New guidance to improve inconsistencies in access and availability of vaccines across Europe 

Vaccines Europe has today issued new recommendations to ensure greater consistency in how and when decisions are taken on implementing vaccination programmes across the 27 EU Member States. 

Improving vaccine assessment and decision-making pathways is critical to improving the timeliness of population access to vaccines, supporting the shift towards life-course immunisation, and strengthening efforts to improve vaccine confidence.   

The guidance will support the European Commission’s ambition to improve access to medicines for all patients, as part of the revision of the pharmaceutical legislation. Despite the focus on vaccines during the COVID-19 pandemic, vaccines access is often side-lined, with access patchy across Member States.  

The recommendations follows research by Vaccines Europe which highlights the stark differences in access to life-saving vaccines across the EU. The analysis of time to population access (TTPA) to new vaccines across EU Member States showed: 

  • In 7 EU countries, the median TTPA is less than two years, including Belgium, Denmark, France, Germany, Greece, Italy and Luxembourg; 
  • In 10 EU countries, the median TTPA is between two and six years, including Bulgaria, Czech Republic, Hungary, Ireland, Latvia, Netherlands, Portugal, Romania, Spain and Sweden;  
  • In 9 EU countries, the median TTPA is more than six years, including Austria, Croatia, Cyprus, Estonia, Finland, Lithuania, Malta, Slovakia and Slovenia. 

This time delay can cause a significant impact on people’s health. For example, the HPV vaccines – which are highly effective in preventing cervical cancers – are still not funded for girls in Romania.  

And, while the first HPV vaccines were launched in Europe before 2007, they are still not recommended for boys in 9 EU member states and when recommended, not funded by the national health system in 2 EU member states (Czech Republic and Luxembourg). Around 14,700 annual cases of anogenital cancers are attributable to HPV, with 5 400 cases diagnosed in men. Head and neck cancers also constitute a heavy burden with an estimated 13,800 cases diagnosed annually (11,000 in males)1.  

As Europe begins to look beyond the COVID-19 pandemic, there is a unique opportunity for decision makers to take necessary actions to enhance the design and implementation of routine vaccination programmes.  

The policy paper published by Vaccines Europe emphasises the need to make improvements in four key areas: Timeliness, inclusiveness, consistency and transparency.  

Timeliness: Timely assessments of and decision-making on vaccines should be a core feature of national immunisation systems in all EU Member States, with delays having detrimental consequences for the health of individuals and populations more broadly.  

Inclusiveness: NITAGs (National Immunisation Technical Advisory Groups) and HTA (Health Technology Assessment) bodies should ensure there are mechanisms for engagement and consultation with all relevant vaccines stakeholders. 

Consistency: While recognising that the organisation of health systems (including immunisation systems) is a national competence, this paper will highlight the need for consistency in two main areas: core procedures that should form part of vaccine assessment & decision-making pathways in all countries; and the methods and approaches used for vaccine assessment – with a key role that can be played by the EU HTA Regulation. 

Transparency: Transparency is a fundamental principle for the governance of health systems and is especially relevant for the vaccines ecosystem where vaccine hesitancy is a growing challenge. The roles of different public bodies such as NITAGs and HTA bodies, and their ways of working, should be clarified. 

This policy paper also sets out a set of recommendations at National and European level. 

National level – Vaccines Europe calls for: 

  1. Ministries of Health (MoHs) to convene all relevant stakeholders to examine national pathways for vaccine assessment and decision-making. Where improvement opportunities are identified, and after appropriate consultation, MoHs should design and implement reforms. 
  1. MoHs to ‘Review the composition, terms of reference and capacity of NITAGs (National Immunisation Technical Advisory Groups) to develop evidence-based recommendations for immunization across the life course’ (in line with the World Health Organization’s European Immunization Agenda 2030). Transparency should also be embedded in NITAG terms of reference. 
  1. Finance ministries and MoHs – in view of the high social and economic value of vaccination – to ensure that immunisation financing is sustainable, flexible (in order to respond to rising demand) and supports the shift towards life course vaccination. 

European level – Vaccines Europe calls for: 

  1. The Council of the EU to develop and adopt a Recommendation on vaccination for resilient health systems. Inter alia this could provide non-binding guidance to governments on best practices and methodologies for vaccine assessments and decision-making. 
  1. The establishment of a European vaccine clinical HTA committee to ensure appropriate implementation of the EU Regulation on Health Technology Assessment with respect to vaccines, including through the development of guidance on vaccine-specific clinical HTA methods and processes. 
  1. The European Commission to encourage Member States to make sustainable investments in life-course immunisation programmes and monitor national immunisation spending / budgets (e.g. via the European Semester and/or State of Health in the EU cycle). 

Sibilia Quilici, Executive Director, Vaccines Europe, said:  

“European responses to the pandemic have clearly shown the link between timely decision-making on vaccines, population health, and broader economic and societal outcomes. Timely and equitable access to vaccination and well implemented vaccination programmes represent your best preparedness plan towards building healthcare system and society resilience. 

Vaccination programmes save millions of lives globally and generate significant economic and societal value through better individual and population health – it is critical that the decisions taken to implement vaccination programmes are consistent throughout Europe so that all Europeans have equal access to vaccines, the best public health tools for preventing disease.” 

1 ECDC HPV Vaccination Guidance: