EMACOLEX
Budapest 12 and 13 May 2011
QUESTIONNAIRE ON CLINICAL TRIALS
Insurance matters
1.
Who is responsible for insuring participants
in clinical trials in your country?
• Sponsor: Malta, Cyprus, Austria, Estonia, Bulgaria,
Portugal, Italy, Slovakia, Netherlands, Czech Republic,
Germany, Latvia, Poland, Ireland, UK (and investigator),
Belgium, Switzerland
• Canada remarks:
There is no express regulatory requirement that clinical trial sponsors hold
insurance for those that participate in clinical trials. However...
-Are MA holders obliged to take insurances for
those that participate in clinical trials?
• Yes: France, Italy, Belgium
• Yes, if the MA holder and the sponsor is the same
legal person: Cyprus, Austria, Bulgaria, Latvia
• Netherlands: Sponsor is by law obliged to insure participants (part of the protocol)
• Malta: Ambiguous - trial cannot be approved without insurance.
-Is insurance coverage provided for by national
law?
• Yes:
-France, Estonia, Bulgaria, Portugal, Italy, Slovakia,
Latvia, Poland, Belgium
-Cyprus: The relevant legislation is the Medicinal Products for Human Use (Good Clinical Practice) Regulations of 2004
that transpose the corresponding provisions of Directive 2001/20/EC as amended .
-Austria: According to the Austrian Medicinal Product ACT an insurance for study participants is mandatory.
However, the insurance sum is not further specified in the law – it is according to the potential risk.
-Switzerland: According to art.7, par.1 and 2 of the Federal Ordinance on Clinical Trials of
Therapeutic Products (OClin), the sponsor is liable for harm caused to a trial subject within the framework
of a clinical trial and he must guarantee this responsibility. Link: (German)
http://www.admin.ch/ch/d/sr/8/812.214.2.de.pdf or (French)
http://www.admin.ch/ch/f/rs/8/812.214.2.fr.pdf),
...Is insurance coverage provided for by national law?
…Yes:
-Netherlands: According to the Dutch Law on Medicinal Scientific research with humans an
insurance for participants is mandatory.
-Czech Republic: Yes, insurance clinical trials is required by national law: Act 378/2007 Coll. on
Pharmaceuticals, section 52 3) f) Quotes of the Act: Section 52 (3) A clinical trial may be undertaken only if: f) a
liability insurance covering the investigator and the sponsor has been concluded prior to the commencement of
the clinical trial, which shall cover also the damages in the event of the death of the trial subject or in the event of
an injury to the health of the trial subject arising due to the conduct of the clinical trial; the sponsor shall be
responsible for concluding such insurance.
-Germany: German Drug Law stipulates that the insurance of trial subjects is mandatory. The coverage sum
is fixed based on a potential risk evaluation; the sum of 500.000 Euro at least needs to be available in case of
death or continuous occupation disability of a trial subject.
-Ireland: Under Irish legislation, the conditions and principles which apply to all clinical trials include ‘Provision has been
made for insurance or indemnity to cover the liability of the investigator and sponsor, which may arise in relation to the
clinical trial’. Under the legislation ‘insurance or indemnity’ is defined as ‘includes a contract of insurance, a contract of
indemnity, a guarantee, a surety, a warrant and a bond and which in any case shall be available to cover the liability of the
sponsor and the investigator to provide for compensation in the event of any injury, loss or damage to, or the death, of any
subject arising out of the arrangement for, or conduct of, the clinical trial and which the sponsor, or investigator, shall become
liable to pay to such subject, or in respect of such subject [i.e. a participant in the clinical trial], by way of damages or costs’.
...Is insurance coverage provided for by national law?
• -UK: Yes, (A) Article 3(2)(f) of 2001/20/EC provides that a clinical trial may only
be undertaken if "provision has been made for insurance or indemnity to cover the
liability of the investigator and sponsor".
