ABSTRACT
Recently, spread of COVID-19 and viruses from same family has been classified as “pandemic” by World Health Organization. With the global contagion of the epidemic, different opinions from public started to form regarding development of new medicines and vaccines in Turkey like every other country and this situation caused misleading news and information to be published.
PHARMACEUTICAL INDUSTRY IN TURKEY
Pharmaceutical industry in Turkey; is an important sector which continues to grow from year to year especially in terms of domestic R&D investment. According to the reports in 2019, the sector has grown even more compared to the previous year and reached a sales volume of approximately TRY 31 billion in 2018. When evaluated on the box basis, more than 2 billion boxes of pharmaceuticals sold in Turkish pharmaceutical market. With these rates, Turkey has the 17th biggest market at global pharmaceutical industry.
At an important industry like this, authorization process of medicines are subject to supervision of Turkish Medicines and Medical Devices Institution (Institution) which is a subsidiary of Ministry of Health (Ministry). Institution is responsible from determining the rules and standards regarding the licensing, production, storage, sale, import, export, placing on the market, distribution, putting into service, collection and use of products falling within its field of duty; authorizing, inspecting and imposing sanctions when deemed necessary public and private legal entities and real persons to carry out these activities. Institution conducts authorization processes of medicines in accordance with Human Medicinal Products Authorization Regulation dated 19.01.2005 (Regulation).
AUTHORIZATION PROCESS
Authorization process begins with the application of applicant to the Institution with the related documents and reports. All the documents and reports submitted at this stage kept confidential and this confidentiality is protected by the Institution. Within 30 (thirty) days after the application is received by the Institution; the application gets reviewed and Institution send the prior results to the applicant. If there are any missing documents, applicants should complete them in 30 (thirty) days.
After application’s completion is full, authorization application is taken into evaluation of Institution and finalized within 210 days excluding state of emergency and completion of missing subjects requested from applicant. When authorizing a medicine, the product is evaluated whether it meets all the criteria of being proven efficient and reliable under the prescribed conditions of use, having appropriate technical and pharmaceutical properties. However, in cases where public health requires, the Institution may abandon the application of some of the criteria mentioned above with taking into account the pharmacoeconomic data.
As a result of the examination and evaluation of the information and documents submitted to the Institution by the applicant, an authorization is issued for the drugs determined to be in accordance with the criterias stipulated in the regulation and the applicant is informed regarding this matter. In addition, the names of the products authorized, the name and surname of the license holder and the authorization number are announced in the Official Gazette.
The authorization holder shall provide the Institution with information on quality, reliability and effectiveness, covering all changes from the date of issuance, together with the necessary pharmacovigilance data regarding authorized medicine at least 3 (three) months before the end of the first 5 (five) years following the authorization date.
The responsibility of the authorization holder does not end with the receipt of the relevant authorization. Authorization holders also continue to be responsible against the Ministry in accordance with the conditions set out in Article 24 of the Regulation for the production of medicines in accordance with the specified specifications, safe use, product availability in the market and, most importantly, public safety.
Responsibility of authorization holders after process are followed and enforced in a strict manner both at all around the world and Turkey. For example, in 2018, Monsanto, a Bayer group company, was sentenced to pay USD 289 million in compensation on the grounds that the weed dryer, named Roundup, was carcinogenic. In Turkey, people and institutions who are illegally distributing and selling drugs are fined 6 million and 650 thousand TRY as administrative penalty in 2019.
CONCLUSION
In the light of the processes described above; authorization processes of medicines supervised in a strict manner Turkish Medicines and Medical Devices Institution which is a subsidiary of Ministry of Health in order to protect public health and ensure the highest level of compliance to international agreements and regulations. Even just obtaining authorization after development stage of the medicine takes nearly a year in Turkey. Even if this period can be shortened in cases of emergency such as epidemic; the institution continues its related supervision in a strict manner.
In this context, especially the misleading new regarding Coronavirus pandemic that is being published on the internet or broadcasted at media are misleading the masses. Because even if a drug is developed in a short time, it takes a long time to complete clinical trials, R&D and licensing processes. For example, it is predicted by the World Health Organization that effective drugs for Coronavirus outbreaks, which are affecting the whole world today, can be released in the spring of 2021 at the earliest. In addition, it should be taken into consideration that the responsibility of the authorization holder continues after the authorization of a medicine.