Turkish pharmaceutical policy has changed radically and made progress starting from the last decade. In the meantime, some controversial topics such as reimbursement, pricing, authorisation, intellectual property rights, and quality and harmonisation process with the EU were and in fact still are the highly disputed issues. As a consequence of EU harmonisation process, patent, data protection and data exclusivity are one of the foremost areas of the debate. Within the framework of bilateral or multilateral agreements (TRIPs, Customs Union Agreement with the EU) Turkey needed to apply the international terms and conditions of patent and data protection.
Data Exclusivity and Regulations in Turkey
In order to demonstrate a drug’s efficacy and safety for its intended therapeutic use, it is necessary for the originator of the drug to conduct extensive testing on animals and humans in pre-clinical and clinical trials as well as toxicology, manufacturing feasibility and other scientific studies. The results of these tests and studies, which are proprietary, are contained in a registration dossier that is submitted to governmental authorities to obtain marketing approval for the drug. The generation of this confidential registration data involves a very substantial amount of time and expense for the originator; the entire drug development process from discovery to marketing may take as long as fifteen years and cost, on average, $500 million in industrialised countries. The data required for registration are provided to the authorities in confidence and are not meant to be referred to by third parties. If these data were immediately available to third parties, there would be no incentive for a company to generate these data in the first instance, unless the investment in terms of both time and costs were protected by another means. Therefore, WTO regulated provisions with the TRIPs agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) in order to ensure data protection. In that context, TRIPs 39/3 mentions that;
“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.”
An interesting point occurs considering the differences between patent and data exclusivity that, it is responsibility of the patent owner to follow up the implementation of the patent for 20 years where it is state’s responsibility to monitor data exclusivity on behalf of original drug owner. State cannot accept or consider any kind of generic drug applications in that certain time limit.
In Turkey, this protection is regulated by the Decree-Law No.551 Pertaining to the Protection of Patent Rights. According to the Article 83/3:
“Where an application for patent has been filed for pharmaceutical or veterinary products/drugs and for chemicals destined to agriculture, the authorities issuing authorizations/licenses for the manufacture and sale of such products and requesting for this purpose information and test results, that were not disclosed to the public and the realization and accumulation of which requires considerable expenses and efforts, shall keep such information and test results secret/confidential. The authority asking for such information and test results shall take the necessary measures to prevent unjustified/illegitimate use thereof.”
In this way, if the patent period has expired, or there is no patent on a product, data exclusivity will act independently to delay the entry of any generic companies wishing to enter the market until the period of data exclusivity is over. It is important to note that in most cases the period of data exclusivity may have no material effect if it is within the patent period, because exclusivity is protected by the patent. Although patent period may cover the time frame of data exclusivity, when patent is expired data exclusivity may remain effective until the time limit ends. Time frame for the protection is limited to six years in Turkey starting with the time drug licence obtained. After six years period, generic companies gain the right to refer to the original drugs clinical data and take place in the market.
The limitation arising from data protection is very controversial at some point. Especially considering public benefit and the ability to purchase same substance with less money, generic drugs may seem fair practice to some people. Government also show an approach to encourage national pharmaceutical companies regarding the application of generic drugs in order to dynamise Turkish pharmaceutical market. However, the generation of the data especially for the marketing approval of an original drug requires a very significant investment of time, expertise, resources and money. If generic drugs could enter the market so easily, there would be no privileges and advantages for the one who did all the effort to reach the data. The originators of the drug must be given an opportunity, motivation and the incentive to recover the excessive amount of costs involved in generating such data before a competitor is permitted to rely on those data for the approval of the generic alternative. Although, it is almost around 10 years in many countries, pharmaceutical companies can enjoy this privilege for six years in Turkey.
Encouragement of New Clinical Drug Development: The Role of Data Exclusivity, International Federation of Pharmaceutical Manufacturers Associations 30, rue de Saint-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland, 2000.
Agreement on Trade-Related Aspects of Intellectual Property Rights Article 39/3.
Decree-Law No.551 Pertaining to the Protection of Patent Rights Article 83/3.