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Free Medications in Cancer Treatment: Smart Drug and Immunotherapy Lawsuits, Social Security Institution Coverage, and Legal Process Guide

Cancer remains one of the most common and serious health problems of our time. With the rapid advancement of medical science, traditional chemotherapy methods have been replaced by "smart drugs" (targeted therapies) that directly target cancerous cells and "immunotherapy" methods that activate the body's immune system against cancer . These new generation treatment methods significantly increase the lifespan and quality of life of patients.

However, the biggest drawback of these modern and innovative cancer drugs is their exorbitant cost. Monthly doses can cost hundreds of thousands of Turkish Lira, exceeding the economic means of families and leaving patients facing a life-threatening situation. The Social Security Institution (SGK) generally refuses to cover the cost of these new generation drugs on the grounds that they are not included in the Health Application Communiqué (SUT) list.

Our legal system, in accordance with the constitutional right to health and the principle of the social state, asserts that no citizen can be deprived of access to treatment due to financial difficulties. In this context, "Cancer Drug Social Security Institution Coverage Lawsuits" (smart drug lawsuits) are the only legal solution that ensures patients have completely free access to these vital medications

This comprehensive legal article will examine in detail the constitutional basis for the free provision of medications in cancer treatment, the application and litigation processes with the Social Security Institution (SGK), the vital importance of "stay of execution" and "preliminary injunction" decisions, the recovery of previously paid medication costs, and precedent decisions of the Supreme Court/Constitutional Court.

1. Constitutional and International Legal Foundations for Free Medications in Cancer Treatment

The Constitution of the Republic of Turkey and the international conventions to which Türkiye is a party recognize the right to life and the right to access healthcare as the most sacred values ​​that the state must protect. The Social Security Institution's (SGK) refusal to pay for cancer medications on grounds such as "limited financial resources" or "budget balance" directly contradicts these overarching norms.

1.1. Evaluation within the Scope of the Turkish Constitution

  • The Principle of the Social State (Article 2 of the Constitution): The Republic of Turkey is a democratic, secular, and social state governed by the rule of law, respecting human rights. A social state is one that guarantees the minimum living standards of its citizens and protects them against economic and social threats. A system that cannot provide medicine to its citizens battling a deadly disease like cancer violates the principle of the social state.

  • Personal Inviolability, Material and Moral Existence (Article 17 of the Constitution): “Everyone has the right to life, to protect and develop their material and moral existence.” The protection of material existence is directly related to the protection of health. The state's duty here is to eliminate elements that endanger the individual's right to life.

  • Health Services and Environmental Protection (Article 56 of the Constitution): “The State shall ensure that everyone lives their life in good physical and mental health; it shall regulate the planning and provision of health services by a single authority in order to increase efficiency and productivity in human and material resources and to achieve cooperation. The State shall fulfill this duty by utilizing and supervising health and social institutions in both the public and private sectors.”

1.2. International Agreements

According to Article 90 of the Constitution, international agreements duly put into effect have the force of law, and in cases where laws and agreements contain conflicting provisions regarding fundamental rights and freedoms, the provisions of the agreement shall prevail.

  • Article 2 of the European Convention on Human Rights (ECHR) (Right to Life): States have a duty (positive obligation) to take necessary measures to protect the lives of persons within their jurisdiction. The withholding of necessary medical treatment by the state may be considered a violation of the right to life.

  • Article 12 of the International Covenant on Economic, Social and Cultural Rights: States parties to the Covenant recognize the right of everyone to enjoy the highest attainable standards of physical and mental health.

2. Obstacles posed by the Social Security Institution (SGK) and the Health Application Communiqué (SUT)

Institution (SGK) determines the healthcare services and medications it finances the Health Application Communiqué (SUT) . The SUT lists which medications will be covered by the state under what conditions, for which types and stages of cancer (SUT Positive List).

2.1. Medical Developments Lagging Behind the SUT List

Cancer drugs are being developed very rapidly worldwide and are being approved by the FDA (US Food and Drug Administration) and EMA (European Medicines Agency) before being made available for use. However, it can take years for a drug to be licensed in Türkiye and then included in the Social Security Institution's (SGK) reimbursement list.

