Providing Cancer Patients with Medicinal Products

 

November 29, 2022

BRACE Law Firm ©

 

In recent years, cancer detection rates have increased both globally and in Russia. Statistics show that in most countries, malignant neoplasms are the second leading cause of death after cardiovascular diseases. In this situation, the timely provision of medical care to cancer patients, of which drug therapy is an integral part, is extremely important.

Currently, the Russian Federation lacks a single regulatory act governing the procedure for providing medicinal products to cancer patients. The procedure for provision and financing depends directly on the stage of medical care: outpatient or inpatient treatment.

This article examines in detail the rules for providing medicinal products to cancer patients, as well as the practical problems arising when obtaining necessary medications.

Drug Provision at the Outpatient Stage

At the outpatient stage, drug provision for cancer patients occurs through the so-called "federal benefit", and the "regional benefit", as well as under the "Seven Nosologies" state program.

The "federal benefit" is established based on Federal Law No. 178-FZ dated July 17, 1999, On State Social Assistance (the "Law on State Social Assistance"). Pursuant to the Law on State Social Assistance, the following persons have the right to receive a set of social services:

• war invalids;
• participants of the Great Patriotic War;
• combat veterans from among the persons specified in sub-clauses 1–4 of Clause 1 of Article 3 of the Federal Law On Veterans;
• military personnel who served in military units, institutions, and military educational organizations that were not part of the active army between June 22, 1941, and September 3, 1945, for at least six months; military personnel awarded orders or medals of the USSR for service during the specified period;
• persons awarded the "Resident of Besieged Leningrad" badge, and persons awarded the "Resident of Besieged Sevastopol" badge;
• persons who worked during the Great Patriotic War at air defense facilities, on the construction of defensive structures, naval bases, airfields, and other military facilities within the rear boundaries of active fronts, operational zones of active fleets, or on front-line sections of railways and highways, as well as crew members of transport fleet ships interned at the beginning of the Great Patriotic War in the ports of other states;
• family members of deceased (deceased) war invalids, participants of the Great Patriotic War, and combat veterans; family members of persons killed in the Great Patriotic War from among the personnel of self-defense groups of facility and emergency teams of local air defense, as well as family members of deceased employees of hospitals and clinics in the city of Leningrad;
• disabled persons;
• disabled children.

The set of social services for such patients includes, among other things, provision of necessary medicinal products in accordance with medical care standards for the disease in a volume no less than provided for by the List of Vital and Essential Drugs [1] (the "VED List"). The federal budget funds these expenses.

Note that according to the Law on State Social Assistance, a citizen has the right to opt out of the set of social services in favor of a cash payment by submitting an application to the Pension Fund of the Russian Federation by October 1 of the current year. However, such an opt-out does not deprive a disabled person of the right to receive medications under the "regional benefit" [2]. The right to receive free medications can be restored in the same manner as the opt-out, with the provision of the social service package resuming on January 1 of the following year.

The procedure for regional privileged drug provision for cancer patients (the "regional benefit") is regulated by Decree of the Government of Russia No. 890 dated July 30, 1994, On State Support for the Development of the Medical Industry and Improving the Provision of Medicinal Products and Medical Devices to the Population and Healthcare Institutions (the "Decree No. 890").

The List of population groups and disease categories for which medicinal products and medical devices are dispensed by doctors' prescriptions free of charge (Appendix No. 1 to Decree No. 890) includes:

• Oncological diseases. Patients with such diseases receive all medicinal products; incurable cancer patients additionally receive dressing materials.
• Hematological diseases and hemoblastoses (tumor diseases of hematopoietic and lymphatic tissue). Patients with such diseases receive cytostatics, immunosuppressants, immunocorrectors, steroid and non-steroidal hormones, antibiotics, and other drugs for treating these diseases and correcting complications from their treatment.

Each constituent entity of the Federation independently forms the list of medicinal products dispensed in accordance with Decree No. 890 within its territorial program of state guarantees for the free provision of medical care to citizens. However, pursuant to Article 81 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection"), their volume cannot be less than the VED List. This requirement is also established by the federal Program of state guarantees for the free provision of medical care to citizens in Russia. Note that regional state authorities may expand the list of free medications beyond the VED List.

The budgets of the constituent entities of the Russian Federation fund the expenses for drug provision under Decree No. 890.

