„Now the application of both laws is stopped by the Constitutional Court, which reduces for a period these risks for drug users. If these laws come into force as they are already published, we risk running out of drugs in full pandemic...”
The end of 2020 brought major changes in Moldovan legislation on pharmaceutical activity and changed the regulation of drug prices. They are mainly related to the implementation of initiatives on mobile pharmacies.
The intentions were among the best: it was intended to bring the medicines closer to the people in the villages, where pharmacies are lacking. But perhaps out of haste or lack of deep analysis, the laws passed have brought a string of serious risks, including the risk of leaving the country without major drugs in the midst of a pandemic.
When we read carefully, we note that by implementing Law No.236/2020 and Law No.240/2020 in the approved and published version in the Official Gazette No.353-357/278 of 22.12.20 and Official Gazette No. 360-371 (7688-7699) of 25.12.2020, foresee significant changes in the following areas of pharmaceutical activity: The release of medicinal products from pharmacies (including compensated medicinal products); Quality assurance of medicines; Formation of drug prices; Location of community pharmacies.
These changes will generate a number of pharmaceutical risks with a significant impact on human health. Let's take the most important ones one by one at a time.
Approval of mobile pharmaceutical units will give rise to the following risks:
The impossibility of ensuring the quality of medicines up to the final consumer. Manufacturers of medicinal products, certified according to GMP (Good Manufacturing Practice Rules) conditions, are responsible for the quality of the products up to the final consumer. In order to ensure quality throughout the value chain, manufacturers impose strict quality requirements on importers and distributors of medicines in Moldova. Mobile pharmaceutical units do not meet the principles and quality requirements imposed by manufacturers of medicinal products. Medicines manufactured in countries with strict requirements for the quality of medicines will not be accessible in mobile units.
Risk of deterioration of the quality of pharmaceutical practices. The release of medicines is allowed in the Republic of Moldova in pharmacy, licensed according to special conditions and requirements, designed to ensure the quality of medicines. Licensing conditions do not provide for requirements for mobile units.
The risk of increasing the unreasonable consumption of medicines. The pharmacist is the specialist who possesses sufficient knowledge for the release of medicines. The conditions for licensing a pharmacy in Moldova clearly specify the requirements for the staff of the pharmaceutical unit. Mobile units shall be admitted to work without the presence of the pharmacist. There is also the risk of uncontrolled release of medicines.
Risk of faulty records and limited control over stocks. The way in which pharmaceutical products are recorded, keep price controls, stocks and shelf life in mobile establishments have a direct impact on the quality of medicinal products, their accessibility and their rational use.
The risk of non-compliance with the rules of good pharmaceutical practice for the distribution of medicinal products under the conditions of mobile units. The logistics and transport of medicinal products are an area strictly regulated by European law.
It should be noted that, in 2020, during the pandemic, the service of home delivery of medicines by various couriers or postal services appeared. These services are not covered by current legislation, do not ensure the quality of medicinal products until final consumers and impose the same risks as mobile pharmaceutical units. A review of the system of supply of medicinal products is required in the context of new conditions. Or we prohibit, or strictly regulate, these activities.
Changes to the price formation mechanism will bring us more risks than benefits.
The risk of rising drug prices. The proposed amendments contain severe implications for the mechanism of formation of drug prices in the Republic of Moldova. These changes do not change qualitatively the system of formation of drug prices, however they will have a direct quantitative impact on drug prices for the final consumer – prices for medicines will increase.
The risk of many medicines disappearing from the market. At the same time, in order to make these changes, the involvement of external factors, i.e. drug manufacturers, which are responsible for the applications for price registration in the National Catalogue of Drug Prices, is required. The proposed laws do not provide for a transitional period, necessary to carry out these applications. In particular, we will face an acute shortage of many medicines on the Moldovan market during the pandemic period. The physical and financial accessibility of medicines for consumers will be reduced. Patients with chronic diseases will suffer the most.
The increase in prices of OTC products (medicines dispensed without a prescription) will decrease their consumption. The removal of the trade mark-up on OTC products will impact an increase in the prices of these products. For the most part OTC products are essential medicines used in children and elderly adults. The increase in prices of these products will have a negative impact on each household's monthly consumption basket.
The risk of damaging the process of purchases of medicines for hospitals. The lack of medicines will also influence public procurement processes in healthcare units, the quality of the medical act in hospitals, increase unfair competition, contribute to the increase of illicit imports, increase the rate of counterfeit medicines.
It is obvious clear to all, that the system of registration of drug prices in Moldova is a vicious one, difficult to control and contains a number of elements, which determine high prices for medicines compared to neighbouring countries. In Moldova:1) is registered the producer price, instead of the maximum price selling in pharmacy; 2) the list of reference countries includes countries with high prices for medicines, and does not include countries with low prices (Turkey; Ukraine); 3) the selection criteria of the reference countries is the population of less than 25 mln; 4) is applied the mark-up to the purchase price to all categories of medicinal products and a fixed fee does not apply, for those offset by the CNAM. These provisions have led several drug manufacturers to abandon the registration of medicines in Moldova and respectively, to abandon the registration of their prices in the National Price Catalog. At the same time, the import of these products is authorised from various sources, sometimes with exaggerated prices, which also leads to a lack of a system of control over the quality of the product.
In the context of accelerated digitization imposed by the pandemic, a review of the system of registration and control over drug prices in Moldova is required, by creating a transparent, efficient and controllable ecosystem at all stages. A review of the authorisation processes for medicinal products is also required to allow legal access to medicinal products of assured and controlled quality up to the final consumer.
Eliminating the mandatory 250-metre distance between pharmacies is absolutely unjustified and brings some major risks.
The risk of uncontrolled expansion of pharmacy networks. The rules for the location of Community pharmacies, licensed in capital construction buildings and the distance between them, are an element in the exercise of the function of control over the pharmaceutical activity by the State.
Risk of deteriorated licensing requirements and criteria vis-à-vis the pharmacy. The mobile unit is not a pharmacy, it is a mobile unit, designed to provide access to medicines in localities where there are no pharmacies. The annulment of this rule will lead to an excessive increase in the number of pharmacies and will contribute to the dominance of commercial interests in pharmaceutical activity.
Changes in the system of compensated medicines with a serious impact on costs and access to medicines will trigger a chain reaction.
Risk of limiting access to compensated medicines. In Moldova there are several models of compensation for drug costs for certain categories of patients. Cost compensation is carried out through National Programs, treatments in medical institutions, prescriptions compensated by CNAM. Any change in the compensation system will have an impact on costs and will require a review of budgets. In the Proposed Laws we have several changes to price calculation models and cost compensation models. Ultimately, consumers of medicines will have to cover these costs, directly or indirectly (inclusively by paying health insurance premiums).
The list of compensated medicinal products and the mechanism for calculating the prices of these medicinal products require a systemic review and the calculation of the impact on budgets.
Direct contracting of drug manufacturers, negotiation of clowback fees, as well as the transmission of medicines from the National Programmes in the lists of medicines compensated by the CNAM, are just some measures aimed at facilitating patients' access to treatments.
Now the application of both laws is stopped by the Constitutional Court, which reduces for a period these risks for drug users. If these laws come into force as they are already published, we risk running out of drugs in full pandemic.