CELEX: 52012PC0049
Language: en
Date: 2012-02-10
Title: 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 medicinal products for human use subject to medical prescription

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		52012PC0049
		
			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 medicinal products for human use subject to medical prescription /* COM/2012/049 final - 2008/0255 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
The Commission presents an amended proposal
for a Regulation 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) 632 final which is consequently
withdrawn. 

1.                      
Background

On 10 December 2008, the Commission adopted a
proposal for a Regulation 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 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 12 amendments on the proposal for a Regulation 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 art, 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:
Recital 1 is modified in accordance with
amendment 1, which underlines that in the Commission Communication transmitted
on 20 December 2007 concerning the "Report on current practices with
regard to the provision of information to patients on medicinal products"
the need for a more precise distinction between advertising and information was
highlighted. 
Amendment 2 specifies in recital 2 that the new
Title introduced in Directive 2001/83/EC is intended to place emphasis on the
rights and interests of patients.
In accordance with Amendment 6, it has been
specified in Article 20b, paragraph 1, that although the pre-control of
information is performed by the Agency for centrally approved medicinal
products, the monitoring of the information rests with Member States. It is
appropriate to ensure consistently that the Agency is also responsible for the
control of the information made available through Internet websites registered
in the Member States. Specific provisions are introduced to clarify the
operation of this control mechanism in such case of information made available
through Internet websites registered with the Member States. 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 Regulation.
Following Amendment 7, the word
"disseminated" has been replaced by "made available" within
Article 20b, paragraph 2. 
Amendment 9 provides for the procedure
regarding cases when the Agency requests for changes within the information
submitted for control and for the fees applicable which should be proportionate
to the additional work. Considering that the normal delay is 60 days, the
subsequent delay should be of 30 days. 
Amendment 10 modifies Article 57, paragraph 1,
concerning the so-called EudraPharm database and provides that it should be
available in all EU languages. Such a change has been introduced as regards the
lay-out of the database; on the other hand, the information contained in the
database will be available in the languages of Member States where the
medicinal product is authorised. In another respect, it is not necessary to
further specify that the information provided is designed for non-experts, as
it is already provided that it should be worded in an appropriate and
comprehensible manner in accordance with article 57. 
Amendment 12 provides that EudraPharm should be
actively promoted to European citizens. This should be done through the
development of the European medicines web-portal established by Regulation (EU)
No 1235/2010 as the central point of access to information about medicinal
products. On the other hand, it is not appropriate that information available
on marketing authorisation holder websites is reproduced on EudraPharm, which
is a public database. 