-The UK's Medicines for Human Use (Clinical Trials) Regulations 2004 require
insurance or indemnity cover to be in place to meet the potential liabilities of the
sponsor (including any co-sponsors) and all investigators. Those regulations do not
specify the amounts of insurance required or how it should be provided.
-Sponsors and investigators within the National Health Service are covered by a
publicly funded indemnity scheme, the Clinical Negligence Scheme for Trusts
(CNST).
-Investigators undertaking trials in private clinical practice are expected to have
indemnity cover from medical defence societies.
• No: Malta,
2.
Who pays for insurances in clinical trials?
• Sponsor: Malta, Austria, Estonia, Bulgaria, Portugal, Slovakia,
Netherlands, Czech Republic, Germany, Latvia, Poland,
Belgium, Switzerland, (Canada).
- -UK: The sponsor of the clinical trial is responsible for ensuring that insurance or indemnity is in place. Different parties
may have different insurance or indemnity arrangements, depending on the type of trial. Commercial sponsors, and some
non-commercial sponsors such as universities and charities, are expected to take out their own commercial insurance cover.
• A Government fund: none
• Certain funds paid for by MA holders: none
• The concerned MA holder - if the MA holder and the sponsor
is the same legal person: Malta, Cyprus, France, Italy, Latvia
…Who pays for insurances in clinical trials?
• Other:
-Netherlands: The site where the research is done
can sometimes be liable.
-Malta: No locally funded trials as yet – but could be
a University abroad.
-Ireland: While the sponsor has responsibility the
funding could be from the MA holder or others.
3.
How are participants in clinical trials
insured?
• Is the insurance based on no-fault compensation: Malta (usually),
Austria, Estonia, Bulgaria, Portugal, Italy, Slovakia, Netherlands,
Germany, Latvia, Poland, Ireland, Belgium, Switzerland
• -UK: Insurance for commercial sponsors is based on no fault compensation, in line with guidelines issued by the
Association of the British Pharmaceutical Industry (ABPI).
The scope of the Clinical Negligence Scheme for Trusts is limited to compensation for negligence.
Other sponsors, such as universities and charities, generally take out insurance for negligence only but may offer ex gratia
payments.
• Is the insurance based on fault compensation:
-France: The insurance is based on alleged fault compensation.
-Slovakia: Each health care provider should have this type of insurance.
Are all insurance companies willing to
provide for no-fault insurance for clinical trials?
4.
• No: -Portugal, Italy, Slovakia, Czech Republic,
-Switzerland: The extent and contractual element of the insurance policies are subject to private negotiations and have no effect on the
sponsor's liabilities regarding the participants of the clinical trial.
-UK: It's a specialist area so in practice, clinical trials insurance is provided by a limited number of companies who specialise in this
field. These companies all provide policies on a no fault basis.
• Not known: Cyprus, France, Bulgaria, Latvia, Poland,
Estonia: All submitted insurances are based on no-fault compensation,
Germany: No information on refused insurances.
• Other:
-Malta:No Insurance companies in Malta have as yet provided insurance for trials.
-Belgium: The insurance contract may set maximum amounts to compensate, as well limit the duration for
coverage of the risk.
5. Is National Health service staff insured for malpractise with regard to participants in clinical trials?
Yes: Austria, Netherlands, Poland
-Malta: Indemnity of Health Care workers in Public Health Sector and private Insurance for Private Health Care Workers.
-Bulgaria: The National Health service staff is compulsory insured for mal-practice in general by the
Medicinal Center in which they work.
-Portugal:
By the National Health system.
-Czech Republic: Most of them are insured for malpractice, but some of them do not have insurance for
research activities. Medical facilities (hospitals) have insurance for its activities, but insurance does not have to cover
research activities.
-Germany: Yes, professional insurances; if applicable hospital insurance.
-UK: Yes , negligence cover is provided under the Clinical Negligence Scheme for Trusts.
Switzerland: Hospitals (which are generally part of the public sector) need an insurance policy of their own or are
covered by the Cantonal (state) Liability Act of the concerned canton.
...Is National Health service staff insured for malpractise with regard to participants in clinical trials?
