Orphan Drugs & Rare Diseases
Keen to learn more about orphan drugs & rare diseases in Turkey? Read on! 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 USD 99.
1. What is the definition of Rare Diseases in your country?
There is no definition of rare diseases in Turkey.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
There was a provision regarding the orphan drugs in the Turkish Ministry of Health’s (“MoH”) Communiqué on Pricing of Pharmaceutical Products published on 11.12.2015. In this communiqué, the orphan drugs are defined based on a quantitative criterion, as “pharmaceuticals used for diseases with an incidence of less than 1/100.000 people in a country, and which are precisely defined”.
However, this communique is no longer in force and was replaced by the Communiqué on Pricing of Human Medicinal Product (“Communiqué”), which was published on the 29.09.2017 in the Official Gazette, and the definition of orphan drugs is not regulated under the Communiqué. In other words, there is no official definition of orphan drugs in Turkey.
3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
Although orphan drugs are regulated in many countries at a national level and by European Commission with specific regulations, there is no specific independent regulation in Turkey for orphan drugs in terms of marketing authorizations, promotion activities, incentives or otherwise. Consequently, obtaining marketing authorization for orphan drugs requires the same procedure as regular drugs.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
5. Is there an expedited pathway for Orphan Drugs?
According to Article 4.3 of the Social Security Institution’s (“SSI”) Health Implementation Communiqué published on 24.03.2015 in the Official Gazette, the drugs, which cannot be obtained in the national market and are required for the people who benefit from the medical care of the SSI, can be obtained from abroad, only if the MoH gives permission for the drug supply by approving the fact that such drugs do not exist in the national market and must be taken by relevant patients. In line with this purpose, a protocol between Turkish Pharmacists Organization (“TEB”) and the SSI was executed on 01.04.2016 and is still in force. Therefore, the orphan drugs may also be obtained through this process.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
In principle, selling pharmaceutical products in Turkey is possible only with a marketing authorization. However, it is possible to sell orphan products to Turkish patients through TEB when requested by the patient having the necessary prescription as explained under Question 5. Otherwise, those who sell pharmaceutical products in Turkey without marketing authorization will have penal, administrative and civil liabilities.
The penal liability for selling pharmaceutical products without a marketing authorization (out of the scope of exception of selling through TEB) is defined as a criminal act under Article 187 of the Turkish Criminal Law, as follows:
Making or Selling Drugs in a Way to Endanger People’s Life and Health
Article 187 – (1) Those who make or sell drugs in a way to endanger people’s life and health shall be condemned to imprisonment from one to five years and a monetary penalty.
(2) In the event that this act is committed by a medical doctor or pharmacist or within the scope of a profession carried out by official permission, the penalty shall be aggravated by 1/3.
Marketing pharmaceutical products without a marketing authorization is considered within the scope of the article referred above.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?
Yes, however, there is no regulation specific to orphan drugs in the reimbursement legislation.
Furthermore, please note that if orphan drugs are obtained through the process explained under Question 5 and are indicated in the “Foreign Drug Pricing List”, which is annexed to the Health Implementation Communique of the SSI as Annex-4/C, then such drugs can be reimbursed.
8. How are the prices of Orphan Drugs regulated?
In general, all drugs are based on a reference pricing method in Turkey. Pursuant to Article 9/e of the Communiqué, orphan products can be priced up to 100% of the reference price. In other words, orphan product prices are set based on the reference price stated in the official documentation from their country of import and manufacture. Prices for these drugs are annually reviewed and revised in parallel with the annual sales volume.
Additionally, the pricing can be determined according to the cost card for the orphan products produced in Turkey. (The cost card is prepared and approved by the applicant and the certified public accountant and shows the cost of the product, which is the basis of determining the sale price of the product, and other expenses.) In this case, however, the price requested on the cost card cannot exceed 15% of the reference product price and if exceeded, such claims will be evaluated by the Price Evaluation Commission (consisting of representatives of the Ministry of Finance, Ministry of Development, Undersecretariat of Treasury and Directorate of Social Security Institution)
9. In case of reference price based on a basket of countries, what countries are included?
In line with our answer to Question 8, the reference price, which is used for the pricing of the orphan products, is based on countries with a basket of 5 members of the European Union. Pursuant to Article 4/1 of the Communiqué, these countries are France, Spain, Italy, Portugal, and Greece.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
The Turkish Pharmaceutical Industry Strategy Document and Action Plan (“Plan”) for the years between 2015 – 2018 has been published by the Turkish Ministry of Industry and Technology, General Directorate for Industry. According to this Plan, the following has been proposed and planned to be implemented latest at the end of 2018; however, they are not yet implemented in Turkey:
- A detailed analysis for the status and analyses will be made regarding rare diseases. As per the results of such analysis, an orphan drug policy will be established.
- With regard to rare diseases, an inventory record system and headquarters, where such rare diseases can be determined, will be established in Turkey. The connection will be made between the current global reference network systems for rare diseases and the national reference system. New policies will be issued to develop and produce the medicines required for rare diseases in Turkey.
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?
No reform or significant changes regarding regulation of orphan drugs exist or are expected in Turkey in the near future.