Archive for the ‘patients rights’ Tag

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