Commission staff working document - Accompanying document to the : #Proposal for a Regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and #Proposal for a Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use#Impact assessment {COM(2008) 662 final} {COM(2008) 663 final} {SEC(2008) 2668}
Date: 2008-10-21
Institutions: Council of the European Union
Subjects: consumer information, dissemination of information, medicine, pharmaceutical legislation, public health, single market

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.12.2008 
SEC(2008) 2667 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending, as regards information to the general public on medicinal products for 
human use subject to medical prescription, Regulation (EC) No 726/2004 laying down 
Community procedures for the authorisation and supervision of medicinal products for 
human and veterinary use and establishing a European Medicines Agency 

and  

Proposal for a  

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

IMPACT ASSESSMENT 

{COM(2008) 662 final} 
{COM(2008) 663 final} 
{SEC(2008) 2668} 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

Procedural issues and consultation of interested parties .............................................. 2 

Organisation and timing ............................................................................................... 2 

Consultation and expertise ........................................................................................... 3 

1.2.1. 

Independent impact assessment study ......................................................................................3 

1.2.2. 

Public consultations ..................................................................................................................3 

2. 

Problem definition........................................................................................................ 6 

2.1.  What is the issue?......................................................................................................... 6 

2.2. 

Current regulatory framework...................................................................................... 8 

2.3.  Who is affected, in what ways, and to what extent? .................................................... 9 

2.3.1. 

Patients' and consumers' perspectives.......................................................................................9 

2.3.2.  Other stakeholders affected.....................................................................................................10 

2.4.  What is the problem?.................................................................................................. 12 

2.5. 

2.6. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

5. 

5.1. 

5.2. 

5.3. 

How the problem would evolve under present policies ............................................. 18 

Does the EU have the right to act? Treaty legal basis and subsidiarity ..................... 20 

Objectives................................................................................................................... 22 

General policy objectives ........................................................................................... 22 

Specific Policy Objective ........................................................................................... 22 

Operational Policy Objectives.................................................................................... 22 

Consistency with Other EU Policies and Horizontal Objectives ............................... 23 

Policy Options ............................................................................................................ 25 

Possible Policy Options.............................................................................................. 25 

Options Discarded at an Early Stage.......................................................................... 25 

Option 1: Retention of Current Legislative Framework ............................................ 27 

Options 2, 3 and 4: Revision of Directive 2001/83/EC.............................................. 27 

Analysis of impacts .................................................................................................... 29 

Introduction ................................................................................................................ 29 

Methodological Approach to Assessing Impacts ....................................................... 31 

Social Impacts ............................................................................................................ 33 

5.3.1.  Mechanisms by which health outcomes may be affected .......................................................33 

5.3.2. 

Preventative effect ..................................................................................................................34 

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5.3.3.  Awareness effect.....................................................................................................................34 

5.3.4.  Anxiety effect .........................................................................................................................35 

5.3.5. 

Interaction effect .....................................................................................................................36 

5.3.6. 

Prescription distortion effect...................................................................................................37 

5.3.7. 

Compliance effect ...................................................................................................................37 

5.3.8.  Overall health impact for Option 2 .........................................................................................38 

5.3.9. 

Breakdown by type of information provision .........................................................................39 

5.3.10.  Health impacts under Options 3 and 4 ....................................................................................39 

5.3.11.  Different channels of communication.....................................................................................40 

5.4. 

Economic Impacts ...................................................................................................... 42 

5.4.1.  Additional costs to healthcare systems ...................................................................................42 

5.4.2. 

Cost of information provision.................................................................................................43 

5.4.3. 

Costs to regulatory bodies.......................................................................................................44 

5.4.4.  Administrative costs................................................................................................................45 

5.4.5.  Other impacts ..........................................................................................................................46 

5.5. 

5.6. 

5.7. 

6. 

Environmental Impacts .............................................................................................. 46 

Impacts outside the EU .............................................................................................. 47 

Compliance Issues...................................................................................................... 47 

Comparing the Impacts .............................................................................................. 48 

6.1. 

Overall Impact of Policy Options............................................................................... 48 

7. 

Monitoring and Evaluation......................................................................................... 51 

7.1. 

Monitoring indicators and arrangements for ex-post evaluation ............................... 51 

8. 

Accompanying documents ......................................................................................... 52 

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TABLE OF FIGURES 
Figure 2.1 Increased demand for greater co-determination (patient-health professional interaction)......7 
Table 2.1 An overview of the stakeholder's opinions in public consultations regarding the current 

situation on information to patients .......................................................................................12 
Figure 2.2: Current status of differentiation between advertisement and information...........................13 
Figure 2.3: Views of Medicines Regulatory Authorities on Interpretation of Directive in their Member 
State .......................................................................................................................................14 
Table 5.1: Preventative effect for Option 2 ............................................................................................34 
Table 5.2: Awareness effect for Option 2 ..............................................................................................35 
Table 5.3: Anxiety effect for Option 2 ...................................................................................................35 
Table 5.4: Interaction effect for Option 2...............................................................................................36 
Table 5.5: Prescription distortion effect for Option 2 ............................................................................37 
Table 5.6: Compliance effect for Option 2.............................................................................................38 
Table 5.7: Overall health benefits less additional healthcare costs under Option 2 (€m) ......................39 
Table 5.8: Breakdown of impacts by category of information provision under Option 2 (NPV of health 
benefits less healthcare costs over 10 years, €m)...................................................................39 

Table 5.9: Comparison of policy options (NPV of health benefits less healthcare costs over 10 years, 

€m) ............................................................................................................................ .............40 
Table 5.11: How impacts may vary by channel of communication .......................................................41 
Table 5.12: Average score given to benefits and risks of “push” and “pull” media ..............................41 
Table 5.13: Estimates of PV of additional costs to healthcare systems over 10 years (€m) ..................43 
Table 5.15: Cost of information provision (€m) ................................................................................. ...44 
Table 5.16: PV of cost of information provision over 10 years (€m) ....................................................44 
Table 5.14: Estimated PV of regulatory costs over 10 years (€m).........................................................44 
Table 5.17: Estimates of annual administrative costs (€m)....................................................................45  
Table 5.18: PV of administrative costs over first 10 years (€m)............................................................46 
Figure 5.1: Average expectation of medicines regulatory authorities regarding the likely level of 

compliance .............................................................................................................................47 

Table 6.1: Overall impact of each policy option (€bn, NPV over 10 years) ..........................................48 
Table 6.2: Sensitivity analysis for Options 3 and 4 - high differential scenario (€bn, NPV over 10 

years)......................................................................................................................................49 

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LIST OF ABBREVIATIONS 

CAP 

Centrally Authorised Medicinal Product 

DALY  

Disability Adjusted Life Years  

DG ENTR 

Directorate-General Enterprise and Industry 

DTCA  

Direct-to-consumer advertisement 

EEA 

European Economic Area 

EMEA  

European Medicines Agency  

EU 

FDA 

G-10 

Generics 

HCP 

HMA 

IA 

MAH 

MRP 

MS 

NAP 

NPV 

NCA 

OTC 

PIL 

“Pull”   

“Push”  

PV 

European Union 

Food and Drug Administration (USA) 

High Level Group on Innovation and the Provision of Medicines 

Medicines containing the same active substance as the originator product after 
patent expiry 

Healthcare Professional 

Heads of EEA Medicines Agencies 

Impact Assessment 

Marketing Authorisation Holder 

Mutual Recognition Procedure; Mutual Recognition authorised Product 

EEA Member State 

Nationally Authorised Medicinal Product 

Net Present Value 

National Competent Authority 

“Over-the-counter” medicine, available without doctor prescription 

Patient Information Leaflet, package leaflet 

Information actively searched by citizens on their own initiative 

Information passively received by citizens (disseminated by the company) 

The net present value of policy impacts over a ten-year period 

QALY  

Quality-Adjusted Life Years  

R&D 

SCM 

SPC 

Research & Development 

Standard Cost Model 

Summary of Product Characteristics 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

This impact assessment examines possible actions, which could set rules on the provision of 
information  by  marketing  authorisation  holders  about  prescription-only  medicines.  These 
actions  would  be  without  prejudice  to  the  provision  of  information  by  other  actors  and  the 
Commission's  declared  intention  that  healthcare  professionals  should  remain  as  they  are 
today, the primary source of health information.  

1.1. 

Organisation and timing  

Article  88a  of  Directive  2001/83/EC,  introduced  by  Directive  2004/27/EC,  called  upon  the 
Commission  to  present  a  report  to  the  European  Parliament  and  the  Council  in  2007  on 
“current practice with regard to information provision – particularly on the internet – and its 
risks  and  benefits  for  patients”.  Article  88a  also  provides  that  “the  Commission  shall,  if 
appropriate, put forward proposals setting out an information strategy to ensure good-quality, 
objective,  reliable  and  non  promotional  information  on  medicinal  products  and  other 
treatments and shall address the question of the information source's liability”. 

On  this  basis,  DG  ENTR  launched  in  April  2007  a  public  consultation  on  a  draft  report 
reviewing the activities carried out by Member States concerning the provision of information 
on  medicinal  products  in  order  to  respond  to  the  needs  of  patients/consumers  under  the 
applicable legislative framework.1 The report was focussing on the use of the internet on the 
provision of information and its role in improving access to information. 

Taking  into  consideration  the  outcome  of  the  public  consultation,  the  Communication  on 
current  practices  with  regard  to  the  provision  of  information  to  patients  on  medicinal 
products, was adopted by the College on 20 December 2007 and transmitted to the European 
Parliament  and  the  Council.2  The  Communication  announced  a  legal  proposal  by  the 
Commission. 

therefore,  pharmaceutical 

The report focused on current practices, and the possible need to act at Community level, in 
the  area  of  information  on  prescription-only  medicines.  Current  Community  rules  do  not 
contain restrictions to the advertising to the general public of non-prescription medicines. For 
such  medicines, 
in  any  kind  of 
communication, and the issue of whether it is of a promotional nature or objective information 
is  of  no  relevance.  For  this  reason  and  in  keeping  with  the  principle  of  proportionality,  the 
legal  proposal  announced  by  the  Commission  is  limited  to  the  regulation  of  information  on 
prescription medicines, the area where it has been identified that divergent interpretations of 
Community  rules  and  different  national  rules  and  practices  on  information  are  creating 
obstacles  to  patients'  access  to  high  quality  information  and  to  the  operation  of  the  internal 
market. 

industry  may  engage 

The  scope  of  any  proposal  to  amend  Community  pharmaceutical  legislation  should  be 
respectful of the legal basis in this field and be circumscribed to the provision of rules linked 
to the placing on the market of medicinal products and the host of resulting obligations to be 
respected  by  marketing  authorisation  holders.  The  legal  proposal  would  therefore  relate  to 

1http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_04/draft_infopatients2007_04.pd

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2http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_12/inf_to_patients_com_2007_8

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medicine-related information and to tasks and obligations of the pharmaceutical industry and 
of competent  and supervisory authorities. Other types of health-related  information, and the 
roles  of  other  key  stakeholders  in  the  field,  would  fall  outside  this  scope.  This  is  without 
prejudice to other on-going Community initiatives in the area of health information. 

The  inter-service  steering  group  composed  of  representatives  from  the  DG’s  for  Health  and 
Consumer  Protection,  Research,  Information  Society  and  Media,  and  from  the  Secretariat-
General, was established and met 4 times between May 2007 and April 2008. The project is 
referenced in the Commission Agenda Planning as 2008/ENTR/018. 

1.2. 

Consultation and expertise 

Within the framework of the impact assessment process the Commission services extensively 
consulted all relevant stakeholders using a wide range of communication means. Two general 
web-based public consultations, carried out according to the Commission’s general principles 
and  minimum  standards  for  consultation,  were  supplemented  by  questionnaire  surveys  and 
interviews  with  representatives  of  key  stakeholder  groups.  Comments  of  the  Commission 
services  raised  during  the  inter-service  steering  group  meetings  were  fully  taken  into 
consideration. 

Independent impact assessment study 

Europe  Economics  was  contracted  by  DG  ENTR  to  assist  in  assessing  the  impact  of  the 
policy  options.  Europe  Economics  carried  out  a  series  of  stakeholder  interviews,  mostly  in 
January and February 2008, to gather views and information. Europe Economics also carried 
out  online  surveys  of  three  stakeholder  groups  to  gather  specific  data  for  the  impact 
assessment.  Usable  survey  responses  were  received  from  20  healthcare  providers  (e.g. 
associations representing healthcare professionals), 13 healthcare payers (e.g. social insurance 
organisations),  and  15  medicines  regulatory  authorities.  Separately,  Europe  Economics 
received  relevant  information  from  a  number  of  pharmaceutical  companies  as  well  as  from 
pharmaceutical  industry  associations.  The  information  which  Europe  Economics  received 
from  stakeholders  has  informed  both  the  qualitative  and  quantitative  analysis  in  this  impact 
assessment.  In  addition  an  extensive  literature  study  provided  useful  evidence  (mostly 
qualitative)  on  the  potential  benefits  and  risks  that  may  result  from  improved  information 
provision.  

Public consultations 

The first formal public consultation was conducted between April and June 2007 on a Draft 
report on current practices without presenting yet any political orientations or proposals.  

The 73 consultation responses received have shown that the draft report reflected, apart from 
some factual details, the current situation. Opinions expressed on the way forward converged 
as  regards  the  needs  to  improve  information  to  patients,  to  adopt  common  standards  and 
quality  criteria,  to  distinguish  between  advertising  and  information  and  to  keep  the  ban  on 
direct  to  consumer  advertising  on  prescription-only  medicines,  and  the  recognition  of  the 
Internet  as  an  important  information  channel.  Different  views  were  expressed  on  how  to 
improve provision of information to patients, on the role of the pharmaceutical industry and 
on the mechanisms to regulate and enforce applicable rules. 

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The  second  public  consultation,  conducted  between  February  and  April  2008,  specifically 
addressed  the  key  ideas  of  the  forthcoming  legal  proposal  on  information  to  patients. 
Contributions were asked from all stakeholders and interested parties dealing with medicines 
or with provision of information on medicinal products to citizen. Citizens and civil society 
organisations were also welcomed to contribute to the consultation.  

The  second  part  of  the  consultation  received  185  contributions  from  the  range  of  relevant 
stakeholder groups with the following overall conclusions: 

•  A number of the respondents (47%) took the view that pharmaceutical industry is not an 
appropriate  source  of  prescription-only  medicine  information  in  general,  mainly  because 
there may be a conflict of interest relating to the financial interests. For instance, European 
Consumer  Consultative  Group  (ECCG)  which  is  the  Commission  advisory  body 
representing  European  and  national  consumer  organization  expressed  concerns  in  its 
opinion on 20 February 20083 about the delivery of information to patients by the industry. 
On the other hand, some of the contributors took the position that if there would be a clear 
distinction  between  advertising  and  information,  pharmaceutical  companies  would  be  a 
valuable source of prescription-only medicine information, because they know the product 
best.  

•  However, most contributors agreed that industry should be allowed to provide information 
on  prescription-only  medicines  to  patients  who  actively  seek  it.  This  could  mean  that 
information  about  a  specific  medicine  should  be  available,  for  example,  on  the  company 
website  in  a  format  that  could  be  downloaded  and  this  should  be  monitored  by  relevant 
authorities. 

•  There  was  a  consensus  that  pharmaceutical  companies  should  be  allowed  to  publish 
summaries  of  product  characteristics  (SPCs)  and  patient  information  leaflets  (PILs),  for 
example  on  their  websites.  As  regards  disseminating  other  limited  medicine-related 
information,  many  respondents  especially  among  healthcare  professionals  and  regulators 
took the view that other information from the industry could probably be focused on new 
medicinal products. 

•  Among  the  responses,  only  six  per  cent  explicitly  supported  TV  and  radio  as  suitable 
means of disseminating information about prescription-only medicines while 35% did not.  
•  As regards enforcement, it was suggested by regulators that the proposed new mechanism 
for  monitoring  would  create  considerable  new  regulatory  work.  The  system  with  co-
regulatory  mechanism  could  be  costly  and  lead  to  different  codes  of  conduct  in  the 
different Member States 

A detailed summary of both public consultations is provided in Annex 1. 

1.3. 

Commission Impact Assessment Board  

A  draft  of  this  Impact  Assessment  was  reviewed  by  the  independent  Commission  Impact 
Assessment Board (IAB). The Board issued its initial Opinion on 6 June 2008 and found that 
the draft Impact Assessment is well explaining the consistency of the general objective of the 
initiative  with  other  EU  policies  and  horizontal  objectives.  The  Board  noted  good  effort  to 
quantify  overall  costs  and  benefits  using  a  broad  set  of  data  sources  and  assessment 

3 http://ec.europa.eu/consumers/cons_org/associations/committ/opinions/eccg_op_ip20022008_en.pdf 

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techniques. The IAB made a number of suggestions to improve the draft and these have been 
included in this revised report. Of note, the report resubmitted to the Board: 

•  Presents  more  clearly  the  problems  and  explains  better  how  they  are  perceived  by  the 
various stakeholders and how they  affect the health of patients and the internal market for 
medicinal products:  

-  by  substantiating  the  extent  to  which  the  various  stakeholders  consider  the  current 
situation as regards information to patients as unsatisfactory through better integration 
of the results of the public consultation. 

-  by presenting more clearly underlying drivers that prevent producers from providing 
information  to  patients  for  medicinal  products  authorized  by  national  authorities  or 
under a harmonized procedure.  

