Informed consent: an empty promise? A comparative analysis between Italy and England,Wales,and Scotland

Abstract

Informed consent (IC), as the process of sharing information between patients and clinicians before undertaking a medical treatment, signals a number of ‘good intentions’. IC, in its theoretical formulation, can be seen as valuing the expertise and contributions of both clinicians and patients, giving expression to the aspirations of both promoting patient autonomy and facilitating doctors to work in partnership with their patients. The Supreme Court judgment in Montgomery v Lanarkshire Health Board¹ and the Italian legislation on IC² are, in this respect, worthy of analysis as both provide valid examples of these ‘good intentions’. However, the reality of how IC has been translated in courtrooms does not always match these expectations. This article, through a comparative reflection, will claim that a gap between the ‘law in theory’ and the ‘law in practice’ is common to both legal systems. The article ultimately claims that changes in both legal and policy approach are needed in order to better safeguard IC.

Introduction

This article examines the issue of informed consent (IC), particularly how the liability of clinicians for violations of IC has been translated in courtrooms, through a comparative approach to the legal frameworks as they currently stand in the two ³ legal systems of Italy and England, Wales, and Scotland. The analysis begins with an overview of the Supreme Court judgment’ in Montgomery v Lanarkshire Health Board, ⁴ as the reference point for an examination of IC in England, Wales, and Scotland. It then moves to consider the Italian legislation and case law surrounding IC, particularly legislation n. 219/ 2017, together with the Supreme Court judgment in ‘San Martino bis’. The broad aim of these first sections of the article is to demonstrate to the reader the shared ‘good intentions’ of both legal systems ‘behind the laws’ on IC while also highlighting the existence of ongoing practical limitations. The final part of the article conducts a closer comparative exercise between both legal systems. Though this might appear simplistic, it is self-evident that there is a structural difference between the legal framework in England, Wales, and Scotland, being a common law system, and the Italian framework, a civil law system. This preliminary consideration helps us to understand some of the reasons why, as will be unpacked throughout the article, IC is regulated differently. In the domestic context, we do not find any legislation addressing the issue of IC in its broad formulation; this is left to case law, particularly the Supreme Court judgment’ in Montgomery. It is legislation n. 219/ 2017 that fundamentally regulates IC in Italy, although this is also accompanied by relevant Supreme Court judgment. However, despite inevitable structural differences, they have parallel aspirations and parallel challenges. Both legal systems have shared ‘good intentions’, although both also dramatically fail to offer a real possibility of successfully safeguarding IC. Ultimately, the aim of this comparative analysis is to highlight that IC is often safeguarded in ‘theory’ but left unprotected in ‘practice’, as well as arguing for a change in approach. It claims that more research is needed to understand how law and policy can more clearly and concretely safeguard this key patient right.

England, Wales, and Scotland: the ‘good intentions’ behind Montgomery?

The 2015 Supreme Court judgment in Montgomery is the key point of reference for a discourse concerning IC in England, Wales, and Scotland. ⁵ This is because the judgment enshrined the right of every patient to be informed, as well as to receive information concerning the risks, benefits, and reasonable alternatives to the proposed treatment. ⁶ The judgment followed in the footsteps of previous professional guidelines, particularly the General Medical Council (GMC) guidelines on consent 2008 ⁷ , and, as will be shown below, consolidated an evolutionary path of domestic case law. Ultimately, it will be highlighted that Montgomery, and hence IC, is an expression of two key ‘good intentions’, namely, facilitating doctors working in partnership with their patients and the promotion of patients’ autonomy.

Delivered with the agreement of seven judges, Montgomery concerned negligence liability for a failure to disclose the risks of a vaginal birth to a pregnant diabetic woman of short stature (Mrs Montgomery). The newborn suffered brain damage as a result of shoulder dystocia, which is the inability of the baby’s shoulders to pass through the pelvis during vaginal delivery. Mrs Montgomery successfully argued that the non-disclosure of this risk, in her circumstances, was indeed negligent. Mrs Montgomery should have been offered the alternative of an elective caesarean section, given the heightened risk of shoulder dystocia for women with her clinical background.

