LS&HC Horizons 2022 - Flipbook - Page 13
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
13
Clinical Trials
A comparison of clinical trials litigation risks: U.S. and EU developments
On 31 January 2022 Regulation EU/536/2014 (CT Regulation)
governing clinical trials with medicinal products in the
EU eventually became applicable. The CT Regulation will
fully replace Directive 2001/20/EC (CT Directive) and the
implementing laws in the member states.
The CT Regulation is directly applicable in the member states.
Having said that, it is important to note that national laws are
still required to fully govern clinical trials.
One important part is damages compensation, as the applicable
system shall be regulated by the Member States. The CT
Regulation explicitly requires Member States to ensure that
systems for compensation for any damage suffered by a subject
resulting from participation in a clinical trial conducted in their
territory are in place in the form of insurance, a guarantee,
or a similar arrangement that is equivalent as regards its
purpose and which is appropriate to the nature and the extent
of the risk. Certain exceptions may apply for low-intervention
clinical trials. The applicable system shall follow the form
appropriate for the Member State concerned where the clinical
trial is conducted. Information about the applicable damage
compensation system is to be included in the informed consent.
Lauren Colton
Partner, Baltimore
In the United States, FDA regulations set forth specific
requirements for informed consent, including the requirement
that the consent must explain whether there is compensation
available in the case of injury, which is typically required by
institutional review boards that are responsible for ensuring
the adequacy of the information in the consent document.
Further, the consent document cannot waive or appear to waive
the rights of the study participant or appear to release those
conducting the study from liability for negligence.
While it is best to strive for global consistency in clinical trial
documentation, when possible, it is important to adhere to
any local requirements. Regardless of the local requirements,
companies should ensure the coverage is defined specifically,
including the types of expenses that will be reimbursable and
the requirement that the expenses be directly caused by the
experimental product.
Matthias Schweiger
Partner, Munich
