EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN 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 establis hing a European Medicines Agency 
 
and  
 
Proposal for a  
 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
 
amending, as regards information to the gene ral 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} 
EN 2   EN 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 medici nes 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 treatm ents and to be more actively involved in 
making decisions regarding their treatments . They have become more empowered and 
proactive consumers of health care, increasingly seeking info rmation about medicines and 
treatments. With the increased use of the inte rnet over recent years, ensuring reliable and 
good quality information available, particular ly on websites, has become essential. 
2. PROBLEM DEFINITION  
Since 1992 Community legislation has di fferentiated between advertisement and 
information on medicines. While EU rules ba nned advertisement on medicines subject to 
prescription to the public and allowed a dvertising 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 framewor k 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 availabl e 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 centr ally by the Commission for distribution under the same 
name in all Member States, for which other as pects of drug approval are dealt with at an 
EU-level, and for information provided thr ough 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 wo rldwide 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 quali ty 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 information provision by industry. However, 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.  
EN 3   EN 3. OBJECTIVES  
Taking into consideration the outcome of the broad public consultation, the 
Communication from the Comm ission 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 Commission proposal on provision of info rmation 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 in ternal market for medicinal products; 
• to better protect health of the EU citizens; 
and should aim specifically to: 
• Provide for a clear framework for pr ovision of information by marketing 
authorisation holders about  their prescription-only medicines to the general 
public with a view to e nhancing the rational use of  these medicines, while 
ensuring that the legislative framew ork continues to prohibit direct-to-
consumer advertising of prescription medicines. 
The specific policy objective has been transl ated into four oper ational objectives:: 
(1) Ensuring the high quality of informati on provided by coherent application of 
clearly defined standard s across the Community.  
(2) Allowing information to be provided through channels addressing needs and 
capabilities of different  types of patients.  
(3) Not inappropriately restricting the ability  of marketing authorization holders to 
provide in an understandable way objec tive and non-promotional information 
about the benefits and the risks of their medicines. 
(4) Ensuring that monitoring and enforcement measures are in place to ensure that 
information providers comply with the quality criteria, while avoiding 
unnecessary bureaucracy. 
                                                 
1
 http://ec.europa.eu/enterprise/pharmaceuti cals/pharmacos/docs/doc2 007/2007_12/inf_to_
patients_com_2007_862_en.pdf 
EN 4   EN 4. POLICY OPTIONS  
There is a range of policy opt ions relating to informati on 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 patien ts 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 re striction on information content. Sub-
options for enforcing such info rmation provision would include: 
– Enforcement by national medicines re gulatory authori ties (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 bod y responsible for self-regulation; 
c) Revision of Directive 2001/83/EC allo wing specific types of advertising of 
prescription medicines within the EU. 
Two of these options were disc arded at an early stage:  
• Revision of Directive 2001/83/EC allowi ng 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 aut horisation holder or “pulled” by patients 
taking the initiative in seeking information: 
a) Information passively r eceived by citizens (or “push” information) when a 
marketing authorisation holder dissemin ates information on prescription-only 
medicines through TV and radio programme s, through printed material actively 
EN 5   EN distributed, through information in prin ted media or through audiovisual and 
written material provided to patien ts by healthcare professionals. 
b) Information searched by citizens (a t ype of “pull” information). This category 
would include: 
• Information disseminated through internet websites or verbally;  
• Answering requests from citizens - Info rmation 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) Take action to prevent disease (e.g. by changing their lifestyle or diet). 
b) 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. 
c) Become anxious about diseases which they do not in fact have. d) Interact better with doc tors during consultations (e.g.  by sharing more relevant 
information on their symptoms) so as to improve the doctor’s prescription decision. 
e) Distort prescription decisions by as king for a specific drug when it is not 
actually the best available treatment. 
f) Comply better with their prescription (e.g. due to greater understanding of how 
the drug should be taken or the benefits of compliance). 
g) Comply worse with their prescription  (e.g. due to more information on possible 
side-effects). 
In addition to these health impacts, there w ould be a number of costs associated with the 
policy, namely: 
a) The cost to healthcare systems across th e EU of any increase in expenditure on 
pharmaceutical drugs, less any reduction in other healthcare costs (e.g. the costs 
of hospitalisations). 
b) The cost to marketing authorisati on holders of the additional information 
provision. 
c) The cost of regulating this information provision. 
EN 6   EN d) The administrative costs to companies of notifying the regulatory body of 
information provision and assisting w ith any investigations arising from 
complaints. 
This impact assessment provides monetary estim ates of these various costs and benefits. 
However, these estimates are based on a la rge number of assumptions and should be 
treated with caution. The estimates are summarised as follows: 
• The impact of changing current legisl ation 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 re lative to the counterfactual of Option 1. However, 
this should not be interpreted as m eaning 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 im pacts have been identified. 
6. R
ESULTS 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 benef it 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 holde rs about their prescription-on ly 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 
EN 7   EN While a majority of stakeholders accepts the need to act in areas of regulatory gaps, a 
number of respondents in the public consu ltation expressed their concerns on possible 
misuse of some “push” information channe ls, 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 medicine s regulatory authorities, Ta ble 2 shows the effect of 
restricting the policy to the provision of “ pull” information actively sought by citizens. 
Although this slightly reduces th e 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) 
Source: Europe Economics calculations 
In order to reduce the risk of “pushed” info rmation (related to anxiety factor), the legal 
proposal should not generally allow mass medi a to distribute info rmation on prescription 
medicines to the general public. Hence, th e recommended approach is to restrict 
information provision to “pull” information provided to patients who actively seek it (including information disseminated through inte rnet websites), to patients who already 
have a prescription for the dr ug and certain printe d 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-regula tion would lead to worse outcomes under all 
scenarios, as shown in Table 3.    Pessimistic Medium Optimistic 
Pull information only -26 39 277 
Pull and push information -88 44 329 
EN 8   EN Table 3: Incremental benefit of adopting self- or co-regulation 
(NPV over 10 years in billions of euros) 
  Pessimistic Medium Optimistic 
Option 3 (self-
regulation) -40 -14 -38 Impact of 
moving from 
Option 2 (direct 
regulation) to Option 4 (co-
regulation) -16 -7 -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 no t 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 th e verification of specific information. While 
there is no need to check information reproduc ing 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 wh at 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 activit ies and the existing national enforcement 
structure should be maintained.