Swedish law requires that in order to perform clinical trials on those unable to give consent themselves through incapacity, consent must instead be obtained from both an authorised representative or custodian as well as the patient’s next of kin.

Pharmaceutical companies claim that this requirement for consent hinders important clinical trials as the time required in obtaining the necessary consents detrimentally affects the performance of the trials. This consent requirement is now being examined by a Swedish County Administrative Court.

Article 13 b § of the Swedish Medicinal Products Act (1992:859) (the “Article”) is based on the Clinical Trials Directive (2001/20/EC) (the “Directive”). The Article states that for individuals whose consent cannot be obtained due to disease, fatigue health condition or other similar conditions, consent must be obtained from both the patient’s next of kin as well as from an authorised representative or custodian pursuant to Chapter 11, Articles 4 or 7 §§ of the Swedish Parental Code (1949:381) who is authorised to provide consent for the patient in question. This consent constitutes the presumed will of the patient.

Orion Pharma AB (“Orion”) applied with the Swedish Medicinal Products Agency (the “Agency”) for clinical trials on patients, of whom a substantial number would not be able to give their consent to the trials due to unconsciousness. The Agency rejected the application and stated that Swedish legislation does not approve trials performed without the patient’s prior consent.

Orion appealed the decision to the Swedish County Administrative Court (the “Court”) (Case No 2147-06, the “Case”) and argued that the procedure for consent in the Article was so timeconsuming that, even in the case of a preliminary decision, the delay in obtaining consent was unreasonably long with regards to the nature of the clinic trial. Orion further argued that the requirements set out in the Article, and consequently the Swedish interpretation of the applicable part of the Directive, exceeded the requirements actually intended by the Directive. The Court was also informed by Orion that the clinical trial in question had been approved in other European countries.

The Agency responded that the Directive stipulated that consent must be obtained from the legal representative and that this legal representative shall be defined by national legislation. Therefore, the persons authorised to give due consent for clinical trials, may differ between countries.

The Government is currently considering a revision of the Parental Code, and some relevant changes with regards the issue of consent were discussed in a Government Official Report (SOU 2004:112). In particular, it considered (i) whether consent from either one of the authorised representative/custodian or next-ofkin should be sufficient; and (ii) whether a medically educated “professional” representative should be authorised to give consent in urgent situations.

The Court is expected to deliver its judgment shortly.