At the 72nd session of the WHO Regional Committee for Europe in September 2022, WHO/Europe, in agreement with the Member States of the WHO European Region, issued a statement of intent to continue to act as a neutral convenor, host and facilitator by creating a formal stakeholder collaboration platform – the WHO/Europe Access to Novel Medicines Platform (NMP) – to improve patient access to novel medicines in the Region.

Aim and objectives

The aim of the NMP is to identify concrete actions, including demonstration projects, to improve affordable and equitable patient access to effective, novel, high-cost medicines in the Region. The specific objectives are to:

• establish a collaboration mechanism to promote dialogue and knowledge exchange between Member States and with non-State actors, other partners and stakeholders, and to identify concrete actions to improve patient access to effective, novel, high-cost medicines;
• agree on actions to improve transparency in order to build trust, promote collaboration, enable horizon scanning, and develop indicators to facilitate accountability and corrective actions;
• strengthen voluntary collaborations that focus on solidarity to achieve patient access, including evidence generation, demand aggregation, procurement and management of the life cycle of medicines;
• develop principles – including for payment, pricing, health technology assessment and reimbursement – that recognize the need for the sustainability of health systems and industry, and that enable risk-sharing and good governance of markets, including ways of addressing market failures and unmet needs; and
• identify policy options for sustainable innovation and access to novel antimicrobials, including a review of incentive coordination mechanisms for enabling sustainable research and development, and the development of access principles for payment, pricing, health technology assessment and reimbursement.

These objectives were approved at the 73rd session of the WHO Regional Committee for Europe in Astana, Kazakhstan, in October 2023, following consultation with all stakeholders to ensure that all relevant perspectives and concerns were considered.

Working groups

Four working groups on the themes of transparency, solidarity, sustainability and novel antimicrobials were proposed to meet the objectives of the NMP and to incorporate the 6 technical areas highlighted in the Regional Committee statement.

Working Group 1: Transparency focuses on:

• agreement on what information can be made more transparent in accordance with the framework set out in the 2019 World Health Assembly resolution WHA72, which calls for improved transparency across multiple aspects of the market, including pricing, patent status, clinical trial results, markups, and research and development costs; and
• identification of indicators to assess patient access to effective, novel, high-cost medicines, and exploration of approaches to improve and standardize their collection, analysis and use.

Working Group 2: Solidarity focuses on:

• a feasibility exercise to explore scaling up existing voluntary efforts to pool demand and support joint negotiation on effective, novel, high-cost medicines; and
• collaboration for the accrual, evaluation and use of evidence of clinical and economic value across the life cycle of these medicines.

Working Group 3: Sustainability focuses on:

• identification of potential deliverables related to reviewing affordable pricing principles; and
• determination of key elements needed for governance of the market, including social contracts and the role of corporate social governance.

Working Group 4: Novel Antimicrobials focuses on:

• identification of policy options for sustainable innovation and access to novel antimicrobials, including:
  • a review of incentive coordination mechanisms for enabling sustainable research and development; and
  • development of access principles, including for payment, pricing, health technology assessment and reimbursement.

In January and February 2023, consultations were held with Member States, non-State actors and other partner organizations to discuss the concept note, strategic aims, work packages and operating principles of the NMP. The 4 working groups were then established by nominations from the NMP focal points.

These working groups will run in 2023–2025 to develop the concrete proposals for adoption by the NMP and to identify resources for implementation. The NMP will convene its first consensus-building meeting on 2–3 July 2024, where all NMP members will meet in person and have the opportunity to hear from the working groups on the development of the concrete proposals put forward for consideration.