Why do victims of adverse drug reactions not get compensation in Europe ?

European Patients Forum – Newsletter written by member organisation France Assos Santé

All of us take medicines, either occasionally or on a regular basis. As such, we might all suffer from an adverse event or from the side effects provoked by pharmaceutical products, even when they have been on the market for years. Some rare adverse events can be extremely severe and seriously harm patients in the long run (for instance Stevens-Johnson syndrome, which can be caused by a variety of very common medicines, such as antibiotics and over-the-counter anti-inflammatory drugs).

Nevertheless, victims of adverse events in Europe are helpless and cannot get compensation from the producers of the medicines responsible for the damage they suffer. This is the paradox created by an EU directive concerning liability for defective products (Directive 85/374/EEC). This text sets up a regime of strict liability of the producers for a broad range of goods, including pharmaceuticals, medical devices and all health products. It was adopted in 1985, following major scandals over pharmaceuticals and blood product safety in the EU, and was originally planned to protect consumers’ rights.

However, it has proved to be much more favourable to the industry’s interests; it constitutes a true deadlock for patients, whose legal actions are blocked by a number of obstacles (very short time limits; concept of “defect” not adapted to medicines; disproportionate burden of proof due to information asymmetry; etc.). The imbalance of risks and responsibilities between patients and pharmaceutical companies is even more pertinent with the trend towards early access to medicines, as the safety profile of these drugs is based on limited data and implies higher potential risks of severe adverse events. Victims of adverse incidents involving implantable medical devices, which undergo less stringent safety controls than pharmaceuticals (CE marking instead of market authorisation), also struggle to get compensation.

In short, the EU directive not only failed to enforce the fundamental right of victims to get compensation, it also decreased their chances to obtain damages in court as it replaced more favourable pre-existing liability regimes in most EU countries.

France Assos Santé wants patients’ rights and safety to come first, overriding any industry interest. That is why we advocate for a substantial revision of the directive and for the creation of a European liability regime that would actually protect patients, making it easier for them to obtain compensation from producers. That is the message we bring to the EU expert group that was created by the European Commission in May last year to interpret and evaluate the liability directive.

If you want to know more about the liability directive and the expert group’s work, or if you are willing to share your experience as victims of adverse reaction or incident relating to pharmaceuticals and other health products, please contact Charlotte Roffiaen and Sophie Le Pallec.

If you have a view as to what action, if any, EPF should take on this matter, please contact policy@eu-patient.eu.

Reference © 2018 European Patients Forum, all right reserved.

89% of clinical trials run by European universities violate EU regulations, study shows

Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

Data released today via the BMJ show that thousands of clinical trials conducted in Europe violate EU rules that require results to be published within 12 months. Failure to publish trial results endangers patients, contributes to exploding drug costs, and slows down the discovery of new treatments and cures, transparimed reports.

Abstract

Objectives
To ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance.

Design
Retrospective cohort study.

Setting
EUCTR.

Participants
7274 of 11 531 trials listed as completed on EUCTR and where results could be established as due.

Main outcome measure
Publication of results on EUCTR.

Results
Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.

Conclusions
Compliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.

Pesticides from agricultural land use : a major threat to small streams and their biodiversity

Large Scale Risks from Agricultural Pesticides in Small Streams (in Germany)

Small streams are important refuges for biodiversity, yet knowledge of the effects of agricultural pesticides on these freshwater bodies is limited.

Researchers have used national monitoring data to determine the number of small streams in Germany where regulatory acceptable concentrations (RACs) of pesticides are exceeded. An analysis of data covering almost 500 pesticides and over 2 000 small streams suggests that agricultural land use is a major contributor of pesticides to streams. Overall, RACs were exceeded at 26% of sampled streams, and exceedances were 3.7 times more likely if a stream was near agricultural land.

“This finding may have implications for environmental monitoring and agrienvironmental measures”,

Science for Environment Policy explains, 5 June 2018.

