Last Friday, the government announced that they plan to consult on proposals to encourage doctors to be more innovative when treating their patients and consider offering them novel treatments, especially where there are few other treatments available, by developing a process to reduce the risk of litigation. This consultation is a welcome step to get both clinician's and patient's views on how the NHS can make it easier for promising new treatments to navigate the regulatory pathway and reach the patients that need them.
Lord Saatchi is concerned that doctors are wary of the consequences of trying innovative new treatments when caring for their patients, that the risk of litigation should a novel treatment go wrong is detering them from trying new approaches. To try and address this, he has drafted a private members bill to define a process of responsible medical innovation which, if followed, would protect a clinician from accusations of clinical negligence.
The government has welcomed Lord Saatchi's initiative to try and encourage more innovation in healthcare, which is vital to discovering new ways to improve health. But they also recognise it is very important to get the right balance between encouraging doctors to offer their patients the opportunity to try novel treatments and putting the safeguards in place to protect patients. With this in mind they have announced a consultation to seek the view of patients, carers and clinicians. They want to better understand the barriers to innovation in healthcare, whether this is the right way to overcome them or whether other approaches are needed. And they want to understand the views of patients and carers, their perceptions of risk and the factors that influence these, and the safeguards they want in place.
The government are planning to launch the consultation in January 2014, and aiming to respond to it by May 2014. They have also said now at the outset that they will seek to legislate at the earliest possible opportunity, dependent on the results of the consultation, reflecting an urge to move quickly on this one.
What does this mean for medical research charities?
Medical research charities want to encourage more innovation to develop new and better ways to treat patients, and they want to ensure that patients with life-limiting conditions can access these new treatments sooner. To do this NHS staff need to be open to trying new and innovative approaches. And patients need to have a say in how these new approaches are trialled to evaluate their effectiveness, and when in the process they want to be able to access them. This clear indication from the government that they see the importance of encouraging medical innovation and plan to ask both clinicians and patients and their families how they want this to work in future is very welcome.
AMRC recently published Our vision for research in the NHS which sets out a number of measures we think are needed to encourage the NHS and NHS staff to become more innovative and take up new treatments faster so patients can benefit from them. Among these are calls to include research in the basic training for all NHS staff, to recognise and reward staff that take part in research, and encourage commissioners and staff to use research evidence to inform which techniques and treatments they commission and use. And central to delivering this vision is strengthening patient's voices in the design and conduct of research, giving them a stronger voice in transforming their care.
As survival rates for common conditions such as cancer and stroke in the UK lag behind other comparable countries (see the OECD report Health at a Glance 2013 out last week) it may be time for a set of new and different approaches to encourage innovation within the NHS. Lord Saatchi offers one such new approach. He identifies a barrier for clinicians - the increasing risk of litigation for medical negligence if things go wrong - and sets out to address this. However there are a mix of views about whether removing the risk of litigation alone will encourage doctors to consider more innovative options when treating their patients, or whether this can be addressed by other routes. More work is needed to assess how patient views can be taken on board. See this article in the HSJ Lord Saatchi is wrong, the law isn't killing patients.
We don't want to open the door to snake oil treatments; evaluating and proving the safety and efficacy of new treatments is still central, but we do need to make it easier for promising new treatments to navigate the regulatory pathway and reach the patients that need them. There are a host of ideas for how we can encourage this. As the MHRA co-ordinated Expert Group on innovation in the regulation of healthcare reported last week, there is flexibility in the regulatory system which could be better exploited, but there are also more adaptive approaches to licensing new treatments which are worth exploring to get a better deal for patients and ensure that there are incentives to develop new treatments and for the NHS to quickly adopt them.
This consultation gives clinicans, patients, carers and charities focused on encouraging medical research the opportunity to feed in their views on all of these approaches. AMRC will be taking that opportunity to respond. But the consultation may find that a mix of different approaches are needed to effectively encourage innovation and its uptake to make a difference for patients.