-  by demonstrating more thoroughly which information needs of patients are currently 
not  served  and  explaining  the  process  by  which  this  leads  to  negative  effects  on 
welfare/health due to the non-availability of information to patients and/or the use of 
'non-authorized' information tools.  

•  Demonstrates limitations of the current legislative approach (listing types of information 
exempted  from  advertisement,  e.g.  PIL,  SPC,  price)  and  added  value  of  the  new  EU 
legislative  framework  on  information  to  patient  in  comparison  to  the  action  at  Member 
State level.  

•  Includes  diagram  clarifying  the  scope  of  action  and  distinction  between  advertising, 

information and information compliant with defined quality criteria.  

•  Explains limited potential of soft-law instruments (such as a recommendation) and private 
public partnerships to tackle the problem described and clarifies the role of EMEA in the 
new framework. 

•  Better  differentiates  between  dedicated  pharmaceutical  company  websites,  general 

websites and internet specific promotional tools (e.g. pop-ups).  

•  Better differentiates between the effects of push and pull information with respect to the 

resulting magnitude of prevention and awareness effects.  

•  Presents social impacts and mechanisms by which health outcomes may be affected and 

analyses them with examples from the literature.  

•  Presents key assumptions and critical methodological issues up-front in the main text by 
providing more systematic and precise references to the corresponding sections in annex 2 
and  stresses  more  clearly  throughout  the  main  report  the  indicative  nature  of  the 
quantitative results achieved. 

Following the re-submission, the Board in its new opinion issued on 22 July 2007, reiterated 
the positive aspects of the initial report and acknowledged that the re-submitted report follows 
most  of  the  Board’s  recommendations.  Nevertheless,  it  proposed  some  few  additional 
improvements, and in this respect the presented revised report: 
•  Better  demonstrates  negative  consequences  of  imperfect  information  on  the  health  of 

patients. 

•  Strengthens  further  the  subsidiarity  aspects,  taking  into  account  the  proposal  for  a 
directive  on  patients'  rights  in  cross-border  healthcare  adopted  by  the  Commission  on  2 
July 2008. 

•  Elaborates on the role of the EMEA in the proposed system. 
•  Clarifies  impacts  of  the  patient  information  policies  on  the  competitiveness  of  the 

industry.  

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2. 

PROBLEM DEFINITION 

2.1.  What is the issue? 

Medicines contribute considerably to the health of EU citizens. The discovery, development 
and effective use of medicines have improved many people's quality of life, reduced the need 
for  surgical  intervention  and  the  length  of  time  spent  in  hospital  and  saved  many  lives. 
Consumption  of  medicines  is  high  and  is  increasing,  with  pharmaceutical  market  value 
reaching  €196.5  billion  (retail  pric es)  in  the  EU  in  2006.  Patients  have  become  more 
empowered  and  proactive  consumers  of  healthcare,  increasingly  seeking  information  about 
medicines and treatments.  

Possible additional information on medicinal products provided to patients might affect their 
behaviour,  to  a  great  extent  this  will  depend  on  the  quality  of  its  content,  the  choice  of  the 
communication  channel,  and  on  the  extent  to  which  the  information  is  “pushed”  by  an 
information provider rather than “pulled” by patients who actively seek the information.  In 
particular, more information could, for instance, lead people to: 

☺  Take action to prevent diseases (e.g. by changing their lifestyle or diet). 
☺  Become  aware  of  their  disease  and  seek  treatment,  in  circumstances  when  this  either 
would not have happened without the information or would not have happened at such an 
early stage. 

(cid:47)  Become anxious about diseases which they do not in fact have. 
☺  Interact  better  with  doctors  during  consultations  (e.g.  by  sharing  more  relevant 

information on their symptoms) so as to improve the doctor’s prescription decisions. 

(cid:47)  Distort prescription decisions by asking for a specific drug when it is not actually the best 

available treatment. 

☺  Comply better with their prescription (e.g. due to greater understanding of how the drug 

should be taken or the benefits of compliance). 

(cid:47)  Comply  worse  with  their  prescription  (e.g.  due  to  more  information  on  possible  side-

effects). 

It is apparent from these effects that the EU legal framework on provision of information to 
patients has potentially a major economic impact (mainly in terms of healthcare expenditure) 
and a major public health impact which may be positive or negative, depending mainly on the 
design of the rules. 

There  has  been  an  apparent  sea-change  amongst  the  general  population  for  greater 
participation in determining their own health outcomes, at least in the context of dealings with 
health  professionals.  This  is  illustrated  in  Figure  2.1  which  summarises  market  research 
undertaken  in  Germany  by  the  Pharmaceutical  Business  Journal  in  1982  and  by  Emnid  in 
2004 on this issue. Patients need valid information about their medicines in order to be able to 
take responsibility for their own health and to take part in the decision making. However, the 
provision of information on medicinal products varies from Member State to Member State. 
In addition, it has been reported that there exist deficiencies, for example the use of complex 
language  and  poor  visual  presentation,  in  the  provision  of  information  on  medicines  to 
patients (Raynor et al. 2007).   

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Figure 2.1 Increased demand for greater co-determination (patient-health professional interaction)4 

Safe distribution of medicines to the public is a major public health challenge. Today, thanks 
to the regulatory framework which has been implemented in the European Union, the Union 
is one of the safest places to buy and use medicines. Since 1992 the Community legislation 
has differentiated between advertisement and information on medicines. While EU rules ban 
advertisement on medicines subject to prescription to the public and allowed advertising for 
other  medicines  under  certain  conditions, 
to 
harmonisation amongst the Member States.  

information  provisions  have  not 

led 

Several  Commission  initiatives  and  repeated  public  debates  focused  on  the  need  to  address 
this lack of a Community framework on information to patients in order to respond better to 
the  needs  of  patients,  in  the  overall  interest  of  health.  However,  the  legal  situation  has  not 
changed fundamentally over the last 15 years. 

In 2002 a High Level Group on Innovation and the Provision of Medicines (G-10), the first 
major initiative of the European Commission addressing information to patients, invited in its 
report  the  European  Institutions,  in  co-operation  with  stakeholders,  to  produce  a  workable 
distinction  between  advertising  and  information  that  would  allow  patients  actively  seeking 
information  to  be  able  to  do  so,  and  to  develop  standards  to  ensure  the  quality  of  such 
information.  

In response to the G-10 Report, in July 2003 the Commission issued the Communication “A 
Stronger  European-based  Pharmaceutical  Industry  for  the  Benefit  of  the  Patient-  A  call  for 
Action”5  in  which  it  outlined  practical  proposals  for  the  implementation  of  the  G-10 
recommendations. Further to the Commission Communication, the Council of the European 
Union  adopted  a  Resolution  on  “Pharmaceuticals  and  public  Health  challenges-focusing  on 

4  Harms  F.  “Innovative  drugs,  Direct  to  consumer  and  Patient  Empowerment”,  http://www.mig.tu-

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berlin.de/files/2005.teaching.ss/mbwl3_2005.06.23_ex.pdf 
COM(2003)383 final, 01.07.2003  

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the patients”6 in which it invited the Commission to explore together with Member States the 
possibility of setting up a European Information System for patients and health professionals, 
with the objective to provide information on medicines and related conditions that is of high 
quality, objective, transparent, comprehensive, reliable and up-to-date.  

In  line  with  its  political  commitments,  the  Commission  made  a  number  of  proposals  in  the 
context  of  the  review  of  the  pharmaceutical  legislation  launched  in  2001,  to  improve  the 
quality  and  availability  of  information  to  patients,  health  professionals  and  the  public  in 
general.  Some  of  these  proposals  are  now  part  of  the  current  legislation,  and  as  such  are 
implementing part of the G-10 recommendations in the area of information to patients. These 
new  provisions  addressed  mainly  product  related  information,  by  improving  its  access  and 
readability, and transparency measures.  

However, more far reaching mechanisms to improve and harmonize the access of patients to 
information  have  been  rejected  in  the  legislative  process  with  reference  to  the  possible 
bureaucratic  burden  caused  by  enforcement  mechanisms  and  the  lack  of  a  clear  distinction 
between advertisement and information.  

2.2. 

Current regulatory framework 

The Community legal framework for the authorisation and market surveillance of medicinal 
products  for  human  use  is  primarily  contained  in  Regulation  (EC)  No  726/2004  and  in 
Directive  2001/83/EC  on  the  Community  code  for  medicinal  products  for  human  use.  This 
framework  contains  numerous  provisions  on  advertising,  information  and  transparency. 
However,  this  information,  which  is  in  most  cases  product  specific,  is  not  always  directly 
intended for patients and is often of a very technical nature. 

Community  pharmaceutical  legislation  only  covers  information,  in  detail,  on  the  content  of 
marketing authorisations. In this regard, all marketing authorisations must contain a summary 
of  products  characteristics  (addressed  to  healthcare  professionals)  and  a  package  leaflet 
(intended  for  patients  and  inserted  in  the  packaging  of  medicinal  products).  These  two 
documents (of a non-promotional nature and approved by the authorities with the marketing 
authorisation)  contain  all  essential  information  for  the  correct  use  of  the  medicinal  product. 
However, the  types of information they can carry is by definition limited by the  static two-
dimensional medium of paper and provided information is not contextualised in relation to the 
condition being treated, nor is information about the condition itself.   

Furthermore,  Directive  2001/83/EC  provides  for  a  harmonised  framework  on  advertising  of 
medicines at Community level (independently on their route of authorisation), the application 
of  which  remains  a  responsibility  of  Member  States.  However,  it  does  not  include  detailed 
provisions  on  information  on  medicinal  products,  providing  only  that  certain  information 
supply activities are exempted from the advertising provisions. Therefore, the Directive does 
not prevent Member States from establishing their own approaches regarding the provision of 
information  on  medicinal  products  as  long  as  the  above  mentioned  rules  on  advertising  are 
respected. 

The ECJ has ruled that Directive 2001/83/EC harmonises completely the rules related to the 
advertising  of  medicinal  products  in  the  EU,  and  that  therefore  a  Member  State  cannot  fall 

6 

OJ C 20, 24.01.2004, p. 2 

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short, or go beyond, the provisions of the Directive (C-374/05, Gintec). However, the absence 
of  a  clear  distinction  between  information  and  advertising  in  the  Directive  has  created  a 
situation  of  considerable  disharmony  in  the  application  of  these  (harmonised)  advertising 
rules (see Section 2.4). 

The  revised  pharmaceutical  legislation  (Regulation  (EC)  No  726/2004  and  Directive 
2004/27/EC,  amending  Directive  2001/83/EC)  did  not  change  the  rules  applying  to 
advertising,  although  it  has  introduced  additional  tools  on  the  provision  of  better  quality 
information to patients and the public in general, e.g. improved readability of the labeling and 
the package leaflet, publication of information on the outcome of the assessment process for 
medicines  and  reinforced  mechanisms  to  provide  information  on  pharmacovigilance.  A 
number  of  transparency  measures  were  introduced  which  will  impact  positively  in  the 
provision of information on medicines. 

The  EudraPharm  database,  provided  for  by  Regulation  (EC)  No  726/2004,  should  become 
gradually  a  central  tool  to  make  existing  product  specific  information  (e.g.  package  leaflet) 
available.  In  addition,  Directive  2001/20/EC  on  the  conduct  of  clinical  trials  has  also 
provisions to ensure patient access to information on clinical trials and Regulation No (EC) 
1901/2006  on  medicinal  products  for  paediatric  use  contains  various  provisions  concerning 
information  on  clinical  trials  and  authorised  medicines  for  children.  A  number  of  further 
provisions  of  the  pharmaceutical  acquis  which  have  either  direct  or  indirect  impact  on 
information provided or made available to patients are analysed in-depth in the “Staff working 
document”7 accompanying the Communication referred in Section 1.1. 

2.3.  Who is affected, in what ways, and to what extent? 

Community  rules  on  information  provision  have  a  direct  effect  on  marketing  authorisation 
holders  and  regulatory  authorities,  while  at  the  same  time  affecting  the  general  public, 
particularly  patients  and  their  relatives,  and  various  stakeholders  including  healthcare 
professionals, insurers and media.  

 Patients' and consumers' perspectives 

The optimal outcomes  of the medicine treatment can not be reached, if the patient does not 
know how to use his/her medicines. In considering impacts on human health, it is important to 
remember  that  there  are  a  range  of  sources  from  which  patients  receive  information  on 
medicinal products, most notably through consultations with healthcare professionals.  

There  are  also  several  other  channels  through  which  patients  and  consumers  may  receive 
information on their medicines, either passively (e.g. through radio and TV), or actively, (e.g. 
by searching the Internet). While the responses to the public consultation generally recognised 
the Internet to be an important channel of communication, several highlighted the fact that not 
everyone has Internet access and that other channels of communication should be considered 
as well. However, millions of searches are performed each day on health-related information, 
including  information  about  medicines  (Eysenbach  and  Köhler  2004).  European  citizens 

7http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_12/comm_native_sec_2007_174

0_1_en_documentdetravail.pdf 

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should  be  able  to  receive  information  which  is  in  line  with  the  Community  legislation,  for 
example  in  terms  of  the  details  of  the  EU  marketing  authorisation  or  in  terms  of  the 
prohibition of advertisement. As indicated in page 18 many European citizens now search for 
information on US websites, where the information provided doesn't necessarily respect EU 
legislation and is of a promotional nature.   

The  different  rules  on  information  provision  across  the  EU  create  inequalities  in  the 
information  available  to  citizens,  patients,  their  relatives  and  consumers  in  different  EU 
Member  States,  potentially  leaving  some  patients  in  the  EU  without  access  to  information 
they may need or want in an easy to understand language. Also a recent study shows that most 
patients do not value the written information they receive and there is a gap between currently 
provided information (e.g. leaflets) and information which patients would value and find more 
useful (Raynor et al. 2007). An impact on human health can be expected as demonstrated later 
on in the impact assessment.  In particular, a lack of information can lead to later diagnosis of 
the disease, suboptimal choice of treatment for the individual patient at an earlier stage of a 
disease and impaired compliance with the prescribed treatment. 

According to the public consultations, patient and  consumer  organisations highlight that the 
information provided should be understandable and patient-friendly and it should be provided 
through different channels reflecting patients' needs. Information should be objective,  neutral 
and  should  promote  the  rational  use  of  medicines.  Opinions  considering  the  role  of  the 
pharmaceutical industry in the provision of information are divided.  Some responses to the 
public consultation were in favour of allowing the pharmaceutical industry greater freedom to 
provide information, arguing also that the industry has the best knowledge of its products.  On 
the  other  hand,  some  responses  were  strongly  opposed  to  such  a  move  and  voiced  concern 
that  industry’s  commercial  interests  meant  that  it  could  not  act  as  a  source  of  unbiased 
information.  

Other stakeholders affected  

Without  prejudice  to  the  provision  of  information  by  other  actors  and  the  Commission's 
declared intention that healthcare professionals should remain as they are today, the primary 
source of health information, the current EU pharmaceutical law places legal obligations only 
on the Member States (and their national competent authorities for medicines), the EMEA, the 
Commission  and  Marketing  Authorisation  Holders  (pharmaceutical  companies).  No  direct 
obligations are placed on the other actors by EU legislation.  

Other stakeholder groups are also affected indirectly by the problem: 

•  The effect on healthcare professionals is ambiguous. On the one hand, the task of patient 
care  may  be  made  harder  if  patients  are  less  well-informed  (e.g.  about  the  benefits  of 
compliance  with  prescriptions).  On  the  other  hand,  the  current  situation  may  also  mean 
that  healthcare  professionals  avoid  problems  arising  from  patients  misinterpreting 
information (e.g. patients making incorrect self-diagnoses). In general, there appears to be 
a broad consensus in this group in support of better information for patients.  

•  Organisations  paying  for  healthcare  may  arguably  benefit  from  the  current  situation 
through lower costs on medicines - for example, as a result of diseases going undiagnosed 
due  to  lack  of  patient  information.  However,  earlier  diagnosis  and  more  effective 
treatment  could,  over  the  long  run,  reduce  complications  and  the  cost  of  emergency 
treatments. Higher drug costs could result in lower total healthcare delivery costs if they 
are related to decreased disability or morbidity or hospital treatment 

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•  Over the last years the editorial content in mass-media related to health information has 
increased significantly following the growing demand of their readers to receive quality 
health  information.  In  this  respect  more  liberal  provisions  on  information  for  patients 
could possibly bring additional revenues for publishing/advertising media. 

The public consultation clearly highlighted that all stakeholders agree on the need to improve 
the quality and quantity of information made available to patients and that the ban on direct-
to-consumer  advertising  should  be  retained.  An  overview  of  the  stakeholders'  opinions  is 
available in Table 2.1.  

Pharmaceutical companies emphasize the quality of the information as a primary determinant 
of  what  information  should  be  allowed  and  stress  that  good  information  should  not  be 
prohibited  solely  because  it  is  produced  by  the  manufacturer.  Pharmaceutical  companies 
consider themselves as an appropriate and an excellent source of information since they are 
legally  liable  for  their  products.  They  have  stressed  that  patients  and  citizens  should  have 
access  to  high  quality  information  in  all  EU  member  States,  however  this  is  not  possible  at 
present  due  to  the  lack  of  an  appropriate  EU  legal  framework  and  other  technical  and 
linguistic  barriers.    Nevertheless,  pharmaceutical  companies  do  not  believe  that  direct-to-
consumer advertising (DTCA) is appropriate in Europe. This position is explained by the fact 
that  the  restrictive  EU  approach  on  DTCA  does  not  lead  in  general  to  a  disadvantage  for 
industry operating in the EU in terms of competiveness. In fact advertisement would increase 
costs for industry in a situation of strong state influence and regulation of price. It is therefore 
possible that increased sales following DTCA would increase pressure on prices, fading out 
the profits of companies and the final effect on the pharmaceutical industry could turn out to 
be negative. 

