Protecting trade secrets: European Parliament MEPs strike a deal with Council

New EU trade secrets law could jail whistleblowers, block drug trial data access

New rules to help businesses obtain legal redress against the theft or misuse of their trade secrets were informally agreed by Parliament and Council negotiators on Tuesday. MEPs ensured that freedom of expression and information will be protected and that the new rules will not restrict the work of journalists.

“The agreement reached today with the Council faithfully reflects the balanced position that we, MEPs on the legal affairs committee, adopted by a very large majority. Our priorities have been met in full by the Council: protection of the fundamental freedoms of opinion, of expression and of the press, which concerns both journalists and whistleblowers, and preservation of workers’ mobility.”

said the European Parliament rapporteur, Constance Le Grip.

The rules will introduce an EU-wide definition of trade secrets and oblige member states to ensure that victims of the misuse of trade secrets will be able to defend their rights in court and seek compensation. The agreed text also lays down rules on the protection of confidential information during litigation.

Safeguarding freedom of expression and information

New EU trade secrets law could jail whistleblowers, block drug trial data access, arstechnica, Apr 14, 2016.

Throughout the negotiations, MEPs stressed the need to ensure that the legislation does not curb the freedom and pluralism of the media or restrict the work of journalists, in particular with regard to their investigations and the protection of their sources.

Under the agreed rules, victims of the theft or misuse of trade secrets will not have the right to redress if a trade secret was acquired, used or disclosed for the following purposes:

  • to exercise the right to freedom of expression and information as set out in the EU Charter of Fundamental Rights, including respect for freedom and pluralism of the media;
  • to reveal misconduct, wrongdoing or illegal activity, provided that the respondent acted in order to protect the general public interest (such as public safety, consumer protection, public health or environmental protection);
  • to protect a legitimate interest, recognized by European Union or national law;
  • the trade secret was disclosed by workers to their representatives as part of the legitimate exercise of their representative functions in accordance with EU or national law, provided that such disclosure was necessary for that exercise.

No unjustified barriers to workers’ mobility

Trade Secrets Directive creates excessive secrecy and must be rejected, euractiv, Apr 11, 2016.

MEPs also ensured that the rules will not create unjustified barriers to workers’ mobility by clarifying that the rules will not limit employees’ use of the experience and skills honestly acquired in the normal course of their employment. These rules should not impose any additional restrictions on employees in their employment contracts other than in accordance with EU or national law, the agreed text says.

Next steps

EU ‘trade secret law’ may criminalize whistleblowers & journalists, petition warns, rt, 16 Apr, 2016.

The informal deal, agreed by the Parliament and Council negotiators on Tuesday, now needs to be endorsed by the legal affairs committee and the full House as well as by the Council of the European Union.

Background

European Parliament’s vote turns health into a trade secret, eubusines, 14 Apr, 2016.

According to the agreed rules, “trade secret” means information which is secret, has commercial value because it is secret, and has been subject to reasonable steps to keep it secret. The new rules set minimum requirements for legal redress so that any member state may provide for more far-reaching protection against the unlawful acquisition, use or disclosure of trade secrets if it wishes to do so as long as it respects the safeguards set in the directive.

Utilisation du Glyphosate interdite dans la Région de Bruxelles-Capitale

Le gouvernement bruxellois a validé l’interdiction de l’utilisation de pesticides contenant du glyphosate à Bruxelles, indique le cabinet de la ministre bruxelloise de l’Environnement Céline Fremault

Sur proposition de la Ministre de l’Environnement Céline Fremault, le Gouvernement bruxellois a validé ce 14 avril 2016 lors du Gouvernement Nature l’interdiction de l’utilisation de pesticides contenant du glyphosate à Bruxelles.

Le glyphosate est la substance active du pesticide bien connu RoundUp de Monsanto. Un produit classifié comme cancérigène probable par l’Agence internationale de recherche sur le cancer de l’OMS que les professionnels et les particuliers utilisent sans toujours utiliser les protections ad hoc et parfois en surdose. Il représente pourtant un réel risque pour la santé humaine et pour l’environnement.

PESTICIDES : L’UTILISATION DU GLYPHOSATE INTERDIT À BRUXELLES, Céline Fremault, Ministre bruxelloise, 15 AVRIL 2016.
Roundup image Mike Mozart.

