Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on 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: 2013-03-18
Institutions: European Commission
Subjects: State health service, administrative transparency, drug surveillance, fixing of prices, health costs, medicinal product, pharmaceutical expenses

EUROPEAN 
COMMISSION 

Brussels, 18.3.2013  
COM(2013) 168 final 

2012/0035 (COD) 

Amended proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

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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  

*  N.B.  Provisions  which  have  been  introduced  in  the  proposal  compared  to  the  initial 
proposal  are  indicated  in  bold,  italic  and  underlined.  Deleted  provisions  of  the  initial 
proposal are indicated in strikethrough. 

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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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.  
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 

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, [2009] ECR 
I-2495  nyr;  Case  C-62/09  Association  of  the  British  Pharmaceutical  Industry  v  Medicines  and 
Healthcare Products Regulatory Agency, [2010] ECR I-3603 nyr. 

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valuable treatments for patients. In 2009, the Commission’s Competition Inquiry into 
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 ASSESSMENTS 

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 
research-based 
insurers, 
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.  

public 
The 
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 
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 

6 

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

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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  30/60  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 
the  framework  of  pricing  and 
bioequivalence)  may  not  be  reassessed 
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 [WHERE NECESSARY] 

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.  

The  proposal  for  a  Directive  repealing  the Council  Directive  89/105/EEC  was  adopted  by 
the Commission on 1 March 2012.  

The European Economic and Social Committee Opinion was adopted on 12 July 2012. 

Negotiations  in  the  Council  Working  Party  on  Pharmaceuticals  and  Medical  Devices 
proved to be difficult, given the politically sensitive nature of the file. Main concerns of the 
Member  States  were  related  to:  the  principle  of  subsidiarity;  the  remedies  procedure 
(Article  8);  the  creation  of  a  system  of  pre-notification  of  draft  national  measures  to  the 
Commission  (Article  16);  shortening  of  the  time  limits  for  taking  decisions  on  pricing  of 
medicines and their inclusion in the scope of health insurance systems (Articles 3, 4, 5, 7); 

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the distinction between originator medicinal products subject to HTA and those not subject 
to HTA (Articles 3, 7); the obligation to consult the interested parties (Article 15).  
The European Parliament adopted its position in 1st reading on 6 February 2013 with 559 
votes  in  favour,  54  against  and  72  abstentions.  The  European  Parliament  put  forward 
amendments  which  provide  a  pragmatic  compromise:  while  maintaining  the  substance  of 
the Commission proposal, they also take into consideration the concerns expressed by the 
Member States. 

As  the  result  of  the  vote  in  Plenary  and  taking  into  consideration  the  position  of  the 
Member  States  in  the  Council,  the  Commission  decided  to  amend  its  Proposal.  The 
amendments  of  the  European  Parliament  voted  in  Plenary  have  been  duly  taken  into 
account.  The  Commission  accepted  or  accepted  in  principle  a  large  number  of  the 
amendments: 50 were acceptable (16 as such and 34 acceptable in principle, even if, a few 
of them were acceptable only in part) and only 7 were unacceptable. These 7 amendments 
were  unacceptable  because  they  represented  a  step  backwards  compared  to  the  existing 
Directive, because they would have introduced legal uncertainty, or they would have gone 
beyond EU competences. 

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2012/0035 (COD) 

Amended proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

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 Committee,7  

After consulting the European Data Protection Supervisor, 

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  medicinal  products, 
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  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  medicinal  products  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 
medicinal  products  es,  to  regulate  their  prices  or  to  establish  the  conditions  of  their 
public funding. Such measures mainly aim at promoting public health for all citizens 

7 
8 
9 

OJ C 299, 4.10.2012, p. 81. 
OJ L 40, 11.2.1989, p. 8. 
OJ L 311, 28.11.2001, p. 67. 

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(5) 

(6) 

(7) 

(8) 

(9) 

by ensuring the availability of adequate supplies of medicinal products at reasonable 
costs, while ensuring the financial stability of public health insurance systems.  