Study Abstract

Small streams are important refuges for biodiversity. In agricultural areas, they may be at risk from pesticide pollution. However, most related studies have been limited to a few streams on the regional level, hampering extrapolation to larger scales.

We quantified risks as exceedances of regulatory acceptable concentrations (RACs) and used German monitoring data to quantify the drivers thereof and to assess current risks in small streams on a large scale. The data set was comprised of 1 766 104 measurements of 478 pesticides (including metabolites) related to 24 743 samples from 2301 sampling sites. We investigated the influence of agricultural land use, catchment size, as well as precipitation and seasonal dynamics on pesticide risk taking also concentrations below the limit of quantification into account. The exceedances of risk thresholds dropped 3.7-fold at sites with no agriculture. Precipitation increased detection probability by 43%, and concentrations were the highest from April to June.

Overall, this indicates that agricultural land use is a major contributor of pesticides in streams. RACs were exceeded in 26% of streams, with the highest exceedances found for neonicotinoid insecticides. We conclude that pesticides from agricultural land use are a major threat to small streams and their biodiversity. To reflect peak concentrations, current pesticide monitoring needs refinement.

Intensive agriculture using pesticides in fields near nature reserves and our ecosystems health

Flying insects in west German nature reserves suffer decline of more than 76% (1973–2000)

Insect numbers in west German nature reserves have fallen by more than 76% in just 27 years, according to a new study. The fall was even higher in the summer months, with 82% on average fewer insects being recorded. It is not just vulnerable species such as bees, butterflies and moths that are at risk: all flying insects have been affected. The reasons for this dramatic fall are unclear.

The researchers ruled out changes in weather, plant cover and local landscape playing a significant role in the observed decline, but suggest that intensive agriculture and pesticides in fields near to the reserves could be responsible.

Science for Environment Policy explains, 19 July 2018.

Whatever the cause, the catastrophic fall in insect numbers will inevitably lead to knock-on effects on ecosystems in the long term, particularly due to their essential role as pollinators and their position in the food web. The researchers say that preserving and protecting insects should now be a priority for conservation policies.

Study Abstract

Global declines in insects have sparked wide interest among scientists, politicians, and the general public. Loss of insect diversity and abundance is expected to provoke cascading effects on food webs and to jeopardize ecosystem services. Our understanding of the extent and underlying causes of this decline is based on the abundance of single species or taxonomic groups only, rather than changes in insect biomass which is more relevant for ecological functioning. Here, we used a standardized protocol to measure total insect biomass using Malaise traps, deployed over 27 years in 63 nature protection areas in Germany (96 unique location-year combinations) to infer on the status and trend of local entomofauna. Our analysis estimates a seasonal decline of 76%, and mid-summer decline of 82% in flying insect biomass over the 27 years of study. We show that this decline is apparent regardless of habitat type, while changes in weather, land use, and habitat characteristics cannot explain this overall decline. This yet unrecognized loss of insect biomass must be taken into account in evaluating declines in abundance of species depending on insects as a food source, and ecosystem functioning in the European landscape.

Fracking, gas drilling, and risks of (further) earthquakes

Induced Earthquakes from Long-Term Gas Extraction in Groningen, the Netherlands : Statistical Analysis and Prognosis for Acceptable-Risk Regulation

A recent overview and analysis shows that increasing amounts of gas drilling at Groningen, the largest gas field in Europe, led to a dramatic rise in regional earthquakes between 2001 and 2013. After a reduction in extraction was introduced by the Dutch Government, earthquake numbers started to fall. Statistical analysis reveals that if high extraction rates were resumed, about 35 earthquakes, with a magnitude (M) of over 1.5 on the Richter scale, might occur annually from the year 2021 onwards, including four with a damaging magnitude of over 2.5.

“Even if extraction was limited to the 2017 rate set by the government (21.6 billion cubic metres – bcm), the annual number of earthquakes would gradually increase again, with an expected all-time maximum M of 4.5, a serious event capable of shaking walls and chimneys, creating considerable damage and posing safety risks to the public.”

