ORGANISATION AND FINANCING OF HEALTHCARE
Organisation
How is healthcare in your jurisdiction organised?
The healthcare 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 healthcare-related
regulations and establish a healthcare system enabling each and
every person living in Turkey to have equal and equitable access to
the healthcare system. The regulatory authority is the MoH and its
subsidiaries. The MoH is responsible for establishing hospitals and
public health institutions to provide healthcare services to the
public. In addition to public hospitals and healthcare
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 healthcare institutions are
also common in places where the purchasing power of the population
is high. There was 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 Medicines and Medical Devices Agency (Agency). In line
with the amendment, the Agency 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 Agency (pharmaceuticals, medical devices, cosmetics, traditional herbal medicinal products and 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.
Financing
How is the healthcare system fnanced in the outpatient and
inpatient 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 beneft
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 inpatient) conducted at public healthcare
institutions and university hospitals, apart from those 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.
Basic structures
What are the basic structures of the provision of care to patients
in statutory and private care?
According to the Fundamental Law on Healthcare Services No. 3,359,
public healthcare institutions are established by the responsible
authority, which is the MoH. A big proportion of the public is
covered by the SSI health insurance, while only a small proportion
benefts 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 the SSI health insurance coverage. The aim is
that all citizens who were not covered by the SSI health insurance
packages now beneft from public health insurance.
HEALTHCARE SERVICES
Authorisation
What steps are necessary to authorise the provision of health
services, and what law governs
this?
The authority to grant licences to private hospitals and healthcare
institutions is given to the Ministry of Health (MoH) under the
Regulation of Private Hospitals . Additionally, universities with
medical faculties may also establish hospitals under the Higher
Education Law No. 2,547. The authorisation procedure of health
services are governed by the Regulation of Private Hospitals that
provides a detailed description of the licence application
procedure. According this Regulation, the MoH is entitled to grant
licences for private hospitals. The applicant, who may be a private
legal entity or a real person, has to obtain preliminary permission
from the MoH concerning construction plan prior to the licence
application. Concerning other types of healthcare institutions, the
authorisation procedure may slightly vary as each institution is
regulated separately.
Structure
Which types of legal entities can offer healthcare services?
Legal entities that are entitled to offer healthcare services are
mainly governed by the Fundamental Law on Healthcare Services No.
3,359. However, different entities are regulated by different
regulations. Accordingly, public hospitals, private hospitals and
training and research hospitals offer full healthcare services. On
the other hand, community health centres, homecare services,
medical clinics, dental clinics, dialysis centers, assisted
reproduction treatment centers and dispensaries generally offer
healthcare services limited to their specialisation.
Services of foreign companies
What further steps are necessary for foreign companies to offer
health services?
The regulatory framework on granting licences for private
healthcare does not allow foreign companies to offer healthcare
services. According to the Regulation on Private Hospitals,
companies shall be established in Turkey and have to be registered
to the Turkish Trade Registry to apply for a licence.
ADVERTISING
Legislation
Which legislation governs advertising of medicinal products to
healthcare professionals?
In Turkey, advertising of medicinal products is governed by the
Pharmaceutical and Medical Preparation Law No. 1,262 , 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.
Further, the Act on Protection of Consumers , Regulation on
Commercial Advertisements and Unfair Practices , and Code of
Obligations are applicable where a matter is not regulated under
Law No. 1,262 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. 6,112 (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 major
industry-based associations in Turkey:
- the Turkey Pharmaceuticals Industry Association;
- the Association of Research-Based Pharmaceutical Companies (member of the European Federation of Pharmaceutical Industries and Associations and the International Federation of Pharmaceutical Manufacturers and Associations); and
- the Pharmaceuticals Manufacturers Association, which have their own codes of promotional practices.
Main principles
What are the main rules and principles applying to advertising of
medicinal products aimed at
healthcare professionals?
The fundamental rule is that marketing authorisation holders and
their representatives may not provide, offer or promise benefts to
healthcare professionals by way of promotional activities.
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 healthcare professionals must contain
information consistent with the products approved, and an updated
summary of product characteristics. Promotion must be aimed at
healthcare professionals, and must include objective, informative
and factual medical data to enable the healthcare professionals to
form their own opinion about the product. The promotional
activities must not be used to encourage unnecessary the use of a
product, and the promotion must be made by certified
representatives. The mandatory certifcation of the sales team is a
requirement that was foreseen by the former regulation as well. All
promotion representatives shall receive certifcates 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 this certifcation is
conducted according to guidelines published by the Ministry of
Health and based on the Promotion Regulation. Individuals without
the aforementioned certifcation are not able to work as promotion
representatives for medicinal companies.