4.                      
budgetary implication

The 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:
2008/0255 (COD)
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 medicinal products for human use
subject to medical prescription
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European on the
Functioning of the European Union Community,
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)       On 20 December 2007, the
Commission submitted a Communication to the European Parliament and the Council
concerning the "Report on current practices with regard to the provision
of information to patients on medicinal products"[5] . The report concludes that
Member States have adopted divergent rules and practices with regard to the
provision of information, resulting in a situation where patients and the
public at large have unequal access to information on medicinal products.
Experience gained from the application of the current legal framework has also
shown disparities in the interpretation of the CommunityUnion rules on advertising, and between national provisions
on information, highlighting the need for a more precise
distinction between advertising and information.
(2)       The introduction of a new
Title VIIIa in Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on a Community code relating to medicinal products
for human use[6]
addresses those concerns through various provisions intended to ensure the
availability of good-quality, objective, reliable and non promotional
information on medicinal products for human use subject to prescription and to place emphasis on the rights and interests of patients.
(3)       Disparities in the
provision of information on medicinal products for human use are not justified
in the case of medicinal products authorised pursuant to Title II of Regulation
(EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
laying down Community
procedures for the authorisation and supervision of medicinal products for
human and veterinary use and establishing a European Medicines Agency[7] for which a single summary of
the products characteristics and package leaflet are approved for the whole CommunityUnion. Therefore Title
VIIIa of Directive 2001/83/EC should also apply to those products. 
(4)       Directive 2001/83/EC
provides, with some exceptions, that certain types of information are
is subject to control by the Member
States' national competent authorities prior to their
dissemination being made available. This concerns 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.In the case of medicinal products
for human use authorised pursuant to Title II of Regulation (EC) No 726/2004,
provision should also be made for certain types of this information
to be subject to prior vetting by the European Medicines Agency (hereinafter
referred to as the 'Agency'), and to clarify the operation of
the control mechanism in the case of information made available through
Internet websites registered with the Member States in accordance with
Directive 2001/83/EC. 
(5)       To ensure the adequate
funding of these activities related to information, provision should be made
for the collection of fees charged to marketing authorisation holders by the
Agency. 
(6)       Information
on medicinal products is already provided at Union level by several databases
and portals managed by the Agency or the Commission concerning inter alia
medicinal products and clinical trials, such as the Orphanet portal for rare
diseases and orphan drugs[8].
It is appropriate to link these different sources of information to facilitate
access by the public. The European medicines web portal created by Regulation
(EC) No 726/2004, as amended by Regulation (EU) No 1235/2010[9], should be the single point of reference for
access to that information.
(7)       As the
prior vetting of information by the Agency will be financed by applicants' fees
which are to be adjusted, it is appropriate to provide for a deferred
application of the provisions on the pre-vetting of information by the Agency. 
(8)       Since the objective of
this Regulation, namely to provide for specific rules on information on
medicinal products for human use subject to prescription authorised pursuant to
Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member States
and can be better achieved at CommunityUnion level, the CommunityUnion 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 Regulation does
not go beyond what is necessary in order to achieve this objective.
(9)       Regulation (EC) No
726/2004 should therefore be amended
accordingly,
HAVE ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 726/2004 is amended
as follows:
(1)          The following Articles 20a, and 20b and 20c are inserted: 
“Article
20a
1.       Title VIIIa of Directive 2001/83/EC
shall apply to medicinal products which are authorised under this Title and are subject to medical prescription.
Article
20b
1.       By way of derogation from Article
100g(1) of Directive 2001/83/EC, medicinal product-related
information referred to in Article 100b(d) of that
Directive concerning medicinal products for human use which
have been authorised in accordance with this Regulation shall be subject
to vetting by the Agency prior to its being made available
dissemination. 
This shall be without
prejudice to Article 100j of Directive 2001/83/EC relating to the monitoring by
the Member States of the information made available. 
2.       For the purposes of paragraph 1, the
marketing authorisation holder shall submit to the Agency a mock-up of the
information to be disseminatedmade
available.
3.       The Agency may object to the
information submitted or parts thereof on grounds related to non-compliance with
the provisions of Title VIIIa of Directive 2001/83/EC within 60 days after
receipt of the notification. If the Agency does not object within 60 days, the
information shall be deemed accepted and may be published.
4. Where the marketing
authorisation holder resubmits to the Agency a mock-up of the information to be
made available following objections by the Agency in application of paragraph
3, if the Agency does not object within 30 days, the revised information shall
be deemed accepted and may be published.
5. The Agency may if
appropriate collaborate with Member States when it performs the tasks set out
in this Article. 
6.       The submission of information to the Agency in accordance
with paragraphs 1 to 4, 2 and 3 shall be subject to a fee payable in accordance
with Regulation (EC) No 297/95.
Article 20c
1. By way of derogation from Article 100h(3) of
Directive 2001/83/EC, the Agency shall be responsible for the prior vetting in
accordance with Article 20b of this Regulation of information relating to medicinal
products authorised in accordance with this Regulation which is contained in
Internet websites registered with the national competent authorities of the
Member States in accordance with Article 100h of Directive 2001/83/EC.
2. Where a marketing authorisation
holder intends to include information on a medicinal product authorised in
accordance with this Regulation in an Internet website registered in accordance
with Article 100h of Directive 2001/83/EC, it shall submit the information to
the Agency for the application of Article 20b of this Regulation prior to it
being made available, and inform the Agency of the Member State where the
Internet website is intended to be or is registered. The Agency shall inform
the concerned Member State of the outcome of the procedure of Article 20b.
3. By way of derogation from
point (c) of Article 100h(4) of Directive 2001/83/EC, if a Member State has
reasons for doubts as to whether the information approved in accordance with
Article 20b of this Regulation made available on a registered Internet website
complies with the requirements of Title VIIIa of Directive 2001/83/EC, it shall
inform the Agency of the reasons for its doubts. The Member State concerned and
the Agency 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 Council Decision
75/320/EEC(*). Any necessary measures may only be adopted after an opinion has
been delivered by that Committee. Member States and the Agency shall take
account of opinions delivered by the Pharmaceutical Committee and shall inform
the Committee of how its opinion has been taken into account.
(*) OJ L 147, 9.6.1975, p.
23."
(2)          In Article 26, the following paragraph 3
is added:
"3. The European
medicines web-portal shall contain at least links to the following:
(a) the database on medicinal
products referred to in point (l) of Article 57(1) of this Regulation;
(b) the Eudravigilance
database referred to in Article 24(1) and point (d) of Article 57(1) of this
Regulation;
(c) the database referred to
in Article 111(6) of Directive 2001/83/EC;
(d) the Orphanet portal for
rare diseases and orphan drugs;
(e) the Health Portal
referred to in Decision 1350/2007/EC of the European Parliament and Council(*).
(*) OJ L 301, 20.11.2007, p.
3."
(3)          In
Article 57(1), point (l) is replaced by the following: 
"(l) creating a database on medicinal
products, to be accessible to the general public and allowing
searches in all official languages of the Union, and ensuring that it is
updated, and managed independently of the commercial
interests of pharmaceutical companies; the database shall facilitate the
search for information already authorised for package leaflets; it shall
include a section on medicinal products authorised for the treatment of
children; the information provided to the public shall be worded in an
appropriate and comprehensible manner. 
(4)          In Article 57(1), the
following point (u) is added:
“(u) delivering opinions
on reviewing information to the
general public on medicinal products for human use subject to medical
prescription.”
(5)          In Article
57(2), the first subparagraph is replaced by the following:
"2. The database provided for in paragraph
1(l) shall include the summaries of product characteristics, the patient or
user package leaflet and the information shown on the labelling. The database
shall be developed in stages, priority being given to medicinal products
authorised under this Regulation and those authorised under Chapter 4 of Title
III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The
database shall subsequently be extended to include any medicinal product placed
on the market within the EUnion. That database shall be
actively promoted to European Union citizens". 
Article 2
This Regulation shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
It shall apply from [OJ:
insert date of entry into force] with the exception of Article 1 (4) and (8)
which shall apply from [OJ: insert date of publication + 4 years].
This Regulation shall be binding in its
entirety and directly applicable in all 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[10] 

