On July 13, 2015 a new set of amendments to Federal Law No. 61-FZ on the Circulation of Medicines of April 12, 2010 was approved by Federal Law No. 241-FZ on Amendments to the Federal Law on the Circulation of Medicines (hereinafter "Law 241-FZ"). The amendments have become the subject of criticism due to a number of provisions of Law 241-FZ.
Law 241-FZ clarifies in particular the set of documents required to confirm state registration of a pharmaceutical for medical application, whether such confirmation is requested before or after January 1, 2016. At the same time, the list of documents required for the respective application after January 1, 2016 includes a copy of a report on the pharmaceutical manufacturer's compliance with the good manufacturing practice rules (hereinafter the Rules) to be issued by the RF Ministry of Industry and Trade. Considering the number of manufacturers to be audited for such compliance, and also the novelty of this requirement and the absence of an approved procedure for carrying out such audits by the Ministry of Industry and Trade, it seems unlikely that the audit of all manufacturers will be successfully completed by the end of 2015. At the same time, foreign manufacturers of pharmaceuticals for veterinary use may submit a report on compliance with the Rules from a competent body of the manufacturer's country by 2017. Accordingly, unless the said deadline is postponed until a later date, the registration of pharmaceutical products for medicinal use by Russian manufacturers after January 1, 2016 may become impossible in practice and, therefore, no new pharmaceutical products will enter the market.
Further difficulties are created by the change in definition of the term "reference drug." That term introduced on July 1, 2015 means a drug that is registered for the first time, the quality, efficacy and safety of which have been proven on the basis of results of pre-clinical and clinical trials, and which is used to evaluate the bioequivalence or therapeutic equivalence, quality, efficacy and safety of a generic or analogue (biologically similar) drug. According to Law 241-FZ, a reference drug must go through the trials stipulated by Federal Law No. 429-FZ on Amendments to the Federal Law on the Circulation of Medicines of December 22, 2014 (hereinafter "Law 429-FZ"), including those of its provisions which are entering into force in 2016. This formally makes it impossible to register a drug as a reference drug before 2016. To prevent a collision between the above-mentioned provisions of law, Law 241-FZ clarifies that until January 1, 2016 an original drug shall be considered as the reference drug. It is worth noting that the very term "original drug" (apparently intended for applying Law 241-FZ) has already been removed from the legislation. According to comments from the Director of the Department of Drug Supply and Regulation of the Circulation of Medical Devices of the Russian Ministry of Health Yelena Maksimkina1, although the term was removed from the law, original drugs that have already been registered will retain their status and will be used as reference drugs. One can only hope that the Russian Health Ministry will indeed follow this principle in practice when registering pharmaceuticals.
At the same time, Law 241-FZ emphasizes the status of reference drugs for veterinary use, clarifying that such drugs must go through pre-clinical and clinical trials in accordance with the requirements established for veterinary drugs. In general, a number of provisions of law are made more detailed by Law 241-FZ, specifically regarding pharmaceuticals for veterinary use. For example, the list of documents to be sent together with the terms of reference for expert review of a veterinary pharmaceutical has been clarified, a procedure for completing the application for confirmation of state registration of a veterinary drug and the documents attached to the application has been detailed.
In addition to this, Law 241-FZ clarifies a number of provisions regarding the powers and interaction of government agencies, including for setting prices on so-called essential (vital) drugs. In order to get expedited expert review of drugs the order of applications for state registration is defined as under one international nonproprietary name of the drug or drug grouping name.
Law 241-FZ also indicates the sequence of actions to be taken when violations of the rules are discovered during the clinical trial of a drug. If such violations affect the completeness and accuracy of the clinical trial, then the competent body (the Federal Healthcare Supervisory Service) suspends the trial and issues an order to remedy the violations. If the medical organization conducting the trial fails to remedy the violations within the stated time period, a decision is taken to stop that trial.
It is also clarified that state registration of drugs for which applications are filed before the effective date of Law 429-FZ, and review of applications for state expert review of drugs filed before the effective date of Law 429-FZ follow the rules of law in effect prior to the entry into force of Law 429-FZ.
Changes to the Russian Federation Law on Veterinary Medicine
On July 1, 2015 the State Duma adopted in the third reading, and on July 8 the Federation Council approved the Federal Law on Amendments to the Russian Federation Law on Veterinary Medicine and Certain Legislative Acts of the Russian Federation. That Federal Law introduces significant changes to the legislation on veterinary medicine.
In particular, it is planned that the Russian Federation Ministry of Agriculture will adopt veterinary regulations governing all areas of veterinary medicine and various types of veterinary activity.
Also, it is intended to create the Federal State Veterinary Information System in which veterinary documents accompanying the products will be generated electronically (which will be mandatory starting January 1, 2018). The Law sets out the principle that veterinary supporting documents will be generated free of charge and that the competent governmental body has the duty to issue them in hard copy at the request of the owner of the product covered by the veterinary control requirement.
The Law obliges the RF Government to develop and approve a procedure for creating, developing and operating the Federal State Veterinary Information System, although it does not set the deadline for such procedure to be put in place. It is also provided that such procedure shall contain requirements to ensure access of individuals and legal entities to information contained in the Federal State Veterinary Information System, to enter information in the system, to obtain information from the system and register those entities in the system.
The Federal State Veterinary Information System will contain, in particular, information about pharmaceuticals, feeds and feed supplements for animals. Inasmuch as the Law does not provide for any provisions governing the procedure for entering data on pharmaceuticals, feeds and feed supplements for animals that have already been registered in that Federal System, it would be reasonable to suppose that such provisions will be included in the procedure for creating, developing and operating the said Federal Veterinary Information System, which the RF Government is responsible for developing and approving, as mentioned above.