Life Sciences 2016, Turkey Chapter

Organisation and financing of health care

1 How is health care in your jurisdiction organised?

The health-care system is governed principally by the Fundamental Law on Healthcare Services No. 3,359, which furnishes the Ministry of Health (MoH) with the authority to issue health-care related regulations and establish a health-care system enabling each and every person living in Turkey to have equal, equitable access to the health-care system. The regulatory authority is the MoH and its subsidiaries.

The MoH is responsible for establishing hospitals and public health institutions to provide health-care services to the public. In addition to public hospitals and health-care institutions, universities with medical faculties may also establish hospitals under the authority granted to universities by the Higher Education Law No. 2,547, and this system is also quite common in Turkey. Private hospitals and health-care institutions are also common in places where the purchasing power of the population is high.

There has been a fundamental change in the structure of the MoH in 2011. The authorities of the General Directorate of Pharmaceuticals and Pharmacy of the MoH have been transferred to the Turkish Pharmaceutical and Medical Device Institution (Institution), which was established by Decree Law No. 663. In line with the amendment, the Institution undertakes the following duties in general:

  • granting licences or authorisations, monitoring and imposing sanctions where necessary and setting forth the standards for licensing, pricing, manufacturing, storing, sales, import, export, marketing, distribution, promotion, monitoring, recall and usage-related activities regarding the products falling under the authority of the Institution (pharmaceuticals, medical devices, cosmetics, traditional herbal medicinal products, all other products marketed with a health claim);
  • regulating, approving and controlling clinical trials with regard to the products falling under its authority; and
  • taking the necessary precautions to maintain the accessibility of pharmaceuticals, medical devices and other products that are of vital importance.

Moreover, the Turkey Public Hospitals Institution has been established as a subordinate body of the MoH in accordance with Decree Law No. 663. The Turkey Public Hospitals Institution is responsible for the following:

  • opening and operating the hospitals, oral and dental health institutions, and any other institutions dedicated to providing second and third-step health services. Province-based public hospitals unions have been established for the operation of the above-mentioned health institutions;
  • monitoring, evaluating and auditing the activities of such institutions; and
  • ensuring that any services related to diagnosis, treatment and rehabilitation are provided in such institutions.

2   How is the health-care system financed in the outpatient and in-patient sectors?

The active population, retirees and their dependants are covered by the health insurance provided by the Social Security Institution (SSI). Employers must pay monthly contributions for their employees, who automatically become covered by the health insurance provided by the SSI; the self-employed may also benefit from this insurance coverage by voluntarily paying monthly contributions. The health insurance provided by the SSI covers practically every physical exam, test and treatment option (both outpatient and in-patient) conducted at public health-care institutions and university hospitals, apart from ones that are not necessary for the health of the insured person, such as cosmetic operations. The SSI also covers emergency services given to the insured at private health institutions.

A big proportion of the public is covered by the SSI health insurance coverage, while only a small proportion benefits from private insurance coverage by paying monthly contributions.

A new plan, the General Health Insurance, has been in place since January 2012, and accordingly every citizen in Turkey is now under SSI health insurance coverage. The aim is that all citizens who were not covered by the SSI health insurance packages now benefit from public health insurance.

Compliance – pharmaceutical manufacturers

3 Which legislation governs advertising of medicinal products to the general public and health-care professionals?

In Turkey, advertising of medicinal products is governed by Pharmaceutical and Medical Preparation Law No. 1262, and the Regulation on Promotional Activities of Medicinal Products for Human Use (Promotion Regulation), which is based on the former. The Promotion Regulation was published and came into effect on 3 July 2015. The enforcement of some articles has been delayed until January 2016. For further information about the important amendments, see question 9.

Further, the Act on Protection of Consumers, Regulation on Principles and Fundamentals of Practices regarding Commercial Advertisements and Announcements, and Code of Obligations are applicable where a matter is not regulated under Law No. 1262 or the Promotion Regulation. Additionally, the Supreme Council of Radio and Television (RTUK) is authorised to conduct examinations for radio and television broadcasts regarding the determination of advertisements that breach the principles set out in the Law on Establishment and Broadcasting of Radio and Television Institutions No. 6112 (RTUK Law). As per article 11/2 of the RTUK Law, no advertisements for prescribed medical products or treatments can be broadcast. There are also three industry-based associations in Turkey: the Turkey Pharmaceuticals Industry Association (TISD), the Association of Research-Based Pharmaceutical Companies (AIFD) and the Pharmaceuticals Manufacturers Association (IEIS), which have their own codes of promotional practices.

