A Judicialização do Acesso aos Medicamentos: forma de circulação da mercadoria medicamento pela indústria farmacêutica e transferência de valor do Brasil para as nações hegemônicas do capitalismo / The Judicialization of Access to Medicines: form of circulation of medicine merchandise by the pharmaceutical industry and transfer of value from Brazil to the hegemonic nations of capitalism

Nesse trabalho verificou-se, com fundamento na Teoria Marxista da Dependência, a utilização da judicialização do acesso a medicamentos pela indústria farmacêutica como forma de promover a circulação de suas mercadorias no Brasil, fechando o ciclo do capital. É discutida, inicialmente, a situação de dependência do Brasil, a teoria marxista do valor e circulação de mercadorias e as novas teorias do imperialismo e da financeirização. Em seguida, analisamos a produção e a circulação de medicamentos no país e a falta de transparência da indústria farmacêutica quanto aos valores de investimento em pesquisa e desenvolvimento, usados para justificar o alto custo de medicamentos. É apresentada a situação da judicialização da saúde no país, as regras de assistência farmacêutica no SUS e é feita a análise da legislação nacional. A metodologia foi da revisão da literatura, análise das decisões judiciais nos processos em que foi requerido ao Estado o fornecimento do medicamento Zolgensma® pela consulta pública no site dos tribunais da justiça comum do Poder Judiciário da União (STF, STJ e TRF's), consulta das compras feitas pelo Ministério da Saúde do medicamento Zolgensma® no SIASG (painel de compras do governo federal) em 2022 e verificação do gasto do Ministério da Saúde com o componente especializado da assistência farmacêutica em 2022, no portal SIGA BRASIL, da Câmara dos Deputados. Conclui-se que o direito à saúde no Brasil tem sido interpretado como o mero consumo de tecnologias em saúde, com fundamento no laudo médico e no art. 196 da Constituição Federal e que a aquisição de medicamentos pelo SUS para atender a ordens judiciais contribui para a transferência de valor do Brasil, país da periferia do capitalismo, pelo intercâmbio desigual, ou seja, pelo déficit na balança comercial, já que o Brasil tem pouca produção de medicamentos sofisticados tecnologicamente e também pelo pagamento de patentes e pela remessa de lucros aos países sede das farmacêuticas ... (AU)

In this work, based on the Marxist Theory of Dependence, the use of the judicialization of access to medicines by the pharmaceutical industry as a way of promoting the circulation of its goods in Brazil, closing the cycle of capital, was verified. Initially, the situation of Brazil's dependency, the Marxist theory of value and circulation of goods and the new theories of imperialism and financialization are discussed. Then, we analyze the production and circulation of medicines in the country and the lack of transparency of the pharmaceutical industry regarding the values of investment in research and development, used to justify the high cost of medicines. The situation of the judicialization of health in the country is presented, the rules of pharmaceutical assistance in the SUS and an analysis of the national legislation is made. The methodology was a literature review, analysis of judicial decisions in cases in which the State was required to supply the drug Zolgensma® through public consultation on the website of the courts of common justice of the Federal Judiciary Power (STF, STJ and TRF's), consultation of purchases made by the Ministry of Health of Zolgensma® in the SIASG (federal government purchasing panel) in 2022 and verification of the Ministry of Health's expenditure with the specialized component of pharmaceutical assistance in 2022, on the SIGA BRASIL portal, of the Chamber of Deputies . It is concluded that the right to health in Brazil has been interpreted as the mere consumption of health technologies, based on the medical report and art. 196 of the Federal Constitution and that the acquisition of medicines by the SUS to comply with court orders contributes to the transfer of value from Brazil, a country on the periphery of capitalism, through unequal exchange, that is, through the deficit in the trade balance, since Brazil has little production of technologically sophisticated medicines and also by paying patents and remitting profits to the pharmaceutical companies' headquarters countries ... (AU)