To receive medicinal products under the "federal" or "regional" benefit, the patient must be included in the Federal Register of Beneficiaries of Privileged Medicinal Products. The Pension Fund branches include patient information in the register for the "federal benefit", while medical organizations do so for the "regional benefit".

Additionally, since 2008, the Russian Federation has implemented the "Seven Nosologies" state program [3]. Under this program, patients with rare and most expensive diseases receive medicinal products at the expense of the federal budget. In particular, malignant neoplasms of lymphoid, hematopoietic, and related tissues are included in the list of such diseases.

The procedure for providing for these patients is defined by Decree of the Government of Russia No. 1416 dated November 26, 2018, On the Procedure for Organizing the Provision of Medicinal Products to Persons with Hemophilia, Cystic Fibrosis, Pituitary Dwarfism, Gaucher Disease, Malignant Neoplasms of Lymphoid, Hematopoietic and Related Tissues, Multiple Sclerosis, Hemolytic-Uremic Syndrome, Juvenile Arthritis with Systemic Onset, Mucopolysaccharidosis Types I, II, and VI, Unspecified Aplastic Anemia, Hereditary Deficiency of Factors II (Fibrinogen), VII (Labile), X (Stuart-Prower), Persons After Organ and (or) Tissue Transplantation, and on Declaring Certain Acts of the Government of the Russian Federation Invalid.

Medicinal products under this Program are also provided during outpatient treatment within the scope of the VED List.

To receive medicinal products under this program, information about the patient must be included in the regional segment of the Federal Register of Persons Suffering from Rare Diseases. Information is entered into the Register within a period not exceeding five working days from the date the patient with an established diagnosis applies to a medical organization at their place of residence or stay (if the stay exceeds six months) based on medical documents reflecting the established diagnosis. After the patient is included in the register, the prescription and dispensing of medicinal products occur within a period not exceeding 20 working days from the date of inclusion. If a patient plans to travel outside the constituent entity of the Russian Federation where they reside for no more than six months, they are prescribed medicinal products for the entire duration of the trip. If the travel period exceeds six months or the place of residence changes, the patient receives medications for one month, and their data is forwarded to the destination region for inclusion in another regional segment.

Note that under current legislation, regions, taking into account the level and structure of the population's morbidity and the fulfillment of financial standards, have the right, when forming territorial programs of state guarantees, to increase the volume and types of medical care, including expanding the scope of drug provision. For example, Decree of the Government of Moscow No. 177-PP dated March 12, 2019, On Guarantees of Additional Drug Provision for Citizens Suffering from Oncological Diseases, establishes a separate list of medicinal products provided to patients suffering from oncological diseases that prevail in the morbidity structure in the city of Moscow.

Drug Provision During Inpatient Treatment

Drug therapy in 24-hour and day hospitals is carried out by the medical organization at the expense of the mandatory medical insurance system. In the vast majority of cases, medicinal products are purchased within the scope of the List of Vital and Essential Drugs.

Furthermore, pursuant to Clause 3 of Article 80 of the Law on Health Protection, in cases of individual intolerance or for life-saving indications, medicinal products not included in the VED List are prescribed by a decision of the medical board of the medical institution. These are also not subject to payment from the personal funds of citizens.

Procedure for Prescribing and Dispensing Free Medicinal Products

The prescription of medicinal products dispensed free of charge at the expense of the federal budget and the budgets of constituent entities for outpatient treatment is carried out by issuing a special prescription. The procedure for issuing privileged prescriptions is regulated by Order of the Ministry of Health of Russia No. 1094n dated November 24, 2021 [4].

To obtain a prescription, one must apply to the polyclinic institution to which they are attached for medical services. The prescription can be obtained by the patient, their legal representative, or a person holding a power of attorney executed in accordance with the Civil Code. A power of attorney is not required for a caregiver to obtain a prescription for an incurable patient at the final stage of their life. In this case, it is sufficient to present a medical document confirming the patient's incurable condition, indicating the full name of the person who will receive the medicinal products, certified by the signature and seal of a medical worker, as well as the seal of the medical organization. The prescription is issued on form No. 148-1/u-04(l) in two copies; for narcotic and psychotropic drugs, form No. 107/u-NP is additionally issued.

To obtain the medication, one must apply to a pharmacy organization authorized to dispense privileged medicinal products in the region. The attending physician will provide information about them when issuing the prescription; the list is also typically posted on the websites of healthcare management bodies.