4 What are the main rales and principles applying to advertising aimed at health-care professionals?

The fundamental rule is that marketing authorisation or marketing authorisation holders and their representatives may not provide, offer or promise benefits to health-care professionals by way of promotional activities, as explained in further detail in question 9. According to the Promotion Regulation, products that are not granted permits or authorisation in Turkey cannot be promoted (off-label promotion is strictly forbidden), and that advertisements directed at health-care professionals must contain information consistent with the products approved, and an updated summary of product characteristics (SmPC).

Promotion must be aimed at health-care professionals, and shall include objective, informative and factual medical data to enable the health-care professionals to form their own opinion about the product. The promotional activities shall not be used to encourage unnecessary use of a product, and the promotion must be made by certified representatives.

The mandatory certification of the sales team is a requirement which was foreseen by the former regulation as well. All promotion representatives shall receive certificates if they are successful in the examination or upon submission of diplomas from the departments of universities educating medical sales representatives. The examinations required for such certification will be conducted according to Guidelines published by the MoH and based on the Promotion Regulation. To date, the MoH has only authorised a single university in Turkey to conduct the vocational education and examinations, although assurances have been made that this number may be extended depending on the demands of the industry regarding said certification. The effective date of the provision coming into force has been delayed until 1 January 2019 in order to establish the implementation system. Once this date has passed, individuals without the aforementioned certification will not be able to work as promotion representatives for medicinal companies.

5 What are the main rales and principles applying to advertising aimed at the general public?

According to the Pharmaceutical and Medical Preparations Law No. 1262 and the Promotion Regulation, it is strictly forbidden to promote medicinal products for human use to the general public. Over-the-counter products are categorised as non-prescribed products and are subject to the same promotion principles as prescribed products. The need for a new law governing over-the-counter products has been under discussion for a long time; however, no official draft has been submitted for comment, and it is therefore unlikely that we will see a new law in the near future.

6 What are the most common infringements committed by manufacturers with regard to the advertising rules?

The Promotion Regulation forbids pharmaceutical companies from making promotional materials available to the public, either intentionally or unintentionally. However, examples of illegal advertising of products can be found, such as in display windows of pharmacies. The other common type of infringement concerns advertisements aimed at health-care professionals that are not supported with sufficient scientific data. Other than these infringements, occasionally health-care professionals may be found not to be fully in line with the applicable legislation.

7 Under what circumstances is the provision of information regarding off-label use to health-care professionals allowed?

According to the Promotion Regulation, off-label promotion is strictly forbidden in Turkey. The only exceptions to this rule are the provision of off-label information during international congresses held in Turkey, or if a health-care professional has asked for the provision of such information in writing. This prohibition does not prevent the provision of scientific material that contains off-label information to health-care professionals. Upon the written request of a health-care professional, the requested information must be delivered by a scientific service representative.

8 Which legislation governs the collaboration of the pharmaceutical industry with health-care professionals? Do different rules apply regarding physicians in the outpatient and in-patient sectors?

The Promotion Regulation governs the relationship between pharmaceutical companies and health-care professionals.

The ethical principles set out by medical associations of which the health-care professional is a member also apply to this relationship.

If a service to be rendered by the health-care professional for the pharmaceutical company is concerned, the Law on Public Officials No. 657 or the Higher Education Law No. 2547 may also be applied, since the rules set forth in this legislation provide limitations regarding the working principles of health-care professionals.

The Regulation on Ethical Principles of Conduct and Procedure and Principles of Application will also apply to the relationship between a health-care professional who is a public official and a pharmaceutical company.

There is no difference in the rules that apply to physicians in the outpatient or in-patient sectors.

9 What are the main rules and principles applying to the collaboration of the pharmaceutical industry with health-care professionals?

