ERNs & ERN eUROGEN

ERNs and ERN eUROGEN

About European Reference Networks in general

Background:

Half a million people in Europe are diagnosed with a rare disease every year, and rare or low-prevalence complex diseases affect the daily lives of around 30 million European Union (EU) citizens. Health systems in the EU aim to provide high-quality, cost-effective care, but this is particularly challenging for rare or low-prevalence complex diseases and conditions. Clinicians face challenges in diagnosing and treating patients due to limited knowledge, information, and exposure to uncommon symptoms and disease mechanisms, meaning many patients have faced a diagnostic odyssey when searching for answers.

Highly specialised care and surgery for rare conditions should occur in centres of excellence with highly trained and experienced surgeons using multi-disciplinary teams (MDTs). This centralised approach is cost-effective and provides the best possible outcomes, improving survival and quality of life.

European Reference Networks (ERNs):

The ERNs are one of the greatest achievements of the rare disease community in Europe. They are virtual networks connecting healthcare providers (HCPs), professionals, and patients across the EU/EEA and aim to tackle rare diseases and complex conditions requiring highly specialised treatment by pooling knowledge and resources and thereby improving diagnoses and treatment for patients with a “Share. Care. Cure.” approach. Using technology and telemedicine, the networks join up the information and expertise scattered across the EU, ensuring that information travels to the patient.

The ERNs are not a time-limited project but an EU initiative based on the 2011 Directive on Patients’ Rights in Cross-border Healthcare, built on a robust policy and legal framework, and benefitting from previous work done by EU-funded projects, programmes, and networks over the decade before their launch.

While there is still much work to do, the ‘birth’ of 24 ERNs has been a landmark moment in the history of European voluntary cooperation in the field of health with the potential to change millions of lives. They have already improved the healthcare management of patients with rare diseases and complex conditions throughout Europe by facilitating knowledge generation and sharing, care coordination, and exchanging of best practices concerning diagnosis, establishing new ways to reduce unfavourable outcomes for patients, improving and innovating the quality of care provided by expert healthcare professionals and their teams, and subsequently diminishing the cumulative cost for society.

The EC has a webpage that outlines how the ERNs work, the legislation and coordination involved, as well as information on the monitoring of the ERNs and the latest news on the networks.

Timeline:

In March 2017, the first 24 ERNs were formally approved, accredited, and launched by the European Commission (EC) and the Board of Member States for ERNs (BoMS), involving more than 900 highly specialised healthcare units from over 300 HCPs.

As required by the legislation, in 2018, HCPs in countries where an ERN has no Full Member were appointed as Affiliated Partners to work with the ERNs to expand the geographical coverage of the ERNs to involve all EU Member States. These HCPs are usually located in Member States with smaller populations that benefit the most from the knowledge transfer from interacting with the high-volume HCPs and expert clinicians in the networks.

The UK withdrawal from the European Union took effect on 31 January 2020, with the transition period ending on 31 December 2020. This meant that UK HCPs ceased to be part of the ERNs.

In January 2022, following a 2019 EC call for proposals for new members to join existing ERNs, the BoMS approved 620 new HCP members assessed by the EC, ERNs, and Independent Assessment Body, meaning the ERNs now include more than 1,400 healthcare units from around 400 HCPs across all 27 EU Member States and Norway.

Funding:

Full financial support for the ERNs has been agreed upon between the Member States, the European Parliament, and the EC, with all ERN grant management, funding, support actions, and innovations currently taken care of by the Health and Digital Executive Agency (HaDEA). Current funding is through the EU4Health Programme, which will be followed by the EC’s next health programme that, according to the EU vision on ERN Developments (ERN2030), will include funding calls for the 24 ERNs.

In the future, collaboration with the medical industry may be another source of funding for the ERNS, and policy developments relating to this are under discussion by the EC, ERN Coordinators Group, and the BoMS.

ERN Information Brochures

The Publications Office of the EU has published the 2023 edition of the official information brochure about the European Reference Networks, featuring an overview of ERN eUROGEN on page 24.

You can click here to download the brochure, which is available in all Member States’ languages, as well as English, Norwegian, and Ukrainian.

Please feel free to share the brochure wherever it would be helpful to do so.

About ERN eUROGEN

ERN eUROGEN is the European Reference Network (ERN) for rare urogenital diseases and complex conditions.  

Millions of people suffer from urogenital conditions annually, but only a small fraction suffer from urogenital conditions that are rare. Generally, the EU considers a condition rare when it affects fewer than 1 in 2,000 people (<0.05%). However, in the case of some highly complex urogenital conditions, the prevalence rate is significantly lower than the EU definition; for example, urethral diverticulum, a localised outpouching of the urethra into the anterior vaginal wall, has an estimated annual incidence of 17.9 per 1,000,000 (0.02%) per year.

Urogenital conditions significantly impact paediatric, adolescent, and adult patients, their families, and their quality of life. The little available knowledge is often scattered amongst a small number of expert specialists and unique centres located in disparate countries and regions, which impedes diagnosis, satisfactory advice, and treatment, and encumbers healthcare systems and society with a significant cumulative economic burden.

Patient-centred parameters, as well as those relating to best practice, expectation management, and disease-specific outcomes, have not previously existed for these diseases and conditions.

Furthermore, a gap has existed between paediatric specialists treating acute postnatal problems and adult outcomes. Rare urogenital diseases and complex conditions can require surgical correction, often during the neonatal period or in childhood, but affected individuals require life-long care pro­vided by multi-disciplinary teams (MDTs) of experts who plan and perform surgery and provide post-operative physiotherapy and psychol­ogical support.

Therefore, ERN eUROGEN aims to address the same issues, challenges, and gaps as those in the overall ERN “Share. Care. Cure.” approach, and additionally, those relating to rare urogenital diseases and complex conditions that affect either the reproductive organs or the urinary system.

ERN eUROGEN’s activities are essential to advance innovation in medicine, address gaps and collect evidence at the European level, improve diagnos­tics, treatment and outcomes, and ultimately create more equitable access for as many patients as possible efficiently and cost-effectively. 

ERN eUROGEN Target Groups

The below target groups all benefit from ERN eUROGEN’s activities:

  • Patients living with a rare disease or complex condition and their families
    • ERN Patient Advisory Group (ePAG) Advocates
    • Associate/Supporting Patient Partners
    • non-partner patient, family, and advisory organisations
  • Healthcare Providers (HCPs)
    • Full Members and Affiliated Partners
    • non-member HCPs
  • Public health authorities and policymakers
    • EU institutions
    • (sub)national authorities
    • regulatory agencies
  • Researchers in the scientific and health community related to rare diseases and/or complex conditions
  • Scientific, academic, and professional societies
    • Supporting Partners
    • non-partner scientific, academic, and professional societies
  • Other ERNs
  • New Member States, European countries outside the EU, and non-EU countries
  • Industry: pharmaceutical and medical device organisations

ERN eUROGEN Work Packages

From October 2023 to October 2027 (using a direct operational grant covering the remainder of the EU4Health Programme), ERN eUROGEN will organise its activities using the below Work Packages (WPs):