Turkey's 2023 11th Development Plan sets out the Turkish government's new objective to build a life sciences sector that is competitive at an international level. This is a radical change, as the former goal was to become a local manufacturing hub to meet domestic demand. The new aim is to become one of the ten largest economies in life sciences in 2023.

The Turkish life sciences industry rose three places in the Intercontinental Marketing Services Health Inc. rankings between 2015 and 2021. Turkey was ranked 14th in the world in 2021, with leading global companies including Pfizer, Novartis, and Roche and operating in the Turkish life sciences sector. As of January 2021, there were 94 (83 pharmaceutical product and 11 raw material) manufacturing facilities in Turkey meeting the highest international standards. The industry employs over 40,000 staff and produces over 12,000 products. Boehringer Ingelheim, one of the largest international pharmaceutical companies, recently announced that it will start pharmaceutical manufacturing in Turkey in co-operation with the Turkish pharmaceutical company Abdi İbrahim. In addition, Toksöz group, a group of three companies that encompasses Arven Pharmaceuticals, Verano Pharmaceuticals, and Montero, sold 30% of its shares in Sanovel Pharmaceuticals, a manufacturer of generic medicines, to a venture capital fund in 2020.

Life sciences start-ups in Turkey received a total investment of USD19.7 million in the first quarter of 2020. The majority of these investments were related to start-ups aiming to meet needs arising from the COVID-19 pandemic, for example, for respirators and COVID-19 tests. In the pharmaceutical sector, investments made in start-ups declined in 2020 and 2021 compared to 2018 and 2019.

Investment incentive certificates received by local pharmaceutical companies totalled USD1.1 billion in 2021. In addition, Turkey's Scientific and Technological Research Council (TÜBİTAK) funded over 35 health care projects during the COVID-19 pandemic. Nevertheless, there remains scope for new incentive schemes and regulatory changes aimed at increasing public funding and facilitating access to capital markets. A fully supportive financial ecosystem still needs to be established for Turkey to be successful in this area.

The Health Services Fundamental Law No 3359 (Law on Health Services) empowers the Ministry of Health (MoH) to issue health care regulations and establishes a health care system allowing every person living in Turkey access to health care.

The MoH oversees the establishment of hospitals and public health institutions providing medical services to the public. These services are funded by the state budget allocated to health services. Reimbursement of health services provided by health institutions, for example, physical examinations, operations, and medical tests, are typically covered under general health insurances funded by the state and personal contributions made by individuals. Pharmaceutical products prescribed to patients are reimbursed by the MoH through the reimbursement plan, which is partly funded by the direct personal contributions of individuals or deductions from employee wages. Private health insurance coverage is very low in Turkey compared to state coverage.

The Higher Education Law No 2547 grants universities with medical faculties the authority to establish hospitals. Various university hospitals throughout Turkey have been established through this method. Private hospitals are also common, especially in cities with a large population.

A pharmaceutical product that is either produced in Turkey or imported into Turkey is usually transferred from the pharmaceutical company through pharmaceutical trade houses to pharmacies, and finally to the patient. This chain may be different for pharmaceutical products used in hospitals, as hospitals may purchase pharmaceutical products from pharmaceutical trade houses or in some cases directly from pharmaceutical companies through tenders.

Under the new administrative regime introduced in Turkey in July 2018, the President of Turkey has the authority to set principles for determining pharmaceutical prices through pricing decisions, based on proposals made by the MoH.

The most recent Decree on the Pricing of Medicinal Products for Human Use (New Pricing Decree) was published in the Official Gazette on 24 February 2017 and entered into force on the same date (although it was significantly amended in the following years). The New Pricing Decree abolished the previous decree, which was dated 15 June 2015 (Old Pricing Decree). In addition, the Communiqué on the Pricing of Medicinal Products for Human Use (Communiqué on Pricing) was published in the Official Gazette and entered into force on 29 September 2017, setting out pricing principles and methods of calculation.

The MoH continues to operate a reference price system under the New Pricing Decree, as it did under the Old Pricing Decree. However, the New Pricing Decree replaces the terminology "reference country" and "reference price" with "origin country" and "real source price" respectively. The "real source price" is the wholesale price of products as licensed and marketed in the country of origin (taking into account the active substance and its form/dosage), as stated in euros in the price list. The calculation of the real source price is set out in detail in secondary legislation. The price of a pharmaceutical product in Turkey is then determined by taking into account in the lowest real source price among the reference EU countries (France, Spain, Italy, Portugal, and Greece). Alternatively, prices may also be set by taking into account the lowest price in the country of import (where other than the countries above) or the country of the batch release.

The Communiqué on Pricing also replaces the term "20-year-old product" with "price-protected product". "20-year-old products" were defined in the previous legislation as products with one or more active substances that entered the market before 1 August 1987. The Communiqué on Pricing defines "price-protected products" as products that entered the market in their pharmaceutical form before 1 August 1987.

The source price of a non-price-protected reference product is 100% of the real source price until its generic enters the market. In the event of generic entry, the source price of the non-price-protected reference product is reduced to 60% of the real source price. Non-price-protected generic products can be priced up to 60% of the real source price. Price-protected generic products can be priced up to 80% of the real source price.

