Draft ethical code for
the pharmaceutical industry
- All tests should comply with the World Health Organisation's Guidelines for Good
Clinical Practice for trials on pharmaceutical products
- The preclinical toxicological tests should only be carried out in the home country of
the main office of the company/concern.
- The preclinical toxicological tests should only be carried out on paid volunteers -
(This is one area, where free markets conditions actually could be a progress compared
with present conditions).
- The preclinical toxicological tests should never be carried out on dependent persons -
e.g. prisoners, inmates of psychiatrical institutions, persons below an age of 21 years
etc.
- Phase III clinical tests should be carried out on a statistical cross section of the
worlds population - only limited by the occurrence of the illness.
- Phase III clinical tests should be analysed on difference(s ) in effect according to
age, gender, race etc. Care should be taken in selection of the study group to have
sufficient members to allow this analysis - only limited by the character and occurrence
of the illness.
- The duration, clinical endpoints and general layout (which effects/side effects will be
looked for and how) of phase III clinical tests should be published - e.g. in a special
journal for this purpose, or an internet database - before the tests starts.
- The results of Phase III clinical tests should be published in accordance with the
prepublished plan within a set limited time after the planned end of the tests (e.g. 3
months).
Dokumentet er sidst redigeret: