The European Federation of Organisations for Medical Physics Policy Statement No. 6.1: Recommended Guidelines on National Registration Schemes for Medical Physicists

This EFOMP Policy Statement is an update of Policy Statement No. 6 first published in 1994. The present version takes into account the European Union Parliament and Council Directive 2013/55/EU that amends Directive 2005/36/EU on the recognition of professional qualifications and the European Union Council Directive 2013/59/EURATOM laying down the basic safety standards for protection against the dangers arising from exposure to ionising radiation. The European Commission Radiation Protection Report No. 174, Guidelines on Medical Physics Expert and the EFOMP Policy Statement No. 12.1, Recommendations on Medical Physics Education and Training in Europe 2014, are also taken into consideration.The EFOMP National Member Organisations are encouraged to update their Medical Physics registration schemes where these exist or to develop registration schemes taking into account the present version of this EFOMP Policy Statement (Policy Statement No. 6.1“Recommended Guidelines on National Registration Schemes for Medical Physicists”).     

Changes in European ecosystem productivity and carbon balance driven by regional climate model output

Climate change resulting from the enhanced greenhouse effect together with the direct effect of increased atmospheric CO₂ concentrations on vegetation growth are expected to produce changes in the cycling of carbon in terrestrial ecosystems. Impacts will vary across Europe, and regional-scale studies are needed to resolve this variability. In this study, we used the LPJ-GUESS ecosystem model driven by a suite of regional climate model (RCM) scenarios from the European Union (EU) project PRUDENCE to estimate climate impacts on carbon cycling across Europe. We identified similarities and discrepancies in simulated climate impacts across scenarios, particularly analyzing the uncertainties arising from the range of climate models and emissions scenarios considered. Our results suggest that net primary production (NPP) and heterotrophic respiration (Rh) will generally increase throughout Europe, but with considerable variation between European subregions. The smallest NPP increases, and in some cases decreases, occurred in the Mediterranean, where many ecosystems switched from sinks to sources of carbon by 2100, mainly as a result of deteriorating water balance. Over the period 1991–2100, modeled climate change impacts on the European carbon balance ranged from a sink of 11.6 Gt C to a source of 3.3 Gt C, the average annual sink corresponding with 1.85% of the current EU anthropogenic emissions. Projected changes in carbon balance were more dependent on the choice of the general circulation model (GCM) providing boundary conditions to the RCM than the choice of RCM or the level of anthropogenic greenhouse gases emissions.     

The health of European medical research. Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent

