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Council of European Dentists

CED

The Council of European Dentists (CED) is the representative organisation for the dental profession in the EU, representing over 340,000 practising dentists through 33 national dental associations.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

26 Sept 2025

The Council of European Dentists (CED) welcomes the Commissions envisioned review of the rules for medical devices. We fully share the goal of ensuring patient safety while supporting innovation and competitiveness. But in practice, the way the Medical Devices Regulation (MDR) is being implemented is causing serious problems. While the scale of the problem remains not fully clear, addressing such potential issues is something that is shared as concern between dentists and other healthcare professionals alike. As such, an MDR revision would need to be very robust, and to truly consider safe patient care as a priority, rather than detract from it, as it is the case for the time being. A major concern remains the future availability of provenly safe and effective dental devices. Even with the extended transition timelines, many manufacturers are discontinuing product lines because the costs and administrative burden of MDR certification and re-certification are too high. This affects small and medium-sized enterprises in particular and leads to shortages of both basic and more advanced devices. Some examples in the last couple of years provided by national members of CED include saliva tubes, impression materials, burs and even bone substitution products. At times, there is a need to increasingly rely on third-country suppliers, often from Asia, which undermines the aim of strengthening the European market and increases dependence on imports. These supply gaps mean dentists might have to delay, change treatments or replace devices, which can end up costing more and offer less effective results. Dentists also face unnecessary uncertainty regarding their role under the MDR. In some Member States, dentists are treated as if they were manufacturers or distributors simply for using certain devices in treatment. This creates additional bureaucracy and takes time away from patient care. Dentists already carry full professional responsibility for patient safety and should not be burdened with heightened administrative duties. There are also questions about how the MDR will interact with other EU legislation, such as the European Health Data Space, REACH, the AI Act. Without clear guidance, there is a risk of overlapping requirements and further disruptions to supply. If these problems arent fixed, the MDR could end up working against its own purpose, limiting patient choice and safety, holding back innovation, and driving many European manufacturers out of the market. Most importantly, it will potentially impede patient safety, therefore impacting negatively oral health across Europe. Recommendations to be considered for the envisioned review of the MDR legislation: Simplify and speed up re-certification for devices, especially provenly safe dental devices. A more robust solution would be to also completely withdraw the requirement to recertify already established medical devices or make certificates for such devices valid permanently and without restriction; Continue strengthening and harmonising the work of notified bodies to reduce delays and inconsistencies. Clarify the role of dentists in line with their main responsibility (that of healthcare professionals providing high quality treatment for their patients), and in accordance with the health institution definition ( Art. 2(36) Definitions), within the MDR, to avoid unnecessary administrative burdens. Ensure the MDR works in alignment with other EU legislation to prevent additional barriers. Provide targeted support to SMEs to help European innovation and production remain competitive. The dental profession is committed to patient safety and innovation, but without timely improvements we are concerned that many essential devices could potentially disappear from the EU market in the next 510 years, leaving patients with fewer options, higher costs and lower-quality treatments.
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Response to EU cardiovascular health plan