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[11]

¨ 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[12] 

¨ 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[13] : 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 ([14]) || from EFTA[15] countries || from candidate countries[16] || 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[17] || Year 2017 || Year 2018 || Year 2019 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
  Operational appropriations ||   ||   ||   ||   ||   ||   ||   ||   
 Number of budget line – 17.031001 || Commitments || (1) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (2) ||   ||   ||   ||   ||   ||   ||   ||   
 Number of budget line – 17.031002 || Commitments || (1a) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (2a) ||   ||   ||   ||   ||   ||   ||   ||   
 Appropriations of an administrative nature financed  from the envelop of specific programs[18] ||   ||   ||   ||   ||   ||   ||   ||   
 Number of budget line ||   || (3) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations for DG <.> || Commitments || =1+1a +3 ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || =2+2a +3 ||   ||   ||   ||   ||   ||   ||   ||   
  TOTAL operational appropriations || Commitments || (4) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (5) ||   ||   ||   ||   ||   ||   ||   ||   
  TOTAL appropriations of an administrative nature financed from the envelop of specific programs || (6) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADING <1A.> of the multiannual financial framework || Commitments || =4+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || =5+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
If more than one heading is affected by the proposal /
initiative:
  TOTAL operational appropriations || Commitments || (4) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (5) ||   ||   ||   ||   ||   ||   ||   ||   
  TOTAL appropriations of an administrative nature financed from the envelop of specific programs || (6) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || =5+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
 Heading of multiannual financial framework: || 5 || " Administrative expenditure " 
EUR million (to 3 decimal places)
   ||   ||   || Year 2016 || Year 2017 || Year 2018 || Year 2019 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
 DG: <…….> || 
  Human resources ||   ||   ||   ||   ||   ||   ||   ||   
  Other administrative expenditure ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL DG <…….> || Appropriations ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) ||   ||   ||   ||   ||   ||   ||   ||   
EUR million (to 3 decimal places)
   ||   ||   || Year 2016[19] || 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[20] || 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[21]… ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 - 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[22]
   || 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[23] || 569 100 || 569 100 || 569 100 || 650 400 || 650 400 || 650 400 
 Cost of translation back into submission language23 || 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[24] || 3 073 815 || 2 548 815 || 2 248 815 || 2 589 294 || 2 688 394 || 2 688 394 
 Income fees[25] || 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 [26] || 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[27] of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources ||   ||   ||   ||   ||   ||   ||   ||   
 Other expenditure of an administrative nature ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal outside HEADING 5 of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL ||   ||   ||   ||   ||   ||   ||   ||   

