COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document 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 the public health insurance systems
Date: 2012-03-01
Institutions: European Commission
Subjects: State health service, administrative transparency, drug surveillance, equal treatment, free movement of goods, health costs, medicinal product, pharmaceutical expenses

EUROPEAN COMMISSION 

Brussels, 1.3.2012  
SWD(2012) 29 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying the document 

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 the public health insurance systems 

{COM(2012) 84 final} 
{SWD(2012) 30 final} 

 
 
 
 
  
 
COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 

Accompanying the document 

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 the public health insurance systems 

1. 

INTRODUCTION 

The pharmaceutical market is characterised by its specific structure and by a high degree of 
public  regulation.  On  the  one  hand,  EU  legislation  provides  harmonised  rules  to  ensure  the 
quality, safety and efficacy of medicinal products. Medicines can be placed on the market in 
the European Union only if they have received a marketing authorisation from the European 
Commission  or  from  the  competent  national  authorities.  On  the  other  hand,  pharmaceutical 
expenditure  is  largely  subsidised  by  national  health  systems  in order to ensure the adequate 
provision  of  medicines  to  all  citizens.  In  this  context,  Member  States  adopt  measures  to 
regulate  the  prices  of  medicines  and  the  conditions  of  their  public  funding.  Such  measures 
influence  the  prescription  and  utilisation  of  medicines  in  each  country.  They  may  create 
barriers  to  pharmaceutical  trade  within  the  EU  because  they  affect  the  capacity  of 
pharmaceutical companies to sell their products in domestic markets. 

Directive 89/105/EEC was adopted in the late 1980s to enable market operators to verify that 
national  measures  do  not  create  barriers  to  trade  incompatible  with  the  provisions  of  the 
Treaty governing the free movement of goods. The directive lays down  minimal procedural 
requirements to ensure the transparency of national pricing and reimbursement measures (for 
this  reason,  it  is  commonly  referred  to  as  the  Transparency  Directive).  In  accordance  with 
provisions  of  the  Treaty,  the  directive  does  not  affect  national  pricing  decisions  and  social 
security  policies.  Member  States  are  free  to  adopt  their  own  pricing  and  reimbursement 
decisions,  as  long  as  these  comply  with  the  procedural  obligations  of  the  directive.  These 
obligations  include  specific  time-limits  for  individual  pricing  and  reimbursement  decisions 
(90  days  for  pricing,  90  days  for  reimbursement  or  180  days  for  combined  decisions).  The 
directive  also  requires  the  competent  national  authorities  to  issue  a  statement  of  reasons  for 
each of their decisions, based on objective and verifiable criteria, and to provide appropriate 
legal remedies to the applicant companies. 

This impact assessment examines the need to update Directive 89/105/EEC more than twenty 
years  after  its  entry  into  force.  It  focuses  on  the  fundamental  objectives  of  the  directive, 
without  putting  into  question  the  responsibilities  of  the  Member  States  for  the  organisation 
and financing of their health insurance systems.  

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2. 

PROBLEM DEFINITION 

Since the early 1990s, Directive 89/105/EEC has played an important role in promoting the 
transparency  of  national  pricing  and  reimbursement  measures  and  facilitating  the  internal 
market  in  medicinal  products.  However,  the  evolution  of  the  pharmaceutical  market  has 
created  a  gap  between  the  procedural  rules  laid  down  in  the  directive  and  the  national 
measures  it  intends  to  address.  In  particular,  the  market  structure  has  fundamentally 
changed,for instance with the emergence of generic medicines or the development of highly 
innovative  research-based  medicinal  products.  Furthermore,  Member  States  have  been 
devising increasingly complex and innovative pricing and reimbursement policies in order to 
contain rising pharmaceutical expenditure. 

The main problems observed are summarised below. 

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(1) 

Delays in time to market medicinal products 

The  Pharmaceutical  sector  inquiry  carried  out  by  the  European  Commission  (2008-2009) 
highlighted frequent delays in pricing and reimbursement decisions by Member States, both 
with  respect  to  innovative  (originator)  medicines  and  to  generic  medicines.  These  delays 
contribute  to  postponing  the  entry  of  medicines  in  national  markets  after  the  granting  of  a 
marketing authorisation. 