15 Sept 2025

The Council of European Dentists (CED), representing over 340 000 dentists across Europe, strongly welcomes the European Commissions EU Cardiovascular Health Plan and its efforts to reduce mortality and morbidity rates related to cardiovascular diseases (CVD) and co-morbidities across Europe. The CED strongly supports the three key action areas, and particularly the focus on the initiative for early detection and screening, as well as the suggested development of an EU protocol on health checks for cardiovascular diseases. The CED stresses the need to take into account the close bidirectional relationship between cardiovascular and oral diseases, and the prevalence of oral conditions in large number of patients suffering from CVDs. The significant impact of poor oral hygiene on cardiovascular health is established by a growing body of evidence identifying periodontitis as a leading risk factor of endocarditis, as well as heightened risks of acute myocardial infarction, the development of strokes, coronary heart disease, and high blood pressure. Patients suffering from CVD also have a significant risk of developing co-morbidities, including the further deterioration of pre-existing oral conditions. Furthermore, existing multi-morbidities between oral and other communicable and non-communicable diseases may also, in turn, worsen systemic inflammation and have an impact on the prevalence, gravity and efficacy of CVD treatments. According to the WHO, oral diseases affect more than an estimated 50% of the European population. Periodontal diseases impact over 1.1 billion people worldwide, with a 19% prevalence, and severe periodontitis affecting an estimated 796 million people globally. Periodontal diseases remain a dominant share of oral disease incidence in the European adult population, increasing the risk of developing further health conditions. WHOs Global oral health status report estimated that, 17.89% of European people of over the age of 15 suffered from severe periodontal disease in 2019, with important European disparities. Periodontitis and other periodontal diseases remain preventable through regular oral health screening and check-ups. Furthermore, prescribed treatments for CVD and interlinking co-morbidities may impact the health of the oral cavity. Some medications may cause xerostomia, a reduced flow of saliva leading to a dry mouth, slow healing, and oral surgical complications. An integrated approach to addressing cardiovascular diseases, encompassing both cardiovascular and oral health care in all three key action areas of prevention, early detection and screening, treatment and care, is crucial in ensuring that effective and holistic initiatives are developed under the EU Cardiovascular Plan. Additionally, common risk factors such as sugar, tobacco and alcohol consumption must be urgently addressed under the plan, as these disproportionately increase the risk for the development of both CVD and oral diseases. The CED attaches its latest CED Resolution on sugar, highlighting the urgency to take necessary steps for addressing common risk factors and curbing the promotion of harmful products. The CED therefore calls on the European Commission to ensure the integration of oral health in all initiatives and activities stemming from the EU Cardiovascular Health Plan, relating to prevention, early detection, management and rehabilitation. This includes enhancing the role of dental practitioners in the examination and early identification of CVD, as well as in the screening, diagnosis and early treatment of oral diseases in CVD patients, and the call to integrate systematic dental check-ups into pre-surgical cardiovascular examinations. The European Commission should also acknowledge the responsibility of dentists in promoting oral health and cardiovascular health literacy to patients, as well as raising awareness about common risk factors and the link between oral and cardiovascular health.
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Response to Professional qualifications recognition of nurses, pharmacists and dental practitioners - training requirements update

2 Feb 2024

On behalf of the Council of European Dentists (CED), we appreciate the opportunity to respond to the consultation posted by the European Commission regarding the proposal on the Draft Delegated Act concerning the updated training requirements for nurses, pharmacists, and dental practitioners. We acknowledge and commend the inclusion of various scientific and technical advancements in dental training programs within the proposed amendments, as outlined in the relevant proposal. Specifically, we would like to express our agreement with the proposed changes to Article 34, paragraph 3, which encompasses critical areas such as implantology, gerodontology, interprofessional collaborative care, dental public health, practice management, genetics and genomics, immunology, regenerative medicine/dentistry, and digital technology in dentistry. These advancements are essential to ensuring that dental practitioners are equipped with the knowledge and skills necessary to provide comprehensive and modern dental care. However, we must express our dismay at the limited incorporation of the recommendations we provided to Spark Legal into the results of their study, as expressed in our correspondence with DG GROW. The content of Annex V is outdated and fails to capture the contemporary competences, skills, and techniques required to meet the challenges of the modern dental landscape successfully. In this regard, we strongly advocate for a future review of the structural content of Annex V.3/5.3.1. to replace the mere listing of subjects with comprehensive modules and competences. This approach would better reflect the dynamic nature of the dental field and align with the CED Resolution on Annex V of the Professional Qualifications Directive (PQD), available at: https://www.cedentists.eu/wp-content/uploads/2023/09/EN.pdf , including a justification document: https://www.cedentists.eu/wp-content/uploads/2023/09/Document-titleEN-26.pdf . Furthermore, our concern extends to the wording of the section (e) of the proposed Article 34, paragraph 3: suitable clinical experience under appropriate supervision." We believe that this aspect is not robust enough, considering the prevalent issues and concerns surrounding clinical training within the EU. A recent survey conducted by the CED within its member dental chambers and associations shows that multiple Member States have evidence of dentists practicing in their country with a degree in Dentistry obtained in another Member State who do not have sufficient operative clinical training as an undergraduate to provide proper dental care (see attachment for results). We advocate for the inclusion of stronger and clearer requirements for clinical training, such as specifying a minimum number of hours. This addition would contribute to enhancing the overall quality and consistency of clinical training across Member States and EFTA States. As underlined in the introductory paragraph, it is of utmost importance and absolutely imperative for the dental profession to update the study programme for dental practitioners leading to evidence of formal qualifications in Dentistry. We should endeavour to ensure that the correct terminology is used and that the study programme reflects the concrete competences and skills a dentist should have nowadays, in a modern and realistic way, so that upon graduation, they will be able to use the most updated tools and state of the art techniques and be ready to face new challenges successfully, in the contemporary world. In conclusion, while we appreciate the positive steps taken in recognizing advancements in dental training, we urge the European Commission to consider our suggestions for a more comprehensive and up-to-date framework that truly reflects the evolving needs of dental practitioners and the patients they serve. Thank you for your attention to this matter, and we remain at your disposal for any further clarification or collaboration.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

