The Pharma Legal Handbook: Turkey
The Pharma Legal Handbook: Turkey answers essential questions about the legal and regulatory environment for pharmaceuticals in Turkey. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Moroğlu Arseven, a leading Turkish law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
November 2018
1. Turkey: A Question of Timing: Negative Declaratory Relief in Pharmaceutical IP Practice
Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of similar Court of Appeal decisions.
For pharmaceuticals in particular, negative declaratory relief is considered as an effective market-clearing tool. Anyone with an interest in a pharmaceutical product sufficient to confer standing, may petition a competent court for a declaratory ruling that current and future use of the product is, or, as the case may be, is not, infringement. These actions are initiated both by pharmaceutical and non-pharmaceutical entities as a means of avoiding prospective infringement actions and, concomitantly, of securing rights before entering a market.
As illustrated by the Case, timing of the petition is crucial. This is particularly so for pharmaceuticals both in light of the process for bringing a drug, particularly a competing generic, to market; and of Article 85/3-c of the Turkish Industrial Property Law numbered 6769, referred to colloquially as the Bolar exemption, which provides a safe harbor for non-rights holders to use patented pharmaceuticals for clinical trials without infringing on the patent owner’s rights.
The Bolar exemption is interpreted and applied without uniformity by Turkey’s intellectual and industrial property courts. Accordingly, pharmaceutical companies and IP lawyers have lacked the clarity of a unifying pronouncement of the limits of the Bolar exemption. However, the Court of Appeal has consistently held that an unlicensed pharmaceutical is not subject to IP enforcement.
Under Turkey’s Code of Civil Procedure numbered 6100, standing to file an action requires a sufficient legal interest. Where standing is lacking courts must, ex-officio or upon motion, dismiss the case. In the Case, negative declaratory relief was sought against our client’s registered patent rights. We argued that dismissal was required under the Bolar exemption because the product in question was not licensed and, therefore, the plaintiff lacked standing, and, because the product license dossier might change during the licensing process, it would be impossible, prior to licensing, for the court to rule on the merits of the claim.
The court ruled in favour of the patent holder and dismissed the case. It is reasonable, then, in light of the outcome of the Case, to consider the question of timing settled in accord with the Court of Appeal.
The Case confirms the settled practice of the Court of Appeal and according to the settled practice, in case of negative declaratory actions, timing is important, as the actions might be refused due to lack of legal interest. Considering this settled approach, it is advisable to file a negative declaratory action close to the anticipated time of the pharmaceutical license approval to avoid dismissal of the case.
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2. Turkey: The Impact Of Brexit On CE Certificates Issued By UK Notified Bodies
The shockwaves from the UK’s exit from the European Union have resounded across the continent, including in Turkey, where the country’s pharmaceutical and medical devices regulator has had to adjust its guidance on CE-mark certified devices. Leading lawyers from top Turkish law firm and PharmaBoardroom legal partner Moroğlu Arseven explain the current situation.
CE Certificate Requirement in Turkey
The Regulation on CE Marking, published in the Official Gazette on, and effective as of, 23 February 2012 (the “Regulation”) governs the use of the CE Mark in Turkey. Medical devices covered by the Regulation must bear the CE mark to legally enter the Turkish market. Within Turkey, the CE Mark is symbolic of CE certification by a notified body authorized to conduct product conformity assessments.[1] In addition, the Customs Union Agreement between Turkey and the European Union (the “EU”), to bear a CE Mark a medical device must be CE certified by a notified body within Turkey or the EU.
TMMDA’s Response to Brexit
Upon Brexit, the United Kingdom (the “UK”) has dropped out of the EU, its notified bodies have dissolved, and CE certificates issued by them have been invalidated. Accordingly, medical devices marketed in Turkey and bearing a CE Mark pursuant to a CE certificate issued by a former UK notified body, have been decertified.
The Turkish Medicines and Medical Devices Agency (the “TMMDA”) addressed certain Brexit related CE certification matters in published announcements about a post-Brexit transition period (the “Transition Period”); within which affected devices marketed in Turkey with CE certification from a former UK notified body can become compliant.