For originator medicines, the time-limits of 90/180 days laid down in Directive 89/105/EEC 
are  not  always  complied  with  by  the  competent  authorities  due  to  procedural  or  technical 
delays. This situation affects patients, by delaying the availability of authorised treatments, as 
well as pharmaceutical companies, which benefit from a limited period of time (the patent and 
data  protection  periods)  to  recoup  their  extensive  research  and  development  costs  and  to 
generate profits.  

As regards generic medicines, it takes on average 140 days in EU countries to obtain a pricing 
and  reimbursement  decision.  However,  the  Pharmaceutical  sector  inquiry  demonstrated  that 
national  procedures  could  be  much  shorter  because  generics  contain  the  same,  well-known 
active  ingredients  as  the  reference  (originator)  product  and  the  latter  is  generally  already 
reimbursed at a higher price than its generic versions. In addition, the sector inquiry reported 
specific regulatory approaches or administrative practices which unnecessarily delay pricing 
and reimbursement decisions for generic medicines. These practices include the re-evaluation 
of safety features already assessed during the marketing authorisation process and attempts to 
delay pricing and reimbursement procedures on the basis of arguments relating to intellectual 
property  rights  (patent  linkage).  Unnecessary  delays  in  the  pricing  and  reimbursement  of 
generic medicines affect healthcare budgets (lost saving opportunities due to postponed price 
competition),  generic  companies  (reduced  prospects  of  return  on  investment)  and  patients 
(deferred access to cheaper medicines). 

(2) 

Adequacy and effectiveness of the directive in a changing context 

Directive  89/105/EEC  was  adopted  at  the  end  of  the  1980s  in  consideration  of  the  market 
conditions  and  national  policies  which  prevailed  at  the  time.  The  pharmaceutical  market  as 
well  as  pricing  and  reimbursement  policies  have  tremendously  evolved  since  then.  The 
following problems have arisen in this context: 

(a) 

Issues of legal interpretation, implementation and enforcement  

Directive  89/105/EEC  has  frequently  given  rise  to  interpretation  controversies,  for 
instance  during  infringement  investigations  initiated  by  the  Commission  and  in  the 
framework of cases submitted to the Court of Justice of the European Union (CJEU). 
Different  factors  account  for  these  recurrent  interpretation  debates:  firstly,  the 
increasing complexity of the pricing and reimbursement mechanisms introduced by 
Member States means that national measures do not necessarily match the processes 
described in the directive; secondly, cost-control policies now extend beyond pricing 
and  reimbursement  (supply-side  measures)  to  include  measures  targeted  at  health 
professionals,  pharmacists  and  patients  (demand-side  measures);  thirdly,  several 
provisions of the directive are drafted in such a way that they often trigger divergent 
interpretations.  

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The  CJEU  has  consistently  interpreted  Directive  89/105/EEC  in  an  extensive 
manner,  on  the  basis  of  its  general  objectives,  in  order  to  ensure  its  effectiveness. 
However, Member States tend to advocate a restrictive interpretation of the directive 
and  regularly  dismiss  the  application  of  its  requirements  to  their  pricing  and 
reimbursement measures. Implementation issues also arise when Member States fail 
to  see  concretely  how  the  directive  should  be  applied  to  their  specific  national 
systems.  Finally,  the  frequent  administrative  or  regulatory  changes  introduced  by 
national authorities in all countries have created additional enforcement difficulties.  

(b) 

Relationship with innovative pricing and reimbursement mechanisms  

In  response  to  the  evolution  of  pharmaceutical  expenditure,  Member  States  have 
developed  alternative  pricing  and  reimbursement  mechanisms  which  fundamentally 
differ  from  the  procedural  approaches  envisaged  by  Directive  89/105/EEC. 
Innovative  instruments  include  contractual  agreements  designed  to  facilitate  access 
to  new  medicines  under  specific  conditions  agreed  with  individual  pharmaceutical 
companies (managed entry agreements) and tendering procedures used by the social 
security institutions to determine the prices and reimbursement conditions of specific 
categories  of  medicinal  products.  These  mechanisms  do  not  respond  to  the 
administrative logic of Directive 89/105/EEC and are also covered by specific rules 
such  as  legislation  on  public  procurement  and  administrative  or  contract  law.  This 
leads  to  uncertainty  as  regards  the  legal  relationship  between  these  innovative 
practices and the directive. 

