The rapid advancements in medical science at the molecular level have brought about revolutionary treatment methods, particularly in oncology (cancer) and rare diseases (SMA, cystic fibrosis, various genetic syndromes, etc.). Traditional chemotherapy has largely been replaced by so-called "targeted therapies" and immunotherapies , which activate the body's own immune system to fight cancer . These new generation drugs extend patients' lifespans and significantly improve their quality of life.

However, behind these medical breakthroughs lies an extremely difficult financial barrier for patients and their families to overcome. Many of these drugs cost tens of thousands of Turkish Lira per course, with annual costs reaching astronomical figures in the millions. Even though some of these drugs are approved (licensed) by the Ministry of Health in Turkey, they are not included in the Social Security Institution's (SGK) the Health Application Communiqué (SUT) . In some cases, the drug may not be licensed in Turkey at all, and may be imported with "off-label" (off-package) use approval for the patient's condition.

At this point, within the framework of the constitutional rights of "right to life" and "right to health," smart drug lawsuits filed against the Social Security Institution (SGK) to ensure patients have free access to these medications are of vital importance. In this comprehensive legal review, we will analyze the concepts of smart drugs and off-label drug use, the mandatory administrative application processes before filing a lawsuit, the interim injunction phase where time is of the essence, recourse (claim) lawsuits, and the current and exemplary approaches of judicial authorities on this issue.

1. Basic Legal and Medical Concepts

To properly establish the legal basis for smart drug lawsuits, it is necessary to clarify certain specific concepts found in medical law literature and legislation.

What are Smart Drugs and Immunotherapy?

While traditional chemotherapy agents target all rapidly dividing cells in the body (without distinguishing between cancerous cells), targeted therapies target only specific receptors, genetic mutations, or signaling pathways on the cancerous cell. Immunotherapy drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo), and atezolizumab (Tecentriq) enable the immune system to recognize cancer. Medically, the suitability of these drugs for the patient is usually proven by genetic panels (NGS) or biomarker tests such as PD-L1, which are performed on tumor tissue.

What does off-label drug use mean?

Using a drug for a disease, age group, dosage, or method of administration other than those specified in its package insert (instructions for use) approved by the Turkish Medicines and Medical Devices Agency (TİTCK) off-label drug use .

For example, a targeted therapeutic drug named X might only be licensed for "Lung Cancer." However, new studies in the medical literature may show that this drug is also very successful in "Breast Cancer" patients carrying a specific genetic mutation. If a physician wants to prescribe this drug to a breast cancer patient, this would be an "off-label" use and would require special permission from the Ministry of Health.

Humanitarian Early Access Program (Compassionate Use)

This program is based on the principle that if a drug is not yet licensed in Türkiye and the patient has exhausted all other known treatment options, the drug manufacturer provides the drug to the patient free of charge or as a grant. However, since this program is not always accessible for every drug and every patient, a large number of patients are forced to import the drug from abroad at their own expense.

2. Mandatory Administrative Application Steps Before Filing a Lawsuit

For a smart drug lawsuit against the Social Security Institution (SGK) not to be dismissed on procedural grounds (due to expiration of statutes of limitations or lack of necessary conditions), the administrative procedure preceding the lawsuit must be carried out flawlessly. The process consists of the following steps in chronological order:

+-----------------------------------------------------------------------+ | SMART DRUG PRE-LITIGATION STEPS | +-----------------------------------------------------------------------+ | STEP 1: Preparation of Specialist Physician Report and Prescription | +-----------------------------------------------------------------------+ | v +-----------------------------------------------------------------------+ | STEP 2: Obtaining Approval for Off-Label Use of Drugs from the Ministry of Health (TİTCK) | +-----------------------------------------------------------------------+ | v +-----------------------------------------------------------------------+ | STEP 3: Importation of the Drug by the Turkish Pharmacists Association (TEB) or the Institution | +-----------------------------------------------------------------------+ | v +-----------------------------------------------------------------------+ | STEP 4: Application to SGK for "Reimbursement" and Obtaining a Written Rejection Decision | +-----------------------------------------------------------------------+ | v +-----------------------------------------------------------------------+ | STEP 5: Application to the Court (Filing a Lawsuit with a Request for Provisional Measures) | +-----------------------------------------------------------------------+

Step 1: Application to TİTCK for Off-Label Use

If the prescribed targeted therapy drug is not directly defined in the SUT (Health Services Pricing List) or license for the patient's diagnosis, the oncology/relevant specialist physician treating the patient applies to the TİTCK (Turkish Medicines and Medical Devices Agency) online for "Off-Label Drug Use Approval". Scientific committees within the TİTCK review the patient's medical history and genetic test results to determine whether the drug is medically necessary and appropriate for the patient. If approved, usage permits are generally issued for 3 or 6 months.

