Brussels, 26.4.2018
COM(2018) 244 final
2018/0115 (NLE)
Proposal for a
COUNCIL RECOMMENDATION
on Strengthened Cooperation against Vaccine Preventable Diseases
{SWD(2018) 149 final}
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EXPLANATORY MEMORANDUM
- CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Vaccination is one of the greatest successes of medicine. Vaccination saves lives,
protects our societies, reduces illness and contributes to longer life expectancy.
Before vaccines existed, many children would die young, or become crippled for life.
Vaccination has led to the eradication of smallpox, near elimination of polio and has
prevented countless deaths from many other diseases such as measles, diphtheria and
meningitis.
Worldwide, every year, vaccination prevents 2.7 million people from contracting
measles, 2 million from getting neonatal tetanus, and 1 million from getting
pertussis. In Europe, seasonal influenza vaccination prevents around 2 million people
from getting influenza each year.
And yet, as mentioned in the President Juncker State of the Union speech of 13
September 2017, today, in the European Union, children are still dying from diseases
such as measles that can easily be prevented with vaccines. This is unacceptable.
Vaccination programmes have become increasingly fragile; in the face of low uptake
of vaccines, vaccine hesitancy, the increasing cost of new vaccines and shortages in
vaccine production and supply in Europe.
This proposal is a call for joint action to increase vaccination coverage and to ensure
that everybody in the European Union has access to vaccination bridging inequalities
and gaps in immunisation. The genuine questions and doubts surrounding
vaccination, expressed by citizens throughout Europe, signal the urgent need for
Member States and the health community to recognise and respond accordingly. This
proposal is a concerted effort to respond to such concerns.
Several EU Member States and neighbouring countries are currently facing
unprecedented outbreaks of vaccine-preventable diseases, due to insufficient
vaccination coverage. In 2017 alone, in the EU, over 14,000 people contracted
measles – more than three times the number reported in 2016. In the past two years,
50 persons died due to measles and two due to diphtheria. Europe is failing to
eliminate measles in line with agreed WHO targets.
The risk of poliovirus reintroduction in the EU persists, putting the Union’s polio-free
status at risk. Seasonal influenza vaccination coverage rates remain significantly
below the 75% coverage target for older age groups set out by the 2009 Council
Recommendation on seasonal influenza vaccination. In fact, seasonal influenza
vaccination coverage in older age groups has decreased in the past few years in the
majority of EU Member States.
While national vaccination programmes are planned, organised, and conducted
differently across Member States, all EU countries are grappling with these common
challenges: declining coverage, supply shortages and growing vaccine hesitancy.
There are several drivers contributing to low levels of vaccine coverage and
preventable immunisation gaps:
Vaccine hesitancy and waning confidence. Misconceptions about vaccination have
shifted the public focus away from the benefits of vaccination, towards a distrust in
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science and fear of possible side effects. There are a number of factors at play in this
increased reticence: a lack of reliable information and, in some cases, distrust in the
providers of available information; a lower acceptance of any potential risks
associated with vaccines administered to healthy persons (in particular children); a
lack of understanding on the individual versus community benefits of vaccination;
and media controversies on vaccine safety fuelled by misinformation. As vaccinepreventable diseases have decreased thanks to routine vaccination in the past,
citizens are not sufficiently aware of the vital role of vaccination in saving lives and
the risks of nonvaccination.
Vaccination policies and programmes vary considerably between countries regarding
the selection of vaccines, type of vaccine used, number of doses administered, and
timing. This variance between Member States is often due to social, economic, or
historical factors, or simply due to how the healthcare system is organised at national
level. However, such variances across countries have added to a perception of
diverging opinions on the vaccines themselves, which in turn contributes to the
growing levels of vaccine hesitancy. The rapid spread of disinformation through
online media and vocal vaccine deniers has also fuelled misconceptions. In addition,
given such differences in national vaccination schedules, citizens who live in a
number of EU Member States throughout their lives face difficulties in
understanding which vaccine to take when, which can result in children not taking all
the vaccines they need.
A number of countries are also facing vaccine shortages due to both supply and
demand issues. There is an industry disinvestment in vaccines in the EU, allegedly
due to a fragmented and partially unpredictable demand. In addition, legal difficulties
persist in sharing vaccines across borders in case of crisis. At the same time,
production capacity is limited by long lead times; procurement processes remain
cumbersome and inefficient and the lack of forecast planning coupled with the
variance of vaccination schedules render the demand unpredictable. Changes in the
demography of the target population due to migration and ageing are further
hampering accurate forecast planning.
As a result, some Member States are experiencing problems with vaccines
availability or face high costs of vaccines – which in turn means that national
stockpiles are often not available or limited in scope. In this context, if a Member
State is not able to control an outbreak on its own, in the absence of European cooperation in this area, such outbreak is likely to spread across borders to other
Member states, putting citizens’ health and security at risk throughout the Union.
There are also challenges related to research and development of vaccines.
Substantial financial investment and expertise is needed for the development of new
innovative vaccines and the improvement or adaptation of existing ones (e.g.
improved safety profile, adaptation to different ages, risk groups or pathogens),
which makes research and development much more complex, costly and risky.
Finally, on the resource side, there are constraints linked to public financing.
Vaccination currently represents a minor fraction of prevention budgets in EU
countries, accounting for up to 0.5% of the healthcare budgets and there is evidence
that spending is further decreasing. Spending on vaccination should be regarded as
an essential and smart investment in health, given its broader economic impact and
societal value.
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This Council Recommendation, is aimed at strengthening cooperation and
coordination between EU countries, industry and other relevant stakeholders to help
increase vaccination coverage, foster the possibility of alignment of vaccination
schedules across the EU, promote vaccine acceptance, support vaccine research and
development and strengthen vaccine supply, procurement and stock management,
including in cases of emergency. These activities should ultimately decrease the
incidence of vaccine preventable diseases and increase the health prospects of
European citizens, and improve health security in the European Union as a whole.
The proposal sets out recommendations to the Member States, joint actions by the
Member States and the Commission, and welcomes the Commission’s intention to
carry our a number of initiatives, taking into account ongoing UN and other global
health initiatives.
The Recommendation envisages a possibility of establishing a European Vaccine
Information Sharing System with a view to developing guidelines on a EU
common vaccination schedule, an EU vaccination card and a web-portal with
reliable updated information on the benefits and safety of vaccinations.
Providing possible options towards developing a common EU vaccination card
would ensure the continuty of immunisation when citizens, in particular children,
move from one Member State to another. Currently, the wide variety in vaccination
schedules and recording poses practical issues for effectively tracking, monitoring
and documenting immunisation history, as well as for communication between
different vaccine providers within and across countries. Key issues include:
vaccination documentation in national language only; issues around recalling
whether vaccinations were given and which doses; lack of recognition and ability to
continue an immunisation series already initiated in the country of origin, especially
if the child is in the middle of a vaccination course that is part of the schedule of the
country of origin but not of the country of destination. A common EU card with an
agreed core set of information for each vaccination could facilitate interpretation of
vaccination records, facilitate movement of citizens and lower barriers to vaccination
while providing both citizens and health providers with the relevant information they
need to ensure that citizens are immunised against vaccine preventable diseases. In
the 2009 Commission stakeholder consultation on childhood vaccination, 87% of the
respondents were positive towards having a common EU vaccination card.
The Recommendation further advocates creating a virtual data warehouse of
vaccine needs and stocks which could enable Member States and the Commission
to identify available stocks of vaccines in cases of outbreaks or severe shortages and
to mutually exchange the surpluses. In addition, it envisages identifying the options
for a physical stockpile of vaccines to be available in cases of serious outbreaks or
global shortages. Furthermore, it foresees a Coalition for Vaccination bringing
together representatives of healthcare workers associations and relevant student
associations to commit to increasing vaccination coverage in Europe.
The proposed identification of options for a possible vaccine stockpile stems from
the fact that many EU Member States are experiencing shortages of routine vaccines.
Each Member State needs to have preparedness plans in place and hence the
Recommendation calls for improving forecasting processes. To assist Member States
in covering short term shortages as a result of, for example, disease outbreaks,
underestimating stocks or manufaturing disruptions or extraordinary events, such as
an influx of migrants, a concerted EU assistance would be very beneficial. A 2015
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risk assessment report on vaccine shortages by the European Centre for Disease
Prevention and Control concludes that vaccine shortages in the EU/EEA appeared to
be more significant than in the past and concluded it is advisable for countries to plan
for stockpiles for routine programmes to avoid disruptions of immunisation in case
of future shortages. Member States have already requested vaccines from the
Commission to overcome shortages via the EU Health Security Committee.
However, the current EU health funding instruments do not enable the procurement
of vaccines. For this reason, the Commission now plans to work with Member State
experts and in dialogue with industry to identify options for a stockpile at EU level,
also taking into account the call by the European Parliament on the Commission and
the Member States to develop solutions to increase vaccine supply and availability,
including arrangements for stockpiling vaccines.
• Consistency with existing policy provisions in the policy area
The Council Recommendation on vaccination is consistent with, and builds further
upon, the existing policies in the area of vaccination. The Recommendation will aim
to set out policy orientations for, and better coordination of, the implementation at
Member State level of existing policy instruments, including the Council
recommendation on seasonal influenza vaccination (2009), the Council conclusion
on childhood immunisation (2011) and the Council conclusions on vaccination as an
effective tool in public health (2014).
