PDF(Pubmed)
Abstract：
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.
摘要：
在COVID-19大流行期间，通过双边协议和药品专利池的知识产权许可被用来促进低收入和中等收入国家(LMICs)获得新的COVID-19疗法。将该模型应用于COVID-19的经验教训可能与未来流行病和其他突发卫生事件的准备和应对有关。在LMICs中提供新产品的负担得起的版本的速度是实现该产品潜在的全球影响的关键。在研发生命周期的早期启动时，在大流行期间，许可可以促进低收入国家创新产品的通用版本的快速开发。对合格厂家的预选,例如，在COVID-19大流行期间参与的现有仿制药制造商网络的基础上，分享专有技术和快速提供关键投入,如参考上市药物(RLD),也可以节省大量时间.重要的是在速度和质量之间找到良好的平衡。必要的质量保证条款需要包括在许可协议中，可以探索新的世界卫生组织上市机构机制的潜力，以促进加快监管审查和及时获得安全和质量有保证的产品。数字,容量,许可公司的地理分布和许可协议的透明度对供应的充足性具有影响，负担能力，和供应安全。为了促进竞争和支持供应安全，许可证应该是非排他性的。还需要建立模式，以降低开发关键的大流行疗法的风险，特别是在创新产品被证明是有效的和批准之前开始的通用产品开发。知识产权许可和技术转让可以成为改善制造业多样化的有效工具，需要探索区域制造业，以加快在低收入和低收入国家的大规模获取，并在未来的流行病中提供安全。
