Proposal for a COUNCIL RECOMMENDATION on vaccine-preventable cancers
Date: 2024-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: World Health Organisation, cancer, child, health care, health risk, infectious disease, medical diagnosis, reproductive health, vaccination

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   EUROPEAN COMMISSION  Brussels, 31.1.2024  COM(2024) 45 final 2024/0024 (NLE)  Proposal for a COUNCIL RECOMMENDATION on vaccine-preventable cancers  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Introduction 
Europe’s Beating Cancer Plan1 (the Cancer Plan) is a key public health priority of the 
Commission  and  a  cornerstone  of  the  European  Health  Union2..Together  with  the 
Horizon Europe Cancer Mission3, it is the Commission’s response to the increasing 
number of cancer cases and cancer-related deaths across the EU. 

As  a  flagship  initiative  of  the  Cancer  Plan,  the  Commission  intends  to  support  EU 
Member  States’  efforts  to  strengthen  and  expand  routine  vaccination  of  girls  and 
boys against Human papillomaviruses (HPV) to eliminate cervical cancer and other 
cancers caused by HPV, such as vulvar, vaginal, penile and anal cancers as well as 
some head-and-neck cancers. The goal set in the Cancer Plan is to fully vaccinate at 
least  90 %  of  the  EU  target  population  of  girls  and  to  significantly  increase  the 
vaccination  of  boys  by  2030.  In  the  Cancer  Plan,  the  Commission  also  announced 
that it would help to ensure access to vaccination against Hepatitis B virus (HBV) in 
order  to  boost  vaccination  uptake  and  thus  help  prevent  disease  caused  by  HBV, 
including liver cancer. 

The  Commission  is  therefore  proposing  a  Council  Recommendation  on  vaccine-
preventable  cancers to  help  EU Member States  prevent  and reduce the cancer risks 
linked to HPV and HBV infections by boosting HPV and HBV vaccination uptake. 

The proposed Council Recommendation was included in the 2023 Commission work 
programme4 under the Commission priority ‘Promoting our European Way of Life’.  

It  aims  to  help  EU  Member  States  to  achieve  the  United  Nation’s  Sustainable 
Development Goal 3: Ensure healthy lives and promote well-being for all at all ages, 
specifically Target 3.3: ‘By 2030, end the epidemics of AIDS, tuberculosis, malaria 
and neglected tropical diseases and combat hepatitis, water-borne diseases and other 
communicable diseases’5. 

Both  HPV  and  HBV  vaccines  can  prevent  viral  infections  that  may  lead  to  cancer. 
These vaccines are therefore vital in protecting both individual and public health and 
in supporting resilient and fair health systems. 

They  also  both  fit  into  the  life-course  perspective  on  vaccination  that  the 
Commission  has  been  promoting  since  the  adoption,  in  2018,  of  the  Council 

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Communication  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  Europe's 
Beating Cancer Plan, COM/2021/44 final. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  ‘Building  a  European  Health 
Union: Reinforcing the EU’s resilience for cross-border health threats’, COM/2020/724 final. 
https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-
open-calls/horizon-europe/eu-missions-horizon-europe/eu-mission-cancer_en 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  the  Commission  work 
programme 2023: A Union standing firm and united, COM(2022) 548 final. 
https://sdgs.un.org/goals/goal3 

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Recommendation on strengthened cooperation against vaccine-preventable diseases6. 
That Council Recommendation called for a series of actions7 to increase the uptake 
of  vaccination  throughout  life,  including  the  set-up  of  the  European  Vaccination 
Information  Portal8,  where  people  can  easily  find  evidence-based  information  on 
vaccination and vaccines, including for specific age groups. An EU information and 
awareness-raising  campaign  on  vaccination  as  a  disease  prevention  measure, 
#UnitedInProtection9, that can be adjusted to address national challenges and needs, 
was launched in November 2022 and will run at least until November 2024. 

HPV  and  HBV  vaccination  target  different  population  groups.  HPV  vaccines  are 
mainly  offered  to  adolescent  and  preadolescent  girls  and  boys,  as  well  as  to  young 
adults  as  part of  targeted catch-up campaigns.  HBV vaccines  are  offered to  a large 
number  of  heterogeneous  population  groups,  ranging  from  infants  to  adults  at  high 
risk  and  sometimes  in  disadvantaged  situations,  such  as  people  who  inject  drugs, 
prison  populations,  men  having  sex  with  men,  trans  gender  persons,  migrants, 
asylum seekers and refugees from countries where HBV is endemic, as well as health 
professionals.  This  requires  different  approaches  to  ensure  sufficient  uptake, 
including in terms of communication. 
The COVID-19 pandemic and the new vaccines made available by the Commission10 
and rolled out by EU Member States highlighted the importance of vaccination as a 
crisis  management  tool,  but  the  lockdown  measures  that  were  implemented  by 
countries  to  halt  the  spread  of  the  virus  also  disrupted  the  continuity  of  national 
routine  vaccination  programmes.  In  addition,  the  ‘infodemic’  that  surrounded  the 
pandemic  tested  people’s  confidence  in  vaccination  because  it  was  hard  to 
differentiate between accurate and false information. This situation was made worse 
by mis- and disinformation on social media and other media as well as by feelings of 
‘vaccination  fatigue’.  It  is  therefore  important  that  interdisciplinary  expertise  to 
amplify efforts to counter vaccine mis- and disinformation is used by Member States, 
as  highlighted  in  the  Council  Conclusions  on  vaccination11  that  were  adopted  in 
2022. 

Monitoring of vaccination coverage rates is important to inform interventions aimed 
at increasing vaccination uptake. Whereas some EU Member States have centralised, 
population-based  Immunisation  Information  Systems 
to  monitor  vaccination 
coverage  rates  in  their  country,  including  at  subnational  level,  monitoring  is 
fragmented in others. In addition, some EU Member States report issues in relation to 
the  collection  of  vaccination  data  as  part  of  the  monitoring  of  vaccination 
programmes  in  the  context  of  the  national  approach  to  the  implementation  of 
provisions  of  the  EU’s  General  Data  Protection  Regulation12  which  can  be  further 
specified by EU Member States. From another administrative perspective, some EU 

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12 

Council  Recommendation  of  7  December  2018  on  strengthened  cooperation  against  vaccine-
preventable diseases (OJ C 466, 28.12.2018, p. 1). 
https://health.ec.europa.eu/system/files/2022-12/2019-2022_roadmap_en.pdf 
https://vaccination-info.eu/en 
https://vaccination-protection.ec.europa.eu/index_en 
Communication from the Commission to the European Parliament, the European Council, the Council 
and the European Investment Bank on an EU Strategy for COVID-19 vaccines, COM/2020/245 final. 
https://data.consilium.europa.eu/doc/document/ST-14771-2022-INIT/en/pdf 
Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1). 

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Member States point to issues in the national procedures to obtain parental consent to 
vaccinate minors, having a possible negative impact on the uptake. 

During  the  COVID-19  pandemic,  the  European  Centre  for  Disease  Prevention  and 
Control  (ECDC)  collected,  analysed  and  displayed  data  to  monitor  the  vaccination 
uptake in the EU and the European Economic Area (EU/EEA) countries through the 
COVID-19  Vaccine  Tracker13.  The  data  showed  where  further  public  health  action 
was needed to increase coverage rates. 

Building  on  the  work  already  done  by  the  World  Health  Organization  (WHO)  to 
monitor  vaccination  coverage  rates  for  the  53  countries  in  the  WHO  European 
Region,  the  ECDC  was  tasked  to  monitor  the  level  of  vaccination  coverage  in  EU 
Member  States.  This  is  part  of  the  extended  mandate  given  to  the  ECDC  as  a 
building  block  of  the  European  Health  Union14.  ECDC  can,  however,  only 
accomplish its monitoring task if there are reliable data available from countries. 

The proposed Council Recommendation focuses on supporting EU Member States in 
better monitoring of HPV and HBV vaccination coverage rates. Better monitoring of 
the  uptake  of  HPV  and  HBV  vaccines,  however,  goes  hand  in  hand  with  better 
monitoring  of  the  uptake  of  all  vaccines  included  in  national  immunisation 
programmes and should not be dealt with separately from this. 

HPV-related cancer burden and HPV vaccination 

The  WHO  reports  HPV  to  be  the  most  common viral  infection  of  the  reproductive 
tract causing a range of conditions in both women and men, including precancerous 
lesions  that  may  progress  to  cancer.  While  most  HPV  infections  are  asymptomatic 
and usually resolve spontaneously, some result in disease15. 
Only a few of the more than 200 HPV types identified are oncogenic16, namely HPV 
types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59. These high-risk HPV types 
are,  however,  responsible  for  practically  all  cervical  cancer  cases.  They  are  also 
causally linked to other anogenital cancers (vulvar, vaginal, penile and anal cancers) 
in  both  women  and  men  as  well  as  to  certain  head-and-neck  cancers,  particularly 
oropharyngeal cancers17. 

