Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems
Date: 2012-03-01
Institutions: European Commission
Subjects: State health service, administrative transparency, drug surveillance, equal treatment, free movement of goods, health costs, medicinal product, pharmaceutical expenses

EUROPEAN COMMISSION 

Brussels, 1.3.2012  
COM(2012) 84 final 

2012/0035 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

relating to the transparency of measures regulating the prices of medicinal products for 
human use and their inclusion in the scope of public health insurance systems 

(Text with EEA relevance) 

{SWD(2012) 29 final} 
{SWD(2012) 30 final} 

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EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

General context 

The  legislation  of  the  Union  requires  a  marketing  authorisation  to  be  granted  by  the 
competent  EU  or  national  authorities  before  any  medicinal  product  can  be  placed  on  the 
market.1 The rules in force aim to safeguard public health by ensuring that the quality, safety 
and  efficacy  of  medicines  are  properly  evaluated  before  these  can  be  made  available  to 
patients in the European Union. This legislative framework also intends to facilitate trade in 
medicines  between  Member  States  in  accordance  with  the  principle  of  free  movement  of 
goods. 

Meanwhile,  pursuant  to  Article  168(7)  of  the  Treaty  on  the  Functioning  of  the  European 
Union, Member States are responsible for the organisation of their healthcare system and for 
the delivery of health services and medical care, including the allocation of resources assigned 
to them. In this framework, each Member State can take measures to manage the consumption 
of  medicines,  regulate  their  prices  or  establish  the  conditions  of  their  public  funding.  A 
medicinal  product  authorised  in  accordance  with  EU  legislation  on  the  basis  of  its  quality, 
safety and efficacy profile may therefore be subject to additional regulatory requirements at 
Member State level before it can be placed on the market or dispensed to patients under the 
public  health  insurance  scheme.  For  instance,  Member  States  usually  evaluate  the  cost-
effectiveness of authorised medicines, or their relative efficacy as well as the short- and long-
term  effectiveness  compared  to  other  products  in  the  same  therapeutic  class,  in  order  to 
determine  their  price,  funding  and  utilisation  in  the  framework  of  their  health  insurance 
system.  

National measures to control the funding of medicines and manage their consumption in the 
framework of healthcare systems are susceptible to create barriers to trade as they affect the 
capacity of pharmaceutical companies to sell their products in domestic markets. The settled 
case-law of the Court of Justice of the European Union recognises the right of Member States 
to adopt such measures in view of promoting the financial stability of their health insurance 
system.2  However,  basic  conditions  of  procedural  transparency  must  be  met  to  ensure  their 
compatibility with the rules of the Treaty relating to the Single Market. In particular, pricing 
and  reimbursement  measures  must  be  free  of  discrimination  against  imported  medicinal 
products and based on objective and verifiable criteria which are independent from the origin 
of the products.  

1 

2 

See  Directive  2001/83/EC  of  the  European  Parliament  and  the  Council  of  6  November  2001  on  the 
Community  code  relating  to  medicinal  products  for  human  use  (OJ  L311,  28/11/2001,  p.  67),  as 
amended, and Regulation (EC) N°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 (OJ L 136, 30.4.2004, p. 
1). 

See, for instance, Case 181/82 Roussel Laboratoria [1983] ECR 3849; Case 238/82 Duphar and Others 
[1984] ECR 523; Case C-249/88 Commission v Belgium [1991] ECR I-1275. 

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Directive 89/105/EEC3 codifies the minimum requirements set forth by the Court of Justice. It 
was adopted to enable market operators to verify that national measures regulating the pricing 
and reimbursement of medicines do not contravene the principle of free movement of goods. 
To  this  end,  the  Directive  lays  down  a  series  of  procedural  requirements  to  ensure  the 
transparency  of  pricing  and  reimbursement  measures  adopted  by  the  Member  States.  These 
obligations include specific time limits for pricing and reimbursement decisions (90 days for 
pricing,  90  days  for  reimbursement  or  180  days  for  combined  pricing  and  reimbursement 
decisions).  The  Directive  also  requires  the  competent  national  authorities  to  provide  a 
statement of reasons based on objective and verifiable criteria for each of their decisions and 
to provide appropriate legal remedies to the applicant companies. 

• 

Grounds for and objectives of the proposal 

Directive  89/105/EEC  has  never  been  amended  since  its  adoption.  Its  provisions  reflect  the 
pharmaceutical  market  conditions  which  prevailed  more  than  twenty  years  ago.  However, 
these  conditions  have  fundamentally  changed,  for  instance  with  the  emergence  of  generic 
medicines providing cheaper versions of existing products or the development of increasingly 
innovative (yet often expensive) research-based medicinal products. In parallel, the constant 
rise  in  public  expenditure  on  pharmaceuticals  in  the  last  decades  has  encouraged  Member 
States to devise more complex and innovative pricing and reimbursement systems over time. 

Despite  the  historically  positive  impact  of  Directive  89/105/EEC  on  the  internal  market  for 
medicines, there is evidence that it does not fully achieve its objectives in the present context:  

– 

– 

3 

4 

Firstly, a gap has emerged between the provisions of  the Directive, which describe 
the  main  types  of  pricing  and  reimbursement  procedures  established  in  the  1980s, 
and  the  much  wider  range  of  cost-containment  measures  adopted  nowadays  by 
Member States. Despite the extensive interpretation of the Directive by the Court of 
Justice4,  the  implementation  of  its  provisions  in  national  law  and  the  effective 
enforcement  of  its  principles,  in  particular  by  the  Commission,  have  become 
particularly challenging. This situation not only results in legal uncertainties but also 
in  a  reduced  transparency  of  national  pricing  and  reimbursement  measures,  which 
negatively affects the smooth functioning of the internal market to the detriment of 
European patients and pharmaceutical companies. 

Secondly,  the  time  limits  for  pricing  and  reimbursement  decisions  established  by 
Directive 89/105/EEC are regularly exceeded by Member States. This leads to delays 
in the marketing of medicinal products, which in turn slows down the availability of 
valuable treatments for patients. In 2009, the Commission’s Competition Inquiry into 

Council  Directive  89/105/EEC  of  21  December  1988  relating  to  the  transparency  of  measures 
regulating the pricing of medicinal products for human use and their inclusion in the scope of national 
health insurance system (OJ N°40, 11.2.1989, p. 8). 

See  Case  C-424/99  Commission  of  the  European  Communities  v  Republic  of  Austria  [2001]  ECR 
9285;  Case  C-229/00  Commission  of  the  European  Communities  v  Republic  of  Finland  [2003]  ECR 
5727;  Case  C-317/05  Pohl-Boskamp  [2006]  ECR  I-10611;  Joined  Cases  C-352/07  to  C-356/07, 
C-365/07  to  C-367/07  and  C-400/07 Menarini  Industrie  Farmaceutiche Riunite  and Others, nyr;  Case 
C-62/09  Association  of  the  British  Pharmaceutical  Industry  v  Medicines  and  Healthcare  Products 
Regulatory Agency, nyr. 

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the  Pharmaceutical  Sector5  recalled  that  Member  States  should  comply  with  these 
time limits. The inquiry also demonstrated that unnecessary delays in the pricing and 
reimbursement of generic medicines delay patients’ access to cheaper medicines and 
increase  the  financial  burden  on  Member  States.  The  Commission  therefore 
considered  that  pricing  and  reimbursement  procedures  should  be  shortened  with 
respect to generic medicinal products. In addition, the sector inquiry showed that the 
interference  of  patent  or  safety  related  issues  with  pricing  and  reimbursement 
processes can significantly delay access to cheaper generic medicinal products. 

The fundamental objectives and principles of Directive 89/105/EEC remain fully valid in the 
present  context.  Accordingly,  this  initiative  aims  at  adapting  the  Directive  to  the  current 
pharmaceutical  environment  while  preserving  its  core  foundations.  The  overall  objective  of 
the  proposal  is  to  clarify  the  procedural  obligations  incumbent  upon  Member  State  and  to 
ensure  the  effectiveness  of  the  Directive,  both  in  avoiding  delays  in  pricing  and 
reimbursement  decisions  and  in  preventing  barriers  to  pharmaceutical  trade.  This  shall  be 
done  without  affecting  national  social  security  policies,  except  as  far  as  it  is  necessary  to 
achieve the transparency of national procedures and the effectiveness  of  the  internal  market 
legislation.  

2. 

• 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENT 

Consultation of interested parties 

A  public  consultation  on  a  possible  revision  of  Directive  89/105/EEC  was  held  from  28 
March  to  30  May  2011.  In  response  to  this  consultation,  the  Commission  received  102 
contributions from a broad range of stakeholders including national authorities, public health 
insurers, 
research-based 
pharmaceutical  industry,  the  generic  industry,  the  medical  devices  industry  and  other 
interested  parties  such  as  representatives  of  the  distribution  chain,  health  professional 
organisations, patients and citizens. Small and medium sized enterprises were also consulted 
through the Enterprise Europe Network. 

individual  companies  and  organisations 

representing 

the 

A  large  majority  of  respondents  recognised  the  positive  impact  of  the  Directive  on  the 
transparency  of  national  procedures  and  the  functioning  of  the  internal  market.  However, 
many of them also pointed to its weak implementation by Member States and highlighted its 
shortcomings in terms of legal clarity and enforcement. Opinions differed as to the relevant 
actions  which  should  be  proposed  by  the  Commission.  For  instance,  the  generic  industry 
unanimously advocated a revision of the Directive, while research-based companies and their 
representative  organisations  favoured  a  soft  law  approach  based  on  an  interpretative 
Communication by the Commission.  

