CT-Luso: para uma harmonização ética e regulatória dos ensaios clínicos nos países africanos de língua portuguesa
Objective: to conduct a survey and comparative analysis of current and/or pending legislation in the field of biomedical research, particularly clinical trials, in the five Portuguese-speaking african countries, within the framework of the CT-Luso project. Methodology: documentary analysis based on the systematic survey and examination of 52 legislative instruments, complemented by a technical comparison with international requirements applicable to clinical research, namely Regulation (European Union) No. 536/2014 and the Declaration of Helsinki. Results: significant heterogeneity was found in the legal frameworks for biomedical research in the Portuguese-speaking african countries. Only some of the countries have specific legislation for clinical trials; the rest are governed by general health or research standards. Weaknesses were identified in regulatory authorities and ethics committees with uneven powers, affecting ethical evaluation and participant protection. A lack of alignment with international standards was observed, especially regarding informed consent, data sharing and transparency. However, there was political will for regulatory convergence, expressed in ongoing legislative initiatives and the strengthening of inter-institutional cooperation. Conclusion: the approach adopted by CT-Luso confirms that international legal cooperation is an effective tool for diagnosing vulnerabilities and guiding legislative reforms in clinical research. However, challenges remain in terms of ethical and regulatory harmonisation, which must be overcome in order to consolidate robust legal frameworks, ensure the protection of participants and strengthen the integration of portuguese-speaking african countries into international good scientific practice. The creation of regional coordination mechanisms and the progressive adoption of common ethical and legal benchmarks are decisive steps towards strengthening research governance and its sustainable integration into the global scientific arena. Submitted: 09/28/25| Revision: 11/03/25| Approved: 11/03/25
- Book Chapter
- 10.5772/intechopen.97730
- Nov 3, 2021
Spread across the planet each human being, individually or in community, aspires for well-being and quality of life, according to the ideal of each one. However, we all believe that there are always ways to live better. For many people the measurement of a better life translates into the guarantee of social rights, the right to basic services, good land, seed and sufficient nutritious food for their community members. The Mechanism to Facilitate the Participation of Universities in the Food and Nutrition Security Council of the Community of Portuguese Speaking Countries is a cooperative academic network fomented by the Community of Portuguese Speaking Countries (CPLP) with support from the Food and Agriculture Organization of the United Nations. This mechanism works with teaching, research and extension in the CPLP Food and Nutrition Security Strategy. The pillars of CPLP Strategy are the strengthening of the governance of public policies on Food and Nutrition Security at all levels of government, social protection based on guaranteeing access to food and family farming with a strategy to increase the availability of good quality food, promoting social and environmental sustainability. CPLP University Mechanism has provided training processes for technicians who work in public policies for Food and Nutrition Security and has contributed to the strengthening of postgraduate programs in Portuguese-speaking African countries. As consequence, it has favored participatory research and mixed methods as a theoretical methodological approach. Therefore, it seeks to focus on the territories of Food and Nutrition Security practices to transform reality, as recommended by CPLP Strategy, however, with the autonomous assumptions of the collaborative network. This chapter presents how local researchers perceive the results of a process of inducing an academic network to transform the local reality and promote Food and Nutrition Security in the context of the CPLP.
- Research Article
5
- 10.1186/s12879-024-09803-1
- Aug 29, 2024
- BMC Infectious Diseases
BackgroundHIV-1 infections remain a global public health concern. Scaled-up antiretroviral treatment (ART) is crucial for reducing morbidity and mortality related to HIV/AIDS. The emergence of drug-resistance mutations (DRMs) compromises viral suppression and contributes to the continued HIV-1 transmission. Several reports indicate a recent increase in acquired (ADR) and transmitted (TDR) drug resistance in Africa, probably linked to the lack of implementation of HIV drug resistance (HIVDR) testing and suboptimal treatment adherence. Herein, we will develop a low-cost protocol using third-generation sequencing (Oxford Nanopore Technology) for HIV-1 surveillance in Portuguese-speaking African Countries - PALOP [Angola (AO), Cape Verde (CV), Mozambique (MZ), and Sao Tome & Principe (STP)].MethodsThis is a multicentric cross-sectional study that includes around 600 adult patients newly diagnosed with HIV-1 in the PALOP. An epidemiological questionnaire previously validated by our research team will be used to collect sociodemographic and clinical data. Also, whole blood samples will be collected and the plasma samples will be subjected to drug resistance testing using an in-house low-cost NGS protocol. Data analysis will involve bioinformatics, biostatistics and machine learning techniques to generate accurate and up-to-date information about HIV-1 genetic diversity, ADR and TDR.DiscussionThe implementation of this low-cost NGS platform for HIV-1 surveillance in the PALOP will allow: (i) to increase DRM surveillance capacity in resource-limited settings; (ii) to understand the pattern and determinants of dissemination of resistant HIV-1 strains; and (iii) to promote the development of technical and scientific skills of African researchers for genomic surveillance of viral pathogens and bioinformatics analysis. These objectives will contribute to reinforcing the capacity to combat HIV infection in Africa by optimizing the selection of ART regimens, improving viral suppression, and reducing ADR or TDR prevalence in PALOPs, with relevant implications for public health.
