Communication from the Commission to the European Parliament and the Council concerning the Report on current practice with regard to provision of information to patients on medicinal products in accordance with Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human us {SEC(2007)1740}
Date: 2007-12-20
Institutions: European Commission
Subjects: EU Member State, Internet, consumer information, dissemination of information, medicinal product, pharmaceutical legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 20.12.2007 
COM(2007) 862 final 

COMMUNICATION FROM THE COMMISSION TO THE  
EUROPEAN PARLIAMENT AND THE COUNCIL 

concerning the 

REPORT ON CURRENT PRACTICE WITH REGARD TO PROVISION OF 
INFORMATION TO PATIENTS ON MEDICINAL PRODUCTS 

in accordance with Article 88a of Directive 2001/83/EC, as amended by Directive 
2004/27/EC on the Community code relating to medicinal products for human us 

{SEC(2007)1740} 

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BACKGROUND 

Article  88a  of  Directive  2001/83/EC,  introduced  by  Directive  2004/27/EC,  calls  upon  the 
Commission  to  present  a  report  to  the  European  Parliament  and  the  Council  in  2007  on 
“current practice with regard to information provision – particularly on the Internet – and its 
risks  and  benefits  for  patients”.  Article  88a  also  provides  that  “the  Commission  shall,  if 
appropriate, put forward proposals setting out an information strategy to ensure good-quality, 
objective,  reliable  and  non  promotional  information  on  medicinal  products  and  other 
treatments and shall address the question of the information source's liability”1

 . 

This  report  reviews  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.  Particularly,  the  report  addresses  the  use  of  the 
Internet on the provision of information and its role in improving access to information.  

The basic content of the report is based on information provided by Member States, as well as 
information  published  in  various  literature  sources  and  contributions  from  patient  groups, 
health  professional  organisations  and  other  stakeholders.  The  report  also  takes  into  account 
discussions within the Pharmaceutical Forum on Information to Patients. Within this overall 
framework and based on a thorough analysis the report considers in particular: 

•  Existing information mechanisms and technologies on an EU and Member States level; 

•  The needs of patients; 

•  The role of different stakeholders. 

The draft report was published for consultation on the website of the Pharmaceuticals Unit, 
DG Enterprise and Industry, on 19 April 2007. Citizens, stakeholders and all interested parties 
were invited to express their views on the issues presented in the draft report by 30 June 2007. 
During  the  consultation  DG  ENTR  received  73  contributions  which  can  be  grouped  as 
follows:  patient  organisations  (14),  consumer  and  citizen  organisations  (4),  pharmaceutical 
industry  organisations  and  companies  (18),  healthcare  professional  organisations  (16), 
regulators  (9),  individual  citizens  (3),  EU  and  national  social  insurance  organisations  (2), 
media and others (7). All the responses were carefully analysed and taken into consideration 
whenever possible.  

The  report  responds  to  the  call  on  the  Commission  to  consider  a  strategy  on  information  to 
patients  with  clear  recognition  of  the  important  developments  of  society.  Patients  have 
become more empowered and proactive users of healthcare, increasingly seeking information 
about  their  illnesses  and  treatment  options  including  medicines  from  an  ever  growing  and 
diverse  range  of  sources.  Patients  and  consumers  have  expectations  to  have  access  to 
information on existing medicines and treatments and to be more actively involved in making 

1 

The full wording of the article states: “Within three years of entry into force of Directive 2004/27/EC, 
the Commission shall, following consultation with patients’ and consumers’ organizations, Member 
States and other interested parties, present to the European Parliament and the Council a report on 
current practice with regard to information provision – particularly on the Internet – and its risks and 
benefits for patients. Following analysis of the above data, the Commission shall, if appropriate, put 
forward proposals setting out an information strategy to ensure good-quality, objective, reliable and 
non-promotional information on medicinal products and other treatments and shall address the question 
of the information source’s liability”.  

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decisions regarding their treatments. With the increased use of the Internet over recent years, 
ensuring reliable and good quality information available on websites has become essential. 

