Healthcare Enforcement and Litigation 2020 in Turkey
1-) In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.
In Turkey, there are two options for funding healthcare services, including access to medicines and medical devices. As a first option, the patient may fund the relevant service on his or her own. Generally, patients benefit from private health insurance services as an alternative to public funding provided by the Social Security Institute (SSI).
The second option is the public funding provided by the SSI. However, the public funding is more limited as it necessitates that the medicine and medical devices to be financed should be registered on the reimbursement list of the SSI. The registration to the reimbursement list is made upon an application of the manufacturer. After the product is registered in the reimbursement list (positive list), its price will be subject to obligatory discounts. The applied discount rates may differ according to the type of product (eg, non-prescription pharmaceuticals or 20-year-old products, etc).
Moreover, the reimbursement procedure varies with respect to the public or private nature of the health institution; a different regime is applied in public hospitals within the scope of the Public Tender Law and those that are not.
2-) In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.
In Turkey, healthcare is delivered through public and private institutions. The state is the primary healthcare provider through a large network of public healthcare institutions, such as public hospitals, training and research hospitals, university hospitals and clinics under the local administrative authorities, etc. In addition to these, it is possible for the patients to benefit from private hospitals, private services of university hospitals, polyclinics and doctors working individually, etc.
However, it should be noted that all of these institutions are regulated and controlled by the Ministry of Health (MoH) regardless of being in the public or private sector.
3-) Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.
The key legislation governing the delivery of healthcare and establishing the regulatory framework is the Healthcare Services Fundamental Law numbered 3359 and, for regulating various aspects of pharmaceutical products, the Pharmaceuticals and Medical Preparations Law numbered 1262.
In Turkey, there are also several regulations specifically and separately governing the authorization, marketing, sale and supply of pharmaceutical products. Examples of the main legislation are:
Pharmaceuticals Licensing Regulation (Licensing Regulation);
Regulation on Manufacturing Plants of Pharmaceuticals (Manufacturing Regulation);
Regulation on Promotional Activities of Human and Medicinal Products (Promotion Regulation);
Pharmaceuticals Packaging and Labelling Regulation;
Regulation on Classification of Pharmaceuticals;
Regulation on Safety of Medicines;
Regulation on Pharmacy Warehouses and Products Located in Pharmacy Warehouses.
In Turkey, medical devices, cosmetics, and nutritional products are regulated separately under specific legislation. Medical devices are mainly regulated by the:
Medical Devices Regulation;
In-Vitro Medical Diagnosis Devices Regulation;
Active Implementable Medical Devices Regulation;
Medical devices Clinical Trial Regulation; and
Regulation on Sales, Advertisement, and Promotion of Medical Devices.
Cosmetics are regulated by the Cosmetics Law and the Cosmetics Regulation.
The Regulation on the Importation, Manufacture, Processing, and Supplying to the Market of Nutritional Products and the Turkish Food Codex Nutritional Products Communiqué regulate nutritional products.
All regulations regarding medical devices and cosmetics are issued by the MoH. The regulations on nutritional products are issued by the Ministry of Agriculture and Forestry.
4-) Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?
The main agency that is responsible for the enforcement of laws and rules applicable to the delivery of healthcare in Turkey is the MoH. The breaches of the rules on pharmaceuticals and devices and the suitable sanctions for these breaches are supervised and enforced by the MoH. In addition to that, sub-service units of the MoH – especially the Directorate of Healthcare Services, the Directorate of Emergency Healthcare Services, the Directorate of Amelioration of Health, the Directorate of Health Surveys, and the Directorate of Health Investments – are empowered for enforcement of laws in healthcare delivery. The Public Health Agency of Turkey, the Public Hospitals Agency of Turkey, and the Turkish Pharmaceuticals and Medical Devices Agency (TPMDA) are the affiliates also organizing the enforcement of laws. Apart from the above, the SSI affiliated to the Ministry of Labour, Social Services, and Family is another agency monitoring healthcare delivery services.
These agencies are funded by the general state budget. Also, the agencies generate income through the transactions that they perform by collecting official fees from the counterparty participating in such transactions. However, no portion of their funding depends on their enforcement activities.
Scope of Enforcement
5-) What are the scope of their enforcement and regulatory responsibilities?
The scope of the enforcement and regulatory responsibility of the agencies is determined individually in detail within Decree-Law No. 663 Regarding Organisations and Duties of the MoH and its affiliates. In general, the main responsibilities of the agencies are planning, regulating technical arrangements and permissions, determining the healthcare standards, and fulfilling the relevant transactions for meeting these responsibilities.
