It could be said that this report is yet another sad indictment of the failures of the healthcare system to respond appropriately to overwhelming evidence of adverse outcomes conveyed by patients. Many will make the links with other health inquiries, not just in terms of the failure to listen to patient concerns but also to the cohort of patients affected, as here again, it is women who have suffered from poor treatment.
This Report, from the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, sets out findings from two years of assessment as to the impact of two medications (Hormone Pregnancy Tests and Sodium Valproate) and a medical device (Pelvic Mesh Implants). The review runs to 268 pages and conveys the experiences of hundreds of patients, as well as clinicians, and representatives from Royal Colleges, the pharmaceutical industry, manufacturers and regulators.
This article concentrates on 1 of the 9 report recommendations, namely the establishment of a Redress Agency, and considers if this could be the future for dispute resolution in the healthcare space.
The current position for patient complaints, litigation and resolution of disputes:
As the report recognises, currently, if a patient identifies that they may have suffered an adverse outcome following a procedure, there are a multitude of routes available for them to explore. In a complaint context the options include contacting the practitioner, clinic, hospital, regulators and the Parliamentary and Health Services Ombudsman. Litigation is also available (although the Pre-Action Protocol for the Resolution of Clinical Disputes was conceived to avoid litigation where possible). There is also the 'yellow card' system run by the MHRA (Medicines and Healthcare Products Regulatory Agency), enabling patients and clinicians to notify adverse outcomes associated with medicines and devices.
The patient groups affected by the medications and products covered by this report, however, were identified as having being poorly served by all of the above routes which has triggered, yet again, a recommendation that there needs to be another way for patients to achieve resolution where 'avoidable harm' is identified. What form could this 'other way' take?
The Redress Agency Concept
For those with long memories and/or experience of practising in Wales, the concept and realities of a redress scheme are not new (NHS Redress Act 2006 - Legislation.gov.uk. The recommendation of this report is that three redress schemes are set up for the victims of HPT, Sodium Valproate and vaginal mesh implants, to be funded by the pharmaceutical and medical devices industries respectively.
The report then expands upon this theme and advocates the creation of a new body, a Redress Agency, as a non-adversarial way of supporting any patient who is the victim of an 'avoidable harm' resulting from a medical device or medicine. The advantages identified are that it does not require (as litigation does) blame being apportioned to individuals/entities and that as such it offers a faster and easier route to a financial award. It also ticks another box – namely offering the potential for central data gathering of adverse outcomes which has been a significant barrier to joining the dots in the patient experience to date. Scheme funding would be via the manufacturers of drugs and products, such businesses not being able to market their products in the UK unless they agreed to contribute. This would enable the schemes' administrators to offer financial recompense and other services (e.g. respite care) to support those harmed.
Whilst the review does not prohibit the scope for those who have suffered harm to litigate, the suggestion is that should a patient wish to use both avenues, any financial support received from the Redress Agency would need to be discounted from a compensatory award.
Reference is made to the success of redress schemes established in Scandinavia and Japan, but if a 'claims culture' is present in England (if not the UK) the scope for such a scheme to change behaviours appears limited. The remit for a redress programme could also generate an ethical dilemma- why should a patient who suffers an adverse outcome from a potentially harmful implant for example be able to get rapid financial support whilst a patient who falls through the cracks of a referral system (such that the diagnosis of their cancer is delayed) cannot?
Other areas for debate
Two other points raised in the report merit consideration in this article.
The first is the suggestion that to avoid patients falling into an 'indemnity gap' a levy on clinicians, akin to the MIB (Motor Insurers Bureau) should be imposed and/or private healthcare providers establish their own fund that the Redress Agency could administer.
The second is the commentary on consent. The feedback from the patient cohort was that they were never told of the risks of proceeding with HPT, Sodium Valproate or a pelvic mesh implant. Whilst some interventions were decades ago, many were more recent and demonstrated a failure to incorporate an appropriate standard of care (Montgomery v Lanarkshire Health Board (2015)) into the consenting process. To address what was seen as an ongoing failure of clinicians to provide a true partnership in decision making when consent for medical intervention was obtained the proposals include:
- Patients must be given the opportunity to speak to/hear from other patients as to their positive and negative experiences before informed consent could be established
- Patient Decision Aids should be validated, standardised and developed with patients' input for procedures, with NICE to lead this process.
- Patients, with consent of the other party, should record the consent discussion so that they can listen again at their leisure to ensure their full understanding of the risks and benefits with a copy also being kept within their electronic records.
The report envisages implementation of the recommendations via a government task force that delivers a healthcare system that listens, hears and acts upon patient concerns in a rapid, compassionate and proportionate way. How viable any of this will be in the current economic climate remains to be seen but healthcare practitioners, providers and manufacturers of drugs/medical products will need to consider carefully the implications of this report as it requires a recalibration in approach to:
- How the consent process is handled and recorded
- How patient data is collected, stored and shared
- How drugs and medical products are brought to the market, tested, outcomes monitored and adverse outcomes scrutinised
- How patient feedback is collated - greater priority to be given to their reports of positive and negative outcomes
- How the complaints process is deployed to investigate and respond to concerns
- What an adversarial litigation solution has to offer versus a redress approach in the context of 'avoidable harm'.
There is much 'food for thought' in this report, and its timing, when health is a key government priority, could resonate with policy makers, sparking an appetite for change- we will see!