The government has launched a consultation on the Medical Innovation Bill (also known as the Saatchi Bill). AMRC will be responding, as will many of our members. This consultation is a useful opportunity to get everyone's views on how the NHS can make it easier for promising new treatments to reach the patients that need them. We all know this is a complicated area but we also know that, as many have said, adoption of innovation by the NHS is "low and slow" and needs to improve. We'd like to hear your views as we develop the AMRC's response. Here are some of our initial thoughts.
Lord Saatchi is concerned that doctors are wary of the consequences of trying innovative new treatments when caring for their patients; perhaps because of the risk of litigation should a novel treatment go wrong. His private members bill published last year aimed to define a process of responsible medical innovation that would protect a clinician from such accusations of clinical negligence. The government welcomed Lord Saatchi's initiative but, recognising that there are many factors affecting the development and adoption of innovative new treatments in the NHS, announced plans for a consultation to seek the view of patients, carers and clinicians. This consultation has now been published.
Last year AMRC published Our vision for research in the NHS, which sets out a number of measures we think are needed to encourage the NHS and its 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 patients' voices in the design and conduct of research, giving them a greater role in transforming their care.
This bill raises important issues
Lord Saatchi's bill aims to end the risk of litigation for medical negligence faced by doctors who wish to try treatments that deviate from standard procedure. The government's consultation notes that clinical negligence claims have increased significantly in the past few years. However there is 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. And others have pointed out that doctors can also already try unlicensed medicines with patients through the "named-patient" scheme. (See also this article in the HSJ Lord Saatchi is wrong, the law isn't killing patients.)
Medical research charities want to encourage more innovation and it's adoption into clinical practice so that we can have 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.
We don't want to open the door to snake oil treatments - evaluating and proving safety and efficacy is paramount. That means understanding the possible benefits of a treatment versus its risks across a set of patients, rather than a case by case approach. And when trialing new treatments it's important to have systems in place to track the patient's progress during treatment and then some way of capturing outcomes afterwards, so that the knowledge gained can benefit others.
But more is needed to speed innovation
The bill tackles only one part of a much bigger picture - there are problems at every stage of the pathway from bench to bedside. We need to make it easier for promising new treatments to navigate the regulatory pathway and reach the patients that need them. There is 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 year, there is some flexibility in the regulatory system which could be better exploited, but more adaptive approaches to licensing new treatments are still urgently needed to get a better deal for patients.
In our response we will be covering:
- The importance of giving patients a voice
- How research regulation and governance can be improved
- New models of licensing treatments
- How drug pricing can encourage innovation
- Creating a research and innovation-friendly NHS workforce
- Sharing of best practice
This consultation gives clinicians, patients, carers and charities the opportunity to feed in their views on all of these approaches. AMRC will be taking that opportunity and we would like to hear the views of our members to help us develop our response. You can contact me here.