REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the Member States’ transposition of Article 118a of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011
Date: 2018-01-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, administrative sanction, illicit trade, industrial counterfeiting, market approval, medicinal product, national implementing measure, penalty, pharmaceutical legislation, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 26.1.2018  COM(2018) 49 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the Member States’ transposition of Article 118a of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011  
 
 
1.  Introduction and legal framework 

The falsification of medicines is a serious threat to public health. Falsification affects a wide range of 
medicines, such as cancer, sexual dysfunction and Hepatitis C treatments. Falsified medicines can and 
do penetrate the legal supply chain, as seen with the discovery in 2014 of falsified vials of the cancer 
treatment Herceptin (trastuzumab) in multiple EU markets1. 

In  2011,  the  European  Parliament  and  the  Council  adopted  Directive  2011/62/EU2  (the  Falsified 
Medicines  Directive)  to  amend  Directive  2001/83/EC3  and  address  increasing  concerns  regarding 
falsified medicines in the legal supply chain.  

The  Falsified  Medicines  Directive  introduces  mandatory  safety  features  on  prescription  medicines 
from  February  2019  (unless  explicitly  exempted),  strengthens  good  distribution  practices  and 
requirements  for  wholesale  distributors,  reinforces  rules  on  importation,  controls  and  inspections  of 
active substances and their manufacturers, and  establishes an EU-wide logo to allow the identification 
of legal online retailers of medicines (applicable from 1 July 2015).  

In  order  to  ensure  effective  enforcement  of  these  provisions,  Article  118a  of  Directive  2001/83/EC 
requires Member States to ‘lay down the rules on penalties applicable to infringements of the national 
provisions adopted pursuant to this Directive and [to] take all necessary measures to ensure that those 
penalties are implemented. The penalties must be effective, proportionate and dissuasive’. Such rules 
are to address inter alia: 

 

‘the manufacturing, distribution, brokering, import and export of falsified medicinal products, 
as  well  the  sale  of  falsified  medicinal  products  at  a  distance  to  the  public  by  means  of 
information society services; 

  non-compliance  with  the  provisions  of  the  Directive  on  manufacturing,  distribution,  import 

and export of active substances; and 

  non-compliance with provisions of the Directive on the use of excipients. 

Where  relevant,  the  penalties  should  take  into  account  the  risk  to  public  health  presented  by  the 
falsification of medicinal products’. 

Member States were to notify the Commission of their measures by 2 January 2013. Article 118a also 
requires  the  Commission  to  submit  a  report  to  the  European  Parliament  and  the  Council  ‘giving  an 
overview  of  the  transposition  measures  of  Member  States  as  regards  [the]  Article,  together  with  an 
evaluation of the effectiveness of those measures’. 

This  report  provides  an  overview  of  the  Member  States’  transposition  measures  and  a  qualitative 
assessment of their effectiveness.  The Commission was aided in its assessment by the TRANSPOSE 
study conducted by an external contractor4. The study provided an overview of transposition measures 
based on information provided by Member States under Article 118a and from legal experts in the 28 

1       https://www.researchgate.net/publication/303445021_Operation_Volcano_-_The_Herceptin_Case  
2    Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on   
the  Community  code  relating  to medicinal  products  for  human  use,  as  regards the  prevention  of  the  entry  into  the  legal 
supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74). 

3     Directive 2001/83/EC of the European 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, p. 67). 

4     Study  on  the  transposition  measures  of  Member  States  in  relation  to  the  pharmaceutical  legislation  (TRANSPOSE)  – 

SANTE/2016/B4/052 

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Member  States.  This  was  complemented  by  a  qualitative  assessment  of  current  penalties  relating  to 
falsified medicines, active substances and excipients. The Commission also consulted Member State 
competent authorities, through the Expert Group on the delegated act on safety features for medicinal 
products for human use, for further information on penalties in force5.  

2.  Overview of the transposition of Article 118a in the Member States 

A total of 26 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, IE, IT, LT, LU, 
LV, MT, NL, PL, PT, RO, SE, SI, SK, UK) have introduced changes to their legislation in relation to 
penalties  for  the  falsification  of  medicines,  active  substances  and  excipients6  in  order  to  transpose 
Article  118a.  Hungary  made  changes  to  its  Criminal  Code  as  a  result  of  the  Council  of  Europe 
Medicrime  Convention7.  Finland  has  not  changed  its  legislation,  as  penalties  were  already  in  place 
before the entry into force of Article 118a.  

Bodily  harm  or  personal  injury  is  covered  by  general  criminal  law  in  all  Member  States.  Member 
States also impose general administrative sanctions for unlawful conduct  involving medicines. These 
sanctions  are  complemented  by  specific  penalties  for  the  falsification  of  medicinal  products,  active 
substances and excipients, as outlined in Article 118a.  

Current penalties for the falsification of medicines, active substances and excipients are imprisonment 
(criminal  penalties),  fines  (criminal  or  civil  penalties)  and/or  administrative  sanctions  (e.g.  the 
revocation of licences or seizure/withdrawal of unlawful products from the market). 

Falsification of medicines 

In all Member States, at least some activities relating to the falsification of medicinal products are a 
criminal offence. In 21 Member States (AT, BE, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IE, IT, 
LU, MT, NL, PT, SI, SK, UK), the manufacturing, distribution, brokering, import, export and sale at a 
distance of falsified medicines all attract criminal penalties.   

In the seven remaining Member States, some activities are covered by civil penalties (such as fines) 
rather  than  criminal  penalties.  In  Bulgaria,  criminal  penalties  apply  only  to  the  import  or  export  of 
falsified medicinal products; the remaining activities are covered by civil penalties. In Finland, there 
are no specific penalties for brokering or export, but these are covered by more general provisions. In 
Latvia, criminal penalties cover manufacturing, distribution and brokering; there are civil penalties for 
import and export. In Romania, import and export are covered by civil rather than criminal penalties. 
In Poland and Sweden, criminal penalties do not cover export, but this is covered by civil penalties. In 
Lithuania, import is covered by civil penalties. 

5    Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the 

European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of 
medicinal products for human use (OJ L 32, 9.2.2016, p. 1); 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2719 

6    Article 1(3b) of Directive 2001/83/EC defines excipients as ‘any constituent of a medicinal product other than the active 

substance and the packaging material’. 

7    Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public 

health (CETS No.211). 

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Figure 1:  

Prison sentences for the falsification of medicinal products8 

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AT BE BG CY CZ DE DK EE EL ES FI FR HR HU IE IT LT LU LV MT NL PL PT RO SE SI SK UK
Member State 

Maximum prison sentences range from one to 15 years (Figure 1).  

All Member States apply criminal or civil fines in relation to the falsification of medicines (Table 1). 
Eight Member States (BE, FI, FR, IE, IT, LU, MT, UK) have criminal fines only. Seven (AT, CZ, HU, 
LT, RO, SI, SK) have civil fines only. The 13 remaining Member States (BG, CY, DE, DK, EE, EL, 
ES, HR, LV, NL, PL, PT, SE) have both criminal and civil fines. Maximum fines range from EUR 4 
300 in Lithuania to EUR 1 million Spain9. 

Table 1:  
* For non-euro Member States, an approximate euro amount is given. 

Maximum fines for the falsification of medicines (EUR)  

AT 

BE 

BG 

CY 

CZ 

DE 

50 000 
EL 

240 000 
ES 

200 000 
LT 

1 000 000 
LU 

25 500 
FI 
not 
specified 
LV 

85 000 
FR 

775 000 
HR 

750 000 
MT 

20 000 
NL 

4 300 
SE 
not 
specified 

20 000 
SI 

14 000 
SK 

116 469 
UK 

450 000 

120 000 

25 000 

unlimited 

25 000 
HU 
not 
specified 
PL 
not 
specified 

DK 
not 
specified 
IE 

EE 

32 000 
IT 

300 000 
PT 

15 600 
RO 

180 000 

6 500 

In 24 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IE, LT, LV, NL, PL, 
PT, RO, SE, SI, SK, UK), there are specific administrative sanctions for the falsification of medicinal 
products. 

8       In the United Kingdom, offences under the Trade Marks Act, which may apply to the falsification of medicines, carry a 

maximum prison sentence of 10 years. 

9       In Spain, the level of the fine depends on the severity of the offence. A fine of EUR 1 million would apply in the case of a 

‘very serious’ offence. 

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Misconduct involving active substances 

In 23 Member States (AT, BE, BG, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LU, LV, MT, 
NL, PL, PT, SK, UK), misconduct in relation to active substances is a criminal offence. 

Prison sentences for misconduct with respect to active substances 

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Figure 2:  
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AT BE BG CZ DE DK EE EL ES FI FR HR HU IE IT LU LV MT NL PL PT SK UK
Member State 

In  17  of  those  Member  States,  misconduct  in  the  manufacturing,  distribution,  import  and  export  of 
active substances are all covered by criminal penalties.  In Bulgaria,  criminal penalties only apply to 
misconduct in the import or export of active substances; the remaining activities are covered by civil 
penalties.  In  Finland,  Poland  and  the  United  Kingdom,  there  are  no  specific  penalties  covering  the 
export  of  active  substances.  In  Latvia  and  Malta,  criminal  penalties  only  cover  manufacturing  and 
distribution of active substances, but Latvia imposes civil penalties to misconduct involving the import 
and  export  of  active  substances.  Maximum  prison  sentences  imposed  range  from  six  months  to  15 
years (Figure 2). 

