The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement.

BACKGROUND: It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization's (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. METHODS: We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries. RESULTS: Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions. CONCLUSIONS: Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

Impact of the COVID-19 pandemic on blood supply and demand in the WHO African Region.

BACKGROUND AND OBJECTIVES: The coronavirus disease 2019 (COVID-19) affected millions of people worldwide and caused disruptions at the global level including in healthcare provision. Countries of the WHO African region have put in place measures for the COVID-19 pandemic containment that may adversely affect blood system activities and subsequently reduce the supply and demand of blood and blood components. This study aims to assess the impact of the COVID-19 pandemic on blood supply and demand in the WHO African Region and propose measures to address the challenges faced by countries. MATERIALS AND METHODS: A survey questionnaire was sent to all 47 countries in the WHO African Region to collect information on blood supply and demand for the first 5 months of 2019 and 2020, respectively, and on COVID-19 Convalescent Plasma therapy in September 2020. RESULTS: Thirty-seven countries provided responses. The total number of blood donations dropped in 32 countries while it increased in five countries. The proportion of blood drives also decreased in 21 countries and increased in nine countries. The blood requested and issued for transfusion decreased for blood demand and for blood issued for transfusion in 30 countries. Ten countries reported some activities of convalescent plasma. However, very few units of this product collected have been transfused to COVID-19 patients. CONCLUSION: The COVID-19 pandemic has led to a reduction of blood related activities in the region, including the supply and demand. Countries preparedness plans for health emergencies need more emphasis to maintaining blood stock.

A review of policies and programmes for human organ and tissue donations and transplantations, WHO African Region.

Several resolutions, endorsed by the World Health Assembly and the United Nations General Assembly, articulate the need to improve the availability, quality and safety of organ and tissue donation and transplantation, as well as to prevent and combat trafficking in human organs. Here we assessed the implementation of these resolutions pertaining to organ and tissue donations and transplantations by sending out a questionnaire to all 47 countries in the World Health Organization African Region. From 33 countries that provided data, we identified several obstacles and challenges. Compared to other regions, there are very limited data on organ donation and transplantation. Most countries are lacking legal and regulatory frameworks, since they did not yet establish a specific or comprehensive legislation covering donation and transplantation of human organs and tissues. Countries also have a poor national capacity to perform organ and tissue transplantations and the organization and management of national programmes are weak. Funding, both from domestic and external sources, is insufficient to implement effective transplantations programmes and patients have inadequate financial protection. To address these challenges, we propose that countries and partners should develop and implement policies, strategies, plans and regulatory frameworks for all aspects of organ and tissue donations and transplantations, including fighting against organ trafficking and transplant tourism. Where donation and transplantation programmes exist, stakeholders should develop the skills of human resources, adopt technical standards and quality management procedures to improve donation and transplantation of human organs and tissues.

De nombreuses résolutions approuvées par l'Assemblée mondiale de la Santé et l'Assemblée générale des Nations Unies ont souligné le besoin d'améliorer la disponibilité, la qualité et la sécurité des dons et de transplantations d'organes et de tissus humains, de même que celui d'assurer la prévention et la lutte contre le trafic d'organes. Dans ce document, nous avons étudié la mise en œuvre de ces résolutions relatives aux dons et transplantations d'organes et de tissus, par le biais d'un questionnaire envoyé aux 47 pays appartenant à la région Afrique de l'Organisation mondiale de la Santé. Nous avons identifié de nombreux obstacles et défis dans les 33 pays qui nous ont transmis des données. Par rapport à d'autres régions, il existe très peu d'informations à ce propos. La plupart des pays ne possèdent pas de cadres juridiques et réglementaires car ils n'ont pas encore établi de législation spécifique ou exhaustive couvrant les dons et transplantations d'organes et de tissus. Certains manquent également de moyens au niveau national pour réaliser des greffes d'organes et de tissus, tandis que leur organisation et leur gestion des programmes nationaux sont inadaptées. Tant les fonds provenant de l'intérieur que ceux fournis par l'extérieur ne permettent pas d'instaurer des programmes de transplantation efficaces. Enfin, les patients ne bénéficient pas d'une protection financière suffisante. Afin de pouvoir relever ces défis, nous proposons que ces pays et leurs partenaires développent et appliquent des politiques, stratégies, projets et règles pour tous les aspects liés aux dons et transplantations d'organes et de tissus, y compris la lutte contre le trafic d'organes et le tourisme de la transplantation. Et là où des programmes de dons et de transplantations existent, les intervenants devraient acquérir des compétences en ressources humaines, mais aussi adopter des normes techniques et des procédures de gestion de la qualité afin d'optimiser les dons et transplantations d'organes et de tissus.

Diversas resoluciones que la Asamblea Mundial de la Salud y la Asamblea General de las Naciones Unidas aprobaron articulan la necesidad de mejorar la disponibilidad, la calidad y la seguridad de la donación y el trasplante de tejidos y órganos, así como de prevenir y combatir el tráfico de órganos humanos. En el presente documento se evalúa la implementación de estas resoluciones relacionadas con la donación y el trasplante de tejidos y órganos por medio del envío de un cuestionario a los 47 países de la Región de África de la Organización Mundial de la Salud. De los 33 países que suministraron los datos, se identificaron varios obstáculos y desafíos. En comparación con otras regiones, existen muy pocos datos sobre la donación y el trasplante de órganos. La mayoría de los países carecen de marcos normativos y legales, ya que todavía no han establecido una legislación específica o integral que aborde la donación y el trasplante de tejidos y órganos humanos. Los países también tienen una capacidad nacional deficiente para realizar los trasplantes de tejidos y órganos, además de que la organización y la gestión de los programas nacionales son débiles. El financiamiento, tanto de fuentes nacionales como internacionales, es insuficiente para implementar programas de trasplantes efectivos y los pacientes tienen una protección financiera inadecuada. Para hacer frente a estos desafíos, se propone que los países y los socios elaboren e implementen políticas, estrategias, programas y marcos normativos de todos los aspectos de la donación y el trasplante de tejidos y órganos, incluida la lucha contra el tráfico de órganos y el turismo de trasplantes. Cuando existan programas de donación y trasplante, las partes interesadas deberían desarrollar las habilidades de los recursos humanos y adoptar estándares técnicos y procedimientos de gestión de calidad para mejorar la donación y el trasplante de tejidos y órganos humanos.