(c) 

Adequacy to address medical developments 

The  development  of  new 
therapeutic  approaches  based  on  patient-specific 
information  (e.g.  genetic  profile)  may  create  further  challenges  for  the  internal 
market  in  the  context  of  pricing  and  reimbursement  decisions.  In  particular, 
“personalised medicines” closely associate medicinal products with medical devices, 
such  as  in-vitro  diagnostic  tests.  This  feature  implies  that  disconnections  between 
pricing and reimbursement decisions for the medicinal product and for the associated 
diagnostic/medical  device  might  result  in  trade  barriers  and  market  access  delays. 
This particular situation was not foreseen by the current directive.  

(3) 

Transparency of pricing and reimbursement procedures for medical devices 

Directive  89/105/EEC  only  applies  to  medicinal  products.  Medical  devices  are  currently 
excluded  from  the  scope  of  the  directive.  Despite  the  specificity  of  the  medical  devices 
market,  including  major  differences  with  the  pharmaceutical  sector  in  terms  of  pricing  and 
coverage  by  health  insurance  systems,  some  medical  devices  can  be  subject  to  price 
regulation  and  administrative  reimbursement  decisions.  The  relevance  of  Directive 
89/105/EEC to these products therefore requires examination. 

3. 

ANALYSIS OF SUBSIDIARITY 

Pursuant to Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), 
Member States are responsible for the definition of their health policy and the organisation of 
their healthcare system, including the allocation of resources assigned to health services and 
medical  care.  Directive  89/105/EEC  is  based  on  Article  114  TFEU,  which  foresees  the 

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adoption  of  measures  for  the  establishment  and  functioning  of  the  internal  market.  Its 
provisions  provide  for  minimal  harmonisation:  they  do  not  affect  national  policies  on  price 
setting and reimbursement, except as far as necessary to ensure procedural transparency.  

The proper functioning of the internal market requires timely and transparent decisions on the 
pricing and reimbursement of medicines. Despite the extensive interpretation of the directive 
by the Court of Justice, the notion of procedural transparency is understood differently in each 
Member  State,  so  that  action  by  individual  Member  States  would  not  provide  sufficient 
guarantees  of  procedural  transparency  for  economic  operators.  Nevertheless,  this  initiative 
shall  take  into  account  the  responsibilities  of  the  Member  States  for  the  organisation  and 
financing  of  their  health  insurance  system.  It  should  therefore  focus  on  the  possible 
clarification  of 
the  general  procedural  rules  framing  pharmaceutical  pricing  and 
reimbursement. Issues of substance – such as the content of national policies or the challenges 
linked to differences in the prices, availability and affordability of medicines across Europe – 
are linked to the exercise of national competences and therefore remain outside the scope of 
the analysis. 

4. 

OBJECTIVES 

The  overall  objective  of  this  initiative  is  to  ensure  the  transparency  of  national  measures 
intended  to  regulate  the  prices  of  medicinal  products,  to  manage  their  consumption  or  to 
establish the conditions of their public funding in order to avoid obstacles to pharmaceutical 
trade prohibited by the Treaty.  

In  light  of  the  situation  described  in  Section  2,  any  policy  initiative  relating  to  Directive 
89/105/EEC should specifically aim at: 

(1) 

(2) 

Ensuring  timely  pricing  and  reimbursement  decisions  for  medicinal  products 
(Objective A); 

Ensuring  the  adequacy  and  effectiveness  of  the  directive  in  a  changing  context 
(Objective B); 

(3) 

Examining the relevance of the directive to the medical devices market (Objective C).  

5. 