If the pharmacy organization does not have the medicinal product at the time of application, the prescription is placed on "deferred service". Deferred service means a period during which the retail entity must provide the necessary drug to the prescription holder. Note that until September 1, 2022, the Rules for Dispensing Medicinal Products for Medical Use [5] regulated the timeframes for deferred service of prescriptions. However, this clause of the rules has currently expired, and new deferred service timeframes have not yet been approved, which will certainly negatively affect the timing of provision.

Additionally, it is prohibited to issue privileged prescriptions for medicinal products during the period when patients are receiving inpatient treatment. Drug therapy with necessary medications in a 24-hour or day hospital is provided by the medical organization where the patient is undergoing treatment.

Judicial Practice on Drug Provision for Cancer Patients

Despite the state-guaranteed right to drug provision at all stages of treatment, patients often face refusals and delays in obtaining necessary medications. Let us consider the main reasons for refusals using examples from judicial practice.

1. The drug is not included in the VED List, medical care standards, etc.

Citizen B. filed a lawsuit against the regional Department of Health for the provision of a medicinal product. In support of the claim, she indicated that she had undergone inpatient treatment at the Research Institute of Hematology and Transfusiology of the FMBA of Russia, where she was selected for and received therapy with a specific medicinal product because she had established resistance (unresponsiveness) to other types of chemotherapy. Based on the treatment results, it was recommended to continue treatment according to this scheme at her place of residence.

The patient applied to the Department of Health with an application for the provision of the necessary drug. However, the Department refused to provide the medication, citing the absence of the drug in all lists of medicinal products used for provision and in the treatment standard.

The court pointed out that pursuant to Article 37 of the Law on Health Protection, the prescription of medicinal products not included in the relevant medical care standard is permitted in cases of medical indications (individual intolerance, life-saving indications) by a decision of the medical board. The patient had the necessary medical documents: a decision of the medical board, a conclusion from the chief external specialist, and the attending physician of the Research Institute of Hematology and Transfusiology of the FMBA of Russia. The claims were satisfied in full [6].

No less difficulty arises for patients if the medicinal product has not undergone the state registration procedure in Russia. Such drugs are initially absent from all standards, lists, etc. The Supreme Court of the Russian Federation recognizes the right to be provided with unregistered medicinal products if the patient has medical documents confirming the need for them for life-saving indications [7].

2. Medical board documents were improperly executed.

Citizen M. filed a lawsuit against the regional Department of Health to compel provision of the medicinal product "Pomalidomide" and for recovery of moral damages in the amount of 300,000 rubles. In support of the claims, he indicated that he is a person with a Group II disability and suffers from an oncological disease. A federal medical research center issued a conclusion on the necessity of "Pomalidomide" therapy for life-saving indications due to the exhaustion of standard treatment methods and the progression of the disease. An application to the regional Department of Health resulted in a refusal to purchase the drug at the expense of the regional budget. The court of first instance satisfied the claims for drug provision but denied the recovery of moral damages. Upon appeal by the Department of Health, the appellate court overturned the decision, denying the claim in its entirety due to the improper execution of medical documents (the certificate of the city polyclinic's medical board was not formatted as a protocol, and there was no indication of medical indications). The Supreme Court of the Russian Federation found the appellate court's conclusions incorrect, stating the following:

• the plaintiff is disabled and suffers from a socially significant disease;
• legislation guarantees such patients drug provision;
• the proper execution of documents is the duty of the medical board; the patient should not suffer adverse consequences due to violations of the execution procedure.

The decision of the court of first instance was upheld [8].

3. The necessary drug was not purchased by the hospital.

A prosecutor filed a lawsuit in the interest of Citizen Ya. to declare the inaction of an Oncology Dispensary unlawful and to recover funds in the amount of 300,000 rubles. As established by the court, Citizen Ya. was undergoing treatment at the oncology dispensary. By decision of the institution's medical board, he was prescribed maintenance therapy with the drug "Durvalumab" once every two weeks. The dispensary conducted a one-time purchase of the drug. Two courses of treatment were administered to the patient, but further treatment was refused due to the absence of the drug; a decision was made to issue a referral to a clinic in Moscow. The patient filed a complaint with the Territorial Body of Roszdravnadzor and also purchased the drug at his own expense for home administration. The courts satisfied the prosecutor's claim, stating that the dispensary failed to properly perform its duties to provide the patient with the necessary drug therapy [9].