Among  the  high-risk  HPV  types,  HPV16  and  HPV18  have  the  biggest  oncogenic 
potential. HPV16, the most  oncogenic type of all,  is  consistently  the most  frequent 
type detected in HPV-related cancers both in Europe and worldwide18. The low-risk 
HPV  types  6  and  11  are  associated  with  anogenital  warts  and  recurrent  respiratory 
papillomatosis.  It  is  estimated  that  there  are  around  28 600  cases  of  and  13 700 
deaths from cervical cancer every year in EU/EEA countries19. The age-standardised 

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16 
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18 
19 

https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab 
Regulation  (EU)  2022/2370  of  the  European  Parliament  and  of  the  Council  of  23 November  2022 
amending  Regulation  (EC)  No 851/2004  establishing  a  European  centre  for  disease  prevention  and 
control (OJ L 314, 6.12.2022, p. 1). 
https://www.who.int/news-room/fact-sheets/detail/cervical-cancer 
Meaning that they may cause cancer. 
European Centre for Disease  Prevention and Control. Guidance on HPV vaccination in EU countries: 
focus  on  boys,  people  living  with  HIV  and  9-valent  HPV  vaccine  introduction,  2020.  Stockholm: 
ECDC; 2020. 
Ibid. 
ECIS  - European Cancer Information System, accessed on  27/10/2023. EU/EEA figures computed as 
the sum of values for EU-27, Norway, and Iceland. 

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incidence rates (European std. population 2013) are 11.8 cases and the mortality rates 
are  5.3  deaths  per  100 000  women20.  In  addition,  among  the  most  relevant  HPV-
related head-and-neck cancers, it is estimated that there were around 19 700 cases of 
oropharyngeal  cancers  in  EU/EEA  countries  in  2022,  mostly  (around  15 000)  in 
men21.  Whereas  this  figure  does  not  cover  only  HPV-related  cancers,  increasing 
trends  in  the  incidence  of  HPV-positive  head  and  neck  cancers  have  been 
consistently observed in the last decade in concomitance with the decline in tobacco 
use22.  HPV  infections  are  thought  to  play  an  important  role  in  connection  with 
oropharyngeal  cancer  globally23,  especially  in  Europe  and  North  America24.  In  line 
with this, the United States’ Centres for  Disease Control and Prevention report that 
HPV is thought to cause 70 % of oropharyngeal cancers in the United States25. 

All  EU  Member  States  recommend  vaccinating  adolescent  and  preadolescent  girls 
against HPV, and many also recommend it for boys of those age groups. In some EU 
Member  States,  the  recommendations  are  currently  being  extended,  via  targeted 
catch-up  campaigns,  to  also  cover  young  adults  who  did  not  get  vaccinated  during 
adolescence or preadolescence or who are only partially vaccinated, including due to 
the lockdown measures implemented during the COVID-19 pandemic. 

There  are  currently three HPV vaccines licensed  in  the EU: a bivalent  vaccine that 
contains  virus-like-particles  of  HPV  types  16  and  18,  a  quadrivalent  HPV  vaccine 
that  includes  virus-like-particles  of  HPV  types  6,  11,  16  and  18  and  a  nonavalent 
vaccine that contains virus-like-particles of HPV types 6, 11, 16, 18, 31, 33, 45, 52 
and 58. All vaccines contain virus-like-particles of HPV types 16 and 18, the high-
risk  HPV  types  with  the  biggest  oncogenic  potential.  Vaccine  products  in  use  in 
individual EU Member States depend on national public procurement policies. 

Coverage  rates  vary  significantly  across  the  EU.  For  example,  data  for  vaccination 
uptake show that whereas a few EU Member States have vaccinated 90 % or more of 
adolescent  and  preadolescent  girls  with  one  dose  out  of  the  two  doses  required  for 
those age groups, this figure remains low, below 50 %, in other EU Member States26. 

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22 

23 

24 

25 
26

Ibid. 
Ibid. 
European Centre for Disease Prevention and Control.  Guidance on HPV vaccination in EU countries: 
focus  on  boys,  people  living  with  HIV  and  9-valent  HPV  vaccine  introduction,  2020.  Stockholm: 
ECDC; 2020. 
Castellsagué  X,  Alemany  L,  Quer  M,  Halec  G,  Quirós  B,  Tous  S,  Clavero  O,  Alòs  L,  Biegner  T, 
Szafarowski  T,  Alejo  M,  Holzinger  D,  Cadena  E,  Claros  E,  Hall  G,  Laco  J,  Poljak  M,  Benevolo  M, 
Kasamatsu  E,  Mehanna  H,  Ndiaye  C,  Guimerà  N,  Lloveras  B,  León  X,  Ruiz-Cabezas  JC,  Alvarado-
Cabrero  I,  Kang  CS,  Oh  JK,  Garcia-Rojo  M,  Iljazovic  E,  Ajayi  OF,  Duarte  F,  Nessa  A,  Tinoco  L, 
Duran-Padilla  MA,  Pirog  EC,  Viarheichyk  H,  Morales  H,  Costes  V,  Félix  A,  Germar  MJ,  Mena  M, 
Ruacan A, Jain A, Mehrotra R, Goodman MT, Lombardi LE, Ferrera A, Malami S, Albanesi EI, Dabed 
P,  Molina C, López-Revilla R, Mandys V, González  ME, Velasco J, Bravo IG, Quint W, Pawlita M, 
Muñoz  N,  de  Sanjosé  S,  Xavier  Bosch  F;  ICO  International  HPV  in  Head  and  Neck  Cancer  Study 
Group.  HPV  Involvement  in  Head  and  Neck  Cancers:  Comprehensive  Assessment  of  Biomarkers  in 
3680  Patients.  J  Natl  Cancer  Inst.  2016  Jan  28;108(6):djv403.  doi:  10.1093/jnci/djv403.  PMID: 
26823521. 
de Martel C, Plummer M, Vignat J, Franceschi S. Worldwide burden of cancer attributable to HPV by 
site, country and HPV type. Int J Cancer. 2017 Aug 15;141(4):664-670. doi: 10.1002/ijc.30716. Epub 
2017 Jun 8. PMID: 28369882; PMCID: PMC5520228.  
https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm  

https://immunizationdata.who.int/pages/coverage/hpv.html?CODE=EUR&ANTIGEN=PRHPV1_F&Y

EAR=&ADVANCED_GROUPINGS=EURO 

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Only limited data are currently available for vaccination uptake in boys as well as for 
young adults. 

The proposed Council Recommendation calls for measures to increase the uptake of 
HPV vaccination among adolescent and preadolescent girls and boys. It also calls for 
better monitoring  of HPV vaccination  uptake, to  close data gaps and  inform public 
health action. 

HBV-related cancer burden and HBV vaccination 

HBV  is  a  global  health  challenge,  and  chronic  infection  with  the  virus  is  a  major 
cause  of  chronic  liver  disease,  cirrhosis  and  liver  cancer.  Globally,  HBV  and 
Hepatitis  C  virus  (HCV)  infections  are  estimated  to  cause  1.1  million  deaths  per 
year27.  For  2021,  30  EU/EEA  countries  reported  16 187  newly  diagnosed  HBV 
infections, a large share of those (43 %) being classified as chronic28. Based on data 
from  2015,  it  is  estimated  that  across  the  EU/EEA  and  the  United  Kingdom,  HBV 
and HCV infections are responsible for approximately 55 % of all liver cancer deaths 
and 45 % of all deaths due to cirrhosis and other chronic liver disease and result in 
approximately 64 000 deaths annually29. 

Transmission of HBV, which is a bloodborne virus, may happen perinatally at birth 
from  infected  mothers  to  children  (vertical  transmission)  or  through  sexual 
intercourse,  unsafe  injecting  of  drugs,  contaminated  blood  or  blood  products,  or 
suboptimal infection prevention and control practices in healthcare settings. 

Despite a steady decline in the overall incidence of HBV over time due to effective 
vaccination  programmes  and  other  prevention  strategies,  it  is  estimated  that 
approximately  3.6  million  people  in  EU/EEA  countries  are  living  with  a  chronic 
HBV infection30. Modelling studies31 suggest that associated morbidity and mortality 
could rise if responses are not further scaled up. 

The burden of infection with HBV in EU/EEA countries is higher in some population 
groups at high risk and sometimes in disadvantaged situations, including people who 
inject drugs, prison populations, men having sex with men, trans gender persons and 
migrants, asylum seekers and refugees from countries where HBV is endemic, than 
in  the  general  population.  However,  heterosexual  intercourse  remains  a  common 
route of HBV in Europe. And even if vertical transmission is now uncommon in this 
part of the world, prevention strategies are needed as most infants who are infected 
perinatally will become chronically infected32. 

Most  EU  Member  States  recommend  vaccination  of  all  children  against  HBV.  In 
addition,  countries  have  various strategies in  place to  prevent  vertical  transmission, 
including  screening  of  pregnant  women  for  hepatitis  B  surface  antigen  (HBsAg), 
vaccination with the first HBV vaccine dose within 24 hours from birth (also known 
as  ‘birth  dose’)  and  post-exposure  prophylaxis  for  infants  born  to  HBV-infected 
mothers. 

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32 

Prevention of hepatitis B and C in the EU/EEA. Stockholm: ECDC; 2022. 
Hepatitis B. In: ECDC. Annual epidemiological report for 2021. Stockholm: ECDC; 2022. 
Prevention of hepatitis B and C in the EU/EEA. Stockholm: ECDC; 2022. 
Ibid. 
Such as Razavi-Shearer, D. et al. The disease burden of hepatitis B and hepatitis C from 2015 to 2030: 
the long and winding road [Abstract OS050]. J. Hepatol. 77, S43 (2022). 
Prevention of hepatitis B and C in the EU/EEA. Stockholm: ECDC; 2022. 

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There are 12 HBV vaccines authorised in the EU, all of which use HBsAg adsorbed 
onto aluminium adjuvants. Whereas one vaccine is authorised for use in all ages, the 
others are authorised for specific age groups. Four vaccines are authorised for use in 
children,  of  which  three  also  include  antigens  for  diphtheria,  tetanus,  pertussis, 
poliomyelitis  and  Haemophilus  influenzae  type  b.  In  addition  to  the  12  vaccines 
authorised in the EU, two others are authorised nationally only. Vaccine products in 
use in individual EU Member States depend on national public procurement policies. 

In 2017, the WHO, in the Action plan for the health sector response to viral hepatitis 
in  the  WHO  European  Region,  put  forward  the  goal  of  eliminating  hepatitis  as  a 
public  health  threat  in  its  European  Region  by  203033.  However,  data  from  2021 
show, despite gaps, that coverage rates in many  EU Member States still need to be 
improved  to  reach  even  the  2020  interim  targets  set  by  the  WHO  of  1)  95 % 
coverage  with  three  doses  of  HBV  vaccine  in  countries  that  implement  universal 
childhood  vaccination,  and  2)  90 %  coverage  with  interventions  to  prevent  vertical 
transmission (HBV birth-dose vaccination or other approaches)34, not to mention the 
2030  targets  of  1)  95 %  vaccination  coverage  (3rd  dose)  of  childhood  HBV 
vaccination,  2)  95 %  of  pregnant  women  screened  for  HBsAg,  and  3)  95 %  of 
newborns  who  received  timely  (within  24  hours  of  birth)  HBV  birth-dose 
vaccination35. 

Many  EU  Member  States  also  recommend  vaccination  for  groups  at  high  risk  and 
sometimes in disadvantaged situations, such as the ones referred to above, as well as 
for health professionals. There are, however, gaps in data on vaccination uptake. 

The  proposed  Council  Recommendation  calls  for  measures  to  increase  access  to 
HBV vaccination for all population groups for whom vaccination is recommended in 
order  to  increase  vaccination  uptake.  It  also  calls  for  better  monitoring  of  HBV 
vaccination  uptake,  to  close  data  gaps  and  facilitate  efficient,  data-driven  public 
health action. 

Looking into the future 

Other  vaccines  against  cancers  caused  and  not  caused  by  infections  are  in 
development,  including  though  the  mRNA  platform  that  was  also  used  for  some 
COVID-19  vaccines.  Research  on  prophylactic  vaccines  against  cancers  caused  by 
infections  is  being  supported  by  the  Commission’s  Horizon  Europe  (2021-2027) 
Framework  Programme  for  Research  and  Innovation.  For  example  through  the 
Vax2Muc36  project,  targeting  the  bacterium  Helicobacter  pylori  that  can  cause 
stomach cancer. In addition, the Innovation Task Force of the European Medicine’s 
Agency  (EMA)  and  its  PRIME  scheme  provide  support  to  the  development  of 
innovative  medicines  targeting  unmet  medical  needs.  In  the  future,  prophylactic 
vaccines  against  cancers  caused  by  infections  may  therefore  have  an  even  more 
important role to play than today. Such perspectives, however, go beyond the scope 
of the proposed Council Recommendation and are not addressed therein. 

33 

34 
35 

36 

World  Health  Organization.  Regional  Office  for  Europe. (2017). Action  plan  for  the  health  sector 
response to viral hepatitis in the WHO European Region. World Health Organization. Regional Office 
for Europe. 
Prevention of hepatitis B and C in the EU/EEA. Stockholm: ECDC; 2022. 
Regional  action  plans  for  ending  AIDS  and  the  epidemics  of  viral  hepatitis  and  sexually  transmitted 
infections 2022-2030 (2023). World Health Organization. Regional Office for Europe.  
https://cordis.europa.eu/project/id/101080486 

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Commission supportive actions 

The  proposed  Council  Recommendation  contains  recommendations  to  EU  Member 
States  to  boost  HPV  and  HBV  vaccination  uptake.  The  Commission  is  planning  to 
carry  out  a  series  of  actions 
the 
recommendations.  These  actions  will,  in  particular,  aim  to  support  EU  Member 
States  in  communicating  about  the  importance  of  HPV  and  HBV  vaccination  in  a 
cancer  prevention  perspective  and  better  monitoring  vaccination  uptake  to  inform 
public health interventions, but will also go beyond those areas. 

to  support  countries 

implementing 

in 

On communication, the Commission intends to develop a model for evidence-based 
awareness-raising  campaigns  on  the  importance  of  HPV  and  HBV  vaccination  as 
cancer  prevention  tools,  adaptable  to  national  challenges  and  needs  and  taking  into 
account  national  specificities, and with  the involvement of stakeholder associations 
at  European  level,  including  health  professionals’  associations,  and  national 
counterparts,  and  with  an  in-built  strategy  to  continue  monitoring  and  addressing 
mis- and disinformation specifically related to HPV infection and HPV vaccination, 
including on social media. It also intends to request the European Medicines Agency 
and  the  ECDC  to  communicate  regularly  on  the  outcomes  of  updated  reviews  and 
studies  on  the  safety  and  effectiveness  of  the  HPV  and  HBV  vaccines  in  order  to 
provide up-to-date information and address safety-driven acceptance issues faced in 
the EU, including through the European Vaccination Information Portal. 

On monitoring, the Commission intends to support EU Member States in developing 
or  upgrading  electronic  vaccination  registries  in  compliance  with  the  General  Data 
Protection Regulation, including by mapping national approaches across the EU and 
discussing  successful  ones  with  Member  States.  This  would  happen  without 
prejudice to the tasks of the national data protection authorities and in respect of any 
relevant  guidance  of  the  European  Data  Protection  Board.  The  Commission  also 
envisages  to  support  EU  Member  States  in  streamlining  their  procedures  for 
obtaining parental consent to vaccinate minors in respect of national legislation in the 
field,  including  by  sharing  and  discussing  national  approaches.  Moreover,  it  is  the 
Commission’s  intention  to  continue,  in  collaboration  with  the  ECDC,  to  develop 
state-of-the-art  guidance  to  EU  Member  States  in  terms  of  building  or  upgrading 
electronic  vaccination  registries  that  enable  the  availability  of  data  at  national  and 
subnational  level  and  to  which  data  recorded  by  different  vaccine  providers  can  be 
seamlessly  transferred,  in  order  to  improve  and  strengthen  the  monitoring  of 
vaccination coverage rates, including for HPV and HBV vaccination. By the end of 
2024, the Commission intends to request that the ECDC displays available national 
data  on  HPV  and  HBV  coverage  rates  in  EU  Member  States  in  a  dedicated 
dashboard together with national monitoring methodologies and goals and targets to 
be met. 

Going  beyond  communication  and  monitoring,  the  Commission  intends  to  support 
the development of modelling tools and analysis to estimate the cost-effectiveness of 
preventing cancers caused by HPV and HBV infection by vaccination, to support EU 
Member  States  in  their  decision-making  on  the  integration  of  these  types  of 
vaccination  in  their  national  immunisation  programmes  and  cancer  prevention 
programmes. The Commission also intends to further promote research, development 
and innovation in relation to HPV and HBV vaccines, including through the Horizon 
Europe  programme  and  its  successor  programmes.  And  it  envisages  to  further 
support  action  to  promote  HPV  and  HBV  vaccination  at  global  level,  including  in 
terms  of  identifying  behavioural  determinants  for  vaccine  uptake  and  addressing 

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obstacles to vaccination, working with international partners, such as the WHO, the 
Organisation  for  Economic  Cooperation  and  Development  (OECD)  and  the  United 
Nations  Children’s  Fund  (UNICEF).  Finally,  the  Commission,  in  line  with  its 
comprehensive approach to mental health37, and taking the EU Strategy on the Rights 
of the Child38 and the European Child Guarantee39 into account, intends to develop a 
prevention toolkit addressing the links between mental and physical health, including 
physical health linked to vaccination,  of children and thus making an impact in the 
most vulnerable and formative years of their lives. 

