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EU Cross-border Healthcare and Health Law

In: European Journal of Health Law
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  • 1 Professor Emerita of Health LawVice-Chair, European Association of Health LawThe Netherlands
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Introduction

The first report on the operation of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (hereafter referred to as the Directive) will be drawn up by the European Commission by 25 October 2015 (Article 20 of the Directive).1 The main emphasis of the reporting lays on patient flows, financial dimensions of patient mobility, including the system of prior authorisation for the reimbursement of costs of cross-border healthcare, national contact points and the implementation of the European reference networks. The forthcoming report was preceded by a Commission report of February 2014 on the possible effects resulting from the joint application of the Directive and the Social Security Regulations.2 At that time it was considered too early to draw conclusions on questions such as whether there were, or were not, any disproportional effects resulting from the implementation of the Directive, on the use Member States have made of the possibility to introduce prior authorisation systems under the Directive, and on the possible substitution effects with the Social Security Regulations. However, the report provides useful advice for the October 2015 impact measurement reporting. The concept of a medically justifiable time limit under the prior authorisation system should be the same under both the system of the Directive and the Social Security Regulations. Data gathering under both systems should be improved for the sake of comparison, as well as — in the case of the Directive — in order to demonstrate whether the system of prior authorisation (planned healthcare) meets the overall requirements of necessity and proportionality.

To be able to properly determine the substitution effects of the Directive on the number of patients that make use of the Social Security Regulations, the 2014 European Commission report insists upon a ‘baseline’ zero-measurement against which future impacts could be measured. The report also provides for a set of requirements for data assembling after transposition of the Directive. This will give insight in the dynamic impact of the Directive in relation to the Regulations. An example of this is the question whether more patients will receive prior authorisation under the Regulations as a result of additional information on undue delay coming available to patients under the Directive, or as a result of increased awareness about patients’ rights.3

The forthcoming 2015 report on the operation of the Directive is an opportunity to place the Directive in a broader perspective.

Financial Dimension, Prior Authorisation

In relation to the financial dimension of patient mobility, the European Court of Justice, in a judgment of 9 October 2014, has reiterated the limits to the financial duties of the Member State of affiliation.

The reimbursement of medical expenses incurred in another Member States cannot be refused where a lack of basic medical supplies and infrastructure makes it impossible for the insured person to receive hospital treatment in good time in his Member State of residence. The question whether it is impossible to receive hospital treatment must be assessed by reference to all the hospital establishments that are capable of providing the treatment in the Member State in question and of the period within which the treatment could be received in good time.4

Differences in (the application of) professional medical guidelines and recommendations among Member States can influence prior authorisation policies. Recently, this was the reason for Dutch health insurance companies (who as private undertakings are performing a public task) to tighten their rules by requiring prior authorisation for more medical interventions elsewhere in the European Union than before. This opens the door for authorisation policies to become based on a market-oriented, simplified standardisation of health services, rather than that the interest of the individual patient prevails. As pointed out by the president of the CPME in 2012; ‘it is in the nature of healthcare that it is a very individualised and specialised service which would put the patient at risk if reduced to a market-oriented technically simplified standardisation. Every patient has the right to receive optimal care, adapted to the individual situation’.5

Professional evidence-based guidelines and professional autonomy are fundamental to ensure quality of treatment and patients’ rights.6 It may well be that in a specific patient-case the best outcome can be achieved by deviating from the guideline. European standardisation of healthcare services (other than technical standardisation of the products and facilities supporting healthcare) by bringing them under the European standardisation system,7 a system that aims at the improvement of the free movement in the single economic market, may pose a threat to patient safety. This, aside from the quality differences between guidelines issued by the various guideline institutes in the EU Member States. The opposition by the CPME to the involvement of standardisation institutes in regulating healthcare services does not come as a surprise.8

National Contact Points (NCP)

National contact points (NCP) have a crucial position, as they are the ones who primarily should show patients the way when they wish to be treated in an EU Member State other than that of their affiliation.9, 10 The information must be easily accessible, sufficiently clear and adequate for well-informed decision-making by the patient. It should include information on the health system of the Member State in question, as well as information on individual patients’ rights11 and how these are implemented in daily practice. However, the NCP’s informational duty cannot replace the duty of the healthcare professional to provide the patient with the relevant information in the event of healthcare delivery in another Member State, irrespective of whether this is planned or unplanned.

