Compulsory licensing of medicines should not influence prices, choice
The compulsory licensing of medicines should not influence their prices and choice, the Indian Pharmaceutical Manufacturers' Association in Ukraine (IPMA) has said.
IPMA said that the absence of a detailed mechanism and rules for the application of this legal requirement hinders the application of this tool in Ukraine.
"Although the compulsory licensing is mentioned in the law, a lack of a clearly defined mechanism and rules for the application of the law restricts its application in Ukraine. The development of an understandable legal act that would be based on international experience would facilitate the application of this special tool," the association told Interfax-Ukraine, commenting on of the Health Ministry's initiative to improve the tool for the use of compulsory licensing.
IPMA said that the compulsory licensing as an element of the rules of the international trading system, as provided for by the relevant international agreements, is a necessary phenomenon, and it is necessary to adapt these rules to the public health needs in the poorest countries and countries with limited production capacities in the pharmaceutical sector.
"Despite the fact that Ukraine has its own production pharmaceutical resource, it often does not keep up with the needs of the domestic healthcare system, so if not to adapt the legislation related to the rules of providing medicines during a special period in case of acute need, patients may face a shortage of some medicines," IPMA said.
The association said that the compulsory licensing rules do not ignore the rights of patent owners, but only for a certain period they limit these rights with the subsequent compensation and restoration of these rights after the end of the special period.
"The Health Ministry should have such a tool, and we consider its existence in Ukraine a prerequisite for timely provision of patients with necessary and modern medicines in extraordinary cases," the association said.
At the same time, IPMA said that the compulsory licensing under WTO rules is "an exceptional tool for achieving concrete goals for a limited period." This is an exception to the general rules of trade that provides for the issuance of a license, usually by a foreign producer to the manufacture of medicines for territory of another country and for a limited period. This tool for providing medicines should not be considered as a market tool for lowering prices and for increasing the choice.