POLICY OPTIONS 

Two extreme policy options were discarded at an early stage, namely: 

–  the  full  harmonisation  of  pricing  and  reimbursement  measures,  which  would  be 
incompatible with the rules of the Treaty recognising the competence of Member States for 
the definition and financing of their health policies; 

–  the  mere  repeal  of  Directive  89/105/EEC,  which  would  represent  a  step  backward  in  the 

operation of the single market. 

Besides  the  baseline  scenario  (options  A.1,  B.1  and  C.1),  the  following  options  were 
examined in relation to each of the specific objectives outlined above: 

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(1)  Objective  A:  Ensure  timely  pricing  and  reimbursement  decisions  for  medicinal 

products  

•  Option A.2: soft law 

•  Option A.3: revision of the directive to improve the enforcement of the time-limits 

–  Option A.3/a: financial penalties by national judges 

–  Option  A.3/b:  automatic  inclusion  of  individual  products  in  the  health  insurance 

system after expiry of the deadlines and until a decision is adopted  

–  Option  A.3/c:  obligation  to  communicate  and  publish  reports  on  pricing  and 

reimbursement approval times 

•  Option A.4: revision of the directive to avoid unnecessary delays for generic medicines 

–  Option  A.4/a:  shorter  time-limits  for  pricing  and  reimbursement  decisions 

concerning generic products 

–  Option A.4/b: prohibition of patent linkage and of the duplication of assessments 

carried out during the marketing authorisation phase 

•  Option  A.5:  shorter  time-limits  for  pricing  and  reimbursement  decisions  concerning 

originator medicines 

(2)  Objective B: Ensure the adequacy and effectiveness of the directive in a changing 

context  

•  Option B.2: soft law 

•  Option B.3: revision of the directive to align its provisions with major developments in the 

pharmaceutical market 

–  Option B.3/a: minimal revision of the directive to reflect the case-law of the Court 

of Justice 

–  Option  B.3/b:  extensive  revision  of  the  directive  to  bring  it  into  line  with  the 

current pharmaceutical environment 

•  Option  B.4:  notification  of  draft  national  measures  to  facilitate  the  enforcement  of  the 

directive 

(3)  Objective  C:  Possible  extension  of  the  scope  of  the  directive  to  cover  medical 

devices 

The extension of the directive to the medical devices market as a whole was discarded at an 
early stage. Indeed, many medical devices are not reimbursed as such to the patients: they are 
instead  covered  by  health  insurance  systems  as  part  of  the  global  health  interventions 
practised by health professionals. One option was therefore examined in addition to the status 
quo: 

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–  Option C.2: partial extension of the directive to cover medical devices subject to 

pricing and inclusion in reimbursement lists. 

6. 

ASSESSMENT OF IMPACTS 

Given  the  merely  procedural  nature  of  Directive  89/105/EEC,  no  environmental  impact  has 
been identified for the analysed options. Economic and social impacts are summarised below. 

(1)  Objective  A:  Ensure  timely  pricing  and  reimbursement  decisions  for  medicinal 

products  

Option A.1:  

Delays for originator medicines 

Status quo 
(baseline 
scenario) 

• 

• 

• 

Originator  companies:  lost  revenues  linked  to  delayed  market  entry  (estimate:  35  to  100 
million EUR per medicine), reduced capacity to invest in R&D, viability of SMEs at stake. 

Patients:  welfare  losses  due  to  the  delayed  availability  of  medicines  (order  of  magnitude  in 
monetary value: up to 970 million EUR/country/year). 

Member States: pricing and reimbursement delays do not necessarily represent a budgetary 
gain (the reduction in non-pharmaceutical spending resulting from the introduction of a new 
medicine may be higher than the cost induced by the prescription of that medicine). 

Delays for generic medicines 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

Option A.2:  

Soft Law 

Option A.3/a: 

Financial 
penalties by 
national judges 

Option A.3/b: 

Automatic 
inclusion in 
reimbursement 
after expiration 
of the time-limits 
and until a 
decision is 
adopted 

Generic companies: lost return on investment and revenues linked to delayed market entry. 

Member  States:  lost  savings  (estimate:  3  billion  EUR  for  the  period  2000-2007  based  on  a 
sample of medicines in 17 EU countries). 