Though built on the same principles, variations in their application among Member States, due to different legal frameworks and approaches, and cultural and ethical values, affect the way in which patients’ rights come to expression in daily practice. An EU cross-border web-site giving access per Member State to clearly specified rights, conditions and practicalities according to its national legislation along the lines as advised in the context of e-health by the art. 29 Data Protection Working Party on epSOS,12 would be a simple, patient friendly solution for meeting with the different approaches.

Pooling of Resources and Expertise

In times of scarcity, when national governments have to make priority choices in respect of their healthcare systems, pooling of resources and expertise, particularly in border regions, is indicated. Therefore it is of interest to also look into the question of whether, and if so, in how far, the Directive effectively contributes to such a pooling. If there are obstacles in this respect, the European Commission should be called upon to remove them (whereas para. 51 of the Directive). If one wants to gain full insight in the effects the Directive has on the accessibility of healthcare, insight in situations of ‘planned scarcity’ combined with “outsourcing” of specific health services to another Member State with more advantageous price levels would also be valuable.13 This in particular also against the background that some Member States consider the attraction of “foreign” patients (so-called export of healthcare) from elsewhere in the EU as a contributor to the earning capacities of the country.

Pooling of resources in the context of dynamic European Reference Networks (ERN, Art. 12 Directive), the third subject to be covered in the forthcoming report by the European Commission, must increase access to high quality, accessible and cost-effective healthcare services by patients with rare diseases requiring a particular concentration of resources or expertise. Pooling at European level of very special treatment facilities can significantly contribute to the national and European responsibility for the right to care for health. In the case of rare diseases in particular, in the long(er) run, their national availability might well become substituted by an international one. Important pre-conditions in this respect are not only a sound European policy, but also the acceptance at national level that some of the national health policies are supplemented or even in some cases replaced by European undertakings.14

Patient empowerment and patient centred care are core-elements of the Commission’s Delegated Decision on the subject matter.15 In relation to patients’ rights and the “whereas” of the Delegated Decision, refers to the Charter of Fundamental Rights, the EU clinical trials legislation and specifies in more detail the informed consent requirement necessary for exchange of personal (health) data between healthcare providers and members of an ERN.

For the purpose of informed consent, the use of a common single consent model subject to the requirements of the EU data protection legislation is recommended. 16

Electronic Data Exchange, Interoperability, Personal Health Data and Privacy Protection

Cross-border healthcare involves without question electronic exchange of personal health data between healthcare providers of different Member States. To facilitate such exchange, the e-Health Network17 has developed a first common set of guidelines on ‘minimum non exhaustive patient summary data set’.18, 19 Though designed for emergency or unplanned care events,20 they will no doubt have a radiating effect on planned cross-border care as well. The guidelines make it possible for patients, upon explicit request, to have a summary of their electronic health record available when visiting another Member State. The guidelines must be complemented by guidelines for discharge summaries.21

In the context of cross-border care, Member States need to ensure that processing and storage of patient data are interoperable from the technical and semantic point of view, irrespective whether use is made of e-health (including electronic health records, EHR) or m-health. ‘Legal interoperability’ is an essential requirement. Interoperability through a supranational central server as is sometimes suggested, would raise serious concerns about storing electronic medical records in a central location, in particular because of the privacy threat posed by a supranational network. A centralised system should only be developed after a decentralised system has proven to be unworkable.

