European Court of Human Rights
Source: Volume 22, Issue 5, pp 492 - 507 (Source: European Journal of Health Law)
Source: European Journal of Health Law - October 28, 2015 Category: Medical Law Authors: Joseph Dute Source Type: research
Physician Specialists’ Perceptions of the Medical Malpractice System in Belgium
Source: Volume 22, Issue 5, pp 481 - 491 (Source: European Journal of Health Law)
Source: European Journal of Health Law - October 28, 2015 Category: Medical Law Authors: Tom Vandersteegen, Wim Marneffe and Dominique Vandijck Source Type: research
Direct-to-consumer Genetic Testing: Changes in the Regulatory Landscape
Source: Volume 22, Issue 5, pp 463 - 480Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet in the form of direct-to-consumer genetic testing. In the EU, the IVD Directive has been animadverted for its inability to tackle the challenges direct-to-consumer genetic testing has posed. Currently, the EU legislation is in a transition state. It is thus, timely to assess, to what extent the proposed IVD Regulation is intended to address the performance requirements and utility of direct-to-consumer genetic tests, which are made available to consumers w...
Source: European Journal of Health Law - October 28, 2015 Category: Medical Law Authors: Santa Slokenberga Source Type: research
Encountering Challenges with the Regulation on Advance Therapy Medical Products
This article aims at analysing how well the Advanced Therapy Medical Product Regulation (EC) No. 1394/2007 (ATMP Regulation) meets the needs of small and medium-sized enterprises (SMEs), academia and public tissue establishments developing advanced therapy medical products (ATMPs). Benefits and shortcomings of the ATMP Regulation are identified, and possible amendments are proposed to accelerate the translation of research into advanced therapies and to facilitate the commercialisation of ATMPs whilst ensuring safety. It was set up as a lex specialis to ensure the free movement of ATMPs within the EU in order to facilitate...
Source: European Journal of Health Law - October 28, 2015 Category: Medical Law Authors: Juli Mansnérus Source Type: research
’s Legalisation of Mitochondrial Donation in Treatment: A Challenge to the International Community or a Promotion of Life-saving Medical Innovation to Be Followed by Others?
Source: Volume 22, Issue 5, pp 405 - 425Mitochondrial DNA diseases are rare genetic disorders, which can have a devastating effect on the patients’ health and well-being. There is no cure for such diseases, although recent experiments suggest that there may be a way to prevent them by genetically altering the eggs or embryos through a procedure known as mitochondrial donation. However, such a procedure not only raises serious safety and ethical concerns, but legal challenges as well, since it involves germline gene modification, which until recently was not legal in the UK or elsewhere. In February 2015, the British Parl...
Source: European Journal of Health Law - October 28, 2015 Category: Medical Law Authors: Samvel Varvaštian Source Type: research