To take advantage of the Transition Period, a medical device manufacturer, or its local representative or distributor had to, in a timely manner, file with the TMMDA a confirmation letter from the associated notified body stating that the assessment is in process; and, thereupon, the TMMDA would grant an automatic 120 day extension of CE certification during which a new CE certificate for the device had to be uploaded to the TMMDA’s online registration system.
The TMMDA has sought to minimize the impact of Brexit both on domestic consumers and global producers of medical devices marketed in Turkey.
Implementation of Post Brexit Plan
The Transition Period concluded on 31.12.2020. On 01.01.2021, all CE certifications obtained from former UK notified bodies were invalidated.
The TMMDA announced the following new post-Brexit rules for devices CE certified by a former UK notified body:
- The expiration of all CE certificates issued by former UK notified bodies, even if facially valid beyond 31.12.2020, are accelerated, and all such certifications are deemed expired as of 31.12.2020. No extension is available.
- CE certificates issued by a former UK notified body and facially valid beyond 31.12.2020, and with respect to which the 120 day extension period granted by the TMMDA has lapsed, are deemed expired as of 31.12.2020. No extension is available.
- CE certificates issued by former UK notified bodies which expired naturally on or before 31.12.2020 are deemed expired. No extension is available.
Conclusion
The global ramifications of Brexit cannot be underestimated. We have had several opportunities to communicate both with TMMDA and the TR Ministry of Health about their position on post-Brexit CE certification. Both insist on maintaining Turkey’s formal CE certification process. Nevertheless, both remain open to considering exceptional cases, substantiated by official documentation from authorized national or international authorities, where a necessary medical device not yet CE certified may require an exemption from certain regulatory requirements due, in whole or in part, to issues arising from the COVID-19 pandemic, or for other reasons deemed, in its discretion, satisfactory by the TMMDA.
[1] A notified body is an organization accredited by at least one EU Member State to conduct conformity assessments under relevant EU Directives, and based thereupon, issue CE certificates. After certification, a manufacturer may legally affix a CE Mark to the certified product.
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3. Compulsory Licensing & Public Health during the COVID-19 Pandemic in Turkey
The COVID-19 pandemic continues to spread rapidly across the globe amid critical supply shortages of medical devices and medicines. The rapid spread of the virus, on the one hand, threatens supply chains and causes shortages, on the other hand, it also strengthens global solidarity.
Brands from different sectors make an effort towards helping in the fight against the pandemic. Fashion brands are manufacturing masks, luxury cosmetic brands are supporting disinfectant manufactures, the entrepreneur ecosystem swept into seeking alternative ways to support healthcare heroes who are facing the growing shortage of personal protective gear. News keeps coming from the technology industry, 3D printing of protective gears ramps up, people even have started using their personal printers for such purpose. Furthermore, pharmaceutical companies across the world are diligently working to develop vaccines and antivirals.
Not surprisingly, all these developments raise questions about compulsory licensing. Intellectual property rights, patents primarily, are protected to support and secure future inventions and developments. Because the main purpose is to support the actors who have contributed to the field to ensure continuous and stable development. Disclosing the invention to the public and making it available for others are also required for that purpose. In this sense, there is always a delicate balance between those who should use existing inventions and the inventors who need support for future inventions. In some exceptional cases, compulsory licensing mechanism comes along with patent protection, to maintain this balance.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is one of the main sources of the World Trade Organization (“WTO”) members regarding legislative purposes of intellectual property rights. TRIPS covers the patent protection and exceptional limitations to be imposed. Accordingly, WTO members, including Turkey, are expected to implement those into their law systems.
In Turkey, IP Law protects inventors by enabling them to patent their inventions and exercise their rights. Basically, the patent is an exclusionary right that permits the patent right holder to prevent others from making, using or selling the patented invention for a limited period. This exclusionary right is subject to exemptions, as well. Compulsory licensing mechanisms are one of the exemptions.