By itself already, the protection of personal health data in cross-border healthcare and research situations is a challenge. Any form of cross-border healthcare, including e-health and m-health, involves the exchange of patient data. The European Data Protection Supervisor (EDPS) in its 200822 opinion on the proposal for the Cross-border Healthcare Directive pointed at the increased risks of cross-border exchange of data, such as inaccurate or illegitimate data processing. The lack of coordination of healthcare-related initiatives with regard to ICT use, privacy and security would hamper the adoption of a universal data protection approach towards healthcare, especially with regard to the use of new ICT technologies. In relation to this, the EDPS pointed more in particular at the necessity link and/or interconnect from the privacy perspective closely interrelated fields of EU legislation concerning organ donation and transplantation, telemedicine, and the electronic health records.

The Commission’s legal framework on cross-border interoperability of EHRs underlines patients’ self-determination as to storage and disclosure of personal data concerning health.23 The before mentioned guidelines of the e-Health Network put emphasis on the principles of proportionality and necessity, as well as on patients’ rights in relation to the personal data available in cross-border care, including questions about access and requests for rectification, erasure and blocking data.24, 25 In my opinion, it follows from the patients’ right to informational privacy that the patient should also have the possibility to indicate agreement with, respective refusal of secondary use of the data, notably for research purposes. This should be added to the e-Health Network’s list of patients’ rights in relation to their personal data in cross-border care. The patient in the driver’s seat. With the assistance of modern communication technology exemptions from the consent requirement for the secondary use of personal health date in research, as envisaged under the forthcoming Data Protection Regulation, can (and should) be kept to the minimum, taking into account the requirements of necessity and proportionality. A similar approach towards the autonomy of the patient should be followed in relation to the secondary use of human biological material.

Even with the adoption of a risk based approach in data-protection legal frameworks, ‘there is no question of the rights of individuals being weakened in respect of their personal data’. . . . ‘The key issue is respect for the patient’s reasonable expectation that their health information will be kept confidential and not used or disclosed without their consent than to those directly involved in patient care and directly related activity’.26 The aim of the forthcoming Data Protection Regulation is to put individuals back in control of their data by updating their rights in order to fully respect Article 8 of the EU Fundamental Rights Charter.27 The Delegated Decisions28 foreseen in the draft text to give guidance on the application of the EU data protection law in respect of health services are not intended to allow further limitations of the rights of the subjects,29 should have the patient’s autonomy as point of departure,30 and involve all stakeholders during the drafting process. Health law, being one of the stakeholders, should have significant input.

Patient Safety and Quality of Care in a Competitive Market

The Cross-border Directive is often seen as instrumental for opening up competitive markets, in particular for e- and m-health. Although they are not yet proven to be cost-benefit technologies, they are supposed to be important contributors to innovative and sustainable healthcare that could result in an increase in equity in access. However, in this respect, economic considerations that come with innovations and/or outcomes of research often constitute an impediment. Systems that primarily follow the rule of economics, as is often the case when the budget is slinking, are a serious risk for the symmetry of interests of the medical professional and the patient. To protect patients against an inducement of physicians by commercial factors, the CPME recently drew up guidelines on the transparency of relationships between physicians and the healthcare industry.31

In relation to cross-border healthcare, quality and safety is high on the EU agenda. Serious concerns about the effects of health-related EU legislation for patient safety have instigated a number of changes in relevant EU legislation.32 At the same time, the opportunity of the revision process was taken to enhance economic recovery. Time will show whether the revisions are sufficiently robust to meet with the potential conflicting interests of competition in a market economy on the one hand and patient interest as the central concern on the other.

Access to high quality healthcare is a patient right which must be safeguarded by the legal and economic framework. Healthcare is one of the largest economic sectors in the EU.

Although the Cross-border Directive refers in the first ‘whereas’ to Art. 168(1) TFEU on the high level of human health protection, its legal basis is Art. 114 TFEU on the functioning of the internal market and the free movement of goods person and services. This internal market perspective was strengthened during the constitution process of the new EU Commission in 2014. In the initial proposal, the Directorate General Health and Consumers was nearly decimated by bringing the European Medicines Agency under the Directorate General responsible for trade. Medicines may yet remain under Public Health, but the Commissioner in charge of Public Health and Food Safety has to work in tango with the Commissioner responsible for trade. Having two captains on one ship is asking for problems.