For  small  or  medium  size  enterprises  that  possess  limited  funds  for  introduction  of  a  new 
therapy to practitioners on their own, clearer EU rules on the provision of information would 
be beneficial.    They currently require partnerships with larger companies  to remain  solvent, 
even  when  their  initial  investments  in  the  science  pay  off.  Giving  inventors  more  diverse 
opportunities  to  communicate  with  patients  on  an  EU-wide  level  could  help  to  level  the 
playing  field  and  allow  more  of  the  smaller  firms,  often  focused  on  the  most  advanced 
therapies,  to  remain  independent  and  become  important  market  players  in  the  future.  This 
would create a synergy with a number of tools introduced at EU level (free scientific advice, 
fee waivers) in order to facilitate centralised marketing authorisation procedure for SME’s.  

Regulators  and  insurers  highlight  the  role  of  national  competent  authorities  in  information 
provision.  According  to  their  opinion,  national  bodies  are  also  the  best  places  to  make 
decisions  by  differentiating  between  what  is  and  what  is  not  advertising.  In  the  public 
consultation  they  had  a  view  that  the  proposed  mechanism  for  monitoring  would  create 
additional regulatory work. The co-regulatory mechanism system could be costly and lead to 
different codes of conduct in the different Member States.  

The  responses  of  the  healthcare  professionals  underlined  in  particular  that  healthcare 
professionals are and should remain the first source of information to patients, and dialogues 
between  health  professionals  and  patients  should  remain  the  central  point.  Healthcare 
professionals also expressed great doubts for the  possibilities to  make a distinction between 
advertising  and  information.    Other  information  to  patients  should  be  made  available,  for 
example, from databases that should be monitored by regulators.  

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According to the public consultations, the majority of healthcare professionals, regulators and 
social  insurance  institutions  do  not  support  pharmaceutical  companies  as  information 
providers,  because,  for  example,  the  information  that  comes  from  the  producer  can  not  be 
neutral. Pharmaceutical industry and media highlighted the role of pharmaceutical companies 
as  information  providers,  because,  for  example,  nobody  knows  the  product  better  than  its 
producer.  However,  the  great  majority  of  the  respondents  agreed  that  pharmaceutical 
companies could be allowed to disseminate information that is approved by authorities.  

Table 2.1 An overview of the stakeholder's opinions in public consultations regarding the current 

situation on information to patients 

Should information provision to patients 
be improved? 

Should the ban on direct-to-consumer 
advertising be retained? 

Is the pharmaceutical industry a good 
source of information to patients? 

Is self-regulation by the pharmaceutical 
industry a good approach? 

Patients 
organisations 

 Consumer 
and citizens 
organisations 

Yes 

Yes 

Yes 

Yes 

Mixed views 

 Mixed views 

Mixed views 

 No 

 Pharmaceutic. 
industry 

Healthcare 
professionals 

Regulators 

Payers 

Media and 
others 

 Yes 

 Yes 

 Yes 

 Yes 

Yes 

Yes 

Yes 

Yes 

Mixed views 

Mixed views 

No 

Mixed views 

 Yes 

 Yes 

 No 

 No 

 Yes 

 Yes 

 Yes 

 Yes 

 Yes, but not 
the only 
channel 

Is the internet a good channel through 
which to provide information to patients? 

Yes, but not the 
only channel 

 Yes, but not the 
only channel 

 Yes, but not the 
only channel 

Yes, but not the 
only channel 

Yes, but not the 
only channel 

 Yes, but not the 
only channel 

Is new EU legislation required? 

Mixed views 

 Mixed views 

 Yes 

Mixed views 

  No 

 No 

 Yes 

The responses from all stakeholders, except media, did not support TV and radio as channels 
to  disseminate  information  about  prescription-only  medicines.  It  was  highlighted  that  there 
are  difficulties  to  distinguish  between  advertising  and  information  and  there  are  great 
possibilities to misuse TV and radio in information provision. 

In  many  responses  it  was  agreed  that  the  pharmaceutical  industry  should  be  allowed  to 
provide  information  on  prescription-only  medicines  to  patients  who  actively  seek  it.  
Information about a specific medicine could be available on the company website in a format 
that can be downloaded and this should be monitored by relevant authorities.  

2.4.  What is the problem? 

 Article  86(1)  of  Directive  2001/83/EC  defines  advertising  as  "any  form  of  door-to-door 
information, canvassing activity or inducement designed to promote the prescription, supply, 
sale  or  consumption  of  medicinal  products".  In  turn,  paragraph  2  of  the  same  provision 
excludes from the scope of the rules on advertising certain kind of information (labelling and 
package  leaflets;  correspondence  answering  questions  about  particular  medicinal  products; 
factual,  informative  announcements  and  reference  material;  information  relating  to  human 
health  or  diseases).  However,  other  than  excluding  these  activities  from  the  rules  on 
advertising, the Directive does not regulate information provision in detail. 

The notion of advertising of Article 86 of Directive 2001/83/EC is interpreted very differently 
across Member States. Because the definition is linked to the subjective intent of promoting 
the  prescription,  supply,  sale  or  consumption  of  medicinal  products,  those  Member  States 
which follow the widest interpretation of advertising consider that any information provided 
by  industry  amounts  to  advertising,  as  pharmaceutical  companies  will  inevitably  aim  at 
promoting  their  sales.  This  interpretation  leads  de  facto  to  a  prohibition  of  the  provision  of 

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information  by  industry  as  regards  prescription  medicines.  It  is  not  a  hypothetical 
interpretation, as shown in case study 1, where a German court concluded that the publication 
on  the  internet  by  a  pharmaceutical  company  of  the  package  leaflets  for  its  products 
constituted  prohibited  advertising.  Other  Member  States  follow  a  more  restrictive 
interpretation  of  advertising  and  therefore  of  the  mentioned  prohibition  (see  case  study  2). 
However, the range of what is considered advertising and what non-promotional information 
varies.  

Figure 2.2: Current status of differentiation between advertisement and information 

Provided by: health care professionals, patient’ organizations, private-public 
partnerships, general media, private individuals etc.

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Figure  2.3:  Views  of  Medicines  Regulatory  Authorities  on  Interpretation  of  Directive  in  their 

Member State 

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Interpretation of Directive by Member State
(1 = least restrictive, 5 = most restrictive)

Source: Survey of medicines regulatory authorities in the EU 

These  differences  are  illustrated  by  figure  2.3,  which  shows  responses  from  medicine 
regulatory  authorities  in  eleven  EU  Member  States  to  a  survey  question.  Two  of  these 
regulators  assessed  the  regime  in  their  country  as  representing  the  most  restrictive  possible 
interpretation of what constitutes advertising under the Directive consistent with EU law. At 
the other end of the scale, one regulator assessed the regime in its country as representing the 
least restrictive possible interpretation consistent with EU law, other three giving a response 
towards the same end of the scale. 

In  addition  to  the  lack  of  clarity  as  regards  the  boundaries  of  the  notion  of  advertising,  the 
directive  does  not  explicitly  provide  that  non-promotional  information  is  allowed.  In  such 
circumstances  Article  86(2),  by  excluding  from  the  scope  of  the  directive  certain  types  of 
information, also lends itself to different interpretations as regards the margin of manoeuvre 
for Member States to regulate information at national level. For some, Directive 2001/83/EC 
restricts advertising but, a contrario, allows information. For others, Member States are free 
to lay down any rule, including strict restrictions, on information. 

Case Study 1: Germany 

In  a  court  case  opposing  two  pharmaceutical  companies,  the  Hanseatisches  Oberlandesgericht, 
Hamburg, Germany, ruled that the naming of the product name, the indication and/or the package 
leaflet  of  a  prescription-only  medicinal  product  published  on  the  company's  webpage  without 
asking for a password for access had to be considered advertising according to the German Code on 
Advertising  of  Medicinal  products.  The  information  given  would  incite  an  prescription  and 
administration interest in the prescription-only medicine. The Court furthermore stated that it could 
not be deduced from Art 86 of Directive 2001/83/EC and those subsequent to it that the information 
provided could not be considered being advertising. Thus, the German provision was considered to 
be in conformity with EU-legislation (3 U 43/05, Ruling of 23 November 2006). 

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Moreover,  the  exclusion  from  the  advertising  provisions  of  certain  types  of  information  by 
Article 86(2) is not helpful either in ensuring a common approach on information, as it is too 
succinct and does not clarify under which conditions such information is allowed. Case study 
1  concerning  the  ruling  of  a  German  court  again  illustrates  this  point.  The  interpretation  of 
Article  86(2)  in  German  legislation  and  by  the  national  courts  does  not  consider  package 
leaflet as advertising when inserted in the packaging of medicinal products as provided for by 
Directive 2001/83/EC, whereas any other dissemination of the same leaflet by industry (e.g. 
on a company website) is considered advertising. In other Member States, any means for the 
dissemination  of  the  package  leaflet  as  approved  by  the  authorities  would  be  considered 
excluded from the restrictions on advertising.  

In  times  when  information  was  provided  mainly  on  paper  and  in  the  majority  of  cases  on 
pharmaceuticals  authorised  by  national  authorities,  this  situation  did  not  have  a  major 
negative impact. However, certain factors have changed the overall situation over the past ten 
years dramatically: 

•  An  increasing  range  of  pharmaceuticals  are  authorised  centrally  by  the  Commission  for 
distribution under the same name in all Member States. This fact results from a step by step 
widening  of  the  scope  of  the  centralised  procedure  by  amendments  to  Community 
legislation; 

•  These  products  under  a  centralised  authorisation  are  the  innovative  pharmaceuticals,  i.e. 
those  creating  new  treatment  options  for  patients.  It  is  evident  that  such  pharmaceuticals 
attract the attention of patients and create a demand for information; 

•  Patients have changed behaviour and rely less exclusively on the information provided by 
their  healthcare  professional.  Instead,  they  search  for  information  and  take  a  more  active 
role in the choice of their treatment. 

•  The internet has revolutionised the distribution of and access to information. More than 60 
percent  of  EU  citizens  have  today  access  to  the  internet  and  can  search  information  on 
pharmaceuticals  available  worldwide  based  on  the  active  substance.  Therefore,  neither 
different national practices of Member States, nor EU-wide prohibitions on advertising will 
be  able  to  stop  the  search  by  patients.  Nevertheless,  reliable  sources  of  good  quality 
information  could  result  in  the  search  being  successful  and  supporting  rational  use  of 
medicines. 

The current situation is marked by patients not finding such good quality information on EU-
based websites  and even information requested by patients from companies are denied (e.g. 
industry  reported  a  case  of  a  Japanese  man  with  asthma  being  in  Belgium  who  wanted  the 
package  leaflet  of  a  drug  in  English  and  could  not  get  it).  This  could  also  affect  any  EU 
citizen travelling within the Community and, any patient seeking treatment abroad, which will 
be further promoted by a proposal for a directive on the application of patients' rights in cross-
border healthcare, recently adopted by the Commission, introducing a principle of recognition 
of  prescriptions.  The  restrictive  interpretation  and  the  lack  of  harmonisation  makes  it 
impossible  to  companies  to  address  this  situation  by  providing  important  information  in  an 
easy-to-understand  language.  This  could  lead  to  incorrect  use  of  medicines  and  lead  to 
consequential  medication  errors  and  side-effects,  e.g.  use  of  a  medicine  with  teratogenic 
effects  by  a  pregnant  women.  Only  few  Member  States  have  build  up  structures  allowing, 
often  in  public-private  partnership,  the  distribution  of  such  information  within  Internet 
websites (see examples in case study 2).  

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Case Study 2 Examples of mechanisms facilitating provision of information to patients 

According to the Medicines and Healthcare products Regulatory Agency, in the UK , the statutory 
information on some marketed medicines is available via the Internet. The majority of this electronic 
inforamtion is made available through the websites of pharmaceutical companies and more recently 
through the electronic medicines compendium (www.medicines.org.uk). The UK Government, along 
with UK stakeholders they consulted, believe that the purpose of information rather than its source is 
the key factor when considering if information is advertising or information. They permit industry to 
communicate  with  patients  at  certain  times,  for  example  post  prescription  and  through  disease 
awareness campaigns, and these are greatly valued by patients. In their view, the example in the UK 
of allowing industry to communicate with patients in certain circumstances could serve as a useful 
model for the rest of Europe. (Source: public consultation responses). 

In Denmark, the Danish Pharmaceutical Association has developed several leaflets with information 
on both diseases and possible treatments, on adverse reactions, compliance and many other subjects 
related  to  diseases  and  medicines.  Much  of  this  information  is  available  on  the  website  of  the  this 
association.  Denmark does not accept any form of prior control of information material by national 
authorities  as  this  would  be  considered  censorship  and  thereby  an  infringement  of  Danish 
constitution. (Source: response of Ministry of Inferior and Health to the public consultation). 

In  Sweden,  information  on  prescription  medicines  to  the  general  public  are  supplied  by  the 
companies within the framework of a unique FASS information portal. This information is supplied 
only  to  the  extent  permitted  by  the  Medical  Products  Agency  and  monitored  by  a  self-regulatory 
body  established  by  the  Association  of  Swedish  Pharmaceutical  Industry.  Questions  as  to  whether 
the information supplied by the pharmaceutical industry and the marketing measures adopted by it 
are compatible with the rules and with good business practice are examined by the Pharmaceutical 
Industry's  Information  Examiner  (IGM)  and  the  Information  Practices  Committee  (NBL).  This 
committee also has the ongoing task of establishing further rules in this area. (Source; www.fass.se) 

52 per cent of patients reading the package leaflet found it hard to remember and 57 per cent 
found it difficult to understand (Vander Stichele et al, 1991). This negatively affects patient 
compliance  with  the  prescribed  treatment  or  even  leads  to  unnecessary  interruption  of  the 
treatment due to perceived side effects and thus deteriorates health outcomes. In addition as a 
patient is given the package leaflet after the prescription decision, it does not promote sharing 
the decision-making between the patient and healthcare professional. Preliminary information 
could improve relationships between patients and health professionals and could help patients 
think  of  questions  which  they  might  want  to  ask.  This  could,  for  instance,  prevent 
unnecessary termination of the treatment upon manifestation of a trivial adverse reaction, of 
which patient could have been informed. 

In  reality  the  agreement  of  all  Member  States  would  be  necessary  for  launching  an  all-
European  webpage  by  a  company  and  the  most  restrictive  Member  State  would  set  the 
standard. This legal uncertainty is particularly unsatisfactory for centrally authorised products 
circulating in the Common market. For instance, the Commission services being approached 
by a major pharmaceutical company that wanted to warn patients against counterfeits of their 
centrally authorised product via the internet, was unable to give an answer how this would be 
legally possible.  

An EU citizen searching for information will nowadays find counterfeit producers or non EU 
based webpage as a source. A simple Google search will demonstrate this reality:  sites which 
are  run  by  dubious  sources,  containing  poor  quality  or  even  misleading  or  dangerous 
information.  Counterfeit  medicines,  offered  over  the  Internet,  have  a  considerable  negative 
impact on public health: this includes death, additional medical interventions and prolonged 

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hospitalisation  and  long-term  disabilities  (e.g.  after  strokes,  loss  of  hearing).  There  are  also 
related costs in the form of treatment, absence from work, etc. In addition there can be more 
far-reaching consequences in terms of the patient's trust in the legal supply chain, in particular 
the supply of medicinal products through pharmacies.  

The  behaviour  of  EU  citizens  in  these  circumstances  is  illustrated  by  a  survey  of  a 
multinational  company  on  the  use  of  their  US  medicines  websites  (see  case  study  3).  More 
than 600.000 hits from the EU were noticed between September 2006 and August 2007 and 
the number has increased by 7 percent within one year. For certain innovative products, more 
than 10 percent of the overall hits result from the EU. 

Case study 3: Use of internet 

Despite the fact that the U.S. websites of multinational pharmaceutical companies clearly state that 
the information on them, including advertisement on prescription only medicines are  intended only 
for residents of the United States, a survey of Pfizer U.S. medicines websites, revealed that large 
numbers of EU citizens are using these sites - more than 600,000 hits annually from citizens of all 
EU  Member  States,  although  English  language  levels  and  internet  penetration  greatly  influenced 
usage levels. 

The  statistics    show  that  proportionally  higher  numbers  of  Europeans  use  sites  aimed  on  rarer 
conditions reaching up to 17% of all hits on the Somavert (growth hormone for acromegaly) site 
and 14% on the Genotropin (for growth hormone deficiency) site being from Europe. This is not 
surprising  considering  that  in  both  cases  the  U.S.  sites  are  provided  as  the  best  matches  by  the 
“google” search engine. 

Certainly,  English-language  sources  of  health-related 
information  have  proliferated, 
particularly  Internet  sites  based  in  the  USA.  Notable  examples  include  netdoctor.co.uk, 
webMD.com, MedicineNet.com, rxlist.com. These are commercial entities supported largely 
by advertising revenues in some form or another. Rxlist.com, for instance, makes significant 
use of sponsored content - such as the AstraZeneca Cancer Support Network - which is not 
subject to any editorial control and facilitates click-throughs to an online pharmacy. Clearly,  
this  has  led  to  a  number  of  inequalities  arising  within  Europe  as  English-speaking  citizens 
with access to US media content (whether on the internet or otherwise), including US-sourced 
promotional material, are potentially facing “choice overload”, whilst internet-based options 
outside the English speaking world are typically rather less extensive in coverage. Above all, 
the information provided by the US site doesn't reflect the EU legal situation in terms of the 
details  of  the  EU  marketing  authorisation  (particularly  with  regard  to  approved  indications, 
target populations and safety warnings) or in terms of the prohibition of advertisement. This 
situation could lead to: 

•  use of medicines for non-approved indications, 
•  inappropriate dosage of medicines, 
•  use of medicines by the population, for which it is not intended  
•  absence of important safety warning, 

and resulting medication errors associated with considerable risks to patient health. 

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The following conclusions can be drawn from the above: 

1)  The  EU  industry  hardly  provides  information  on  prescription  medicines  to  citizens,  in 

particular in the internet, except for package leaflets. 

2)  The  large  majority  of  EU  citizens  have  hardly  access  to  good  quality  information  on 

prescription medicines, except when approaching a healthcare professional. 

3)  The situation varies widely for citizens, depending on their nationality, language skills, 

access to the internet and behaviour. 

The above also suggests that in order to establish a workable distinction between advertising 
and information it is not enough to rely on a definition of advertising or on the general listing 
of  categories  of  information  allowed.  The  distinction  between  advertising  and  information 
will  frequently  depend  on  the  way  information  is  presented  or  the  communication  channels 
used.  

2.5. 

How the problem would evolve under present policies 

Today,  restrictions  on  the  possibilities  of  pharmaceutical  companies  to  provide  information 
result from the lack of clarity of the Community rules as regards the definition of advertising 
and,  consequently,  the  distinction  between  advertising  and  information.  The  situation 
described in section 2, alongside the fact that many marketing authorisation holders operate at 
European  scale,  currently  lead  to  companies  applying  the  lowest  common  denominator  of 
what is allowed and to provide very limited information on their medicinal products. In this 
respect, in various forums a number of approaches have been discussed: soft-law instruments 
(such as a recommendation), promotion of private public partnerships or more centralised EU-
level policy options (e.g. via the EU Health portal). Nevertheless, as the repeal or amendment 
of  Community  provisions  on  advertising  is  not  under  consideration,  the  clarification  of  the 
distinction  with  non-promotional  information  needs  to  be  operated  at  the  level  of  those 
Community rules. 

Continued  lack  of  harmonisation  would  result  in  the  persistence  of  the  problems  described 
above.  Due  to  the  continuation  of  the  major  trends  which  resulted  in  the  current  problems 
(more centrally authorised products, change of citizens behaviour, importance of the internet), 
the situation would become worse with a high degree of probability. A particular risk of the 
future  would  be  the  building-up  of  websites  specifically  for  EU  citizens  on  servers  placed 
outside the EU. Once such sites would be established, prominently placed in search engines 
and accepted by users, a change of the EU legal situation would probably lead to few changes 
in reality, because the industry and citizens would have build-up what seemingly is a viable 
alternative from their perspective.   

These  assumptions  are  supported  by  the  conclusions  of  Eysenbach  et  al  (2002)  who 
demonstrated  that  consumers  rely  predominantly  on  search  engines  to  find  information, 
generally only exploring the first few links given by search engine results. The study found 
that the factors which consumers said they would use to assess the credibility of sites in the 
focus groups did not match their observed behaviour. Actually in interviews, few participants 
had noticed and remembered where they had obtained information from.  

Obviously it is not excluded that some gaps in the information available may be filled as time 
proceeds by other private or public sector information provision initiatives. For example, third 
parties such as patient organisations may provide more information on diseases and available 
treatments in order to meet growing patient demand for such information. Member States may 

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also introduce their own initiatives to facilitate information provision by industry.  The variety 
of  approaches  on  how  to  deliver  information  to  patients  on  diseases  and  treatment  options 
presented  to  the  Pharmaceutical  Forum  involve  multiple  possibilities  of  public-private 
collaborations  and  public-public  collaborations.  Leading  examples  of  national  information 
provision initiatives which have been adopted by some Member States include: 

•  the FASS project in Sweden, which involves collaboration between the pharmaceutical 

industry and the Swedish healthcare system with a view to provide patients with extensive 
information on treatments related and medicines  in written form and on the Internet. 
Information provided by numerous public bodies complement information provided by 
companies on their products as described in case study 2. 

•  The UK Medicines Project, which involves a number of stakeholders (including the 
pharmaceutical industry) and which provides information to patients through online 
Medicines Guides. 

Currently,  the  Pharmaceutical  Forum  (see  section  3.4)  has  produced  a  set  of  tools  based  on 
these high quality examples. The exchange of best practices provided members of the Forum 
and other actors involved in the field with different ways forward to improve the situation. 

It  is  clear  that  some  of  the  best  practices  examples  provide  for  the  governmental  bodies 
maintaining  the  role  of  the  editor.  The  EudraPharm  project  of  the  EMEA  funded  by 
Community subsidies belongs in the same category. The potential for addressing some of the 
unmet  patients  needs  is  obvious.  A  clear  advantage  is  the  possibility  to  be  broad  in  content 
e.g.  the  disease  in  general  and  treatment  alternatives  may  be  explained.  However  these 
initiatives are out of the scope of this impact assessment. A possible revision of Community 
legislation  would  deal  exclusively  with  the  rights  and  obligations  of  pharmaceutical 
companies. Consequently this impact assessment focuses on the risks and benefits of different 
options in this context, and, in terms of patients’ needs, which of the options serves patients 
best. 

Community legislation harmonises the way key information on medicinal products is drafted 
(summary of products characteristics and package leaflet) and makes these documents the key 
tools to promote the proper and rational use of medicines among healthcare professionals and 
patients.  In  a  system  where  the  rules  on  the  authorisation  of  medicines  and  on  product 
information are fully harmonised to ensure the same level of protection of public health across 
the Community, this objective will remain undermined if widely divergent national rules on 
the dissemination of such key information are accepted. 

The need for action at Community level is also linked to the evolution of Community internal 
market  rules  on  marketing  authorisations  for  medicines.  Since  1995,  certain  medicinal 
products  are  authorised  by  the  Commission  which  grants  a  Community-wide  marketing 
authorisation.  These  products  (so-called  "centrally  authorised")  circulate  freely  within  the 
Community  and  have  the  same  summary  of  product  characteristics  and  package  leaflet, 
approved  by  the  Commission,  for  the  whole  Community.  Similar  considerations  apply  to 
products  authorised  by  the  Member  States  under  the  mutual  recognition  framework.  Since 
1995, any medicinal product authorised in more than one member States follow a procedure 
of  mutual  recognition  leading  to  harmonised  marketing  authorisations,  including  the  same 
summary  of  product  characteristics  and  package  leaflet.  This  development  has  not  been 
reflected in the Community provisions on advertisement/information yet. 

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Case study 4: Juers-Pharma (ruling of the ECJ in case C-143/06) 

The  case  concerned  the  sending  of  price  lists  of  medicines  to  pharmacies,  for  products  not 
authorised in the Member State concerned and imported from abroad. The ECJ considered that 
the products concerned were excluded from the scope of the directive (they fell under one of the 
exclusions to its scope). Therefore, it examined the situation from the point of view of Article 28 
of the EC Treaty and concluded that prohibiting the sending of price lists was disproportionate 
and  contrary  to  Art  28.  To  reach  this  conclusion  it  relied  on  the  rules  of  the  Directive,  which 
exclude price lists from the scope of rules on advertising (Art 86(2)), i.e. the legislator had not 
considered  it  necessary  to  introduce  restrictions  on  the  sending  of  such  price  lists  when 
regulating advertising. 

If the regulation of information on medicinal products is left up to each Member State, it may 
lead  to  restrictions  of  the  free  movement  of  goods  in  violation  of  Art  28  EC.  Moreover,  it 
would almost inevitably lead to the adoption of national rules running counter to the spirit and 
effectiveness  of  the  system  of  the  directive.  Indeed,  if  the  directive  lays  down  detailed 
restrictions  on  advertising  and  excludes  certain  types  of  information  from  these  restrictions, 
any national rules prohibiting or unduly restricting such information would alter the balance 
introduced by Art 86 of the directive. In this context, there seems to be no room for national 
rules /practices related to cultural differences/ ethics as illustrated in case study 4.  

2.6. 

Does the EU have the right to act? Treaty legal basis and subsidiarity 

The  objectives  of  the  proposal  are  consistent  with  the  overall  objective  of  the  Community 
pharmaceutical  legislation  of  removing  disparities  between  national  provisions  in  order  to 
ensure the proper functioning of the internal market for medicinal products, while at the same 
time safeguarding a high level of protection of public, human and animal health. 

Following  the  entry  into  force  of  the  Treaty  of  Amsterdam,  all  the  legislative  provisions 
adopted by the European Parliament and the Council as regards medicinal products for human 
use,  are  adopted  on  the  basis  of  Article 95  of  the  Treaty  as  a  legal  basis  for  achieving  the 
objectives set out in Article 14 of the Treaty, which include the free movement of goods and 
hence of medicinal products for human use. This is because the differences between national 
laws,  regulations  and  administrative  provisions  on  medicinal  products  result  in  obstacles  to 
intra-Community trade which directly affect the operation of the internal market.  

The proposal also respects Article 152(1) of the Treaty establishing the European Community, 
which  lays  down  that  a  high  level  of  human  health  protection  shall  be  ensured  in  the 
definition and implementation of all Community policies and activities.  

As regards subsidiarity, only a common approach on information provision can better ensure 
the  uniform  promotion  of  public  health  across  the  Community  through  the  rational  use  of 
medicines. Harmonised provisions would allow that citizens in all Member States have access 
to the same type of information on prescription-only medicinal products based on a common 
set  of  quality  criteria.  Thereby  health  risks  stem  from  the  current  situation  (suboptimal 
treatment choice, impaired compliance, premature treatment termination, use of medicines by 
population groups, for which the medicine is not intended – see pages 11, 16 and 18 for more 
details) can be addressed. This holds true in particular for those products authorised either by 
the Commission or by the mutual recognition procedure with a harmonized set of indications, 

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dosage  regimes  side  effects  and  other  key  product  characteristics  in  a  situation  of  growing 
importance of the Internet as a source of information proactively searched by the EU citizens,  

In  response  to  the  growing  cross-border  health-care  within  the  EU,  on  2  July  2008,  the 
Commission adopted a proposal for a Directive on the application of patients' rights in cross-
border  healthcare  (COM(2008)  414  final  -  2008/0142  (COD)),  in  order  to  ensure  that  the 
necessary  requirements  for  high-quality,  safe  and  efficient  healthcare  are  ensured  for  cross-
border care. Amongst other provisions, this proposal for a directive aims at the introduction of 
a  principle  of  recognition  of  prescriptions,  which  should  allow  for  medicinal  products 
prescribed  in  one  Member  State  to  be  dispensed  in  another.  In  practice,  this  will  entail  that 
medicinal  products  subject  to  medical  prescription  will  be  dispensed  in  a  Member  State 
different from the Member State of origin of the patient and the prescribing doctor. 

In  such  circumstances,  ensuring  that  the  patient  understands  the  information  concerning  the 
pharmaceutical  product  and  its  instructions  for  use  will  be  important  for  the  recognition  of 
prescriptions  to  realise  its  objective  of  improving  health-care.  A  harmonised  European 
situation  as  regards  the  information  available,  allowing  for  the  dissemination  of  essential 
product information such as the patient information leaflet, would contribute to this objective 
and help address language barriers in the case of the cross-border dispensing of products. In 
contrast  a  restrictive  approach  and  divergent  interpretation  in  times  of  increasing  level  of 
cross-border health care is creating new health risks. 

Besides,  the  rules  on  the  authorisation  and  supervision  of  medicinal  products,  including  the 
rules  on  advertising,  are  already  harmonised  at  Community  level,  for  public  health  and 
internal market reasons. It should be noted in this regard that the European Court of Justice 
has  ruled  in  case  C-374-05,  Gintec,  that  Directive  2001/83/EC  contains  a  complete 
harmonisation in the area of advertising, and that therefore Member States cannot fall short, 
or go beyond, the provisions of the directive. 

In such circumstances, to preserve the effectiveness of the Community pharmaceutical acquis 
as regards advertising, it is appropriate that the issue of information provision is addressed at 
Community level. If this matter continues to be left for national rules, it will almost inevitably 
lead to the adoption of national rules running counter to the spirit of Directive 2001/83/EC. 
Indeed,  as  the  directive  lays  down  detailed  restrictions  on  advertising  and  excludes  certain 
types  of  information  from  these  restrictions  (Article  86),  any  national  rules  prohibiting  or 
unduly restricting such information could alter the balance introduced by the directive.  

Moreover,  national  rules  and  practices  on  information  may  lead  to  restrictions  to  the  free 
movement of goods in violation of Art 28 EC, impacting negatively on the completion of a 
single  market  in  pharmaceuticals  which  the  harmonised  legal  framework  on  medicinal 
products  tries  to  achieve.  The  European  Court  of  Justice  has  already  found  certain  national 
provisions on information on medicinal products to be contrary to Article 28 (case C-143/06, 
Juers-Pharma).  

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3. 

OBJECTIVES 

3.1. 

General policy objectives  

The Commission proposal on provision of information about medicines to the general public 
is fully in line with the overall objectives of the Community pharmaceutical legislation: 

•  to ensure proper functioning of the internal market for medicinal products 
•  to better protect health of the EU citizens  

3.2. 

Specific Policy Objective 

In addition this proposal aims specifically to: 

•  Provide  for  a  clear  framework  for  provision  of  information  by  marketing  authorisation 
holders  about  their  prescription-only  medicines  to  the  general  public  with  a  view  to 
enhancing  the  rational  use  of  these  medicines,  while  ensuring  that  the  legislative 
framework continues to prohibit direct-to-consumer advertising of prescription medicines. 

3.3. 

Operational Policy Objectives 

The specific policy objective could be best achieved by: 

•  Ensuring  the  high  quality  of  information  provided  by  coherent  application  of  clearly 

defined standards across the Community.  

•  Allowing information to be provided through channels addressing needs and capabilities 

of different types of patients.  

•  Not inappropriately restricting the ability of marketing authorization holders to provide in 
an understandable way objective and non-promotional information about the benefits and 
the risks of their medicines. 

•  Ensuring  that  monitoring  and  enforcement  measures  are  in  place  to  ensure  that 
information  providers  comply  with  the  quality  criteria,  while  avoiding  unnecessary 
bureaucracy. 

Figure 3.1: Scope of the proposal  

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Provided by: health care professionals, patient’ organizations, private-public 
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Schematic diagram: areas do not necessarily reflect extent of information in each subgroup. 

3.4. 

Consistency with other EU policies and horizontal objectives 

The European Commission created in June 2005 the Pharmaceutical Forum8 to work on the 
three  most  crucial  issues  outstanding  from  the  G10  Medicines  process  (Information  to 
Patients,  Relative  Effectiveness  and  Pricing/Reimbursement).  The  Pharmaceutical  Forum, 
jointly  chaired  by  Vice  President  Verheugen,  responsible  for  Enterprise  and  Industry,  and 
Commissioner Vassiliou, responsible for Health, provides a high level platform for discussion 
and strategic recommendations on the competitiveness of the European-based pharmaceutical 
industry and related public health issues.  

The  objective  of  the  Information  to  Patients  Working  Group  is  to  develop  proposals  to 
improve  the  quality  and  accessibility  of  information  to  patients  on  medicines  and  health 
issues.  During  the  two  first  years  of  the  Pharmaceutical  Forum,  the  Working  Group  has 
reached  a  common  understanding  on  the  needs  and  the  challenges  existing  in  the  field  of 
information  to  patients  for  disease  and  treatments.  However,  the  Information  to  Patients 
Working  Group  is  focusing  on  patient  information  in  general,  not  to  information  on 
prescription-only medicines. 

The  objectives  of  the  proposed  policy  are  in  line  with  the  EU  Health  Strategy  aiming  to 
mainstream EU action in a strategic and systematic way and to better respond to new health 
challenges. One of its main goals is the citizens’ empowerment - individuals must play a role 
in  taking  care  of  their  own  health,  and  therefore  citizens'  and  patients'  participation  and 

8 http://ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm 

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empowerment needs to be regarded as core values in all health-related work at EC level. The 
access  of  citizens  and  patients  to  reliable  and  understandable  information  is  considered  as 
crucial for them for making healthy choices and achieving better treatment results. 

The planned directive on patients' rights in cross-border healthcare would place an obligation 
on  authorities  of  the  country  where  the  treatment  is  provided  to  ensure  that  healthcare 
providers provide all relevant information to enable patients to make an informed choice, in 
particular  on  availability,  prices  and  outcomes  of  the  healthcare  provided  and  details  of  the 
means  of  personal  or  collective  protection  with  regard  to  professional  liability.  The 
Commission's CLWP 2008 item on patient safety emphasises that efforts to improve patient 
safety,  both  at  national  and  EU  levels,  would  be  aided  by  the  provision  of  accurate,  timely 
information from a reliable source.  

"Information  provision",  particularly  on  the  Internet,  is  one  of  the  key  priorities  for  the 
European  Commission.  The  Health-EU  Portal,9  launched  in  May  2006,  aims  at  providing  a 
trusted  single  point  of  entry  for  health-related  information  in  all  official  languages.  In 
addition,  

DG INFSO promotes patients empowerment by encouraging the widespread availability and 
accessibility  of  ICT-based  services,  especially  those  that  have  the  greatest  impact  on  the 
quality  of  life  of  citizens.  The  eHealth  action  plan,10  sets  out  a  strategy  to  promote  wider 
dissemination  of  eHealth  services,  from  electronic  prescriptions  and  health  cards  to  new 
information systems that reduce waiting times and error, to facilitate a more harmonious and 
coordinated approach to eHealth in Europe.  

