Esta es la versión HTML de un fichero adjunto a una solicitud de acceso a la información 'Meetings with the pharmaceutical industry since December 1st 2019'.



Document 03
Ref. Ares(2020)453105 - 24/01/2020
EUROPEAN COMMISSION 
DIRECTORATE-GENERAL 
TAXATION AND CUSTOMS UNION 
Customs 
Protection of citizens and enforcement of IPR 
Report on the COM/EFPIA meeting 
Brussels (J 79-2/02), 09/12/2019
1.
LIST OF PARTICIPANTS
COM participants
-
TAXUD :
A.5),
A.5),
-
SANTE :
-
GROW :
F.3),
-
TRADE :
External participants 


, EFPIA Secretariat 
@efpia.eu 


Servier  
@servier.com 

, Pfizer 
@pfizer.com 

Boehringer Ingelheim 
@boehringer-ingelheim.com  

 Novartis 
@novartis.com   

 Pharmaceutical Security Institute 
@psi-inc.org 

GSK 
@gsk.com 

@pfizer.com 

bayer.com  
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 
Office: 
 Tel. direct line +32 
@ec.europa.eu 

 
2. 
ISSUES DISCUSSED 
-  the increase of counterfeit medicines; 
-  the decrease of customs seizures of medicines; 
-  the health risks counterfeit medicines can pose and the opportunity to deal with it 
as an EU political priority; 
-  the scope and application of Regulation 608/2013 (customs enforcement of IPR at 
the EU borders) and of Directive 2001/83 (medicinal products for human use) as 
amended by Directive 2011/62 (Falsified Medicines); 
-  the lack of information from customs to pharma right holders (RHs) – in case of 
Reg. 608/2013 – and from national medical authorities to pharma right holders 
(RHs) – in case of Directive 2001/83 and Directive 2011/62;  
-  the lack of full implementation of article 52 b) of Directive 2011/62 – action by 
customs in transit; 
-  the lack of request from RHs that customs use the small consignment procedure 
and the lack of use of the same procedure by customs when a RH has requested it; 
-  the opportunity to create a Pharma Working Group; 
-  the opportunity to create a memorandum of understanding (MoU) with TAXUD. 
3. 
COM COMMENTS 
TAXUD 
-  acknowledged the conflicting trends (increase of counterfeit  and decrease of customs 
detentions) and agreed on the importance to protect IPR as it is essential and 
beneficial to businesses and to the health of the EU citizens; 
-  showed its availability to raise the points of concerns at technical level within the 
framework of the Customs Expert Group, IPR section meetings regarding Regulation 
608/2018 and in the PARCS meeting (group gathering TAXUD and customs experts 
from MS on customs controls on prohibition and restrictions) to discuss the 
difficulties MS customs may encounter when implementing the Directive 2001/83 
and the Directive 2011/62; 
-  recalled that under Regulation 608/2013 the RHs should receive information from 
customs and asked the Pharma representative to name the national customs that do 
not do so: Pharma companies replied that actually they do not receive information 
from customs because they do not act under Regulation 608/2013 but prefer instead 
to act under Directive 2001/83 under which there is no requirement to inform right 
holders; 
-  pointed out that customs face constraints in terms of resources especially due to the 
increase of volumes of small consignment shipments and recalled that there is under 
Regulation 608/2013 a simplified procedure for small consignments that apparently is 
not so used by the pharma companies
 
 
 
 
 nevertheless, in the daily practice, Pharma 
companies confirmed that indeed they would prefer customs to use the standard 
procedure under Reg. 608/2013 rather than Directive 2001/83 (because under the 


 
latter there is no requirement for customs or medicines authorities to inform them; 
national medicines authorities have also declined to inform them due to data 
protection constraints); in practise customs authorities may have been using more the 
tools offered by Directive 2001/83; 
-  asked EFPIA about what they would like to use the information from 
customs/national medical authorities for; EFPIA explained that those information 
would be very important to create intelligence, to raise awareness and to share 
information with enforcement authorities in third countries;  

 
 EFPIA stated that the French association LEEM was 
in the process of making a report on the implementation of article 52 b) of Directive 
2011/62 and promised to share the report once available; 
-  showed its availability to discuss with MS the points of concerns above mentioned 
during the support visits to be carried out under the current Action Plan; 
-  does not see the opportunity nor the need to establish a Pharma Working Group as 
there is already an annual joint meeting customs/private sector where customs 
implementation of Regulation 608/2013 could be raised; in addition ad hoc meetings 
like the one organised today could be a more effective way to address specific 
questions from Pharma industries; 
-  regarding the proposal of MoU it is not a TAXUD practice to enter in such 
memorandums. 
 
SANTE 
-  explained that Directive 2011/62 is aimed at protecting the legal supply chain from 
falsified medicines, including an end-to end verification system; 
-  recalled that the Directive does not cover IP infringements; 
-  explained that only authorised pharmacies may sell medicines online to patients and 
offers of sales on platforms (Facebook, Ebay etc) are illegal; 
-  offered to raise the issue of cooperation between medicines authorities, customs and 
the pharmaceutical industry at their next Expert Group on safety features to better 
understand what MS are doing to prevent falsified medicines from entering the EU 
territory from third countries.  
 
GROW 
-  explained the main on-going workstreams on IPR enforcement, in particular the MoU 
on the sale of counterfeit goods via the internet and the MoU on online advertising 
and IPR), and invited EFPIA to (re) assess the opportunity to join these industry-led 
initiatives; 
-  detailed the work carried out in the EUIPO Observatory’s Expert Group ‘Cooperation 
with Intermediaries’; 
-  offered to check if the issue of counterfeit medicines could be further discussed in 
meetings gathering various law enforcement authorities, such as EUIPO meetings on 
Joint Efforts against IP Crime and EUIPO Enforcement Working Group meetings, 
instead of creating a new forum (as requested by EFPIA). 
 


 
TRADE 
-  TRADE informed EFPIA about the upcoming Counterfeiting and Piracy Watch List 
and invited EFPIA to contribute to its preparation. 
-  TRADE informed EFPIA about the negotiations on an African Continental Free 
Trade Area and invited EFPIA to send information on the pharmaceutical industries’ 
priorities. 
4. 
CONCLUSIONS 
COM committed to investigate the points of concerns discussed with the MS, namely 
about the implementation of Regulation 608/2013 (TAXUD) and Directives 2001/83 and 
2011/62 (SANTE) and to inform EFPIA accordingly. 
EFPIA will investigate the opportunity to join the MoUs currently in force as presented 
by GROW. 
EFPIA will share the report of LEEM on implementation of article 52 b) of Directive 
2011/62. 
Other ad hoc meeting like this meeting could be replicated once a year (in the same 
format, or bilaterally with specific DGs). 
 
 
 
 
 
 
 
 
 
Report done by 
 (TAXUD), 
 (TAXUD) with contributions 
from 
 (SANTE), 
 (GROW) and 
 
(TRADE).