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High cost of data exclusivity

Details of the report prepared by the Monitor Group of US, has been presented to the government officials and bureaucrats in Ankara.

Members of the Pharmaceutical Manufacturers Association of Turkey presented the research report prepared on the subjects of the implementation data exclusivity that is recently brought to the public agenda and its possible effects of on the national economy and the pharmaceutical industry, to the government officials and bureaucrats at a meeting held in Ankara.

The research conducted by the the world's leading independent research organizations, Monitor Group of the US shows that in the event of the implementation of the data exclusivity promise made by the decision of the Customs Union without completing the waiting period, the pharmaceutical expenses of the government will exceed $1.2 billion and the loss of the national pharmaceutical industry will approximate $660 million within in six years.

Moreover, in the report, emphasis has been made on the possibility of a shut down of the domestic raw material production facilities that are dependent on the domestic market, on that the sectoral employement will be negatively affected and there will be an increase in the dependency on the importation.

In his speech before the presentation of the report, the Chairman of the Pharmaceutical Manufacturers Association of Turkey Bülent Eczacıbaşı, reminded the past meeting that was held by the attandence of the public and private sector representatives on the data exclusivity in April 2003 with the coordination of the Ministry of Health, and he further added: " At this meeting, a decision has been made on the preparation of a detailed sectoral and national report which included the financial dimension on the the data exclusivity, in order to strenghten the negotiative positioning of the Ministry of Foreign Affairs in EU, and the task of preparing this report has been given to our Union by the Ministry of Health. Our union, has decided that his work to be conducted by the Monitor Group company which also works with the headquarters of the multinational firms that are represented on the Board of Directors, and which has international experience and reputation".

Eczacıbaşı, in the studies for the report, has also said that the senior managers of two local and two international firms of the Pharmaceutical Industry Union members, have taken active roles by serving in the steering committee of the study.

Bülent Eczacıbaşı who indicated that the report revealed very striking results, drew attention to the danger of extinction of the national pharmaceutical industry, as well as the large increase in the government’s health care expenses and in conflict with the promises made to the IMF.

"The conceptual confusions show be prevented"

Eczacibasi who stated that recently some discussions have been moved to the agenda with the heading of the  intellectual and industrial property rights, highlighted that the data protection and data exclusivity should not be confused as there were used interchangaeably in these discussions creating confusion of concepts,  with which Turkey is tried to be represented as a nation with no intellectual property rights, and he further said: “The requested Data Exclusivity is the prevention of the data of the original licensed products being given as reference during the license application process by the generic drug manufacturers after the expiration date of the patent and is the permission for the right of licensure only for the original product, and thus has nothing to do with the Intellectual and Industrial Property Rights. 

Eczacibasi emphasizing that National Phrmaceutical industry is not opposed to the data exclusivity application in line with its strategy towards the integration with the EU, said: “Our approach to the concept of patent was the same. The projected model is a transition term application that has been adopted by most of the EU contries. We think that this process is important and necessary for both the public and the national pharmaceutical industry in order to ensure compliance 

Chairman of IEIS Eczacibasi, drew attention to that in a period in which we are not even able to determine the date for the Turkey's accession negotiations, the process of data exclusivity that is being tried to forced upon would be a huge sacrifice when compared to the other EU candidate countries with nothing in return, and he said: “Countries such as Hungary and Poland who has strong national pharmaceutical industry can be given as an example to this. Indeed, in these countries, the application of data exclusivity has been decided to start at the full membership or a year before the full membership".

Bulent Eczacibasi by emphasizing that with the data exclusivity, there will be a dramatic increase of the prevention of the generic drugs to be developed and licensed by the domestic pharmaceutical companies, and our country being dependent upon the foreign market for the pharmaceutical supply, concluded his words as:“The drawback regarding the national security strategies caused by the abolishment of the national independence of the pharmaceutical sector that has a crucial priority should not be ignored”.

The report of the Monitor Group 

The presentation of the report prepared by the Monitor Group was made by Monitor Group Consultant ​​Partha Gosh. Gosh stated that in order to form an objective result regarding the possible effects of data exclusivity in the pharmaceutical industry and the health sector economy first they got in touch with all stakeholders and had 20 interviews with the World Trade Organization, the Pharmaceutical Research and Manufacturers Association of America, the European Union Commission, the European Federation of Pharmaceutical Industries and Associations, European Generic Medicines Association, EU Permanent Representative of Turkey, the relevant ministries in Turkey and manufacturers of branded and generic products.

Stating that they have presented different scenarios by taking different effects such as the date on data exclusivity will begin and the application time into account, Gosh further commented that the likely effects of the data exclusivity application will emerge in three phases; "first effect", "future effects" and "indirect effects".

Partha Gosh stated that the future impacts of data exclusivity application will reach significant numbers. Expressing that they assumed that the data exclusivity application will direct the original product manufacturers to bring more new molecules at Turkey during the calculations, Gosh further claimed that as the number of products affected by data exclusivity increases the effects of application on the health sector economy and national pharmaceutical industry will also increase.