Patent pooling to increase access to essential medicines

Poor control of cardiovascular disease accounts for a substantial proportion of the disease burden in developing countries, but often essential anticoagulant medicines for preventing strokes and embolisms are not widely available. In 2019, direct oral anticoagulants were added to the World Health Organization’s WHO Model list of essential medicines. The aims of this paper are to summarize the benefits of direct oral anticoagulants for patients with cardiovascular disease and to discuss ways of increasing their usage internationally. Although the cost of direct oral anticoagulants has provoked debate, the affordability of introducing these drugs into clinical practice could be increased by: price negotiation; pooled procurement; competitive tendering; the use of patent pools; and expanded use of generics. In 2017, only 14 of 137 countries that had adopted national essential medicines lists included a direct oral anticoagulant on their lists. This number could increase rapidly if problems with availability and affordability can be tackled. Once the types of patient likely to benefit from direct oral anticoagulants have been clearly defined in clinical practice guidelines, coverage can be more accurately determined and associated costs can be better managed. Government action is required to ensure that direct oral anticoagulants are covered by national budgets because the absence of reimbursement remains an impediment to achieving universal coverage. Tackling cardiovascular disease with the aid of direct oral anticoagulants is an essential component of efforts to achieve the World Health Organization’s target of reducing premature deaths due to noncommunicable disease by 25% by 2025.

The interplay between intellectual property rights (IPRs) and clinical trials presents a complex challenge in the realm of healthcare innovation. This paper examines the critical role of IPRs, particularly patents, in incentivizing pharmaceutical research and development while simultaneously addressing their implications for access to essential medicines, especially in low- and middle-income countries (LMICs). We explore the phases of clinical trials that underpin medical advancements and highlight the significant financial and temporal investments required for drug development. The discussion also delves into the tensions created by monopolistic pricing, data exclusivity, and evergreening practices that hinder equitable access to healthcare. Through a review of international agreements like the TRIPS Agreement and case studies on HIV/AIDS, hepatitis C treatments, and COVID-19 vaccines, we illustrate the urgent need for policy reforms and alternative incentive models, including prize funds, patent pools, and tiered pricing strategies. Our findings underscore the necessity for a balanced approach that fosters innovation while ensuring that life-saving medications are accessible to all populations. Ultimately, this paper calls for collaborative efforts among governments, international organizations, and the private sector to create an equitable healthcare landscape that prioritizes public health needs without stifling innovation.

The People's Vaccine: Intellectual Property, Access to Essential Medicines, and the Coronavirus COVID-19

Collective licensing and asymmetric information: The double eff ect of the Medicine Patent Pool on generic drug markets