Pharmaceuticals Policy and Law - Volume 17, issue 3-4
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The maintenance of a guaranteed, adequate level of healthcare services and the need of control on public expenditures constitute the background on which the newest innovations for the protection of the right to health stand out. On the sidelines, the principle of autonomy and responsibility in the development of therapeutic choices, it is exactly the economic aspect which, as a result of the global crisis that is featuring the twenty-first century, affects the provision of healthcare services, conditioned by population protection requirements and the need to maintain balanced budgets.
Keywords: Healthcare services, public expenditures, healthcare system
Abstract: The European Union organisation, which was established to regulate the relations of economic nature, has expanded its scope, including among its objectives the protection of the citizen fundamental rights; this is a result of the evolving case-law of the Court of Justice pursuant to the information contained in the Charter of Nice and the Treaty of Lisbon. Only from the early 70's health policies have begun to affect community entities, especially since carriers through which contribute to achieving the four main freedoms expressed in community legislation. On April 16th 2014 regulation No 536/2014 on clinical trials on medicinal products…for human use was adopted by the European Parliament and the Council. As can be seen from reading the text, the target of the regulation is to ensure the robustness and reliability of data on clinical trials throughout the Union, while guaranteeing respect for the rights, safety, dignity and well-being of the subjects. The European regulation is at the heart of a contrast between two different wishes that the EU, the regulation seeks to combine: on one hand, the need for the EU to remain an attractive place to conduct clinical trials. And on the other hand, the need to ensure respect for the rights, safety, dignity and well-being of those involved in clinical trials.
Keywords: EU intervention in healthcare, regulation No 536/2014 on clinical trial, European right to health protection
Abstract: The progress of medicine is based on scientific research as essential elements to guarantee the fundamental right of health protection. Trials considered as activities conducted on human subjects designed to test the validity and the effects of a drug or a medical device in order to evaluate its safety and efficacy. The normative evolution in the field of clinical trials shows that interventions in sucessive time, and today, built in preparation and seek to build a consistent ``corpus'' or set of rules to ensure the exchange of results of experiments and, therefore, satisfy the health ``need'' on an international scale.…In this context are the two major areas of experimentation: those promoted by profit promoters and those promoted by non-profit promoters; the first aims to commercialize the drug, while the second wants the improvement of clinical practice. The two types are related to an specific legislation, under a general order dictated internationally for profit, ad-hoc established by individual States on the basis of said general legislation for non-profits. Clinical trial, then, in its normative evolution, the detailed analysis of the distinction between profit and non-profit and its problems and future prospects.
Keywords: Clinical trials, clinical study, profit and non profit, drugs, medical devices, distinctive element, ethics committees, legislation, health protection
Abstract: Ethics committees are created as a response to requests coming from some sections of public opinion, especially from those who experience a disconnect between the evolution of medical science and technological progress and the development of a corresponding ethical maturity on the part of health professionals. Ethics committees tend to develop in areas as different from those of traditional end-of-life decisions, playing roles that appear distant from the original one. New fields of activity are ethics committees identified in North American clinical practice, for example, to ensure that women who want to give their child up for adoption are adequately…informed about the adoption alternatives, or to express opinions to assess the lawfulness by parents, Jehovah's witnesses, to refer their children exclusively to surgical treatments that do not involve the use of blood transfusions. In this work we tried to examine the role and experiences of U.S. Ethics Committees in the field of clinical trials, comparing these organisms with the Italian reality, in order to highlight differences, but also similarities. The work ends by focusing on a few issues that are still unresolved, such as the profile concerning the composition of the ethical committees and the anticipation of establishment of a single national Ethics Committee.
Abstract: This article allows toanalyze drug testing from the standpoint of prescriptive appropriateness, as a tool and a resource to implement a welfare state system, in which the NHS provides an equitable access to innovative pharmaceutical treatments that might cause clinical benefits. In pursuing these interests it is necessary to ensure the due interaction between the economic and the legal profile. This implies the need of analyzing and balancing risks and benefits of experimental treatments with the objective of lowering health care costs for state budgetary purposes. In this respect, both economic process trends and social dynamics will bedealt with, given…their link with market globalization, as well as compensatory measures, tax reliefs and settlements designed to streamline and reduce public spending in this area. - As far as the latter aspect is concerned, the international regulatory framework will be taken into account at a global and a local level, in the perspective of the European and the national level, by highlighting the positive and negative aspects of systems integration and of public intervention in favour of society health. - A special profile that will be analyzed is related to testing of innovative treatments and to the expansion of production and sales of new drugs also in developing countries while facing pandemic situations. In this regard, the attention will be addressed to the role of Health Technology Assessment (HTA), as a tool for health policy in support of technological innovation and the use of off label drugs, in light of interchangeability, aimed at ensuring more prescription appropriateness and economic advantage. Several issues concerning orphan drugs and to compassionate use will deserve a special focus too. The exemplary case of Stamina will be examined, being one of the most revealing one in highlighting both gaps and limitations of internal regulations, in recent times. - In order to ensure a balance between the interests involved and guarantee the access of innovative medicines, while maintaining the accuracy and safety of the experiments, as well as balance the state budget, we will try to expose a path over the forming Legal Department, able to fully assess and implement the most appropriate measures to optimize and most appropriate functionalization of health care to an equitable distribution of resources and the burden on the community. In a de jure perspective flavoring we will try to identify any areas to bridge the gaps and to overcome the weaknesses in the regulatory level.
Abstract: The contribution aims to analyze a topic closely related to the subject of experimentation, in terms of protection of patients undergoing drug therapy: the use of off-label drugs, that is, in summary, the possibility to use a medicine for therapeutic indications not covered within the marketing authorisation (M.A.) of the drug. Moving from European discipline on medicines for human use, the analysis focuses on the peculiarities of the Italian legislation, representing in Europe an emblematic case of off-label rules. A particular focus is dedicated to the case of drugs Avastin® and Lucentis® , which in recent years has highlighted…the limits of that national legislation, including the possible contrast with European regulations. In particular, the choice of legislator, recently upheld by the Italian Constitutional Court, to submit the possibility, as well as the definition of what are the minimum requirements of safety and efficacy for a drug ``off-label'' may be prescribed to patients, are the main issues on which we intend to stimulate reflection on the reader.
Keywords: Health care, off-label drugs, clinical trials, health expenditure
Abstract: The research work will trace the normative and historical evolution of the institution of medically assisted procreation from its earliest applications up to the present day through the analysis of controversial cases and related ethical issues. It also seeks to highlight the different doctrinal concepts that were strengthened and the recent legislation in Europe. Specifically, the work focuses on the discipline rules provided for in Italian law No 40 of 2004 and subsequent case law, then extending the Community rules and also decisions of the European Court of human rights and the Court of Justice of the European…Union. This analysis shows that despite legislative efforts of various European countries for the domestic regulation of MAP (medically assisted procreation), still lacks a common framework that can offer a valuable contribution that aims at a balance of rights and ethical values.
Keywords: Medically, assisted procreation and jurisprudence
Abstract: In 2004, in Italy, it appears, for the first time, a law that regulates limits and the methods on assisted reproduction techniques. One of the principles on which is based the already famous 40 law, and that will strongly affect its forecast, is the protection of the human embryo, accompanied, in the structure of the regulatory text, a related limitation of other interests that they found a weaker response from the legislature. It is easy to detect the valorization of the human embryo in several steps; its correlation with the needs of scientific research are included in this framework, and…we will try to provide some observations on the following pages, also in the light of important judicial interventions.
Keywords: Embryo, human reproduction, scientific research