The 2001 EU Clinical Trials Directive aimed to harmonize the regulation of medical research, but achieved the opposite. Various attempts are underway to update the directive to make it easier to safely conduct medical research in Europe.Medical research, similarly to finance and business, works best with light regulation; however, protecting patients during clinical trials, and afterwards when treatments have been approved, requires regulation. Attempts to square this circle and the challenge of testing sophisticated drugs and therapies have resulted in increasingly strict regulation of clinical research, particularly in Europe''s leading medical research powers Germany, France, the Netherlands and the UK. There is growing concern among these countries with established pharmaceutical industries that clinical trials are increasingly hard to conduct; in fact, the number of applications has declined significantly during the past decade (Cressy, 2010).There is growing concern among these countries with established pharmaceutical industries that clinical trials are increasingly hard to conduct…Meanwhile, the number of applications for clinical trials has increased in the USA, Canada and some southern European countries, notably Italy and Spain, where the regulatory touch has been lighter and combined, in some cases, with financial incentives, according to Paul Stewart, Dean of Medicine at the University of Birmingham in the UK. There is a danger therefore that Europe''s leading research nations could lose their competitive edge in medical research at a time when radical new treatments are on the horizon. “Europe''s weight in clinical research is diminishing,” commented Markus Hartmann, senior consultant at European Consulting & Contracting in Oncology (Saarbrücken, Germany), which provides advice about medical regulatory affairs. The risk of falling behind extends beyond drug-based therapies to surgery and medical devices, Hartmann added. He explained that the European Commission now considers medical devices and drugs as ‘products'' that can be sold in the internal market, and therefore require a common and harmonized regulatory framework.Hartmann, along with other researchers, traces the recent decline in European clinical trial activity back to the European Union (EU)''s Clinical Trials Directive (CTD) 2001/20, which was supposed to provide a common framework for unifying regulation within the EU by 2020. “The Clinical Trials Directive is contributing to this effect, but is not the only factor,” said Hartmann.The root cause of the problem might be growing aversity to risk—which puts more emphasis on patient protection even when this is not necessary—but the EU directive has certainly fuelled this mood. “That initial EU Directive was actually quite a sensible document, but what was crazy was the legal creep that followed,” said Stewart. “What the lawyers did was legislate for the worst possible scenario, instead of seeing the directive as a facilitating document enabling people to go and do research.”The directive actually had the opposite effect from the original intent: it led to even more regulatory fragmentation within the EU. This was first identified in a 2006 report, co-authored by Hartmann, which cited significant divergence in the national implementations of the EU directive (Hartmann & Hartmann-Vareilles, 2006). France was found to have the strictest regime, in which all trials including those involving cosmetics were rigorously supervised.The directive actually had the opposite effect from the original intent: it led to even more regulatory fragmentation within the EUThis divergence still exists. “Basically, the lack of harmonisation has not been resolved, as the Clinical Trials Directive has been transposed into national legislation in the form of laws, ordinances and rules of implementation that still differ in so many procedural and technical aspects,” said Hartmann.Moreover, although the 2001 directive underlined maintaining current levels of patient protection, Hartmann argued that it has done little if anything to improve safety. “Do not forget the TeGenero disaster with compound TGN1412, tested in spring 2006 in a Northern London hospital,” he said. “This was Europe''s largest clinical research catastrophe so far and happened in the UK, after the UK switched from a very liberal trial notification system, where phase I trials with healthy volunteers were even exempted from notification or authorisation, to the provisions laid down by the Clinical Trials Directive.”These problems have now been acknowledged by both national governments and the EU itself, according to Liselotte Højgaard, chair of the Standing Committee of the European Medical Research Councils, and a medical imaging specialist at the University of Copenhagen in Denmark. “We have had very many meetings in Brussels about the issue […] and in the last year the EU has become convinced it is a problem,” she said. As a result the directive is going to be redrafted well before it runs its full 20-year course. “We have been invited to help them draft a new directive,” said Højgaard. “That is a major achievement.”The aim is to learn from previous mistakes and frame the new document to encourage harmonization and a reduction in bureaucracy and paperwork. “We must make it easier to implement in each member state,” commented Højgaard, who added that the approval process also needs to be streamlined so that clinical trial teams do not have to repeat the same steps at different stages of the approvals process. “One of the things we are thinking about here in Denmark is whether we can make a one-stop-shop approvals process so you don''t have to go in and send an application to the medicinal agency, and also to the ethical committee, and also to clinicaltrials.gov,” said Højgaard. She hopes this new structure will be in place by the time Denmark holds the EU presidency in early 2012, and will encourage the rest of Europe to adopt a similar approach.The aim is to learn from previous mistakes and frame the new document to encourage harmonization and a reduction in bureaucracy and paperworkHartmann also acknowledges progress on the harmonization front. He cited the Voluntary Harmonisation Procedure (VHP), which was introduced in early 2009 by a network of national authorities, the Clinical Trials Facilitation Group (CTFG). It was set up precisely to coordinate implementation of the 2001/20 directive across EU member states, with little success at first. Now, the VHP allows applicants to submit protocols for trials to be conducted in many EU countries to the respective authorities, which agree on an assessment. “Then in a subsequent step, the applicant can submit the protocol to the national authorities for authorisation,” said Hartmann. “The VHP pilot aims to prevent divergent outcomes in the trial authorisation process, for example when a protocol approved in one country is blocked in another country.”These developments could eventually lead to a Europe-wide agency dedicated to clinical research regulation, along the same lines as the European Research Council for fundamental research, which Højgaard described as a great success. Such an agency would organize trials across the whole continent through a single streamlined approvals process, thereby covering a population of 500 million people.Attempts to amend the EU 2001 directive have also been welcomed by big funding bodies such as the Wellcome Trust in the UK, a charitable foundation that funds medical and clinical research globally. “We recently issued a response to a public consultation paper from the European Commission, Assessment Of The Functioning Of The “Clinical Trials Directive” 2001/20/EC, in which we highlighted areas where the Directive could be streamlined to reduce bureaucracy, while maintaining an appropriate regulatory framework,” said David Lynn, Head of Strategic Planning and Policy at the Wellcome Trust. “We would like to see a more risk-based approach to regulation of clinical trials, a rationalisation of the multiple layers of bureaucracy and the approvals process.”Bureaucracy notwithstanding, a fundamental problem is finding the right balance between risks associated with different drugs or therapies. The 2001 directive has instead led to a one-size-fits-all approach, according to Stewart. “Part of the work we''ve been doing at the level of the UK Clinical Research Consortium is to look at risk–benefit analysis, so that you have a lower level of regulation on some things and higher on others that are unproven.” If, for example, an existing drug turns out to be effective against a disease for which it was not originally developed, it would not be necessary to conduct thorough safety trials. This was the case with aspirin, initially developed as a pain killer over a century ago, which also protects against both vascular disease and bowel cancer (ATT Collaboration, 2009; Din et al, 2010). During these trials, safety was still an issue as the drug was being used in a different context, but, even so, it was clear that acute side effects were highly unlikely.Bureaucracy notwithstanding, a fundamental problem is finding the right balance between risks associated with different drugs or therapiesWhile medical regulations in Europe err on the side of safety, they do little to regulate and harmonise the reporting of results after trials have occurred. The results from many clinical trials are never published as they fall victim to reporting bias for various reasons, notably because the pharmaceutical companies providing funding have an interest in promoting results favourable to their products and suppressing negative findings. A recent study by the Institute for Quality and Efficiency in Health Care (IQWiG) in Cologne, Germany, confirmed widespread publication bias in the past, which harmed patients through under-reporting of side effects (McGauran et al, 2010).“The most prominent example of harm caused by publication bias is probably the case of Class I anti-arrhythmic drugs,” said Beate Wieseler, deputy head of IQWiG''s Drug Assessment Department. In this 1980 trial, 9 of 49 patients with suspected acute myocardial infarction who were treated with a class I anti-arrhythmic drug (lorcainide) died, compared with only one patient in the placebo group, and yet the investigators ludicrously dismissed this as chance (Cowley et al, 1993). The results of the trial were not published until 1993 and, although the development of lorcainide was discontinued for commercial reasons, the investigators concluded that as a result of this delay in publication, the continuing use of class I drugs had led to several unnecessary deaths.By the same token, ineffective drugs have sometimes gained market approval after over-reporting of their benefits, in some cases ignoring other, more negative, studies. Wieseler and colleagues found that studies reporting positive results for a particular drug were published in higher impact journals and were more likely to be picked up by other publications and the mass media.Many cases of reporting bias, especially involving suppression of negative results, occurred 10 or more years ago. According to Stewart the situation has improved, although he concedes that, almost inevitably, journals will be drawn towards positive results given the increasing competition for readers and advertisers. “Whether publication bias goes on to the same extent now is debatable,” said Stewart, pointing out that clinical trials now have to be registered in Europe and the USA so that the data is public, even if it is not published in a journal.There will inevitably be some risk of bias in research funded by pharmaceutical companies, which, after all, are in the business to make money. It is therefore important to support ‘investigator-driven'' trials that are independent of any company, and it is here that the Wellcome Trust has an important role. “The Wellcome Trust supports the proposal for Investigator Driven Clinical Trials as joint collaborations across Europe,” said Lynn. “We fund academic clinical trials, which are usually independent of drug company interests.”Independent money for academic clinical trials has indeed been more crucial during the past few years, since the EU 2001/20 directive tends to favour research funded by drug companies with the money and resources to overcome the increasingly high bureaucratic hurdles. Lynn commented that universities had not been well served by recent legislation. “Academic institutions are less-well resourced and equipped than commercial sponsors to deal with the bureaucratic burden imposed by the Directive,” he said.In some cases these burdens have caused even young scientists to give up on promising research because they cannot stomach the paperwork involved…In some cases these burdens have caused even young scientists to give up on promising research because they cannot stomach the paperwork involved, according to Højgaard. “For the first time in my life as a boss, I had the experience when I came in to a morning conference and asked one of the young consultants ‘shouldn''t we do a clinical study on this'' and he said ‘no I simply haven''t got the energy for all this paper workload''.” This experience spurred her to lobby for change. Critics such as Højgaard and others therefore hope that the redrafting of the amendment and the ensuing changes in national legislation will liberate European medical research from the regulatory shackles that have held it back.     

Cephalopods in neuroscience: regulations,research and the 3Rs

Cephalopods have been utilised in neuroscience research for more than 100 years particularly because of their phenotypic plasticity, complex and centralised nervous system, tractability for studies of learning and cellular mechanisms of memory (e.g. long-term potentiation) and anatomical features facilitating physiological studies (e.g. squid giant axon and synapse). On 1 January 2013, research using any of the about 700 extant species of “live cephalopods” became regulated within the European Union by Directive 2010/63/EU on the “Protection of Animals used for Scientific Purposes”, giving cephalopods the same EU legal protection as previously afforded only to vertebrates. The Directive has a number of implications, particularly for neuroscience research. These include: (1) projects will need justification, authorisation from local competent authorities, and be subject to review including a harm-benefit assessment and adherence to the 3Rs principles (Replacement, Refinement and Reduction). (2) To support project evaluation and compliance with the new EU law, guidelines specific to cephalopods will need to be developed, covering capture, transport, handling, housing, care, maintenance, health monitoring, humane anaesthesia, analgesia and euthanasia. (3) Objective criteria need to be developed to identify signs of pain, suffering, distress and lasting harm particularly in the context of their induction by an experimental procedure. Despite diversity of views existing on some of these topics, this paper reviews the above topics and describes the approaches being taken by the cephalopod research community (represented by the authorship) to produce “guidelines” and the potential contribution of neuroscience research to cephalopod welfare.     