The eEurope Action Plan aims to achieve an Information Society for all European citizens on-
line in all aspects of their lives. One of the specific targets of the Action Plan is to improve 
web access for people with disabilities and, of course, to adopt and implement the results of 
the  Web  Accessibility  Initiative  project,  which  promotes  means  to  perceive,  understand, 
navigate, and interact with the Web for people with disabilities.11 On 8 November 2007, the 
Commission adopted the Communication entitled "European i2010 initiative on e-Inclusion - 
to be part of the information society".  

9 http://ec.europa.eu/health-eu/index_en.htm 
10 http://ec.europa.eu/information_society/doc/qualif/health/COM_2004_0356_F_EN_ACTE.pdf 
11 http://www.w3.org/WAI/gettingstarted/Overview.html 

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4. 

POLICY OPTIONS 

4.1. 

Possible Policy Options 

There is a range of policy options relating to information provision by industry which could 
be considered in order to meet the policy objectives. These include: 

a)  Retention of the current legislative framework (referred as Option 1 in the further text); 
b)  Revision of Directive 2001/83/EC to harmonize rules on what information industry is 
allowed to provide to patients. Sub-options for enforcing such information provision 
would include: 
•  Enforcement by national medicines regulatory authorities (Option 2); 
•  Self-regulation  by  pharmaceutical  industry  associations,  with  membership  of  such 

associations continuing to be voluntary (Option 3); 

•  Co-regulation, in which some regulatory responsibilities are given to a co-regulatory 

body while others are given to medicines regulatory authorities (Option 4). 

•  A self-regulatory model in which all marketing authorisation holders are required to 

belong to the industry body responsible for self-regulation; 

c)  Revision of Directive 2001/83/EC allowing specific types of advertising of prescription 

medicines within the EU. 

As discussed below, some of these options were discarded at an early stage, while others have 
been subject to more detailed analysis as part of this impact assessment. 

4.2. 

Options Discarded at an Early Stage 

The following policy options have been discarded at an early stage: 

•  Allowing specific types of advertising of prescription medicines within the EU. 

Direct-to-consumer advertising of prescription medicines within the EU was not considered to 
be appropriate as it would fail to meet the objectives of the policy (which include maintaining 
the current prohibition on such advertising).  

This  choice  is  based  on  the  following  reflections  on  substance:  Nelson  (1970,  1974)  argues 
that  even  advertising  that  does  not  contain  direct  information  may  be  signalling  efficiency, 
reminding consumers of previous experiences with the product, or indicating a match between 
products  and  the  buyers  to  whom  the  advertisement  is  targeted.  Bagwell  (2005)  further 
discusses the work of Nelson and identifies three competing views of advertising 

•  The informative view – advertising provides consumers with useful information (e.g. 

on products and prices), thus facilitating the process of competition. 

•  The persuasive view – advertising is manipulative and distorts consumers’ decisions. 
Advertising can also have anti-competitive effects by enabling firms to gain market 
power. 

•  The  complementary  view  –  consumers  derive  enjoyment  from  watching  adverts 

together with purchasing the associated products. 

Thus,  it  can't  be  denied  that  certain  forms  of  advertisement  would  lead  to  a  better  level  of 
information.  The  sole  intention  to  increase  sales,  being  the  major  element  of  distinguishing 
legally  between  advertisement  and  allowed  information,  is  not  automatically  leading  to 

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unreliable  or  low  quality  information.  The  above  "complementary  view"  even  suggests  that 
information coupled with enjoyment better reaches the recipient of the information.  

This  approach  is  supported  by  Vanilla  Research  (2007)  which  provided  a  number  of  case 
studies  relating  to  the  provision  of  regulated  information  (i.e.  information  which  regulation 
requires  firms  or  other  parties  to  provide  to  consumers).  It  concludes  that  regulated 
information  is  not  working  for  the  intended  purpose  and  that  more  information  does  not 
necessarily  amount  to  better  information.  This  conclusion  appears  to  be  supported  by 
stakeholders  views  expressed  in  the  public  consultation  pointing  to  the  deficiencies  of  the 
package  leaflet  being  the  major  source  of  regulated  information  in  the  area  of  prescription-
only pharmaceuticals. 

On the other hand, the literature identifies in general a number of ways in which advertising 
could  harm  social  welfare.  For  example,  the  literature  suggests  that  combative  advertising 
(which seeks to redistribute brands among consumers) may exceed the social optimum where 
real differences between brands are modest.  

In the specific circumstances of medicinal products the harmful effects are evident. There is a 
body  of  literature  on  the  effect  of  specific  types  of  direct-to-consumer  advertising  of 
prescription  medicines  in  New  Zealand  and  the  U.S  suggesting  that  such  advertising  would 
fail to meet the objective of providing patients with non-promotional information. According 
to Meek (2001), advertising of prescription medicines in New Zealand, while leading to more 
frequent  and  informed  consultation  of  general  practitioners,  raised  prescription  costs  and 
divert expenditure away from treating illness to those who are not ill. In relation to the US, 
the  review  cites  direct-to-consumer  advertising  as  a  factor  in  raising  prescription  costs  and 
health insurance premiums. 

Similar  findings  are  revealed  by  the  National  Institute  for  Healthcare  Management  (2000) 
which discussed the reasons for the increase in prescription drug spending observed in the US 
between  1998  and  1999.  The  report  argues  that  this  growth  was  largely  attributable  to  the 
Food  and  Drug  Administration's  relaxation  of  restrictions  on  drug  advertising  in  1997.  It 
found that mass media advertising on prescription drugs tends to be concentrated on relatively 
few drugs, and that sales of these drugs accounted for most of the jump in spending in 1999. 

Gellad  and  Lyles  (2007)  refer  to  empirical  studies  in  the  US  showing  consumer 
misconception  of  advertisement  on  prescription  medicines  and  an  increasing  number  of 
patient requests for specific drugs and related increases of prescription volumes. 

In  line  with  these  critical  findings,  the  majority  of  stakeholders  in  the  public  consultation, 
including the pharmaceutical industry, have stated that they are opposed to such advertising. 
Hence this policy option, even if restricted to specific types of advertisement, would not only 
go clearly against the specific objective of enhancing rational use of medicines, but also fail to 
gain the support and confidence of citizens, regulators and healthcare professionals. 

•  A self-regulatory model in which all marketing authorisation holders are required to 

belong to the industry body responsible for self-regulation. 

A self-regulatory model in which all marketing authorisation holders are required to belong to 
the industry body responsible for self-regulation would address a major shortcoming of self-
regulation  as  identified  by  a  specific  paper  issued  by  the  Ministry  of  Consumer  Affairs  in 
New Zealand: The opt-out by firms, in particular in the event of a possible sanction. At the 

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same  time,  the  same  source  points  out  in  general  that  the  objectives  of  consumers  and 
governments  may  not  be  met  by  self-regulation.  Palzer  and  Scheuer  (2004)  stress  other 
disadvantages: self-regulation can't ensure compliance and may lack legitimacy and lead to a 
duplication of institutional structures.  

Furthermore, this option was not considered to be appropriate as it would widen the scope of 
the  policy.  In  particular,  this  policy  option  would  potentially  require  the  introduction  of 
regulation  on  membership  of  pharmaceutical  industry  associations.  It  might  also  prevent 
industry associations using expulsion or suspension of membership as a sanction under a self-
regulatory regime. 

4.3. 

Option 1: Retention of Current Legislative Framework 

As discussed above, the first option is to leave the current EU legislative framework on the 
provision of information to patients by the pharmaceutical industry as it is. In this case, the 
EU  and  Member  States  would  continue  with  existing  policies,  including  implementation  of 
any initiatives already announced (see section 2.5). 

Actually  the  legal  status  quo  would  result,  most  likely,  in  the  persistence  of  the  existing 
situation,  where  pharmaceutical  companies  generally  do  not  distribute  information  on  a  EU 
wide basis. This would have limited negative consequences for products marketed on a purely 
national  level,  while  for  products  with  a  central  marketing  authorisation  or  products  under 
mutual  recognition  it  would  entail  negative  public  health  consequences,  in  particular  in 
Member States having a restrictive approach on information. Many people in those Member 
States would be left without access to information on their medicines, others would more and 
more consult websites with promotional character. 

4.4. 

Options 2, 3 and 4: Revision of Directive 2001/83/EC 

An alternative would be to revise Directive 2001/83/EC to establish a legal framework for the 
provision of certain information to patients by the pharmaceutical industry, while maintaining 
the current prohibition on direct-to-consumer advertising of prescription medicines. 

Common features of policy options 2, 3 and 4 

Under  policy  options  2,  3  and  4,  communication  to  patients  by  marketing  authorisation 
holders  would  be  permitted  where  it  was  not  covered  by  the  definition  of  advertising,  and 
provided that it met certain quality standards. These options are assumed to be equivalent in 
terms  of  defined  quality  criteria  standards,  possible  information  channels  and  degree  of 
restriction on content: 

(a) The quality standards would require the information to be objective and unbiased, patient 
oriented,  evidence-based,  up-to-date,  accessible,  transparent,  relevant  and  consistent  with 
approved  product  information.  Comparisons  between  medicinal  products  would  not  be 
allowed.  Detailed,  specific  criteria  should  be  laid  down  in  implementing  legislation  by  the 
Commission. 

(b) The information permitted under the proposed policy would comprise: 

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•  Information compatible with approved summaries of product characteristics (SPCs) and 

patient information leaflets (PILs), neither contradicting nor going beyond the key 
elements in them; 

•  Other limited medicine-related information (information about scientific studies, 

prevention of disease such as by vaccination, accompanying measures to medicinal 
treatment, prices). 

(c)  Two  categories  of  information  channels  of  information  would  be  considered  varying  in 
their  extent  to  which  information  was  “pushed”  by  the  marketing  authorisation  holder  or 
“pulled” by patients taking the initiative in seeking information: 

•  Information passively received by citizens (or “push” information) when a marketing 

authorisation holder disseminates information on prescription-only medicines through TV 
and radio programmes, through printed material actively distributed, through information 
in printed media or through audiovisual and written material provided to patients by 
healthcare professionals. 

•  Information searched by citizens (a type of “pull” information). This category would 

include: 

•  Information disseminated through dedicated internet websites12 or verbally;  
•  Answering  requests  from  citizens  -  Information  which  the  industry  provides  to 

patients through the post or by email in reply to their enquiries. 

An important feature of Options 2-4 is that once a marketing authorisation holder has notified 
the regulatory body in one Member State about an information provision initiative and in the 
absence  of  any  objection  from  that  specific  regulatory  body,  the  MAH  would  be  entitled  to 
provide the material (translated into other languages where appropriate) across the EU.   

While Options 2, 3 and 4 share the above listed common features, they differ with regard to 
how such information provision would be enforced, as discussed below. Three different forms 
for such a new framework have been identified. These have certain key features in common 
and are outlined below. 

Option 2: Regulation by medicines regulatory authorities 

Those  responsible  for  the  enforcement  would  be  the  Member  State  regulators  currently 
responsible  for  the  enforcement  of  statutory  information  provision  by  the  pharmaceutical 
marketing authorisation holders. For centrally authorised products, the EMEA could be tasked 
with giving expertise for centrally authorised products. . 

Option 3: Industry Self-regulation 

The  responsibility  for  regulation  would  rest  with  existing  pharmaceutical 
industry 
associations. In other words, this option would involve industry self-regulation. Membership 
of the industry association would continue to be on a voluntary basis. 

12  Please  note  that  this  refers  only  to  the  specific  websites  with  a  defined  content  as  notified  by  MAH’s  to  a 
regulatory  body.  These  websites  would  be  continuously  monitored  by  competent  regulatory  bodies. 
This  information  shall  not  include  any  information  provided  on  general  websites  maintained  by  third 
parties.  No  form  of  promotion  will  be  allowed,  particularly  pop-up  windows  or  sponsored  links  in 
search engines. 

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Option 4: Co-regulation 

The  Commission’s  February  2008  consultation  paper13  described  this  option  in  more  detail. 
Under this policy option: 

•  Each  Member  State  would  set-up  a  national  co-regulatory  body,  consisting  of  public 
authorities  and  a  mix  of  stakeholders,  including  healthcare  professionals,  patient 
organizations  and  the  pharmaceutical  industry.  These  co-regulatory  bodies  could  be 
responsible for: 

•  Adopting a code of conduct on information to patients 
•  Monitoring and following up of all information activities by the industry. 
•  Each Member State could charge its competent authorities to act in the case of repeated 

and severe cases of non-compliance and to apply sanctions. 

•  If  regulatory  bodies  in  other  Member  States  had  serious  doubts  as  to  whether  the 
information material was compliant with the law, they would refer the matter to the EU 
Pharmaceutical Committee, which would act as an EU advisory committee. 

5. 

ANALYSIS OF IMPACTS 

5.1. 

Introduction 

The consumption of prescription medicines is the result of a “directed” demand - the doctor, 
or  other  appropriate  health  professional,  will  act  as  a  gatekeeper  to  ensure  appropriate 
consumption  of  prescription  medicines  by  patients.  Demand  for  these  medicinal  products  is 
the outcome of a composite process, normally initiated by an individual seeking out medical 
help.  Given  the  knowledge  or  prejudice  that  he  or  she  has,  a  patient  evaluates  the  expected 
benefits of seeking medical advice against the costs. 

Because  the  needs  of  patients  are  different,  the  information  should  be  made  available  from 
different  sources.  This  includes  pharmaceutical  companies  that  have  all  the  documentation 
about their own products. A key issue in assessing the impact of the policy is reaching a view 
on  what  information  the  industry  will  actually  be  permitted  to  provide  without  being 
considered in breach of the advertising ban. While a certain degree of uncertainty will persist 
depending  on  how  the  law  is  interpreted  in  future  rulings  by  the  European  Court  of  Justice 
(ECJ), for the purpose of this impact assessment it has been assumed that the following “pull” 
information would be permitted: 

•  Reference information on drugs available to patients who actively seek it, including on 

websites and in the form of printed leaflets available on request or in appropriate 
locations (refer to “Reference websites” in table 5.8). 

•  Information provided to patients who already have been given a prescription in order to 
support concordance, e.g. leaflet available from pharmacists alongside prescription drug, 
telephone helpline (refer to “Materials to support concordance”). 

13http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_02/info_to_patients_consult_20

0802.pdf 

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•  Information provided to individual patients in response to enquiries (refer to “Answer to 

enquiries”). 

To illustrate the potential impact of push information, we have considered the possibility that, 
if  the  above  notification  procedure  were  applied  to  disease  awareness  campaigns,  it  would 
lead to a higher number of such campaigns taking place across a broader range of media. 

The  extent  to  which  such  information  provision  is  already  permitted  varies  across  Member 
States, and hence the policy will lead to greater change in some Member States than in others. 
In addition to the above uncertainty regarding what information will be provided, there is also 
substantial uncertainty relating to how patients will respond to additional information and the 
effect that changes in patient behaviour will have on health outcomes and healthcare budgets. 

Given this uncertainty, the analysis presented in this section is based on optimistic, medium 
and pessimistic scenarios of the impact of the policy. For questions where respondents were 
asked  to  indicate  a  percentage  range,  the  medium  scenario  is  based  on  averaging  the  mid-
points of the ranges specified by respondents. The pessimistic scenario combines low benefit 
and high cost assumptions to give the lowest possible estimate of the net benefit of the policy. 
Conversely, the optimistic scenario combines high benefit and low cost assumptions to give 
the highest possible estimate of the net benefit of the policy. 

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5.2.  Methodological Approach to Assessing Impacts 
The main impacts of the policy which need to be assessed are summarised below. 

Social / Public Health impacts 

•  Changes in health outcomes for patients 

Economic impacts 

•  Changes in expenditure on pharmaceuticals (plus any changes in other healthcare 

costs) 

•  Costs incurred by industry in providing additional information to patients 

•  Costs of enforcing information provision standards 

•  Administrative burdens associated with notifying the regulatory body of 

information provision 

•  Other possible impacts (e.g. on competition and innovation) 

Environmental impacts 

•  No significant environmental impacts have been identified. 

A  multi-criteria  analysis,  which  consists  of  a  qualitative  evaluation  of  the  impacts  of  the 
policy  options,  was  chosen.  This  type  of  analysis  allowed  including  potentially  divergent 
input from the literature, expert groups and relevant stakeholders. Therefore, a decision had to 
be made on the trade-off between different criteria, either by making a judgment or by placing 
explicit weightings on each criterion to produce an overall ranking of options (see Section 1 
of  Annex  2).  The  fact  that  assessment  of  costs  and  benefits  is  at  the  heart  of  an  impact 
assessment does not mean that it is possible to quantify every relevant cost and benefit for this 
IA  and  thus,  in  many  cases,  only  a  subjective  assessment  and  scoring  by  informed  opinion 
was possible. The impact assessments should take also account of the risks and uncertainties 
surrounding policy impacts rather than just focusing on central estimates. 

A  number  of  elements  of  research  have  been  carried  out  to  gather  data  to  inform  an 
assessment of these impacts: 

•  The  literature  review  has  generated  some  useful  qualitative  and  quantitative  material 
relevant to the impact of providing information to patients about medicinal products and 
health-related  issues  in  order  to  gather  evidence  on  (see  Annex  3  for  the  literature 
review): 

•  The effects on patients, health professionals, health systems and public health of 

the provision of information to patients on medicinal products and illnesses. 

