Healthcare across EU borders: a safe framework - European Union Committee Contents

CHAPTER 7: Redress and indemnity

The issue

138.  In this chapter, we examine the draft Directive's provisions for redress and compensation, including the provisions on clinical negligence insurance or indemnity (see Box 5).

The proposal

139.  Article 5(1)(d) obliges Member States to ensure that patients have a means of making complaints and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive. Under Article 4 of the draft Directive, "harm" is defined as "adverse outcomes or injuries stemming from the provision of healthcare".

140.  Article 5(1)(e) obliges Member States to ensure that systems of professional liability insurance "or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk" are in place for treatment provided in their territory.

141.  A range of systems are deployed across the EU for the provision of indemnity arrangements, ranging from voluntary systems to mandatory systems that place the obligation either on individual practitioners or on the healthcare institutions. The position in the UK is explained in Box 5.


Clinical negligence claims in the UK

Under the Medical Act 1983 (Amendment) and Miscellaneous Amendments Order 2006, and the Dentists Act 1984 (Amendment) Order 2005, licensed primary care medical and dental practitioners must have adequate and appropriate insurance or indemnity cover, as explained below.

All clinical negligence claims against member NHS bodies in secondary care—care which is typically provided in local hospitals on referral from primary care—are handled by the Clinical Negligence Scheme for Trusts, which is run by the National Health Service Litigation Authority.

In primary care—care received on first contact with the medical system—medical defence organisations (such as the Medical Defence Union and the Medical Protection Society) offer one of the systems below, or a combination of both, against the cost of clinical negligence claims brought against primary care providers such as GPs and dentists.

Clinical negligence insurance provides a contractual right to assistance for professional negligence claims arising out of treatment in the primary care and independent sectors, subject to the terms of the policy. Financial limits are applied. Cover is provided on a "claims-made" basis, which means that existing members are entitled to assistance as long as they were a member at the time of the incident. Cover is discretionary for those who have ceased to be members.

Under a system of discretionary indemnity, cover is provided at the discretion of the indemnifying organisation and is not therefore guaranteed. There are no financial caps and it is offered on a "claims-incurred" basis which means that all claims that arise from any period when an individual was a member of the scheme fall within the cover even if the claim may be reported many years after they ceased to be a member.

142.  The Medical Defence Union (MDU) outlined their understanding of provision in most other EU countries. In Austria, Germany, Latvia and France and Slovakia it is mandatory for doctors to have insurance. In the Czech Republic, Finland, Hungary, Poland and Spain there is a requirement for healthcare institutions and individual doctors to be insured. In Lithuania and Portugal there is a requirement for institutions to be insured and it is advised that doctors be insured. In Italy and Estonia, insurance is voluntary. In Denmark and the Netherlands there is a state indemnity scheme. Sweden also has a state indemnity scheme but there is an additional requirement that doctors practising in the private sector are insured either personally or through the service companies in which they work. Discretionary indemnity is allowed in the UK, Ireland and Malta. The MDU were unclear of the provisions in Greece, Luxembourg and Slovenia. (Q 108)


143.  The importance of a system of redress was emphasised by a number of witnesses. The General Medical Council asserted: "there have to be effective systems that lead to regulatory action or redress for patients if they have been harmed." (Q 192) The Medical Protection Society agreed and indicated that, in many European countries, "it is actually very difficult to bring a claim against a doctor." (Q 127) UNISON warned that there was inadequate consideration of how compensation procedures would operate in a cross-border situation, which could lead to lengthy, complicated and expensive legal procedures becoming the norm. (p 134) PA Consulting took the view that a proportion of cross-border healthcare procedures were likely to go wrong and, if it was not clear what would happen in those circumstances, "we would certainly be worried". (Q 32)

144.  Dawn Primarolo MP, Minister of State, explained, "Our view is that Article 5 is not clear enough with regards to how complaints, liability and negligence fit together", although she agreed that patients would be subject to the systems in place in the host Member State. (Q 76) As such, she warned that UK citizens may not receive as much cover as they would expect in the UK and may therefore wish to insure themselves further. PA Consulting emphasised how critical the transparency of the complaint procedure was, and that patients must be aware of how to make a complaint. (Q 24)

145.  The Minister added that clarification would be needed about how the home Member State might deal with problems caused in the host Member State. (Q 78) Similarly, the BMA suggested that the system of redress should allow for a mechanism by which the home Member State could claim compensation for the cost of rectifying clinical mistakes made by the host Member State. (p 119)

146.  The importance of patient information on redress mechanisms was referred to by several witnesses (see paragraph 100). The British Medical Association wanted absolute clarity that redress could be obtained across international boundaries, and how that was done should be a clear part of the information available to patients. (Q 312) More specifically, the Law Society believed that the Directive should include an express information obligation on Member States, informing patients at the point of delivery of the appropriate avenue for complaints and judicial recourse. (pp 167-168)

Definition of "harm"

147.  A number of witnesses questioned the definition of "harm" in the draft Directive (see paragraph 139), considering that it fails to distinguish between harm caused by poor care and accidental harm. The British Medical Association supported the amendment of the definition of harm along the lines of "avoidable adverse outcomes or injuries stemming from the provision of healthcare". (p 130) They would ideally like to see such a definition accompanied by a "no-fault" compensation system that would provide for compensation in cases of accidental harm that were not related to poor quality or inappropriate care.

