Abstract :
Drugs are especially dangerous products and because of this a very demanding evaluation process is imposed on them before they reach the
market. Due to previous episodes in which severe injuries
were caused by drugs, such as in the Thalidomide case,
nowadays in most legal systems drugs can only enter into
the market after a rigorous approval process. At the end of
this, a drug may obtain a marketing authorisation (MA)
and can then be commercialised and used by patients,
although there are some exceptions.
However, the demanding nature of the drug approval
procedure raises some issues. Drugs are essential for
promoting and maintaining health, improving quality of
life and even avoiding death. Accordingly, if the approval
process is too long or too demanding, the chances are
that the drug will arrive on the market too late for some
patients or will not arrive at all, either because the MA
has been denied or because the pharmaceutical company
abandons it, overwhelmed by its many legal requirements
and liabilities and by the huge investment involved. The drug approval procedure involves a very difficult
balance. The approval process must be demanding enough
so that only the safest drugs are selected, but it cannot
be so demanding that patients do not have access to new
medicines that are essential to their life and well-being.
Unlike other products, in the case of drugs safety
cannot be defined as the total absence of risk, because in
this particular context that goal is impossible to achieve.
Instead, a drug is considered safe when its risks are
tolerable, based on an analysis of its expected benefits and
the existing therapeutic alternatives.1 In other words, a
drug is never totally safe, but merely safe enough.