A total of 26 Member States (BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, IE, IT, LT, LU, LV, 
MT, NL, PL, PT, RO, SE, SI, SK, UK) apply criminal or civil fines in relation to active substances 
(Table 2). Seven Member States (BE, FI, IE, LU, MT, PL, UK) have criminal fines only. Seven (CY, 
CZ, LT, RO, SE, SI, SK) have only civil fines. The 12 remaining Member States (BG, DE, DK, EE, 
EL,  ES,  FR,  HR,  IT,  LV,  NL,  PT)  have  both  criminal  and  civil  fines.  The  maximum  fines  for 
misconduct  involving  active  substances  range  from  EUR  1  500  in  Lithuania  to  EUR  1  million  in 
Spain. 

Table 2:  
* For non-euro Member States, an approximate euro amount is given. 

Maximum fines for misconduct involving active substances (EUR) 

BG 
10 000 
FI 

BE 
240 000 
ES 
1 000 000  not specified 
LV 
14 000 
SK 
35 000 

MT 
11 647 
UK 
unlimited 

CZ 
775 000 
HR 

CY10 
42 000 
FR 
375 000  20 000 
NL 
PL 
450 000  not specified 

DE 
25 000 
IE 
300 000 
PT 
180 000 

DK 
not specified 
IT 
100 000 
RO 
6 500 

EE 
32 000 
LT 
1 500 
SE 
not specified 

EL 
100 000 
LU 
10 000 
SI 
120 000 

10  

In Cyprus, the fine may be increased by EUR 341 for each day the violation continues. 

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In 21 Member States (BG, CY, CZ, DE, DK, EE, ES, FR, HR, HU, IE, IT, LT, LV, NL, PL, PT, RO, 
SI, SK, UK), there are specific administrative sanctions in  place for misconduct in relation to active 
substances. 

Misconduct involving excipients 

In  14  Member  States  (AT,  BE,  DK,  EL,  ES,  FI,  FR,  HR,  IE,  LU,  LV,  NL,  PL,  PT),  misconduct  in 
relation to excipients is a criminal offence.  

Figure 3:  

Prison sentences for misconduct with respect to excipients  

15
14
13
12
11
10
9
8
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AT

BE

DK

EL

ES

FI

FR

HR

IE

LU

LV

NL

PL

PT

Member State 

In nine of those Member States, misconduct in the manufacturing, distribution, import and export of 
excipients  are  all  covered  by  criminal  penalties.  In  Finland,  misconduct  in  relation  to  the  export  of 
excipients  is  not  covered  by  criminal  penalties.  In  Ireland,  only  misconduct  in  relation  to  the 
manufacturing of excipients is covered by criminal penalties. In Latvia and Poland, criminal penalties 
only cover misconduct in the manufacturing and distribution of excipients; however, Latvia has civil 
penalties  for  import  and  export  involving  excipients.  In  Luxembourg,  criminal  penalties  cover 
misconduct in the manufacturing and import of excipients. Maximum prison sentences for misconduct 
in relation to excipients range from six months to 15 years (Figure 3). 

A total of 20 Member States (BE, CY, CZ, DK, EL, ES, FI, FR, HR, IE, IT, LU, LV, NL, PL, PT, RO, 
SE, SI, SK) also apply criminal or civil fines in relation to misconduct with excipients (Table 3). Five 
Member States (BE, FI, IE, LU, PL) have only criminal fines for misconduct with excipients. Seven 
(CY, CZ, IT, RO, SE, SI, SK) have only civil fines. The eight remaining Member States (DK, EL, ES, 
FR, HR, LV, NL, PT) have both criminal and civil fines. The maximum fines range from EUR 2 200 
in Romania to EUR 1 million in Spain. 

Table 3:  
* For non-euro Member States, an approximate euro amount is given. 

Maximum fines for misconduct involving excipients (EUR) 

BE 

240 000 
HR 
20 000 
RO 
2 200 

CY11 
42 000 
IE 
300 000 
SE 
not specified 

CZ 

DK 

EL 

ES 

FI 

775 000 
IT 
18 000 
SI 
120 000 

not specified 
LU 
10 000 
SK 
25 000 

100 000 
LV 
14 000 

1 000 000  not specified 
NL 
450 000 

PL 
not specified 

FR 

375 000 
PT 
180 000 

11  

In Cyprus, the fine may be increased by EUR 341 for each day the violation continues. 