Quality value transfer of substance benchmarks in Sanpian Decoction / 中国中药杂志

According to the polarity of different components in Sanpian Decoction, two fingerprints were established. Then the substance benchmark freeze-dried powder of 15 batches of Sanpian Decoction was prepared, followed by the determination of the fingerprints, index component content, and dry extract rates, the identification of attribution of characteristic peaks, and the calculation of similarities between these fingerprints and the reference(R), the content and transfer rate ranges of ferulic acid, sinapine thiocyanate, liquiritin, and glycyrrhizic acid, and the dry extract rate range. The results showed that the similarities of 15 batches of the substance benchmark fingerprints with R were all greater than 0.900.Further summarization of the characteristic peaks revealed that there were a total of 20 characteristic peaks in fingerprint 1, among which, eight were from Sinapis Semen, four from Paeoniae Radix Alba, six from Chuanxiong Rhizoma, and two from Glycyrrhizae Radix et Rhizoma. A total of 16 characteristic peaks were observed in fingerprint 2, including one from Sinapis Semen, three from Paeoniae Radix Alba, eight from Chuanxiong Rhizoma, and four from Glycyrrhizae Radix et Rhizoma. The average dry extract rate of 15 batches of substance benchmarks was 18.25%, with a dry extract rate range of 16.28%-20.76%. The index component content and transfer rate ranges were listed as follows: 0.15%-0.18% and 38.81%-58.05% for ferulic acid; 0.26%-0.42% and 36.51%-51.02% for sinapine thiocyanate; 0.09%-0.15% and 48.80%-76.61% for liquiritin; 0.13%-0.24% and 23.45%-35.61% for glycyrrhizic acid. The fingerprint, dry extract rate, and index component content determination was combined for analyzing the quality value transfer of substance benchmarks in the classic prescription Sanpian Decoction.The established quality evaluation method for the substance benchmarks was stable and feasible, which has provided a basis for the quality control of Sanpian Decoction and the follow-up development of related preparations.

Quality value transfer of material benchmark of Guizhi Jia Gegen Decoction / 中国中药杂志

A total of 15 batches of the substance reference of Guizhi Jia Gegen Decoction(GZGGD) were prepared and the characteristic fingerprints of them were established. Furthermore, the similarity of the fingerprints and peak attributes were explored. The extraction rate, and the content and the transfer rate ranges of the index components, puerarin, paeoniflorin, liquiritin, and ammonium glycyrrhizate were determined for the analysis of the quality value transfer. The result demonstrated that the fingerprints of the 15 batches of the samples showed high similarity(>0.99). A total of 15 characteristic peaks were identified from the fingerprints, with 10 for Puerariae Lobatae Radix, 1 for Cinnamomi Ramulus, 2 for Paeoniae Radix Alba, and 2 for Glycyrrhizae Radix et Rhizoma. The content of puerarin was 11.05-18.35 mg·g~(-1) and the average transfer rate was 21.27%-39.49%. The corresponding figures were 7.95-10.90 mg·g~(-1) and 23.28%-43.23% for paeoniflorin, 3.25-4.95 mg·g~(-1) and 32.31%-61.27% for ammonium glycyrrhizate, and 3.65-5.80 mg·g~(-1) and 14.57%-27.05% for liquiritin. The extraction rate of the 15 batches of samples was in the range of 16.85%-21.78%. In this paper, the quality value transfer of the substance reference of GZGGD was analyzed based on characteristic fingerprint, content of index components, and the extraction rate. This study is expected to lay a basis for the quality control and further development of GZGGD.

Quality value transfer of substance benchmarks in Huanglian Decoction / 中国中药杂志

Following the preparation of substance benchmarks in Huanglian Decoction from 18 batches, the method for detecting their characteristic spectra was established to identify the similarity range and peak attribution. The content and transfer rate ranges of the index components coptisine, palmatine, berberine, liquiritin, glycyrrhizic acid, 6-gingerol, and cinnamaldehyde and the extraction amount were combined for analyzing the quality value transfer from the Chinese medicinal pieces to substance benchmarks and clarifying the key quality attributes of substance benchmarks in Huanglian Decoction. The results showed that the substance benchmarks in Huang-lian Decoction of 18 batches exhibited good similarity in characteristic spectra(all greater than 0.98). There were 17 characteristic peaks identified in the substance benchmarks of Huanglian Decoction, including 10 from Coptidis Rhizoma, 3 from Glycyrrhizae Radix Et Rhizoma Praeparata Cum Melle(processed with water), 1 from Zingiberis Rhizoma, and 3 from Cinnamomi Ramulus. The contents and average transfer rates of the index components were listed as follows: coptisine 2.20-6.46 mg·g~(-1) and 18.50%±2.93%; palmatine 3.03-8.13 mg·g~(-1) and 26.56%±4.69%; berberine 7.71-22.29 mg·g~(-1) and 17.34%±3.00%; liquiritin 0.88-2.18 mg·g~(-1) and 9.88%±4.88%; glycyrrhizic acid 1.83-4.44 mg·g~(-1) and 8.50%±3.72%; 6-gingerol 0.56-1.43 mg·g~(-1) and 11.36%±2.37%; cinnamaldehyde 1.55-3.48 mg·g~(-1) and 19.02%±4.36%. The extraction amount of the substance benchmarks from the 18 batches was controlled at 10.65%-13.88%. In this paper, the quality value transfer of substance benchmarks in Huanglian Decoction was analyzed based on the characteristic spectra, the index component contents and the extraction amount, which has provided a basis for the subsequent development of Huanglian Decoction and the quality control of its related preparations.