Patients: additional costs in case of co-payment (depends on the national system). 

Stronger  basis  for  the  enforcement  of  existing  time-limits  but  legal  certainty  will  not 
significantly improve. 

Possibly  effective  to  reduce  delays  for  originator  products  (based  on  collaborative  actions 
such  as  EUNetHTA)  but  success  depends  on  Member  States’  cooperation.  Unlikely  to  be 
successful  for  generics:  guidance  provided  by  the  Pharmaceutical  sector  inquiry  has  not 
reduced unnecessary delays in all EU countries. 

Compensation of economic damage for pharmaceutical companies. 

Budgetary impact for national authorities depends on their capacity to comply with the time-
limits. 

Incentive  for  Member  States  to  comply  with  the  time-limits  but  effectiveness  will  depend  on 
the  willingness  of  economic  operators  to  enforce  their  rights  and  on  the  level  of  sanctions 
decided by national judges. 

Problem  of  delayed  access  to  medicines  for  patients  is  not  addressed.  Patients  even  pay 
twice,  first  due  to  delayed  access  and  second  due  to  financial  compensations  paid  by 
taxpayers’ money. 

Pharmaceutical  companies:  improved  market  access  and  additional  predictability  in  the 
absence of unjustified delays. 

Member States: incentive to comply with the time-limits but some Member States may need 
to  streamline  or  improve  the  efficiency  of  HTA  procedures.  Potentially  significant  impact  on 
public health budgets (budgetary impact proportionate to the level of non-compliance with the 
time-limits) but mitigated by specific safeguards (ability to stop the clock) and Member States’ 
capacity to make the final decision. 

Patients:  quicker  access  to  medicines  in  the  absence  of  decision  by  the  competent 
authorities. 

Potential  unintended  effects:  insecurity  for  patients  and  companies  if  the  decision  issued 
beyond the time-limits is negative. 

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Option A.3/c: 

Benchmarking 
reports 

Options A.4/a 
and A.4/b: 

- Shorter time-
limits for 
generics 

- Prohibition of 
patent linkage 
and duplication 
of assessments  

Option 5:  

Revision of the 
directive to 
improve market 
access delays 
for originator 
products 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

Public  pressure  on  Member  States:  facilitates  monitoring  of  compliance  with  the  time-limits 
and provides a basis for dialogue with competent authorities. 

Only effective if Member States  provide accurate data and  are  willing to draw lessons from 
poor compliance. 

Additional  compliance  costs  for  public  authorities,  although  very  limited  if  reporting  takes 
place no more than once per year. 

Originator  companies:  short-term  losses  due  to  earlier  competition  but  encourages  the 
pursuit of innovation. 

Generic companies: quicker return on investment and profits due to earlier market entry. 

Member  States:  significant  savings  for  public  health  budgets  (order  of  magnitude:  several 
hundred million EUR/country if time-limits for the pricing and reimbursement of generics are 
reduced  to  30  days).  One-off  adjustment  costs  for  public  authorities,  in  particular  Member 
States  will  long  decision-making  timeframe  for  generics,  but  unlikely  to  offset  long-term 
savings resulting from earlier price competition.  

Patients: possible savings in case of co-payment (depends on national system). 

Originator  companies:  earlier  return  on  investment  with  potentially  positive  effects  on 
research and innovation. 

Public  authorities:  significant  adjustment  costs  due  to  the  necessity  to  streamline  and 
improve pricing and reimbursement procedures. 

Patients: earlier access to medicines with associated welfare gains. 

Possible unintended effects: non-inclusion of medicinal products into reimbursement in order 
to respect the shorter time-limits imposed by the directive.  

(2)  Objective B: Ensure the adequacy and effectiveness of the directive in a changing 

context  

Option B.1:  

Status quo 
(baseline 
scenario) 

Option B.2:  

Soft Law 

Option B.3/a: 

Minimal revision 
to reflect case-
law 

Option B.3/b: 

Extensive 
revision to align 
with the current 
pharmaceutical 
environment 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

Discrepancy  between  the  provisions  of  the  directive  and  the  current  pharmaceutical  market 
will  remain,  leading  to  persistent  problems  of  legal  interpretation,  implementation  and 
enforcement. 

