EFGCP Multi-Stakeholder Workshop on ‘Indemnity Schemes for Clinical Trials: A Societal Obligation?’ – December 5, 2013
| Event Name | EFGCP Multi-Stakeholder Workshop on ‘Indemnity Schemes for Clinical Trials: A Societal Obligation?’ |
| Dates | 05/12/2013 |
| Location | Brussels, Belgium |
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| Website Link | http://www.efgcp.be/ |
| Contact Details | EFGCP Secretariat +3227328783 conférences@efgcp.eu |
| Organization | European Forum for Good Clinical Practice |
| Short Description | Indemnity coverage of subjects enrolled in clinical trials is a vital ethical pre-requisite and an important element in Good Clinical Practice (GCP). Ensuring fast and easily accessible coverage of healthcare costs for healthy volunteers and patients enrolled in clinical trials with drugs who experience any kind of damage – independent of a potential causal relationship with the study medication – is a formal sponsor obligation. However, especially in academically sponsored studies the current level of insurance fees to be paid to insurance companies becomes prohibitive to independent academic drug research. The requirement in the Directive that, “provision has been made for the insurance or indemnity to cover the liability of the investigator and sponsor,” has been interpreted differently in different member states, meaning that separate insurance is needed and different models of covering exist from country to country. Insuring international trials is not only very costly, it is also bureaucratic and complex. In addition, this patchwork of regulation results in the ethically dubious position that patients taking part in the same trial in different countries, have different levels of insurance protection. In their Draft Regulation on Clinical Trials the European Commission is proposing that the national health care systems cover the liability for patients in – at least – the publicly sponsored clinical trials. This suggestion is opposed by different Member States and stakeholder groups for a variety of reasons. As the period for consensus finding is coming to an end it appears important to bring representatives from different stakeholder groups together to evaluate the pro’s and con’s of existing national practices and conditions in Europe, to achieve a better understanding of the needs and expectations of the different stakeholders and to work out pragmatic recommendations that could satisfy stakeholder needs while preserving European attractiveness for biomedical research. |