The 
public 
http://ec.europa.eu/enterprise/sectors/healthcare/public-consultation/index_en.htm.

consultation 

results 

the 

are 

of 

available 

at: 

5 

Commission  inquiry  into  the  European  pharmaceutical  sector  pursuant  to  Article  17  of  Regulation 
1/2003.  The  results  of  the  inquiry  are  published  in  the  Communication  from  the  Commission: 
“Executive  Summary  of  the  Pharmaceutical  Sector  Inquiry  Report”  (COM(2009)351  final)  and  the 
annexed  Staff  Working  Document: 
Inquiry”. 
“Report  on 
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html. 

the  Pharmaceutical  Sector 

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Impact assessment 

Responses to the public consultation were carefully considered during the impact assessment 
carried out by the Commission services. The impact assessment report identifies and assesses 
regulatory  and  non-regulatory  options  to  achieve  the  overall  objective  of  ensuring  that 
adequate  and  effective  transparency  rules  apply  to  the  pricing  and  reimbursement  measures 
adopted by Member States. The proposal to revise the Directive is based on the combination 
of options recommended in the framework of the impact assessment, namely: 

– 

– 

To ensure timely pricing and reimbursement decisions: options A.3/c (regular reports 
on pricing and reimbursement approval times), A.4/a (shorter time-limits for pricing 
and  reimbursement  decisions  concerning  generic  medicinal  products)  and  A.4/b 
(prohibition of patent linkage and re-assessment of safety features). 

To  ensure  the  adequacy  and  effectiveness  of  the  Directive  in  the  current  context: 
options  B.3/b  (extensive  revision  of  the  Directive  to  clarify  its  scope  and  wording) 
and B.4 (notification of draft national measures to facilitate enforcement). 

The  possible  extension  of  the  Directive  to  include  medical  devices  was  examined  in  the 
impact assessment but discarded due to the specificities of this market. 

Furthermore,  in  spite  of  the  difficulty  to  conclude  on  the  overall  cost-benefit  balance  of 
reducing  the  time  limits  with  respect  to  originator  medicines,  a  reduction  from  the  current 
90/180 days to 60/120 days is proposed in light of the positive impact it would have on the 
swift  availability  of  innovative  medicines  to  patients  and  on  rewarding  pharmaceutical 
innovation when medicines are approved for reimbursement. However, given the complexity 
of  the  health  technology  assessment  (HTA)  procedures,  it  was  deemed  necessary  to  find  a 
more differentiated approach for the time limits; therefore, different time limits are proposed, 
depending  on  whether  the  medicinal  products  are  subject  to  health  technology  assessment 
(90/180 days) or not (60/120 days). 

The impact assessment report and its executive summary are available at:   
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm. 

3. 

• 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis and subsidiarity 

The  main  objective  of  Directive  89/105/EEC  is  to  facilitate  the  functioning  of  the  internal 
market  for  medicinal  products.  The  legal  basis is therefore  Article 114  of the Treaty  on the 
Functioning of the European Union. 

The existing Directive has as its underlying principle the idea of minimum interference in the 
organisation by  Member States of their domestic social  security policies.6 This fundamental 
principle  is  maintained  in  the  proposal.  The  proposed  requirements  to  ensure  timely  and 
transparent decisions carefully balance the obligation to preserve the competences of Member 
States in the field of public health against the necessity to guarantee the effectiveness of the 

6 

Case C-245/03 Merck, Sharp & Dohme [2005] ECR I-637, point 27. 

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Directive in meeting its internal market objectives. In order to respect the responsibilities of 
the Member States under the Treaty, the proposal does not provide for the approximation of 
national  pricing  and  reimbursement  measures,  nor  does  it  restrain  the  ability  of  Member 
States to freely determine the prices of medicines and the conditions of their public funding 
on the basis of the criteria they choose. The impact assessment report explains in further detail 
how  the  subsidiarity  and  proportionality  principles  have  been  taken  into  account  in  the 
proposal.  

• 

Overview of the main legal elements 

The proposal maintains  the  core principles of the existing Directive but also  puts  forward a 
comprehensive adaptation of its legal provisions based on the following key elements:  

– 

– 

– 

– 

– 

Clarification of the scope of the Directive: the transparency requirements apply to all 
pricing and reimbursement measures understood in a broad sense, including “demand 
side”  measures  to  control  or  promote  the  prescription  of  specific  medicines. 
Nevertheless,  measures  involving  public  procurement  and  voluntary  contractual 
agreements with individual companies are excluded from the scope of the Directive 
in order to avoid interference with other bodies of law. 

Comprehensive coverage of national measures and legal clarity: the provisions of the 
Directive  are  reworded  in  accordance  with  general  principles  (rather  than  on  the 
basis  of  specific  national  procedures)  and  incorporate  the  case-law  of  the  Court  of 
Justice.  Several  key  provisions  are  clarified  and  updated  to  avoid  interpretation 
controversies.  In  particular,  it  is  made  clear  that  the  time  limits  for  pricing  and 
reimbursement  decisions  include  all  procedural  steps  leading  to  the  decision, 
including health technology assessments where applicable. 

Adaptation  of  the  time  limits  for  pricing  and  reimbursement  decisions:  the  time 
limits applicable to generic medicines are reduced to 15/30 days when the reference 
product  has  already  been  priced  and  included  in  the  health  insurance  system.  The 
time  limits  applicable  to  all  other  medicinal  products  are  reduced  to  60/120  days. 
However,  in  cases  where  national  authorities  subject  medicinal  products  to  health 
technology assessment procedures in order to assess the relative efficacy or the short- 
and long-term effectiveness, as an integral part of their decision-making process, the 
time-limits shall be 90/180 days.  

Non-interference  of  patent  and  safety  issues  with  pricing  and  reimbursement 
procedures: the proposal clarifies that intellectual property rights should not interfere 
with  pricing  and  reimbursement  procedures,  as  is  already  the  case  for  marketing 
authorisation procedures. In addition, elements already assessed in the framework of 
the  marketing  authorisation  process  (quality,  safety  and  efficacy,  including 
bioequivalence)  may  not  be  reassessed 
the  framework  of  pricing  and 
reimbursement procedures.  

in 

Dialogue  and  enforcement  tools:  different  instruments  are  put  in  place  to  facilitate 
dialogue  on  the  implementation  of  the  Directive  and  to  ensure  its  effective 
enforcement (consultation on draft measures at national level and pre-notification to 
the  Commission,  the  creation  of  a  remedies  procedure  in  case  of  non-compliance 
with the time-limits related to the inclusion of medicinal products in health insurance 
systems).  

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• 

Repeal of Directive 89/105/EEC 

The  amendments  proposed  to  Directive  89/105/EEC  are  substantial  and  cover  all  major 
provisions  currently  in  force.  For  the  sake  of  legal  clarity,  and  in  accordance  with  the 
principle of better regulation, the adoption of the proposal will lead to the repeal of existing 
legislation. However, the effects of Article 10 of Directive 89/105/EEC shall be maintained. 

No  correlation  table  is  foreseen  as  the  existing  EU  legislation  referring  to  Directive 
89/105/EEC does so in a general way without pointing to specific provisions of the Directive. 

4. 

BUDGETARY IMPLICATION  

The  Commission's  proposal  has  no  impact  on  the  European  Union  budget  beyond  what  is 
already foreseen for the years to come in the Multiannual Financial Framework. The details of 
the financial resources are indicated in the Legislative Financial statement. 

5. 

TRANSPOSITION 

The  notification  of  the  Member  States'  transposition  measures  must  be  accompanied  by 
correlation tables explaining the relationship between the components of a directive and the 
corresponding parts of national transposition instruments. This is necessary due to: 

• 

• 

• 

The complexity of the Directive, which does not touch upon the substance but 
only  lays  down  minimum  procedural  requirements  to  ensure  the  transparency 
of the measures regulating the prices of medicinal products for human use and 
their inclusion in the scope of public health insurance systems.  

The complexity of the transposition process due to the difficulties related to the 
interpretation  of  the  Directive.  The  application  of  a  set  of  procedural  rules  to 
the  complicated  architecture  of  the  pricing  and  reimbursement  systems  is  not 
always easy and straightforward.  

The constant evolution of national measures on pricing and reimbursement in 
view  of  controlling  pharmaceutical  expenditure,  which  makes  it  difficult  to 
monitor the implementation process.  

Therefore, the obligation to communicate correlation tables will facilitate the implementation 
process. 

6. 

ADDITIONAL INFORMATION  

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the  European 
Economic Area. 

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2012/0035 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

relating to the transparency of measures regulating the prices of medicinal products for 
human use and their inclusion in the scope of public health insurance systems 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 
thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee7,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

Council  Directive  89/105/EEC  of  21  December  1988  relating  to  the  transparency  of 
measures regulating the pricing of medicinal products for human use and their inclusion in 
the scope of national health insurance systems8 was adopted so as to remove distortions to 
intra-Community trade in medicinal products.  

In  order  to  take  into  account  the  evolution  of  the  pharmaceutical  market  and  of  national 
policies to control public expenditure on medicines, substantive changes are necessary to all 
major  provisions  of  Directive  89/105/EEC.  Therefore,  in  the  interest  of  clarity,  Directive 
89/105/EEC should be replaced. 

Union  legislation  provides  a  harmonised  framework  for  the  authorisation  of  medicinal 
products for human use. According to 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,9  medicinal  products  may  be  placed  on  the  market  in  the  Union  only  after 

7 
8 
9 

OJ C , , p. . 

OJ L 40, 11.2.1989, p. 8. 

OJ L 311, 28.11.2001, p. 67. 

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they have received a marketing authorisation based on the evaluation of their quality, safety 
and efficacy. 

(4)  Member States have been confronted to a steady rise in pharmaceutical expenditure over the 
last  decades,  leading  to  the  adoption  of  increasingly  innovative  and  complex  policies  to 
manage  the  consumption  of  medicines  in  the  framework  of  their  public  health  insurance 
systems.  In  particular,  Member  States’  authorities  have  implemented  a  broad  range  of 
measures to control the prescription of medicines, to regulate their prices or to establish the 
conditions of their public funding. Such measures mainly aim at promoting public health by 
ensuring  the  availability  of  adequate  supplies  of  medicinal  products  at  reasonable  costs, 
while ensuring the financial stability of public health insurance systems.  

(5) 

(6) 

(7) 

(8) 

(9) 

Disparities  in  national  measures  may  hinder  or  distort  intra-Union  trade  in  medicinal 
products  and  distort  competition,  thereby  directly  affecting  the  functioning  of  the  internal 
market in medicinal products. 

In  order  to  reduce  the  effects  of  the  disparities  on  the  internal  market,  national  measures 
should  comply  with  minimum  procedural  requirements  enabling  the  parties  concerned  to 
verify that those measures do not constitute quantitative restrictions on imports or exports or 
measures  having  equivalent  effect  thereto.  However,  those  requirements  should  not  affect 
the policies of those Member States which rely primarily upon free competition to determine 
the price of medicinal products. They also should not affect national policies on price setting 
and on the determination of social security schemes, except as far as it is necessary to attain 
transparency  within  the  meaning  of  this  Directive  and  to  ensure  the  functioning  of  the 
internal market.  

In  order  to  ensure  the  effectiveness  of  the  internal  market  in  medicinal  products,  this 
Directive  should  apply  to  all  medicinal  products  for  human  use  within  the  meaning  of 
Directive 2001/83/EC.  

Due  to  diversity  of  national  measures  managing  the  consumption  of  medicines,  regulating 
their  prices  or  establishing  the  conditions  of  their  public  funding  it  is  necessary  to  clarify 
Directive  89/105/EEC.  In  particular  this  Directive  should  cover  all  types  of  measures 
devised by Member States and susceptible to impact the internal market. Since the adoption 
of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have 
become more complex. While some Member States have interpreted the scope of Directive 
89/105/EEC  restrictively,  the  Court  of  Justice  ruled  that  those  pricing  and  reimbursement 
procedures  fall  within  the  scope  of  Directive  89/105/EEC  given  the  objectives  of  that 
Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the 
developments in national pricing and reimbursement policies. Given that specific rules and 
procedures  exist  in  the  area  of  public  procurement  and  voluntary  contractual  agreements, 
national  measures  involving  public  procurement  and  voluntary  contractual  agreements 
should be excluded from the scope of this Directive. 

Any  measure  to  regulate,  either  directly  or  indirectly,  the  prices  of  medicinal  products,  as 
well as any measure to determine their coverage by public health insurance systems should 
be  based  on  objective  and  verifiable  criteria  that  are  independent  from  the  origin  of  the 
product and should provide adequate legal remedies, including judicial remedies, to affected 
companies. These requirements should equally apply to national, regional or local measures 
to control or promote the prescription of specific medicinal products as such measures also 
determine their effective coverage by health insurance systems.  

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(10)  Applications to approve the price of a medicinal product or to determine its coverage by the 
health insurance system should not delay the placing on the market of that product beyond 
what is necessary. It is therefore desirable that this Directive sets out mandatory time limits 
within which national decisions should be made. In order to be effective, the prescribed time 
periods  should  run  from  the  receipt  of  an  application  until  the  entry  into  force  of  the 
corresponding  decision.  They  should  include  all  expert  evaluations,  including  health 
technology  assessments  where  applicable,  and  all  administrative  steps  required  for  the 
decision to be adopted and take legal effect. 

(11)  The time-limits for the inclusion of medicinal products in the health insurance systems set 
out  in  Directive  89/105/EEC  are  mandatory  as  clarified  by  the  case-law  of  the  Court  of 
Justice. Experience has shown that those time limits are not always respected and that there 
is need to ensure legal certainty and improve the procedural rules related to the inclusion of 
medicinal products in the scope of health insurance system. Therefore, an effective and rapid 
remedies procedure should be put in place.  

(12) 

In its Communication "Executive Summary of the Pharmaceutical Sector Inquiry Report"10 
the  Commission  demonstrated 
that  pricing  and  reimbursement  procedures  often 
unnecessarily delay the launch of generic medicines in Union markets. Approving the price 
of generic medicinal products and their coverage by the health insurance system should not 
require any new or detailed assessment when the reference product has already been priced 
and included in the health insurance system. It is therefore appropriate to lay down shorter 
time limits for generic medicinal products in those cases. 

(13)  The judicial remedies available in the Member States have played a limited role in ensuring 
compliance with the time limits due to the often lengthy procedures in national jurisdictions, 
legal  action.  Therefore,  effective 
which  deter  affected  companies  from 
mechanisms are necessary to control and enforce compliance with the time limits for pricing 
and reimbursement decisions. 

initiating 

(14)  The  quality,  safety  and  efficacy  of  medicinal  products,  including  the  bioequivalence  of 
generic medicinal products with the reference product, are ascertained in the framework of 
marketing  authorisation  procedures.  In  the  framework  of  pricing  and  reimbursement 
procedures,  Member  States  should  therefore  not  re-assess  the  elements  on  which  the 
marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of 
the medicinal product. 

(15) 

In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid 
ground  to  refuse,  suspend  or  revoke  a  marketing  authorisation.  By  the  same  token, 
applications,  decision-making  procedures  and  decisions  to  regulate  the  prices  of  medicinal 
products  or  to  determine  their  coverage  by  health  insurance  systems  should  be  considered 
administrative  procedures  which,  as  such,  are  independent  from  the  enforcement  of 
intellectual  property  rights.  The  national  authorities  in  charge  of  those  procedures,  when 
examining  an  application  with  respect  to  a  generic  medicinal  product,  should  not  request 
information concerning the patent status of the reference medicinal product and should not 
examine the validity of an alleged violation of intellectual property rights should the generic 
medicinal product be manufactured or placed on the market subsequently to their decision. 

10 

COM(2009) 351 final.  

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Consequently, intellectual property issues should neither interfere with nor delay pricing and 
reimbursement procedures in the Member States. 

(16)  Member  States  have  frequently  amended  their  health  insurance  schemes  or  adopted  new 
measures  falling  within  the  scope  of  Directive  89/105/EEC.  It  is  therefore  necessary  to 
establish information mechanisms intended, on the one hand, to ensure the consultation of 
interested  stakeholders  and,  on  the  other  hand,  to  facilitate  preventive  dialogue  with  the 
Commission as regards the application of this Directive. 

(17)  Since the objective of the action to be taken, namely providing minimal transparency rules 
to  ensure  the  functioning  of  the  internal  market,  cannot  be  sufficiently  achieved  by  the 
Member States, as the notion of transparency of national measures is understood and applied 
differently in each Member State, and can therefore, by reason of the scale of the action be 
better  achieved  at  Union  level,  the  Union  may  adopt  measures,  in  accordance  with  the 
principle  of  subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In 
accordance with the principle of proportionality, as set out in that Article, this Directive does 
not go beyond what is necessary in order to achieve that objective. 

(18) 

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.  

HAVE ADOPTED THIS DIRECTIVE: 

Chapter I 

Scope and definitions 

Article 1 

Subject matter and scope 

1. 

Member States shall ensure that any national, regional or local measure, whether laid down 
by law, regulation or administrative action, to control the prices of medicinal products for 
human  use  or  to  determine  the  range  of  medicinal  products  covered  by  public  health 
insurance systems, including the extent and conditions of their coverage, complies with the 
requirements of this Directive. 

2. 

