The idea that the supply of breakthrough drugs in the UK is drying up is a myth, researchers from Birmingham University reported in BMJ Open.
In fact, the authors point out that if we look over the last four decades, the opposite seems to be the case – the supply of innovative pharmaceuticals in the UK has risen and continues to do so.
For some reason, many in the press, medical profession, and even in the pharmaceutical industry believe that the medical innovation industry has been dwindling, with fewer innovative products coming onto the market today compared to decades ago. People further complain that this should not occur if so much money has been invested in or awarded to R&D (research and development).
The authors wanted to determine whether this was really the case. Was the innovative pharmaceutical industry in decline? They gathered and examined data on all new prescription medications that were added to the British National Formulary (BNF) from 1971 to 2011. The BNF is known as the British prescribing and dispensing drugs bible – a reference book which is updated twice a year.
The average number of new prescription medications coming from the UK each year averaged just under 24 – the highest year saw 34 new drugs, and the lowest nine.
During the 40-year period there were some peaks and troughs, including two marked dips – in 1998 and 2006. However, since 2006 the number of new prescription drugs coming out of the UK have increased again.
The researchers found that there was no significant linear trend pointing downwards in the number of new medications introduced into the United Kingdom over the forty years. After most of the trough periods, there were surges in new arrivals. Over the last seven years there have been 0.16 more medications entering the market each year than there were during the 1970s.
The researchers said that this study differs from others in that it covers several years. Most other studies had focused on small periods.
Senior author, Dr. Derek Ward explained that there was a great deal of pessimism within the industry about how many new drugs were entering the market. “We found that looking at the data over the longer term there was a slight increase. This is obviously a good thing for patients, if more new medicines are becoming available.”
The United Kingdom is the second largest source of new drug development worldwide, after the USA. Over 10% of all new prescription drugs worldwide come from the UK.
The 1997-2006 decade was seen as a decline period, but mainly because it followed a high peak, which itself had come after another dip.
Put simply – over the last forty years there have been several peaks and troughs in the number of new drugs coming from the UK and entering the market, but the long-term trend has been a steady rise.
This study does not take into account “degrees of innovation”, the researchers pointed out. Simply looking at the number of launches does not tell the whole story regarding the health of the pharmaceutical industry. However, they add that theirs is the “most up-to-date UK study of new launch trends”.
In 1960 it took an average of 3 years to bring a new drug to market, forty years later it was taking 12 years. Bringing new molecules from the research stage to development, then through animal and human studies, and finally to present them to the regulatory authorities for approval has become an extremely expensive and lengthy process.
Drug development today is a huge challenge for pharmaceutical companies. To launch any new medication, investments of $1 billion and at least a decade in time are typical, and often promising candidates fail to become marketable and/or manufacturable therapies.
Written by Christian Nordqvist