Brian Edwards CBE
University of Sheffield, UK
HOPE (European Hospital and Healthcare Federation),
The latest set of EU legislative proposals on patient information continue the long-standing ban on the advertising of prescription medicines in Europe. The Commission proposals do, however, allow pharmaceutical companies to use the internet to publish the information contained in their patient information leaflets for individual drugs, and information that will enable patients to access objective and non-promotional information about the risks and benefits of medicines.
It is internet marketing that is forbidden for prescription drugs but the distinction between marketing and patient information has had to be clarified.
The ban cannot of course apply to overseas internet sales, which appear to be growing…despite the quality risks for patients.
The European public data base (EudraPharm) will be further developed to act as a central point for the access of information about medicinal products and will now include information about products authorised for children. A new service will provide email updates in product areas.
The next step is for the Commission’s proposals to be debated in the European Parliament, representing citizens, and in the Council, representing Member States. The proposals, which are now quite modest, look likely to be approved.
The Commission has also published the results of its consultation on “Measures for improving the recognition of prescriptions issued in another member state.”
Was the prescription presented to a dispenser issued by a properly regulated health professional who was legally entitled to issue the prescription? A simple question with very complicated answers.
The current Directive deals with some of the problems but does not resolve problems associated with either language and handwriting or the fact that some medicinal products are not available in all EU countries. Avoiding Latin terms may help the patient but results in a loss of technical accuracy. Improved information for dispensers, including diagnosis, may infringe data protection rules in some countries.
As the consultation paper itself acknowledges prescribers, authentication in a cross-border context may come at a high cost/administrative burden.
So is it worth it? The EU must surely have more important priorities. The purists about open markets will fret about this and might want to open up the issue of a standard EU prescription pad that contains an imbedded identity link to the individual prescriber. A charter for fraud if there ever was one. The emergency supply rules should resolve most cross-border issues. This issue needs to be quietly tucked away, with some simple advice to dispensers who are faced with a problem. If in doubt, don’t dispense unless there is a clear emergency.
The Commission are also working on updating the ‘Transparency Directive’, with a view to speeding up approval processes for marketing medicines in Europe. For pricing and reimbursement decisions relating to innovative medicines, the Commission plan a limit of 120 days (from 180) and 30 days (again from 180) for generic medicines. What now needs to be worked out is how, if at all, these regulations will apply to the National Institute for Health and Clinical Excellence and other assessment agencies and local agencies that determine eligibility for individual patients.
Medicine is becoming one of the most highly regulated industries in the European economy. Often this regulation is in the interests of the consumer, as is the case of patient safety, but sometimes the need to sustain a healthy industry comes into play. A very delicate balance to achieve.