Application form for TAIEX Workshop
Please note: TAIEX can undertake the majority of the arrangements and costs for its workshops. However please note that in making this request for a workshop the following support must be provided by your country: 1. Submission of draft law, laws or policy statements, and/or relevant documentation or a short written summary of the current situation regarding the sector.
2. Liaison with participants regarding the event and submission of a complete list of participants (with their job title, full contact details & name of administration), no later than 21 calendar days before the event. 3. When appropriate, assistance to TAIEX representatives, chairperson and experts/speakers during the event. 4. Submission of a short evaluation report of the event.
Beneficiary country: Beneficiary Ministry/Service
Turkey Istanbul University/ Çapa Faculty of Medicine; The Turkish Ministry of Health/ Directorate General of Pharmaceuticals and Pharmacy, Directorate General of Mother and Child Healthcare and Family Planning, Directorate General of Primary Healthcare Services, Directorate General of Curative Services
Date of submission:
15 October 2008
1. Person submitting the application:
Title1: First Name: Surname: Ministry or Institution: Department: Function: Office address (street/number/office number): Ms. (Dr.) EBRU KORKMAZ BAYIL The Turkish Ministry of Health Department of Pharmaceuticals and Pharmacy Medical Doctor Ph. Cankırı Cad. Dışkapı No: 57 Post code: City: Office Tel: Office Fax:
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06434 Ankara +90 (312) 309 11 41 - +90 (312) 309 28 56 +90 (312) 309 71 18
Personal data contained in this document will be processed in accordance with the privacy statement of the TAIEX instrument (See http://taiex.ec.europa.eu/privacystatement) and in compliance with the Regulation (EC) N° 45/2001. Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 1 of 6
E-mail:
ebru.korkmaz@iegm.gov.tr
2. Workshop content:
Proposed title of the workshop Workshop for enhancing the Orphanet database for rare diseases in Turkey Proposed date (indicative) Expected number of participants: Target audience: (specify if Ministries, institutions, regulatory authorities, professional associations or other) 2008-2009 50 The Turkish Ministry of Health (relevant DGs), Orphanet Turkey Team (Istanbul University/Çapa Faculty of Medicine), relevant Regulatory Scientific Commission Experts, relevant Research Institutes and Academic Experts
3. EU Legislation (acquis communautaire) for this event:
Sector of EU legislation
CELEX N°/Natural number: Type of legislation: 32000R0141 / 141/2000/EC; 32000R0847 / 847/2000/EC Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products; Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority' Screening chapter: Free Movement of Goods
Main topic/content
Agenda: Indicate specific items which should be included on the agenda and/or attach draft programme, if available
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Rare diseases, including those genetically inherited or acquired, are life-threatening or chronically debilitating diseases. Such diseases manifest low prevalence, and therefore require special combined efforts in diagnosis. Accurate diagnosis of such diseases help to prevent morbidity/mortality rates in specific populations or considerable reduction in patients' quality of life. (http://ec.europa.eu) The European Commission (EC) has defined rare diseases in Europe as "diseases which have prevalence of under 5 per 10 000 individual. (www.rdtf.org) Conditions and the lack of information, research, diagnosis, treatment expert availability in relation to rare diseases, manifesting very low prevalence, affect populations where benefits from health resources are scarce and service is insufficient. Even though they can cause serious difficulties and severe complications to patients, due to the low prevalence, rare diseases can be regarded as having ommittable impact on populations. A global approach to consequences of rare diseases - in areas of scientific and biomedical research, drug research and development, industrial policy, information technologies, social benefits, in- and out-patient treatment - could provide some solutions. (http://ec.europa.eu) On emergence of the above necessities, the Rare Disease Task Force (RDTF) was funded by the EC in 2004 with the following aims: • to advise and assist the European Commission Public Health Directorate in promoting the optimal prevention, diagnosis and treatment of rare diseases in Europe, in recognition of the unique added value to be gained for rare diseases through European co-ordination; • to provide a forum for discussion and exchange of views and experience on all issues related to rare diseases. RDTF was formed for a five year period between 2003 - 2008 for the duration of the public health programme. (www.rdtf.org) In relation to RDTF, the Orphanet project was established in 1997 by the French Ministry of Health and the INSERM (French National Institute for Health and Medical Research). Encyclopaedia and data collection in European countries, both belonging to this project, have been funded by the EC since 2000. Also, the development of the OrphanXchange database and orphan drugs data collection are sponsored by the French pharmaceutical companies association. Orphanet operates under the French headquarters, establishing the project coordination team. Turkey is participating as a member among numerous national teams following active participation in this project. The mission of each national team data collection of information about clinical services, research activities and patient organisations at the country level. Current teams also manage the translation of the Orphanet Encyclopaedia summary entries into their national languages. In each country, a scientific advisory board has been established. This board is in charge of advising the local Orphanet team and validating the information about services provided in the country before their publication in the Directory of Services. The coordination team in Paris, France takes under the responsiblity of maintaining the worldwide database and the website, updating the diseases list and classification, producing the Orphanet Encyclopaedia, coordinating the national team efforts and implementing quality control. (www.orpha.net) Under the scope of the above mission on rare diseases worldwide, the aims of this project are to: - Establish an internet website for Orphanet Turkey, in national language, from which all society, from patients to physicians can be able to attain useful information on rare diseases; - Gather a specific scientific advisory board on a regulatory platform, which will collaborate with Orphanet Turkey in issues regarding data provided to Orphanet within the country; - Form a consortium of experts within the Turkish Ministry of Health, who shall follow-up with data collection and maintain quality control of current/emerging rare diseases within the country. In parallel with this aim, relevant experts from within Orphanet Turkey, the Turkish Ministry of Health, relevant Regulatory Scientific Committees and academia shall be invited to Ankara to recieve initial and detailed information about the operation of the Orphanet Project in a 3-day workshop meeting, where executive officials from INSERM are foreseen to present their mission and share ideas with Turkish healthcare professionals.
