Proposal for a Regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency {SEC(2008) 2667} {SEC(2008) 2668}
Date: 2008-10-21
Institutions: European Commission
Subjects: consumer information, dissemination of information, medicine, pharmaceutical legislation, public health, single market

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.12.2008 
COM(2008) 662 final 

2008/0255 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

{SEC(2008) 2667} 
{SEC(2008) 2668} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of the proposal 

The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation 
(EC)  No  726/2004  are  in  line  with  the  overall  objectives  of  the  Community  pharmaceutical 
legislation.  These  are  intended  to  ensure  the  proper  functioning  of  the  internal  market  for 
medicinal products for human use and to better protect health of EU citizens. Following this 
line, the proposals aim specifically to: 

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

This aim shall be achieved by: 

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

defined standards across the Community. 

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

different types of patients. 

•  Allowing  marketing  authorization  holders  to  provide  in  an  understandable  way  objective 

and non-promotional information about the benefits and the risks of their medicines. 

•  Ensuring that monitoring and enforcement measures are in place to ensure that information 

providers comply with the quality criteria, while avoiding unnecessary bureaucracy. 

1.2. 

General context 

Directive 2001/83/EC on the Community code relating to medicinal products for human use1 
provides  for  a  harmonised  framework  on  advertising  of  medicines  at  Community  level,  the 
application of which remains a responsibility of Member States. This legislation prohibits the 
advertising to the general public of medicines subject to prescription. 

However, neither the Directive nor Regulation (EC) No 726/2004 include detailed provisions 
on  information  on  medicinal  products,  providing  only  that  certain  information  supply 
activities  are  exempted  from  the  advertising  provisions.  Therefore,  Community  legislation 
does  not  prevent  Member  States  from  establishing  their  own  approaches  regarding  the 
provision  of  information  on  medicinal  products  as  long  as  the  above  mentioned  rules  on 
advertising  are  respected.  In  addition,  the  boundaries  between  advertising  and  information, 
and  therefore  the  field  of  application  of  the  legislation's  restrictions  on  advertising,  are  not 
interpreted consistently across the Community. 

1 

OJ  C  L  311,  28.11.2001,  p.  67.  Directive  as  last  amended  by  Directive  2008/29/EC  (OJ  L  81, 
20.3.2008, p. 51). 

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Article  88a  of  Directive  2001/83/EC,  introduced  by  Directive  2004/27/EC2,  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.” 

On  the  basis  of  this  provision,  a  Communication  from  the  Commission  to  the  European 
Parliament  and  the  Council  concerning  the  "Report  on  current  practices  with  regard  to  the 
provision of information to patients on medicinal products"3 was adopted and submitted to the 
European Parliament and the Council on 20 December 2007.  

It follows from the Report that rules and practices on what information can be available vary 
significantly among Member States. Certain Member States apply 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.  

Moreover,  divergences  in  terms  of  rules  and  practices  on  what  information  can  be  made 
available have a negative impact on legal certainty for marketing authorisation holders with 
cross-border activity. 

1.3. 

Existing provisions in the area of the proposal 

Directive 2001/83/EC 

Directive  2001/83/EC  does  not  contain  detailed  rules  on  information  on  prescription-only 
medicinal  products  by  the  marketing  authorisation  holder  to  the  general  public.  However, 
Article  86(2)  of  Directive  2001/83/EC  provides  that  certain  information  activities  are  not 
covered  by  the  rules  on  advertising  of  medicinal  products  for  human  use  that  are  currently 
contained  in  Titles  VIII  and  VIIIa  of  Directive  2001/83/EC.  The  exemption  concern  cases 
where a marketing authorisation holder answers a specific question about a particular product 
(Art.  86(2)  2nd  indent),  where  he  makes  factual,  informative  announcements  (Art.  86(2)  3rd 
indent) or where general information relating to human health or diseases without reference to 
a particular product is given (Art. 86(2) 4th indent). 

Experience  has  shown  that  the  interface  between  the  types  of  information  excluded  and  the 
prohibition  of  advertising  of  prescription-only  medicines  is  not  interpreted  uniformly  across 
the Community. 

2 
3 

OJ L 136, 30.4.2004, p. 34. 
COM(2007)  862.  The  Communication  is  supported  by  Commission  Staff  Working  Document 
SEC(2007) 1740. 

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1.4. 

