Policy responses and statements
Background: This letter sought views on proposals to amend section 58 of the Medicines Act 1968 and Article 2 of the Prescription Only Medicines Human Use Order 1997 (POM Order) to enable United Kingdom (UK) pharmacists to dispense prescription only medicines (POMs) lawfully prescribed by doctors and dentists in other EEA States and, possibly, Switzerland (EEA doctors and dentists). Application to Wales, Scotland and Northern Ireland: The proposed changes would be effected in regulations made under powers conferred by section 2(2) of the European Communities Act 1972 and have effect throughout the United Kingdom. Background information: The current legal position is set out in Annex B. For the reasons explained below, the UK requirement for appropriate practitioners to be registered in the UK before a UK pharmacist can dispense their prescriptions has served to safeguard the health of patients and provides a means by which a pharmacist can fulfil his professional responsibilities. Where a pharmacist in the UK is asked to supply against a prescription, he is under an obligation, pursuant to his professional Code of Ethics, to consider the welfare of the individual patient. He has a professional responsibility to exercise control over all medicinal products and related products which are purchased or supplied. A pharmacist who is presented with a prescription, completed by a doctor or dentist can, under the present system, if the practitioner is not known to him, easily access the relevant professional register to check that the prescriber is on it and is qualified to prescribe that particular medicinal product. If there is no need for a prescriber to be on a register the pharmacist will have to use other means to satisfy himself of the authenticity of the prescriber. These other means may not be so straightforward or reliable as recourse to a register and so, if removal of the requirement for every prescriber of a POM medicine to be on a register means that a pharmacist will be unable to easily confirm the authenticity of the prescriber, the risk to public safety may be increased. However, an effect of the requirement is that, in practice, prescriptions for POMs written by doctors and dentists in other Member States cannot be accepted for dispensing. This is because, although doctors and dentists can become registered on the appropriate UK register, they are unlikely to do so. Thus, by reason of the legislation a pharmacist in the UK cannot supply a POM against a prescription written in another Member State by a non UK registered practitioner, even if he knows that the prescription is genuine and has no concerns of a public health nature. Such a situation may arise where the patient and prescriber are known to the pharmacist, for example. Against this background the European Commission have asserted that the provisions of section 58 of the Medicines Act 1968, Article 2 of the POM Order, the Medical Act 1983 and, by association, the Dental Act 1984 are contrary to the principle of the freedom to provide services enshrined in Article 49 of the EC Treaty. In the Commission’s view the provisions may deter patients who live in other Member States from coming to the UK to seek services because of difficulties in obtaining their POMs whilst in the UK. It also considers that UK residents may be deterred from seeking medical services elsewhere in the Community because of the difficulty of getting their prescriptions honoured when they return to the UK. The Commission does not consider that UK pharmacists must always dispense against a prescription written in another Member State by a non UK registered practitioner. Rather, the Commission’s view is that, by imposing a complete prohibition of the supply of POMs against prescriptions written by non registered practitioners, the legislation goes beyond what is reasonably required for the purposes of ensuring public health and safety. The Commission considers that pharmacists, as highly trained professionals, can exercise proper judgement themselves, when deciding whether or not it is safe to supply a POM against a prescription given to them by a patient. COMMENTS ON
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