Publications by authors named "Stanislav Kniazkov"

4 Publications

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

BMC Public Health 2021 03 11;21(1):490. Epub 2021 Mar 11.

Adjunct Faculty, Daystar University School of Law, Nairobi, Kenya.

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.
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http://dx.doi.org/10.1186/s12889-021-10374-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951129PMC
March 2021

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

Vox Sang 2021 Aug 2;116(7):774-784. Epub 2021 Feb 2.

World Health Organization (WHO) Regional Office for Africa, Brazzaville, Republic of Congo.

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.
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http://dx.doi.org/10.1111/vox.13071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014179PMC
August 2021

Prevention, Detection and Response to incidences of substandard and falsified medical products in the Member States of the Southern African Development Community.

J Pharm Policy Pract 2020 20;13:71. Epub 2020 Oct 20.

WHO Regional Office for Africa, Medicines, Infrastructure and Medical Equipment Unit, Brazzaville, Republic of Congo.

Background: Medical products are an integral and pivotal part of health care delivery. They need to be available, affordable and quality-assured. The SADC region is prone to threats arising from the availability and use of substandard and falsified (SF) medical products. This is something that needs to be actively addressed.

Method: A survey, constructed around four themes, was carried out between September 2018 and January 2019. The National Medicines Regulatory Authorities (NMRAs) of the 16 Member States within the SADC region were asked to respond to the survey questionnaire. The objective was to map existing fameworks, mechanisms and approaches to prevention, detection and response (PDR) to SF medical products.

Results: Responses were received from twelve out of the sixteen NMRAs. Only three of the twelve respondents had included elements for PDR for SF medical products in their national medicine policies. Regardless of the status in terms of policies, legislation is however in place for the majority of NMRAs. The mandate for regular sampling, an important detection mechanism, was enshrined in the legislation of nine of the twelve respondents. In terms of response mechanisms, six of the respondents had both inter-agency and intra-agency co-ordination for responding to SF products.

Conclusion: Though findings point to some deficiencies in terms of policies and implementation plans, the majority of countries have the mandate and legislation to deal with substandard and falsified medical products. Effective enforcement requires more investments into human resources, infrastructure, stakeholder coordination and public outreach. WHO has an important source of actionable information about incidience of substandard and falsified medical products. It needs to be leveraged to improve outreach to stakeholders and to raise awareness about SF problem and mechanisms available to address it. The extent, to which mechanisms and procedures are in place, varies. Some elements of the desired approach exist in the region; however, they will benefit from targeted strengthening to ensure a holistic approach across 12 action areas recommended by WHO.
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http://dx.doi.org/10.1186/s40545-020-00257-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574476PMC
October 2020

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

Bull World Health Organ 2020 Jun 28;98(6):420-425. Epub 2020 Apr 28.

World Health Organization Regional Office for Africa, Cite du Djoue, P.O. Box 06, Brazzaville, Congo.

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.
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http://dx.doi.org/10.2471/BLT.19.236992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265924PMC
June 2020
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