Consistency with the other policies and objectives of the Union 

The  proposals  are  consistent  with  the  overall  objective  of  the  Community  pharmaceutical 
legislation, which is to remove disparities between national provisions in order to ensure the 
proper  functioning  of  the  internal  market  for  medicinal  products,  while  at  the  same  time 
safeguarding  a  high  level  of  protection  of  public,  human  and  animal  health.  The  proposals 
also comply with Article 152(1) of the Treaty establishing the European Community, which 
provides  that  a  high  level  of  human  health  protection  shall  be  ensured  in  the  definition  and 
implementation of all Community policies and activities. 

The  proposals  should  be  seen  as  part  of  a  wider  Community  agenda  on  health  information. 
This  also  includes  initiatives  such  as  the  follow-up  to  the  Pharmaceutical  Forum's  work  on 
information  to  patients,  the  EU  Health  Strategy,  the  EU  Health  Portal,  programmes  funded 
under the EU Health Programme and initiatives concerning eHealth. These initiatives have a 
broader  focus  than  information  regarding  prescription-only  medicines,  and  are  thus 
complementary to the proposals. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

2.1. 

Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

As a first step, the Commission services conducted a survey in 2006 amongst Member States 
medicines  regulatory  agencies  to  gather  information  on  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. 

Between  19  April  and  30  June  2007,  a  first  public  consultation  was  conducted  on  a  Draft 
report on current practices with regard to the provision of information to patients on medicinal 
products,  summarising  the  current  state  of  play  without  presenting  yet  any  political 
orientations or proposals. 

A second public  consultation, conducted between 5 February and  7 April 2008, specifically 
addressed  the  key  ideas  of  the  forthcoming  legal  proposal  on  information  to  patients. 
Contributions  were  asked  from  all  stakeholders  and  interested  parties  concerned  by  the 
provision of information on medicinal products to citizens. 

Both  public  consultation  documents  were  published  on  the  website  of  Directorate  General 
Enterprise and Industry.  

Summary of responses and how they have been taken into account 

As regards the first public consultation on a Draft report on current practices with regard to 
the  provision  of  information  to  patients  on  medicinal  products  conducted  in  2007,  73 
responses  were  received  from  various  sources.  These  include  patients’  organisations, 
consumer  and  citizen  organisations,  pharmaceutical  industry  organisations  and  companies, 
healthcare  professionals,  regulators,  social  insurance  organisations,  media  organisations  and 
individual citizens. 

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Concerning  the  public  consultation  conducted  between  5  February  and  7  April  2008  on  the 
key ideas for a legal proposal, in total 193 contributions were received. These comprise 185 
responses 
available  on 
http://ec.europa.eu/enterprise/pharmaceuticals/patients/patients_responses_200805.htm. 

comments.  The 

supportive 

responses 

eight 

and 

are 

The results of the public consultation conducted in 2007 are contained in the 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 and 
the  accompanying  Commission  Staff  Working  Document  submitted  to  the  European 
Parliament and the Council on 20 December 2007. 

The  responses  to  the  second  public  consultation  conducted  between  5  February  and  7  April 
2008  were  analysed  and  were  taken  into  account  by  the  Commission  when  preparing  this 
proposal. 

2.2. 

Impact assessment 

The  details  of  the  impact  assessment  are  provided  in  the  Commission  Staff  Working 
Document ‘Impact Assessment’ attached to this proposal. 

Three basic policy-options were developed for the impact assessment:  

1. Retention of the current legal framework (Option 1);  

2.  Revision  of  Directive  2001/83/EC  to  harmonize  rules  on  what  information  industry  is 
allowed to provide to patients combined with different enforcement mechanisms. This option 
includes four sub-options for the enforcement of the information provision (a. enforcement by 
national  competent  authorities  (Option  2),  b.  self-regulation  by  pharmaceutical  industry 
association with voluntary membership (Option 3), c. co-regulation involving a co-regulatory 
body and medicines regulatory authorities (Option 4), d. self-regulation via an industry body 
with compulsory membership);  

3.  Revision  of  Directive  2001/83/EC  allowing  specific  types  of  advertising  of  prescription 
medicines within the EU.  

The  revision  of  Directive  2001/83/EC  allowing  specific  types  of  advertising  of  prescription 
medicines  within  the  EU  and  the  sub-option  foreseeing  self-regulation  via  an  industry  body 
with compulsory membership were discarded at an early stage. The first was not considered to 
be appropriate as it would run counter the objective to maintain the current ban on direct-to-
consumer advertising for prescription-only medicinal products. The latter was discarded as it 
was considered inappropriate on grounds of lack of legitimacy, duplication of structures and 
exceeds the policy scope. 

