EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN 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 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 
  
IMPACT ASSESSMENT  
{COM(2008) 662 final} {COM(2008) 663 final} 
{SEC(2008) 2668} 
EN    EN TABLE OF CONTENTS 
1. Procedural issues and consulta tion of interested parties .............................................. 2  
1.1. Organisation and timing............................................................................................... 2 1.2. 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 consumer s' perspectives.......................................................................................9  
2.3.2.  Other stakeholders affected.................................................................................................... .10 
2.4. What is the problem?.................................................................................................. 12 
2.5. How the problem would evol ve under present policies ............................................. 18 
2.6. Does the EU have the right to act?  Treaty legal basis and subsidiarity ..................... 20 
3. Objectives................................................................................................................... 22  
3.1. General policy objectives........................................................................................... 22 3.2. Specific Policy Objective........................................................................................... 22 3.3. Operational Policy Objectives.................................................................................... 22 3.4. Consistency with Other EU Polic ies and Horizontal Objectives ............................... 23 
4. Policy Options............................................................................................................ 25  
4.1. Possible Policy Options.............................................................................................. 25 4.2. Options Discarded at  an Early Stage.......................................................................... 25 
4.3. Option 1: Retention of Current Legislative Framework ............................................ 27 4.4. Options 2, 3 and 4: Revision of Directive 2001/83/EC.............................................. 27 5. Analysis of impacts .................................................................................................... 29  
5.1. Introduction .............................................................................................................. .. 29 
5.2. Methodological Approach to Assessing Impacts....................................................... 31 5.3. Social Impacts ............................................................................................................ 33 
5.3.1.  Mechanisms by which health outcomes may be affected .......................................................33  
5.3.2.  Preventativ e effect ............................................................................................................ ......34  
EN    EN 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 h ealthcare systems ...................................................................................42  
5.4.2.  Cost of information provision.................................................................................................4 3 
5.4.3.  Costs to regulatory bodies..................................................................................................... ..44 
5.4.4.  Administrative costs........................................................................................................... .....45  
5.4.5.  Other impacts.................................................................................................................. ........46  
5.5. Environmental Impacts .............................................................................................. 46 
5.6. Impacts outside the EU .............................................................................................. 47 5.7. Compliance Issues...................................................................................................... 47 6. 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  
  
EN    EN TABLE OF FIGURES 
Figure 2.1 Increased demand for greater co-determi nation (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 differentiati on between advertisement and information...........................13 
Figure 2.3: Views of Medicines Regulatory Authoriti es 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 add itional healthcare costs under Option 2 (€m) ......................39 
Table 5.8: Breakdown of impacts by category of in formation provision under Option 2 (NPV of health 
benefits less healthcare co sts over 10 years, €m)...................................................................39 
Table 5.9: Comparison of policy opt ions (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 re gulatory authorities regarding the likely level of 
compliance..................................................................................................................... ........47 
Table 6.1: Overall impact of each po licy 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 
EN    EN LIST OF ABBREVIATIONS 
 
CAP Centrally Authorised Medicinal Product DALY  Disability Adjusted Life Years  DG ENTR Directorate-Genera l Enterprise and Industry 
DTCA  Direct-to-consumer advertisement EEA European Economic Area EMEA  European Medicines Agency  EU European Union 
FDA Food and Drug Administration (USA) 
G-10  High Level Group on Innovation and the Provision of Medicines 
Generics Medicines containing the same activ e substance as the originator product after 
patent expiry 
HCP Healthcare Professional HMA Heads of EEA Medicines Agencies IA Impact Assessment MAH Marketing Authorisation Holder MRP Mutual Recognition Procedure; Mu tual Recognition authorised Product  
MS EEA Member State NAP Nationally Authoris ed Medicinal Product 
NPV Net Present Value NCA National Competent Authority OTC “Over-the-counter” medicine, avai lable without doctor prescription 
PIL Patient Information Leaflet, package leaflet “Pull”  Information actively search ed by citizens on their own initiative 
“Push”  Information passively received by citizens (disseminated by the company) 
PV  The net present value of polic y impacts over a ten-year period 
QALY  Quality-Adjusted Life Years  R&D Research & Development SCM Standard Cost Model SPC Summary of Produc t Characteristics 
EN 2   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
This impact assessment examines possible actio ns, 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 prov ision of information by other actors and the 
Commission's declared intenti on that healthcare pr ofessionals should remain as they are 
today, the primary source of health information.  
1.1. Organisation and timing  
Article 88a of Directive 2001/83/EC, intr oduced by Directive 2004/27/EC, called upon the 
Commission to present a report to the Eur opean Parliament and the Council in 2007 on 
“current practice with regard to information pr ovision – particularly on the internet – and its 
risks and benefits for patients” . Article 88a also provides th at “the Commission shall, if 
appropriate, put forward proposals setting out an  information strategy to ensure good-quality, 
objective, reliable and non promotional info rmation 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 provisi on of information to patients on medicinal 
products, was adopted by the College on 20 De cember 2007 and transmitted to the European 
Parliament and the Council.2 The Communication announced  a legal proposal by the 
Commission. 
The report focused on current practices, and the po ssible 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, therefore, pharmaceutical  industry may engage 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 ke eping with the principl e of proportionality, the 
legal proposal announced by the Commission is lim ited 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. 
The scope of any proposal to amend Comm unity 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/pharm aceuticals/pharmacos/docs/doc2007/2007_ 04/draft_infopatients2007_04.pd
f 
2http://ec.europa.eu/enterprise/ pharmaceuticals/pharmacos/docs/doc2007 /2007_12/inf_to_pa tients_com_2007_8
62_en.pdf 
EN 3   EN medicine-related information and to tasks and ob ligations 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, w ould fall outside this scope. This is without 
prejudice to other on-going Co mmunity 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 So ciety and Media, and from the Secretariat-
General, was established and met 4 times be tween 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 assessmen t process the Commission services extensively 
consulted all relevant stakehol ders using a wide range of co mmunication means. Two general 
web-based public consultations, carried out acco rding to the Commission’ s general principles 
and minimum standards for consultation, were  supplemented by questionnaire surveys and 
interviews with representatives of key st akeholder groups. Comments of the Commission 
services raised during the in ter-service steering group meeti ngs were fully taken into 
consideration. 
Independent impact assessment study 
Europe Economics was contract ed by DG ENTR to assist in assessing the impact of the 
policy options. Europe Economics carried out a se ries of stakeholder interviews, mostly in 
January and February 2008, to gather views and information. Europe Economics also carried 
out online surveys of three stak eholder groups to gather sp ecific data for the impact 
assessment. Usable survey responses were received from 20 healthcare providers (e.g. associations representing health care professionals), 13 healthcar e payers (e.g. social insurance 
organisations), and 15 medi cines regulatory authorities. Separately, Europe Economics 
received relevant information from a number of pharmaceutical companies as well as from 
pharmaceutical industry associations. The info rmation which Europe Economics received 
from stakeholders has informed both the qualitative and quantitati ve analysis in this impact 
assessment. In addition an extensive literature study provided useful evidence (mostly qualitative) on the potential be nefits and risks that may result from improved information 
provision.  
Public consultations 
The first formal public consultation was c onducted between April and June 2007 on a Draft 
report on current practices  without presenting yet any politica l orientations or proposals.  
The 73 consultation responses received have shown that the draft report reflected, apart from 
some factual details, the curre nt situation. Opinions expresse d on the way forward converged 
as regards the needs to improve information to patients, to adopt common standards and 
quality criteria, to distinguish between adver tising and information a nd to keep the ban on 
direct to consumer advertising on prescripti on-only medicines, and th e 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 a nd enforce applicable rules. 
EN 4   EN The second public consultation, conducted betw een February and April 2008, specifically 
addressed the key ideas of the forthcoming legal proposal on info rmation 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 fo llowing overall conclusions: 
• A number of the respondents (47%) took the vi ew that pharmaceutical industry is not an 
appropriate source of prescription-only medici ne information in general, mainly because 
there may be a conflict of interest relating to the financial interests. For instance, European 
Consumer Consultative Group (ECCG) wh ich is the Commission advisory body 
representing European and national consumer  organization expressed concerns in its 
opinion on 20 February 20083 about the delivery of informati on to patients by the industry. 
On the other hand, some of the contributors took the position that if th ere would be a clear 
distinction between advertis ing 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 indus try 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 characteri stics (SPCs) and patient info rmation leaflets (PILs), for 
example on their websites. As  regards disseminating other limited medicine-related 
information, many respondents especially among healthcare profession als and regulators 
took the view that other information from th e industry could probabl y be focused on new 
medicinal products. 
• Among the responses, only six per cent explic itly supported TV and radio as suitable 
means of disseminating information about pres cription-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 l ead to different codes of conduct in the 
different Member States 
A detailed summary of bot h public consultations is provided in Annex 1. 
 
