Баранович Мария, юрист ЮК "Правовой Альянс"
Over the last several years the pharmaceutical markets of some countries of the former Soviet Union have witnessed strengthening positions of domestic production of medicines, as well as the general tendency of the imported medicines substitution by the domestically produced pharmaceutical products (so-called “import substitution”). The governments of the Russian Federation, Kazakhstan, Belarus are trying to reduce reliance on foreign supplies. These trends are specified in the respective governmental programs.
Ukraine is going to use the abovementioned experience of the neighboring countries. In April 2011 the Ministry of Health of Ukraine developed a draft decree of the Cabinet of Ministers of Ukraine “The Concept of the National Targeted State Program for the Development of Import-Substituting Manufacturing Industries in Ukraine and Substitution of Imported Medicinal Products with Domestic Products, Including Biotechnological Medicinal Products and Vaccines, for 2011-2021”.
Moreover, in May 2011 the Draft Regulation “On Approval of the Concept of National Targeted Economic Program for Import Substitution for the Period until 2015” was placed at the official website of the Ministry of Economic Development and Trade of Ukraine for public consideration. This draft Program provides favorable conditions to reduce the dependence of the Ukrainian economy on import of goods (and services) by identifying and implementing the priority projects of economy sectors and specifying types of products aimed at import substitution, and to satisfy domestic demand for high quality products of national manufacturing.
In July 2011 the Prime-Minister of Ukraine instructed the Ministry of Economic Development and Trade of Ukraine to develop a comprehensive program for support of export and import substitution and deliver it to the government till September 01, 2011.
Besides, recently the Minister of Health has said Ukraine is ready to support foreign investors who encourage development of the Ukrainian national manufacturing. He has welcomed representatives of the Jordanian pharmaceutical company Hikma Pharmaceuticals, who are eager to invest into the pharmaceutical sector of Ukraine and intend to establish a national Ukrainian enterprise.
Having taken into account the abovementioned trends, foreign pharmaceutical companies are looking for efficient ways to adapt to the policy of import substitution on the Ukrainian market. They are actively optimizing their businesses in order not to lose their market positions in Ukraine. Many international pharmaceutical companies reduce their production in Europe and transfer their enterprises to the developing countries, including the member countries of the Commonwealth of Independent States. For example, such international manufacturers of medicines as: Nycomed, Sanofi, Gedeon Richter, Polpharma, KRKA, STADA CIS, Servier have already started to place their enterprises within the territory of Russia, and some of them are going to develop their manufacturing in Ukraine as well.
The foreign pharmaceutical companies, which intend to take part in public procurement of pharmaceutical products in Ukraine, should pay their attention to the main provisions of the draft concept of import substitution, which concern this field, in particular:
- public procurement of only domestic pharmaceutical products, except indispensable patented foreign medicines;
- top-priority public procurement of the domestic pharmaceutical products, which are developed at the expense of public funds;
- providing preferences to the national pharmaceutical enterprises in the procedure of public procurement etc.
Possible ways of the foreign pharmaceutical companies’ adaptation to the policy of import substitution on the Ukrainian market include the following ones:
- purchase of manufacturing facilities in Ukraine;
- greenfield establishment of manufacturing facilities in Ukraine;
- contractual manufacturing of medicines;
- cooperation with the Ukrainian national manufacturers;
- using only the last packing stage of the medicines manufacturing in Ukraine, etc.
Peculiarities, advantages and disadvantages of each of the abovementioned ways of optimizing business in Ukraine require detailed analysis. Besides, practical implementation of these schemes needs a qualified legal support.