The Council of European Dentists (CED) is a European not-for-profit association representing over 340,000 dentists across Europe. Established in 1961, CED comprises 33 national dental associations from 31 European countries, all of which share a collective commitment to upholding the highest standards of dental care across the European Union (EU). We appreciate the opportunity to provide our input on the new pharmaceutical legislation proposed by the European Commission. Firstly, we would like to express our support for the new pharmaceutical strategy. In the aftermath of the unprecedented challenges posed by the COVID-19 pandemic, we firmly believe that Europe requires an updated and comprehensive pharmaceutical strategy to address the evolving healthcare needs of its citizens. The proposed legislation presents a timely and vital framework for achieving these objectives. As representatives of the dental profession, we wish to highlight the critical importance of antimicrobial agents in our field. Dentists frequently rely on these agents to manage infections and ensure patient safety during various dental procedures. Thus, we wholeheartedly welcome the focus on antimicrobial as outlined in the proposed Regulation. Innovation in this area promises to enhance patient outcomes and improve the overall quality of dental care across Europe. However, it is equally important to emphasize the continued availability of existing antibiotics. Older medicines play an indispensable role in dental practice, and their accessibility is essential to safeguard public health. We encourage the European Commission to ensure that article X of the proposed Regulation effectively harnesses research, developments, and innovation in this area while also preserving access to established antibiotics. Furthermore, affordability and availability of medicines are crucial considerations for both healthcare providers and patients. We urge that the new pharmaceutical legislation incorporates measures to promote fair pricing and ensure that essential medicines remain accessible to all European citizens, regardless of their socioeconomic status. This will contribute to the overall sustainability of healthcare systems across the EU. Patient safety is of paramount concern to our profession, and we commend the proposed legislation's commitment to this principle. We emphasize the importance of proper disposal of medicines to prevent environmental harm and support initiatives that encourage responsible pharmaceutical waste management. Furthermore, we believe that public education on these issues is essential, as informed patients are more likely to participate actively in safeguarding their own well-being and that of the environment. In conclusion, the Council of European Dentists welcomes the new pharmaceutical legislation as a forward-looking strategy that addresses the healthcare challenges facing Europe in the post-COVID-19 era. We appreciate the opportunity to contribute our perspective, and we remain committed to collaborating with the European Commission to ensure that the dental profession continues to provide high-quality, safe, and accessible care to all EU citizens.
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Response to Communication on maximising the potential of talent mobility as part of the European Year of Skills

