Patient Safety

The National Health Service (Cross Border Healthcare) Regulations 2013, implementing EU Directive 2011/24/EU, should represent a new frontier in patient autonomy. The freedom to access treatment elsewhere in the EU allows some patients to sidestep waiting lists for surgery and exercise self-determination in when and where they seek care; the Directive also reinforces the rights-based model of healthcare that has become increasingly prevalent in the UK  since the mid-1980s. Progress has been slow, and many enormous challenges remain, but the landscape and culture of the NHS has changed significantly. Patients now enjoy a much greater degree of autonomy: the law on consent leans heavily towards the patient, who can now expect to be comprehensively advised on treatment options and relative risk; NHS organisations are now bound by a statutory duty of candour to offer meaningful explanations when treatment has failed. Do NHS patients really want to lose these protections by undergoing treatment abroad under a different health system, whether by a state or private provider?

Beyond the immediate benefits of the Directive lie serious issues for patients; how can patients harmed by negligent treatment seek redress, and should the state be doing more to protect them? The maxim characterising the Directive has been: 'If you are entitled to it here, you can get it there'. This builds understandable boundaries around the NHS' obligation to approve funding, and lends a large degree of foreseeability. However, this reciprocity is not reflected in the accountability provisions. Unsurprisingly, professional and regulatory bodies were keen to seek advice on what the liability position for their members would be, and organisations like the British Medical Association and the Royal College of Nurses were quick to establish that responsibility for negligent treatment lay with the provider of the service, not the NHS.

One of my key areas of interest is the liability and indemnity position of the NHS where it has outsourced services to the private sector, and where this leaves the patient injured by a private provider. In 2007, we acted in a case arising from the Government's Independent Sector Treatment Centre programme, where a patient suffered a severe burn injury from a diathermy wand during a hip replacement operation, performed by surgeons from the South African healthcare provider Netcare operating at the Haslar Hospital Portsmouth. Despite the negligence being attributed to Netcare's surgeons, an unseemly battle ensued over responsibility for the patient's injuries and corrective surgery, and the Claimant had no option but to sue the NHS.

In the outsourcing claims we handle today, nearly a decade on from the Netcare scandal, the NHS remains the proper Defendant in these claims, and it remains unclear whether compensation and costs liabilities are being recouped by the NHS from private providers. However, in this scenario, the injured patient at least has recourse to a solvent, responsible body when things go wrong. Take away the overarching duty of the NHS to its patients, and the positon of claimants becomes dicier.

My experience in litigating cross-jurisdictional claims has focused on the private sector – patients travelling abroad, for various forms of surgery, to be treated at independent clinics. The nature of the Defendant in these cases is hugely significant – is the treatment provider, or its surgeons, properly insured? Are there any contractual or statutory provisions stipulating that actions against it must be commenced in the foreign jurisdiction? Even if these criteria are met, a Claimant who secures a Court judgement in his or her home jurisdiction may struggle to enforce that judgement against the overseas provider. 

From a patient perspective, the concern is that, if the NHS is not responsible for patients seeking treatment abroad under the Directive, the ability to seek redress for negligent treatment is significantly diminished. Even where a patient is receiving treatment from, say, a member state provider, with funding approved by the NHS, if the treatment fails he or she will be in no better a position than the privately-paying individual, as liability will have, ostensibly, been handed over to the provider of the treatment. Medical travel (or, more colloquially, medical tourism) comes with its own risks, and it seems that patients taking advantage of the Directive may be exposing themselves to these without the benefit of the NHS safety-net. I believe that NHS patients travelling abroad for treatment must remain the responsibility of the NHS, with mechanisms in place to claw back any losses, and the expense of corrective surgery for returning patients. Otherwise, the benefits of the Directive to UK nationals are significantly reduced.

The Directive and patient choice

The take-up of the rights conferred by the Directive has been low, in spite of growing waiting lists, evidence of implicit rationing of certain treatments and concerns over standards of care as fresh scandals emerge in the NHS. The argument has been raised that there is insufficient awareness of the Directive across Europe; the European Commission's 'state of play' report on the Directive, published in September 2015, noted that, while there had been 'improved transparency and patient mobility throughout the EU', around half of member states were not making it clear which treatments required prior authorisation, with others applying funding calculations that did not fully reimburse patients who had already sought treatment. 'If you are entitled to it here, you can get it there', therefore, becomes more complicated.

