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Chapter 28, Health Protection, 16 May 2011

Chapter 28, Health Protection, 16 May 2011. Organizational Chart of the Ministry of Welfare. Tobacco. Manufacture, presentation and sale of tobacco products EU:

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Chapter 28, Health Protection, 16 May 2011

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  1. Chapter 28, Health Protection, 16 May 2011

  2. Organizational Chart of the Ministry of Welfare

  3. Tobacco Manufacture, presentation and sale of tobacco products EU: • Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products. ICE: • The legislation is fully transposed into Icelandic law. In force since 30 June 2006. • Implemented by amending the Tobacco Control Act No 6/2002- see English translation: http://eng.velferdarraduneyti.is/acts-of-Parliament/nr/19484 • and by issuing Regulation No 236/2003 on warning labeling on tobacco and measurement and maximum yields of harmful substances.

  4. Tobacco (cont.) Advertising and sponsorship of tobacco products EU: • Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products. ICE: • The legislation is fully transposed into Icelandic law – In force April 8 2009. • Iceland had a minor problem with Art. 3 of the Directive concerning the meaning of “Professionals in trade”, as tobacco is sold in food stores in Iceland and only one special tobacco store exists. The Directive was implemented by amending the Tobacco Control Act No 6/2002, amended by Act No 33/2009. • Iceland was among the first nations to enact a ban on tobacco advertising. Since l971 there has been a clear trend in legislation which has led to a total ban on tobacco advertising and other forms of promoting tobacco goods, which is found in Art 7 of the Tobacco Control Act No 6/2002, see also Regulation No 326/2007 on Smoking Restrictions and Regulation No 236/2003 on warning labeling on tobacco and measurement and maximum yields of harmful substances.

  5. Tobacco (cont.) Use of colour photographs or other illustrations as health warnings on tobacco packages EU: • Commission Decision 03/641/EC of 5 September 2003 on the use of colour photographs or other illustrations as health warnings on tobacco packages. • Decision C 2005/1452/EC of 26 May 2005 on the library of selected source documents containing colour photographs or other illustrations for each of the additional warnings listed in Annex 1 to Directive 2001/37/EC of the European Parliament and of the Council . • Decision C 2006/1502/EC on amending Commission Decisions C 2005/1452 on the library of selected sources documents containing color photographs or other illustrations for each of the additional warnings listed in annex 1 to Directive 2001/37. ICE: • The provisions of the Decision 03/641/EC of 5 September 2003 have been implemented by amending Art 6 of the Tobacco Control Act No. 6/2002. The Minister of Welfare is permitted to issue regulations on photographic warnings in accordance with the EU Directives and Decisions. • Concerning Decisions C 2005/1452/EC and Decision C 2005/1502/EC, The Ministry of Welfare has prepared amendments to Regulation No 236/2003 on health warnings on tobacco products in order to permit the use of color photographs as health warnings in accordance with the Commission Decision. The Regulation in currently undergoing technical notification process and can be found on ESA web-page: http://www.eftasurv.int/media/notification-of-dtr/2011_9005_IS._2pdf.pdf

  6. Tobacco (cont.) WHO Framework Convention on Tobacco Control EU: • Council Decision 04/513/EC of 2 June 2004 concerning the conclusion of the WHO Framework Convention on Tobacco Control. ICE: • Iceland ratified the Framework Convention on Tobacco Control in 2004. • The Icelandic Tobacco Control Act No. 6/2002 contains strict legislation on Tobacco Control and the general principles in the Convention were already a part of the Icelandic legislation and administration when the Convention was ratified. • Iceland has not participated in the follow up of the FCTC, including the work of the Conference of the Parties and Intergovernmental Negotiation Bodies.

  7. Tobacco (cont.) Prevention of smoking and initiatives to improve tobacco control Smoke-free environments EU: • Council Recommendation of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control. ICE: • The Icelandic legislation in this field already fulfils the requirements being made in the Council Recommendation on smoke-free environments. The Tobacco Control Act No. 6/2002 and governmental regulations on tobacco are in accordance with the Council Recommendation. They go even further as the sale of tobacco in vending machines is forbidden and there is a total ban on advertising tobacco products. There is a visibility ban of tobacco at points of sale.

  8. Communicablediseases Specificquestionsto ICE from EU: • Iceland's plans relatedto a possiblefuturedevelopment of thecommunicablediseasesreportingsystem, inparticularconcerning: reportingoncryptosporidiosisandyersiniosis; diagnosticcapacityandreportingonmalariaandtetanus (consideringalsolaboratoryarrangementwithanothercountry). Thereportingsystem of communicablediseasesinIceland is continuouslybeeingrevised. AlthoughthesepathogensarerareinIcelandthaywillbeincludedinthereporting. Malaia is not anendemicdiseaseinIceland (nomosquitoesinIceland). Cases (imported) arenotifiable. Tetanus is a subjecttoregistrationbut is a veryrarediseaseinIceland. LaboratoryfacilitiesinIcelandaresufficient. • Is thereanyconsideration of theissue of threediseasesthathadbeenroutinelyreported (syphilis, tetanusandtoxoplasmosis ) upto 2008, butwere, surprisingly, not reportedonin 2009? Syfilis is a sublecttoregistrationinIceland. In 2009 therewerenocases of syfilisreportedinIceland. Thesameapplies for tetnaus. Toxoplasmosis is a notifiabledisease. Nocasesreportedin 2009.

  9. Communicable diseases Laws and regulations EU: • Decision No 2119/98/EC of the European Parliament of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. ICE: • Act on Health Security and Communicable Diseases No. 19/1997 - see English translation: http://eng.velferdarraduneyti.is/media/Reglugerdir-enska/Act_on_Communicable_Diseases_2007.pdf.

  10. Communicablediseases (cont.) Case definitions for reporting communicable diseases to the Community network EU: • 2000/96/EC: Commission Decision of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council. ICE: • Regulation no 420/2008 on reporting of communicable diseases under Act on Health Security and Communicable Diseases No. 19/1997 .

  11. Communicablediseases(cont.) Participation in the early warning and response system for the prevention and control of communicable diseases (EWRS) Early warning and response • 2009/547/EC: Commission Decision of 10 July 2009 amending Decision 2000/57/EC on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document number C(2009) 5515). Health Security Committee • COMMUNICATION FROM THE COMMISSION TO THE COUNCIL on transitional prolongation and extension of the mandate of the Health Security Committee in view of a future general revision of the structures dealing with health threats at EU level. Iceland • Ministerial decision for Icelandic participation in EWRS and HSC

  12. Communicablediseases(cont.) Seasonal influenza vaccination • Regulation No, 221/2001 on vaccinations in Iceland • Seasonal vaccination recommended for • People ≥ 60 years of age • People at risk (lung and heart diseases etc.) • (Available for all) • ≈ 17% of the total population vaccinated • ≈ 20-30 % of risk groups vaccinated. • Aim for 75% of the risk groups covered. • Co-operation with ECDC • The European Influenza Surveillance Network (EISN). Epidemiological and virological surveillance data on influenza are collected through The European Surveillance System (TESSy).

  13. Communicablediseases(cont.) Prevention and control of healthcare associated infections • ECDC • Antimicrobial Resistance and Healthcare-associated Infections Programme.  • ICE • Regulation no 414/2007 on measures against health threats an communicable diseases.

  14. Communicablediseases(cont.) For consideration • Act no. 19/1997 on Health Security and Communicable Diseases • Art. 9. A physician who discovers through his/her work that an individual is infected with a disease that is subject to registration by the provisions of this Act, or has reason to believe this is so, shall immediately inform…1) the Chief Epidemiologist. • Directors of laboratories, hospital departments and other health institutions are subject to the same obligation. Laboratories carrying out tests of samples from patients with communicable diseases as provided in this Act must be licensed by the Ministry of Welfare. • Those involved are under an obligation to assist [the Chief Epidemiologist and the relevant district physician, cp. par. 4, Art 4],1) e.g. by providing information they regard as necessary for measures against spread of disease. • [Directors of health care institutions must send the Chief Epidemiologist information of the quantity of antimicrobial drugs used in the institution in question, classified by department when appropriate.]2) • 1)Act 93/2002, Art. 16. 2) Act 55/2004.

  15. Blood Quality and safety of human blood and blood components: EU: • Dir. 02/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance). • Dir. 04/33/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance). ICE: • Fully transposed by Iceland • Both directives implemented on 24 May 2006 with [Regulation No 441/2006 on collection, processing, storage and distribution of blood].

  16. Blood (cont.) Quality system for blood establishments: EU: • Dir. 05/61/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance). • Dir. 05/62/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance). ICE: • Fully transposed by Iceland. • Both directives implemented with [Regulation no. 441/2006 on the collection, treatment, storage and distribution of blood, with amendments no. 411/2010 and 1024/2007)] .

  17. Blood (cont.) EU: • Dir. 2009/135/ECallowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic. ICE: • Fully transposed by Iceland. • Implemented with [Regulation no. 441/2006 on the collection, treatment, storage and distribution of blood, with amendments no. 411/2010] .

  18. Tissuesandcells Quality and safety of human tissues and cells EU: • Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. ICE: • Fully transposed by Iceland. • Implemented on 25 October 2007 with [Regulation No 990/2007 on quality and safety when treating (handling) human tissues and cells, Regulation No 990/2007 has since been replaced with Regulation No 1188/2008].

