The development of ‘specialty drugs’
in the health care industry has created legal, ethical, and public policy
issues because patients are not able to get access to their prescribed
medications based on the expense. Specialty
drugs are usually biologicals, treat serious conditions, and are very expensive with no cheap
alternatives. Although there is debate
about how much finances should influence medical decision making, it is a
conversation that can not be ignored when patients can not get access to
treatment based on ability to pay. There should be increased access to these
drugs but how to increase access is up for debate.
One posed solution has been the
creation of biosimilar which are the generic version of a specialty drug. A
biological medication is different from a traditional drug in molecular make
up. “A biologic drug is ‘a substance that is made
from a living organism or its products[,]’” while a traditional prescription drug is made
up of simple molecules. This difference means that biologicals are
scientifically more difficult to produce because a more elaborate research is
necessary. This also means making a generic form, known
as a biosimilar, is more expensive and harder to make.
Generally, a biological is “twenty times more expensive per patient than
traditional small-molecule pharmaceuticals.”
There also are patent infringement concerns when making biosimilar.
From ethics perspective, one of the
key aspects of justice is ensuring equal access to healthcare or at least
fairly allocating available resources. For biosimilar drugs, it truly depends
on what insurance company, what insurance plan, and what pharmacy benefit
manager the patient has as to whether the patient will even have a chance to
get these drugs.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.