Consent

English law has entered an era in which the well-informed patient is being placed at the heart of medical services. The recent ruling in Montgomery v Lanarkshire Health Board  signalled a significant step forward for patient choice over medical paternalism; a patient is entitled to receive any information that he or she may reasonably find significant, failing which the consent they give before a procedure may be rendered void. Coupled with the increasing trend in healthcare for patients to be treated as consumers of services, the developing picture is one of diminishing medical paternalism and a greater emphasis on the prerogative of the patient.

In this context, a patient in The UK will have an expectation, founded in law, of a certain standard of pre-treatment information. As the NHS authorises treatment abroad, can it be assured that the high standards to which it is bound are upheld after a patient disembarks at an overseas airport? The Lords Justices in Montgomery concluded that the duty of a doctor to inform his patient extended beyond simply supplying outcomes statistics or other literature; there needs to be real dialogue between doctor and patient, with the former ensuring that the risks are genuinely understood. Transpose this stipulation to hospitals elsewhere in Europe – differing legal and regulatory standards, language barriers and expectations of consent may make this difficult, if not impossible, to achieve.

Data, safety and monitoring of contracts 

I acted for the families caught up in the Bristol children's cardiac surgery scandal of the 1990s, leading to the 2001 Kennedy Report which heralded a sea-change in clinical accountability, audit and evaluation of NHS services on a national level. However, even in The UK, accurate, informative data can be difficult to locate. In my specialism of child heart surgery, hospitals do collect data on mortality, but only up to a 30-day cut-off point; deaths occurring outside this window can be recorded as successful outcomes. In addition, despite the dozens of children who suffered severe neurological damage as a result of negligent surgery at Bristol, there is still no centralised collection of data on cardiac morbidity, meaning that those suffering life-limiting complications are not recognised as surgical failures. In this context, families choosing a cardiac centre in in The UK often struggle to interpret the data to make properly informed decisions about units and surgeons; how much more difficult will this be when considering the performance of hospitals overseas?

The health think tank Centre for Health and the Public Interest (CHPI) has published a report identifying concerns over the ability of the NHS to manage and monitor the safety of outsourcing contracts within The UK , which makes it even more difficult to see how cross-jurisdictional arrangements with private providers, with the NHS at an even greater remove, will be monitored. This is a concern for patient and NHS alike; it may prove to be far more difficult for the NHS to divest itself of legal responsibility to the patient where it has approved both the treatment and the establishment carrying it out.

Accreditation is not a familiar concept in the UK, and there is no universally accepted system of accreditation of hospitals and clinics, although bodies such as the US JCI (Joint Commission International) have reported a significant increase in membership numbers over the last ten years. The JCI appears to hold less sway in the EU than in the US.

Legal redress

Medical travel was, of course, taking place long before the implementation of the Directive, and is a phenomenon that is becoming increasingly prevalent in a globalised healthcare environment. Putting aside any political arguments, one of the cornerstones of English medical care is that patients who have suffered avoidable injury as a result of negligence expect to be able to claim compensation for their losses. How this translates into the multifarious world of treatment under the Directive is an issue requiring further consideration.

My experience is that, when faced with the threat of legal action, overseas clinics and surgeons often seek to take advantage of the discrepancies in national laws, as well as jurisdictional hurdles for the claimant, in an attempt to escape liability and shift the blame to the surgeon, who may turn out to be uninsured and, possibly, untraceable. Foreign clinics and doctors are often uninsured for medical negligence claims, with clinics not regulated to satisfactory standards. There are also concerns over the regulation of the devices used in these operations, such as breast implants. In many of these cases where foreign treatment has failed, sometimes with disastrous results, it can be difficult, if not impossible, for us to obtain compensation for the client.

The complications below will not arise if patients, exercising their rights under the Directive, remain NHS patients; otherwise, they may face numerous obstacles. The legal basis of the arrangement between patient, NHS and foreign clinic or hospital is unclear. The Directive extends to state as well as private establishments. Where patients are expected to enter into contractual arrangements, this would bring into play EU consumer contract provisions entitling the patient to choose jurisdiction.