The Promotion Regulation imposes limitations on the relationship between pharmaceutical companies and health-care professionals. The fundamental rule is that marketing authorisation holders and their representatives cannot provide, offer or promise benefits to health-care professionals by way of promotional activities. The marketing authorisation holder shall not encourage the prescription of its products by offering any kind of benefit to a health-care professional. In this regard, the value of the reminder promotional materials, may not exceed 2.5 per cent of the applicable minimum wage per month. Moreover, with the amendment to the Promotion Regulation, the limitations regarding congress and symposium sponsorships are further extended. Namely, a health-care professional may benefit from sponsorships only four times in one year, and at most twice from the same pharmaceutical company. In addition, only two out of these four sponsorships may be used abroad. However, organisations that healthcare professionals attend as a speaker are not limited by the above rule.

With regard to the seasons, as per article 5 of the Promotion Guidelines, congresses and symposia cannot be organised at certain periods during the year in ski centres or at seaside holiday resorts. All organisations have to be notified to the MoH. Furthermore, health-care professionals have to state the support that they have been given by the pharmaceutical companies at the beginning of their presentations and at the end of their articles, as per the amended version of the Promotion Regulation.

Regarding services to be rendered by health-care professionals to a pharmaceutical company, a law that was published in January 2014 had banned physicians working in state or university hospitals from working privately, and a transitional period was granted to those physicians that held private clinics to close those clinics by 18 April 2014. Just before the expiry of the transitional period, the Constitutional Court stayed the execution of the law ordering physicians to close their private clinics by 18 April and recently cancelled the article granting this transitional period. However, the provision banning state and university physicians from having private practices remains in force.

As a result of this court decision, physicians with private clinics founded before the publication of the said law, do not have to close those clinics. However, it has stated that the provision banning state and university physicians from private practice is still in force.

The most important change introduced by the Regulation is the obligation of disclosure. Together with article 11/7 of the Promotion Regulation, value transfers (in cash or in kind) that are provided to healthcare professionals, health-care institutions and organisations, universities, unions, associations and foundations active in the field of health care and NGOs established for the purpose of the protection and the advancement of health, by the marketing authorisation holders, exceeding 10 per cent of the applicable gross monthly minimum wage in terms of its monetary value shall be disclosed to the Institution. The disclosure of value transfers for a calendar year shall be submitted within the first six months of the subsequent year. The system of disclosure introduced by the Promotion Regulation only necessitates the disclosure of information by the marketing authorisation holders to the Institution, without providing for an additional mechanism for disclosure to the public.

10 What are the most common infringements committed by manufacturers with regard to collaboration with health-care professionals?

The most common infringement with regard to collaboration with healthcare professionals is seen in congress-symposium sponsorship relations. These congresses and symposia, which at times have only a minimal scientific purpose, have sometimes been used as a way to offer holidays or extra benefits to health-care professionals.

Together with the new Promotion Regulation, marketing authorisation holders may organise or sponsor scientific meetings held abroad on the condition that the meeting is international, or a majority of the participants are health-care professionals not working in our country. These conditions are in fact implemented owing to some cases that the Institution faced in the recent years. This provision will avoid the global companies to be the sponsor for the organisation ofthese meetings and Turkish companies affiliated to these global companies to be the sponsor to all of the participant healthcare professionals working in Turkey.

11 What are the main rales and principles applying to the collaboration of the pharmaceutical industry with patient organisations?

There are no official regulations regarding the collaboration of the pharmaceutical industry with patient organisations. However, industry associations such as TISD, AIFD and IEIS have their own codes of practice that govern relations with patient organisations. According to the AIFD Code of Ethics, if a pharmaceutical company decides to provide support to a patient organisation, either financially or through rendering services, a written agreement shall be signed between the parties. Pharmaceutical companies shall not have an influence on the content of the printed or visual materials of a patient organisation to gain commercial advantages, and cannot stipulate being the sole supporter of a patient organisation or a project.

12 Are manufacturers’ infringements of competition law pursued by national authorities?

The Turkish Competition Law is applicable to the sale of goods and services in Turkey; the sale of goods and services outside Turkey that do not have any effect on Turkish market are not covered by the Competition Law. The Turkish Competition Authority is the body authorised to monitor competition in the market.