4. An analogue of the medicinal product was offered.

Citizen R. filed a lawsuit against the Department of Health for recovery of compensation for the independently purchased medicinal product "Nexavar" in the amount of 160,000 rubles and moral damages in the amount of 30,000 rubles. In support of the claims, she indicated that this drug was recommended by the N.N. Blokhin National Medical Research Center of Oncology; however, the Department of Health refused to provide this drug. The court established that the medical board of the oncology dispensary had prescribed the medicinal product with the INN "Sorafenib" to patient R. The prescription and purchase of medicinal products are carried out by International Nonproprietary Names (INN). The name "Nexavar" is the trade name of the medicinal product prescribed to her. The Department purchased the domestic drug "Sorafenib" for patient R., which is an analogue of "Nexavar". However, the plaintiff insisted on receiving exclusively the drug "Nexavar" in accordance with the recommendations given to her by the N.N. Blokhin National Medical Research Center of Oncology. At the same time, at the time the plaintiff purchased the drug "Nexavar", she lacked a prescription from her attending physician and a conclusion from a medical board, and the consultation certificate from the N.N. Blokhin National Medical Research Center of Oncology is advisory in nature. The claims were denied [10].

5. The patient is absent from the register of beneficiaries of privileged drugs.

The spouse of patient Ch. filed a lawsuit against the Republic's Ministry of Health to declare inaction in failing to provide medicinal products unlawful, to recover the cost of purchasing medicinal products in the amount of 366,304 rubles, and moral damages in the amount of 500,000 rubles.

In support of the claim, he indicated that his spouse had been diagnosed with an oncological disease and prescribed treatment with the antitumor drug "Bevacizumab". However, out of nine prescribed courses, only three were provided; the drug for the remaining courses was purchased at the family's expense. According to the Ministry of Health's responses, delays in dispensing the drug were due to Ch.'s temporary absence from the Federal Register of Beneficiaries of Privileged Drugs in connection with Ch. undergoing re-certification at the bureau of medical and social expertise.

The court of first instance partially satisfied the claims: it recovered moral damages in the amount of 5,000 rubles but denied the recovery of funds for independently purchased medicinal products because the patient had died, and the right to receive such compensation, in the court's opinion, cannot pass to another person, including by inheritance.

The Supreme Court of the Russian Federation sent the case back for a new trial: the lower courts failed to justify the significant reduction of the moral damages amount claimed in the lawsuit and did not consider the severity of the moral suffering caused to the plaintiff. The case was sent for a new trial [11].

6. Lack of budget funding.

The spouse of deceased cancer patient K. filed a lawsuit against the regional Health Committee for the recovery of funds spent on the purchase of a medicinal product in the amount of 406,833 rubles.

In support of the claim, she indicated that by decision of the oncology dispensary's medical board, K. was prescribed therapy with the drug "Regorafenib" for life-saving indications. Due to the absence of the drug in the VED List, the dispensary applied to the regional Health Committee to conduct a personalized purchase of the drug. However, the Committee decided to postpone the provision of K. until additional funding was allocated. As a result, the drug was purchased at the family's expense.

The courts of first and cassation instances denied the claim, stating that the right to receive a medicinal product free of charge is inextricably linked to the patient's personality, and only monetary amounts that were actually accrued but not received by the date the inheritance was opened are included in the estate.

The Supreme Court of the Russian Federation overturned the decisions, stating that the requested monetary amount represents K.'s losses in the form of expenses for the independent purchase of the medicinal product. The claim was satisfied in full [12].

7. Absence of the medicinal product in the pharmacy organization at the time of application with a privileged prescription.

Patient M. filed a lawsuit against the authorized pharmacy organization and the regional Ministry of Health for the recovery of material damage in the amount of 95,550 rubles and moral damages in the amount of 100,000 rubles.

In support of the claims, she indicated that she is disabled and, due to an oncological disease, was prescribed treatment with the drug "Gefitinib". A privileged prescription for this drug was issued to her by a medical institution. Due to the absence of the drug in the pharmacy on the day of application, the prescription was placed on deferred service. However, at the end of the deferred service period, the prescribed drug was not issued to her, so the patient purchased it at her own expense. The court of first instance partially satisfied the claims: the damage from purchasing the drug was recovered in full, while moral damages were reduced to 5,000 rubles. The appellate court found no fault on the part of the pharmacy institution in failing to provide for the patient, since by the time the patient applied, the pharmacy had already fully performed the state contract and the annual stocks of the drug had run out.