The exclusionary status of patent rights makes the compulsory licensing mechanisms very rare and exceptional. Since the very beginning of the patent protection in Turkey, there has been only one case for compulsory license requests which had been concluded with a settlement without a court decision.
Even though, the compulsory license may not be required as we are all together in this fight against the outbreak, the current trend on the rapid raises of the shortages indicates that this mechanism might be triggered soon.
COMPULSORY LICENCE PROCEEDINGS IN TURKEY
The IP Law sets certain conditions for granting Compulsory Licence (“CL”) in Turkish practice and regulates the following CL request/grant proceedings respectively:
- In case of non-use arguments: – The courts are entitled to handle these requests.
- In case of interdependency of the subjects of the patents – The courts are entitled to handle these requests.
- In cases where plant breeders cannot develop a new type of plant without infringing on a preceding patent.
- In cases where patent holders engage in activities that prevent, distort or restrict competition while using the patent. – Turkish Competition Authority is entitled to handle these requests.
- To meet requirements of the Doha Declaration (The export of pharmaceutical products to foreign countries experiencing public health problems.) – The courts are entitled to handle these requests.
- In the interest of public order – Turkey’s Ministry of Health and the Ministry of National Defence are entitled to request these CLs and the President decides on the granting.
THE CL PROCEEDINGS IN THE INTEREST OF PUBLIC ORDER
The IP Law regulates that where public health or national security is at stake, at the request of the Ministry of Health and the Ministry of National Defence, the President of Turkish Republic is entitled to grant a compulsory license.
In accordance with their exclusionary nature, such rights are protected with patents and aimed to be protected as strong as possible. Due to this nature, compulsory licensing is exceptional for them.
However, at some point, this protection might upset the market balance. The non-use status of the patent or the activities of the patent holder which are not compatible with competition rules is relatively common ways of compulsory license granting mechanisms. On the other hand, the licenses granted by the President of the Turkish Republic are rarely seen in this exceptional situation. The granting mechanism – the procedural steps that need to be followed are relatively straightforward in comparison with the other compulsory license types. This is not surprising given that this license type can only be granted in cases of a national emergency and/or extreme urgency regarding public health or national security.
EXPORT/IMPORT STATUS OF THE PHARMACEUTICALS PRODUCED UNDER A COMPULSORY LICENCE:
Today, we are experiencing a global outbreak, COVID-19 is a true example of “extreme urgency”. Therefore, it comes as no surprise in case this mechanism is triggered in Turkey in case of need.
The compulsory license mechanism brings the questions on whether licensee will be entitled to the export and import of the pharmaceuticals that are produced under a compulsory license.
In principle, the nature of the CL does not allow the licensee the right of the exportation/importation. It is only granted for producing the generics “predominantly for the supply of the domestic market”, not for export purposes. Also, the product must be produced in the market, not be imported This principle leads to two primary consequences:
- Limiting the exportation amount when the pharmaceuticals are manufactured under the CL.,
- Effecting the countries with insufficient manufacturing capacity. These countries will face difficulties when supplying their needs.
The first exception to this principle is CL proceedings for the exportation of the pharmaceutical goods manufactured under the CL. Levels of the spread of the virus and severity vary from country to country, and each has its own weaknesses and strengths. On the other hand, each country has different level of manufacturing facilities, capacities, technologies or stocks on chemicals or active ingredients. Therefore, a country in the near future might be in need of pharmaceuticals products which it is not capable of manufacturing it. In such a case, the exportation of the products from a country where the products are being manufactured will be possible under the compulsory license.
With Doha Declaration and relevant amendments, Turkey has agreed to import the pharmaceutical products manufactured under CL only in a national emergency or other circumstances of extreme urgency, which forms the second exception. Considering the extreme urgency of maintaining fast and uninterrupted access to these vital pharmaceutical products, in case a need arises while granting such compulsory license, the Presidency can grant the right of importation to the licensee. This authority must be limited to the need and must be granted temporarily.
In Turkey the applicable law provides the basis to act either as exporters or as importers, or as both. Regarding the COVID-19 outbreak, it is very gripping to follow the developments to see whether CL proceedings is going to be applied ever.