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.  Those  minimum 
procedural requirements should also ensure legal certainty and transparency for all 
the parties involved in the process of pricing of medicinal products and inclusion in 
the health insurance systems, while promoting the production of medicinal products, 
accelerating  the  entry  into  the  market  of  generic  medicinal  products  and 
encouraging research and development of new medicinal products. 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. 

Competent  authorities  and  marketing  authorisation  holders  increasingly  engage  in 
voluntary  contractual  agreements  to  provide  patients  with  access  to  innovative 
treatments. In particular, those agreements allow the inclusion of a medicinal product 
in  the  scope  of  the  health  insurance  systems  while  at  the  same  time  addressing  the 
evidentiary  uncertainties  relating  to  the  relative  efficacy  and/or  effectiveness  of  a 
specific  medicinal  product  by  monitoring  the  elements  agreed  upfront  and  for  a 
defined  period  of  time.  The  delay  in  defining  the  terms  and  conditions  of  such 
voluntary contractual agreements often exceeds the time limits set in this Directive and 
justifies  the  exclusion  of  such  agreements  from  its  scope.  Those  agreements  should 
effectively  facilitate  or  enable  patients'  access  to  innovative  medicinal  products, 
should remain voluntary and should not affect the right of the marketing authorisation 

EN 

10 

   EN 

holder to submit an application for the inclusion of a medicinal product in the health 
insurance system pursuant to this Directive. 

(10)  Any measure taken by the Member State 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  transparent  objective  and 
verifiable  criteria  that  are  independent  from  the  origin  of  the  product  and  should 
provide  adequate  legal  remedies,  including  judicial  remedies,  in  accordance  with 
national procedures, 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.  

(11)  The  Union's  support  for  cooperation  on  health  technology  assessment  (hereinafter 
“HTA”)  in  accordance  with  Article  15  of  Directive  2011/24/EU  of  the  European 
Parliament and of the Council of 9 March 2011 on the application of patients' rights in 
cross-border healthcare10 aims to optimise and coordinate HTA methodologies which 
should  ultimately  also  reduce  delays  in  pricing  and  reimbursement  procedures  of 
medicinal  products  for  which  Member  States  use  HTA  as  part  of  their  decision-
making  process.  HTA  includes,  in  particular,  information  on  the  relative  efficacy  as 
well  as  on  the  short-term  and  long-term  effectiveness,  where  appropriate,  of  health 
technologies,  also  taking  into  account  broader  economic  and  social  benefits  or  cost-
effectiveness of the assessed medicinal product, in accordance with the methodology 
of  the  competent  authorities.  HTA  is  a  multidisciplinary  process  that  summarises 
information about the medical, social, economic and ethical aspects relating to the use 
of health technology in a systematic, transparent, unbiased and robust manner. Its aim 
is  to  contribute  to  the  formulation  of  safe,  effective,  health  policies  that  are  patient-
focused and that seek to achieve best value. 

(12)  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. 

(13) 

In  order  to  facilitate  compliance  with  the  time  limits  set  in  this  Directive,  it  may  be 
useful  for  applicants  of  a  marketing  authorisation  to  start  informal  negotiations  for 
price  approval  or  for  inclusion  of  a  medicinal  product  in  the  public  health  insurance 
systems  already  before  the  marketing  authorisation  is  granted.  To  this  end,  Member 
States  should  have  the  possibility  to  allow  such  applicants  to  submit  a  request  for 
informal negotiations for price approval of a medicinal product or for its inclusion in 
the  health  insurance  systems  after  the  scientific  assessment  is  finalised  by  the 
Committee  for  Medicinal  Products  for  Human  Use  or  by  the  national  competent 
authority  in  charge  of  the  marketing  authorisation  procedure,  as  appropriate.  In  such 
cases the time limits for decisions on the price of a medicinal product or its inclusion 
in  the  health  insurance  system  should  run  from  the  formal  application  for  pricing  or 

10 

OJ L88; 4.4.2011; p.45 

EN 

11 

   EN 

                                                 
inclusion  in  the  health  insurance  systems  after  the  granting  of  the  marketing 
authorisation.  

