Improving Processes for Access to Medicines

This session seeks to explore to what extent and under what conditions new and more structured approaches to collaboration and dialogue between the R&D based pharmaceutical industry and governments, regulators and civil society in Europe could make a positive contribution to improving medicines access processes in an environment characterized by economic uncertainty and budgetary pressures.

Debates on pharmaceutical pricing have reached a political and global dimension, often with an adversarial and acrimonious stance. At the same time, we have seen emerge a stronger interest from various stakeholders in developing more structured approaches to collaboration and dialogue aimed at better predictability for both the public authorities involved in making funding decisions and for the R&D based pharmaceutical companies that have to make important investment decisions. This session seeks to take a closer look at two areas in particular, both of which are based on the underlying idea of starting a dialogue well before the marketing authorization of a medicine:

So-called “Horizon-scans” or “pipeline scans” can help identify upcoming breakthrough innovations with high outcomes impact and initiate discussions on health system implications and funding

The EU is currently exploring permanent models for joint ‘early dialogue’ which refers to the process of advice by HTA bodies (HTABs) and regulatory authorities sought at the initiative of a manufacturer on the appropriateness of study design during the development phase of a medicine. It helps companies address areas of uncertainty by better anticipating evidentiary needs for coverage decision-making by national authorities while bridging the evidentiary requirements for HTABs and regulatory approval.
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What role can pipeline scans have in increasing budgetary predictability and planning in the pharmaceuticals sector? How can capabilities for pipeline scans be increased at national or even European level? What model for a permanent joint early dialogue would best meet the needs of all involved? Can joint dialogue accelerate a more harmonised approach to value assessment in Europe? Will any of this matter for an improved dialogue and ultimately for improved access to innovation for patients?