In the UK, pharmaceutical innovation seems to be dying. The supply of new medicines has conspicuously dwindled in recent decades but that is not due to innovation issues, it is because regulations have caused the costs of drug development to soar, along with the time it takes to bring a new drug to market: from 3 years in 1960 to 12 in 2000.
The UK is historically the second largest source of new drug development, generating more than 10% of all new medicines around the globe. The US has historically been the runaway leader though output looks bleak in America as well, for similar reasons.
It's not a money issue, the authors in a BMJ Open article suggest. The government-run health care system has pumped plenty of money into research and development, so they wanted to find out why fewer drugs are showing up. They looked at all the new medicines added every year to the prescribing and dispensing drugs bible, the British National Formulary (BNF) over 30 years. The BNF is updated every six months. All new synthetic chemical entities and new biological drugs, such as vaccines, blood products, and gene therapies were included, based on their first appearance in the BNF between 1982 and 2011.
New products covered modifications of existing drugs as well as breakthrough treatments. Different doses and formulations containing the same active ingredients were only counted once, and generic versions of brand drugs were excluded.
They found no significant linear trend pointing to a decline in the number of new drugs introduced into the UK over that period, which averaged just under 24 a year. Instead, they found a pattern of peaks and troughs, with dips invariably followed by a surge in new arrivals. After a dip in the mid-1980s, with around a dozen new drugs coming on to the market between 1985 and 1987, new arrivals increased every year, peaking at 34 in 1997.
This peak was again followed by a dip, with around 20 new drugs a year between 2003 and 2006, followed by a further peak in 2010. And extending the timeline back to the 1970s indicated an overall slight but significant increase of 0.16 new drugs every year between 1971 and 2011, "contradicting the widely held view that the number of new medicines being launched is declining," say the authors. The UK is just in another 'innovation valley'.
This looks bad but broadened out to a longer period, 1982 to 2011, it is just an innovation valley and a peak may be coming again. Credit: doi:10.1136/bmjopen-2012-002088
"Although there was indeed a dip in new drug introductions during the decade from 1997 to 2006, this was largely an artefact of a peak in 1997, which was itself preceded by an unusually low number of launches in 1985-87," they write. "Additionally, the peak number of new drugs added to the BNF in 1997 was matched in 2010."
The authors point out that their study does not distinguish between varying degrees of innovation, and launches are not the only indicator of pharmaceutical industry health. But theirs is the most up to date UK study of new launch trends, they say.
Citation: Derek J Ward, Orsolina I Martino, Sue Simpson, Andrew J Stevens, 'Derek J Ward, Orsolina I Martino, Sue Simpson, Andrew J Stevens', BMJ Open 2013;3:e002088 doi:10.1136/bmjopen-2012-002088 (FREE TO READ)