Blood Safety Status in WHO African Region Countries: Lessons Learnt from Mauritius.

In 2001, the WHO Office for Africa adopted a strategy for blood safety defining four targets. This paper describes the progress made by Mauritius in the implementation of this strategy. The blood safety indicators were collected and compared with the norms recommended by WHO. The country has formulated its blood policy and developed a strategic plan for its implementation since 2004. The total number of blood donations increased from 31,228 in 2002 to 43,742 in 2016, giving an annual blood collection rate evolving from 26.3 per 1000 inhabitants in 2002 to 34.2 per 1000 inhabitants in 2016. The percentage of voluntary donations rose from 60% to 82.5%. Since 2002, all the blood units collected have been tested for the mandatory infectious markers. The Blood Transfusion Service has been certified ISO2008-9001 and nucleic acid testing has been introduced. The preparation of blood components increased from 60% to 98.2%. The most transfused blood components were red cell concentrates, platelet concentrates, and fresh frozen plasma. In addition to transfusion activities, there were other departments performing antenatal serology, tissue typing, special investigations, and reagent preparation. Despite the progress made, some challenges remain, namely, legal framework and haemovigilance system. A regulatory system for blood needs to be established.

External financial aid to blood transfusion services in sub-Saharan Africa: a need for reflection.

Jean-Pierre Allain and colleagues argue that, while unintended, the foreign aid provided for blood transfusion services in sub-Saharan Africa has resulted in serious negative outcomes, which requires reflection and rethinking.

Deletions and recombinations in the core region of hepatitis B virus genotype E strains from asymptomatic blood donors in Guinea, west Africa.

The prevalence of hepatitis B virus (HBV) surface antigen (HBsAg) chronic carriage in west Africa is the highest in the world, but its molecular epidemiology remains relatively poorly investigated. Plasma samples from random asymptomatic carriers of HBsAg in Conakry, Guinea, were studied and the complete genome sequences of 81 strains were obtained. Three additional samples from Kumasi, Ghana, were also included in the analysis. Phylogenetic analyses confirmed the dominance of genotype E (95.1%), including 8.6% of strains (viral load, 5x10(3)-2.6x10(8) IU ml(-1)) comprising dominant variants with large deletions in the core region and minority wild-type variants. The presence of two different patterns of deletions in two and four donors suggested targeted genome fragility between nt 1979 and 2314. The remaining sequences included one subgenotype A3 (1%) and six A/E recombinant forms (4-7%). A/E strains with identical points of recombination in three donors suggested strongly that these recombinant HBV strains are circulating and transmitted in the population. Recombination points were concentrated in the core gene. The detection of similar A/E recombinant strains in Ghana suggested a geographical extension of recombinant HBV to the region. The quasispecies of one additional Ghanaian strain sequenced in the pre-surface/surface region resolved into dominant clones of either the A or E genotype, but also three different patterns of A/E recombinant variants. The observation that both deletions of genotype E strains and A/E recombination points are mostly located in the core gene at specific positions indicates a region of the genome where genetic rearrangements preferentially take place.

Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity.

A new rapid immunochromatographic assay based on the signal amplification system (SAS) has been developed by Diagnostics for the Real World (Europe) Ltd. for the detection of hepatitis B virus surface antigen (HBsAg) in plasma or serum specimens. The SAS format features enhanced sensitivity as a result of an increased binding valence of the detector molecules. We have now evaluated the performance of the new HBsAg rapid test (DRW-HBsAg) in comparison with a well-established commercial rapid test (Determine HBsAg; previously from Abbott Laboratories; now from Inverness Medical Innovations) and with a CE-marked enzyme immunoassay (EIA) (Hepanostika HBsAg Ultra; BioMérieux) as the gold standard. Testing of serially diluted in-house HBsAg-positive samples, the World Health Organization standard, and sensitivity and reference panels yielded an analytical sensitivity for the DRW test of 0.2 to 0.8 IU/ml across HBsAg serotypes. Evaluation with eight commercially available seroconversion panels showed that the DRW-HBsAg test detected HBsAg an average of 6.1 days (range, 3 to 8 days) earlier than the Determine assay (P = 0.0078). Test sensitivity was also examined with two low-titer HBsAg EIA-positive panels in Beijing, China. Whereas 100% of these samples were detected by the DRW-HBsAg test, only 15.0% (P < 0.0001) and 87.3% (P < 0.0001), respectively, were detected by the Determine HBsAg test. The performance of the DRW-HBsAg test was further evaluated with samples determined to be HBsAg positive or negative by the EIA in Conakry, Guinea, and Beijing, China. No significant difference in sensitivity between the DRW and Determine tests was apparent with the HBsAg EIA-reactive samples from Guinea (96.7% versus 94.4%, respectively) or China (99.46 versus 98.92%, respectively). The specificity of the Determine HBsAg test was slightly higher than that of DRW-HBsAg test (100 versus 99.2%, respectively) with samples from EIA-negative blood donors in China. In conclusion, the new DRW HBsAg rapid test is more sensitive than the Determine HBsAg test and is suitable for diagnostic and blood screening in resource-limited settings.