Advertising of medical devices
Is the advertising of medical devices to healthcare professionals
regulated as rigorously as advertising in the pharmaceuticals
sector? What are the main differences?
The Regulation on the Sale, Advertisement and Promotion of Medical
Devices came into force on 15 May 2014 and was recently amended on
2 September 2020. The advertisement and promotion of medical
devices was previously unregulated, leading to a lack of uniformity
in practice across the Turkish medical devices market. A
distinction that has been introduced specifcally 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. Advertising of devices that
are sold, adapted or implemented only in hearing aid centres,
tailored prosthetics and orthosis centres,opticians, or dental
prosthetics laboratories; and devices that are intended to be used
or implemented exclusively by healthcare professionals or that
require implementation in medical device sales centres, addressed
to the consumer, are prohibited. On the other hand, advertising of
devices other than previously mentioned, can be made only in the
internet environment where the device is sold, and devices listed
in Annex-3 of the Regulation can be advertised without any
limitation.
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 healthcare professionals and technical staff
working in the medical device feld who are employed by healthcare
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, scientifc
and educational activities, activities taking place in simulation
or cadaver centres, 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
healthcare professionals, quotas relating to the amount of congress
sponsorships that healthcare professionals can make use of each
year, and transparency and notifcation obligations.
DATA PROTECTION, PRIVACY AND DIGITISATION IN
HEALTHCARE
Digitisation
What are the legal developments regarding digitisation in the
healthcare sector and industrial networks or sales channels?
The biggest step regarding the digitisation of healthcare services
is taken by the Ministry of Health (MoH). In 2015, the MoH
introduced the E-Nabiz (e-Pulse), which is a personal health record
system. E-Nabiz stores encrypted personal health records and helps
patients to access and review their records such as laboratory
tests, prescriptions, previous diagnosis and X-ray results. The
system also allows patients to:
- switch doctors and determine which doctors will be authorised to access such information;
- manage their own data; and
- request amendments to, or the deletion of, the data.
The data is encrypted and patients are able to access their data
only by entering their e-government password.
Provision of digital health services
Which law regulates the provision of digital health services, and
to what extent can such services be provided?
Personal Health Data Regulation No. 30,808, published in the Ofcial
Gazette on 21 June 2019 and Circular No. 2016/6 on the E-Nabiz
Personal Health System, is the legal basis governing E-Nabiz. The
Circular mentions that the fundamental aim of E-Nabiz is to ensure
a citizen's right to access and manage their personal health
records pursuant to article 20 of the Constitution on the personal
data. The system is accessible 24 hours a day, seven days a week
and free of charge through computers, mobile phones and wearable
technology. According to MoH Health Information Systems Department
statistics, as of December 2019, 10 million citizens were using
E-Nabiz.
Authorities
Which authorities are responsible for compliance with data
protection and privacy, and what is the applicable legislation?
Have the authorities issued specifc guidance or rules for data
protection and privacy in the healthcare sector?
On 7 April 2016, Data Protection Law No. 6,698 (Data Protection
Law) came into force. The Data Protection Law regulates the
protection of personal data and created new obligations that
persons or entities dealing with personal data must comply
with.
The Data Protection Law has been prepared in line with EU Directive 95/46/EC on data protection (EU Data Protection Directive), rendering it similar to the EU Data Protection Directive. However, the Data Protection Law is not idential to the EU Directive.
The Turkish Data Protection Authority (DPA) was granted the power to implement the Data Protection Law. Accordingly, the Turkish DPA may investigative powers to ascertain whether data controllers and data processors are in compliance with the provisions of the Data Protection Law and, if deemed necessary, it may implement temporary preventative measures.
Pursuant to article 6 of the Data Protection Law, personal data relating to health, sexual life, biometric and genetic data are deemed sensitive personal data. While sensitive personal data other than data relating to health and sexual life may be processed without seeking explicit consent of the data subject in the cases provided for by other laws, personal data relating to health and sexual life may only be processed without seeking explicit consent of the data subject, by persons or authorised public institutions and organisations that have a confdentiality obligation explicitly for the purposes of:
- protecting public health;
- the facilitation of preventive medicine;
- medical diagnosis;
- treatment and nursing services; and
- the planning and management of healthcare services, including their fnancing.