REFERENCES
- https://www.wto.org/english/news_e/pres03_e/pr350_e.htm
- https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm
- https://www.wto.org/english/thewto_e/glossary_e/paragraph6_e.htm
- https://www.wto.org/english/res_e/reser_e/ersd201507_e.htm
- https://www.wto.org/english/news_e/pres03_e/pr350_e.htm
- https://www.resmigazete.gov.tr/eskiler/2014/03/20140315-4-1.pdf
- https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm
This article was originally published on April 20th 2020 here
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4. Biosimilars & Biologics: Turkey
The low-down on the situation regarding biosimilars & biologics in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.
1. Are biosimilar medicines considered the same as generic medicines in your country?
Generic medicines include identical molecules with the original reference product, and these molecules are small and chemically stable molecules produced through chemical synthesis. However, biosimilar is the name of medicine, which is similar (not identical) with the reference licensed biological medicine.
The active ingredient of a biosimilar is only the similar of the reference medicine. Generics are different than biosimilars because they are considered equivalents and includes the same active ingredient. Biosimilar and reference biological medicines are used to treat the same illness with the same effect.
Since every biologic has a unique manufacturing process, it is impossible to produce the perfect identical of a biologic. A biosimilar’s active ingredient should be highly similar to the active ingredient of the reference biological medicine in terms of molecules and biology. The active ingredients of the biologic and biosimilars are basically similar, yet they have different cell lines and a different manufacturing process.
As generics are chemical-based, and the active ingredients of the original and the generic is the same, they are only different in terms of packaging and trademarks.
2. Are all biologic medicines, including biosimilar medicines patentable in your country?
The patents are regulated under the Industrial Property Rights Law numbered 6769 (“IP Law”).
According to the IP Law, in order to be patentable, an invention must be novel, include an inventive step and be industrially applicable.
According to the Intellectual Property Law, the following are considered non-inventions:
- scientific discoveries and theories;
- mathematical methods;
- schemes, methods and rules for performing mental acts, playing games and doing business;
- computer programs;
- literary, scientific and aesthetic works or creations; and
- presentations of information.
Further, under the Intellectual Property Law, the following inventions are considered non-patentable:
- inventions that are contrary to public order or morality;
- inventions concerning plant or animal varieties or essentially biological processes for the production of plants or animals, excluding the microbiological processes or the products thereof;
- diagnostic methods that are practiced on humans or animals and all such treatment methods, including surgical methods;
- the human body at various stages of its formation and development and the discovery of one of its elements, including the sequence or partial sequence of a gene; and
- the use of human embryos for industrial or commercial purposes, including processes for:
o cloning human beings;
o modifying the germline or genetic identity of human beings; and
o modifying the genetic identity of animals in ways that are likely to cause them suffering without any substantial medical benefit to humans or animals.
However, the IP Law notably lacks an explicit definition of ‘biotechnological inventions’, as outlined by Article 52 of the European Patent Convention (“EPC”) and Rules 27 and 29 of the Implementing Regulations. As a result, each patent is evaluated individually, and as long as they meet the general criterion of novelty, an inventive step and are applicable to the industry, such inventions may also be patented.
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
In general, the identification of biologics is considered harder than the identification of the chemical derivatives. Three-dimensional structure, the amount of acid-base variations or glycosylation profiles may change drastically due to “minor” changes in the production process. Therefore, for biosimilar products, the approach for the generics are not suitable, and thus further comparability studies for quality, safety and efficiency is required.
TMMDA under MoH has published the “Guideline on Biosimilar Medicinal Products” (“Guideline”) in 2009. There are several issues set forth in the Guideline specifically addressing the marketing authorization process for biosimilars.
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
In general, there are several data, which is required for all types of pharmaceuticals, for their application for marketing authorization. For biosimilars, the Guideline underlines that the following should be met:
- All requirements for quality, efficiency and safety related data for all types of pharmaceuticals should be met including criteria in the monographs of European Pharmacopoeia, in updated guidelines of Committee for Human Medicinal Products and International Committee for Harmonization
- The pharmaceutical form, power and application form of the biosimilar should be the same with the referenced biologic. In this case, additional data should be submitted in terms of comparative studies.
