Health has moved to the very top of the European Commission’s agenda and to the epicentre of policymaking over the last three years, as the COVID-19 pandemic laid bare the urgent imperative to build a resilient and strong European Health Union.
We have seen the strengthening of agencies (ECDC, EMA), the creation of a new authority (HERA), and a range of new actions and goals for digital transformation and global health security. However, with medicines accounting for roughly one-fifth of Europe’s health spend, the major channel through which the EU shapes health systems is invariably via pharmaceutical legislation. The Commission’s November 2020 Pharmaceutical Strategy is a response not only to internal market issues, but also to global competition pressure in the sector.
A key pillar of the Strategy – the highly anticipated legislative proposals overhauling the EU’s pharmaceutical legislation – is finally expected to be published in March. The Commission says it is trying to balance a range of interests: equitable access for patients to therapies and cures, the success and competitiveness of industry, the sustainability of national health systems and incentives that encourage research into AMR.
Industry is hoping that the revision of the decades-old legislation will seek to fix long-standing problems, create a first-class, 21stcentury regulatory framework that will help reduce regulatory burden, speed up access and ensure Europe is a globally competitive region for medical innovation. Patient advocates are hopeful the legislation will help bring down prices by allowing greater competition across the bloc and by introducing more transparency to the cost of medicines.
Once published, the stage is set for at least two years of very intensive discussions between the institutions and stakeholders. With high aims, high stakes, strong competing positions, and a European populace more engaged in health than ever before, this re-evaluation of many of the basic concepts of pharmaceutical law will have widely felt economic and social consequences.