Much of the work carried out in overseas hospitals and clinics across Europe will be of the highest standard, but my experience is, of course, skewed by the fact that I only see patients who have suffered an adverse outcome. In private overseas treatment, however, my experience of the cases that have been referred to us is that it is rare for a patient to have signed meaningful documentation with the hospital or clinic, setting out the responsibilities of the treating body, the nature of the treatment to be carried out, what will happen in the event of post-operative complications, the full cost of the procedure, the insurance position and how any post-operative complications will be addressed. Even though such terms may not be upheld by Courts across the EU, the hospital or clinic may insert terms into the contractual documentation which purport to limit or exclude its legal responsibility and liability.  It will often insert a jurisdiction clause, which will generally stipulate that any litigation or legal dispute must be pursued in the hospital or clinic's home jurisdiction. 

When no jurisdiction clause exists, we have successfully applied to the Courts in The UK, where our Courts have accepted jurisdiction to hear the case in this country. There are, however, further procedural points to contend with. Even within the EU, no two legal systems are the same, and many countries have different limitation periods to our three-year period: Hungary and Italy, for example, are five years, France 10, but Spain is one year.  Some countries do not recognise the concept of a continuing tort, or do not extend the commencement of the running of time to reflect date of knowledge as we do. 

Even if our Courts accept jurisdiction, however, there remains a separate issue over the 'applicable law'; the system of law to be applied by our Courts when determining the case.  Generally, but not always, our Courts will apply the legal system and principles of the foreign hospital or clinic to the substantive elements of the case, but English law to the procedural aspects. 'Substantive' elements would include the interpretation of the contractual terms, the extent of the duty of care owed by the doctor or clinic and the standard of care to be applied. 'Procedural' elements would include the losses that can be claimed, how damages are assessed and whether or not to apply a damages cap or tariff system.

Any analysis of the contractual and jurisdictional implications of the arrangements between patient and clinic involves consideration of how the treatment was advertised, the claims and representations made by the clinic or a facilitator, the contents of the documents and the sequence in which the documentation was seen and/or signed by the parties.

To succeed in an application to have a claim heard in our client's home jurisdiction, we have to demonstrate key factors linking the contractual arrangements and the treatment to this country. Claims within the EU are governed by the Brussels Regulation (recast), passed earlier this year; this covers jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. An English judgment should be enforceable in all other EU countries; however, if the clinic is uninsured or holds no assets, it may be impossible to enforce and collect money under that judgment. 

Indemnity

This is a particular concern. The level of monitoring and oversight of these contracts is crucial, and we need to be assured that the NHS is taking steps, on behalf of the taxpayer, to be in a position to secure reimbursement from a private provider in the event of failures in outsourced treatment. As discussed above in the context of the Netcare scandal, and, more recently, in the Musgrove Park NHS-Vanguard cataract outsourcing saga (something I have dubbed 'Netcare Revisited') , an outsourced patient will remain the responsibility of the NHS in the absence of an agreement to the contrary with the provider. To date, I have yet to see clear evidence that the NHS is enforcing any commitment from the private provider to indemnify the NHS for its losses and compensation pay-outs; the impression from the outside is that, because of their haste to outsource services and shorten waiting lists, NHS trusts and their insurers find themselves meeting claims arising from the negligence of private companies without recourse.

Recent reports suggest that the major insurance broker Lockton is investigating indemnity arrangements on the commercial insurance market, with a reported 17 NHS trusts contemplating departure from the body that underwrites NHS services, the Clinical Negligence Scheme for Trusts (CNST). How the potentially gargantuan liabilities of a full-service NHS trust could possibly be attractive to a commercial insurer remains unclear and, in the meantime, the outsourcing drive continues to accelerate. The fear is that inadequately insured outsourced providers may be unable to meet their obligations to injured patients, leaving the NHS to foot the bill. In the context of the Directive, the protection of the NHS may be removed entirely from those who are treated overseas, leaving patients with no choice but to brave the treacherous straits of cross-jurisdictional litigation in search of a remedy.