12 Oct 2023

The Council of European Dentists is a European not-for-profit association representing over 340,000 dentists across Europe. The association is composed of 33 national dental associations from 31 European countries. The CED is committed to upholding the highest standards of dental care across the European Union (EU). One key aspect of maintaining these standards is the recognition of dental qualifications acquired in third countries. In the following, the CED highlights the importance of subjecting third-country qualifications to rigorous scrutiny by Member States (MS) to ensure they meet the minimum training requirements set forth in the Professional Qualifications Directive (PQD) within the EU; as well as the need for a clear position on language requirements in the recognition process. The CED conducted a survey among its member associations on this topic. The results have provided crucial insights into the recognition processes in CED member countries. The findings (Annex1) allow us to recommend the following: 1. Rigorous Scrutiny of Third Country Qualifications: The CED urges all EU MS to rigorously scrutinize the qualifications of dentists who received them in third countries, regardless of their nationality, to ensure that they meet the minimum training requirements as stipulated in the PQD. This is crucial in maintaining the highest standards of dental care and ensuring the safety of patients across the EU. 2. Consistent Recognition Process: The CED recommends that EU MS establish standardized recognition processes for dental qualifications obtained in third countries. These processes should prioritize assessing whether the training aligns with the PQD's minimum training requirements. This standardization will help create a level playing field and foster confidence in the quality of care provided by recognized dental professionals. 3. Simplified or Expedited Recognition Process: MS that employ simplified or expedited recognition processes for qualifications that do not meet PQD requirements should review these processes and consider aligning them more closely with EU standards to ensure patient safety and the quality of dental care. While the CED supports measures allowing for simplification and acceleration of the recognition procedures, it is strongly against lowering the training and language requirements. The EU law clearly requires that access in the MS to the professions of doctor,[...] dental practitioner, [...] should be made conditional upon the possession of a given qualification ensuring that the person concerned has undergone training which meets the minimum conditions laid down (recital 19 of Directive 2005/36/EC). 4. Clear Language Requirements: Recognizing the importance of effective communication between dentists and patients, the CED strongly encourages MS to establish clear language requirements for dentists seeking recognition. Language proficiency should be evaluated as part of the recognition process, ensuring that dental professionals can provide safe and effective care to patients. The CED emphasizes the need to ensure that dental qualifications acquired in third countries are rigorously scrutinized to guarantee they meet the minimum training requirements set forth in the PQD. The CED believes that this approach is vital in maintaining the high quality of dental care and patient safety across the EU. Additionally, establishing consistent recognition processes, reviewing simplified or expedited processes, and enforcing clear language requirements will contribute to the overall quality of dental care provided within the EU. We would also like to stress the unequal distribution of dental practitioners within the EU. As such, there is no shortage of dentists, but a concentration in specific countries and a lack of them in others, which would require redistribution policies from the EC.
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Response to Mercury – review of EU law

7 Sept 2023

The CED continues supporting the proactive and effective phase down of dental amalgam in Europe. Nevertheless, in light of the European Commission (EC) proposal for the revision of the Mercury Regulation ((EU) 2017/852), we would like to express several considerations, important for patients, dental care delivery and the dental profession. The proposal and its Impact Assessment (IA) present an incomplete, politicised picture of the dental amalgam use status quo and the envisioned future implications this legislation will bring. It is crucial to ensure that dentists and patients will continue having full control over the choice and materials for the course of treatment and according to each national healthcare system. A continuous phase down of dental amalgam remains the most feasible choice, ensuring that there will be no increased legislative, regulatory and administrative burden, and treatment and healthcare system costs, while also successfully delivering on crucially important environmental priorities. In recent decades, the use of amalgam had decreased by about 50 % and the EC prognoses a further continuous phase down for the next decade based on the present Mercury Regulation from 2017. Several considerations on the proposal include: - There are severe discrepancies across EU MS in terms of tooth decay experience and amalgam use, based on the varying oral health and population needs, healthcare systems, healthcare budgets. The proposal offers a 'one-size fits all' solution for 27 MS, disregarding Article 168(7)of the Treaty on the Functioning of the European Union (TFEU):'Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organization and delivery of health services and medical care'. The TFEU is clear about the autonomy and responsibility of MS on the organization and delivery of health care services. As such, regulatory action for a phase-out would mean that the EC is in breach of its obligation towards MS as per Art.168 TFEU. - Materials for treatment, such as dental amalgam, must remain part of the dentist-patient choice: while the text states that it 'is safeguarding the right of the dental practitioners to still use it when deemed strictly necessary for addressing specific medical needs of the patient', it also prohibits manufacture and export of dental amalgam in the EU. This will lead to restrictions in treatment choices and opens the question as to whether the choice of treatment with amalgam will need to be justified further, imposing additional administrative burdens to dentists. - The proposed ban does not account for legacy fillings, mostly responsible for the environmental impact of amalgam as well as the fact that the dental profession is already using effective amalgam separators as per the 2017 EU Mercury Regulation. - Alternative materials exist but cannot universally replace amalgam, taking medical and economic aspects into consideration, where the latter aspect varies between EU MS health care systems. - Costs of treatment will increase in some MS and have been underestimated in the IA: it is important to consider the impact that an amalgam ban would have for the entirety of the healthcare system - it is not a matter of a one-off cost but rather an issue that spans across the national healthcare universe. This is also a factor that will vary among MS. From the start of the revision consultation period, the CED has been actively engaging with policymakers, calling for a balanced approach that respects both the environmental policy needs and the national circumstances and healthcare systems, as well as the dentist's expertise and patient's choice when it comes to dental treatment materials. We urge policymakers to adopt a tailored approach that will not cause further rifts in a Europe of stretched and overburdened healthcare systems.
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Response to A European Health Data Space

