After the obligation of pharmaceutical companies to report sponsoring activities was first introduced under Romanian law in early 2014, there was an almost immediate need for subsequent clarifications from the Romanian regulator. The manner in which sponsoring activities in general, and the reporting obligation related to them, in particular, were regulated, was unclear and had the potential of leading to discrepancies in the manner in which these provisions would have been applied by interested parties.
Order no. 194/2015 approving the Norms on evaluation and approval of advertising for medicinal products for human use (the “Norms”), issued by the Ministry of Health and recently published in the Official Gazette on March 11th, 2015, does provide certain useful clarifications on this matter.
The competent authority for evaluating and approving advertising materials and other forms of advertising for medicines for human use (including sponsoring activities) is the National Agency of Medicines and Medical Devices (the “Agency”).
Sponsoring activities are regulated by the Norm as a form of advertising for medicines of human use, specifically as far as the following activities are concerned: (a) sponsoring promotional meetings with the participation of individuals qualified to prescribe or distribute drugs; and (b) sponsoring scientific conferences to which individuals who are qualified to prescribe or distribute drugs participate, especially by payment of transport and accommodation costs.
As a principle, no form of sponsoring intended for professionals in the health care sector should be linked to the name of a medical product, irrespective of its status when dispensed i.e. with or without a prescription. Further, sponsoring activities may not involve direct or indirect promotional messages for medical products.
Producers, holders of marketing authorizations or their representatives in Romania, as well as wholesale and retail distributors of medical products have the obligation to report to the Agency, until the 31st of March of each year, all sponsoring activities carried out in the previous year. The same market participants must report to the Agency all expenses incurred in the previous year for professionals in the health care sector, professional organizations, patients organizations and any other type of organization that carries out activities related to human health, medical or pharmaceutical assistance, by the same deadlines. The beneficiaries of such sponsoring activities (physicians, nurses, organizations etc) have the same reporting obligation.
Based on the template forms included in the Norm, the following information will need to be reported to the Agency: (a) name of the reporting entity; (b) name of the beneficiary (health care professional, institutions in the medical field, organizations etc); (c) specialty of the health care professional; (d) principal professional address; (e) nature of sponsorship; (f) description of activity (e.g. conference, consultancy, advisory board, expert opinion, training etc); (g) amount; (h) date of agreement; (i) date of payment/ remittance of goods.
The information thus reported shall be published on the website of the Agency, of the sponsor and of the beneficiary entities, in the second quarter of the reporting year for sponsoring performed/received in the previous year.
By way of derogation from the general reporting deadline, in 2015, the forms shall be submitted to the Agency until the 30th of June 2015, and the information will be published on the websites accordingly, until the 30th of September 2015.
Separately, the Norms also deal with sponsoring activities intended for the general public, providing, as in the case of activities of professionals in the health care sector, that such activities cannot be linked to the name of medicine, dispensed with or without a prescription. Also, such sponsoring activities cannot contain direct or indirect promotional messages for medicine, whether dispensed with or without a prescription. Further, charity programs cannot be undertaken in the name of a medical product.
Failure to comply with the provisions related to advertisement for medicinal products is punished by the Agency with a fine between RON 5,000 – 10,000 (approx. EUR 1,200 – 2,400).