It is not unrealistic to predict that the main driver of EU policies concerning cross-border healthcare and related fields such as pharmaceuticals, medical devices, IVD’s and other health technologies, will be the market rather than the health interest of the patient. Yet, healthcare services cannot be equated to services that are purely commercial in nature; they are not subject to conventional market forces or competitiveness. Investing in health must be driven by the objective of improving patients’ outcomes and quality of care.33

The aim of improving economic competitiveness in healthcare must be accompanied by respect for fundamental social standards, patients’ rights and professional autonomy. For this, the implementation of the Directive will be a litmus test. In order to achieve the purpose of a high level of human protection, a ‘Health in All Policy’ within the Directorate General of Public Health, and between that DG and other Directorate Generals is a pre-requisite. Also, different cross-border policies followed by Member States in relation to public health threats, as was the case with EBOLA, are no longer appropriate.

The Directive and Patients’ Rights

Conditions essential for an effective implementation of the Directive are an overall increase in equity in access to healthcare services in the EU member states, that are safe and of good quality. Healthcare cannot be safe when respect for patients’ rights falls short. It is self-evident that patients’ rights must be part of the future agenda on quality of care with special emphasis on patient safety, at this moment under consideration by the EC.34

The Directive requires complaint procedures and systems of professional liability being in place, stipulates protection of privacy with respect to the processing of personal data in accordance with respective EU rules and gives the patient a right to access his/her medical record (remote or by cc). In relation to Article 12 of the Directive on European Reference Networks, in addition to the right of access to healthcare, the rules for joining a reference network35 are explicit on individual patients’ rights. The right to human dignity, to the integrity of the person, and to the protection of personal data are expressly referred to as part of the conditions (‘whereas’ para. 10), as well as more specifically, the free an informed consent required by the Charter of Fundamental Rights of the EU (‘whereas’ para. 11). The other EU legislation of importance in relation to cross-border healthcare, mentioned in Art. 2 of the Directive also has a focus on patients’ rights. Healthcare that does not respect patients’ rights is not patient centred.

Cross-border Healthcare, the Input of Health Law

Assessments of the Directive must take place at regular intervals. Next to the information mentioned in Article 20 of the Directive on the reports to be drawn up by the European Commission, assessments should also focus more in particular on the impact the Directive has on national health systems and individual rights of the patient, as well as on the contribution of the Directive to the quality and safety of healthcare within the EU. For a complete picture, it is imperative to also assess the relationship between the Directive and the other relevant EU health legislation linked to the Directive’s objectives.36 The input of health law in these assessments is indispensable.

The Directive brings about the necessity to reflect on a number of other subjects inherent to cross-border patient mobility as well, where the input of health law is required. New emerging health technology often brings with it new health law-related questions. Health law has a significant role to play when it comes to health technology assessment, not only at a national level, but also at the level of the European Union. In my opinion, whenever relevant, health law should have input on the work of the health technology network created under Article 15 of the Directive.37

The proposed Regulation for In Vitro Diagnostic Medical Devices (IVD)38 is an example of a field which gives rise to a number of health law questions, notably when it concerns diagnostic tests providing information about a pre-disposition to a medical condition or disease (genetic tests). In April 2014, the European Parliament adopted amendments to the Commission’s IVD proposal, aiming at the inclusion of conditions about e.g., the provision of information, mandatory counselling, free informed consent, and the requirement of a medical prescription. At present, these elements are the subject of discussion as the amendments could interfere with the practice of medicine, violate the subsidiarity principle and would fall outside the competence of the EU to legislate in certain fields.

