The following news was published in Turkish daily "Vatan" on 19 February 2018 (please click here to see the original publication) and should not be associated with the owner of the blog. The translation of the news is presented in this blog for information only and does not necessarily mean that we agree with the arguments made thereby.
As the bureaucracy, about whom President Recep Tayyip Erdogan told "they fasten our feet in shackles," could not show the national and domestic reflexes as in the defence industry, the pharmaceutical market has been overtaken by US and European pharmaceutical companies. Turkey spends 25 billion TRY on pharmaceutical a year. 95 of the 100 pharmaceuticals that have the highest turnover are imported. They earn 7 billion Turkish Lira over 100 products yearly.
Pharmaceutical cartels are comfortable enough to prevent local manufacturers by obtaining new patents and licenses, ie claiming that leukaemia medicine is good for stomach cancer. The domestic producer is trying to survive despite bureaucratic obstacles.
Those who fail to resist either sell their factories or become a subcontractor. The practices of Turkish Pharmaceuticals and Medical Devices Agency (TİTCK) cause the reactions.
The Medical Bureaucracy's regulations affecting the pharmaceutical market since 2016 have brought the domestic leap made during the last 15 years to the ending point.
The new regulations, general guidelines, guidelines for harmonisation with the EU, which contradict the AK Party's national and national policies and government programs, left the players of the domestic sector helpless against the global corporations.
In view of the Global Pharmaceutical Report, prepared to guide the global pharmaceutical companies that are monopolised in the world, the bureaucracy taking the steps projected between 2017 and 2021 one by one served Turkey to the global players.
Since the positive discrimination to the domestic pharmaceuticals has come to end, some of the domestic companies either became a subcontractor or they came out from the industry by selling foreign factories as they could not compete with global companies.
Global companies are now pulling out any pharmaceuticals out of the market and the citizens who do not the truth wail and confront the government. On the other hand, they are making billions.
LOCAL PRODUCTS TO BE COLLECTED
Since Turkey's Pharmaceuticals and Medical Devices Agency (TİTCK) put "the Guideline for the Procedures and Principles of the Priority Assessment Board for Human and Medical Products" into force in 2016, the domestic pharmaceutical industry is having a hard time.
While domestic firms were given priority as from 2002 upon the order of President Recep Tayyip Erdogan, the special inspections were applied against the imported products. This reversed, however, with the effects of the guidelines issued two months before the July 15 coup attempt in 2016. Domestic producers became unable to take priority in the authorisation process.
The marketing authorisations which were granted on the domestic producers before are being invalidated by the introduction of the marketing authorisation regulations and applications in compliance with Europe on the grounds of harmonisation with the EU and many pharmaceuticals produced by the domestic firms due to the lapse of patent term is under the risk of confiscation.
EU HARMONIZATION PROCESS' COMPLETED
Turkey, which started to accession negotiations with EU on 3 October 2005, had fulfilled its obligations relating to the Health Chapter and that chapter has been closed with success. In fact, a much better health system was established than in European countries.
However, since May 2016, EU harmonisation, the bureaucratic claim that "domestic industry is creating unnecessary workload by taking unnecessary marketing authorisations " and the amendments related to re-applications for authorisation, all these have made Turkey's pharmaceutical policy dependent on the foreigners. With the slot application which only allows applying for authorisation during certain months of the year, the access to the pharmaceutical authorisation of the domestic industry is prevented.
LICENSE CHARGES SOARED
It is stated that the pricing procedures applied in the process of pharmaceutical marketing authorisation, especially, have hit R&D investments. With the price list published in September 2017, the fees paid at the end of the authorisation proceedings were started to be received at the beginning of the proceedings.
This will put domestic producers, who pay fees for the pharmaceuticals that are not certain to get authorisation, into even more difficulty.
In the price list published in 2018, it is required exorbitant consultation fees, which are not even required in Europe. TICKK added a fee in the tariff under the name of "Scientific Advisory Fee", which amounts to 50.000,00 TRY per consultation.
