• THE CODE OF ETHICAL CONDUCT CONTAINS A BINDING SET OF PRINCIPLES, TRANSPARENCY RULES AND SANCTIONS APPLICABLE TO ALL MEMBER COMPANIES OF APMGR
  • THE UNDERTAKING, COMPLIANCE AND IMPLEMENTATION OF THIS CODE OF ETHICS WILL BE MANDATORY REQUIREMENTS FOR ANY COMPANY THAT WANTS TO BE A MEMBER OF THE ASSOCIATION
  • THE CODE PROHIBITS OFFERING, PROMISING OR GIVING OF BENEFITS IN EXCHANGE FOR PRESCRIBING A CERTAIN MEDICINE
  • THE PROMOTION OF MEDICINES DISPENSED ONLY ON PRESCRIPTION WILL BE DIRECTED EXCLUSIVELY TO THE MEDICAL STAFF

BUCHAREST, FEBRUARY 19, 2013– The Association of Generic Medicine Producers from Romania (APMGR), association representing the interests of major investors on the Romanian market, adopted on Tuesday, February 19, 2013, a Code of Ethics regarding the promotion of prescription medicines. The document seeks to provide the necessary framework for implementing ethical standards to promote prescription medicines.

“The Code of Conduct contains a set of strict rules inspired both from international norms, and the experience of each of its member companies. Basically, in this document we have gathered together a set of principles, of strict rules of transparency and good conduct on promoting prescription medicines. The adoption of this Code of Ethics is a further evidence of the seriousness with which we operate and illustrates the accuracy and commitment of our companies thoroughly committed to the Romanian market. The Code is, on the other hand, a reflection of our constant concern to improve market conditions and, ultimately, the patients’ situation, which should always be the focus of all stakeholders in the healthcare system”said Dragos Damian, President APMGR.

The code is divided into ten chapters and contains a set of mandatory principles, transparency rules and sanctions applicable to infringements of the norms. The adherence to the Code of Ethics will be a sine qua non precondition for obtaining membership status in the Association.

Among the MOST RELEVANT PROVISIONS included in this Code of Ethics we draw attention upon:

  • The total ban of the practice of offering, promising or giving to the medical staff or corresponding administrative staff remuneration, including gifts, pecuniary advantages, benefits in kind and so on, as an inducement to prescribe, supply, sell or administer a medicine.
  • The obligation that the promotion of prescription medicines to be sent or directed exclusively to the medical personnel.The launching of promotional materials is prohibited in places that are accessible to the general public such as pharmacies, waiting rooms, hospitals lobbies and health clinics, etc.
  • The prohibition of any form of promotion inconsistent with the terms of the marketing authorization (“off-label promotion”).
  • The promotion needs to encourage the rational use of drugs presenting them objectively and without exaggerating their properties.
  • The prohibition of the use of phrases such as “safe” or “with no risk” to describe a drug without a proper argumentation.
  • The promotion of medicines should not be disguised. Promotional and advertising materials must be kept separate from other content and to have clearly indicated that it is an ad.
  • The document’s provisions will be applicable including “when a Member authorises or gives guidance to third parties to carry out promotional activities on its behalf.”

The document contains a separate chapter stipulating PENALTIES applicable to infringements of its provisions. These range from a warning to pecuniary penalties or even the exclusion from the ranks of the Association.

The full text of the Code of Ethics of APMGR can be found on the website of the Association at https://www.apmgr.org/ro/cod.