The proposed IVD Regulation may guarantee the patient safety of the technology as such, however, it does not extend to the nature of the information it brings about. For this, one should turn to the work of the Council of Europe in this field.39 However, the amendments adopted by the European Parliament bring into the picture the question whether different legal approaches by EU Member States in relation to the provision of health-related information to employers and insurers could create an obstacle for cross-border healthcare. In other words, the question arises as to whether the patient who receives cross-border healthcare (for instance in the form of e-health) is sufficiently protected against undue trans-border transmission of information to insurance companies and employers in the patient’s country of affiliation? Genetic technology and other medical (health) technology, can be misused as a tool for distribution of social goods. Healthcare ought to be accessible without fear for discrimination. In this respect, one does not get the impression that the present European legal response to the use of information derived from genetic technology sufficiently protects the privacy of the individual.40

These and other questions inherent in particular to (but not exclusive for) genetic testing are particular relevant for a topical debate in the context of the joint EAHL/EJHL Workshop to be held during the forthcoming 5th European Association of Health Law Conference on ‘Health Law and Cross-border Health Care in Europe’.41

The conference provides an opportunity to further reflect in depth on the future EU agenda on equity in access and quality of healthcare, with a special emphasis on patient safety and patients’ rights, and the related question whether further legislation is necessary.

Collaboration across borders in the light of legal, ethical, medical and technical heterogeneity is a major challenge. Health law can have an important contribution to European research in this field. Especially in relation to cross-border healthcare, it is important to have the voices of health law permeate European institutions, as indicated by Graeme Laurie in his editorial on the founding conference of the EAHL in 2008 in this journal.42

The increased Europeanisation of public health and even broader implications in the world trade context,43 calls for increased co-operation among health lawyers.

Henriette D.C. Roscam Abbing

Professor Emerita of Health Law

Vice-Chair, European Association of Health Law, The Netherlands

roscamabbing@zonnet.nl

1

See European Journal of Health Law, Special Issue, 21 (1) (2014) on the EU Cross-Border HealthCare Directive for a first impression of implementation in national law by some EU Member States. The Directive does not affect the existing national laws on internet sales of medicinal products and devices. It does not apply to public vaccination programs against infectious diseases (exclusively national, subject to planning and implementation measures). Services in the field of long term care the purpose of which is to support people in need of assistance in carrying out routine, everyday tasks and allocation of/access to organs for the purpose of organ transplants are also excluded.

2

Art. 20(3) Directive; COM: 2014) 44 final of 3 February 2014.

3

Para. 4 of the Report.

4

Judgment in Case C-268/13; EU Court of Justice, Press release no. 134/14, 9 October 2014.

5

Statement made by Konstanty Radziwill, President of the Standing Committee of European Doctors, EURACTIV.COM, 22 March 2012.

6

CPME position paper on standardisation of healthcare services, 8 May 2014, CPME2014/020/Final.

7

Regulation (EU) 1025/2012 on European Standardisation.

8

See supra note 5.

9

Arts. 4, 5 and 6 of the Directive.

10

Herman Nys, ‘The transposition of the Directive on Patients’ Rights in Cross-border Healthcare in national law by the Member States: Still a lot of effort to be made and questions to be answered,’ European Journal of Health Law 21(1) (2014) 1-14, Editorial, para. 4.

11

Informed consent, protection of personal data, length of data storage, data-sharing, secondary use of data and human tissue, medical confidentiality, (remote) access to the patient’s record (or at least to have a copy) etc.

12

European Patients Smart Open Services, Article 29 working Party, Working Document 01/2012 on epSOS, WP 189, 25 January 2012. The epSOS project resulted in ‘Guidelines on minimum/non exhaustive patient summary data set for electronic exchange’, adopted by the e-Health Network on 19 November 2013 on the basis of Art. 14, 2.b, I of the Directive. Guidelines for e-prescriptions were adopted on 18 November 2014.

13

Article 10 of the Directive.

14

H.D.C. Roscam Abbing, International Organisations in Europe and the Right to Health Care (Deventer: Kluwer, 1997), p. 256.

15

Art. 2e of the Commission’s Delegated Decision, 10 March 2014, 2014/286 / OJ L147, p. 73, 17-5-2014. First Conference on European Reference Networks, Brussels, 23 June 2014, Report, p. 19.

16

See also ‘Public consultation on the implementation of European Reference Networks (ERN), Summary of the replies’, Brussels, June 2013.

