# EUR-Lex - 52012PC0048 - EN

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# 52012PC0048

**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 amending, asregards information to the general public on medicinal products subject to medicalprescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use /* COM/2012/048 final - 2008/0256 (COD) */**

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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. For legal clarity
and in order to facilitate the ordinary legislative procedure, this text
replaces COM(2011) 633 final which is consequently withdrawn.

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 to include measures setting high standards
of safety for medicinal products. Therefore in view of the entry into force of
the Treaty of Lisbon since the adoption of the Commission proposal, article
168(4) of the Treaty on the Functioning of the European Union is added as legal
basis to the amended proposal.

Lastly, this amended proposal 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.

4.
Explanatory documents accompanying the notification
of transposition measures and budgetary implication

Directive 2001/83/EC does not prevent Member
States from establishing their own approaches regarding the provisions on
information on medicinal products. Member States have different pre-existing
national legislation, which the amended proposal aims to harmonise by providing
for a clear framework for provision of information by marketing authorisation
holders about their prescription-only medicines to the general public.
Furthermore, the amended proposal provides for national obligations which may
be transposed in various branches of the national legal order. In view of these
elements, the Commission considers that explanatory documents from Member
States are necessary for carrying out its task of overseeing the application of
Union law.

The amended proposal has no implication for the
budget of the Union.

5.
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 amending, as
regards information to the general public on medicinal products subject to
medical
prescription, Directive 2001/83/EC on the Community code relating to medicinal
products for human use

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community on the
Functioning of the European Union, and in particular
Article 95 114 and Article 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],

Having regard to the opinion
of the Committee of the Regions[3],

Acting in accordance with the ordinary legislative procedure laid down in Article 251 of the Treaty[4],

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[5] 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 dissemination 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 disseminated 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"[6].
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 Community 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 Community Union
rules on advertising, and between national provisions on information have a
negative impact on the uniform application of Union Community 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 Community Union, this objective
is undermined if widely divergent national rules on the dissemination
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 disseminate make available information on medicinal products is not the
same across Member States, while information disseminated
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 Community
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 European 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 important
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 dissemination 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.

(910)   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 Community Union
rules allow the advertising to the general public of medicinal products not
subject to prescription, under certain conditions.

(1011) 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 disseminated
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.

(1112) In order to further ensure that patients
have access to marketing authorisation holders
disseminate only high-quality information and to distinguish
non-promotional information from advertising, the types of information which
may be disseminated 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 disseminate also make available the contents of the approved summaries of product characteristics
and package leaflet, information that is compatible with those documents
without going beyond their key elements, and other well-defined
medicinal product-related information.

(1213) Whether obligatory or not,
Iinformation to
the general public on prescription-only medicinal products should only be
provided through specific channels of communication, including Internet and health-related publications, to avoid that the effectiveness
of the prohibition on advertising is undermined by unsolicited provision of
information to the public. Where information is disseminated
made available via television,
or radio or printed media,
patients are not protected against such unsolicited information and such dissemination channels of information
should therefore not be allowed.

(1314) 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 Sspecific 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.

(1415) Monitoring of information on prescription-only medicinal
products should ensure that marketing authorisation holders only disseminate 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 dissemination
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. or
if there is a different mechanism in place to ensure an equivalent level of
adequate and effective monitoring.

(1516) 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)     In order
to clarify the information allowed, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission. 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.

(1619) Since
the objective of this Directive to harmonise the rules on information on
medicinal products subject to prescription across the Community
Union cannot be sufficiently achieved by the Member
States and can therefore be better achieved at Community
Union level, the Community 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.

(20)     In
accordance with the Joint Political Declaration of Member States and the
Commission on explanatory documents of 28 September 2011, Member States have
undertaken to accompany, in justified cases, the notification of their
transposition measures with one or more documents explaining the relationship
between the components of a directive and the corresponding parts of national
transposition instruments. With regard to this Directive, the legislator
considers the transmission of such documents to be justified.

(1721) Directive
2001/83/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is amended as follows:

(1)          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.

(1)          Article
86(2) is replaced by the following:

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;

- factual, informative
announcements and reference material relating, for example, to pack changes,
adverse-reaction warnings as part of general drug precautions, trade catalogues
and price lists, provided they include no product claims;

(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 is subject to
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. "

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

"4.      The prohibition set out in
paragraph 1 shall not apply to vaccination campaigns and
other campaigns in the interest of public health 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.";

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

(4)          Article 88a is deleted;

(5)          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.       Member States
shall allow the marketing authorisation holder to disseminate, either directly
or indirectly through a third party, 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. provided that it is in accordance with the provisions of this
Title.

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.

Such iInformation 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;

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

(bc)    material
provided by the marketing authorisation holder to healthcare professionals for distribution to patients 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 types of information on
authorised medicinal products subject to medical prescription may be disseminated made available
by the marketing authorisation holder to the general public or members thereof:

(a) the summary of product
characteristics, labelling and package leaflet of the medicinal product, as
approved by the competent authorities, and the publicly accessible version of
the assessment report drawn up by the competent          authorities;

(b) information which does
not go beyond the elements of the summary of product characteristics, labelling
and the package leaflet of the medicinal product, and   the publicly accessible
version of the assessment report drawn up by the     competent authorities, but
presents them in a different way;

(ca)
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;,

(d c) information on and factual,
informative announcements and reference material relating, for example, to
pack changes or adverse-reaction warnings;

(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.

