Moldova. Licensing of Pharmaceutical Enterprises

The Licensing Chamber, a public organ under the Ministry of Economy is currently responsible for licensing of pharmaceutical enterprises. This leads to fragmentation of responsibilities between the MMDA, the Licensing Chamber and the National Evaluation and Accreditation Office. A transfer of the licensing function to the MMDA was envisaged in the Medicines Agency Road Map for 2012–2014, which was approved by the Government in April 2012.

However, a draft document to modify the law on pharmaceutical licensing activities was never approved due to lack of support from the other ministries. In addition to not have the licensing function under a specialised authority, as is the case in other countries, there are also no pharmacists within the licensing Chamber. On the 1st of April 2011, the Parliament approved new rules for opening a pharmacy. The new requirements included a minimal distance between pharmacies and location to be based on demographic criteria. The law also required the Government to approve, within three months, a national plan to determine the location of new pharmacies based on these new criteria.

The Ministry of Economy was opposed to this national plan and the idea of involving the Government, mainly arguing that regulating the opening of new enterprises is against free market principles. It thus provided negative feedback on the proposed plan and proposed to instead develop a new revision of the law to cancel all the new criteria. The Ministry of Health developed the new draft law which revoked the demographic criteria for pharmacy opening locations as well as the national plan. However, the final text currently under review by the Parliament will likely result in the removal of all three stipulations as requested by the Ministry of Economy.

It is therefore still unclear whether any new criteria on opening new pharmacies will be introduced. Regardless, even if new criteria are approved, complexities in access would still remain and thus further considerations could be needed. For example, based on population criteria, the municipality of the capital Chisinau had too many pharmacies, calling for a moratorium on new openings. In 2012 there were 1,838 inhabitants per pharmacy in the capital rayon (district) of Chisinau vs. an average of 4,488 inhabitants per pharmacy in the other rayons.

But in reality, there were certain villages near the capital (still part of the municipality of Chisinau) or in the recentlybuilt ‘microrayons’ (‘microdistricts’) where the number of pharmacies per capita was too low. However, because the average number of pharmacies in the rayon was too high, it was not possible to open new pharmacies in those undersupplied areas.

Source: Journal of Pharmaceutical Policy and Practice