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

CHAPTER 8: Co-Operation between Member States

The issue

159.  In this chapter we consider the Commission's proposals for increased co-operation between Member States. In particular we discuss potential problems with the cross-border recognition of prescriptions, such as language barriers, differences in drug names and the differing availability of medicines across Member States. We also examine some of the practical problems in respect of the interoperability of e-health systems and consider the merits of European reference networks.

Contents of the proposal

160.  Article 13 of the Directive obliges Member States to co-operate with each other to the extent necessary for the implementation of the Directive.[45] The Commission considers that this requirement is necessary to facilitate co-operation between the providers, purchasers and regulators of different Member States in order to ensure safe, high quality and efficient care across borders.[46]

161.  The draft Directive provides for the cross-border recognition of prescriptions, so long as the authenticity and content of the prescription are clear. Any restrictions on recognition must be limited to what is necessary and proportionate to safeguard human health and must be non-discriminatory, or based on legitimate and justified doubts about the prescription's authenticity or content.[47] To facilitate this, the Commission intends to develop a Community prescription template and introduce measures to exclude specific categories of medicinal products from the recognition of prescriptions where this is considered necessary to safeguard public health.

162.  European reference networks are also introduced under co-operation measures. The objectives of these include: providing healthcare to patients who have conditions requiring a particular concentration of resources or expertise; acting as focal points for medical training and research; facilitating information dissemination and evaluation; and providing quality and safety benchmarks.[48]

163.  E-health is introduced as another method of co-operation between Member States and consists of the provision of health services through the use of information and communication technology, where neither patient nor practitioner physically moves between countries. Member States are not obliged to introduce e-health systems or services, but the proposal aims at ensuring the interoperability of these systems where they do exist or are introduced.[49] Any measure adopted under e-health must respect the fundamental right to the protection of personal data in accordance with the applicable law.[50] The proposal is without prejudice to the existing framework provided for by the Directive 2000/31/EC[51], which ensures the free movement of information society services, including e-health services, between the Member States, and it will apply only insofar as the measures are not already covered by the existing Directive.[52]

Cross-border recognition of prescriptions

164.  The Government noted that they have recently amended medicines legislation to facilitate the mutual recognition of prescriptions. As a result UNISON questioned the need for prescriptions to be addressed in the Directive: "the Department of Health is already addressing this issue around co-operation on prescriptions and e-health with other Member States, so I am not quite sure why we need extra elements of this in terms of this Directive if that is already going on." (Q 350, p 19)

165.  The Commissioner stated that while a rule already exists on the cross-border recognition of prescriptions "often we have problems in applying this rule because … there are confusions, there are doubts as to the authenticity of the prescription, of the signature of the doctor and so on". She went on to clarify that the Commission were aiming to use the Directive "to agree on certain rules which will facilitate the exercise of this right of mutual recognition and to make it easier for people to do". (Q 391)

166.  The cross-border recognition of prescriptions was welcomed by several of the groups we heard from, including PA Consulting, the Nursing and Midwifery Council (NMC) and the Royal College of Nursing (RCN). (QQ 2, 202-203, pp 4, 93) However, all three groups qualified their support by highlighting areas where they felt greater consideration was needed.

167.  In the view of the NMC, EU-wide prescribing would be difficult to achieve in practice due to the different languages and alphabets in use across the Member States—a point echoed by the General Medical Council who suggested that such differences would pose major challenges to patient safety. (QQ 202, 206-207) The Royal Pharmaceutical Society (RPS) noted that there may be difficulties in understanding prescriptions across borders due to differences in drug names and variations in the abbreviations used. One such example is a medicine with the generic name captopril, which is marketed in the UK as Acepril. However, if a prescription for Acepril was issued in Switzerland,[53] the correct generic name would be enalapril and if it was issued in Denmark, it would be called lisinopril. (QQ 168-169) A further problem is that different drugs are available in different Member States. (QQ 181, 349)

168.  Another issue is that of nurse and midwife prescribers. As the RCN reported, the ability of nurses to prescribe medication for patients is limited to a minority of Member States: the UK, Ireland, Spain, Sweden and the Netherlands. (p 93) The NMC suggested that this would not be widely recognised across the EU and stated that they would like it to be ensured "that prescriptions written by an authorised nurse or midwife prescriber in the UK will be recognised in other Member States." This view was shared by the RPS and the RCN. (Q 202, pp 64, 76, 93) In addition, the NMC suggested that this practice should be taken into account in any measure developing a Community prescription template. (p 76)

169.  The RPS took the view that the Community prescription template would be advantageous and believed it was achievable, though they stressed that it would not necessarily mitigate the potential confusion over the different drug names used across Member States. (QQ 171, 177) The NMC echoed the concern that language could act as a barrier: "there are some fundamental communication issues which the NMC is not convinced will be picked up purely by having an EU-wide electronic template for prescribing" and suggested that EU-wide prescribing would be difficult to implement. (Q 202) The Minister suggested that templates could be fraught with difficulties as they implied vast systems that would make it difficult to maintain the planning of Member States' health services. The Government also stated that they would need to consider whether the template would go beyond the information required on UK prescriptions. (Q 88, p 19)