Legal Significance: This approval from the Turkish Medicines and Medical Devices Agency (TİTCK) signifies that a state institution has officially acknowledged that the drug is medically necessary and without alternative for the patient's treatment. This approval document is the strongest legal evidence for any lawsuit or request for interim measures.

Step 2: Submitting a Written Application to the Social Security Institution (SGK)

After obtaining TİTCK approval (or, if the drug is already licensed and not on the SUT reimbursement list, starting directly from this stage), the patient or their representative applies in writing to the SGK İbn-i Sina Health Social Security Center or the relevant regional directorate.

The petition states that the patient's diagnosis indicates that other treatments have been insufficient, that the targeted therapy drug in question is vital, and that the cost of the drug be fully covered by the institution without any deductions . The petition is accompanied by a physician's report, prescription, TİTCK (Turkish Medicines and Medical Devices Agency) approval letter, and genetic test reports, if available.

Step 3: Social Security Institution's (SGK) Rejection or Implicit Rejection

The Social Security Institution (SGK) consistently rejects these applications. The reason for rejection is that the drug is "not included in the Reimbursement List (Annex-4/A) of the Health Application Communiqué (SUT)" or does not meet the specific conditions in the SUT (e.g., limitations such as "having received at least 2 rounds of chemotherapy").

• The Social Security Institution (SGK) may either provide a written rejection of this request or, in accordance with the legislation, implicitly reject . For a lawsuit to be filed, either this written rejection must be received or the thirty-day legal period must have expired.

3. The Heartbeat in Smart Drug Cases: The Provisional Injunction Process

Cancer and rare diseases are aggressive illnesses. Considering that a lawsuit can take 1 to 2 years under normal legal procedures, the patient does not have time to wait for the outcome. Every day that the medication is unavailable means a risk of tumor growth or the patient's death. Therefore, requesting a preliminary injunction in accordance with Article 389 and subsequent articles of the Code of Civil Procedure (HMK) at the time the lawsuit is filed is the most critical stage of the case

Principles of Requesting Interim Measures

What was requested from the court "due to the patient's life being in danger until the end of the trial and the high cost of the medication, the Social Security Institution (SGK) would cover the cost of each course of treatment without interruption and free of charge .

According to Article 389/1 of the Code of Civil Procedure, two fundamental conditions must be met in order for a provisional injunction to be issued:

1. Concern that Delaying the Medication Will Cause Serious Harm or Risk of Harm: If the patient has cancer and inability to take the medication will lead to disease progression, this automatically proves that it will cause irreparable harm (death or permanent disability).

2. Approximate Proof: This refers to the plaintiff demonstrating their case to the court earlier than possible in subsequent stages of the trial, by providing supporting documents (such as TİTCK approval or a doctor's report).

Obtaining a Precautionary Measure Without Securities

Normally, when courts issue interim injunctions, they request a security deposit from the plaintiff (Article 392 of the Code of Civil Procedure) in case the court rules against the possibility of losing the case. However, in smart drug cases, given that the patient already lacks the financial means to obtain the drug and the matter directly relates to the "right to life," courts issue interim injunctions without requiring a security deposit

Appeal Procedures in Case of Rejection of the Request for Interim Measures

If the local court unfairly rejects the request for an interim measure based on the case file, or chooses to refer the matter to an expert instead of making a decision, this puts the patient's life at risk. According to Article 391/3 of the Code of Civil Procedure, an appeal against the decision to reject the request for an interim measure can be filed with the Regional Court of Appeals within two weeks of the notification of the decision. The Court of Appeals will examine this appeal as a priority and with urgency.

4. Determining the Competent Court: Labor Court or Administrative Court?

One of the biggest procedural errors in smart drug lawsuits is filing the case in the wrong court. The competent court is determined according to the patient's insurance status (4/a, 4/b, 4/c). A case filed in the wrong court will be dismissed due to lack of jurisdiction, and the time lost in this process poses a life-threatening risk to the patient.

The Role of Labor Courts

According to Article 101 of the Social Security and General Health Insurance Law No. 5510, Labor Courts have jurisdiction over all disputes arising from the application of the provisions of this law. Lawsuits filed on behalf of workers, tradespeople, or their dependent family members (spouse, children, mother, father) must be filed in a Labor Court. In locations where a Labor Court does not exist, the lawsuit in the Civil Court of First Instance (acting as a Labor Court) .

