The Experts below are selected from a list of 102 Experts worldwide ranked by ideXlab platform
Raffaella Ravinetto - One of the best experts on this subject based on the ideXlab platform.
-
Pharmaceutical quality assurance of local private Distributors a secondary analysis in 13 low income and middle income countries
BMJ Global Health, 2018Co-Authors: Kerlijn Van Assche, Ariadna Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Achilleas Tsoumanis, Bruno Meessen, Raffaella RavinettoAbstract:Introduction The rapid globalisation of the Pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private Pharmaceutical Distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private Pharmaceutical Distributors in 13 LMICs. We assessed the Distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies9. Descriptive statistics describe the compliance for the whole sample, for Distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private Pharmaceutical Distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private Pharmaceutical Distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.
-
Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?
BMJ Global Health, 2017Co-Authors: A Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Bruno Meessen, Bruno Marchal, Pierre Massat, S Thys, Raffaella RavinettoAbstract:Objective In today9s context of globalisation of Pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of Pharmaceutical Distributors active in sub-Saharan Africa with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’, and we investigated factors favouring or hindering the adequate implementation of the guideline. Methods We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design. Findings Our analysis suggests that international Distributors based in Europe perform, on average, better than sub-Saharan African Distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. Conclusions Our findings suggest that Pharmaceutical Distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards.
Man Mohan Sharma - One of the best experts on this subject based on the ideXlab platform.
-
The Indian Competition Appellate Tribunal cancels fine due to the lack of evidence against individual executive member of charged association and investigation errors (Swapan Kumar Karak)
2015Co-Authors: Man Mohan SharmaAbstract:COMPAT quashes penalty for individual liability imposed on a member of Executive Committee of a Pharmaceutical Distributors' association* COMPAT vide its order dated December 7, 2015 set-aside…
-
The Indian Competition Appellate Tribunal (COMPAT) cancels fine for anticompetitive conduct against individual executive member of charged association due to lack of evidence against him and investigation errors (Swapan Kumar Karak / Competition Comm
2015Co-Authors: Man Mohan SharmaAbstract:COMPAT quashes penalty for individual liability imposed on a member of Executive Committee of a Pharmaceutical Distributors' association* COMPAT vide its order dated December 7, 2015 set-aside…
A. Balashov. - One of the best experts on this subject based on the ideXlab platform.
-
Contradictions of Government Policy in the Field of Regulating Drug Prices
Problems of Economic Transition, 2020Co-Authors: I. Kotliarov, A. Balashov.Abstract:The article analyzes the existing model of regulation of prices on medicines in the Russian Federation. The problems of this model are described (especially the fact that it stimulates elimination of cheaper medicines from the product range of pharmacies and Pharmaceutical Distributors and hinders investments in local development of innovative medicines). Ways to solve these problems are proposed. It is demonstrated that all medicines should be divided into three groups according to their price, and for each group a special method of price regulation should be used. It is also proposed to implement a guaranteed level of profitability for local developers of innovative medicines.
-
Contradictions of Government Policy in the Field of Regulating Drug Prices: Problems and Ways to Solve Them
Problems of Economic Transition, 2013Co-Authors: I. Kotliarov, A. Balashov.Abstract:The article analyzes the existing model of regulation of prices on medicines in the Russian Federation. The problems of this model are described (especially the fact that it stimulates elimination of cheaper medicines from the product range of pharmacies and Pharmaceutical Distributors and hinders investments in local development of innovative medicines). Ways to solve these problems are proposed. It is demonstrated that all medicines should be divided into three groups according to their price, and for each group a special method of price regulation should be used. It is also proposed to implement a guaranteed level of profitability for local developers of innovative medicines.
-
The Contradictions of the State Policy on Regulation of Prices on Medicines: Problems and Ways of Their Solving
Voprosy Economiki, 2011Co-Authors: I. Kotlyarov, A. Balashov.Abstract:The article analyzes the existing model of regulation of prices on medicines in the Russian Federation. Problems of this model are described (especially the fact that it stimulates elimination of cheaper medicines from the product range of pharmacies and Pharmaceutical Distributors and hinders investments into local development of innovative medicines). Ways to solve these problems are proposed. It is demonstrated that all medicines should be divided into three groups according to their price, and for each group a special method of price regulation should be used. It is also proposed to implement a guaranteed level of profitability of local developers of innovative medicines.
Jean Michel Caudron - One of the best experts on this subject based on the ideXlab platform.
-
Pharmaceutical quality assurance of local private Distributors a secondary analysis in 13 low income and middle income countries
BMJ Global Health, 2018Co-Authors: Kerlijn Van Assche, Ariadna Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Achilleas Tsoumanis, Bruno Meessen, Raffaella RavinettoAbstract:Introduction The rapid globalisation of the Pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private Pharmaceutical Distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private Pharmaceutical Distributors in 13 LMICs. We assessed the Distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies9. Descriptive statistics describe the compliance for the whole sample, for Distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private Pharmaceutical Distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private Pharmaceutical Distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.
-
Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?
BMJ Global Health, 2017Co-Authors: A Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Bruno Meessen, Bruno Marchal, Pierre Massat, S Thys, Raffaella RavinettoAbstract:Objective In today9s context of globalisation of Pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of Pharmaceutical Distributors active in sub-Saharan Africa with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’, and we investigated factors favouring or hindering the adequate implementation of the guideline. Methods We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design. Findings Our analysis suggests that international Distributors based in Europe perform, on average, better than sub-Saharan African Distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. Conclusions Our findings suggest that Pharmaceutical Distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards.
Bruno Meessen - One of the best experts on this subject based on the ideXlab platform.
-
Pharmaceutical quality assurance of local private Distributors a secondary analysis in 13 low income and middle income countries
BMJ Global Health, 2018Co-Authors: Kerlijn Van Assche, Ariadna Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Achilleas Tsoumanis, Bruno Meessen, Raffaella RavinettoAbstract:Introduction The rapid globalisation of the Pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private Pharmaceutical Distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private Pharmaceutical Distributors in 13 LMICs. We assessed the Distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies9. Descriptive statistics describe the compliance for the whole sample, for Distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private Pharmaceutical Distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private Pharmaceutical Distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.
-
Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?
BMJ Global Health, 2017Co-Authors: A Nebot Giralt, Jean Michel Caudron, Benedetta Schiavetti, Corinne Pouget, Bruno Meessen, Bruno Marchal, Pierre Massat, S Thys, Raffaella RavinettoAbstract:Objective In today9s context of globalisation of Pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of Pharmaceutical Distributors active in sub-Saharan Africa with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’, and we investigated factors favouring or hindering the adequate implementation of the guideline. Methods We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design. Findings Our analysis suggests that international Distributors based in Europe perform, on average, better than sub-Saharan African Distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. Conclusions Our findings suggest that Pharmaceutical Distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards.