FACING MARKET DELAYS
Beyond pricing policy challenges, the pharmaceutical industry is also dealing with slow drug approvals and limited market
access. A 2011 AIFD survey found that the regulatory approval procedure in Turkey is far from reaching European Union standards.
According to the survey, the average waiting time for drug approval is 772 days and can be as long as 1,500 days for some
drugs. In the EU, the standard timeframe for regulatory approval is set at 210 days. Turkey had committed to make an effort
to meet this standard.
For Olcay Gündüz, CEO of Münir Şahin, one of the oldest pharmaceutical companies in Turkey, many companies are trying to catch
up to international standards. "Outside Turkey, most countries have changed their registration process; they are now all following
the European Medicines Agency (EMA) or the Food & Drug Administration (FDA). As a result, they are all looking for Common
Technical Document (CTD) format files."
"Turkish companies only adopted the CTD format in 2005 and 2006. I myself started to prepare CTD dossiers in 2008, and I am
still translating some files for foreign managers. In general, Turkey has been very much unprepared to international regulatory
processes," said Gündüz.
Additionally, with the application of Good Manufacturing Practices (GMP) certification rules, it is increasingly difficult
for companies to import products. Özbay of Daiichi Sankyo said, "If you produce a product outside Turkey, the Turkish Minster
of Health send inspectors to your production site, who approve it."
"As the Minister of Health has a limited number of inspectors, this whole process takes time. There are today 350 products
in the waiting list, and with the current frequency of inspectors visiting the different sites, it is said that it will take
five years to have all these products approved," he said.
Dr. Şebnem Avşar Tuna, Novo Nordisk's general manager in Turkey, said that due to such entry barriers, the company has not
been able to introduce a new product in the country for the last six years. "This has put us in a very difficult and uncomfortable
position not only as a business, but also as a provider of drugs. I believe this is a lost opportunity for the Turkish public
since these are promising products for the treatment of diabetes patients as well as patients with growth hormone deficiencies,"
Dr Şebnem Avşar Tuna, general manager of Novo Nordisk Turkey