Paula Lobato de Faria

Pandemic influenza control in Europe and the constraints resulting from incoherent public health laws.

BackgroundWith the emergence of influenza H1N1v the world is facing its first 21st century global pandemic. Severe Acute Respiratory Syndrome (SARS) and avian influenza H5N1 prompted development of pandemic preparedness plans. National systems of public health law are essential for public health stewardship and for the implementation of public health policy[1]. International coherence will contribute to effective regional and global responses. However little research has been undertaken on how law works as a tool for disease control in Europe. With co-funding from the European Union, we investigated the extent to which laws across Europe support or constrain pandemic preparedness planning, and whether national differences are likely to constrain control efforts.MethodsWe undertook a survey of national public health laws across 32 European states using a questionnaire designed around a disease scenario based on pandemic influenza. Questionnaire results were reviewed in workshops, analysing how differences between national laws might support or hinder regional responses to pandemic influenza. Respondents examined the impact of national laws on the movements of information, goods, services and people across borders in a time of pandemic, the capacity for surveillance, case detection, case management and community control, the deployment of strategies of prevention, containment, mitigation and recovery and the identification of commonalities and disconnects across states.ResultsResults of this study show differences across Europe in the extent to which national pandemic policy and pandemic plans have been integrated with public health laws. We found significant differences in legislation and in the legitimacy of strategic plans. States differ in the range and the nature of intervention measures authorized by law, the extent to which borders could be closed to movement of persons and goods during a pandemic, and access to healthcare of non-resident persons. Some states propose use of emergency powers that might potentially override human rights protections while other states propose to limit interventions to those authorized by public health laws.ConclusionThese differences could create problems for European strategies if an evolving influenza pandemic results in more serious public health challenges or, indeed, if a novel disease other than influenza emerges with pandemic potential. There is insufficient understanding across Europe of the role and importance of law in pandemic planning. States need to build capacity in public health law to support disease prevention and control policies. Our research suggests that states would welcome further guidance from the EU on management of a pandemic, and guidance to assist in greater commonality of legal approaches across states.

Ownership Rights in Research Biobanks: Do We Need a New Kind of ‘Biological Property’?

This chapter first revisits the classical ongoing legal debate around ownership rights in human biological material, based on the two opposite perspectives – one that defends an absolute non-patrimonial view, denying the possibility of the existence of a property right in this field and the other that defends the existence of a property right over human bodily material and considers that denying participants in scientific research property right over their biological material may be a source of unfairness to them. Second, it analyses the consequences of the application of classical property rights to the biological material, such as the Portuguese Law does, advancing several arguments from in support of the conclusion that classical property rights do not adjust to the juridical characteristics of human biological material and its use in biobanks for research. The chapter ends up, in a third part, with a draft proposal of a new juridical construction for contemporary law, within property rights, that is, a new concept of ‘biological property’, which should be shaped by a balanced respect for both individual and scientific/society interests and a specific legal framework within property rights law that could reflect the norms of biolaw already applying in our societies to human biological material (e.g. principle of non-commercialisation and principle of informed consent). Because of its novelty and complexity the idea of a ‘biological property’ presented in this chapter is in need of further development. Only an international normative framework would be adequate to create and determine the juridical background of a new kind of property adjustable to human biological material and its significance in modern societies.

Dificuldades políticas, éticas e jurídicas na criação e aplicação da legislação sobre álcool e tabaco: contributo para o desenvolvimento da investigação em Direito da Saúde Pública

Resumo Introducao A aplicacao de leis de Saude Publica na area das determinantes da saude relacionadas com os estilos de vida e comportamentos, onde se incluem as lutas contra o consumo nocivo de alcool e contra o tabagismo, necessita de ser analisada e discutida tendo em consideracao a complexidade muito propria desta realidade, de onde nunca se podem dissociar as medidas a tomar dos varios actores sociais envolvidos. De facto, nestas areas, as actividades de lobby da industria bem como dos agentes de distribuicao e de venda, denotando a existencia de interesses concorrentes com os das politicas de Saude Publica, interferindo nos resultados destas e impedindo a sua efectividade. Material e metodos Tendo por fundo esta premissa, o presente artigo elabora uma breve reflexao sobre os pontos fortes e fracos do uso dos instrumentos legais em Saude Publica, tomando como exemplo as leis do alcool e do tabaco portuguesas, em relacao as quais, situacoes de ambiguidade, indefinicao pratica, faltas de controlo e de sancionamento efectivo do seu incumprimento, impedem uma efectividade das mesmas, ilustrando com exemplos recentes as armadilhas a Saude Publica que podem surgir mesmo em leis cujo objecto e o de reduzir o consumo de substâncias com risco para a saude e os seus potenciais danos. Tal e o caso da lei norte-americana n.° 111–31 de 22 de Junho de 2009 que deu a FDA ( Food and Drug Administration ) o poder de controlar os produtos do tabaco e que tem sofrido duras criticas por parte das autoridades em Saude Publica. Afirmamos o poder incontestavel do instrumento legislativo para mudar comportamentos e atitudes, manifestando, contudo, a preocupacao de que a lei e ainda um instrumento de Saude Publica mal explorado e pouco avaliado. Identificar as forcas e fraquezas nas leis de Saude Publica e uma tarefa tao complexa quanto a multidisciplinaridade das ciencias e a diversidade social dos actores envolvidos. Uma das premissas do processo de elaboracao e implementacao das leis de saude publica, e, pois, a necessidade de um conhecimento aprofundado do contexto a que estas mesmas leis se vao aplicar, incluindo o ambiente e os actores sociais que delas sao alvo. Os efeitos potenciais da lei sao dificeis de prever a partida ou de padronizar, contudo, de acordo com alguns autores que recentemente se tem debrucado sobre o tema, podemos tentar analisar e avaliar o processo legislativo em Saude Publica e os resultados obtidos com o recurso a um modelo logico. Sabemos que apesar do consumo de alcool e danos a ele associados bem como do consumo de tabaco e da exposicao ao fumo deste estarem plenamente documentados no que diz respeito ao risco para a saude individual e colectiva, as politicas publicas preconizadas estao ainda longe de serem efectivas para debelar estas praticas, pelo que todas as discussoes em torno do problema de uma ideal concepcao da lei nos parecem essenciais para se poder comecar a atingir os resultados pretendidos em Saude Publica e nao apenas os resultados possiveis face aos interesses em jogo. Conclusao Com a reflexao apresentada neste artigo, gostariamos de munir os actores e organismos que actuam em prol da Saude Publica em Portugal de alguns instrumentos e argumentos de discussao que permitam promover a accao da lei nas areas acima mencionadas, de uma forma mais esclarecida e pro-activa, bem como de contribuir para o desenvolvimento da investigacao em Direito da Saude Publica, nomeadamente atraves da construcao e utilizacao de metodos eficazes de avaliacao do impacto das leis e das politicas relativas as epidemias comportamentais relacionadas com o estilo de vida, no sentido de melhorar os seus resultados e assim potenciar uma sociedade mais saudavel.