Certain exceptions apply for specific types of pharmaceutical products, for example, orphan drugs.

In addition, the Price Determination Commission also determines a fixed euro exchange rate to be used in pricing calculations each year. According to the New Pricing Decree, the exchange rate used to determine the price is 60% of the previous year's average EUR/TRY exchange rate as announced by the Turkish Central Bank. Under the latest development, a new provisional Article was added to the Pricing Decree by Presidential Decree published in the Official Gazette dated 8 July 2022 No 31890. Under this provisional Article, the Turkish Lira equivalent of EUR1 (determined as TRY6.29 for 2022 by the Price Determination Commission on 14 February 2022) will increase by 25% in July 2022. In parallel to this change, the pegged exchange rate to be used was increased to TRY7.86.

Following price determination through the reference pricing system, certain trade house and pharmacy profit margins are also added (along with VAT) to calculate the retail price of a product.

The Social Security Institution (SSI) is in charge of the reimbursement of pharmaceutical products. Public health insurance is broad in scope and therefore the SSI buys most pharmaceutical products sold in Turkey through the reimbursement system.

Pharmaceutical products to be reimbursed by the public health system must be registered with the reimbursement list of the SSI. This means that additional discounts of up to 41% are applied to prices of products, depending on the determined price of the product under the Health Implementation Communiqué dated March 2013 (as amended periodically). In addition, the SSI introduced an alternative reimbursement regime that may also result in extra discounts to be applied to product prices, depending on case-specific agreements negotiated and signed between pharmaceutical companies and the SSI.

However, patients are free to take out private insurance policies. Private insurance policies usually cover pharmaceutical products and treatments that are not covered by the SSI's reimbursement list in a more extensive manner (and may either include a product or treatment that is totally excluded by the SSI's reimbursement list or offer a higher percentage of reimbursement). It is also usual for private insurance policies to allow patients to benefit from treatments in private hospitals, and not only public hospitals.

As with the previous legislation, the Communiqué on Pricing sets the profit ratios for pharmaceutical trade houses and pharmacies to be applied over the factory prices. Over-the-counter transactions for prescription pharmaceutical products are still common, despite legislative efforts to combat this practice. Therefore, direct payment by patients to pharmacies is another source of income.

As in most jurisdictions, pharmacies serve as retailers of pharmaceutical products. Sales made by pharmacies are highly regulated and are under the scrutiny of the Turkish Pharmaceutical Product and Medical Device Agency (Agency) and the SSI. Pharmacies are governed by:

If a pharmaceutical product requires a prescription, the pharmacy must ask for the prescription and submit it to the SSI's online system called MEDULA. If the prescription includes products covered by the reimbursement list, the pharmacy does not collect any payments from the patient (or only collects the portion exceeding the reimbursement percentage and other fees determined by the SSI). The costs of pharmaceutical products and treatments that are not (or only partially) covered under the SSI's reimbursement list are normally covered by the patients themselves.

Under Law No 1219 on the Practice of Medicine and Medical Sciences (Law on Medicine), doctors have the sole authority to treat patients and prescribe pharmaceutical products. Dentists are also authorised to treat patients and prescribe medicine in relation to their area of expertise.

The Law on Pharmacies requires medicinal products to be sold exclusively at pharmacies, regardless of whether the product is over-the-counter or prescription-only. Medicinal products include:

The Law on Pharmacies prohibits the sale of medicinal products through the internet or any other kind of electronic platform. As such, the sale of such products through the internet, email, or mail order is prohibited in Turkey.

The wholesale distribution of medicinal products is conducted by pharmaceutical trade houses, which are mainly regulated under the Regulation on Pharmaceutical Trade Houses and Products Stored in Pharmaceutical Trade Houses (Regulation on Pharmaceutical Trade Houses). The Regulation on Pharmaceutical Trade Houses defines pharmaceutical trade houses as establishments where one or all of the activities of supply, storage, sales, distribution, and export of medicinal products and active substances are carried out.

The Regulation on Pharmaceutical Trade Houses covers the whole supply chain and regulates the procedures and principles regarding the purchase, sales, storage, brokerage, distribution, export, and transportation of medicinal products and active substances in accordance with the Guidelines on Good Distribution Practices for Medicinal Products for Human Use (GDP) and domestically and internationally accepted standards.

The movement of medicinal products and active substances must be within the legal supply chain (Article 5, Regulation on Pharmaceutical Trade Houses). The legal supply chain consists of persons, institutions, and organisations that have been granted a licence/permit/authorisation under the relevant legislation to carry out the purchase, sales, export, storage, brokerage, distribution, or transportation of medicinal products and active substances. Manufacturing activities such as dividing, shredding, and repackaging cannot be carried out in pharmaceutical trade houses.

Pharmaceutical trade houses must:

Pharmaceutical trade houses can only sell medicinal products and active substances to:

In addition, pharmaceutical trade houses can only make wholesale sales to:

Pharmaceutical trade houses cannot make wholesale or retail sales to individuals, subject to certain exceptions.