- Research Article
4
- 10.1016/j.marpol.2019.02.027
- Mar 2, 2019
- Marine Policy
ODA in Galicia (Spain). The importance of the fisheries sector and the cultural priority
- Research Article
- 10.57054/ad.v49i3.5882
- Mar 5, 2025
- Africa Development
The project that led to this issue emerged in Recife, during the 3rd Conference on Activism in Africa, held in September 2021 in online format owing to restrictions related to the pandemic. The three organisers of this issue took part in the conference, co-ordinating panels and proposing papers along the theme of social movements and their demands in the defence of human rights. In the process they identified the fundamental axes for building an intellectual link and civic commitment between Africa and Brazil. Therefore, in 2024 we decided to organise a special issue on topics re- lated to the Portuguese-speaking global South. We were keenly aware that this would be a challenge, for several reasons. First, scientific production in the Portuguese-speaking African countries (PALOP) is still below par. Second, we wanted to go beyond the generally institutional representations of these countries, including studies on the Afro-Brazilian reality. There are numerous studies on bilateral or multilateral relations within the Community of Portuguese Language Countries (CPLP) and the activities of various national governments. However, they avoid uncomfortable subjects such as LGBTQAI+ in the PALOP or the failure of many Portuguese-speaking countries, especially in Africa, to protect the human rights of their citizens or migrant populations. This is the context for our effort to create this intellectual link between the epistemological, historical and sociological universes on both sides of the Atlantic and the African Indian Ocean, the connections between which are more alive today than ever before.
- Research Article
3
- 10.14568/cp2018040
- Mar 4, 2020
- Conservar Património
The Instituto de Investigação Científica Tropical/University of Lisbon (IICT/UL), Portugal, holds the most important scientific collections from Portuguese-speaking African countries, which include anthropological, archaeological, ethnographic, mineralogical, botanical and zoological collections, as well as libraries and historical archives. The aim of this paper is to document the advances in conservation and management of IICT collections between 2005 and 2015, namely how the implementation of institutional initiatives created new challenges for the scientific community. After an overview of the IICT's scientific heritage since the creation of the Cartography Commission in 1883, we characterise several recent actions aimed at preserving and providing access to the collections. Considerations on the current preservation of the IICT collections are presented. It is argued that these collections are unique for tropical science and of critical importance for scientific cooperation with Portuguese-speaking countries in Africa.
- Research Article
1
- 10.1093/eurpub/ckz185.623
- Nov 1, 2019
- European Journal of Public Health
Introduction It is unclear whether migrant women experience worse pregnancy outcomes than native women. A better comprehension of obstetric care provision, including controversial interventions such as episiotomy, is important to improve equity of service provision, overall maternal and neonatal health and to support evidence-informed perinatal health policy-making. We aimed to determine if migrant and native women giving birth vaginally have different risks of episiotomy and if the risk differs by migrant sub-groups. Methods This study is based on a cross-sectional survey of foreign-born women with a random sample of native women, implemented in 32 public maternity units in mainland Portugal. We included 3583 women with vaginal delivery. Migrant status was defined by the woman’s country of birth (migrants, born abroad, vs natives, born in Portugal), then as subgroups of migrants from Brasil, Portuguese-speaking African countries (PSAC) and non Portuguese-speaking countries vs natives. The association between migrant status and episiotomy was assessed using multilevel logistic regression models, stratified by delivery mode, and adjusted for main risk factors of episiotomy. Results The overall frequencies of episiotomy were 52.6% and 48.2% among the 1707 natives and the 1876 migrants, respectively (p = 0.01). With spontaneous delivery, migrant women had decreased odds of having an episiotomy (adjusted OR 0.70 [95% CI 0.58-0.83]), especially those from PSAC (aOR 0.57 [0.46-0.71]). However, with instrumental delivery, migrant women had increased odds of episiotomy (aOR 2.47 [95% CI 1.50-4.07]), especially those from Brasil (aOR 3.24 [1.18-8.92]) and non Portuguese-speaking countries (aOR 3.75 [1.82-7.71]). Conclusions These results suggest non-medically justified differential care during childbirth and highlight the importance of developing evidence-based recommendations for episiotomy use, in a country with a high frequency of medical intervention during delivery. Key messages Portugal displays a high frequency of medical interventions during delivery, including episiotomy, highlighting the need for developing evidence-based recommendations. Migrant and native women have different risks of episiotomy, suggesting non-medically justified differential care.