•  The distinction between information and advertising. 
•  The  relative  effectiveness  of  different  information  channels,  such  as  the  internet 

and written information. 

•  The effects of how information is presented (drawing on behavioural economics 

research into framing effects).  

•  The  advantages  and  disadvantages  of  different  regulatory  models,  such  as  state 

regulation, co-regulation and self regulation. 

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•  Three separate surveys using customised questionnaires to gather data from key 

stakeholders, respectively (see Annex 2, Sections 2-5, for a detailed analysis of the 
questionnaires): 

•  Medicines regulatory authorities; 
•  Organisations paying for healthcare; 
•  Organisations providing healthcare or representing healthcare professionals; 
•  Targeted interview programme with a number of pharmaceutical companies and industry 

associations for gathering information from the pharmaceutical industry; 

•  Other interviews with stakeholders including patient representatives; 
•  Two case studies, one on heart disease in the UK and the other on an initiative relating to 

patient information in France. 

More details on some of these elements of research can be found in the annexes. Based on this 
research,  policy  impacts  have  been  analysed  both  qualitatively  and  quantitatively,  as 
summarised below: 

•  First, chapter 5 reveals estimates of the impact of changing the current legislation to allow 
greater  information  provision  by  industry,  including  by  allowing  companies  to  choose 
which  Member  State’s  regulatory  body  to  notify.  This  is  presented  by  showing  in  more 
detail  the  impact  of  Option  2  relative  to  the  counterfactual  of  Option  1.  The  same 
assessment as regards options 3 and 4 is presented in a summary table only.  

Health  benefits  and  additional  healthcare  expenditure  were  assessed  based  on  the  above 
mentioned  survey  of  healthcare  providers.  A  series  of  questions  exploring  the  potential  for 
behavioural change (see chapter 5.3.1 below) and the extent to which the options cause this to 
happen  had  to  be  answered  with  reference  to  particular  bandings.  The  answers  lead  to 
estimates of the size of these effects in terms of the number of patients who might respond in 
different ways. The survey estimates providing a relative size of various effects were scaled to 
ensure consistency with assumptions (based on regulatory authorities and payers surveys) on 
the degree of information provision by industry. 

To  quantify  and  monetise  impacts  on  human  health,  the  concept  of  Quality-Adjusted  Life 
Years  was  used  (1  QALY  equals  one  year  of  life  expectancy  in  full  health.  The  similar 
concept of Disability Adjusted Life Years was also deployed). Taking into account a recent 
study by Mason et al. (2006) the assumed value of a QALY was assumed to be 40.000 Euro 
(pessimistic),  60.000  Euro  (medium)  and  80.000  Euro  (optimistic  scenario).  Additionally, 
calculations of unit costs of unnecessary consultations of general practitioners resulting from 
the anxiety effect were used. 

Some of the costs are one-off in nature, whereas other costs and benefits are ongoing. In order 
to assess the overall impact of the policy, we have calculated the net present value of policy 
impacts  over  a  ten-year  period  (at  the  discount  rate  of  4  per  cent  recommended  in  the  EC 
Impact Assessment guidelines).  

•  Second,  chapter  5  compares  the  different  approaches  for  the  enforcement  of  information 
provisions  under  new  legislation  by  presenting  estimates  of  the  incremental  costs  and 
benefits of self-regulation (Option 3) and co-regulation (Option 4) relative to enforcement 
by medicines regulatory authorities (Option 2). 

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The  costs  to  regulatory  bodies  were  calculated  by  multiplying  the  assumed  volume  of 
information provided by industry by assumed unit cost, differentiated for the three different 
enforcement options. One-off set-up costs and ongoing costs were calculated separately. 

Additionally, the administrative burdens for marketing authorisation holders were calculated 
using  the  Standard  Cost  Model.  Notification  requirements  and  assistance  to  investigations 
were assumed to be the major factors.  

•  Chapter  5  also  presents  estimates  showing  how  the  impact  of  the  policy  may  change 

depending on whether or not “push” information is allowed to be provided. 

5.3. 

Social Impacts 

Mechanisms by which health outcomes may be affected 

The most important social impact of the policy is expected to be on human health. To analyse 
health impacts in a systematic way, the literature review provided evidence for assessing the 
effects on patients and public health of the provision of information to patients on medicinal 
products  and  illnesses.  In  line  with  this  literature,  the  impact  assessment  considered  the 
following  mechanisms  whereby  information  to  patients  may  affect  patient  behaviour  and 
health outcomes: 

•  Preventative effect – information on disease risk factors may lead to patients taking action 

(e.g. making changes to their diet or lifestyle) which prevents them getting a disease. 

•  Awareness effect – information on diseases and their symptoms may lead to patients with 
diseases becoming aware of their health problem. In turn, this could lead to them receiving 
treatment  which  they  might  not  otherwise  have  received,  or  being  diagnosed  and  starting 
treatment earlier than otherwise. 

•  Anxiety  effect  –  information  on  diseases  and  their  symptoms  may  create  unnecessary 
anxiety among citizens who in fact do not have the diseases they become worried about. 
•  Interaction effect – information about diseases and treatment options could allow patients 
to  have  a  more  informed  discussion  with  healthcare  professionals  (e.g.  better  sharing  of 
relevant  information  about  their  symptoms),  potentially  leading  to  improved  prescription 
decisions. 

•  Prescription  distortion  effect  –  Information  about  diseases  and  prescription  drugs  could 
lead to citizens asking healthcare professionals to prescribe them specific drugs, even when 
the  prescription  is  not  actually  necessary  or  is  not  the  best  treatment  for  their  health 
problem. 

•  Compliance effect – Information about prescription drugs and the diseases they treat could 
affect the extent of patient compliance with prescriptions. For instance, compliance might 
improve  if  information  led  to  better  understanding  of  prescription  instructions  or  the 
reasons  why  compliance  was  important;  or  compliance  might  deteriorate  if  information 
made patients more concerned about possible side-effects. 

Each of these mechanisms is analysed in turn below, focusing on the potential scale of each 
impact under Option 2 (direct regulation). The impact assessment then discusses the overall 
impact on health for Option 2 and how these impacts may differ for Options 3 and 4. 

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Preventative effect 

A  preventative  effect  may  arise  where  access  to  information  about  a  particular  illness  or 
condition might result in lifestyle changes, and consequently improved health but without any 
requirement  for medicinal products per se.  For example research has indicated that lifestyle 
changes, including dietary modification and increase in physical activity, can prevent type 2 
diabetes  (Hu  et  al.  2006).  Lifestyle  intervention  including  information  about  the  disease 
resulted in sustained lifestyle changes and a reduction in diabetes incidence (Lindström et al. 
2006).  

Considering  the  limited  scope  of  the  proposal,  it  seems  unlikely  that  the  proposed  policy 
would lead to any significant preventative effect. This is because: 

•  The proposed policy focuses on information on medicinal products and the diseases 

which they treat, rather than information on how patients can take preventative action. 
•  Pharmaceutical companies would appear to have little commercial incentive to spend 
money telling the public how to prevent disease (except in certain cases as vaccines). 

On  the  other  hand,  it  could  be  argued  that  if  companies  undertake  disease  awareness 
campaigns,  then  regulatory  pressure  might  force  them  to  include  information  on  disease 
prevention  as  well  as  information  about  the  disease  itself.  It  is  unclear  how  significant  this 
effect would be. 

The assessment of the real value of the preventative effect to patients is complex, because too 
many  “patient-related  effects”  may  influence  the  results,  including  the  personal  values, 
attitudes and skills of each individual. However, for the purpose of this impact assessment, we 
have  adopted  the  conservative  assumption  that  the  policy  would  not  lead  to  a  preventative 
effect in the pessimistic scenario. We have assumed a small preventative effect in the medium 
and optimistic scenarios.  

Table 5.1: Preventative effect for Option 2 

Reduction in DALYs across EU per year 
Annual benefit (€m) 
PV benefit over 10 years (€m) 
Additional annual treatment cost (€m) 
PV cost over 10 years (€m) 
Net benefit from policy over ten years (€m) 

Pessimistic 
0 

0 
0 
0 
0 
0 

Medium 

Optimistic 

42,364 
2,542 
20,616 

0 
0 

112,860 
9,029 
73,232 

0 
0 

20,616 

73,232 

Note: A DALY is a disability adjusted life year. DALYs are used as a measure of lost quality of life and lost life expectancy as a result of 
disease. Our calculations assume that the value of a DALY equals the value of a quality adjusted life year (QALY). 

Source: Europe Economics calculations 

Awareness effect 

In general, the improvement of a patient’s health can be considered dependent on, or at least 
proportional  to,  the  medical  treatment  adopted. An  awareness  effect  occurs  where  access  to 
information targeted directly at consumers might increase a patient’s awareness of a particular 
disease  or  of  the  existence  of  new  or  alternative  treatments.  At  this  stage,  then,  the 
information  accessed  by  the  patient  has  affected  the  choice  of  seeking  medical  advice  by 

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increasing awareness of a disease and/ or treatment (i.e. it has increased the expected benefit 
from medical advice). 

As  a  result  of  improved  information,  a  patient  might  (appropriately)  seek  medical  advice 
when he or she would otherwise not have done so. In the patient's perspective, early diagnosis 
could lead to better clinical outcomes. This has been demonstrated for example with asthma 
where  the  delayed  diagnosis  has  an  influence  on  the  prognosis  and  efficacy  of  therapeutic 
intervention  and  the  benefits  of  early  treatment  of  symptomatic  asthma  have  been  shown 
(Haahtela 1999). Patient information could have a particularly valuable role in facilitating the 
diagnosis  of  rare  diseases,  where  doctors  may  have  little  or  no  experience  of  the  disease 
which  their  patient  is  suffering  from.  These  examples  clearly  demonstrate  the  awareness 
effect also for pulled information, although in smaller order of magnitude, as a patient might 
also search for information pending final diagnosis. 

The table below shows estimates of the awareness effect which might result from the policy. 
These numbers are based on the assumptions shown in  2 (pages 10-14), and should be treated 
with caution given the uncertainty involved. 

Table 5.2: Awareness effect for Option 2 

Change in QALYs per year 
Annual benefit (€m) 
PV of benefit over 10 years (€m) 
Additional annual treatment cost (€m) 
PV of cost over 10 years (€m) 
Net benefit from policy over ten years (€m) 

Source: Europe Economics calculations 

Pessimistic 

Medium 

Optimistic 

10,327 

413 

3,351 

413 

3,351 
0 

22,630 
1,358 
11,013 

679 

5,507 
5,507 

46,407 
3,713 
30,112 
928 

7,528 
22,584 

In the medium scenario, more and earlier diagnosis of disease leads to a benefit worth €5.5bn 
over ten years. In the pessimistic scenario, the additional health benefits from more and earlier 
diagnosis are assumed to be offset by the additional cost of the pharmaceutical drug, yielding 
a  zero  net  benefit.  By  contrast,  in  the  optimistic  scenario  there  is  a  significant  net  gain  of 
€22bn over ten years. 

Anxiety effect 

There are numerous factors that influence how patients consider the information they receive, 
depending on the patient’s personality, kind of information and their environment (Koo et al. 
2003).  Unnecessary  anxiety  caused  by  information  on  diseases  (e.g.  antidepressants  are  in 
some cases prescribed to people who are healthy and request them, rather than to those who 
are seriously, clinically depressed) could have two negative impacts on citizens: 

•  First, anxiety may reduce people’s quality of life; 
•  Second, where such anxiety leads to additional consultations with healthcare 

professionals, this may increase costs for the healthcare system. 

The table below shows estimates of this effect, based on the assumptions shown in Annex 2 
(page 10-14).  

Table 5.3: Anxiety effect for Option 2 

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35 

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Change in QALYs per year 
Annual benefit (€m) 
PV benefit over 10 years (€m) 
Additional annual cost of consultations (€m) 
PV cost over 10 years (€m) 
Net benefit from policy over ten years (€m)  

Source: Europe Economics calculations 

Pessimistic 

Medium 

-221,950 
-8,878 
-72,008 
1,075 
8,716 
-73,752 

-17,660 
-1,060 
-8,595 
228 

1,849 
-8,964 

Optimistic 
0 

0 
0 
0 
0 

0 

In the medium scenario, the anxiety effect leads to a social cost of around €9bn  over ten years. 
In the pessimistic scenario, the social costs resulting from unnecessary anxiety are greater at 
€74bn over ten years. By contrast, in the optimistic  scenario it is assumed that the policy will 
not lead to additional anxiety, and hence the impact is zero.  

Interaction effect 

Patients  differ  in  many  respects  and  a  doctor  has  to  identify  not  only  the  occurrence  of  a 
disease but also those characteristics of the patient that are relevant to the choice of treatment. 
Patient-doctor  interaction  can  be  thought  of  as  a  process  by  which  a  doctor  observes  some 
signal that leads him (or her) to update a priori beliefs on the type of patient being dealt with. 
Improved interaction - which might result if patients were better informed - may improve the 
quality  of  information  available  to  the  doctor  and  thus  in  the  identification  of  a  superior 
treatment.  For  instance,  suppose  that  the  doctor  does  not  know  whether  his  patient  has 
intolerance  for  certain  side  effects  or  not.  The  patient  might  learn  about  whether  different 
brands  of  medicine  could  give  rise  to  such  side-effects.  The  patient’s  mention  of  this 
intolerance  to  the  doctor  might  result  in  a  better  prescription  and  his  awareness  of  the 
importance of side effects may also be enhanced.  

From  patient's  perspective  the  positive  interaction  effect  was  reported  for  example  in  cases 
where patients first consulted online sources with a view to receive information, which they 
could  further  discuss  with  their  doctor.    A  study  involving  6,369  participants  showed  that 
49.5% of them preferred their physicians as sources of specific health information. Yet, when 
asked what they actually did, 48.6% reported going online first, with only 10.9% asking their 
physicians  first.  The  majority  of  the  patients  used  more  than  one  source  to  receive  the 
information they needed (Hesse et al. 2005). 

The table below shows estimates of the interaction effect, based on the assumptions shown in 
Annex 2 (pages 10-14).  

Table 5.4: Interaction effect for Option 2 

Change in QALYs per year 
Annual benefit (€m) 
PV benefit over 10 years (€m) 
Additional annual treatment cost (€m) 
PV cost over 10 years (€m) 
Net benefit from policy over ten years (€m) 

Source: Europe Economics calculations 

Pessimistic 

Medium 

Optimistic 

15,050 

602 

4,883 

602 

4,883 
0 

40,532 
2,432 
19,725 
1,216 
9,863 
9,863 

86,623 
6,930 
56,207 
1,732 
14,052 
42,155 

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36 

   EN 

 
 
In the medium scenario, the interaction effect leads to a net benefit of around €10bn over ten 
years.  In  the  pessimistic  scenario,  it  is  assumed  that  the  additional  healthcare  gains  from 
giving patients more appropriate prescriptions as a result of the interaction effect is offset by 
the incremental costs of the better prescription drug they are given. In the optimistic scenario, 
on the other hand, there is a substantial benefit of around €42bn over te n years from improved 
prescription decisions. 

Prescription distortion effect 

A  recent  study  identified  the  following  factors  affecting  a  prescriber’s  treatment  choice: 
patient  demand,  professional  experience,  clinical  needs  of  patient,  peer  networks,  and  drug 
company representatives.14 In terms of patient demand, there is a prescribing cost faced by the 
doctor  that  can  be  thought  of  as  deriving  from  decreased  patient’s  satisfaction  with  the 
doctor’s services if the drug that the patient expects is not prescribed, or as a cost in terms of 
the  doctor’s  time  which  would  be  lost  for  deviating  from  such  drug.  Giving  a  patient  a 
prescription for a medically inappropriate or relatively non-cost-effective drug he or she has 
specifically  requested  is  presumably  often  much  easier  -  and  must  always  be  faster  -  than 
refusing with an explanation. Cockburn and Pit showed that patients expecting a medication 
were nearly three times more likely to receive it compared to other patients.  

Estimates of the prescription distortion effect are shown below, based on the assumptions in 
Annex 2 (pages 10-14). Again, these estimates should be treated with caution. 

Table 5.5: Prescription distortion effect for Option 2 

Change in QALYs per year 
Annual benefit (€m) 
PV benefit over 10 years (€m) 
Additional annual treatment cost (€m) 
PV cost over 10 years (€m) 
Net benefit from policy over ten years (€m)  

Source: Europe Economics calculations 

Pessimistic 

Medium 

-15,913 

-3,212 

-637 

-193 

-5,163 
0 
0 
-5,163 

-1,563 
0 
0 
-1,563 

Optimistic 
0 

0 
0 
0 
0 

0 

The table shows that the prescription distortion effect may be smaller in magnitude than some 
of  the  other  effects,  yielding  a  net  cost  of  around  €1.6bn  in  the  medium  scenario.  In  the 
pessimistic  scenario,  there  is  a  net  cost  of  around  €5bn,  whereas 
optimistic scenario.15  

the  impact  is  zero  in  the 

Compliance effect 

The  actual  health  outcome  is  also  influenced  by  the  compliance  of  the  patient  with  the 
prescribed drug therapy. There is evidence that non-compliance is a substantial problem, and 
that  access  to  more  information  and  better  patient-doctor  interaction  can  help  to  reduce  it. 
Deyo  showed  in  a  US  study  that  only  51–78%  of  patients  followed  drug  prescriptions 

14  

15  

Ling, T et al, “Prescribing in Primary Care — understanding what shapes GP’s prescribing choices and 
how might these be changed” 
The calculations assume that the drug which patients request is not more expensive than the drug which 
the doctor would otherwise have prescribed.  If in fact the drug is more expensive, then the prescription 
distortion effect would create further costs. 

