Changes in rules on advertising for pharmaceuticals in France

Stephen Leacock, a Canadian writer (1869 - 1944), has stated somewhere that “Advertising may be described as the science of arresting the human intelligence long enough to get money from it”. In the case of pharmaceuticals it seems that this science is particularly prosperous, despite the constant attempts made by regulatory authorities to make its practice a little more burdensome. Controlling advertising for medicines remains a preoccupation of regulators in Europe (seemingly unlike the USA and with the possible exception of the European Commission who has struggled rather ineffectively to introduce at least some form of DTC for Rx medicines), with variable success. 

At the end of the year 2011, France has adopted a whole set of new rules defining the legal framework of medicines, including new legal rules on advertising (the Law n° 2011-2012 on the reinforcement of health security of medicines and healthcare products). This act was supplemented in May 2012 by an additional legal instrument: Decree 2012-741 containing rules relating to advertising of human medicinal products. A different decree (2012-743) was adopted to establish rules on the advertising of medicinal devices, but in the lines below I will limit the discussion to the field of pharmaceuticals.

The said legal acts are interesting for a number of innovations they have brought about in the pharmaceutical regulatory field (e.g. the explicit authority granted to ANSM, the new French medicines agency, to require comparative trials against active comparators), but those in the field of advertising are among the most thought-provoking and it is likely that they will be followed in a form or another by other EU competent authorities.

According to the new article L5122-9 of the Code of Public Health, „the advertising for a medicinal product to the members of healthcare professionals entitled to prescribe or dispense medicinal products or to use them in the exercise of their profession is subjected to a prior authorization of the National Agency for the Safety of Medicines and Healthcare Products named ‘advertising visa’”. This means that the former rule of an a posteriori control of advertising materials, common in most of EU Member States has been replaced in France by an a priori control by the competent authority (ANSM). The challenge for the ANSM is considerable. According to their official estimates, while the annual number of advertising materials for the large public (OTC products) is around 2000, the annual number of advertising materials for health professionals is about 5 times higher (around 10,000).

For each year, through a decision (adopted before 1^st of November of the preceding year), the Director General of ANSM sets a timetable establishing the periods (time slots) when applications for “advertising visas” may be submitted. The timetable includes at least 4 periods a year, of at least one week and at most two months, during which applications may be submitted (art. 5122-5 of the Code of Public Health).  For 2013, for instance, the following 4 periods have been provided:

·         2-15 January (about 2 weeks)

·         18 March – 22 April (over 4 weeks)

·         1-22 July (about 3 weeks)

·         23 September– 18 October (about 4 weeks)

No application may be submitted outside the time slots decided by the Director General (but there is one exception, see below). ANSM has two months (to be calculated from the end of the time slot) to notify its decision to the applicant. In the absence of a decision of the Director General at the end of the legal term, the application is deemed approved. A visa granted by ANSM is valid two years, but it cannot exceed the validity of the marketing authorization). The visa may be withdrawn if violating the legal rules applicable to advertisements of medicinal products (e.g. if deceptive, not objective in its form and content, no in line with the terms of marketing authorization or with the “therapeutic strategies” recommended by HAS (la Haute Autorité de santé)) or when the benefit-risk balance of the product is being reassessed. The withdrawal process allows the applicant to submit written or oral conclusions and support its position. In cases of emergency, the Director General may suspend the visa for up to 3 months.

When submitting the application, the applicant gives to each advertising material an internal reference number, according to rules adopted by a decision of the Director General of ANSM. This reference number has to be mentioned on the material advertised to healthcare professionals, unless it is a radio material (I am not aware of any case of using radio to advertise materials to healthcare professionals, but this is how article R. 5122-14 reads).

The use of free samples is limited in principle to the first two years following the first effective placing on the market in France of a product, or for a new strength or dosage form, if the authorization is accompanied by an extension of indication, or for a change in classification. If in the former regulatory setting a limit of 10 samples per year and per healthcare professional (prescriber or dispenser within a hospital pharmacy) was established, this has now been changed to 4 samples per year and healthcare professional.

For medicinal products subjected to a special or “restricted” medical prescription, such as those products exclusively used in a hospital setting, those for which treatment may be only initiated in a hospital, those restricted to certain specialists or requiring special monitoring during treatment, the advertising may only be carried out to healthcare professionals able to prescribe it and dispensing it, respectively.

Probably the most revolutionary new provision related to advertising of pharmaceuticals in France, however, comes not from these set of rules, but from Law 2011-2012 of 29 December 2011 on the reinforcement of health security of medicines and healthcare products. But I will discuss it in a next post.