The same fee being received for the pharmaceutical, total turnover of which is expected around 100.000,00-200.000,00 TRY, and the pharmaceutical making billions turnover, a box of which is 100.000,00 TRY, has immediately daunted the domestic pharmaceutical producers.
TWO DIFFERENT PRICES FOR THE SAME PRODUCT
Each medicine has a patent life of 20 years. While the domestic firm is preparing the product the patent terms of which lapsed, the foreign company is getting a second patent claiming that the pharmaceutical recovers a different disease as well. In this way, the patent term is extended and the domestic firms are prevented to produce. The most important example of these patent games is Glivec-named cancer pharmaceutical.
For Glivec presented to the market for patients with leukaemia, no difference is received from the patients and the entire cost of the medicine is covered by SGK. However, the company is collecting the price difference, it can not get from leukaemia patients, through "secondary indications usage patents".
TIME EXTENDED UNDER THE PRETEXT OF CANCER
Novartis, the manufacturer of the pharmaceutical , has obtained patent for secondary use of the same pharmaceutical, which is claimed to be good for the gastrointestinal cancer as well, at the Patent Office and asked a new price for the pharmaceutical for the uses of gastrointestinal cancer patients by filing application with Turkey Pharmaceuticals and Medical Devices Agency. The company, whose application was accepted, started to get a difference of 397,00 TRY from stomach cancer patients. Glivec is sold to the state for 2 thousand by 384,00 TRY.
SGK is paying the entire price of the pharmaceutical while purchasing it for leukaemia patients. In the case of stomach cancer subject to the second use indications patent, the state pays 1.987,00 TRY. The difference of 397,00 TRY is collected from the citizen.
The fact that the 2017-2021 Global Pharmaceutical Report (IMS), prepared to guide global pharmaceutical companies for their actions around the world, has mentioned in respect of Turkey that it is expected that global products will be given priority for accelerated licensing period, brought the allegations that the law and regulations of "prioritisation" implemented since 2016 and hitting the domestic pharmaceuticals have been prepared by lobbying activities of the consulting firms in Turkey of the global companies.
ITS DOMESTIC WAS 11,00 TRY, AND NOW 303,00 TRY
One of the most concrete consequences of the bureaucracy's surrendering to the global pharmaceutical companies and the current situation of the domestic pharmaceutical is the Mestinon named pharmaceutical.
Until a few years ago when the domestic production in Turkey was encouraged and the importation was subject to the tight sanctions, the license of Mestinon tablets produced in Turkey by Roche was sold to the Sweden company "Meda".
Well after the import barriers are removed, Meda has finalised its production in Turkey and started to produce the product in its factories abroad and sell to the pharmacies in Turkey.
When the alternative payment channel only allowing the importation for emergency situations is expanded, the company has cut off the importation.
The product sold for 11,00 TRY when it is produced in Turkey can be only brought through an alternative payment channel. The price of one box of the product is 303 euro.
ONE BOX COSTS 49.000,00 TRY
There are 6328 pharmaceutical items in Turkey's pharmaceutical market. When these pharmaceuticals are arrayed from the expensive to the cheap, one box of the cheapest of the first 20 pharmaceuticals cost 11,00 TRY. Harvoni 90 Mg / 400 Mg 28 Film Tablet, the first in the row, is priced at 49.750,00 TRY as of today. We need to pay more than 6.000,00 TRY today for a box of this medicine sold to 44.000,00 TRY yesterday.
Despite the sale of only 162 boxes of this pharmaceutical, 6.700.000,00 TRY turnover was obtained in 2017. It is stated that the cost of this pharmaceutical used by advanced hepatitis C patients does not even reach 1.500,00 TRY. Today it is reported that there are more than 500000 patients who may have benefit from the use of this medicine. This means that we will spend a much higher amount tomorrow for Hepatitis C patients at baseline we cannot treat today because of the inhibition of the development of the domestic pharmaceutical industry.
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