1.3. Commission Impact Assessment Board  
A draft of this Impact Assessment was revi ewed 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 th e consistency of the general objective of the 
initiative with other EU policies and horizont al 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 
EN 5   EN 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 explai ns 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 va rious stakeholders consider the current 
situation as regards information to patient s as unsatisfactory th rough better integration 
of the results of th e public consultation. 
- by presenting more clearly underlying driver s that prevent producers from providing 
information to patients for medicinal produ cts authorized by national authorities or 
under a harmonized procedure.  
- by demonstrating more thoroughly which info rmation needs of patients are currently 
not served and explaining the process by wh ich this leads to negative effects on 
welfare/health due to the non-av ailability 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 patie nt in comparison to the action at Member 
State level.  
• Includes diagram clarifying the scope of ac tion and distinction between advertising, 
information and information compliant  with defined quality criteria.  
• Explains limited potential of soft-law instrume nts (such as a recomm endation) and private 
public partnerships to tackle the problem desc ribed and clarifies the role of EMEA in the 
new framework. 
• Better differentiates between dedicated pharmaceutical company websites, general 
websites and internet specific pr omotional tools (e.g. pop-ups).  
• Better differentiates between the effects of pus h and pull information with respect to the 
resulting magnitude of preven tion and awareness effects.  
• Presents social impacts and mechanisms by which health outcomes may be affected and 
analyses them with exampl es from the literature.  
• Presents key assumptions and critical methodological issues up-front in the main text by 
providing more systematic and precise refere nces to the corresponding sections in annex 2 
and stresses more clearly throughout the main report th e 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. Neve rtheless, it proposed some few additional 
improvements, and in this respec t the presented revised report: 
• Better demonstrates negative consequences of  imperfect information on the health of 
patients. 
• Strengthens further the subsidiarity aspect s, taking into account  the proposal for a 
directive on patients' rights in cross-border hea lthcare adopted by the Commission on 2 
July 2008. 
• Elaborates on the role of the EMEA in the proposed system. 
• Clarifies impacts of the patient informati on policies on the competitiveness of the 
industry.  
EN 6   EN  
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 health care, 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 th e extent to which the information is “pushed” by an 
information provider rather than “pulled” by pa tients who actively seek the information.  In 
particular, more information coul d, 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 informati on 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 cons ultations (e.g. by shar ing more relevant 
information on their symptoms) so as to improve the doctor’s prescription decisions. 
/ Distort prescription decisions by asking for a sp ecific drug when it is not actually the best 
available treatment. 
☺ Comply better with their prescription (e.g. due to greater underst anding 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). 
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 po pulation for greater 
participation in determining their own health outc omes, 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 th eir own health and to take part in the decision making. However, the 
provision of information on medicinal products va ries from Member State to Member State. 
In addition, it has been reported that there exis t deficiencies, for example the use of complex 
language and poor visual presen tation, in the provision of information on medicines to 
patients (Raynor et al. 2007).   
EN 7   EN Figure 2.1 Increased demand for g reater co-determination (patient-h ealth 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 me dicines. Since 1992 the Community legislation 
has differentiated between advertisement and in formation on medicines. While EU rules ban 
advertisement on medicines subject to prescripti on to the public and allowed advertising for 
other medicines under certain conditions, in formation provisions have not led to 
harmonisation amongst the Member States.  
Several Commission initiatives and repeated pub lic debates focused on the need to address 
this lack of a Community framework on informati on to patients in orde r 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 Pr ovision 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-operatio n with stakeholders, to produce a workable 
distinction between adve rtising and information that woul d 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 consum er and Patient Empowerment”, http://www.mig.tu-
berlin.de/files/2005.teachin g.ss/mbwl3_2005.0 6.23_ex.pdf 
5 COM(2003)383 final, 01.07.2003  
EN 8   EN the patients”6 in which it invited the Co mmission 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 medi cines and related conditi ons that is of high 
quality, objective, transparent, compre hensive, reliable and up-to-date.  
In line with its political commitments, th e Commission made a number of proposals in the 
context of the review of the pharmaceutical le gislation launched in 2001, to improve the 
quality and availability of information to pa tients, health professi onals 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 rela ted 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 mechan isms and the lack of a clear distinction 
between advertisement and information.  
2.2. Current regulatory framework 
The Community legal framework for the authoris ation and market surveillance of medicinal 
products for human use is primarily contai ned in Regulation (EC) No 726/2004 and in 
Directive 2001/83/EC on the Community code fo r medicinal products fo r human use. This 
framework contains numerous provisions on advertising, in formation and transparency. 
However, this information, which is in most cases product specific, is not always directly 
intended for patients and is ofte n of a very technical nature. 
Community pharmaceutical legislation only covers  information, in detail, on the content of 
marketing authorisations. In this regard, all ma rketing authorisations must contain a summary 
of products characteristics (addressed to heal thcare professionals) and a package leaflet 
(intended for patients and inserted in the packaging of medicina l products). These two 
documents (of a non-promotional nature and ap proved by the authorities  with the marketing 
authorisation) contain all essential informati on 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 informa tion is not contextualised in relation to the 
condition being treated, nor is informa tion about the condition itself.   
Furthermore, Directive 2001/83/EC provides fo r a harmonised framework on advertising of 
medicines at Community level (i ndependently on their route of au thorisation), the application 
of which remains a responsibility  of Member States. However,  it does not in clude detailed 
provisions on information on medicinal product s, providing only that certain information 
supply activities are exempted fr om the advertising pr ovisions. Therefore, the Directive does 
not prevent Member States from establishing th eir 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 therefor e a Member State cannot fall 
                                                
 
6 OJ C 20, 24.01.2004, p. 2 
EN 9   EN short, or go beyond, the provision s 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 a pplication of these (har monised) advertising 
rules (see Section 2.4). 
The revised pharmaceutical legislation (R egulation (EC) No 726/2004 and Directive 
2004/27/EC, amending Directive 2001/83/EC) di d not change the rules applying to 
advertising, although it has introduced additi onal tools on the provision of better quality 
information to patients and the public in genera l, e.g. improved readabil ity of the labeling and 
the package leaflet, publication of information on the outcome of the assessment process for medicines and reinforced mechanisms to pr ovide information on pharmacovigilance. A 
number of transparency measures were intr oduced 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 ma ke existing product specific info rmation (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 informati on on clinical trials a nd Regulation No (EC) 
1901/2006 on medicinal products for paediatric us e 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 patient s 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 ma rketing authorisation 
holders and regulatory authorit ies, while at the same time affecting the general public, 
particularly patients and their relatives, an d 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 hum an health, it is important to 
remember that there are a range of sources  from which patients receive information on 
medicinal products, most notably through cons ultations with health care professionals.  
There are also several other channels through which patien ts and consumers may receive 
information on their medicines, either passivel y (e.g. through radio and TV ), or actively, (e.g. 
by searching the Internet). While  the responses to the public c onsultation generally recognised 
the Internet to be an important channel of communication, several highlighted the fact that not 
everyone has Internet access and that other ch annels of communication should be considered 
as well. However, millions of searches are pe rformed each day on health-related information, 
including information about medicines (Eysen bach and Köhler 2004). European citizens 
                                                 