26 Jul 2022

The Council of European Dentists (CED), a European not-for-profit association representing 340,000 dentists across Europe welcomes the European Commission’s Proposal for European Health Data Space (EHDS) Regulation. It is important to ensure that the proposal and its future implementation are truly workable and beneficial for healthcare professionals (HCPs), dentists included. Considerations throughout the EHDS Proposal: - In light of the subsidiarity principle, the EHDS should take into consideration EU Member States (MS) national health systems, their evolved structures and specific circumstances especially through a realistic and workable implementation period. - Since EHDS touches on various existing and developed legislations, it is important to provide clear information on their interplay. For example, in the case of dentistry, the Medical Device Regulation has a continuous impact – as such, it needs to be clarified what type (if any) additional compliance will be required in the case of a medical device that is providing health data. - High levels of data protection should be ensured throughout the EHDS, and especially for secondary data use. - In addition to that, in light of the envisioned goal of having a functioning health data system, it is important to clarify how the costs for any additional software, trainings and administrative efforts for registering data will be covered, and by which stakeholders. Any costs and administrative burdens for EHDS introduction and implementation should be kept as low as possible for HCPs. Primary health data use: - The CED welcomes the EHDS and its focus on ensuring that natural persons are granted easier access to their health data; this would help facilitate the digital workflow and dentists’ interaction with the patient, dentists and other HCPs. - The CED welcomes the provision of access to health data of natural persons under treatment by HCPs, irrespective of MS of affiliation and MS of treatment, important for optimizing cross-border treatments and follow-up treatment plans. - The CED welcomes the identification of priority categories of electronic health data (esp. patient summaries, electronic prescriptions, medical images). CED highlights the importance of ensuring that dental data sets are part of the European electronic health record exchange format, mentioned in Art. 6.1 EHDS. - The CED highlights that data protection, both for the patient and the dentist, are crucially important. A fine balance should be ensured between the provisions in Art3.9 and Art.3.10 of EHDS alike. Natural persons should have full control over restricting access to their health data without impeding dentists from providing diagnosis and treatment of importance. By having full access to a broad overview of the relevant patient health records, the dentist would also have an overview of all necessary health information (e.g. medical history, risk factors, comorbidities). Access to such data is to be treated with respect to all relevant data protection legislation and guidelines. - As work on EHDS progresses, it is crucial to clearly outline the responsibilities of HCPs in terms of registering health data, categories of data to be registered, data quality requirements (Art.7.3 EHDS). Secondary health data use: - According to the current definition in EHDS, HCPs such as dentists qualify as data holders, who have specific duties (Art. 41). This current definition remains rather broad and needs further specification, especially in the case of HCPs - at the intersection of accessing data but also registering and holding such data. - The provision of data for secondary purposes by HCPs, dentists included, should be streamlined with the already envisioned process for primary data registration, to avoid overburdening and duplicating the process. This should be taken into account by the health data access bodies that MS should designate to deal with secondary data use (Art. 36, 37 EHDS).
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Response to Cancer Screening Recommendation

