Deputies submitted a bill to the State Duma of the Russian Federation on the phased implementation of drug labeling until July 1, 2020. The text of document No. 834261–7 is published on the portal of draft legal acts. 64 deputies and 3 members of the Federation Council have already joined the initiative.
The bill says that “medicinal products for medical use intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, people after transplantation of organs and (or) tissue entered into civil circulation before October 1, 2019, as well as other medicinal products for medical use, introduced into civil circulation before July 1, 2020, must be stored, released, implemented, transmissioned, without the use of identification means applying till their expiration date".
According to the current legislation, from January 1, 2020, more than 350 thousand market participants must be registered in the Drug movement monitoring (DMM) system, the system will track over 6 billion packages of medicines. However, according to Federal Service for Surveillance in Healthcare (Roszdravnadzor) as of November 13, 2019, only 37,351 legal entities were registered in the system, and this is only 15%.
Elena Kudryavtseva, Deputy Head of the Department for Organization of State Quality Control of Medical Products of Roszdravnadzor, said: “In October, the number of participants increased by 11,000. Now the number of participants increases by 1 thousand on average per day.” If the dynamics continue, by July 1, over 130,000 participants will remain unregistered.
There is a month and a half left until the end of the experiment. Manufacturers, distributors, pharmacies note the unavailability of the industry and express their concerns. At a meeting of the Inter-Fractional Working Group on Improving Legislation in the Field of Medicinal Supply of Citizens and the Circulation of Medicines on November 14, they said that it was necessary to move systematically taking into account business realities. The benefit for the State from the intensive implementation of a complex project is not worth the risks that could affect the health and lives of the end user. But not all wishes and requirements are taken into account in the new bill. According to the Director General of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev: “It was promised that each manufacturer will receive free access to data on the movement of own products, while access to analytics is closed. Today, the manufacturer, as soon as the product is shipped, loses the ability to track the movement of drugs. Manufacturers bear the cost of introducing labeling, as well as marketing research. Therefore, we can say that today there is no practical benefit from the DMM system for the manufacturer. This is an alarming and painful moment, we hope that this will be solved. "The group of drugs that receive cryptocode for free is not expanded. The business insisted on including drugs of a low price segment up to 50 rubles. In addition, the postpay for code is also not provided.
Sergey Shulyak, CEO of DSM Group: “In the market structure, the share of drugs up to 20 rubles is only 1% of the turnover, but in the structure of sales in packages it is 19%. If you expand the list of free labeling to 50 rubles, then this is 42% of the packages of the market! Advanced Technology Development Center (ATDC) is a commercial structure, no one will go down by almost 2 times ”.
However, the main goal of the project is not to increase the incomes of the ATDC, but to make the market more transparent, saving it from falsified and substandard drugs.
The head of the ARPM drew attention to the fact that the text of the amendments does not have a clear wording of the concept of “entering into civil circulation”. Valentina Kosenko, Deputy Head of Roszdravnadzor, proposed taking as a basis the wording of Government Decision No. 1556: “On Approving the Regulation on the System for Monitoring the Movement of Medicinal Products for Medical Use” dated 12/14/2018. In addition, the number of cryptocode characters remained unchanged, although the industry still insists on 20 characters.
“The provisions of the bill are aimed at improving the situation of the subjects of circulation of medicines, as they clarify the rights and obligations of the government of the Russian Federation and issuers of identification measures,” the explanatory note says. But the measures taken are not enough and despite the complexity of the current moment, forums, conferences and meetings talk about painful things, in the hope that both the regulator and the operator will hear them.
The information systems of the experiment participants are under development. Their adaptation to the processes of each company and testing will take time. Ready-made IT solutions for the pharmaceutical industry and the DMM system will not appear until the second quarter of 2020.
Margarita Mustafina, Project Manager, TEVA: “It’s not only important to print the code, create a report, send something to the DMM, but for this it is necessary to describe the drug. We managed to do this for 198 products, 68 are still in the description stage with some mistakes, and what to do about it?”
Vladimir Anikeev, Advisor to the Director General for Legal Affairs, Biocad: “Information from the DMM must have a fixed legal qualification. If we read and see that something is wrong, then measures should be taken to seize drugs, some kind of administrative response. For this, it is necessary to amend 61-FL. The withdrawal of drugs from circulation is what is lacking. ”
The industry has been systematically preparing for the beginning of this serious project for three years. But the rules of the game are constantly changing, and a month and a half before the start, changes are coming again. Good or bad — time will tell. The business hopes that all necessary amendments will be introduced and adopted at least in the second reading.
“In the end, the patient will pay for everything, at the cost of his life. Let’s work so that the proverb “wanted to do the best, but it turned out as always” was not realized, ”summarized Yuri Zhulev, co-chair of the All-Russian Union of Patient Public Associations.