Cancer patients, however, do not have the time to wait for months or years. The Social Security Institution (SGK) rejects a modern targeted therapy drug or immunotherapy drug (such as Keytruda (Pembrolizumab), Opdivo (Nivolumab), Tecentriq (Atezolizumab), Lynparza (Olaparib), etc.) prescribed by the patient's doctor, simply on the grounds that "this indication is not included in the SUT list. "

Legal Reality: The SUT (Health Services Pricing Regulation), being an administrative directive, cannot override the "Right to Life" and "Right to Health" guaranteed by the Constitution. The Supreme Court and the Council of State have ruled that medications not included in the SUT but medically essential for a patient's life must be reimbursed by the Social Security Institution (SGK).

3. Legal Process for Obtaining Cancer Medications Free of Charge (Step-by-Step)

The process for the government to provide cancer medication free of charge consists of two main stages: administrative and legal. Managing this process flawlessly is vital for ensuring the fastest possible access to the medication.

[Step 1: Medical Report and Prescription] │ ▼ [Step 2: Turkish Medicines and Medical Devices Agency (TİTCK) Off-Label Drug Approval] (If the drug is unlicensed or off-label) │ ▼ [Step 3: Written Application to SGK] (Request for free medication) │ ▼ [Step 4: SGK Rejection Decision] (Or 30 days of silence) │ ▼ [Step 5: Filing a Lawsuit in the Labor Court] + [Request for Provisional Injunction / Stay of Execution] │ ▼ [Step 6: Court Issues Provisional Order] -> (Medication begins to be provided free of charge)

3.1. Step 1: Medical Report, Prescription, and Off-Label Use Approval

  • Oncology Specialist Report: The specialist physician (medical oncologist) treating the patient prepares a detailed medical summary and a health board report stating that current standard treatments (chemotherapy, etc.) have not been beneficial and that the use of the targeted therapy drug or immunotherapy drug in question medically necessary .

  • TITCK Approval: If the requested drug is not licensed in Turkey, or if it is licensed but not approved for use in that specific type of cancer (for example, the drug is actually licensed for lung cancer, but the doctor wants to use it for breast cancer in the patient), an application must be made to the Turkish Medicines and Medical Devices Agency (TITCK) , which is affiliated with the Ministry of Health, to obtain "Off-Label Drug Use Approval" . This approval is the most important evidence showing that the use of the drug in that patient is scientifically appropriate.

3.2. Step 2: Application to the Social Security Institution (SGK)

Medical reports, prescriptions, and, if applicable, the Turkish Medicines and Medical Devices Agency (TİTCK) off-label approval certificate are submitted to the Social Security Institution (SGK) in writing. The application states the urgency of the patient's condition, the inability to purchase the medication due to its exorbitant price, and the irreparable harm (risk of death) that will result from not having access to the medication. It requests that the cost of the medication be fully and without any deductions covered by the SGK

3.3. Step 3: SGK's Rejection and Litigation Phase

The Social Security Institution (SGK) usually responds to these applications in writing within 30 days, or implicitly rejects them by leaving the application unanswered. A lawsuit should be filed immediately following the SGK's rejection (or implicit rejection).

  • Competent Court: If the patient is insured or dependent under SSK (4/a), Bağ-Kur (4/b) or the Pension Fund (4/c), the competent court the Labor Court. (If the patient is an actively working civil servant, in some cases it may be necessary to file a lawsuit in the Administrative Court, but the established practice is generally the Labor Courts).

  • Defendant: Presidency of the Social Security Institution.

4. Race Against Time: Request for Provisional Injunction (Suspension of Execution)

In cancer drug litigation cases, waiting for the normal trial process (average 1-2 years) can lead to the patient's death. Therefore, as soon as the lawsuit is filed, "Preliminary Injunction" (or a Stay of Execution in Administrative Courts) is requested from the court.

4.1. Conditions for Provisional Measures Pursuant to Article 389 of the Code of Civil Procedure

According to Article 389 of the Code of Civil Procedure (HMK), a precautionary measure may be issued regarding the subject matter of a dispute in cases where, due to a possible change in the current situation, obtaining the right would become significantly more difficult or completely impossible, or where delay would be detrimental or would cause serious harm

The grounds for issuing restraining orders in cancer cases are as follows:

  • Risks of Delay: If the medication is not taken, there is a risk of cancer cells spreading rapidly, metastasizing, and the patient losing their life.

