Newborn screening in Europe Expert Opinion document

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FINAL 28/08/2011population health, ranging from health promotion and disease prevention to treatment andrehabilitation. 22 Moreover, benefits tend to be defined more broadly now to include moreintermediate outcomes, such as preparing parents prior to the onset of illness and reduction inthe length of the diagnostic odyssey, even if life expectancy or quality of life of the patientmay not be altered. As the definition of benefit evolves, this raises questions of what issocially acceptable. The potentially broadening goals of NBS (from identifying conditionswhere irreparable health damage can be avoided by early diagnosis to include reduction ofdiagnostic odyssey) should be subject to public debate.Neonatal screening programs and related interventions should be defined in a way that theyare consistent with the overall health care strategies, capacities and the culture of a country.Screening goals and benefits should be assessed versus goals and benefitsestablished/accepted for other clinical and public health interventions and strategies adoptedin the country. The opportunity offered by neonatal screening should also be assessed takinginto consideration the possibility of screening at a later life stage, for those goals(reproductive choices?) and disorders where preventive intervention is still timely, so thatparticipation in screening can be decided directly by the subject. Presymptomatic testing inminors shall generally be limited to conditions where there is direct benefit, because earlytreatment can prevent irreparable damage.Relevant charters, declarations and principles recognised by EUmember statesBesides the Wilson and Jungner criteria 25 for neonatal screening (Chapter 4), which have beenfollowed with varying flexibility in many EU countries, other principles have been developedfor different purposes, which, however, have bearing on the context of neonatal screening andon this document.Article 168 of the Treaty on European Union 26 indicates that a high level of health protectionis to be sought in the Union policies, with the European Union action being subsidiary tonational policies.In 2006 the EU EPSCO Council also signed a declaration 27 recognizing that universality,access to good quality care, equity and solidarity are common values of the EU healthsystems, although differences in approaches and the need for financial sustainability limit theuniform operation of the health care in EU. It is also recognised that EU citizens should findhealth systems anywhere in the EU that operate on principles such as quality; safety; care thatis based on evidence and ethics; patient involvement; redress; privacy and confidentiality.The charter of fundamental rights of the European Union 28 , solemnly proclaimed by the EUParliament, the Council and the Commission in 2007, recognises, among other fundamentalrights:the free and informed consent of the person concernedthe prohibition of eugenic practices25 http://whqlibdoc.who.int/php/WHO_PHP_34.pdf26 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:083:0047:0200:EN:PDF27 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:146:0001:0003:EN:PDF28 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2007:303:0001:0016:EN:PDF14
FINAL 28/08/2011Non-discrimination (with reference to any discrimination based on any ground such assex, race, colour, ethnic or social origin, genetic features, language, religion or belief,political or any other opinion, membership of a national minority, property, birth,disability, age or sexual orientation).Children shall have the right to such protection and care as is necessary for their wellbeing.They may express their views freely. Such views shall be taken into considerationon matters which concern them in accordance with their age and maturity.Health care: Everyone has the right of access to preventive health care and the right tobenefit from medical treatment under the conditions established by national laws andpractices.A large number of EU countries have also signed the Council of Europe Convention onHuman Rights and Biomedicine, 29 whose aim, as defined in Article 1, is to protect the dignityand identity of all human beings and guarantee everyone, without discrimination, respect fortheir integrity and other rights and fundamental freedoms with regard to the application ofbiology and medicine. This document underlines fundamental aspects with regard to consent,the protection of persons not able to consent, private life and right to information, nondiscrimination,non-selection of sex, protection of persons undergoing research, research onembryos in vitro, and organ and tissue removal. With regard to consent, interventions in thehealth field may only be carried out after the person concerned has given free and informedconsent to it. This person shall beforehand be given appropriate information as to the purposeand nature of the intervention as well as on its consequences and risks. Where, according tolaw, a minor does not have the capacity to consent to an intervention, the intervention mayonly be carried out with the authorisation of his or her representative or an authority or aperson or body provided for by law, and may only be carried out for direct benefit of thatperson.On 7 May 2008 the Committee of Ministers of the Council of Europe adopted the AdditionalProtocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testingfor Health Purposes. 30 Although this document is not a binding document at this moment, ithas underlined various crucial elements in the provision of genetic services. In particular, itunderlines the non-discrimination and non-stigmatisation, the quality of genetic services, theimportance of clinical utility, individualised medical supervision, information, geneticcounselling and consent, protection of persons not able to consent, respect for private life andright to information, genetic screening programs.Article 19 states that “A health screening program involving the use of genetic tests may onlybe implemented if it has been approved by the competent body. This approval may only begiven after independent evaluation of its ethical acceptability and fulfillment of the followingspecific conditions:a) the program is recognised for its health relevance for the whole population or section ofpopulation concerned;b) the scientific validity and effectiveness of the program have been established;29 http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=&DF=&CL=ENGIn total 28 countries have signed and ratified this text. But important countries such as U.K., the Netherlands,France, Belgium, Poland, Germany did not ratify it yet.30 http://conventions.coe.int/Treaty/en/Treaties/html/203.htm15
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