31 Jan 2022

The Council of European Dentists (CED) suggests to include screening for oral cancer in the updated Recommendation. Oral cancer is one of the cancers with the lowest survival rate in the European Union, due to late detection. The survival rate decreases from 80% in cases of early detection to just 50% in case of late detection. What this means in real life is that there were 45,547 estimated cases of oral and lip cancer in Europe in 2018, out of which 15 103 are thought to be fatal.18 In fact, Europe is second and only behind South-East Asia when it comes to the age-standardised rate specific to oral and oropharyngeal cancer. The principal causes for oral cancer are tobacco and alcohol consumption and the human papillomavirus (HPV). It is thus crucial to increase early detection through increasing awareness and knowledge among the medical profession, patients and the public. As all cancers, early detection is crucial for quality of life and survival. A number of risk factors that have been addressed can lead to oral cancer, including smoking and alcohol consumption, but also the sexually transmitted human papillomavirus (HPV) for which a vaccine exists. Patients need to be made aware that they need to go to a dentist regularly to facilitate early detection of oral cancer, which only has a 50% survival chance when detected late. CED advises that HPV vaccination should be offered to girls and boys.
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Response to Requirements for Artificial Intelligence

6 Aug 2021

The Council of European Dentists (CED) welcomes the European Commission’s Proposal for a Regulation on AI to establish a legal framework on AI Systems and believes it to be a step in the right direction in the EU’s effort to categorize AI applications according to risk and acceptability. As in other sectors, AI is also increasingly applied in healthcare, and dentistry is no exception. The human factor is particularly relevant for professions such as dentists that are relying on patient trust. Algorithms can help dentists in making diagnoses, guided by the principles of patient-centered health care, but the CED believes that they should never replace them in this task. In healthcare, trust and empathy are of crucial importance and cannot be replaced. Thus, suitable regulatory frameworks are required to assure their safe usage and to define the boundaries of AI applications in healthcare. Apart from diagnosis, treatment and patient management, the CED recognises the wider potential for the application of AI in dentistry. An example of recent innovation could be AI-driven orthodontics where AI could offer automation of the procedure i.e., going from the 3D scan to the appliance without any user intervention. This would mean that AI would take over several steps that are now done by humans and allow for fully customised and personalised appliances. AI application in implantology and endodontics creates even more opportunities for more precise treatment and preventive actions. Robotic dental procedures would require AI for vision, instrument manipulation and real-time decision making. We would like to share the following key points to ensure that the application of AI in healthcare benefits patients: - The draft Regulation needs to establish clarity as to the conditions under which AI processes can be used, especially in view of the MDR Regulation (EU) 2017/745. There is concern that the existence of different risk assessments under the AI and MDR might create confusion. We believe that this is needed for legal certainty and consistency reasons and to avoid interpretation issues. - The draft Regulation would need to clarify how human oversight and the provision of information to users is defined and applicable, especially, examples from medical device software would be appreciated. Algorithmic transparency is also crucial to ensure patient rights to information and explanation of how a decision might have been reached. Clear standards and legally binding assessment criteria to ensure transparency of AI systems in healthcare are needed. - The draft Regulation should ensure full respect of EU data protection rules (notably the GDPR), while observing the balance between the interests of advancements in medical research and citizen protection. - The list of high-risk AI systems detailed in Annex III of the draft Regulation currently lacks some use cases which involve significant risks, such as the use of AI for assessing medical treatments or for health research purposes. The Annex will need to be regularly updated to ensure that its scope is appropriate. - To digitally revolutionize the healthcare system, an educated, well-trained workforce is paramount. The EU and Member States should put in place mechanisms to ensure professional and educational assistance to both patients and the healthcare professionals to better understand and assess AI decision-making. Priority should be given to the implementation of digital skills education into the healthcare studies curriculum. Professionals should have the opportunity to undertake courses on algorithm functioning, as well as receiving adequate training on AI tools management. The workforce needs to be appropriately trained and financially supported during the introduction and application of AI systems in healthcare settings. Understanding AI processes and their application is a first step in supporting confidence in AI technologies among healthcare professionals, including dentists.
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Response to Mercury – review of EU law

