COVID-19: enhanced public health and workplace safety measures

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

1. 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.
2. 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.
3. 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.

4. 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.
5. 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.