This Directive shall not apply to the following: 

(a)  voluntary  contractual  agreements  concluded  between  public  authorities  and  the 
holder of a marketing authorisation for a medicinal product that have as their object 
to  enable  the  effective  provision  of  this  medicine  to  patients  under  specific 
conditions; 

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11 

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(b)  national  measures  intended  to  determine  the  prices  or  the  coverage  of  medicinal 
products by public health insurance systems which are subject to national or Union 
legislation  on  public  procurement,  in  particular  Council  Directive  89/665/EEC,11 
Council  Directive  92/13/EEC12  and  Directive  2004/18/EC  of  the  European 
Parliament and of the Council.13 

The  provisions  of  this  Directive  shall  apply  to  measures  intended  to  determine  which 
medicinal  products  may  be  included  in  contractual  agreements  or  public  procurement 
procedures.  

3. 

Nothing  in  this  Directive  shall  permit  the  placing  on  the  market  of  a  medicinal  product 
which  has  not  received  marketing  authorisation  as  provided  for  in  Article  6  of  Directive 
2001/83/EC. 

Article 2 

Definitions 

For the purposes of this Directive, the following definitions apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

“medicinal  product”  means  a  medicinal  product  as  defined  in  Article  1  of  Directive 
2001/83/EC; 

“reference medicinal product” means a reference medicinal product as defined in point (a) 
of Article 10(2) of Directive 2001/83/EC; 

“generic medicinal product” means a generic medicinal product as defined in point (b) of 
Article 10(2) of Directive 2001/83/EC . 

“health  technology”  means  a  health  technology  as  defined  in  point  (l)  of  Article  3  of 
Directive 2011/24/EU of the European Parliament and of the Council;14  

“health  technology  assessment”  means  an  assessment  of  the  relative  efficacy  or  of  the 
short-  and  long-term  effectiveness  of  the  medicinal  product  compared  to  other  health 
technologies in use for treating the associated condition. 

11 
12 
13 
14 

OJ L 395, 30.12.1989, p. 33. 

OJ L 76, 23.3.1992, p. 14. 

OJ L 134, 30.4.2004, p. 114. 

OJ L 88, 4.4.2011, p. 45. 

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Chapter II 

Pricing of medicinal products 

Article 3 

Price approval 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Paragraphs 2 to 9 shall apply if the marketing of a medicinal product is permitted only after 
the competent authorities of the Member State concerned have approved the price of the 
product. 

Member States shall ensure that an application to approve the price of the product can be 
introduced  by  the  marketing  authorisation  holder  at  any  point  in  time.  The  competent 
authorities shall provide the applicant with an official acknowledgement of receipt.  

Member  States  shall  ensure  that  a  decision  on  the  price  which  may  be  charged  for  the 
medicinal product concerned is adopted and communicated to the applicant within 60 days 
of the receipt of an application submitted, in accordance with the requirements laid down 
in the Member State concerned, by the holder of a marketing authorisation. However, with 
respect to medicinal products for which Member States use health technology assessment 
as part of their decision-making process, the time-limit  shall be  90 days.  With respect to 
generic medicinal products, that time limit shall be 15 days, provided that the price of the 
reference medicinal product has been approved by the competent authorities. 

Member States  shall  establish in  detail  the  particulars  and documents  to be  submitted by 
the applicant. 

If the information supporting the application is inadequate, the competent authorities shall 
forthwith notify the applicant of the detailed additional information required and take their 
final  decision  within  60  days  of  receipt  of  this  additional  information.  However,  with 
respect to medicines for which Member States use health technology assessment as part of 
their  decision-making  process,  the  time-limit  shall  be  90  days.  With  respect  to  generic 
medicinal products, that time limit shall be in all events 15 days, provided that the price of 
the reference medicinal product has been approved by the competent authorities. Member 
States  shall  not  request  any  additional  information  which  is not  explicitly  required under 
national legislation or administrative guidelines.  

In the absence of a decision within the relevant time limit set out in paragraphs 3 and 5, the 
applicant shall be entitled to market the product at the price proposed. 

If  the  competent  authorities  decide  not  to  permit  the  marketing  of  the  medicinal  product 
concerned at the price proposed by the applicant, the decision shall contain a statement of 
reasons based on objective and verifiable criteria, including any evaluation, expert opinion 
or recommendation on which it is based. The applicant shall be informed of all remedies 
available,  including  judicial  remedies,  and  of  the  time  limits  for  applying  for  such 
remedies. 

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13 

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8. 

9. 

1. 

2. 

3. 

Member  States  shall  publish  in  an  appropriate  publication  and  communicate  to  the 
Commission  the  criteria  which  the  competent  authorities  must  take  into  account  when 
approving the prices of medicinal products.  

If  the  competent  authorities  decide  to  reduce  the  price  of  a  specific  named  medicinal 
product on their own initiative, the decision shall contain a statement of reasons based on 
objective  and  verifiable  criteria, 
including  any  evaluation,  expert  opinion  or 
recommendation on which it is based. The decision shall be communicated to the holder of 
the  marketing  authorisation,  who  shall  be  informed  of  all  remedies  available,  including 
judicial remedies, and of the time limits for applying for such remedies.  

Article 4 

Price increase 

Without prejudice to Article 5, paragraphs (2) to (6) shall apply if an increase in the price 
of  a  medicinal  product  is  permitted  only  after  prior  approval  has  been  obtained  from  the 
competent authorities. 

Member States shall ensure that an application to increase the price of the product can be 
submitted  by  the  marketing  authorisation  holder  at  any  point  in  time.  The  competent 
authorities shall provide the applicant with an official acknowledgement of receipt.  

Member States shall ensure that a decision on an application submitted in accordance with 
the requirements laid down in the Member State concerned, by a marketing authorisation 
holder  to  increase  the  price  of  a  medicinal  product  is  adopted  and  communicated  to  the 
applicant within 60 days of its receipt.  

In case of an exceptional number of applications, the time limit set out in this paragraph 
may be extended once only for a further 60 days. The applicant shall be notified of such an 
extension before the expiry of the time limit set out in this paragraph. 

4. 

Member  States shall establish in detail  the  particulars  and documents to be  submitted by 
the applicant.  

The applicant shall furnish the competent authorities with adequate information, including 
details  of  those  events  intervening  since  the  price  of  the  medicinal  product  was  last 
determined  which  in  his  opinion  justify  the  price  increase  requested.  If  the  information 
supporting  the  application  is  inadequate,  the  competent  authorities  shall  forthwith  notify 
the  applicant  of  the  detailed  additional  information  required  and  take  their  final  decision 
within  60  days  of  receipt  of  this  additional information.  Member  States  shall  not  request 
any  additional  information  which  is  not  explicitly  required  under  national  legislation  or 
administrative guidelines.  

5. 

6. 

In the absence of a decision within the relevant time limit referred to in paragraphs 3 and 4, 
the applicant shall be entitled to apply the price increase requested. 

If  the  competent  authorities  decide  not  to  permit  the  whole  or  part  of  the  price  increase 
requested,  the  decision  shall  contain  a  statement  of  reasons  based  on  objective  and 

EN 

14 

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verifiable criteria and the applicant shall be informed of all remedies available, including 
judicial remedies, and of the time limits for applying for such remedies. 

Article 5 

Price freeze and price reduction 

1. 

2. 

3. 

In the event of a price freeze or price reduction imposed on all medicinal products or on 
certain categories of medicinal products by the competent authorities of a Member State, 
that Member State shall publish a statement of reasons for its decision based on objective 
and verifiable criteria, including, if applicable, a justification of the categories of products 
subject to the price freeze or price reduction. 

Marketing  authorisation  holders  may  apply  for  a  derogation  from  a  price  freeze  or  price 
reduction if this is justified by particular reasons. The application shall contain an adequate 
statement of reasons. Member States shall ensure that applications for a derogation can be 
introduced  by  the  marketing  authorisation  holder  at  any  point  in  time.  The  competent 
authorities shall provide the applicant with an official acknowledgement of receipt.  

Member  States  shall  ensure  that  a  reasoned  decision  on  an  application  referred  to  in 
paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of 
the application. If the information supporting the application is inadequate, the competent 
authorities  shall  forthwith  notify  the  applicant  of  the  detailed  additional  information 
required  and  take  their  final  decision  within  60  days  of  receipt  of  this  additional 
information. If the derogation is granted, the competent authorities shall forthwith publish 
an announcement of the price increase allowed. 

If  there  is  an  exceptional  number  of  applications,  the  relevant  time  limit  set  out  in 
paragraph  3  may  be  extended  once  only  for  a  further  60  days.  The  applicant  shall  be 
notified of such extension before the expiry of the time limit set out in paragraph 3 

Article 6 

Controls on profits 

Where a Member State adopts a system of direct or indirect controls on the profitability of persons 
responsible for placing medicinal products on the market, the Member State concerned shall publish 
the following information in an appropriate publication and communicate it to the Commission: 

(a) 

(b) 

(c) 

the method or methods used in the Member State concerned to define profitability: 
return on sales and/or return on capital; 

the  range  of  target  profit  currently  permitted  to  persons  responsible  for  placing 
medicinal products on the market in the Member State concerned; 

the  criteria  according  to  which  target  rates  of  profit  are  accorded  to  an  individual 
responsible for placing medicinal products on the market, together with the criteria 
according  to  which  they  will  be  allowed  to  retain  profits  above  their  targets  in  the 
Member State concerned; 

EN 

15 

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(d) 

the maximum percentage profit which any person responsible for placing medicinal 
products  on  the  market  is  allowed  to  retain  above  his  target  in  the  Member  State 
concerned. 