The Role of Administrative Courts

The rejection of an application to the Social Security Institution (SGK) by a patient who is an active civil servant (4/c) constitutes a unilateral "administrative act" by the administration. Therefore, the lawsuit to be filed for active civil servants is a case of Annulment of Administrative Act and Full Judgment , and should be filed in the Administrative Courts.

• Critical Detail: While administrative courts were previously considered competent for retired civil servants, recent decisions by the Court of Conflicts of Jurisdictions have led to the conclusion that, since retired civil servants' employment relationship with their institution is terminated and their healthcare services are managed under Law No. 5510, labor courts considered competent.

5. Constitutional Basis and Precedent Approaches of the High Courts (Constitutional Court, Court of Cassation, Council of State)

The Social Security Institution (SGK) typically relies on actuarial arguments such as "maintaining the institution's financial balance," "the SUT (Health Services Pricing) budget," and "the inability to reimburse for drugs not included in the legislation." However, the Turkish judicial system has clearly demonstrated that the principles of property and budget balance cannot override human life and the right to life

Framework of the Turkish Constitution

The cases are primarily based on the following articles of the Constitution:

• Article 17 of the Constitution: “Everyone has the right to life, to protect and develop their material and spiritual existence.” The State is obligated to take the necessary measures to protect the lives of individuals.

• Article 56 of the Constitution: “The State shall regulate the management and provision of health services by health institutions under a single authority, with the aim of ensuring that everyone lives their life in good physical and mental health.”

• Article 60 of the Constitution: “Everyone has the right to social security. The State shall take the necessary measures and establish the organization to provide this security.”

The Approach of the Constitutional Court

In numerous individual applications submitted to the Constitutional Court, the court has accepted requests for interim measures made by applicants who stated that their lives were at risk due to their inability to afford medication . The Constitutional Court's decisions clearly established that the state has a positive obligation to ensure patients have access to necessary medical treatments to protect their lives, and that exposing a patient to the risk of death due to financial difficulties constitutes a violation of Article 17 of the Constitution.

Supreme Court of Appeals General Assembly and Chamber Decisions

The Supreme Court has developed very clear case law in smart drug cases coming from Labor Courts. According to the Supreme Court:

1. The SUT reimbursement list is not a static (fixed) list; it must be updated according to developments in medical science.

2. that is included in internationally recognized guidelines (NCCN, ESMO, etc.), approved by the Turkish Medicines and Medical Devices Agency (TİTCK), and indispensable (vital) , simply because it is not on the SUT (Health Services Pricing List) list.

3. Courts should prioritize the patient's right to life, not the Social Security Institution's budget.

6. Recourse (Reimbursement of Past Medication Costs) Process and Claims

Many patients, unsure of the length of legal proceedings or due to the urgency, purchase the first few courses of medication at their own expense, by borrowing from relatives or organizing fundraising campaigns, in the time leading up to the filing of a lawsuit or the issuance of an injunction.

Getting a refund for paid bills from the Social Security Institution (SGK)

lawsuit filed regarding smart drug policies not only seeks provisional reimbursement for future drug costs but also the recovery (reimbursement) from the Social Security Institution (SGK) of past drug payments made out of pocket by the patient, along with legal interest . Technically, this is a "Debt and Cancellation" lawsuit.

Proof Requirements to be Considered in the Recourse Process:

• Original Invoices and Pharmacy Documents: Original invoices, bank statements, and prescriptions proving that the patient purchased the medication from a pharmacy or the Turkish Pharmacists Association (TEB) Overseas Drug Supply Unit must be submitted to the court file in their entirety.

• Treatment Tracking: Hospital discharge summary records and chemotherapy nurse observation forms detailing which treatment course was administered on which date should be included as evidence. When examining the recourse claim, the court will verify whether the medication was actually administered to the patient and the accuracy of the invoice.

7. The Law of Evidence in Litigation and the Methodology of Expert Examination

Even if a preliminary injunction is issued quickly in smart drug cases, the court will inevitably send the file to an expert panel . The expert examination is the most dynamic stage in determining whether the case will be won or lost.

Structure of the Expert Panel

The court typically forms a panel of experts selected from university medical schools. Depending on the nature of the case, the following experts are mandatory on this panel:

• Medical Oncology Specialist (for cancer cases) or Related Department Specialist (for rare diseases),

• Pharmacology Specialist (Drug Scientist),

• Social Security Law Expert (for SUT legislation and calculations).