Restrictions brought under the Data Protection Law leave limited
room for processing health data without explicit consent.
Unfortunatly, to date, the DPA has issued no specifc guidiance or
rules focusing on data protection in the healthcare sector.
On the other hand, the MoH has issued Personal Health Data
Regulation No. 30,808, published in the Ofcial Gazette on 21 June
2019, which aims to regulate the procedures and principles to be
followed in the processes and practices carried out by the central
and provincial organisational units of the MoH and the health
service providers operating in conjunction with them.
Requirements
What basic requirements are placed on healthcare providers when it
comes to data protection and privacy? Is there a regular need for
qualifed personnel?
On 30 December 2017, the DPA issued the Regulation on Data
Controllers' Registry that provides details of the obligations
that data controllers must comply with. Data controllers must
appoint either a contact person or an authorised representative
depending on whether the data controller is based inside or outside
Turkey. This person's name and contact details shall be
published online and they shall be responsible for establishing the
communication between the data subjects and the data controllers.
However, this person is not a data protection ofcer as defned by
Regulation (EU) 2016/679 (General Data Protection Regulations).
Even though the MoH published a personal health data regulation
aiming to regulate the procedures and principles to be followed in
the processes and practices carried out by the central and
provincial organisation units of the MoH and the health service
providers operating in connection with them, the rules mentioned in
this regulation are merely a replica of the rules set by the Data
Protection Law.
Common infringements
What are the most common data protection and privacy infringements
committed by healthcare
providers?
The DPA has already started to investigate and issue decisions on
matters brought to the authority's attention and on matters
examined ex ofcio. However, to date, no decision has been issued
against a healthcare provider.
In practice, both patients and companies notice that healthcare
providers do not convey information to their patients according to
the obligations set by the Communiqué on the Obligation of
Information . Even if they do, this information lacks important
provisions and fails to inform data subjects in a transparent
manner. In addition, despite the Data Protection Law being in force
for three years, it is deemed that healthcare providers took no
measures to protect patients' personal data.
COLLABORATION
Legislation
Which legislation governs the collaboration of the pharmaceutical
industry with healthcare professionals? Do different rules apply
regarding physicians in the outpatient and inpatient sectors?
The Regulation on Promotional Activities of Medicinal Products for
Human Use (Promotion Regulation) governs the relationship between
pharmaceutical companies and healthcare professionals.
The ethical principles set out by medical associations of which the healthcare professional is a member also apply to this relationship.
If a service to be rendered by the healthcare professional for the pharmaceutical company is concerned, Law on Public Ofcials No. 657 or the Higher Education Law No. 2,547 may also be applied, as the rules set forth in this legislation provide limitations regarding the working principles of healthcare professionals.
The Regulation on Ethical Principles of Conduct and Procedure and Principles of Application will also apply to the relationship between a healthcare professional who is a public ofcial and a pharmaceutical company.
There is no difference to the rules applicable to physicians in
the outpatient or inpatient sectors.
Collaboration with healthcare professionals
What are the main rules and principles applying to the
collaboration of the pharmaceutical industry with healthcare
professionals?
The Promotion Regulation imposes limitations on the relationship
between pharmaceutical companies and healthcare professionals. The
fundamental rule is that marketing authorisation holders and their
representatives cannot provide, offer or promise benefts to
healthcare professionals by way of promotional activities. The
marketing authorization holder must not encourage the prescription
of its products by offering any kind of beneft to a healthcare
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 healthcare
professional may beneft 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 times of the year at ski or coastal holiday resorts. All organisations have to be notifed to the Ministry of Health. Furthermore, healthcare 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 healthcare professionals to a pharmaceutical company, a law that was published in January 2014 banned physicians working in state or university hospitals from working privately, and a transitional period was granted to those physicians who held private clinics to close them by 18 April 2014. Just before the expiry of the transitional period, the Constitutional Court stayed the law's execution 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 this law do not have to close those clinics. However, the Court 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, healthcare institutions and
organisations, universities, unions, associations and foundations
active in the feld of healthcare and non-governmental organisations
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 Turkish Medicines and
Medical Devices Agency (Agency). The disclosure of value transfers
for a calendar year shall be submitted within the frst 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 Agency,
without providing for an additional mechanism for disclosure to the
public.
