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Paediatric ARVs: Giving industry a seat at the table

By Marissa Vicari and Sébastien Morin, International AIDS Society

 

There must be a partnership between business and the community - without that this battle will not be won.” – Nelson Mandela

 

In his closing address at the 2000 International AIDS Conference in Durban, South Africa, Nelson Mandela recognized the necessity of industry’s involvement in the HIV response -- even before generic antiretrovirals (ARVs) were made available at low cost to the world. At the time, the relationship between industry and civil society was characterized, at best, as tense.

To address this, the International AIDS Society (IAS) founded the Industry Liaison Forum (ILF) in 2001 under the leadership of Joep Lange to, in his words, ““accelerate scientifically promising, ethical HIV research in resource-limited countries, with a particular focus on the roles and responsibilities of industry as sponsors and supporters of research”.

Today, historic progress has been made with 15 million people on treatment and the availability of 28 approved HIV medicines in 2015. But gaps in treatment access still remain for many populations, particularly children. Nearly 76% of children living with HIV – three out of four – are not receiving ARV treatment. The IAS has made addressing this disparity part of its mission through two of its programmes, ILF and the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER).

Through multi-stakeholder dialogues that bring together civil society, health care workers, industry, donors and international normative and regulatory agencies, we have identified a few key challenges around paediatric ARVs:

  • Technical difficulties developing child-friendly formulations. This is due to challenges recruiting children in clinical trials – including finding parents and caregivers who are willing to expose their children to interventions of unknown benefit. This also includes the limited availability of appropriate formulations for different ages (e.g., palatable formulations) that negatively affects implementation of the WHO guidelines.
  • Difficulty including industry in the development of normative guidance. All too often, colleagues working in industry are included too late (or not at all) in the development process of developing guidelines. Although it is understood that there must be some parameters in place to prevent conflicts of interest, the benefits from industry experience would help avoid impractical or unfeasible formulation guidance.
  • Differing definitions and product specifications. Variations in definitions of age groups and weight bands for paediatric products across different regulatory authorities (e.g., U.S. FDA and EMA) and the WHO are some of the challenges of regulatory pathways. This is a burden in terms of data gathering, performing the necessary studies and filing, which further delays access to vital ARV treatments.
  • Difficulty obtaining reliable market forecasts. This refers to the difficultly of predicting the market size for many different drugs and their geographical distribution within various countries. It has negative impacts on research and development, industrial production, as well as the corresponding procurement and supply chain. This is particularly challenging when trying to respond to a relatively small and fragmented market and often discourages investments from drug manufacturers.
  • Lack of awareness of paediatric initiatives. Several major initiatives, programmes and working groups are involved in the HIV/AIDS paediatric HIV response. Unfortunately, these are not always well known by the different stakeholders involved -- in particular industry. This represents a barrier to seeking out opportunities and synergies from working together, eventually preventing the above-mentioned issues to be fully addressed.

It is clear that everyone involved in the HIV response understands the importance of collaboration. Looking ahead, the IAS is invested in continuing to provide a forum for multi-stakeholder dialogue and collaboration in order to drive forward: increased advocacy for more optimal paediatric ARV options; greater awareness of the complexities of performing clinical trials with children; and pro-active inclusion of industry feedback as part of the normative guidance development processes.

It is time to truly work together with industry and stakeholders across the board if we want to reach our common goal: timely availability of optimal paediatric ARVs.

Read the ILF CIPHER report here to learn more and stay tuned for more updates.

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