Physiological changes in the Norway lobster Nephrops norvegicus (L.) escaping and discarded from commercial trawls on the West Coast of Scotland: II. Disturbances in haemolymph respiratory gases, tissue metabolites and swimming performance after capture and during recovery

The physiological states of trawled and creel-caught (control) Norway Lobsters (Nephrops norvegicus (L.)) captured on grounds off the West Coast of Scotland (120–150 m) were compared. Undersized “discards” (<25–35 mm carapace length) were sampled directly from the cod-end and following recovery in underwater (u/w) cages at a mean depth of 24 m. “Escaped” animals which had passed through the cod-end meshes and collected in a small-meshed net “cover” were transferred without emersion (air-exposure) for sampling on-board. Some of these individuals were also transferred by SCUBA divers to u/w cages. Haemolymph PO₂, PCO₂ and pH measurements showed that both discarded and escaped animals experienced moderate internal hypoxia, hypercapnia and acidosis which became severe after 1 h emersion of the former on deck. A marked handling effect was evident in which haemolymph PO₂ declined and PCO₂ became elevated in both controls and recovering trawled animals. In both discarded and escaped animals haemolymph l-lactate and d-glucose concentrations were high compared to controls, but with levels significantly lower in escapes suggesting less tail-flip swimming activity within the cod-end cover. Further emersion had little effect on haemolymph l-lactate in discards. Recovery to control levels of both metabolites occurred within 24 h in u/w cages but the exercising of captured individuals (by tactile stimulation) produced further significant increases. Abdominal flexor muscle concentrations of l-lactate were also elevated in discards and escapes and positively correlated with haemolymph levels. Muscle glycogen showed severe depletion in both groups compared to unexercised controls and 1 h emersion reduced levels drastically (to 20% of normal concentrations). High haemolymph ammonia (T_amm) was characteristic of both trawled groups but was reduced rapidly during recovery. These metabolite changes were accompanied by reductions in the number of escape swimming tail-flips that could be elicited before exhaustion, particularly in discards. This reduction in performance was evident in discards even after 24 h recovery, but escapes showed almost normal responses. The severity of the physiological stresses experienced during trawling, and to a lesser extent in escaped animals, and their effects on recovery of undersized discards regaining the seabed, is discussed. These findings may help us predict the survival, longer-term recovery and fitness of fished N. norvegicus, and their potential contribution to the regeneration of exploited populations.     

Strategic Responses to Environmental Regulation in the U.K. Automotive Sector: The European Union End-of-Life Vehicle Directive and the Porter Hypothesis

As of 1 January 2006 all automotive OEMs (original equipment manufacturers) and component manufacturers operating within the European Union will need to comply with the End-of-Life Vehicle Directive (referred to hereafter as the EU ELV Directive). The EU ELV Directive compels all OEMs to take back and dismantle all motor vehicles for domestic use at the end of their useful lives. Each component part will then be either reused or recycled. To this end, the ultimate goal of the EU ELV Directive is that all motor vehicles for domestic use will have a reuse or recyclable content of 85% at the end of their useful lives, moving toward 95% by 2015. The burden of the EU ELV Directive falls on both the OEMs and their component manufacturers, forcing them to innovate and "design for disassembly." This being the case, it offers a unique real world example with which to test the Porter Hypothesis. Porter asserts that strict, correctly formulated environmental regulation can offer a firm secondary benefits through improved product design and the reduction of waste. This in turn allows the firm to offset the cost of compliance. Because the EU ELV Directive has been fashioned to force firms into a process of innovation and redesign, the magnitude of these so-called offsets can be judged. This article employs Rugman and Verbeke's 1998 strategic matrix of firm response to environmental regulation to examine qualitative details of the strategic response of automotive component manufacturers and OEMs in the United Kingdom to the demands of the directive to judge the volume of offsets generated. This analysis shows no support for the Porter Hypothesis and challenges the assumptions of Rugman and Verbeke's model.     

The effect of the EU Tissues and Cells Directive on bone banking in Denmark: a case study

As a result of the EU Tissues and Cells Directive (2004/23/EC), therapeutic tissue banking is currently being restructured throughout Europe. The stated objectives are to enhance a safe and stable supply of bone and tissue in Europe and to facilitate internal exchange. We conducted an interview study to explore the effect of the Directive on Danish bone banks in terms of (1) organizational restructuring, (2) supply and range of exchange, (3) economic costs. We found that the Directive stimulated extensive re-organization of bone banks with a substantial adjoining workload; that it is doubtful whether it will increase supply and range of exchange; and that the transposition of the Directive is associated with considerable extra cost. Additionally, we found that elements in the documentation of safety were fabricated by surgeons to avoid what was seen as unnecessary questioning of potential donors.     

European experimental animal use declines ever so slightly

The latest report on experimental animal use in the EU indicates a slight decrease. However, the figures, which are for 2008, show that around 12 million animals are still used in laboratories throughout Europe. To date, only a summary of the data has been published, and so this report is limited to giving a comparison of trends and significant changes. The impact on the figures of the revision of Directive 86/609/EEC and the 7th Amendment to the Cosmetics Directive 76/768/EEC is discussed. In addition, consideration is given to which areas of research and regulation will need to be closely monitored, and the importance of continuing to push for the implementation of Three Rs initiatives is highlighted.     

The ecology of European ponds: defining the characteristics of a neglected freshwater habitat

There is growing awareness in Europe of the importance of ponds, and increasing understanding of the contribution they make to aquatic biodiversity and catchment functions. Collectively, they support considerably more species, and specifically more scarce species, than other freshwater waterbody types. Ponds create links (or stepping stones) between existing aquatic habitats, but also provide ecosystem services such as nutrient interception, hydrological regulation, etc. In addition, ponds are powerful model systems for studies in ecology, evolutionary biology and conservation biology, and can be used as sentinel systems in the monitoring of global change. Ponds have begun to receive greater protection, particularly in the Mediterranean regions of Europe, as a result of the identification of Mediterranean temporary ponds as a priority in the EU Habitats Directive. Despite this, they remain excluded from the provisions of the Water Framework Directive, even though this is intended to ensure the good status of all waters. There is now a need to strengthen, develop and coordinate existing initiatives, and to build a common framework in order to establish a sound scientific and practical basis for pond conservation in Europe. The articles presented in this issue are intended to explore scientific problems to be solved in order to increase the understanding and the protection of ponds, to highlight those aspects of pond ecology that are relevant to freshwater science, and to bring out research areas which are likely to prove fruitful for further investigation. Guest editors: R. Céréghino, J. Biggs, B. Oertli and S. Declerck The ecology of European ponds: defining the characteristics of a neglected freshwater habitat     

A phytoplankton trophic index to assess the status of lakes for the Water Framework Directive

Despite improvements in wastewater treatment systems, the impact of anthropogenic nutrient sources remains a key issue for the management of European lakes. The Water Framework Directive (WFD) provides a mechanism through which progress can be made on this issue. The Directive requires a classification of the ecological status of phytoplankton, which includes an assessment of taxonomic composition. In this paper, we present a composition metric, the plankton trophic index, that was developed in the WISER EU FP7 project and demonstrate how it has been used to compare national phytoplankton classification systems in Northern and Central Europe. The metric was derived from summer phytoplankton data summarised by genus from 1,795 lakes, covering 20 European countries. We show that it is significantly related to total phosphorus concentrations, but that it is also sensitive to alkalinity, lake size and climatic variables. Through the use of country-specific reference values for the index, we demonstrate that it is significantly related to other national phytoplankton assessment systems and illustrate for a single European (intercalibration) lake type how it was used to intercalibrate WFD boundaries from different countries.     

Assessing the Effects of Climate Change on Waterborne Microorganisms: Implications for EU and U.S. Water Policy

Despite advances in water treatment, outbreaks of waterborne diseases still occur in developed regions including the United States and Europe Union (EU). Water quality impairments attributable to elevated concentrations of fecal indicator bacteria, and associated with health risk, are also very common. Research suggests that the impact of such microorganisms on public health may be intensified by the effects of climate change. At present, the major regulatory frameworks in these regions (i.e., the US Clean Water Act [CWA] and the EU Water Framework Directive [WFD]), do not explicitly address risks posed by climate change. This article reviews existing U.S. and EU water quality regulatory legislation for robustness to climate change and suggests watershed modeling approaches to inform additional pollution control measures given the likely impacts on microbial fate and transport. Comprehensive analysis of future climate and water quality scenarios may only be achievable through the use of watershed-scale models. Unless adaptation measures are generated and incorporated into water policy, the potential threat posed to humans from exposure to waterborne pathogens may be amplified. Such adaptation measures will assist in achieving the aims of the EU WFD and US CWA and minimize impacts of climate change on microbial water quality.     

New directions for migration policy in Europe

There is a growing debate about the future direction of migration policy in Europe. After nearly 30 years of pursuing restrictive immigration and asylum policies, many European Union (EU) governments are beginning to re-assess their migration policies and to call for a new approach. For the first time in many years, several EU governments have begun to talk again about the benefits of labour migration and, even more significantly, have even begun to take action to recruit more migrants, especially skilled workers. This paper looks at the background to current calls for a new approach to migration in Europe and public reaction to these new initiatives. It first describes recent trends in migration in Europe and then briefly considers the demographic case for more migration. This is followed by a brief outline of some of the measures being considered by European governments to promote selective labour migration. The remainder of the paper is devoted to a discussion of some of the implications of this change in policy, focusing on two main issues: the likely consequences for sending countries, and the implications for the fight against the smuggling and trafficking of people.     

Environmental diagnosis: Integrating biodiversity conservation in management of Natura 2000 forest spaces

The conservation of biodiversity in Europe is defined by Directive 92/43/EEC – commonly known as the Habitats Directive – relating to the conservation of natural habitats and of wild flora and fauna. This Directive established the creation of an ecological network of European protected areas – the Natura 2000 network – , and also recognised the need to manage these areas to maintain their “favourable conservation status”.This paper proposes a methodology which enables the conservation of biodiversity to be integrated into the management of Natura 2000 forest spaces. The methodology comprises an “environmental diagnosis” in three phases. The first phase evaluates the current conservation status of habitats using the following criteria: vital functions; floristic richness; forest structure; area occupied by the habitat; and recovery capacity. The second phase assesses the fragility of the space to determine the degree of vulnerability of habitats. This involves evaluating the fire hazard, erosion hazard, and the fragility of the vegetation. The last phase combines the two previous ones to generate management areas (optimum, intermediate or unfavourable) and to prioritise management actions.This methodology was applied in a protected forest area in the Natura 2000 network, located in Avila (Spain). Different management areas were generated for biodiversity conservation, and each habitat was associated to one of them. Finally, actions were prioritised and designed to raise the habitats to a “favourable conservation status”.     