The  Commission  intends  to  implement  all  supportive  actions  in  close  cooperation 
with EU Member States. 

• 

Consistency with existing policy provisions in the policy area 

The proposed Council Recommendation complements other actions in the context of 
the  Cancer  Plan.  These  are  most  notably  the  European  Code  against  Cancer,  also 
calling for increased uptake of HPV vaccination, the EU Cancer Screening Scheme 
that  foresees  the  updating  of  recommendations  on  screening  and  new  guidelines 
together  with  quality  assurance  schemes  and 
the  recent  Council 
Recommendation  on  strengthening  prevention  through  early  detection:  a  new  EU 
approach on cancer screening40 and the European Cancer Inequalities Registry41. The 
initiative  also  complements  –and  in  relation  to  HPV  builds  directly  on–  the  joint 
action PartnERship to Contrast HPV (PERCH)42. As announced in the Cancer Plan, 
the  EU4Health  programme  and  other  EU  instruments  are  key  tools  to  provide 
support to EU Member States in their efforts to combat cancer. 

includes 

• 

Consistency with other Union policies 

Besides complementing other actions in the context of the Cancer Plan, the proposed 
Council  Recommendation  builds  on  and  amplifies  the  impact  of  the  actions 
implemented  based  on  the  above-mentioned  2018  Council  Recommendation  on 
strengthened  cooperation  against  vaccine-preventable  diseases,  including  those 
implemented by the European Joint Action on Vaccination43, which ran from 2018 to 
2022. The initiative also draws on vaccination-related actions under the EU4Health 
programme, including the ‘Overcoming Obstacles to Vaccination44’ project on how 
to  reduce obstacles to  vaccination  of physical,  practical  or  administrative  nature  by 

37 

38 

39 

40 

41 
42 
43 

44 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  a  comprehensive  approach  to 
mental health, COM(2023) 298 final, 7.6.2023. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions on an EU strategy on the rights of 
the child, COM(2021) 142 final, 24.3.2021. 
Council Recommendation (EU) 2021/1004 of 14 June 2021 establishing a European Child Guarantee 
(OJ L 223, 22.6.2021, p. 14. 
Council Recommendation of 9 December 2022 on strengthening prevention through early detection:  a 
new  EU  approach  on  cancer  screening  replacing  Council  Recommendation  2003/878/EC  (OJ  C  473, 
13.12.2022, p. 1). 
https://cancer-inequalities.jrc.ec.europa.eu/ 
https://www.projectperch.eu/ 
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/projects-
details/31061266/801495/3HP 
https://overcomingobstaclestovaccination.eu/en 

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2. 

• 

identifying  exemplary  practices  in  EU  Member  States  through  the  Commission’s 
Best Practice Portal45 and piloting those practices in interested countries. 

The  proposed  Council  Recommendation  also  complements  the  EU  Strategy  on  the 
Rights  of  the  Child46  and  the  European  Child  Guarantee47,  in  which  access  to 
vaccination  is  a  key  element  in  terms  of  ensuring  the  right  to  healthcare  for  all 
children. Furthermore, the initiative supports the protection of the health of children 
and  young  people  in  the  most  vulnerable  and  formative  years  of  their  lives,  as 
mentioned  in  the  Commission  Communication  on  a  comprehensive  approach  to 
mental  health48  that  calls  for  a  holistic  approach  to  health  in  general  and  mental 
health in particular, including access to preventive healthcare, such as vaccination. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

This  proposal  for  a  Council  Recommendation  is  based  on  Article 168(6)  of  the 
Treaty  on  the  Functioning  of  the  European  Union  (TFEU),  according  to  which  the 
Council,  on  a  proposal  from  the  Commission,  may  adopt  recommendations  for  the 
purposes set out in that Article to improve public health. According to Article 168(1) 
TFEU, EU  action  must complement national  policies and  must be directed towards 
improving  public  health,  preventing  physical  and  mental  illness  and  diseases,  and 
obviating sources of danger to physical and mental health. The aim of the proposed 
Council Recommendation is to support EU Member States in addressing the cancer 
risks  linked  to  HPV  and  HBV  infections  by  increasing  the  uptake  of  and  ensuring 
access to vaccination. 

• 

Subsidiarity (for non-exclusive competence) 

Vaccination  policies,  programmes  and  services  are  a  national  competence  and 
responsibility. Nevertheless, viral infections, including those causing cancers, do not 
respect borders, and all EU Member States face public health challenges in the field. 
There is therefore a clear added value in addressing vaccine-preventable cancers with 
a set of recommendations at EU level. 

• 

Proportionality 

This  proposal  for  a  Council  Recommendation  takes  into  account  that  EU  action, 
which  must,  as  set  out  in  Article 168  of  TFEU,  complement  national  policies 
(including  policies  on  vaccination),  must  be  directed  towards  protecting  public 
health. As mentioned above, the aim of the initiative is to support EU Member States 
in addressing the cancer risks linked to HPV and HBV infections by increasing the 
uptake  of  and  ensuring  access  to  vaccination.  The  proposal  fully  respects  that 
vaccination is a national competence and responsibility and does not go beyond what 
is needed to reach its objectives. 

45 
46 

47 

48 

https://webgate.ec.europa.eu/dyna/bp-portal/ 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions on an EU strategy on the rights of 
the child, COM/2021/142 final. 
Council Recommendation (EU) 2021/1004 of 14 June 2021 establishing a European Child Guarantee 
(OJ L 223, 22.6.2021, p. 14). 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  a  comprehensive  approach  to 
mental health, COM(2023) 298 final. 

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• 

Choice of instrument 

The  instrument  chosen  for  this  initiative,  namely  a  proposal  for  a  Council 
Recommendation,  fully  respects  the  principles  of  subsidiarity  and  proportionality, 
allowing EU Member States to adapt their approach to national needs. 

3. 

• 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

This proposal for a Council Recommendation is a new initiative. Therefore, ex-post 
evaluations/fitness checks of existing legislation have not been carried out. 

Stakeholder consultations 

Input  for  the  proposed  Council  Recommendation  was  gathered  through  a  call  for 
evidence  on  ‘Cancer  prevention  –  action  to  promote  vaccination  against  cancer-
causing viruses’49, which ran from 9 January 2023 to 6 February 2023. Out of a total 
of 367 responses received, 331 were valid. Of the 331 valid responses, 300 responses 
came from EU citizens. 

Input  was  also  gathered  through  targeted  consultations  of  key  stakeholder  groups 
other  than  EU  citizens,  such  as  EU  Member  State  representatives,  European  Non-
Governmental  Organisations  and  experts  participating  in  EU-funded  projects.  The 
targeted consultations were carried out from February 2023 to April 2023. As part of 
these  consultation  activities,  a  dedicated  Stakeholder  Webinar  on  the  initiative  was 
held on the Commission’s Health Policy Platform50 on 23 March 2023. 

300 responses were received from EU citizens. Out of these responses, 260 focused 
on  misperceptions  regarding  alleged  lack  of  safety  of  vaccination  in  general. 
However,  almost  all  responses  with  concerns  came  from  EU  citizens  from  one  EU 
Member  State  whose  population  size  accounts  for  only  around  1 %  of  the  EU 
population. In addition, the responses with concerns were similar, albeit not identical, 
and this suggests a coordinated campaign promoting a position that is not necessarily 
representative for EU citizens but reiterates the need to increase public confidence in 
vaccines, including by debunking false narratives. 

The key stakeholder groups other than EU citizens had a positive attitude towards the 
initiative.  Stakeholders  stressed  the  importance  of  integrating  HPV  and  HBV 
vaccination in national immunisation programmes. In addition, stakeholders stressed 
that  improved  monitoring  of  vaccination  coverage  rates  is  needed  to  better  inform 
public health action  aimed at  increasing  uptake.  Moreover, stakeholders  invited the 
Commission to coordinate EU Member States’ efforts to implement the General Data 
Protection Regulation in relation to the collection of vaccination data as the national 
approach creates issues in some countries. They also stressed that there could be an 
added value in coordinating vaccination and cancer registries, including to eventually 
increase  the  cost-efficiency  of  cancer  screening  programmes.  Stakeholders  also 
stressed  the  importance  of  increasing  public  confidence  in  vaccines,  including  by 
monitoring  and  addressing  mis-  and  disinformation,  and  of  ensuring  easy  access  to 

49 

50 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13529-Cancer-prevention-
action-to-promote-vaccination-against-cancer-causing-viruses_en 
https://health.ec.europa.eu/eu-health-policy/interest-groups/eu-health-policy-platform_en 

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vaccination,  including  by  providing  vaccination  free  of  charge  to  those  for  whom 
vaccination  is  recommended. Some stakeholders pointed to  issues in  relation  to the 
national  procedures  for  obtaining  parental  consent  to  vaccinate  minors,  having  a 
possible  negative  impact  on  the  uptake.  Some  stakeholders  also  mentioned  supply 
issues and stressed the importance of sufficient supply of vaccines. It was suggested 
that  the  Commission  could  facilitate  the  sharing  of  best  practices  to  increase 
vaccination uptake. 