7http://ec.europa.eu/enterprise/ pharmaceuticals/pharmacos/docs/doc2007 /2007_12/comm_na tive_sec_2007_174
0_1_en_documentdetravail.pdf 
EN 10   EN 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 informat ion 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 citizen s, patients, their relatives a nd consumers in different EU 
Member States, potentially leaving some patient s 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 informa tion which patients would value and find more 
useful (Raynor et al. 20 07). 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 th e individual patient at  an earlier stage of a 
disease and impaired compliance with the prescribed treatment. 
According to the public consultations, patient and consumer organisati ons highlight that the 
information provided should be understandable a nd patient-friendly and it should be provided 
through different channels reflec ting patients' needs. Informati on should be objective,  neutral 
and should promote the rational use of medicine s. 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 industr y greater freedom to 
provide information, arguing also that the industr y 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 inte rests meant that it could not act as a source of unbiased 
information.  
Other stakeholders affected  
Without prejudice to the prov ision of information by other actors and the Commission's 
declared intention that health care 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 ot her actors by EU legislation.  
Other stakeholder groups are also a ffected indirectly by the problem: 
• The effect on healthcare prof essionals 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 othe r hand, the current situation may also mean 
that healthcare professionals avoid probl ems arising from patients misinterpreting 
information (e.g. patients making incorrect self-d iagnoses). In general, there appears to be 
a broad consensus in this group in support of better information for patients.  
• Organisations paying for healthcare may argu ably benefit from the current situation 
through lower costs on medicines - for example,  as a result of dis eases going undiagnosed 
due to lack of patient information. Howeve r, earlier diagnosis and more effective 
treatment could, over the long run, reduce co mplications 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 
EN 11   EN • Over the last years the editorial content in mass-media related to health information has 
increased significantly following the growing de mand of their readers to receive quality 
health information. In this respect more lib eral provisions on information for patients 
could possibly bring additional revenu es for publishing/advertising media. 
The public consultation clearly hi ghlighted that all stakeholders  agree on the need to improve 
the quality and quantity of inform ation made available to patient s and that the ban on direct-
to-consumer advertising should be retained. An  overview of the stake holders' 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 info rmation 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 an d citizens should have 
access to high quality information in all EU memb er States, however this is not possible at 
present due to the lack of an appropriate EU legal fram ework and other technical and 
linguistic barriers.  Nevertheless, pharmaceuti cal 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 doe s not lead in general to a disadvantage for 
industry operating in the EU in terms of competiv eness. In fact advertisement would increase 
costs for industry in a situation of strong state in fluence and regulation of price. It is therefore 
possible that increased sales following DTCA w ould 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 thei r 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 sc ience pay off. Giving inventors more diverse 
opportunities to communicate with  patients on an EU-wide leve l could help to level the 
playing field and allow more of the smaller firms, often focused on the most advanced 
therapies, to remain independe nt and become important market players in the future. This 
would create a synergy with a number of tools in troduced at EU level (free scientific advice, 
fee waivers) in order to facilitate centralise d 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 propo sed mechanism for mon itoring would create 
additional regulatory work. The co -regulatory mechanism system could be costly and lead to 
different codes of conduct in th e different Member States.  
The responses of the healthcare professionals  underlined in particul ar that healthcare 
professionals are and should remain the first so urce of information to patients, and dialogues 
between health professionals and patients sh ould remain the central point. Healthcare 
professionals also expressed great doubts for th e possibilities to make  a distinction between 
advertising and information.  Other informati on to patients should be made available, for 
example, from databases that shou ld be monitored by regulators.  
EN 12   EN According to the public consultations, the majority  of healthcare professionals, regulators and 
social insurance institutions do not suppor t pharmaceutical companies as information 
providers, because, for example, the information that comes from the producer can not be neutral. Pharmaceutical industry and media highl ighted the role of pharmaceutical companies 
as information providers, because, for exam ple, nobody knows the product better than its 
producer. However, the great majority of th e respondents agreed that pharmaceutical 
companies could be allowed to disseminate in formation 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 
  Patients 
organisations  Consumer 
and citizens 
organisations  Pharmaceutic. 
industry Healthcare 
professionals Regulators Payers Media and 
others 
Should information provision to patients 
be improved? Yes Yes  Yes Yes Yes  Yes  Yes 
Should the ban on direct-to-consumer 
advertising be retained? Yes Yes  Yes Yes Yes  Yes  Yes 
Is the pharmaceutical industry a good 
source of information to patients? Mixed views  Mixed views  Yes Mixed views Mixed views  No  Yes 
Is self-regulation by the pharmaceutical 
industry a good approach? Mixed views  No  Yes No Mixed views  No  Yes 
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  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 medi a, did not support TV and radio as channels 
to disseminate information about prescription-on ly medicines. It was highlighted that there 
are difficulties to distinguish between adve rtising and information and there are great 
possibilities to misuse TV and radio in information provision. 
In many responses it was agreed that the ph armaceutical industry should be allowed to 
provide information on prescription-only medi cines 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 defi nes advertising as "a ny form of door-to-door 
information, canvassing activity or  inducement designed to prom ote 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 advertis ing certain kind of information (labelling and 
package leaflets; correspondence answering questions about pa rticular 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 Artic le 86 of Directive 2001/83/EC is  interpreted ve ry differently 
across Member States. Because th e definition is linked to the s ubjective intent of promoting 
the prescription, s upply, sale or consump tion of medicinal products, those Member States 
which follow the widest interpretation of adver tising consider that any information provided 
by industry amounts to advertising, as pharmaceu tical companies will inevitably aim at 
promoting their sales. This interpretation leads de facto to a prohibition of the provision of 
EN 13   EN information by industry as regards prescrip tion medicines. It is not a hypothetical 
interpretation, as shown in cas e study 1, where a German court concluded that the publication 
on the internet by a pharmaceutical company of  the package leafle ts for its products 
constituted prohibited advertising. Other Me mber States follow a more restrictive 
interpretation of advertising and therefore of  the mentioned prohibiti on (see case study 2). 
However, the range of what is  considered advertising and wh at non-promotional information 
varies.  
 
Figure 2.2: Current status of differentiatio n between advertisement and information 
 
Provided by: health care professionals, patient’ organizations, private-public 
partnerships, general media, private individuals etc.
Banned in the EU
• Package leaflet
• Answer to a specific question
• Factual, informative announce-
ments and reference material
 
 
EN 14   EN Figure 2.3: Views of Medicines Regulatory Auth orities on Interpretation of Directive in their 
Member State 
0123456
12345
Interpretation of Directive by Member State
(1 = least restrictive,  5 = most restrictive)Number of regulators giving this response
 
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 interp retation consistent with EU la w, other three giving a response 
towards the same end of the scale. 
In addition to the lack of cl arity as regards the boundaries of the notion of advertising, the 
directive does not explicitly provide that non-promotional info rmation 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 stri ct restrictions, on information. 
 Case Study 1: Germany  
In a court case opposing two pharmaceutical compan ies, 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 inform ation given would incite an prescription and 
administration interest in the prescription-only medi cine. The Court furthermore stated that it could 
not be deduced from Art 86 of Directive 2001/83/EC a nd those subsequent to it that the information 
provided could not be considered being advertising. Thus, the Germ an provision was considered to 
be in conformity with EU-legislation (3 U 43/05, Ruling of 23 November 2006).  
EN 15   EN Moreover, the exclusion from th e advertising provisions of cer tain types of information by 
Article 86(2) is not helpful either in ensuri ng a common approach on information, as it is too 
succinct and does not clarify under which conditi ons 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 th e national courts does not consider package 
leaflet as advertising when inserted in the p ackaging of medicinal produc ts as provided for by 
Directive 2001/83/EC, whereas any other dissemination of the sa me leaflet by industry (e.g. 
on a company website) is considered advertisin g. In other Member Stat es, any means for the 
dissemination of the package leaflet as approv ed 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 authoriti es, 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 au thorised centrally by the Commission for 
distribution under the same name in all Member St ates. This fact results from a step by step 
widening of the scope of th e centralised procedure by amendments to Community 
legislation; 
• These products under a centralised authorisat ion are the innovative pharmaceuticals, i.e. 
those creating new treatment options for patient s. It is evident that such pharmaceuticals 
attract the attention of patients a nd 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 th e internet and can search information on 
pharmaceuticals available worldwide based on th e 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. Ne vertheless, reliable sources of good quality 
information could result in the search being su ccessful and supporting rational use of 
medicines. 
The current situation is marked by patients not finding such good qual ity 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 w ith asthma being in Belgium who wanted the 
package leaflet of a drug in English and could not get it). This coul d also affect any EU 
citizen travelling within the Co mmunity and, any patient seeking treatment abroad, which will 
be further promoted by a proposal for a directive on the application of pati ents' rights in cross-
border healthcare, recently adopted by the Comm ission, introducing a principle of recognition 
of prescriptions. The restrictive interpreta tion and the lack of harmonisation makes it 
impossible to companies to address this situ ation by providing important information in an 
easy-to-understand language. This  could lead to incorrect us e of medicines and lead to 
consequential medication errors and side-effect s, 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 distri bution of such information within Internet 
websites (see examples in case study 2).  
 
EN 16   EN  
52 per cent of patients reading th e 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 ev en 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 le aflet after the prescr iption decision, it does not promote sharing 
the decision-making between the patient and healthcare professional. Preliminary information could improve relationships betw een patients and health professi onals and could help patients 
think of questions which they might want to ask. This could, for instance, prevent 
unnecessary termination of the treatment upon mani festation of a trivial adverse reaction, of 
which patient could have been informed. 
In reality the agreement of al l Member States would be ne cessary 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 fo r centrally aut horised 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, wa s unable to give an answer how this would be 
legally possible.  
An EU citizen searching for information wi ll nowadays find counterfeit producers or non EU 
based webpage as a source. A simple Google sear ch will demonstrate this  reality:  sites which 
are run by dubious sources, co ntaining poor quality or even  misleading or dangerous 
information. Counterfeit medicines, offered ove r the Internet, have a considerable negative 
impact on public health: this includes death, additional medical interventions and prolonged Case Study 2 Examples of mechanisms facilita ting provision of information to patients  
According to the Medicines and Health care 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 adver se reactions, compliance and many other subjects 
related to diseases and medicines. Much of this in formation is available on the website of the this 
association.  Denmark does not accept any form of pr ior 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 Pr oducts Agency and monitored by a self-regulatory 
body established by the Association of Swedish Ph armaceutical Industry. Questions as to whether 
the information supplied by the pharmaceutical indus try and the marketing measures adopted by it 
are compatible with the rules and with good busi ness 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 est ablishing further rules in this area. ( Source; www.fass.s e) 
EN 17   EN hospitalisation and long-term disabi lities (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 notic ed between September 2006 and August 2007 and 
the number has increased by 7 percent within on e year. For certain innovative products, more 
than 10 percent of the overal l hits result from the EU. 
 
