Regulations are stifling development of new drugs
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《英国医生杂志》
London
The volumes of regulations that surround scientific research are stifling the development of new drugs and need to be rationalised if innovative discoveries in biology are to be matched with new medicines and demand by patients for better treatments, said experts this week.
It costs an estimated $800m (￡433m; 645m) to get a new drug to the market, and pharmaceutical companies have to hit first year sales figures of about $500m to cover their expenses, said Professor Michael Rawlins, chairman of the National Institute for Clinical Excellence.
But with outlay costs increasing at a rate of about 10% a year, the cost of developing a new drug by 2015 will be in the region of $2bn, and sales will have to reach $1bn in the first year after launch, a situation that Professor Rawlins described as "unsustainable."
He was speaking at the launch of a new book, The Search for New Medicines, by the journalist and broadcaster Dr Geoff Watts, which highlights the findings of a conference held last September to discuss the future of the pharmaceutical industry and the dwindling supply of new drugs.
Professor Rawlins suggested that lifting some of the inappropriate regulations that surround scientific research, and hence some of the expense, may help to stimulate drug developments.
"Our understanding of biology is extraordinary, and the number of drugs being developed should be huge, but it isn't. I believe that drug regulation has a critical role to play in the development of drugs, but we do need to examine every stage of the evidence base for all the requirements we make, and we need to look at each of these requirements and decide if it is real value for money," said Professor Rawlins.(Zosia Kmietowicz)
The volumes of regulations that surround scientific research are stifling the development of new drugs and need to be rationalised if innovative discoveries in biology are to be matched with new medicines and demand by patients for better treatments, said experts this week.
It costs an estimated $800m (￡433m; 645m) to get a new drug to the market, and pharmaceutical companies have to hit first year sales figures of about $500m to cover their expenses, said Professor Michael Rawlins, chairman of the National Institute for Clinical Excellence.
But with outlay costs increasing at a rate of about 10% a year, the cost of developing a new drug by 2015 will be in the region of $2bn, and sales will have to reach $1bn in the first year after launch, a situation that Professor Rawlins described as "unsustainable."
He was speaking at the launch of a new book, The Search for New Medicines, by the journalist and broadcaster Dr Geoff Watts, which highlights the findings of a conference held last September to discuss the future of the pharmaceutical industry and the dwindling supply of new drugs.
Professor Rawlins suggested that lifting some of the inappropriate regulations that surround scientific research, and hence some of the expense, may help to stimulate drug developments.
"Our understanding of biology is extraordinary, and the number of drugs being developed should be huge, but it isn't. I believe that drug regulation has a critical role to play in the development of drugs, but we do need to examine every stage of the evidence base for all the requirements we make, and we need to look at each of these requirements and decide if it is real value for money," said Professor Rawlins.(Zosia Kmietowicz)