Explanatory Memorandum to COM(2018)244 - Strengthened Cooperation against Vaccine Preventable Diseases

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dossier COM(2018)244 - Strengthened Cooperation against Vaccine Preventable Diseases.
source COM(2018)244 EN
date 26-04-2018


1. CONTEXTOFTHEPROPOSAL

• 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:

2.

Vaccine hesitancy and waning confidence. Misconceptions about vaccination have shifted the public focus away from the benefits of vaccination, towards a distrust in


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 vaccine-preventable 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.

are also challenges related to research and development of vaccines.

3.

There


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.

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

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. LEGALBASIS, SUBSIDIARITYAND 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

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 vaccine-preventable 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 vaccine-preventable 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


States and stakeholders to boost vaccine coverage, reduce immunisation gaps and increase confidence and trust in vaccination.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

Contents

1.

CONSULTATIONS


ANDIMPACTASSESSMENTS

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.

https://ec.europa.eu/info/consultations/open-public-consultation-strengthened-cooperation-against-vaccine-preventable-diseases_en; Commission

4.

Staff Working Document. Synopsis Report Accompanying the Council recommendation on Strengthened Cooperation against Vaccine Preventable Diseases



• 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. BUDGETARYIMPLICATIONS

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. OTHERELEMENTS

• 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

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.

Directive 2000/54/EC of the European Parliament and of the Council of 18 September2000 on the protection of workers from risks related to exposure to biological agents at work, eur-lex.europa.eu/legal-content/EN/TXT/PDF:32000L0054&from=EN

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