 
Certainly, English-language sources of heal th-related information have proliferated, 
particularly Internet sites based in the US A. Notable examples include netdoctor.co.uk, 
webMD.com, MedicineNet.com, rxlist.com. Th ese are commercial entit ies supported largely 
by advertising revenues in some form or another. Rxlist.com, for instance, makes significant 
use of sponsored content - such as the Astr aZeneca Cancer Support Network - which is not 
subject to any editorial contro l and facilitates click-throughs to an online pharmacy. Clearly,  
this has led to a number of inequalities arisin g within Europe as English-speaking citizens 
with access to US media content (whether on th e internet or otherwise), including US-sourced 
promotional material, are potentially facing “choice overload”, whilst internet-based options outside the English speaking world are typically ra ther less extensive in coverage. Above all, 
the information provided by the US site doesn't re flect the EU legal situation in terms of the 
details of the EU marketing authorisation (par ticularly with regard to approved indications, 
target populations and safety warnings) or in te rms 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 th e population, for which it is not intended  
• absence of important safety warning, 
and resulting medication errors associated w ith considerable risks to patient health. 
  Case study 3: Use of internet  
Despite the fact that the U.S. websites of multina tional pharmaceutical companies clearly state that 
the information on them, including advertisemen t on prescription only medicines are  intended only 
for residents of the United States, a survey of Pfi zer 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. 
EN 18   EN 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 a pproaching a healthcare professional. 
3) The situation varies widely for citizens, de pending on their nationa lity, language skills, 
access to the internet and behaviour. 
The above also suggests that in order to establ ish a workable distinction between advertising 
and information it is not enough to rely on a defi nition of advertising or on the general listing 
of categories of information allowed. The dist inction 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 clarit y of the Community rules as rega rds the definition of advertising 
and, consequently, the distin ction between advertising a nd information. The situation 
described in section 2, alongside the fact that many marketing au thorisation holders operate at 
European scale, currently lead to companie s 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 approach es have been discussed: soft-law instruments  
(such as a recommendation), promoti on of private public partnerships  or more centralised EU-
level policy options  (e.g. via the EU Health portal). Neve rtheless, as the repeal or amendment 
of Community provisions on advertising is no t under consideration, the clarification of the 
distinction with non-promotional information n eeds 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 tr ends which resulted in the current problems 
(more centrally authorised products, change of citizens behaviour, importa nce of the internet), 
the situation would become worse with a high de gree of probability. A particular risk of the 
future would be the building-up of websites sp ecifically for EU citizens on servers placed 
outside the EU. Once such sites would be estab lished, 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 conclu sions of Eysenbach et al (2002) who 
demonstrated that consumers rely predomin antly on search engines to find information, 
generally only exploring the first few links gi ven 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 th ey 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 inform ation provision initiatives. For example, third 
parties such as patient organi sations may provide more inform ation on diseases and available 
treatments in order to meet gr owing patient demand for such information. Member States may 
EN 19   EN also introduce their own initiativ es 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 invo lve multiple possibilities of public-private  
collaborations and public-public  collaborations. Leading exampl es of national information 
provision initiatives which have been a dopted 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 medici nes  in written form and on the Internet. 
Information provided by numerous public bod ies complement information provided by 
companies on their products as described in case study 2. 
• The UK Medicines Project, which involves a number of stakehol ders (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 e xchange of best practices provided members of the Forum 
and other actors involved in the field with di fferent 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 E udraPharm project of the EMEA funded by 
Community subsidies belongs in  the same category. The potentia l for addressing some of the 
unmet patients needs is obvious. A clear advantage is the possibili ty to be broad in content 
e.g. the disease in general and treatment a lternatives may be explained. However these 
initiatives are out of the scope of this imp act assessment. A possibl e revision of Community 
legislation would deal excl usively 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 patient s’ 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 packag e leaflet) and makes these documents the key 
tools to promote the proper and rational use of  medicines among healthca re professionals and 
patients. In a system where the rules on th e authorisation of me dicines and on product 
information are fully harmonised to ensure the sa me level of protection of public health across 
the Community, this objective wi ll remain undermined if wide ly 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 pr oduct characteristics a nd package leaflet, 
approved by the Commission, for the whole Co mmunity. 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 packag e leaflet. This deve lopment has not been 
reflected in the Community provisions on advertisement/information yet. 
EN 20   EN  
If the regulation of information on medicinal pro ducts 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 direc tive lays down detailed 
restrictions on advertis ing and excludes certain types of in formation from these restrictions, 
any national rules prohibiting or unduly restricti ng 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 dispari ties between national provisions in order to 
ensure the proper functioning of th e internal market for medicinal products, while at the same 
time safeguarding a high level of protecti on 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 Co uncil 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. Th is is because the differences between national 
laws, regulations and administra tive provisions on medicinal produc ts result in obstacles to 
intra-Community trade which directly affect  the operation of the internal market.  
The proposal also respects Articl e 152(1) of the Treaty establ ishing the European Community, 
which lays down that a high le vel of human health protection shall be ensured in the 
definition and implementation of all Community policies and activities.  
As regards subsidiarity, only a common appro ach on information provision can better ensure 
the uniform promotion of public health acro ss 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 prescrip tion-only medicinal produc ts based on a common 
set of quality criteria. Thereby health risks stem from the current situation (suboptimal 
treatment choice, impaired compliance, premat ure 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 th ose products authorised either by 
the Commission or by the mutual recognition pro cedure with a harmonized set of indications, 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 sc ope 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 conclusi on it relied on the rules of the Directive, which 
exclude price lists from the scope of rules on advert ising (Art 86(2)), i.e. the legislator had not 
considered it necessary to introduce restricti ons on the sending of such price lists when 
regulating advertising.  
EN 21   EN dosage regimes side effects and other key produc t characteristics in a situation of growing 
importance of the Internet as a source of inform ation proactively searched by the EU citizens,  
In response to the growing cross-border hea lth-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) 41 4 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 prescr iption 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 pa tient understands the info rmation concerning the 
pharmaceutical product and its instructions for us e will be important for the recognition of 
prescriptions to realise its objective of im proving health-care. A harmonised European 
situation as regards the information availabl e, allowing for the dissemination of essential 
product information such as the patient informa tion leaflet, would cont ribute 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 in terpretation in times of increasing level of 
cross-border health care is creating new health risks. 
Besides, the rules on the authorisation and supe rvision 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 th is 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 adve rtising, and that therefore Memb er States cannot fall short, 
or go beyond, the provisi ons of the directive. 
In such circumstances, to preserve the eff ectiveness of the Community pharmaceutical acquis 
as regards advertising, it is a ppropriate that the issue of inform ation 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 nationa l rules running counter to the spirit of Directive 2001/83/EC. 
Indeed, as the directive lays dow n detailed restrictions on a dvertising and excludes certain 
types of information from these restrictions (Article 86), any national rules prohibiting or 
unduly restricting such information could alte r the balance introduced  by the directive.  
Moreover, national rules and prac tices 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).  
 
EN 22   EN 3. OBJECTIVES  
3.1. General policy objectives  
The Commission proposal on provision of informa tion 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 in ternal 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 informati on by marketing authorisation 
holders about their prescription-only medicine s 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 advertisi ng of prescription medicines. 
3.3. Operational Policy Objectives 
The specific policy objective c ould be best achieved by: 
• Ensuring the high quality of information pr ovided by coherent appl ication 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-promoti onal 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  
EN 23   EN 
Provided by: health care professionals, patient’ organizations, private-public 
partnerships general media, companies outside the EU, private individuals etc.Banned in the EUInformation not 
allowed: non-
compliant with 
defined content, 
quality criteria, 
communication 
channels
Allowed 
information: 
clearly defined: 
content, quality 
criteria, 
communication 
channels
• Package leaflet
• Answer to a specific question
• Factual, informative announce-
ments and reference material
 
Schematic diagram: areas do not necessarily refle ct 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 out standing from the G10 Medici nes process (Information to 
Patients, Relative Effectiveness and Pricin g/Reimbursement). The Pharmaceutical Forum , 
jointly chaired by Vice President Verheugen, re sponsible for Enterprise and Industry, and 
Commissioner Vassiliou, responsib le for Health, provides a high level platform for discussion 
and strategic recommendations on the competiti veness 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 info rmation 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 a nd 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 system atic way and to better respond to new health 
challenges. One of its main goals is the citizen s’ empowerment - individuals must play a role 
in taking care of their own health, and theref ore citizens' and patients' participation and 
                                                 