It resulted from the impact assessment that harmonised provisions with regard to information 
to  patients  would  have  a  benefit  for  patients.  However,  the  differences  between  the  various 
policy options (option 2, 3 and 4) relating to monitoring and enforcement were not significant.  

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Summary of the proposed action 

The  legal  proposals  to  amend  Directive  2001/83/EC  and  Regulation  (EC)  No  726/2004 
address  the  gap  in  the  current  pharmaceutical  legislation  as  regards  the  provision  of 
information to the general public on prescription-only medicinal product for human use. The 
key elements of the proposals can be summarised as follows:  

•  Clarifying that the provision of information on prescription-only medicines directly to the 
public by marketing authorisation holders is allowed, without prejudice to the prohibition 
on advertising, provided that clearly defined conditions are respected. 

•  Establishing  harmonised  conditions  on  the  content  of  information  which  marketing 
authorisation holders are allowed to disseminate (information approved by the competent 
authorities  for  granting  marketing  authorisation,  whether  used  literally  or  presented  in  a 
different way, and other limited medicine-related information). 

•  Establishing harmonised quality standards for such information, to ensure that it is of high-

quality and non-promotional. 

•  Determining  the  authorised  channels  of  information  provision,  in  order  to  exclude 

unsolicited means of dissemination. 

•  Introducing  the  obligation  for  Member  States  to  establish  a  monitoring  system  to  ensure 
that  the  mentioned  provisions  on  content  of  information,  quality  standards  and 
dissemination  channels  are  complied  with  and  ensure  enforcement  in  case  of  non-
compliance. The proposal leaves it up to the Member States to decide the most appropriate 
monitoring  mechanisms,  but  lays  down  a  general  rule  that  monitoring  should  take  place 
after dissemination of information, with certain exceptions (where prior approval would be 
necessary) in the case of certain modalities of information where the distinction between 
advertising  and  non-promotional  information  is  more  difficult  to  establish.  For  products 
authorised  in  accordance  with  Regulation  (EC)  No  726/2004,  certain  approval  tasks  are 
given to the European Medicines Agency. 

•  Establishing  specific  monitoring  rules  for  information  disseminated  through  websites,  to 
take account of the cross-frontier nature of information provided over the Internet and to 
allow Member State cooperation and avoid duplication of monitoring. 

To  ensure  that  the  provision  of  information  on  prescription-only  medicinal  products  for 
human  use  follows  the  same  rules  regardless  of  the  procedure  according  to  which  these 
products  have  been  authorised,  it  is  appropriate  to  lay  down  the  general  rules  in  the 
Community code on medicinal products for human use (Directive 2001/83/EC), and to cross-
refer  to  them  in  the  regulation  governing  the  centralised  procedure  (Regulation  (EC)  No 
726/2004), with specific provisions for centrally authorised products as regards the role of the 
EMEA in a prior control of information on medicinal products to be disseminated. 

3.2. 

Legal basis 

The proposals are based on Article 95 of the Treaty, which provides for the use of the ‘co-
decision’ procedure referred to in Article 251 of the Treaty. Article 95 is the main legal basis 

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of  the  whole  Community  pharmaceutical  legislation,  including  Directive  2001/83/EC  and 
Regulation (EC) No 726/2004 which these proposals seek to amend. 

3.3. 

Subsidiarity principle 

The proposals do not fall under the exclusive competence of the Community. Therefore the 
subsidiarity principle laid down in Article 5 of the Treaty applies. In this case, action should 
be taken at Community level and problems could not be adequately tackled at national level, 
for a number of reasons. 

Today,  restrictions  on  the  possibilities  of  pharmaceutical  companies  to  provide  information 
result from the lack of clarity of the Community rules as regards the definition of advertising 
and,  consequently,  the  distinction  between  advertising  and  information.  The  clarification  of 
this distinction needs to be operated at the level of those Community rules. 

The need for Community action is furthermore supported by the objective of preserving the 
effectiveness  of  the  Community  pharmaceutical  acquis  as  regards  advertising.  As  the 
pharmaceutical legislation lays down detailed restrictions on advertising and excludes certain 
types  of  information  from  these  restrictions,  any  national  rules  prohibiting  or  unduly 
restricting such information could alter the balance introduced by the directive. 

Moreover,  in  a  system  where  the  rules  on  key  product  information  (summary  of  products 
characteristics and package leaflet) are fully harmonised to ensure the same level of protection 
of  public  health  across  the  Community,  this  objective  is  undermined  if  widely  divergent 
national rules on the dissemination of such key information are allowed.  

The need for action at Community level is also linked to the evolution of Community internal 
market rules on marketing authorisations for medicines. Medicinal products authorised by the 
Commission  enjoy  a  Community-wide  marketing  authorisation,  circulate  freely  within  the 
Community and have the same summary of product characteristics and package leaflet for the 
whole Community. Similar considerations apply to products authorised by the Member States 
under  the  mutual  recognition  framework,  leading  to  a  Community  harmonised  summary  of 
product characteristics and package leaflet. 

Moreover,  national  rules  and  practices  on  information  may  lead  to  restrictions  to  the  free 
movement  of  goods  in  violation  of  Article  28  of  the  Treaty,  impacting  negatively  on  the 
completion of a single market of 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 of the 
Treaty (case C-143/06, Juers-Pharma). 

3.4. 

Proportionality principle 

The  proposals  comply  with  the  proportionality  principle  as  laid  down  in  Article  5  of  the 
Treaty  for  the  following  reasons,  as  the  proposed  action  by  the  Community  does  not  go 
beyond what is necessary to achieve the objectives of the proposal.  

The  proposals  are  limited  in  scope  to  medicinal  products  subject  to  medical  prescription. 
Current  Community  rules  allow  the  advertising  to  the  general  public  of  medicinal  products 
not  subject  to  prescription,  subject  to  certain  conditions;  thus,  pharmaceutical  industry  may 
engage in any kind of dissemination of information for such products. 

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The  proposals  introduce  a  harmonised  set  of  quality  standards  and  rules  with  regard  to  the 
provision of non-promotional information on prescription-only medicines. However, it leaves 
it up to Member States to establish their own monitoring and enforcement system or to make 
use of existing structures, and simply lays down certain general principles. This is in keeping 
with the system currently in place as regards advertising. 

3.5. 

Choice of instruments 

The proposals aim at introducing a harmonised framework for the provision of information on 
prescription-only  medicinal  products  for  human  use  into  Directive  2001/83/EC  and  making 
this framework applicable to prescription-only medicinal products for human use authorised 
following Regulation (EC) No 726/2004. An amending directive and an amending regulation 
are therefore considered the most appropriate legal instruments. 

4. 

Budgetary implication 

The proposals have no implications for the Community budget. 

5. 

ADDITIONAL INFORMATION 

5.1. 

Simplification 

The project is referenced in the Commission Agenda Planning as 2008/ENTR/024. It is part 
of  the  Commission  Legislative  and  Work  Programme  for  2008,  under  Annex  I  (Priority 
Initiatives).4 

This  proposals  aim  at  filling  a  gap  in  the  existing  legal  framework  by  introducing  a 
harmonised  set  of  rules  for  information  provision  to  be  complied  with  throughout  the 
Community.  Currently  Member  States  have  adopted  divergent  rules  relating  to  information 
provision. Thus, marketing authorisation holders have to abide to different rules according to 
the Member State where the information is to be disseminated. In this regard simplification is 
expected as marketing authorisation holders will be subject to the same rules for the provision 
of information in their prescription-only medicinal products in all Member States. Competent 
bodies in turn will be able to apply harmonised rules when monitoring information provided 
and, if necessary, when enforcing. In general a clarification of rules is expected to lead to a 
simplification of the provision of information for all operators. 

5.2. 

European Economic Area 

The proposed act is of relevance to the EEA. 

4 

http://ec.europa.eu/atwork/programmes/docs/clwp2008_en.pdf (see page 20) 

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2008/0255 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1,  

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

On 20 December 2007, the Commission submitted a Communication to the European 
Parliament and the Council concerning the "Report on current practices with regard to 
the provision of information to patients on medicinal products"5 . The report concludes 
that  Member  States  have  adopted  divergent  rules  and  practices  with  regard  to  the 
provision of information, resulting in a situation where patients and the public at large 
have unequal access to information on medicinal products. Experience gained from the 
application  of  the  current  legal  framework  has  also  shown  disparities  in  the 
interpretation of the Community rules on advertising, and between national provisions 
on information. 

(2) 

The  introduction  of  a  new  Title  VIIIa  in  Directive  2001/83/EC  of  the  European 
Parliament and of the Council of 6 November 2001 on a Community code relating to 
medicinal  products  for  human  use6  addresses  those  concerns  through  various 

1 
2 
3 
4 
5 
6 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
COM(2007) 862. 
OJ L 311, 28.11.2001, p. 87. 

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(3) 

(4) 

(5) 

(6) 

provisions  intended  to  ensure  the  availability  of  good-quality,  objective,  reliable  and 
non  promotional  information  on  medicinal  products  for  human  use  subject  to 
prescription. 