Manufacturers’ infringements of competition law are pursued by the Turkish Competition Authority as investigations initiated by the authority itself or upon complaints that can be made by anyone (in most cases by competitors).

The Turkish Competition Authority can impose sanctions including heavy administrative fines on companies and board members, and may invalidate the relevant contract or transaction in cases of infringement of competition.

13 Is follow-on private antitrust litigation against manufacturers possible?

According to article 57 of the Competition Law, anyone who prevents, distorts or restricts competition through practices, decisions, contracts or agreements contrary to this law, or abuses a dominant position in a particular market for goods or services, is obliged to compensate any damages to injured parties. Parties who claim that they have suffered damages and loss arising from anti-competitive acts of manufacturers may claim compensation by filing a lawsuit before the courts. Accordingly, the injured party may ask for an amount equal to three times the actual loss incurred.

Compliance – medical device manufacturers

14 Is the advertising of medical devices and the collaboration of manufacturers of medical devices with health-care professionals and patient organisations regulated as rigorously as advertising and collaboration in the pharmaceuticals sector?

The long-awaited Regulation on the Sale, Advertisement and Promotion of Medical Devices came into force on 15 May 2014 and was amended on 25 July 2015. The advertisement and promotion of medical devices were previously unregulated, leading to a lack of uniformity in practice across the Turkish medical device market. A distinction that has been introduced specifically for the medical device regulatory regime is a provision that distinguishes between medical devices that can be advertised to the public and those that are prohibited from being advertised. Medical devices that must be used or administered exclusively by health-care professionals and medical devices within the scope of reimbursement cannot be advertised to the public, either directly or indirectly. However, the advertisement of devices intended for personal use and that do not fall within the scope of reimbursement is allowed. Regarding this distinction, the Regulation on the Sale, Advertisement and Promotion of Medical Devices finds a balance between the severe restrictions applied to pharmaceutical products and a more variable approach that is better suited to the medical devices industry, which encompasses thousands of very different products.

The term ‘promotional activities for medical devices’ covers the promotion of medical devices that fall within the scope of the Regulation on the Sale, Advertisement and Promotion of Medical Devices to health-care professionals and technical staff working in the medical device field who are employed by health-care institutions and organisations, and activities intended to inform these people on subjects such as operating manuals. Technical support services and clinical support services are not regarded as being within the scope of promotional activities. The Regulation on the Sale, Advertisement and Promotion of Medical Devices introduces rules and principles that relate to promotion to and relationships with healthcare professionals (eg, promotional materials, scientific and educational activities, sponsorships, free samples and donations) that are similar to the established rules and principles applied to the pharmaceuticals sector. Consequently, medical devices are now also subject to provisions that have been modelled on pharmaceutical practice and that are unique to Turkey, including the maximum monetary value applied to reminder promotions directed at health-care professionals, quotas relating to the amount of congress sponsorships that health-care professionals can make use of each year, and transparency and notification obligations.

Pharmaceuticals regulation

15 Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market?

The regulatory framework for granting marketing authorisations is governed by the Regulation on Licensing of Medicinal Products for Human Use (Licensing Regulation). As for placing a pharmaceutical product on the market, additional regulations, such as the Regulation on Labelling and Packaging of Medicinal Products for Human Use and the Regulation on Safety of Medicines, also apply.

16 Which authorities may grant marketing authorisation in your jurisdiction?

The MoH is the sole authority entitled to grant marketing authorisations for pharmaceutical products in Turkey. The MoH fulfils this duty through the Institution.

17 What are the relevant procedures?

No medicinal product for human use can be marketed unless it is granted a marketing authorisation (licensed) by the MoH pursuant to the provisions of the Licensing Regulation. According to the Licensing Regulation, the eligibility criteria for the persons who may apply for pharmaceutical product licence are as follows:

  • natural persons should have a degree from a university providing education in the branches of pharmacy, medicine or chemical sciences and should avail of the authority to practise their profession in Turkey. In line with the related laws, pharmacists should be Turkish citizens able to perform their profession in Turkey. There is no such requirement for chemists. Until quite recently (before the passing of Decree Law No. 663 dated 2 November 2011) only Turkish citizens were allowed to practise as physicians in Turkey; however, foreign physicians may currently conduct their profession in Turkey, under some conditions. This recent amendment is still under discussion; and
  • legal persons should employ someone with an ‘authorised person’ title who has the qualities specified in the above bullet point, and who has sufficient information and experience with regard to the concerned product for which an application is submitted.