8 http://ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm  
EN 24   EN 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 choi ces and achieving bette r treatment results. 
The planned directive on patients' rights in cross-border healthcare
 would place an obligation 
on authorities of the country wh ere the treatment is provided to ensure that  healthcare 
providers provide all relevant information to enab le patients to make an informed choice, in 
particular on availability, prices and outcome s of the healthcare provided and details of the 
means of personal or collective protection w ith 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 In ternet, 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-relate d information in all official languages. In 
addition,  
DG INFSO promotes patients empo werment by encouraging the widespread availability and 
accessibility of ICT-based services, especially those that have the greatest impact on the 
quality of life of citizen s. The eHealth action plan ,10 sets out a strate gy to promote wider 
dissemination of eHealth services, from electr onic 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 Inform ation Society for all European citizens on-
line in all aspects of their lives. One of the sp ecific targets of the Action Plan is to improve 
web access for people with disabilities and, of c ourse, to adopt and implement the results of 
the Web Accessibility Initiative project, whic h promotes means to perceive, understand, 
navigate, and interact with the Web for people with disabilities.11 On 8 November 2007, the 
Commission adopted the Communi cation 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 
EN 25   EN 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 framewor k (referred as Option 1 in the further text); 
b) Revision of Directive 2001/83/EC to harmoni ze rules on what information industry is 
allowed to provide to patients. Sub-options  for enforcing such information provision 
would include: 
• Enforcement by national medicines re gulatory authori ties (Option 2); 
• Self-regulation by pharmaceutical industry asso ciations, with membership of such 
associations continuing to  be voluntary (Option 3); 
• Co-regulation, in which some regulatory res ponsibilities are given to a co-regulatory 
body while others are given to medicine s regulatory authorities (Option 4). 
• A self-regulatory model in which all marke ting authorisation holders are required to 
belong to the industry body res ponsible for self-regulation; 
c) Revision of Directive 2001/83/EC allowing speci fic types of advertis ing 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 a dvertising 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 obj ectives of the policy (which include maintaining 
the current prohibition on such advertising).  
This choice is based on the following re flections on substance:  Nelson (1970, 1974) argues 
that even advertising that doe s not contain direct informati on may be signalling efficiency, 
reminding consumers of previous experiences wi th the product, or indicating a match between 
products and the buyers to whom the advertis ement is targeted. Bagwell (2005) further 
discusses the work of Nels on and identifies three compe ting views of advertising 
• The informative view – advertising provides consumers with useful information (e.g. 
on products and prices), thus facil itating the process of competition. 
• The persuasive view – advertising is manipul ative and distorts c onsumers’ 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 cer tain forms of advertisement would lead to a better level of 
information. The sole intention to increase sale s, being the major element of distinguishing 
legally between advertisement and allowed in formation, is not automatically leading to 
EN 26   EN unreliable or low quality information. The above  "complementary view" even suggests that 
information coupled with enjoyment better re aches the recipient of the information.  
This approach is supported by Vanilla Resear ch (2007) which provided a number of case 
studies relating to the provision of regulated information (i.e. information which regulation 
requires firms or other partie s 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 cons ultation pointing to the deficiencies of the 
package leaflet being the major source of regulat ed information in the area of prescription-
only pharmaceuticals. 
On the other hand, the l iterature identifies in general a number of ways in which advertising 
could harm social welfare. For example, the li terature suggests that combative advertising 
(which seeks to redistribute brands among c onsumers) may exceed the social optimum where 
real differences between  brands are modest.  
In the specific circumstances of medicinal product s the harmful effects are evident. There is a 
body of literature on the effect of specific t ypes of direct-to-consumer advertising of 
prescription medicines in New Zealand and th e U.S suggesting that such advertising would 
fail to meet the object ive 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 genera l 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 account ed 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 re lated increases of pr escription volumes. 
In line with these critical findings, the major ity 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 advert isement, would not only 
go clearly against the specific objective of enhanc ing 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 marke ting authorisation holders are required to 
belong to the industry body re sponsible for self-regulation. 
A self-regulatory model in which all marketing authorisation holders ar e required to belong to 
the industry body responsible for self-regulation would address a major shortcoming of self-
regulation as identified by a spec ific paper issued by the Minist ry of Consumer Affairs in 
New Zealand: The opt-out by firms, in particul ar in the event of a possible sanction. At the 
EN 27   EN same time, the same source points out in ge neral that the objectives of consumers and 
governments may not be met by self-regulati on. Palzer and Scheue r (2004) stress other 
disadvantages: self-regulation can't ensure comp liance 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 w ould potentially requir e the introduction of 
regulation on membership of pharmaceutical i ndustry associations. It might also prevent 
industry associations using expulsion or suspen sion 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 leav e the current EU legislative framework on the 
provision of information to patients by the pharm aceutical industry as it is. In this case, the 
EU and Member States would c ontinue with existing policies, including implementation of 
any initiatives already a nnounced (see section 2.5). 
Actually the legal status quo w ould result, most likely, in th e persistence of the existing 
situation, where pharmaceutical companies generally do not distribute information on a EU 
wide basis. This would have limited negative co nsequences for products marketed on a purely 
national level, while for products  with a central marketing au thorisation or products under 
mutual recognition it would entail  negative public health cons equences, in particular in 
Member States having a restrictive approach on information. Many people in those Member 
States would be left without access to informa tion 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 pres cription medicines. 
Common features of pol icy options 2, 3 and 4  
Under policy options 2, 3 and 4, communicati on to patients by marketing authorisation 
holders would be permitted where it was not c overed by the definition of advertising, and 
provided that it met certain quality standards. Th ese 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 unbi ased, patient 
oriented, evidence-based, up-to-date, accessible, transparent, relevant and consistent with approved product information. Comparisons be tween 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: 
EN 28   EN • Information compatible with approved summ aries of product characteristics (SPCs) and 
patient information leaflets (PILs), neith er contradicting nor going beyond the key 
elements in them; 
• Other limited medicine-related informati on (information about scientific studies, 
prevention of disease such as by vaccin ation, 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 “pushe d” 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 informa tion on prescription-only medicines through TV 
and radio programmes, through printed materi al actively distribute d, through information 
in printed media or through audiovisual a nd written material pr ovided to patients by 
healthcare professionals. 
• Information searched by citizens  (a type of “pull” inform ation). This category would 
include: 
• Information disseminated through dedicated internet websites12 or verbally;  
• Answering requests from citizens - Info rmation which the i ndustry 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 authoris ation holder has notified 
the regulatory body in one Member  State about an information pr ovision initiativ e and in the 
absence of any objection from that specific re gulatory body, the MAH would be entitled to 
provide the material (translated into other languages where appropria te) across the EU.   
While Options 2, 3 and 4 share the above listed common features, they di ffer 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 me dicines regulatory authorities 
Those responsible for the enforcement would be the Member State regulators currently 
responsible for the enforcement of statut ory information provision by the pharmaceutical 
marketing authorisation holders. For centrally authorised produc ts, the EMEA could be tasked 
with giving expertise for centr ally authorised products. . 
Option 3: Industry Self-regulation 
The responsibility for regulation would rest with existing pharmaceutical industry 
associations. In other words, this option w ould involve industry self-regulation. Membership 
of the industry association would con tinue 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, pa rticularly pop-up windows or sponsored links in 
search engines. 
EN 29   EN 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 nati onal co-regulatory body, consisting of public 
authorities and a mix of stakeholders, including healthcare professionals, patient 
organizations and the pharmaceutical indust ry. These co-regulatory bodies could be 
responsible for: 
• Adopting a code of conduct on information to patients 
• Monitoring and following up of all in formation 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 Stat es 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 patie nts. Demand for these medicinal products is 
the outcome of a composite process, normally initiated by an individua l seeking out medical 
help. Given the knowledge or prej udice that he or sh e has, a patient eval uates 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 pol icy is reaching a view 
on what information the industry will actually  be permitted to provide without being 
considered in breach of the adve rtising 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 leafle ts available on reques t or in appropriate 
locations (refer to “Refer ence websites” in table 5.8). 
• Information provided to patient s who already have been give n a prescription in order to 
support concordance, e.g. leaflet available from pharmacists alongs ide prescription drug, 
telephone helpline (r efer to “Materials to support concordance”). 
                                                
 
13http://ec.europa.eu/enterprise/pha rmaceuticals/pharmacos/docs/doc2008/20 08_02/info_to_patients_consult_20
0802.pdf 
EN 30   EN • Information provided to individual patients in response to enquiries (refer to “Answer to 
enquiries”). 
To illustrate the potential impact of push inform ation, we have considered the possibility that, 
if the above notification procedure were appl ied 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 ch ange in some Member States than in others. 
In addition to the above uncertain ty 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 w ill 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 th e 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 a nd low cost assumptions to give 
the highest possible estimate of the net benefit of the policy. 
 
