The ABPI was responding to comments by the chairman of the National Institute for Clinical Excellence, Sir Michael Rawlins, at the Royal Institute of International Affairs where he said that excessive bureaucracy and an obsession with safety are stifling the development of new medicines.
The ABPI said that there had been an increase in development times in Europe over the past few years. This had affected medicines research in many areas, and one example is that of the development of new anti-biotics to deal with the threat of resistance to established medicines.
"This area is a very important one, but it is now so complex in regulatory terms that many major companies have had to pull out of this area of research," said Dr Trevor Jones, Director General of the ABPI.
The number of clinical trials required before the launch of a new medicine has increased dramatically over the past five years so that the average development time for a new medicine has risen to about 13 years.
"This is bureaucratic over-caution, and the result is that it is delaying the latest advances in medicines research from reaching patients," said Dr Jones.
Yet the fact remains that the true value of medicines cannot be known at launch. Medicines need to be used in a wide population of patients over a longer period of time before all their risks and benefits can be fully known.
While it is important to assess the safety of a medicine as early as possible, this has to be balanced against the need to provide genuine advances to patients quickly. An example of an area where this has proved a particular problem is that of the development of anti-cancer medicines.
However, the ABPI stressed that, while there were causes for concern, there was no question of a medicines "drought", and that the low number of new chemical entities registered in 2002 was not a reflection of the industry's overall success in developing new medicines.
"A steady flow of new medicines is still being produced by an industry that ploughs nearly £9 million a day into research and development in the UK alone," said Dr Jones. "But it is taking longer and costing more, and that is our concern."
For further information, please contact: ABPI Press Office 020 7747 1410