The Turkish Ministry of Health ("MoH") is obliged to
keep the content of the license registration dossiers confidential
under Article 28 of the Turkish License Regulation1 and
article 39 of TRIPS2. Despite wide spread rumors
regarding biased practice, the MoH and the courts also recognize
the MoH's confidentiality obligation for both original and
generic pharmaceutical products.
Undoubtedly, the information contained in the license
registration dossiers is invaluable to both the applicant and its
competitors. Even the knowledge of whether a generic product
application exists can be very important. Reportedly, a generic
product can take as little as 3 months to obtain a license from the
MoH whereas it can easily take 3 years for an original product.
Furthermore, as soon as the first generic of an original product is
licensed in Turkey, the original product's sales price to
wholesalers is decreased to 66% of its reference price in the MoH
The Turkish State Council has examined the confidential nature
of the license application and the content of the license
registration dossier in a case initiated by an original
pharmaceutical product license holder.
The said company's lawyers had requested from the MoH copies
of a generic product application dossier which referenced the
original product of the claimant. The claimant asserted that the
MoH should provide copies of the license dossier to the lawyers as
per the Turkish Lawyer's Code article 2 which stipulates that
governmental authorities should assist lawyers in doing their work.
The MoH denied this request citing their confidentiality
obligation. The nature of the information contained in the dossier,
aim and scope of TRIPS article 39 and the relevant provision of the
Regulation were discussed at length throughout the proceedings.
Finally, the Turkish State Council ruled that in light of the
principle of the transparency of the state, the scope of the
MoH's confidentiality obligation is limited to the
"confidential information" contained in the license
application dossier.4 It is confirmed that all
scientific, technical, financial and marketing data contained in
the license application is considered completely confidential and
that the generic dossier cannot be disclosed for the review of
third parties. However, the State Council clarified that the
existence of the registration application, and identity of the
applicant is not confidential and this information can be
shared with the license holder of the original product.
Since timely access to whether there has been a generic license
application is still crucial in many cases, the clarification of
the confidentiality obligation of the MoH by the State Council is
1. License Regulation published in the Official Gazette
dated 19.01.2005 and numbered 25705 "Beşeri ve
Tıbbi Ürünler Ruhsatlandırma
2. TRIPS became part of Turkish law as of its publication
in the Official Gazette dated 25.2.1995 and numbered
3. The Pharmaceutical Pricing Decree published in the
Official Gazette on 22.9.2007 and numbered 26651 (last updated on
4.State Council 10th circuit decision no. 2007/891, dated
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