University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

In order to analyze advertising messages from a legal and ethical standpoint, this research delimits the object of study to the category that corresponds to medicines not subject to prescription. Medicines as a specific type of product that can be commercially promoted and in relation to its advertising activities, produce an object of study with its own characteristics which is usefull to several industries and interest groups such as pharmaceuticals, advertising, education, health, consumers and users. This study is divided into the following major sections: First the theoretical and regulatory framework is analyzed. This framework provides the basis and contextual data to define and focus the specific inquiry, which is centered on the analysis of advertisements from the legal and ethical standpoint. The characteristics of non-prescription medicines and their regulations are examined to serve as preliminary stages in the research. This section delves into legislation affecting the advertising message and into professional ethics and codes of conduct that have been developed in order to solve and prevent possible conflicts of interest involving consumers and/or competition. The analysis of legal provisions and applicable codes of conduct allows us to extract a synthesis of elements and principles which will be added to the interpretation of a sample of one hundred ads, which is representative of the sector under examination. Qualitative and quantitative methods are used in the research. Through sixteen in-depth interviews conducted to professionals in the pharmaceutical and health industries, advertising agencies, and consumers, a number of qualitative variables that serve to accurately define the components and characteristics of advertisements that are analyzed according to the method of content analysis, are distilled. Through triangulation of perspectives, the combination of both types of methodologies will allow us to obtain a set of conclusions regarding which are the keys to interpreting the messages from the advertising sample, and to what extent there is a set of elements that can be analyzed from a legal and ethical standpoint. / Amb l’objectiu d’analitzar els missatges publicitaris des d’un punt de vista legal i ètic, aquest treball d’investigació delimita l’objecte d’estudi en la categoria corresponent als medicaments no subjectes a prescripció mèdica. Tant pel què fa als medicaments, com a tipus de producte específic dels que es pot fer promoció comercial, com en relació a la seva activitat publicitària, ens trobem amb un objecte d’estudi amb unes característiques pròpies i d’interès per a diversos sectors com són la indústria farmacèutica, la publicitat, l’àmbit educatiu, el de la salut, i el dels consumidors i usuaris. Aquest treball està estructurat en els següents grans apartats. En primer lloc s’analitza el marc teòric i regulatiu que serveix de base i ofereix dades contextuals per definir i enfocar una investigació específica que es centra en l’anàlisi dels missatges publicitaris des del punt de vista legal i ètic. Com a etapes prèvies a la investigació, s’estudien les característiques dels medicaments no subjectes a prescripció i la seva regulació. En aquest apartat s’aprofundeix en la legislació que afecta al missatge publicitari, en l’ètica professional i els codis deontològics que s’han elaborat amb la finalitat de solucionar i prevenir eventuals conflictes d’interessos amb els consumidors o entre la competència. L’anàlisi de les disposicions legals i els codis deontològics aplicables ens permet extreure una síntesi d’elements i principis que s’afegiran a la interpretació d’una mostra de cent anuncis, representativa del sector que s’estudia. En la investigació, s’utilitza una metodolgia qualitativa i quantitativa. A través de setze entrevistes en profunditat realitzades a professionals dels sectors de la indústria farmacèutica, la publicitat, la salut i els consumidors, s’estreuen una sèrie de variables qualitatives que serviran per definir amb precisió els elements i característiques dels missatges publicitaris que s’analitzen d’acord amb el mètode de l’anàlisi de contingut. La combinació d’ambdós tipus de metodologies ens permetrà, gràcies a la triangulació de perspectives, obtenir una sèrie de conclusions en relació a quines són les claus per a interpretar els missatges publicitaris de la mostra, i fins quin punt hi ha una sèrie d’elements que podran ser analitzats des del punt de vista legal i ètic.

