Access to medicines
Access to medicines
Developing new life-saving antimalarials is not enough to ensure patient impact. MMV believes that medicines are only effective once they are in the hands of patients who need them. Thus, we are deeply committed to building better access to our medicines. Here are some of the challenges we face, and how we work to overcome them.
Planning for access begins well before products are launched. Patient and caregiver needs inform the R&D process before drug development is finalized, enhancing product acceptability and adoption. This includes palatability testing for children and refined product packaging for ease of use and distribution.
After medicines are quality-approved by Stringent Regulatory Authorities (SRAs), they are registered by national regulatory agencies in endemic countries. Registration lead times can exceed 18-24 months in many countries (and there are over 50 malaria-endemic countries worldwide). MMV engages with regional regulatory harmonization approaches, which can help accelerate these approval processes. Before a drug becomes available, national regulators or malaria control programmes may request evidence about how new medicines work in “real-life” settings – such requirements may trigger additional research.
Registration alone does not, however, translate into inclusion in national treatment guidelines. WHO’s Guidelines for Malaria provide global guidance to countries to help bolster country confidence in policy adoption of new medicines, and MMV carefully monitors evidence requirements that can support the WHO policy process and/or national adoption process.
Ensuring uptake and effective administration
Ensuring uptake and impact new of antimalarial medicines requires knowledge of the markets within which they will be distributed. An imperative to understand market and impact drives MMV to invest in both quantitative and qualitative market research. In addition, linking our pharma partners with market demand forecasts helps ensure advanced visibility for them to prepare for the evolving demand for their products.
In addition, it is critical to ensure patients, caregivers and healthcare professionals readily understand how to administer new medicines safely and effectively and adhere to treatment schedules. MMV conducts behavioral research, and develops and provides training materials to support this process.
Supply and financing
International and domestic financing are also critical, as new products may be more costly than well-established multi-sourced medicines, often due to comparatively lower volumes at launch. MMV carefully considers opportunities for such financing.
Difficult lessons from COVID-19 have shown the importance of ensuring supply chains for global health products are sufficiently diversified so that low- and middle-income countries are not left vulnerable to supply disruptions of key materials. To help mitigate this risk, MMV is working closely with several African manufacturers to support production of antimalarials closer to where patients need them.
By increasing the accessibility of both existing and new antimalarials, we are working with partners in pursuit of a future where no one will suffer or die from malaria.