The government has instructed all concerned departments to agree on the decision to waive the mandatory certification West immunobiological medicinal products. This follows from the minutes of the meeting held on 20 February at the Deputy chief of the government staff by Nelly Naigovzina (a copy of the minutes of the meeting have).
The document States that in the period up to March 15, the Ministry of industry and trade, Ministry of health, Roszdravnadzor and other agencies concerned should agree to the draft resolution of the government to exclude the immunobiological preparations from the single list of products subject to mandatory certification. In addition, agencies should consider amending legal acts, including Federal law “On circulation of medicines”, in terms of state control in the sphere of circulation of immunobiological medicines. Appropriate changes should be worked out in order to bring legal regulation into line with regulation of the Eurasian economic Union, it is specified in the document.
What immunobiological preparations
According to the Federal law №157 “About immunoprofilaktike infectious diseases”, in the category of immunobiological preparations include vaccines, toxoids, immunoglobulins and other medicinal products that are intended to create specific immunity to infectious diseases. According to DSM Group, the annual volume of the market of immunobiological products in the retail segment is about 54 billion rubles, and about 55 million packages. The expenditure budget for the purchase of vaccines under National immunisation schedule (NCP) in 2015 amounted to 10.2 billion rubles.
The press service of the government office and the Ministry of industry and trade has not responded to the request. Representatives of Roszdravnadzor and Ministry of health declined to comment before ruling. But a government source confirmed the meeting at Naigovzina, and a source in the leadership of the Ministry of health reported that the decision to abandon certification of vaccines really worked.
The decision to cancel certification of foreign vaccines may follow after in Russia are experiencing problems with their supplies. In January, the largest foreign vaccine manufacturers, Sanofi and GlaxoSmithKline said it was impossible to place their drugs on the Russian market from-for problems with certification.
Difficulties arose due to the fact that in November of 2015 Federal service for accreditation (Rosakkreditatsia) after an unscheduled inspection has suspended the license of the INSTITUTION “Scientific centre of medical products” (scemp), subordinated to the Ministry of health. In this, the certifying body all vaccines Sanofi and GSK have passed mandatory certification. Because of problems with certification disappeared from the market vaccine “Pentaxim”, “Act Hib” Sanofi “Infanrix Hexa” GSK.
Problems with the supply of foreign vaccines began in early 2015. But then the shortage of vaccines has been associated primarily with insufficient supplies manufacturers, told two sources in the pharmaceutical market. In the end, according to RNC Pharma, the total revenue from the sales of “Pentaxim” and “Infanrix” in Russia in 2015 compared with the previous year decreased by half, to 333,7 million rubles.
The planned withdrawal of certification is not directly connected with the arising deficit, says a source in the Ministry of health. The fact that from 1 January 2016, foreign pharmaceutical companies are obliged to register new drugs in accordance with Russian requirements (GMP), he explains. In addition, the Ministry was vested with the authority to conduct inspections of drug factories directly overseas. In many countries immunobiological preparations should meet the GMP standards, so that their additional certification in Russia is not required, adds the source.
The representatives of GSK, Sanofi and Pfizer (produces the vaccine “Prevenar-13”) reported that they do not know that the government is discussing the abolition of the certification of vaccines. Commenting on this initiative, they refused. The press service of “Natimbi” (“daughter” company “Microgen”, is the only supplier of vaccines for vaccinations that are included in NCP for 2015-2017) are unable to provide a comment.