Cancer screening

PURPOSE : to adopt the Council Recommendation on cancer screening. LEGISLATIVE ACT : Council Recommendation 2003/878/EC on cancer screening. CONTENT : the Council adopted a Recommendation on cancer screening. Roughly 1,000,000 EU citizens die from cancer every year and 1 580 096 new cases of cancer occurred in the EU in 1998. The best practices to be generalised by Member States for cancer screening include pap smear screening for cervical cancer precursors, mammography screening for breast cancer and faecal occult blood screening for colorectal cancer. The Recommendation suggests among others the implementation by Member States of evidence-based cancer screening and screening programmes in accordance with European guidelines on best practices. As regards the implementation of cancer screening programmes, the Council recommends that Member States : - offer evidence-based cancer screening through a systematic population-based approach with quality assurance at all appropriate levels. The tests which should be considered in this context are listed in the Annex and concern pap smear screening for cervical cancer precursors starting not before the age of 20 and not later than the age of 30; mammography screening for breast cancer in women aged 50 to 69 in accordance with European guidelines on quality assurance in mammography; faecal occult blood screening for colorectal cancer in men and women aged 50 to 74; - implement screening programmes in accordance with European guidelines on best practice where they exist and facilitate the further development of best practice for high quality cancer screening programmes on a national and, where appropriate, regional level; - ensure that the people participating in a screening programme are fully informed about the benefits and risks; - ensure that adequate complementary diagnostic procedures, treatment, psychological support and after-care following evidence-based guidelines of those with a positive screening test are provided for; - make available human and financial resources in order to assure appropriate organisation and quality control; - assess and take decisions on the implementation of a cancer screening programme nationally or regionally depending on the disease burden and the healthcare resources available, the side effects and cost effects of cancer screening, and experience from scientific trials and pilot projects; - set up a systematic call/recall system and quality assurance at all appropriate levels, together with an effective and appropriate diagnostic and treatment and after-care service following evidence-based guidelines; - ensure that due regard is paid to data protection legislation, particularly as it applies to personal health data, prior to implementing cancer screening programmes. Concerning the issue of registration and management of screening data, the Council recommends that Member States: - make available centralised data systems needed to run organised screening programmes; - ensure by appropriate means that all persons targeted by the screening programme are invited, by means of a call/recallsystem, to take part in the programme; - collect, manage and evaluate data on all screening tests, assessment and final diagnoses; - collect, manage and evaluate the data in full accordance with relevant legislation on personal data protection. As regards the monitoring aspect, it is recommended that the Member States : - regularly monitor the process and outcome of organised screening and report these results quickly to the public and the personnel providing the screening; - adhere to the standards defined by the European Network of Cancer Registries in establishing and maintaining the screening databases in full accordance with relevant legislation on personal data protection; - monitor the screening programmes at adequate intervals. On training, there should be adequately train personnel at all levels to ensure that they are able to deliver high quality screening. Member States should also seek a high level of compliance, based on fully informed consent, when organised screening is offered and take action to ensure equal access to screening taking due account of the possible need to target particular socioeconomic groups. The Council suggests that the introduction of novel screening tests taking into account international research results should be created which would : - implement new cancer screening tests in routine healthcare only after they have been evaluated in randomised controlled trials; - run trials, in addition to those on screening-specific parameters and mortality, on subsequent treatment procedures, clinical outcome, side effects, morbidity and quality of life; - assess level of evidence concerning effects of new methods by pooling of trial results from representative settings; - consider the introduction into routine healthcare of potentially promising new screening tests, which are currently being evaluated in randomised controlled trials, once the evidence is conclusive and other relevant aspects, such as cost-effectiveness in the different healthcare systems, have been taken into account; - consider the introduction into routine healthcare of potentially promising new modifications of established screening tests, once the effectiveness of the modification has been successfully evaluated, possibly using other epidemiologically validated surrogate endpoints. Member States should report to the Commission on the implementation of this Recommendation within three years of its adoption and subsequently at the request of the Commission with a view to contributing to the follow-up of this Recommendation at Community level. The Commission, on the other hand, is invited to report on the implementation of cancer screening programmes, on the basis of the information provided by Member States, not later than the end of the fourth year after the date of adoption of this Recommendation, to consider the extent to which the proposed measures are working effectively, and to consider the need for further action. Equally, it is invited to encourage cooperation between Member States in research and exchange of best practices as regards cancer screening with a view to developing andevaluating new screening methods or improving existing ones and to support European research on cancer screening including the development of new guidelines and the updating of existing guidelines for cancer screening. ENTRY INTO FORCE : 2 December 2003.