Pharmaceutical and Medical Devices Agencies
6-) Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?
The agencies responsible for the regulation of pharmaceutical products and medical devices are the same as those that are engaged in enforcement in general. However, the main agency principally responsible for the regulation of pharmaceutical products and medical devices is the TPMDA affiliated to the MoH. The TPMDA’s duties and responsibilities include determining the standards for obtaining authorization, manufacturing, placing the products on the market, importing and exporting of the pharmaceutical products and medical devices within the scope of the agency, supervising the promotional activities, regulating clinical trials, etc. The SSI, which is affiliated to the Ministry of Labour, Social Services, and Family, is also one of the regulatory bodies engaged in the regulation of pharmaceutical products and medical devices in Turkey. These agencies are funded by the general state budget. Also, the agencies generate income through the transactions that they perform by collecting official fees from the counterparty participating in such transactions. However, no portion of their funding depends on their enforcement activities.
Scope of Enforcement
7-) What are the scope of their enforcement and regulatory responsibilities?
The scope of the enforcement and regulatory responsibility of the agencies are determined individually in detail within Presidential Decree No. 4 Regarding Organisations of Affiliated, Related and Associated Agencies and Organizations of Ministries and Other Agencies and Organizations. In general, the main responsibilities of the agencies are the planning, regulating technical arrangements and permissions, determining the healthcare standards and fulfilling the relevant transactions for meeting these responsibilities.
8-) Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?
Besides the MoH and SSI, depending on the subject matter of the transaction performed, the Competition Authority, the Capital Markets Board of Turkey and the Board of Advertisement may enter the loop and control the activities of the parties. Also, in the case of suspicion of commitment of a crime, the public prosecutor’s office may carry out an investigation regarding healthcare, pharmaceutical and medical device cases.
9-) Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?
Yes, multiple government agencies can simultaneously conduct investigations on the same subject depending on the nature of the case. Also, since the scope of the responsibilities of the agencies are different from each other, the investigation of an agency would not bar another one from investigating the same facts and circumstances.
REGULATION OF PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES
10-) What powers do the authorities have to monitor compliance with the rules on drugs and devices?
According to the applicable rules, the powers of the authorities that are stated within the answers to questions 6 and 8 for monitoring the compliance of the stakeholders with the regulations pertaining to pharmaceuticals and medical devices mainly comprise the following:
conducting site inspections;
banning activities for a certain time period;
imposing administrative monetary fines; and
revoking manufacturing authorizations.
It is also possible for SSI to request a refund of the money in the event of reimbursement. The application of these sanctions depends on the provisions breached and the severity of the breach but most of the cases highly dependent on the discretion of the authorities that are stated in questions 6 and 8.
Investigation Time Frames
11-) How long do investigations typically take from initiation to completion? How are the investigations started?
There is no definite time frame set for the proceedings related to investigations; it depends on the MoH’s workload, the merits of the matter, the parties involved in the breach and the severity of the breach. On the other hand, in some cases, the breach also may be considered as a crime under the Turkish Penal Code. If this is the case, the administrative investigations may be suspended until the completion of the investigation process of the public prosecutor.
The investigations may be initiated by the MoH ex officio or upon complaints raised, which may be from one of the competitors of the company in question or individuals or third parties.
Access to Investigation Materials
12-) What rights of access does the subject of an investigation have to the government investigation files and materials?
The administrative investigations are generally carried out in a confidential manner, and this confidentiality also affects the parties that are the subject of the investigation as well. Even this may not be the case, meaning that if the administrative authorities permit the subject access to the investigation files, this would be possible on a very limited scale.
13-) If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?
In the case of a pharmaceutical product produced in a foreign country, the authorities may still conduct investigations of the manufacturing processes in that country. Indeed, the issuance of a good manufacturing practice (GMP) certificate for the relevant manufacturing site is subject to an investigation by the MoH. The MoH makes physical site inspections of manufacturing facilities in Turkey and abroad; therefore, a GMP certificate issued by an EU authority alone is not acceptable for the MoH in the event of imported products. GMP site inspection procedures abroad take around one to five years, yet, if it is a life-saving product or a product with special importance, or if the product will be manufactured in a previously approved manufacturing line with the same equipment, the examination time may be shorter.
However, the GMP certificate is not applicable for medical devices, yet CE marks should be attached to the medical devices if required for that type of medical device.
14-) Through what proceedings do agencies enforce the rules?
The agencies may enforce the rules through administrative, legal, or criminal proceedings depending on the merits of the case. In the case of a breach of a legal provision, the agencies may initiate their own administrative investigation proceedings and may apply the sanction as determined under the relevant regulations. However, in circumstances where such breach also constitutes a crime as defined under the Turkish Penal Code, the authorities are also obliged to file a criminal complaint before the public prosecutor. In such a situation, the criminal investigation process is carried out by the public prosecutors only. In addition to these, if the subject breach is related to reimbursement rules or if there is any monetary damage faced by the state, the authorities may order the refund of the money or may proceed with a civil action before the competent courts for the compensation of the damage.
15-) What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?
Depending on the nature of the breach, the relevant regulations provide a variety of punitive measures. The most common enforcement measures are administrative and financial sanctions, such as suspending marketing authorizations, banning promotional activities or administrative fines. Moreover, as per the Law on Preparation and Implementation of Technical Legislation Regarding Products (Technical Legislation Law), in the case of an unsafe product, various sanctions – namely prohibition on placing the product on the market, recalling the product from the market, or removing the products from the market partially or completely – can be imposed against manufacturers and the distributors. Also, the TPMDA may order the publication of the authority’s decision to announcing the unsafe product, and the relevant measures imposed by the authority, to the public.
Sector associations that aim to ensure compliance with the regulations in the sector also evaluate the matters according to their codes of conduct and may impose certain disciplinary sanctions on their members, such as warnings or suspension or invalidation of membership in the event of a violation of their codes.
Actions Against Employees
16-) Can the authorities pursue actions against employees as well as the company itself?
Yes, if the infringement brings forth personal or criminal liability or both, the employees may also be involved within the legal and criminal proceedings together with the company itself. However, the authorities do not automatically assume that the employees are involved in an infringement unless there is a reasonable cause to do so. In general, actions are pursued against the companies.
During the investigation of the action, the findings may show that the infringement does not arise directly from the company policy or from an act or a decision of the company itself, but it is caused directly by the behavior of an employee. In such cases, the company is held liable for the acts of its employees under the name of employer liability and is obliged to bear the consequences of the infringement at the first step. Thereafter, the company may pursue an internal or legal action against the employee in order to compensate for the claim of damage caused by this employee.
Defenses and Appeals
17-) What defenses and appeals are available to drug and device company defendants in an enforcement action?
The general provisions regarding the liability on fault-based or strict liability are also applicable to matters related to pharmaceuticals or medical devices. First of all, the manufacturer shall bring forth the recovery proofs as a defense for liability arising from the pharmaceutical products depending on the case. For instance, in the case of the employer liability, the manufacturer of the pharmaceutical product may claim that he or she had showed required attention to prevent the damage for choosing, giving instruction on the issue and inspecting of the employee. Secondly, it is also possible to claim that the connection of causation is disrupted. Referring to development risk defense, it should be noted that, in the case, the manufacturer proves that all the requirements are satisfied within the development process, he or she may not be held responsible for defects not discoverable in the current state of scientific knowledge in Turkey. In addition to that, in Turkey, there is a regulatory compliance defense based on the Technical Legislation Law. According to the Technical Legislation Law, the manufacturer of the pharmaceutical products may claim that the said product considered unsafe is not offered to the market by him or her, or alternatively the unsafe state of the pharmaceutical product occurred because of conformity to relevant technical regulations required by the MoH.
18-) What strategies should companies adapt to minimize their exposure to enforcement actions and reduce their liability once an enforcement action is underway?
Companies in the pharma sector should initially establish a certain level of compliance awareness among their employees for the purpose of avoiding potential violations. Provision of regular internal training and preparation of company standard operating procedures shall be the primary tasks to be recommended. Additionally, clear and transparent documentation of all the activities and underlying relations is strongly recommended since even this precaution may help to overcome various problems that may be encountered during an investigation. As a precaution before a potential investigation, clearance can be requested from the authorities in relation to controversial issues that the company may expect to be spotted as an issue during an investigation. During the investigation, cooperation with the investigators and providing full access to the requested documents and information are vital.
Recent Enforcement Activities
19-) What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?
Although not very recent, there is a landmark case in Turkey that took place around a decade ago. As a result of the intense investigation at that time, it was identified that several non-compliant and corrupt activities had taken place in relation to the prescription of certain pharmaceuticals by healthcare professionals and corrupt reimbursement benefits received by the company from the SSI. Several criminal actions were initiated against the company, its directors, and the officers of the SSI on the basis of different allegations, some of which were accepted by the courts.
In addition to this matter, which changed the approach of all stakeholders to the provisions regulating the pharma sector, the recent enforcement activities cover mainly the promotion of pharmaceuticals and medical devices and pricing issues.
