT tool would cost €225 000 for the 1st year of its functioning (n+1) and €300 000 per year for the following years.

The total impact of the legislative proposal on EMA budget has been presented in the Tables below.

Table: Impact on EMA budget – establishment plan [15]

| Year 2016 | Year 2017 | Year 2018 | Year 2019 | Year 2020 | Year 2021 |

FTE for core activity + for management overhead (10% of core activity) | | | | | | |

AD - €161 708/year | 4.4 | 4.4 | 4.4 | 5.5 | 5.5 | 5.5 |

AST - €90 091/year | 1.1 | 1.1 | 1.1 | 1.1 | 2.2 | 2.2 |

Contractual Agent | 0 | 0 | 0 | 0 | 0 | 0 |

SNE | 0 | 0 | 0 | 0 | 0 | 0 |

TOTAL staff | 5.5 | 5.5 | 5.5 | 6.6 | 6.6 | 6.6 |

Table: Impact on EMA budget – Statement of income and expenditure (€)

EMA costs | Year 2016 | Year 2017 | Year 2018 | Year 2019 | Year 2020 | Year 2021 |

Total annual staff costs (=Annual salary) | 810 615 | 810 615 | 810 615 | 988 494 | 1 087 594 | 1 087 594 |

Cost of translation into English [16] | 569 100 | 569 100 | 569 100 | 650 400 | 650 400 | 650 400 |

Cost of translation back into submission language(...)19 | 569 100 | 569 100 | 569 100 | 650 400 | 650 400 | 650 400 |

IT cost (development) | 1 125 000 | 375 000 | | | | |

IT cost (maintenance) | | 225 000 | 300 000 | 300 000 | 300 000 | 300 000 |

Total costs [17] | 3 073 815 | 2 548 815 | 2 248 815 | 2 589 294 | 2 688 394 | 2 688 394 |

Income fees [18] | 2 555 000 | 2 555 000 | 2 555 000 | 2 920 000 | 2 920 000 | 2 920 000 |

Balance | -518 815 | 6 185 | 306 185 | 330 706 | 231 606 | 231 606 |

The table shows that the EMA budget might run a negative balance in the first year (2016). This deficit would be covered by other income to the EMA budget.

The calculation made in the table above is based on the model where EMA works in English, and therefore translates into EN applications submitted by applicants and translates into the original language the EMA pre-control position before sending it to the applicant. However reality may demonstrate that another model should be followed in order to ensure more efficiency in working directly in original languages, with the use of in-house resources for the pre-control of the information and therefore not using translation. The staff allocation would have to be revised to a total of 15 AD, with a concomitant reduction of translation costs.

3.2.3. Estimated impact on appropriations of an administrative nature

3.2.3.1. Summary

– The proposal/initiative does not require the use of administrative appropriations

– The proposal/initiative requires the use of administrative appropriations, as explained below:

EUR million (to 3 decimal places)

| Year N [19] | Year N+1 | Year N+2 | Year N+3 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL |

HEADING 5 of the multiannual financial framework | | | | | | | | |

Human resources | | | | | | | | |

Other administrative expenditure | | | | | | | | |

Subtotal HEADING 5 of the multiannual financial framework | | | | | | | | |

Outside HEADING 5 [20] of the multiannual financial framework | | | | | | | | |

Human resources | | | | | | | | |

Other expenditure of an administrative nature | | | | | | | | |

Subtotal outside HEADING 5 of the multiannual financial framework | | | | | | | | |

TOTAL | | | | | | | | |

3.2.3.2. Estimated requirements of human resources

– The proposal/initiative does not require the use of human resources

– The proposal/initiative requires the use of human resources, as explained below:

Estimate to be expressed in full amounts (or at most to one decimal place)

| Year N | Year N+1 | Year N+2 | Year N+3 | … enter as many years as necessary to show the duration of the impact (see point 1.6) |

Establishment plan posts (officials and temporary agents) |

XX 01 01 01 (Headquarters and Commission’s Representation Offices) | | | | | | | |

XX 01 01 02 (Delegations) | | | | | | | |

XX 01 05 01 (Indirect research) | | | | | | | |

10 01 05 01 (Direct research) | | | | | | | |

External personnel (in Full Time Equivalent unit: FTE) [21] |

XX 01 02 01 (CA, INT, SNE from the "global envelope") | | | | | | | |

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) | | | | | | | |

XX 01 04 yy [22] | - at Headquarters [23] | | | | | | | |

| - in delegations | | | | | | | |

XX 01 05 02 (CA, INT, SNE - Indirect research) | | | | | | | |

10 01 05 02 (CA, INT, SNE - Direct research) | | | | | | | |

Other budget lines (specify) | | | | | | | |

TOTAL | | | | | | | |

XX is the policy area or budget title concerned.

The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.

Description of tasks to be carried out:

Officials and temporary agents | |

External personnel | |

3.2.4. Compatibility with the current multiannual financial framework

– X Proposal/initiative is compatible with the multiannual financial framework starting 2014.

– Proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework.

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts.

– Proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework [24].

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.

3.2.5. Third-party contributions

– The proposal/initiative does not provide for co-financing by third parties

– The proposal/initiative provides for the co-financing estimated below:

Appropriations in EUR million (to 3 decimal places)

| Year N | Year N+1 | Year N+2 | Year N+3 | … enter as many years as necessary to show the duration of the impact (see point 1.6) | Total |

Specify the co-financing body | | | | | | | | |

TOTAL appropriations cofinanced | | | | | | | | |

3.3.

Estimated impact on revenue

– X Proposal/initiative has no financial impact on revenue.

– Proposal/initiative has the following financial impact:

– on own resources

– on miscellaneous revenue

EUR million (to 3 decimal places)

Budget revenue line: | Appropriations available for the ongoing budget exercise | Impact of the proposal/initiative [25] |

| | Year N | Year N+1 | Year N+2 | Year N+3 | … insert as many columns as necessary in order to reflect the duration of the impact (see point 1.6) |

Article …………. | | | | | | | | |

For miscellaneous assigned revenue, specify the budget expenditure line(s) affected.

Specify the method for calculating the impact on revenue.

[1] OJ C , , p. .

[2] OJ C , , p. .

[3] OJ C , , p. .

[4] OJ L 311, 28.11.2001, p. 87.

[5] COM(2007) 862 final.

[6] ABM: Activity-Based Management – ABB: Activity-Based Budgeting.

[7] As referred to in Article 49(6)(a) or (b) of the Financial Regulation.

[8] Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[9] As referred to in Article 185 of the Financial Regulation.

[10] Year N is the year in which implementation of the proposal/initiative starts.

[11] Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct research.

[12] Year N is the year in which implementation of the proposal/initiative starts.

[13] Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).

[14] As described in Section 1.4.2. "Specific objective(s)…"

[15] Assumption: there will be an increase in applications and no impact on EMA costs.

[16] For 7 pages

[17] An inflation rate of 2% should be taken into consideration.

[18] The fee for the pharmaceutical company will be €3 650.

[19] Year N is the year in which implementation of the proposal/initiative starts.

[20] Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct research.

[21] CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;

[22] Under the ceiling for external personnel from operational appropriations (former "BA" lines).

[23] Essentially for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[24] See points 19 and 24 of the Interinstitutional Agreement.

[25] As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25% for collection costs.

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