The report is supported by a Commission Staff Working Document (SEC(2007) 1740) which 
provides background information on the different parts of the report as indicated in the text. 

1. 

1.1. 

POLITICAL AND LEGAL FRAMEWORK 

Political Framework - the G10 process and the Pharmaceutical Forum 

Based  on  wide  support  by  stakeholders,  since  1992  Community  legislation  clearly 
differentiates  between advertisement and  information  on  medicines.  While  EU  rules  banned 
advertisement on medicines subject to prescription to the public and allowed advertising for 
to 
other  medicines  under  certain  conditions, 
harmonisation  amongst  the  Member  States.  Several  Commission  initiatives  and  repeated 
public  debates  focused  on  the  need  to  address  this  lack  of  a  Community  framework  on 
information  to  patients  in  order  to  respond  better  to  the  needs  of  patients,  in  the  overall 
interest of health. However, the legal situation has not changed fundamentally over the last 15 
years. A detailed overview of this evolution is contained in Annex I of the Commission Staff 
Working Document. 

information  provisions  did  not 

lead 

As  there  had  been  no  response  to  this  evolution  of  society  and  in  view  of  the  three  most 
crucial issues outstanding from the G10 Medicines process (Information to Patients, Relative 
Effectiveness  and  Pricing/Reimbursement),  the  European  Commission  created  in  June  2005 
the  Pharmaceutical  Forum  2.  Three  technical  working  groups,  supported  by  a  Steering 
Committee, have been established for each of these subjects. The working groups report to a 
high  level  group  with  a  broad  membership  made  up  of  health  ministers  from  all  Member 
States, representatives from the European Parliament and from ten stakeholder organisations 
representing  industry  and  public  health  interests.  The  Forum  is  jointly  chaired  by  Vice 
President Verheugen, responsible for Enterprise and Industry and Commissioner Kyprianou, 
responsible for Health.  

The  objective  of  the  Information  to  Patients  Working  Group  is  to  develop  proposals  for 
improving  the  quality  and  accessibility  of  information  to  patients  on  medicines  and  health 
issues.  During  the  two  first  years  of  the  Pharmaceutical  Forum,  the  Working  Group  has 
reached  a  common  understanding  on  the  needs  and  the  challenges  existing  in  the  field  of 
information to patients for disease and treatments. A detailed description of the achievements 
of the Working Group on Information to Patients is included in Annex I of the Commission 
Staff Working Document. 

1.2. 

Instruments under the current Community pharmaceutical legislation 

The Community legal framework for the authorisation and market surveillance of medicinal 
products for human use is primarily contained in Regulation (EC) No 726/2004 laying down 
Community procedures for the authorisation and supervision of medicinal products for human 
and  veterinary  use  and  establishing  a  European  Medicines  Agency3  and  in  Directive 
2001/83/EC  on  the  Community  code  for  medicinal  products  for  human  use.4.A  detailed 

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http://ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down Community procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30/4/2004 p. 1-33. 
Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community 
code relating to medicinal products for human use, OJ L 311, 28.11.2001. 

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description  of  the  current  legal  instruments  is  provided  for  in  Annex  I  of  the  Commission 
Staff Working Document. 

2. 

CURRENT PRACTICES ON THE PROVISION OF INFORMATION 

2.1. 

Practices in the Member States  

A  survey  was  conducted  by  Commission  services  in  2006  amongst  the  Member  States 
medicines  regulatory  agencies  and  the  three  other  countries  of  the  European  Economic 
Agreement  Area  (EEA)  to  gather  information  about  their  practices  in  the  provision  of 
information on medicines and their experience with the implementation and application at a 
national  level  of  the  legislation  governing  information  on  medicinal  products,  in  particular 
related  to  the  relevant  provisions  of  Directive  2001/83/EC.  This  was  complemented  with 
information  gathered  by  means  of  a  questionnaire  prepared  for  the  Pharmaceutical  Forum 
Information to Patients Working Group. 