Medicinal products for human use that are not licensed in Turkey, or that are licensed but are not available in the market for various reasons, can be procured from abroad for personal use on prescription through public institutions and organisations deemed appropriate by the MoH, the SSI, and the Turkish Pharmacists' Association (Türk Eczacıları Birliği) and may be provided directly to patients. The supply of pharmaceutical products brought in bulk from abroad by hospitals can also be conducted in the same manner. To procure pharmaceutical products in this way, the permit/licence holder must apply for a marketing authorisation within three years of the date of entry into the foreign pharmaceutical product list and obtain marketing authorisation within two years from the date of application. The President of Turkey decides on the continuation of the supply of pharmaceutical products for which no marketing authorisation application has been made or no marketing authorisation has been obtained.

Individuals or legal entities intending to operate as a pharmaceutical trade house must obtain an authorisation certificate by applying to the directorate of the MoH with the information and documents specified in the Regulation on Pharmaceutical Trade Houses.

A pharmaceutical trade house must employ a pharmacist as responsible manager and a responsible manager certificate must be issued by the Agency in the name of the responsible manager. The responsible manager is responsible for the supply, storage, sales, distribution, and export of the products and active substances, except for sales to the end consumer. If a pharmaceutical trade house has branches, a separate responsible manager must be appointed for each branch. At least one responsible manager must always be on duty when the pharmaceutical trade house is in service.

Pharmaceutical trade houses that distribute pharmaceutical products to pharmacies must keep the products included in the Agency's current list of compulsory medicines in a sufficient quantity for at least three pharmacies in the relevant province, and deliver them to the requested locations as soon as possible (Article 16, Regulation on Pharmaceutical Trade Houses). The availability of products in the market will be taken into account in the implementation of this duty.

Exports by authorised pharmaceutical trade houses must be carried out in accordance with the legislation applicable in the country to which the products will be exported (and the Turkish legislation), and they must make notifications to the Pharmaceutical Product Tracking System (ITS) of each export. Under the GDP, the export of medicinal products for human use falls under the definition of wholesale distribution. A person exporting medicinal products for human use must have a wholesale distribution authorisation or manufacturing authorisation, and if required, other appropriate regulatory authorisations. These requirements also apply if the exporting wholesale distributor operates from a free zone.

Pharmaceutical trade houses must:

The Agency has authority to inspect pharmaceutical trade houses. Under Article 21 of the Regulation on Pharmaceutical Trade Houses, premises covered by the Regulation are subject to routine audits in the Agency's risk-assessment programmes. Audits can be carried out outside these programmes if the Agency deems this necessary. The Ministry of Trade can also carry out audits of customs warehouses and temporary storage areas under the relevant legislation.

The Agency will grant audited premises a period to remedy the deficiencies identified in an audit, depending on the nature of the deficiencies. If the deficiencies are not remedied within the specified period, the Agency may, depending on the nature of the breach:

Medicinal products can typically only be imported into Turkey by marketing authorisation holders, although there are special cases, for example, importing prescription pharmaceutical products under the named patient programme or compassionate use programme.

The Communiqué on the Import Audit of Certain Substances Audited by the MoH (Communiqué on Import Audit) requires the importer to obtain a control certificate by applying to the MoH (through the Agency) together with certain listed documents and information. The control certificate is then required by the customs authority for customs clearance. The customs declaration and copies of invoices must be submitted to the Agency within 15 days of the completion of the import of medicinal products. Importing raw materials used for manufacturing medicinal products and foods for special medical purposes is subject to a similar process, but the timelines and the required documents differ.

Under the Law on Pharmaceutical and Medical Preparations No 1262 (Pharmaceutical Code), it is mandatory to obtain authorisation from the MoH before importing medicinal products into Turkey. Importing medicinal products from abroad for commercial purposes without an authorisation, or selling these products on purpose, is a smuggling offence under the Pharmaceutical Code, and the provisions of the Anti-Smuggling Law No 5607 (Anti-Smuggling Law) apply.

The specifications of all starting materials used in the production of pharmaceutical products must be designated by the relevant person or company in the application to the MoH for authorisation for the pharmaceutical products to be produced and registered. These cannot be of a quality lower than the specifications set out in the:

The specifications of pharmaceutical products to be imported must meet the specifications of the country of origin as the basis for the licence in the originating country and must be approved by the MoH.

The health authority of the originating country will be asked to provide a document certifying that each pharmaceutical product starting material was produced according to the appropriate specifications. A serial certificate for each series of medicinal products to be imported, issued by the manufacturer and certified by the health authority of the country of origin, must be submitted to the MoH. This certification is carried out in accordance with the Certification Scheme on the Quality of Pharmaceutical Products in International Trade of the applicable health organisation. The certificate must contain the following information:

The MoH can take samples and check the declared quality of all kinds of pharmaceutical product starting materials and medicinal products at the place of production, distribution, sale, and storage. Substances that do not comply with the specifications cannot be used in the production of medicinal products. If production has already been carried out, sale of the resulting pharmaceutical series will be prohibited.

