Snus and snus-like nicotine products moving across Nordic borders: Can laws protect young people?

Background: Use of snus and snus-like nicotine products is increasing, in particular among young people, in several Nordic countries and Estonia, while snus is legally on the market only in Sweden and Norway. Snus is available in a great variety of tastes and packaging particularly catering for young users. Recently, strong snus-resembling nicotine pouches have emerged on the market. This research investigates the regulatory means to counteract this development. Methods: European Union (EU) and national tobacco control legislation, case law of the European Court of Justice (CJEU) and relevant public health studies are analysed. Results: The research finds that the judgement of the CJEU relating to the sale of snus on Finnish ferries has not been enforced. Permitted large traveller imports for personal use have contributed to wide availability of snus in Finland. Even if the legislation in Sweden is in conformity with the exemption it obtained in the Accession Treaty, the public health impact of snus use for young people in its neighbouring countries has become considerable. Nicotine pouches, -which are not regarded as medical products in terms of medicine legislation, lack harmonised EU-wide regulation. Controlling smuggling across open borders is challenging. Conclusions: The legislation at the EU and national levels should be able to protect young people from new tobacco and nicotine products. It is urgent to harmonise regulation relating to new tobacco and nicotine products taking as a base a high level of protection of health as required in the Treaty on the Functioning of the EU.

Legacy samples in Finnish biobanks: social and legal issues related to the transfer of old sample collections into biobanks.

Biobank operations started officially in Finland in 2013 when the Biobank Act defining and regulating biobank operations came into force. Since then, ten biobanks have been established and they have started to collect new prospective samples with broad consent. The main corpus of biobank samples, however, consists of approximately 10 million "legacy samples". These are old diagnostic or research samples that were transferred to biobanks in accordance with the Biobank Act. The focus of this article is on ambiguities concerning these legacy samples and their transfer in terms of legality, human rights, autonomy, and social sustainability. We analyse the Finnish biobank operations in the context of international regulation, such as the European Convention of Human Rights, the Oviedo Convention, European Charter of Fundamental Rights, the GDPR, and EU Clinical Trials Regulation, and show that the practice of using legacy samples is at times problematic in relation to this regulatory framework. We argue that the prevailing interpretations of these regulations as translated into the Finnish biobank practices undermine the autonomy of individuals by not giving individuals a right to consent or an actionable right to opt-out of the transfer of these legacy samples to the biobank. This is due to the fact that individuals are not given effective notification of such transfers. Thus, issues regarding the legal status of the biobank samples and the social sustainability of biobank operations remain a challenge for biobanks in Finland despite governmental efforts to create pioneering, comprehensive, and enabling legislation.

Proposal for a European Public Health Research Infrastructure for Sharing of health and Medical administrative data (PHRIMA).

In Europe, health and medical administrative data is increasingly accumulating on a national level. Looking further than re-use of this data on a national level, sharing health and medical administrative data would enable large-scale analyses and European-level public health projects. There is currently no research infrastructure for this type of sharing. The PHRIMA consortium proposes to realise the Public Health Research Infrastructure for Sharing of health and Medical Administrative data (PHRIMA) which will enable and facilitate the efficient and secure sharing of healthcare data.