Si les pesticides ont contribué à améliorer la maîtrise des ressources alimentaires et de la santé publique (en particulier dans la lutte contre les insectes ou contre les vecteurs de maladies par exemple), le revers de la médaille est rapidement apparu : des phénomènes de résistance chez les insectes, puis des troubles de la reproduction chez les oiseaux, ont montré de façon spectaculaire les limites et les dangers de ces substances pour l’environnement et pour les écosystèmes. Les dangers de ces substances ont également été identifiés sur les êtres humains. Ils seraient à l’origine de maladies tels que cancers, maladies neurologiques, diminution de la fertilité…

L’Agence internationale de recherche sur le cancer de l’Organisation mondiale de la santé (Iarc) a classé le 20 mars 2015, cinq pesticides comme cancérogènes « probables » ou « possibles » pour l’homme. Il s’agit du malathion, du diazinon, du tetrachlorvinphos, du  parathion et du glyphosate. Pour les quatre premiers, la Belgique avaient déjà pris les mesures pour interdire leur commercialisation et leur utilisation. Aujourd’hui c’est au tour du glyphosate d’être interdit d’utilisation à Bruxelles.

L’avant-projet d’arrêté prévoit que le ministre compétent pour l’environnement puisse accorder une dérogation à l’interdiction notamment pour des raisons de santé publique, de conservation de la nature ou de conservation du patrimoine végétal, et ce, uniquement en dernier recours, lorsqu’il n’existe aucune alternative possible.

L’importance, pour les particuliers comme pour les professionnels, de réduire significativement l’utilisation des pesticides et de favoriser l’usage d’alternatives plus respectueuse d’un développement durable.”

souligne Céline Fremault, Ministre du Gouvernement de la Région de Bruxelles-Capitale chargée du Logement, de la Qualité de Vie, de l’Environnement et de l’Energie.

Le Gouvernement Nature de ce 14 avril a permis aussi de valider plusieurs arrêtés relatifs aux pesticides :

  • L’avant-projet d’arrêté relatif à l’organisation de l’examen de base, de formation initiale et de la formation continue dans le cadre de la phytolicence (certificat pour l’utilisation professionnelle, la distribution ou le conseil de produit). Depuis le 25 novembre 2015, tous les utilisateurs professionnels et distributeurs de pesticides doivent être titulaires d’une phytolicence pour pouvoir utiliser des pesticides. Les formations, ainsi que l’examen de base, doivent être mis en œuvre par les Régions. Le certificat est délivré par le Service Public Fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement.
  • L’avant-projet d’arrêté du Gouvernement de la Région de Bruxelles-Capitale relatif au plan d’application de pesticides dans les espaces publics. Ce plan énumère les mesures nécessaires pour mettre en pratique une réduction progressive de l’utilisation des pesticides dans les espaces publics jusqu’au 31 décembre 2018 au plus tard. Il décrit également les mesures envisagées pour aboutir au respect de l’interdiction de l’utilisation des pesticides dans les espaces publics au plus tard le 1er janvier 2019.
  • L’avant-projet d’arrêté du Gouvernement de la Région de Bruxelles-Capitale relatif à l’affichage et au balisage dans le cadre de l’utilisation de pesticides. Préalablement aux opérations d’application des pesticides, les zones à traiter fréquentées par le grand public sont délimitées par un balisage et font l’objet d’un affichage signalant au public l’interdiction d’accès à ces zones.

Alarming “new” side effect from eating fast food

Fast-food consumption linked to the presence of potentially harmful chemicals

Abstract

Background
Phthalates and Bisphenol-A (BPA) are widely used industrial chemicals that may adversely impact human health. Human exposure is ubiquitous and can occur through diet, including consumption of processed or packaged food.

Objective
To examine associations between recent fast food intake and BPA and urinary metabolites of di(2-ethylhexyl) phthalate (ΣDEHPm) and diisononyl phthalate (DiNPm) among the US population.

Methods
We combined data on 8877 participants from the National Health and Nutrition Examination Survey (NHANES 2003-2010). Using 24-hour dietary recall data, we quantified:

  1. fast food intake (percent of total energy intake (TEI) from fast food);
  2. fast food-derived fat intake (percent of TEI from fat in fast food);
  3. and fast food intake by food group (dairy, eggs, grains, meat, and other). We examined associations between dietary exposures and urinary chemical concentrations using multivariate linear regression.

Recent Fast Food Consumption and Bisphenol A and Phthalates Exposures among the U.S. Population in NHANES, 2003–2010, ehp, 13 April 2016.

