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[22/02/2018 00:00:00] -
Morocco : large ambition concerning clinical trials
Morocco aspires to develop its research and development activities in the pharmaceutical area. There are numerous challenges to face in this promising sector.
During the national symposium organized on February 10th and 11th 2018 in Rabat, on the theme “the biomedical research, challenge of the next decade, ” l’Association Les Entreprises du médicament” of Morocco tried to highlight the huge potentials of development in order to raise Morocco among the first three leaders of the African clinical research.
To reach these objectives, an improvement of the legal basis of the biomedical research with its laws and its application decrees is imperative.
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[20/07/2017 16:03:39] -
RIRCM : LAW JARDÉ : NEW DECREES IN MAY 2017
The Decree of December 2nd, 2016 set the list of the studies called
“Recherches Interventionnelles avec Risques et Contraintes Minimes” for
which an insurance has become compulsory.
Following many polemics between the sponsors and the local authorities,
new decrees were published in May 2017, reducing the number of studies
concerned by this new regulation.
We have updated our documents, in order to send you very quickly proposals based on this new regulation.
For more information, please contact Maryvonne Sevestre (+33 (0)2 97 69 19 16 or maryvonne.sevestre@biomedic-insure.com)
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[16/02/2017 00:00:00] -
RIRCM : BiomedicInsure’s solution to face the new insurance obligation required by Law Jardé
The
Decree of December 2nd, 2016 set the list of the studies called
“Recherches Interventionnelles avec Risques et Contraintes Minimes” for which an
insurance has become compulsory.
Following the publication of this Decree, BiomedicInsure
contacted a lot of sponsors to discuss the types of studies listed in this
Decree, in order to be able to offer a suitable and adapted solution.
Following
a thorough analysis of our medical expert and successful negotiations with the
insurance carriers, BiomedicInsure has implemented the RIRCM solution.
Thanks
to a simple support, you can very easily identify the types of your study, and
BiomedicInsure can very quickly send you a personalized proposition.
For more information, please contact Maryvonne Sevestre (+33 (0)2 97 69 19 16 or maryvonne.sevestre@biomedic-insure.com)
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[30/01/2017 00:00:00] -
Greece
According to the new law the minimum amount has increased from 200.000 € to 300.000 € / participating patient.
The article No 15-concerning the insurance of a clinical trial-will be in effect 3 months after the Decision’s publication into the Official Gazette which is 21/12/2016. On this base, the Decision’s effect starts from March 2017. For studies about which an application has already been made to the ethic committee for approval or for current studies, it seems that the previous law will be in effect.
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[12/01/2017 00:00:00] -
France - Publication of decree N° 2016-1537 of November 16th 2016 (Law Jardé N°2012-300 of March 5th 2012)
Classification of the clinical trials in 3 categories :
1 - interventional studies
2 - interventional
studies (except for drug studies) with minimal risks and constraints (listed by
decree published on December 2d 2016)
3 - non interventional studies
The insurance is from now on compulsory for the first 2
categories, including the studies which were previously considered as standard
care studies.
We can already issue insurance certificates according to
this new regulation.
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[27/09/2016 00:00:00] -
French Class Actions – Health Products & Healthcare Industry
Decree n° 2016-1249 implementing the principal of Class Actions relating to the Health Industry was officially released today 27 September 2016.
This Decree describes the French process for the setting up of class actions relating to healthcare, in application of article 184 of the Law 2016-41 dated 26 January 2016. In particular it provides information on procedures relating to mediation council member’s appointment by the judge and confirms who, among the various legal roles, the association leading the class action can obtain assistance from. The Decree also provides the rules and procedures to introduce such actions before the Civil and Administrative French courts due to the specificity of this type of actions (minding in particular the need for individual assessment of bodily injuries).
From now on, the 500 authorised associations of healthcare users can apply those procedures to introduce litigations. It is now urgent for Health Industry corporations (from product manufacturers to healthcare professional) to assess their insurance coverage and make sure it answers this new risk. https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000033156394 |
[20/06/2016 00:00:00] -
Clinical trials are still waiting for decree concerning the implementation of the new law in Morocco
Adopted on May 2015, the law on clinical trial is not in force yet , due to the lack of implementation decrees. The scientific communauty condemns this delay, which stops the launch of new clinical trials.
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[30/06/2015 00:00:00] -
Netherlands : modification of the law on July 1st 2015
Limits offered for the clinical trial insurance policies are modified on July 1st 2015 to show :
Limit per subject increases from 450.000 euros to 650.000 euros
Limit per protocol increases from 3.500.000 euros to 5.000.000 euros
These new limits concern all the studies which approval is granted from the Ethic Committee after July 1st 2015 and started after this date. This also concerns the studies started before this date but re- submitted to an Ethic committee due to an amendment.
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[07/04/2015 00:00:00] -
20th March 2015 decree
20th March 2015 decree changing the 14th April 2014 decree dictating the terms and conditions of declaration, the form and content of the safety report of a clinical trial about drugs for human use (Legifrance)
Article 2 of the 14th April 2014 decree named above is written as indicated below :
The sponsor forwards the safety report by e-mail to ANSM (l'Agence nationale de sécurité du médicament et des produits de santé).
The sponsor forwards the safety report or its summary by any appropriated way to the concerned Ethic comittee (CPP)
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[10/12/2014 00:00:00] -
Netherlands : modification of the law on January 1st 2015
Limits offered for the clinical trial insurance policies should be modified on January 1st 2015 to show :
650.000 euros instead of 450.000 euros per patient
5.000.000 euros instead of 3.500.000 euros per protocol
However, due to a lack of time, the change may only be effective on July 1st 2015 instead of January 1st.
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