The following documents, in general, shall be submitted to the MoH along with the application for the pharmaceutical product licence:

  • a notarised copy of the diploma indicating that the applicant may practise one of the professions specified above;
  • a certified document indicating that the applicant is authorised to submit an application;
  • in the event of the applicant being a legal person, the original version or a copy of the commercial registry gazette indicating the objectives for the establishment of the company, the relevant members, duties and titles of the persons responsible;
  • the name or corporate name, permanent address, email address, telephone and fax numbers of the applicant;
  • the name, permanent address, telephone and fax number of the manufacturer;
  • product-related information, such as:
    • the name of the product;
    • quantitative and qualitative particulars of all the components of the product (except for the empirical chemical formula) and its international non-proprietary name;
    • a description of its manufacturing method;
    • any therapeutic indications, contraindications and adverse reaction
    • the dosage, pharmaceutical form, method and route of administration;
    • the shelf life and amount in the p ackage;
    • an indication of the disposal method of waste products; and
    • a description of control methods used by the manufacturer (such as sterility tests, tests for measuring the presence of heavy metals,stability tests, biological and toxicity tests);
    • results of physico-chemical or microbiological tests, toxicological and pharmacological tests and clinical trials;
    • a good manufacturing practice (GMP) certificate, issued to the manufacturer by the MoH; and
    • the summary of product characteristics specified in the Regulation on Packaging and Labelling and the patient information leaflet prepared accordingly; the immediate and outer packaging samples with the dimensions and design to be used in the market; and in the case of products authorised abroad and imported or manufactured on licence, the originals of summary of product characteristics, and patient information leaflets from other countries along with their Turkish or English translations, which are declared to have been recently updated;
  • in the context of pharmacovigilance practices, the curriculum vitae, address, telephone and fax numbers and job description of the person responsible for product safety; and
  • in the context of the Promotion Regulation, the document denning the scientific service and its address, telephone and fax numbers.

In the case of imported products or products manufactured under licence, additional documents are requested from the applicant.

Abridged applications are also possible in Turkey under the conditions set forth in the Licensing Regulation.

The MoH follows the European CTD format (including five modules) for the application files.

The Licensing Regulation envisages a 210-day period for the evaluation of the licence application by the MoH following the preparation of all required documents. In practice, however, this may go up to two years or more due to the GMP certification rules of the MoH, which require that each manufacturing facility be audited by Ministry personnel.

18 Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions?

According to the Licensing Regulation, if the concerned product is not actually placed on the market within three years of the issuance of the licence, the licence may be suspended by the MoH. No exception to this rule is set out in the related regulations. However, the licence is not automatically suspended after the lapse of this three-year period, and the MoH shall issue a decision in this regard in order to suspend the licence.

19 Which medicines may be marketed without authorisation?

Medicines that may be marketed without authorisation are those provided to the patient in the scope of ‘compassionate use’ or ‘named patient use’. The details of these programmes are outlined below.

20 Are any kinds of named patient programmes in place? If so, what are the requirements for pre-launch access?

The Compassionate Use Programme is regulated under the Guideline on Compassionate Use Programme and is defined as the provision, free of charge, of a pharmaceutical to a patient by the manufacturer or supplier company for humane reasons, where the drug has no marketing authorisation in Turkey. The Compassionate Use Programme is a patient-based programme. The physician applies to the MoH if he or she feels that a product without marketing authorisation in Turkey is necessary for a patient who is suffering from a life-threatening disease, and that they cannot be healed with any authorised product or be included in clinical trials. According to the Guideline, it is not important whether the pharmaceutical product used in the programme is licensed abroad or not. Ideally, at least phase II trials will have been completed; however, this is not a requirement. During the programme, only the costs of routine tests may be covered by the patient or reimbursed by the SSI; other than that, no cost can be imposed on the patient or the SSI.