The Recommendation also takes into account the report on the implementation of
Decision 1082/2013 on serious cross-border threats to health (2015); the report of the
high-level hearing on the implementation of the Council recommendation on
seasonal influenza vaccination (2015); the European Court of Auditors Special report
28/2016 “Dealing with serious cross-border threats to health in the EU” (2016); the
final report of the SANTE high-level workshop “Seeking new partnerships for EU
action on vaccination” (May 2017); Joint Procurement Agreement to procure medical
countermeasures and the objectives of the Joint Action on Vaccination (start 2018),
co-funded by the Health Programme.
The Recommendation is consistent with EU actions and policy in the area of
occupational safety and health and with the principles of the European Pillar of
Social Rights, especially Principle 10 on health and safety at work and Principle 16
on universal access to preventative and curative health care.
• Consistency with other Union policies
The Recommendation will exploit synergies with related EU actions and policies
e.g., the Agenda on Security, the 2030 Agenda for Sustainable Development, the
European One Health Action Plan against Antimicrobial Resistance, the
Communication on digital transformation of health and care, the Communication on
online disinformation, current and future EU framework programmes for Research
and Innovation, and the European Structural and Investment Funds. - LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
A high level of human health protection shall be ensured in the definition and
implementation of all Union policies and activities as referred to in Article 168(1)
TFEU. Union action, which shall complement national policies, shall be directed
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towards improving public health, preventing physical and mental illness and disease,
and obviating sources of danger to physical and mental health.
In accordance with Article 168(6) TFEU the Council, on a proposal from the
Commission may adopt recommendations for the purposes of that Article to improve
public health, in relation to in particular fight against major health scourges,
monitoring, early warning of, and combating serious cross-border threats to health.
Vaccine-preventable diseases are considered major health scourges. The Union
action in the field must respect the responsibilities of the Member States for the
definition of their health policy and for the organisation and delivery of health
services and medical care.
• Subsidiarity (for non-exclusive competence)
Vaccination programmes are the responsibility of Member States. However, vaccine
preventable diseases are not confined within national borders. One Member State’s
immunisation weakness puts at risk the health and security of citizens across the EU,
and all Member States are facing the vaccination challenges highlighted above. Due
to the cross-border nature of vaccine-preventable communicable diseases, Member
States have requested intensified EU level support, and stressed the need for common
EU action and more coordinated approaches to limit the spread of vaccinepreventable diseases across borders.
There is clear added value in strengthening cooperation among all relevant sectors at
EU level, including health authorities, the vaccine industry, research and innovation,
and healthcare actors. A Council Recommendation requires engagement,
commitment and endorsement by the Member States. Moreover, Member States are
broadly united on the benefits of vaccination and a Council Recommendation will
enable the presentation of a joint EU position reflecting science-based risk
assessments and risk management, reducing the impact of vaccine hesitancy,
building public confidence and cooperation and improving the effectiveness of EU
vaccine research and development. At the same time, it respects Member States
competence for the definition of their health policy and for the organisation and
delivery of health services and medical care.
• Proportionality
The proportionality principle is fully respected as the recommendations put forward
are limited to actions within the respective scope and mandates of the European
institutions and the Member States.
• Choice of the instrument
The instrument appropriate for the initiative is a Council Recommendation,
providing guidance to Member States on how to strengthen cooperation, improve
vaccination coverage, and as a result, reduce the impact and severity of vaccinepreventable diseases.
The Recommendation allows the EU level and the Member States to work further
together to address the different dimensions of the problem at the appropriate level.
The key added value of a Recommendation is to call for action and galvanise
political support to reboost policies and actions on vaccination and immunisation in
Europe. This focused approach will provide the necessary political visibility, raise
awareness and build momentum. Concerted efforts are needed from all Member
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States and stakeholders to boost vaccine coverage, reduce immunisation gaps and
increase confidence and trust in vaccination. - RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
CONSULTATIONS AND IMPACT ASSESSMENTS
• Stakeholder consultations
Several stakeholder consultations have been conducted to inform this initiative over
the course of 2017 and in early 2018. This included an open public consultation and
targeted meetings with representatives of Member States through the Health Policy
Platform.
Specifically, a public consultation took place between 21 December 2017 and 15
March 2018, during which 8,984 responses were received1
.
A stakeholder consultation took place in January and February 2018, with 33
responses to a questionnaire and six targeted meetings with healthcare professionals
associations, international organisations, non-governmental organisations working on
public health, the scientific community and the vaccine industry.
There was a clear call for more transparent and easily accessible information on
vaccination in general and in particular on the safety and potential side effects of
different vaccines. The pivotal role of healthcare workers in explaining vaccination
to their patients was highlighted whilst at the same time the need for more emphasis
on vaccination in medical curricula and continued professional training was
mentioned. There was also broad agreement that vaccination should be offered in
different settings and that there is a need to simplify the process.
