Richard Amenyah | Bridge the divide – ensure access to long-acting HIV medicines in the Caribbean

There have been significant and innovative scientific breakthroughs in HIV prevention and treatment that make the ambitious goal of ending AIDS as a public health threat more possible. However, for many countries in the Caribbean, the systemic economic and regulatory barriers to accessing patented medicines and other medical technologies remain formidable and undermine progress.

Among the latest and most promising breakthroughs are long-acting injectable antiretrovirals like Lenacapavir, which was produced by Gilead and is administered twice a year and is 100 per cent effective for preventing HIV.

In the absence of a cure or vaccine for HIV, long-acting HIV medicines could be game-changers if they are accessible and affordable for everyone to benefit. Indeed, if made widely accessible in the developing countries, they could revolutionise HIV care by improving adherence, offering more convenient treatment options, and providing a lifeline for those living with or at risk of HIV. Research indicates that generic forms of Lenacapavir could cost US$40 or less per person per year.

The region confronts substantial barriers to accessing medicines, often resulting in higher procurement costs, compared to other parts of the world. Many countries are classified as middle- or high-income, based on GDP per capita, often disqualifying them from accessing affordable generic versions of essential medicines through mechanisms like the Medicines Patent Pool.

Consequently, these countries are burdened with exorbitant prices for branded innovations, placing immense pressure on their already stretched health budgets. Furthermore, patents held by pharmaceutical companies restrict the production or importation of affordable generic alternatives. Licensing negotiations for these drugs often overlook smaller markets like the Caribbean, leaving the region reliant on expensive imports and limiting its access to cost-effective solutions.

LEVERAGING REGIONAL COOPERATION AND GLOBAL FLEXIBILITIES

Ending AIDS as a public health threat by 2030 is within reach, but only achievable if the Caribbean can secure access to the latest medical innovations and reduce barriers to access. Lenacapavir and other long-acting antiretrovirals represent a major turning point in HIV care, offering a glimmer of hope for those living with or at risk of contracting HIV. However, this is only possible if action is taken to address the economic, regulatory and systemic barriers impeding access.

1. Leverage TRIPS flexibilities for public health

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement offers flexibilities such as compulsory licensing, which allow countries to produce or import generic drugs during public health emergencies. Gilead has signed a non-exclusive, royalty-free voluntary licensing agreement with six pharmaceutical manufacturers to make and sell generic Lenacapavir for 120 high-incidence, resource-limited countries (including all Caribbean countries) even before registration. This sets a standard that should become the norm, because the rapid availability of generic versions will determine whether this medicine can truly be transformative. Caribbean governments must collectively advocate for the use of these flexibilities to access game-changing Lenacapavir and other life-saving innovations.

2. Strengthening regional procurement mechanisms

Building on existing frameworks like the Pan American Health Organization’s (PAHO’s) Revolving Fund or the Strategic Fund, countries should establish a pooled procurement mechanism for HIV medicines. This would increase their collective bargaining power, reduce costs, and ensure equitable access across the region.

3. Engaging in collaborative negotiations

CARICOM and its institutions like Caribbean Public Health Agency (CARPHA) can play a pivotal role in negotiating with pharmaceutical companies. By presenting a unified front, they can advocate for tiered pricing models or voluntary licensing agreements that make medicines affordable for smaller economies. This can result in the manufacture and supply of high-quality, low-cost versions of Lenacapavir accessible in the region. The recent decision by the Council for Human and Social Development (COHSOD) on the need for strategic dialogue on Public Health and Intellectual Property to enhance access to essential medicines is a step in the right direction for the region.

4. Investing in local production capacity

The Caribbean can take inspiration from Africa’s strides in local vaccine production, such as the African Vaccine Manufacturing Accelerator (AVMA), which highlights the value of regional strategic partnerships, including collaborations with Latin America, to build pharmaceutical manufacturing capacity. Establishing a regional hub for producing generics, including long-acting injectables of antiretrovirals, would enhance the Caribbean’s health security and economic resilience. This initiative would reduce reliance on external suppliers, ensure a sustainable and affordable supply of medicines, and leverage economies of scale to strengthen the region’s ability to address health challenges effectively.

5. Policy advocacy for economic reclassification in health contexts

Caribbean leaders must continue to push for a re-evaluation of the economic classification criteria used by global health agencies. Classification based on GDP or GNI per capita, which reflects a country’s income, fails to capture the full picture. It overlooks the region’s unique vulnerabilities, such as the costs of addressing natural disasters or servicing debt, especially during health crises. Advocating for health equity-based reclassification could unlock access to essential medicines at more affordable costs. Advancing the dialogue on the Multidimensional Vulnerability Index for Small Island Developing States is crucial and must be brought to a resolution to address the ecological and economic vulnerabilities faced by the Caribbean.

The ongoing negotiations for the Pandemic Treaty offer an unprecedented opportunity to institutionalise equitable access to health technologies. Caribbean nations should advocate for provisions that prioritise access to essential medicines during pandemics and public health emergencies. The treaty’s draft in Article 10 on equitable access to medical countermeasures during pandemics, and its direct connection with “sustainable and geographically diversified local production”, could serve as a blueprint for building the region’s capacity to produce and procure advanced pharmaceuticals.

Further, regional initiatives like the Health Development Partnership for Africa and the Caribbean (HeDPAC), launched in 2023, provide a platform for South-South cooperation, including support for the local production of medical products to ensure timely access to essential healthcare supplies. By strengthening ties with African counterparts, the Caribbean can share expertise, technology, and resources, incentivise manufacturers to bolster their health systems, and improve access to innovative treatments and prevention technologies.

CALL TO ACTION

UNAIDS has called for governments and pharmaceutical manufacturers to ensure that long-acting antiretrovirals reach people at risk of contracting HIV to drastically reduce new HIV infections globally. The announcement by The Global Fund and The President’s Emergency Fund for AIDS Relief (PEPFAR) and others to coordinate efforts to provide two million people with access over three years to accelerate the fight to end AIDS is welcome news. Caribbean policymakers must ensure they are not left behind in these developments.

UNAIDS encourages governments to act decisively, leveraging regional cooperation, internationally agreed TRIPS flexibilities, and innovative financing mechanisms to ensure no one is left behind in the region. This game-changing innovation in HIV has the potential of preventing all people at risk of contracting HIV. Making medical technologies and innovations widely available, accessible and affordable, where they are most needed, is the right thing to do.

Dr Richard Amenyah is a medical doctor and public health specialist. He is the director for the UNAIDS multicountry office for the Caribbean. Follow him on X (formerly Twitter) at @RichardAmenyah or @UNAIDSCaribbean. Send feedback to jamaica@unaids.org.