The Russian Pharmaceutical Forum of the Adam Smith Institute was held on May 14-15 in St. Petersburg. The leading players in the pharmaceutical market discussed the most pressing issues: labeling, reference pricing, government procurement, drug insurance, innovation potential, relationships with pharmacy chains, digitalization of healthcare, and a patient-oriented approach.
The participants of the event examined significant mergers and acquisitions in the Russian market in 2018 and development trends in this area this year; discussed one of the hottest trends in the global pharmaceutical industry — the use of data from real clinical practice in collecting evidence about the effectiveness of medicines. Prospects for the development of this area in the world and in Russia, problems of legislative regulation, issues of building effective partnerships with medical institutions and patients.
The discussion of drug labeling, which is scheduled for the end of 2019, caused a particularly heated discussion. Viсtor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, emphasized that the industry supports the ideology and goals of drug labeling, but it does not seem possible to implement labeling in accordance with the requirements of Government Resolution No. 1556 of December 14, 2018. This is due to the fact that the percentage of defect increases by 20-30%, and in some cases up to 89%, which is unacceptable and leads to large financial losses for producers. In addition, productivity is reduced, and cost increases, and that leads to an increase in the final selling price of drugs.
Until now, no final decision has been made on the size of the cryptocode. Regulators offer 44 signs, and manufacturers insist on reducing it at least twice. Data on the shelf life of the drug and the batch number are important for the industry and consumers, and lawmakers propose to remove this information.
Victor Dmitriev stressed that the current requirements for cryptographic protection, even if a decision is made to reduce the number of cryptocode characters, will inevitably lead to the impossibility of implementing the project on time. And this can lead to a man-made collapse and social tension. That is, in the first half of 2020 we will be left without drugs. Medicines will be in stock, but it will be prohibited to sell them without a label with a cryptocode.
The launch will be postponed for at least 12-18 months, taking into account the length of the approval and amendment of federal legislation.
Reminder that from January 1, 2020 labeling of drugs will be mandatory. Its order is defined by the Federal Law of December 28, 2017 No. 425-FL “On Amendments to the Federal Law“ On Circulation of Medicines ”. Pharmaceutical manufacturers, as well as legal entities and individual entrepreneurs who import, store, sell, use and destroy medicines, will have to enter information about medicines into the system for monitoring the movement of medicines for medical use. With the help of this system, any individual will be able to verify its legality when purchasing a drug.
The procedure for registering in the system, operating the system and entering information into it by participants in the drug market is established by Decree of the Government of the Russian Federation of December 14, 2017 No. 1556 “On Approval of the Regulations on the System for Monitoring the Movement of Medicinal Drugs for Medical Use”.
A separate section was devoted to issues of immunization and vaccination.
The Ministry of Industry and Trade suggests a 85% increase in the share of domestic vaccines by 2025. But in Russia, along with the positive aspects, there are serious problems that occur in the system of immunization. In our country, the immunization schedule includes 12 items, it is significantly less than in the developed countries. So in the EU there are 17, and in the US — 20. ARPM Director General Victor Dmitriev noted that many domestic vaccines are technologically outdated, and their production requires major reconstruction and bringing it in line with GMP requirements. The domestic pharmaceutical industry does not produce associated vaccines, which include 5 or more antigens, as well as vaccines against chickenpox, rotavirus and pneumococcal infection. There is no modern combined penta-and hexavaccine for children 1-2 years of age. There is no production of acellular pertussis vaccine, with a significant cost of imported, as well as inactivated polio and rubella vaccine.
New vaccines in the country have not been developed for a long time. Vaccines that were made in addition to the vaccination schedule are of foreign manufacture.
Recall that the expansion of the national immunization schedule is expected. It should include varicella and rotavirus vaccines. The effectiveness of vaccine prevention in the fight against infections is indisputable and generally accepted. It is proven by many years of world experience.