The  information  referred  to  in  the  first  subparagraph  shall  be  updated  once  a  year  or  when 
significant changes are made. 

Where, in addition to operating a system of direct or indirect controls on profits, a Member State 
operates  a  system  of  controls  on  the  prices  of  certain  types  of  medicinal  products  which  are 
excluded  from  the  scope  of  the  profit  control  scheme,  Articles  3,  4  and  5  shall,  where  relevant, 
apply to such price controls. However, those Articles shall not apply where the normal operation of 
a system of direct or indirect controls on profits results exceptionally in a price being fixed for an 
individual medicinal product. 

Chapter III 

Coverage of medicinal products by public health insurance systems 

Article 7 

1. 

2. 

3. 

4. 

Inclusion of medicinal products in health insurance systems 

Paragraphs  2  to  9  shall  apply  if  a  medicinal  product  is  covered  by  the  public  health 
insurance  system  only  after  the  competent  authorities  have  decided  to  include  the 
medicinal product concerned in the scope of that system. 

Member States shall ensure that an application to include a medicinal product in the scope 
of  the  public  health  insurance  system  can  be  introduced  by  the  marketing  authorisation 
holder  at  any  point  in  time.  If  the  public  health  insurance  system  comprises  several 
schemes or categories of coverage, the marketing authorisation holder shall be entitled to 
apply  for  the  inclusion  of  its  product  in  the  scheme  or  category  of  its  choice.  The 
competent  authorities  shall  provide  the  applicant  with  an  official  acknowledgement  of 
receipt.  

Member  States shall establish in  detail  the  particulars  and documents to be  submitted by 
the applicant.  

Member States shall ensure that a decision on an application to include a medicinal product 
in  the  scope  of  the  public  health  insurance  system,  submitted  by  the  marketing 
authorisation  holder  in  accordance  with  the  requirements  laid  down  in  the  Member  State 
concerned,  is  adopted  and  communicated  to  the  applicant  within  60  days  of  its  receipt. 
However,  with  respect  to  medicinal  products  for  which  Member  States  use  health 
technology assessment as part of their decision-making process, the time-limit shall be 90 
days. With respect to generic medicinal products, that time limit shall be 15 days, provided 
that  the  reference  medicinal  product  has  already  been  included  in  the  public  health 
insurance system. 

EN 

16 

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5. 

6. 

7. 

8. 

1. 

2. 

If the information supporting the application is inadequate, the competent authorities shall 
forthwith notify the applicant of the detailed additional information required and take their 
final  decision  within  60  days  of  receipt  of  this  additional  information.  However,  with 
respect to medicinal products for which Member States use health technology assessment 
as part of their decision-making process, the time-limit  shall be  90 days.  With respect to 
generic  medicinal  products,  that  time  limit  shall  be  15  days,  provided  that  the  reference 
medicinal  product  has  already  been  included  in  the  public  health  insurance  system. 
Member States shall not request any additional information which is not explicitly required 
under national legislation or administrative guidelines.  

Irrespective  of  the  organisation  of  their  internal  procedures,  Member  States  shall  ensure 
that the overall period of time taken by the inclusion procedure set out in paragraph 5 of 
this Article and the price approval procedure set out in Article 3 does not exceed 120 days. 
However,  with  respect  to  the  medicinal  products  for  which  Member  States  use  health 
technology  assessment  as  part  of  their  decision-making  process,  the  time  limit  shall  not 
exceed  180  days.  With  respect  to  generic  medicinal  products,  that  time  limit  shall  not 
exceed 30 days, provided that the reference medicinal product has already been included in 
the public health insurance system. Those time-limits may be extended in accordance with 
paragraph 5 of this Article or Article 3(5).  

Any  decision  not  to  include  a  medicinal  product  within  the  scope  of  the  public  health 
insurance system shall contain a statement of reasons based upon objective and verifiable 
criteria. Any decision to include a medicinal product within the scope of the public health 
insurance system shall contain a statement of reasons justifying the decision, including the 
extent  and  conditions  of  the  product’s  coverage,  on  the  basis  of  objective  and  verifiable 
criteria.  

The decisions referred to in this paragraph shall also include any evaluation, expert opinion 
or  recommendation  on  which  they  are  based.  The  applicant  shall  be  informed  of  all 
remedies available, including judicial remedies, and the remedies procedure set out Article 
8, of the time limits for applying for such remedies. 

Member  States  shall  publish  in  an  appropriate  publication  and  communicate  to  the 
Commission  the  criteria  which  the  competent  authorities  must  take  into  account  when 
deciding whether or not to include medicinal products within the scope of the public health 
insurance system.  

Article 8 

Remedies procedure in case of non-compliance with the time limits related to the inclusion of 
medicinal products in health insurance systems 

Member States shall ensure that effective and rapid remedies are available to the applicant 
in case of non-compliance with the time limits set in Article 7.  

For  the  purposes  of  the  remedies  procedure  Member  States  shall  designate  a  body  and 
entrust it with the powers to:  

EN 

17 

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(a) 

(b) 

take,  at  the  earliest  opportunity  and  by  way  of  interlocutory  procedures,  interim 
measures  with  the  aim  of  correcting  the  alleged  infringement  or  preventing  further 
damage to the interests concerned; 

award  damages  to  the  applicant  in  case  of  non-compliance  with  time  limits  set  in 
Article 7 where damages are claimed, unless the competent authority may prove that 
the delay is not imputable to it; 

(c) 

impose a penalty payment, calculated by day of delay.  

For  the  purposes  of  point  (c),  the  penalty  payment  shall  be  calculated  depending  on  the 
seriousness of the infringement, its duration, the need to ensure that the penalty itself is a 
deterrent to further infringements.  

Member  States  may  provide  that  the  body  referred  to  in  the  first  subparagraph  may  take 
into  account  the  probable  consequences  of  potential  measures  taken  under  the  present 
paragraph  for  all  interests  likely  to  be  harmed,  as  well  as  the  public  interest,  and  may 
decide  not  to  take  such  measures  when  their  negative  consequences  could  exceed  their 
benefits.  

A decision not to grant interim measure shall not prejudice any other claim of the applicant 
seeking such measures.  

Member  States  shall  ensure  that  decisions  taken  by  bodies  responsible  for  remedies 
procedures can be effectively enforced.  

The body referred to in paragraph 2 shall be independent of the  competent authorities in 
charge  of  controlling  the  prices  of  medicinal  products  for  human  use  or  in  charge  of 
determining the range of medicinal products covered by health insurance systems. 

The body referred to in paragraph 2 shall state reasons for its decision. Furthermore, where 
that  body  is  not  judicial  in  character,  provision  must  be  made  to  guarantee  procedures 
whereby any allegedly illegal measure taken by the independent body or any alleged defect 
in  the  exercise  of  powers  conferred  on  it  can  be  subject  to  judicial  review  or  review  by 
another body which is a court or tribunal within the meaning of Article 267 of the Treaty 
on  the  Functioning  of  the  European  Union  and  independent  of  both  the  competent 
authority and the body referred to in paragraph 2.  

The  members  of  the  body  referred  to  in  paragraph  2  shall  be  appointed  and  leave  office 
under the same conditions as members of the judiciary as regards the authority responsible 
for  their  appointment,  their  period  of  office,  and  their  removal.  At  least  the  president  of 
that  body  shall  have  the  same  legal  and  professional  qualifications  as  members  of  the 
judiciary. That body shall take its decisions following a procedure in which both sides are 
heard,  and  these  decisions  shall,  by  means  determined  by  each  Member  State,  be  legally 
binding. 

3. 

4. 

5. 

6. 

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Article 9 

Exclusion of medicinal products from health insurance systems 

Any decision to exclude a medicinal product from the scope of the public health insurance 
system,  or  to  modify  the  extent  or  the  conditions  of  coverage  of  the  product  concerned, 
shall  contain  a  statement  of  reasons  based  on  objective  and  verifiable  criteria.  Such 
decisions  shall  include  any  evaluation,  expert  opinion  or  recommendation  on  which  they 
are  based.  The  applicant  shall  be  informed  of  all  remedies  available,  including  judicial 
remedies, and of the time limits for applying for such remedies. 

Any  decision  to  exclude  a  category  of  medicinal  products  from  the  scope  of  the  public 
health  insurance  system,  or  to  modify  the  extent  or  the  conditions  of  coverage  of  the 
category concerned, shall contain a statement of reasons based on objective and verifiable 
criteria and be published in an appropriate publication. 