Contributions have been provided by the Competent Authorities of 23 EU Member States and 
of the 3 other countries members of the EEA. This information is summarised in the report, 
complemented by an overview of the situation in the Member States of the European Union 
and the EEA countries and about the situation concerning availability of information on the 
internet, provided as Annex II of the Commission Staff Working Document. 

Based  on  the  information  received,  there  are  a  significant  number  of  initiatives  of  varied 
nature  which  intend  to  provide  information  on  medicines  and/or  illnesses  to  healthcare 
professionals  and  the  public.  Accurate  information  on  medicines  is  available  from  many 
sources,  for  example  from  physicians,  pharmacists,  pharmaceutical  companies,  medicines' 
regulatory  authorities,  health  professional  and  scientific  organisations  and  patient  and 
consumer groups. Patients can also use libraries, drug bulletins and other information services 
to access information.  

Probably the most important difference between Member States is the type of information that 
can be made or is available to the public on the Internet. Some adopt a stricter approach while 
others allow more information for the public on the Internet. 

Others indicated they are currently developing processes to ensure its availability in the short 
term. 

In accordance with the information received, different practices can be distinguished: In some 
Member  States  the  provision  of  information  is  mainly  ensured  by  public  authorities,  and 
includes  predominantly  product  related  information  they  have  approved.  Amongst  these 
Member States, there are some which go beyond the provision of product related information 
by  covering  other  types  of  information,  such  as  guidelines  on  treatments,  or  comparative 
information on the value of medicines 

In  contrast  there  are  a  number  of  Member  States  which  have  in  place  public  private 
partnerships or similar initiatives to provide information specifically intended to cover wider 
patient  needs,  such  as  treatment  options  or  guides  covering  specific  diseases  or  therapeutic 
areas. Some of these practices include the participation of the pharmaceutical industry. 

In  2006-2007  amongst  the  Member  States,  approximately  78%  provide  access  through  the 
internet  to  all  or  some  of  the  following  approved  information:  the  package  leaflet  and  the 
summary  of  product  characteristics.  This  information  is  normally  supplied  by  National 

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Competent Authorities (NCAs). 18 NCAs indicated that they publish the summary of product 
characteristics on their websites; while 16 publish both the summary of product characteristics 
and the package leaflet.  

Concerning Public Assessment Reports they are publicly available for all products having a 
Community  marketing  authorisation.  For  medicines  authorised  by  the  National  Competent 
Authorities app. 18% of the Member States are also providing access to these reports. Some 
others  indicated  they  are  currently  developing  processes  to  ensure  availability  in  the  short 
term.  

Databases  containing  information  on  different  aspects  related  to  medicinal  products  exist 
across the Member States. However, the content and access to these databases varies widely; 
some  Member  States  provide  free  access  to  basic  information  on  all  authorised  medicines 
(e.g. names, composition, price) in order to provide an overview on all medicines and ensure 
transparency. In some cases these databases may be used by other organisations for their own 
purposes,  such  as  health  services,  insurance  boards,  patients  associations  or  health 
professionals’  organisations.  In  the  Netherlands,  for  example,  the  Pharmacists  Association 
(KNMP)  uses  the  official  database  to  develop  a  database  with  information  on  diseases  and 
medicines, together with other sources. 

In  2007,  there  were  also  other  prominent  examples  of  Member  States’  actions  to  improve 
access of patients to information. 

In  Germany,  there  are  a  number  of  different  information  platforms  which  are  directed  to 
consumers,  patients  and  health  professionals  and  which  provide  information  concerning 
medicines,  illnesses,  diagnostic  possibilities  and  therapeutic  treatments.  The  providers  are 
authorities, healthcare assessment agencies, healthcare providers and professionals, patients’ 
associations and others. 