On the other hand, within recent years, the authorities have focused on the localization of the drug manufacturers. Recent legislation supports locally established drug manufacturers against foreign companies. It reflects the decisions of public agencies regarding the equivalency of drugs, drug pricing activities, etc.
Besides, the Competition Authority has recently concluded in a case that direct and indirect export bans are not violating the Turkish Competition Law because the effects of these export bans are not seen in the Turkish market. Accordingly, it was found rightful for pharmaceutical manufacturers to insert a term in their agreements with pharma warehouses stipulating that the warehouses shall neither export the products themselves nor sell the products to those who are strongly anticipated to export the products.
20-) Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organizations police members’ conduct?
There exist self-governing bodies for the companies active in the pharma sector engaged in pharmaceutical products and medical devices, such as the Association of Research-Based Pharmaceutical Companies (AIFD), the Foundation of Medical Products, the Association of Research-Based Medical Technologies Manufacturers, and the Pharmaceuticals Manufacturers Association of Turkey.
RELATIONSHIPS BETWEEN HEALTHCARE PROFESSIONALS AND SUPPLIERS
21-) What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?
The rules that govern the nature of financial relationships between healthcare professionals and suppliers of products and services aim to prevent any kind of benefit being provided to healthcare professionals by pharmaceutical companies through promotional activities. Accordingly, the Promotion Regulation and the associations’ codes of conduct put some limitations on promotional activities, including distributing samples and organizing conferences and seminars.
On the other hand, if the healthcare professional is a public official, the provisions of Law No. 657 on Public Officials, Law No. 2547 on Higher Education, and the Regulation on Ethical Principles of Conduct and Procedure and Principles of Application for Public Officials also apply. Accordingly, a service agreement to be concluded with a public official by a healthcare company should be first approved and permitted by the relevant public institution where such public official is employed. Also, the payment to be made to such public official should be made through the relevant public institution. Direct payments made to public officials are strictly prohibited. Breach of this rule may lead to severe sanctions as both the company and the public official may be subject to criminal prosecutions owing to the breach of bribery provisions.
22-) How are the rules enforced?
The compliance with the rules regulating the financial relationships between healthcare professionals and suppliers of products and services is scrutinized by the MoH ex officio during the inspections or upon complaints raised by competitors and individuals or third parties. In addition, if companies do not abide by the rules of the promotion, administrative sanctions such as warnings, suspending promotional activity, canceling certification of sales representatives, and banning the sponsoring of conferences may be applied. Additionally, liability from unfair competition may arise.
23-) What are the reporting requirements for such financial relationships? Is the reported information publicly available?
There is a requirement for pharmaceutical firms to disclose to the MoH any financial support ‘in kind’ or cash exceeding 10 percent of the gross minimum wage provided to healthcare professionals, institutions or organizations. These value transfers shall be notified to the MoH together with certain information, such as the details of the beneficiary and grounds of the transfer such as donation, support to the expenses in relation to activities, support (sponsorship) agreements, service and consultancy fees and any other kind of value transfers and written consent of the beneficiary for the acceptance and disclosure of such value transfer. The value transfer requirement in the Promotion Regulation only stipulates the disclosure to the MoH, rather than a general public announcement.
The AIFD also imposes certain disclosure obligations on its members, which goes beyond the notification requirements under the Promotion Regulation as AIFD requires similar information to be disclosed on publicly available websites instead of disclosure to the MoH only.
REGULATION OF HEALTHCARE DELIVERY
24-) What powers do the authorities have to monitor compliance with the rules on the delivery of healthcare?
The authorities ensure compliance with the rules on the delivery of healthcare by various powers, which are regulated under different regulations. For instance, conducting site inspections or examining the files may be routed for ensuring the adherence to the prescribed standards. In the case of a breach, banning the public offering and activities for a certain time period, imposing administrative monetary fines and revoking authorizations in certain cases may be counted as the powers of said authorities. It should be noted that the sanctions might vary depending on the provisions breached.
Investigation Time Frames
25-) How long do investigations of healthcare providers typically take from initiation to completion? How are the investigations started?
See question 11.
Access to Investigation Materials
26-) What rights of access does the subject of an investigation have to the government investigation files and materials?
See question 12.
27-) Through what proceedings do agencies enforce the rules?
See question 14.
Defenses and Appeals
28-) What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare
Sanctions imposed by the authorities include the imposition of fines, closure of the healthcare facilities, and filing criminal complaints in the event the infringement also involves allegations of crime.
Defenses and Appeals
29-) What defenses and appeals are available to healthcare providers in an enforcement action?
