Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on consultation MLX 342 on proposed changes to legislation to enable pharmacists to dispense prescriptions issued by doctors and dentists registered or originating from another EU state and Switzerland.
The NPA represents the interests of community pharmacies. We have, in voluntary membership, over 12,000 community pharmacies, which comprises virtually all the community pharmacies in the UK. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses.
The NPA agrees in principle that there is a need to amend existing national legislation to comply with European Law in order to allow pharmacists the freedom to make a professional judgement to decide whether or not to dispense a prescription originating from another EU state. This will clarify the legal position and remove the legal barriers and associated consequences with dispensing prescriptions originating from another EU state or Switzerland.
The consultation also requests opinions on various topics associated with the proposed amendment, and the NPA view on these topics is illustrated below.
Future Proofing
MLX 342 requests opinions on the topic of ‘future proofing’ any amendments so that ‘if and when’ other member states legislate to allow prescribers other than doctors and dentists to prescribe in their own countries, then amended UK legislation will allow these to be recognised here subject to ministerial approval.
The NPA regard ‘future proofing’ amendments to be proactive and believe it would be beneficial if the legislative framework is in place for the possibility of recognising similarly suitably qualified health professionals from the EU. This will reduce the possibility of future conflicts with existing European Law.
Exclusion of CDs – schedules 1-5 from the amendment proposals
The NPA would not support the proposal to restrict in law the dispensing of controlled drugs against prescriptions originating from another EU member state. Instead we propose that restrictions should be introduced in the form of professional guidance rather than an ironclad legislative framework. This will allow for flexibility and the utilisation of the judgement of the individual pharmacist based on the facts in hand. It will still allow the government and the regulatory bodies to maintain controls over the supply of controlled drugs by using good practice guidance should this be required. Furthermore some medicines in schedule 4 and 5 are routinely prescribed including medicines for pain relief or short term anxiety. It is our view that pharmacists are vigilant when dispensing controlled drugs and would be even more so when deciding whether to dispense against a prescription originating in another EU member state. We acknowledge that changes to existing controlled drug legislation may be required for this to be workable.
Marketing Authorisation
The default position of the MHRA on market authorisations is that amendments will not be made to allow pharmacists to dispense unlicensed medicines against prescriptions from EU prescribers. This would apply to unlicensed medicines where no product licence exists, and off-licence use when a product is prescribed for a use outside of its product licence.
The NPA view is that there should be no legal restriction preventing the dispensing of products without a UK marketing authorisation and that again it should be a decision made by the pharmacist based on their professional judgement and the individual circumstances of the case. Our view is based on the fact that pharmacists deal with prescriptions for unlicensed medicines by UK registered doctors on a day to day basis, safely and effectively, and that in some patients such as children, and in pregnancy, use of unlicensed medicines or off-licence use is common. By allowing EU prescriptions but yet keeping restrictions on unlicensed medicines is counter productive and unnecessary. Important practical issues include difficulties if not impossibilities in the pharmacy ascertaining if an item is being used off-licence which will depend on whether the prescriber can be contacted. In addition, prescriptions from other EU countries are likely to be for products licenced in that country but which may not have a UK marketing authorisation.
As a result it is important for amendments to be made to explicitly allow pharmacists to make the decision to supply or not to supply when a product does not have a UK marketing authorisation.
Form of the prescription
A15 Prescription Only Medicines (Human Use) Order 1997 (POM Order) lays down the requirements that need to be on a standard prescription. A12 POM Order exempts prescriptions in hospitals from needing to comply with these requirements.
The consultation proposes that the requirements that need to be on a prescription originating in the EU for the supply to be valid are the same requirements which are required for hospital prescriptions i.e. a similar A12 POM Order exemption would apply.
The NPA would be concerned as there would appear to be an anomaly if EU doctors and dentists could write prescriptions with fewer controls than a UK doctor or dentist.
To illustrate, it is nonsensical that if identical prescriptions which were both non-compliant with A15 POM Order were presented by a UK registered practitioner in primary care and an EU prescriber, then the UK prescription would be invalid whilst the EU prescription would be valid due to the A12 POM Order exemption. It is possible that this too would fail to comply with EU principles if legislation in effect makes it easier for non UK registered EU prescribers to provide a service compared to UK registered prescribers.
Due diligence defence and Forged prescription defence
It is important that provisions in A13 POM Order and A14 POM Order are extended to cover the possible scenarios of prescriptions being presented in error or fraudulently from EU prescribers. When due diligence has been exercised then it is necessary in the interests of natural justice that there no liability for pharmacists dispensing these prescriptions. This is especially important as many of the other EU states do not have registration systems so in practice it will be difficult to ascertain for sure if a prescription originates from a legitimate source.
Professional guidance
The NPA feel strongly that any official guidance needs to be highly detailed and comprehensive. It is important that there is particular focus on the practical aspects of what should be done when presented with an EU prescription.
It is particularly worrying that most other EU states do not have a registration system. In light of this it is vital that guidance explains what a pharmacist can do to in order to exercise their professional judgement when there can be no way of ensuring that the prescription originates from a legitimate prescriber.
Specific areas which need to be addressed include:
1. Contact details of relevant regulatory bodies i.e. GMC and GDC equivalents in order to check registration
2. What measures to take if the member state has no formal registry system
3. Practical measures for how to contact the prescriber
4. What action to take if the item prescribed is off-licence or unlicensed
5. Which resources to use to check European names for drugs
6. What to do in the event of receiving a prescription for a branded European product
7. What if the branded European product is known to the pharmacist? For example due to common parallel import use is known.
8. What to do if the branded European product can be identified, can it be substituted with an equivalent UK medicine
9. What if the product is written in a foreign language but can be identified e.g. amlodipina
10. Specific guidance on when to refuse to dispense and the right of a pharmacist not to dispense depending on the circumstances
11. Practical guidance on detection of forged prescriptions and an explanation of the due diligence and forged prescription defences and when they apply
12. A list of different abbreviations commonly used in other member states
The NPA would want to be closely involved in the development of any professional guidance in this area.
Impact on business
There will be associated legal implications once the law is amended to explicitly allow the dispensing of EU prescriptions as pharmacists will no longer be able to rely on national legislation in order to refuse to dispense a European prescription. Instead they will need to judge each case on its merits which is likely to result in extra workload which we acknowledge could be compensated for by a levy. There could possibly be an increased risk of litigation as a result.
EEA, EU and Switzerland
The consultation uses the phrases ‘EEA State’ and ‘Member State’ interchangeably. The NPA would point out that for legislative purposes it is vital that the correct terms are used as the two are not necessarily the same. It is our understanding that there are 27 member states whilst the EEA states include the same 27 members in addition to Iceland, Liechtenstein and Norway. Switzerland is not a member state or an EEA state. Any amendments should be restricted to legal requirements under EU law and treaty obligations. As a result the additional 3 EEA states and Switzerland should only be included if it is mandatory to do so and only on the basis that obligations are mutual.