In  Denmark,  Finland,  Norway  and  Sweden,  the  National  Competent  Authorities  have  a 
special  information  on  medicines  section  for  consumers  on  their  website(1)  5.  This  includes 
mostly  safety  information,  basic  information  about  how  to  use  medicines  and  information 
about medicinal products (1). 5 Portugal and the Czech Republic have also an extensive set of 
information on medicines directed to the public. 

Denmark  and  Sweden  publish  information  on  current  treatment  guidelines.  Portugal  also 
publishes  a  “Prontuário  Terapêutico”  with  comparative  guidance  on  medicines  for  health 
professionals, prepared by an expert group under the responsibility of the Medicines Agency 
(INFARMED). 

Various  other  mechanisms  of  providing  information  for  the  public,  such  as  magazines  and 
journals,  leaflets,  campaigns,  workshops,  symposiums  have  been  identified  in  the  Member 
States. This includes also dissemination through pharmacies and the media. 

The aim is mainly to give basic information about treatments and medication associated with 
diseases,  offering  informed  choice  for  patients,  as  well  as  to  educate  and  train  health  care 
professionals. 

5 

Cf. Annex V of Commission Staff Working Document SEC(2007) 1740. 

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There  are  a  wide  range  of  public-private  partnerships  (PPP)  across  the  EU.  In  relation  to 
activities performed under these partnerships (some involving pharmaceutical industry) or by 
private  organisations,  including  patient’s  associations  and  the  pharmaceutical  industry, 
practical examples are given in Annex II of the Commission Staff Working Document. 

A  profound  assessment  on  the  perception  of  the  different  practices  in  Member  States  is  not 
available. 

2.2. 

The use of the Internet and other innovative technologies 

The  Internet  differs  from  the  more  traditional  forms  of  communication  for  a  number  of 
reasons.  It  clearly  supersedes  country  boundaries  and  the  information  –  subject  to  rare 
exceptions  –  is  available  everywhere  in  all  countries,  which  have  the  necessary  technology 
infrastructures.  This  may  lead  to  uncertainties  in  applicable  rules  and  enforcement 
possibilities.  The  Internet,  more  than  other  forms  of  communication,  requires  active  action 
from  users  before  information  is  available  to  them.  This  can  specifically  influence  the 
distinction between advertising and information. 
The Internet is a widely used tool for consumers to search for information.(2) 5 In the European 
Union more than half (51.8 %, June 2007) of the population uses the Internet.(3) 5 The Internet 
usage penetration in the European Economic Area varies between 23.4 %, in Romania , and 
75.6  %,  in  Sweden  (June  2007).  In  2006,  the  level  of  Internet  access  in  households  in  the 
European Union (27 countries) was 49 %.(4)  5 The use of the Internet is increasing. Between 
2000 and 2007 (June) the use of the Internet in the EU increased by 206 %. (3) 5 
During 2006, about 21% of individuals in the European Union (27 countries) used the Internet 
to interact with public authorities.(5) 5 Patients also search for information on medicines on the 
Internet  more  than  before.(6)  5  Internet  usage  varies  according  to  age,  education,  gender  and 
socio-economic conditions. 

Concerning  current  uses  of  Internet  and  other  technological  developments  to  provide 
information  on  medicines  to  healthcare  professionals  and  to  patients,  it  is  clear  that  the 
majority of Member States Competent Authorities (79%) exploit the Internet as a main tool to 
supply  approved  information  (like  the  summary  of  product  characteristics,  package  leaflets 
and  public  assessment  reports),  as  well  as  other  information  such  as  details  about  treatment 
and medication associated with diseases, administrative data on all authorized products (list of 
authorised  medicines,  marketing  authorization  holders,  etc),  monographs,  comments  on  the 
value of medicinal products comparison to other treatments, or scientific reviews. 

Patients  are  now  turning  more  and  more  to  the  Internet  as  the  first  port  of  call  for  general 
information on medical conditions and prescribed medication. The Internet is a powerful tool 
and its main benefits are being widely used, well recognized and quickly accessible. 