Pharmaceutical companies: legal uncertainty and lack of business predictability; lack of level 
playing  field  with  potential  effects  on  competitiveness  (reduced  pharmaceutical  sales,  R&D 
and employment). 

Patients:  potentially  unjustified 
consequences on health and well-being. 

limitations 

in 

terms  of  access 

to  medicines,  with 

Stronger  basis  for  the  enforcement  of  existing  obligations  but  legal  certainty  would  not 
significantly improve: this option is unlikely to address the persistent issues of enforcement if 
Member States continue to advocate a restrictive interpretation of the directive. 

Important  resources  required  to  draft  guidelines  (e.g.  regular  cooperation  between  the 
Commission and Member States). 

Implementation  of  the  directive  by  Member  States  and  verification  of  compliance  by  the 
Commission would be facilitated. 

improvement 

Limited 
the  variety  of  pricing  and 
reimbursement  policies  would  not  be  addressed  (e.g.  uncertainties  regarding  tendering 
procedures and contractual agreements would remain). 

legal  clarity  and  predictability: 

in 

Limited flexibility to adjust reegulatory framework over time. 

Improvement  in  legal  clarity  and  effectiveness  of  the  directive:  unjustified  barriers  to  trade 
could be more easily detected and deterred or sanctioned. Directive drafted on the basis of 
general principles would be more ‘future proof’. 

Better regulation: clear delimitation between the directive and other relevant legal instruments 
(e.g. public procurement law, contract law). 

Potential delays in pricing and reimbursement procedures relating to personalised medicines 
could be avoided through better  coordination  within the competent authorities but  approach 
abandoned  because  it  raises  subsidiarity  issues  and  it  gathered  weak  support  in  the  public 
consultation.  

Limited flexibility to adjust regulatory framework over time. 

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Option B.4: 

Notification of 
draft national 
measures 

• 

• 

Preventive dialogue and improved enforcement 

Compliance  costs  for  public  authorities  and  risk  of  financial  costs  linked  to  the  delayed 
adoption of national measures (no impact on individual pricing and reimbursement decisions 
addressed to companies). 

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(3)  Objective  C:  Possible  extension  of  the  scope  of  the  directive  to  cover  medical 

devices  

Option C.1:  

Status quo 
(baseline 
scenario) 

Option C.2:  

Partial extension 
of the directive 
to cover a 
specific segment 
of the medical 
devices market 

• 

• 

• 

• 

• 

• 

• 

• 

Strong support from Member States and industry for this option.  

Maintenance of the regulatory delimitation between medicines and medical devices. 

No  fundamental  impact  on  the  medical  devices  market:  approximately  85%  of  the  medical 
devices  sold  in  the  EU  (in  value)  are  not  subject  to  price  regulation  and  to  mechanisms  of 
inclusion in reimbursement. Transparency issues in the medical devices sector mostly relate 
to  public  procurement  (purchasing  by  hospitals)  and  can  be  addressed  via  other  legal 
instruments. 

The segment of the medical devices market subject to pricing and reimbursement decisions 
is small (15%) and decreasing. 

Medical devices are covered by the obligations of the Treaty governing the free movement of 
goods. 

Early  market  access  for  medical  devices  subject  to  price  regulation  and  inclusion  in 
reimbursement lists (application of time-limits):  benefits for companies in terms of return on 
investment and for patients due to swift access to health technologies. However, no industry 
support for this option. 

Legal  and  technical  complexity.  Increased  market  fragmentation  due  to  the  differentiated 
treatment  of  similar  products  depending  on  the  national  rules  governing  their  pricing  and 
reimbursement.  

Additional burden/costs for some Member States. 

7. 

COMPARISON OF OPTIONS 

The  options  relating  to  medicinal  products  have  been  compared  against  the  main  criteria  of 
effectiveness to achieve the objectives pursued, efficiency (taking into account the burden and 
costs on Member States), legal certainty and enforcement. 