When applying for marketing authorisation for import of a pharmaceutical product, companies must submit:

The Agency must be notified of any suspension or revocation of marketing authorisation or withdrawal or recall of imported medicinal products for human use due to quality, efficacy, or safety reasons.

To import blood products, the importer must submit a document showing the country/countries in which the other products used in each series of plasma pools present in the relevant series are sold, along with their quantities.

The following additional information must be submitted to the MoH when importing traditional herbal medicinal products:

The movements of all imported medicinal products for human use are monitored through the ITS.

The MoH certifies the conformity of the medicinal products imported under the Communiqué on Import Audit in terms of human health and safety with a control certificate. To obtain a control certificate, an application must be made to the MoH together with the documents set out under the Communiqué. The control certificate must be submitted to the relevant customs authority during the registration of the customs declaration.

Parallel imports of medicinal products are not allowed in Turkey. A medicinal product must be manufactured or imported under either a local marketing authorisation or an authorisation from the Agency.

However, free circulation of CE marked medical devices is allowed if the registration obligations are met through registration in the Agency's national database (TITUBB).

Advertising/promoting pharmaceutical products is strictly regulated in Turkey. The legislation regulating advertisements is:

The Agency, as the regulatory body, issues and regularly updates several guidelines for pharmaceutical companies' obligations in their promotional activities, including:

Industry associations in Turkey also have their own rules on promotional practices, including:

Although these rules are not binding legislation, in practice, reputable pharmaceutical companies affiliated with these associations ensure compliance with these rules in addition to the mandatory rules under the legislation.

The Promotion Regulation defines promotion as including:

As the Promotion Regulation does not provide an exhaustive list of all promotional activities, similar activities may also be deemed to be promotion subject to the Promotion Regulation.

The Promotion Regulation forbids the advertising of both over-the-counter and prescription pharmaceutical products to the general public. Marketing authorisation/permit holders can only promote licensed products to health care professionals. There are only a few exceptions to this where information on the relevant pharmaceutical products can be provided to the general public with the MoH's permission and strictly following the procedures and principles set by the MoH, such as for:

Under the Promotion Regulation, marketing authorisation/permit holders must establish a scientific services committee (and designate a responsible person among the members of the committee) responsible for monitoring and ensuring the licence holder's legislative compliance in its promotional activities. The committee must consist of doctors, dentists, or pharmacists.

The scope of the definition of promotion under the Promotion Regulation is comprehensive (see Question 10). While the requirements for different promotional activities vary, as a general principle, marketing authorisation/permit holders must act in compliance with the Promotion Regulation and the Agency's guidelines in all of their promotional activities. The Promotion Regulation requires the Agency's prior approval for certain promotional activities, including publishing a press release of a product supplied to the market for the first time or organising or sponsoring a scientific or promotional meeting. There is also a notification requirement for other promotional activities including:

The Promotion Regulation does not impose any restrictions on comparative advertising as it forbids the advertising of both over-the-counter and prescription pharmaceutical products to the general public.

The Promotion Regulation prohibits the promotion of unlicensed pharmaceutical products, except for:

The Promotion Regulation forbids the advertising of both over-the-counter and prescription pharmaceutical products to the general public. Marketing authorisation/permit holders can only promote licensed products to health care professionals. The Promotion Regulation further states that this restriction covers any direct and indirect promotional activities in or on any type of public media or communication platform (including the internet, shows, movies, television, news programmes, or similar methods).

However, a pharmaceutical product's instructions for use, as approved by the Agency, can be published on licence holder's website. In practice, licence holders only provide summary information on the pharmaceutical product on their website and require users to confirm that they are health care professionals before accessing this.

The Agency, as regulatory body, can audit the promotional activities of the licence holders ex officio or on the complaint of a third party. In an audit, the Agency can order the suspension or termination of a specific promotional activity or amend the information provided through the promotional activity if the information is not accurate.

If the Agency warns the licence holder about a breach and the licence holder breaches the Promotion Regulation again within a one-year period, the licence holder will be suspended from carrying out promotional activities for three months. If the licence holder breaches the Regulation again within a one-year period following a three-month suspension period, it will be suspended from carrying out promotional activities for one year.

The Promotion Regulation also regulates sanctions for medical representatives breaching the Promotion Regulation, which can result in suspension of their authorisation certificate.

In addition, the Pharmaceutical Code allows for the imposition of administrative fines of up to five times the preceding year's total sales value of the relevant pharmaceutical product against a licence holder breaching the rules on promoting pharmaceutical products, and the blocking of websites that include any information or activities contrary to the promotion rules.

The Agency closely monitors promotional activities, and licence holders therefore accord great importance to ensuring compliance with the promotion rules.

The advertising of medicinal products for human use to the public is strictly prohibited in Turkey. The promotional rules do not differ for over-the-counter and prescription-only products. The Promotion Regulation prohibits the advertising of both to the general public.

The legislation only allows pharmaceutical companies to promote their licensed products to health care professionals under the requirements and exceptions set out by the Promotion Regulation.

Providing free samples, special offers, or any kind of inducements to the public is not permitted. The Promotion Regulation prohibits the advertising of both over-the-counter and prescription products to the general public.

