The cost of creating a new medicine

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