EN 31   EN 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 providin g 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 anal ysis allowed including potentially divergent 
input from the literature, expert groups and rele vant stakeholders. Therefore, a decision had to 
be made on the trade-off between different crite ria, either by making a judgment or by placing 
explicit weightings on each cr iterion to produce an overall ra nking of options (see Section 1 
of Annex 2). The fact that assessment of cost s and benefits is at th e heart of an impact 
assessment does not mean that it is possible to qu antify every relevant cost  and benefit for this 
IA and thus, in many cases, only a subjectiv e 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 informa tion 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 professiona ls, 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 pres ented (drawing on behavioural economics 
research into framing effects).  
• The advantages and disadvant ages of different regulator y models, such as state 
regulation, co-regulation and self regulation. 
EN 32   EN • 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 numbe r of pharmaceutical companies and industry 
associations for gathering informa tion 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 el ements of research can be found in the annexes. Based on this 
research, policy impacts have been analys ed 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 industr y, including by allowing companies to choose 
which Member State’s regulatory body to notif y. 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 additiona l healthcare expenditure were  assessed based on the above 
mentioned survey of healthcare providers. A se ries of questions expl oring the potential for 
behavioural change (see chapter 5.3. 1 below) and the extent to wh ich 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 re lative size of various ef fects were scaled to 
ensure consistency with assumptions (based on regulatory authorities an d payers surveys) on 
the degree of information provision by industry. 
To quantify and monetise impacts on human hea lth, 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 wa s also deployed). Taking into account a recent 
study by Mason et al. (2006) th e assumed value of a QALY was assumed to be 40.000 Euro 
(pessimistic), 60.000 Euro (medium) and 80.000 Eu ro (optimistic scenario). Additionally, 
calculations of unit costs of unn ecessary consultations of genera l practitioners resulting from 
the anxiety effect were used. 
Some of the costs are one-off in nature, wherea s 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 appr oaches 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 au thorities (Option 2). 
EN 33   EN The costs to regulatory bodies were calculated by multiplying the assumed volume of 
information provided by industry by assumed un it cost, differentiated for the three different 
enforcement options. One-off set-up costs a nd ongoing costs were cal culated separately. 
Additionally, the administrative bur dens for marketing authorisa tion 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” info rmation 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 liter ature review provided evidence for assessing the 
effects on patients and public health of the pr ovision of information to patients on medicinal 
products and illnesses. In line with this literature, the imp act assessment considered the 
following mechanisms whereby information to patients may affect patient behaviour and 
health outcomes: 
• Preventative effect  – information on disease risk factor s may lead to patients taking action 
(e.g. making changes to their diet or lifestyl e) which prevents them getting a disease. 
• Awareness effect  – information on diseases and their sy mptoms 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 thei r symptoms may create unnecessary 
anxiety among citizens who in f act do not have the diseases they become worried about. 
• Interaction effect – information about diseases and tr eatment 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 understa nding of prescription in structions 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 re gulation). The impact assessment  then discusses the overall 
impact on health for Option 2 and how these impacts may differ for Options 3 and 4. 
EN 34   EN Preventative effect 
A preventative effect may arise where access to information about a particular illness or 
condition might result in lifesty le changes, and consequently improved health but without any 
requirement for medicinal products per se. For ex ample research has indi cated that lifestyle 
changes, including dietary modification and incr ease in physical activity, can prevent type 2 
diabetes (Hu et al . 2006). Lifestyle intervention includi ng 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 preven tative 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 fo rce them to include information on disease 
prevention as well as informati on about the disease its elf. It is unclear how significant this 
effect would be. 
The assessment of the real value of the preventa tive 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 
 Pessimistic Medium Optimistic 
Reduction in DALYs across EU per year 0 42,364 112,860 
Annual benefit (€m) 0 2,542 9,029 
PV benefit over 10 years (€m) 0 20,616 73,232 
Additional annual treatment cost (€m) 0 0 0 PV cost over 10 years (€m) 0 0 0 Net benefit from policy over ten years (€m) 0 20,616 73,232 
Note: A DALY is a disability adjusted lif e year. DALYs are used as a measure of lost quality of life and lost life expectancy a s a result of 
disease. Our calculations assume that the value of a DA LY equals the value of a quality adjusted life year (QALY). 
Source: Europe Economics calculations 
Awareness effect 
In general, the improvement of a patient’s heal th can be considered de pendent 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 awar eness of a particular 
disease or of the existence of new or altern ative treatments. At this stage, then, the 
information accessed by the patient has affect ed the choice of seeking medical advice by 
EN 35   EN increasing awareness of a disease and/ or treatme nt (i.e. it has increase d the expected benefit 
from medical advice). 
As a result of improved information, a patien t 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 informatio n could have a particularly valu able 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 informa tion, although in smaller order of magnitude, as a patient might 
also search for information pending final diagnosis. 
The table below shows estimates of the awarenes s 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 
 Pessimistic Medium Optimistic 
Change in QALYs per year 10,327 22,630 46,407 
Annual benefit (€m) 413 1,358 3,713 
PV of benefit over 10 years (€m) 3,351 11,013 30,112 
Additional annual treatment cost (€m) 413 679 928 
PV of cost over 10 years (€m) 3,351 5,507 7,528 
Net benefit from policy over ten years (€m) 0 5,507 22,584 
Source: Europe Economics calculations 
In the medium scenario, more and earlier dia gnosis 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 addi tional cost of the pha rmaceutical drug, yielding 
a zero net benefit. By contrast , in the optimistic scenario ther e is a significant net gain of 
€22bn over ten years. 
Anxiety effect 
There are numerous factors that influence how pa tients 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 informati on on diseases (e.g. antid epressants are in 
some cases prescribed to people who are healthy and request them, rather than to those who are seriously, clinically depressed) co uld have two negative impacts on citizens: 
• First, anxiety may reduce people’s quality of life; 
• Second, where such anxiety leads to addi tional consultations with healthcare 
professionals, this may increase co sts for the healthcare system. 
The table below shows estimates of this eff ect, based on the assumptions shown in Annex 2 
(page 10-14).  
Table 5.3: Anxiety effect for Option 2 
EN 36   EN  Pessimistic Medium Optimistic 
Change in QALYs per year -221,950 -17,660 0 
Annual benefit (€m) -8,878 -1,060 0 
PV benefit over 10 years (€m) -72,008 -8,595 0 Additional annual cost of consultations (€m) 1,075 228 0 
PV cost over 10 years (€m) 8,716 1,849 0 
Net benefit from policy over ten years (€m)  -73,752 -8,964 0 
Source: Europe Economics calculations 
In the medium scenario, the anxi ety effect leads to a social cost of around €9bn over ten years. 
In the pessimistic scenario, the social costs re sulting 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 ha s to identify not only the occurrence of a 
disease but also those characteristics of the patie nt 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 pati ents were better informed - may improve the 
quality of information available to the doctor and thus in the identification of a superior 
treatment. For instance, s uppose that the doctor does not know whether his patient has 
intolerance for certain side e ffects or not. The patient might learn about whether different 
brands of medicine could give rise to such  side-effects. The pati ent’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 interact ion effect was reported for example in cases 
where patients first consulted online sources wi th 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 phy sicians as sources of specific health information. Yet, when 
asked what they actually di d, 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 interact ion effect, based on the assumptions shown in 
Annex 2 (pages 10-14).  
Table 5.4: Interaction effect for Option 2 
 Pessimistic Medium Optimistic 
Change in QALYs per year 15,050 40,532 86,623 
Annual benefit (€m) 602 2,432 6,930 
PV benefit over 10 years (€m) 4,883 19,725 56,207 
Additional annual treatment cost (€m) 602 1,216 1,732 
PV cost over 10 years (€m) 4,883 9,863 14,052 
Net benefit from policy over ten years (€m) 0 9,863 42,155 
Source: Europe Economics calculations 
EN 37   EN In the medium scenario, the interaction eff ect 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 bene fit of around €42bn over te n years from improved 
prescription decisions.  
Prescription distortion effect 
A recent study identified the following factors a ffecting a prescriber’s  treatment choice: 
patient demand, professional experi ence, clinical needs of patie nt, 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 prescrib ed, or as a cost in terms of 
the doctor’s time which would be lost for de viating 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 r eceive it compared to other patients.  
Estimates of the prescription di stortion effect are shown below,  based on the assumptions in 
Annex 2 (pages 10-14). Again, these estim ates should be treated with caution. 
Table 5.5: Prescription distortion effect for Option 2 
 Pessimistic Medium Optimistic 
Change in QALYs per year -15,913 -3,212 0 
Annual benefit (€m) -637 -193 0 
PV benefit over 10 year s (€m) -5,163 -1,563 0 
Additional annual treatment cost (€m) 0 0 0 PV cost over 10 years (€m) 0 0 0 Net benefit from policy over ten years (€m)  -5,163 -1,563 0 
Source: Europe Economics calculations 
The table shows that the prescription distortion e ffect 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 the impact is zero in the 
optimistic scenario.15  
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  Ling, T et al, “Prescribing in Primary Care — under standing what shapes GP’s prescribing choices and 
how might these be changed” 
15  The calculations assume that the drug which patients request is not more expensive than the drug which 
the doctor would otherwise have pres cribed.  If in fact the drug is mo re expensive, then the prescription 
distortion effect would create further costs. 
EN 38   EN 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 satisfactio n 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 “c ompliance effect”. In theory, the policy could 
either: 
• Increase compliance (e.g. due to increased und erstanding of prescrip tion 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 res ponded to the survey thought that 
compliance would either stay the same or im prove. 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 cau tion given the uncertainty involved. 
Table 5.6: Compliance effect for Option 2 
 Pessimistic Medium Optimistic 
Change in QALYs per year 0 57,597 309,162 
Annual benefit (€m) 0 3,456 24,733 
PV benefit over 10 years (€m) 0 28,030 200,606 
Additional annual treatment cost (€m) 0 0 0 PV cost over 10 years (€m) 0 0 0 Net benefit from policy over ten years (€m) 0 28,030 200,606 
Source: Europe Economics calculations 
The net benefits from improved compliance am ount to €28bn over 10 y ears in the medium 
scenario. Patient's improved compliance could no t 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 scen ario assumes a signifi cant 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 additi onal 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 h ealthcare system (e.g. lower hospitalisation costs due 
to avoided complications). 
EN 39   EN benefit is €53bn, whereas in the pessimistic scen ario the net benefit is  -€79bn (i.e. a net cost 
of €79bn) and in the optimistic s cenario the net benefit is €339bn.  
These figures do not include certain  costs associated w ith the policy (e.g. th e 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 0 20,616 73,232 
Awareness effect 0 5,507 22,584 
Anxiety effect -73,752 -8,964 0 Interaction effect 0 9,863 42,155 
Prescription distortion effect -5,163 -1,563 0 
Compliance effect 0 28,030 200,606 
Overall health impact -78,914 53,488 338,577 
Source: Europe Economics calculations 
Breakdown by type of information provision 
The table below shows estimated impacts on health (less additional expenditure on 
healthcare) broken down by type of informa tion provision. While a ll the categories of 
information provision yield net benefits in the me dium 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 -59,001 7,542 54,683 
Pull information    
Reference websites -19,913 17,916 83,288 
Material to support concordance 0 22,424 160,485 
Answers to enquiries 0 5,606 40,121 Total -78,914 53,488 338,577 
Source: Europe Economics calculations 
Health impacts under Options 3 and 4 
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 fa ctors (shown in Annex 2, page 14- 19). The results suggest that 
Option 2 yields the greatest health benefits net of additional healthcare co sts. 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 differe ntial” set of scaling factors and a “high 
differential” set of scaling f actors (see Annex 2, page 22-23). 
EN 40   EN 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 -19,913 45,946 283,894 
Pull and push information -78,914 53,488 338,577 Option 3 (self-regulation)       
Pull information only -29,870 36,973 246,399 Pull and push information -118,372 40,554 300,962 Option 4 (co-regulation)       
Pull information only -23,896 40,675 256,860 
Pull and push information -94,697 46,633 311,495 
Source: Europe Economics calculations 
Different channels of communication 
The potential benefits and risks of Options 2, 3 and 4 may vary across different channels of 
communication. It is apparent th at the quality of content a nd choice of the channel of 
communication could have a critical impact upon how increased patient information about 
medicinal products affects health outcomes a nd the cost of public he althcare 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 communi cation 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 healthcar e providers, and ranks 
different channels of communicatio n in terms of likely risks relativ e to likely benefits. The list 
is presented with the channels deemed likely to cr eate 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, aver aged 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 risk s than “push” media (Annex 2, page 21, shows 
classification of different channels of comm unication into “push” and “pull” channels). 
EN 41   EN Table 5.11: How impacts may vary by channel of communication 
Healthcare providers Medicines regulatory authorities 
Rank  Channel  Rank Channel 
1 Internet pop-ups 1 Internet pop-ups 
2 Unsolicited posting, e-mails or telephone calls 2 Short radio slots, not li nked to the content of 
programmes 
3 Short TV slots, not linked to the content of the 
programme 3 Unsolicited posting, e-mails or telephone calls 
4 Mobile phone text messages 4 Mobile phone text messages 
5 Short radio slots, not linked to the content of programmes 5 Posters or billboards 
6 Posters or billboards 6 Short TV slots, not linked to the content of the 
programme 
7 DVDs or videos 7 Seminars or oral presentations to patients or the 
general public, organised by the industry 
8 Seminars or oral presentations to patients or the general 
public, organised by the pharmaceutical industry 8 Solicited telephone information (e.g. telephone help lines) 
9 Internet sites (in general) 9 Radio programmes with factual content 
10 TV programmes with factual content 10 Internet sites (in general) 
11 Solicited written communication (e.g. post, e-mails, 
answers to questions) 11 DVDs or videos 
12 Solicited telephone information (e.g. telephone help lines) 12 TV programmes with factual content 
13 Radio programmes with factual content 13 Magazines dealing predominantly with health issues 
14 Generalist printed media (e.g. books, articles in newspapers, general magazines) 14 Solicited written communication (e.g. post, e-mails, answers to questions) 
15 Magazines dealing predominantly with health issues 15 Generalist printed media (e.g. books, articles in 
newspapers, general magazines) 
Ranking: 1 (highest risk relative to benefit) …. 15 (lowest risk relative to benefit) 
Source: Survey of medicines regulatory aut horities and healthcare providers in the EU 
This table demonstrates the need to different iate 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 th e active search of the 
user leads to the information. Therefore, a clear distinction shou ld 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 authorisati on 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 
Healthcare provid ers Regulators   
Benefits Risks Benefits Risks 
“Push” media 2.0 4.1 2.2 4.1 
“Pull” media 2.5 3.7 2.7 3.6 
Note: Classifying media into “push” and “pu ll” media inherently involves an element of judgment. The classification used to pro duce this 
table is shown in Annex 2. 
Source: Survey of medicines regulatory aut horities and healthcare providers in the EU 
 