5 

 
 
  
 
 
 
 
 
 
 
 
                                                            
 
 
 
 
In  15  Member  States  (CZ,  DK,  EE,  ES,  FR,  HR,  HU,  IT,  LT,  LV,  PL,  PT,  RO,  SI,  SK),  there  are 
specific administrative sanctions in place for misconduct in relation to excipients. 

Overall transposition 

All  28  Member  States  apply  criminal  penalties  in  the  form  of  imprisonment  for  the  falsification  of 
medicines.  One Member  State (LV) penalises  falsification that causes physical harm or death  (harm 
crimes) and two Member States (ES, PT) falsification that causes a risk or danger to the health of a 
person  or  public  health  (concrete  endangerment).  Four  Member  States  (EL,  LT,  RO,  SI)  penalise 
falsification  that  is  shown  to  be  generally dangerous,  i.e.  the  falsified  medicine  contains  insufficient 
active  ingredients  or  harmful  substances  (concrete-abstract  endangerment).  In  the  remaining  21 
Member  States,  falsification  per  se  is  penalised,  without  the  need  to  prove  that  the  product  is 
dangerous to health (abstract endangerment). For active substances, 23 Member States apply criminal 
penalties. For excipients, 14 Member States apply criminal penalties. 

Where criminal penalties apply for the falsification of medicines, the maximum prison sentence is at 
least three years in 20 Member States (AT, BG, CY, DE, EE, ES, FR, HR, HU, IE, IT, LT, LU, LV,  
NL, PL, PT, RO, SI, SK). A prison sentence of at least three years means that the crime falls under the 
European Investigation Order12. 

As  outlined  above,  all  Member  States  apply  fines  for  the  falsification  of  medicines.  For  active 
substances, 26 Member States apply fines. For excipients, 20 Member States apply fines. Fines may 
take the form of criminal or civil penalties, although maximum levels vary across Member States. 

All Member States except Finland, Luxembourg and Malta have introduced additional administrative 
sanctions for the falsification of medicines, active substances and/or excipients.  

3.  Effectiveness 

It  is  difficult  to  measure  the  effectiveness  of  specific  national  penalties  due  to  a  lack  of  exhaustive 
data on incidents in the Member States and the inherent illegal nature of the activities. Many of the 
national legal experts consulted as part of the TRANSPOSE study were unable to provide estimates 
of  the  effectiveness  of  specific  penalties  in  relation  to  falsified  medicines,  active  substances  and 
excipients13. 

Experts  in  10  Member  States  provided  estimates  of  the  effectiveness  of  national  penalties  in 
preventing  falsified  medicines  from  penetrating  the  legal  supply  chain  (i.e.  manufacturers,  parallel 
importers, wholesale distributors and pharmacies). They considered that all of the penalties in place 
(criminal,  civil  and  administrative)  had  at  least  some  effect  in  reducing  the  presence  of  falsified 
medicines  in  the  legal  supply  chain.  Overall,  administrative  sanctions  were  rated  as  effective  more 
often. Eight experts provided estimates of the extent to which the presence of falsified medicines in 
the legal supply chain had been reduced since the introduction of Directive 2011/62/EU. Six experts 

12   See Directive 2014/41/EU of the European Parliament and of the Council of 3 April 2014 regarding the European 

Investigation Order in criminal matters (OJ L 130, 1.5.2014, p. 1). The European Investigation Order is based on mutual 
recognition, which means that Member States are obliged to recognise and act on each other’s requests for evidence in the 
same manner as they would act on a request from their own authorities. 

13   Seventeen experts did not provide any replies regarding the effectiveness of penalties in the legal supply chain. Fifteen 

experts did not provide any replies regarding the effectiveness of penalties in the illegal supply chain. 

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considered a reduction of more than 25 % had occurred, whereas two considered a reduction of less 
than 5 % had occurred. 

For the illegal supply chain (e.g. purchases of medicines from illegal online pharmacies), experts in 
12  Member  States  provided  estimates  of  the  effectiveness  of  national  penalties.  Six  considered  that 
the criminal penalties had at least some effect in reducing the presence of falsified medicines in the 
illegal  supply  chain.  Two  experts  considered  that  civil  penalties  had  a  small  effect  and  three 
considered administrative sanctions to have had at least some effect. Overall, criminal penalties were 
rated as effective more often. Four experts considered that the presence of falsified medicines in the 
illegal  supply  chain  had  been  reduced  by  at  least  25  %  since  the  introduction  of  Directive 
2011/62/EU; seven estimated the reduction at less than 25 %. 