On this basis, the preferred options are: 

–  Options  A.3/b,  A.3/c,  as  well  as  options  A.4/a  and  A.4/b,  to  ensure  timely  pricing  and 

reimbursement decisions; 

–  Options  B.3/b  and  B.4  to  ensure  the  adequacy  and  effectiveness  of  the  directive  in  a 

changing context. 

Performance of options against key criteria – Objective A 

Objective A: Ensure timely pricing and 
reimbursement decisions 

Effectiveness 

Efficiency = 
Effectiveness vs. 
burden/costs for 
Member States 

Legal certainty 

Enforcement 

Option A.1:  
Status quo (baseline scenario) 

Option A.2:  
Soft Law 

Option A.3/a: 
Financial penalties by national judges 

Option A.3/b: 
Automatic inclusion in reimbursement after 
expiry of the time-limits and until decision 

Option A.3/c: 
Benchmarking reports 

Option A.4/a: 
Shorter time-limits for generics 

Option A.4/b: 
Prohibition of patent linkage and 

- 

± 

± 

+ + 

+ 

+ + 

+ + 

- 

+ 

+ 

± 

+ 

+ 

- 

± 

+ 

+ 

+ 

+ 

+ + 

+ + 

- 

± 

± 

+ 

± 

(cid:50) 

(cid:50) 

EN 

10 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
duplication of assessments 

Option 5: 
Shorter time-limits for originator medicines 

+ 

- 

+ 

(cid:50) 

Performance of options against key criteria – Objective B 

Objective B: Ensure the adequacy and 
effectiveness of the directive in a changing 
context 

Effectiveness 

Efficiency = 
Effectiveness vs. 
burden/costs for 
Member States 

Legal certainty 

Enforcement 

Option B.1:  
Status quo (baseline scenario) 

Option B.2:  
Soft Law 

Option B.3/a: 
Minimal revision to reflect case-law 

Option B.3/b: 
Extensive revision to align with the current 
pharmaceutical environment 

Option B.4: 
Notification of draft national measures 

- 

± 

± 

+ 

+ 

- 

+ 

± 

+ 

± 

- 

± 

+ 

+ + 

+ 

- 

± 

+ 

± 

+ + 

Performance levels: + + Very high + High ± Moderate - Negative (cid:50) No impact  

(cid:134)(cid:134)(cid:134)(cid:134) :  Preferred options 

The options relating to the possible extension of the directive to medical devices have mainly 
been compared in terms of general benefits and drawbacks. The conclusion is that the benefits 
of extending the directive to the small share of the medical devices market subject to pricing 
and  inclusion  in  reimbursement  lists  do  not  counterbalance  the  drawbacks,  in  particular  the 
legal  and  technical  complexities  of  such  an  extension  as  well  as  the  risk  of  further  market 
fragmentation. 

Performance of options against key criteria – Objective C 

Objective C: Possible extension of 
Directive 89/105/EEC to medical 
devices 

Effectiveness 

(impact on 
transparency of 
the market) 

Efficiency = 
Effectiveness vs. 
burden/costs for 
Member States 

Legal certainty 

Option C.1:  
Status quo 

Option C.2:  
Partial extension to a specific 
segment of the medical devices 
market 

± 

± 

+ 

- 

+ 

- 

Synergies  exist  between  the  preferred  options.  For  instance,  the  objective  of  scrapping 
unnecessary pricing and reimbursement delays for generic medicines will be more effectively 
achieved by combining different options. However, synergies could not be quantified as they 
essentially lie in the mutually reinforcing legal effects of the recommended options.  

The main implications of the proposed set of policy options for each of the main stakeholders 
are presented below. 

EN 

11 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
Member 
States  

• 

• 

• 

Originator 
companies 

• 

Generic 
companies 

Patients 

• 

• 

• 

• 

• 

Advantages/Benefits 

Disadvantages/Costs 

• 

• 

• 

• 

• 

• 

• 

enforcement 

Stronger 
instruments 
requiring  more  systematic  compliance. 
Potential impact on public health budgets 
in  case  of  non-compliance  with  the  time-
limits. 

Need  to  improve  or  streamline  pricing 
and  reimbursement  processes  (including 
expert assessments such as HTA). 

