Program
Opening Speeches
Nezih Barut
IEIS Chairman
Dr. Mahmut Tokaç
Director General of the Ministry of Health and Pharmaceuticals
Prof. Dr. Habib Asan
President of the Turkish Patent Institute
Panel
Moderator: Assoc. Pr. Tekin Memiş
Kadir Has University, School of Law
European Commission for the Investigation of the Pharmaceutical Sector
Elke Grooten
Drug Policy Director
European Association for Generic Drugs
The report for "The patent barriers for the market launch of the generic drugs in the EU"
Kristof Roox
Report Editor
Brussels Bar Attorney
The Barriers Regarding The IntellectualProperty Rights for The Market Launch of the Generics in Turkey
Zeynep Ulusoy
Member of the Commission of Intellectual Property Rights
Pharmaceutical Manufacturers Association of Turkey
Questions - Answers
Lunch
Press Release
The panel titled “THE BARRIERS FOR THE MARKET ETNRY OF THE GENERICS, THE EVALUATION FOR EU AND TURKEY REGARDING THE INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS” has been held at the Ankara Sheraton Hotel on Wednesday March 4th 2009 by the Union for Pharmaceutical Manufacturers Association of Turkey (İEİS). The opening speeches have been given by the IEIS Chairman; Nezih Barut, the Director General of the Ministry of Health and Pharmaceuticals; Dr. Mahmoud Tokaç, and the President of the Turkish Patent Institute; Prof. Dr. Habib Asan.
In the panel, the Drug Policy Director of the European Association for Generic Drugs (EGA) Elke Grooten has presented the evaluation on the Investigation of the Pharmaceutical Sector of the European Commission regarding the competition bids. The results of the the report for "The patent barriers for the market launch of the generic drugs in the EU" has been discussed by the Report Editor and the Brussels Bar Attorney Kristof Roox. The Member of the Commission of Intellectual Property Rights of the İEİS Zeynep Ulusoy has reported The Barriers Regarding The Intellectual and Industrial Property Rights for The Market Launch of the Generic Drugs in Turkey.
The host and the IEIS Chairman Nezih Barut who started his speech by reporting that the generic and referecence drug industries should be in harmony and balance, has touched the following points further in his speech: “The intellectual and industrial property rights warrant and innovative structure that provides that the pharmaceutical industry supplying the people with novel drugs”. Barut continued his speec as follows: “We, as the generic drugs industry, are in great support of the intellectual property rights that have been design for encouraging the innovation. However, we need to say that two aspects of these rights need to be highlighted. First of all, protection should be given only to the discoveries that bring novelty for treatments. Secondly, when the monopoly right is given to the inventer, the abuses regarding this right and the wrongful applications of the right must be prevented”.
Moreover, in his speech, Nezih Barut further said that through the use of generic drugs in Europe, saving more than 20 billion euros for the patients and the public finances have been supplied, savings achieved with the use of generic drugs in our country in the last 5 years has become $ 3.8 billion TL, as well as the possible further increase of these savings by preventing the delay of the market launch and promoting the use of the generic drugs.
What should we do?
Mr. Barut concluded his speech as follows: As it is shown by by the results of the “The European Commision pre-report of the pharmaceutical sector and EGA Report, the barriers for the immediate market launch of the genric drugs need to be removed. What can be done to remove these barriers? First, the development and the high quality patent should be encouraged for the development and the future of the pharmaceutical industry, and the patent-making procedures should be developed. Secondly, a system that encourages the use of generic drugs needs to be established. In our country, in order to increase the use of generic drugs, the creation and implementation of stimulation policies such as the lowering the contrubution stake for the generic drugs or giving generic products to pharmacists and providing direct premium payments to when they prescribe generic drugs, are of urgent importance.
Directorate General for Competition of the European Commission has initiated “a sector investigation” because of the delays of the market launch of the generic drugs and very few drugs being launched to the market in January 2008 and publisged the 400-page preliminary report for the investigation in November 2008. At the panel held on March 4th (today), in the preliminary report that was evaluated by EGA Drug Policy Director Elke Grooten points that “reference drug companies are producing up to 1,300 patent registrations on a single drug" and thus creating patent networks”. Referans ilaç üreten firmaların tek bir ilaç üzerinde 1.300’lere varan patent tescil ederek “patent ağları” oluşturdukları” belirtiliyor. Elke Grooten, in her presentation, has pointed out the following regarding the report: "The reference drug producing companies create a legal dispute against generic companies. Nearly 700 lawsuits with the average duration of of 2.8 years have been identified. The majority of these cases are filed by the reference drug companies, however in almost all of the cases; the winning side has been the generics companies. All of these processes confirm the delay in the the market launch of the generic drugs. "
Simultanously with the other report, another report has been published related to the patent barriers for the European market launch of the generic drugs by EGA that includes İEİS as one of its members. A description of this report was given by the the Report editor Christopher Roox at the panel. Regarding the report, Kristof Roox said: "It has been identified that the reference pharmaceutical manufacturing companies, because of the reduction of the products that are newly licensed and at the developing stage, are extending the patent monopoly of existing products in an unfair manner. After all, with the strategy called "evergreening" (a term that is used to describe the reference drug companies’ efforts to prevent the generic drug competition products by extending the duration of protection of their products) it is aimed to the competing generic products to be kept from the market. The reference drug manufacturers, using this method, protect the features of the same drug via continuation patents" he further added.