The Turkish Competition Board has launched an investigation into
the alleged blocking by the Turkish Pharmacists Union (known by its
Turkish acronym "TEB") of "named
patient sales" by pharmaceutical warehouses, further
complicating the fight between elements in the Turkish government
seeking greater competition and private sector involvement and
those wishing to maintain centralized control. At stake is the
rapidly growing and lucrative market for named patient
Many medicines, including those critical to treat illnesses like
leukemia, tuberculosis and hepatitis, are not readily available on
the Turkish market. The reasons for this include the lack of
approval for sale in Turkey, low profitability due to government
pressure on medicine prices, and logistical hurdles.
To make these medicines available to patients in Turkey, for
years TEB had the exclusive authority to procure them abroad, if
prescribed by a physician and permitted by the Ministry of Health.
This exceptional supply route for medicines, known as "named
patient sales," has grown enormously over the last several
years, creating a market of approximately TRY 1.2 billion (approx.
USD 450 million) annually.
TEB's monopoly on named patient sales was further strengthened
by its protocol with the Social Security Institution
("SSI") which allows reimbursement by
the government of medicines imported for named patient sales.
In 2013, as a first step towards eliminating TEB's monopoly,
the SSI's Communiqué on Health Practices was
amended to permit private entities to import unauthorized medicines
for named patient sales. This was followed by the Turkish Medicine
and Medical Device Authority ("TITCK"),
the semi-independent authority under the Ministry of Health's
umbrella, issuing its controversial Guidelines on the
Importation of Medicines and Their Use (the
"Guidelines"), which authorized 22
pharmaceutical warehouses to import unauthorized pharmaceuticals.
TEB, however, remained the only importer entitled to government
reimbursement, giving it a significant competitive advantage over
the private pharmaceutical warehouses.
Suspension of the Guidelines
After the Guidelines granted private warehouses permission to
import medicines, on 6 August 2014, TEB filed an administrative
lawsuit at the Council of State, seeking cancellation of the
Guidelines and a stay of their implementation. TEB's main
argument is that the Guidelines allow pharmaceutical warehouses to
conduct retail sales even though they are prohibited from doing so
under the Regulation on Pharmaceutical Warehouses and Products
Stored at Pharmaceutical Warehouses (the
"WarehouseRegulation"). On 2 April 2015, the Council of
State ruled in TEB's favor and suspended the Guidelines. The
decision was publicly announced on 16 July 2015.
Just two weeks after the announcement of the Council of State
decision, on 31 July 2015, TITCK issued a revised Warehouse
Regulation, exempting named patient sales from the prohibition on
pharmaceutical warehouses engaging in retail sales. This cured the
legal defect which the Council of State cited as the reason for
suspending application of the Guidelines. It further revised the
Guidelines in a way to expressly refer to the Warehouse
Regulation's provisions which permit named patient sales by
The Competition Authority enters the fray
Complicating the legal maneuvering between TEB and TITCK, the
Turkish Competition Authority announced on 23 July 2015 that it had
launched an investigation into TEB's alleged abuse of its
dominant position in the named patient sales market. Although not
clear in the Competition Authority's announcement, the basis of
the investigation may be that TEB somehow prevented SSI from
entering into reimbursement agreements with private warehouses.
Implications for pharmaceutical companies
Despite TITCK's amendments to the Warehouse Regulation, the
Council of State's decision to suspend application of the
Guidelines remains in force. Named patient sales through private
pharmaceutical warehouses, therefore, continue to be prohibited.
The Competition Authority's investigation is ongoing with few
In this fluid legal environment, legal advice should be sought
when supplying medicines from abroad directly to private
Baker & McKenzie provides multidimensional advice on all
aspects of pharmaceutical and healthcare law, including
pharmaceutical and healthcare regulations, compliance, employment
and pharmaceutical sector-specific contracts.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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