The Supreme Court judgment in Montgomery cemented a move away from a doctor-centred (and thus paternalistic) stance, as enshrined in the previous standard of information disclosure in Bolam v Friern Hospital Management Committee. ⁸ In Bolam, justice McNair explained to the jury that a clinician ‘is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art ⁹ ’ (words which became known as ‘the Bolam test’). The paternalistic stance of Bolam ¹⁰ is clearly shown by the standard of information disclosure laid down in this case, whereby both risk assessment and treatment options were determined by medical expertise and assessment alone. From the later case of Sidaway v Board of Governors of the Bethlem Royal Hospital ¹¹ to modern cases like Pearce v United Bristol Healthcare NHS Trust ¹² and Chester v Afshar, ¹³ case law has gradually moved away from expressing the determination to value patients’ voices through IC, and thus enhance their autonomy. Montgomery can, in this respect, be considered a key point on a journey that started much earlier. Ultimately, however, it is this 2015 Supreme Court judgment that clearly expresses that patients are no longer to be regarded as mere passive recipients of clinicians’ advice, but as ‘person[s] holding right[s]’, ¹⁴ via the safeguard of IC.

In this sense, the novelty of the Montgomery approach lies in complementing the precedent of the past while also advancing on the journey outlined above. Prior to Montgomery, information-sharing was still considered to be part of the medical expertise and merely an exercise of professional skill and judgement. Montgomery distinguishes between the assessment of risks and benefits, which still forms part of the medical expertise according to the Bolam-standard, and the information-sharing which can also be shaped by the patient’s point of view. ¹⁵

According to Lord Kerr and Lord Reed, the gradual legal evolution leading towards Montgomery has also signified a change in how patients are perceived. The latter are treated

so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices. ¹⁶

Through a new test of negligence liability, the ‘materiality test’ of disclosure ¹⁷ , medical professionals are called upon to place patients at the heart of the disclosure process, balancing more clinical considerations with patients’ needs. The materiality test is structured around two limbs, which represent two alternative ¹⁸ routes for assessing what information should be disclosed. ¹⁹ The first limb focuses on the disclosure of what a reasonable person in the patient’s position would wish to know. A reasonable person in the patient’s position should thus be made aware, for instance, of reasonable treatment options ²⁰ and the associated medical risks / benefits / alternatives whose primary, though not exclusive, assessment belongs to clinicians. ²¹ The second limb focuses on the particular patient’s needs and, in circumstances where it is reasonable for the doctor to be aware of them, requires the disclosure of more patient-oriented information. In this sense, although it is sufficient to rely on only one limb for the test of materiality to be satisfied, what emerges on a more general level is that information disclosure is no longer purely a question of doctors’ expertise, but of balancing this with patients’ needs. The materiality test implies that clinical and patient-oriented aspects should be taken into account when assessing the materiality of information. ²² In addition, information disclosure is no longer focused on the magnitude of risks ²³ arising or on the patient proactively asking questions. ²⁴ There is a desire to limit the risk of a priori exclusion of material information from the medical side. The duty to obtain IC is strictly and clearly tied to a partnership approach to the doctor–patient relationship, since it is only when a collaboration between clinicians and patients is sought that both medical expertise and patients’ needs and values can be balanced. ²⁵ Patient autonomy and medical partnership both matter.

Some commentators ²⁶ challenge the novelty of the Montgomery approach, considering it a mere reiteration of what was already stated at the soft-law level in the GMC guidance on consent and the National Institute for Health and Care Excellence (NICE) guidelines. ²⁷ A move towards a new model for consent which highlights patients’ contributions was already emphasised in professional guidelines and pre-Montgomery case law. Ultimately, this line of reasoning considers the Montgomery approach as a mere ‘echo’ of the soft-law regulation and case law. In this vein, it appears to be correct to state that the Montgomery case should not be considered in isolation, something that Lords Kerr and Reed recognized within the judgment itself. ²⁸ The decision should indeed be placed within the context of a gradual evolution of the healthcare practice, as expressed in pre-Montgomery case law and soft-law regulation. This gradual evolution was also prepared by other legal and social aspects. On a purely legal level, the Montgomery case is the predictable outcome of a change in the healthcare law context ²⁹ at both the national and international levels. However, it is also indicative of wider social changes. Negligence case law, coupled with the enactment of the Human Rights Act 1998, has gradually prepared the ground for a new understanding of the doctor–patient relationship. The context in which the Montgomery case was delivered was also one in which patients could easily access medical information, for instance, via the use of online platforms (e.g. Google). ³⁰ Patients should no longer be framed as ‘passive recipients’ ³¹ of medical advice, but as persons whose voices need to be heard. For these reasons, it might be too reductionist to consider Montgomery as a purely symbolic judgment.