148.  Contributors to the NHS European Office's consultation on the directive also identified the definition of "harm" in the Directive as "very problematic". The proposed definition should be replaced by a reference to "adverse events" or a definition based on avoidable incidents arising from negligence which resulted in serious harm. (p 112)

149.  UNISON considered the Directive's approach to redress and professional liability to be "too simplistic". In their view, the Directive assumed that a health professional was always culpable, whereas the building or conditions in which the worker is providing services could have an equally important bearing on serious incidents taking place. (p 134)

150.  The Commissioner confirmed that the intention of the Directive was not to cover unavoidable harm and that the Commission would have no hesitation in accepting an amendment to the Directive that would clarify this. (Q 396)

Provision of indemnity

151.  The Medical Defence Union (MDU), which operates a system of insurance, took the view that patients rely on the state to ensure that there are adequate provisions in place for healthcare indemnity. It therefore considered that "it is in the interests of protecting patients that there should be an EU-wide requirement for mandatory regulated insurance or state systems providing equal certainty in respect of liability for clinical negligence claims." (Q 99) The MDU concluded that all patients who are negligently harmed as a result of healthcare must be confident that they would receive compensation, regardless of the Member State of treatment. It did not consider that discretionary indemnity would meet the expectations of the majority of EU patients as it is only used in the UK, Ireland and Malta. (Q 108)

152.  The MDU was concerned that the wording of Article 5(1)(e) could be interpreted as allowing discretionary indemnity to be used for clinical negligence claims. (p 36) By contrast, the Medical Protection Society (MPS), which operates a system of discretionary indemnity, was supportive of Article 5(1)(e) and considered that its construction "encompasses both insurance and other equivalent arrangements, such as discretionary indemnity." (Q 120, p44) It was acknowledged by the MPS, however, that "discretionary indemnity is likely to be a concept that is not familiar to a number of Member States." (p 44)

153.  As the General Medical Council recalled, the UK Parliament discussed the merits of insurance and discretionary indemnity in the course of its debates[44] on the amendments to the Medical Act 1983 and the Dentists Act 1984 (see Box 5). When adopting that legislation, Parliament allowed the possibility of both insurance and indemnity, reflecting the fact that, in the UK, "there is a long history of successful protection of patients through indemnity as well as insurance." (Q 225)

154.  Some of our witnesses asserted that it was above all crucial to ensure that Member States maintained the right to determine their own mechanisms for patients to seek redress and indemnity if they were to suffer harm as a result of cross-border healthcare. (Q 130, p 157)

Conclusions and recommendations

155.  The availability, and public awareness, of a transparent complaints and redress mechanism for patients is critical to the functioning of a cross-border healthcare system in the EU's internal market. We consider that not only should the Directive require a means of redress to be in place but that Article 5(1)(d) should be amended so as to require that the redress process be transparent and that patients must be aware of it. Information on the applicable redress mechanism should be made available to patients when investigating the possibility of securing healthcare treatment in a different Member State and responsibility for provision of that information should be made clear.

156.  The Directive does not provide clarity on how the home Member State might seek compensation from the host Member State for the cost of rectifying clinical mistakes made by the host Member State. For the purpose of delivering cross-border healthcare, we consider it essential that the Commission examines how a home Member State may be able to claim compensation for the cost of tackling problems caused by clinical errors in the host Member State.

157.  The definition of "harm" in the draft Directive does not distinguish between harm caused by poor or negligent care and accidental harm. We recommend that the definition be amended to ensure that it does not cover unavoidable harm. We would also emphasise that provision should be made for compensation in the event of accidental harm.

158.  It is important, as indicated in the draft Directive, that practitioners hold professional liability insurance or similar and it is also crucial that the principle of subsidiarity be respected. We consider that the precise nature of the insurance system or similar is a matter for each individual Member State. However, we recommend that clear information on the systems chosen by each Member State must be made available to patients at the national contact point in the home Member State. This information should include the extent of insurance cover for institutions and practitioners and the implications of insurance systems for patients and practitioners.

44   For example, HL Deb 6 July 2006 cols 399-403 Back

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