Medicines Regulation in West Africa: Current State and Opportu-nities

Ndomondo-Sigonda et al. (2017) observed that there is scarcity of information on human resources (person-nel devoted to regulation of medicines) in the domain of medicines regulation in the sub-Saharan Africa (SSA). The published information on medicines regulation by the National Medicines Regulatory Authorities (NMRAs) in the Economic Community of West African States (ECOWAS) region are no longer current and consistent with the current realities in the NMRAs. In order to reveal this occurrence, show the trends that exist over the years and make appropriate recommendations, data were collected and compared from 2005, 2010 and 2017 research reports on seven regulatory features of the fifteen Members States of ECOWAS. The re-sults show that there was missing information per regulatory feature and country. There was also an overall increasing trend in the number of NMRAs in the region that showed progress with respect to the measured regulatory features - Autonomy (Authority and Legal form), Marketing Authorization), GMP inspection, Quality Control, Quality Management System, Information Management System and Harmonization and International cooperation. People of Africa have a valuable story to tell as it relates to medicines regulation. This report is written by a West African from the perspective of a West African involved in the study and practice of medi-cines regulation by the NMRAs in the ECOWAS.

PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?

IntroductionThe European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.MethodsData were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).ResultsSince the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.ConclusionsWe observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.

Evidence based medicine? Access to information & medicines regulation in New Zealand

<p>This paper explores one very important issue in the regulatory regime for medicines in New Zealand and around the world- the deficit of information about medicines available to doctors, patients and independent researchers. Much of the information about safety, efficacy and quality of drugs is held and controlled by pharmaceutical companies and regulators. The public is entitled to this information in full.</p>

Evidence based medicine? Access to information & medicines regulation in New Zealand

<p>This paper explores one very important issue in the regulatory regime for medicines in New Zealand and around the world- the deficit of information about medicines available to doctors, patients and independent researchers. Much of the information about safety, efficacy and quality of drugs is held and controlled by pharmaceutical companies and regulators. The public is entitled to this information in full.</p>

Media and Science Policy: Who Influences Whom Regarding Complementary and Alternative Medicines Regulation

This paper analyses the synergies between press and politics in the debate on the regulation of complementary and alternative medicines (CAM) in Spain between 1979 and 2018. We argue that longitudinal analysis and comparison of this interaction and synergy reveal how the mainstream discourse has shifted. We use a dataset of news ( N = 2,059), a news sample ( n = 325) and a dataset of parliamentary records ( N = 86). Using both quantitative and qualitative approaches, the dynamics of the interaction between the different institutions and actors involved is assessed. Specifically, the study analyses the media and parliamentary attention to CAM issues (agenda setting), how CAM is addressed (framing), and the actors who have a voice in the discourse (costructuring of power relations). The results indicate that relevant changes in the public debate on CAM have only occurred over the last few years, corresponding to three overlapping dynamics of influence of the media on politics: amplification, framing, and costructuring of power relations. This recent period has seen convergence in the discussion and narratives/frames used, which also corresponds to more widespread skepticism regarding CAM.

Determinants of dispensing antibiotics without prescription in Eritrea: a mixed-method qualitative study on pharmacy professionals’ perspective

ObjectiveAntimicrobial resistance is a global public health challenge. Dispensing of antibiotics without prescription (DAWP), a major contributor to antibiotic resistance, is extensive in Eritrea. This study was, therefore, aimed at deeply understanding, qualitatively, the pharmacy professionals’ perspective on the factors that trigger DAWP and how this practice could be mitigated.DesignA qualitative exploratory study design was employed.SettingDrug retail outlets of Asmara, capital of Eritrea, and pharmaceutical services of Eritrea.ParticipantsThirty pharmacy professionals who were owners and employees of the drug retail outlets stationed in Asmara and six key informants from the pharmaceutical services of all administrative regions of Eritrea, selected purposively, were the study participants.Data collection and analysisThe data were collected using focus group discussions and key informant interviews between March and September 2020. The collected data were transcribed verbatim, translated to English and finally thematically analysed using an inductive approach.ResultsThe main triggering factors were related to the drug retail outlet owners, dispensers, healthcare system and patients. Knowledge and attitude-based motivation, economic interest, inadequate services in health facilities, weak regulatory enforcement, inadequate training, trust and satisfaction of patients, previous successful experience, seriousness of a condition and saving time and money were reported among others as determinants of DAWP.ConclusionsThe triggering factors to DAWP were found to be very complex and some of them were important that might require immediate attention from policymakers. Ensuring readily available and accessible healthcare services, empowering medicines regulation and continuing sensitisation of dispensers are highly recommended to minimise DAWP.