- Research Article
1
- 10.1093/eurpub/ckz186.068
- Nov 1, 2019
- European Journal of Public Health
Background Breastfeeding provides benefits for children, mothers, society and the environment. The promotion of optimal breastfeeding, from an early stage in life is, therefore, a public health priority. Infant feeding can be influenced by maternal country of birth. However, studies carried out in European settings point to inconsistent findings. This study aims to compare first day in-hospital exclusive breastfeeding among migrant and native women in Portugal. Methods This study is based on a national project on perinatal health among migrants and natives in Portugal (baMBINO). Out of 39 public maternity units in mainland Portugal, 32 were enrolled. Women aged 18 years old or older with a live birth were recruited. The final sample included 5109 participants (2431 natives and 2678 migrants). Logistic regression was used to assess the association between maternal country of birth and in-hospital exclusive breastfeeding. Results Migrant participants included women from Portuguese-speaking African countries (PSAC) (49,7%), Brazil (18%), Eastern Europe (10.2%), other European countries (9.6%), Asia (5.5%) and other countries (7.0%). No differences were found between migrants and natives, with the exception of women from PSAC who were more likely to exclusively breastfeed during the first day of hospital stay (aOR 1.34 CI95% 1.05-1.72), irrespective of maternal age, education, parity, type of pregnancy, reproductive assistance, tobacco use, gestational age, newborn birth weight, mode of delivery and antenatal care. Conclusions In Portugal, women from PSAC are more likely to exclusively breastfeed their babies during the first day of hospital stay when compared to native women. Strategies to maintain healthy breastfeeding practices in this population are fundamental. Key messages Women from PSAC are more likely to breastfeed exclusively in the first day after delivery than Portuguese natives. They should be supported in the maintenance of optimal breastfeeding practices.
- Research Article
8
- 10.3389/fpubh.2024.1415588
- Jul 3, 2024
- Frontiers in public health
Health literacy among migrants is a matter of public health and social justice. Migrants from diverse backgrounds encounter challenges such as linguistic barriers, cultural disparities, restricted access to health services, and heterogeneous migration statuses. Addressing these challenges requires careful consideration of their unique experiences and needs to promote equitable health outcomes. This can hinder their ability to navigate the healthcare system, understand health information, and engage in health-promoting behaviours. However, there is still a significant gap in our understanding of health literacy within migrant communities. This study has a dual aim: to identify health literacy strengths and needs among migrants from Portuguese-speaking African Countries (PALOP) countries in the Lisbon Metropolitan Area and to examine associations between demographic, socioeconomic, migration and health condition characteristics and the health literacy domains. A cross-sectional survey was conducted. Data were collected from 506 PALOP migrants using the Health Literacy Questionnaire (HLQ). We also collected demographic, socioeconomic, migration, and health condition data. We employed multiple linear regression to understand the relationship between the HLQ nine domains and these characteristics. The HLQ scores revealed distinct patterns of health literacy between the groups. Health literacy needs were particularly evident in the domains related to feeling understood and supported by healthcare providers and navigating the healthcare system. Conversely, higher scores and potential strengths were observed in actively managing one's health and understanding enough health information to make informed decisions. However, in these, the average scores suggest that a high proportion of people recognised difficulties. 'The results also indicated that a higher educational level was associated with increased health literacy. In contrast, low self-perceived health status, living alone, shorter duration of residence in Portugal, and being either undocumented or in the process of obtaining legal status were associated with lower health literacy. Our study highlights the importance of migration-related variables and self-reported health status in understanding health literacy among migrant communities. Factors such as length of stay and low self-perceived health status are associated with potentially disadvantageous levels of health literacy, which could exacerbate health inequalities. Assessing these variables is critical to identify gaps in health literacy and develop tailored interventions to reduce health inequalities.
