Rus Eng
Main / Company's news / GEROPHARM discussed the issues on harmonization of the requirements for drug circulation at the round table of the EAEU

GEROPHARM discussed the issues on harmonization of the requirements for drug circulation at the round table of the EAEU

20 May 2016

On May 19 GEROPHARM took part in the round table "Harmonization of the requirements for drug circulation within the territory of the Eurasian Economic Union" that was held in the framework of the IVCongress of the Euro-Asian Society for Infectious Diseases. Dmitry Chagin, the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union, was the moderator of the event.

The discussion raised such issues like drugs interchangeability, pricing methods, protection of intellectual property rights, compliance with GMP regulations and state inspection strategy of external sites of pharmaceutical manufacturers.

The Economic Security Director Andrey Akhantiev noted that the most pressing issue for company is the compliance with the law "On the contract system", which is often violated - tenders are announced on the basis of trade names or other kinds of protection, leading to the procurement of a particular drug by its trade name. Following the results of 2015, only one third of all tenders were carried out in accordance with the law on trademarks. When the law violations are considered in the regions, the customers often promote the idea that insulin drugs are not interchangeable. "We hope that the procedure supposed to identify drug products interchangeability, which has been already implemented in the Russian legislation, will help to deal with the law violations and deprive customers of the opportunity to refer to the problem of insulin non-interchangeability," said Andrey Akhantiev. "Of course, the procedure should beclearly set out, and a number of amendments to the law on drug circulation is required, so that patients could have some guarantee that they get good-quality and effective drugs, and manufacturers could not face additional difficulties and administrative barriers. So, there should be, for example, stop time for the period when additional tests for interchangeability confirmation are carried out. On the whole, this procedure is extremely necessary, and I hope that the legal succession will be respected during the transition to the single market of the Union".

At the conclusion of the round table, the key messages,focused on the strengthening of interactionbetween the Association and the medicaland patientcommunities, were formulated, and the main stages, necessary for the creation of National Drug Policy, were defined.

You are a health care professional?

Go up