Specifically on HPV vaccination, stakeholders suggested to: 1) offer vaccination free 
of charge as part of national immunisation programmes; 2) offer vaccination (also) in 
schools/educational settings; 3) carry out targeted catch-up campaigns and/or extend 
eligible  age  groups  in  the  wake  of  the  COVID-19  pandemic;  4)  increase  public 
knowledge on the cancer risks linked to HPV infection for both girls and boys and 
the  importance  of  HPV  vaccination  for  both  genders;  and  5)  de-sexualise 
communication  efforts,  promoting,  together  with  health  professionals  and/or  youth 
influencers, HPV vaccination as a cancer prevention tool in addition to being a tool 
to sexual/reproductive health. 

Stakeholders also invited the Commission to look into a possible reassessment of the 
marketing authorisation conditions of the HPV vaccines currently on the EU market 
in  view  of  allowing  for  a  one-dose  schedule,  as  this  could  reduce  costs  for  EU 
Member States  and  make vaccination  a one-step procedure, possibly  increasing  the 
uptake  among  disadvantaged  groups.  It  was  suggested  to  define  a  specific  goal  for 
the  percentage  of  the  EU  target  population  of  boys  that  should  be  vaccinated  by 
2030, parallel to the one for girls. 

Specifically on HBV, stakeholders suggested to: 1) offer vaccination free of charge 
to all eligible population groups, reaching out to groups at high risk and sometimes in 
disadvantaged  situations,  such  as  people  who  inject  drugs,  prison  populations,  men 
having  sex  with  men,  trans  gender  persons  and  migrants,  asylum  seekers  and 
refugees from countries  where HBV is endemic; and 2) carry out targeted catch-up 
campaigns  in  the  wake  of  the  COVID-19  pandemic.  Stakeholders  also  called  for 
studies to monitor progress towards the WHO hepatitis elimination targets, including 
those  related  to  childhood  vaccination  and  prevention  of  vertical  transmission  of 
HBV. 

The opinions put forward by stakeholders were analysed and taken into consideration 
in  the  initiative  to  the  extent  possible.  The  following  elements  were  considered 
particularly pertinent to reach its objectives: 

– 

– 

– 

– 

ensuring  easy  access  to  vaccination,  with  a particular  focus on  disadvantaged 
groups; 

increasing  public  confidence  in  vaccines,  including  by  monitoring  and 
addressing mis-and disinformation; 

improving  monitoring  of  vaccination  coverage  rates 
inform 
interventions,  including  by  solving  issues  experienced  by  some  EU  Member 
States  in  relation  to  the  collection  of  vaccination  data  in  the  context  of  the 
national  approach  to  the  implementation  of  provisions  of  the  General  Data 
Protection Regulation which can be further specified by EU Member States; 

to  better 

streamlining  parental  consent  procedures  to  vaccinate  minors  in  respect  of 
national legislation in the field; 

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– 

– 

– 

integrating  vaccination  in  cancer  prevention  programmes,  at  operational  level 
but also to provide integrated health communication on cancer prevention; 

coordinating vaccination and cancer registries, including to eventually increase 
the cost-efficiency of screening programmes; 

sharing of best practices. 

As regards a possible reassessment of the marketing authorisation conditions of the 
HPV  vaccines  currently  on  the  EU  market,  it  should  be  noted  that  a  one-dose 
schedule can be seen as more relevant in a situation of general vaccine shortage that 
is  not  the  case  within  the  EU.  Stakeholders’  call  for  studies  to  monitor  progress 
towards the WHO hepatitis elimination targets, including those related to  childhood 
vaccination  and  prevention  of  vertical  transmission  of  HBV,  was  taken  into 
consideration  to  the  extent  that  the  ECDC  is  already  supporting  countries  in  the 
monitoring of progress towards those targets. 

In  addition  to  the  consultation  activities  directly  linked  to  this  proposed  Council 
Recommendation,  the  public  consultation,  the  targeted  consultations  and  other 
consultation activities carried out in relation to the Cancer Plan51 informed it. Multi-
faceted  cancer  prevention  efforts  and  the  protection  of  children  and  young  people 
against  cancers  that  can  occur  later  in  life  were  priorities  for  those  who  provided 
input  to  those  consultation  activities.  Vaccination,  such  as  against  HPV  and  HBV, 
was also identified as a high priority. 

• 

Collection and use of expertise 

To prepare for this policy initiative, the Commission, in spring 2022, sent a formal 
request  to  the ECDC, working with  EMA  and the European Monitoring Centre  for 
Drugs  and  Drug  Addiction  (EMCDDA),  for  scientific  input  on  HPV  and  HBV, 
focusing  on  vaccination.  The  ECDC,  the  EMA  and  the  EMCDDA  were  consulted 
again  during  the  actual  preparation  of  the  proposal.  The  contributions  from  the 
ECDC, the EMA and the EMCDDA added to the scientific base of the initiative. 

• 

Impact assessment 

An  impact  assessment  was  not  carried  out  as  a  Council  Recommendation  implies 
non-binding measures  and will allow  EU Member States to adapt their approach to 
national needs. 

• 

• 

51 

Regulatory fitness and simplification 

Not applicable. 

Fundamental rights 

As  mentioned  above,  this  policy  initiative  complements  the  EU  Strategy  on  the 
Rights  of  the  Child  and  the  European  Child  Guarantee,  in  which  access  to 
vaccination  is  a  key  element  in  terms  of  ensuring  the  right  to  healthcare  for  all 
children. 

Commission Staff Working Document – Stakeholder Consultation – Synopsis Report – Accompanying 
the Communication from the Commission to the European Parliament and the Council on the Europe's 
Beating Cancer Plan, COM(2021) 44 final. 

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4. 

BUDGETARY IMPLICATIONS 

This policy initiative will not generate any budgetary impact for the Commission. 

5. 

• 

• 

• 

52 

53 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The  Commission  intends  to  invite  EU  Member  States  to  regularly  provide 
information  to  allow  to  monitor  the  implementation  of  the  recommendations 
contained  in  the  proposed  Council  Recommendation.  It  envisages  to  do  so  through 
the  Public  Health  Expert  Group  established  in  202252.  This  expert  group  has  a 
subgroup on vaccination and one on cancer. 

The recommendations to EU Member States are oriented towards the achievement of 
the 2030  goals  and targets  set  for HPV and HBV vaccination coverage  rates in  the 
Cancer Plan and by the WHO53 respectively. 

The Commission intends to monitor progress towards the HPV and HBV vaccination 
coverage rates by requesting, by the end of 2024, that the ECDC displays available 
national data on HPV and HBV vaccination coverage rates in EU Member States in a 
dedicated dashboard together with national monitoring methodologies and goals and 
targets  to  be  met.  Progress  indicators  would  relate  to  vaccination  coverage  rates  in 
countries.  The  level  of  completeness  of  the  data  displayed  by  the  ECDC  would 
depend  on  the  monitoring  and  reporting  of  vaccination  coverage  rates  by  EU 
Member  States.  It  may  improve  as  national  monitoring  systems  are  strengthened 
through the implementation of related individual recommendations in the initiative. 

The  reporting  on  the  implementation  of  recommendations  to  EU  Member  States 
would  happen  through  updates  to  EU  Member  States  in  the  Public  Health  Expert 
Group after 4 years and again in 2030. 

The reporting and monitoring is envisaged to continue until 2030. 

Explanatory documents (for directives) 

Not applicable. 

Detailed explanation of the specific provisions of the proposal 

Not applicable. 

Commission Decision of 7 December 2022 setting up a Commission expert group on public health and 
repealing  Commission  Decision  setting  up  a  Commission  expert  group  ‘Steering  Group  on  Health 
Promotion, Disease Prevention and Management of Non-Communicable Diseases’, C(2022) 8816 final. 
The  targets  set  by  WHO  for  HBV  also  include  the  target  of  95 %  of  pregnant  women  screened  for 
HBsAg. This target is also considered for the purposes of implementation and monitoring in the context 
of the proposed Council Recommendation. 

