Shortages of medicines and disruption of the supply chain have become more frequent in recent years for various reasons, greatly affecting the health of patients unable to access the treatments they need. The issue has been faced both centrally by the European Medicines Agency and European Commission and locally by single governments and national competent regulatory authorities, those last implementing local measures to reduce the impact on public health, improve access and rationalise the use of medications.
This is also true for Latvia, where from 1st April 2020 a new system for the prescription of reimbursed medicines has been implemented based on the use of international non-proprietary names (INN) of the active ingredients.
The main features of the new system
Latvia’s new system reflects indications by the World Health Organisation and the Organisation for Economic Cooperation and Development. Medical doctors must prescribe just indicating the INN name of the active ingredient instead of the brand name; community pharmacists are obliged to dispense lowest price’s medicines of equivalent therapeutic efficacy to patients. Doctors are left a 30% free choice to prescribe branded pharmaceutical products, provided they justify it from the medical point of view. The same type of procedure has been already implemented by Estonia and Lithuania, as well as other EU countries like Germany, Finland, Netherlands, Denmark, Sweden and Greece.
The new law innovate the previous “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment” dated to 2006. The new system is expected to improve access to medicines for low income patients. Local health authorities worked also to ameliorating the IT infrastructure needed to support doctors with the prescribing procedure; patients are expected to continue treatment with their already in use drugs in 85% of cases. The announcement of the activation of the new modalities for prescription also caused a price rebate for 250 medicinal products in Latvia’s market.
The transition has been supported by many informative materials for doctors and pharmacists, both in paper and electronic format, while the campaign “Know and Don’t Overpay” was launched to inform the general public. Out-of-patent medicines represents 74% of total consumes in Latvia in years 2018-2019 (SAM data). The local total market amounted to € 411,3 million in 2018 (43% unbranded products) and € 472 million in 2019 (41% unbranded).
The Medicinal Products Register
Latvia’s State Agency of Medicines (SAM) manages the Medicinal Products Register, listing all medicines available in the internal market (it is accessible online at this link). The Register represents a transparent data tool to be searched upon active ingredients; it also includes information on the availability of different dosage forms of a certain product. The information is gained through the reporting of remaining stock wholesalers are obliged to daily transmit to SAM in order to monitor national inventories, identify risks of non-availability and prevent artificial inaccessibility of certain medicines (see the “Procedures Regarding the Distribution and Quality Control of Medicinal Products”).
Marketing authorisation holders (MAHs) are also requested to report about shortages; pharmacies, hospitals and even the general public can forward a notification should a drug not be present on the market. All information is available on the dedicate webpage. The daily update of the Register allows to better forecast procurement for the internal market on the basis of actual data and demand, to identify points needing attention and/or activation of additional mechanisms, to control artificial shortages and gain insight of medications being exported.
Even if all MAHs have a duty to report and are aware of this, also those that do not have a local office in Latvia, not all MAHs fulfill this duty. Therefore, the system still suffers some operative issues, also due to some medications present on the market and which lack competition, thus making more difficult the prediction of shortages. SAM released a note for MAHs to clarify the notification has to be submitted to the Agency at least two months prior to the supply disruption or discontinuation of a medicinal product. According to SAM the situation refers to the case none of the local wholesalers are able to purchase a medicinal product. With reference to products included in regulatory enactments regarding the procedure for reimbursement of expenses for the purchase of medicinal products and medical devices intended for outpatient treatment, Latvia’s legislation establishes that said list of reimbursable medicinal products cannot be delivered within 24 hours and within 48 hours for other medicinal products. Artificial unavailability refers to the case a pharmaceutical wholesaler refuses to supply a particular medicinal product even though this is in stock at that time, or to the situation a pharmacy did not request the specific medicinal product from the wholesaler where it was available.
Pharmaceutical companies have to submit the notifications even in case the date of possible shortage is not known or cannot be estimated; the approximate date can then be updated through an additional notification. Detailed information on procedures for the notification can be found on the dedicated page of the SAM website; here is the link to access the module template to be used for the notification.
Easy of search for improved transparency
The search engine of the Medicinal Products Register lists products according to different categories (see here more):
- “KZS L” indicates the lowest price product among those of equivalent efficacy and reimbursed (KZS) by the National Health Service;
- “KZS L1-L5” lists the following cheaper medicines with respect to reference product (KZS R) or lowest price product of equivalent efficacy;
- a white X on red background indicates the medicine is not available from wholesalers and cannot be dispensed;
- a white X on green background indicates the product is available.
The tool provides also information on the presumed date of availability. An e-mail address is provided to forward any suggestion on how to ameliorate the system: email@example.com.
The following screenshots are an example of the information that can be obtained from the Latvia’s Medicinal Products Register (access here the corresponding webpage).