26 Mar 2021

Please find attached the Council of European Dentists (CED)'s reply to the Inception Impact Assessment on the Revision of Regulation (EU) 2017/852 on mercury, and repealing Regulation (EC) No 1102/2008.
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Response to A European Health Data Space

3 Feb 2021

The Council of European Dentists (CED) welcomes the opportunity to provide feedback on the assessment by the European Commission on the need for a legislative proposal on the European Health Data Space (EHDS). A robust and secure EHDS is long overdue and has the potential to create new ways to communicate between health care professionals and patients and to empower the latter. The CED key objectives are to promote high standards of oral healthcare and dentistry and effective patient-safety centred professional practice. Digital health poses a critical challenge to the personal health data protection of patients. The CED emphasises the importance of compliance with the Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation [GDPR]) while processing personal data of individuals in the EU. Patients must give their explicit consent for use of their health data and can withdraw it whenever needed, except for the cases explicitly mentioned in the GDPR. Access for all healthcare professionals with a legitimate reason, to national and European health records will result in the improvement of the quality and continuity of care offered to citizens. Access to health-related information should be given to healthcare professionals, whether they are part of the public system or not. Dentists should have access to medical system databases which contain information on patients’ medical and social history. Following the development of the European Health Record, CED recommends that a dental data set should be included in the cross-border information exchange. The EHDS should also contribute to a reduction of the existing fragmentation of rules on health data processing and scientific research to ensure the legitimate and ethical use and re-use of the data within the EHDS. The CED believes that easier access to patients’ data should always be backed by strong data protection safeguards. Anonymization and pseudomisation should be the default position for information provision. In case of data misuse resulting in patient harm, transparency, liability and remedy procedures should be in place. The CED recognises and values the potential of AI in terms of augmenting capabilities, enhancing efficiency and accuracy and reducing costs. AI needs vast amounts of data to be developed. This, however, also raises new questions about the security of personal data, reliability of algorithm-driven diagnosis, transparency, ethical use of AI, and the extent of accountability and responsibility of developers and healthcare professionals. CED acknowledges the difficulty of creating an ‘ideal’ environment for AI implementation and advocates for early inclusion of dentists in the discussion on the process of health care AI design and development and professional oversight over AI clinical validation. It is crucial to develop rules for testing, validating and tracking the performance of AI algorithms in clinical practice. In this context: • Algorithmic transparency is crucial to ensure the need to respect patient rights to information and explanation. • Privacy of the individual patient must be safeguarded. • In terms of data collection, patient consent must always be obtained, and patients need to be informed about who accessed their medical records and when, ensuring that personal health data is used in a scientifically sound and ethically acceptable manner. • An educated, well-trained workforce is paramount to the successful introduction of new technologies into healthcare. • A robust ethical and regulatory framework is needed. • The involvement of healthcare professionals at an early stage of every discussion on digital technologies in healthcare is essential.
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Response to Europe’s Beating Cancer Plan

