The 2020 statistics of the World Health Organization (WHO) show that one in every five people in the world develops cancer during their lifetime, and that one in every eight men and one in every eleven women lose their lives to cancer. Where the medicines for such a common and fatal illness are not covered by the Social Security Institution (SGK), this creates hardship for patients and their relatives that cannot be prevented. The very high cost of these medicines is a situation that prevents people from attaining the right to a healthy life, which is a constitutional right. In this article we set out the legal routes and court processes to be followed where medicines are not taken into the scope of payment by the SGK.
Methods used in cancer treatment:
Although many methods are used today for the treatment of cancer, the most effective are immunotherapy and targeted drug therapy.
Immunotherapy is a form of treatment in which certain parts of the patient’s own immune system are used to fight a group of diseases including cancer. The aim here is to enable the cells of the immune system to target cancer cells and destroy them. It is regarded as a form of treatment that works by enabling the damaged immune system to function healthily again.
Targeted drug therapy, on the other hand, is aimed only at killing tumour cells and is a treatment method directed at a target.
Unfortunately, the treatment methods mentioned are not cheap enough to be easily accessible. For example, targeted cancer medicines were sold for prices ranging between TRY 100,000 and TRY 500,000 for the year 2024.
The Social Security Institution covers the cost of the medicines that appear in the Health Implementation Communiqué and in the List of Medicines Whose Cost Is Paid published on the SGK’s website. The fact that a medicine appears there does not, however, mean directly that its cost will be covered by the SGK. In some cases the medicine must be used in the treatment of a particular type of cancer; in others, conditions may be sought as to whether the patient has or has not received particular treatments. Factors such as the diagnosis made, the stage and the general state of health of the patient are extremely important in whether medicines are covered. The side effects of the medicine and the existence of alternative treatment methods are also considered within this scope.
Some targeted medicines not covered by the SGK:
Besponsa, with the active substance inotuzumab
Keytruda, with the active substance pembrolizumab
Opdivo, with the active substance nivolumab
Altuzan, with the active substance bevacizumab
Cyramza, with the active substance ramucirumab
Imfinzi, with the active substance durvalumab
Bavencio, with the active substance avelumab
Lynparza, with the active substance olaparib
Perjeta, with the active substance pertuzumab
Reampla, with the active substance palbociclib
Tagrisso, with the active substance osimertinib
Valamor, with the active substance ribociclib
Rozlytrek, with the active substance entrectinib
Verzenios, with the active substance abemaciclib, and the like.
What can be done if the cost of the medicines to be used in treatment is not covered by the SGK?
The legal route to be followed in this case is, in order, as follows:
1. Application for off-label use of a medicine (an optional method)
After the most suitable medicine to be used in treatment has been determined by the doctor, an application for off-label use should first be made to the Turkish Medicines and Medical Devices Agency. An off-label medicine is any use of a medicine outside the indication approved for it in Türkiye: in short, a medicine whose main purpose is not to fight cancer, or which was not produced specifically for that type of cancer, but which nevertheless benefits the illness and for which there is evidence to that effect. As a rule this application is not compulsory. Approval for off-label use, however, makes it easier to obtain an interim injunction in the court process to be brought later.
Where, at the end of the assessment carried out by the Turkish Medicines and Medical Devices Agency, the medicine is not on the SGK’s List of Medicines Whose Cost Is Paid, the request generally results negatively. If the off-label application is not approved, it may still be possible to obtain approval by making a fresh off-label application to the Turkish Medicines and Medical Devices Agency with up-to-date PET/CT reports after the medicine has been obtained by the patient and used for a few months. That also increases the likelihood that the request for an interim injunction will be accepted in the court process.
2. Application to the SGK
Where the medicine prescribed by the doctor cannot be obtained free of charge from the pharmacy, an application is made to the SGK before bringing an action. This is extremely important because it is a condition for the action to be brought later. The application must be made in accordance with the Social Security Institution Medicine Reimbursement Regulation and the Procedures and Principles Concerning Social Security Institution Medicine Reimbursement Applications.
The application to be made to the SGK must comply with the procedure and the law and must be prepared without omitting any detail. The petition containing the request must include the examination reports and documents relating to the diagnosed illness, the medicines prescribed, an approved copy of the medicine use report, which hospitals were attended for tests and examinations, the doctor’s prescriptions and documents containing the opinion that these medicines may benefit the patient, examples of practice concerning the treatment of the illness, and scientific writings and articles. On this matter it is extremely important to obtain legal support from a lawyer.
