The forecasts draw an optimistic picture. The global
pharmaceutical market is expected to grow at a 4-6% compound annual
growth rate (CAGR) in developed markets and 7-9% CAGR in
pharmerg-ing markets by 2019. The market size for Turkey stood at
$6.2 billion in 2014 and is expected to grow to $10.9 bn until
Article 15 of the Licensing Regulation issued by the Turkish
Ministry of Health (MoH), in parallel with the European Directive
2001/83/EC, foresees that a pharmaceutical product is granted a
marketing authorisation within 210 days. This is the explicit rule
stated under the Regulation itself, but there is doubt as to
whether this is always reflected in practice.
The MoH adopted a parallel application opportunity through which
applicants could apply simultaneously for both the GMP certificate
and the marketing authorisation. However this opportunity has been
introduced only for products that fall under the so-called
‘first category1 i.e. innovative products that have no
generics, and for first generics. Although there are further
incentives for GMP auditing for generic products, these are not
valid for original products.
After the replacement of a cost based pricing system with the
reference pricing system back in 2004, companies announced the
cheapest ex-factory price among the reference countries (France,
Italy, Spain, Portugal, and Greece) which will be accepted by the
MoH as the ‘highest ex-factory price.’ In addition, it
has to undergo mandatory discounts applied by the Social Security
Institution (SSI), the Health Implementation Communique, as well as
the commercial discounts made to warehouses and pharmacies.
More dramatically, the Pricing Commission had frozen the
exchange rate at 1.9595 Turkish Lira (TRL) until a very recent
amendment, due to a court decision. The decision stated that the
Commission’s failure to make any changes to the current
exchange rate is against the law. In line with this decision, the
Commission revised the exchange rate, raising it to TRL 2.0787. The
court actions are still ongoing and the industry is waiting for
better revisions in the exchange rate to give more accurate prices
compared with the prices in the reference countries.
As an upside of having the cheapest prices in Europe, the
reimbursement levels are relatively high in Turkey. Indeed there
are around 8,200 different pharmaceutical products within the
reimbursement list of the SSI. In 2014, the SSI financed more than
337 million prescriptions in total which equals to TRL 16 billion
Considering the expectations, we may conclude that a lot has
been accomplished, yet still there is way to go. Along the way,
there is no doubt that all the parties, not only the government but
also the private players, need to act cooperatively and
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Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
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