EN 42   EN 5.4. Economic Impacts 
In addition to health benefits for patients, ther e would be a number of costs associated with 
the policy, namely: 
• The cost to healthcare systems across th e EU of any increase in expenditure on 
pharmaceutical drugs, less any reduction in ot her healthcare costs (e.g. the costs of 
hospitalisations). These were discussed above, particularly in rela tion to the awareness 
and interaction effects. 
• The cost to marketing authorisation holde rs of the additional information provision. 
• The cost of regulating this information provision. 
• The administrative costs on companies of no tifying the regulatory body of information 
provision and assisting with any inves tigations arising from complaints. 
These costs are considered in turn below. 
 
Additional costs to healthcare systems 
Meet (2001) reviews international policy and ev idence 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 th is has the effect of making 
patients more likely to visit their GP, have an  informed consultation a nd receive medicines of 
benefits.  At the same time, direct-to-consumer  advertising is found to raise prescription costs 
and divert expenditure away from treating il lness 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. Cl early, the above mentioned literature sources 
referring to DTCA could provide upper bound estim ates of the effect of providing more non-
promotional information.  For example, any pr escription 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 consump tion in Europe in out- and in-patients.
18 A striking 
finding was the marked differences in antibioti c 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 we ll established systems providing an extensive 
access to non-promotional information on prescr iption medicines, including antibiotics. This 
suggests that consumption of prescription medici nes is driven by differences in health care 
systems, culture and education, while better acce ss to information by patients is available in 
those countries with the obs erved restrictive use.  
                                                 
18 Goossens H, Ferech M, Vander Stichele R, et al. Ou tpatient antibiotic use in Europe and association with 
resistance: a cross-national database study. Lancet. 2005; 365:579-587. 
EN 43   EN Estimates of additional healthcare costs were included  in the earlier quantifications of the 
awareness, anxiety and interact ion 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 nette d off the health benefits presented earlier.) 
The estimates suggest that the policy would te nd 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 co sts (e.g. for on-patent drugs), some of the 
additional healthcare expenditure would repres ent 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 5,901 11,038 15,557 
Pull and push information 9,976 15,739 21,580 
Option 3 (self-regulation)       
Pull information only 5,190 9,160 12,797 
Pull and push information 11,303 16,212 21,831 
Option 4 (co-regulation)       
Pull information only 5,617 10,287 14,453 
Pull and push information 10,507 15,928 21,680 
Source: Europe Economics calculations 
On the other hand these additional costs could lead to a better public health outcome and 
perhaps longer-term savings in healthcare deli very 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 provision
20 
The tables below show the estimated increm ental 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 ther e would be a greater 
                                                 
19  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 ha ve 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. 
20  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 scenario s 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 44   EN increase in expenditure on disease awaren ess campaigns under self-regulation or co-
regulation than under regulation by me dicines regulatory authorities. 
Annex 2 (pages 3-6) presents in detail the assumptions made for estimation of incremental 
industry spending resulting from the policy in e ach of these areas.  These assumptions were 
informed by input from the inte rviews with a number of indus try associations and individual 
pharmaceutical companies. 
 
