INSURANCE FOR PHASE ONE STUDIES Dr' Richard Tiner

1
INSURANCE FOR PHASE ONE STUDIESDr. Richard
Tiner Medical Director, ABPI rtiner_at_abpi.org.uk
2
ARTICLE 3

• Protection of clinical trial subjects
• Benefits must justify risks
• Prior interview
• Right to withdraw at any time
• Written consent
• Insurance or indemnity

3
ARTICLE 9

• Trial may not begin without a favourable opinion
  from REC and no grounds for non-acceptance by
  MHRA
• MHRA assessment may involve external expert advice

4
POST TGN 1412

• DH have invited ABPI and BIA to consider the
  insurance issues around clinical trials
• Working Group has recently finished its work and
  has submitted its recommendations to the DH and
  MHRA Inspectorate hopefully for endorsement
• Aim to provide a clear statement to the ethics
  committee about the insurance and/or indemnity
  package for a trial

5
ABPI/BIA/CCRA GUIDELINES

• Legal Framework
• Injury can arise without evidence of fault by
  either Sponsor or Investigator
• Relevant EC Directives and UK Regulations dont
  establish any absolute requirements in relation
  to arrangements for payment of compensation to
  injured research subjects
• RECs have an obligation to consider all such
  arrangements and have discretion to decide
  whether they represent adequate protection for
  volunteers

6
COMPENSATION ARRANGEMENTS IN PRACTICE

• PI has traditionally accepted on ethical grounds,
  an obligation to compensate even where legal
  liability could not be established
• Under current ABPI Guidelines, before the start
  of the Phase I study, the sponsor must have
  agreed with the research subject to provide
  compensation for injury whenever a causal
  relationship with participation is demonstrated
• Essence of the undertaking
• If health of volunteer deteriorates due to taking
  part, Sponsor will compensate irrespective of
  volunteer proving fault
• Amount of compensation based on amount that would
  have been awarded by English court had liability
  been proven
• Where dispute occurs, formulaic arbitration occurs

7
INSURANCE

• Current advice from DH is that the Regulations
  require provision of insurance or indemnity to
  cover the liability of the Investigator and
  Sponsor
• This cannot be met by self-insurance
• ABPI policy for Phase I studies is that the
  subject is entitled to compensation if the injury
  arises through participation in the study
• There should not be an exclusion clause relating
  to Investigator negligence

8
LIMITS OF INDEMNITY

• The Guidelines recommend that a distinction be
  made between first in man studies and
  subsequent studies
• Adverse events cannot be excluded but the risk of
  an event is inevitably greater in a first in
  man study
• Minimum level of cover of 5m in aggregate per
  protocol for first in man studies
• Minimum level of cover of 2.5m in aggregate per
  protocol for other studies
• Some Sponsors do a large number of studies and
  may purchase for a single premium insurance for
  all protocols per year. In this case Sponsor must
  confirm to REC that required level of aggregate
  cover for individual study is still available
• Aggregate level should exclude reasonable legal
  costs and expenses incurred by the insured

9
LIMITS OF INDEMNITY (contd)

• Insurance should be written to include an
  obligation to respond to claims consistent with
  ABPI Guidelines ie where claimant does not need
  to prove negligence or strict liability, but only
  that injury arose due to participation
• Generally today, insurance is written on a
  claims made basis ie the claim must be made in
  the policy period during which the insurance is
  in force. Therefore an extended discovery period
  of three years is recommended
• The sponsors declaration to the REC should
  include a statement to the effect that the
  insurance contains no additional exclusions of a
  type not normally found in insurance of this type
  

10
USUAL EXCLUSIONS

• Intentional misconduct on part of the insured
• Failure to meet the requirement that the study be
  authorised by the competent authority
• Failure to disclose to insurer background facts
  of the study that would be material to the
  insurers willingness to accept the risk
• Failure to make timely notification of a claim to
  the insurer or compromising it without the
  agreement of the insurer

11
INSURANCE OR INDEMNITY OF INVESTIGATOR

• Before the start of the study, the Sponsor must
  indemnify the Investigator or CRO against any
  loss incurred by the Investigator as a result of
  claims arising from the study, except where such
  claims arise from negligence of the Investigator
• Exclusion from the indemnity of claims due to
  negligence only affects the relationship between
  Sponsor and Investigator
• The Phase I unit must have insurance to cover
  claims for negligence in respect of its employees
  or sub-contractors
• Investigator and other HCPs involved in Phase I
  studies must have appropriate insurance or
  indemnity against claims based on negligence

12
CONCLUSION

• The UK was a very safe place to do FIM studies
  pre TGN 1412
• It remains so and indeed is probably even safer
  now
• The regulatory system works well and in a timely
  fashion
• The UK is open to business, why would you want to
  go elsewhere for your FIM studies?