Free samples can only be provided to doctors, dentists, and pharmacists where the licence holders comply with the provisions of the Promotion Regulation and guidelines published by the Agency.

The Promotion Regulation sets out general rules for donations to public and non-profit health institutions and organisations. These donations:

The Regulation on Job and Duty Descriptions of Health Care Professionals and Other Professionals in Health Care Services defines health care professionals as doctors, dentists, pharmacists, nurses, midwives, and opticians, and certain other professionals defined in the Law on Medicine.

Health care organisations include all:

The Promotion Regulation only allows pharmaceutical products to be promoted to doctors, dentists, and pharmacists (despite the fact that the scope of health care professional is broader).

Promotional activities include:

These promotional activities are regulated in detail under the Promotion Regulation and communiqués and guidelines published by the Agency. These impose general principles to be followed by licence holders including, among other things, that:

Symposiums or conferences sponsored by licence holders that are attended by health care professionals are restricted and closely monitored by the Agency in relation to details including the amount of sponsorship, place of the symposium or meeting, and type of costs covered. Marketing authorisation holders must notify the Agency of the symposiums or conferences that they sponsor. Restrictions on donations also apply (see below, Gifts and Incentives).

It is prohibited to encourage the prescription, use, and recommendation of pharmaceutical products by offering any benefits or incentives (whether in cash or in kind) to health care professionals. Providing reminder promotional materials is not considered within the scope of this restriction if the value of the promotional material does not exceed 2.5% of the minimum wage per month (approximately TRY161 for 2022)

In addition, Article 29 of the Public Officials Code No 657 and Article 15 of the Regulation on the Principles of Ethical Conduct of Public Officials prohibit public officials from receiving or requesting gifts or any kind of benefit.

Receiving or providing a bribe is an offence under the Turkish Criminal Code. In addition to criminal sanctions imposed on both the briber and recipient of the bribe, special measures may be imposed on a legal entity that benefits from a bribe. These include:

Licence holders must notify the Agency annually of any transfers of value exceeding 10% of the gross monthly minimum wage to health care professionals and health care organisations. Further details of value transfers must be disclosed to the Agency through the Agency's electronic platform within the first six months of the following fiscal year.

All documents and records relating to value transfers must be kept at least for five years.

In addition, licence holders must notify the Agency of the details of the scientific or product promotion meetings they sponsor (for example participants, expenses, and activities) within 30 days of the meeting, in addition to obtaining the Agency's prior permission to conduct the meeting.

Non-compliance with the promotion rules can result in suspension of promotional activities and administrative fines (see Question 16). The Promotion Regulation also provides for disciplinary processes against health care professionals before the relevant health care institution or professional association.

Non-compliance relating to the provision of benefits to health care professionals can be construed as a bribe, which is a criminal offence subject to imprisonment for all participating individuals, and special measures for the licence holder entity, for example, the cancellation of official permits and seizures of financial value.

The Industrial Property Code No 6769 (Industrial Property Code), which abolished Decree Law No 551 on the Protection of Patent Rights (Patent Decree Law), is the primary legislation regulating patents. To be granted a patent, an invention must:

(Article 82, Industrial Property Code.)

Turkey is a party to the following international agreements regarding patents:

The Industrial Property Code only recognises examined patents. For any invention to be granted a patent, it must be examined to ascertain whether it meets the patentability criteria. While unexamined patents were recognised under the abolished Patent Decree Law, they are not included within the scope of the Industrial Property Code. However, the Industrial Property Code enables unexamined patent applications that were made before the abolishment of the Patent Decree Law to be converted into examined patent applications through the legislation that was in force at the time of application (Provisional Article 1, Industrial Property Code).

The following are not covered by patent protection because they are not inventions:

(Article 82, Industrial Property Code.)

Inventions that are against public order or generally accepted moral values cannot be protected by patents, and certain medical and biological processes and discoveries. See below, Specific Provisions for the Life Sciences Industry.

In general, any inventions that meet the patentability criteria can be granted a patent. However, under the Industrial Property Code, the following cannot be subject to a patent:

(Article 82, Industrial Property Code.)

There are no specific provisions under the Industrial Property Code on second medical uses. Although there is as yet no established precedent, as long as a second medical use invention meets the patentability criteria, it can be granted a patent.

Law No 5042 on the Protection of Plant Breeders' Rights of New Variety of Plants regulates topics including the process to issue compulsory licences to plant breeders in cases of public interest and the scope of plant breeders' rights.

The Industrial Property Code changed the name of the Turkish Patent Institute to the Turkish Patent and Trademark Institute (TPTMI). Patent applications must be made to the TPTMI. The TPTMI's website provides information on the fees and regulations for the application procedure in both Turkish and English.

It is also possible to apply to WIPO (under the PCT) or the European Patent Office (EPO) for an international or European patent and then extend the application to cover Turkey as a region under the international treaties to which Turkey is party. This route grants patent protection in Turkey as soon as a patent is granted. This is generally the preferred route for international pharmaceutical patent owners seeking to extend their patent protection into Turkey.