17

The network comprises national responsible authorities on eHealth as provided for by Art. 14 of the Directive.

18

‘Guidelines on minimum/non exhaustive patient summary data set for electronic exchange,’ adopted by the e-Health Network on 19 November 2013. The set of guidelines is considered as a common base-line of patient summaries at national level (p. 21 of the document). An overview of national laws on EHR in the EU Member States and their interaction with the provision of cross-border e-health services of 23 July 2014 was released 23 December 2014. Available on the e-health website of the EC.

19

Guidelines on an ‘e-prescription (medicaments and medical devices) data set for electronic exchange’ were adopted on 18 November 2014 (Art. 11, 2 b of the Cross-border Directive). They are intended to be complementary to Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the validation of medical prescriptions issued in another Member State.

20

Art. 14, 2b, i of the Cross-border Directive.

21

N. Doring, P. Doupi, K. Glon, et al., ‘Electronic discharge summaries in cross-border care in the European Union: How close are we to making it to happen’, International Journal of Care Coordination, 17 (2014) 38-51.

22

OJ EU, 6.6.2009 (2009/C128/03).

23

Commission Recommendation on ‘Cross border interoperability of electronic health records’, 2 July 2008, para. 14, a.

24

Guidelines Supporting Information, p. 30.

25

Guidelines on an ‘e-prescription (medicaments and medical devices), data set for electronic exchange’ were adopted on the 18 November 2014 (on the basis of Art. 11, 2b of the Cross- border Directive). They are intended to be complementary to Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the validation of medical prescriptions issued in another Member State.

26

Article 29 Data Protection Working Party ‘Statement on the role of a risk-based approach’, WP 218, 30 May 2014, pp. 2, 3.

27

Staff Working Party Document on the application of the Charter of Fundamental Rights in 2013.

28

Delegated and implementing acts (Art. 290 resp. 291 TFEU) are adopted by the Commission, without involvement of the European Parliament or Committee of Ministers. They may include important political choices and have a significant impact on European citizens.

29

EPF Position Statement on the European Commission’s proposal for a General Data protection Regulation, December 2012, p. 7.

30

As is the case with the delegated decision 2014/286 EU of 10 March 2014, setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil.

31

CPME/AD/Brd/15112014/055_Final, 15 November 2014.

32

Henriette D.C. Roscam Abbing, ‘Patients’ Right to quality of healthcare: how satisfactory are the European Union’s regulatory policies’, European Journal of Health Law 19(5) (2012) 415-422; Henriette D.C. Roscam Abbing, ‘Twenty year WHO Principles of patients’ rights in Europe, a common framework: looking back to the future’, European Journal of Health Law 21(4) (2014) 334-335.

33

CPME response to the public consultation on the Europe 2020 strategy, CPME 2014/077 FINAL, 11 September 2014.

34

Expert Panel on effective ways of investing in health, EXPH, ‘Future EU agenda on quality of health care with a special emphasis on patient safety, final opinion’, European Commission, 9 October 2014.

35

Commission Delegating Decision, March 2014, 2014/286/EU.

36

Article 2 of the Directive.

37

Strategy for EU co-operation on Health Technology Assessment, 29 October 2014.

38

Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, COM (2012) FINAL, 26. 9. 2012.

39

The additional protocol to the Convention on Human Rights and Biomedicine concerning genetic testing for health purposes (2008); the European Guidelines proposed in the report on ‘Medical examinations preceding employment and/or private insurance, a proposal for European guidelines’, Council of Europe, April 2000.

40

Gerard Quinn, Aisling de Paor and Peter Blanc (eds).Transatlantic Perspectives on the Case for a European Level Legal Response (Abingdon: Routledge, November 2014).

41

Prague, 1-2 October 2015.

42

Graeme Laurie, ‘The European Association of Health Law, Addressing Unmet Needs in Policy, Practice and Research’, European Journal of Health Law 15(3) (2008) 251-259.

43

August 2014, a trade agreement was in principle concluded between Canada and the EU. Deliberations with the USA and the EU on a trade agreement, TTIP, are ongoing.

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