the second half of the 20th century was
a golden era for the development of
medicines new medicines like antibiotics
and treatments for cancer and heart
disease revolutionized health care now
though we have entered an era in which
we have realized how complex many
diseases are and it is getting more
challenging and costly to generate new
medicines to target the mechanisms of
diseases more effectively when
discussing cost and affordability it's
important to first understand how a new
medicine is developed it begins with
understanding of how diseases behave and
identifying key targets in the body
scientists including pharmacologists
then create a selection of compounds
that could work as a new medicine any
potential medicine must go through
preclinical testing to see how a
compound works and whether it is safe in
cells tissues and as required by law in
two species of animal if the trial
compounds proved effective the best
performing compound starts the four
phases of clinical trials in humans the
first phase usually involves healthy
volunteers who are monitored to see how
well they tolerate the compound and
whether there are any adverse side
effects next the potential medicine is
tested in a small number of actual
patients to see if the compound is
effective in treating the disease the
third phase is about proving that the
potential medicine works in a large
number of patients and whether it is
better than any existing drugs for
treating that particular disease after
the first three stages are complete and
if the results are promising a company
will seek a license for the medicine to
be used by patients once it is licensed
another process called pharmacovigilance
identifies rarer adverse side effects
initial discovery work can generate
around 10,000 compounds but only around
250 are successfully taken into
preclinical testing if just for leave of
those reach the first phase of clinical
development on average only one new
medicine will emerge successfully by the
end of the third for
the pharmaceutical industry has always
worked hard to make sure new medicines
are safe efficient and of good quality
but now it also has to consider cost
effectiveness or value for money it is
only once this has been assessed by the
National Institute for Health and Care
excellence in england and wales and the
scottish medicines consortium in
scotland that a pharmaceutical company
is likely to begin to recoup its
investment an american university
recently estimated the cost of
developing a successful medicine at more
than 2.5 billion u.s. dollars or just
under two billion pounds the british
pharmacological society works with its
members across the world to improve the
development of new medicines so patients
can benefit from quicker and affordable
access to treatments today science
tomorrow's medicines