  • Irreparable Damage: There is no alternative to human life and health that can be measured in money or subsequently compensated for.

4.2. Interim Measures Without Security Deposit

Courts usually require the plaintiff to deposit security (money) when issuing interim injunctions. However, considering the situation of cancer patients, injunctions are issued "without security" in accordance with Article 392 of the Code of Civil Procedure . When the court accepts the request for an injunction, it instructs the Social Security Institution (SGK) to "continuously cover the cost of the cancer medication the patient will use until the end of the lawsuit." This decision is usually issued within 1 to 3 weeks after the lawsuit is filed , and the patient begins receiving their medication free of charge.

5. Three Key Criteria the Court Sought in its Main Decision

An interim injunction is a temporary solution; for the case to be won permanently, the court must prove its merits during its substantive review. Courts and appointed expert panels (usually oncology professors from university hospitals) look at the following three criteria:

No Critical Criterion Legal/Medical Meaning
1 Medical Necessity and Vitality The medication must be absolutely necessary to prolong the patient's life or improve their health; it must not be a luxury or experimental treatment.
2 Lack of Alternative Treatment The patient must have been tried and failed with other chemotherapy or chemotherapy drugs covered by the state in the SUT list (or there must be no other legally suitable alternative for the patient's condition).
3 Scientific and Academic Literature Support The drug in question is listed in international guidelines (NCCN, ESMO, etc.) indicating success in treating cancer cases of the patient's stage and type.

6. Recovering Past Medication Costs from the Social Security Institution (Reimbursement Lawsuits)

Many patients and their relatives, in order to prevent interruptions in treatment while waiting for the bureaucratic stages of the lawsuit process, purchase the first few doses from pharmacies at their own expense, by taking out loans or selling assets.

Our legal system allows for the reimbursement from the Social Security Institution (SGK) of medication costs that the patient paid for out of pocket before a lawsuit is filed.

  • Conditions: In order to receive a refund for past doses, the "medical necessity" and "lack of alternative treatment" conditions listed above must have been present at the time those doses were used.

  • Evidence: Pharmacy receipts, hospital administration forms showing that the medication was administered to the patient, nurse observation sheets, and doctor's prescriptions must be presented to the court.

  • Interest Claim: The court is requested to recover from the Social Security Institution (SGK) the money paid in the past, legal interest , and to return it to the patient (or their heirs in case of death).

7. Precedent Decisions of the Court of Cassation, the Council of State, and the Constitutional Court

While legal cases regarding the free provision of cancer drugs were once an uncertain process, they are now based on a solid legal foundation thanks to established case law by the high courts.

7.1. The Approach of the Supreme Court's General Assembly of Civil Law and Relevant Civil Law Chambers

The Supreme Court consistently emphasizes that human life takes precedence over financial considerations in response to the Social Security Institution's (SGK) defenses based on "budget constraints." Supreme Court rulings generally include the following statements:

“According to Articles 2, 17, and 56 of the Constitution, the state has an obligation to protect the right to life and health of its citizens. The fact that a drug is not included in the SUT (Health Services Pricing List) does not relieve the institution of its payment obligation in cases where that drug is vital and there is no alternative. The cost of the drug, which is scientifically determined to be essential for the patient's treatment, must be covered by the defendant institution.”

7.2. Constitutional Court (AYM) Decisions

The Constitutional Court also issues "interim measures within the scope of the Right to Life" in cancer drug cases brought before it through individual applications. In cases where local courts reject requests for interim measures, and if there is a risk of irreversible deterioration in the patient's health, the Constitutional Court issues urgent interim measures in favor of the applicant, ordering the Social Security Institution (SGK) to pay for the medication.

8. Common Procedural Errors and Risks in Cancer Drug Lawsuits

A professional approach is essential to manage the process without any loss of rights. The most common procedural errors encountered in practice are as follows:

  • Applying to the Social Security Institution (SGK) without obtaining TİTCK (Turkish Medicines and Medical Devices Agency) approval: If the drug is used off-label, applications made without this approval may lead to delays or rejection of the case in court.

  • Forgetting to Request a "Preliminary Injunction" When Filing a Lawsuit: In cases filed solely on the merits, the court may not automatically order a precautionary measure. In this case, the patient may not receive medication free of charge until the end of the lawsuit (for months).

