Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation.

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 to dramatically limit the number of products on the market whilst encouraging price competition to keep drug expenditure low and was credited with encouraging the development of drugs with genuine added therapeutic value and reducing the incidence of antimicrobial resistance. Norway was forced to abandon its Medical Need Clause (MNC) when it joined the European Economic Area as it was incompatible with the acquis communautaire of the European Union.

Can a medical need clause help manage the growing costs of prescription drugs in the EU?

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

Single-radius, multidirectional total knee replacement.

Purpose: The present study was designed to evaluate the mid-term (5- to 8-year) survival rate of a new total knee replacement (TKR) with a single-radius femoral component and a multidirectional, highly congruent tibial component, in comparison with an historical group (TKR with multi-radius design and fixed bearing).

Methods: Four hundred and thirty patients were included, of which 369 patients (86 %) completed the 5-year follow-up with Knee Society Score evaluation and radiograph examination (study group = 387, control group = 83).

Results: There was a significant improvement for all analysed items between pre-operative status and late follow-up.

From DTCA-PD to patient information to health information: the complex politics and semantics of EU health policy.

Rationale, Aims And Objectives: Between 2001 and 2011 the pharmaceutical industry, supported by DG Enterprise, was engaged in an ongoing campaign to repeal/amend the European Union (EU) ban on direct-to-consumer advertising of prescription drugs (DTCA-PD). As it became increasingly clear that the ban would not be repealed, DTCA-PD supporters tried to shift the debate away from advertising and towards the provision of 'patient information' and the rights of patients to access such information. Meanwhile, a variety of national and European health organizations, supported by DG SANCO, sought to maintain the ban and oppose the industry-supported 'patient information' campaign.

What can complexity do for diabetes management? Linking theory to practice.

Background: Diabetes presents a multifaceted picture with its rapidly rising prevalence associated with changing demographics and increasing levels of obesity in the developed world. Deaths from diabetes are predicted to rise by 25% over the next 10 years. The enormity of this public health challenge has been recognized the world over, but little attention has been paid to the theoretical frameworks underpinning practical management.

Using 'complexity' for improving educational research in health care.

Systematic reviews of health care education have consistently reported a lack of long-term effects, failure to use theory, and inadequate methodological rigour. Such findings have highlighted the lack of a clear causality and predictability in health care education research and therefore the inadequacy of a traditional scientific framework with its focus on analysis, prediction and control. This article argues that in order to develop an effective and standardised framework we must go beyond such a restrictive agenda and toward one that appreciates education as a complex adaptive system.