Moldova. Regulation of Pharmaceutical Market
The Republic of Moldova is a lower-middle-income country in eastern Europe with a population of 3.5 million (1st of January 2013, data do not include the districts on the left side of the river Dniester and the municipality of Bender) and a gross domestic product of US$ (current) 2,038 per capita in 2012. The economy is heavily based on remittances from Moldovan citizens working abroad. The country was part of the former Soviet Union, from which it obtained independence in 1991. Since independence, Moldova, including its health sector, has undergone profound social, political and economic transformations. While some reforms were introduced in the hospital sector, much remains to be done and the most important changes so far were compelled by the introduction of a mandatory health insurance system in 2004. These included strengthening of primary health care and ensuring access to a limited number of medicines in privatised pharmacies and selected national programmes (e.g. insulin, rare diseases, tuberculosis (TB), HIV/AIDS, immunisation).
Regulation of the pharmaceutical system is a crucial, yet often neglected, component in ensuring access to safe and effective medicines. While medicines financing, selection and procurement are essential, an effective, transparent regulatory system which manages conflict of interest (COI) and has a well-functioning post-marketingsystem (including product a recall system and pharmacovigilance)
is crucial to prevent entry of substandard products.
The latter pose a threat to patients’ health and cause
wastage of resources spent on ineffective and/or unsafe
products. The importance of regulatory control in ensuring
equitable access to essential medicines is also included
in the World Health Organization (WHO) framework for
collective action.
Despite the importance of regulatory functions in ensuring
access to essential medicines, few studies are available
which explore pharmaceutical regulatory issues in
countries of the former Soviet Union.
These include a
1996 review of the transparency levels across regulatory
systems worldwide which looked at Estonia and Latvia, a 1998–9 review of regulatory systems worldwide including
Estonia, a study analysing fees charged by
regulatory authorities which included Latvia, a more
recent study (2008) on pharmacovigilance activities including
Belarus, the Republic of Moldova, the Russian
Federation and Ukraine and two studies on the quality
of information provided on websites of drug regulatory
authorities which included Estonia, Latvia and
Lithuania.
The objectives of this study are twofold. First, to provide
an in-depth analysis of the existing pharmaceutical
regulation, including recent changes, in the Republic of
Moldova by reviewing gaps and progress in the main
pharmaceutical system functions. Second, using the case
of the Republic of Moldova, this paper aims to highlight
the importance of pharmaceutical regulation in ensuring
access to quality medicines. As issues of transparency
and gaps in regulatory pharmaceutical functions are common
in most low- and middle-income countries, this
paper is expected to stimulate the debate in the area and
encourage similar analysis in other countries.
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