(14)  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.  

(15) 

In  its  Communication  "Executive  Summary  of  the  Pharmaceutical  Sector  Inquiry 
Report"11  the  Commission  demonstrated  that  pricing  and  reimbursement  procedures 
often  unnecessarily  delay  the  launch  of  generic  medicinal  products  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. Same conditions might apply where appropriate to 
biosimilar medicinal products.  

(16)  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,  which  deter  affected  companies  from  initiating  legal  action. 
Therefore,  effective  mechanisms  are  necessary  to  ensure  swift  infringement 
resolution besides the judicial proceedings if necessary so as to control and enforce 
compliance with the time limits for pricing and reimbursement decisions. To this end, 
Member  States  should  have  the  possibility  to  designate  an  existing  administrative 
body. 

(17)  The quality, safety and efficacy of medicinal products, including the bioequivalence of 
generic medicinal products or the biosimilarity of biosimilar medicinal products with 
the  reference  product,  are  ascertained  in  the  framework  of  marketing  authorisation 
procedures. In the framework of pricing and reimbursement procedures, the competent 
authorities  Member  States  should  therefore  not  re-assess  the  elements  on  which  the 
marketing  authorisation 
the  quality,  safety,  efficacy  or 
including 
bioequivalence  or  biosimilarity  of  the  medicinal  product  which  have  been  already 
assessed  during  the  marketing  authorisation  process.  Similarly,  in  the  case  of 
orphan  medicinal  products,  the  competent  authorities  should  not  re-assess  the 
criteria of the orphan designation. However, competent authorities should have full 
access  to  the  data  used  by  the  authorities  responsible  for  granting  the  marketing 
authorisation of a medicinal product as well as the possibility of using or generating 
additional  relevant  data  for  the  purpose  of  assessing  a  medicinal  product  in  the 
context of its inclusion in the scope of the public health insurance system. 

is  based, 

(18)  The non-reassessment of the elements on which the marketing authorisation is based 
within the framework of pricing and reimbursement procedures should not, however, 
prevent the competent authorities from requesting, accessing and using data generated 
during  the  marketing  authorisation  process  for  the  purpose  of  HTA.  Data  sharing 
between  the  competent  authorities  responsible  for  marketing  authorisation  and  for 
pricing and reimbursement should be possible at national level if such sharing exists. 

11 

COM(2009) 351 final.  

EN 

12 

   EN 

                                                 
(19) 

The  competent  authorities  should  also  be  able  to  use  available  data  or  generate 
additional relevant data for health technology assessment purpose. 

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  or  biosimilar 
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  or  biosimilar  medicinal 
product  be  manufactured  or  placed  on  the  market  subsequently  to  their  decision. 
Consequently,  intellectual  property  issues  should  neither  interfere  with  nor  delay 
pricing and reimbursement procedures in the Member States. 

(20)  The Commission and the Member States might investigate possibilities to co-operate 
in  the  view  of  setting  up  and  maintaining  price  information  database  on  medicinal 
products and relevant conditions so as to provide a Union-wide added value in terms 
of price transparency while respecting the Member States’ competences in this field.  

(21) 

In order to ensure the transparency, integrity and independence of the decision-making 
process within the national competent authorities, the names of experts participating in 
the  bodies  responsible  for  pricing  and  reimbursement  decisions,  together  with  their 
declarations of interest and the procedural steps leading to pricing and reimbursement 
decisions should be disclosed to the public. 

(22)  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  an  information  mechanism  mechanisms  intended,  on  the  one 
hand,  to  ensure  the  consultation  of  all  interested  stakeholders  including  civil  society 
organisations,  such  as  patient  and  consumer  groups  and,  on  the  other  hand,  to 
facilitate  preventive  dialogue  with the  Commission  as  regards  the  application  of  this 
Directive.  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. 

(23) 

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.  

EN 

13 

   EN 

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. Member States shall also 
ensure  that  the  national  procedures  related  to  the  pricing  of  medicinal  products 
and their inclusion in the health insurance systems are not duplicated at regional 
or local level in their respective territories. 