 
Table 5.15: Cost of information provision (€m) 
 Low (Options 
2, 3 and 4) High (Option 
2) High (Options 3 
and 4) 
One-off costs     
Online reference information 56 450 450 
Annual costs       
Disease awareness campaigns 6 326 407 
Online reference information 45 368 368 
Information to support concordance 30 270 270 Information in response to enquiries 9 52 52 Total annual costs 89 1,017 1,098 
Source: Europe Economics calculations 
Table 5.16: PV of cost of inform ation provision over 10 years (€m) 
 Low (Options 
2, 3 and 4) High (Option 
2) High (Options 3 
and 4) 
Pull information only 733 6,034 6,034 
Pull and push information 780 8,678 9,339 
Source: Europe Economics calculations 
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 regulat ory 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 ba sed 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 regul atory 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 sc rutiny required by legislation. Th e question, whether EMEA staff 
or a national authority would assess the comp liance 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 reg ulatory costs over 10 years (€m) 
EN 45   EN   Low High 
Option 2 (medicines regulatory authorities)   
Pull information only 11.0 204 
Pull and push information 11.1 207 Option 3 (self-regulation)     
Pull information only 7.4 135 Pull and push information 7.4 137 Option 4 (co-regulation)     
Pull information only 9.8 182 Pull and push information 9.9 185 
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 marke ting authorisation holders. In 
particular, pharmaceutical companies would be required to inform the regulatory body before 
engaging in any “push” information provision, a nd would also have to notify the regulatory 
body of information disseminated through website s. In addition, marketing authorisation 
holders would presumably need to provide info rmation to the regulatory body to assist with 
investigations into any complaints which aris e 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 in dustry, some publicly av ailable data and the 
use of assumptions where necessary. Completed ve rsions 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 an nual costs (including on e-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 1.1 32.2 
Pull and push information 1.1 32.5 
Option 3 (self-regulation)     
Pull information only 1.0 28.2 
Pull and push information 1.0 28.6 
Option 4 (co-regulation)     
Pull information only 1.0 28.8 
Pull and push information 1.1 29.1 
Source: Europe Economics calculations 
For the purpose of comparison with other policy costs and benefits, the table below presents 
the present value (PV) of administrative co sts over the first ten years of the policy. 
EN 46   EN  
Table 5.18: PV of administrative costs over first 10 years (€m) 
  Low High 
Option 2 (medicines regulatory authorities)   
Pull information only 6.5 214 
Pull and push information 6.6 216 
Option 3 (self-regulation)     
Pull information only 5.8 191 
Pull and push information 5.9 194 
Option 4 (co-regulation)     
Pull information only 5.9 192 
Pull and push information 6.1 194 
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 th e range €6–194m. 
These cost estimates are of a much smaller or der 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 provisi on focuses mainly on “pull” 
information (e.g. from patients who have alread y been given a prescription for the relevant 
drug), then companies may compete partly on th e basis of the post-pres cription service which 
they provide to patients. For instance, post-pr escription services for patients could become a 
selling point when advertising drugs  to healthcare professionals.  
There could be impacts on innovation if the pr oposed policy were to lead to significant 
increases in spending on prescription drugs (a s 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 associat ed 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 wi ll be any significant environmental impact s. 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 su ch impacts we consider that it would be 
disproportionate to analyse them in further detail. 
EN 47   EN  
5.6. Impacts outside the EU 
Revision of Directive 2001/83/EC  to allow greater informa tion provision by marketing 
authorisation holders to  citizens of EU Member States co uld 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 info rmation 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 bette r 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 info rmation provision may differ between the three 
policy options. The figure belo w shows the views of medicine s 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 re gulatory authorities regarding the likely level of 
compliance 
0 . 01 . 02 . 03 . 04 . 05 . 0Option 1
(current legislation)Option 2 
(direct regulation)Option 3 
(self-regulation)Option 4 
(co-regulation)
Level of compliance
(0 = very low, 5 = pe rfect or near perfect)
 
Source: Survey of medicines regulatory authorities in the EU 
EN 48   EN 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 esti mates for the net benefit of each policy option 
are presented below21. (Note that the impact of Option 1 is zero by definition, si nce this is the 
counterfactual against which all th e 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) 0 0 0 
Option 2 (medicines regulatory authorities)       
Pull information only -26 39 277 
Pull and push information -88 44 329 
Option 3 (self-regulation)       
Pull information only -31 36 245 
Pull and push information -128 31 291 
Option 4 (co-regulation)       
Pull information only -30 34 250 
Pull and push information -104 37 302 
 Source: Europe Economics calculations 
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 cl ear framework for provision of information 
by marketing authorisation holders about thei r prescription-only medi cines to the general 
public. However, the impact of the policy is rather uncertain: for example, when push information is included the estimated net benef it 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 re sponding to our surveys) suggest that Option 2 
(direct regulation by medicines regulatory author ities) would perform s lightly better than 
Option 3 (self-regulation) and Option 4 (co-re gulation). However, given the uncertainties 
involved in our calculations, we  also assessed results for the “low differential” and “high 
differential” sensitivity anal yses (see Annex 2, page 22-23). 
In the “low differential” case, the choice of th e 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 regulator y authorities and administra tive 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. 
EN 49   EN expenditure. In this sensitivity analysis, direct  regulation by medicines regulatory authorities 
performs yet again better than se lf-regulation or co-regulation.  
 
Table 6.2: Sensitivity analysis for Options 3 an d 4 - high differential scenario (€bn, NPV over 10 
years) 
 Pessimistic Medium Optimistic 
Option 1 (no change to current regime) 0 0 0 
Option 2 (medicines regulatory authorities)    
Pull information only -26 39 277 Pull and push information -88 44 329 
Sensitivity - high differential  
Option 3 (self-regulation)    
Pull information only -51 17 182 
Pull and push information -173 14 234 
Option 4 (co-regulation)       
Pull information only -36 27 216 
Pull and push information -128 27 265 
 
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 univers ally true (i.e. it is not true under the “low differential” 
sensitivity). However, considering additional ad ministrative burden and cost of set-up of new 
self-regulation and co-re gulation mechanisms and the lack of  confidence of self-regulation, 
these options would be disproportio nate and should not be pursued. 
The current form of regulation for informati on provision by industry differs between Member 
States (e.g. there is an elemen t of self-regulation in some Me mber 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 term s of minimising set-up costs, and would be 
consistent with the prin ciple of subsidiarity.   
Nevertheless, decisions taken by the regulat ory 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 criter ia 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 enfor ceable. In addition, a fo rum for Member States 
to discuss controversial borderline cases would also be need ed, like the existing 
Pharmaceutical Committee.  
As regards centrally authorised innovative pr oducts, the European Medicines Agency could 
be given certain tasks as con cerns the verification of specific information. While there is no 
need to check information reproducing the packag e leaflet, it would be a clear advantage if 
specific information going beyond be subjec t 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 condi tion to be prevented or treated. 
EN 50   EN The EMEA disposes of all scientific docum entation 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 info rmation provided could be strengthened. As a 
matter of principles, these EMEA act ivities should be fee financed. 
Member States have better oversight of wh at information is provided on their national 
territory. Thus, enforcement could be left to Memb er States as they have  better possibilities to 
detect infringements and to react accordin gly without delay. Under such circumstances, the 
existing national enforcement st ructure should be maintained. 
 
Highlight trade-offs and synergies  
From the analysis, it is appare nt 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 th e cost of public healthcare delivery.  
Consequently, a large number of respondents in  the public consultati on, including patient and 
consumer organisations, expressed their conc erns on possible misuse of some “push” 
information channels, notably TV and radio, fo r 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 provide rs generally assessed 
“push” media as being associated with lower bene fits 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 pr oposed 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 re stricting the policy to the provision of “pull” 
information actively sought by citizens. Although th is slightly reduces the net benefit of the 
policy in the medium scenario, it also substa ntially reduces the risk of negative impacts 
(shown by the pessimi stic scenario). 
On this basis, limiting the policy to pull information lessens the spread between the 
pessimistic and optimistic scen arios and thus reduc es 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 propos al should not allow mass media to distribute 
information on prescription medicines to genera l public. Hence, the reco mmended 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 regulat ory 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 
EN 51   EN (differentiation between advertising and informa tion). As a specific case, printed information 
in journals or in the context of treatments c ould be considered, where anxiety effects can be 
reduced to a minimum and awareness raising woul d 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 stud ies should be considered. 
In terms of subsidiarity and proportionalit y, 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 woul d be supported in general by th e majority of stakeholders. 
The lack of clarity of the current legal pr ovisions should be addressed by limiting the 
information allowed by combining rules on the cont ent 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 legislativ e framework for provision of information to 
patients by amendment to Directive of the Council and the Pa rliament (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 establ ished 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 co ntribute to the implementation, although no 
scientific assessment of information will be necessary. 
 With regard to ex-post  evaluation of the operational objec tives, 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. num ber of leaflets distri buted per year; number 
of hits on relevant web-pages 
• Patient awareness of this information (a que stion in the Eurobarometer survey could be 
considered) 
• Measuring the effect of information on patie nt behaviour and on health outcomes. An 
assessment of the behavioural and health im pacts might require a formal study several 
years after the introduction of the policy. 
The overall objectives of the Community pharm aceutical 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 th e operation of the procedures ever y 10-years) which will apply to 
the new provisions, any ex-post  evaluation should therefore incl ude these general reviews and 
any external study should be conducted in this context (to ensure best use of resources). 
 
EN 52   EN  
8. ACCOMPANYING DOCUMENTS  
• Executive Summary  of the Impact Assessment Report 
• Annexes:  
• Annex 1:     Summary of public consultations. 
• Annex 2:   Annexes on methodology, calcu lations and case studies provided by 
Europe Economics 
• Annex 3:     Literature study