EU Accession Hopes to Drive Turkey Regulatory Reform
As in other areas of industry, convergence with EU norms and the prospect of eventual accession is a key driver of development in Turkey. In the domestic drug industry, recent legislation has focused upon harmonisation with EU guidelines, especially in the areas of patent protection and intellectual property rights.
Despite progress, patent legislation remains a contentious area. Patent protection for pharmaceuticals is a relatively new concept in Turkey, and was only properly introduced in 1995. US trade association PhRMA and the Office of the US Trade Representative (USTR) have led criticism of current regulations. The USTR's 2004 Special 301 Report on Intellectual Property Protection singles out the lack of progress made by the Turkish drug authorities over the last year, noting their failure to adopt any administrative or legal mechanism to protect proprietary commercial data.
Notably, the report claims that Turkey "lags far behind other EU aspirant countries" in protecting data. However, this claim, which should be of concern to Turkey's image-conscious government, is tempered by the USTR's decision to revise the country's report status from "priority watch" in 2003 to "watch" level in 2004, in light of some improvement in copyright protection. This change in ranking suggests that development is taking place.
Given the all-important negotiations aimed at winning accession to the EU in
2010, further regulatory improvement should be expected. However, the timetable
of reform remains a matter of conjecture, and it appears likely that the reform
process will be slow and problematic as the government continues to protect
its local industry, despite questions over the legality of much of its output.