2. 

This Directive shall not apply to the following: 

(a)  voluntary  contractual  agreements  which  are  concluded  between  competent 
authorities  and  the  marketing  authorisation  holder  for  a  medicinal  product 
which is not mandatory nor represents the only possibility for the medicinal 
product  to  be  included  in  the  health  insurance  systems,  and  which  aims  to 
include  a  medicinal  product  under  the  scope  of  a  health  insurance  system 
while monitoring elements are agreed upfront among both parties relating to 
the effectiveness and/or relative efficacy of the given medicinal product, with 
a view to enabling the effective provision of that medicine to patients under 
specific conditions and during an agreed period of time. 

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; 

(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,12  Council  Directive  92/13/EEC13  and  Directive 
2004/18/EC of the European Parliament and of the Council.14 

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.  In  accordance  with  Union  and  national  law  regarding  business 
confidentiality, information regarding the name of the medicinal product and the 
name of the marketing authorisation holder included in contractual agreements or 

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. 

EN 

14 

   EN 

 
                                                 
public  procurement  procedures  shall  be  made  publicly  available  once  those 
agreements or procedures are concluded. 

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. 

This Directive shall be without prejudice to the marketing authorisation relating to 
a  medicinal  product  granted  in  accordance  with  the  procedure  referred  to  in 
Article 6 of Directive 2001/83/EC and Article 3 of Regulation (EC) No 726/2004 of 
the European Parliament and of the Council. 15 

Article 2 

Definitions 

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

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

1. 

15 
16 

“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; 

“biosimilar  medicinal  product”  means  biological  medicinal  product  which  is 
similar to a reference biological medicinal product; 

“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 Council16; 

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

Chapter II 

Pricing of medicinal products 

Article 3 

Price approval 

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. 

OJ L 136, 30.4.2004, p. 1. 

OJ L 88, 4.4.2011, p. 45. 

EN 

15 

   EN 

                                                 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

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 of the formal application for pricing within 10 days of its receipt.  

Member  States  may  provide  the  possibility  to  the  applicant  of  a  marketing 
authorisation to submit a request for informal negotiations on price approval when 
the Committee for Medicinal Products for Human Use established by Article 5 of 
Regulation  (EC)  No  726/2004  or  the  national  competent  authority  has  issued  an 
opinion in favour of the granting of a marketing authorisation  for  the  medicinal 
product concerned.  

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 
90  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  30 15  days,  provided  that  the  price  of the  reference  medicinal  product  has 
been approved by the competent authorities.  

Where  Member  States  decide  to  include  health  technology  assessment  as  part  of 
their  decision-making  process  on  the  pricing  of  medicinal  products,  such 
assessment  shall  be  carried  out  within  the  time  limits  set  out  in  the  first 
subparagraph. 

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  90  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 3015 
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 
legislation  or 
administrative guidelines.  

is  not  explicitly  required  under  national 

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. 

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.  Member  States  shall  make 

EN 

16 

   EN 

9. 

1. 

2. 

3. 

publicly available the information on those criteria and decision-making bodies at 
national or regional level. 

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.  The  decision  and  summary  of  the  statement  of  reasons  shall  be  made 
publicly available by the competent authorities without delay, after deletion of any 
information of a commercially confidential nature. 

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 in accordance with national 
law at any point in time. The competent authorities shall provide the applicant with 
an  official  acknowledgement  of  receipt  of  the  application  within  10  days  of  its 
receipt. 

Member  States  shall  ensure  that  a  decision  to  approve  or  reject  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  90  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  90  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.  

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 

17 

   EN 

5. 

6. 

EN 

1. 

2. 

3. 

objective and 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 

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. Once a year 
Member States shall assess whether the price freeze or the price reduction is still 
justified taking into account the macro-economic conditions and adopt necessary 
changes where appropriate. 

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 of the formal applicationfor inclusion of the medicinal 
product in the health insurance system within 10 days of its 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 90 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  90  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 

18 

   EN 

(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 

1. 

2. 

3. 

4. 

