Showing papers in "European Journal of Health Law in 2015"

European Court of Human Rights. ECHR 2015/17 Case of Temchenko v. Ukraine, 16 July 2015, no. 30579/10 (Fifth Section).

Abstract: The applicant had been arrested in 1997 on suspicion of carrying out a number of armed robberies on mini-cab drivers. He agreed to participate in identification parades but failed to attend on the day on which they were due to take place. Instead he sent a doctor’s note stating that he was too ill to go to work. The parades were rearranged and notice to that effect was sent to the applicant’s home address. The applicant did not attend the rearranged parade, stating that he had not received notification as he had changed address. A further robbery then occurred for which the applicant was arrested. The applicant again agreed to stand on an identification parade, but again failed to attend on the day that it was to take place. Following this failure to attend two more robberies were committed with which the applicant was subsequently charged. The mainstay of the prosecution’s case against the applicant would be the ability of a number of witnesses to make visual identifications and for this reason submitting the applicant to an identification parade was of great importance. In light of the applicant’s failure to attend the parades that had been arranged, the police decided to arrange a video identification. Permission to film the applicant covertly for this purpose was sought from the Deputy Chief Constable under Home Office guidelines. The applicant was taken from prison, where he was being detained in relation to another matter, to a police station. Both the applicant and the prison authorities had been informed that this was for identification purposes and further interviews regarding the armed robberies. On arrival at the police station he was invited to participate in an identification parade but refused. The custody suite at the police station was fitted with a camera which was kept running at all times and covered an area in which police officers and other suspects came and went. Before the applicant arrived at the police station an engineer made adjustments to the camera to ensure that clear images were obtained that were suitable for use in a video identification. The footage of the applicant was then used in a compilation with footage of 11 other volunteers who imitated the actions of the applicant. Two of the witnesses who viewed the video compilation picked out the applicant. Neither the applicant nor his solicitor were informed that a tape had been made or used for identification purposes and were, therefore, not given an opportunity to view it prior to its use.

Advance Directives in Some Western European Countries: A Legal and Ethical Comparison between Spain, France, England, and Germany.

Abstract: We have studied national laws on advance directives in various Western European countries: Romance-speaking countries (Italy, France, Portugal, and Spain), English-speaking countries (Ireland and the United Kingdom), and German-speaking countries (Austria, Germany, and Switzerland). We distinguish two potentially complementary types of advance medical declaration: the 'living will' and the nomination of a legal proxy. After examining the similarities and differences between countries, we analyse in detail the legislation of four countries (Spain, France, England, and Germany), since the other countries in this survey have similar legal principles and/or a similar political approach. In conclusion, we note that in all the countries examined, advance directives have been seen as an instrument to enable the patient's right to self-determination. Notwithstanding, in Romance-speaking countries, the involvement of physicians in the end-of-life process and risks arising from the execution of advance directives were also considered.

Encountering Challenges with the EU Regulation on Advance Therapy Medical Products.

Abstract: 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 their access to the internal market and to foster the competitiveness of European pharmaceutical companies, while guaranteeing the highest level protection of public health. Since the adoption of the ATMP Regulation in late 2008, only 5 ATMPS have been granted marketing authorisations thus far. Hence, there is a need to analyse whether the ATMP Regulation meets its objectives.

Living Wills in Italy: Ethical and Comparative Law Approaches

Abstract: In this article, advance directives will be analysed through ethical and comparative law approaches. Their importance, the two different types of advance directives and the so-called three steps hierarchy, will be discussed. Living wills will be treated in detail, considering the criticism they have attracted, as well as their known benefits. A thorough examination of the latest version of Arts. 3 and 4 of Italian Bill No. 2350, as approved by the Italian Senate in March 2009 and then amended by the Chamber of Deputies in July 2011, is included. This bill grants advance directives advisory force, limits their application in time and does not allow the validity of oral declarations. This political decision limits autonomy. Furthermore, there are doubts about the constitutionality of this bill, especially with respect to Arts. 2, 13 and 32 of the Italian Constitution, related to the right of self-determination. Further, this article will include a comparative approach of the legal aspects, with particular attention to the French and German models. To conclude, some ethical principles that the Italian legislator must take into consideration are indicated. In addition, some possible modifications of this Bill are suggested based on the experience of other European legislation.

Off-label Prescription of Medication.

Abstract: Off-label use of medication refers to prescribing a registered medicine outside its approved marketing authorization, purpose, target group, or indication. Off-label prescription is a widely accepted practice. However, no or little regulation can be found. In this article, the legal status of off-label prescription will be examined. Does off-label prescription fall under the therapeutical freedom and is it free from regulation? Or should we equalize off-label prescription with a therapeutical experimentation and should it follow the rules of experimentation? I will also examine whether the patient can give an informed consent. Whether or not this is possible leads to intense discussions. Finally, the potential liability of the prescribing physician is of great importance.

Medical Liability: The Current State of Italian Legislation

Abstract: The professional liability of healthcare professionals is a decidedly current issue. In the past decade, litigation for alleged medical malpractice incidents has increased exponentially in Europe. In Italy, the last 20 years have been witness to significant upheavals in this sense. In this article, we analyse the evolution of professional liability legislation in Italy, as well as addressing, in some detail, the changes introduced by Law 189/2012, with which the Italian legislators radically revolutionized the medical liability sector. Particular attention is dedicated to the jurisprudential developments most affected by this reform.

The Right to Travel for Abortion Services: A Case Study in Irish 'Cross-border Reproductive Care'.

Abstract: Abortion is illegal in Ireland, except in very limited circumstances, but the Irish Constitution guarantees the right of women to travel abroad to obtain abortion services. Every year, large numbers of women travel to the UK to obtain abortions. This article argues that this can be regarded as an illustration of cross-border reproductive care (CBRC). CBRC is the phenomenon whereby people travel abroad to obtain assisted reproduction services that are illegal in their country of origin. A leading commentator, Guido Pennings, argues that CBRC is to be welcomed as a means by which society might compromise on issues of profound moral disagreement. Other commentators believe CBRC is highly problematic. This article argues that the Irish abortion example, when examined as an example of CBRC, illustrates both the advantages and disadvantages of CBRC identified by Pennings and his critics.

UK's Legalisation of Mitochondrial Donation in IVF Treatment: A Challenge to the International Community or a Promotion of Life-saving Medical Innovation to Be Followed by Others?

Abstract: Mitochondrial 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 Parliament amended the relevant legislation to allow such. a procedure, making the UK the first state to openly challenge the global policy on germline gene modification. The article presents the scientific background to the procedure and discusses the regulatory challenges brought by the first case of its legalisation.

Should Reproductive Medicine Be Harmonized within Europe

Abstract: The medical as well as societal developments in reproductive medicine and respectively artificial reproductive technologies have challenged lawmakers, courts, politicians, medical experts and society itself over the last decades. Challenges can be seen in cross-border reproductive care, equal access to reproductive care, social freezing, disposal of embryos, multiple implantation, homosexual parenthood or surrogacy. Since different regulatory regimes have been enacted throughout Europe (e.g. liberal system in Spain, restrictive system in Austria) to accommodate, limit and regulate reproductive issues, we are analysing the question, if reproductive medicine should be harmonized within Europe. Therefore we are not only discussing already existing approaches e.g. self-regulation, or minimal standards of safety and quality, but we are also scrutinizing the role of high courts, such as the European Court of Human Rights (EC HR) and international declarations and conventions. Concluding we are briefly sketching aspects of a proposal for a potential harmonisation of reproductive medicine in Europe.

Patentability of Parthenogenic Stem Cells: International Stem Cell Corporation v. Comptroller General of Patents

Abstract: The European Court of Justice (ECJ) has recently issued a ruling in Case C-364/13 International Stem Cell Corporation v. Comptroller General of Patents Designs and Tademarks (Case) that aims at harmonising the patenting practices regarding interpretation of Article 6.2.c of Directive 98/44/EC (Biotech Patent Directive) in respect of patentability of human parthenogenic stem cells (hpSCs). The Case alters the patenting regime for human embryonic stem cell (hESC) applications, by stating that moral restrictions against hESC-patents are only applicable to such cells derived from embryos that had the potential to develop into a human being. Consequently, hpSC-based inventions may be patentable in Europe. This Case represents a leap forward to striking a balance between protecting human dignity and integrity whilst granting patent incentives for biomedical research.

Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape.

Abstract: Rapid 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 within the EU over the Internet, and discuss the developments vis-a-vis the IVD Directive. To compare with the IVD Directive, the IVD Regulation presents a major shift in how direct-to-consumer genetic testing is treated in the E U. It remains unclear, whether and how the EU requirements can be applied beyond the EU market.

Safety of Birth: A Comparative Analysis of the Legal Guarantees in Maternity Care (Belgium — France — The Netherlands)

Abstract: The birth process is crucial for the child's later motor and intellectual development. Abroad review of medical liability proceedings in Belgium, France and The Netherlands shows that the chances of a safe birth can be maximised if four conditions are met. Well-educated midwives and obstetricians with sound expertise in foetal heart rate monitoring is the first condition. The second is recognition of an obstetric risk or pathology. The third condition is making the appropriate choice of medical intervention: instrumental or caesarean delivery. Adequate use of the instruments is the last condition. Not answering to these 'standards of safe birth' can involve the medical liability of the midwife and obstetrician. In accordance with Article 2 of the European Convention on Human Rights, Belgium, The Netherlands and France offer procedural guarantees to the parents of an injured baby to determine the liability.

Mental Disorders and Decision-Making Capacity: What Is the Role of Law?

Abstract: When a patient appears to have a mental disorder, doubts may arise about his or her decision-making capacity. Health professionals must then assess the patient's capacity in order to make sure of the validity of his or her consent or refusal. Incapacity has indeed legal consequences, as law provides for the appointment of a surrogate decision-maker in case of incapacity. With Belgian law as a point of departure, this contribution is aiming at identifying the role of law in capacity assessment itself, prior to the decision about (in)capacity. In order to protect the patient's rights and to support the task of those carrying out the assessment, law should provide for a global definition of decigion-making capacity and for a frame-procedure guiding this assessment. In my opinion, it is possible for law to contribute to the complex task of capacity assessment without interfering embarrassingly with healthcare practice.

Of Sound Mind? Dementia and Aspects of Assessing Legal Capacity.

Abstract: As dementia progresses, it weakens a person's legal capacity Both legal and medical aspects are closely intertwined in the assessment of legal capacity It is a legal problem whose solution requires medical expertise and a medical point of view It is essential for lawyers to have basic knowledge about the effects of dementing illnesses in order to properly understand medical evidence presented in a case For a physician it is necessary to have knowledge about different kinds of legal capacities and the complexity of legal assessment

Use of Force for Medical Purposes--A Danish Perspective.

Abstract: 1.