The Contested Norms on the Procedure for the Reimbursement of Expenditures for the Acquisition of Medicinal Products Comply with the Satversme
On 9 April 2013 the Constitutional Court pronounced Judgement in Case No. 2012‑14‑03 “On Compliance of Para 84.1 and Para 89 of the 31 October 2006 Cabinet of Ministers Regulation No. 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medicinal Devices Intended for Out-patient Medical Treatment” with Article 91 and Article 111 of the Satversme of the Republic of Latvia.”
The State has fulfilled its obligation to ensure the accessibility of reimbursement medicinal products
The Contested Norms
At the moment of submitting the Application 31 October 2006 Cabinet of Ministers Regulation No. 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal products and Medicinal Devices Intended for Out-patient Medical Treatment” (hereinafter – also the Regulation)
Para 841: “If the patient in the framework of reimbursement procedure previously has not received medicinal products or medicinal devices included in list A envisaged for the concrete diagnosis, the physician shall prescribe on the special form for prescription the common name of the medicinal product or medicinal device intended for this diagnosis.”
Para 89: “If a physician, in writing a prescription for reimbursable medicinal products, has used the common name of a medicinal product, the duty of a pharmacist is to dispense the cheapest reimbursable medicinal products, which conform with this name, the prescribed pharmaceutical form and strength, but if the list of reimbursement medicinal products contains two or more medicinal products with the lowest basic price for reimbursement – the medicinal product, which has been granted the status of the cheapest medicinal product by the National Health Service. If a physician, in writing a prescription for reimbursable medicinal devices, has used the common name of a medicinal device, the duty of a pharmacist is to dispense the cheapest reimbursable medicinal devices, which conform with this name and the type of usage, but if the list of reimbursement medicinal devices contains two or more medicinal devices with the lowest basic price for reimbursement – the medicinal device, which has been granted the status of the cheapest medicinal device by the National Health Service. It is prohibited within the framework of reimbursement procedure to dispense medicinal products or medicinal devices that do no comply with these terms.”
During the period for preparing the case the Cabinet of Ministers amended the third sentence of Para 89 of this Regulation, wording it as follows: “If the pharmacy has submitted to the State Inspectorate information referred to in Para 91 of this Regulation concerning the inaccessibility of the reference medicinal products or medicinal devices or the cheapest medicinal products or medicinal devices to be reimbursed in the framework common name, the pharmacist may dispense to the patient the next cheapest medicinal product or medicinal device.”
The Norms of Higher Legal Force
Article 91 of the Satversme: “All human beings in Latvia shall be equal before the law and the courts. Human rights shall be realised without discrimination of any kind.”
Article 111 of the Satversme:” The State shall protect human health and guarantee a basic level of medical assistance for everyone.”
The Facts
The applicants – twenty members of the 11th Saeima – note that the contested norms create two groups of patients, with different procedures for reimbursing the expenditures for acquisition of medicinal products. Those patients, who previously received reimbursement medicinal products envisaged for concrete diagnosis, retain the right to receive the medicinal product with a concrete name, indicated in the prescription, in case of necessity paying the difference between the chosen and the cheapest reference medicinal product. But the second group of patients, who previously have not received reimbursement medicinal products in the framework of reimbursement procedure, may receive those reference medicinal products, which have been granted the status of cheapest medicinal product by the National Health Service. This situation is incompatible with Article 111 of the Satversme and violates the principle of equality.
The Cabinet of Ministers, in its turn, notes that the contested norms have been adopted with the aim to promote competition between the producers and distributors of medicinal products, which would lead to decrease in the prices of reimbursement medicinal products. Thus, the contested norms ensure saving of patients’ and the State’s resources, as well as more extensive possibilities to channel resources for satisfying other needs within the framework of reimbursement system.