When filing for a patent, the applicant must (among other things) explain the invention, its features, and any pictures referred to under the explanations. The name of the applicant is also included in the application documents. (However, it is also possible to file an anonymous application.)

The key stages of a patent application, which typically take two to six years, are as follows:

Any application filed in Turkey or in a Paris Convention or TRIPS signatory nation benefits from priority for 12 months from the application date.

Patent applications cannot be reviewed by third parties before publication in the Official Patent Bulletin. However, if a third party claims that the applicant will use the patent protection against them and proves this allegation, the patent application can be reviewed by the third party before publication.

Any third party can challenge the patent application by arguing that:

Any challenges filed must also be notified to the applicant. The applicant can submit their reviews and explanations within three months of this notification. The TPTMI then reviews the objections after receiving the explanations of both parties.

If no objection is filed or the objections are resolved, TPTMI finalises its review and announces the patent in its Official Patent Bulletin.

A patent applicant, patent owner, or any related third parties can file an objection against the decisions of the TPTMI within two months of the decision being notified.

Patent protection lasts 20 years from the date of filing the application.

The subject of the patent becomes public property following expiry of the patent protection period (Article 140, Industrial Property Code). Turkish law does not allow for the renewal of a patent. Patent holders must pay annual fees to maintain patent protection, and patent protection lapses if the annual fees are not paid.

Turkish law does not allow for the extension of patent protection, and supplementary protection certificates are not granted or applied in Turkey.

A patent grants the holder rights regardless of the place of invention, its technological field, or whether the products are exported or domestically produced. The rights granted by a patent include:

A patent holder or applicant can file an infringement lawsuit in specialised IP courts in Istanbul, Ankara, and Izmir, and in civil courts in other cities. The claimant can claim the following remedies:

(Article 149, Industrial Property Code.)

The claimant can request compensation for any resulting damages, including reputational damages and loss of income (Article 151, Industrial Property Code). The patent holder can choose the calculation of damages based on one of the following:

Under the Turkish Code of Obligations No 6098 (Turkish Code of Obligations), the prescription period for civil law claims is two years from the infringement being discovered by the rights holder, and ten years following the infringement taking place. The Industrial Property Code has removed criminal law proceedings for patent infringement.

The following acts constitute patent infringement:

(Article 141, Industrial Property Code.)

Research exemption. Use for experiments, including tests and experiments conducted for the licensing of pharmaceutical products does not constitute patent infringement (known as the Turkish Bolar exemption).

IP exhaustion. The doctrine of exhaustion of intellectual property rights applies in Turkey. The general rule is that third persons cannot use, produce, sell, or import a patented invention for commercial purposes or introduce it to trading areas by any other means without the consent of the patent holder. However, if the invention has been introduced to the market with the consent of the patent holder, the doctrine on territorial exhaustion applies, and the patent holder can no longer prevent the re-sale of the invention based on a claim of ownership. For the exhaustion principle to apply, the invention must have been introduced to the Turkish market. Any invention introduced to foreign markets does not result in the exhaustion of the patent holder's rights in Turkey.

Other exemptions. The exemptions listed under the Industrial Property Code are:

Turkey is a party to the following international IP treaties:

Turkey is a party to the following international patent treaties:

Turkey is a party to the following international trade mark treaties:

The Industrial Property Code, which abolished Decree Law No 556 on the Protection of Trade Marks (Trade Mark Decree Law), is the primary legislation regulating trade marks. The following can be registered as a trade mark, provided that they are distinctive:

(Article 4, Industrial Property Code.)

The following cannot be registered as a trade mark:

(Article 5, Industrial Property Code.)

Medicinal brands can be registered as trade marks in Turkey. However, international non-proprietary names (INN) cannot be registered as trade marks since they are not distinctive and are not capable of being accepted as an original trade mark. It is also not possible to register phrases that are similar to INNs.

Pharmaceutical product brand names are controlled by the TPTMI during the trade mark registration process and by the Agency during the marketing authorisation process.

Trade mark applications must be made to the TPTMI. TPTMI's website provides information on the fees and regulations regarding the application procedure in both Turkish and English.

It is also possible to apply to WIPO or the European Union Intellectual Property Office for an international or EU trade mark choosing Turkey as a designated country, which extends the application to Turkey under the international treaties to which Turkey is a party.

The MoH is normally not involved in trade mark review before the TPTMI, as it usually reviews licensing applications filed under the Regulation on the Licensing of Medicinal Products for Human Use (Licensing Regulation). Therefore, even if the trade mark is registered before the TPTMI, the MoH may decide that the name is not appropriate for licensing.

The key stages of a trade mark application, which takes 10 to 12 months (if no opposition is filed), are as follows:

Any application filed in Turkey or one of the contracting states of the Paris Convention and TRIPS benefits from priority for six months after the application date. To benefit from this priority, the applicant must either be a citizen or resident, or have a commercial enterprise in one of the Paris Convention or TRIPS contracting states.

