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Objetivo: proponer un procedimiento metodológico para la realización de búsquedas de libertad de acción utilizando información técnica legal de documentos de patentes. Métodos: primeramente se caracterizaron numerosas bases de datos de patentes de acceso gratuito disponibles en internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org y Patentinspiration) con respecto a la cobertura temporal y a la cantidad de patentes cubanas, y se identificaron y estudiaron dos fuentes de información que recogen estados legales de estas (INPADOC y WIPO Register Portal). Resultados: Patentscope® e Invenes se consideraron como las mejores bases, ya que permiten la búsqueda en el documento completo (título, resumen, descripción y reivindicaciones) mediante palabras clave; y Depatisnet se considera útil cuando se consulta mediante el Código Internacional de Patentes reclasificado por la Oficina de Patentes Alemana. No obstante, se recomienda el uso de todas las bases estudiadas para evadir errores relacionados con los contenidos y otras limitaciones relacionadas con las facilidades de búsqueda. A partir de las prestaciones detectadas en las fuentes de información analizadas, se implementó y perfeccionó un proceso de búsqueda sobre un medicamento preventivo contra el VIH/SIDA que demostró que existía libertad de acción en Cuba para su explotación, así como también la pertinencia de las herramientas y la metodología utilizadas para realizar este tipo de búsquedas. Conclusiones: este estudio de caso permite poner en práctica un procedimiento para realizar búsquedas y evidencia la importancia de la implementación del servicio de búsqueda libertad de acción para facilitar el acceso a invenciones patentadas, especialmente en el campo médico-farmacéutico(AU)
Objective: a methodological procedure is proposed to conduct freedom-to-operate searches using patent documentation-related legal technical information. Methods: first, characterization was performed of a large number of open-access patent databases available on the Internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org and Patentinspiration) with respect to time coverage and number of Cuban patents, followed by identification and analysis of two information sources referring to their legal status (INPADOC y WIPO Register Portal). Results: Patentscope® and Invenes were considered to be the best databases, since they allow to search the entire document (title, abstract, description and claims) by means of key words. Depatisnet was found to be useful for inquiries about the International Patent Classification as re-classified by the German Patent Office. However, it is recommended to use all the databases studied to avoid content-related errors and other limitations to do with search functions. Based on the possibilities offered by the information sources analyzed, a search procedure for an HIV/AIDS preventive drug was implemented and perfected, showing that there was freedom-to-operate in Cuba for its exploitation, as well as the relevance of the tools and the methodology used to perform this type of search. Conclusions: in this case study a procedure is made operational and evidence is provided of the importance of implementing the freedom-to-operate search service to facilitate access to patented inventions, especially in the medical-pharmaceutical field(AU)
Subject(s)
Humans , Patents as Topic/legislation & jurisprudence , Medical Informatics Applications , Databases as Topic/standards , Access to InformationABSTRACT
OBJECTIVE:To compare the licensed pharmacist system in China and the USA,and to provide reference for im-proving pharmaceutical care and promoting public safety of drug use in China. METHODS:The relevant literatures in recent 10 years were retrieved from CJFD and Wanfang database. The differences of legal status,access qualification,legal obligations and responsibilities of licensed pharmacists in the USA and China were compared,and suggestions on improving the licensed pharma-cists system in China were put forward. RESULTS & CONCLUSIONS:At present,the problems of licensed pharmacist system in China are mainly that the legal status is not high,the access threshold is low,the legal obligations and responsibilities are not clear. However,the licensed pharmacist system in the USA has been developed for a century and formed a relatively strict legal sys-tem. Model State Pharmacy Act promulgated by National Association of Boards of Pharmacy in USA has clearly defined the access qualifications,legal obligations and responsibilities of licensed pharmacists. The pharmacy acts of the states were enacted on its blueprint. In view of current problems in China,it is necessary to learn from the above experience of the USA to improve the legal status,access qualification,legal obligations and responsibilities of licensed pharmacists and the quality of pharmaceutical care.
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Along with the application and development of the assisted reproductive technology in vitro fertilization and embryo transfer,the emergence of frozen embryos in the law,medicine,and ethics area are gradually increased.Two-child policy makes more older couples choose assisted reproductive technology,which will cause more disputes about frozen embryos.There is no unified conclusion of the legal status of human embryos,and there exists three main views of embryos namely property,person and intermediate state.Defined the legal status of frozen embryos as ethical substance,this paper analyzed the main position and possible legal and ethical issues involved in the disposal of frozen embryos through three typical cases.
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Standardization of Forensic Sciences is a worldwide judicial topic, with the implementation of judicial reform and the government’s intention on the standardization work, China,the golden age of the establishment of forensic identiifcation standards will becoming. However, the current standards of forensic identiifcation are less in quantity;uneven quality;slow updating; lack of scientiifcity in making standards procession and other issues, leading to the derailment of Forensic work and practice, many projects identiifed lack of identiifed standards. To this end, the authors suggested that a correct understanding of the legal status of forensic identiifcation standards and the presence of errors, committing to build forensic identiifcation standardization.