Disparities  in  the  provision  of  information  on  medicinal  products  for  human  use  are 
not  justified  in  the  case  of  medicinal  products  authorised  pursuant  to  Title  II  of 
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  Agency7  for  which  a  single  summary  of  the  products  characteristics  and 
package  leaflet  are  approved  for  the  whole  Community.  Therefore  Title  VIIIa  of 
Directive 2001/83/EC should also apply to those products.  

Directive 2001/83/EC provides that certain types of information are subject to control 
by the Member States' national competent authorities prior to their dissemination. This 
concerns  information  about  non-interventional  scientific  studies,  or  accompanying 
measures  to  prevention  and  medical  treatment,  or  information  which  presents  the 
medicinal product in the context of the condition to be prevented or treated. In the case 
of medicinal products for human use authorised pursuant to Title II of Regulation (EC) 
No  726/2004,  provision  should  also  be  made  for  certain  types  of  information  to  be 
subject to prior vetting by the European Medicines Agency (hereinafter referred to as 
the 'Agency').  

To  ensure  the  adequate  funding  of  these  activities  related  to  information,  provision 
should be made for the collection of fees charged to marketing authorisation holders 
by the Agency.  

Since  the  objective  of  this  Regulation,  namely  to  provide  for  specific  rules  on 
information  on  medicinal  products  for  human  use  subject  to  prescription  authorised 
pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member 
States  and  can  be  better  achieved  at  Community  level,  the  Community  may  adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty. In accordance with the principle of proportionality, as set out in that Article, 
this  Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  this 
objective. 

(7) 

Regulation (EC) No 726/2004 should be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 726/2004 is amended as follows: 

(1) 

The following Articles 20a and 20b are inserted:  

“Article 20a 

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OJ L 136, 30.4.2004, p. 1. 

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Title  VIIIa  of  Directive  2001/83/EC  shall  apply  to  medicinal  products  which 

1. 
are authorised under this Title and are subject to medical prescription. 

Article 20b 

By  way  of  derogation  from  Article  100g(1)  of  Directive  2001/83/EC, 
1. 
medicinal product-related information referred to in Article 100b(d) of that Directive 
shall be subject to vetting by the Agency prior to its dissemination. 

For  the  purposes  of  paragraph  1,  the  marketing  authorisation  holder  shall 

2. 
submit to the Agency a mock-up of the information to be disseminated. 

The  Agency  may  object  to  the  information  submitted  or  parts  thereof  on 
3. 
grounds  related  to  non-compliance  with  the  provisions  of  Title  VIIIa  of  Directive 
2001/83/EC within 60 days after receipt of the notification. If the Agency does not 
object  within  60  days,  the  information  shall  be  deemed  accepted  and  may  be 
published. 

4. 
The submission of information to the Agency in accordance with paragraphs 1, 
2  and  3  shall  be  subject  to  a  fee  payable  in  accordance  with  Regulation  (EC)  No 
297/95.” 

(2) 

In Article 57(1), the following point (u) is added: 

“(u) delivering opinions on information to the general public on medicinal products 
for human use subject to medical prescription.” 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

A Regulation amending, as regards information to the general public on medicinal products 
for human use subject to medical prescription, Regulation (EC) No 726/2004, and a Directive 
amending, as regards information to the general public on medicinal products subject to 
medical prescription, Directive 2001/83/EC (CLWP Item 2008/ENTR/024 and is part of the 
Commission Legislative and Work Programme for 2008, under Annex 1 Strategic and 
Priority initiatives)8. 

Note: 

The  Legislative  Financial  Statement  is  proposed  based  on  the  fact  that  the  legislative 
proposal,  if  adopted,  foresees  that  specific  information  activities  of  marketing  authorization 
holders  for  centrally  authorized  medicinal  products  subject  to  medical  prescription  will  be 
subject of fees charged by the European Medicines Agency (EMEA). The legislative proposal 
foresees  the  insertion  of  new  articles  20a  and  20b  to  the  existing  Regulation  (EC)  No 
726/2004  laying  down  in  one  of  its  paragraphs  that  the  “submission  of  information  to  the 
Agency in accordance with this Article shall be subject to a fee payable in accordance with 
Regulation (EC) No 297/95.” 

The EMEA shall be charged with delivering opinions on information to the general public on 
medicinal products subject to medical prescription. In this regard Article 57(1) of Regulation 
(EC) No 726/2004 shall be amended. 