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4. Current situation:
Please describe briefly your current situation concerning the sector of the acquis communautaire indicated above and explain why the workshop is necessary now: Under the scope of the EU Pharmaceutical Legislation, Directorate General of Pharmaceuticals and Pharmacy (DGPP) operating under the Turkish Ministry of Health has adapted the "Regulation on Licensing for Medicinal Products for Human Use" as such: The purpose of this regulation is to identify the rules and procedures to be applied in the licensing process in order to ensure that medicinal products for human use, which are industrially produced for marketing purposes, have required efficacy, reliability and quality, and to determine implementation rules of the licensed medicinal products for human use. This Regulation comprises the human medicinal products, which are industrially manufactured for human use or imported, and/or real and corporate persons who have applied for licensing and/or who have been given licenses. However, the following are not included within the scope of this regulation: a) Any medicinal product, which is prepared in a pharmacy in accordance with a medicinal prescription for an individual patient, commonly known as magistral formula, b) Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question, commonly known as official formulas, c) Without prejudice to the provisions of the Regulation on Clinical Studies on Human Medicinal Products, the medicinal products intended for research and development trials d) Intermediate products intended for further processing by an authorized manufacturer, e) Any radionuclides in the form of sealed sources, f) Whole blood, plasma or blood cells of human origin. This Regulation aims to implement European Union legislation related to medicinal products for human use in parallel to Directive on medicinal products for human use numbered 2001/83/EC and it is based on the Law on Pharmaceutical and Medicinal Preparations (No. 1262), Article 3 (k) of the Basic Law on Medicinal Services (No. 3359), Article 8 of the Law on Blood and Blood Products (No. 2857), and Article 43 of the Ministerial Decree on Organization and Responsibilities of the Ministry of Health (No. 181). (www.iegm.gov.tr) Human medicinal products, whose efficacy and safety have been scientifically approved with sufficient clinical researchonly under the relevant indication for use in the treatment of any disease and those which have been licensed upon determination of their standard dosage, may be used. Subjects with regard to use of imported medicinal products which have not yet been licensed and of medicinal products under the scope of licensed off-label use and/or over their standard dosage limits, are considered as a gradually growing issue of our country in medicinal, ethical, legal and pharmacoeconomic aspects. Achieving scientific standards for treatments with the use of those medicinal products under the said scope and not proceeding with implementation without the consent of our Ministry are mandatory. (www.iegm.gov.tr)
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LOGISTICAL ASPECTS – WORKSHOP DETAILS
Contact person for administrative questions and practical matters related to this event
Title2: First Name: Surname: Ministry or Institution: Department: Function: Office address (street/number/office number): Mrs Filiz ÖZYİĞİT The Turkish Ministry of Health Directorate of Pharmaceuticals and Pharmacy Medical Doctor, Pharmacologist Çankırı Cad No: 57 Post code: City: Office Tel: Office Fax: E-mail: 06434 Ankara 90 (312) 309 11 41 90 (312) 309 71 18 filiz.ozyigit@iegm.gov.tr
Is accommodation required? (applies only to journey of 100km and above) Is interpretation required? If yes, between which languages? Does your administration have suitable conference facilities available? If yes, are these facilities free of charge?
Yes Yes
Between
No No
English and Turkish
Yes Yes
No No
Conference venue address: (street, number, office number)
Saglik Bakanligi Ankara Sosyal Tesisleri (Hekimevi)
Kolej Post code: City: Office Tel.: Office Fax.: E-mail: 06420 Ankara (90) 312 425 6440 -
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Data received from you is to be used for the organisation of TAIEX events only, and for no other purpose unless stated. You are entitled to have your data deleted or removed from our database at any time.
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 5 of 6
Please complete and return to: European Commission, Institution Building unit (TAIEX) Rue de la Loi 200, B-1049 Brussels Fax: +32-2-296 76 94 E-mail: Elarg-Taiex@ec.europa.eu
Please note: The information contained in this form will be made available on-line to the Permanent Representation, or Mission of your country in Brussels. All applications received directly from the Western Balkans' administrations will be forwarded to the EU Delegation in the country concerned, and in the case of Kosovo to the EC-Liaison Office, for a preliminary evaluation.
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 6 of 6