The Supreme Court of the Russian Federation overturned this decision, stating: the pharmacy did nothing to obtain or purchase the necessary drug, and further asked the medical institution to revoke the prescription; therefore, it acted unlawfully. The decision of the court of first instance was upheld in full [13].

Thus, a positive trend in judicial authorities' support for patients' rights to receive vital medicinal products should be noted. The same cannot be said for claims for the recovery of moral damages, which are often denied or significantly reduced, without considering the severity of the experiences endured by patients and their relatives.

In summary, let us highlight the main problems arising in drug provision for cancer patients:

• lack of sufficient continuity in providing for patients at all stages of treatment, including due to different sources of financing;
• duration and bureaucracy of drug procurement procedures, leading to delays in the supply of vital drugs;
• clinical recommendations, in accordance with which medical care is provided, lagging behind effective modern medicinal products released into circulation.

Overcoming these problems, in our view, is possible through the unification of rules for providing medicinal products to privileged categories of citizens, the determination of a single source of financing, and the simplification of drug procurement procedures.

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References

1. Approved by Order of the Government of Russia No. 2406-r dated October 12, 2019.
2. Letter of the Ministry of Health and Social Development of Russia No. 489-VS dated February 3, 2006, On Dispensing Medicinal Products to the Population by Doctors' Prescriptions for Outpatient Treatment Free of Charge and with a 50 Percent Discount.
3. At the current moment, the list of nosologies has been expanded.
4. Order of the Ministry of Health of the Russian Federation No. 1094n dated November 24, 2021, On Approval of the Procedure for Prescribing Medicinal Products, Forms of Prescription Blanks for Medicinal Products, the Procedure for Formatting Said Blanks, Their Accounting and Storage, Forms of Prescription Blanks Containing a Prescription for Narcotic Drugs or Psychotropic Substances, the Procedure for Their Manufacture, Distribution, Registration, Accounting and Storage, as well as the Rules for Formatting Prescription Blanks, Including in the Form of Electronic Documents.
5. Order of the Ministry of Health of the Russian Federation No. 1093n dated November 24, 2021, On Approval of the Rules for Dispensing Medicinal Products for Medical Use by Pharmacy Organizations, Individual Entrepreneurs Holding a License to Carry Out Pharmaceutical Activities, Medical Organizations Holding a License to Carry Out Pharmaceutical Activities, and Their Separate Subdivisions (Ambulatories, Feldsher and Feldsher-Obstetric Stations, Centers (Departments) of General Medical (Family) Practice) Located in Rural Settlements Where There Are No Pharmacy Organizations, as well as the Rules for Dispensing Narcotic Drugs and Psychotropic Substances Registered as Medicinal Products for Medical Use, Medicinal Products for Medical Use Containing Narcotic Drugs and Psychotropic Substances, Including the Procedure for Dispensing Immunobiological Medicinal Products by Pharmacy Organizations.
6. Appellate Ruling of the Civil Case Division of the Ivanovo Regional Court dated October 19, 2018, in Case No. 33-2077/2018.
7. Ruling of the Civil Case Division of the Supreme Court of the Russian Federation No. 14-KG19-10 dated October 7, 2019.
8. Ruling of the Civil Case Division of the Supreme Court of the Russian Federation No. 57-KG18-13 dated September 10, 2018.
9. Ruling of the Civil Case Division of the First Cassation Court of General Jurisdiction dated April 25, 2022, in Case No. 8G-8168/2022/88-11325/2022.
10. Decision of the Leninsky District Court of Ivanovo, Ivanovo Region, dated August 21, 2019, in Case No. 2-1477/2019.
11. Ruling of the Civil Case Division of the Supreme Court of the Russian Federation No. 49-KG20-21-K6 dated January 25, 2021.
12. Ruling of the Civil Case Division of the Supreme Court of the Russian Federation No. 16-KG21-16-K4 dated August 23, 2021.
13. Ruling of the Civil Case Division of the Supreme Court of the Russian Federation No. 53-KG17-32 dated February 19, 2018.