It is thus the case that Montgomery has marked a crucial step in the move towards a focus on patients’ autonomy and medical partnership. ³² Pre-Montgomery case law and GMC guidelines ³³ were expressions of a desire to give more space to patients’ views (i.e. autonomy) in the medical context. Montgomery is a response to that need, clearly expressed via (1) the provision of a new test of disclosure, which balances clinical contributions and patient voices (autonomy), ³⁴ and (2) the acknowledged relevance attributed to dialogue and advice between the parties and the importance of reaching a shared decision (medical partnership). ³⁵

Montgomery, in this sense, was a clear expression of a desire to cement a partnership-oriented and patient-centred practice through IC. Both medical partnership and patients’ autonomy should thus be considered key ‘good intentions’ behind IC developments.

The reality behind the ‘good intentions’: the limitations of Montgomery

Although Montgomery represents a significant step towards the protection of medical partnership and patient-centred practices (autonomy) through IC, these aspirations are also bounded by several limitations. Two key limitations will be outlined below: (1) the broad limitations arising from the law of negligence per se, and (2) the pervasive influence of the previous standard of disclosure as laid down in Bolam. Both limitations provide further explanations for why a gap between the ‘good intentions’ and the ‘law in practice’ can be observed. This article will ultimately show that there is still a long way to go in the journey of unpacking the ‘good intentions’ of Montgomery in courtrooms.

The broad limitations arising from the law of negligence

Liability in negligence is structured in such a way as to limit the possibility for patients to make a successful claim for a pure violation of IC (namely, one which is not associated with any physical or psychological harm to the claimant). Negligence is indeed not actionable per se and requires that an actual harm arises as a result of the breach of duty. In this sense, liability does not arise for a failure to protect the decision-making process (i.e. IC), but only when this is reflected in a recognised harm.

It should be added that to date, courts have been very reluctant to grant damages ³⁶ for a failure to satisfy the right to IC when this is the solo violation. IC has been mostly valued in courts only when coupled with the existence of an actual harm, as is the case, for instance, with ‘wrongful birth’. ³⁷ Take, for example, the wrongful birth case of Mordel v Royal Berkshire NHS Foundation Trust ³⁸ where the failure to comply with an IC process led the court to award damages to the claimant. ³⁹ In this case, which applied the Montgomery ruling, the claimant was granted damages for a breach of the IC process by the clinician. She claimed that had she known about the possibility of her child having Down’s syndrome, she would have had an abortion. In this case, the court held that there was a failure within the informative process which, in line with Montgomery, had to imply that a space for a more extensive dialogue had to be found, one that goes beyond a mere ‘yes or no’ approach.

It is the case that the lack of a successful claim for a solo violation of IC might be due to (1) the general reluctance of courts to grant damages for a violation of IC processes itself, where this does not result in harm beyond the informative violation per se, and also (2) to the potential difficulty in proving that the harm arising is causally ⁴⁰ related to clinicians’ lack of disclosure.

However, it is claimed here that a pure violation of IC is worthy of legal protection in and of itself, since it challenges the safeguard of patients’ autonomy ⁴¹ and medical partnership. In other words, the failure to protect the decision-making process (IC) is a violation which should be worthy of a legal protection per se, if the ‘good intentions’ behind IC are to be protected.

Viewed more closely, the limitations of the law of negligence cannot be overcome by reliance on wider tort law claims, particularly the law of battery. In battery, liability arises every time there is a direct and intentional application of force from one person to another without the latter’s consent. ⁴² It positively requires that, within the medical context, before any medical intervention is put into place, the requirements for a valid consent are satisfied. These can be broadly identified ⁴³ as: the patient’s capacity, the disclosure of broad information, the voluntariness of the decision, and compliance with public policy. The first, the patient’s capacity, concerns the mental status of the patient, the Mental Capacity Act 2005 (MCA) requiring the application of a two-stage test for incapacity that evidences (1) the lack of an ‘impairment or disturbance of the mind or brain’ ⁴⁴ and (2) the ability of the patient to understand, retain, use, or weigh the medical information relevant to the decision and to communicate their decision. ⁴⁵ The law of battery also safeguards the voluntariness of the decision, requiring it to be free from undue influence, that is to say, from certain third parties’ pressure and/or coercion. ⁴⁶ When it comes to information disclosure, however, to meet the requirement for a valid consent, the law of battery requires only the provision of general and broad information, ⁴⁷ merely providing an overview of the medical intervention in question. It does not require any extra or more detailed information-sharing processes.

