JLT keeps industry abreast of legal changes affecting clinical trials
By on February 10, 2010 10:23 AM
As many of our clients know, JLT keeps their clients up to date with legal and regulation changes on a regular basis. The latest 6 monthly update focuses on countries such as Argentina, Australia, Austria, Belgium, Denmark, Germany and Spain. Some of this directly affects insurance whereas other areas directly affect the submission process.
As an example, Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on Good Clinical Practice, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission.
As an example, Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on Good Clinical Practice, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission.
Argentina
Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on GCP, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission (contact me for a copy of the exhibit).
Australia
Pursuing the implementation of enforcement guidelines in the Clinical trials area, the Australian government implemented Therapeutic Goods Amendment Regulations 2009 (No.5) enabling issuing of infringement notices.
The Therapeutic Goods Amendment Regulations (the Regulations) were registered on the Federal Register of Legislative Instruments on 10 September 2009, and commenced on 11 September 2009.
The said Regulations allow an issuing officer (the National Manager of the Therapeutic Goods Administration (TGA), or an Assistant Secretary of a Branch or Office of the TGA) to give a person alleged to have committed a strict liability offence or contravened a civil penalty provision of the Act, and in relation to whom legal proceedings will otherwise be brought by the Commonwealth, the option of addressing that matter by paying a penalty specified in an infringement notice, as an alternative to being taken to court.
A person issued with an infringement notice is under no compulsion to pay the penalty stated in the notice, and may elect instead to have the matter dealt with by a court. If a person issued with a notice does pay the penalty in accordance with the Regulations, the person's liability for the offence or contravention will be discharged in full, and no further action may be taken against the person for the offence or contravention.
Austria
The Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH / AGES) published guidance for Clinical Trial Applications (CTAs) for the conduct of a clinical trial according to Austrian Medicinal product Act (contact me for a copy of the exhibit). This publication was the occasion to obtain current and precise information on regulatory and practice concerning clinical trials implemented in Austria, in particular about the sponsor's obligations.
In particular, on the basis of the AGES checklist of the Information required by the Austrian Competent Authority (CA) for the request for authorisation of a clinical trial on a medicinal product for human use, the sponsor must provide provision for indemnity or compensation in the event of injury or death attributable to the clinical trial as well as for any insurance or indemnity to cover the liability of the sponsor or investigator (contact me for a copy of the exhibit).
Belgium
The Belgian Federal Agency for Medicines and Health Products has published a special Guidance to the Conduct of Exploratory Trials in Belgium (contact me for a copy of the exhibit). As precised in this guidance, this is a working document concerning the conduct of clinical exploratory trials in Belgium, while awaiting the development of guidelines at the European level.
Denmark
As it has received many enquiries about amendments to clinical trials, the Danish Medicines Agency has drawn up a form containing a list of significant changes for which it is necessary to apply for an authorisation. The form also indicates which changes are only to be provided to the regional ethics committee (contact me for a copy of the exhibit).
This was the occasion to the Danish Medicines Agency to publish forms regarding the authorisation to make changes/amendments to the clinical investigation, the notification of completion of the clinical investigation of medical devices and the notification for serious adverse events or near-incidents with medical devices during the clinical investigation (contact me for a copy of the exhibit)
Germany
The German Federal Drug Law has implemented a specific procedure for variations (national, MRP and DCP) based on the assessment of paediatric clinical trials with authorised medicinal products in accordance with Article 45 of Regulation (EC) No1901/2006 (Paediatric Worksharing).
Spain
The Spanish Ministry of Health took a "resolucion" dated October 26, 2009 as regards the Clinical Trials electronic register, describing all clinical trials realised in Spain (contact me for a copy of the exhibit).
Regarding European regulation, the last version of the "Guidance Documents Applying to Clinical Trials" in the European Union is available - please contact me for a copy. As far as insurance is concerned, this version states that:
According to Article 3(2) (f) of Directive 2001/20/EC, a clinical trial may be undertaken only, if provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
There are no specific Community provisions on when this insurance coverage can stop. However, the purpose of Article 3(2)(f) of Directive 2001/20/EC is to ensure that a clinical trial subject can obtain compensation for damages caused by the clinical trial- independently of the financial capacity of the investigator/sponsor. In view of this purpose of the provision, and in the absence of specific Community rules, the insurance should provide coverage for the period in which such damages can arise and lawfully be claimed by the clinical trials subject.
As a Community Directive by definition is binding to the result to be achieved while leaving open to EU Member States the choice of form and methods, it is up to the Member State to establish specific rules, if any. If no such rules are established at Member States level, it is up to the sponsor to assess, on the basis of the principle set out above and the clinical trial in question (in particular in view of the risk it implies for the clinical trials subject), the necessary period of coverage. Note, that, in accordance with Article 6(3)(i) of Directive 2001/20/EC, aspects of insurance or indemnity to cover the liability of the investigator and sponsor are considered by the Ethics Committee or, in accordance with Article 6(4) of Directive 2001/20/EC, by the national competent authority of the Member State concerned.
Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on GCP, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission (contact me for a copy of the exhibit).
Australia
Pursuing the implementation of enforcement guidelines in the Clinical trials area, the Australian government implemented Therapeutic Goods Amendment Regulations 2009 (No.5) enabling issuing of infringement notices.
The Therapeutic Goods Amendment Regulations (the Regulations) were registered on the Federal Register of Legislative Instruments on 10 September 2009, and commenced on 11 September 2009.
The said Regulations allow an issuing officer (the National Manager of the Therapeutic Goods Administration (TGA), or an Assistant Secretary of a Branch or Office of the TGA) to give a person alleged to have committed a strict liability offence or contravened a civil penalty provision of the Act, and in relation to whom legal proceedings will otherwise be brought by the Commonwealth, the option of addressing that matter by paying a penalty specified in an infringement notice, as an alternative to being taken to court.
A person issued with an infringement notice is under no compulsion to pay the penalty stated in the notice, and may elect instead to have the matter dealt with by a court. If a person issued with a notice does pay the penalty in accordance with the Regulations, the person's liability for the offence or contravention will be discharged in full, and no further action may be taken against the person for the offence or contravention.
Austria
The Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH / AGES) published guidance for Clinical Trial Applications (CTAs) for the conduct of a clinical trial according to Austrian Medicinal product Act (contact me for a copy of the exhibit). This publication was the occasion to obtain current and precise information on regulatory and practice concerning clinical trials implemented in Austria, in particular about the sponsor's obligations.
In particular, on the basis of the AGES checklist of the Information required by the Austrian Competent Authority (CA) for the request for authorisation of a clinical trial on a medicinal product for human use, the sponsor must provide provision for indemnity or compensation in the event of injury or death attributable to the clinical trial as well as for any insurance or indemnity to cover the liability of the sponsor or investigator (contact me for a copy of the exhibit).
Belgium
The Belgian Federal Agency for Medicines and Health Products has published a special Guidance to the Conduct of Exploratory Trials in Belgium (contact me for a copy of the exhibit). As precised in this guidance, this is a working document concerning the conduct of clinical exploratory trials in Belgium, while awaiting the development of guidelines at the European level.
Denmark
As it has received many enquiries about amendments to clinical trials, the Danish Medicines Agency has drawn up a form containing a list of significant changes for which it is necessary to apply for an authorisation. The form also indicates which changes are only to be provided to the regional ethics committee (contact me for a copy of the exhibit).
This was the occasion to the Danish Medicines Agency to publish forms regarding the authorisation to make changes/amendments to the clinical investigation, the notification of completion of the clinical investigation of medical devices and the notification for serious adverse events or near-incidents with medical devices during the clinical investigation (contact me for a copy of the exhibit)
Germany
The German Federal Drug Law has implemented a specific procedure for variations (national, MRP and DCP) based on the assessment of paediatric clinical trials with authorised medicinal products in accordance with Article 45 of Regulation (EC) No1901/2006 (Paediatric Worksharing).
Spain
The Spanish Ministry of Health took a "resolucion" dated October 26, 2009 as regards the Clinical Trials electronic register, describing all clinical trials realised in Spain (contact me for a copy of the exhibit).
Regarding European regulation, the last version of the "Guidance Documents Applying to Clinical Trials" in the European Union is available - please contact me for a copy. As far as insurance is concerned, this version states that:
According to Article 3(2) (f) of Directive 2001/20/EC, a clinical trial may be undertaken only, if provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
There are no specific Community provisions on when this insurance coverage can stop. However, the purpose of Article 3(2)(f) of Directive 2001/20/EC is to ensure that a clinical trial subject can obtain compensation for damages caused by the clinical trial- independently of the financial capacity of the investigator/sponsor. In view of this purpose of the provision, and in the absence of specific Community rules, the insurance should provide coverage for the period in which such damages can arise and lawfully be claimed by the clinical trials subject.
As a Community Directive by definition is binding to the result to be achieved while leaving open to EU Member States the choice of form and methods, it is up to the Member State to establish specific rules, if any. If no such rules are established at Member States level, it is up to the sponsor to assess, on the basis of the principle set out above and the clinical trial in question (in particular in view of the risk it implies for the clinical trials subject), the necessary period of coverage. Note, that, in accordance with Article 6(3)(i) of Directive 2001/20/EC, aspects of insurance or indemnity to cover the liability of the investigator and sponsor are considered by the Ethics Committee or, in accordance with Article 6(4) of Directive 2001/20/EC, by the national competent authority of the Member State concerned.
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