دورية أكاديمية

Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response.

التفاصيل البيبلوغرافية
العنوان: Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response.
المؤلفون: Braimoh T; Strategy, Policy and Market Access, Medicines Patent Pool, Geneva, Switzerland. tbraimoh@medicinespatentpool.org., Burrone E; Strategy, Policy and Market Access, Medicines Patent Pool, Geneva, Switzerland., Gore C; Management, Medicines Patent Pool, Geneva, Switzerland., Vijayaraghavan P; Governance Board, Medicines Patent Pool, Geneva, Switzerland.
المصدر: Globalization and health [Global Health] 2024 Jul 02; Vol. 20 (1), pp. 52. Date of Electronic Publication: 2024 Jul 02.
نوع المنشور: Journal Article; Letter
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101245734 Publication Model: Electronic Cited Medium: Internet ISSN: 1744-8603 (Electronic) Linking ISSN: 17448603 NLM ISO Abbreviation: Global Health Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2005-
مواضيع طبية MeSH: Intellectual Property* , Licensure* , COVID-19*/epidemiology , COVID-19*/prevention & control , Developing Countries*, Humans ; Pandemics ; COVID-19 Drug Treatment ; Antiviral Agents/therapeutic use ; Drug Industry/legislation & jurisprudence ; Drug Industry/organization & administration ; Pandemic Preparedness
مستخلص: During the COVID-19 pandemic, intellectual property licensing through bilateral agreements and the Medicines Patent Pool were used to facilitate access to new COVID-19 therapeutics in low- and middle-income countries (LMICs). The lessons learnt from the application of the model to COVID-19 could be relevant for preparedness and response to future pandemics and other health emergencies.The speed at which affordable versions of a new product are available in LMICs is key to the realization of the potential global impact of the product. When initiated early in the research and development life cycle, licensing could facilitate rapid development of generic versions of innovative products in LMICs during a pandemic. The pre-selection of qualified manufacturers, for instance building on the existing network of generic manufacturers engaged during the COVID-19 pandemic, the sharing of know-how and the quick provision of critical inputs such as reference listed drugs (RLDs) could also result in significant time saved. It is important to find a good balance between speed and quality. Necessary quality assurance terms need to be included in licensing agreements, and the potentials of the new World Health Organization Listed Authority mechanism could be explored to promote expedited regulatory reviews and timely access to safe and quality-assured products.The number, capacity, and geographical distribution of licensed companies and the transparency of licensing agreements have implications for the sufficiency of supply, affordability, and supply security. To foster competition and support supply security, licenses should be non-exclusive. There is also a need to put modalities in place to de-risk the development of critical pandemic therapeutics, particularly where generic product development is initiated before the innovator product is proven to be effective and approved. IP licensing and technology transfer can be effective tools to improve the diversification of manufacturing and need to be explored for regional manufacturing for accelerated access at scale in in LMICs and supply security in future pandemics.
(© 2024. The Author(s).)
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فهرسة مساهمة: Keywords: Access; COVID-19; Generic; Intellectual property; LMICs; Therapeutics; Voluntary licensing
المشرفين على المادة: 0 (Antiviral Agents)
تواريخ الأحداث: Date Created: 20240703 Date Completed: 20240703 Latest Revision: 20240705
رمز التحديث: 20240705
مُعرف محوري في PubMed: PMC11221111
DOI: 10.1186/s12992-024-01057-5
PMID: 38956614
قاعدة البيانات: MEDLINE
الوصف
تدمد:1744-8603
DOI:10.1186/s12992-024-01057-5