- Research Article
83
- 10.1093/heapol/13.3.332
- Sep 1, 1998
- Health policy and planning
To explore the type of private practice supplementary income-generating activities of public sector doctors in the Portuguese-speaking African countries, and also to discover the motivations and the reasons why doctors have not made a complete move out of public service. Cross-sectional qualitative survey. In 1996, 28 Angolan doctors, 26 from Guinea-Bissau, 11 from Mozambique and three from S Tomé and Principe answered a self-administered questionnaire. All doctors, except one unemployed, were government employees. Forty-three of the 68 doctors that answered the questionnaire reported an income-generating activity other than the one reported as principal. Of all the activities mentioned, the ones of major economic importance were: public sector medical care, private medical care, commercial activities, agricultural activities and university teaching. The two outstanding reasons why they engage in their various side-activities are 'to meet the cost of living' and 'to support the extended family'. Public sector salaries are supplemented by private practice. Interviewees estimated the time a family could survive on their public sector salary at seven days (median value). The public sector salary still provides most of the interviewees income (median 55%) for the rural doctors, but has become marginal for those in the urban areas (median 10%). For the latter, private practice has become of paramount importance (median 65%). For 26 respondents, the median equivalent of one month's public sector salary could be generated by seven hours of private practice. Nevertheless, being a civil servant was important in terms of job security, and credibility as a doctor. The social contacts and public service gave access to power centres and resources, through which other coping strategies could be developed. The expectations regarding the professional future and regarding the health systems future were related mostly to health personnel issues. The variable response rate per question reflects some resistance to discuss some of the issues, particularly those related to income. Nevertheless, these studies may provide an indication of what is happening in professional medical circles in response to the inability of the public sector to sustain a credible system of health care delivery. There can be no doubt that for these doctors the notion of a doctor as a full-time civil-servant is a thing of the past. Switching between public and private is now a fact of life.
- Research Article
- 10.1016/j.ejso.2023.107262
- Nov 10, 2023
- European Journal of Surgical Oncology
Fellowship in surgical oncology: The results of an experience in Portuguese-speaking African countries
- Research Article
1
- 10.1590/s0102-311x2009000300022
- Mar 1, 2009
- Cadernos de Saúde Pública
This forum on the challenges of preventing STD/AIDS in Portuguese-speaking African countries contains three articles and a postscript. The first paper reviews academic production on the topic from the fields of the social sciences and of health, with special attention on how local cultural and socioeconomic factors impact the dynamics of the epidemic. Based on an ethnographic study of a region in southern Mozambique, the second paper analyzes the notion of 'tradition' within the context of Mozambique and how it affects perceptions of the local population's vulnerability to STD/AIDS. The third and final article discusses common ground and differences between government and civil society in gender approaches by community HIV/AIDS projects in Mozambique. Their observations suggest that important mistakes have been made in STD/AIDS prevention discourse and initiatives in African countries because the unique features of local development models and cultural systems have not been taken into account.
- Research Article
- 10.47814/ijssrr.v7i9.2216
- Sep 3, 2024
- International Journal of Social Science Research and Review
This paper highlights some of the challenges faced by the Portuguese-speaking African Countries (PALOPs) to consolidate Sociology as a relevant area of knowledge, both at university and school level. For this purpose, we will rely on part of the scarce existing bibliography on the subject, as well as on interviews with African teachers and students. Decolonial thinking inspires the elaboration of this article, as it criticizes the perspective of the modernity of knowledge solely linked to Eurocentric or American thinking. In these young countries, the university and this field of knowledge are new and lack institutionalization. The lack of investment by the State, the precarious structure, the difficulty of academic cooperation, the persistence of a strong coloniality in the production of knowledge and linguistic obstacles further complicate the process. It is important to seek synergy between countries, with exchanges of experiences and international cooperation - including Brazil - and also between professors and students in the struggle for the consolidation of the discipline.
