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 #Summary of the impact assessment {COM(2008) 662 final} {COM(2008) 663 final} {SEC(2008) 2667}
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) 2668 

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 

SUMMARY OF THE IMPACT ASSESSMENT 

{COM(2008) 662 final} 
{COM(2008) 663 final} 
{SEC(2008) 2667} 

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1. 

INTRODUCTION 

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 bill ion (retail prices) in the EU in 2006.  

The EU citizens, patients, their relatives and consumers have expectations to have access 
to information on existing medicines and treatments and to be more actively involved in 
making  decisions  regarding  their  treatments.  They  have  become  more  empowered  and 
proactive consumers of healthcare, increasingly seeking information about medicines and 
treatments. With the increased use of the internet over recent years, ensuring reliable and 
good quality information available, particularly on websites, has become essential. 

2. 

PROBLEM DEFINITION 

Since  1992  Community  legislation  has  differentiated  between  advertisement  and 
information on medicines. While EU rules banned advertisement on medicines subject to 
prescription  to  the  public  and  allowed  advertising  for  other  medicines  under  certain 
conditions,  a  lack  of  detail  on  information  provision  has  led  to  the  current  situation  in 
which different Member States interpret the EU regulatory framework in very different 
ways,  leading  to  legal  uncertainty  for  potential  information  providers,  namely  the 
pharmaceutical  industry.  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. An impact on human health can be 
expected. 

This  situation  could  be  seen  as  especially  inappropriate  for  an  increasing  range  of 
pharmaceuticals authorised centrally by the Commission for distribution under the same 
name in all Member States, for which other aspects of drug approval are dealt with at an 
EU-level, and for information provided through media which cross national boundaries. 
In particular, 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 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. Some gaps in the information 
available may be filled as time proceeds by private or public sector information provision 
initiatives.  For  example,  Member  States  may  also  introduce  their  own  initiatives  to 
facilitate 
such  national  and 
intergovernmental  initiatives  have  a  limited  character  and  would  not  lead  to  sufficient 
harmonisation  of  rules  and  practices  at  the  EU  level,  so  that  the  above  described 
deficiencies would persist.  

information  provision  by 

industry.  However, 

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3. 

OBJECTIVES 

the  outcome  of 

into  consideration 

Taking 
the 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council 
concerning the Report on current practices with regard to the provision of information to 
patients  on  medicinal  products  was  adopted  by  the  College  on  20  December  2007  and 
transmitted  to  the  European  Parliament  and  the  Council.1  The  Communication 
announced a legal proposal by the Commission. 

the  broad  public  consultation, 

The  Commission  proposal  on  provision  of  information  about  medicines  to  the  general 
public should be fully in line with 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; 

and should aim specifically to: 

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

The specific policy objective has been translated into four operational objectives:: 

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. 

(1) 

(2) 

(3) 

(4) 

1

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

patients_com_2007_862_en.pdf 

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4. 

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) 

b) 

Retention  of  the  current  legislative  framework  (referred  as  Option  1  in  the 
further text); 

Revision  of  Directive  2001/83/EC  to  harmonize  rules  on  what  information 
industry is allowed to provide to patients combined with different enforcement 
mechanisms.  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,  used  specific  information 
channels  and  respected  a  degree  of  restriction  on  information  content.  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. 

Two of these options were discarded at an early stage:  

•  Revision of Directive 2001/83/EC allowing specific types of advertising of 

prescription medicines within the EU. 

•  A self-regulatory model in which all marketing authorisation holders are 
required to belong to the industry body responsible for self-regulation. 

All  other  options  have  been  subject  to  more  detailed  analysis  as  a  part  of  the  impact 
assessment. 

Two categories of information channels were 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: 

a) 

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 

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distributed,  through  information  in  printed  media  or  through  audiovisual  and 
written material provided to patients by healthcare professionals. 

b) 

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

•  Information disseminated through internet websites or verbally;  

•  Answering requests from citizens - Information which the industry provides 

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

5. 

IMPACT ASSESSMENT METHODOLOGY 

Possible  positive  and  negative  impacts  which  the  policy  might  have  on  patient  health 
have been analysed by looking at the ways in which additional information on medicinal 
products  and  the  diseases  they  treat  might  affect  patient  behaviour.  In  particular,  more 
information could lead people to: 

a) 

b) 

c) 

d) 

e) 

f) 

g) 

Take action to prevent disease (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. 

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 
decision. 

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). 

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

In addition to these health impacts, there would be a number of costs associated with the 
policy, namely: 

a) 

b) 

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). 

The  cost  to  marketing  authorisation  holders  of  the  additional  information 
provision. 

c) 

The cost of regulating this information provision. 

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d) 

The  administrative  costs  to  companies  of  notifying  the  regulatory  body  of 
information  provision  and  assisting  with  any  investigations  arising  from 
complaints. 

This impact assessment provides monetary estimates of these various costs and benefits. 
However,  these  estimates  are  based  on  a  large  number  of  assumptions  and  should  be 
treated with caution. The estimates are summarised as follows: 

•  The  impact  of  changing  current  legislation  to  allow  greater  information 
provision  by  industry,  including  by  allowing  companies  to  choose  which 
Member  State’s  regulatory  body  to  notify.  These  are  presented  by  showing 
the impact of Option 2 relative to the counterfactual of Option 1. However, 
this  should  not  be  interpreted  as  meaning  that  Option  2  is  the  preferred 
option. 

•  Estimates how the impact of the policy may change depending on whether or 

not “push” information is allowed to be provided. 

•  The  different  enforcement  approaches  are  compared  by  presenting 
calculations of  the  incremental  benefit of self-regulation (Option 3) and  co-
regulation  (Option  4)  relative  to  enforcement  by  medicines  regulatory 
authorities (Option 2). 

No substantial environmental impacts have been identified. 

6. 

RESULTS OF THE IMPACT ANALYSIS 

Taking all of the  impacts listed  above into account, indicative calculations suggest that 
Options 2, 3 and 4 would all yield a net benefit in the medium scenario (see Tables 1 and 
3), 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 pessimis tic scenario to +€329 b illion in the optimistic 
scenario.  

Table 1: Net benefit of new rules on information provision (for Option 2)  

(NPV over 10 years in billions of euros) 

Pessimistic  Medium 

Optimistic 

Impact  of  moving  from  Option  1 
(current  regime)  to  Option  2  (direct 
regulation) 

-88 

44 

329 

Note:  the  figures  in  this  table  assume  regulation  by  medicines  regulatory  authorities.  This  is  simply  a 
choice made for presentational purposes, and should not be interpreted as meaning that this is a preferred 
option. The incremental impacts of moving to self-regulation and co-regulation are discussed below. 

Source: Europe Economics calculations 

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While  a  majority  of  stakeholders  accepts  the  need  to  act  in  areas  of  regulatory  gaps,  a 
number  of  respondents  in  the  public  consultation  expressed  their  concerns  on  possible 
misuse  of  some  “push”  information  channels,  notably  TV  and  radio,  provided  to  the 
general public. A key area of concern with the proposed policy is the risk of a significant 
negative impact (i.e. if the pessmistic scenario shown in the tables were to materialise). 
The  possibility  of  negative  impacts  appears  to  be  particularly  associated  with  “push” 
information.  

Assuming enforcement by medicines regulatory authorities, Table 2 shows 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). 

Table 2: Impact of inclusion or exclusion of push information 

(NPV over 10 years in billions of euros) 

Pessimistic  Medium 

Optimistic 

Pull information only 

Pull and push information 

-26 

-88 

39 

44 

277 

329 

Source: Europe Economics calculations 

In order to reduce the risk of “pushed” information (related to anxiety factor), the legal 
proposal should not generally allow mass media to distribute information on prescription 
medicines  to  the  general  public.  Hence,  the  recommended  approach  is  to  restrict 
information  provision  to  “pull”  information  provided  to  patients  who  actively  seek  it 
(including information disseminated through internet websites), to patients who already 
have  a  prescription  for  the  drug  and  certain  printed  information  having  a  clear  positive 
public health impact. 

The calculations also suggest that switching from enforcement by medicines regulatory 
authorities  to  self-regulation  or  co-regulation  would  lead  to  worse  outcomes  under  all 
scenarios, as shown in Table 3.  

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Table 3: Incremental benefit of adopting self- or co-regulation 

(NPV over 10 years in billions of euros) 

Pessimistic  Medium 

Optimistic 

of 
Impact 
moving 
from 
Option  2  (direct 
regulation) to 

Option 
3 
regulation) 

(self-

-40 

Option 
regulation) 

4 

(co-

-16 

-14 

-7 

-38 

-28 

Note: the optimistic scenario gives the highest estimate for the net benefit from Options 2, 3 and 4 when 
they are compared to Option 1, but not necessarily when they are compared to each other. Similarly, the 
pessimistic  scenario gives  the  lowest  estimate  for  the net  benefit  from Options 2,  3  and  4  when  they  are 
compared to Option 1, but not necessarily when they are compared to each other. 

Source: Europe Economics calculations 

As  regards  centrally  authorised  innovative  products,  the  European  Medicines  Agency 
should 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. 

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,  fees  should  finance  activities  and  the  existing  national  enforcement 
structure should be maintained. 

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