- Any difference between the biosimilar and the referenced biologic should be evaluated through suitable studies for each case.
- Due to different varieties of biologics, additional data required should be determined considering the special features of the specific biologic. If the referenced biologic addresses more than one indication, the efficiency and safety of the biosimilar should be proven for each indication.
In this context, the following are generally required:
- For quality
o Detailed comparison of the features of the products - For Pre-clinical Phase:
o Depending on the complexity of the molecule, sub chronic toxicity test,
o Local tolerance testing,
o Pharmacokinetics and pharmacodynamics studies - For Clinical Phase:
o Phase 1 pharmacokinetics and pharmacodynamics studies
o Phase 3 studies for each indication
o Risk Management Plans
5. What are the requirements for the choice of the reference comparator product?
The choice of the reference comparator product should be a licensed pharmaceutical, whose application has been made to the relevant authority in another country including all data for administrative, quality and clinical data.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
Yes. See Question 5 above.
Biosimilars themselves cannot be referenced. Moreover, the reference biologic should get licensed with a full file. The tradename, pharmaceutical form, formulation, production date, and expiry date of the referenced pharmaceutical that shall be used for the comparative study, should be clearly indicated.
The reference standards in the pharmacopoeia, cannot be cited as referenced pharmaceutical. If the referenced pharmaceutical has different strengths, the same strengths should also be chosen for the comparison of the subject biosimilar.
7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?
In Turkey, the pricing of biosimilars is regulated under the Communiqué on Pricing of Pharmaceutical Products for Human Use (“Communiqué”). According to Article 9/g of the Communiqué, biosimilars’ prices are determined as 100% of its reference price (Reference price means the sale prices to warehouseman. This price is the lowest price of the reference product). If this is not available, the price of a biosimilar is the 100% of the reference price of the referenced original biologic. If the biosimilar of a biologic enters to the market, the reference price of the reference original biologic does not change.
8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?
According to the Communiqué on Health Practices published by the SSI, the financing of treatments and health services which are reimbursed by the SSI is determined under the lists annexed to the Communiqué on SSI’s Health Application. Within these lists, the SSI should evaluate the diagnostics and treatment and confirm that it’s appropriate due to the Communiqué on SSI’s Health Application.
Accordingly, the Commission shall determine the reimbursement to be made by the SSI. There are not specific regulations on the reimbursement of biosimilars, however, there are several biosimilar currently being reimbursed in Turkey.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
As explained in Question 7, the reference price of the referenced biologic does not change as a biosimilar enters into the market. Because every biologic product, including the biosimilar is deemed to be a separate product. Neither the reimbursement policy changes with the biosimilar’s market entry. However, considering new market conditions and new competition caused by the launch of the biosimilar and high prices of the biologics, we observe that a voluntary discount can be applied to biologics by the marketing authorization holder to maintain the reimbursement status.
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
There is not any specific regulation in Turkey for prescribing or dispensing biosimilars. Thus, there are not any differences between biologics and biosimilar in this context.
In general, according to the Regulation on the Classification of Human Medicinal Products, pharmaceuticals are classified only as prescription and nonprescription pharmaceuticals. Both prescription and nonprescription pharmaceuticals are allowed be sold at pharmacies and pharma-organizations only (such as pharmaceutical warehouses) (Article 1, Law on Pharmaceuticals and Medical Preparations). The Turkish legislation prohibits the sale of pharmaceuticals via the Internet or any other electronic medium (Article 24, Law on Pharmacists and Pharmacies).
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
No, there are not any regulation on the interchangeability of the biosimilars with biologics. In general, physicians have discretion to prescribe the biologic or biosimilar versions, where applicable.
The Turkish Law does not regulate interchangeability specifically, the subject is only examined with respect to reimbursement policies. Meaning that pharmacists are entitled to offer patients to switch from a biologic and dispense the biosimilar versions.