Both in the application to the SGK and in the court’s injunctions it is extremely important to use the expression “uninterrupted throughout the treatment”. Otherwise an injunction may be granted for a temporary period only.
The application is sent to the relevant branch of the SGK dealing with that medicine. After examination it is generally refused in practice, on grounds such as the medicine not being on the List of Medicines Whose Cost Is Paid, or the type of cancer not being among the diagnoses set out in the Health Implementation Communiqué. After the application has been refused, the process of bringing an action against the SGK should begin.
3. Bringing an action against the SGK with a request for an interim injunction
Where the application to the SGK is unsuccessful, an action should be brought seeking the annulment of that decision, the reimbursement of the cost of the medicine and the covering of the cost of the medicine thereafter.
Here it is important that the statement of claim be prepared completely and in accordance with the procedure. The following must be submitted: the monthly dose and average cost of the cancer medicine; the stage and type of the illness and the average survival rates; information, if any, that equivalent and conventional treatments have been tried without result; that according to the PET/CT report the illness still exists, continues to spread and that other treatments must be used; that an application was made to the SGK and refused, this being a condition of the action; information about the licence if the medicine is licensed and, if it is not licensed, information that an off-label application was made (this off-label application may be requested from the physician, who can make it quickly through their own systems; if there is a medicine use report, the physician may also be asked to make a separate application to the Turkish Medicines and Medical Devices Agency); the SGK service record; and finally a report from the physician giving the opinion that “there is no equivalent medicine or treatment”. The preparation and submission of these documents in the action to be brought is extremely important.
It will be more useful for the action to be brought as a partial action. Since the loss continues, the limitation period will run from the last loss. Although it is accepted in the doctrine that “if it is impossible for biological reasons to determine the amount claimed, an action for an unliquidated claim may be brought”, it will be safer to bring a partial action rather than take the risk of the action being dismissed for that reason alone.
It will also be useful to set out the SGK regulations in the petition you prepare. In practice these regulations may escape the attention of judges.
It is possible for that action to be brought “with a request for legal aid”. Under article 334 of the Code of Civil Procedure (HMK), those who lack the means to pay the necessary litigation costs, in whole or in part, without placing themselves and their family in significant difficulty may benefit from legal aid, provided that their claims are not manifestly ill-founded. As a result of this, exemption from court fees and expenses is obtained.
In which court is the action brought?
In actions to be brought against the SGK concerning the covering of the cost of a medicine, the competent court varies according to the social security body with which the patient is connected.
For patients under the SGK and Bağ-Kur:
In actions to be brought against the SGK by patients under the SGK and Bağ-Kur, the competent courts are the labour courts. In places where there is no labour court, the action is brought before the civil courts of first instance sitting as labour courts. This action should be brought with a request for an interim injunction. That request must be stated in the statement of claim as being “until a final decision is given in the case and until a fresh assessment is made and an interim decision is taken on the matter”.
For patients under the Pension Fund (Emekli Sandığı):
In an action to be brought against the SGK by patients under this scheme, the competent courts will be the administrative courts.
It has been established by the decisions of the Court of Jurisdictional Disputes that the administrative judiciary is also competent in actions to be brought by insured employees or retired persons within the scope of subparagraph 4/c.
*Where the competent court in an SGK cancer medicine case is the administrative court, a stay of execution may be requested during the case for the cost of the medicines to be covered by the SGK.
Where is the action brought?
The courts with jurisdiction are those of the place where the SGK branch that issued the refusal decision whose annulment is sought is located.
What is the process after an interim injunction or a stay of execution?
When requesting an interim injunction, the person must prove that serious, rapid and irreversible harm will occur if they do not use the medicine. If this cannot be proved, the request for an interim injunction may be refused, as in the following examples.