The consultations carried out showed that there is a high degree of Member States
interest in more EU-level action on this issue, while also showing the extent of the
concerns expresed by those who refuse or who are reluctant to accept vaccination as
well as who oppose mandatory vaccination in some societal groups.
• Collection and use of expertise
The Recommendation relies on a thorough scientific basis and expertise, a review of
established scientific consensus, an analysis of current vaccination trends derived
from comparative data, and the results of a public and stakeholder consultation.
The collaboration with international expert groups, such as the World Health
Organisation’s Strategic Advisory Group of Experts on Immunization (SAGE) and
the European Technical Advisory Group of Experts on Immunization (ETAGE), and
the Global Health Security Initiative and Agenda processes has added to the EU
expertise.
• Impact assessment
No impact assessment is needed for this initiative as it will not introduce new
regulatory requirements beyond what already provided or planned through relevant
existing policy instruments.
1
https://ec.europa.eu/info/consultations/open-public-consultation-strengthened-cooperation-against-vaccine-preventable-diseases_en; Commission
Staff Working Document. Synopsis Report Accompanying the Council recommendation on Strengthened Cooperation against Vaccine Preventable
Diseases
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• Regulatory fitness and simplification
Some key expected impacts stemming from this Recommendation would be
improved coordination within and among Member States and simplified monitoring
and reporting criteria for vaccination and vaccine-preventable diseases.
• Fundamental rights
The initiative strengthens the entitlement of the European citizens to preventive and
curative health care of good quality, as enshrined in the European Pillar of Social
Rights.
- BUDGETARY IMPLICATIONS
This Recommendation has no direct financial implications to the EU budget. All
work related to Recommendations aimed at the Commission will be carried out
within existing resources. - OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
The Commission would monitor implementation in the Member States and review
the Recommendation in cooperation with the Member States and after consulting the
concerned stakeholders, ensuring a sufficiently long period to evaluate the effects of
the initiative after it has been fully implemented. The effectiveness of the
Recommendation could be measured on the basis of existing and new data and of
information gathered through Member States’ reporting.
At the same time, one of the current impediments to a comparative evaluation of
European protection against these diseases is the absence of standardized tracking
criteria. More standardized criteria is needed to encourage Member States to collect
and publish reliable – and comparable – statistics on vaccination.
• Detailed explanation of the specific provisions of the proposal
Points # 1 to 9 of the Recommendation are for the consideration of the Member
States, aim to accelerate the development and implementation of national vaccine
action plans to meet the goals and targets of the World Health Organization’s
European vaccine action plan. There is also specific emphasis on measles
vaccination given the current outbreak in Europe. The proposal recognises the need
to simplify and broaden the opportunities for vaccination and for targeted outreach
towards vulnerable groups in order to close immunity gaps. The proposal calls for
educational authorities to strengthen vaccination training in medical curricula and
continuous medical training for all health workers. It further highlights the need for
increased communication and awareness raising activities on the benefits of
vaccination. Exploiting the synergies with eHealth and digital technologies to
establish electronic vaccination records for all citizens is also an important element
of the proposal that would be included into the information exchange between
healthcare providers across borders in the context of the work of the eHealth
Network.
Points # 10 to 16 concern actions that the Commission intends to undertake in close
cooperation with Member States and include aiming at establishing a European
Vaccination Information Sharing system which could bring together related
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vaccination information and expertise together with the national public health
authorities. Under this system, various stakeholders could come together to develop
guidelines for a possible core EU vaccination schedule, share common
methodologies for monitoring coverage, and launch a web portal with transparent
evidence on vaccines benefit and risks including tracking vaccine myths and
misinformation. The proposal also highlights the need to strengthen the effectiveness
of the exisiting Directive2
on health and safety at work which guarantees that health
workers are vaccinated against specific diseases.
Finally, to address shortages and increase supply, the proposal puts forward the idea
of creating a virtual data warehouse for Europe on vaccine needs and stocks
and a mechanism for mutual exchange of vaccines among Member States;
identification of options for a physical vaccine stockpile in case of outbreaks or
global shortages of vaccines and envisages working with industry and other
stakeholders to improve EU manufacturing capacity of vaccines.
Points # 17 to 25 welcome the Commission’s intention to carry out a number of
activities including presenting options for a common EU vaccination card with
standardised information on vaccination history; presenting a report on the State of
Vaccine Confidence in the EU is requested in addition to actions to better understand
the barriers and increase access to vaccination for disadvantaged and socially
excluded groups; convening a Coalition for Vaccination with associations of
European healthcare workers and relevant student associations aimed at promoting
vaccination and strengthening partnerships and collaboration on vaccination with
international partners is another important element of this propsoal.
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