However, there are also issues that need to be addressed in using the Internet for the provision 
of information to patients. Internet sites have to be properly managed in order to guarantee the 
reliability  and  quality  of  the  information  they  provide.  In  2002  in  a  Communication  to  the 
Council, the European Parliament, the Economic and Social Committee and the Committee of 
the Regions the Commission published quality criteria for health-related websites(7) 6. 
Firstly,  there  are  issues  related  to  the  quality  of  information.  The  amount  of  information 
provided to different target groups is increasing every day, raising difficulties in finding valid 
information  on  medicines.  This  underlines  the  need  to  validate  the  information  provided  to 

6 

Cf. Annex V of Commission Staff Working Document SEC(2007) 1740. 

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patients against agreed standards to ensure an appropriate level of quality in particular if this 
information is not originated from public authorities. There are however some Member States 
that  have  developed  mechanisms  such  as  internal  procedures  or  self–control  practices  that 
could help information providers to improve the quality of information. In addition, keeping 
information on medicines on the Internet updated is a challenge for medicine authorities and 
other information providers. 

Secondly, the access to information on the Internet raises questions. Although this technology 
is a powerful and simple tool to facilitate access to information it also poses difficulties for 
certain parts of the population. Even if the internet technologies are constantly developed, for 
certain groups it can be difficult to access (e.g. the elderly) and there is a need the information 
available through traditional media means. 

Thirdly,  the  Internet  is  not  able  to  respond  to  the  specific  needs  of  certain  groups  of  the 
population and of citizens with special needs (e.g. people with disabilities). These groups of 
citizens will require other means to access and receive information. 

Besides  the  Internet,  there  are  also  other  technological  developments  available  which  can 
facilitate  dissemination  and  access  to  information,  such  as  interactive  television  or  mobile 
communication. For example, in the UK the NHS Direct Interactive, based on digital satellite 
television, boasts a wide range of information on conditions, health questions, and a guide to 
healthy living. 

2.3. 

Activities by the Commission and the EMEA 

An overview of the activities developed by the European Commission and the EMEA, such as 
the  information  on  medicinal  products  provided  in  the  websites  of  Directorate-General 
Enterprise  and  Industry  and  the  European  Medicines  Agency  (EMEA),  the  activities  of  the 
EMEA with Patients’ Organisations and the Health-EU Portal run by Directorate-General for 
Health  and  Consumer  Protection,  is  given  in  Annex  III  of  the  Commission  Staff  Working 
Document. 

3. 

THE PATIENT NEEDS ON THE PROVISION OF INFORMATION AND ITS 
BENEFITS AND RISKS 

The  provision  of  information  on  medicinal  products  requires  taking  into  consideration  the 
needs  of  patients  in  the  context  of  healthcare  provision.  Most  sources  available  point  to  the 
increasingly active role of patients in this regard; patients have a right to be informed and in 
this context they should be able to access information about their health, medical conditions 
and the availability of treatments. Patients are no longer simply taking what is prescribed for 
them, but are increasingly involved as managers of their health.  (8)  7 They become intensely 
involved with their illness, show great interest in health issues and have a constantly growing 
need  for  information.  (8)  7  Recent  evidence  indicates  that  patients  are  however  often 
unsuccessful in playing a larger role in their health decisions. (9) 7 

Annex IV of the Commission Staff Working Document includes additional information on the 
evidence  on  patients’  needs  in  terms  of  information  and  on  the  role  of  health  professionals, 
patient organisations and partnerships, the pharmaceutical industry and the media. 

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Cf. Annex V of Commission Staff Working Document SEC(2007) 1740 

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The  risk  and  benefits  of  current  practices  are  twofold:  On  the  one  hand,  EU-legislation 
provides for a number of information mechanisms as described in Chapter 2 which have clear 
benefits in informing the public and health professionals in an objective way about individual 
medicinal products. On the other hand, in view of the absence of clear Community provisions, 
Member  States  have  established  their  own  approaches  on  additional  factual  information  to 
patients,  and  these  approaches  differ  widely.  This  situation  has  created  obstacles  and  risks 
from a Community perspective: 

Firstly,  EU  citizens  have  unequal  access  to  information.  Access  depends  mainly  on  the 
Member  State  in  question,  but  also  other  factors  like  technological  skills,  language,  income 
and age whether information is de-facto accessible. In essence, the lack of detailed provisions 
concerning  provision  of  information  in  Community  legislation  may  lead  to  inequality  in 
access for patients in the different Member States.  

