Will Turkey Ever Regulate Its OTC Market?

Turkey’s Ministry of Health has announced work on extending the list of non-prescription medicines to reduce the financial burden on the country's Social Security Institution. However, Turkey first needs to take other steps to open up its marketplace for non-prescription drugs.

A scientific committee of the Turkish Medicines and Medical Devices Agency (TMMDA) is working on extending its list of non-prescription medicines allowed to be marketed and expects to complete the work by 2017, agency President Hakki Ersoz disclosed in July.

It is not clear which products will be added to the list and information has not been made available on the scientific committee's discussions so far. However, the industry likely would conduct lobbying activities to influence committee members, academicians well-known to companies.

The pharmaceutical industry prefers more transparency from the government and to have input on identifying products that can be marketed without prescription, but the TMMDA does not seem to be inclined to engage in negotiations with the industry.

A workshop was organized between TMMDA and Turkish pharma industry representatives prior to Ersoz' statement, but an extension of the non-prescription medicines list was not on the agenda. Industry once again underlined the need for a clear regulation, defining OTC products and allowing for advertisement of non-reimbursed products.

Regulation Urgently Needed

Currently, almost no products on the non-prescription medicines list are eligible for reimbursement, but many are prescribed by doctors so their patients receive reimbursements from Turkey's Social Security Institution. Additionally, many products available non-prescription in the US or Europe remain prescription-only in Turkey, meaning the SGK (the country’s drug reimbursement body) reimburses consumers for medicines commonly sold OTC outside the country.

Turkey applies to OTC drugs sales and marketing the same regulation it imposes on prescription medicines, banning advertising for the products and limiting sales to pharmacies.

The industry hopes that the TMMDA's scientific committee recommends transferring many products currently available prescription-only to the non-prescription list and that the government will allow advertisements for the products.

While consumers would not be reimbursed for a larger number of products if the non-prescription list is expanded, pharma firms believe they can charge more realistic prices in a market free of government pricing pressure on reimbursed products.

The government on the other hand is concerned about possible consequences of taking some products off the reimbursement list. Rather than purchase less expensive non-prescription products on their own, patients might prefer more expensive, but reimbursable, prescription products, which would increase SGK's costs. Additional measures would be necessary to prevent this patient behavior.

Resistance From Pharmacists

Passing an OTC law through the Parliament and allowing direct promotion to consumers for these products has been a hot issue in Turkey, discussed heavily over the past decade. However, making more drugs available without prescriptions faces strong opposition from pharmacists, who suspect the changes would result in OTC products being sold outside pharmacies, in drugstore chains.

Pharmacists do not oppose advertisements completely, but they definitely object to losing their monopoly for sales of the drugs. Although Ersoz' statement specifically underlined that all products with active molecule ingredients will remain available only in pharmacies, the pharmacists do not feel very assured.

In recent years some international companies like Alliance Boots GMBH and some local companies have been rumored to be preparing infrastructure for operations of chain drugstores, but the expected legal regulations never came, due to the resistance of pharmacist lobbies.

Growing OTC Market

Turkey is a growing market with a strong potential. Many firms, including multinationals like Merck & Co. Inc. and Sandoz International GMBH, as well as local companies like Abdi Ibrahim Ilac Sanayi ve Tic AS, Ilko and Zade Vital have made investments in OTC market in recent years.

Analgesics, cough/cold/allergy drugs, dermatologic products, gastrointestinal remedies, lifestyle products promoted for health benefits such as weight loss, nutrition and strength-training, and vitamins, comprise the basic OTC categories in Turkey. The market was worth TRY3.7bn ($1.2bn) in 2012 and in 2015 reached almost TRY5bn, a 34% increase.

It is clear that the OTC market is one of the main areas the government can look into for controlling its pharmaceutical bills, and regulation of this market is long overdue. It won’t be a total surprise for the pharmaceutical industry if the government imposes an OTC regulation in addition to extending its list of non-prescription drugs in 2017. In fact, many analysts in the industry are hoping this happens.

From the editors of PharmAsia News.