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2024/0024 (NLE) 

Proposal for a 

COUNCIL RECOMMENDATION 

on vaccine-preventable cancers 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(6) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

Under Article 168 of the Treaty on the Functioning of the European Union (TFEU), a 
high  level  of  human  health  protection  is  to  be  ensured  in  the  definition  and 
implementation  of  all  Union  policies  and  activities.  Union  action,  which  is  to 
complement  national  policies,  is  to  be  directed  towards  improving  public  health, 
preventing physical and mental illnesses and diseases, and obviating sources of danger 
to physical and mental health, including cancer. 

Vaccination policies, programmes and services are the competence and responsibility 
of Member States. However, the Commission supports and coordinates national efforts 
due  to  the  cross-border  nature  of  vaccine-preventable  diseases.  It  does  this,  amongst 
others,  through  communication  efforts  such  as  setting  up  the  European  Vaccination 
Information Portal, where people can find reliable information about vaccination and 
vaccines,  and  developing  information  and  awareness-raising  campaigns,  such  as  the 
ongoing #UnitedInProtection campaign, which is adaptable to national challenges and 
needs. 

Some types of cancers, namely cancers caused by Human papillomaviruses (HPV) and 
Hepatitis B virus (HBV), can be prevented by vaccination. Vaccination remains one of 
the most powerful and efficient public health measures at Member States’ disposal. 
In  Europe’s  2021  Beating  Cancer  Plan1  (the  Cancer  Plan),  the  Commission  put 
forward the objective to fully vaccinate at least 90 % of the Union target population of 
girls against HPV and significantly increase the vaccination of boys against HPV by 
2030.  In  addition,  the  Commission  announced  that  it  would  help  ensure  access  to 
vaccination against HBV in order to increase vaccination uptake. 

Some  Member  States  have  centralised,  population-based  Immunisation  Information 
Systems  in  place to  monitor vaccination  coverage rates in  their country,  including  at 
subnational  level.  However,  monitoring  is  fragmented  in  other  Member  States,  and 
some  of  the  countries  report  issues  in  collecting  vaccination  data  as  part  of  the 
monitoring  of  vaccination  programmes  in  the  context  of  the  national  approach  to 

1 

Communication  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  Europe's 
Beating Cancer Plan, COM(2021) 44 final, 3.2.2021. 

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(6) 

(7) 

(8) 

(9) 

implementing  Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the 
Council2, the Union’s General Data Protection Regulation. 

Some Member States have encountered issues in relation to the national procedures for 
obtaining parental consent to vaccinate minors, having a possible negative impact on 
the uptake. 

Any  processing  of  personal  data  by  Member  States  for  vaccination  purposes  should 
comply  with  EU  data  protection  law,  in  particular  the  General  Data  Protection 
Regulation,  with  a  focus  on  the  provisions  governing  the  processing  of  special 
categories  of  personal  data  within  the  meaning  of  Article  9  of  the  General  Data 
Protection Regulation. These provisions can be further specified by Member States. 

It  is  envisaged  to  give  Union  support  to  Member  States  to  develop  or  upgrade 
electronic  vaccination  registries  in  line  with  the General  Data  Protection  Regulation, 
without prejudice to the tasks of the national data protection authorities and in respect 
of  any  relevant  guidance  of  the  European  Data  Protection  Board,  as  well  as  to 
streamline parental consent  procedures, in  respect  of national  legislation in  the field. 
This would, amongst others, happen by mapping national approaches across the Union 
and discussing successful ones with Member States. 

HPV infection can lead to cervical cancer in women. In the  Union and the European 
Economic  Area  (EEA),  there  are  around  28 600  cases  of  and  13 700  deaths  from 
cervical  cancer  every  year3.  Infection  with  HPV  can  also  lead  to  other  anogenital 
cancers in both women and men (vulvar, vaginal, penile and anal cancers) as well as 
head-and-neck cancers, such as oropharyngeal cancers, of which there were around 19 
700 cases in the Union and the EEA in 2022, mostly (around 15 000) in men4.  

(10)  While risk-based screening in line with the Council Recommendation on strengthening 
prevention through early detection: a new EU approach on cancer screening5 can help 
prevent  cervical  cancer in women, no high-quality  screening  programme  is  currently 
available in all Member States and EEA countries for women to prevent other cancers 
caused by HPV infection. And so far, there is no organised screening for such cancers 
available for men. 

(11)  Vaccination  against  HPV  as  part  of  national  immunisation  programmes  provides  a 

benefit in preventing cancers in both women and men. 

(12)  All  Member  States  recommend  vaccination  of  adolescent  and  preadolescent  girls 
against HPV. Many Member States also recommend it for boys of those age groups, 
some of the countries extending recommendations to also cover, via targeted catch-up 
campaigns,  young  adults  who  did  not  get  vaccinated  or  fully  vaccinated  during 
adolescence or preadolescence. 

(13)  Data for vaccination uptake show that whereas a few Member States have vaccinated 
more than 90 % of adolescent or preadolescent girls with one out of the two doses that 

2 

3 

4 
5 

Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27 April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1). 
ECIS  - European Cancer Information System, accessed on  27/10/2023. EU/EEA figures computed as 
the sum of values for EU-27, Norway, and Iceland. 
Ibid. 
Council Recommendation of 9 December 2022 on strengthening prevention through early detection:  a 
new  EU  approach  on  cancer  screening  replacing  Council  Recommendation  2003/878/EC  (OJ  C  473, 
13.12.2022, p. 1). 

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are  needed  for  those  age  groups6  this  figure  remains  low,  below  50 %,  in  other 
Member  States7.  Only  limited  data  are  currently  available  for  vaccination  uptake  in 
boys as well as in young adults. 

(14)  Public  confidence  in  HPV  vaccines  is  falling  across  the  Union,  in  particular  among 
young  people.  Although  confidence  among  health  professionals  in  these  vaccines  is 
overall high, it varies between Member States8. 

(15)  Confidence  issues  in  relation  to  HPV  vaccination  should  be  tackled  by  addressing 
persistent safety concerns as well as low perceived risk of getting cancer due to HPV 
infection.  The  underestimation  of  the  importance  of  HPV  vaccination  as  a  cancer 
prevention tool, in particular among boys and their parents, should also be addressed 
by  continuing  communication  efforts  and  by  monitoring  and  addressing  mis-  and 
disinformation related to HPV infection and HPV vaccination. 

(16)  Access  issues  in  relation  to  HPV  vaccination  should  be  addressed  by  offering  free 
vaccination in schools and educational settings, and through targeted efforts, including 
by  working  with  health  professionals,  local  associations  and  trusted  individuals  at 
community level,  to  address  structural  barriers and increase HPV vaccination uptake 
among  adolescent  and  preadolescent  girls  and  boys  belonging  to  disadvantaged 
groups,  such  as  migrants,  asylum  seekers  and  refugees,  displaced  persons  from 
Ukraine, Roma, persons with disabilities and lesbian, gay, bisexual, trans, intersex and 
queer (LGBTIQ) people. 
In  2022,  the  joint  action  PartnERship  to  Contrast  HPV  (PERCH)9,  was  launched, 
bringing together European countries to fight cancers caused by HPV infection from a 
wide range of perspectives. 

(17) 

(18)  A coordinated approach to HPV-related cancer prevention across the Union, building 
on the goal put forward in the Cancer Plan as well as the work carried out by the joint 
action  PartnERship  to  Contrast  HPV  (PERCH),  and  taking  into  account  Member 
States’  individual  situations  in  terms  of  cancer  burden  from  HPV  infection,  could 
boost  national  efforts  in  the  field.  Defining  a  specific  goal  for  the  percentage  of  the 
Union target  population  of boys that should be vaccinated by 2030  for public health 
and gender equality reasons could help in this respect. 

(19) 

Infection  with  HBV  can  become  chronic  and  develop  into  chronic  liver  disease, 
cirrhosis  and  liver  cancer.  For  2021,  30  Member  States  and  EEA  countries  reported 
16 187 newly diagnosed HBV infections, a large share of those, 43 %, being classified 
as chronic10. Despite a steady decline in the overall incidence of HBV over time due to 
effective vaccination programmes and other prevention strategies, it is estimated that 

6 
7

8 

9 
10 

Three doses are needed for older young people. 

https://immunizationdata.who.int/pages/coverage/hpv.html?CODE=EUR&ANTIGEN=PRHP

V1_F&YEAR=&ADVANCED_GROUPINGS=EURO  
A. de Figueiredo, R.L. Eagan, G. Hendrickx, E. Karafillakis, P. van Damme and H.J. Larson, ‘State of 
Vaccine Confidence in the European Union 2022’, Luxembourg: Publications Office of the European 
Union; 2022. 
https://www.projectperch.eu/ 
Hepatitis B. In: ECDC. Annual epidemiological report for 2021. Stockholm: ECDC; 2022. 