Secondly,  the  lack  of  EU  quality  standards  for  information  to  patients  increases  the  risk  of 
wrong, misleading or confusing information creating health risks. One example is counterfeits 
of  medicines  illegally  advertised  and  sold  while  there  is  no  EU-wide  framework  for  the 
industry  to  provide  information  on  the  medicines  and  risks  of  such  counterfeits.  Another 
example  are  easily  accessible  internet  pages  with  promotional  character  for  medicines 
authorised  in  third  countries,  while  factual  information  on  medicines  with  the  same  active 
substance  may  not  be  given  on  an  EU  wide  basis.  This  lack  of  a  consistent  approach 
compounds inequalities in access to information between citizens in different Member States. 

Thirdly,  lack  of  information  may  result  in  uninformed  choices.  Best  practices  in  Member 
States  demonstrate  that  information  platforms  on  the  internet  and  in  paper  format  integrate 
and  link  specific  medicines  information  with  related  areas,  like  information  on  diseases, 
diagnostic  possibilities  and  different  treatment  choices.  Such  practices  aim  at  educating 
patients,  enabling  them  to  make  an  informed  choice,  and  training  health  professionals.  Not 
using  existing  possibilities  throughout  the  EU  means  perpetuating  existing  practices  of 
uninformed choices including late diagnosis, or lifestyle based on low risk awareness. 

Although  there  is  insufficient  evidence  published,  an  increase  in  the  quality  and 
appropriateness  of  information  available  to  patients  would  be  expected  to  contribute  to 
achieve  better  health  conditions  and  also  to  contribute  to  a  more  efficient  use  of  resources. 
Better-informed patients are expected to adhere better to treatments and to better understand 
clinical decisions. This should lead in the long term to social and economic benefits. 

The  risks  that  better  informed  patients  will  demand  more  healthcare  could  raise  concerns, 
especially in respect to an increase in healthcare costs. Although there is some evidence that 
provision of information may increase referrals to healthcare professionals and possibly costs, 
there is also evidence of benefits in facilitating earlier diagnosis and management of diseases. 

The  balance  between  the  benefits  and  risks  of  providing  information  indicates  the  need  for 
clear  rules  that  apply  to  information,  ensuring  its  objectivity  and  avoiding  any  promotional 
character. This would also require that benefits and risks inherent to the use of any medicinal 
product are clearly stated. 

4. 

SUMMARY AND CONCLUSIONS  

4.1.  Main findings on the basis of the report 

Based  on  a  common  basic  principle  that  advertising  to  the  public  is  prohibited  for 
prescription-only medicines, evidence shows that the rules and practices on what information 
can be available still vary significantly among Member States. Certain Member States apply 

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very restrictive rules, while others allow for several types of non-promotional information to 
be made available. Some Member States foresee a quite extensive role of public authorities, 
namely medicines regulatory agencies, in the provision of various kinds of information, while 
other Member states allow information activities performed under partnerships of public and 
private organisations, including health professionals’ associations, patients’ organisations and 
the pharmaceutical industry. This results in unequal access of patients, and the public at large, 
to information on medicinal products.(17) 8 

At  the  same  time  patients  have  become  more  empowered  and  proactive  regarding  the 
treatment of their illnesses. Information needs of patients as regards medicinal products range 
from information on adverse effects to information about efficacy of the medicine to treat the 
disease concerned, including also information about the costs and duration of treatments. 

