Cross Border Healthcare & Patient Mobility: Public Consultation on Scotland's Transposition and Implementation of Directive 2011/24 EU on the Application of Patients' Rights in Cross-border Healthcare.

Article 11 - Recognition of prescriptions issued in another Member State

15.1 This Article requires Member States to accept and dispense prescriptions issued by medical doctors from other Member States. This would mean that, for example, a UK GP could write a prescription that would be dispensed in another EU Member for continuity of care purposes. However, it does not affect any national rules that States have for prescribing and dispensing - particularly ethical rules, e.g. for the right of pharmacists to refuse to dispense had the prescription been issued in the home system.

15.2 Article 11 also sets out proposals covering issues such as how to identify the medicinal products prescribed and how to verify the identity of the prescriber. Through the formation of two expert groups, the Commission shall adopt:

• Measures on verification and authenticity of prescriptions through developing a non-exhaustive list of elements to be included in the prescription as well as where necessary facilitating contact between prescriber and dispenser;
• Guidelines supporting States on the interoperability of e-prescriptions;
• Measures to facilitate the identification of products or devices and on substitution.
• Measures to facilitate that patients have appropriate information about the prescription including on active substance and dosage;

15.3 These measures will be developed through a committee comprised of the Member States and are to be adopted 20 months after the coming into force of the Directive. Article 11(4) confirms that the Commission must have regard to the proportionality and cost compliance on Member States of any measures or guidelines brought forward by this work. The Commission must also take measures as to specific products or devices that are to be excluded under the recognition provisions to safeguard public health.

Non-exhaustive list of elements to be included in cross-border prescriptions.

15.4 The Commission adopted the non-exhaustive list of particulars to be contained in a cross-border prescription in November 2012, following meetings of the expert groups. In terms of the overall policy on medicinal products, this is a Medicines and Healthcare products Regulatory Agency (MHRA) lead and the provisions are governed by the Human Medicines Regulations 2012, which is UK-wide in scope. Under the Regulations, provisions are already in place that provide much of what Article 11 aims to achieve - pharmacists can currently dispense prescriptions written by doctors and dentists lawfully practising medicine or dentistry in another EEA State or Switzerland, provided certain conditions are met. The decision to accept the prescription is subject to the professional judgement of the pharmacist.

15.5 The conditions which must be met are that the prescription is signed by the EEA prescriber in ink or, if it is an electronic prescription, signed with an advanced electronic signature. The prescription must also contain the address of the prescriber, an indication of whether he or she is a doctor or dentist and the name of the patient.

15.6 The new non-exhaustive list sets out more detailed particulars although in practice, many are routinely included in UK prescriptions. As far as outgoing prescriptions from the UK are concerned, these particulars would only apply to a prescription when the patient indicates that they wish to use it in another Member State.

15.7 The UK Government intend to amend UK-wide medicines legislation to adopt the non-exhaustive list for both incoming and outgoing cross-border prescriptions. This will benefit patient safety and offer more certainty for the dispensing pharmacist. Nevertheless, the pharmacist will retain discretion over whether the prescription is accepted or not. No changes will be made to the present arrangements for prescriptions written by UK prescribers for dispensing in the UK.

Controlled drugs

15.8 During negotiations on the this Directive it was established that the controlled drugs exclusion under current domestic regulations will come within the scope of medicinal products subject to special medical prescription (SMP) under Article 11(6).

15.9 Under European and domestic legislation, unless they are exempted by legislation, medicinal products require a marketing authorisation under which the product is classified as one which is either available only on prescription - prescription only medicines (POM) or is available without a prescription. Although the relevant governing Directive (2001/83/EC) allows Member States to designate certain types of SMP products as a sub-category of POM, this designation has never been made in UK legislation because the requirement is not mandatory - and in the UK Government's and Scottish Government's opinion, no compelling need to make such a designation was identified.

15.10 Upon implementation of the Cross-border Directive, the SMP category of medicines will need to be designated in domestic legislation, as there is no provision in the Directive to deem certain products as if they were SMP products only. In January 2010, the Commission was notified that drugs in Schedules 1 - 3 of the UK Misuse of Drugs Regulations would be designated as SMP - and therefore remain excluded from EEA prescriptions.

15.11 The changes will be implemented by way of an amending UK-wide SI using the power in section 2(2) of the European Communities Act 1972. In terms of the overall policy on medicinal products, this is a Medicines and Healthcare products Regulatory Agency (MHRA) lead and the provisions are governed by the Medicines Act 1968, as amended, which is UK-wide in scope.

15.12 Provisions are in place in domestic legislation that provide much of what Article 11 aims to achieve - where they are not, separate implementing legislation will be prepared by the MHRA. The Agency does not envisage that the adoption of the SMP category into UK law will impact on stakeholders as any practical effects will fall on its internal administrative processes