The primary piece of legislation governing anti-competitive practices and the competition law rules protecting effective competition in all Turkish markets, including the pharmaceutical the sector, is Law No 4054 on the Protection of Competition (Competition Act). The Competition Act provides a general framework modelled after the relevant principles under the European competition law regime, while secondary legislation, including communiqués, regulations, directives, and the Competition Authority's guidelines, significantly shapes competition law enforcement trends. The following block exemption communiqués also apply:

According to the Competition Authority's Report on the Pharmaceutical Sector, the pharmaceutical sector was one of the primary sectors subject to competition law in Turkey, and merger control reviews and competition law infringements in this sector are major aspects of the Competition Board's workload. In 2021, in relation to the pharmaceutical sector (including pharmaceutical products, hospitals and health equipment, and materials), the Competition Board rendered:

In addition, further to judicial orders, the Competition Board reviewed its own decisions and changed its position in three cases, which is the highest number of decisions altered after judicial review of any sector. This trend was maintained in the first half of 2022, as the Competition Board issued three infringement decisions along with two exemption/negative clearance decisions and 12 merger control rulings relating to the sector.

The Competition Authority is the main regulatory body responsible for public enforcement of the Competition Act. The Competition Board is the Competition Authority's decision-making body. Its final decisions are subject to judicial review before administrative courts and the Council of State, which is the highest court for appeals against the administrative courts' decisions. Although there is not a specialised court or an appellate body established and trained specifically for competition law-related matters, there are certain chambers that are regularly assigned cases brought against the Competition Board's decisions. However, cases before the administrative courts and the Council of State are not subject to sectoral allocation.

Arbitration is not yet accepted as an alternative dispute resolution mechanism for competition law-related cases in Turkey, and private enforcement of competition law rules must take place before the civil courts in anti-competition damages actions under the general civil procedure rules.

According to the Competition Authority's Report on the Pharmaceutical Sector, no competition issues are typically associated with the generic entry of pharmaceutical products onto the market. However, in theory, an abuse of dominant position could occur if the undertaking with rights over the original pharmaceutical product decides to prevent a generic brand from entering the market.

Even if patent litigation is initiated by the original product owner against generic manufacturers in Turkey, the Turkish Bolar exemption (see Question 27, Defences to a Patent Infringement Action) prevents these actions being made against generic product applicants for marketing authorisations that are in the application phase. Therefore, there are no specific barriers against generic entry.

Although the Competition Act prohibits abuse of a dominant position, it does not set out a certain percentage of market share as a benchmark for a dominant position. The Guidelines on the Exclusionary Conducts by Dominant Undertakings state that it is very unlikely for entities with a market share of less than 40% to be considered to have a dominant position in the market. However, the Competition Board has issued a number of decisions where it has held that an entity with a market share of less than 40% had a dominant position. In these decisions, it took the market structure, entry barriers, number of players, specialities, and dynamics of those markets into consideration.

Article 6 of the Competition Act non-exhaustively lists examples of market abuse as including:

Each year, a number of complaints are filed against pharmaceutical companies (mostly by pharmaceutical trade houses) for abuse of dominance allegations. The complaints mostly derive from a pharmaceutical company either refusing to provide pharmaceutical products or seeking to impose certain commercial terms (for example, export restrictions) on trade houses. Only some of those complaints have been accepted by the Competition Board. For example, the Competition Board decided that Sanofi Aventis decreasing its payment terms from 60 to 180 days down to 15 days was a clear abuse of its dominant position. Sanofi Aventis was ordered to pay an administrative fine of TRY3,648,045 (Decision 09-16/374-88, 20 April 2009).

Some entities with an important role in the pharmaceutical sector have also been scrutinised by the Competition Board for market abuse. For example, in 2019, the Competition Board held that the exclusivity provision included in an agreement by the Turkish Pharmacists' Association (the association authorised to supply pharmaceutical products from foreign countries) constituted an abuse of dominance. The Competition Board imposed an administrative fine of TRY18,062,307.32 on the Turkish Pharmacists' Association (Decision 16-42/699-313).

The Competition Act does not specifically regulate parallel imports. However, Article 4 of the Competition Act prohibits an entity from implementing boycotts or other activities to exclude opponents from the market or to prevent additional entries to the market. Similarly, abuse of a dominant position is prohibited by Article 6 of the Competition Act.

Several structures or provisions included in pharmaceutical companies' commercial agreements may appear to restrict competition and therefore violate Article 4 of the Competition Act. The most common examples of these restrictions are:

However, depending on the nature of the restriction, these restrictions may either benefit from block exemptions (for example, the Vertical Block Exemption) or be granted an individual exemption by the Competition Board on application by the relevant parties.

To benefit from the Vertical Block Exemption, the following criteria must be met:

If one of the criteria is not met, the restriction automatically falls under Article 4 of the Competition Act. However, the parties can still argue that economic efficiencies and benefits to consumers outweigh the potential hindrance to effective competition by:

Depending on the nature of the commercial arrangement, other block exemption communiqués for agreements (for example, technology transfer agreements, research and development agreements, or specialisation agreements) may be applicable. Each communiqué sets its own application criteria.

For the past two years, the Competition Board's position on selective distribution systems has become the most contentious topic in relation to competition law enforcement in the pharmaceutical sector.