Article 7 

Inclusion of medicinal products in health insurance systems 

Paragraphs 2 to 8 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.  The  competent  authorities  shall  provide 
the applicant with an official acknowledgement of receipt of the application within 
10 days of its receipt. 

Member  States  may  also  provide  the  possibility  to  the  applicant  of  a  marketing 
authorisation  to  submit  a  request  for  informal  negotiations  on  inclusion  of  a 
medicinal  product  in  the  scope  of  the  publisc  health  insurance  systems  when  the 
Committee  for  Medicinal  Products  for  Human  Use  established  by  Article  5  of 
Regulation  (EC)  No  726/2004  or  the  national  competent  authority  has  issued  an 
opinion in favour of the granting of a marketing authorisation for  the medicinal 
product concerned.  

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. 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 90 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 

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limit shall be 15 30 days, provided that the reference medicinal product has already 
been included in the public health insurance system.  

Where  Member  States  decide  to  include  health  technology  assessment  as  part  of 
their  decision-making  process  on  the  pricing  of  medicinal  products,  such 
assessment  shall  be  carried  out  within  the  time  limits  set  out  in  the  first 
subparagraph 

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  90  60  days  of  receipt  of  the  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 30 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 120 180 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  60  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.  Member  States  shall  make  publicly  available  the 
information  on  those  criteria  and  decision-making  bodies  at  national  or  regional 
level. 

5. 

6. 

7. 

8. 

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Article 8 

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

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

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

For the purposes of the remedies procedures referred in paragraph 1, Member States 
may  designate  a  body  and  entrust  it  with  the  powers  to  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. 

The body in charge of the remedies procedures shall be independent of the competent 
authorities in charge of controlling the prices of medicinal products or in charge of 
determining the range of medicinal products covered by 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:  

(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 

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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. 

Article 9 

1. 

2. 

3. 

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. 

Any  decision  to  exclude  a  medicinal  product  or  a  category  of  medicinal  products 
from  the  scope  of  the  public  health  insurance  system  shall  be  made  publicly 
available, together with a summary of the statement of reasons, after deletion of any 
information of a commercially confidential nature. 

Article 10 

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

1. 

2. 

3. 

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.  

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4. 

1. 

2. 

3. 

4. 

1. 

2. 

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. 

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 and made available to the public.  

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  remedies,  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. 

If  the  decision  making  process  involves  negotiations  between  the  marketing 
authorisation holder and the competent authority, provided that it is agreed by both 
parties, the time limits laid down in Articles 3, 4, 5 and 7 shall be suspended from the 
time  the  competent  authority  communicates  its  proposals  to  the  marketing 
authorisation  holder  until  the  competent  authority  receives  the  response  to  its 

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proposals  from  the  marketing  authorisation  holder.  Member  States  shall  make 
available to the public the practical modalities for such suspension. 

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 
the  quality,  safety,  efficacy,  or  bioequivalence,  or  biosimilarity  of  the  medicinal 
product  or  the  criteria  for  orphan  designation  which  have  already  been  assessed 
during the marketing authorisation procedure. 

Paragraph  1  shall  be  without  prejudice  to  the  right  of  the  competent  authorities  to 
request  and  have  full  access  to  data  generated  during  the  marketing  authorisation 
process for the purpose of health technology assessment, so that they can assess the 
relative efficacy as well as the short- and long-term effectiveness, where appropriate, 
of a medicinal product. 

The  competent  authorities  shall  also  be  able  to  use  the  available  data  or  generate 
additional relevant data for the purpose of health technology assessment. 

Article 14 

Non interference of intellectual property rights 

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. 

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

1. 

2. 

3. 

1. 

2. 

3. 

Chapter V 

Transparency mechanisms 

Article 15 

Consultation of interested parties 

Where a Member State intends to adopt or amend any legislative measure falling within the 
scope  of  this  Directive,  it  shall  give  civil  society  organisations,  including  patient  and 
consumer  groups,  and  other  interested  parties,  the  opportunity  to  comment  on  the  draft 
measure  within  a  reasonable  period.  The  competent  authorities  shall  publish  the  rules 

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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 

Transparency of decision-making bodies and prices 

1. 