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properly.16 The importance of the compliance has also been shown in the treatment of chronic 
illnesses  where  patients  are  supposed  to  implement  the  treatment  to  their  daily  routines. 
Patients  suffering  from  mental  illnesses  and  reporting  low  adherence  to  medication  have 
reported  to  have  significantly  lower  satisfaction  with  information  they  had  received  about 
their  prescription-only  medicines  (Bowskill  et  al.  2007).  An  improved  adherence  and 
compliance to asthma medication may also reduce symptoms and improve clinical outcomes 
of the treatment (Närhi et al. 2001). 

The degree of compliance depended largely on how much information and understanding the 
patient  had  at  the  outset.  We  term  this  the  “compliance  effect”.  In  theory,  the  policy  could 
either: 

•  Increase compliance (e.g. due to increased understanding of prescription instructions or 

the benefits of compliance); or 

•  Reduce compliance (e.g. due to greater awareness of possible side-effects). 

In practice, the majority of healthcare professionals who responded to the survey thought that 
compliance  would  either  stay  the  same  or  improve.  Estimates  of  the  compliance  effect  are 
shown in the table below. These figures are based on the assumptions in Annex 2 (pages 10-
14), and should be treated with caution given the uncertainty involved. 

Table 5.6: Compliance effect for Option 2 

Change in QALYs per year 
Annual benefit (€m) 
PV benefit over 10 years (€m) 
Additional annual treatment cost (€m) 
PV cost over 10 years (€m) 
Net benefit from policy over ten years (€m) 

Source: Europe Economics calculations 

Pessimistic 
0 

0 
0 
0 
0 
0 

Medium 

Optimistic 

57,597 
3,456 
28,030 

0 
0 

28,030 

309,162 
24,733 
200,606 
0 
0 
200,606 

The  net  benefits  from  improved  compliance  amount  to  €28bn  over  10  y ears  in  the  medium 
scenario. Patient's improved compliance could not lead only to better clinical outcomes, but 
also  to  improved  quality  of  life,  which  can  be  seen  in  changes  of  QALYs.  The  pessimistic 
scenario  assumes  no  change  in  compliance,  in  line  with  the  views  of  some  healthcare 
professionals.  By  contrast,  the  optimistic  scenario  assumes  a  significant  improvement  in 
compliance yielding a large benefit of around €201bn over 10 years. 17 

Overall health impact for Option 2 

The  table  below  summarises  the  overall  health  benefits,  net  of  additional  healthcare  costs, 
which  might  result  from  Option  2  over  a  10-year  period.  In  the  medium  scenario,  the  net 

16   Deyo, RA (1991), “Compliance with therapeutic regimes” in Arthritis: issues, current status, and a future 

agenda seminars in arthritis and rheumatism, Vol 12 , p233-244 

17  

The scenario assumes that there is no increase in treatment cost, either because there is no change in the 
number of drugs dispensed (i.e. the effect of the policy is simply that these drugs are taken as the patient 
was  instructed),  or  because  any  increased  pharmaceutical  cost  due  to  long-term  persistence  with 
medication is offset by savings elsewhere in the healthcare system (e.g. lower hospitalisation costs due 
to avoided complications). 

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benefit is €53bn, whereas 
of €79bn) and in the optimistic s cenario the net benefit is €339bn.  

in the pessimistic scenario the net benefit is -€79bn (i.e. a net cost 

These figures do not include certain costs associated with the policy (e.g. the cost to industry 
of providing information to patients), which are discussed separately later. 

Table 5.7: Overall health benefits less additional healthcare costs under Option 2 (€m) 

Pessimistic 

Medium 

Optimistic 

Preventative effect 
Awareness effect 
Anxiety effect 
Interaction effect 
Prescription distortion effect 
Compliance effect 
Overall health impact 

Source: Europe Economics calculations 

0 
0 

-73,752 

0 
-5,163 
0 

-78,914 

20,616 
5,507 
-8,964 
9,863 
-1,563 
28,030 
53,488 

73,232 
22,584 

0 

42,155 

0 
200,606 
338,577 

Breakdown by type of information provision 

The  table  below  shows  estimated  impacts  on  health  (less  additional  expenditure  on 
healthcare)  broken  down  by  type  of  information  provision.  While  all  the  categories  of 
information provision yield net benefits in the medium scenario, the largest risks are attached 
to disease awareness campaigns, followed by reference websites. 

Table  5.8:  Breakdown  of  impacts  by  category  of  information  provision  under  Option  2  (NPV  of 

health benefits less healthcare costs over 10 years, €m) 

Pessimistic 

Medium 

Optimistic 

Push information 
Disease awareness campaigns 
Pull information 
Reference websites 
Material to support concordance 
Answers to enquiries 
Total 

Source: Europe Economics calculations 

Health impacts under Options 3 and 4 

-59,001 

7,542 

54,683 

-19,913 
0 
0 
-78,914 

17,916 
22,424 
5,606 
53,488 

83,288 
160,485 
40,121 
338,577 

The  impacts  estimated  above  have  been  scaled  to  produce  estimates  for  Options  3  and  4, 
guided by survey responses from regulators and payers. 

The table below shows health benefits less additional healthcare costs for each policy option, 
using a central set of scaling factors (shown in Annex 2, page 14-19). The results suggest that 
Option 2 yields the greatest health benefits net of additional healthcare costs. As for Option 2, 
impacts  are  more  uncertain  and  there  is  a  greater  risk  of  negative  impacts  when  push 
information is included. 

As  a  sensitivity  test,  we  also  applied  a  “low  differential”  set  of  scaling  factors  and  a  “high 
differential” set of scaling factors (see Annex 2, page 22-23). 

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Table 5.9: Comparison of policy options (NPV of health benefits less healthcare costs over 10 years, 

€m) 

Pessimistic 

Medium 

Optimistic 

Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

Source: Europe Economics calculations 

Different channels of communication 

-19,913 
-78,914 

-29,870 
-118,372 

-23,896 
-94,697 

45,946 
53,488 

36,973 
40,554 

40,675 
46,633 

283,894 
338,577 

246,399 
300,962 

256,860 
311,495 

The potential benefits and risks of Options 2, 3 and 4 may vary across different channels of 
communication.  It  is  apparent  that  the  quality  of  content  and  choice  of  the  channel  of 
communication  could  have  a  critical  impact  upon  how  increased  patient  information  about 
medicinal  products  affects  health  outcomes  and  the  cost  of  public  healthcare  delivery.  The 
same  patient  information  leaflet  posted  on  the  company  dedicated  website  would  affect 
patients in  different way than  its show  in a TV  prime-time.  An  important distinction  is  that 
made between reactive and proactive communication channels, depending on whether or not 
the  information  is  provided  only  to  active  information-seeking  consumers.  Table  5.11  is 
constructed  from  the  survey  responses  of  regulators  and  healthcare  providers,  and  ranks 
different channels of communication in terms of likely risks relative to likely benefits. The list 
is presented with the channels deemed likely to create the most risks relative to benefits at the 
top. 

Table 5.12 presents the average score (on a scale of 1 to 5) attributed by survey respondents to 
the benefits and risks of different media, averaged over “push” and “pull” media respectively. 
The  figures  show  that  both  healthcare  providers  and  regulators  assessed  “pull”  media  as 
giving  rise  to  higher  benefits  and  lower  risks  than  “push”  media  (Annex  2,  page  21,  shows 
classification of different channels of communication into “push” and “pull” channels). 

EN 

40 

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Table 5.11: How impacts may vary by channel of communication 

Healthcare providers 

Channel 

Internet pop-ups 

Unsolicited posting, e-mails or telephone calls 

Short TV slots, not linked to the content of the 
programme 

Rank 
1 

2 

3 

4  Mobile phone text messages 
5 

Short radio slots, not linked to the content of programmes 

Posters or billboards 

DVDs or videos 

6 

7 

8 

9 
10 

11 

Seminars or oral presentations to patients or the general 
public, organised by the pharmaceutical industry 
Internet sites (in general) 
TV programmes with factual content 
Solicited written communication (e.g. post, e-mails, 
answers to questions) 
Solicited telephone information (e.g. telephone help lines) 

12 
13  Radio programmes with factual content 

14 

Generalist printed media (e.g. books, articles in 
newspapers, general magazines) 

15  Magazines dealing predominantly with health issues 

Medicines regulatory authorities 

Channel 

Internet pop-ups 
Short radio slots, not linked to the content of 
programmes 

Unsolicited posting, e-mails or telephone calls 

Rank 
1 

2 

3 

6 

4  Mobile phone text messages 
5 
Posters or billboards 
Short TV slots, not linked to the content of the 
programme 
Seminars or oral presentations to patients or the 
general public, organised by the industry 
Solicited telephone information (e.g. telephone help 
lines) 
Radio programmes with factual content 
Internet sites (in general) 

7 

8 

9 
10 

11  DVDs or videos 

TV programmes with factual content 

12 
13  Magazines dealing predominantly with health issues 
Solicited written communication (e.g. post, e-mails, 
answers to questions) 
Generalist printed media (e.g. books, articles in 
newspapers, general magazines) 

15 

14 

Ranking: 1 (highest risk relative to benefit) …. 15 (lowest risk relative to benefit) 
Source: Survey of medicines regulatory authorities and healthcare providers in the EU 

This  table  demonstrates  the  need  to  differentiate  information  distributed  via  the  internet. 
Depending on the circumstances of use and the technical solution chosen, the Internet can be 
either “push”, to be treated as a TV-like channel, or “pull”, when only the active search of the 
user  leads  to  the  information.  Therefore,  a  clear  distinction  should  be  made  between 
information provided on websites with a general content (e.g. a news site) maintained by third 
parties  and  dedicated  websites  of  a  marketing  authorisation  holder  with  no  promotional 
content or “pop-up” windows as defined in section 4.  

Table 5.12: Average score given to benefits and risks of “push” and “pull” media 

“Push” media 
“Pull” media 

Healthcare providers 

Regulators 

Benefits 
2.0 
2.5 

Risks 
4.1 
3.7 

Benefits 
2.2 
2.7 

Risks 
4.1 
3.6 

Note: Classifying media into “push” and “pull” media inherently involves an element of judgment. The classification used to produce this 
table is shown in Annex 2. 
Source: Survey of medicines regulatory authorities and healthcare providers in the EU 

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5.4. 

Economic Impacts 

In addition to health benefits for patients, there would be a number of costs associated with 
the policy, namely: 

•  The cost to healthcare systems across the EU of any increase in expenditure on 

pharmaceutical drugs, less any reduction in other healthcare costs (e.g. the costs of 
hospitalisations). These were discussed above, particularly in relation to the awareness 
and interaction effects. 

•  The cost to marketing authorisation holders of the additional information provision. 
•  The cost of regulating this information provision. 
•  The administrative costs on companies of notifying the regulatory body of information 

provision and assisting with any investigations arising from complaints. 

These costs are considered in turn below. 

Additional costs to healthcare systems 

Meet  (2001)  reviews  international  policy  and  evidence  on  direct-to-consumer  advertising  of 
prescription  medicines.    In  relation  to  the  US,  this  review  refers  to  direct-to-consumer 
advertising as a factor in raising prescription costs and health insurance premiums (see also 
Section 4.2). In New Zealand, direct-to-consumer advertising has been also permitted, albeit 
with mandatory pre-vetting since, 2000.  The review finds that this has the effect of making 
patients more likely to visit their GP, have an informed consultation and receive medicines of 
benefits.  At the same time, direct-to-consumer advertising is found to raise prescription costs 
and divert expenditure away from treating illness to treating those who are not ill.   

Much  less  information  is  available  on  economic  impacts  of  high  quality  non-promotional 
information accessible by the general public. Clearly, the above mentioned literature sources 
referring to DTCA could provide upper bound estimates of the effect of providing more non-
promotional  information.    For  example,  any  prescription  distortion  effect  resulting  from  the 
policy  changes  being  considered  is  likely  to  be  significantly  less  than  the  prescription 
distortion effect observed from in the US from direct-to-consumer advertising.   

The  European  Surveillance  of  Antimicrobial  Consumption  (ESAC)  project,  granted  by  the 
DG  SANCO,  established  for  the  first  time  a  comprehensive  database  of  internationally 
comparable data on antibacterial consumption in Europe in out- and in-patients.18 A striking 
finding  was  the  marked  differences  in  antibiotic  prescribing  in  primary  care  in  Europe.  In 
general,  antibiotic  use  was  highest  in  Southern  and  Eastern  Europe,  and  lowest  in  Northern 
Europe, including Sweden and the U.K. with well established systems providing an extensive 
access to non-promotional information on prescription medicines, including antibiotics. This 
suggests  that  consumption  of  prescription  medicines  is  driven  by  differences  in  health  care 
systems, culture and education, while better access to information by patients is available in 
those countries with the observed restrictive use.  

18  Goossens  H,  Ferech  M,  Vander  Stichele  R,  et  al.  Outpatient  antibiotic  use  in  Europe  and  association  with 

resistance: a cross-national database study. Lancet. 2005; 365:579-587. 

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Estimates  of  additional  healthcare  costs  were  included  in  the  earlier  quantifications  of  the 
awareness, anxiety and interaction effects. The table below summarises these estimates on a 
PV  basis  over  10  years  for  Options  2,  3  and  4,  both  with  and  without  inclusion  of  push 
information. (These costs have already been netted off the health benefits presented earlier.) 

The  estimates  suggest  that  the  policy  would  tend  to  increase  healthcare  expenditure.  The 
estimated size of this impact is significantly greater if the policy includes push information. 
Where drug prices exceed marginal production costs (e.g. for  on-patent drugs), some of the 
additional  healthcare  expenditure  would  represent  a  transfer  to  pharmaceutical  companies 
rather than a net social cost.19  

Table 5.13: Estimates of PV of additional costs to healthcare systems over 10 years (€m) 

Pessimistic 

Medium 

Optimistic 

Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

Source: Europe Economics calculations 

5,901 
9,976 

5,190 
11,303 

5,617 
10,507 

11,038 
15,739 

9,160 
16,212 

10,287 
15,928 

15,557 
21,580 

12,797 
21,831 

14,453 
21,680 

On  the  other  hand  these  additional  costs  could  lead  to  a  better  public  health  outcome  and 
perhaps  longer-term  savings  in  healthcare  delivery  costs.  While  short-term  health  care 
delivery  costs  may  increase,  earlier  diagnosis  and  more  effective  treatment  could,  over  the 
long run, reduce complications and the cost of emergency treatments. Higher drug costs thus 
could  result  in  lower  total  healthcare  delivery  costs  (particularly  those  related  to  decreased 
disability or morbidity or hospital treatment).  

Cost of information provision20 

The  tables  below  show  the  estimated  incremental  costs  to  the  industry  of  providing 
information to patients, for each of the types of information provision which are assumed to 
result  from  the  policy.  For  the  high  estimates,  it  is  assumed  that  there  would  be  a  greater 

19  

20  

The price of on-patent drugs can be seen as including an element of remuneration for sunk R&D costs.  
However, because these R&D costs have already been sunk, by definition they are not incremental costs 
resulting  from  the  policy.    Hence,  this  element  of  the  price  of  on-patent  drugs  represents  a  transfer 
rather than a net social cost. 
For  the  costs  of  information  provision,  the  costs  to  regulatory  bodies  and  administrative  costs,  we 
present high and low estimates rather than pessimistic, medium and optimistic scenarios.  As discussed 
earlier, the pessimistic, medium and optimistic scenarios are all based on the high estimates for the cost 
of information provision.  This is because the most optimistic scenario which can be conceived involves 
high  spending  on  information  provision  leading  to  a  positive  impact,  whereas  the  most  pessimistic 
scenario which can be conceived involves high spending on information provision leading to a negative 
impact. 

EN 

43 

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increase  in  expenditure  on  disease  awareness  campaigns  under  self-regulation  or  co-
regulation than under regulation by medicines regulatory authorities. 

Annex  2  (pages  3-6)  presents  in  detail  the  assumptions  made  for  estimation  of  incremental 
industry spending resulting from the policy in each of these areas.  These assumptions were 
informed by input from the interviews with a number of industry associations and individual 
pharmaceutical companies. 

Table 5.15: Cost of information provision (€m) 

One-off costs  
Online reference information 
Annual costs 
Disease awareness campaigns 
Online reference information 
Information to support concordance 
Information in response to enquiries 
Total annual costs 

Source: Europe Economics calculations 

Low (Options 
2, 3 and 4) 

High (Option 
2) 

High (Options 3 
and 4) 

56 

6 
45 
30 
9 
89 

450 

326 
368 
270 
52 

450 

407 
368 
270 
52 

1,017 

1,098 

Table 5.16: PV of cost of information provision over 10 years (€m) 
Low (Options 
2, 3 and 4) 
733 
780 

Pull information only 
Pull and push information 

Source: Europe Economics calculations 

High (Option 
2) 

High (Options 3 
and 4) 

6,034 
8,678 

6,034 
9,339 

Costs to regulatory bodies 

The tables below shows high and low estimates of the PV of costs to regulatory bodies across 
the EU of setting up and running the new regulatory regime to oversee information provision 
by  industry.  These  estimates  are  based  on  the  assumptions  in  Annex  2  (page  25-27),  and 
should  be  treated  with  caution  as  they  are  based  on  extrapolation  from  a  small  number  of 
survey responses.  

