European Reference Networks (ERN ) What, Why, Where and how do we face the future ?

1. European Reference Networks (ERN)What, Why, Where and how do we face the future ? • “Scottish Parliament, Implications of BREXIT • Peter A Mossey, University of Dundee 5th February 2019

2. ERN is a possible vehicle for change? • Directive 2011/24/EU European Reference Networks (ERN) involve centres of expertise to improve access to high-quality, accessible and cost-effective healthcare • Patients with rare medical conditions requiring a concentration of specialized expertise / resources(see Recital 54 of the Directive).  • ERNs will be focal points for medical training and research, information dissemination and evaluation for rare diseases.

3. Craniofacial anomalies (complex clefts, craniosynostoses and facial dysostoses)

4. Cleft lip and palate – nsOFC for the most part

5. Odontogenic abnormalities

6. ENT ? – identify overlap with CFA / cleft care !

7. EU Parliament 9th October 2012

8. Research in the ERNs • Tremendous potential within the ERN and RD is a theme in H2020 • Track record: many aspects of EU research in rare diseases world leading • Innovation part of but goes well beyond “standards of care” • Basic science, innovation and evidence base are all part of quality of care • Will be the concern of each discipline, but also needs inter-disciplinary focus

9. ERNs are the potential solution ? • ERNs are a mechanism of cooperation between healthcare providers of highly specialised services all over Europe • Healthcare providers are expected to collaborate amongst themselves in a dedicated field of expertise in order to establish and sustain these Networks. • The Members of a network will work in accordance with the legislation of their Member State • Funding will be required to unlock this potential

10. ERN “CRANIO” mission: • 1. To establish and manage a steady referral network for patients with craniofacial anomalies; cleft lip/palate; odontologic anomalies; and ENT disorders throughout Europe; • 2. To improve the quality of care by enhancing diagnosis, treatment and follow-up of the patients with rare craniofacial anomalies and ENT disorders; • 3. To minimize any deviations from our operational standards and to create best practices through suitable quality improvement initiatives, while monitoring their effectiveness using measures and indicators; • 4. To stimulate innovation through multicentre research projects on (genetic) causes, pathophysiology, and associated problems, and introduction of eHealth. • 5. To support the continuous learning and development of all our members by providing high quality educational and training opportunities to medical, nursing and other healthcare professionals; • 6. To disseminate gained knowledge throughout Europe and outside, making it available to all stakeholders;

11. Standards of care: next steps • Available clinical guidelines in all CRANIO phenotypes and all disciplines - significant task, so where do we start ? • No need to re-invent the wheel when we may already have Formula One – well refined, high tech, tried and tested !! • Which ones are “accepted” and by whom – professional bodies and societies, PAGs, governments ? • Scope ? – have we defined this – what do we mean by standards of care in the ERN context ? • Which are standards common to all CRANIO phenotypes / disciplines, and which will be discipline specific ?

12. ERN survey – Clinical Practice Guidelines, plans and priorities survey to support workshop discussion on 6–7 December 2017 Outline anticipated activities relating to CPGs: • Patient centred care • The specialist team • Referral times and communication • Treatment standards • Anaesthetic standards • Psychology standards • Clinical genetic standards • Speech and language therapy • Audit and clinical governance • Research and development • Management and organisation • Paediatric standards

13. Standards of care documents relating to OFC • WHO: 2002. Global strategies to reduce the healthcare burden of craniofacial anomalies, (particularly orofacial clefts) http://apps.who.int/iris/bitstream/10665/42594/1/9241590386.pdf • CEN Technical Report (CEN/TR 16824:2015) includes recommendations for the care of babies born with cleft lip and/or cleft palate. May 2015. https://www.cen.eu/news/brief-news/pages/news-2015-007.aspx • NHS ENGLAND: STANDARD CONTRACT FOR CLEFT LIP AND / OR PALATE SERVICES INCLUDING NON-CLEFT VELOPHARYNGEAL DYSFUNCTION (VPD) (ALL AGES)..March 2000. • https://www.england.nhs.uk/wp-content/uploads/2013/06/d07-cleft-lip.pdf • American Cleft Palate Association (ACPA): Standards of Approval for Team Care: http://acpa-cpf.org/team-care/standardscat/standards-of-approval-for-team-care/

14. UK Government recommendations (1998) • Reduce 57 centres to 11 regional services • 30 new personal cases per surgeon/ orthodontist/speech therapist • Comprehensive teams • Standard database • National quality assurance • Research programme

15. ICHOM_Cleft lip and palate • nsCPsubphenoytpes • nsCLPsubphenotypes

16. A breakfast meeting at the European Parliament HostedbySeánKellyMEP Leader,FineGael Delegationinthe EP Tuesday, 20th February | 0800hrs – 0930hrs http://www.epp.eu/ “Individuals and families with birth defects in Europe and the additional burden of inequalities” European Parliament, Brussels, 20th February 2018

17. Consumers, Health, Agriculture and Food Executive Agency • La CommissioneEuropea, attraverso The Consumers, Health, Agriculture and Food Executive Agency (Chafea), ha pubblicatoil secondo bando 2018 del ProgrammaeuropeoSalute 2014-2020. • In particolare, la call "Implementation of best practices to promote health and prevent non-communicable diseases and to reduce health inequalities" mira a implementarebuonepratichegià testate in un paeseeuropeo in altripaesimembridell'Unioneeuropea; in particolare, due sono le buonepraticaidentificate (tra cui unaitaliana) checorrispondonoancheai topic della call: • Topic 1: Transferring the Swedish Physical Activity on Prescription Initiative to other countries • Topic 2: Transferring the Italian CARDIO 50 programme to other countries • La scadenza per inviare le proposteprogettuali è fissata per tuttii topic al 13 settembre 2018. 

18. Science meets Parliament EoIFP9 – Prof.Mariana MAZZUCATO …………MISSIONS