It is thus the case that battery can be a useful legal tool to protect against treatments without a valid consent ⁴⁸ , but it is of limited application to protect the patient, more widely, from an uninformed medical decision (i.e. without IC). This is because, as argued by Cave, ‘informed consent is not necessarily valid (if it is not voluntary or capacitous) and consent that is valid is not necessarily adequately informed. This flows from the different informational thresholds that apply in battery and negligence’. ⁴⁹

A preliminary challenge to the Montgomery ideal of IC stems from the inherent broad limitations of the law of negligence, and hence the lack of a concrete safeguarding in law of IC per se, something that the law of battery is of no assistance in overcoming.

The ‘Bolam legacy’

The second limitation of the ‘good intentions’ of Montgomery is found in the pervasive influence of the previous standard of disclosure as laid down in Bolam. There is indeed a tension between what Cave and Milo have phrased as the ‘Montgomery supremacy’ and ‘the Bolam legacy’. ⁵⁰ In that paper, it was argued that Bolam remains relevant to aspects of medical advice, and that the patient-centredness (autonomy) enshrined in Montgomery is not uniformly applicable across all aspects of medicine. It is claimed here that, crucially, such a challenge supports the idea that the ‘good intentions’ behind IC can be undermined by the influence of the previous standard of disclosure as laid down in Bolam.

Cave and Milo outlined four interpretative challenges as evidence of a Bolam legacy. I am here only briefly recalling two of them since they are the most relevant for this analysis. First, the Bolam test has relevance in relation to constructive knowledge of risks associated with proposed treatment. ⁵¹ The disclosure of material information implies that clinicians should know about these risks. However, if information on risk is material, but the clinician was not aware of it, this opens the question as to the reasonableness of the clinician’s position and how this ought to be judged. In Duce v Worcester Acute Hospitals NHS Trust, ⁵² the Montgomery test was spelled out in a two-part test: ⁵³ the first reflects on the clinician’s awareness of the risks and falls under the remit of Bolam, while the second refers to the reasonableness of risk disclosure which is determined by the court and falls under the remit of Montgomery. In light of Duce, it therefore appears that Bolam and Montgomery will apply concurrently to different aspects of the disclosure issue.

In addition, there is still a lack of clarity concerning the separation between the selection of treatment options and the disclosure of options, and hence the relevant test to be applied in these circumstances. Cave and Milo ⁵⁴ have argued that the two tests, Bolam and Montgomery, are likely to sit alongside each other in the assessment of constructive knowledge of risk and reasonable alternative options and their communication to patients. While Bolam remains relevant to aspects of medical advice, the precise line of division between the Bolam and Montgomery materiality tests is not yet clear. This issue creates an overlap between the two standards of disclosure. ⁵⁵

The existence of an ongoing tension between a ‘Bolam legacy’ and a ‘Montgomery supremacy’ crucially represents an additional limitation of the ‘good intentions’ of Montgomery. Medical partnerships and patient autonomy both matter. However, the safeguard of IC as a patient-oriented approach is challenged by a tension between the two standards of disclosure. Specifically, the risk is that of a return to a doctor-centred approach, and with it the possibility of undermining patient autonomy.

Conclusion

Montgomery, as the referral point for an analysis of IC, in the domestic context is filled with what I call ‘good intentions’. The protection of both medical partnerships and patient autonomy as the principles behind IC represents clear positive aspects and a step forward from the previous doctor-centred approach in Bolam. However, these ‘good intentions’ risk being stated in theory, but denied in practice. Two limitations have been provided above as evidence of this challenge: the inherent unsuitability of the law of negligence in safeguarding IC per se, and the ongoing tension between Montgomery and Bolam and hence the standard of disclosure to be followed. The next section will analyse the regulation and case law surrounding IC in Italy to show that, despite the inevitable differences, the gap between the ‘law in theory’ and the ‘law in practice’ is clearly also present in that legal context. This comparative analysis will ultimately call for much needed reflection on how IC can be better protected.

The Italian scenario on IC: the ‘good intentions’ behind IC in the Italian context

Having explored potentials and limitations of the judgment in Montgomery, this article now moves to a parallel analysis of the Italian legal framework concerning IC. The Italian framework comprises both legislation and case law on IC. For the purpose of our analysis, I will be focusing on the law n. 219/2017 and the most relevant Supreme Court judgment on the topic. It will be apparent through the below analysis that the Supreme Court (Corte di Cassazione) judgment in San Martino bis ⁵⁶ goes some way towards highlighting the relevance and remit of IC, particularly the consequences of the violation of such right on the side of clinicians. However, crucial limitations still exist that problematise an actual safeguarding of IC, and hence of medical partnerships and patient autonomy. This reflection will then lead to a closer comparative analysis of differences and shared challenges of the two chosen legal systems. A crucial gap between ‘good intentions’ and law in practice exists in both legal systems.

