N. Sharavskaya: Innovative medicine through a prism of the current law

| By | FAS Russia, innovative medicine

Representatives of the pharmaceutical business and the authorities discussed the prospects for innovative medicine in the Russian markets

Last week Moscow hosted the “Formula of the Future” I National Congress devoted to development of innovations in the pharmaceutical and medical industry. The position of the competition authority was outlined by Deputy Head of FAS Department for Control over Social Sphere and Trade, Nadezhda Sharavskaya, at the session “How to integrate innovative medicine in the landscape of domestic pharmaceutical market”.

One of the discussed items was expediency of formalizing the concept of “innovativeness” at the legislative level.

A system for evaluating innovativeness should be introduced and it is being introduced. First of all, however, it is necessary to understand, for which purposes it will be used”, pointed out Nadezhda Sharavskaya. “Today the Federal Antimonopoly Service does not clearly comprehend the goals of introducing the new concept to the law, except marketing by companies. We believe that the current law already contains sufficient number of concepts that cover all meanings of the term – “innovative medicine”, particularly, patent-protected medicine, reference medicine, etc.

She emphasized that Russian law has a system of preferences for such medicine that includes intellectual property protection, fast-track procedure of expert examination of medicine for the purposes of official registration of orphan medicine, simplified registration of such medicine, the declarative principle for registering reference medicine prices, support to localized manufacturers under the Pharma-2020 Programme, as well as the system for evaluating innovative medicine in order to include in the government programmes for medicines supplies to the population.

For instance, Nadezhda Sharavskaya pointed out that medicine are included in the list of vital and essential medicine on the basis of their comprehensive assessment, particularly, assessment of therapeutic advantages and economic efficiency of including certain medicine. At the same time, the speaker underlined the importance of improving the current system.

“To make the procedure of including medicine in the list of vital and essential medicines maximum transparent, we must move as soon as possible from subjective to quantitative estimates”, stated Deputy Head of FAS Department for Control over Social Sphere and Trade.

Regarding risk-sharing, Nadezhda Sharavskaya pointed out that the Antimonopoly Service supports only the projects where the following conditions are met in their totality:

  • patent protection of a medicine;
  • no registered analogues;
  • medicine is not on the list of vital and essential ones;
  • ex-works price does not exceed the level of prices estimated in accord with the guidelines;
  • need to use a drug is determined by inability to use any other medicine and is aimed at protecting the rights of the population for access to new medicines in life-threatening situations or as palliative therapy (particularly, in the absence of registered indications);
  • project is necessary to assess economic efficiency of using the medicine provided there is 100% costs compensation of budgetary funds – by themedicine supplier if the project outcome is negative;
  • patients that receive a medicine under the project must be insured in accord with No. 61 Federal Law “On medicinal drugs circulation” of 12.04.2010;
  • project is executed in line with the common rules, requirements, document samples drafted and approved by the Ministry of Healthcare.

Unfortunately, FAS has been receiving only those projects for approval that do not meet the above conditions. For example, FAS found the project of the Ministry of Healthcare on providing “Abirateron” to the population anticompetitive since its four analogues are available in the market.

Medicine pricing was also discussed. The draft law, submitted to the State Duma provides for re-registering prices on all medicines on the list of vital and essential medicine.

“Prices will be reviewed according to the current rules and method, additional price leverages. The State Register of Prices should be put in order and unified”, explained Nadezhda Sharavskaya.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.