The Legislative Financial Statement proposes that all costs relating to activities resulting from 
the legislative proposal will be recuperated through fees. On this basis, the calculation made 
leads  to  the  conclusion  that  the  proposals  are  not  expected  to  have  a  significant  financial 
impact on the Community budget (see the Annex to this Legislative Financial Statement). 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned and associated Activity/Activities: 

Policy area(s): Internal Market (Article 95 of the EC Treaty). 

Activities: 

•  Promoting public health across the Community through providing for harmonized 

rules on information on medicinal products subject to medical prescription; 

•  Supporting the achievement of the internal market in the pharmaceutical sector; 

8 

http://ec.europa.eu/atwork/programmes/docs/clwp2008_en.pdf (see page 20) 

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3. 

BUDGET LINES 

3.1. 

Budget lines including headings: 

02.030201 – European Medicines Agency — Subsidy under Titles 1 and 2 

02.030202 – European Medicines Agency — Subsidy under Title 3 

3.2. 

Duration of the action and of the financial impact: 

The  assumption  is  that  the  proposals  on  information  to  the  general  public  on  medicinal 
products  subject  to  medical  prescription  would  apply  from  late  2011  (year  "n").  The 
calculation in the Annex has been calculated for 2011-2016. 

3.3. 

Budgetary characteristics: 

Budget 
line 

02.03020
1 

02.03020
2 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Non-
comp 

Non-
comp 

Differen
tiated 

Differen
tiated 

NO 

YES 

NO 

YES 

NO 

NO 

No 1a 

No 1a 

4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

n + 1

n + 2

n + 3

n + 4 

Year 
n 

n + 5 
and 
later 

Total 

Operational expenditure9 

Commitment Appropriations 
(CA) 

N.A. 

Payment 
(PA) 

Appropriations 

N.A. 

a 

b 

Administrative expenditure within reference amount10 

Technical  &  administrative 
assistance (NDA) 

N.A. 

c 

9 
10 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 

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TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

N.A. 

a+c

Payment Appropriations 

N.A. 

b+c

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Administrative expenditure not included in reference amount11 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

N.A. 

d 

N.A. 

e 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

N.A. 

TOTAL  PA  including  cost 
of Human Resources 

N.A. 

a+c
+d
+e 

b+c
+d
+e 

4.1.2.  Compatibility with Financial Programming 

⌧  Proposal is compatible with existing financial programming. 

4.1.3.  Financial impact on Revenue 

⌧  Proposal has no financial implications on revenue (see details of calculation in 

the Annex) 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

Year 
2011 

2012 

2013 

2014 

2015 

2016 
and 
later 

Total  number  of  human 
resources 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

Patients have become more empowered and proactive consumers of healthcare, increasingly 
seeking  information  about  medicines  and  treatments.  While  Directive  2001/83/EC  provides 
for a harmonised framework on advertising of medicines at Community level , the application 
of  which  remains  a  responsibility  of  Member  States,  neither  Direcitve  2001/83/EC  nor 
Regulation  (EC)  No  726/2004  include  detailed  provisions  on  information  on  medicinal 

11 

Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

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products.  Therefore,  Community  legislation  does  not  prevent  Member  States  from 
establishing their own approaches. 

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. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Considering  the  existing  harmonised  EU  legislation  on  the  authorisation  and  supervision  of 
medicinal  products  a  common  approach  on  information  provision  has  to  be  taken. 
Harmonised  provisions  would  allow  that  citizens  in  all  Member  States  have  access  to  the 
same type of information. If this matter continues to be left for national rules, it will almost 
inevitably lead to the adoption of national rules running counter to the spirit of the existing 
pharmaceutical legislation.  

National rules and practices on information may lead to restrictions to the free movement of 
goods in violation of Art 28 EC, impacting negatively on the completion of a single market in 
pharmaceuticals  which  the  harmonised  legal  framework  on  medicinal  products  tries  to 
achieve.  

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

The high level objective of the proposal is to improve the protection of health of EU citizens 
and to ensure the proper functioning of the internal market for medicinal products for human 
use. Following this line, the proposal aims specifically to: 

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

This aim shall be achieved by: 

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

clearly defined standards across the Community. 

•  Allowing  information  to  be  provided  through  channels  addressing  needs  and 

capabilities of different types of patients. 

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

•  Ensuring  that  monitoring  and  enforcement  measures  are  in  place  to  ensure  that 
the  quality  criteria,  while  avoiding 

information  providers  comply  with 
unnecessary bureaucracy. 

