Pharmaceuticals
 
Republic of Moldova

The Moldovan pharmaceutical distribution sector underwent a major process of privatization in 1994. Today many pharmacies are privatized (although pharmacies in large hospitals are generally not). The state, however, remains a shareholder in a number of the privatized enterprises, so Moldova actually has a mixed system of state and private pharmacies. The large scale privatization was undertaken to try to ensure an adequate and regulated drug supply in the face of an economic collapse and the state's consequent difficulties running its own drug supply and distribution system. The weaknesses in the state drug supply and regulatory system that arose shortly after independence led to the formation of a large and unregulated black market in pharmaceuticals alongside a collapse in the national prescription system. Today, the black market is considered insignificant and regulation of sales through privatized pharmacies is helping to ensure quality of the pharmaceutical supply. With the exception of a few restricted items, however, drugs continue to be freely available from all pharmacies without a prescription, although this continues to be technically illegal.

Regulation of the pharmaceutical sector is a responsibility of the Ministry of Health. It has set profit limits (40% on wholesale price) on pharmacies on drugs and also regulates which drugs may be sold in the country. While the privatization of the pharmaceutical sector has helped ensure drug supply and the regulation has helped ensure that only approved drugs are marketed, the pharmaceutical privatization process has allowed situations to develop where doctors may have professional conflicts of interest. Many doctors bought pharmacies under the privatization programme and these are often in the clinic or hospital where they work. Unscrupulous professionals might be interested in prescribing expensive or even inappropriate drugs to patients to increase their own pharmacy profits. To help rationalize prescribing and encourage doctors to prescribe effective but inexpensive drugs, an essential drugs list was drawn up in 1998, based on WHO recommendations. It was reviewed and revised in 2001. Moldova has one main generic drug production company, Farmaco, which manufactures a limited range of products, and around twelve smaller drug production companies. The country thus imports most of its drug requirements.

Prior to independence, Moldova was able to obtain and distribute drugs through the centralized Soviet pharmaceutical system. It became clear at postindependence that it could no longer continue this centralized approach to drug purchasing. As part of the health reform process, it moved to a system of local hospital-level purchasing. Exceptions to this new system include certain drugs such as insulin and haemophilia drugs that are supposed to be supplied directly to the hospitals by the state. The state is often unable to provide these items but sometimes the shortfall is met by nongovernmental organizations such as Pharmaciens Sans Frontières (PSF). Under the local purchasing scheme, hospitals are supposed to receive money for specified drugs and prepare tenders to purchase these competitively. However, the money from the state budget for these drugs purchases is often inadequate. Humanitarian agencies continue to play an important role in supplying basic drugs to the population. In some hospitals, up to 50% of the pharmaceutical supply for children is supplied by the international aid community. At the national level, international agencies such as UNICEF provide direct support to the pharmaceutical supply by providing vaccines for the national immunization programme.

Access to pharmaceuticals is difficult for many people because of the costs. For patients with chronic conditions, such as diabetes, the situation is very precarious. Although under the minimum package most drugs for children under 5 years supposed to be free, the mechanism for this is unclear and it is unlikely that many children are benefiting from this arrangement.

The Law on Pharmaceutical Activity (1993, amended 1998), that outlines who can perform pharmaceutical duties, and the importing, production and registration of drugs, and the Law on Pharmaceuticals (December 1997), that covers quality control issues of pharmaceuticals, manufacturing and trials, form the key parts of the Moldovan pharmaceutical regulation.

 

arrowFrom the HiT (Healthcare Systems in Transition) of the Republic of Moldova (2002) [pdf, 403KB] 
 Also available in: ru[pdf, 1MB]