  19. Tissuesandcells (cont.) Quality and safety of human tissues and cells (cont.) EU: • Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. • Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. ICE: • Commission Directive No 2006/17/EC and Commission Directive No 2006/86/EC were implemented by [Regulation No 990/2007 on quality and safety when treating (handling) human tissues and cells. Regulation No 990/2007 has since been replaced with Regulation No 1188/2008] .

  20. Organs Quality and safety of human organs intended for transplantation: EU: • Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. • Communication from the Commission Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States. ICE: • [Act on the rights of live organ donors for temporary financial assistance, no. 40/2009]. • [Act on procurement of organs, no. 16/1991]. • [Act on determination of death, no. 15/1991].

  21. Tissuesandcells(Cont.) Guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells: EU: • Commission decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for the Directive 2004/23/EC of the European Parliament and the Council (2010/453/EU). ICE: • Underconsideration (Not yetincorporatedintothe EEA Agreement).

  22. Mental Health EU: • Council Recommendation of 18 June 2003 on the prevention and reduction of health-related harm associated with drug dependence. • Council conclusions of 15 November 2001 on combating stress and depression-related problems. • Council Conclusions of 2 June 2003 on combating stigma and discrimination in relation to mental illness. • Council conclusions 9805/05 on a Community Mental Health Action of 3 June 2005 • EU Pact on Mental Health and Well-being, 2008. ICE: • Regulation No 920/2006 on planning and implementation of health and safety at workplaces. • Regulation No 426/1999 on work participation of children and adolescents - see English translation: http://eng.velferdarraduneyti.is/legislation/regulations/nr/960 • Regulation No 931/2000 on precautions to increase security and health in the workplace for impregnated women, women that have recently given birth or those breastfeeding . • Regulation No 1000/2004 on action against bullying in the workplace. • Regulation No 787/2007 on Primary Health Care Facilities.

  23. Socio-economic determinants of health-health inequalities EU: • Commission Communication – Solidarity in Health: Reducing Health Inequalities in the EU, published on 20 October 2009. • EP Resolution on Reducing Health inequalities in the EU, adopted 8 March 2011. • Europe 2020 Strategy. • EU Health Programme. • EU PROGRESS (2008-2013). • EU Structural Funds.

  24. Socio-economic determinants of health-health inequalities (cont.) ICE: • National Health Plan 2020 (draft). • Reports on drug consumption from Research and Analysis, 2010. • Reports from the Public Health Institute on Obesity, nutriation and physical activity, 2010. • Housing Policy, report 2011. • Cost of living index, report 2011. • Violence against women, report 2011. • Food support to vulnerable groups, report 2010.

  25. Alcoholabuseprevention EU: • EU Alcohol Strategy. • The European Union Information System on Alcohol and Health (EUSAH), (COM & WHO). • The European school survey project on alcohol and other drugs (ESPAD). ICE: • National Health Plan to year 2020 (draft). • National ESPAD reports. • Reduce youth drinking. • Reduce drink driving. • Not advertising of alcohol .

  26. Cancer Questions to ICE from EU: • Iceland has nominated a representative to the European Partnership for Action Against Cancer - that was Ms Gudrun Sigurjonsdottir, who was at the time of nomination at the Embassy of Iceland in Brussels. SANCO has been informed that she is no longer there. Please provide either new contact details of the nominated representative or a new contact person to re-establish the contact. Ms Gudrun Sigurjonsdottir will remain the contact until a new contact will be established (likely to be the same contact as the contact to SANCO). • Please provide information on the current status/if any developments on colorectal cancer screening. In 2008 there was a plan for introduction of a colorectal cancer screening programme in Iceland based on fecal blood detection and colonoscopy of those positive for blood. The age group to be screened was 60 – 69 years of age. A regular screening of colorectal cancer in this age group is expected to start in 2013. Aware of the European guidelines for quality assurance in colorectal cancer screening and diagnosis 1 st edition published in February 2011.

  27. Cancer Questions to ICE from EU (cont.): 3) Please provide more information on the breast and cervical cancer screening programmes which were reported to be in conformity with Council Recommendation on cancer screening and the relevant guidelines (e.g. what is the coverage of the target population, is there any explanation for the attendance rate of 62% in breast cancer screening - is higher participation targeted in the future?). – The National Cancer Registry is looking into this at the moment.

  28. Cancer EU: • Council Recommendation of 2 December 2003 on cancer screening. • Council Conclusions on reducing the burden of cancer (10 June 2008). • Council Conclusions on action against cancer (13 September 2010). ICE: • There are legislative and regulatory provisions in force in the area of Cancer, i.e. the Health Service Act No 40/2007, Health Insurance Act No 112/2008, and Regulation No 1204/2008 on the cost of health service paid by the patient. Research has to be in accordance with Regulation No 286/2008 on scientific research in the health care sector. There are no legislative or regulatory provisions in force regarding Cancer screening and cancer treatment. There are, however, administrative provisions. • Concerning recommendation of 2 December 2003 on screening for breast, cervical and colorectal cancer: Screening for breast and cervical cancer is performed in accordance with the European guidelines. However, colorectal cancer screening will wait for some time due to the fact that it is difficult to allocate funds to new activities because of the economical situation in Iceland. Nevertheless, survival rates after cancer diagnosis are among the best in Europe. Vaccinations of all 12 year old girls against HPV infection and cervical cancer were approved in June 2010 but a decision on when to start these vaccinations has yet to be taken do to the same reason as for colorectal cancer screening.

