Healthcare professionals (HCPs) and pharmaceutical industry regularly work in close cooperation in order to improve the lives of patients through medical advances and enhanced care. This relationship on the one hand allows HCPs to acquaint the pharmaceutical industry with the issues and unmet medical needs, and on the other hand the industry, through sponsoring research and education, as well as professional gatherings of HCPs, provides invaluable learning and development opportunities which ultimately lead to better quality health care. Due to the sensitive nature of this issue, however, the relationship between HCPs and the industry cannot be left unregulated, and in most jurisdictions this is done through limiting the amounts of various sorts of sponsorship that are provided to HCP’s.
On the European level, greatest efforts in this regard have been made through European Federation of Pharmaceutical Industries and Associations (“EFPIA”) – under the auspices of which the Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations was produced. This document contains detailed provisions on different types of sponsorship, donations and grants that can be bestowed upon HCPs by pharmaceutical companies, and serves as a basis for similar codes that have been put in place in national associations on the European level.
The relationship between pharmaceutical companies and HCP’s, in terms of Serbia’s legislation on this matter, is only regulated in the Drugs and Medical Devices Act (“DMDA”), and the Rulebook on Advertising of Drugs and Medical Devices (“Rulebook”).
The Rulebook is somewhat lacking in terms of determining specific limits on the amount of different type of sponsorship that pharmaceutical companies may bestow upon HCPs. The Rulebook prohibits any sponsorship (not specifying the form of sponsorship) towards HCP’s to be of such an extent so as to influence their decision whether to prescribe or recommend a drug or medical device to a patient. Further, it prohibits sponsorship of professional gatherings to be conditioned by seeking, or giving any material/non–material benefits, and for the pharmaceutical companies sponsoring the professional gatherings to affect the content of the professional gatherings. The Rulebook also requires all pharmaceutical companies to annually publish on their web sites information of all professional gatherings they have sponsored in the respective year along with the amount of funds used for those purposes. Although the Rulebook also introduces the possibility for the health inspection to fine entities which are in breach of said provisions, the lack of precise limits, notwithstanding the obligation of pharma companies to publish total amounts used for sponsorship, may pose an issue in practice.
In Serbia, largest efforts to increase transparency of the relationship between HCP’s and the industry was demonstrated by The Association of Manufacturers of Innovative Drugs INOVIA (“INOVIA“), which introduced the Code on Promotion of Prescription Only Medicines to Healthcare Professionals. The Code is largely based on the previously mentioned EFPIA’s code, thus securing the level of scrutiny to be the same as in other European countries, and contains much more detailed provisions than the Rulebook.
In line with this, the Code only allows representatives of pharmaceutical companies to provide educational and informational materials to HCPs under the condition that their value is under EUR 30. Further, the Code provides that the maximum amount of food allowance for HCPs is EUR 50, and that professional gatherings sponsored by members of INOVIA cannot be hosted in hotels which are categorized as 5 star facilities. The Code is binding on 16 pharmaceutical companies which conduct business in Serbia, members of INOVIA, as well as on two non–members which pledged to abide by its provisions.
All of the above demonstrates that the detailed approach that professional associations of pharmaceutical companies have taken in dealing with this delicate issue serves its purpose much more effectively. While self-regulation is better than no regulation, the issue of this importance, which can affect the quality of healthcare on national level deserves to be regulated in more detail in legislation, as well. Regular interaction of pharmaceutical industry with HCPs is one of the keys on the basis of which pharmaceutical companies improve their understanding of medical therapy. Raising the level of transparency in relationships between pharmaceutical industry and HCPs will secure that this cooperation is better understood by all participants of the healthcare system, as well as the general public.