2017 ROME ACTION PLAN

FOCUS

WHO committed to:

WHO committed to:

Action 1: Continue to host the Paediatric ARV Drug Optimization (PADO) process and update the list of priority products with a view to providing a consistent, clear, and harmonized set of products that will be communicated to industry and regulators in a timely manner, and ensure inclusion of PADO priority products in the WHO Expression of Interest list as soon as dosing is provided.

Action 2: Update treatment guidelines in a timely manner to ensure that more effective drugs are recommended for children as soon as pharmacokinetic (PK) and safety data is available.

Action 3: Continue to use the Paediatric ARV Working Group (PAWG) mechanism to provide recommendations on optimal dosing and ratios for formulation development.

Action 4: In collaboration with other partners, continue to revise the Optimal ARV Formulary and ensure its inclusion in Essential Medicine List.

Research networks committed to:

Action 5: Focus research efforts on optimal drugs and formulations as defined by PADO.

Pharmaceutical companies committed to:

Action 6: Prioritize PADO products in research and development plans.

SRAs committed to:

Action 7: Prioritize the review of Pediatric Study Plans (PSPs) and Paediatric Investigation Plans (PIPs) for paediatric ARVs on the list of PADO priority products over lower priority drugs.

Donors committed to:

Action 8: Support and fund clinical and implementation research to inform development and approval as well as use of paediatric formulations included in the PADO list.

Action 9: Only fund the procurement of drugs and formulations recommended by WHO that are included in the Optimal Formulary.

Implementing Partners committed to:

Action 10: Promote the revision of national procurement plans to align with WHO recommended regimens and the Optimal Formulary, and support the provision of reliable forecasts and the consolidation of orders.

ACCELERATE

WHO committed to:

Action 11: Continue to convene the PAWG to provide advice to innovators prior to submission of PSPs/PIPs, communicate technical opinions to SRAs in a timely manner, and provide dosing and ratio recommendations to generics for development of new FDCs.

Action 12: Reestablish the Paediatric Regulatory network to accelerate national registration and facilitate in-country registration of specific products under the Collaborative procedure established by WHO.

Pharmaceutical companies commit to:

Pharmaceutical companies committed to:

Action 13: In pre-clinical and clinical development, initiate paediatric formulation development as soon as a given drug shows potential public health impact in adults, soon after Phase II trials are completed.

Action 14: Include adolescents when conducting initial adult efficacy trials, where possible and practical, or conduct parallel trials with the goal of providing information to support licencing for adolescents at the same time as adults.

Action 15: In the design of paediatric PK and safety studies, use weight-based dosing and enroll all children above 4 weeks concurrently, unless a strong rationale exists for not doing so.

Action 16: Assess acceptability and palatability of formulations for low-resource settings at early stages of the formulations development.

Action 17: Engage in early and regular consultations with the PAWG on PIP/PSPs, as well as recommended dosing and ratios for FDC development.

Action 18: Take all possible measures to rapidly complete development of priority paediatric drugs and formulations in the pipeline, with the goal of providing the maximum number of new formulations by end of 2018, especially for infants and young children.

Research networks committed to:

Action 19: Undertake studies that use weight-based dosing, enroll all paediatric weight-band groups concurrently irrespective of age, and maximize opportunities to accelerate enrollment of subjects.

SRAs committed to:

Action 20: Accept and encourage the accelerated steps outlined in Actions 14-18 when evaluating paediatric development plans and reviewing drug applications and encourage formulation development to begin soon after Phase II dosing selection.

Donors committed to:

Action 21: Provide funding to support actions required for quickly introducing and scale-up new, optimal paediatric formulations.

Implementing Partners, and Faith-Based Organizations committed to:

Action 22: Support the early adoption of priority formulations and diagnostics and take steps to facilitate their wider roll-out, including by developing introductory guidance, materials, and other tools for health facilities.

The Global Accelerator Partners committed to:

Action 23: Call on regulatory authorities to expedite and simplify the review of priority paediatric formulations and diagnostics, including by:

  • Making better use of sub-regional collaborative regulatory approval processes and the WHO Collaborative procedure for accelerated registration;

  • Increasing reliance on evaluations and opinions of stringent regulatory authorities (SRAs) and the WHO prequalification program, up to providing full waivers for high priority paediatric drugs;

  • Allowing compassionate use until drugs are registered; and

  • Ending requirements for local clinical trials when sufficient PK and safety data exists, even when no innovator equivalent exists.

Action 24: Develop a toolkit to set standards and support accelerated research, development, and introduction of priority paediatric formulations.

UNICEF committed to:

Action 25: Work with countries on creating demand for paediatric HIV treatment services including generation of age disaggregated data to inform the better planning and supply forecasting.

Action 26: Through UNICEF supply Division, support rapid country adoption of new recommended regimens by including them on the UNICEF procurement services product lists and tenders for long term agreements.

Networks of PLHIV, Implementing Partners, and Faith-Based Organizations committed to

Action 27: Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.

Action 28: Raising awareness in global fora about the unmet diagnostic and treatment needs of children with HIV.

Action 29: Promote uptake by mobilizing their networks of hospitals and community structures to distribute paediatric medicines in hard to reach places and in situations of conflict and crisis.

COLLABORATE

Pharmaceutical companies committed to:

Action 30: Strengthen and expand collaboration to overcome intellectual property challenges and otherwise facilitate technology transfer and knowledge sharing that can promote faster paediatric formulation development, including on challenges like taste-masking.

All stakeholders committed to:

Action 31: Work together in a coordinated and transparent manner to ensure paediatric formulations are rapidly registered, introduced, and made widely available at an affordable cost in a maximum of high-burden countries.

Action 32: Identify alternative incentives and innovative financial mechanisms for the research, development and sustained supply of paediatric formulations, including advanced purchase commitments or other interventions.

Action 33: In addition to paediatric drugs and formulations in the pipeline, support the greater use of currently available WHO prequalified diagnostics and drugs in the WHO recommended regimens.

Implementing Partners committed to:

Action 34: Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.

UNAIDSand PEPFAR as co-chairs of Start Free, Stay Free AIDS Free Framework committed to:

Action 35: Provide high level political leadership and advocacy at global, country and regional levels to scale up access to paediatric HIV medications for children; production of high quality data to support implementation; and Country level support to roll out.

Action 36: Continue to convene and coordinate stakeholders at a high level, including the pharmaceutical industry, FBO and civil society service providers, national governments and multilateral partners, and partners in the Start Free, Stay Free, AIDS Free Framework.

The Co-Chairs of the AIDS Free Working Group of the Start Free, Stay Free, AIDS Free framework committed to:

Action 37: Take responsibility for monitoring implementation of the Action Plan and holding actors to account, including monthly calls of principals, tracking progress towards milestones, and regularly communicating with participants about progress on their commitments and overall implementation of the Plan.

Action 38: Develop a set of milestones in 2018 to highlight progress on the Action Plan and establish opportunities for stakeholders to take on more specific commitments.

Action 39: GAP-f partners develop a work plan for finalization, roll-out and increasing demand for and accelerating access to 2-3 high priority drugs planned for approval in 2018.

Action 40: Continue to refine the Global Accelerator for Paediatric Formulations concept as a key component of the AIDS Free work stream, including by establishing leadership, roles and responsibilities, and a financing mechanism.

Action 41: Organize a follow-up meeting focused on diagnostics for children in Q1 2018.