The Guideline explicitly states that compassionate use and off-label use cannot be conducted at the same time.

Another alternative is the ‘special importation’ of pharmaceuticals that have no marketing authorisation in Turkey, or that have a marketing authorisation but are not marketed in Turkey for various reasons. These products are imported from abroad on a named patient basis. The MoH recently published a new Guideline regarding the Supply from Abroad and the Use of Pharmaceuticals. While there are provisions allowing for a number of distributors to import pharmaceuticals by such means, the lasting practice is for such importation to be conducted by the Turkish Pharmacists’ Association (TEB). A protocol was first signed between the SSI and the TEB in April 2007 which stipulates the reimbursement conditions for the imported pharmaceuticals. To date, there have been no further such protocols signed by the SSI. Consequently, as the reimbursement of pharmaceuticals imported by other distributors remains at the discretion of the SSI, pharmaceuticals imported by TEB in accordance with the protocol are more likely to be reimbursed.

Accordingly, TEB and other distributors are authorised to import the necessary products. Pharmaceuticals that will be imported on a named patient basis shall be supplied from a pharmaceutical warehouse authorised by the health authority of the country of origin, or directly from its manufacturer in accordance with the regulations of the country from which the product is imported. For the purpose of preventing the importation of counterfeit products or illegal importation, during the importation application process to the MoH distributors must submit documents confirming that the manufacturer was aware of all the phases that the product went through, from the manufacturer until the point of reaching Turkey.

The physician of a patient who needs to use such product for his or her treatment under a prescription may apply for its special importation if the physician believes that there is a scientific advantage to importing the pharmaceutical without a Turkish marketing authorisation. The results of these applications are collected in a Pharmaceuticals List that is published on the Institution’s website every Friday. Acceptance of these applications is up to the discretion of the Institution.

Pricing and reimbursement of medicinal products

21 To what extent is the market price of a medicinal product governed by law or regulation?

The principles for determining pharmaceutical prices are set by the Council of Ministers in the Pricing Decree, and in the Pricing Communique published by the MoH based on the Pricing Decree. In accordance with these, the MoH has adopted a reference price system; the maximum sales prices ofpharmaceutical products are determined by taking into account the lowest price among the reference countries (France, Greece, Italy, Portugal and Spain), or the lowest price in the country of import or the country of manufacture. The reference price takes the active substance into consideration for each product. Then it determines the price of different forms and dosages of this active substance by using a proportioning method.

The price of an original pharmaceutical is revised and becomes maximum 60 per cent of the reference price upon the launch on the market of its first generic.

22 Must pharmaceutical manufacturers negotiate the prices of their products with the public health-care providers?

According to the reference price system, the maximum price of a pharmaceutical is automatically determined; therefore, there is no place for negotiation in the system. On the other hand, manufacturers are free to sell their products below the ceiling price determined through the reference price system. Public health-care providers must follow the public tender procedures and, as a general rule, the participant company offering the lowest price in the tender is awarded the tender.

23 In which circumstances will the national health insurance system reimburse the cost of medicines?

The cost of a medicine is reimbursed provided that it is registered in the reimbursement list of the SSI.

24 If applicable, what is the competent body for decisions regarding the pricing and reimbursability ofmedicinal products?

The MoH, through the Institution, is the competent authority regarding the pricing of medicinal products. The competent body for reimbursement decisions is the SSI. There are also two important committees: the Pricing Committee, which is coordinated under the authority of the MoH and involves the participation of delegates from the Ministry of Finance, the Secretariat of State Planning Organisation, the Secretariat of Treasury and the SSI; and the Reimbursement Committee, which is organised by the Ministry of Finance and includes delegates from the MoH, the Secretariat of State Planning Organisation, the Secretariat of the Treasury and the SSI. These Committees review the applications and approve their conformity in line with the related pricing and reimbursement legislation.