In  general,  the  study  noted  that  Member  States  should  introduce  both  criminal  penalties  and 
administrative  sanctions  in  order  to  safeguard  the  legal  supply  chain  and  tackle  the  illegal  sale  of 
falsified  medicinal  products.  Criminal  penalties  are  effective  and  dissuasive  for  actors  in  both  the 
legal and illegal supply chains.  Administrative sanctions are useful in addressing  misconduct in the 
legal  supply  chain  (where  operators  are  dependent  on  licences),  but  cannot  adequately  address 
operators  in  the  illegal  market,  who  already  act  without  authorisations,  i.e.  illegally.  However, 
administrative sanctions are generally easier to enforce than criminal penalties.  

As regards criminal penalties, the study noted that it is easier to enforce broader provisions that do not 
require  proof  of  direct  harm  to  patients,  but  rather  cover  medicinal  products  that  are  dangerous  or 
falsified. For example, in many Member States falsification  per se is penalised, without the need to 
prove that the product is dangerous to patients’ health. 

Applying maximum prison sentences of at least three years can also facilitate the sharing of evidence 
through  a  European  Investigation  Order12,  which  may  be  relevant  if  crimes  have  been  committed 
across multiple Member States. In any case, cooperation is necessary to ensure that evidence is shared 
for crimes with cross-border relevance. 

The effective enforcement of existing penalties is crucial in addressing the falsification of medicines, 
active substances and excipients. It is important to ensure that enforcement officials are well trained 
and given adequate resources to investigate pharmaceutical crimes.  

The  Working  Group  of  Enforcement  Officers14  (established  by  the  Heads  of  Medicines  Agencies 
network) is an important forum to ensure cooperation and sharing of best practices between medicines 
agencies and enforcement authorities in the European Economic Area. Interpol also works to support 
international  cooperation,  provide  training  and  encourage  the  exchange  of  information  between 
police, customs, medicines authorities, scientists and industry15. 

Member  States  should  monitor  enforcement  to  ensure  that  penalties  are  effectively  applied.  For 
example, since 2015 Germany has been collecting more detailed crime statistics on the falsification of 

14  
15  

http://www.hma.eu/wgeo.html  
https://www.interpol.int/Crime-areas/Pharmaceutical-crime/Pharmaceutical-crime   

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medicines  and  related  offences16.  This  should  allow  in  future  for  a  clearer  understanding  of  the 
effectiveness of penalties.  

4.  Conclusions 

Member  States’  transposition  of  Article  118a  of  Directive  2001/83/EC  is  satisfactory.  To  further 
reinforce  measures  in  place  and  strengthen  their  overall  effectiveness,  certain  Member  States  could 
consider  introducing  additional  criminal  penalties  or  administrative  sanctions  in  relation  to  falsified 
medicines, active substances or excipients. 

Member  States  should  ensure  that  adequate  resources  and  personnel  are  allocated  to  enforcing 
penalties in place (e.g. by training new enforcement officers). Increased monitoring and data collection 
could  allow  for  more  accurate  assessment  of  the  effectiveness  of  specific  national  provisions, 
especially given the difficulties in obtaining accurate estimates of the extent of falsification in the EU 
market. 

The falsification  of medicines is a serious threat to public health. The Falsified Medicines  Directive 
has introduced a number of measures to protect the legal supply chain of medicines from falsification 
in  the  EU.  This  includes  mandatory  safety  features  on  prescription  medicines,  strengthened  GDP 
requirements,  reinforced  rules  on  importation  of  active  substances,  and  an  EU-wide  logo  for  online 
pharmacies. 

The Commission will continue to support Member States’ implementation of the Falsified Medicines 
Directive, in particular the medicine authentication system which becomes applicable in the Member 
States in February 2019. The system is designed to ensure that medicines in the legal supply chain are 
genuine, safe and of high quality. The EU logo for online pharmacies should ensure that consumers do 
not  unknowingly  buy  medicines  from  illegal  suppliers  and  should  assist  Member  States  in  their 
enforcement efforts.  

Discouraging  the  falsification  of  medicines  through  suitable  penalties  will  only  be  possible  on  the 
basis of continued cooperation, sharing of best practices and effective monitoring of the legislation in 
place.  

16   Polizeiliche Kriminalstatistik [police crime statistics] [Germany] 2015, p. 122; 

https://www.bka.de/DE/AktuelleInformationen/StatistikenLagebilder/PolizeilicheKriminalstatistik/PKS2015/pks2015_nod
e.html  

8