In general, the internet plays a central role for those who are seeking information, since the 
information they can find is either mainly provided through the internet or it complements or 
strengthens  other  more  traditional  forms  of  communicating.  Nevertheless,  the  continued 
importance  of  non-electronic  tools  should  be  recognised  as  they  are  still  relevant  for  large 
parts of the population (like the elderly, or patients with special needs).  

The  quality  of  information  is  currently  very  variable,  in  particular  in  view  of  the  Internet 
where the providers have no or limited accountability toward EU citizens. Patients may also 
still  have  difficulties  in  finding  valid  information  on  medicines  authorised  in  the  EU  by 
national authorities. Mechanisms such as educating consumers, encouraging self-regulation of 
healthcare  providers,  evaluation  of  information  by  third  parties  and  the  use  of  different 
enforcement procedures can be potential tools for quality management of information. 

Currently  public  authorities  play  a  central  role  in  providing  information,  either  information 
they approve as a result of the evaluation of medicines or other types of information prepared 
for specific purposes, e.g. by expert groups. However, the information that they provide varies 
widely, thus creating inequalities in access to information about medicines throughout the EU. 

Member States authorities may not be in a position to fully address patients’ needs in terms of 
the substance of information and the access via different means. In turn, the pharmaceutical 
industry possesses the key information on their medicines but this information can currently 
not be made available to patients and healthcare professionals throughout the EU. 

4.2. 

Conclusions in view of public consultation responses 

This  Report  on  Current  Practice  with  Regard  to  Provision  of  Information  to  Patients  on 
Medicinal Products provides an overview of the current state of play and indicates issues to be 
addressed. The public consultation has provided an extensive set of contributions where views 
from the different sectors were expressed. A summary of the outcome of this consultation was 
published  on  the  website  of  DG  Enterprise  and  Industry’s  Pharmaceuticals  Unit.  The 
consultation  responses  have  shown  that  the  draft  report  reflected,  apart  from  some  factual 
details,  the  current  situation.  Nevertheless  criticism  refers  to  the  lack  of  detailed  impact 
assessment and to the depth of the analysis. While the limited number of factual issues  and 
misunderstandings  were  corrected  and  figures  were  updated,  the  overall  analysis  was 
maintained with relevant clarifications added where appropriate.  

Opinions  expressed  on  the  way  forward  converged  as  regards  the  needs  to  improve 
information  to  patients,  to  adopt  common  standards  and  quality  criteria,  to  distinguish 
between advertising and information and to keep the ban on direct to consumer advertising on 

8 

Cf. Annex V of Commission Staff Working Document SEC(2007) 1740. 

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prescription-only medicines, and the  recognition of the Internet as an important information 
channel.  Different  views  were  expressed  on  how  to  improve  provision  of  information  to 
patients,  on  the  role  of  the  pharmaceutical  industry  and  on  the  mechanisms  to  regulate  and 
enforce applicable rules. 

On  the  basis  of  the  outcome  of  this  consultation,  the  Commission  intends  to  propose  to  the 
European  Parliament  and  the  Council  amendments  to  the  current  rules  on  the  provision  of 
information to patients by the end of 2008. This proposal will put the interests of patients first 
and  with  this  perspective  should  aim  at  reducing  differences  in  access  to  information  and 
should  ensure  the  availability  of  good-quality,  objective,  reliable  and  non  promotional 
information on medicinal products. The following main policy objectives will be pursued by 
this legal proposal:  

(1) 

Establishing a framework which provides citizens of EU Member States with 
understandable,  objective,  high-quality  and  non-promotional  information 
about the benefits and the risks of their medicines, and which  maintains  the 
confidence of citizens, regulators and healthcare professionals. 

(2)  Maintaining  the  ban  on  direct-to-consumer  advertising  of  prescription 
medicines,  making  sure  that  there  is  a  clear  distinction  between  advertising 
and non-promotional information. 

(3) 

Avoiding  unnecessary  bureaucracy,  in  line  with  the  principles  of  Better 
Regulation 

In accordance with Better Regulation practices the proposal will be substantiated by an impact 
assessment of the different policy options. 

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