Member  States  shall  ensure  that  the  competent  authorities  controlling  the  prices  of 
medicinal  products  or  determining  the  coverage  of  medicinal  products  by  public 
health  insurance  systems  make  publicly  available  a  regularly  updated  list  of  the 
members of their decision-making bodies, together with their declarations of interest. 

2. 

Paragraph 1 shall also apply to the body referred to in Article 8(2). 

1. 

2. 

3. 

4. 

5. 

1. 

Article 16 

Notification of draft national measures 

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 
timetable  originally  envisaged  for 
the 
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. 

Article 17 

Report on the implementation of the time limits 

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: 

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(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.  

together  with 
an  analysis  of 
recommendations  to  bring  decision-making  processes  into  line  with  the  time 
limits laid down in this Directive. 

the  main  reasons  for  delays, 

if  any, 

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  year  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.]. 

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.  

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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)]. 

Article 22 

Addressees  

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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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

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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) 
Policy area(s) concerned in the ABM/ABB structure17  

1.2. 

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  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. 

17 

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

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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  90/180  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  days. 
Furthermore,  the  timeframe  is  reduced  to  30/60  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. 

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. 

EN 

30 

   EN 

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) envisaged18  

(cid:58) Centralised direct management by the Commission  

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. 

18 

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 

31 

   EN 

                                                 
-  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 

32 

   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 year six months) 

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

3/  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 

33 

   EN 

3. 

3.1. 

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. 
(19) 

from 
EFTA20 
countries 

from 
candidate 
countries21 

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, 
of 
particularly 
notification,  certification  and  sectoral 
aproximation 

fields 

the 

in 

–  Operation 

and 
02.01.04.01 
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 

Heading of 
multiannual 
financial 
framework 

Heading 
1 

Heading 
1 

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

19 
20 
21 

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. 

34 

   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 

Appropriations 
administrative 
 from the envelope for specific programmes22  
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 
for DG ENTERPRISE 

Commitments 

Payments 

=1+1a 
+3 

=2+2a 

+3 

0,700 

0,735 

0,585 

0,585 

0,785 

0,585 

0,585 

... 

0,150 

0,500 

0,500 

0,500 

0,700 

0,500 

0,500 

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 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

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

(4) 

(5) 

(6) 

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 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0,209 

0,558 

0,558 

0,558 

0,558 

0,558 

0,558 

EN 

36 

EUR million (to 3 decimal places) 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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

Year 
N = 
2014  

Year 
N+1 = 
2015 

Year 
N+2 = 
2016 

Year 
N+3 = 
2017 

Year 
N+4 
=2018 

….. Action 
continued …..  

TOTAL 

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 

37 

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) 

Indicate 
objectives and 
outputs  

(cid:216) 

Type 
of 
output
23 

Average 
cost  
of the 
output 

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

Translation 

(A)  

0,495 

IT database 

(B) 

0,15 

N
u
m
b
er 
of 
o
ut
p
ut
s 

1 

1 

Cost 

N
u
m
b
e
r

o
f

o
u
t
p
u
t
s 

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 

0,495 

1 

0,495 

1 

0,495 

0,15 

0,6 

0,09 

0,6 

0,09 

1 

0,6 

0,495 

1 

0,495 

1 

0,495 

1 

0,495 

0,09 

0,6 

0,09 

0,6

0,09 

0,6 

0,09 

… 

… 

23 

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. 

EN 

38 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Transposition 

(C) 

0,15 

0 

1 

0,15 

0 

0 

0 

0 

0 

0,15 

Sub-total for specific objective N°1 

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 

39 

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 524 
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) 

Year 
N= 
2014 

Year 
N+1= 
2015 

Year 
N+2= 
2016 

Year 
N+3= 
2017 

….. Action continued ….. 

24 

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

EN 

40 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(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)25 

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

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

XX 01 04 yy 26 

- at Headquarters27 

- 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 

-- 

25 

26 

27 

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 

41 

   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 

42 

   EN