In March 2020, the COVID-19 pandemic shook European Union (EU). The EU responded to multifaceted challenge with an integrative leap forward. Member States substantially increased their investment in existing health policy tools such as civil protection and financing for initiatives. There was innovation law, where a process of redefining public began, strategies vaccines pharmaceuticals, took on direct significant role medicines procurement first time. We use framework neofunctionalism...

EU health policy is a forged in crisis. Whilst maintaining the strict limitations on EU's role that are described treaties, crises have historically been followed by incremental but integrative change. Given this trend, should we be expecting radical expansion of aftermath Covid-19? And, if so, what parameters and characteristics might new agenda have? As enter period which will try to elaborate its policy, paper uses Complexity perspective assess how emerging compares existing historical...

Abstract The European Union (EU) post‐COVID‐19 investment and reform programme, the Recovery Resilience Facility (RRF), has been hailed as novel ambitious, both a fiscal instrument lever for accelerating progress towards EU climate commitments. Yet, its design also exhibits strong path dependency, drawing on existing processes Adapting theories of institutional change models hard/soft governance, we argue that RRF is an example significant yet gradual – evolution rather than revolution...

ABSTRACT Though often framed as a technocratic tool, impact assessment is core element of the political agenda‐setting process. In this article, we show that decisions about what subject to legislative debate are made during assessment; specifically, drafting report. Using social process tracing methodology, analyze removal from agenda provisions for stronger alcohol advertising rules revision EU's Audiovisual Media Services Directive. We identify and test three possible explanations...

The European Union's "good governance" program, known as Better Regulation, seeks to improve the quality of EU legislation by controlling policy-making process. Despite its importance, it is rarely accounted for in health policy literature. Seeking address this gap, article introduces Regulation context making. It conceptualizes a model regulatory chill, drawn from literature on international trade, interrogate impact processes. Using examples and data series interviews with officials,...

Meta-regulation - the rules that govern how individual policies are developed and reviewed has not received much attention in study of health policy. We argue these rules, far from value-free objective, have significant potential to shape policy outputs and, as such, outcomes. Channelling operationalising wider paradigms like neoliberalism, they determine, for instance, what is considered 'good' policy, decisions made, based on which evidence, whose voices matter. Exploring an archetypal...

Abstract European Union (EU) fiscal governance, especially the Semester, is an ambitious new governance architecture involving surveillance and discipline, across both Eurozone non-Eurozone member state policies, in pursuit of rigor. It most recent several attempts to expand EU powers over policy with goal austere budgeting, one that has led remarkable claims authority by health policies as detailed medical school admissions role primary care. expected it would be resisted not just those who...

EU governance is experiencing a shift towards soft frameworks that incorporate 'harder' elements. Using qualitative case study approach and an original set of elite interviews, we examine two policy areas – health energy where similar such architectures the European Semester Energy Union Governance Regulation are now core tools. Three research questions addressed: (1) What mechanisms employed to harden these frameworks? (2) driving this shift? And, drawing on more extensive experience...

Upon taking office as President of the European Commission in 2014, Jean-Claude Juncker initiated a series reforms to internal workings EU executive. Existing research suggests that these have been successful increasing political steering, creating which focuses on fewer fields, controls policy activism its officials and produces less legislative output. However, much this whole. This article addresses gap literature by exploring how impacted upon policy-making structures dynamics within two...

Models of interest group politics can help public health professionals (PHPs) to identify potential allies and establish mechanisms sustainable political influence. This article focusses on a particular model, known as the Advocacy Coalition Framework (ACF), its explanations coalition behaviour, role scientific information ways in which coalitions bring about policy change. The analysis illustrates relevance ACF for by drawing examples from recent debate direct-to-consumer advertising...

Abstract Innovation in the development of new drugs has to balance needs health actors and administrators, pharmaceutical industry patients. Differing perspectives on what constitutes an innovation, where research should be directed how evaluated priced cause ongoing tensions within regulatory framework. In current climate, Europe’s systems face rising demand for services increasingly restricted resources, efficiency regulation drug is under even greater scrutiny. How can foster innovation...

COVID-19 has exposed and exacerbated the health inequalities across between European Union member states. It also raised profile of EU policy highlighted value cooperation in health. Early failures to respond adequately, coupled with this increased salience, have given rise a series initiatives designed strengthen expand EU’s role This presents an opportunity address imbalances institutional legal structure which prevent it from addressing more effectively. Drawing on changes underway public...

The 2015-2018 revision of the European Union's Audiovisual Media Services Directive, which governs marketing alcohol and unhealthy food to minors, failed align with international best practice. Previous research has explained this 'missed opportunity' reference deficient political will, difficulties advocating for health, industry pressure. We explore another explanation: role impact assessment (IA) process in shaping decision-making.

Abstract Rationale, aims and objectives Between 2001 2011 the pharmaceutical industry, supported by DG E nterprise, was engaged in an ongoing campaign to repeal/amend uropean U nion ( EU ) ban on direct‐to‐consumer advertising of prescription drugs DTCA ‐ PD ). As it became increasingly clear that would not be repealed, supporters tried shift debate away from towards provision ‘patient information’ rights patients access such information. Meanwhile, a variety national European health...

Abstract Until 1994, pharmaceutical products seeking market authorisation in Norway were required to demonstrate a fulfilment of unmet medical need. This clause enabled the national regulator dramatically limit number on whilst encouraging price competition keep drug expenditure low and was credited with development drugs genuine added therapeutic value reducing incidence antimicrobial resistance. forced abandon its Medical Need Clause ( MNC ) when it joined European Economic Area as...