The law on IC in Italy: law n. 219/2017

Since 2017, the Italian legal framework has entrusted the regulation of IC to a hard-law tool, law n. 219/2017. This is the first ever legislation enacted in Italy on this topic. Prior to this, IC was largely left to case law. ⁵⁷ The relevant act, in this sense, reflects the gradual evolution of case law on this topic from a doctor-centred approach ⁵⁸ to a more patient-centred perspective ⁵⁹ and attempts to provide a clearer point of reference. This act is, however, not devoted exclusively to IC, but is part of a broader regulatory framework concerning end-of-life decisions, particularly advance directives. It is at art. 1, ⁶⁰ s.1/11, that an understanding of principles and the standard of disclosure surrounding IC is outlined.

As far as principles are concerned, art. 1 s.1 and 2 ⁶¹ are of key relevance. S.1 states that the legislation will, at a more general level, protect the right to life, right to health, dignity, and autonomy of every patient. S.2 then goes on to outline that ‘a relationship of care and trust between a doctor and a patient is to be promoted, this is based upon informed consent where the autonomy of the patient and the competences and professional autonomy of the clinician meet’. It is hence clear from these enunciations that the Italian legislation attaches primary importance to, among others, medical partnerships and patient autonomy as the two foundational principles ⁶² behind IC.

A further clear endorsement of such principles is found at s.8, where it is stated that ‘the time invested in a communicative exchange between a clinician and a patient, is a time of care’. S.8 clearly enunciates two things: first, that IC is an ongoing communicative process, which is not merely fulfilled with a ‘signature on a paper’, but involves dialogue and communication between the parties; second, that IC is not to be framed as an obstacle to the timely administration of a medical treatment; quite the opposite, in fact. The time spent in disclosing information is treated as an integral part of medical care and can crucially serve patients’ interests, here expressed in the desire to support their autonomy via information awareness.

It is thus the case that from the outset, Italian law also recognizes as two foundational principles the same ‘good intentions’ identified at the heart of Montgomery, namely, patient autonomy and medical partnerships. This, as we will further unpack later, is a first point of contact between the two legal systems.

The articulation of the standard of disclosure is then found in s.3 ⁶³ , which states that

every person has a right to be made aware of his/her health conditions, and to be informed in a complete, up-to-date and understandable way concerning diagnosis-prognosis, benefits and risks connected to diagnosis and suggested treatments, as well as alternatives and possible consequences of the refusal of a medical treatment or further diagnostic checks.

In this passage, the law details the characteristics of the disclosure process, calling for a process that is accurate, up to date, and framed in a way that patients can understand. However, s.3 crucially lacks an explicit mention of whether the standard is to be judged in light of a doctor-centred approach or a patient-centred one. This lacuna can possibly be bridged via a broad interpretation of what seems to be the ‘spirit’ of art. 1. In this sense, particularly in light of art. 1 (s.1 and 2), it can be said that the standard of disclosure can be interpreted as being led by a patient-centred dimension, rather than a purely doctor-centred one. According to s.3, read together with the principles enunciated in s.1 and 2, it is thus the case that doctors owe a duty to disclose information in a way that patients can understand and that provides a comprehensive picture of risks/benefits/alternatives. Nevertheless, the lack of clear guidance on how the standard of disclosure should be assessed still leaves open the possibility of misinterpretations, and with it the likelihood of a return to a purely doctor-centred approach.

A further risk of a return to a doctor-centred stance is also evident with s.3’s requirement of a ‘complete’ disclosure. S.3 does not specify how this is to be interpreted. This is particularly concerning, as if ‘complete’ is interpreted as ‘full’ disclosure, and then this risks potentially ‘bombarding’ patients with information which would not always be relevant to them.

In addition, and partially counterbalancing the lack of clarity expressed concerning the standard of disclosure, a clearer patient-centred approach is endorsed where a right to refuse IC is also granted (s.3). Patients not only have a right to be made aware of information, they also have a corresponding right to refuse to receive it altogether. ⁶⁴ It is also interesting to note that patients can also decide to allocate a third party or a family member who will be in charge of this information and provide consent on his or her behalf. The latter scenario is particularly tied with end-of-life decisions, which the remaining parts of the legislation are devoted to.

It is hence the case that, despite some preliminary challenges from the literal formulation of the Italian legislation, both the relevance of a medical partnership and the relevance of an autonomy-oriented approach are valued. In this respect, the Italian legislation endorses the same ‘good intentions’ noted in Montgomery, upon which IC is based.

