jurisdiction
1. Drug adverse effects: kinds of responsibility
1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?
2. Claiming compensation for damages caused by adverse drugs reactions
Which are the conditions for claiming compensation (including the burden of proof)?
2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:
2.2 Which are the grounds for exclusion of liability?
2.3 Which are the time limits for submitting a claim for compensation?
2.4 Which damages can be compensated?
2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?
3. Compassionate use programmes
3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?
4. Off-label use
4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?
5. Vaccines
5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?
5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?
6. Insurance issues
6.1 Which liabilities can be insured? Is there any compulsory insurance?
7. Procedural issues (litigation)
7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?
