Medicamentos órfãos em Portugal no contexto internacional (séculos XX-XXI) / Orphan drugs in Portugal in the international context (XX-XXI centuries)

A consciência científica, clínica e pública da existência das doenças raras tem aumentado nos últimos anos. Os medicamentos denominados de “medicamentos órfãos” são aqueles que são apropriados para o tratamento de doenças raras. As doenças raras, comparadas com outras doenças, apresentam uma baixa incidência demográfica. Por esta razão, e em virtude das condições vigentes de comercialização, as indústrias farmacêuticas não apostam fortemente nos medicamentos órfãos. Os produtores não teriam oportunidade de recuperar o capital investido na investigação e desenvolvimento do medicamento. Neste estudo os autores fazem um historial dos medicamentos órfãos em Portugal tendo como fontes a legislação e regulamentação portuguesas no quadro da legislação e diretivas europeias, o papel das indústrias farmacêuticas em Portugal, a regulamentação e fiscalização realizada pelo INFARMED, IP, bem como o acesso dos doentes aos medicamentos órfãos e o papel fulcral das associações de doentes (AU)

Contribution of Arabic Medicine and Pharmacy to the Development of Health Care Protection in Bosnia and Herzegovina - the First Part.

The time interval from the 9th to the 13th century remained known as the "Golden period of the Arab science", and a significant place among the taught sciences are occupied by Medicine and Pharmacy. In the history of medicine, Islamic medicine, also known as Arabic medicine, refers to the science of medicine developed in the Islamic Golden Age, and written in Arabic Arabs were able to use their cultural and natural resources and trade links to contribute to the strong development of pharmacy. After the collapse of the Arab rule, the Arab territorial expanses and cultural heritage were taken over by the Turks. Although scientific progress in the Turkish period slowed down due to numerous unfavorable political-economic and other circumstances, thanks to the Turks, Arab culture and useful Islamic principles expanded to the territory of our homeland of Bosnia and Herzegovina. Significant role in the transfer of Arabic medical and pharmaceutical knowledge was also attributed to the Sephardic Jews who, with their arrival, continued to perform their attar activities, which were largely based on Arab achievements. However, insufficiently elaborated, rich funds of oriental medical and pharmaceutical handwriting testify that Oriental science has nurtured in these areas as well, and that the Arab component in a specific way was intertwined with other cultures and traditions of Bosnia and Herzegovina.

[Legislation on the pharmaceutical industry in Morocco during the French protectorate 1912 - 1956]. / La législation sur l'industrie pharmaceutique au Maroc durant le Protectorat français 1912-1956.

In Morocco, the pharmaceutical industry was born with the French protectorate. She knew a great evolution: from a limited production for local needs, it became an important activity, organized to export pharmaceutical patent medicines. This article revisits the birth and history of this industry during the protectorate. It refers to the situation at the time by listing some examples of active establishments and some specialities marketed. It also aims to increase knowledge about the industry and provides an overview of the situation of practitioners remembering the texts governing the profession. Based on the available literature, we examined and analyzed the arrangements related to the establishment, organization and evolution of the pharmaceutical industry.

GRANTING A LICENCE FOR OPENING A PHARMACY IN BOLOGNA DURING ACTIVITY OF THE BOLOGNESE ARTE DE' SPEZIALI (13TH - 18TH CENTURY).

The article discusses the main changes in legislation concerning granting the licenses for opening a new pharmacy in Bologna in the Middle Ages and Early Modern period. The organization of all traders, including apothecaries, was subordinated, as almost everywhere in Italy, to the Guilds. In the 2nd half of 16th century the Arte de' Speziali of Bologna came under the jurisdiction of the Collegio di Medicina, leading to disagreements between the two corporations. Giovanni Baldi, in his Notizie storiche su la farmacia bolognese (Bologna, 1955) mentioned one of these controversies, dating on the second half of 18th century. The Authors present this controversy basing on original documents from Archivio di Stato di Bologna.

[Inspection of pharmacies in Morocco during the French protectorate 1912-1956]. / L'inspection des pharmacies au Maroc pendant le Protectorat français 1912-1956.

In Morocco, the inspection of the pharmacy as currently practiced has enjoyed a great evolution: from a small body born during the protectorate, which originally had two inspectors, it has become a well-organized and prioritized sector. This article revisits the birth and history of this inspection during the French protectorate. Based on the available literature, we examined and analyzed the arrangements related to the establishment of the inspection, its various reorganizations as well as the powers allocated to inspectors.

[From ancient pot collections to the modern medicines. Menier's pot collection-19th century]. / L'arsenal thérapeutique du XIXe siècle a travers le droguier Menier.

At the beginning of the 19th century in 1816, Jean Antoine Brutus Menier founded the "Maison Centrale de Droguerie Menier". It supplied most of the pharmacies in France with drugs of animal, plant and mineral origin for the pharmaceutical preparations recommended at that time. The company provided training for many chemists and pharmacists, and as such, had a collection of pots containing over seven hundred drugs that is currently held at the head office of the Council of the College of Pharmacists in Paris. After having described the pot collection, set it against the 19th century background which experienced a real revolution within this profession, and after retracing its history, a study was then carried out in order to compare the former uses with the modern uses for each of the drugs. Thanks to this detailed, comparative analysis it is now possible to evaluate the relevance of the therapeutic range of drugs in the first half of the 19th century, before the significant rise in chemistry. The Germinal Law changed the pharmacist's profession, and with the birth of chemistry, the art of the pharmacy was revolutionised. However, the drugs, and particularly those of plant origin, have managed to keep a dominant position in today's pharmaceutical domain and in the French or European Pharmacopoeia.

