Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
New Regulatory Environment in Turkey
Seval Tangut (Abschlußjahr: 2007)
Turkey is the only pluralist secular democracy in the Moslem world and has always attached great importance to developing its relations with other European countries. Historically, Turkish culture has had a profound impact over much of Eastern and Southern Europe. Turkey began westernising its economic, political and social structures in the 19th century. Following the first World War and the proclamation of the Republic in 1923, it chose the Western Europe as the model for its new secular structure. Turkey is a founding member of the United Nations, a member of NATO, the Council of Europe the OECD and an associate member of the Western European Union.
During the Cold War Turkey was part of the Western alliance. Having close cooperation with Western Europe in the political field and with respect to the historical background, shortly after creation of the European Economic Community (EEC) in 1958, Turkey made its first application to join the EEC in July 1959. The first negotiations resulted in an Agreement creating an association between Turkey and EEC (Ankara Agreement) on 12 September 1963. Ankara Agreement envisaged the implementation of Customs Union. In 1987 Turkey applied for Full Membership. Commission s decision given in 1989 basically underlined the eligibility for Membership adding that the Customs Union should be completed in 1995. With respect to this stipulation the EU-Turkish customs union came into effect on 31 December 1995. In December 1999 Turkey has been recognised as a candidate for accession at the Helsinki European Council. Helsinki marks a qualitatively new beginning and a process for Turkey-EU relations. Turkey announced its National Program for the adoption of the acquis after Helsinki. Improvements have been taken and first in 2003 Accession Partnership has been revised, as of October 3, 2005 accession negotiations between Turkey and the EU have started.
After first revision of the Accession Partnership in 2003, number of important steps have been taken towards aligning the pharmaceutical legislation with European Union legislation in accordance with the adoption of the acquis.
New Regulation on registration of pharmaceutical products for human use has been published which is in alignment with the concerned EU directives regarding most issues. Number of changes are still being expected. Number of changes are still being expected. Intellectual Property Rights in terms of Data Exclusivity is not in alignment with EU as data excusivity period is 6 years with preconditions. Lack of transparency in regulatory bodies is a gap according to opinion of pharmaceutical manufacturers as well as opinion of oganisations and associations.
Pharmaceutical policy is collectively shaped by various authorities in Turkey. The General Directorate of Pharmaceuticals and Pharmacies (GDPP), one of the Directorates of Ministry of Health, is the main authority in charge of marketing approval/authorisation, pricing of pharmaceuticals, legal classification and inspection.
While the main authority for pharmaceuticals for human use is MoH, the administrative unit for pharmaceutical products for veterinary use is Ministry of Agriculture and Rural Affairs. In accordance with a Health Transformation programme declared by the government in 2003 establishment of a National Institute of Medicinal Products and Medical Devices is proposed which will be in charge of pharmaceutical products both for human use and veterinary use. This Institute will also be the unique authorised body in terms of pricing and reimbursement. In one hand from industry point of view this proposal is very welcomed while on the other hand this caused a lot of discussions between organisations and the government with respect to gathering all the authoritised bodies in one hand. In order to handle this problem steps to be taken regarding the transparency of the regulatory bodies gaining more importance.
Classification of medicinal products have been defined with a Regulation published in 2005 in line with the respective EU directive, which opens the way how to use the advertising opportunities of medicinal products, which are not subject to prescription, as it is declared in the Regulation on Advertising and Promotion of pharmaceutical products. However this is one of the other discussion subjects in Turkey since the basic law on medicinal products which is still in force does not allow advertising of medicinal products.
Although there are numbers of essential changes in pharmaceutical legislation in Turkey with the aim of harmonising the legislation with EU pharmaceutical legislation, there are still problems in implementing the new legislation.
Turkey entered a comprehensive shift at the beginning of 2005 with respect to registration process. It is still too early to interpret the results. However certain issues can be foreseen before waiting for the impacts of the new legislation elements.
First among these is the interpretation of the 210 days. It is not clear that if 210 days is calendar days or working days. According to the experiences which the pharmaceutical industry has until now in terms of the overall timeline of registration process it is more than 12 months still. If the Ministry of Health provides a detailed report on applications including the statistical data on annual basis this could be understood. Transparency is very important step to be taken by the regulatory bodies. Lack of guidelines is a problem to be able to interpret correctly what is meant in the regulations.
Proposal of establishing an Institute of Medical Devices and Medicinal Products is an important step in terms of gathering all fuctions in one institute. Legislation on veterinary medicinal products comprises the Regulations published by MoH and MARA and this causes complexity and confusion with respect to the competent authority for the veterinary medicinal products. The new Institute will comprise all functions in charge of pharmaceutical products for human use, for veterinary use and medical devices and will be in alignment with EU legislation and EU institutional structure.
Turkey is very open to progresses in itself with its personal, technological and cultural capacity but hurdles by authorities should be removed. Beside transposing the EU pharmaceutical legislation into national legislation a National Pharmaceuticals Policy should be established as basis. From 1954 until today 44 Ministers from different political parties have been in charge of Ministry of Health. Since National Pharmaceuticals Policy does not exist, number of opinions have been come into force as Decrees, radical changes have been arised, thus a steady period can never be achieved.
R&D studies should be encouraged by establishing the required regulations particularly in biotechnological aspects since there are no biotechnological production sites in Turkey in spite of initiatives of The Scientific and Technological Research Council of Turkey. All the biotechnological products on the market are import products. There are no Guidelines in terms of Biotechnological products. Biosimilarity is not clearly defined in the existing Regulations.
Harmonisation of Pharmaceutical Legislation with the respective EU legislation improves the Regulatory Environment of Turkey however since pharmaceutical industry is directly related to health and human it needs to be ensured that all parties involved fulfil their obligations to ensure a high level of public health. The first aim should be to improve the public health.