Collaboration with patient organisations
What are the main rules and principles applying to the
collaboration of the pharmaceutical industry with patient
organisations?
There are no ofcial regulations regarding the collaboration of the
pharmaceutical industry with patient organisations. However,
industry associations such as the Turkey Pharmaceuticals Industry
Association, the Association of ResearchBased Pharmaceutical
Companies (AIFD) and the Pharmaceuticals Manufacturers Association
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 fnancially or through rendering services, a
written agreement shall be signed between the parties.
Pharmaceutical companies shall not have an infuence 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.
Common infringements
What are the most common infringements committed by pharmaceutical
manufacturers
regarding collaboration with healthcare professionals?
The most common infringement with regard to collaboration with
healthcare professionals is seen in congresssymposium 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 benefts to healthcare professionals.
Together with the Promotion Regulation, marketing authorisation
holders may organise or sponsor scientifc meetings held abroad on
the condition that the meeting is international, or a majority of
the participants are healthcare professionals not working in
Turkey. These conditions are in fact implemented owing to some
cases that the Agency faced in the recent years. This provision
will avoid the global companies being the sponsor for the
organisation of these meetings and Turkish companies afliated to
these global companies being the sponsor to all of the participant
healthcare professionals working in Turkey.
Collaboration on medical devices
Is the collaboration of manufacturers of medical devices with
healthcare professionals and patient organisations regulated as
rigorously as collaboration in the pharmaceuticals sector? What are
the main differences?
Similar to the Promotion Regulation, the Regulation on the Sale,
Advertisement and Promotion of Medical Devices governs the relation
between medical devices manufatureres and the healthcare
professionals.
There are no ofcial regulations regarding the collaboration of
the medical devices manufacturers with patient organisations.
However, industry associations such as the Association of Research
Based Medical Technologies Manufacturers (ARTED), a MedTech Europe
member, have their own codes of practice that also govern relations
with patient organisations. According to the ARTED Code of Ethics,
if a member medical device company decides to provide a donation to
a patient organisation or a non-proft organisation, a written
agreement shall be signed between the parties.
COMPETITION LAW
Authority enforcement
Are infringements of competition law by healthcare providers
pursued by national authorities?
The Turkish Competition Law is applicable to all undertakings that
operate in a market for goods or services within the borders of
Turkey. The Turkish Competition Authority (TCA) is the public
authority to monitor and maintain the competition in the market
In Turkey, public hospitals shall not be considered as an undertaking in terms of the Competition Law, as they are nonproft organisations. As for private hospitals and clinics, in many TCA decisions 'private hospital management' is deemed a market service. Accordingly, private hospitals and clinics, and the companies that operate them, are subjected to the Turkish Competition Law.
In recent years, most TCA decisions regarding the private hospital management market deal with the merger and acquisition of private hospitals. However, as an undertaking operating in a market of service in Turkey, a private healthcare provider may be pursued by the TCA as an investigation ex ofcio initiated by the TCA itself, or upon a complaint that can be made by anyone (in most cases, by competitors).
Once the infringement of competition is established, the TCA can
impose sanctions including heavy administrative fnes on companies
and board members, and may invalidate the relevant contract or
transaction that causes the infringement.
Private enforcement
Is follow-on private antitrust litigation against healthcare
providers possible?
According to article 57 of the Turkish 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 the
anticompetitive acts of manufacturers may claim compensation by
fling a lawsuit before the courts. Accordingly, the injured party
may ask for an amount equal to three times the actual loss
incurred.
Anti-corruption and transparency
What are the main anti-corruption and transparency rules applicable
to healthcare providers?
Under Turkish law, there is no umbrella legislation that covers
every type of anti-corruption issue. Crimes such as bribery and
ofcial misconduct are punishable according to Turkish Criminal Code
No. 5,237 , regardless of the sector in which they are committed.
In terms of bribery regulated under article 252 of Turkish Criminal
Code No. 5,237, any kind of beneft provided for executing a legal
transaction, which should be executed or vice versa, is prohibited
with a zero-tolerance approach. In addition to the Turkish Criminal
Code, the Regulation on the Code of Ethics of Public Ofcials and
Application Procedures and Principles is establishing the basic
principle for public ofcials not to receive or give gifts and not
to derive interest as a result of their duty. This Regulation also
defnes a black list of all sorts of goods and benefts that public
ofcials cannot receive.