3 Mar 2020

The Council of European Dentists (CED) welcomes the Roadmap on Europe’s Beating Cancer Plan as a timely and much-needed initiative. CED believes that prevention is better than cure, and therefore is of the opinion that the plan is heading in the right direction by shifting the focus from a curative to a preventive approach and integrating healthy living issues. CED is highly concerned with oral cancer and would like to emphasize that oral cancer needs to be taken into consideration in the plan along with other cancers that were explicitly mentioned. Oral cancer includes cancers of the lip, tongue and oral cavity. In Europe, oral cancer is the 10th most common cancer, with around 13,800 new cases diagnosed each year in the EU. CED would like to mention that dental practitioners take their responsibility of being at the frontline of early detection of oral cancer seriously. More than half of all cancers, including oral cancer, can be prevented by eliminating common risk factors as tobacco, alcohol, poor nutrition, lifestyle choices and through education, raising awareness, and regular screening tests. Some cancers may be prevented through vaccines, as the vaccination against human papilloma virus (HPV). 5% of the cancers are caused by HPV 16. While the roadmap outlines preventive measures, as healthy living decisions, it does not focus enough on tackling social and economic disparities, that lie at the root of many people's options in their health choices. Research shows that oral cancer affects disproportionately many people in lower socioeconomic classes. Rates of incidence are associated with the socioeconomic status. These socially vulnerable and excluded groups face increased burdens of oral cancer and greater barriers to access prevention and treatment. Usually, survival rates of cancer also have marked differences between socio-economic groups as they are higher for affluent groups. Oral cancer is one of the cancers with the lowest survival rate in the EU, due to late detection. The survival rate decreases from 80% in cases of early detection to just 50% in case of late detection. As with other cancers, the five-year survival rate of oral cancer is high if caught early. However, once the cancer has metastasized, that rate drops considerably. Early diagnosis is thus crucial, and dentists can play an important role. A best practice example could be the joint early detection and intervention program for Oral Cancer of the Portuguese Ministry of Health and the Portuguese Dental Association which brings together healthcare professionals from different specializations including primary healthcare to improve early diagnosis. CED is happy to provide more information if this would prove useful. We acknowledge that where it concerns oral cancer there are no national cancer plans in place in many EU countries along with the necessary funding for them and not every cancer patient in Europe will receive the same level of care or the same type of cancer treatment. Oral cancer survival rates show distinct geographical differences across Europe. Access to innovation also tends to be unequal. CED believes that the action plan should aim for every European citizen to have the same opportunities independently of where they live. The CED calls on Europe’s Beating Cancer Plan to: •Promote healthy lifestyles and reduce exposure to risk factors, inform citizens and raise awareness of cancer, the importance of early detection and prevention; •Provide cancer patients with the best possible treatment and care, exchange information on best practices for diagnosis, treatment, rehabilitation and palliative care; •Encourage research that aims to identify the causes of cancer and to develop better strategies for prevention, diagnosis, treatment and cure; •Tackle the root causes of poverty and inequality. Prevention and early detection must be directed towards those from low socioeconomic groups where there is the greatest risk and need.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

4 Jul 2019 · - Future of health in the EU - Awareness campaigns for oral health - Vaccines - AMR

Response to European Electronic Health Record (EHR) Exchange Format

3 Dec 2018

The CED recognizes that digital health services play an important role in supporting and enhancing communication and sharing of knowledge with patients. In addition to that, advances in digital technology are providing new diagnostic tools, documentation capabilities and fabrication methods that enhance dentists’ ability to provide optimal care. The CED is supporting the initiatives aiming to improve the secure cross border data exchange required for a digital transformation of healthcare in the Digital Single Market. As the organization representing dentists we stress the need of early involvement of healthcare professionals in a discussion on implementation of digital technologies as they are the users making the system operational. Therefore, more investment and promotion of digital literacy is required (at national, regional and local level), through financing models and reimbursement schemes. This should cover appropriate education, identification of barriers to digital tools access, training and support of dentists and the dental team. Member States started the transformation of their healthcare system at their own pace and lack of coordination and harmonization of standards prevents from broader cross border collaboration. Without the common framework and evaluation of common technical specification, the interoperability will not be ensured. All Member States are wrestling with similar problems but on a national basis which is too limited to allow them to seize all the opportunities and deal with all the challenges of this transformational change. We would urge interoperability of national solutions in order that subsequent cross-border initiatives can be more easily completed. The CED supports the definition of a minimum common set of patient data for the exchange of core information to ensure effective interoperability of eHealth systems. The CED welcomes the recommendations listed in the Roadmap and maintains committed to monitor their transposition into concrete actions on the national level. For more information on the CED position, in the attachment you can find the CED Resolution on Data Sharing as part of eHealth: Workflow, Prescription and Protection.
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