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The EU's new paediatric medicines legislation: serving children's needs?
Archives of Disease in Childhood
In new legislation for paediatric medicines which came into effect on 26 January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children's needs for medicines in Europe. This article reviews the legislation's main proposals and makes some comparisons with equivalent legislation in the USA. We argue that the legislation suffers from several gaps and uncertainties in relation to the specific proposals and their intended aims. As the establishment of new legislation in this area offered the EU an opportunity to set some clear guidelines and objectives, and had the potential to go beyond the equivalent American rules, we thus see the proposals as something of a disappointment.
European Union; paediatric medicines policy; legislation; research incentives; obligations
SUPPORT Tools for evidence-informed health Policymaking (STP) 13: Preparing and using policy briefs to support evidence-informed policymaking
Lavis, John N
Oxman, Andrew D
Health Research Policy and Systems
This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers.
Policy briefs are a relatively new approach to packaging research evidence for policymakers. The first step in a policy brief is to prioritise a policy issue. Once an issue is prioritised, the focus then turns to mobilising the full range of research evidence relevant to the various features of the issue. Drawing on available systematic reviews makes the process of mobilising evidence feasible in a way that would not otherwise be possible if individual relevant studies had to be identified and synthesised for every feature of the issue under consideration. In this article, we suggest questions that can be used to guide those preparing and using policy briefs to support evidence-informed policymaking. These are: 1. Does the policy brief address a high-priority issue and describe the relevant context of the issue being addressed? 2. Does the policy brief describe the problem, costs and consequences of options to address the problem, and the key implementation considerations? 3. Does the policy brief employ systematic and transparent methods to identify, select, and assess synthesised research evidence? 4. Does the policy brief take quality, local applicability, and equity considerations into account when discussing the synthesised research evidence? 5. Does the policy brief employ a graded-entry format? 6. Was the policy brief reviewed for both scientific quality and system relevance?
Bioethical Implications of Globalization: An International Consortium Project of the European Commission
Novotny, Thomas E
Pedersen, J. Martin
The BIG project looks at some of the ethical concerns surrounding globalization and health.
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