Quality control mode based on engineering quality view of Chinese medicine pharmacy / 中国中药杂志

Due to the characteristics of confusing varieties of Chinese medicinal materials, different sources, complex chemical composition, non-standard preparation process, and non-standard pharmaceutical equipment, the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation. The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation. The "overall, dialectical, and dynamic" multi-factor engineering quality view, covering original medicinal materials, preparation technologies, pharmaceutical equipment, and Chinese medicinal preparations, ensures the traceable process, measurable procedures, and feedback quality. The quality control mode of Chinese medicinal preparation with controllable sources, standardized preparation technologies, green pharmaceutical equipment, and intelligent manufacturing is built up.

Analysis on quality value transfer of substance benchmarks of Zhenwu Decoction / 中国中药杂志

By preparing 15 batches of Zhenwu Decoction substance benchmarks,the characteristic map,index component content and paste-forming rate were determined to define the peak attribution,similarity range,paste-forming rate range,paeoniflorin and6-gingerol content range and transfer rate range. The similarity between the substance benchmark characteristic map and the control map R generated from the 15 batches of substance benchmarks was higher than 0. 970. There were 19 characteristic peaks in total. By further summarization of the characteristic peaks,it could be seen that tuckahoe had 3 characteristic peaks,white peony root had 10 characteristic peaks,atractylodes had 3 characteristic peaks,ginger had 1 characteristic peak,and Aconite root had 3 characteristic peaks; among them,white peony root and aconite root had 1 common peak. The contents and transfer rates of the 15 batches were0. 50%-0. 93 and 16. 11%-26. 20%; those for 6-gingerol were 0. 018 2%-0. 033 9% and 13. 16%-24. 10%,respectively. The pasteforming rate ranged from 10. 00% to 14. 85%. In this study,the transfer process of substance benchmark value of classic formula Zhenwu Decoction was analyzed based on the characteristic map,the paste-forming rate and the content of the index components; a scientific and stable substance benchmark quality evaluation method was preliminarily established to provide a basis for subsequent development of classic formula Zhenwu Decoction and quality control of relevant preparations.

Analysis on quality value transfer of substance benchmarks of Taohong Siwu Decoction / 中国中药杂志

By preparing 15 batches of substance benchmarks of Taohong Siwu Decoction, the methodology of the characteristic spectrums of substance benchmarks was established. The paste-forming rate range, the contents and the transfer rate range of the index components, hydroxy safflower yellow A, ferulic acid and paeoniflorin, the characteristic peaks and the similarity range of the characteristic spectrums of Taohong Siwu Decoction were determined to define key quality attributes of substance benchmarks of Taohong Siwu Decoction.In the 15 batches of substance benchmarks of Taohong Siwu Decoction, the similarity of characteristic spectrums was higher than 0.9. Furthermore, based on summarization of the characteristic peak information, there were 13 characteristic peaks in the whole decoction. Baishao had three characteristic peaks, Honghua had seven characteristic peaks, and Chuanxiong and Danggui had three characteristic peaks. The paste-forming rate of the 15 batches of substance benchmarks was controlled at 33.11%-40.62%. The content of hydroxy safflower yellow A was 0.129%-0.203%, with the average transfer rate of 16.596%±0.669%.The content of ferulic acid was 0.043%-0.055%, with the average transfer rate of 20.489%±1.772%.The content of paeoniflorin was 0.676%-0.943%, with the average transfer rate of 29.112%±3.273%.The quality value transfer of substance benchmarks of classical prescription Taohong Siwu Decoction was analyzed by the combination of characteristic spectrums, paste-forming rate and the content of index components. The established substance benchmark quality evaluation method was stable and feasible, and could provide a basis for quality control and subsequent development of relevant preparations of Taohong Siwu Decoction.

