Moldova. Medicines Promotion

Control on medicines promotion is an important regulatory area in Moldova where doctors are known to be heavily influenced by pharmaceutical representatives through financial incentives. Due to very low salaries (the average salary of a primary health care doctor was Lei (Moldovan) 3,500 (US$ 260) in 2012) the latter can easily double physicians’ income making this practice very difficult to eradicate without first addressing the problem of low wages.

Beyond financial issues, lack of training in rational prescribing and evidence-based medicine make physicians easy preys of the pharmaceutical industry. This is compounded by a lack of guidance from the public institutions in areas such as patient education and disease self-management which further strengthened industry’s role and influence. For example, doctors are required to run diabetes and hypertension schools but they do not have a standardised curriculum and are not provided with patient education materials to distribute so they rely on the pharmaceutical industry to provide patient education materials.

There is a law on medicines (# 1409 from 1997/12/17 in the chapter VI) providing general regulation on medicines’ information and advertising. The draft of regulation and executive order which sets out definitions, requirements, procedures of authorisations, prohibitions, monitoring and complaints procedure on advertising on medicines was presented at the beginning of 2012 to the Ministry of Health for approval and is currently still under discussion. The law on advertising (# 1227 from 22.06.1997) outlines the general principles for advertising, including provisions on adverting medicines and commodities.

The provisions on medicine promotion and advertising include explicit mention of the different forms of promotion but post-marketing scientific studies, speakers’ fees and consultancies, promotion of exported medicines and restrictions and limits on gifts and gimmicks. In addition, the provisions do not foresee an enforcement mechanism on promotion and advertisement of medicines, stating the sanctions in cases of violation. In addition to legal gaps, there are also procedural ones. For example, while a formal complaints procedure to report unethical promotional practices exists, there is no evidence that this is used.

Further, despite a standard check list for pre-approval and monitoring is available, it does not provide SOPs and there are gaps in the guidelines on COI for committee members or public officials involved in the control of medicine promotion activities. A revision of the law on advertising was launched by a group of deputies in early 2012 with a proposal to prohibit advertising of medicines on television. The Government accepted the proposal but it was refused by the Parliament. As in other regulatory areas, a number of other regulations remain in draft form pending approval the Ministry of Health. These include the number of samples pharmaceutical representatives are allowed to provide, advertisement on the internet, enforcement rules and training of medial or sales representatives.

Positive developments

A draft of the quality manual of MA has been developed

Source: Journal of Pharmaceutical Policy and Practice