(1)

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.

(2)

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.

(3)

Some types of precancerous conditions and 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.

(4)

In Europe’s 2021 Beating Cancer Plan (2) (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.

(5)

Some Member States have 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 implementing Regulation (EU) 2016/679 (3), the Union’s General Data Protection Regulation.

(6)

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

(7)

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. This provision allows Member States to maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health.

(8)

It is envisaged to give Union support to Member States to develop or upgrade electronic vaccination registries or equivalents 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 optimise procedures for parental or legal guardian consent, 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.

(9)

HPV infection can lead to precancerous conditions of the cervix and 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 year (4). 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 men (5). This emphasises the importance and need of vaccinating all adolescent and preadolescent girls and boys against HPV and of enabling equitable access to vaccination to reach high vaccination coverage rates not only in girls, but also in boys.

(10)

Risk-based screening in line with the Council Recommendation on strengthening prevention through early detection: a new EU approach on cancer screening (6) can help prevent cervical cancer in women. However, no organised population-based or targeted screening programme is currently recommended in 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 recommended for men. Furthermore, secondary prevention programmes can be an important contribution to reducing HPV-related cancer burden, especially in at-risk population groups.

(11)

Vaccination against HPV within national immunisation programmes is crucial for cancer prevention in both women and men but also ensuring access beyond this framework is essential for broader coverage and protection.

(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 are needed for those age groups (7) this figure remains low, below 50 %, in other Member States (8). 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 States (9).

(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 or legal guardians, 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 through low-threshold vaccination offers and education. This could involve free vaccination, for example, in schools and educational settings, a structured invitation and reminder system and 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 persons with disabilities, people experiencing homelessness, migrants, asylum seekers and refugees, displaced persons from Ukraine, Roma, people with high risk sexual behaviour (e.g. sex workers) and LGBTI (10) persons.

(17)

In 2022, the joint action PartnERship to Contrast HPV (PERCH) (11), was launched, bringing together European countries to fight cancers caused by HPV infection from a wide range of perspectives.

(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 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 chronic (12). 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 Member States and EEA countries are living with a chronic HBV infection (13).

(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 with high risk sexual behaviour (e.g. sex workers), people who inject drugs and men who have 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 infected (14).

(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, people with high risk sexual behaviour (e.g. sex workers), men who have 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 2030 (15).

(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) (16).

(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 vaccination (17).

(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 coverage rates in many Member States must still be improved to reach even the 2020 interim targets (18). 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, people with high risk sexual behaviour (e.g. sex workers), men who have 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, or 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 and people experiencing homelessness, 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 Union (19), the ECDC is tasked to monitor the level of vaccination coverage in Member States based on reliable data available from countries.

(32)

The Council takes note that, 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 targets (20) to be met. Coordination with relevant international bodies should be encouraged and double reporting should be avoided.

(33)

There is a need to better integrate HPV and HBV vaccination in 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, screening and cancer registries or equivalents 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 Council takes note that 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 stakeholder associations at European level, including health professionals’ associations, scientific partners 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, at Union level. Nevertheless, communication campaigns need to take into account national specificities of the Member States.

(35)

The Council takes note that 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.

(36)

The Council takes note that, in line with its comprehensive approach to mental health (21), and taking the EU Strategy on the Rights of the Child (22) and the European Child Guarantee (23) into account, the Commission intends to develop a prevention toolkit addressing the links between mental and physical health in children, including physical health linked to vaccination, and thus making an impact in the most vulnerable and formative years of their lives.

(37)

Vaccination data should also be provided in digital, structured and reusable form and Union citizens’ access to their vaccination data should be further facilitated via existing initiatives and taking into account emerging infrastructures. 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, to implement HPV and HBV vaccination programmes, including communication activities to promote them, could reduce health inequalities and health inequities linked to access to and availability of vaccination.

(40)

The Council takes note that the Commission intends to support the development of modelling tools and analysis in order 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 prevention programmes, especially for cancer. The Commission also intends to promote research, development and innovation in relation to HPV and HBV vaccines at Union level, including through the Horizon Europe programme and its successor programmes.

(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 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 Council takes note that the Commission intends to invite Member States to regularly provide information (using, unless otherwise justified, existing data, indicators and submission dates, including those used for international organisations) 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.