Results
We observed evidence of a positive, dose-response relationship between fast food intake and exposure to phthalates (p-trend<0.0001) but not BPA; participants with high consumption (≥34.9% TEI from fast food) had 23.8% (95% CI: 11.9%, 36.9%) and 39.0% (95% CI: 21.9%, 58.5%) higher levels of ΣDEHPm and DiNPm, respectively, than non-consumers. Fast food-derived fat intake was also positively associated with ΣDEHPm and DiNPm (p-trend <0.0001). After adjusting for other food groups, ΣDEHPm was associated with grain and other intake, and DiNPm was associated with meat and grain intake.

Researchers have found a ‘striking’ new side effect from eating fast food, washingtonpost, April 15 2016.

Conclusion
Fast food may be a source of exposure to DEHP and DiNP. These results, if confirmed, could inform individual and regulatory exposure reduction strategies.

European Parliament votes to ban most uses of glyphosate

Monsanto’s ‘probably carcinogenic’ Roundup is still on open retail sale

The EU Parliament has responded to the health concerns of millions by calling on the Commission to severely restrict permitted uses of the toxic herbicide glyphosate, including an effective ban on pre-harvest dessication of crops.

The European Parliament today adopted a resolution strongly opposing the Commission’s proposal to reapprove the controversial weedkiller glyphosate for use in Europe for 15 years.

The resolution flags significant concerns with the Commission’s proposal, notably calling for significantly restricting the uses for which glyphosate – best known in Monsanto’s ‘Roundup’ formulation – could be approved.

The Parliament’s vote precedes a decision by EU government representatives on whether or not to support the Commission proposal to approve glyphosate for use in the EU. This may take place at the next EU pesticides committee meeting on 18-19 May.

While the 374 to 225 vote is non-binding on the Commission and EU governments, it will nonetheless carry strong moral weight since it comes from the EU’s only elected body directly representing EU citizens and will force a discussion of the issues raised.

The resolution calls for no approval of glyphosate – recently determined to be “probably carcinogenic” by the WHO’s cancer watchdog, the IARC – for many uses now considered acceptable, including:

  • non-professional uses;
  • in or close to public parks, playgrounds and gardens;
  • where integrated pest management systems are sufficient for necessary weed control.

It also calls for the renewal to be limited to just seven years instead of the 15 proposed by the Commission.

Pre-havest ‘dessication’ strictly limited

The resolution additionally demands strict limits on ‘pre-harvest’ applications on crops, with a strong recital calling such uses “unacceptable”. This refers to the practice of spraying crops up to two weeks before harvest to ‘dessicate’ the plants and make havesting easier.

Pre-harvest application of glyphosate is a clear route for human exposure to glyphosate via the harvested crop. Currently glyphosate formulations are licenced for a wide range of crops including wheat, barley, oats, oilseed rape (canola), linseed, field beans and peas.

This use of glyphosate is believed to be the main source of the herbicide and its residues in bread and NGOs including the UK’s Soil Association are campaiging to stop this use.

European Parliament votes to ban most uses of glyphosate, the ecologist, 13th April 2016.
Roundup image Mike Mozart.

The resolution further calls for:

  • An independent review of overall toxicity of glyphosate;
  • A call on the Commission and EFSA to immediately disclose all scientific evidence for the positive classification of glyphosate, given the overriding public interest in disclosure;
  • A call on the Commission to test and monitor glyphosate residues in foods and drinks produced in the Union as well as in imported produce;
  • Strong criticism of the Commission for accepting an incomplete dossier with regard to endocrine disruption;
  • strong criticism of the problem of resistances of weed created by glyphosate, and the toxic spiral by agro-biotech companies adding further resistances to plants.

OpenTrials : all available information on all clinical trials

The project aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials

Abstract

OpenTrials: towards a collaborative open database of all available information on all clinical trials, BiomedCentral, 8 April 2016.

OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.

Background

Trials are used to inform decision making, but there are several ongoing problems with information management on clinical trials, including publication bias, selective outcome reporting, lack of information on methodological flaws, and duplication of effort for search and extraction of data, which have a negative impact on patient care. Randomised trials are used to detect differences between treatments because they are less vulnerable to confounding, and because biases can be minimised within the trial itself. The broader structural problems external to each individual trial result in additional biases, which can exaggerate or attenuate the apparent benefits of treatments.