Science for Environment Policy explains, 19 July 2018.

2018 Study Abstract

Recently, growing earthquake activity in the northeastern Netherlands has aroused considerable concern among the 600,000 provincial inhabitants. There, at 3 km deep, the rich Groningen gas field extends over 900 km2 and still contains about 600 of the original 2,800 billion cubic meters (bcm).

Particularly after 2001, earthquakes have increased in number, magnitude (M, on the logarithmic Richter scale), and damage to numerous buildings. The man-made nature of extraction-induced earthquakes challenges static notions of risk, complicates formal risk assessment, and questions familiar conceptions of acceptable risk.

Here, a 26-year set of 294 earthquakes with M ≥ 1.5 is statistically analyzed in relation to increasing cumulative gas extraction since 1963. Extrapolations from a fast-rising trend over 2001-2013 indicate that-under “business as usual”-around 2021 some 35 earthquakes with M ≥ 1.5 might occur annually, including four with M ≥ 2.5 (ten-fold stronger), and one with M ≥ 3.5 every 2.5 years. Given this uneasy prospect, annual gas extraction has been reduced from 54 bcm in 2013 to 24 bcm in 2017. This has significantly reduced earthquake activity, so far.

However, when extraction is stabilized at 24 bcm per year for 2017-2021 (or 21.6 bcm, as judicially established in Nov. 2017), the annual number of earthquakes would gradually increase again, with an expected all-time maximum M ≈ 4.5. Further safety management may best follow distinct stages of seismic risk generation, with moderation of gas extraction and massive (but late and slow) building reinforcement as outstanding strategies.

Officially, “acceptable risk” is mainly approached by quantification of risk (e.g., of fatal building collapse) for testing against national safety standards, but actual (local) risk estimation remains problematic. Additionally important are societal cost-benefit analysis, equity considerations, and precautionary restraint. Socially and psychologically, deliberate attempts are made to improve risk communication, reduce public anxiety, and restore people’s confidence in responsible experts and policymakers.

How can Europe lead the way to a non-toxic environment ?

12 priority actions to end the problematic use of harmful chemicals

“A non-toxic environment should be understood as an environment that is free from chemical pollution and of exposures to hazardous chemicals at levels that are harmful to human health and to the environment. This target would take into consideration the need to provide vulnerable groups with as much protection as possible, to take account of potential delays between exposure and disease expression, to prevent accumulations of very persistent substances to ensure the quality of material flows foreseen as part of the Circular Economy“

The Health and Environment Alliance (HEAL) released its vision for Europe leading the transition towards a non-toxic environment and called on the European Commission to finally draw its long promised strategy for a non-toxic environment. For that, HEAL recommends 12 priorities actions.

HEAL’s vision for Europe leading the way towards a non-toxic environment

  1. put vulnerable population groups (e.g., pregnant women, children, adolescents, the elderly) first,
  2. reduce chemical exposure across sources, taking into account chemicals’ lifecycle and disposal,
  3. tackle endocrine disrupting chemicals (EDCs) beyond pesticides and biocides (e.g., in toys, food contact materials, cosmetics),
  4. take on flame retardants,
  5. tackle per- and polyfluoroalkyl substances (PFASs),
  6. address excessive use of pesticides,
  7. accelerate identification of substances of very high concern (SVHCs),
  8. translate identification of SVHCs across all other relevant legislations,
  9. address exposure to chemical mixtures,
  10. improve knowledge generation and communication,
  11. involve the health community in the strategy for better disease prevention,
  12. and implement consumers’ right to know

Brussels, 7 June 2018 press release.