To guide pharmaceutical companies interacting with healthcare professionals, the Ministry of Health (MoH) defned sector-specifc rules. In this sense, provisions regarding promotional interactions like congress sponsorship of healthcare professionals, donations made to healthcare organisations, as well as all kinds of promotional materials that can be given to healthcare professionals are regulated under the Promotion Regulation.
On 3 July 2015, the MoH introduced a requirement to disclose to
the Turkish Medicines and Medical Devices Agency transfers of value
made to healthcare professionals by pharmaceutical companies.
Companies started documenting transfers of value made in 2016 and
submitted this documentation in 2017. This data is not intended to
be disclosed to the public at this stage, but will be reviewed and
retained by the MoH.
PRICING AND REIMBURSEMENT
Price regulation
To what extent is the market price of a medicinal product or
medical device governed by law or regulation?
The principles for determining pharmaceutical prices were set by
the Council of Ministers in the Pricing Decree and in the Pricing
Communiqué published by the Ministry of Health (MoH) based
on the Pricing Decree. However, as a result of the referendum, held
on 16 April 2017, an amendment has been made to the Constitution
and a transition has been made to the Presidential Government
System. The most fundamental feature of this system is the transfer
of all executive authorities to the President with the annulment of
the ofce of Prime Ministry. The President has become both the head
of state and the head of executive power. Consequently, the rules
and procedures for determination of pharmaceutical prices are
determined by the President, not by the Cabinet of Ministers.
The MoH is still applying the reference price system. The maximum sales prices of pharmaceutical products are determined by taking into account the lowest price of the product available on the market respectively in the reference countries (France, Greece, Italy, Portugal and Spain) and the countries of batch release and import. Where this is not available, the lowest price of the product available in EU countries - or, failing that, the ex-factory price (the sale price to wholesalers) of the product available on the market in any country across the world. 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 at most 60 per cent of the reference price upon the launch on the market of its frst generic.
One of the most discussed topics relating to pharmaceutical pricing in Turkey is the euro and Turkish lira currency rate (Fx rate) determined by the Price Assessment Commission competent for calculating the price of a product. According to the Pricing Decree, the Fx rate should be adapted to currency fuctuations. However, the Fx rate set to 1.95 Turkish lira in 2007 was not amended until 2009. The industry formally requested the MoH to change the Fx rate. Upon rejection of this application, the industry associations fled an action against the MoH. The Council of State examining the case held its decision in favour of the industry and decided that the Pricing Assessment Commission should render a new decision with respect to the determination of the Fx rate. The Pricing Assessment Commission decided not to change the Fx rate. Although the administration bodies should comply with Court decision, because the Council of State's decision indicated taking a decision regarding the matter, the Pricing Assessment Commission was, in theory, not in contradiction with the Court's decision. However, the industry associations fled a new action against the MoH, which was again accepted. During this process, the Pricing Assessment Commission set the Fx rate to 2 Turkish lira and then to 2.07 Turkish lira.
The Pricing Decree was amended in July 2015 and the Fx rate was accepted as 70 per cent of the average annual euro value. Accordingly, the Price Evaluation Commission would gather within the frst 45 days of every year and announce the ?1 value based on a calculation of 70 per cent of the average value of the previous year.
However, an amendment was published in the Ofcial Gazette on 14 February 2019 and the rate of 70 per cent given in the Decision was changed to 60 per cent. Hence, the new exchange rate for 2019 was announced as 3.40 Turkish lira, with an increase of 26.4 per cent compared to that of 2018. On 14 February 2020, the Price Evaluation Commission determined the Fx rate for 2020 as 3.81 Turkish Lira, which brings an automatic increase of 12 per cent, when compared to 2019.
Negotiations between manufacturers and providers
Must pharmaceutical and medical device manufacturers negotiate the prices of their products with public healthcare providers?
According to the reference price system for pharmaceuticals, the maximum price of a pharmaceutical is automatically determined. Therefore, there is no place for negotiation in the system. Manufacturers are free to sell their products below the ceiling price determined through the reference price system.
On the other hand, complementary provisions were introduced with the Regulation on the Alternative Reimbursement of Pharmaceuticals published in February 2016 allowing companies and the Social Security Institution (SSI) the beneft of discussing the terms and conditions of an alternative reimbursement model for special products. The ultimate aim of the system is to provide quicker access to patients of innovative drugs with respect to their reimbursement. The price set is confdential.