Academic labour shortages. A lack of trained scientists could slow down research in Europe

A shortage of skilled science labour in Europe could hold back research progress. The EU will increase science funding to address the problem, but real long-term measures need to start in schools, not universities.Scientists have always warned about the doom of research that could result from a shortage of students and skilled labour in the biomedical sciences. In the past, this apocalyptic vision of empty laboratories and unclaimed research grants has seemed improbable, but some national research councils and the European Union (EU) itself now seem to think that we may be on the brink of a genuine science labour crisis in Europe. This possibility, and its potential effects on economic growth, has proven sufficiently convincing for the European Commission (EC) to propose a 45% increase to its seven-year research and development budget of 45%—from €55 billion, provided under the Framework Programme (FP7), to €80 billion—for a new strategic programme for research and innovation called Horizon 2020 that will start in 2014.This bold proposal to drastically increase research funding, which comes at a time when many other budgets are being frozen or cut, was rigorously defended in May 2012 by the EU ministers responsible for science and innovation, against critics who argued that such a massive increase could not be justified given the deepening economic crisis across the EU. So far, the EU seems to be holding to the line that it has to invest more into research if Europe is to compete globally through technological innovation underpinned by scientific research.Europe is caught in a pincer movement between its principle competitors—the USA and Japan, which are both increasing their research budgets way ahead of inflation—and the emerging economies of China, India, Brazil and Russia, which are quickly closing from behind. The main argument for the Horizon 2020 funding boost came from a study commissioned by the EU [1], which led the EC to claim that Europe faces an “innovation emergency” because its businesses are falling behind US and Japanese rivals in terms of investment and new patents. As Martin Lange, Policy Officer for Marie Curie Actions—an EU fellowship programme for scientists—pointed out, “China, India and Brazil have started to rapidly catch up with the EU by improving their performance seven per cent, three per cent and one per cent faster than the EU year on year over the last five years.”According to Lange, Europe''s innovation gap equates to a shortage of around 1 million researchers across the EU, including a large number in chemistry and the life sciences. This raises fundamental issues of science recruitment and retention that a budget increase alone cannot address. The situation has also been confused by the economic crisis, which has led to the position where many graduates are unemployed, and yet there is still an acute shortage of specialist skills in areas vital to research.This is a particularly serious issue in the UK, where around 2,000 researcher jobs were lost following the closure of pharmaceutical company Pfizer''s R&D facility in Kent, announced in February 2011. “The travails of Pfizer have affected the UK recruitment market,” explained Charlie Ball, graduate labour market specialist at the UK''s Higher Education Careers Services Unit. The closure has contributed to high unemployment among graduates, particularly chemists, who tend to be employed in pharmaceutical research in the UK. “Even among people with chemistry doctorates, the unemployment rate is higher than the average,” he said.The issue for chemists, at least in the UK, is not a skills shortage, but a skills mismatch. Ball identified analytical chemistry as one area without enough skilled people, despite the availability of chemists with other specialties. He attributes part of the problem to the pharmaceutical industry''s inability to communicate its requirements to universities and graduates, although he concedes that doing so can be challenging. “One issue is that industry is changing so quickly that it is genuinely difficult to say that in three or four years time we will need people with specific skills,” Ball explained.So far, the EU seems to be holding to the line that it has to invest more into research […] to compete globally through technological innovation underpinned by scientific researchAlongside this shortage of analytical skills, the UK Medical Research Council (MRC) has identified a lack of people with practical research knowledge, and in particular of experience working with animals, as a major factor holding back fundamental and pre-clinical biomedical research in the country. It has responded by encouraging applications from non-UK and even non-EU candidates for doctoral studentships that it funds, in cases where there is a scarcity of suitable UK applicants.But, the underlying problem common to the whole of Europe is more fundamental, at least according to Bengt Norden, Professor of Physical Chemistry at the University of Gothenburg in Sweden. The issue is not a shortage of intellectual capital, Norden argues, but a growing lack of investment into training chemists, which in turn undermines life sciences research. Similarly to many other physical chemists, Norden has worked mainly in biology, where he has applied his expertise in molecular recognition and function to DNA recombination and membrane translocation mechanisms. He therefore views a particularly acute recruitment and retention crisis in chemistry as being a drag on both fundamental and applied research across the life sciences. “The recruitment crisis is severe,” Norden said. “While a small rill of genuinely devoted‘young amateur scientists‘ still may sustain the recruitment chain, there is a general drain of interest in science in general and chemistry in particular.” He attributes this in part to sort of a ‘chemophobia'', resulting from the association of chemistry with environmental pollution or foul odours, but he also blames ignorant politicians and other public figures for their negative attitude towards chemistry. “A former Swedish Prime Minister, Goran Persson, claimed that ‘his political goal was to make Sweden completely free from chemicals'',” Norden explained by way of example.Scientists themselves also need to do a better job of countering the negative perceptions of chemistry and science, perhaps by highlighting the contribution that chemistry is already making to clearing up pollution. Chemistry has been crucial to the development of microorganisms that can be used to break down organic pollutants in industrial waste, or clear up accidental spillage during transport. In fact, chemistry has specifically addressed the two major challenges involved: the risk that genetically engineered microorganisms could threaten the wider environment if they escape, and the problem that the microorganisms themselves can be poisoned if the concentration of pollutants is too high.A team at the University of Buenos Aires in Argentina has solved both problems by developing a material comprising an alginate bead surrounded by a silica gel [2]. This container houses a fungus that produces enzymes that break up a variety of organic pollutants. The pores of the hydrogel can limit the intake of toxic compounds from the polluted surroundings, thus controlling the level of toxicity experienced by the fungus, whilst the fungus itself is encapsulated inside the unit and cannot escape. Norden and others believe that if such examples were given more publicity, they would both improve the reputation of chemistry and science in general, and help to enthuse school students at a formative age.