Pre-licence: what can you say about a medicine?
UK
The advertising of medicines in the UK is governed by a combination of national legislation and industry self regulation. In particular, the Human Medicines Regulations 2012 (the "Regulations") and the Association of the British Pharmaceutical Industry Code of Practice (the "Code") both govern promotion and advertising of medicines in the UK.
As a general rule, if a product requires a marketing authorisation to put that product on the market in the UK, a company must not promote or advertise the product until it has received a valid marketing authorisation in the UK.
However, the following activities are permitted in relation to a product that does not have a marketing authorisation. In each of these cases, the licensing status of the product must be made clear.
For new treatments:
where the treatment is expected to give rise to significant changes in costs from currently available treatments, companies can provide limited factual information to health authorities and hospital budget holders to enable them to plan their spending over future years. The information should focus on cost and should be targeted at those making budgetary decisions, and should be non-promotional in nature; and- companies may provide factual information where required by national public advisory or horizon scanning bodies such as the National Institute for Health and Clinical Excellence.
For treatments being reclassified from prescription-only or pharmacy sale, to pharmacy sale or general sale respectively, companies may provide limited factual information (and not promotional information) to potential trade buyers for the sole purpose of enabling listing for the product.
Licensed manufacturers and suppliers of unlicensed "specials" medicines may:
- at reasonable intervals or in response to an enquiry, provide price lists to healthcare professionals to whom the price of specials may be relevant, such as potential customers and budget managers. These price lists must not contain claims about the product but may set out factual information including details of the active ingredient, strength, dosage form, pack size and price for each product listed; and
- provide a "special" medicine only in response to an unsolicited request
In addition to the permitted actions set out above, companies may provide a factual answer (which is not promotional in nature) to an unsolicited question about an unlicensed medicine, or about use of a licensed medicine outside the terms of its licence.
In addition to the permitted actions set out above, companies may provide a factual answer (which is not promotional in nature) to an unsolicited question about an unlicensed medicine, or about use of a licensed medicine outside the terms of its licence.
Under the Regulations, it is a criminal offence to promote a medicine that does not have a marketing authorisation. Any person who is guilty of this criminal offence is liable to pay a fine, or in serious instances, to a prison term of up to two years.
The MHRA's "Blue Guide" provides further guidance on what can be said before the grant of a marketing authorisation.
Austria
Furthermore in Austria the advertising on medicines is governed not only by law, but also by the Code of Conduct of the Association of the Austrian Pharmaceutical Industry (Pharmig).
Also, in Austria no advertising for a pharmaceutical is admissible prior to marketing authorization, but there is one important exception: The prohibition of advertising for medicinal products prior to approval does not apply to specialist advertising within the context of scientific events where participants come predominantly from abroad.
According to the Code of Conduct, correspondence and documents of non-promotional nature needed to answer a specific question on a particular medicinal product shall not be deemed to be promotional such as sales catalogues and price lists (provided they do not include product information) issue-related information relating to diseases or human health, (provided no reference is made to a medicinal product), information as part of the pharmacovigilance activities, company-related information, information on non-authorized medicinal products in response to a document that request such information from specialist circles; correspondence with the authorities, and texts approved by the authorities, for example the summary of product characteristics or the patient information leaflet.
Scientific and expert information must be state of the art, accurate, balanced, fair, objective, verifiable and complete in order to give the recipient the possibility to form his own personal opinion.
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"As a general rule, if a product requires a marketing authorisation....a company must not promote or advertise the product until it has received a valid marketing authorisation."