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approximately 3.6 million people in Member States and EEA countries are living with 
a chronic HBV infection11. 

(20)  The burden of infections with HBV in Member States and EEA countries is higher in 
some  population  groups,  including  migrants,  asylum  seekers  and  refugees  from 
countries  with  a  high  HBV  endemicity,  prison  populations,  people  who  inject  drugs 
and  men  having  sex  with  men,  than  in  the  general  population.  Heterosexual 
intercourse,  however,  remains  a  common  route  of  HBV  transmission  in  Europe,  and 
even  if  vertical  transmission  is  now  uncommon  in  this  part  of  the  world,  prevention 
strategies  are  needed  as  most  infants  who  are  infected  perinatally  will  become 
chronically infected12. 

(21)  Vaccination  against  HBV  as  part  of  national  immunisation  programmes  is  key  to 
prevent disease caused by chronic infection with HBV, including liver cancer. 

(22)  Most  Member  States  recommend  vaccinating  all  children  against  HBV.  They  also 
have  various  strategies  to  prevent  mother-to-child  (vertical)  transmission,  including 
vaccination of infants with the first HBV vaccine dose within 24 hours from birth (also 
known as ‘birth  dose’),  screening  of pregnant  women for hepatitis  B surface  antigen 
(HBsAg)  and  post-exposure  prophylaxis  targeted  at  infants  born  to  HBV-infected 
mothers. 

(23)  Many Member States have HBV vaccination recommendations for groups at high risk 
and  sometimes  in  disadvantaged  situations,  such  as  people  who  inject  drugs,  prison 
populations,  men  having  sex  with  men,  trans  gender  persons  and  migrants,  asylum 
seekers and refugees from countries with a high HBV endemicity, as well as for health 
professionals. However, data gaps exist in relation to vaccination uptake. 

(24) 

In 2017, the WHO, in the Action plan for the health sector response to viral hepatitis 
in the WHO European Region, put forward the goal of eliminating hepatitis as a public 
health threat in its European Region by 203013. 

(25)  Specifically on vaccination, the WHO set interim targets for 2020 of 1) 95 % coverage 
with  three  doses  of  HBV  vaccine  in  countries  that  implement  universal  childhood 
vaccination, and 2) 90 % coverage with interventions to prevent vertical transmission 
(HBV birth-dose vaccination or other approaches)14.  

(26) 

In 2022, the WHO updated the regional Action plan and set 2030 targets of 1) 95 % 
vaccination  coverage  (3rd  dose)  of  childhood  HBV  vaccination,  2)  95 %  of  pregnant 
women screened for HBsAg, and 3) 95 % of newborns who received timely (within 24 
hours of birth) HBV birth-dose vaccination15. 

(27)  The  ECDC  supports  the  monitoring  of  Member  States’  progress  towards  WHO 
hepatitis  elimination  targets,  including  those  related  to  childhood  vaccination  and 
prevention of vertical transmission of HBV. Data from 2021 show, despite gaps, that 

11 

12 
13 

14 
15 

European Centre for Disease Prevention and Control, ‘Prevention of hepatitis B and C in the EU/EEA’, 
Stockholm: ECDC; 2022. 
Ibid. 
World  Health  Organization.  Regional  Office  for  Europe. (2017). Action  plan  for  the  health  sector 
response to viral hepatitis in the WHO European Region. World Health Organization. Regional Office 
for Europe. 
Ibid. 
Regional  action  plans  for  ending  AIDS  and  the  epidemics  of  viral  hepatitis  and  sexually  transmitted 
infections 2022-2030 (2023). World Health Organization. Regional Office for Europe. 

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coverage rates in many Member States must still be improved to reach even the 2020 
interim targets16. For the 2030 targets, the challenge is not less important. 

(28)  Public  confidence  issues  in  relation  to  HBV  vaccination  should  be  addressed  by 
improving health literacy among groups at high risk and sometimes in disadvantaged 
situations, such as people who inject drugs, prison populations, men having sex with 
men, trans gender persons and migrants, asylum seekers and refugees from countries 
where HBV is  endemic,  as well as  health professionals,  and by advocating for HBV 
vaccination as a cancer prevention tool. 

(29)  Access  issues  in  relation  to  HBV  vaccination  should  be  addressed  through  targeted 
efforts  to  understand  structural  barriers  and  by  offering  vaccination  in  local  settings 
adjusted  to  target  groups  in  line  with  their  risk  profile  and  situation,  for  example  by 
making use of mobile units, offering vaccination during other healthcare events, such 
as medical check-ups, and ensuring that vaccination is provided free of charge. 

(30)  Special attention should be paid to older persons and people living in remote areas as 
well  as  to  people  who  inject  drugs,  making  HBV  vaccination  routine  in  drug 
treatment,  prison  and  harm-reduction  services,  in  a  stigma-free  environment,  on  a 
voluntary basis, without costs for the person being vaccinated, and with the possibility 
for accessing an accelerated dosing schedule. 

(31) 

In  the  extended  mandate  given  to  the  European  Centre  for  Disease  Prevention  and 
Control (ECDC) under the European Health Union17, the ECDC is tasked to monitor 
the  level  of  vaccination  coverage  in  Member  States  based  on  reliable  data  available 
from countries. 

(32)  By  the  end  of  2024,  the  Commission  intends  to  request  ECDC  to  display  available 
national  data  on  HPV  and  HBV  coverage  rates  in  Member  States  in  a  dedicated 
dashboard together with national monitoring methodologies and goals and targets18 to 
be met. 

(33)  There  is  a  need  to  better  integrate  HPV  and  HBV  vaccination  in  cancer  prevention 
programmes, at operational level but also to provide integrated health communication 
on cancer prevention, promoting vaccination as a cancer prevention tool in addition to 
being  a  tool  to  sexual/reproductive  health.  There  is  also  a  need  to  coordinate 
vaccination  and  cancer  registries  to  measure  the  overall  impact  of  vaccination  and 
cancer  prevention  programmes,  including  in  view  of  eventually  increasing  the  cost-
efficiency  of  screening  programmes.  As  the  aim  is  to  increase  vaccination  coverage 
rates  among  children  and  young  people,  particular  attention  should  be  paid  to  the 
effect and role of social media and digital platforms. 

(34)  The  Commission  intends  to  develop  a  model  for  evidence-based  awareness-raising 
campaigns  on  the  importance  of  HPV  and  HBV  vaccination  as  cancer  prevention 
tools,  adaptable  to  national  challenges  and  needs,  and  with  the  involvement  of 
including  health  professionals’ 
stakeholder  associations  at  European 
associations,  and  national  counterparts,  and  with  an  in-built  strategy  to  continue 

level, 

16 
17 

18 

Prevention of hepatitis B and C in the EU/EEA. Stockholm: ECDC; 2022. 
Regulation  (EU)  2022/2370  of  the  European  Parliament  and  of  the  Council  of  23 November  2022 
amending  Regulation  (EC)  No 851/2004  establishing  a  European  centre  for  disease  prevention  and 
control (OJ L 314, 6.12.2022, p. 1).. 
The  targets  set  by  WHO  for  HBV  also  include  the  target  of  95 %  of  pregnant  women  screened  for 
HBsAg. This target is also considered for the purposes of implementation and monitoring in the context 
of the proposed Council Recommendation. 

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monitoring  and  addressing  mis-  and  disinformation  specifically  related  to  HPV 
infection  and  HPV  vaccination,  including  on  social  media,  at  Union  level. 
Nevertheless,  communication  campaigns  need 
into  account  national 
specificities of the Member States. 

take 

to 

(35)  The Commission envisages to request the European Medicines Agency and the ECDC 
to  communicate  regularly  on  the  outcomes  of  updated  reviews  and  studies  on  the 
safety and effectiveness of the HPV and HBV vaccines in order to provide up-to-date 
information  and  address  safety-driven  acceptance  issues  faced  in  the  EU,  including 
through the European Vaccination Information Portal. 
In line with its comprehensive approach to mental health19, and taking the EU Strategy 
on  the  Rights  of  the  Child20  and  the  European  Child  Guarantee21  into  account,  the 
Commission  intends  to  develop  a  prevention  toolkit  addressing  the  links  between 
mental and physical health, including physical health linked to vaccination, in children 
and thus making an impact in the most vulnerable and formative years of their lives. 

(36) 

(37)  Union  citizens’  access  to  their  vaccination  data  should  be  further  facilitated.  This 
would empower them to better follow their vaccination history and make decisions on 
vaccination.  The  exchange  of  such  data  for  continuity  of  care  purposes  across  the 
Union should also be further facilitated. 

(38)  The  Commission  and  the  World  Health  Organization  (WHO)  have  entered  a 
partnership  to  develop  the  WHO  Global  Digital  Health  Certification  Network  that 
takes up the EU Digital COVID Certificate technology. This technology may be used 
in other cases, such as routine immunisation records in view of delivering better health 
for Union citizens. 