The general provisions regarding the liability on fault-based or strict liability are also applicable to matters related to healthcare providers. For instance, in the case of employer liability, it is possible to claim that he or she showed required attention to prevent the damage for choosing, giving instruction on the issue and inspecting of the employee. Secondly, it is also possible to claim that the connection of causation is broken.
30-) What strategies should healthcare providers adopt to minimize their exposure to enforcement actions and reduce their liability once an enforcement action is underway?
See question 18.
Recent enforcement Activities
31-) What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?
In recent years, the authorities have focused on decreasing malpractice. Even though the sanctions may vary depending on the matter, one of the most seen sanctions is administrative fines.
32-) Are there self-governing bodies for healthcare providers? How do those organizations police members’ conduct?
Even though the Association of Private Hospitals and Health Institutions (OHSAD) does not have a specific code regulating healthcare delivery, as a self-governing body, the OHSAD conducts its activities aiming to protect members’ interests in line with the Association’s by-law.
Remedies for Poor Performance
33-) What remedies for poor performance does the government typically include in its contracts with healthcare providers?
The state provides health delivery services through public hospitals. However, in the event of any poor performance that breaches the relevant regulation, the sanctions, which are also mentioned above, shall be applicable for both public and private institutions.
Causes of Action
34-) What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?
For the enforcement of healthcare regulations, the citizens or other private bodies may file complaints before the administrative authorities, file criminal complaints or civil actions for malpractice and compensation of damages.
Framework for Claims
35-) What is the framework for claims of clinical negligence against healthcare providers?
In the case of malpractice matters, the claims may be directed to both the institution and the healthcare professionals. The courts do not differentiate between the public and private healthcare providers while assessing the malpractice claims. The damages to be awarded by the court would depend on the merits of the case.
A successful claim must prove the causal connection between the damage arising from clinical negligence and the action. The courts penalize the actions to the extent of proved causal connection regardless of dealing with public or quasi-public healthcare providers.
36-) How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?
The purchasers or users of pharmaceuticals or devices may seek recourse for regulatory and legal infringements by filing complaints before the administrative authorities, filing criminal complaints, or civil actions for pecuniary and immaterial damages.
37-) Are there any compensation schemes in place?
It is obligatory for healthcare professionals to maintain insurance for malpractice.
Class and Collective Actions
38-) Are class actions or other collective claims available in cases related to drugs, devices and provision of care?
No, there is no class action practice in Turkey.
39-) Are acts, omissions, or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?
Yes, the acts, omissions, or decisions of public and private institutions are subject to judicial or administrative review following a complaint from interested parties. For instance, initiating full remedy action or action for nullity or appealing to the institution shall be applicable against the acts or decisions of public institutions. All kinds of legal and criminal actions shall be applicable against the acts or decisions of private institutions as well.
40-) Are there any legal protections for whistleblowers?
It should be noted that the whistleblower concept is indicated within the competition and criminal law regulations. However, it is not defined within the healthcare legislation. Therefore, there is no legal protection for whistleblowers as regards to healthcare law.
41-) Does the country have a reward mechanism for whistleblowers?
See question 40.
42-) Are mechanisms allowing whistleblowers to report infringements required?
See question 40.
CROSS-BORDER ENFORCEMENT AND EXTRATERRITORIALITY
Cooperation with Foreign Counterparts
43-) Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?
44-) In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?
Enforcement activities of foreign authorities may trigger a local investigation in Turkey provided that the matter involves an infringement of Turkish domestic laws.
Pursuing foreign entities for infringement
45-) In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?
In the case the infringement occurs or leaves an impact in Turkey, foreign companies and foreign nationals can be pursued for infringing Turkey’s healthcare laws.
UPDATE AND TRENDS
Key Developments of the Past Year
46-) What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?
In the coming year, we expect the authorities to maintain their focus on the newly-developed product tracking system (ÜTS) which will monitor all the medical devices starting from the manufacturing phase until it is consumed or used by the consumer or end-user and the data will be displayed to the public as well. The MoH is expected to consummate such a system since it will become an example for foreign countries to establish a similar system.
Apart from the above-mentioned, the authorities tend to support the locally established drug manufacturers against the foreign companies as we have explained under question 19 with regards to the localization of the drug manufacturer. However, as Turkey had imposed various requirements on the production, import, and approval for reimbursement, pricing, and licensing of pharmaceutical products, which is inclining a tendency for localization, the European Union has brought two disputes in the World Trade Organization on April 2, 2019. Although Turkey had not yet shown a clear approach regarding its position, there are a few options that are being considered.
Firstly published in Lexology GTDT on October 02, 2019.