The Court Findings and Ruling
On the obligation of the State in ensuring the right to health
The Constitutional Court recognised that the obligation of the State to ensure accessibility of medicinal products follows from Article 111 of the Satversme, however, the State has the task to allocate the resources at its disposal and to define, who is entitled to what kind of treatment and under what kind of conditions. [12]
Examining, whether the State has met its obligation to ensure accessibility of medicinal products, the Constitutional Court assessed, whether:
- the legislator has implemented measures to ensure realisation of this right:
- these measures have been duly implemented, i.e., whether persons have been ensured the possibility to exercise their rights at least in the minimum scope;
- the general principles of law following from the Satversme have been complied with. [13]
The Court found that a system has been established within the State to ensure the accessibility of health care and medicinal products, thus the first criterion for assessment has been met.
On the possibility for persons to realise their rights at least in minimum scope
The Constitutional Court noted that the obligation to ensure accessibility of medicinal products contains not only the establishment of a general system, but also the obligation to see to it that medicinal products are available to patients. This obligation can be met by establishing a system of health insurance, by granting benefits for the acquisition of medicinal products, by reimbursing the resources spent for the acquisition of medicinal products or in other ways. [15]
The Constitutional Court established that the contested norms promote competition among the producers and distributors of medicinal products, thus decreasing the prices of medicinal products and devices. Therefore the inhabitants gain the possibility to acquire cheaper medicinal products and the state budget expenditure for reimbursing expenditure for the acquisition of medicinal products decreases. The saved resources can be used to ensure the accessibility of reimbursement medicinal products and medicinal devices to a broader range of persons. [15]
Moreover, if there are medical reasons for it, the physician, within the framework of reimbursement procedure, may also prescribe other medicinal products or devices, starting with the lowest price within the framework of the generic name. [15.1]
Thus, the State has ensured the accessibility of reimbursement medicinal products at least on the minimum level. [15.2]
On compliance of the contested norms with the principle of equality
The Constitutional Court recognised that the same disease, for the treatment of which the same medicinal product or medicinal device is needed, is a feature uniting all patients, irrespectively of the fact, whether they have received previously the reimbursement medicinal products or medicinal devices intended for the concrete diagnosis. However, the shared feature does not always serve as sufficient argument for establishing that two groups of persons are under similar and mutually comparable conditions. The use of concrete medicinal products in different stages of disease has different significance. Because of medical and psychological considerations, to those patients, who have previously received concrete reimbursement medicinal product or medicinal device, the possibility to continue the course of treatment that has already been started should be ensured. As regards patients, who have not previously received concrete reimbursement medicinal product or medicinal device, it is even impossible to ensure the possibility to “continue” using them, as they have never used the concrete medicinal product or medicinal device. [17.2]
Thus, these two different groups of patients are not in similar and mutually comparable conditions, and the contested norms are not incompatible with the principle of equality, enshrined in the first sentence of Article 91 of the Satversme. [17.2]
On terminating judicial proceedings in part of the Case
The Constitutional Court established that the third sentence of Para 89 of the Regulation in the contested wording has become invalid and that there are no conditions pointing to the need to continue judicial proceedings in this part of the claim. Hence, the Court decided to terminate judicial proceedings in this part of the Case. [16]
The Constitutional Court held:
- to recognise Para 84.1 and the first and the second sentence of Para 89 of the 31 October 2006 Cabinet of Ministers Regulation No. 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medicinal Devices Intended for Out-patient Medical Treatment” compatible with Article 91 and Article 111 of the Satversme of the Republic of Latvia.
- to terminate judicial proceedings regarding the compliance of the third sentence of Para 89 of the 31 October 2006 Cabinet of Ministers Regulation No. 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medicinal Devices Intended for Out-patient Medical Treatment”, in the wording of 27 December 2011 with Article 91 and Article 111 of the Satversme of the Republic of Latvia.
The Judgement is final and not subject to appeal, it comes into force as of the day of its pronouncement.
Linked case: 2012-14-03