Article 10 

Classification of medicinal products in view of their inclusion in health insurance systems 

Paragraphs  2,  3  and  4  shall  apply  where  medicinal  products  are  grouped  or  classified 
according to therapeutic or other criteria for the purpose of their inclusion within the scope 
of the public health insurance system. 

Member  States  shall  publish  in  an  appropriate  publication  and  communicate  to  the 
Commission the objective and verifiable criteria according to which medicinal products are 
classified in view of their inclusion in the public health insurance system. 

For the medicinal products subject to such grouping or classification, Member States shall 
publish  in  an  appropriate  publication  and  communicate  to  the  Commission  the 
methodologies  used  to  determine  the  extent  or  conditions  of  their  inclusion  in  the  public 
health insurance system.  

At  the  request  of  the  holder  of  a  marketing  authorisation,  the  competent  authorities  shall 
specify the objective data on the basis of which they have determined the arrangements of 
coverage  for  their  medicinal  product,  in  application  of  the  criteria  and  methodologies 
referred  to  in  paragraphs  2  and  3.  In  such  a  case,  the  competent  authorities  shall  also 
inform  the  marketing  authorisation  holder  of  all  remedies  available,  including  judicial 
remedies, and of the time limits for applying for such remedies. 

Article 11 

Measures to control or promote the prescription of specific medicinal products 

Paragraphs  2,  3  and  4  shall  apply  where  a  Member  State  adopts  measures  intended  to 
control or promote the prescription of specific named medicinal products. 

Measures referred to in paragraph 1 shall be based on objective and verifiable criteria. 

1. 

2. 

1. 

2. 

3. 

4. 

1. 

2. 

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3. 

4. 

Measures  referred  to  in  paragraph  1,  including  any  evaluation,  expert  opinion  or 
recommendation on which they are based, shall be published in an appropriate publication.  

At the request of the holder of a marketing authorisation whose interests or legal position 
are  affected  by  the  measures  referred  to  in  paragraph  1,  the  competent  authorities  shall 
specify  the  objective  data  and  criteria  on  the  basis  of  which  these  measures  have  been 
taken with respect to its medicinal product. In such a case, the competent authorities shall 
also inform the marketing authorisation holder of all remedies available, including judicial, 
and of the time limits for applying for such remedies. 

Chapter IV 

Specific requirements 

Article 12 

Effectiveness of the time limits 

The  time  limits  laid  down  in  Articles  3,  4,  5  and  7  shall  be  construed  as  the  period  between  the 
receipt of an application or additional information, as the case may be, and the effective entry into 
force of the corresponding decision. All expert evaluations and administrative steps necessary for 
taking the decision and bringing it into effect shall be carried out within the prescribed time limits. 

Article 13 

Additional proof of quality, safety, efficacy or bioequivalence 

In  the  framework  of  pricing  and  reimbursement  decisions,  Member  States  shall  not  re-assess  the 
elements  on  which  the  marketing  authorisation  is  based,  including  the  quality,  safety,  efficacy  or 
bioequivalence of the medicinal product. 

Article 14 

Non interference of intellectual property rights 

1. 

2. 

Applications, decision-making procedures and decisions to regulate the prices of medicinal 
products in accordance with Article 3 or to determine their inclusion within the scope of 
public health insurance systems in accordance with Articles 7 and 9 shall be considered by 
Member  States  as  administrative  procedures  which,  as  such,  are  independent  from  the 
enforcement of intellectual property rights.  

The protection of intellectual property rights shall not be a valid ground to refuse, suspend 
or revoke decisions relating to the price of a medicinal product or its inclusion within the 
public health insurance system. 

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3. 

Paragraphs  1  and  2  shall  apply  without  prejudice  to  the  Union  and  national  legislation 
relating to the protection of intellectual property.  

Chapter V 

Transparency mechanisms 

Article 15 

Consultation of interested parties 

Where  a  Member  State  intends  to  adopt  or  amend  any  measure  falling  within  the  scope  of  this 
Directive, it shall give interested parties the opportunity to comment on the draft measure within a 
reasonable period. The competent authorities shall publish the rules applicable to consultations. The 
results  of  consultations  shall  be  made  publicly  available,  with  the  exception  of  confidential 
information in accordance with Union and national legislation regarding business confidentiality.  

Article 16 

Notification of draft national measures 

1. 

2. 

3. 

4. 

5. 

Where  Member  States intend  to adopt or amend  any  measure  falling  within  the  scope  of 
this Directive, they shall immediately communicate to the Commission the draft measure 
envisaged, together with the reasoning on which the measure is based.  

Where appropriate, Member States shall simultaneously communicate the texts of the basic 
legislative  or  regulatory  provisions  principally  and  directly  concerned,  if  knowledge  of 
such texts is necessary to assess the implications of the measure proposed.  

Member  States  shall  communicate  the  draft  measure  referred  to  in  paragraph  1  again  if 
they  make  changes  to  the  draft  that  have  the  effect  of  significantly  altering  its  scope  or 
substance, or shortening the timetable originally envisaged for implementation. 

The Commission may send its observations to the Member State which has communicated 
the draft measure within three months. 

The observations of the Commission shall be taken into account as far as possible by the 
Member  State  concerned,  in  particular  if  the  observations  indicate  that  the  draft  measure 
may be incompatible with Union law.  

When  the  Member  State  concerned  definitively  adopts  the  draft  measure,  it  shall 
communicate  the  final  text  to  the  Commission  without  delay.  If  observations  have  been 
made  by  the  Commission  in  accordance  with  paragraph  4,  this  communication  shall  be 
accompanied  by  a  report  on  the  actions  taken  in  response  to  the  observations  of  the 
Commission. 

EN 

21 

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Article 17 

Report on the implementation of the time limits 

1. 

By  31  January  of  […]  [insert a date - the year following the date referred to in the first 
subparagraph  of  Article  18(1)],  and  by  31  January  and  1  July  of  every  year  thereafter, 
Member  States  shall  communicate  to  the  Commission  and  publish  in  an  appropriate 
publication a detailed report providing the following information: 

(a) 

(b) 

(c) 

the number of applications received in accordance with Articles 3, 4 and 7 during the 
preceding year; 

the amount of time taken to issue a decision on each of the applications received in 
accordance with Articles 3, 4, and 7.  

an analysis of the main reasons for delays, if any, together with recommendations to 
bring  decision-making  processes  into  line  with  the  time  limits  laid  down  in  this 
Directive. 

For the purposes of point (a) of the first subparagraph, a distinction shall be made between 
generic medicinal products subject to shorter time limits in accordance with Articles 3, 4 
and 7 and other medicinal products. 

For the purposes of point (b) of the first subparagraph, any suspension of the procedure to 
request additional information to the applicant shall be reported with a clear indication of 
the duration of the suspension and the detailed reasons for the suspension.  

2. 

The Commission shall publish every six months a report on the information submitted by 
Member States according to paragraph 1. 

Chapter VI 

Final provisions 

Article 18 

Transposition 

1. 

Member States shall adopt and publish, by [last day of the 12th month following publication 
of  this  Directive  in  the  Official  journal  of  the  European  Union]  at  the  latest,  the  laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive.  They 
shall forthwith communicate to the Commission the text of those provisions.  

They  shall  apply  those  provisions  from  [the  day  after  the  date  set  out  in  the  first 
subparagraph.]. 

EN 

22 

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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 19 

Report on the implementation of this Directive 

1. 

2. 

Member  States  shall  send  a  report  to  the  Commission  on  the  implementation  of  this 
Directive  by  [insert  date  -  within  two  years  after  the  date  referred  to  in  the  second 
subparagraph of Article 18(1)] and every three years thereafter. 

By [insert date - within three years after the date referred to in the second subparagraph 
of Article 18(1)], the Commission shall submit a report to the European Parliament and the 
Council on the implementation of this Directive. The report may be accompanied by any 
appropriate proposals. 

Article 20 

Repeal 

Directive  89/105/EEC  is  repealed  from  [the  date  set  out  in  the  second  subparagraph  of  Article 
18(1)].  

The effects of Article 10 of Directive 89/105/EEC shall be maintained. 

References to the repealed Directive shall be construed as references to this Directive.  

Article 21 

Entry into force and application 

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

Article  16  shall  apply  from  [insert  the  date  -  date  set  out  in  the  second  subparagraph  of  Article 
18(1)]. 

EN 

23 

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Article 22 

Addressees  

This Directive is addressed to the Member States. 

Done at Brussels, 1.3.2012 

For the European Parliament 
The President 

For the Council 
The President 

EN 

24 

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LEGISLATIVE FINANCIAL STATEMENT 

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

EN 

25 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  relating  to  the 
transparency  of  measures  regulating  the  prices  of  medicinal  products  for  human  use  and 
their  inclusion  in  the  scope  of  public  health  insurance  systems  (Repealing  Directive 
89/105/EEC) 

1.2. 

Policy area(s) concerned in the ABM/ABB structure15  

Title 02 – Enterprise 

1.3. 

Nature of the proposal/initiative  

(cid:58) The proposal/initiative relates to the extension of an existing action  

1.4. 