  29. Cancer (cont.) ICE: • Concerning the Council Conclusionson reducing the burden of cancer (10 June 2008) and on action against cancer (13 September 2010), the Minister of Welfare has announced that he will start work on a comprehensive Cancer Plan this summer. The Icelandic Health Plan to the year 2020 is under way and one of the priority projects are Cancer prevention. Concerning population-based cancer registration, a National Cancer Registry operated by the Icelandic Cancer Society on behalf of the Directorate of Health. The National Cancer Registry contains information on cancer diagnosis in Iceland since 1955 and it is one of few such registries containing information on a whole nation.

  30. HealthandEnvironment Limitation of exposure of the general public to electromagnetic fields EU: • 1999/519/EC: Council Recommendation of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz). ICE: • According to paragraph 1 of section 4 of Act No 44/ 2002 on Radiation protection (Unofficial English translation: http://www.gr.is/media/stofnunin/law2002English.pdf), the Icelandic Radiation Safety Authority (IRSA) must implement safety measures against radiation from any radiological equipment. The Institute is under the auspices of the Minister of Welfare. Its role is to implement safety measures against ionizing radiation from radioactive substances and radiological equipment. The definition of radiological equipment includes non-ionizing radiation, such as sun beds, mobile phones, high-voltage lines etc. Specific Governmental Regulations enforced by IRSA exist for the use of lasers and sun beds, but not for electromagnetic fields. However, IRSA uses the ICNIRP’s 1998 reference values as basis for the safe use of electromagnetic fields. These limits are the same as in the EU 1999 recommendation. • IRSA has the administrative and technical capacity to fulfill the requirements of the acquis on electromagnetic fields. IRSA has equipment and expertise to measure fields from 1 Hz to 5 GHz. One of the technical experts at IRSA is assigned the task of monitoring public exposure of electromagnetic fields.

  31. RareDiseases EU: • Council Recommendation of 9 June 2009 on a European Action in the field of rare diseases - Rec. 2009/C 151/02. • 2009/872/EC: Commission Decision of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases. ICE: • There are no legislative or regulatory provisions. The Ministry of Welfare has decided that rare diseases in accordance with the Council Recommendation shall be within the domain of the Chief Epidemiologist. • Iceland participates in the committee of Expert on Rare Diseases, Dr. Sveinn Magnússon at the Ministry of Welfare is a member and the Chief Epidemiologist Dr. Haraldur Briem an alternate.

  32. Prevention of injuryandpromotion of safety EC: • 07/C164: Council Recommendation of 31 May 2007 on the prevention of injury and the promotion of safety. ICE: • No legislative or regulatory provisions in force. There are however administrative provisions. In accordance with Medical Directorate of Health Act No. 41/2007 (with amendments) and on Directorate of Health and Act on Traffic No. 50/1987.

  33. Preventionof injuryandpromotion of safety (cont.) EU: • Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. ICE: • The Chief Epidemiologist is legally obliged to monitor the consumption of antimicrobial agents in humans, according to item 3 and 4, Art 3, item 3 Art 5, item 4, Art 9 of Act No 19/1997 on Health Security and Communicable Diseases. The Chief Epidemiologist is also legally obliged to monitor healthcare associated infections according to Art 4 of Regulation No 420/2008. The Chief Epidemiologist is legally obliged to provide advice to physicians and others dealing with measures to combat the inappropriate use of antimicrobial agents and to promulgate information and educational material to the public on these matters according to items 5 and 6, Art 5 of Act No 19/1997 on Health Security and Communicable Diseases.

  34. Patients‘ rightsincross-borderhealthcare EU: • Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare. Transposed into national law before 25th October 2013. • Commission of the European Communities: Proposals for a Directive of the European Parliament and the Council on the application of patients´ right in cross-border healthcare. Brussels, 2.7.2008, COM(2008) 414 final. ICE: • Act on Health Insurance no. 112/2008; paragraphs 8. and 23 – see English translation: http://eng.velferdarraduneyti.is/acts-of-Parliament/nr/20110 • Regulation No. 712/2010 on urgent medical treatment abroad when it can not be undertaken in Iceland. • Preparation for the incorporation of the cross-border healthcare directive into national law has started. • Report on Cross-border healthcare soon to be published by the Ministry of Welfare.

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