(39)  Continued  use  by  Member  States  of  funding  opportunities  from  the  Union’s  budget, 
including the European Regional Development Fund, the European Social Fund+ and 
the  EU4Health  Programme,  in  accordance  with  each  instrument’s  focus  and  legal 
basis, 
including 
implement  HPV  and  HBV  vaccination  programmes, 
communication activities to promote them, could reduce health inequalities linked to 
access to and availability of vaccination. 

to 

(40)  The Commission intends to support the development of modelling tools and analysis 
to  estimate  the  cost-effectiveness  of  preventing  cancers  caused  by  HPV  and  HBV 
infection by vaccination, to support EU Member States in their decision-making on the 
integration  of  these  types  of  vaccination  in  their  national  immunisation  programmes 
and  cancer  prevention  programmes.  The  Commission  also  intends  to  promote 
research, development and innovation in relation to HPV and HBV vaccines at Union 
its  successor 
level, 
programmes. 

the  Horizon  Europe  programme  and 

including 

through 

(41) 

It is envisaged to further promote Union action to increase HPV and HBV vaccination 
at global level, including in terms of identifying behavioural determinants for vaccine 

19 

20 

21 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  a  comprehensive  approach  to 
mental health, COM(2023) 298 final, 7.6.2023. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions on an EU strategy on the rights of 
the child, COM(2021) 142 final, 24.3.2021. 
Council Recommendation (EU) 2021/1004 of 14 June 2021 establishing a European Child Guarantee 
(OJ L 223, 22.6.2021, p. 14). 

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uptake and addressing obstacles to vaccination, by working with international partners, 
such  as  the  WHO,  the  Organisation  for  Economic  Cooperation  and  Development 
(OECD) and the United Nations Children’s Fund (UNICEF). 

(42)  The Commission intends to invite Member States to regularly provide information to 
allow  to  monitor  the  implementation  of  the  recommendations  contained  in  this 
Council Recommendation through the Public Health Expert Group and to report on the 
implementation of recommendations to Member States through updates in the Public 
Health Expert Group after 4 years and again in 2030. 

HEREBY RECOMMENDS THAT MEMBER STATES: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

22 

23 

Introduce  or  strengthen  the  implementation  of  HPV  and  HBV  vaccination 
programmes 
immunisation 
to  boost  cancer  prevention  as  part  of  national 
programmes,  including  by  providing  vaccination  free  of  charge  and/or  fully 
reimbursing  related  costs  for  those  for  whom  vaccination  is  recommended,  and  by 
ensuring accessibility for groups at high risk and/or in disadvantaged situations. 

Strengthen  the  integration  of  HPV  and  HBV  vaccination  in  cancer  prevention 
programmes,  at  operational 
integrated  health 
level  but  also 
communication on cancer prevention. 

to  provide 

In respect of the Union’s data protection law, establish or strengthen links between 
vaccination  and  cancer  registries  to  measure  the  overall  impact  of  vaccination  and 
cancer prevention programmes, including in view of  eventually increasing the cost-
efficiency of cancer screening programmes. 

Develop  actions  to  increase  the  uptake  of  HPV  and  HBV  vaccination  in  a  cancer 
prevention perspective,  namely by facilitating the identification and transfer of best 
or promising practices to increase vaccination uptake, including in the context of the 
Public Health Expert Group, established in 202222, and its subgroups on vaccination 
and  cancer,  and  through  targeted  calls  for  practices  on  the  Commission’s  Best 
Practice Portal23. 

In compliance with the General Data Protection Regulation, improve the monitoring 
of vaccination coverage rates, including for HPV and HBV vaccination, by building 
or  upgrading  population-based  electronic  vaccination  registries  that  enable  the 
availability of data at national level and subnational level and to which data recorded 
by  different  vaccine  providers  can  be  seamlessly  transferred,  to  inform  efficient, 
data-driven public health action. 

Streamline national procedures for obtaining parental consent to vaccinate minors in 
respect  of  national  legislation  in  the  field,  including  by  sharing  and  discussing 
national approaches, to facilitate the uptake.  

Actively  participate  in  efforts  to  further  facilitate  Union  citizens’  access  to  their 
vaccination  data,  empowering  them  to  follow  their  vaccination  history  and  make 
decisions on vaccination, as well as to further facilitate the exchange of such data for 
continuity of care purposes across the Union.  

Commission Decision C(2022) 8816 final of 7 December 2022 setting up a Commission expert group 
on public health and repealing Commission Decision setting up a Commission expert group ‘Steering 
Group  on  Health  Promotion,  Disease  Prevention  and  Management  of  Non-Communicable  Diseases’ 
(OJ C 471, 12.12.2022, p. 8). 
https://webgate.ec.europa.eu/dyna/bp-portal/ 

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8. 

9. 

10. 

11. 

12. 

13. 

14. 

Actively  participate  in  efforts  to  further  develop  the  WHO  Global  Digital  Health 
Certification  Network,  including  its  potential  use  for  routine  immunisation  records 
that could support Union citizens for health purposes. 

Make  full  use  of  funding  opportunities  from  the  Union  budget,  including  the 
European  Regional  Development  Fund,  the  European  Social  Fund+  and  the 
EU4Health Programme, in accordance with each instrument’s focus and legal basis, 
to  implement  HPV  and  HBV  vaccination  programmes,  including  communication 
activities  to  promote  them,  to  reduce  health  inequalities  linked  to  access  to  and 
availability of vaccination. 

Specifically for HPV vaccination,  strengthen national  efforts  to reach, by 2030,  the 
objective set  in  the Cancer Plan of  fully  vaccinating  at  least  90 % of the  EU target 
population of girls and significantly increasing the vaccination of boys, including by 
offering  vaccination  to  adolescent  and  preadolescent  girls  and  boys  in  schools  and 
educational  settings,  addressing  structural  barriers 
to 
disadvantaged  groups,  such  as  migrants,  asylum  seekers  and  refugees,  displaced 
persons  from  Ukraine,  Roma,  persons  with  disabilities  and  LGBTIQ  people,  and 
extending  recommendations  to  also  cover,  via  targeted  catch-up  campaigns,  young 
adults  who  did  not  get  vaccinated  or  fully  vaccinated  during  adolescence  or 
preadolescence. 

those  belonging 

for 

Enhance targeted communication and outreach efforts, by working with stakeholder 
associations,  including  health  professionals’  associations,  the  education  sector  and 
trusted partners at community level, to increase HPV vaccination uptake among  the 
target  populations  specified  in  Recommendation  10,  while  ensuring  monitoring  of 
the uptake in a central data repository at national level.  

Building  on  the  work  carried  out  by  the  joint  action  PartnERship  to  Contrast  HPV 
(PERCH),  develop  and  implement  coordinated  efforts  for  HPV-related  cancer 
prevention,  taking  into  account  the  specific  situation  in  Member  States  in  terms  of 
cancer  burden  from  HPV  infections,  as  well  as  the  status  of  vaccination  and 
screening  programmes,  and,  as  part  of  such  coordinated  efforts,  define  a  concrete 
goal for the percentage of the EU target population of boys that should be vaccinated 
by 2030. 

Specifically  for  HBV,  strengthen  national  efforts  to  reach  the  2030  targets  set  by 
WHO of 1) 95 % vaccination coverage (3rd dose) of childhood HBV vaccination, 2) 
95 %  of  pregnant  women  screened  for  HBsAg,  and  3)  95 %  of  newborns  who 
received timely (within 24 hours of birth) HBV birth-dose vaccination, including by 
strengthening  systems  for  the  monitoring  of  progress  towards  those  targets  and  by 
making use of available support from ECDC if needed. 

Facilitate childhood vaccination and prevention of vertical transmission of HBV, and 
adapt  vaccination  services  to  the  needs  of  different  target  groups,  including  by 
offering  vaccination  in  local  settings  and  by  continuing  targeted  efforts  to  increase 
the uptake in groups at high risk and sometimes in disadvantaged situations, such as 
people who inject drugs, prison populations, men having sex with men, trans gender 
persons  and  migrants,  asylum  seekers  and  refugees  from  countries  where  HBV  is 
endemic, as well as health professionals, while ensuring monitoring of the uptake in 
a central data repository at national level. 

15. 

Pay special attention to people who inject drugs, making HBV vaccination routine in 
drug treatment, prison and harm-reduction services, in a stigma-free environment, on 

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a voluntary basis, without costs for the person being vaccinated, with the possibility 
for accessing an accelerated dosing schedule. 

16. 

Regularly provide information to the Commission to allow to monitor and report on 
the 
this  Council 
the 
Recommendation through the Public Health Expert Group. 

recommendations  contained 

implementation  of 

in 

Done at Brussels, 

For the Council 
The President 

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