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New roads for compliance in research!

Posted by on 27 April, 2017

New roads for compliance in research!

New rules, binding or not, aimed to regulate research activities, have been recently adopted on a global level. Besides the provisions of General Data Production Regulation regarding research and the Regulation on clinical trials, new rules have been set in the revised edition of the European Code of Conduct for Research Integrity. The Code was published by the European Federation of Academies of Sciences and Humanities in the form of “soft law”.  1) Who are bound by the European Code of Conduct for Research Integrity? The Code sets...

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Big Data & Health: New Guidelines issued by the Council of Europe

Posted by on 23 March, 2017

Big Data & Health: New Guidelines issued by the Council of Europe

The rapid development of informatics and broad Internet use by the majority of institutions, enterprises and individuals has led to proliferation of transferred, collected and stored data. Most of data fall within the definition of personal data and they are subject to legal protection according to international, European and national legal texts. Moreover, health data processing is regulated by stricter rules. Big Data use is expected to contribute to greater efficiency of healthcare services, healthcare cost reduction and finally improvement...

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The new EU Directive on trade secrets enhances whistleblowers’ protection

Posted by on 22 February, 2017

The new EU Directive on trade secrets enhances whistleblowers’ protection

The protection of undisclosed know-how and trade secrets has long troubled businesses, which, irrespective of their size, value trade secrets as much as patents and other forms of intellectual property. For many, confidentiality can be used as a business competitiveness and research innovation management tool, which covers a diverse range of information that extends beyond technological knowledge, to commercial data such as information on customers and suppliers, business plans, market research and strategies. In this context, the EU...

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Food law compliance: Based on administrative monitoring or individuals’ action?

Posted by on 9 February, 2017

Food law compliance: Based on administrative monitoring or individuals’ action?

The number of court decisions regarding violations of food labelling law has proliferated on the other side of the Atlantic, and has amazingly surpassed the number of cases regarding food safety. This can be explained by the fact that technological and scientific advancements have improved the food quality and storage conditions. On the contrary, given that there is fierce competition among food companies, they tend to unlawful practices, one of which is misleading consumers in terms of food ingredients, properties and their origin. 1. Will...

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Food for thought about food law!

Posted by on 19 January, 2017

Food for thought about food law!

In view of the upcoming application of the new rules regarding the declaration of food nutrients on food packaging, our article will focus on the current European legislation on food labelling, which was enacted in the form of Regulation in the entire EU region. When did the new Legislation on food labelling apply? Regulation No 1169/2011 on the provision of food information to consumers came into force on 19 November 2011. However, most provisions came into application on 13 December 2014 except for the Article 9(1) concerning nutrition...

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Drones: a revolution that flies for the healthcare industry

Posted by on 3 November, 2016

Drones: a revolution that flies for the healthcare industry

Drones have recently attracted a lot of attention not only regarding their specific military use but also for other purposes, such as amusement, artistic, cultural etc. The use of drones in many developing countries serves humanitarian aims as these small aircrafts help carry medicine or blood to isolated areas. However, it is important to answer whether their use is legally regulated and if so, what is the current legal context. Consider the following answers: 1) Does harmonized European legislation exist in relation to the use of drones? The...

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Clearing Up the Smoke: the Legal Dispute on the new EU rules for electronic cigarettes

Posted by on 2 November, 2016

Clearing Up the Smoke: the Legal Dispute on the new EU rules for electronic cigarettes

On 20 September 2016, Greek Law No 4419/2016 incorporated the Directive 2014/40/EU on the manufacture, marketing and sale of tobacco and tobacco-related products in the Greek legal system.Besides the main points of the new Directive, which we discussed in our previous article, both the new Law and the Directive impose new rules regarding electronic cigarettes (Article 20), the sales of which have sharply increased in Greece as well as in other EU countries in the past few years. Which was the legal framework before the adoption of the new...

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Guide to the ΕU-US Privacy Shield

Posted by on 6 October, 2016

Guide to the ΕU-US Privacy Shield

On July 12, 2016, following a long negotiation period with the US authorities, the European Commission  presented the EU-US Privacy Shield (Decision (EU) 2016/1250 of 12 July 2016, pursuant to Directive 95/46/EC) in order to ensure the protection of personal data transferred from Europe to the US. In this context, the European Commission published a guide, including a Q&A, regarding how the Privacy Shield can be activated and which are indeed a data subject’ rights. This guide provides important clarifications on how the Privacy Shield...

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Up in Smoke: Recent EU and Greek Legislation Tries to Kill Ambiguity for Tobacco Products

Posted by on 22 September, 2016

Up in Smoke: Recent EU and Greek Legislation Tries to Kill Ambiguity for Tobacco Products

Cigarette packages labelled with images that can dissuade humans from smoking habit, which were distributed last summer, come as a result of a new European legislation on the manufacture, marketing and sale of tobacco and related products, namely the Directive 2014/40/EC. More specifically: Which products fall within the scope of the new Directive? The new rules cover not only cigarettes, but also pipe tobacco, roll-your-own tobacco, water pipe tobacco, electronic cigarettes, as well as herbal products for smoking. What is the time...

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Biosimilars: the obvious alternative or a simmering source of future friction?

Posted by on 8 September, 2016

Biosimilars: the obvious alternative or a simmering source of future friction?

In the few past years, biosimilars have found their place in the pharmaceutical market. Having already played a significant role in European life, they continue to win market share in the EU and the international market. The constantly increasing state expenditure favor their growth as they appear to assist in the sustainability of the global health system. States can indeed insure more patients and simultaneously save costs. However, the success of biosimilars depends on the rules and legislation of every individual market. Biosimilars...

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