  • Filing a Lawsuit in the Wrong or Incorrect Court: For example, civil servant patients might miss the crucial detail that requires filing a lawsuit in the Administrative Court instead of the Labor Court, or vice versa, leading to a loss of time due to lack of jurisdiction.

  • Loss of Invoices and Receipts: Failure to present official invoices to the court when requesting refunds for past payments will result in the forfeiture of earnings from that period.

9. Frequently Asked Questions (FAQ)

1. How long does a lawsuit to make cancer medication free take?

The final resolution of the case (expert reports, hearings, etc.) takes an average of 6 months to 1.5 years . However, the crucial Interim Injunction Order is usually issued within 10 to 20 days of the lawsuit being filed . This allows the patient to start using the medication free of charge without waiting for the case to conclude.

2. Can the Social Security Institution (SGK) refuse to pay for the medication despite a court-issued injunction?

No, they cannot refuse. Court decisions are binding on all administrative institutions and organizations, including the Social Security Institution (SGK) (Article 138 of the Constitution). SGK officials who fail to comply with the precautionary measure and do not cover the medication can be charged with "Abuse of Office," and the institution will be directly responsible for any resulting damages. The SGK generally complies with precautionary measures immediately.

3. Do I need to file a new lawsuit every month to receive the medication free of charge during the court proceedings?

No. Unless otherwise specified, a court-issued injunction “until the end of the case and throughout the treatment period .” As long as your doctor deems it appropriate for you to use the medication, with a single injunction, you will continue to receive your medication free of charge from the pharmacy or hospital for each dose.

4. What happens if the patient unfortunately passes away while the case is ongoing?

One of the most tragic situations in cancer cases is when a patient dies while the trial is ongoing. In this case, the provision of "injunctive relief" for free medication is eliminated. However, if the patient had to pay for medication out of pocket or had outstanding hospital/pharmacy debts before their death, their legal heirs (spouse, children, etc.) can continue the case and recover those past payments with interest.

5. Could medicines imported from abroad and not licensed in Türkiye also be obtained free of charge through this lawsuit?

Yes, it can be obtained. The fact that the drug is not licensed in Türkiye alone does not relieve the Social Security Institution (SGK) of its payment obligation. What is important is that the Ministry of Health (TİTCK) has approved the importation of that drug into Türkiye for individual treatment (through the Turkish Pharmacists Association – TEB or authorized warehouses) and that it has been medically proven that the drug is vital for the patient.

6. Is there a risk of losing the smart drug case? What happens if it is lost?

As with any case, there are risks involved. If the expert panel issues a report stating that "This drug is completely ineffective for the patient's type of cancer, is purely experimental scientifically, or there is another drug with the exact same effect on the market that is covered by the state," the case may be dismissed. If the case is dismissed, the interim injunction is lifted, and the Social Security Institution (SGK) can demand reimbursement from the patient for the cost of the drugs it provided free of charge during the lawsuit. Therefore, the oncologist's opinion and the supporting literature must be very strong at the beginning of the case.

7. Can patients with green cards (those without social security contributions) also file this lawsuit and receive targeted therapies free of charge?

Yes. Citizens covered by the General Health Insurance (GSS) system, whose premiums are paid by the state (formerly known as Green Card holders), also have equal health rights under the Turkish legal system. The competent court is still the Labor Court, and the process works exactly the same way.

10. Conclusion and Legal Roadmap for Cancer Patients

Providing targeted therapies and immunotherapy free of charge in cancer treatment is not a favor or a privilege; it is a requirement of the most fundamental "Right to Life and Health" . The Social Security Institution's budgetary justifications or the SUT (Health Services Pricing Regulation) cannot override a person's struggle for survival.

The legal steps that patients and their relatives who cannot access these medications due to financial difficulties must take are clear: obtain a clear necessity report from a medical oncologist, complete all administrative applications, and immediately a lawsuit against the Social Security Institution (SGK) requesting an "Interim Measure" for cancer medication .

Given the need for the process to proceed very quickly and the strict rules of procedural law (jurisdiction, authority, off-label approval processes, objections to expert reports), having these cases handled by an experienced healthcare lawyer is the most accurate way to access medication in the safest and fastest way. It should be remembered that in the fight against cancer, law is at least as powerful a treatment tool as medicine.

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