Conclusions

OpenTrials paper published, OpenTrials Blog, 2016/04/12.

We are building an open free database and web service to identify, aggregate, store, match, index and share all available documents and data on all clinical trials. We are keen to receive feedback on the current methods, design, and data schema; feature requests; offers or suggestions of further data sources; and collaborations or methods to expand or improve the specification. Progress can be viewed at OpenTrials.​net where the service will be hosted.

Why Nurses are Essential to Delivering Cost-Effective Care

In the U.S., 1.2 million vacancies for registered nurses will emerge between 2014 and 2022

This infographic by The University of San Francisco explores the various reasons why the need for hiring more nurses is crucial for such things as lowering patient mortality, increasing cost-effective care, and reducing number of days patients spend in hospitals. As you can see, hospitals with lower patient-to-nurse ratios had total of 6,239 fewer infections, with an annual cost saving of up to $68 million.

Air pollution associated with higher risk of preterm birth

Many environmental factors have been independently linked to preterm birth

Previous research has linked poor air quality, particularly particulate matter, ozone and nitrogen dioxide, with an increased risk of preterm birth, but few studies have explored the cumulative effects of exposure across a range of environmental domains or across a range of population densities (e.g. urban to rural communities).

This study explored the relationship between environmental quality across five domains (air, water, land, built and sociodemographic) and the risk of preterm birth. It also explored the effect of a single environmental quality (EQI) domain, which combined these five categories, on the risk of preterm birth over the period 2000 to 2005. The study also considered the impact of urbanisation, categorising 3131 counties in the USA as metropolitan urban, nonmetropolitan urban, less urban and rural/isolated communities.

The associations between environmental quality and preterm birth in the United States, 2000–2005: a cross-sectional analysis, BiomedCentral, 9 June 2015.
Salt Lake City by Augie Ray.

Ethnicity, marital status, educational attainment and age are also factors known to influence the risk of preterm birth. For the county-level analysis, the authors took into consideration racial mix, while individual risk analyses were adjusted for age, educational attainment and marital status. Preterm birth was defined as a birth occurring between 20 and 36 weeks of completed gestation (inclusive).

The researchers found poor air quality (measured using data on 93 air pollutants, obtained from the US Environmental Protect Agency) was associated with an increase in preterm birth across the four urban—rural classifications at the county level, but found no evidence of a link between preterm birth and the water, built and land domains. The impact of sociodemographic factors on preterm birth varied across the urban—rural classifications, with a link between sociodemographic deprivation and preterm birth evident in urban metropolitan areas only. In contrast, increasing sociodemographic disadvantage was associated with a lower risk of preterm birth in non-metropolitan urban, less urban and rural/isolated areas.

Similar patterns were seen when the data were analysed to produce individual level odds ratios (which use individual level data rather than data aggregated to the county-level), which included more than 22 million women. The researchers found the risk of preterm birth increased as air quality worsened across all four urban–rural classifications. Sociodemographic disadvantage again was only associated with an increased risk of preterm birth in metropolitan urban areas.

Poor air quality associated with increased risk of preterm birth, Science for Environment Policy News Alert, 25 February 2016.

The combined measure, the EQI, was designed to measure overall environmental quality. For both the county level and individual odds ratios, the EQI indicates that worsening environmental quality is associated with a decreased risk of preterm birth, even accounting for the fact that air quality was associated with an increased risk of preterm birth. This highlights the importance of considering different environmental domains and potential causal mechanisms when identifying health risks.

The authors note that, because data is less readily available for sub-urban and rural areas, they are more reliant on estimation than urban areas. In addition, the authors say that county-level data may be more representative of exposure in rural areas than in urban areas. This is because county-level data fails to account for individual differences in exposure in urban areas.

Médecins, Laboratoires, et les Conflits d’Intérêts

Les conflits d’intérêts sur la sellette

Comment lutter au mieux contre les conflits d’intérêts dans le domaine de la santé ?

Sur le même sujet

On ne peut pas laisser tomber les gueules cassées du médicament

Irène Frachon, qui avait révélé le scandale du Médiator est coauteure de “Effets secondaires, le scandale français”

” Il ne s’agit pas de taper sur la pharmacovigilance, bien au contraire, il faut la développer, la promouvoir, en faire une filière universitaire attractive, qui forme des experts indépendants, la doter des moyens de faire des études pharmaco-épidémiologiques, éduquer le grand public.

