The European Commission recently announced a new industrial strategy and pharmaceutical roadmap, largely focused on revising legislation dating back nearly two decades, with the aim of laying out a concrete plan by the end of 2020. The commission’s priority is to revitalize medical innovation in Europe, a chief concern voiced by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Ahead of the publishing of the new strategy, EFPIA Director General Nathalie Moll outlined the need for “novel, evidence-based, flexible and collaborative models to solve access and shortages issues, supporting a stable, predictable regulatory and incentives environment to drive research into the next generation of treatments and the adoption of a renewed industrial strategy for Europe to ensure the industry remains an innovator and world leader.”
Indeed, in order to address the issue of medical innovation and competitiveness, the Commission has laid out three key priorities: maintaining and increasing European pharma’s competitiveness both inside and outside Europe, becoming climate-neutral by 2050 and embracing a digital business environment.
Within these overarching goals, specific steps taken will be to secure European sources of raw materials, fight against the stealing of intellectual property, creating a framework for sustainability and digital transformation, and update legislation and rules around competition.
Furthermore, a pillar of the industrial strategy will be the removal of trade barriers within Europe, simplifying currently complex rules and administrative procedures.
Further issues the industrial strategy and pharma roadmap will tackle involve revising pharma pricing, addressing drug shortages, and orphan and paediatric regulation.
On pricing, EFPIA recommends payment approaches such as indication-based, outcomes-based, combination-based, over-time and subscription, as well as novel pricing and it is expected that new cost-benefit analyses for therapeutics will be introduced, with an emphasis on delivering value.