…Europe''s innovation gap equates to a shortage of around 1 million researchers across the EU, including a large number in chemistry and the life sciencesUnfortunately, this is not happening in schools, according to Norden, where the curriculum is failing both to enthuse pupils through practical work, and to inform them of the value of chemistry across society: “school chemistry neither stimulates curiosity nor does it promote understanding of what is most important to everybody,” he said. “It should be realized that well-taught chemistry is a necessary tool for dealing with everyday problems, at home or at work, and in the environment, relating to function of medicines, as well as what is poisonous and what is less noxious. As it is, all chemicals are presented simply as poisons.”Norden believes that a broader cultural element also tends to explain the particular shortage of analytical skills in chemistry. He believes that young people are more inclined than ever before to weigh up the probable rewards of a chosen profession in relation to the effort involved. “There seems to be a ‘cost–benefit'' aspect that young people apply when choosing an academic career: science, including maths, is too hard in relation to the jobs that eventually are available in research,” he explained. This ‘cost–benefit'' factor might not deter people from studying subjects up to university level, but can divert them into careers that pay a lot more. Ball believes that there is also an issue of esteem, in that people tend to gravitate towards careers where they feel valued. “Our most able graduates don''t see parity in esteem between research and other professions being represented by the salary they are paid,” he explained. “That is an issue that needs to be resolved, and it is not just about money, but working hard to convince these graduates that there is a worthwhile career in research.”Our most able graduates don''t see parity in esteem between research and other professions being represented by the salary they are paid,Lange suggests that it would be much easier to persuade the best graduates to stay in science if they were able to pursue their ideas free from bureaucracy or other constraints. This was a main reason to start the Marie Curie Actions programme of which Lange is a part, and which will be continued under Horizon 2020 with a new name, Marie Skłodowska-Curie Actions, and an increased budget. “The Marie Curie Actions have been applying a bottom-up principle, allowing researchers to freely choose their topic of research,” Lange explained. “The principle of ‘individual-driven mobility'' that is used in the Individual Fellowships empowers researchers to make their own choices about the scientific topic of their work, as well as their host institutions. […] It is a clear win–win situation for both sides: researchers are more satisfied because they are given the opportunity to take their careers in their own hands, while universities and research organizations value top-class scientists coming from abroad to work at their institutes.”Lange also noted that although Marie Curie Fellows choose their own research subjects, they tend to pursue topics that are relevant to societal needs because they want to find work afterwards. “More than 50% of the FP7 Marie Curie budget has been dedicated to research that can be directly related to the current societal challenges, such as an ageing population, climate change, energy shortage, food and water supply and health,” he said. “This demonstrates that researchers are acting in a responsible way. Even though they have the freedom to choose their own research topics, they still address problems that concern society in general.” In addition, Marie Curie Actions also encourages engagement with the public, feeding back into the wider campaign to draw more people into science careers. “Communicating science to the general public will be of importance as well, if we want to attract more young people to science,” Lange said. “Recently, the Marie Curie Actions started encouraging their Fellows to engage in outreach activities. In addition, we have just launched a call for the Marie Curie Prize, where one of the three Prize categories will be ‘Communicating Science''.”Another important element of the EU''s strategy to stimulate innovative cutting edge research is the European Research Council (ERC). It was the first pan-European funding body for front-line research across the sciences, with a budget of €7.5 billion for the FP7 period of 2007–2013, and has been widely heralded as a success. As a result, the ERC is set to receive an even bigger percentage increase than other departments within Horizon 2020 for the period 2014–2020, with a provisional budget of €13.2 billion.Leading scientists, such as Nobel laureate Jean-Marie Lehn, from Strasbourg University in France, believe that the ERC has made a substantial contribution to innovative research and, as a result, has boosted the reputation of European science. “The ERC has done a fantastic job which is quite independent of pressures from the outside,” he said. “It is good to hear that taking risks is regarded as important.” Lehn also highlighted the importance of making it clear that there are plenty of opportunities in research beyond those funded, and therefore dictated, by the big pharmaceutical companies. “There is chemistry outside big pharma, and life beyond return on investment,” he said. Lehn agreed that there must be a blend between blue sky and goal-oriented research, even if there is an argument over what the blend and goals should be.…the ERC has made a substantial contribution to innovative research and, as a result, has boosted the reputation of European scienceThere is growing optimism that Europe''s main funding bodies, including the national research councils of individual countries, have not only recognized the recruitment problem, but are taking significant steps to address it. Even so, there is still work to be done to improve the image of science and to engage students through more stimulating teaching. Chemistry in particular would benefit from broader measures to attract young people to science. Ultimately, the success of such initiatives will have much broader effects in the life sciences and drug development.     