Near-complete ban on the use of neonicotinoid insecticides across the EU

Government representatives approved on Friday a European Commission proposal to impose a near-total ban on three neonicotinoid pesticides that have been linked to drastic falls in populations of bees

Brussels, 27th April – Today, Member States have backed the proposal from the European Commission to ban all outdoor uses of 3 bee-killing neonicotinoids. By the end of the year, imidacloprid, clothianidin and thiamethoxam insecticides will finally disappear from our environment for the sake of our bees. PAN Europe warmly welcomes the European Commission’s steadiness in resisting to several Member States and the agroindustry that favour unsustainable practices in conventional farming.

A quarter of a century after being approved, neonicotinoids will be banned within a few months. EU Member States were requested to vote today on the proposal from the European Commission to ban all outdoor uses of 3 bee-killing neonicotinoids.

Since their approval at EU-level in the 90’s, neonicotinoids have been largely proven to harm honey bees, other pollinators and the environment as a whole. Several studies also indicate toxicity on human health.

After years of battle from beekeepers and environmentalists, the European Commission restricted the use of 3 highly bee-toxic neonicotinoids in 2013. Imidacloprid, clothianidin and thiamethoxam were then banned on bee-attractive crops.

Since then, evidence showed that even application of neonicotinoids on non-bee-attractive crops led to exposure of bees as these substances are highly persistent in the environment. In the meantime, the European Food Safety Authority (EFSA) published a series of reports highlighting that there is no safe use for bees for these 3 insecticides. Based on EFSA’s conclusions, DG Sante sent to the Member States a proposal to ban all outdoor uses for these 3 substances in March 2017. Another EFSA report from February 2018 has permitted DG Sante to speed up the process and to ask Member States to vote on its proposal today.

Martin Dermine, PAN Europe’s Health and Environment Policy Officer said:

‘Authorising neonicotinoids during a quarter of a century was a mistake and led to an environmental disaster. Today’s vote is historic. A majority of Member States gave a clear signal that our agriculture needs transition. Using bee-killing pesticides cannot be allowed anymore and only sustainable practices should be used to produce our food’.

PAN Europe is a member of the Save the Bees Coalition, a coalition gathering more than 100 EU NGOs that acted at EU and national levels to obtain today’s ban.  Reference.

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Réautorisation du Glyphosate

“La toxicité aiguë du glyphosate est très nettement moins élevée que celle de produits plus courants comme la caféine ou le sel de table” ~Monsanto~

Très attendu, le vote n’a finalement pas eu lieu le mercredi 25 octobre 2017, pour décider des conditions de renouvellement de la licence du glyphosate, herbicide controversé.

La Commission européenne, qui a proposé de renouveler son autorisation pour une durée de cinq à sept ans, a fait savoir qu’elle allait “réfléchir” après avoir pris note des positions des différentes délégations, précisant qu’une nouvelle date de réunion serait fixée “sous peu”. La proposition initiale de la Commission, faite l’été dernier, portait sur une période de réautorisation de dix ans.

Dessin via telerama newsletter.

2018 measures to avoid valproate exposure in pregnancy recommended by the European Medicines Agency

PRAC new restrictions on valproate use; pregnancy prevention programme to be put in place

The European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in the womb. Babies exposed are at risk of malformations and developmental problems.

Main measures recommended by the PRAC

Where licensed for migraine or bipolar disorder

  • In pregnancy – valproate must not be used.
  • In female patients from the time they become able to have children – valproate must not be used unless the conditions of a new pregnancy prevention programme (see below) are met.

For epilepsy

  • In pregnancy – valproate must not be used. However it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.
  • In female patients from the time they become able to have children – valproate must not be used unless the conditions of the new pregnancy prevention programme are met.

Drugs Packaging

  • The PRAC has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy. In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level.
  • A patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.
  • Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.

New valproate pregnancy prevention programme

Assessing patients for the potential of becoming pregnant, and involving the patient in evaluating her individual circumstances and supporting informed decision making, pregnancy tests before starting and during treatment as needed, counselling patients about the risks of valproate treatment, explaining the need for effective contraception throughout treatment, carrying out reviews of treatment by a specialist at least annually, introduction of a new risk acknowledgement form that patients and prescribers will go through at each such review to confirm that appropriate advice has been given and understood.

