Archive for March, 2011|Monthly archive page

Draft EU directive on patient’s rights on cross border health care

The draft directive is part of the social agenda package of 2 July 2008. It focusses  on a triple goal:

1. to guarantee that all patients have care that is safe and of good quality,

2. to support patients in the exercise of their rights to cross-border healthcare;

3. and to promote cooperation between health systems.

The aim of the second goal is to codify the case-law of the Court of Justice on reimbursement of cross-border healthcare.

More information can be found on:
http://www.consilium.europa.eu//uedocs/cms_data/docs/pressdata/en/lsa/114992.pdf

In January 2011 the European Parliament voted in favour of this new EU Directive.
John Dalli said: “Today’s vote marks an important step forward for all patients in Europe. I congratulate and thank the Rapporteur, Mrs Grossetete, for all her work.”

See also: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/53&format=HTML&aged=0&language=en

The EC has published a Q&A for cross border health care which can be found here: http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/11/32&format=HTML&aged=0&language=en&guiLanguage=en

 

Amsterdam, 26 March 2011

Antoinette Collignon

 

 

 

 

 

 

 

 

The EU Register of Clinical Trials is launched Online.

On 22 March the EU register of clinical trails has been launched online
The aim is more transparency for patients and avoidance of unnecessary duplication of clinical trials

Clinical trials performed in the EU must be conducted by the EU Clinical Trials Directive (2001/20/EC) and implementing legislation. This legislation lays down principles and detailed guidelines for good clinical practice for investigating medicinal products for human use. It aims at ensuring a high level of protection of patient safety, as well as reliability and robustness of the data generated in a trial. To this end, the legislation and implementing guidance specify various aspects of clinical trials including:

* Information that must be submitted to the competent authorities and to the ethics committees
* Requirements for ‘informed consent’ of the clinical trial participants
* Requirements on safety monitoring and the reporting of adverse reactions
* Requirements on Good Clinical Practice, including the documentation, of the clinical trials
* Specific requirements on the products tested, including manufacturing and labelling
* The inspections of competent authorities and applicable procedures.

The Clinical Trials register has information about clinical trials authorised in the EU, whether they take place in one Member State or in several. It includes clinical trials conducted by both industry and research institutions. The information is rendered public once the clinical trial has been authorised.

The register also includes the clinical trials contained in a Paediatric Investigation Plan – the research and development program that aims to generate the data required to authorise a medicinal product for use in children. The clinical trials contained in such a Plan are published even if they are performed outside the EU.

The clinical trials register:
http://www.ClinicalTrialsRegister.eu

Further information:
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm

Source: press release of RAPEX 22 March: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/339&format=HTML&aged=0&language=en&guiLanguage=en

Accident prevention information of OSHA

As well as the cost in terms of lost lives and suffering to workers and their families, accidents affect business and society as a whole. Fewer accidents means less sick leave, which results in lower costs and less disruption to the production process. It also saves employers the expense of recruiting and training new staff, and can cut the cost of early retirement and insurance pay-outs.

Slips, trips and falls are the largest cause of accidents in all sectors from heavy manufacturing to office work. Other hazards include falling objects, thermal and chemical burns, fires and explosions, dangerous substances and stress. To prevent accidents occurring in the workplace, employers should establish a safety management system that incorporates risk assessment and monitoring procedures.

Use of #mobile while driving= #dangerous

It is now evident that if you are using a mobile phone while driving you are approximately four times more likely to be involved in a crash than a driver who is not using a phone. This risk appears to be similar for both hand-held and hands-free phones, because it is the cognitive distraction that is an issue, not only the physical distraction associated with holding the phone. Text messaging appears to have an even more severe impact on driving behaviour and crash risk.

Pain and suffering awards in the Netherlands

If you have had an accident in the Netherlands and suffered injuries and provided that there is a liable party from which you can claim damages  under Dutch law one of the questions you will ask yourself could be: Am I entitled to an award for pain and suffering?

According to Dutch law (article 6:95 in combination with article 6:106 BW)  there is a limited right to non-pecuniary damages.  The main source for these damages is article 6:106 Dutch Civil Code. According to article 6:97 Dutch Civil Code the judge is entitled to quantify the total amount of damages suffered .

Where an injured person suffers mentally from the consequences of physical injuries sustained, there are no specific requirements about the degree of seriousness of the mental suffering. If a victim has only suffered psychiatric injury, the threshold is that there is a recognizable psychiatric illness. Annoyance of greater or lesser mental discomfort will not suffice.
There is a wide margin of appreciation deciding on the amount of non-pecuniary damages.  The victim doesn’t need to specify to what extent he suffered non-pecuniary damages nor is he obliged to demand a specific amount. It is however wise to state all relevant facts and circumstances.
The Dutch Supreme Court has set out some basic rules. First of all a judge has to look at all circumstances of a particular case .  More specifically a judge should consider the injuries and the consequences of the injuries on the victims life. The injuries and disabilities are particularly relevant, as well as the age at which the accident occurred. As a rule the more severe the injuries and the younger the victim, the higher the damages awarded for pain and suffering.
Furthermore the judge  has to pay attention to case law in similar cases. This process is simplified by the collection of abstracts in a special edition in the review of traffic law ‘ Verkeersrecht ‘, the ‘ Smartengeldbundel ‘  which provides index-linked awards.  Judges can also refer to awards for non-pecuniary damages in other countries, albeit that the award can no be solely determined on that basis. A judge may also look at the nature of the liability.  There is no  absolute limit on the amount of non-pecuniary damages that can be awarded. There are no caps set by law or baremes. Awards are among the lowest in Europe.

An important thing to know is that a victim should explicitly claim an award for pain and suffering. If he or she fails to do so and dies the heirs can’t claim these damages.

If you need further information about Dutch law on negligence and damages you can contact Antoinette Collignon at antoinette.collignon@legaltree.nl

Amsterdam, 6 March 2011

copyright Antoinette Collignon

WHO | Key facts Road Safety

This page contains links to the key facts in the Road Safety Report of 2009.

WHO | 10 facts on global road safety

About 1.3 million people die each year on the world’s roads and between 20 and 50 million sustain non-fatal injuries. Road traffic injuries are the leading cause of death among young people, aged between 15 and 44.

This fact file presents data from the Global status report on road safety. This is the first broad assessment of the road safety situation in 178 countries. The results show that road traffic injuries remain an important public health problem, particularly for low-income and middle-income countries, and that significantly more action is needed to make the world’s roads safer.