Darbo tikslas - Įvertinti šeimos gydytojų požiūrį į farmacijos kompanijų medicinos atstovų teikiamą informaciją apie vaistus ir nustatyti, kaip ta informacija pasitelkiama, skiriant vaistus pacientams. Tyrimo metodika. 2008 m. balandžio – gruodžio mėnesiais, buvo apklausti Kauno mieso šeimos gydytojai dirbantys viešosiose ir privačiose įstaigose. Buvo išdalintos 229 anketos, atsakė – 133 respondentai (atsakas – 58, 1 proc.). Anketiniai duomenys analizuoti naudojant statistinę duomenų analizės programą SPSS 13.0. Statistinis duomenų reikšmingumas tikrintas pagal Chi kvadrato kriterijų, laisvės laipsnių skaičių ir statistinį reikšmingumą (p). Hipotezė apie dviejų nepriklausomų imčių vidurkių lygybę buvo tikrinama naudojant Mann – Whitney testą. Rezultatai. Dažniausiai šeimos gydytojai informaciją apie vaistus sužino medicinos atstovų individualių vizitų metu. Efektyviausi būdai informacijai apie vaistus sužinoti yra konferencijos, individualūs medicinos atstovų vizitai, bei specialisto vedamos apvalaus stalo prezentacijos. Lankančių šeimos gydytojus medicinos atstovų profesija dažniausiai yra gydytojai ir farmacininkai. Beveik trys ketvirtadaliai (72,2 proc.) šeimos gydytojų pastebi skirtingų profesijų medicinos atstovų kompetencijos skirtumus ir geriausiai vertina gydytojų bei farmacininkų kompetenciją pateikiant informaciją apie vaistus. Didžioji dalis (71,4 proc.) šeimos gydytojų bendravimą su medicinos atstovais vertina kaip dalykinį, jų nuomone, bendraujant su medicinos... [toliau žr. visą tekstą] / Aim of the study. To evaluate general practitioners view on how pharmaceutical companies present information about medicines and to determine how this information is used by doctors while prescribing them for patients. Methods. The general practitioners, who worked in private and public health centers in Kaunas city, were anonymously questioned from April to December in 2008. In total, 229 questionnaires were distributed, 133 of which were answered and returned back (the response rate was 58%). Statistical analysis of the obtained data was performed using the SPSS v. 13.0 software package. The associations between the variables were tested by Chi squared test. The hypothesis about the differences between means of two independent samples was evaluated using a criterion of Mann-Whitney test. Results. General practitioners most often get information about medicines from personal visits of medical representatives. The most effective ways of finding out the information about medicines are conferences, personal visits of medical representatives and round table meetings lead by specialists. General practitioners were most often visited by medical representatives who have doctor’s or pharmacist‘s qualifications. Almost three quaters (72.2%) of general practitioners have noticed different competence in qualification of medical representatives and those who had doctor‘s or pharmacist‘s qualification were evaluated best in providing the information about medicines. The greater part (71... [to full text]

In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.

O gerenciamento adequado de resíduos na indústria farmacêutica demonstra preocupação com a questão ambiental, a saúde pública e o combate ao desperdício. O objetivo desta dissertação foi contribuir para a otimização da produção de medicamentos no LAFERGS, mediante o gerenciamento de resíduos e, desta forma, colaborar para a melhoria da qualidade ambiental e da vida da população. A metodologia deste trabalho baseou-se na pesquisa bibliográfica para o embasamento teórico, na pesquisa documental em legislações relacionadas ao tema, em estudo de caso realizado no LAFERGS, no período de setembro de 2003 a agosto de 2004, para identificar os resíduos gerados e na elaboração do Plano de Gerenciamento de Resíduos (PGR). No estudo de caso foram caracterizados os resíduos químicos e recicláveis das atividades dos setores de produção e controle de qualidade de medicamentos, bem como os resíduos comuns recicláveis e não recicláveis gerados nas demais áreas do laboratório. O estudo forneceu dados para a elaboração do PGR e para melhorias no processo produtivo. Conclui-se que os resíduos químicos gerados na produção, no controle de qualidade e nos almoxarifados, são enquadrados no grupo B. Classificados como D estão os resíduos comuns, recicláveis e não recicláveis, resultantes das atividades industriais, administrativas, de refeitório, de sanitários e de jardinagem. Materiais perfurocortantes, como vidraria de laboratório quebrada, lâminas e lamínulas, classificam-se no grupo E. Não existe geração de resíduos do grupo C, que são os radioativos. Como contribuição para a otimização da produção indica-se a modernização tecnológica do laboratório, a efetiva implantação de um sistema de garantia da qualidade e a busca de maior agilidade e autonomia administrativo-financeira e a implantação do PGR com a adoção de técnicas de produção mais limpa e minimização da geração de resíduos. / The suitable management of waste in the pharmaceutical industry shows the concern for issues related to the environment, public health and the fight against waste. The purpose of this dissertation was to contribute for the optimization of drug production at LAFERGS (Pharmaceutical Laboratory of Rio Grande do Sul), through the management of waste and, in this way, to work together for the improvement in the quality of the environment, as well as the life of the population. The methodology is based on bibliographic research for theoretical grounding, in document research on legislation related to the theme, on a case study performed at LAFERGS, from September 2003 to August 2004, to identify the waste generated, and in the development of the Waste Management Plan (WMP). In the case study the chemical and recyclable waste from the drug production and quality control sector activities were characterized, as well as the common recyclable and non-recyclable waste generated in other areas of the laboratory. The study supplied data for the development of the WMP and for improvement in the productive process. It was concluded that the chemical waste generated in production, quality control and in the warehouses, fit within Group B. Common, recyclable and non-recyclable waste resulting from industrial and administrative activities, as well as from the cafeteria, restrooms and garden are classified as Group D. Cutting materials, such as broken laboratory glassware, blades and micro slides are classified in Group E. There is no management process for waste in Group C, made up of radioactive materials. Technological modernization of the laboratory, the effective implementation of a quality assurance system and the search for greater flexibility and administrative-financial autonomy, along with the implementation of the WMP, with the adoption of cleaner production techniques, and a reduction in the generation of waste, are all indicated as forms of optimizing production.