170.  It was also suggested to us that it might be difficult for those dispensing prescriptions to verify the legitimacy of the prescriber. (Q 205; p 64) The RPS believed "this would need web-based searchable registers of prescribers who are fit to practise in their Member State." (p 64)

European reference networks

171.  The NHS Confederation considered European reference networks an area of great interest, though they questioned the need for co-operation between Member States to be addressed in the Directive. "We have not yet seen evidence to suggest that it is necessary and appropriate to provide a legal basis for this work." They also suggested that any work on co-operation should be project-based. They were considering the implications of the proposed co-operation measures in relation to subsidiarity. (Q 262, p 90)

172.  The Government believed that the European reference networks were workable, but from the perspective of having participated in the European Reference Network pilot project, stated that "We support the aim of the reference networks but think their remit should be limited to covering treatment for rare diseases." (p 19)

173.  The Royal College of Nursing highlighted that "whether this Directive exists or not, there is much more collaboration taking place. There is a lot more collaborative research being undertaken, not to make everyone the same but to learn from experiences in other countries. That is a reality, whether this Directive is introduced or not." (Q 263)


174.  PA Consulting questioned the scope of the action outlined under the provisions for e-health. This area was probably "the most far-reaching and radical element of the Directive and does raise for me some questions about how feasible it is and exactly what the nature of the powers being transferred are." (Q 33) This concern was shared by the Government, "The Government notes that the provisions in the directive relating to e-health are potentially quite wide. It will be seeking to clarify the scope of this provision." (p 19)

175.  The importance of the interoperability of e-health systems was noted by a number of witnesses. The Royal College of Nursing (RCN) considered interoperability, particularly in relation to patient records, will have a significant impact on ensuring the safety and continuity of care (see Chapter 6). The RCN and UNISON cautioned that achieving interoperability among systems in the UK alone had proved difficult and believed that greater challenges would be faced in achieving cross-border interoperability, including language barriers and the use of different terminologies. (Q 262, p 134)

176.  The RCN emphasised the need to identify examples of best practice for the interoperability of e-health and to share this across Member States. (Q 262) The British Dental Association pointed out that e-health is not particularly far advanced in dentistry and that opportunities in dentistry for e-health are currently underdeveloped as a result. (Q 307) The British Medical Association (BMA) stated that "It is very unlikely that e-Health systems will be fully interoperable by the time that this proposal is implemented across the EU." (p 119)

177.  Patient safety was another concern relating to e-health. The BMA was concerned that Article 16 of the Directive did not offer adequate protection for patients; "The BMA calls for the regulation of telemedicine[54] to be mentioned explicitly in this article. The BMA calls for doctors who undertake cross-border telemedicine … to have the equivalent regulatory requirement to practitioners in the country where the patient accesses healthcare." (p 131) The General Medical Council also wanted to see a responsibility on those placing the contract for the service to ensure that it could only be delivered in the distant country by properly qualified healthcare professionals. (Q 209)

Conclusions and recommendations

178.  Cross-border recognition of prescriptions is desirable, particularly to ensure continuity of care for those who require follow-up treatment on returning home. While we recognise that this is already taking place (see paragraphs 164-165), we recommend that the Commission develops detailed rules for this system to ensure that confusion is avoided, particularly in relation to language, the names of medicinal products and the verification of whether a prescription has been issued by a legitimate prescriber. The consequence of not doing so would be to undermine the safety and easy accessibility of cross-border healthcare. We consider that common rules on the content and drafting of prescriptions would assist in overcoming this confusion. This need not imply the introduction of a common prescription template.

179.  With or without the Directive, we note that collaboration between service providers across the European Union already takes place in order to share best practice. We nevertheless consider that European reference networks have the potential to assist the delivery of health services across borders and within each Member State. We conclude that such networks may be most effective if they are speciality-based as this would allow relevant experience and best practice to be taken into account. We also believe it is important that the reference networks should not become overburdened by regulation. We recommend that European reference networks could be a useful forum in which to develop EU-wide benchmarking on quality standards.

180.  It is clear to us that the electronic interoperability of systems is important, particularly to ensure continuity of care, but we note that this has proved challenging even within Member States. We therefore urge the Commission and Member States not to underestimate the challenge of this task and to assess carefully the impact and modalities of introducing any system across the EU.

45   (COM(2008) 414) Article 13 Back

46   (COM (2008) 414) (p18) Back

47   (COM(2008) 414) Article 14  Back

48   (COM(2008) 414) Article 15  Back

49   (COM (2008) 414) recital 41 Back

50   (COM(2008) 414) Article 16  Back

51   Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (OJ L 178, 17.7.2000, pp 1-16) Back

52   (COM(2008) 414) (p 6) Back

53   While Switzerland is not a Member State of the EU, the variation in drug names outlined here is likely to apply in many other Member States (as with Denmark in this instance) and to other generic drug names. Back

54   "Telemedicine" is defined in (COM (2008) 689) by the Commission as the provision of healthcare services at a distance, using electronic means of communication (either clinician to clinician or between clinician and patient). Back

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