The NHS Consultants' Association

Patients` Rights in Europe: the Health Services Directive

It was Prime Minister Margaret Thatcher, before her Eurosceptic anti-Jacques Delors period, who espoused the Single European Act, at that time the most significant development and strengthening of the European Community, as it was then known, since its inception in the 1950s. She saw this as the means to provide a market of (eventually) close on 500,000,000 people for the UK`s successful service industries (banking, insurance, etc.) to exploit. To prevent any member state (France?) from blocking the development of this new market, she supported the invention of qualified majority voting (QMV) and the granting of increased powers for the European Parliament; hitherto all decisions had been made on the basis of unanimity of all member states meeting in the Council of the European Community. Since then, the use of QMV has been much extended and the powers of the European Parliament greatly increased, in the Treaties of Maastricht, Amsterdam, and Nice, and in the “Reform Treaty”, currently under discussion, such that nowadays nearly all decisions in the European Union (EU) are taken on the basis of equality of powers between Parliament (EP) and Council (EC), with decisions in the Council being made by QMV. These reforms in the ways that both the EC and EP operate have enabled the introduction of radical legislation to support the operation of the Single Market, and the new Health Services Directive appears likely to add to the list of such pieces of legislation.

For manufactured goods, the Single Market became more or less completed by the late 1990s, and all legislation on industrial standards and trade, etc., takes place at EU level. However, member states were still able to enforce restrictions on the operation of the free market in the sphere of services (for example, France was very successful at limiting the capacity of the UK insurance industry to operate as freely in France as in the UK). So the European Commission (EC) proposed to the EP and EC a massive new piece of legislation, the Services Directive, designed to “free up” the provision of all services across the EU. In its original form, the Services Directive covered all services, including, therefore, both health and education services; however, many MEPs saw health and education services as “different”, and the Socialist Group led a move to remove them from this legislation. However, so as to achieve a majority for this, their amendment included an instruction to the EC to introduce special legislation for these particular services (because many MEPs were not content that services implicating such substantial components of the GDP of member states should be excluded altogether from the operation of the Single Market); accordingly, but after considerable acrimony, health services were excluded from the Services Directive, which finally passed into law in December 2007; member states have a short period of grace during which they are required to implement it.

Meanwhile, as the EC was required to introduce specific health services-related legislation, it undertook an extensive consultation on how this should happen, over what timescale, and on what should be included; many UK-based bodies responded to this consultation exercise. DG Sanco (the Directorate General of the EC responsible for Health and Consumer Affairs) has been proceeding towards presentation of legislative proposals, based on the outcomes of the consultation, for some months. However, this work has taken place in the midst of an increasingly frenetic political atmosphere in Brussels. On one side are many MEPs (and the EP Socialist Group in general) and those working in the health services as operating in most member states, and their representatives, who share a common vision of such services as being inherently different to other more “commercial” services; throughout the EU there is a perception of health services as being organised close to local communities in a manner designed to meet their specific needs, and essentially in a non-commercial manner. On the other side are powerful interests (apparently including certain Commissioners and their civil servants working in other DGs of the EC, and also substantial numbers of MEPs, mainly from the more right wing parties in the EP) who see health services as a vital 10% of the EU`s GDP, such that they cannot on principle be allowed any substantial exclusion from the Single Market. The BBC and other media had been primed that the new draft Directive would be published shortly before Christmas 2007, and there was a detailed interview on this subject on the Radio 4 Today programme on the day in question – but no Directive appeared. The Commission itself met that morning (supposedly to ratify agreement to the new proposed legislation), but it seems that objections from DG Internal Market, concerned that far too many concessions were being made to the health lobby, forced a rethink, so that no draft legislation was available on the afternoon when it had been promised. However, DG Sanco continue to insist that it will appear very shortly – indeed, current information (at the time of writing) is that it will be published on 2^nd April.

The original Services Directive had included within its legislative proposals for health services (amongst others) arrangements for freeing up procedures:

• for patients to obtain treatment wherever they wished throughout the EU,

• for telemedicine services across EU internal borders,

• for services based in one member state to provide services in another (so that, for example, the Manchester Royal Infirmary could set up services in Amsterdam, or so that a German joint replacement provider could operate in Bristol, each operating within the normal arrangements for health services provision in the host member state), and

• for designation of EU centres of reference (for example, for management of certain “rare diseases”).