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5.4.  Method of Implementation (indicative) 

⌧  Centralised Management 

⌧ 

indirectly by delegation to: 

⌧ 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation  

⌧  Shared or decentralised management 

⌧  with Member states 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: The Community system for regulating medicinal products operates as a 
network  between  the  Commission,  the  European  Medicines  Agency  (EMEA)  and  the 
National competent authorities for medicinal products. Responsibilities are frequently shared 
with  the  exact  split  depending  on  whether  a  medicine  is  centrally  authorised  (with  the 
Commission  as  competent  authority)  or  nationally  authorised  (with  the  Member  States 
providing the competent authorities). 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The Commission has established mechanisms for working with the Member States to monitor 
transposition and in the pharmaceutical sector the Commission's Pharmaceutical Committee is 
a key forum for exchanging information in this regard.  

The  EMEA  should  contribute  to  the  implementation,  although  no  scientific  assessment  of 
information will be necessary. 

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

•  Extent of compliance with rules  
•  Information provision by industry  
•  Indicators of use of this information  
•  Patient awareness of this information  
•  Measuring the effect of information on patient behaviour and on health outcomes.  

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

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

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services  raised  during  the  inter-service  steering  group  meetings  were  fully  taken  into 
consideration. 

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

The  second  public  consultation,  conducted  between  February  and  April  2008,  specifically 
addressed the key ideas of the forthcoming legal proposal on information to patients.  

6.2.2.  Measures taken following an intermediate/ex-post evaluation  

Experience in the area of information to patients exists on a Member State level. In 2006, the 
Commission conducted a survey amongst medicines regulatory agencies to gather information 
about their practises, 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. 

The  report  concluded  that  Member  States  have  adopted  divergent  rules  and  practices  with 
regard to the provision of information. This shall be changed by providing a clear framework 
on what information may be disseminated, through which channels and by establishing a set 
of quality criteria which have to be respected. 

Experience  with  the  current  legal  framework  has  also  shown  that  the  notions  of  advertising 
and  information  are  not  interpreted  consistently  throughout  the  Community,  thus  restricting 
possibilities of pharmaceutical companies to provide information.  

6.2.3.  Terms and frequency of future evaluation 

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

7. 

ANTI-FRAUD MEASURES  

The European Medicines Agency has specific budgetary control mechanisms and procedures. 
The  Management  Board,  which  comprises  representatives  of  the  Member  States,  the 
Commission and the European Parliament, adopts the budget, as well as the internal financial 
provisions. The European Court of Auditors examines the execution of the budget each year.  

Regarding fraud, corruption and other unlawful activities, the provisions of Regulation (EC) 
No  1073/1999  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  concerning 
investigations  conducted  by  the  European  Anti-Fraud  Office  (OLAF)  apply  to  the  EMEA 
without restriction. Besides, a decision concerning co-operation with the OLAF was already 
adopted on 1 June 1999 (EMEA/D/15007/99). 

Finally,  the  Quality  Management  System  applied  by  the  Agency  supports  a  continuous 
review. Several internal audits are undertaken each year as part of this process. 

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Annex: details of calculation 

Introduction 

The Legislative Financial Statement is proposed based on the fact that the legislative proposal 
foresees  that  specific  information  activities  of  marketing  authorization  holders  for  centrally 
authorized medicinal products subject to medical prescription will be subject to fees charged 
by the European Medicines Agency (EMEA).  

The  Legislative  Financial  Statement  and  the  calculations  in  this  annex  demonstrate  that  all 
costs relating to activities resulting from the legislative proposal will be recuperated through 
fees. On this basis, the calculation in this Annex leads to the conclusion that the proposals on 
information  to  the  general  public  on  medicinal  products  subject  to  medical  prescription  are 
not expected to have a financial impact on the Community budget. 

The  EMEA  budget  was  €163  million  in  2007.  The  Community  contribution  has  increased 
from  €15.3  million  in  2000  to  €41  million  in  2007.  The  remainder  of  the  increase  of  the 
budget  over  time  has  been  covered  by  fees  charged  by  the  EMEA  to  the  pharmaceutical 
industry (estimated at 77% of total income in 2008 and based on Council Regulation (EC) No 
297/95 as amended by Commission Regulation No 312/2008 of 3 April 2008). Fee revenues 
are anticipated to further increase in the coming years in line with the general increase in the 
number  of  centrally  authorised  products.  It  should  be  noted  that  based  on  fee  income  the 
EMEA budget has run at a surplus in recent years and use has been made of the carry-over 
facility. Indeed, in 2006 the surplus was superior to €8 million. 