Analysis on quality value transfer of substance benchmarks of Qingwei San / 中国中药杂志

By preparing 10 batches of substance benchmarks freeze-drying powder( lyophilized powder),the methodology of the characteristic spectrum and the content of index component for substance benchmarks of Qingwei San was established. The characteristic peaks and the similarity range of the characteristic spectrum,the contents and the transfer rate range of isoferulic acid,palmatine and paeonol,and the paste-forming rate range were determined to define key quality attributes of substance benchmarks of Qingwei San. In the10 batches of substance benchmarks of Qingwei San,the similarity of characteristic spectrum was higher than 0. 90. In further comparison of the characteristic peak information,a total of 16 characteristic peaks were identified,including 5 characteristic peaks from Cimicifugae Rhizoma,5 characteristic peaks from Coptidis Rhizoma,2 characteristic peaks from Angelicae Sinensis Radix and 4 characteristic peaks from Moutan Cortex. The content of isoferulic acid was 0. 10%-0. 18%,with the average transfer rate of 49. 82%±4. 02%. The content of palmatine was 0. 17%-0. 31%,with the average transfer rate of 15. 84% ±2. 39%. The content of paeonol was 0. 41%-0. 75%,with the average transfer rate of 23. 41%±3. 23%. The paste-forming rate of the 10 batches of substance benchmarks were controlled at 27%-33%,with the transfer rate between the theoretical paste-forming rate and the actual paste-forming rate was 86. 59%±3. 39%. In this study,the quality value transfer of substance benchmarks of Qingwei San was analyzed by the combination of characteristic spectrum,the content of index component and the paste-forming rate. A scientific and stable evaluation method was preliminarily established,so as to provide the basis for subsequent development and quality control of relevant preparations of Qingwei San.

Design and application of performance appraisal program at clinical departments based on the concept of value transfer / 中华医院管理杂志

Performance appraisal is one of the key points of hospital management. The authors introduce a comprehensive hospital performance appraisal scheme based on the concept of value transfer, including qualitative and quantitative index system, weight and appraisal method.In the pilot practice of a hospital, it is found that the appraisal scheme can effectively improve the operational efficiency, social and economic benefits, and has a strong incentive role for employees. This scheme weighs the operability and scientificity of performance appraisal, and provides a reference for clinical department performance appraisal.

Investigations on the effect of measuring value transfer for human serum samples assigned by the reference laboratory network / 临床检验杂志

Objective To investigate the effect of measuring value transfer for human serum samples assigned by the reference laboratory network on improving the trueness of seven enzyme activities in clinical laboratories,such as ALT,AST,GGT,LDH,CK,AMY and ALP.Methods Depending on the medical imtitutions at all levels contacted by 5 reference laboratories in North China,South China,East China and Southwest China,the corresponding clinical laboratory measuring value transfer/traceability network was established.The frozen human serum samples with good interehangeability and standard material characteristics,including calibrator,sample 1 and sample 2,were provided by Beijing Aerospace General Hospital,and were assigned by 5 reference labotatories in four regiom.These samples were sent to 48 clinical laboratories.These clinical laboratories measured sample 1 and sample 2 according to their standard operating procedures,and then measured.the two samples again after adjusting their measurement system by using the supplied calibrator.The changes of trueness of detection results in these laboratories were evaluated according to the WS/T 403-2012 standard,and the changes of consistency for ALT and AST before and after measuring value tramfer were investigated.Results The results of AMY,ALP,GGT,CK and LDH calibrator,sample 1 and sample 2 assigned by the established network were 138.7 U/L,278.5 U/L and 68.3 U/L,265.3 U/L,94.5 U/L and 134.4 U/L,195.8 U/L,89.0 U/L and 158.9 U/L,393.7 U/L,260.0 U/L and 645.3 U/L,and 302.0 U/L,250.0 U/L and 452.7 U/L,respectively.The percentages of sample 1 and sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value transfer for AMY,ALP and GGT were 65.9％ and 61.0％,76.6％ and 78.7％,and 66.7％ and 70.8％,respectively,while after measuring value transfer,they were 89.2％ and 83.8％,86.7％ and 80.0％,and 85.4％ and 91.7％,respectively.The percentages of sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value transfer for CK and LDH were 64.6％ and 58.3％,respectively,while after measuring value trander,they were 93.5％ and 84.8％,respectively.The coefficients of variation (consistency) of sample 1 and sample 2 for ALT and AST before measuring value tramfer were 12.9％ and 11.3％,and 10.2％ and 8.9％,respectively,while after measuring value transfer,they were 9.3％ and 8.2％,and 5.6％ and 5.9％,respectively.Conclusion The calibration of routine measurement systems based on the measuring value transfer for human serum samples assigned by the reference laboratory network may improve the comparability of 7 enzyme actvities measurement results in chnical laboratories at all levels obviously,which deserves to be further spread.