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Extracts from Rosmarinus officinalis L., more commonly known as rosemary, have been approved for use in the EU as food additive E932 under Regulation 1333/2008 of the European Parliament and the Council. Rosemary extracts are currently widely used to increase shelf life of food products. Rosemary extracts are characterised by two reference antioxidant compounds, carnosol and carnosic acid. This characterization allows for differences in rosemary extracts. Four approved production methods, as described by Commission Regulation 231/2012, produce rosemary extracts with different compositions and antioxidant activity. This results in difficulties to compare scientific data and to assess the safety of approved rosemary extracts. Based on unpublished studies for each of the four approved extract types, EFSA concluded that “the proposed uses and use levels would not be of safety concern“. Yet, gaps in knowledge still exist for the approved extracts as many different rosemary extracts are used in scientific research.
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Sulphites or sulphiting agents refer to sodium hydrogen sulphite, sodium metabisulphite, potassium metabisulphite, calcium sulphite, calcium hydrogen sulphite, and potassium hydrogen sulphite. As food additives, they are widely used by the food industry with a variety of commercial uses in food and beverages. Sulphites are effective bleaching agents, antimicrobials, oxygen scavengers, reducing agents, and enzyme inhibitors. Wine, beer, dehydrated fruits and vegetables, jam, juice, sugar, processed potatoes, seafood, meat and baked products are some of the food categories in which sulphites are added. Sulphites have been implicated in various health related issues. Asthmatic reactions and some antinutritional consequences such the degradation of thiamine (vitamin B1) are adverse reactions associated with sulphites. In many countries, sulphites have been regulated. Sulphites are generally recognized as safe in the USA with some exceptions when using in raw fruits and vegetables. In the European Union sulphites are also controlled, and the permitted amount varies according to the food product.
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Este artigo tem por objetivo relacionar as normas éticas sobre pesquisas com seres humanos com o Código Civil brasileiro, lei que trata de diversos aspectos relacionados à proteção da pessoa humana. Em geral, os pesquisadores da área médica desconhecem a legislação civil, não se dando conta das consequências jurídicas dos erros causados pelas pesquisas realizadas. Apresenta-se, no início, um resumo da disciplina ética sobre pesquisas com seres humanos, com o Código de Nuremberg e a Declaração de Helsinque, além da disciplina infralegal no Brasil, realizada pelo Conselho Nacional de Saúde. Em seguida, com o intuito de demonstrar a inexistência de um vazio legislativo nessa matéria, analisaram-se os aspectos do Código Civil relativos às pesquisas com seres humanos, como a personalidade jurídica, a capacidade de agir, os direitos da personalidade e a responsabilidade civil.
This study seeks to relate the ethical norms for research on human subjects with Brazilian Civil Code, a law that considers many aspects of protection for individuals. In general, medical researchers are unaware of civil legislation and do not realize the legal consequences of any errors caused by their research. First, a summary of the ethical aspect of research on humansubjects is presented, along with the Nuremberg Code and the Declaration of Helsinki, as well as the non-statutory aspect of Brazilian law, which is performed by the Brazilian NationalHealth Council. Second, to demonstrate the inexistence of a lack of legislative consistency in this area, the study analyzes the aspects of Civil Code relative to research on human subjects,as well as legal status, the ability to act, rights to legal status, and civil liability.
Subject(s)
Humans , Male , Female , Bioethics , Damage Liability , Ethics Committees, Research , Human Experimentation/legislation & jurisprudence , Informed Consent , Constitution and Bylaws , Helsinki Declaration , Research and Development ProjectsABSTRACT
This paper identified misunderstandings of the measures taken in China to overcome the problems incurred by off-label uses (namely reliance on drug makers to modify their medicine specifications,on medical institutions to enhance their regulation and management of off-label uses,and on informed consent to avoid risks).Based on such findings,the paper named defects found with such measures,and puts forward feasible ideas and methods to make such off-label uses legitimate and reasonable.These include clarification of the legal status of the medicine specifications,encouraging authoritative guidance for off-label uses,and determining the subject of evaluation to approve the off-label uses as reasonable.Such efforts aim at helping off-label uses out of the legal difficulties.
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As the core of a digitalized hospital, electronic medical records have drawn considerable public attention. After the implementation of the PRC Electronic Signatures Law, electronic medical records acquired the legal environment for their development. The paper discusses the legal significance of medical records and electronic medical records, the evidential value of medical records in medical disputes, the relationship between the Electronic Signatures Law and electronic medical records, and electronic medical records related issues of social concern. Hence the demonstration of the feasibility of and necessary conditions for the application of electronic medical records.
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OBJECTIVE: To upgrade the rational use of drug in China.METHOD: The importance of Chinese essential medicine policy in upgrading rational use of drug was analyzed by establishing the legal status of the current essential medicine policy.RESULTS&CONCLUSIONS: The undesirable practice of the essential medicine policy was one of the key reasons for unsatisfactory situation of rational drug use in China.Only by legislating, law enforcing and publicizing can we upgrade the rational use of drugs