• No: Estonia, Italy,
-Latvia: In general no, but it is sometimes done by several hospitals.
-Belgium: No, damage from mal practice where there is no causality with the trial, falls under the common
medical contractual liability.
• Not known: Cyprus, France,
• Other:
• -Slovakia: There is no National Health Service in Slovakia.
• Canada: Doctors, nurses and hospitals and universities involved in clinical trials insure themselves. There is no central
insurance scheme (e.g. run by either the federal or provincial/territorial governments).
6. What is the procedure for claiming compensation
if a participant in a clinical trial suffers from AE/SAE?
•
Malta, Slovakia, Czech Republic, Latvia: Participant contacts investigator who ensures contact with sponsor and the insurance company.
•
Austria, Netherlands: Approach at the insurance company may be supported by the patient lawyer.
•
Estonia, Germany: Claims should be filed to the insurance company. (All disagreements between patient and insurance company will be settled by national courts – Estonia)
•
Bulgaria: The patient can either approach the insurance company, or in case of a dispute issue a claim in front of a national court.
•
Portugal: No specific procedure is established in the national legislation for this purpose.
•
Italy: By a legal representative – no form is available.
•
Poland: Procedures set in insurance policies and insurance law.
•
UK:
•
Switzerland: Deposit of the claim by the investigator. Should the process then result in a litigation, this second
Each sponsor will have its own procedures for handling claims. In the case of commercial sponsors, claims are referred to independent adjudication under the
ABPI Guidelines.
matter.
•
Belgium: Common insurance law: the participant can act directly against the sponsor.
•
•
Not known: Cyprus, France
Canada: Compensation for damages/ harm would be sought through the court system.
step is treated by a civil court competent for the
7. Which national authority is responsible for deciding
whether insurance coverage in clinical trials is sufficient?
• The National Ethics Committee: Cyprus, France, Austria, Estonia, Bulgaria,
Portugal, Netherlands, Czech Republic, Germany, Latvia, Ireland, Belgium,
Switzerland
• The National Medicines Agency: Latvia, Poland
• Other, who:
-Local Ethics Committees: Italy, Slovakia,
-UK: It will be the ethics committee that undertakes the ethical review of the trial concerned which will make this assessment .
This could be any one
of around 60 ethics committees with statutory recognition to review clinical trials in the UK.
• Netherlands: Can also be Central Committee on Research inv. Human subjects.
• Malta: None - not assessed-but trials are funded by local bodies.
• Canada: Research Ethics Boards (REBs) consider whether adequate arrangements are in place to compensate clinical trial subjects in the
event of harm in deciding whether to give their approval of it.
Summary
Outcome of answers
1. Sponsor is responsible for insuring participants (17)Insurance coverage is provided for by national law (17)
2. Sponsor pays for insurances in clinical trials (14)
3. Insurance is normally based on no-fault compensation (15)
4. Not all insurance companies provide these insurances
5. According to answers –national health service staff is insured
6. Procedure for claiming compensation is most often:
participant – investigator – sponsor – insurance company
7. The National Ethics Committee is most often responsible for
determining if insurance coverage is sufficient (13) – in 2
countries it´s the Medicines Agency – or regional ethics
committees.
The situation in Iceland with regard to
insurance matters in clinical trials
1.
2.
3.
4.
5.
6.
7.
Sponsor is responsible for insuring participants. Soft law in insurances – but
no insurance coverage according to law.
Sponsor pays for insurances
Insurance is based on fault-compensation – if insured by an Icelandic
company – not if multi-national
Icelandic insurance companies do not sell no-fault compensation insurances
in clinical trials – foreign insurances too costly for sponsors
National health-care staff is not insured for mal-practise with regard to
participants in clinical trials
Procedure for claiming compensation – same as most countries
Both the National Ethics Committee and the Medicines Agency are
responsible for determining insurance coverage – will be changed
Because of this situation – insufficient insurance coverage for participants –
Iceland is losing clinical trials from the country!