The reality behind the ‘good intentions’ in the Italian system: the ‘San Martino bis judgment’ and the lack of a clear mechanism of redress

Beyond the existence of ‘good intentions’, however, the reality is not free from legal challenges. An exploration of the most relevant Italian case law in this field reveals a gap between the ‘law in theory’ and the ‘law in practice’. This section will particularly explore the hardships in safeguarding of IC per se, especially when this is not connected with the existence of a harm on the side of the claimant.

The key point of reference to understand where this limitation lies is judgment n. 28985/2019 of the Italian Supreme Court (Corte di Cassazione), known as the ‘San Martino bis judgment’. ⁶⁵ In this case, a cancer patient sought damages for the non-disclosure of the risk of myelopathy arising from excessive radiotherapy. The patient’s claim was unsuccessful because this risk was still unknown by the scientific community at the time (1986).

Despite this being an unsuccessful claim, it is still relevant to unpack how the court addressed the issue of IC in this context. The court begins its analysis acknowledging that an ‘omission’, that is to say, the lack of information disclosure from the doctor’s side, is conduct which has the potential to lead to a series of ‘offences’ (so-called pluri-offensive conduct). This is because such behaviour has the potential to harm the patient’s right to health, as well as their right to autonomy. This also means that to prove that factual causation exists, the claimant needs to show that the clinician’s conduct infringed both rights.

In light of this starting point concerning the nature of the offence and the rights that are challenged by such conduct, the Supreme Court attempted to outline five possible scenarios where IC may have been violated and offer guidance on when damages may be recovered for that violation. ⁶⁶

The first scenario arises where there is a lack of or insufficient information disclosure concerning a treatment that the patient would have undergone anyway, even if he or she had been correctly informed. If such treatment were performed negligently, leading to physical and mental harm to the patient, the only damage that could be recovered is for the violation of the right to health. The latter, according to the court, should be granted in a way that redresses (1) an external violation ⁶⁷ , meaning the dynamic-relational implications (or better social and relational) of the negligent conduct, and (2) an internal violation, referred to the internal suffering of the patient (e.g. grief, fear, lack of self-esteem, desperation). In this case, however, it is to be noted that the focus is on the negligent administration of the treatment, rather than the violation of IC per se.

The second scenario concerns the failure to disclose or the provision of insufficient information related to a treatment that the patient would possibly not have undergone had she or he been correctly informed, combined with negligent performance of the treatment resulting in physical and mental harm to the patient. In this instance, the Supreme Court outlines that both violations of the right to health and right to autonomy, as broadly related to the violation of IC, can be recovered. The violation of the right to health is in this instance causally related to both the negligent conduct of the clinician in performing the treatment and the information deficit.

The third scenario is the failure to provide information (or sufficient information) regarding a treatment that the patient would have potentially not undergone had they been correctly informed. In this case, the medical treatment has been administered correctly by the clinician; however, some minor complications arise, for example, an aggravation of a patient’s pre-existing clinical condition. In this circumstance, both the right to autonomy and the right to health can be compensated, the latter taking into account the difference between the pre-existent clinical conditions and their subsequent deteriorations. In this case, it should be highlighted that the violation of both rights is here causally related to the violation of the information deficit.

The fourth scenario is the omission or insufficient information related to a medical treatment that the patient would have undergone anyway had they been correctly informed. In this case, the treatment was correctly performed and there was no negative impact on the patients’ health. In these circumstances, the Supreme Court has highlighted that no damages will be recovered. The violation of IC per se does not lead to any compensation.

The fifth and final scenario is the one and only hypothesis where the Supreme Court outlines the possibility of granting damages for violation of the right to autonomy, and thus IC per se. However, the court appears to be extremely vague in delineating this scenario. The court highlights that an omission or a lack of diagnosis from which a violation of the right to health does not arise can still lead to damages if non-economic consequences arise on the side of the claimant. The latter are explained as subjective sufferings and limitations of one’s liberty, in both a physical and a psychological sense. It is thus not clear whether the court is referring to the hypothetical claim in wrongful birth ⁶⁸ , for the existence of a diagnostic omission, or to something else, for example, by recognising more broadly the loss of autonomy to make an informed choice, as is the case where there is a serious failing in the information-sharing process.