Read the full press release.

Pesticide risk assessment regulatory use designed and/or promoted by the industry

The chemical industry writes its own rules

Summary

Research done by the Pesticide Action Network reveals that in 92% (11 out of 12) of the EU-methods for pesticide risk assessment examined, it was the industry that designed and/or promoted their regulatory use. Industry is writing its own rules. This is a major conflict of interest. The cases concern criteria and methods (risk assessment methodologies) on HOW the rules of the pesticide Regulation 1107/2009 should be used in decision-taking on individual pesticides. In most cases European Food Safety Authority, EFSA, drafted the guidelines on the use of these criteria and methods. Such methods are used to dismiss tumours observed in animal toxicity testing of pesticides, to approve carcinogenic pesticides in our food, to classify polluting pesticide metabolites in our groundwater as irrelevant, to allow the dying of 50% of the insects in every spraying turn, to construct ‘safe’ levels for harmful pesticides without any experimental evidence, among others.

Industry, spearheaded by industry lobby group ILSI (International Life Sciences Institute), developed their desired methods during the past 15 years in a series of invited-only meetings with industry employees and a few university professors that generally shared their views. Next it tried to get its allies in regulatory expert panels that draft opinions on the methods like the panels of EFSA, IPCS/WHO (World Health Organisation/ International Program on Chemical Safety), JMPR (WHO Joint Meeting on Pesticide Residues) and other agencies.

In 75% (9 out of the 12) of the risk assessment methods studied by the Pesticide Action Network, industry-linked experts managed to get
a seat in EU and global panels where these methods were produced. Generally there were only a handful of experts present in the panels that decided on far-reaching opinions about the methods. Only rarely were experts present in these meetings that are actively conducting experimental scientific work. In any case, not much science is used for drafting opinions on risk assessment methods in panels. “Expert judgement” is the prevailing practice, which is in fact just the opinions and ‘feelings’ of those that are present in the room. The global scientific societies that bundle the hundreds of thousands of scientists that do scientific research in the world are not involved nor asked to do a peer-review of these methods of risk assessment, which is the standard procedure for scientific work. In none, 0% (0 out of 12) of the methods studied by the Pesticide Action Network, the method was peer-reviewed by independent academic scientists.

Since a solid conflict-of-interest policy was lacking in the beginning of this century in most agencies, many expert panels have been dominated by experts that support the views of industry. In the case of TTC (Threshold of Toxicological Concern; a method to design safe levels for pesticides) up to 77% (10 out of the 13) of the experts in the EFSA-working group were linked to industry and were promoting this method in the past.

Food Authority EFSA is known for having close ties to industry. In 50% (6 out of the 12) of the methods studied by the Pesticide Action Network, EFSA and other agencies had exclusive meetings with industry on the design of the methods, sidelining other stakeholders.

Industry obtained most of its inspiration from the US where citizens are not protected by the precautionary principle and the burden of proof on harmfull effects of pesticides is put largely on the public. An entirely different system therefore from the EU system. Yet, in 67% (8 out of the 12) of the methods studied by the Pesticide Action Network, an US-origin could be seen. Without a doubt the US-type of risk assessment is invading the EU-system through the backdoor.

The 12 methods studied here all are designed to lower the level of protection of the public and to enable the approval of pesticide that can cause harm. On top of this, the methods adopted are even misused in practice. In 92% (11 out of 12) of the methods studied by the Pesticide Action Network misuse was observed in actual decision-making of EU pesticide approval.

A full revision of the EU risk assessment methods is needed, according to the Pesticide Action Network. Fully independent scientists that are actively conducting experimental work as a daily practice should be tasked to do this to protect the public with the newest scientific in sights and knowledge.

Continue reading Industry writing Its own rules, a research report written by the Pesticide Action Network Europe, January 2018.