Following its exit from the Soviet Union, the Republic of Moldova started its independent life with a poorly-regulated medical system that lacked the proper means of ensuring patient safety.
However, in the last few years Moldova has increasingly adjusted its legislation to Europe’s, securing the rights of patients and improving the quality of drugs administered in the country.
The most recent achievement on this front is the transposition of the European Pharmacopeia into Moldovan law, which represents a significant accomplishment in terms of protecting society against such phenomena as adverse reactions to medical products and inferior drugs.
Evolution of the Pharmacovigilance System
Even before the pharmacovigilance system was established, several legal provisions ensuring the safety of drugs placed on the Moldovan market were included in the country’s domestic legal framework.
The first attempts of the Moldovan legislator to impose certain drug safety standards were made by means of the Law on Drugs in 1997, which established the requirement that medicines be of good quality, proper for their purpose, and without undue adverse reactions. In 2003, though not yet a member to the Convention on the Elaboration of a European Pharmacopeia, Moldova nevertheless introduced the concept of the European Pharmacopeia into its legal framework by supplementing The Law on Pharmaceutical Activity of 1993 with a general requirement that drugs must comply with the standards established by the European Pharmacopeia. Also, between 2006 and 2015 the Ministry of Health of Moldova enacted additional secondary legislation, establishing a number of measures to be followed by medical staff and drug manufacturers in respect to drug safety, drug registration, and the reporting of recorded adverse reactions. The above-mentioned acts constituted stepping-stones towards today’s Moldovan pharmacovigilance system.
Pharmacovigilance Today
Moldova’s current pharmacovigilance system is a well-developed mechanism, with several methods for ensuring that the drugs offered to Moldovan patients comply with European safety requirements. By adhering to the Convention on the Elaboration of a European Pharmacopeia in 2016, Moldova has undertaken to observe and comply with the standards and requirements established by the European Pharmacopeia and impose them on any drug manufactured in or imported into Moldova. In 2017 and 2019, the Ministry of Health set the timeline for transposing the ninth and tenth editions of the European Pharmacopeia into Moldovan law. Edition No. 10 is to become fully enforceable in Moldova by 2022.
The current pharmacovigilance system includes a centralized mechanism instituted within the Medicines and Medical Devices Agency that provides for the collection of reports on adverse reactions and also imposes certain measures to ensure that drugs that may cause unforeseen adverse reactions are excluded from the market.
Thus, under the Regulation on Execution of Pharmacovigilance Activities, the holders of drug registration certificates are required to develop a pharmacovigilance plan ensuring the quality control of the medicinal products placed on the market. Such entities are required to report any adverse reactions to their products to the VigiBase database. Furthermore, these entities are required to perform continuous scientific research of their products, undertake necessary actions to minimize any risks posed by the drugs they place on the market, and adopt appropriate preventive measures.
Besides the holders of drug registration certificates, medical staff that has been informed of adverse reactions to particular medicinal products and patients that have experienced them are also required to report to the Agency.
Pharmacovigilance Effectiveness
Though it is a new mechanism and the practice of reporting adverse reactions is still under development, the pharmacovigilance system has already registered significant results, having attained its core objective – ensuring that drugs posing a risk to human health are prohibited and/or removed from the Moldovan market. The number of adverse reactions reported has risen from 277 in 2016 to 940 in 2018. Most of the reports (91.38% in 2018) were submitted by medical staff informed of adverse reactions to drugs administered to patients.
Although still in development, the Moldovan pharmacovigilance system appears to be a mechanism well-shaped and adjusted to European standards, representing an intrinsic tool for ensuring public health.
By Marina Zanoga, Head of Regulatory, and Doina Doga, Associate, ACI Partners
This Article was originally published in Issue 7.3 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.