Although the Italian Supreme Court judgment in ‘San Martino bis’ advances things in a positive direction, by attempting to provide a clear outline of five hypothetical scenarios where the violation of IC can be safeguarded, only one of these hypotheses, admittedly the most opaque ⁶⁹ (i.e. the fifth scenario), entails a possibility of safeguarding IC per se. However, the complexity related to the possibility of an actual redress is further influenced by the burden of proof on the claimant. The latter needs to prove that had they been rightly informed, they would have not undergone the treatment. In addition, a further aspect that the claimant needs to prove in order to recover damages is the existence of a harm (whether financial or otherwise) which is causally related to the violation. ⁷⁰

It is hence the case that compensation for the violation of IC per se is very rare, being confined to the most extreme scenarios. In the vast majority of cases, even in the Italian legal context, the redress is theoretical, ⁷¹ rather than actual.

Differences, common challenges, and possible ways forward

Having briefly explored the legal frameworks concerning IC both in England, Wales, and Scotland and in Italy, this section will embark on a closer comparative exercise. This reflection will be focused on two key aspects of IC, concerning (1) the standard of care and (2) the degree of information disclosure. This comparative analysis will outline the existence of some commonalities between the two legal systems with regard to (1) and differences with regard to the latter (2). This analysis will then be followed by a reflection on a key ‘shared challenge’, namely, the lack of a clear safeguarding of IC.

Standard of disclosure

The first issue which might be considered worthy of a comparative analysis is, crucially, the standard of care. From an analysis of Italian law, it is apparent that the Act ⁷² lacks clarity in this respect. Particularly, as noted above, it is not clear whether the assessment of what information should be disclosed is to be conducted from the doctor’s point of view or not.

Further case law has prima facie gone some way towards attempting to tackle this issue. Take as an example the Supreme Court judgment 2019 n. 23328. ⁷³ Here, the court specifies the importance of tailoring the disclosure process in light of patients’ educational backgrounds and subjective needs, and beyond the framing of IC as a signed document, so as to protect patients’ knowledge and understanding of information. This judgment may go some way towards tackling the lack of clarity concerning the standard of disclosure and orienting it in a more patient-centred way. However, on closer analysis, this judgment risks only specifying the characteristics of the disclosure process, in its call for a process that is framed in a way that patients can understand. But patient understanding is clearly differentiated from an assessment of the standard of disclosure. The former gives the direction or the orientation of disclosure (i.e. understanding of information), whereas the latter asks what to disclose (i.e. standard of disclosure). This still leaves the issue of the standard of disclosure unclear, since it lacks a clear enunciation of whether this is to be judged in light of a doctor-centred approach or a patient-centred one.

Above I have suggested that one way to overcome this challenge, and thus to fill this evident lacuna, is to look at the broad interpretation of the spirit of the law which emphasizes patient-centredness. However, even this suggestion does not rule out possible misinterpretations, and with it a return to what was stated above concerning an unclear and possibly doctor-centred approach.

Montgomery, conversely, is clearer at least in the wording of the standard of disclosure. The judgment proposes this new test of materiality, ⁷⁴ where key importance is to be given to both medical partnerships and patient autonomy, as has been noted in previous sections. However, this does not mean that Montgomery is free from broader practical challenges in the context of standard of disclosure. It has been noted above that the relationship with the previous standard of care, as laid down in Bolam, is still challenging, leaving the balance between doctor-centred and patient-centred approaches in a problematic state.

When it comes to the enunciation of the standard of care, it can ultimately be said that the domestic context at least attempts to provide a clearer theoretical approach compared to the Italian one. However, both share challenges of a possible return to a paternalistic stance, since the balance between medical and patient’s contribution is not clear in either of the legal systems.

Degree of disclosure

A further key issue to be comparatively analysed is the degree of information disclosure. This is a clear point of difference between the two legal systems. When Italian law specifies the characteristics of the disclosure process, it mentions a ‘complete’ ⁷⁵ disclosure of information. However, it is not clear whether complete means full disclosure or whether there is any room for a more tailored approach that considers the patient’s needs and circumstances. Although in the same section the Act mentions the importance of sharing information that a patient can understand, this does not in any way safeguard against a process of information disclosure whose content is tailored around a doctor-centred stance, more than a patient-centred one. In addition, the right to refuse IC cannot go sufficiently far to safeguard patient-centredness, but can only promote the possibility of a refusal of information from the patient’s side altogether. The Italian approach is crucially different from their Montgomery ⁷⁶ counterpart where the materiality test clearly outlines the importance of both medical expertise and patients’ contributions ⁷⁷ , and in no way seems to suggest that complete disclosure is the norm. In the latter context, the degree of disclosure is very much dependent on the circumstances of the case and the needs of patients. ⁷⁸

Such uncertainty concerning the degree of disclosure also risks leading to a possible return to a doctor-centred approach, and with it an undermining of the ‘good intentions’ behind IC.

