Registration & access

Putting new tools in motion

Registration & access

Putting new tools in motion

DNDi’s commitment to the health and well-being of neglected patients guides everything we do, including our work to ensure equitable and affordable access to the treatments we develop.

From our experience supporting the registration and introduction of eight new treatments so far, we have learned that the transition from approval of a new treatment to widespread patient access is one of the most challenging aspects of our mission.

A wide range of potential obstacles can block patients’ access to the treatments they need:

  • New medicines may not be registered and approved for use in countries where they are needed
  • Treatment guidelines may not be updated to include new medicines
  • Medicines may be unaffordable for patients and health systems
  • Manufacturing may be insufficient, and supply chains or service delivery systems may be weak
  • Diagnosis and treatment may be unavailable where patients seek care, or clinicians may not be trained in their use

No organization can address complex access challenges like these alone – and the challenges can vary widely for different products, market conditions, diseases, and settings. We work from the very beginning of the R&D process to ensure the treatments we develop reach patients in need, continuously identifying potential roadblocks and building the partnerships needed to overcome them.

Chagas disease: accelerating access to testing and treatment

We’re working to simplify testing and make treatment available closer to home for patients in a remote region of Colombia

Our strategic access priorities

DNDi’s access strategy relies on partnerships with health ministries, national control programmes, industrial partners, NGO allies, patient groups, and others to reach neglected patients and communities, and achieve maximum public health impact.

With several new treatments in late-stage development, we are laying the groundwork for treatment access in three main areas of intervention.

Securing affordable and sustainable production and supply

We work with industry and non-industry partners (e.g. Ministries of Health, the World Health Organization, NGOs, and civil society groups) to secure medical products of the highest quality standard at the lowest sustainable price, and to secure long-term supply agreements based on the principles of transparency, equity, and fairness. This includes:

  • Negotiating agreements with manufacturers for sustainable production of drugs at the lowest sustainable price
  • Providing support to global and national drug regulators to accelerate registration of new products
  • Supporting interventions to reduce procurement and supply chain bottlenecks
  • Supporting technology transfer to local manufacturing partners, where feasible

Facilitating introduction and uptake of new treatments

We work to make sure new products are introduced and adopted at the national and regional levels by:

  • Collaborating with industrial partners to develop ‘go-to-market’ strategies that are sustainable and lead to long-term impact for patients
  • Conducting Phase IIIb and Phase IV studies and in-country demonstration projects to assess acceptability, feasibility, and knowledge, attitudes, and practices on diseases and treatments
  • Supporting updates to treatment guidelines and policies
  • Providing technical support to Ministries of Health, including for operational planning, training and mentoring, tool-kit development, patient awareness, and data management
  • Developing investment cases as tools to unlock long-term funding
  • Engaging public leaders and civil society to encourage patient advocacy, strengthen access interventions, and share lessons learned

Improving market dynamics

We work to influence the practices of manufacturers, buyers, suppliers, governments, donors, healthcare providers, and consumers to improve how treatment is produced, procured, distributed, and delivered. This includes:

  • Promoting transparency and informed decision making by systematically collecting and compiling market intelligence at several points during product development and launch
  • Identifying solutions to market barriers and working with partners to deploy them
  • Leveraging the reach and capacity of organizations with buying power to achieve market-shaping objectives
  • Identifying strategies to incentivize sustainable pricing and production
  • Supporting advocacy efforts related to market-shaping