Parallèlement à cela, il faut surtout prendre en charge les victimes du médicament : on ne peut pas les laisser patauger dans le fossé et se débattre comme on voit se débattre les victimes du Médiator®, de la Dépakine ou du Distilbène®, pots de terre contre pots de fer, dans des procédures épouvantables.

Il faut qu’on assume de parler des risques et il faut qu’on assume les risques lorsqu’ils se réalisent. Aujourd’hui, leur parcours est un vrai scandale : les grands labos confient ces affaires à quelques cabinets d’avocats bien rodés qui sont impitoyables. On ne peut pas tolérer que notre système de santé leur livre ainsi les gueules cassées du médicament pour qu’elles se fassent écraser et enterrer vivantes. C’est inacceptable !  “.

Lisez l’interview complet du Docteur Irène Frachon – On ne peut plus mettre sous le tapis les risques liés aux médicaments!, 07 avril 2016.

Le Distilbène DES, en savoir plus

EDCs are contributing to declining male fertility in the developed world

Human exposure to endocrine disrupting chemicals and fertility: a case–control study in male subfertility patients

Subfertility, the inability to conceive for a prolonged period, is a common problem, and becoming more so. It has generally been assumed that declining fertility rates are the result of changes to socio-economic and lifestyle factors, such as postponing having children in order to establish a career. However, accumulating evidence suggests increasing exposure to EDCs could also be contributing to downward trends in reproductive health.

Are endocrine disrupting chemicals responsible for downward trends in male fertility?, Science for Environment Policy News Alert, 7 January 2016.

Contaminants known to have hormone-disrupting properties include phthalates, bisphenol A (BPA), triclosan, and a range of brominated and perfluorinated compounds. These emerging chemicals are present in a growing number of products, from personal care products and clothes to cooking materials and electrical equipment. Yet, even contaminants that are now banned or restricted can continue to affect human health, such as dioxins, PCBs and chlorinated pesticides.

This study aimed to investigate whether exposure to EDCs is associated with subfertility in men (defined as involuntary infertility, meaning that a couple has tried to conceive unsuccessfully for a year or longer). The researchers measured biomarkers of EDC exposure and key fertility parameters in 163 men recruited through four fertility clinics in Belgium. Semen samples were analysed following the guidelines of the World Health Organization, using a total motility count (TMC) of 20 million as a threshold value for normality.

Human exposure to endocrine disrupting chemicals and fertility: A case–control study in male subfertility patients, ScienceDirect, Environment International, Volume 84, November 2015, Pages 154–160.
Couple by kusmierz.

The researchers recruited ‘cases’ – male partners of couples who were experiencing involuntary infertility– and ‘controls’ – male partners of couples with a documented or suspected female cause of infertility, or sperm donors.

Patients were assigned to the case group when two semen samples (collected at least one week apart) had a TMC less than 20 million. If both samples had a TMC of 20 million or above, the patient was assigned to the control group. Of the 163 patients, 80 met the criteria to be controls and 40 to be cases. Blood and urine samples were also taken to analyse levels of EDCs and sex hormones.

The study revealed associations between exposure and subfertility for a number of compounds, including:

  • Chlorinated pesticides (chlordane and HCB): A 50% increase (from the mean level in the control group) in serum concentration of oxychlordane (the primary metabolite of chlordane) was associated with a 1.98 increased risk of subfertility, a 33% decrease in sperm concentration and a 5% drop in sperm motility. For HCB, an approximate increase of 1.5 in serum concentration was associated with a 28% decrease in sperm concentration.
  • Brominated flame retardants (BDE209): Detectable levels of BDE209 in serum were associated with a 7.2 increased risk of subfertility and a 33% reduction in sperm motility.
  • Phthalates and triclosan: Levels of these compounds in urine were associated with the levels of two sex hormones (inhibin B and LH), which may reflect reduced testis function.
  • BPA: Urinary BPA correlated negatively with testosterone levels.

While serum levels of chlorinated pesticides and BDE209 reflect accumulated exposure in the body, and therefore are likely a sign of past exposure, urinary levels of phthalates, triclosan and BPA reflect more recent exposure, and may provide evidence for changes to fertility during adulthood.

This study shows that concentrations of EDCs in the male body are associated with an increased risk of subfertility, as well as changes to hormone levels, supporting the hypothesis that EDCs are contributing to declining male fertility in the developed world. The authors say their results highlight the importance of reducing the levels of these chemicals in the environment.