From my experience, if I were advising a would-be patient seeking to exercise his rights under the Directive, I would caution him to make sure that he remains, at all times, an NHS patient. He then has a clear route to financial redress if the treatment fails, and an understanding of who will be responsible for the costs of his future treatment in the event of complications or the need to post-operative follow-up.

Conclusion

Medical travel is not a passing phase, and the Directive is more a consummation of existing rights than a revolution. To date, I have not acted for a client who has exercised, or is contemplating the exercise of, his or her rights under the Directive, but I anticipate that it will not be long before claims of this kind begin to emerge. My team and I have are regularly approached by medical travel patients who have undergone a range of treatments including bariatric, ophthalmic, gender re-assignment and cosmetic surgery, and who have suffered often disastrous outcomes. Almost without exception, we have had to turn them away because of the near-impossibility of securing compensation, let alone answers and accountability. 

My article, published in Clinical Risk, sets out details of a claim we pursued against the Elyzea cosmetic surgery clinic in Belgium, on behalf of a British national, who suffered severe nerve damage . We secured jurisdiction in The UK, and succeeded in establishing negligence. Our client was awarded damages in excess of £100,000 plus our costs but, to date, none of this has been recovered, despite the fact that Elyzea is still operating and advertising its services. The case report encapsulates all of the problems faced by the medical traveller.

In the absence of clear evidence to the contrary, I can only conclude that, at present, the risks of medical travel under the Directive are a serious, prohibitive factor. This is not to detract from the potential benefits to patients – if regulated, monitored and executed adequately, there is much to be gained from a versatile, pan-European healthcare scheme. However, the concerns I have outlined above have, in many cases, remained unresolved for the best part of a decade and, unless they are addressed, I would hesitate to advocate use of the Directive. Patients must not be left to fend for themselves on this new frontier of healthcare.

APPENDIX – IS MEDICAL TRAVEL A COST OR BENEFIT TO THE NHS?

Although medical care is an imperative to patients, it is also an industry, and an opportunity to forge new marketplaces – something on which the providers of outsourced care to the NHS have been quick to capitalise. Arguments about whether The UK will attract more patients than it exports are moot; the perceived quality of NHS treatment must be balanced by questions over waiting times and policy. Nonetheless, inbound medical tourists can represent a significant revenue stream; since the Health and Social Care Act 2012 abolished 2% cap on NHS ‘private patient income.’ Now, only ‘the majority’ (51%) of a foundation trust's income must come from publicly-funded treatment, allowing significant opportunity for taking on paying overseas patients.

A study by Hanefeld, Smith et al in October 2013  found that inbound travel remained stable while outbound travel was increasing – the UK is now a net exporter of medical tourists. According to the Office for National Statistics' International Passenger Survey of 2014, some trusts reported that, although medical tourists made up only a small percentage of their total patient list (around 7%), this accounted for a quarter of their income. There are provisions in the guidance to the 2013 regulations implementing the Directive stating that providers of care do not have to prioritise care for inbound patients. The fear that an influx of overseas patients will consume the time and resources of NHS hospitals should, therefore, be allayed, although the potential income for trusts that may otherwise be struggling for funds cannot but be seductive.

There is, of course, a milieu of considerations over the relative benefits of medical tourism. A 2014 study carried out by the University of York  found that over a quarter of multiple births result from overseas fertility treatment, costing the NHS, in 2010, around £15.5m. Cosmetic tourism resulted in a cost of £8.2m per annum to the NHS, as complications in returning patients were addressed. On the export side, sending patients abroad for bariatric surgery may represent a net saving for the NHS. Whatever the eventual arrangements, the basic position must be that any treatment costs incurred by inbound patients are recouped promptly and effectively – member states cannot simply be allowed to accrue substantial debts over care costs. A watertight and enforceable mechanism must be in place to facilitate this.

There are more formal international arrangements already in place, such as the partnership between South Kent Care Commission Group (CCG) and the Centre Hospitalier de Calais. The private French hospital will provide surgery to NHS patients, with the aim of reducing waiting lists, with Trust staff reassuring patents that the quality of care would be equal to that in Kent. Some 70 nurses will receive English lessons in preparation for the deal, which will cover general surgery, gynaecology, cataract surgery, pain management and orthopaedics. Clearly, borderless healthcare applies at all levels, from individuals to entire trusts.