In the light of this fact, the reference biologic manufacturer needs to preserve its spot in the reimbursement mechanism and maintain its market share, therefore in order to stay as reimbursed, the referenced biologic companies voluntarily offer further discount around 20%. It is important to underline that such discount does not derive from legal obligations and such decision is only based on marketing strategies. The companies may not choose to offer such discount considering its profitability.
12. What are the post-authorization requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
No, there are not any specific regulations for biosimilars. However, as stated in the Guideline, Risk Management Plans shall be submitted to the MoH. Moreover, as it is the same for all pharmaceuticals, post-approval safety studies should be conducted, all measures be taken to minimize the risks and the regular risk-benefit reports be prepared.
13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?
There are not any specific requirements for labelling biosimilar products in the event of second medical use patents.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
As the patent protection for many biologics expires in 2019 and 2020 in Turkey, there are many preparations in the market to launch upon the expiry date, including the support of the government. Therefore, we expect many lawsuits and other developments in the sector with the launch of new biosimilars.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
A draft Guideline on Biosimilar Medical Products was released on 30 May 2017 by the TMMDA. However, there is no indication as to the possible date of entry into force of the draft.
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5. Localization: Turkey
The ins and outs of localization in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
Localization is a developing and ongoing plan in Turkey. Increasing employment, attracting foreign investment, and maintaining the quality reached in the Turkish pharmaceutical industry encouraged localization in our Turkey. Thus, localization was first announced/proposed in the Action Plan of the 64th Government for the Year 2016 (“Action Plan”). In the meantime, follow-up announcements were also made within this framework by both the Turkish Medicines and Medical Devices Agency (“TMMDA”) and Social Security Institution (“SSI”) on their official websites.
Action 46 of the Action Plan is to enhance the medical equipment and the process of reimbursement, pricing, authorization of strategical and domestic drugs. It has been stated in the Action Plan that “The imported drugs, which will be removed from the list of reimbursement, will be determined, provided that the required security for providing a proper treatment is ensured.” In this regard, the number of sales of the products, which have an import license with more than one generic, has been reviewed as per this Action Plan.
In addition, TMMDA’s announcement mentions that, in light of the negotiations and discussions with the relevant association, union and firms, a time plan is prepared regarding localization of the products, whose rate in manufacturing is more than 50%, as a first step, in order to prevent any supply problem in the market. The announcement is available in Turkish on TMMDA’s website at https://www.titck.gov.tr/duyuru/2521.
Furthermore, within the scope of the localization, a new Commission on Transferring from Import to Produced has been established with the participation of the representatives of the TMMDA, SSI, Turkish Ministry of Development, Ministry of Finance, Ministry of Economy, Undersecreteriat of the Treasury. In this regard, all process in relation thereto will be followed by this commission accordingly.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
N/A
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
According to the announcement made by TMMDA and the time plan referred to above, it was planned to commence with the process of localization of the equivalent groups determined as of 4 April 2016. In this regard, it has been also stated in the abovementioned announcement that relevant firms shall provide their undertaking for the domestic production to the Directorate of Drug Licensing of the TMMDA as of 22 March 2016. If such firms cannot or did not provide the undertaking regarding localization for the products, then the reasoning in relation thereto shall be provided as of 22 March 2016.
In addition, it has been stated in the Action Plan that the drugs, which are applied to be produced in Turkey, will be licensed expeditiously by the MoH.
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
The Action Plan states that the reimbursement policies of the drugs, which are applied to be produced in Turkey, will be considered and reviewed. The SSI shall accelerate the evaluation process in order to add the medical products produced in Turkey to the list of reimbursement and by making required regulations in the legislation. The imported drugs, which will be removed from the list of reimbursement, will also be determined, provided that the required security for providing a proper treatment is ensured.
In this regard, TMMDA’s announcement has mentioned that the Action Plan in relation thereto does not aim to remove the imported products from the list of reimbursement but aims to promote/encourage the domestic production within predictable time.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?
N/A
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
N/A
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
N/A