Objectives 

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

1a. Competitiveness for growth and employment 

1.4.2. 

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

Specific objective No.1. 

To continually develop existing internal market acquis and propose new legislative or non-
legislative action whenever appropriate 

ABM/ABB activity(ies) concerned 

Chapter 02 03: Internal market for goods and sectoral policies 

1.4.3.  Expected result(s) and impact 

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

The  proposal  provides  for  a  comprehensive  update  of  Directive  89/105/EEC  in  view  of 
ensuring the transparency of national measures regulating the prices of medicinal products 
for  human  use  and  their  inclusion  in  the  scope  of  social  security  systems.  The  existing 
directive  has  become  outdated  and  difficult  to  enforce  due  to  the  evolution  of  the 
pharmaceutical  market  in  the  last  twenty  years  and  to  the  multiplication  of  national 
measures to contain growing pharmaceutical costs. The proposal aims at avoiding barriers 
to  the  free  movement  of  goods  prohibited  by  the  EU  Treaty,  while  respecting  the 

15 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 

EN 

26 

   EN 

 
                                                 
responsibilities of the Member States for the organisation of their health insurance systems. 
The initiative is expected to: 
- Improve legal clarity and certainty for all interested parties;  
- Provide a level playing field for pharmaceutical companies operating in Europe; 
- Facilitate the enforcement of the procedural obligations incumbent upon Member States. 

1.4.4. 

Indicators of results and impact  

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

The  proposal  consists  in  a  directive  to  be  transposed  into  national  legislation  by  the 
Member States. The first indicator will therefore be the actual transposition rate by the end 
of  the  transposition  deadline.  Budget  is  earmarked  in  order  to  ensure  the  verification  of 
transposition by Member States.  

Effective implementation will be monitored as a second step. The key objectives pursued 
by  the  proposal  consist  in  a)  guaranteeing  that  national  pricing  and  reimbursement 
decisions are made within specific time-limits and b) ensuring the effectiveness of minimal 
transparency  rules  for  national  pricing  and  reimbursement  measures.  Results  will  be 
measured against the following indicators: 

1/  Actual  timing  for  pricing  and  reimbursement  decisions  in  the  Member  States 
(monitoring instrument: mandatory annual reporting by Member States). 

2/  Number  of  non-compliance  cases  identified  in  the  Member  States  (monitoring 
instruments: mandatory notification of draft national measures by national authorities and 
statistics of infringement procedures). 

1.5. 

Grounds for the proposal/initiative  

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

The text of the proposal essentially requires Member States to ensure that: 

1/  Pricing  and  reimbursement  decisions  are  made  within  60/120  days.  However,  with 
respect to medicines for which Member States use health technology assessment as part of 
their  decision-making  process,  the  time-limit  shall  be  90/180  days.  Furthermore,  the 
timeframe is reduced to 15/30 days with respect to generic medicinal products. 

2/ Any measure intended to regulate the prices of medicines, to manage their consumption 
or to determine their reimbursement status is adopted in a transparent manner on the basis 
of objective and verifiable criteria. 

3/ Effective judicial remedies are available to affected pharmaceutical companies. 

1.5.2.  Added value of EU involvement 

National pricing and reimbursement measures have a clear transnational impact linked, in 
particular, to the potential disruption they might cause to the internal market for medicinal 
products.  The  proper  functioning  of  the  internal  market  therefore  requires  timely  and 
transparent decisions to be made by Member States. The notion of procedural transparency 
is understood differently across the EU so that action by individual Member States would 
not provide sufficient guarantees of transparency for economic operators. 

EN 

27 

   EN 

 
1.5.3.  Lessons learned from similar experiences in the past 

In  the  last  twenty  years,  Directive  89/105/EEC  has  played  a  key  role  in  promoting  the 
transparency  of  national  pricing  and  reimbursement  measures.  However,  experience  in 
managing the directive has shown that: 

1/  National  pricing  and  reimbursement  policies  evolve  at  a  quick  pace,  so  that  the 
requirements  of  the  directive  should  be  based  on  general  principles  rather  than  on  the 
description of specific types of measures. 

2/  The  effective  monitoring  of  national  legislation  in  this  field  of  competence  belonging 
essentially  to  the  Member  States  requires  stronger  information  and  enforcement 
mechanisms.  

1.5.4.  Coherence and possible synergy with other relevant instruments 

The  proposal  must  be  seen  in  the  context  of  the  Commission’s  efforts  to  reinforce  the 
internal  market  and  to  generate  favourable  conditions  for  a  competitive  pharmaceutical 
industry  that  provides  safe,  innovative  and  accessible  medicines  to  European  citizens.  It 
relates to a number of recent or on-going initiatives, in particular: 

1/  The  Commission  Communication  on  a  renewed  vision  for  the  pharmaceutical  sector 
(2008), which announced that the application of Directive 89/105/EEC would be enhanced 
to ensure genuinely transparent and speedy pricing and reimbursement decisions. 

2/  The  Commission’s  Pharmaceutical  Sector  Inquiry  (2008-2009),  which  concluded  that 
the  Commission  might  examine  the  potential  need  to  review  Directive  89/105/EEC  in 
order to facilitate timely market access for generic medicines. 

3/  The  political  initiatives  to  foster  cooperation  between  Member  States  on  pricing  and 
reimbursement  challenges,  in  particular  the  High  Level  Pharmaceutical  Forum  (2005-
2008)  and  the  Process  on  Corporate  Responsibility  in  the  Field  of  Pharmaceuticals 
launched by the European Commission in 2010.  

4/  Voluntary  cooperation  between  Member  States  on  health  technology  assessments 
currently  take  forward  in  the  framework  of  the  EUNetHTA  Joint  Action  and  to  be 
formalised  through  the  implementation  of  Directive  2011/24/EU  on  the  application  of 
patients’ rights in cross-border healthcare. 

1.6. 

Duration and financial impact  

(cid:58) Proposal/initiative of unlimited duration 

–  Depending  on  progress  with  the  legislative  process,  implementation  is  envisaged  to 
begin in 2014 (adoption by Council and Parliament) with a deadline for transposition by 
Member States in 2015. 

1.7. 

Management mode(s) envisaged16  

(cid:58) Centralised direct management by the Commission  

16 

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. 

EN 

28 

   EN 

 
                                                 
Comments  

Member  States  will  be  responsible  for  implementing  the  provisions  of  the  directive.  The 
Commission’s role will mainly consist in: 

-Facilitating  and  verifying  the  transposition  of  the  Directive.  Budget  impact:  administrative 
expenditure (missions, conferences, etc.) and expert support (verification of transposition). 
- Facilitating the implementation of the Directive in the context of the Committee created according 
to Article 10 of Directive 89/105/EEC and composed of national representatives and chaired by the 
Commission  services.  Budget  impact:  administrative  expenditure  for  the  organisation  of  the 
Committee. 
- Checking the compliance with the provisions of the Directive of draft national measures notified 
to  the  Commission.  Budget  impact:  this  activity  involves  the  mobilisation  of  additional  human 
resources,  external  translation  work  as  well  as  the  development  of  specific  IT  tools  for 
communication with Member States. 
- The financial resources required will be met by the existing resources (internal market line) which 
are already assigned to the management of the actions and/or by redeployment within the DG. 

EN 

29 

   EN 

 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

The proposal requires Member States to communicate to the Commission: 

1/ The criteria they use to approve the prices of medicines and to decide whether or not to 
include  medicinal  products  within  the  scope  of  the  public  health  insurance  system.  Any 
amendment to these criteria should be reported as well. 

2/  Specific  information  on  the  effective  timing  for  their  pricing  and  reimbursement 
decisions (frequency: every six months) 

3/ Any draft proposal falling within the scope of the Directive (permanent verification of 
compliance and early dialogue). 

4/  A  report  on  the  implementation  of  the  Directive  within  two  years  following 
transposition. 

The  information  communicated  will  be  assessed  by  the  Commission  and,  if  necessary, 
discussed with the Member States for appropriate follow-up. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

The main risks in managing the proposed legislation relate to the following three phases: 

- Initial transposition in national laws; 
- Compliance of any new national measure falling within the scope of the Directive; 
- Effective implementation of the procedural requirements laid down in national law. 

2.2.2.  Control method(s) envisaged  

The  control  methods  envisaged  are  described  in  detail  in  the  Transposition  and 
Implementation Plan (TIP). They mainly consist in: 

- The provision of technical expertise by the Commission during the transposition phase; 
-  The  adoption  of  interpretative  guidelines  by  the  Commission,  in  cooperation  with  the 
Member States, to clarify implementation issues, if any; 
- The verification of compliance of draft national measures by the Commission; 
-  The  review  of  national  implementation  reports,  the  drafting  by  the  Commission  of  an 
implementation report and possible follow-up measures. 

2.3.  Measures to prevent fraud and irregularities  

This initiative does not involve any particular risk of fraud as it only lays down procedural 
requirements  to  be  followed  by  Member  States  in  their  pharmaceutical  pricing  and 
reimbursement  policies.  The  Commission  will  ensure  the  overall  management  of  the 
regulatory  framework  through  administrative  involvement,  subject  to  the  Commission’s 
internal control standards. 

