SciCombinator

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Concept: Directive

39

More than 130 million microwaves are affected by European Union (EU) legislation which is aimed at reducing the consumption of electricity in the standby mode (‘Standby Regulation’) and at more sustainable management of end-of-life electrical and electronic waste (‘WEEE Directive’). While legislation focuses on these two life cycle stages, there is little information on the environmental impacts of the entire life cycle of microwaves. To address this gap, this paper presents a comprehensive life cycle assessment of microwaves and assesses the environmental implications of the Standby Regulation and the WEEE Directive at the EU level. The impacts are first considered at the level of individual appliances and then at the EU level, with the aim of evaluating the potential environmental implications of the full implementation of the above two EU regulations by 2020. The effects of the electricity decarbonisation and the expected increase in the number of microwaves in use have also been considered. The results suggest that implementation of the EU regulation by 2020 will reduce the environmental impacts considered by 4%-9% compared to the current situation. The majority of these reductions is due to the Standby Regulation, with the contribution of the WEEE Directive being small (~0.3%). However, the expected decarbonisation of electricity will result in much higher reductions (6%-24%) for most impact categories. The results also show that the materials used to manufacture the microwaves, the manufacturing process and end-of-life disposal are environmental hot-spots for several impacts, including depletion of abiotic elements. Therefore, efforts to reduce the environmental impacts of a future electricity mix should be combined with the development of specific eco-design regulations for microwaves that stipulate optimisation of resource consumption. Possible future trends, such as shorter lifetimes and limited availability of some resources, make the development of such product regulations more critical.

Concepts: European Union, Regulation, Recycling, Waste, European Union law, Citizenship of the European Union, Directive, Green computing

39

The 2014 European Union (EU) Tobacco Products Directive (TPD) was negotiated in a changed policy context, following adoption of the EU’s ‘Smart Regulation’ agenda, which transnational tobacco companies (TTCs) anticipated would increase their influence on health policy, and the WHO Framework Convention on Tobacco Control (FCTC), which sought to reduce it. This study aims to explore the scale and nature of the TTCs' lobby against the EU TPD and evaluate how these developments have affected their ability to exert influence.

Concepts: European Union, Tobacco, United Kingdom, Council of Europe, Bulgaria, European integration, Directive, Charter of Fundamental Rights of the European Union

29

To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably “high” for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation.

Concepts: European Union, Risk, Management, Risk management, Regulation, Risk assessment, Seroconversion, Directive

26

In 2010, EFOMP issued Policy Statement No. 12: “The present status of Medical Physics Education and Training in Europe. New perspectives and EFOMP recommendations” to be applied to education and training in Medical Physics within the context of the developments in the European Higher Education Area arising from the Bologna Declaration and with a view to facilitate the free movement of Medical Physics professionals within Europe. Concurrently, new recommendations regarding qualifications frameworks were published by the European Parliament and Council which introduced new terminology and a new qualifications framework - the European Qualifications Framework (EQF) for lifelong learning. In addition, a new European directive involving the medical use of ionizing radiations and set to replace previous directives in this area was in the process of development. This has now been realized as Council Directive 2013/59/Euratom of 5 December 2013 which has repealed directive 97/43/Euratom. In this regard, a new document was developed in the context of the EC financed project “European Guidelines on the Medical Physics Expert” and published as RP174. Among other items, these guidelines refer to the mission statement, key activities, qualification framework and curricula for the specialty areas of Medical Physics relating to radiological devices and protection from ionizing radiation. These developments have made necessary an update of PS12; this policy statement provides the necessary update.

Concepts: European Union, European Commission, European Parliament, European Council, Regulation, Council of Europe, European Union law, Directive

24

Akkermansia muciniphila is an intestinal anaerobe which has been proposed as a new functional microbe with probiotic properties. However, the species is not included in the European Union qualified presumption of safety (QPS) list and has not yet been assessed. Moreover, products containing A. muciniphila are not on the market and are thus controlled by the Novel Foods Regulation, which requires extensive safety assessment. This review addresses the safety aspects of the use of A. muciniphila based on published information on its functions in humans and predictions based on its activity in model animals. Further, comprehensive studies related to A. muciniphila and its safety properties have gradually appeared and are summarised here. Many of the criteria required for novel food safety assessment in Europe can thus be fulfilled. However, studies focusing on the toxicological properties of A. muciniphila, including long-term and reproduction studies, have not so far been reported and are discussed in the light of the observation that most, if not all, healthy subjects are known to carry this intestinal anaerobe. As this also applies to other beneficial bacteria found in the human intestinal tract, the A. muciniphila case can be seen as a model for the comprehensive safety evaluations required by the European authorities.

Concepts: Human, Bacteria, European Union, Microbiology, Food, Europe, Largest urban areas of the European Union, Directive

14

The Clinical Trials Regulation (CTR) (EU No 536/2014) repealing the EU Clinical Trials Directive (2001/20/EC) is expected to be implemented in all EU countries in 2016. The European Medicines Agency (EMA) policy on publication of clinical data for medicinal products for human use “Policy 0070” became operative as of 1 January 2015.

Concepts: European Union, Directive

6

Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.

Concepts: European Union, Regulation, Estonia, European integration, Legislature, Citizenship of the European Union, Directive

4

The European Orphan Medicinal Products (OMP) Regulation has successfully encouraged research to develop treatments for rare diseases resulting in the authorisation of new OMPs in Europe. While decisions on OMP designation and marketing authorisation are made at the European Union level, reimbursement decisions are made at the national level. OMP value and affordability are high priority issues for policymakers and decisions regarding their pricing and funding are highly complex. There is currently no European consensus on how OMP value should be assessed and inequalities of access to OMPs have previously been observed. Against this background, policy makers in many countries are considering reforms to improve access to OMPs. This paper proposes ten principles to be considered when undertaking such reforms, from the perspective of an OMP manufacturer. We recommend the continued prioritisation of rare diseases by policymakers, an increased alignment between payer and regulatory frameworks, pricing centred on orphan medicinal product value, and mechanisms to ensure long-term financial sustainability allowing a continuous and virtuous development of orphan medicinal products. Our recommendations support the development of more consistent frameworks and encourage collaboration between all stakeholders, including research-based industry, payers, clinicians, and patients.

Concepts: European Union, United Kingdom, Europe, Estonia, Norway, European integration, Latvia, Directive

4

This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

Concepts: European Union, United States, Portugal, Europe, Estonia, European integration, Legislature, Directive

3

EU regulation 726/2004 authorises manufacturers to provide drugs to patients on a temporary basis when marketing authorisation sought centrally for the entire EU is still pending. Individual Member States retain the right to approve and implement such ‘compassionate use’ programmes which companies will usually provide for free. Nevertheless some companies have opted not to partake in such programmes, in effect restricting access to drugs for patients in need. Here we survey the state of compassionate use programmes in the EU with particular reference to the rare disease field, and provide legal and ethical arguments to encourage their increased compassionate use in the EU and beyond. We contend that if enacted, these recommendations will be mutually beneficial to companies as well as patients.

Concepts: Clinical trial, European Union, United Kingdom, Human rights, Slovakia, State, Rare disease, Directive