Draft
MEPs:
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Dear Madam/Sir,
Thank you for your letter of…….on the off-label use of the authorized medicinal products. The issue raised in your letter was presented to the Heads of Medicines Agencies at their meeting on 28th April in Visegrád and it is my honour to present to you the position of HMA, which resulted from the discussion.
The term ‘off label use’ covers a variety of situations with very different risk implications, namely:
· Prescription for an unapproved indication for which the indication is authorised in another product with the same composition and the same dosage (f. ex. Generics),
· Prescription in an unapproved age group (f. ex. Paediatrics),
· Prescription in an unapproved dose or form of administration,
· Prescription to treat the condition for which it was approved, but outside specifications of Summary of Product Characteristics.,
· Prescription to use a product approved for one disease to treat a completely different one, for which no treatment is available,
· Prescription to use a product approved for one disease to treat a completely different one, for which a registered treatment is already available.
The issue is recognized by European health authorities as potentially having serious impact on public health and as such deserving due attention and the development of tools which can help mitigating risks to public health.
Regulatory agencies authorize medicinal products for indications, which are stated in the Summary of Product Characteristics (SmPC) and monitor the compliance of advertising with it, in the case of the non-prescription products – to the public and, in the case of prescription products – to prescribers and distributors. In this respect a promotion of the off-label use of the authorized product would breach the relevant provisions of the Directive 2001/83/EC on advertising and may trigger an appropriate legal action by the competent authority.
In their regulatory tasks under the Directive 2001/83/EC regulatory authorities in the European network strive to harmonise Summary of Product Characteristics and Package Leaflets of non centralised products, making use of provisions for referral in Art. 30, paragraph 1 and Art. 31, and submitting a list of medicinal products for which a harmonised Summary of Product Characteristics should be drawn up to the European Commission according to Art. 30 paragraph 2. Through these procedures, indications can be harmonised accross all products with the same active substance, protecting patients and consumers from the potentially confusing situation of being prescribed a product for which the indication is not present in the patient information.
Regulation (EC) No 1901/2006 on medicinal products for paediatric use in Art. 45 and 46 provides regulatory authorities with a provision to access paediatric studies for assessment and possible amendment of the Summary of Product Characteristics . Data shall be exchanged among competent authorities thus achieving further harmonisation and potentially narrowing down off-label use for paediatric indications.
The national agencies are also responsible for pharmacovigilance tasks and in this respect it should be noted, that the new legislation on pharmacovigilance has introduced a new definition of an adverse reaction, which shall include all uses of the product, regardless whether the indication is compliant with Summary of Product Characteristics or not. The legislation provides for legal instruments to stop the marketing of the product in case of serious adverse reactions, also including those resulting from the off-label use.
The off-label use per se of the authorized product though remains beyond the scope of the harmonized EU pharmaceutical legislation and the remit of the medicines regulatory agencies and is mainly connected with the medical practice in Member States, since it is the physician, who is responsible for prescribing the product for the off-label use and may be held liable for the resulting damage. The medical practice varies widely across Member States and these differences may also pertain to the professional approval of the use of the products for non-authorized indications. There is no legal basis to ban such practices and it should be borne in mind that in some cases they may constitute the only help for the patients. Some Member States have included provisions relating to the off-label use in their national legislations on medicinal products or on medical practitioners.
As we have tried to outline above – the medicines regulatory agencies have rather limited instruments to cope with the national issue of off-label use of the authorized medicinal products. This problem should be treated rather as a public health issue, which should be addressed by the health professionals and health authorities and possibly become a subject of the information campaigns on the hazards of the off-label use to be launched by the health authorities in the Member States.
We take the liberty of suggesting that this issue be brought up by the European Parliament with the Council and the Commission with the view to assess the real extent of the off-label use of the authorized medicinal products in the EU and its risk/benefit balance in order to develop the EU wide approach and to undertake the appropriate action.