Patent or trade mark licences or the payment of royalty fees do not have to be approved or accepted by a regulatory body. These agreements become enforceable when put into force between the parties. However, patent or trade mark licences can be registered with the TPTMI, regardless of whether the parties are foreign, if the parties wish to make their licence enforceable against third parties.

There is an exception for secretive patents that are related to inventions that are considered important for reasons of national security. In these cases, the patent application process can be conducted in confidence (Article 124, Industrial Property Code). In case of doubt, the TPTMI must notify the Ministry of Defence about the application. If the Ministry of Defence also believes that the subject matter of the patent is important for national security, not only will the patent application process be confidential, but the owner of the patent can use the inventions only to the extent allowed by the Ministry of Defence (therefore, the use of the patent, including transfer, may be limited). The patent owner can request compensation from the government for not using the patent.

The Code on Product Safety and Technical Regulations No 7223 (Products Code) sets out the general framework for the market monitoring and auditing of products put on the market in Turkey, and is the main legislation regarding product safety. These issues are further regulated in detail by the Regulation on General Product Safety.

The general provisions of the Turkish Code of Obligations and the Consumer Protection Law No 6502 (Consumer Law) also apply to medicinal product safety and liability issues.

The Regulation on the Safety of Pharmaceutical Products is one of the main pieces of legislation regulating the safety of pharmaceutical products. This sets out, among other things, the obligation to observe adverse effects and to notify adverse effects to the Turkish Pharmacovigilance Centre (TUFAM).

Under the Recall Regulation, the Agency is the key regulator in the recall of medicinal products. If the Agency detects a defective medicinal product on the market, it has the power to:

(Article 5, Recall Regulation.)

The Agency can impose penalties for non-compliance.

The contractual relationships in a pharmaceutical product supply chain are typically between:

Therefore, a consumer may not have a direct contractual claim against the manufacturer of the pharmaceutical product, which may prevent them claiming damages through a claim for breach of contract.

A person who has caused damage to another person through a fault-based or unlawful act must pay compensation for the damage (Article 49, Turkish Code of Obligations). To claim damages through a tort suit, the following elements must be established:

It is possible for a consumer to file a tort claim against the manufacturer of the pharmaceutical product. However:

Pharmaceutical product liability claims are complex for consumer courts to deal with, since they generally deal with simpler claims.

The decisions rendered by the civil courts and consumer courts (both based on contractual and tort liability) are open to the public. However, the parties may also settle out of court, during mediation, or through other adversarial or amicable dispute resolution methods that are confidential. If parties settle out of court, the result can remain confidential and there is no disclosure requirement for this specific type of settlement.

Under the Regulation on the Liability for Damages Caused by Defective Products (Regulation on Defective Products), a manufacturer/importer of a defective product is liable for death, injury, or property damage caused by a defective product.

A manufacturer and market authorisation holder that produces or imports a defective pharmaceutical product is liable in tort under the Turkish Code of Obligations and under the relevant legislation on product liability.

However, in practice, doctors are most often pursued for complications caused by defective medicinal products through malpractice lawsuits. This is mainly because doctors are the first point of contact for patients, and patients are not usually able to distinguish malpractice claims from product liability claims. To mitigate the risk, health professionals and pharmaceutical companies usually take out professional liability insurance. The normal procedure for malpractice claims against medical practitioners provides both a defence for medical practitioners and an obstacle to claimants. It is common for courts hearing malpractice lawsuits to appoint the Forensic Medicine Institute (Adli Tıp Kurumu) as an expert witness. Due to its workload, it takes around two years for the Forensic Medicine Institute to submit its expert opinion report to the court. It is also common for the Board of the Forensic Medicine Institute, which is composed of doctors, to conclude its expert opinion report in favour of the defendant doctor. These issues are subject to heavy criticism.

The proper user instructions and warning information contained in medicinal product package inserts will provide specific defences to medicinal product liability claims, including defences such as abnormal use/misuse, assumption of risk, and intended user. There are also standard defences that can be invoked against any type of claim. For example, the defendant may request that the court dismiss a tort or product liability claim on the grounds that the elements required for bringing such a claim are not present. The defendant may also claim that the statute of limitations has expired, which would also result in dismissal of the case (see Question 39, Limitation Periods).

In addition, under the Regulation on Defective Products, product liability can be challenged on certain technical grounds. For instance, the manufacturer can defend itself against any potential claims by asserting that the:

For compensation claims arising under the Products Code, a three-year limitation period applies from the date the claimant becomes aware of the damage and identity of the person liable for the damage. The prescription period for tort claims is just two years. Claims become time-barred after ten years.

Class actions are not generally allowed under Turkish law. However, associations and other legal entities can bring lawsuits to protect their members' interests (Article 113, Civil Procedure Code No 6100). Therefore, it is possible for consumer associations to file class actions on behalf of their members for product liability claims.

Under the Turkish Code of Obligations, consumers can claim one of the following remedies from the seller in the event of a contractual breach:

In tort law, the consumer can claim reimbursement for both material and immaterial damages. The court will determine the damages incurred by the consumer and rule on the amount sufficient to reimburse the damages.

Punitive or exemplary damages are not allowed in Turkey.