Shorter time-limits for generics may entail 
initial  compliance  costs 
if  national 
procedures need to be adapted. 

Limited  administrative  costs  linked  to 
reporting  obligations  and  notification  of 
draft national measures. 

inclusion 

Automatic 
in  case  of  non-
compliance with the time-limits may have 
the  side  effect  of  encouraging  Member 
States to issues negative decisions within 
the deadlines. 

inclusion  occur 

in 
Should  automatic 
the 
practice,  potential 
decision  eventually 
the 
competent  authorities  beyond  the  time-
limits is negative.  

if 
issued  by 

insecurity 

inclusion  occur 

in 
Should  automatic 
practice,  potential 
the 
decision  eventually  issued  beyond  the 
time-limits by the competent authorities is 
negative.  

insecurity 

if 

Increased 
implementation 
requirements. 

legal  clarity  and  easier 
procedural 

the 

of 

Potential  cost  savings  linked  to  quicker 
pricing and reimbursement for generics. 

interference  of 

No 
intellectual  and 
industrial  property  rights  with  day-to-day 
pricing and reimbursement activities. 

legal 

Increased 
enforcement 
‘future proof’ legislation will: 

stronger 
instruments  and  more 

clarity, 

- bring additional business predictability; 
- improve market access; 
- improve competitiveness and foster
innovation. 

Earlier  competition  with  generics  will 
encourage the pursuit of innovation. 

legal 

Increased 
enforcement 
‘future proof’ legislation will: 

stronger 
instruments  and  more 

clarity, 

- bring additional business predictability; 
- improve market access; 
- improve competitiveness and foster
innovation. 

time-limits 

Shorter 
for  pricing  and 
reimbursement decisions and clarification 
of the non-interference of safety and IPR 
issues  with  pricing  and  reimbursement 
procedures  will  ensure  earlier  market 
entry  and  more  effective  competition  in 
off-patent markets. 

Access  to  medicines  not  hampered  by 
delays 
in  pricing  and  reimbursement 
decisions. 

• 

Cost  savings  linked  to  earlier  generic 
entry  and  price  competition  in  off-patent 
markets (in case of co-payment). 

inclusion  occur 
in 
Should  automatic 
practice,  potential 
insecurity  or  even 
health  impact  if  the  decision  eventually 
issued  beyond  the  time-limits  by  the 
competent  authorities  is  negative  and 
patients have to switch their treatment. 

8. 

MONITORING AND EVALUATION 

The monitoring and implementation plans will mainly rely on: 

–  Cooperation  between  the  Commission  and  the  Member  States  in  the  framework  of  the 
Transparency  Committee  established  by  the  directive.  The  Committee  will  meet  on  a 
regular  basis  during  the  transposition  phase  to  monitor  and  facilitate  transposition  by  the 
Member States. 

–  The  proposed  pre-notification  mechanism  to  monitor  the  adequate  implementation  of  the 

directive and enable bilateral dialogue with the Member States. 

EN 

12 

   EN 

 
 
 
 
 
 
 
 
 
 
–  Implementation reports to be communicated by Member States within three years after the 
entry into force of the directive, followed by an assessment of the operation of the directive 
by the Commission within three years after the date of entry into force. 

The core progress indicators and monitoring instruments which will be used to assess whether 
the new directive is meeting its objectives are presented below. 

Objectives 

Progress indicators 

Monitoring instruments 

A. Timely pricing and reimbursement 
decisions: compliance with the time-
limits 

Observed timing for pricing and 
reimbursement decisions in the Member 
States 

Annual mandatory reporting on the 
actual time taken for individual pricing 
and reimbursement decisions.  

B.  Adequacy  and  effectiveness:  legal 
clarity and enforcement  

a)  Changes  in  national  measures  and 
compliance  of  notified  drafts  with  the 
directive  (compliance  rate  based  on 
pre-notification system) 

b)  Complaints  filed  and  investigated  by 
the  Commission,  Commission  referrals 
to  the  Court  of  Justice  of  the  European 
Union  

Notification  of  draft  national  measures 
to the Commission 

Infringement statistics 

EN 

13 

   EN