Partner Ana-Maria Baciu, NNDKP, talked about the challenges and legal limitations of promoting pharmaceutical products at Pharma Marketing Conference.
At the first edition of the event, speakers discussed about: multi-channel communication methods, the challenges and advantages of unified communication for generics producers, advertising trends and the impact of digital communication on the pharmaceutical market etc.
Addressing the most relevant legal issues of drug advertisement for the general public, Ana-Maria presented the regulations governing online advertising, details about discounts in relation to co-payment programs and the terms for permitted promotion of drugs. For example, pharmaceutical companies are forbidden to directly distribute drugs to the general public for advertising purposes, and the Ministry of Health can authorize direct distribution only in special cases. Moreover, the National Agency for Medicines and Medical Devices (NAMMD) must approve all advertising material for medication released without a prescription, but forbids promoting drugs that require one, that contain narcotics or that are granted through the public health insurance system. Legislation also prohibits advertising of pharmaceutical products through social media.
When referring to advertising for the medical professionals (medics, nurses, pharmacists), Ana-Maria pointed out the conditions for receiving sponsoring and attendance to medical events, the regulation of online advertising and the categories of promotional materials which must be approved by the NAMMD. For example, advertising materials aimed at professionals in the field do not need prior approval, irrespective of being prescription medication or not. Instead, educational materials must be approved by the NAMMD. In any of the above cases, the holders of the marketing authorization must keep the promotional materials for a minimum of three years.
"On a dynamic and heavily regulated market, this year's emergency ordinance brings a series of new legal aspects that must be taken into consideration by companies in their advertising strategies. Among the issues, it is essential that all sponsorships and all other hospitality on medics, nurses and professional organizations in the medical field must be declared to the Ministry of Healthcare and the NAMMD", explained Ana-Maria Baciu. She added that "all pharmaceutical companies are responsible to comply with legal provisions, even in the case of third party concessions. If the legislation in force is not complied with in what concerns drug advertisement, sanctions vary from fines to suspending of even withdrawing the marketing authorization".
Organized by Evensys, one of the most important players on the Romanian events market, the conference brought together 20 speakers, communication or advertising specialists and strategy or promotion consultants, both from agencies, but also from companies and associations in the pharmaceutical and medical field.
***
About NNDKP's Pharmaceutical and Healthcare Practice:
With a team of five specialized lawyers, the Pharmaceutical and Healthcare Practice has been rapidly expanding in the past eight years, by offering legal assistance with regard to all commercial and regulatory aspects, including drug, medical devices and food supplements distribution contracts, approval and/or notification by relevant authorities of marketing these products in Romania, but also advertising aspects, claw-back, pricing, interventional or observational clinical studies. The team assists clients such as: producers or distributors of pharmaceutical products, companies offering healthcare services, laboratories and medical devices producers.
***
For more information please contact:
Irina Melecciu | Director of Marketing and Communication
Nestor Nestor Diculescu Kingston Petersen
Attorneys & Counselors | Intellectual Property Counseling| Tax Advisory Services
Tel: (40-21) 20 11 200 | Fax: (40-21) 20 11 210 | Mob: (40-72) 86 66 232
irina.melecciu@nndkp.ro | www.nndkp.ro