(d) medicinal
product-related information about non-interventional scientific studies, or
accompanying measures to prevention and medical treatment, or information which
presents the medicinal product in the context of the condition to be prevented
or treated.

Article 100c

Information on authorised medicinal products
subject to medical prescription disseminated made available by the marketing authorisation holder to the
general public or members thereof shall not be made available on television, or 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;health-related publications
as defined by the Member State of publication, to the exclusion of unsolicited
material actively distributed to the general public or members thereof;

(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 disseminated made available by
the marketing authorisation holder to the general public or members thereof
shall fulfil the following conditions:

(a)     it must 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 must shall be patient-oriented to adequately meet the needs take into account the general needs and expectations of
patients;

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

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

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

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

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

(h)     it mustshall 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 disseminated by made
available by or on behalf of or following instructions of a named marketing authorisation holder;

(d)     a postal mail 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, Tthe
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).

Those measures, designed to
amend non-essential elements of this Directive by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny referred to
in Article 121(2a).

Article 100e

1.       Member States shall ensure that
marketing authorisation holders' Internet websites for the
dissemination of on which information on
medicinal products subject to medical prescription are making
available reproduce the documents referred to in
Article 100b(1). the summary of product
characteristics and the package leaflet of the medicinal products concerned in
the official languages of the Member States where they are authorised.

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 Community
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 12.0, 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 may amend this paragraph to take account of technical
progress This measure, designed to amend non-essential
elements of this Directive, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 121(2a).

Article 100g

1.       Member States shall ensure that there are adequate and effective methods of monitoring to avoid
misuse when information on authorised medicinal products subject
to medical prescription is disseminated made available by the marketing authorisation holder to the
general public or members thereof only 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 mechanismsthods shall ensure be based on the control of information prior to its
dissemination, unless

- the content of the
information has already been approved by the competent authorities; or

- an equivalent a level of adequate and
effective control monitoring
equivalent to the approval referred to in paragraph 1 is ensured through a different mechanism.

The methods may include the
voluntary control of information on medicinal products by self-regulatory or
co-regulatory bodies and recourse to such bodies, if proceedings before such
bodies are possible in addition to the judicial or administrative proceedings
available in the Member States.

23. After consulting
the Member States and stakeholders, the Commission
shall draw up guidelines concerning information allowed under this Titleand containing a code of conduct for marketing authorisation
holders providing information to the general public or members thereof on
authorised medicinal products subject to medical prescription. The
Commission shall draw up these guidelines on the entry into
force of this Directive [OJ: insert date of 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 Community 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 material content actively
distributed to the general public or members thereof. Those
websites shall not contain web-TV.

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. of the contents disseminated on that website.

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 disseminated made
available on the Internet website registered with the national competent
authority of another Member State;

(cb)    If
a Member State has reasons for doubts as to whether the information disseminated 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 allow 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 dissemination of making available information that does not comply with this
Title or, if such information has not been disseminated made available but dissemination this is imminent, to prohibit the making
available of such information order
prohibition of such dissemination;

(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 or bodies
responsible for monitoring information on medicinal products, a sample of all
information disseminated made
available in accordance with this Title and
information on its volume of dissemination, together
with a statement indicating the persons to whom it is addressed, the method of dissemination communication and
the date on which the information was of first made available dissemination;,

(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;,

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

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

(de)   ensure
that the decisions taken by the authorities or bodies
responsible for monitoring information on medicinal products are immediately
and fully complied with.

Article 100k

Information on homeopathic medicinal products
referred to in Article 14(1) that have been classified as prescription-only
shall be subject to the provisions of this Title.

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."

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

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

(8)          In Article 106,
the following first subparagraph is inserted:

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

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

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

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

1.2.
Policy area(s) concerned in the ABM/ABB
structure[7]

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[8]

 ̈ 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[9]

 ̈ 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[10] : 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.

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

Number [Description........................................] || DA/NDA ([11]) || from EFTA[12] countries || from candidate countries[13] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

1A || 17.031001 - European Medicines Agency — Subsidy under Titles 1 and 2 || DA || YES || NO || NO || NO

|| 17.031002 - European Medicines Agency — Subsidy under Title 3 || DA || YES || NO || NO || NO

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

Ÿ 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[15] || || || || || || || ||

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

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

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

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

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

Ÿ 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:

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

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

Ÿ 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: <.......> ||

Ÿ Human resources || || || || || || || ||

Ÿ 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[16] || 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 ò || || || 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[17] || 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[18]... || || || || || || || || || || || || || || || ||

- 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[19]

|| 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[20] || 569 100 || 569 100 || 569 100 || 650 400 || 650 400 || 650 400

Cost of translation back into submission language20 || 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[21] || 3 073 815 || 2 548 815 || 2 248 815 || 2 589 294 || 2 688 394 || 2 688 394

Income fees[22] || 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

–
x 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 [23] || 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[24] 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) ||

Ÿ 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) || || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[25] ||

|| 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 [26] || - at Headquarters[27] || || || || || || || ||

|| - 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[28].

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[29]

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
C , , p. .

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

[6]               COM(2007)
862 final.

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

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

[9]               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

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

[11]             DA=
Differentiated appropriations / DNA= Non-Differentiated Appropriations

[12]             EFTA:
European Free Trade Association.

[13]             Candidate
countries and, where applicable, potential candidate countries from the Western
Balkans.

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

[15]             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.

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

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

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

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

[20]             For
7 pages

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

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

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

[24]             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.

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

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

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

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

[29]             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.