25 Are manufacturers or distributors of medicinal products statutorily obliged to give a discount?

According to the Health Implementation Communique, the discount rate that is applied to original pharmaceuticals where no generic version is on the market is 41 per cent in total (11 per cent base discount plus 30 per cent additional discount), and 28 per cent (11 per cent base discount plus 17 per cent additional discount) for original products where the generic version is on the market. Twenty-eight per cent (11 per cent base discount plus 17 per cent additional discount) of the discount is applied to generic products.

The applied discount rates may differ according to the type of product, for example pharmaceuticals that are over 20 years old, over-the-counter pharmaceuticals or blood-derivative products.

Medicine quality and access to information

26 What rules are in place to counter the counterfeiting and illegal distribution of medicines?

Under article 18 of Law No. 1262 (as amended in January 2014), the sale of counterfeit medicines is subject to an administrative fine ranging from a minimum of 100,000 Turkish liras up to a statutory maximum of five times the aggregate of the annual sale proceeds of the counterfeit medicine in question. If the infringing acts are repeated, an administrative fine of twice the amount of the original fine will be issued. In a situation where the counterfeit medicines are being sold or distributed online, access to the infringing website will be blocked.

The counterfeiting and illegal distribution of medicines is also subject to the Turkish Criminal Code. According to article 186, any person who sells, procures or stores decayed or transformed foodstuffs, beverages or drugs and thereby causing risk to another’s life and health is punished with imprisonment for a period ranging from one to five years and faces a punitive fine up to 150,000 Turkish lira to be paid to the state. The punishment to be imposed is increased by one-third if the offence is committed by a person who is qualified as a professional in his or her business area (eg, if the concerned person is a pharmacist and sells decayed drugs, the punishment will be increased by one-third).

In addition to this, according to article 187 of the Turkish Criminal Code, any person who produces or sells drugs in such a way as to risk another’s life and health is punished with imprisonment for a period ranging from one to five years. The punishment to be imposed is increased by one-third if the offence is committed by a physician or pharmacist, or within the scope of a professional activity.

On the other hand, if the name of the medicine is registered as a trademark in Turkey, the use of the trademark on counterfeit products is subject to the general provisions of trademark law regulated under the Decree-Law No. 556 pertaining to the Protection of Trademarks. As per article 61 of the Decree-Law, the use of the same or confusingly similar trademarks without the consent of the proprietor of the trademark shall be considered an infringement of the trademark.

Furthermore, if counterfeit medicines are imported into Turkey without being subject to customs procedures, article 19 of Law No. 1262 stipulates that these products will be subject to the general provisions set forth in the Law to Counter Smuggling No. 5607.

27 What recent measures have been taken to facilitate the general public’s access to information about prescription-only medicines?

No measure has been taken by the relevant authorities to facilitate public access to information about prescription-only medicine.

28 Outline major developments to the regime relating to safety monitoring of medicines.

As a major development regarding the regime relating to safety monitoring of medicines, the Regulation on the Safety of Medicines (Regulation)

Update and trends

A new Pricing Decision was published in the Official Gazette dated 10 July 2015, which brings new rules but does not change the reference pricing system. Accordingly, the Ministry of Health is currently drafting a new Communiqué on the Pricing of Pharmaceutical Products for Human Use (Communiqué). The draft Communiqué is expected to provide further details for the application of the new extended criteria for the determination of the source price and the different evaluation regimes to be applied to the categories of special pharmaceutical products that have been identified in the Pricing Decision. As the draft Communiqué has undergone multiple revisions, it cannot be said that the full content has been finalised beyond any possible changes. However, in the interim, the Pricing Decision, has stated that the provisions of the current Communique (based on the previous Pricing Decisions) that do not conflict with the provisions of the current Pricing Decision will remain in effect. This, in turn, has lead to some difficulties in application. The primary area of difficulty concerns the periodic notification to the Ministry of Health of price changes to die reference-prices; with this period having been defermtned as six months in the current Pricing Decisions, and as three months under the Communiqué. As the new Communiqué that determines the principles of application of the Pricing Decision has not yet been finalised, companies operating in the pharmaceutical sector remain unsure as to which exact standards to apply to their notifications to the Ministry of Health. However, it is expected that the rinalisation of the new Communiqué in the near future will resolve these lingering problems in application.

First published by Getting The Deal Through, in 30.05.2016