The  legal  proposal  foresees  that  the  EMEA  shall  be  charged  with  supervision  of  specific 
pieces of information on centrally authorised products: Medicinal product-related information 
about  non-interventional  scientific  studies  or  accompanying  measures  to  prevention  and 
medical treatment, or information which presents the medicinal product in the context of the 
condition  to  be  prevented  or  treated  shall  be  notified  to  the  EMEA  prior  to  publication  in 
health-related publications or in an Internet site.  

The  notification  shall  be  subject  to  a  fee  payable  in  accordance  with  Regulation  (EC)  No 
297/95. The assessment of the information submitted shall be fully conducted by EMEA staff. 
Due  to  the  fact  that  EMEA  activities  only  have  an  opinion  giving  character  and  that 
subsequent  monitoring  will  be  undertaken  by  Member  States,  administrative  procedures 
within the Agency will not be burdensome. 

The average cost of 1 full time equivalent (FTE) AD Staff Member for the EMEA in London 
has  been  provided  by  the  EMEA  (draft  2007  costs)  as:  Salary:  €112.113  and  Salary and 
overheads: €161.708 and these are the staff co sts used for the calculations below.  

Fees charged by the EMEA to the pharmaceutical industry 

Regarding EMEA fees, the following estimates can be made: 

At the moment approx. 400 centrally authorised medicinal products exist. It can be estimated 
that  during  the  first  year  after  entry  into  force  of  the  proposed  directive  approximately  100 
submissions of information to be disseminated to the general public will be submitted to the 
Agency for an opinion. For following years an increase in submissions to the Agency can be 
expected. The estimated fee charged to the pharmaceutical industry is €2,300. Based on these 

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estimates the additional income to the EMEA from patient information fee revenue will be in 
the first year €230,000 and €345,000 in the following years. 

Cost to the EMEA 

As  explained  above,  it  can  be  estimated  that  100  submissions  for  an  opinion  about 
information to patient on centrally authorised products will need to be checked by the Agency 
in  the  first  year.  An  increase  of  this  number  is  to  be  expected  to  150  submissions  once 
pharmaceutical companies have got familiar with the new procedure.  

It can be estimated that total costs for EMEA is made up by the annual salary of the staff.  
On the basis of the following tasks: 

–  checking the information on the basis of the documentation that has been provided by the 

pharmaceutical company and on the basis of other scientific information, 

–  contacts with pharmaceutical companies if there is a need for extra information; 

–  internal discussions, 

–  administrative processing of the submission (incl. drafting of the opinion), 

it can be assumed that it takes 2.5 working days to check one application.  
If  there  are  200  working  days  per  year  and  one  application  takes  2.5 days,  there  will  be  80 
submissions handled by one person in a year. This will mean a need for 1.5 administrators for 
the first year (number of submissions is 100) and a need for 2 administrators in other years 
(150 submissions).  

The average cost of 1 full time equivalent (FTE) AD Staff Member for the EMEA in London 
has  been  provided  by  the  EMEA  (draft  2007  costs)  as:  Salary:  €112.113  and  Salary and 
overheads: €161.708 and these are the staff co sts used for the calculations below.  

There  will  be  no  extra  costs  for  literature  screening  by  EMEA,  because  the  information  to 
patients  shall  be  based  on  the  documentation  that  the  pharmaceutical  companies  provide  in 
their application. It can also be assumed that there is no need for one-off costs; since EMEA 
already  disposes  information  sources  (i.e.  scientific  journals  and  databases)  existing  IT-
systems can be used when checking the content of the information provided.  

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Impact on EMEA budget 

The  total  impact  of  the  legal  proposal  on  EMEA  budget  has  been  presented  in  the  Table 
below. Based on a need for 1.5 or 2 extra vacancies, a slight negative balance in the first year 
followed by a slight positive balance in subsequent years are to be expected.  
Table: Impact on EMEA budget16 

EMEA costs  Year 2011  Year 2012  Year 2013  Year 2014  Year 2015  Year 2016 

Number 
of 
applications 
submitted 

100 

150 

150 

150 

150 

150 

FTA 

1.5 

2 

2 

2 

2 

2 

costs 

Total 
(=Annual 
salary) 
(€) 17 

Income 
fees18 

242,562  

323,416 

323,416 

323,416 

323,416 

323,416 

230,000  

345,000 

345,000 

345,000 

345,000 

345,000 

Balance  

-12,562  

21,584 

21,584 

21,584 

21,584 

21,584 

16 
17 
18 

Assumption: there will be an increase in applications and no impact on EMEA costs. 
Covers salary and overheads, €161,708/year. 
The fee for the pharmaceutical company will be €2,300. 

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