The medicines and medical devices sector helps save lives by providing innovative solutions for the diagnosis, prevention, monitoring and treatment of various diseases. This sector is becoming more and more important for the medical assistance of the citizens of the Republic of Moldova.
In this context, the Court of Accounts of the Republic of Moldova examined today, February 17, the results of the compliance audit of the market introduction and management of medicines and medical devices in the Republic of Moldova. The selection and conduct of the audit mission emerged from the relevance of the field both for the entire health system and for citizens - beneficiaries of medical services.
The audit area included entities of different levels and subordinations, resulting from their responsibilities and attributions, such as: The Medicines and Medical Devices Agency, the Center for Centralized Public Procurement in Health, the Forensic Medicine Center, the Public Health Institutions, the Republican Center for Medical Diagnostics, the Mother and Child Institute, the Dermatology and Communicable Diseases Hospital. Audit evidence was also collected from 48 other authorities and entities.
The audit found difficulties and non-compliances, which further require the strengthening of the medical system with the accountability of all parties involved.
One of the findings of the audit reveals that the reduced number of medicines registered in the Republic of Moldova attests to the withdrawal from the market of a significant number of medicines, which can lead to a decrease in the number of competitors and producers for the international common names of medicines.
In 2021, 5,800 medicines were registered in the State Nomenclature, which is 350 medicines less compared to 2020. The situation was caused by the fact that applications for the authorization of the drugs were not submitted. These circumstances condition risks regarding the discontinuity of drug stocks on the market of the Republic of Moldova, with an impact on patients' access to drug assistance.
With reference to the manufacturers' prices of both imported and domestic drugs, there are deficiencies due to the fact that the holders of the Medicines Registration Certificate did not ensure the declaration of the manufacturer's price. Thus, in the National Price Catalog the prices were declared and approved for only 3195 types of medicines, which represents 55% of the medicines registered in the State Nomenclature. This situation creates premises for increasing the prices of medicines delivered to medical institutions and purchased by citizens, because they are not approved by regulation.
Regarding the import of unauthorized medicines in the Republic of Moldova, there is a significant increase in the number of authorizations issued, as non-compliances were found in the import of medicines in the amount of 289 million lei. Thus,
- the import of unauthorized medicines was allowed, in the amount of 260 million lei, in the absence of arguments presented by the economic operators, although the normative framework expressly provides that, in case of non-correspondence of the documents presented or in the absence of arguments, the application for authorization of the import will be rejected medicinal products not authorized in the Republic of Moldova;
- the issuance of the authorization to import an unauthorized antiviral drug – Fabiflu, in the amount of 7.7 million lei, was carried out non-compliantly;
- the unauthorized drugs, in the amount of 13 million lei, which were procured for the national health programs, although they obtained permission for import, were not evaluated and documented according to the regulations within the Committee for the authorization of the import of unauthorized pharmaceutical products in the Republic of Moldova, etc.
In the framework of centralized public procurement procedures in health, unauthorized medicines intended for about 60 thousand patients from 23 national health programs were contracted. It was established that 28% of the medicines needed by the health services were unauthorized in the Republic of Moldova.
Medicines for the implementation of the National Program for the control of rare diseases - namely Wilson-Konovalov disease, were not procured according to the needs submitted by the specialized committee, being reduced by 50% the quantities of medicines initially requested for these patients.
Another situation found by the audit refers to the acceptance of the import of an unauthorized medicine (in the amount of 69 thousand dollars), which is intended for people with diseases of the cardiovascular system. The import of this drug was carried out at the price of 10.6 dollars, although later the price approved in the National Price Catalog was 4.8 dollars. The amount of drugs actually imported was 35 thousand dollars more expensive, which indicates that these expenses were borne by the citizens.
Regarding the import of medicines, the audit found deficiencies because the quantity, price and date of import did not correspond to the dates of the import authorization, namely:
- the drugs were imported at higher prices compared to the one requested at the authorization stage, cumulatively exceeding by 11 million lei the price of the drugs from the technical and price specification presented by the economic operators;
- medicines in the amount of 55 million lei were imported into the country after the expiration of the validity period of the import authorization;
- drugs in the amount of 117 million lei were imported into the country before the import permit authorization was issued;
- economic operators imported medicines exceeding the quantity permitted for import, and the value of imported medicines over the allowed limit was 1 million lei.
With reference to the import of a medicine (Linex), it was found that it was classified as a food supplement, with VAT of 20% and not 8% being applied, which conditions the increase of the final sales price by 1 million lei, compared to the case in that the preparation is classified as a medicine.
Regarding access to pharmaceutical assistance, the audit found that pharmaceutical institutions were established and located in cities with non-compliance with demographic norms. As an example, for 935 thousand people in 7 cities, licensed pharmaceutical institutions exceeded by 40% the requirement to establish a pharmacy per 3,000-4,000 people, and in some rural localities, pharmacies are insufficient and affect access to pharmaceutical assistance for 71 thousand people.
Another problem found relates to the commercial addition of medicines and medical devices. The commercial allowance for medical devices is not regulated by the legislation in force, which generates significant expenses when procuring them by medical institutions, in the amount of 10 million lei.
The data on medical devices used in the health system are imprecise and not updated, on the grounds that not all medical devices have been registered in 2 information systems managed by the Medicines and Medical Devices Agency. Thus, the public medical and sanitary institutions did not register 707 medical devices in the information system, in the amount of 165.9 million lei out of 2906 medical devices under their management.
The Court of Accounts concludes that the authorities and institutions involved in these processes did not, in some cases, show the appropriate responsibility in terms of the compliant achievement of the objectives, a situation conditioned including by the fragmented inter-sectoral communication, the non-updated regulatory framework and the lack of the necessary resources. The findings of the audit indicate the need to hold the institutions involved in providing the population with medicines and medical devices accountable, to develop a systemic action plan aimed at reducing risks and non-compliances.