[The birth of the modern Moroccan pharmaceutical legislation]. / La naissance de la législation pharmaceutique marocaine moderne.

Currently the Moroccan pharmaceutical profession is about to celebrate its centenary. Since the French protectorate period a great evolution occurred; from little herbalist shops in the countryside the dispensaries became real small companies managed by doctors in pharmacy. The objective of this study is to clarify the first pharmaceutical legislative texts in Morocco and the context of their adoption. It also aims at pointing out, describing and analyzing the provisions' evolution that governed the general pharmacy practice conditions during protectorate. Based on the information available we examined and studied successively these practice conditions and more particularly the diploma, the age and the officinal training course.

[The first set of legislation for doctors in Denmark and its source of inspiration]. / Den første lovgivning for laeger i Danmark--dens mulige forbillede og tilblivelse.

The first set of legislation for doctors in Denmark was conditional on a national need to regulate the conditions of the pharmaceutical and medical professions. By request of the king, this legislation, which came into force in 1672, was made by doctors residing in Denmark. These doctors had all been educated at foreign universities where the existing legislation had Roger II's and Friedrich II's legislation from the 12th and 13th centuries' South Italy as its source of inspiration. Thus, it is reasonable to presume that the doctors who participated in the making of the Danish legislation were familiar with this legislation. A translation into Danish of Roger II's and Friedrich II's sections regarding the work of a doctor has been made in order to be able to compare it with the content of the Danish set of legislation from 1672. The result of this comparison is that there are so many similarities that there can hardly be any doubt about the fact that the medieval legislation has been used as source for the Danish legislation from 1672.

O exercício farmacêutico na Bahia da segunda metade do século XIX / Pharmaceutical practice in Bahia in the latter half of the 19th century

Ao longo do Oitocentos, observa-se uma delimitação crescente dos ofícios relacionados às artes de curar no Brasil, enfatizando-se prerrogativas e responsabilidades. Verifica-se, na medicina acadêmica, progressiva distinção entre os que prescreviam e aqueles envolvidos na fabricação e comercialização de medicamentos. Procuramos investigar esse processo enfatizando o exercício farmacêutico na província da Bahia, na segunda metade do século XIX. Alguns dos aspectos que analisamos são as mudanças e permanências na legislação e a sua execução local, a relação dos farmacêuticos com as autoridades, os médicos e aqueles que atuavam ilegalmente fabricando e vendendo remédios sem autorização.

O exercício farmacêutico na Bahia da segunda metade do século XIX / Pharmaceutical practice in Bahia in the latter half of the 19th century

Ao longo do Oitocentos, observa-se uma delimitação crescente dos ofícios relacionados às artes de curar no Brasil, enfatizando-se prerrogativas e responsabilidades. Verifica-se, na medicina acadêmica, progressiva distinção entre os que prescreviam e aqueles envolvidos na fabricação e comercialização de medicamentos. Procuramos investigar esse processo enfatizando o exercício farmacêutico na província da Bahia, na segunda metade do século XIX. Alguns dos aspectos que analisamos são as mudanças e permanências na legislação e a sua execução local, a relação dos farmacêuticos com as autoridades, os médicos e aqueles que atuavam ilegalmente fabricando e vendendo remédios sem autorização. (AU)

[Pharmaceutical practice in Bahia in the latter half of the 19th century]. / O exercício farmacêutico na Bahia da segunda metade do século XIX.

The nineteenth century brought the progressive demarcation of the professions devoted to the healing arts in Brazil, with a emphasis on rights and responsibilities. Academic medicine made a growing distinction between those who prescribed medicine and those who engaged in making or selling it. The article explores this process, with an emphasis on pharmaceutical practice in the province of Bahia in the latter half of the century. Within this context, it addresses changes and constancies in laws and in their local enforcement as well as relations between pharmacists, on the one hand, and, on the other, the government, physicians, and those who made or sold medicine illegally or without authorization.

[Fifty years after the enactment of the law to separate drug dispensing from doctors].

This report summarizes the action of Mr. Usho Mizoroki, who was not a pharmacist but was an activist for enacting the law to separate drug dispensing from doctors (Division of Labour Law). We collected the information Mrs. Shigeko Mizoroki revealed about her husband's activities towards enacting the Division of Labour Law, and added the historical background of that era. Nobody knows of his activities related to the enactment of the Division of Labour Law. It may be possible that the law itself was not successful, or that Mr. Usho Mizoroki was not a pharmacist. However it is important to know his efforts because the present division of labour practice is the result of the efforts of many people like him.

[The decree of June 15th, 1888, the first text that legislates the pharmacy practice in Tunisia and the progress of the pharmaceutical legislation before and after the independence]. / Décret du 15 juin 1888, premier décret réglementant l'exercice de la pharmacie en Tunisie, et évolution de la législation pharmaceutique avant et après l'indépendance.

In 1881, the French protectorate is established in Tunisia whose independence will not be officially declared before March 20th, 1956. This article presents the content of the decree of June 15th, 1888, the first text that legislates pharmacy practice in Tunisia. The publication of this decree, a real fundamental text, did not put an end to the illegal practice of pharmacy in the Regency, which could be explained by the few shortcomings of the text, the legislator's inability to implement the law, the ignorance and the inadvertency of the diplomats, and also the "regime of the surrenders" (le régime des capitulations) which, by preventing the pharmaceutical inspection, gave free rein to all the offenders. This situation led in the course of time to the promulgation of a number of laws which progressively allowed a better organization of the pharmaceutical profession in the Regency. The progress made by the pharmaceutical legislation throughout the French protectorate continued after the independence of Tunisia as is attested by the law number 73-55 of August 3rd, 1973 which is still in use at present.