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Scientists scrutinise whether society can pay the costs of future medicines

Scientists and policymakers discussed how society could afford the cost of future new medicines at the launch of the Royal Pharmaceutical Society’s “New medicines” report, which looks at the science underpinning pharmaceutical practice.

Scientists and policymakers discussed how society could afford the cost of future new medicines at the launch of the Royal Pharmaceutical Society’s “New medicines” report, which looks at the science underpinning pharmaceutical practice. 

Some of the issues discussed at the London meeting, held at the Royal Society yesterday (8 May 2014), included the expense of conducting clinical trials, regulatory barriers for the sector and whether the pharmaceutical industry was spending too much on marketing as opposed to research and development budgets. 

Mark Baker, director of the centre for clinical practice at the National Institute for Health and Care Excellence, told the meeting: “There is no doubt that conducting clinical trials that look for small benefits requires large numbers of patients. Clinical trials become very expensive … so I do sympathise that the cost of demonstrating new therapies is a very significant burden on industry and other funders of research.”

But he felt that the process was necessary. “I’m afraid it is a cost that has to be borne and industry cannot complain that it is undercharging us for the drugs. They are recouping their costs and we are paying the price that is appropriate for the science that goes into [it].”

He thinks that the onus is on the industry “to do the right trials in order to go to market with a very positive message rather than to do those trials which get a product licensed soonest”. 

Tony Moffat, emeritus professor of pharmaceutical analysis at the UCL school of pharmacy and one of the panel members who created the report, challenged Professor Baker on who is responsible for conducting trials. 

In answer, Professor Baker said: “The responsibility, I guess, lies with those who are inflicting poisons on the public as all drugs are poisons. There are certain circumstances where a government would sponsor treatments … but in most [cases] it is the producer of the agent that has the primary responsibility for first demonstrating its safety and … its effectiveness.”

One delegate believed that society may need to consider other models for R&D funding rather than the current model — ie, the company trying to generate profit through the sale of medicines. He suggested partnerships or even “crowdfunding”. 

Bina Rawal, medical and innovation director of the Association of the British Pharmaceutical Industry, said it was “difficult to view this as a one-size-fits-all model”. She said the regulatory framework for drug development is evolving, noting that there are processes such as adaptive licensing in Europe, which can help bring forward new innovative medicines earlier to patients. She added that, over the past 10 years, there has been far more collaboration between the industry and academia, as well as between companies, on drug development.

Professor Baker declared that “the system isn’t broken”. He added that “both healthcare systems across the world and the pharmaceutical industry have done pretty well out of the relationship built up between them … but it is evolving and new approaches may well be required”.

However, Humphrey Rang, president of the British Pharmacological Society, was concerned that the pharmaceutical industry spends about twice as much on marketing as it does on research and development, stating that it “got into that way of operation when the hunt was for huge blockbuster products”.

He said: “The various companies were all in competition against each other for very similar classes of drugs. One would like to think that with personalised medicine gradually evolving that these blockbuster ambitions are probably no longer relevant.”

He asked: “So is there a prospect for cutting down the marketing spend if you have a drug that really works extraordinarily well, although be it in a defined population of patients. You really don’t need to spend a lot of money … in persuading people to use it.” He hopes that in future the marketing spend will “go down a lot” and consequently keep the cost of the products under control.

Dr Rawal stressed that the industry was already in that evolution from the “blockbuster” to the “nichebuster” model, with targeted, personalised medicines. In the UK, compared with other sectors, the pharmaceutical industry is the heaviest investor in R&D by a long way, with 28 per cent of all R&D in the UK coming from the pharmaceutical industry, she pointed out.

“Slavish” adherence to NICE guidance 

The opportunity to save money by better prescribing is “enormous” and there is no question of society not being able to afford new and exciting treatments, said Professor Baker. “It would be a scandal if the NHS does not make these treatments available.”

He was also concerned that some NICE guidelines may have “slavish” adherence but others may be rarely acted upon. “What is increasingly clear is the slavish adherence to existing guidance results in people receiving lot of treatments for which they are likely to benefit very little. One of the things that we are starting to do now is to look at the attributable benefit from individual treatments … the question is whether [treatments] work well enough for the adverse events.” For example, when a person receives a treatment they have a 100 per cent opportunity of getting the adverse events but they may not have a 100 per cent opportunity of getting the clinical benefits, he said.

He added: “Sensible prescribing does not mean treating every condition in the way prescribed by NICE guidelines; it means treating the conditions from which the patient is going to suffer the most, and using the treatments which are going to benefit the patient most or harm them least.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138249

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  • Mark Baker believes the onus is on the industry to do the right trials

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