Submitted by Vinícius Augusto Gil (vinicius_agil@yahoo.com.br) on 2016-11-07T19:58:23Z No. of bitstreams: 1 Motivadores de Aquisições na Industria Farmaceutica Brasileira - Vinícius Augusto Gil (MPA) VF05.pdf: 950629 bytes, checksum: b6ef77ff337abd818695315ac9700dab (MD5) / Approved for entry into archive by Fabiana da Silva Segura (fabiana.segura@fgv.br) on 2016-11-07T20:04:13Z (GMT) No. of bitstreams: 1 Motivadores de Aquisições na Industria Farmaceutica Brasileira - Vinícius Augusto Gil (MPA) VF05.pdf: 950629 bytes, checksum: b6ef77ff337abd818695315ac9700dab (MD5) / Made available in DSpace on 2016-11-08T11:26:47Z (GMT). No. of bitstreams: 1 Motivadores de Aquisições na Industria Farmaceutica Brasileira - Vinícius Augusto Gil (MPA) VF05.pdf: 950629 bytes, checksum: b6ef77ff337abd818695315ac9700dab (MD5) Previous issue date: 2016-10-21 / According to the literature, portfolio of products at risk due to the loss of exclusivity and the search for innovation are mentioned as drivers of acquisitions in the pharmaceutical industry. Considering data of 530 companies and 56 acquisitions in the Brazilian pharmaceutical market from 2005 to 2015, we analyzed how buyers evaluate their targets according to their products profile, innovation scores and indicators of assets at risk due to the loss of technological exclusivity. In contrast to the current literature in developed markets, we found empirical evidences that the main driver of buyers in Brazil is the excess of capacity due to technological shocks, but there is no active search for new technologies. This scenario shows that asset transactions are translated into a continuous substitution of innovations by copies in the structure of the companies. / De acordo com a literatura, a presença de portfólio de produtos em risco pela perda de exclusividade e a busca por inovação são citados como motivadores de aquisições na indústria farmacêutica. A partir de bases de dados com 530 empresas e 56 aquisições ocorridas no mercado farmacêutico brasileiro entre 2005 e 2015, analisamos como empresas compradoras avaliam suas empresas-alvo segundo o perfil de seus produtos, scores de inovação e indicadores de ativos em risco pela perda de exclusividade tecnológica. Contrariamente à literatura para mercados desenvolvidos, encontramos evidências empíricas de que a principal motivação das empresas compradoras no Brasil é o excesso de capacidade devido à choques tecnológicos, porém não há busca ativa por novas tecnologias. Neste sentido, as transações de ativos no setor se traduzem na substituição contínua de inovações por cópias nas estruturas das empresas.