“… at this stage, since there is no document in the file sufficient to form the view, and sufficient to serve as a basis for an injunction, that a failure to use the medicine would cause serious, rapid and irreversible deterioration in the claimant’s health, or death, or a serious reduction in life expectancy, or intense pain, and since the requirement of prima facie proof has not been met, and since it was concluded that the request, by its result, would exceed the nature of an interim injunction and would resolve the case on the merits, it was understood that there was no contravention of procedure or law in the court’s factual and legal assessment refusing the request for an interim injunction, and it was decided to dismiss the claimant’s counsel’s appeal on the merits under article 353/1-b.1 of the Code of Civil Procedure no. 6100…” (Regional Court of Appeal decision – Ankara Regional Court of Appeal, 11th Civil Chamber, case no. 2020/837, decision no. 2020/902, dated 7.7.2020)
“… In the concrete case at hand, given that neither the prescription showing how much of the medicine named X1 is to be used and when, nor a health board report stating that it is of vital importance, was present in the physical file (or in the file in the UYAP system), it was understood that an injunction could not be granted for the use of that medicine with its cost covered by the institution and without any period being specified, and that the court’s decision was correct in this respect, so that it was necessary to decide to dismiss the appeal of the claimant’s counsel…” (Regional Court of Appeal decision – Ankara Regional Court of Appeal, 10th Civil Chamber, case no. 2020/550, decision no. 2020/512, dated 2.4.2020)
Where the request for an interim injunction is granted or a stay of execution is decided, the relevant department of the SGK Health Security Centre must be contacted regarding “the medicine being invoiced directly to the SGK by the hospital”. If that department gives a favourable opinion to the hospital on this matter, a petition is written concerning the request for “the medicine to be invoiced directly to the SGK”. In the process thereafter, until a final decision is given in the case and a fresh assessment is made and an interim decision taken on the matter, or for the period stated in the court’s decision, the cost of the medicine is covered by the SGK and it is obtained by the patient free of charge.
The case does not end with the granting of the interim injunction. Even though the court may grant the request for an injunction, it may not uphold the claim. In that case, once again the quality of the statement of claim to be prepared comes to the fore, and it must not contain any omissions.
Where the final decision of the court is favourable, that is, where it is accepted that the cost of the medicines is to be covered by the SGK, the court’s decision must be attached to the petition to be written to the SGK so that the decision is implemented.
*Where the court dismisses the action brought for cancer medicines not covered by the SGK, an application may be made to the Constitutional Court once the ordinary legal remedies have been exhausted and, once domestic remedies have been exhausted, to the European Court of Human Rights in the context of the right to life.
*In application no. 2019/41507, decided on 7/1/2020 (applicant Hira Bilici), concerning the allegation that the right to protection of material and moral existence had been violated because an injunction granted by the judicial authorities concerning the covering of the cost of medicines by the SGK had not been implemented, the Constitutional Court granted an interim measure that the cost of the medicine to be administered for the treatment period deemed necessary in the doctor’s report be paid immediately to the body authorised to import the medicine.
Can amounts already paid for a cancer medicine also be claimed?
Yes. In the action to be brought, the reimbursement by the SGK of amounts previously paid for the medicine may also be claimed. What matters here is that the request for reimbursement is also included in the application made to the SGK. Failing to do this may result in the amounts paid not being reimbursed and in economic loss to the patient. In conclusion, both by making the application to the SGK, which is a condition of the action, and by conducting the court process correctly and swiftly, the patient may both use the medicines without paying for them and recover the amounts previously paid.
Under article 2 of the European Convention on Human Rights, “Everyone’s right to life shall be protected by law…”.
Under article 17 of the Constitution, “Everyone has the right to life and the right to protect and develop their material and moral existence…”.
Under article 60 of the Constitution, “Everyone has the right to social security. The State shall take the necessary measures and establish the organisation to provide this security.”
The protection of the right to life, a right of such importance, should be the foremost duty of states. Within the scope of these principles, social states should open every field to their citizens and take every measure they must take to that end. The social state is a model of state that envisages intervention by the state in order to maximise the social welfare of society. The principle of the social state is a principle contained in the Constitution which also includes the state’s obligation to meet the health needs of its citizens. Health services are included within the scope of the right to social security that the state must provide to its citizens. For this reason it is obligatory that the cost of the medicines used by a patient be covered by the SGK within the scope of the right to life and the right to social security.
The legal routes to be followed concerning cancer medicines not covered by the SGK are long and arduous and require patience and care. A great role falls to the patient’s relatives here. In order for the legal routes to be pursued together, and so that the patient does not face bad outcomes, it is very important to work with a lawyer. Our office provides services in this field. You may contact us to obtain legal support.
