Pharmacists Stall Turkey's Launch Of Regulated Consumer Health Market
This article was originally published in The Pink Sheet
Executive Summary
Turkish regulators published a list of 241 products, based on 62 ingredients, selected to become available nonprescription but withdrew it after pharmacists argued that consumers in the country typically are not knowledgeable about health care issues and might buy the wrong drug product without a doctor’s advice.
Turkey's health care regulators expected recently to pass a milestone in establishing a regulated OTC market by publishing a list of active ingredients and products before pharmacists' objections sent the agencies back to the drawing board.
The Ministry of Health and the Turkish Medicines and Medical Devices Agency in December published a list of 241 products, based on 62 ingredients commonly available in other countries in OTC or nonprescription drugs in categories of cough/cold, allergy, analgesic and antipyretic, dermatology and gastrointestinal in addition to vitamins, minerals and dietary supplements.
The list includes antihistamines diphenhydramine and pheniramine, topical treatments salicylic acid and benzoyl peroxide, allergy remedy fexofenadine, analgesics ibuprofen and paracetamol/acetaminophen and antacid famotidine in addition to several substances regulated as herbals or botanicals.
While around 80 pharmaceutical and vitamin products already are available nonprescription in parts of Turkey, the list – the result of almost two years of work by the ministry and TMMDA – would commence the country's first regulation for sales of consumer health care products. (Also see "Turkey Poised To Stretch Consumer Health Market; Rigid On Ads, Access" - Pink Sheet, 29 Sep, 2017.)
However, the products on the list currently and officially remain available only by prescription after pharmacists reacted strongly and argued that Turkish consumers typically are not knowledgeable about health care issues and might buy the wrong drug product without a doctor’s advice.
"Further scientific discussions on this issue on a wider base of sector representatives are needed.” – Turkish pharma industry regulator
They also claimed OTC distribution would be the first step toward removing the products from country's reimbursement list and allowing advertising.
In Instanbul, TMMDA head Hakki Gursoz assured pharmacists that products on the list would remain eligible for reimbursement and that the agency, like the ministry, is opposed to allowing advertising for OTC medicines. He also said claims that the products would be sold by drugstore chains are “nonsense."
TMMDA initially set Jan. 5 as the deadline for pharmacists' associations to submit their opinions and extended the period through the end of the month before deciding to revoke the list. In a statement on its website, TMMDA said “it has been seen that further scientific discussions on this issue on a wider base of sector representatives are needed.”
The regulators' list was not alone in triggering pharmacists' response recently. After a personal care store chain began selling Bayer AG's Bepanthol creams formulated with pantothenic acid, or vitamin B5, pharmacists said their suspicions were confirmed that sales of consumer health products outside pharmacies are beginning.
Following pharmacists' criticism on social media platforms and other public debate, Bayer said in a statement that although sales of Bepanthol, a cosmetic product, are allowed through any channels, including online platforms and personal care stores. it distributes the product in Turkey to pharmaceutical warehouses and pharmacies. However, the firm said some rogue warehouses must be supplying Bepanthol products to personal care stories.
In another recent move, pharmacists' associations filed a complaint against TV advertising for what are described as complementary food and herbal products, to Turkey's regulator of broadcasts and advertisement in electronic media. Currently the products are licensed by the Ministry of Agriculture and advertising is allowed, but the Ministry of Health is attempting to bring the products under its oversight.
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