The  one-off  costs  would  be  higher  for  setting-up  of  the  new  regimes  and  particularly  in 
Member States without any appropriate regulatory unit in place at the moment. The ongoing 
costs to regulatory bodies are likely to depend on the scale of information provision and the 
intensity of the regulatory scrutiny required by legislation. The question, whether EMEA staff 
or  a  national  authority  would  assess  the  compliance  of  information  with  future  rules  has 
limited impact on costs. In any case costs could be born by fees paid by companies. 

Table 5.14: Estimated PV of regulatory costs over 10 years (€m) 

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44 

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Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

Low 

11.0 
11.1 

7.4 
7.4 

9.8 
9.9 

High 

204 
207 

135 
137 

182 
185 

Note: To show the small incremental cost to regulatory bodies associated with push information, the low estimates are presented to 1 
decimal place. 

Source: Europe Economics calculations 

Administrative costs 

The policy proposals would create administrative costs for marketing authorisation holders. In 
particular, pharmaceutical companies would be required to inform the regulatory body before 
engaging in any “push” information provision, and would also have to notify the regulatory 
body  of  information  disseminated  through  websites.  In  addition,  marketing  authorisation 
holders would presumably need to provide information to the regulatory body to assist with 
investigations into any complaints which arise from answers they have provided in response 
to enquiries from citizens. 

The  EU  standard  cost  model  (SCM)  has  been  used  to  calculate  estimates  of  these 
administrative  costs,  drawing  on  views  from  industry,  some  publicly  available  data  and  the 
use of assumptions where necessary. Completed versions of the template spreadsheet will be 
provided to DG Enterprise and Industry. 

The table below presents low and high scenarios to represent a range of possible outcomes for 
administrative  costs.  The  figures  represent  annual  costs  (including  one-off  administrative 
costs  incurred  in  the  first  year  of  the  policy),  as  calculated  by  the  template  spreadsheet 
attached in Annex 2 (page 30). 

Table 5.17: Estimates of annual administrative costs (€m) 

Low 

High 

Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

Source: Europe Economics calculations 

1.1 
1.1 

1.0 
1.0 

1.0 
1.1 

32.2 
32.5 

28.2 
28.6 

28.8 
29.1 

For the purpose of comparison with other policy costs and benefits, the table below presents 
the present value (PV) of administrative costs over the first ten years of the policy. 

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Table 5.18: PV of administrative costs over first 10 years (€m) 

Low 

High 

Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

6.5 
6.6 

5.8 
5.9 

5.9 
6.1 

214 
216 

191 
194 

192 
194 

Note: to show the small incremental cost of regulatory bodies associated with push information, the low estimates are presented to 1 
decimal place. 

Source: Europe Economics calculations 

The administrative costs associated with the policy are estimated to be in the range €6–194m. 
These cost estimates are of a much smaller order of magnitude than the possible impacts on 
human health discussed earlier. 

Other impacts 

In  addition  to  the  above  impacts,  it  is  possible  that  the  policy  could  affect  competition  and 
innovation in markets for pharmaceutical drugs. 

Assuming that, due to the ban on advertising, information provision focuses mainly on “pull” 
information  (e.g.  from  patients  who  have  already  been  given  a  prescription  for  the  relevant 
drug), then companies may compete partly on the basis of the post-prescription service which 
they provide to patients. For instance, post-prescription services for patients could become a 
selling point when advertising drugs to healthcare professionals.  

There  could  be  impacts  on  innovation  if  the  proposed  policy  were  to  lead  to  significant 
increases  in  spending  on  prescription  drugs  (as  suggested,  for  instance,  by  payers).  This 
would tend to increase incentives for research and development (R&D), since the payoff from 
successful R&D would be higher. 

On the other hand, a negative impact on innovation is also a theoretical possibility. This might 
occur if the proposed policy were to increase the costs associated with bringing new drugs to 
market  (i.e.  due  to  the  costs  of  providing  the  patient  information  required  to  match 
competitors) without a corresponding increase in expected sales revenue. 

5.5. 

Environmental Impacts 

It  seems  unlikely  that  there  will  be  any  significant  environmental  impacts.  There  could  be 
minor environmental impacts – for instance, more paper might be used in providing printed 
information,  which  could  have  environmental  impacts  if  not  from  a  sustainable  source. 
However,  given  the  minor  nature  of  any  such  impacts  we  consider  that  it  would  be 
disproportionate to analyse them in further detail. 

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5.6. 

Impacts outside the EU 

Revision  of  Directive  2001/83/EC  to  allow  greater  information  provision  by  marketing 
authorisation  holders  to  citizens  of  EU  Member  States  could  lead  to  spill-over  effects  for 
citizens of non-EU countries. 

Perhaps the most obvious spill-over impact is that any additional information provided online 
by the pharmaceutical industry would be available for citizens of non-EU countries to access. 
There  is  not  likely  to  have  much  impact  on  English-speaking  people  outside  the  EU,  given 
that  there  is  already  a  large  amount  of  information  on  medicinal  products  available  on  the 
internet in English (e.g. on US websites). However, it could have a larger impact on people 
outside the EU who can read other European languages. 

As  with  information  provided  within  the  EU,  such  information  could  have  either  positive 
effects (e.g. improved compliance leading to better health outcomes) or negative effects (e.g. 
distortion of prescription decisions leading to worse health outcomes). 

5.7. 

Compliance Issues 

The level of compliance with the rules on information provision may differ between the three 
policy  options.  The  figure  below  shows  the  views  of  medicines  regulatory  authorities  who 
responded  to  our  survey  on  the  likely  level  of  compliance  under  each  policy  option.  State 
regulation  was  seen  as  likely  to  give  the  highest  level  of  compliance  and  self-regulation  as 
likely to give the lowest. 

Figure  5.1:  Average  expectation  of  medicines  regulatory  authorities  regarding  the  likely  level  of 

compliance 

Option 4 
(co-regulation)

Option 3 
(self-regulation)

Option 2 
(direct regulation)

Option 1
(current legislation)

0.0

1.0

2.0

3.0

4.0

5.0

Level of compliance
(0 = very low, 5 = perfect or near perfect)

Source: Survey of medicines regulatory authorities in the EU 

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6. 

COMPARING THE IMPACTS 

6.1. 

Overall Impact of Policy Options 

The  monetary  estimates  of  costs  and  benefits  discussed  in  the  previous  section  have  been 
summed to give pessimistic and optimistic estimates for the net benefit of each policy option 
are presented below21. (Note that the impact of Option 1 is zero by definition, since this is the 
counterfactual against which all the policy options are assessed.) 

Table 6.1: Overall impact of each policy option (€bn, NPV over 10 years) 

Pessimistic 

Medium 

Optimistic 

Option 1 (no change to current regime) 
Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 
Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

 Source: Europe Economics calculations 

0 

-26 
-88 

-31 
-128 

-30 
-104 

0 

39 
44 

36 
31 

34 
37 

0 

277 
329 

245 
291 

250 
302 

The  figures  show  that  Options  2,  3  and  4  would  all  yield  a  net  benefit  in  the  medium 
scenario, which indicates a positive impact of a clear framework for provision of information 
by  marketing  authorisation  holders  about  their  prescription-only  medicines  to  the  general 
public.  However,  the  impact  of  the  policy  is  rather  uncertain:  for  example,  when  push 
information is included the estimated net benefit of Option 2 ranges from -€88 billion (i.e. a 
net cost of €88 billion) in the  pessimistic scenario to +€329 billion in the  optimistic scenario.  

The  estimates  for  the  central  set  of  scaling  factors  (informed  by  estimates  provided  by  the 
medicines regulatory authorities and payers responding to our surveys) suggest that Option 2 
(direct  regulation  by  medicines  regulatory  authorities)  would  perform  slightly  better  than 
Option  3  (self-regulation)  and  Option  4  (co-regulation).  However,  given  the  uncertainties 
involved  in  our  calculations,  we  also  assessed  results  for  the  “low  differential”  and  “high 
differential” sensitivity analyses (see Annex 2, page 22-23). 

In the “low differential” case, the choice of the enforcement regime does not affect impacts on 
health  outcomes  or  healthcare  expenditure,  and  hence  any  small  differences  between  the 
estimated  impact  for  Options  2,  3  and  4  are  due  to  differences  in  the  cost  of  information 
provision, the costs to regulatory authorities and administrative costs to companies.  

By contrast, in the extreme “high differential” case (presented in Table 6.2), the choice of the 
enforcement  regime  could  have  a  substantial  impact  on  health  outcomes  and  healthcare 

21  

In doing so, we have used the high estimates for the cost of information provision, the cost of regulation 
and administrative costs, since the scale of information provision implied by the low estimates would be 
inconsistent with the scale of the estimated impacts on patient behaviour and health outcomes. 

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expenditure. In this sensitivity analysis, direct regulation by medicines regulatory authorities 
performs yet again better than self-regulation or co-regulation.  

Table 6.2: Sensitivity analysis for Options 3 and 4 - high differential scenario (€bn, NPV over 10 

years) 

Pessimistic 
0 

Medium 
0 

Optimistic 
0 

Option 1 (no change to current regime) 
Option 2 (medicines regulatory authorities) 
Pull information only 
Pull and push information 

-26 
-88 

Sensitivity - high differential 

Option 3 (self-regulation) 
Pull information only 
Pull and push information 
Option 4 (co-regulation) 
Pull information only 
Pull and push information 

-51 
-173 

-36 
-128 

39 
44 

17 
14 

27 
27 

277 
329 

182 
234 

216 
265 

Hence,  while  the  estimates  suggest  that  direct  regulation  by  medicines  regulatory 
authorities  performs  better  than  self-regulation  and  co-regulation  in  many  of  the  cases 
considered,  this  is  not  universally  true  (i.e.  it  is  not  true  under  the  “low  differential” 
sensitivity). However, considering additional administrative burden and cost of set-up of new 
self-regulation  and  co-regulation  mechanisms  and  the  lack  of  confidence  of  self-regulation, 
these options would be disproportionate and should not be pursued. 

The current form of regulation for information provision by industry differs between Member 
States (e.g. there is an element of self-regulation in some Member States but not in others). 
Hence, the possibility for each Member State to make use of its existing regulatory structures 
would  have  some  obvious  advantages  in  terms  of  minimising  set-up  costs,  and  would  be 
consistent with the principle of subsidiarity.  

Nevertheless,  decisions  taken  by  the  regulatory  body  in  one  Member  State  would  affect 
information provision in other Member States. Therefore mutual confidence between MS in a 
situation  of  mutual  recognition  of  regulatory  decisions  would  be  crucial.  Achieving  such 
confidence  would  require  more  detailed  criteria  on  what  would  be  allowed,  than  those 
foreseen in the Commission consultation document, to be fixed on the EU level.  Also  from 
the  legal  point  of  view,  the  consultation  results  show  that  precise  quality  criteria  are 
indispensable in order to make the rules enforceable. In addition, a forum for Member States 
to  discuss  controversial  borderline  cases  would  also  be  needed,  like  the  existing 
Pharmaceutical Committee.  

As  regards  centrally  authorised  innovative  products,  the  European  Medicines  Agency  could 
be given certain tasks as concerns the verification of specific information. While there is no 
need  to  check  information  reproducing  the  package  leaflet,  it  would  be a  clear  advantage  if 
specific  information  going  beyond  be  subject  to  scrutiny  by  EMEA.  This  should  cover 
medicinal  product-related  information  about  non-interventional  studies,  or  accompanying 
measures  to  prevention  and  medical  treatment,  or  information  which  presents  the  medicinal 
product in the context of the condition to be prevented or treated. 

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The  EMEA  disposes  of  all  scientific  documentation  and  scientific  know-how,  due  to  its 
scientific  assessment  of  centrally  authorised  products.  Consistency  of  the  information 
provided to EU citizens throughout the Community could thus be ensured and, as a result of 
this,  confidence  of  the  consumer  in  the  information  provided  could  be  strengthened.  As  a 
matter of principles, these EMEA activities should be fee financed. 

Member  States  have  better  oversight  of  what  information  is  provided  on  their  national 
territory. Thus, enforcement could be left to Member States as they have better possibilities to 
detect  infringements  and  to  react  accordingly  without  delay.  Under  such  circumstances,  the 
existing national enforcement structure should be maintained. 

Highlight trade-offs and synergies 

From  the  analysis,  it  is  apparent  that  the  quality  of  content  and  the  choice  of  information 
channel could have a critical impact upon how increased patient information about medicinal 
products affects health outcomes and the cost of public healthcare delivery.  

Consequently, a large number of respondents in the public consultation, including patient and 
consumer  organisations,  expressed  their  concerns  on  possible  misuse  of  some  “push” 
information  channels,  notably  TV  and  radio,  for  hidden  advertisement  of  their  products  by 
companies,  with  all  the  consequences  outlined  in  section  4.2.  Similarly,  respondents  to  the 
surveys  of  medicines  regulatory  authorities  and  healthcare  providers  generally  assessed 
“push” media as being associated with lower benefits and higher risks than “pull” media. Also 
a recent study from the USA asserts that print tends to be more informative than TV, which is 
not considered as an appropriate channel to e.g. presenting risk information in comprehensible 
manner (Macias et al. 2007). 

A key area of concern with the proposed policy is the risk of a significant negative impact if 
the  pessimistic  scenario  were  to  materialise.  Indeed  the  possibility  of  negative  impacts 
appears to be particularly associated with “push” information provided to the general public. 
This is the case despite the fact that the assessment has only considered a limited example of 
“push”  information  (i.e.  a  higher  number  of  disease  awareness  campaigns  across  a  broader 
range of media). 

Table  6.1  clearly  demonstrates  the  effect  of  restricting  the  policy  to  the  provision  of  “pull” 
information actively sought by citizens. Although this slightly reduces the net benefit of the 
policy  in  the  medium  scenario,  it  also  substantially  reduces  the  risk  of  negative  impacts 
(shown by the pessimistic scenario). 

On  this  basis,  limiting  the  policy  to  pull  information  lessens  the  spread  between  the 
pessimistic  and  optimistic  scenarios  and  thus  reduces  the  degree  of  uncertainty  as  the 
estimates for the pessimistic scenario suggest that the risk of a large negative impact is lower 
when only pull information is permitted. In order to reduce the risk of “pushed” information 
(related  to  anxiety  factor),  the  legal  proposal  should  not  allow  mass  media  to  distribute 
information on prescription medicines to general public. Hence, the recommended approach is 
to  restrict  information  provision  to  “pull”  information  (see  Chapter  4  for  definition) 
provided  to  patients  who  actively  seek  it  (including  information  disseminated  through 
dedicated internet websites monitored by regulatory authorities) and to patients who already 
have a prescription for the drug. This approach would have the highest benefits (patients will 
be able to receive information under European legislative rules) and the lowest disadvantages 

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(differentiation between advertising and information). As a specific case, printed information 
in journals or in the context of treatments could be considered, where anxiety effects can be 
reduced to a minimum and awareness raising would provide a clear benefit. A further step to 
reduce the risk of negative impact would be a restrictive approach to the kind of information 
being  permitted  beyond  the  package  leaflet  and  SPC.  In  this  regard,  warnings  of  some 
stakeholders of the risks of presenting clinical studies should be considered. 

In  terms  of  subsidiarity  and  proportionality,  limited  changes  targeting  the  main  gaps  and 
shortcomings of the current directive can only be addressed by EU legislation amending the 
current legal framework and would be supported in general by the majority of stakeholders. 
The  lack  of  clarity  of  the  current  legal  provisions  should  be  addressed  by  limiting  the 
information allowed by combining rules on the content of the information, the quality criteria 
to be fulfilled and the means of communication which may be used. 

7. 

MONITORING AND EVALUATION 

7.1.  Monitoring indicators and arrangements for ex-post evaluation 

As  the  proposal  modifies  the  EU  legislative  framework  for  provision  of  information  to 
patients  by  amendment  to  Directive  of  the  Council  and  the  Parliament  (Directive 
2001/83/EC), the first parameter to monitor will be the implementation of this new framework 
notably transposition by the Member States. The Commission has established mechanisms for 
working with the Member States to monitor the transposition process. 

The existing Pharmaceutical Committee could be tasked with the role of assuring consistency 
of  implementation.  The  EMEA  could  also  contribute  to  the  implementation,  although  no 
scientific assessment of information will be necessary. 

 With regard to ex-post evaluation of the operational objectives, these can be evaluated by: 

•  Extent of compliance with rules (incidence of complaints/requests could be measured) 
•  Information provision by industry (measured by quantity of information or expenditure) 
•  Indicators of use of this information e.g. number of leaflets distributed per year; number 

of hits on relevant web-pages 

•  Patient awareness of this information (a question in the Eurobarometer survey could be 

considered) 

•  Measuring the effect of information on patient behaviour and on health outcomes. An 
assessment of the behavioural and health impacts might require a formal study several 
years after the introduction of the policy. 

The  overall  objectives  of  the  Community  pharmaceutical  legislation  are  to  ensure  proper 
functioning  of  the  internal  market  for  medicinal products  and  to  better protect  health  of  the 
EU  citizens.  Given  that  the  Directive  2001/83/EC  contains  existing  general  review  clauses 
(Commission  report  on  the  operation  of  the  procedures  every  10-years)  which  will  apply  to 
the new provisions, any ex-post evaluation should therefore include these general reviews and 
any external study should be conducted in this context (to ensure best use of resources). 

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8. 

ACCOMPANYING DOCUMENTS 

•  Executive Summary of the Impact Assessment Report 

•  Annexes: 

•  Annex 1:     Summary of public consultations. 
•  Annex 2:   Annexes on methodology, calculations and case studies provided by 

Europe Economics 

•  Annex 3:     Literature study 

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