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Research article
Marion Motari
Daystar University Nairobi Campus
Corresponding Author
License:
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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. 39 countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions.
Discussion
Countries of the WHO African Region operate within a multi-layered –intellectual property regulatory landscape globally and at regional level which is characterized by inconsistencies and misalignment which limit the extent to which countries can implement TRIPS flexibilities.
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.
Keywords
Access to Medical Products, Biomedical R&D, Innovation, Intellectual Property, TRIPS Flexibilities, WHO, African Region
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View the published article at BMC Public Health.
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Editorial decision: Minor revision
On 27 Dec, 2020
Reviewers invited
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Reviewer #1 agreed
On 21 Dec, 2020
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Received 21 Dec, 2020
Editor assigned
On 15 Dec, 2020
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On 15 Dec, 2020
Editor invited
On 15 Dec, 2020
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On 30 Nov, 2020
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Received 30 Nov, 2020
Editorial decision: Major revision
On 30 Nov, 2020
Reviewer #1 agreed
On 26 Nov, 2020
Review #1 received
Received 26 Nov, 2020
Editor assigned
On 25 Nov, 2020
Reviewers invited
Invitations sent on 25 Nov, 2020
Submission checks complete
On 25 Nov, 2020
Editor invited
On 25 Nov, 2020
No comments provided
Editorial decision: Major revision
On 23 Sep, 2020
Review #2 received
Received 22 Sep, 2020
Reviewer #2 agreed
On 15 Sep, 2020
Review #1 received
Received 15 Sep, 2020
Reviewer #1 agreed
On 14 Sep, 2020
Reviewers invited
Invitations sent on 10 Sep, 2020
Editor assigned
On 01 Sep, 2020
Submission checks complete
On 31 Aug, 2020
Editor invited
On 31 Aug, 2020
First submitted
On 28 Aug, 2020
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at BMC Public Health.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Marion Motari
Daystar University Nairobi Campus
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Public Health.
Version 4
Posted 21 Jan, 2021
No community comments so far
Editorial decision: Minor revision
On 19 Jan, 2021
Editor assigned
On 10 Jan, 2021
Submission checks complete
On 10 Jan, 2021
Editor invited
On 10 Jan, 2021
No comments provided
Editorial decision: Minor revision
On 27 Dec, 2020
Reviewers invited
Invitations sent on 21 Dec, 2020
Reviewer #1 agreed
On 21 Dec, 2020
Review #1 received
Received 21 Dec, 2020
Editor assigned
On 15 Dec, 2020
Submission checks complete
On 15 Dec, 2020
Editor invited
On 15 Dec, 2020
No comments provided
Reviewer #2 agreed
On 30 Nov, 2020
Review #2 received
Received 30 Nov, 2020
Editorial decision: Major revision
On 30 Nov, 2020
Reviewer #1 agreed
On 26 Nov, 2020
Review #1 received
Received 26 Nov, 2020
Editor assigned
On 25 Nov, 2020
Reviewers invited
Invitations sent on 25 Nov, 2020
Submission checks complete
On 25 Nov, 2020
Editor invited
On 25 Nov, 2020
No comments provided
Editorial decision: Major revision
On 23 Sep, 2020
Review #2 received
Received 22 Sep, 2020
Reviewer #2 agreed
On 15 Sep, 2020
Review #1 received
Received 15 Sep, 2020
Reviewer #1 agreed
On 14 Sep, 2020
Reviewers invited
Invitations sent on 10 Sep, 2020
Editor assigned
On 01 Sep, 2020
Submission checks complete
On 31 Aug, 2020
Editor invited
On 31 Aug, 2020
First submitted
On 28 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Public Health.
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. 39 countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions.
Discussion
Countries of the WHO African Region operate within a multi-layered –intellectual property regulatory landscape globally and at regional level which is characterized by inconsistencies and misalignment which limit the extent to which countries can implement TRIPS flexibilities.
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.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
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