3.2.3.2.    
 Estimated requirements of human resources 

–     
¨  The proposal/initiative does not require the use of human
resources 
–     
¨  The proposal/initiative requires the use of human resources, as
explained below:
Estimate to be expressed in full amounts
(or at most to one decimal place)
 ||   || Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) 
 ||  Establishment plan posts (officials and temporary agents) || 
 || XX 01 01 01 (Headquarters and Commission’s Representation Offices) ||   ||   ||   ||   ||   ||   ||   
 || XX 01 01 02 (Delegations) ||   ||   ||   ||   ||   ||   ||   
 || XX 01 05 01 (Indirect research) ||   ||   ||   ||   ||   ||   ||   
 || 10 01 05 01 (Direct research) ||   ||   ||   ||   ||   ||   ||   
  External personnel (in Full Time Equivalent unit: FTE)[28] || 
 || 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 [29] || - at Headquarters[30] ||   ||   ||   ||   ||   ||   ||   
 || - 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[31].
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[32] 
 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]               COM(2007)
862.
[6]               OJ
L 311, 28.11.2001, p. 87.
[7]               OJ
L 136, 30.4.2004, p. 1.
[8]               COM(2008)
679 final.
[9]               OJ
L 348, 31.12.2010, p. 1.
[10]             ABM:
Activity-Based Management – ABB: Activity-Based Budgeting.
[11]             As
referred to in Article 49(6)(a) or (b) of the Financial Regulation.
[12]             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
[13]             As
referred to in Article 185 of the Financial Regulation.
[14]             DA=
Differentiated appropriations / DNA= Non-Differentiated Appropriations
[15]             EFTA:
European Free Trade Association. 
[16]             Candidate
countries and, where applicable, potential candidate countries from the Western
Balkans.
[17]             Year
N is the year in which implementation of the proposal/initiative starts.
[18]             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.
[19]             Year
N is the year in which implementation of the proposal/initiative starts.
[20]             Outputs
are products and services to be supplied (e.g.: number of student exchanges
financed, number of km of roads built, etc.).
[21]             As
described in Section 1.4.2. "Specific objective(s)…"
[22]             Assumption:
there will be an increase in applications and no impact on EMA costs.
[23]             For
7 pages
[24]             An
inflation rate of 2% should be taken into consideration.
[25]             The
fee for the pharmaceutical company will be €3 650.
[26]             Year
N is the year in which implementation of the proposal/initiative starts.
[27]             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.
[28]             CA=
Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune
Expert en Délégation" (Young Experts in Delegations); LA= Local Agent;
SNE= Seconded National Expert; 
[29]             Under the ceiling for external personnel from operational appropriations (former "BA"
lines).
[30]             Essentially
for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and European
Fisheries Fund (EFF).
[31]             See
points 19 and 24 of the Interinstitutional Agreement.
[32]             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.