As to medical devices, product prices are not determined by the MoH. However, medical device companies may negotiate with the reimbursement authority and set a discounted price for their products.
In all cases, public healthcare 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.
Reimbursement
In which circumstances will the national health insurance system
reimburse the cost of
medicines?
The cost of medicines is reimbursed, provided that they are
registered on the SSI reimbursement list.
Price adjudication
If applicable, what is the competent body for decisions regarding
the pricing and reimbursability of medicinal products?
The MoH, through the Turkish Medicines and Medical Devices Agency,
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 Treasury and Finance and the SSI; and
- the Reimbursement Committee, which is organised by the Ministry of Treasury and Finance and includes delegates from the MoH and the SSI.
These committees review the applications and approve their
conformity in line with the related pricing and reimbursement
legislation.
Discount
Are manufacturers or distributors of medicinal products statutorily
obliged to give a discount to health insurance schemes or third
parties?
According to the Health Implementation Communiqué , the
discount rate applied to original pharmaceuticals where no generic
version is on the market is 41 per cent in total (11 per cent base
discount plus a 30 per cent additional discount), and 28 per cent
(11 per cent base discount plus a 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 a 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 more than 20 years
old, over-the-counter pharmaceuticals or blood-derivative
products.
UPDATE AND TRENDS
Key developments of the past year
Is there any legislation expected in the near future that will
have a major impact on the current legal environment for medicines
or medical devices?
The Turkish Medicines and Medical Devices Agency (Agency) is
expected to make amendments to:
- the Regulations on Licensing of Medicinal Products for Human Use;
- the Regulation on Bioavailability and Bioequivalence Evaluation of Pharmaceutical Preparations; and
- the Regulation on Promotional Activities of Human Medicinal Products.
- its regulations on medical devices.
Coronavirus
What emergency legislation, relief programmes and other initiatives
specifc to your practice area
has been implemented to address the pandemic? Have any existing
government programmes, laws or regulations been amended to address
these concerns? What best practices are advisable for clients?
The outbreak of covid-19, which has been declared a pandemic by the World Health Organization, has led to widespread measures being taken in Turkey to combat its effects, including legislative initiatives.
First, the Law on Amendment of Certain Laws No. 7,226 entered into force upon publication in the Ofcial Gazette No. 31080 dated 26 March 2020. This Law suspended all procedural terms until 30 April 2020 to prevent any loss of rights with regard to trials or administrative periods. Following this Law, a Presidential Decree was issued extending this suspension of procedural terms until 15 June 2020.
Government health authorities also issued number of announcements to manage this public health crisis as smoothly as possible. The Agency published an announcement regarding precautions to be taken in clinical trials owing to the pandemic in Turkey on 20 March 2020. In line with the European Medicines Agency Guidance, the announcement states that sponsors of clinical trials should continuously assess risk and update their research organisations accordingly. This risk assessment should consider the covid-19-related priorities, reduce the burden of research centres and follow social isolation rules. The frst issue to be considered at this stage is the safety of the clinical trial subjects.
On 19 March 2020, the Agency prohibited product promotion representatives from making physical visits, allowing promotional activities carried by product promotion representatives to take place only via electronical means.
Owing to the decreasing number of new covid-19 cases, a 'normalisation process' in Turkey began in June. The Agency published an announcement on 5 June 2020 to amend the precautions for the promotion representatives that had been put in place. The amendments allow promotion representatives to engage in product promotion activities in primary healthcare institutions within the visiting days and hours determined by each institution by paying utmost attention to the social distancing rules as of 8 June 2020, and they are also allowed to visit healthcare providers in hospitals allowing such visits except in hospitals treating patients diagnosed with covid-19 as of 15 June 2020, with the additional condition that the visits shall not be made in inpatient services.
Our clients, to harmonise their business activities with the
measures of authorities taken owing to the pandemic, have started
to hold web-based meetings and have updated their IT infrastructure
and systems so that they can get the necessary approvals with
regard to protection of personal data to conduct all kinds of
activities online in accordance with the requirements of these
regulations. Even though a normalisation process has been
implemented, most of the companies are choosing not to visit any
institution for the time being.
LAW STATED DATE
Correct on
Give the date on which the information above is accurate.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.