EN 

30 

   EN 

 
3. 

3.1. 

Heading of 
multiannual 
financial 
framework 

Heading 
1 

Heading 
1 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

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. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

Diff./non-
diff. 
(17) 

from 
EFTA18 
countries 

from 
candidate 
countries19 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

– 

Operation 

02.03.01 
and 
development  of  the  internal  market, 
particularly 
of 
notification,  certification  and  sectoral 
aproximation 

fields 

the 

in 

–  Operation 

02.01.04.01 
and 
development  of  the  internal  market, 
particularly 
of 
notification,  certification  and  sectoral 
---  Expenditure  on 
approximation 
administrative management 

fields 

the 

in 

Diff 

YES 

NO 

NO 

NO 

Non-
Diff 

YES 

NO 

NO 

NO 

* Financial headings and budget lines will need to be adapted to the new legal basis to be adopted 
under the financial perspectives 2014-2020. 

17 
18 
19 

EN 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations. 

EFTA: European Free Trade Association.  

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

31 

   EN 

 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

1 

1.a Competitiveness for growth and employment 

EUR million (to 3 decimal places) 

DG: ENTERPRISE 

(cid:121) Operational appropriations  

Year 
N = 
2014 

Year 
N+1= 
2015 

Year 
N+2 = 
2016 

Year 
N+3 = 
2017 

Year 
N+4 = 
2018 

….. Action 
continued ….. 

TOTAL 

02.03.01 – Operation and development of 
the internal market, particularly in the fields of 
notification, certification and sectoral 
approximation 

Commitments 

Payments 

(1) 

(2) 

0,645 

0,735 

0,585 

0,585 

0,585 

0,585 

0,585 

… 

0,150 

0,500 

0,500 

0,500 

0,500 

0,500 

0,500 

of 

an 

administrative 
Appropriations 
 from the envelope for specific programmes20  
02.010401 – Operation and development of 
the internal market, particularly in the fields of 
notification, certification and sectoral 
approximation — Expenditure on 
administrative management 

nature 

financed 

(3) 

0,050 

0,200 

TOTAL appropriations 

Commitments 

=1+1a 
+3 

0,700 

0,735 

0,585 

0,585 

0,785 

0,585 

0,585 

... 

20 

EN 

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. 

32 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
for DG ENTERPRISE 

(cid:121) TOTAL operational appropriations  

Payments 

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

=2+2a 

+3 

(4) 

(5) 

(6) 

0,150 

0,500 

0,500 

0,500 

0,700 

0,500 

0,500 

0,645 

0,735 

0,585 

0,585 

0,585 

0,585 

0,585 

0,150 

0,500 

0,500 

0,500 

0,500 

0,500 

0,500 

0,050 

0,200 

TOTAL appropriations  
under HEADING 1 
of the multiannual financial framework 

Commitments 

=4+ 6 

0,700 

0,735 

0,585 

0,585 

0,785 

0,585 

0,585 

Payments 

=5+ 6 

0,200 

0,500 

0,500 

0,500 

0,700 

0,500 

0,500 

Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

Year 
N = 
2014 

Year 
N+1 = 
2015 

Year 
N+2 = 
2016 

Year 
N+3 = 
2017 

Year 
N+4 = 
2018 

….. Action 
continued …..  

TOTAL 

EUR million (to 3 decimal places) 

DG: ENTERPRISE 

(cid:121) Human resources  

(cid:121) Other administrative expenditure  

0,159 

0,050 

0,508 

0,050 

0,508 

0,050 

0,508 

0,050 

0,508 

0,050 

0,508 

0,050 

0,508 

0,050 

TOTAL DG ENTERPRISE 

Appropriations  

0,209 

0,558 

0,558 

0,558 

0,558 

0,558 

0,558 

… 

… 

TOTAL appropriations 

(Total 

commitments 

0,209 

0,558 

0,558 

0,558 

0,558 

0,558 

0,558 

EN 

33 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
under HEADING 5 
of the multiannual financial framework  

= Total payments) 

Year 
N = 
2014  

Year 
N+1 = 
2015 

Year 
N+2 = 
2016 

Year 
N+3 = 
2017 

Year 
N+4 
=2018 

….. Action 
continued …..  

TOTAL 

EUR million (to 3 decimal places) 

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

Commitments 

0,859

1,293

1,143 

1,143

1,093

1,093

1,093

Payments 

0,409

1,058

1,058 

1,058

1,258

1,008

1,008

Note: The financial resources required will be met by the existing resources (internal market line) which are already assigned to the management of 
the actions and/or by redeployment within the DG.  

EN 

34 

EN 

 
  
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:58)  The proposal/initiative requires the use of operational appropriations, as explained below: 

Year 
N=2014 

Year 
N+1=2015 

Year 
N+2=2016 

Year 
N+3=2017 

….. Action continued …..  

TOTAL 

OUTPUTS 

Commitment appropriations in EUR million (to 3 decimal places) 

N
u
m
b
er 
of 
o
ut
p
ut
s 

Cost 

N
u
m
b
e
r

o
f

o
u
t
p
u
t
s 

Indicate 
objectives and 
outputs  

Type 
of 
output
21 

Average 
cost  
of the 
output 

(cid:216) 

SPECIFIC OBJECTIVE : To 
continually develop existing internal 
market acquis and propose new 
legislative or non-legislative action 
whenever appropriate 

Cost 

Nu
mb
er 
of 
out
put
s 

Cost 

Numb
er 
of 
outpu
ts 

Cost 

N
u
m
b
e
r 
o
f 
o
u
t
p
u
t
s 

Cost 

N
u
m
b
e
r

o
f

o
u
t
p
u
t
s 

Cost 

N
u
m
b
e
r 
o
f 
o
u
t
p
u
t
s 

Cost 

Total 
numbe
r of 
output
s 

Total  
cost 

Translation 

(A)  

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

… 

21 

EN 

Outputs  are products  and services  to be  supplied  (e.g.: number  of  student  exchanges financed,  number of  km  of roads  built,  etc.).  (A)  =  translation work,  (B)  =  IT  support,  (C)= 
Services – Verification of transposition. 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
IT database 

Transposition 

(B) 

(C) 

0,15 

0,15 

1 

0 

Sub-total for specific objective N°1 

0,15 

0,6 

0,09 

0,6 

0,09 

1 

0,15 

0 

0,6 

0 

0,09 

0,6 

0,09 

0,6

0,09 

0,6 

0,09 

0 

0 

0 

… 

0,15 

TOTAL COST 

2 

0,645 

2,6 

0,735 

1,6 

0,585 

1,6 

0,585 

1,6 

0,585 

1,6

0,585 

1,6 

0,585 

… 

EN 

36 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:58)  The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below.  

EUR million (to 3 decimal places) 

Year 
N =2014 

Year 
N+1 = 
2015 

Year 
N+2 = 
2016 

Year 
N+3 = 
2017 

Year 
N+4 = 
2018 

….. Action continued …..  

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

0,159 

0,508 

0,508 

0,508 

0,508 

0,508 

0,508 

… 

Other administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 522 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

0,050 

0,050 

0,050 

0,050 

0,050 

0,050 

0,050 

0,209 

0,558 

0,558 

0,558 

0,558 

0,558 

0,558 

… 

0,050 

0,050 

0,200 

TOTAL 

0,259 

0,558 

0,558 

0,558 

0,758 

0,558 

0,558 

… 

3.2.3.2.  Estimated requirements of human resources  

–  (cid:58)  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) 

22 

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. 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Year 
N= 
2014 

Year 
N+1= 
2015 

Year 
N+2= 
2016 

Year 
N+3= 
2017 

….. Action continued ….. 

(cid:121) Establishment plan posts (officials and temporary agents) 

02 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

0,159 

0,508 

0,508 

0,508 

0,508 

0,508 

… 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)23 

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 24 

- at Headquarters25 

- 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 

0,159 

0,508 

0,508 

0,508 

0,508 

0,508 

… 

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 

Overall management of the Directive (coordination with Member States, organisation 
of  consultative  committee,  legal  interpretation,  infringement  procedures,  etc.), 
assessment  of  draft  national  measures  notified  to  the  Commission,  secretarial  and 
administrative support.  

External personnel 

-- 

23 

24 

25 

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

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

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

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.4.  Compatibility with the current multiannual financial framework  

–  (cid:58)  Proposal/initiative is compatible the current multiannual financial framework. 

–  Financial headings and budget lines will need to be adapted to the new legal basis 

to be adopted under the financial perspectives 2014-2020 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Note:  

Financial headings and budget lines will need to be adapted to the new legal basis to be adopted under 
the financial perspectives 2014-2020.  

3.2.5.  Third-party contributions  

–  (cid:58) The proposal/initiative does not provide for co-financing by third parties  

3.3. 

Estimated impact on revenue  

–  (cid:58)  Proposal/initiative has no financial impact on revenue 

EN 

39 

   EN