Ultimately, when it comes to the definition of a standard of disclosure, both legal systems share the same challenge. The balance between the doctors’ involvement and patients’ involvement is clearly left unresolved in both legal systems. Conversely, when it comes to the degree of information disclosure, the approach appears to be markedly different. The Italian system calls for a process of complete disclosure, without specifying what this actually entails, whereas Montgomery highlights the importance of a more patient-tailored approach.

The lack of a clear safeguard of IC in both legal systems

Having analysed some preliminary comparative aspects of IC in both legal systems, this section delves into a key shared challenge: the gulf between the ‘good intentions’ of IC and the ‘law in practice’. In other words, the gap between the enunciation of principles of medical partnership and autonomy, and the lack of a clear safeguard of these. This, crucially, calls for a wider reflection on IC, if this key patient right is to become more than an ‘empty promise’.

The key reason why, in both systems, IC risks being an ‘empty promise’ is evidenced by the lack of a clear safeguarding of IC per se. The ‘San Martino bis judgment’ analysed above tried to go further than Montgomery, attempting to outline five hypotheses in which IC could be protected, and hence the circumstances in which a successful claim for violation of IC can be brought. However, the only hypothesis mentioned in which IC per se might be safeguarded is likely to be very rare and difficult to satisfy. ⁷⁹ This also does not exempt the claimant from the burden of proving the existence of harm ⁸⁰ connected to the violation of IC, rendering the idea of a protection of IC per se an illusion.

The same challenge is evident in England, Wales, and Scotland and is mostly related to how the law of negligence is structured. As has been highlighted above, the inherent limitations of proving factual and legal causation imply that practically IC is only safeguarded when a harm to patient arises, beyond harm to autonomy. A violation of IC per se is, even in the domestic context, not considered to be significant enough for a successful claim in negligence to arise.

What this means in practice is that there is little, if any, room for the ‘good intentions’ stated in both Montgomery and within the Italian legislation and case law ⁸¹ to be translated into robust legal protection. Both legal systems have clearly embarked on a journey where patient-centredness is valued, at least in theory, more and more via IC. However, as outlined above, the crucial challenge that both legal systems face stands in the difficulty of translating these ‘good intentions’ into reality through the possibility of a successful legal claim for patients.

The existence of such a gap calls for further research on IC, particularly regarding how to enhance its safeguarding in court. It is not the intention of this article to outline what exact shape a legal reform should take, but to suggest that this should embrace a clear focus: a protection of the principle of medical partnership and autonomy. Research should also consider the implications of any revised approach for the National Health Service (NHS), particularly its costs, ⁸² and the risk that this might feed a ‘fear of the law’ ⁸³ culture among clinicians. In addition, whether or not legal reforms are pursued, this should also be coupled with a reflection on possible policy changes. Professional guidelines will need to play a vital role in this context. In light of the publication of the GMC 2020 guidelines on consent ⁸⁴ and the core relevance attributed to IC in this guidance, there are also signs that a slow, yet positive cultural change is occurring, where IC is valued not as a tick-box exercise or a one-off event ⁸⁵ but as a process which concretely hears and values every patient’s journey.

Conclusion

This article has embarked on a comparative exercise between Italy and England, Wales, and Scotland on the law surrounding IC. It has outlined that both legal systems share a desire to value IC as a tool to endorse patient-centred practices (autonomy) and the relevance of medical partnership, which have been here framed as the ‘good intentions’ behind IC. The Supreme Court judgment in Montgomery and the Italian law n. 219/2017 are good examples of this approach. This can be clearly summarised with reference to the same Italian law, which states that the time spent in a fruitful conversation with the patient is all part of medical care. ⁸⁶

However, the ‘good intentions’ of valuing patient autonomy and medical partnerships through IC are crucially marked by the inherent limitations surrounding this area of the law. In the domestic context, there is still a pervasive influence played by the previous doctor-centred standard of care in Bolam, which is ill-placed to safeguard IC. The Italian legislation is also not clear on the standard of disclosure, since it does not expressly mention how this standard is going to be addressed. It also raises concerns about the ‘complete’ disclosure process and the risk of this amounting to an overly inflexible approach. Both legal systems also face the inevitable challenge of the lack of a means to redress a violation of IC per se, when this is not connected with the existence of a harm.

In light of such challenges, it is of key importance to brainstorm new ways to better translate into practice the ‘good intentions’ behind IC in order for these to become more than an ‘empty promise’. Ultimately, if both medical partnerships and patient autonomy are to be safeguarded in practice – as they should be – new, clearer directions need to be explored by both lawmakers and policymakers.