Four Critical Criteria Examined by Experts

The criteria that the court asked the expert about, and which are required for a positive expert report, are as follows:

+------------------------------------------------------------------------+ | EXPERT REVIEW CRITERIA | +------------------------------------------------------------------------+ | 1. Accuracy of Diagnosis: Is the patient's stage and clinical picture appropriate? | +------------------------------------------------------------------------+ | 2. Medical Necessity: Does the drug have an effect on the patient's genetic mutation? | +------------------------------------------------------------------------+ | 3. Lack of Alternatives: Have other standard drugs in the SUT (Health Services Pricing List) been tried? | +------------------------------------------------------------------------+ | 4. Life Expectancy: Has it been proven that the drug will prolong the patient's life? | +------------------------------------------------------------------------+

1. Disease Stage and Clinical Presentation: Whether the patient has any contraindications (risk of side effects) that would prevent the use of this medication, given their current condition.

2. Medical Necessity of the Drug: Whether this drug is considered the “gold standard” or recommended treatment for the patient’s current cancer type and stage according to international oncology guidelines (NCCN, ESMO).

3. Priority (Lack of Alternatives): Whether other conventional chemotherapy or standard drugs listed in the SUT (Health Services Pricing List) have been exhausted, or whether it has been determined that administering these standard drugs to the patient would not be medically beneficial (resistance has developed).

4. Impact on Lifespan: Whether the drug will concretely contribute to the patient's progression-free survival (the time the disease remains stable) and overall survival time.

Legal Strategy: In case the expert report is negative, one of the most effective legal methods to influence the expert panel and persuade the court is to include in the case file the guidelines of world-renowned oncology centers, the results of the drug's phase 3 clinical trials, and an Expert Opinion (Scientific Opinion) from professors specializing in the subject, in accordance with Article 293 of the Code of Civil Procedure, when filing the lawsuit.

8. Frequently Asked Questions and Practical Legal Answers

Question 1: Will the Social Security Institution (SGK) immediately cover the cost of the medication after a precautionary measure is taken? How does the process work?

Answer: After the court issues a preliminary injunction, this decision is notified to the Social Security Institution (SGK). The patient must present the court order when obtaining the medication from a pharmacy or through the Turkish Pharmaceuticals Association (TEB) each time a new course of treatment is due. The SGK, in accordance with the injunction, either pays the cost of the medication directly to the pharmacy/intermediary institution or refunds it to the patient's bank account within a few days after the patient submits the invoice to the institution. The SGK does not have the luxury of not implementing the court order; otherwise, "Abuse of Office" .

Question 2: What can be done if the Turkish Medicines and Medical Devices Agency (TİTCK) (Ministry of Health) rejects a request for approval of an off-label drug?

Answer: The Turkish Medicines and Medical Devices Agency (TİTCK)'s rejection decision is an administrative act. An appeal against this rejection decision, requesting a stay of execution, must be filed within 60 days of notification in the Ankara Administrative Courts . In this appeal, the medical necessity of the drug must be proven with international reports, and TİTCK approval must be obtained through legal means. Following this, a case against the Social Security Institution (SGK) can be initiated.

Question 3: If the lawsuit is lost, will the Social Security Institution (SGK) demand a refund of the medication costs it paid as a precautionary measure?

Answer: A precautionary measure is a temporary decision. If the case is dismissed entirely on its merits (for example, due to a negative expert report stating that "the medication is medically unnecessary"), the Social Security Institution (SGK) has the right to reclaim all medication costs it paid to the patient during the lawsuit, along with legal interest. Therefore, it is crucial to thoroughly analyze the medical necessity at the beginning of the case and not to open the case with weak arguments. However, in practice, the rejection rate for correctly managed cases approved by the Turkish Medicines and Medical Devices Agency (TİTCK) is extremely low.

Conclusion and Recommendations for Patients Who Will Pursue the Case

Cases involving targeted drug use (off-label drug use) in cancer and rare diseases are not merely technical debt collection cases; they are, quite literally, a struggle for rights and a fight for life,. The limitations of the Social Security Institution's budget or the outdated health insurance lists cannot justify depriving any citizen of their right to treatment. Turkish courts and the Constitutional Court, as a requirement of the social state principle, largely side with the patient in these cases.

The key to success in this process, to making the precautionary decision within days and accessing uninterrupted treatment, is:

• Completing all administrative application steps fully and in accordance with deadlines

• The court in charge (Labor or Administrative) must make an accurate determination according to the patient's insurance status

• The goal is to prepare all medical evidence (NGS, biopsy, discharge summary, international guidelines) to be submitted to the case file.

In these challenging illnesses where time is the most valuable asset, professionally managing legal processes and an experienced lawyer specializing in health law, malpractice, and social security cases is the most natural and rational right of patients to avoid irreparable losses due to procedural errors.