Overview and application of the AQEM assessment system

The main objective of the European Union (EU) funded project AQEM¹was to develop a framework of an assessment system for streams in Europe based on benthic macroinvertebrates that fulfils the requirements of the EU Water Framework Directive. Initial assessment methods for 28 European stream types and more generally applicable tools for stream biomonitoring in Europe were generated. The development of the system was based on a newly collected data set covering stream types in Austria, the Czech Republic, Germany, Greece, Italy, The Netherlands, Portugal and Sweden. Altogether, 901 benthic invertebrate samples were taken using a standardised multi-habitat sampling procedure and a large number of parameters describing the streams and their catchments was recorded for all sampling sites. From the stream and catchment characteristics measures of stress were derived. A large number of metrics was tested independently for each of the stream types, to identify the response of each metric to degradation of a site. This process resulted in up to 18 core metrics for the individual stream types, which were combined into a different multimetric index in each country. The multimetric AQEM assessment system is used to classify a stream stretch into an Ecological Quality Class ranging from 5 (high quality) to 1 (bad quality) and often provides information on the possible causes of degradation. AQEM provides a taxa list of 9557 European macroinvertebrate taxa with associated autecological information, a software package for performing all the calculations necessary for applying the multimetric AQEM assessment system and a manual describing all aspects of the application of the system from site selection to data interpretation.     

The Target Animal Safety Test—Is it Still Relevant?

In Europe, the target animal safety test (TAST) is stipulated by 52 European Pharmacopoeia monographs, by three European Union (EU) Directives and a number of EU guidelines as a routine test for veterinary immunologicals, to be carried out on the finished product. TAST data from seven European Official Member States Control Laboratories (OMCLs) and 14 manufacturers were retrospectively analysed. During 1994–1997, 11 185 vaccine batches had been submitted for batch release, and the OMCLs had tested 670 batches in the TAST (665 passed, 4 passed after retesting, 1 failed). In total, 82 of these batches were not released; however, in only one case this was due to failure in the TAST. The data received from the 14 manufacturers covered the years from 1997 to 1999. 11 386 batches were tested in the TAST, of which 215 passed after retesting and 7 failed. Although only 30% of the OMCLs provided data and the data of the manufacturers are not complete they clearly indicate that the TAST does not contribute to the safety of veterinary vaccines and should therefore not be required as a routine batch test. In cases, where it appears to be necessary, detailed guidance on the test design and evaluation should be given. Copyright 2002 Published by Elsevier Science Ltd on behalf of The International Association for Biologicals.     

Patentability of life and ethics

Patent law has relied in part on ethical considerations since its inception in Europe. Such considerations have been introduced more recently in the United States. Whereas the EU Directive on the protection on the occasion of the Human Genome Project of biotechnological inventions was intended to foster economic development in Europe, its implementation is outweighted by controversy about patenting life and commercialization of science. The confusion created must be cleared at the international level through harmonization of patent office policies preventing abusive commercial practices in the absence of inventiveness.     

NOx emission trading in a European context: discussion of the economic,legal, and cultural aspects

Emission trading is a new instrument in environmental policy. It is an alien notion in most European countries and it is often viewed with hesitation. The paper discusses the economic, legal, and perhaps more importantly, the cultural aspects to consider when one tries to explore the prospects for trading emissions of NOx and other substances in Europe. Issues to be addressed are the present legal framework in Europe in relation to the national emission ceilings on NOx and other substances on the basis of relevant EU directives and UNECE protocols. The paper will discuss the extent to which the legal framework within the EU imposes constraints on the design of a national emission trading scheme, and what options are available to fit emission trading into that legislative structure. The NOx emission trading programme developed in the Netherlands will be used to demonstrate the various aspects in a European context.