Advanced therapies and the outer limits of DNA regulation: new horizons for patents or a scaffold too far?

This Regulation seeks to regulate existing and future advancedtherapy medicinal products intended for the market in MemberStates, being either prepared industrially or manufactured bya method involving an industrial process, and introduces additionalprovisions to those laid down in the pharmaceutical legislationDirective 2001/83.     

The role of beta-amyloid precursor protein (beta-APP) staining in the neuropathologic evaluation of sudden infant death and in the initiation of clinical investigations of subsequent siblings

This report highlights the importance of undertaking immunohistochemical staining of the brains of infants who die unexpectedly, as it may not only assist with the evaluation of the cause of death in an individual infant but may also help with the clinical management of subsequent siblings. A 5-month-old male infant who died suddenly was found to have diffuse beta-amyloid precursor protein (beta-APP) staining in the brain, with no unusual features in his history, death scene examination, routine autopsy dissection, and ancillary tests to suggest any definite cause of death. Due to the beta-APP staining, the possibility of previous episodes of occult trauma, apparent life threatening events (ALTEs), and accidental or inflicted suffocation was raised in the autopsy report. As detailed analyses and investigations provided no supportive evidence for trauma or inflicted injury, hypoxia was clinically considered the most likely cause. Because of these concerns, sleeping oxygen saturation levels were monitored following the birth of a subsequent sibling who had normal APGAR scores and no evidence of any health problems. Oxygen desaturation to 70% occurred in association with a color change while on the postnatal ward, and a subsequent polysomnogram showed multiple episodic significant desaturations to around 80% in association with central apnea. Other testing was unremarkable. These cases demonstrate that beta-APP staining of the brain may not only provide clues as to possible mechanisms of death in pediatric forensic cases but may indicate a need for careful clinical evaluation of subsequent siblings for possible central apnea requiring oxygen therapy.     

Social Science and the Public Interest

Social Science and the Public Interest

Social Science and the Public Interest November/December 2010     

Oxfam Australia's experience of ‘bottom–up’ accountability

Oxfam's experience suggests that ‘bottom–up’ accountability can be an important mechanism whereby men and women living in poverty can hold others to account. The first section of this article illustrates this with two examples of Oxfam experience in Vietnam and Sri Lanka. The second section draws out some of the lessons from these examples and attempts to situate them within the broader debate about approaches to accountability. In the third section some suggestions are put forward about what would need to change if active citizenship and ‘speaking truth to power’ were to become the renewed focus of accountability.     

Gender and evidence-based planning: the CIET methods

Epidemiological combined with experiential evidence from communities can produce important and sometimes surprising insights into gender relations, to inform policies that address changing needs. CIET has standardised a community-based cross-design for the gender-sensitive collection and analysis of three types of evidence: impact, coverage, and costs. Five steps help to ensure that women's voices are heard in planning. Gender-stratified analysis of existing data is a starting point. Stratification of all responses by sex of the respondent prevents a numerical bias in favour of men translating into a gender bias in the analysis. Female focus groups inform survey design, interpretation, and appropriate strategies for change. Gender is a factor in risk and resilience analysis. Finally, gender-sensitive logistics ensure women's equal participation. First-order outputs include actionable gender data to advocate in favour of women. Second-order outputs include an enabling environment for equitable development, challenging the gendered patterns of economic marginalisation.