Following its consultation exercise, DG Sanco concluded that it was not practicable to introduce all of the above in one piece of legislation, and that, in the case of health services, the principles of the Single Market could only be introduced practically in several stages, if any degree of consent for this was to be obtained. It was therefore envisaged that several separate pieces of legislation might be required, and that the first of these would limit itself to the first bullet point above, as current practice in this area (to limit treatment possibilities, in most cases, to those available in the country of residence, irrespective of whether services are provided in either Bismarckian or Beveridgean models of health care) has been declared to be illegal by the European Court of Justice (ECJ) (the best known case in the UK concerned a Mrs Watts, who obtained her hip replacement in France, for which her PCT was ordered to pay by the ECJ).

The draft legislation, at least in its form current as at the end of January, has been widely available, and was indeed the subject of a meeting at that time in the Royal College of Physicians of London, at which the main speaker was Robert Madelin, the Director General (senior civil servant) of DG Sanco. The new Directive would enable patients to obtain investigation and treatment services anywhere in the EU. For any services not requiring any overnight stay (primary care, day hospital care or investigation services, etc.), no advance notice to the “purchasing organisation” (e.g. the PCT covering the area where the patient lives in England, the social insurance fund in Germany, etc.) would be necessary. For elective inpatient investigation or treatment, the purchaser would have to be informed in advance, but it appears that they would not normally have any power to prevent such arrangements being pursued. However, the patient would be expected to pay for the health services received, and to reclaim these costs subsequently from the purchaser. In such circumstances, the purchaser would be liable only to pay the costs to the limit payable for similar services in the “home” member state, although if the patient can demonstrate that other special circumstances apply (such as “unreasonable delay” to provide necessary treatment in the “home” country, the purchaser might have to cover all investigation and treatment costs, even if higher than would have been expected at home).

Legal responsibility for service delivery, professional accountability, complaints, etc., would all be located in the country of treatment, rather than in any patient`s home member state. Following major surgery or other treatment, aftercare, rehabilitation, etc., could be obtained where this treatment was received, paid for on a similar basis; however, following discharge from hospital, it is likely that most patients would wish to return home, as to stay near the treatment hospital would require, for most people, hotel expenses to be incurred, which could not be reclaimed,. So in most cases it is likely that such aftercare will be sought back at home; this will necessitate much improved systems of communication (including electronic systems for patient records, etc.). The proposed legislation includes requirements for better information systems generally, including for would-be patients to obtain information on opportunities available to them in other member states, and on quality assurance of potential service providers; all member states will be required to set up an official “clearing house” for information of this kind, through which would-be providers could advertise their services, if quality requirements are satisfied.

The aspect of these proposals that has been most criticised is the expectation that patients would be expected to pay for care received “up front”, reclaiming the money back subsequently; this would appear to promote social inequality, by favouring those with the means to obtain such immediate cash, even if only for a short period. The proposal is surprising, as it is foreign to custom and practice in most parts of the EU: the general expectation in both Bismarkian and Beveridgean health services is that most treatment (and certainly hospital treatment) is free at the point of delivery (the only obvious exception to this practice is France). However, the EC states that it would be possible for member state governments to make arrangements for prepayment on behalf of their citizens when they receive care elsewhere in the EU, but there would not appear to be much incentive for governments to facilitate such arrangements.

The Directive would not seek to interfere with “social security” (in EU jargon this includes health services) arrangements in member states, and therefore sees the strategic planning of health services as remaining as the responsibility of the member states. However, health service planners are alarmed at the possibility of either major outflows of patients (rendering local hospitals financially unviable), or major patient inflows which might prejudice the availability of health care to local residents. In practice, such worries are much more likely to be realised in continental Europe, where open borders are close to population centres on both sides, than in the UK, although similar substantial patient flows might occur in south east England.

Should the NHSCA develop a formal position on the Health Services Directive? The main issues to consider would appear to be:

• is it appropriate that patients should have complete freedom of choice as regards where to be investigated and treated throughout the EU , including in private sector institutions?

• do the current proposals for patients to pay for treatment and to reclaim costs later promote greater social inequality, and, if so, what should be done about this?

• do these proposals present real threats to the viability of services for local populations?

• will the promised information systems provide adequate advice to patients, including on quality assurance, and will proper continuity of care be assured, when this is provided in more than one EU member state?

CHRISTOPHER BIRT

Guest Editor