In 1986, European Directive 86/609/EEC, regulating the use of animals in research, was one of the first examples of common legislation to set standards for animal protection across the Member States of the former European Economic Community, now the European Union, with the aim of securing a level European playing field. Starting in 2002, a process of revising European animal experimentation legislation was undertaken, with one of its key aims being to ensure high standards of welfare for laboratory animals across Europe. This resulted in Directive 2010/63/EU, which has regulated this activity in Europe since 2013. Since this is a European Union Directive, transposition into national legislation is a necessary and important part of the implementation of the new legislation. This paper gives an overview of the transposition process followed by an analysis of the potential to reach the different objectives of the directive, particularly with a focus on securing the same high standards of animal protection across member countries. The analysis focuses on three separate issues: (1) minimum standards for laboratory animal housing and care, (2) restrictions on the use of certain animal species, and (3) project review and authorization.

Drawing on the views of donors and recipients about anonymity in a country that is experiencing a transition towards non-anonymous gamete donation mandated by the Constitutional Court, we explore how the intersection between rights-based approaches and an empirical framework enhances recommendations for ethical policy and healthcare. Between July 2017 and April 2018, 69 donors and 147 recipients, recruited at the Portuguese Public Bank of Gametes, participated in this cross-sectional study. Position towards anonymity was assessed through an open-ended question in a self-report questionnaire, which was subject to content analysis. Preference for an anonymous donation regime was mentioned by 82.6% of donors and 89.8% of recipients; and all those with children. Instead of the rights-based reasoning used by the Constitutional Court, donors highlighted concerns over future relationships and recipients focused on socioethical values linked with the safeguard of safety, privacy and confidentiality. The remaining participants advocated the choice between anonymity or non-anonymity (double-track policy), invoking respect for their autonomy. The complex, diverse ethical views and reasoning of donors and recipients expand a traditionally dichotomous discussion. Their perspectives challenge the transition towards non-anonymity and international guidelines, raising awareness to the need for their involvement in the design of policies to enable choice according to their values and preferences, and of psychosocial counselling responsive to their socioethical concerns and sensitive to their parental status. Empirical frameworks complement rights-based approaches to uphold justice, fairness and equal respect, and to incorporate utility, beneficence and non-maleficence in policymaking and healthcare in the transition towards non-anonymity.

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Resumo: Conhecer a discussão em torno dos desafios sociais e éticos da doação de gametas é fundamental para a boa governança das técnicas de reprodução assistida. Neste artigo, analisam-se os tópicos que orientaram o debate nas organizações de ética portuguesas, discutindo as suas conexões com os temas abordados internacionalmente. Para tal, em março de 2018, pesquisamos sistematicamente os websites do Conselho Nacional de Procriação Medicamente Assistida e do Conselho Nacional de Ética para as Ciências da Vida. Procedemos à análise de conteúdo temática de 25 documentos. Os resultados indicam que o debate se centrou na acessibilidade, no anonimato e na compensação de doadores e, em menor extensão, nas responsabilidades profissionais. Observaram-se posicionamentos heterogêneos e tensões entre múltiplos direitos e princípios éticos associados a receptores, a pessoas nascidas com recurso à doação de gametas e a doadores. Esses têm em comum três alegações: a escassez de evidência científica; as experiências de outros países; e regulamentações oriundas de entidades internacionais. Na literatura abordam-se tópicos adicionais, nomeadamente: uma via dupla que conjugue anonimato/identificação de doadores; implementação de sistemas de registo reprodutivo para receptores e doadores; limites do rastreio genético a doadores; doação por familiares/conhecidos; e o papel dos doadores na decisão quanto ao destino de embriões criopreservados e na escolha das características dos receptores dos seus gametas. Há espaço para expandir o debate e promover a pesquisa em torno das implicações sociais e éticas da doação de gametas, considerando a participação de todos os cidadãos.