Medicines Patent Pool, Geneva, Switzerland.
Medicines Patent Pool, Mumbai, India.
J Int AIDS Soc. 2023 Jul;26 Suppl 2(Suppl 2):e26092. doi: 10.1002/jia2.26092.
Emerging long-acting (LA) prevention and treatment medicines, technologies and regimens could be game-changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations-backed, not-for-profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low- and middle-income countries (LMICs).
While voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements-of amplified importance for more complex LA HIV medicines-that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs: Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders Consolidating a multidisciplinary network and strengthening early-stage coordination and collaboration to foster innovation Embedding public health considerations in product design and delivery Building innovative partnerships for product development and commercialization Raising awareness of and creating demand for emerging LA products Estimating the market size, ensuring sufficient competition and protecting sustainability Using technology transfer and hands-on technical support to reduce product development timelines and costs Exploring de-risking mechanisms and financial incentives to support generic manufacturers Optimizing strategies for generic product development and regulatory filings Aligning and coordinating efforts of stakeholders across the value chain.
Rapid access to emerging LA prevention and treatment regimens and technologies can be facilitated by voluntary licensing-catalyzed and supplemented by enabling collaborative and non-duplicative efforts of various other stakeholders. This can effectively lead to improved-accelerated and cheaper-access to quality-assured medicines for populations in LMICs.
新兴的长效（LA）预防和治疗药物、技术和方案可能会彻底改变艾滋病防治工作，有助于实现到 2030 年遏制艾滋病流行的宏伟目标。为实现这一目标，通过加速和加强竞争，包括原始研发公司和仿制药公司在内的全球卫生利益攸关方必须迅速扩大大规模、可持续、有质量保证且负担得起的 LA 艾滋病毒预防和治疗产品供应。要做到这一点，全球卫生利益攸关方应该利用知识产权（IP）的自愿许可，例如通过联合国支持的非营利性药品专利池，作为支持在中低收入国家（LMICs）广泛获得现有艾滋病毒药物的既定机制。
虽然自愿许可可能会为专利到期前的仿制药竞争开辟可能性，但对于更复杂的 LA 艾滋病毒药物，还需要考虑其他一些更重要的因素。本文讨论了 10 种促进知识产权自愿许可的手段，以此作为在 LMICs 中快速扩大大规模、可持续、有质量保证且负担得起的 LA 艾滋病毒预防和治疗方案供应的模式：在早期研发阶段识别有前途的 LA 技术平台和药物配方，并与专利持有人合作；整合多学科网络，加强早期协调与合作，以促进创新；在产品设计和交付中纳入公共卫生考虑因素；为产品开发和商业化建立创新伙伴关系；提高对新兴 LA 产品的认识并创造需求；估计市场规模，确保充分竞争并保护可持续性；利用技术转让和实际技术支持来缩短产品开发时间表和降低成本；探索降低风险机制和财务激励措施，以支持仿制药制造商；优化仿制药产品开发和监管备案策略；协调价值链上各利益攸关方的努力。
通过自愿许可促进并辅以各种其他利益攸关方的协作和非重复努力，可以加速获得新兴的 LA 预防和治疗方案和技术，从而为 LMICs 的人群提供更优质、更快速且更廉价的药物。