- Research Article
27
- 10.1007/s10096-017-2915-x
- Feb 3, 2017
- European Journal of Clinical Microbiology & Infectious Diseases
High rates of trimethoprim/sulfamethoxazole (SXT) resistance, a combination of two antifolate antibiotics trimethoprim (TMP) and sulfamethoxazole (SMZ), have been reported among Staphylococcus aureus isolates in Portuguese-speaking African countries. Our study aimed to evaluate the occurrence of TMP resistance markers in major SXTR methicillin-resistant S. aureus (MRSA) clones from these countries. We accessed also different fitness traits that could explain the success of these isolates over the Brazilian MRSA (the most successful SXTR MRSA clone worldwide but never identified in these countries). Minimum inhibitory concentrations for SXT, TMP and SMZ were determined, and genes encoding TMP resistance (dfrG, dfrA, dfrK and dfrB) were searched. Representatives of the Brazilian clone and of the major MRSA African clones were evaluated for their fitness by individual growth curves, competition assays, survival under desiccation, autolytic activity, resistance to oxidative stress, and also growth at high osmolarity and in acid and alkaline environments. Although all African isolates showed high-level resistance to TMP, the majority presented hetero-resistance to SXT. TMP resistance was linked to the presence of dfrG (78%), dfrA (19%) or both (3%) genes. Compared to the Brazilian clone, the African isolates showed higher growth rates and autolytic activity, and better survival to desiccation and alkaline conditions. Since isolates exhibiting SXT hetero-resistance are frequent in Africa, the implementation of standardized guidelines to detect this phenomenon is of major interest. The predominant MRSA clones in Portuguese-speaking African countries likely possess significant advantages over other clones, such as the Brazilian MRSA, that may explain their epidemiological success.
- Research Article
- 10.4324/9781315818023-26
- Jan 10, 2014
Introduction The former Portuguese Minister for Foreign Affairs, Luis Amado, said in an interview that when the Treaty of Lisbon entered into force in December 2009 Portugal symbolically closed a foreign policy cycle.1 In other words, the focus given to Portugal’s European integration, at least in its previous form, was over. From the transition to democracy in April 1974 and until 2009, Portugal’s foreign policy was structured between three main pillars. Transatlantic relations were one of them, in particular the relationship with the US on a bilateral level, as well as within multilateral structures, such as NATO. Although the transatlantic pillar always went beyond the US, the fact was, and still is, that the US was primus inter pares. Portugal’s entry into the European Union, on the one hand, and the end of the Cold War on the other, had inevitable consequences regarding the relevance of transatlantic relations, both from a political and an economic point of view. European integration was the second pillar. Until the transition to democracy, in large measure, Portugal had its back turned on Europe. The regime change unblocked Portugal’s strategic approach to Europe. As a consequence, after 1985 and until 2010, Portugal dived into European affairs with its heart and soul. In those 25 years, Portuguese efforts towards full integration within Europe were a source of national consensus. In each stage of Europe’s institutional developments – whether economic/financial, political, or military – Portugal was always in the leading group. Last but not least, Portugal’s political, economic and diplomatic relations with Portuguese-speaking countries – Brazil in Latin America, Angola, Cape Verde, Guinea-Bissau, Mozambique and Sao Tome and Principe in Africa, and Timor-Leste in Southeast Asia – was the third pillar. The historic legacy and in particular the wounds of decolonization regarding the Portuguese-speaking African countries (PALOP) has taken some time to overcome. Indeed, it was only in 1996, more than 20 years after Portugal’s regime change and subsequent decolonization, that conditions were met to allow the Portuguese-speaking countries to create a multilateral forum. Thus, as a consequence, this is the least mature pillar and the one still waiting for further consolidation. Inevitably,relations among Portuguese-speaking countries face challenges; but they will also have bilateral and multilateral opportunities in the forthcoming years. Whether they will be addressed successfully remains to be seen. This chapter is divided into three sections. The first one deals with the period between 1985 and 1996. It begins with Portugal’s accession to the European Union and ends with the establishment of the Community of the Portuguesespeaking Countries (CPLP). In large measure, it corresponds to the slow normalization of diplomatic, political and economic relations between Portugal and the PALOP. The second section covers the period between 1996 and 2009. During these 14 years, relations among Portuguese-speaking countries were upgraded and taken to the multilateral level. The third section is a prospective exercise, and aims to provide some leads regarding the path that will be taken in the forthcoming years. The chapter ends with some final remarks.
- Book Chapter
3
- 10.4018/978-1-7998-7619-9.ch014
- Jan 1, 2022
The Portuguese-speaking African countries (PSAC) have been at the forefront of the Chinese presence in Africa. These countries have been no exception in the Chinese strategy to use Special Economic Zones (SEZ) around the globe as an effective tool to promote international trade and foreign direct investment with mainland. However, the establishment of SEZ does not necessarily warrant success in boosting investment and trade. The performance of SEZ worldwide has so far been mixed and many have not performed well for reasons such as poor site locations, uncompetitive policies and lack of differentiation, poor development practices, and bulky processes and ill-designed administrative frameworks. The authors look at two case studies of Chinese SEZ in PSAC, namely in Angola (Bengo SEZ, Luanda) and Mozambique (Manga-Mungassa SEZ, Beira), to discuss their common characteristics. The authors draw lessons on how to make Chinese SEZ in Africa work bearing in mind country-specificities.
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