February is the time to set goals for the coming year. The Director General of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev summed up the results of 2019, announced plans and dreams for 2020 at the meeting of the Russian Association of Pharmaceutical Marketing (RAPM). Welcoming the audience, the head of the ARPM noted that "it is impossible to change the past, but to draw conclusions, to analyze errors is simply necessary."
Disruptions in public procurement of vital medicines have become widespread. The main reason is the methodology of the Ministry of Health in the formation of the maximum contract price. The Ministry thus tried to equalize purchase prices across the country, but it became unprofitable for manufacturers to enter the auction. “Unfortunately, goal-setting moved out at a certain time, the Ministry of Health said that their main task is not to conduct tenders, but to protect themselves from possible checks and accusations of embezzlement of state funds,” Victor Dmitriev noted.
Drug labeling. The experiment began in 2017 and was supposed to end on December 31. Throughout the year, the industry reported unpreparedness, indicating serious problems. The rules and requirements changed, there was a risk of a lack in drugs. As a result, the official deadline for the start of mandatory marking has been postponed, but questions regarding regulatory support, tracking goods online, and others remain unresolved. To date, the most prepared link are pharmaceutical manufacturers. In the labeling system, 72% of drugs in Russia are registered. And by July 1, 2020 there should be 100% readiness of the entire supply chain, all processes have to be worked out. “The countdown has been launched, a watch is installed on the website of the Association of Russian Pharmaceutical Manufacturers, where you can see up to a second how much time is left before the mandatory start. Today we have 138 days left. In the February issue of the journal “Pharmaceutical Industry”, a joint project of the ARPM and the Advanced Technology Development Center (ATDC) is launched, where specialists will talk, explain, and train how to work in the system and with the system,” Victor Dmitriev explained.
“4 months are left before the mandatory labeling comes into force. Our task is to make labeling easier to handle and record drugs for pharmacies and medical institutions and give patients confidence in the originality and quality of the drugs,” said Dmitry Alkhazov, Director General of the ATDC Operator.
Drug reimbursement model. According to the order of the President of the Russian Federation V.V. Putin, by July 1, 2020, the government needs to submit methodological proposals for a pilot project. Today, at the federal level, there is no understanding of how drug reimbursement models will be implemented, and there are no regulatory legal acts. “There is a pilot project that was implemented in Kirov, it is not perfect, but it is an experience and it needs to be considered,” the expert said.
Today, we have identified 47 regions that have agreed to join the pilot and 23 drugs that will participate in this. It remains only to determine the model and approve all the nuances at the legislative level. So far, inter-agency disagreements have been hindering this.
“Regulatory guillotine” will eliminate unnecessary norms in the pharmaceutical market. The industry hopes that the reform of control and supervision activities will not only eliminate all obsolete acts, eliminate duplicate norms, and change the structure of the regulator.
Rosleknadzor (Drug Surveillance). The “many-headedness” of the regulator impedes market opportunities and industry development. ARPM position — there should be a single oversight body in the country, as in all civilized countries. It is planned that in 2020, nine constituent entities of the Russian Federation will become participants in a pilot project to create a unified body of state power, responsible for the implementation of control and supervision activities. This was reported in the Ministry of Economic Development, according to the TASS.
Import of unregistered drugs. Last year was associated with the tragedies of small patients in need of foreign medicines. In a message to the Federal Assembly, the head of state ordered that this problem be resolved. From March 1, it is planned to allow unregistered psychotropic drugs necessary for the treatment of patients to be imported into the country. The Ministry of Health has published a list of psychotropic drugs not registered in the Russian Federation. Victor Dmitriev expressed concern that “as a result of such actions, originating companies will simply leave the market: why spend money and time on registration, clinical trials, it is easier to raise patient communities and relatives of patients and import unregistered”.
Interchangeability. Why is this needed? The Russian pharmaceutical market today is awash with a huge number of original drugs and generics. And their manufacturers are very different. There should be a single system that would be regularly updated as new drugs are released. Viсtor Dmitriev supports interchangeability, but "it should be applied at the registration stage, and not after the drug has been rolled out on the market for 20 years."
Compulsory licensing and patent protection. The development, testing, production and launch of innovative drugs on the market is aimed at improving the quality and life expectancy of the population. The innovator invests huge intellectual and financial resources, and wants to protect his developments. The protection of intellectual property in the pharmaceutical field is one of the paramount areas. To minimize the risks of unfair competition, it is necessary to regulate the decision-making procedure for issuing a compulsory license. Market participants must clearly and unequivocally understand: when it is possible, to whom is it possible and what does the patent holder receive? Today, Rospatent has created an Interdepartmental Working Group on Intellectual Property in the field of pharmaceuticals. And the final proposals and decisions of the working group will be included in a separate block of the action plan — the development strategy of the pharmaceutical industry "Pharma 2030".
Online drug sales. Scientific and technological progress does not stand still, in the world remote trade is developing at a furious pace. The pharmaceutical market is waiting for big changes, on the one hand — these are risks, on the other — a benefit. However, today there is no unequivocal opinion — are patients ready to buy medicines online? Who will deliver the orders and how? Is there a risk of acquiring low-quality or expired goods? Victor Dmitriev voiced the position of the business on such an urgent and difficult issue: “The Internet is the main way to spread counterfeit products. You should not rush into this undertaking, there must be a certain phasing, both temporary and structural. The rules must be clearly defined, who can and what is the responsibility.” To date, the remote sale of drugs in Russia is prohibited. In general, the professional community is confident: despite all the risks, there are pluses. Internet commerce will create convenience for the busy mobile part of society.
Eurasian Economic Union. The process of re-registration of medicines according to the uniform rules of the Eurasian Union has begun. Until December 31, 2020, pharmaceutical companies have the right to choose according to which rules to register their drugs — national or union. From January 1, 2021, all medicines will be registered only according to the uniform rules of the Union. And the authorized person of the company must be certified according to the rules of the EAEU, and this is more than 1000 people. The Ministry of Health for this procedure has to approve additional regulations. At an interagency meeting with representatives of the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Education and Science and specialized higher education institutions, the Association of Russian Pharmaceutical Manufacturers proposed re-certification of authorized persons through the recognition of the Russian GMP certificate (according to formal terms), and later, upon expiration of the certificate, certification in accordance with Eurasian rules in a planned manner. At present, amendments are being prepared to improve the certification procedure and eliminate redundant provisions and requirements.
Leading industry experts have high hopes for the new composition of the Ministry of Health, in particular for Mikhail Murashko, who named the priorities for the development of healthcare in Russia. According to the head of the Ministry of Health, the main priority will be patient orientation.
Association of Russian Pharmaceutical Manufacturers
The Association of Russian Pharmaceutical Manufacturers (ARPM) was founded in 2002. ARPM unites leading Russian pharmaceutical enterprises, which account for more than 90% of drugs manufactured in the country, about 45% of exports, more than 75% of domestic drugs in the Provision of Essential Medicines program. The activities of the Association are designed to promote the competitiveness of the domestic pharmaceutical industry and to facilitate the integration of the domestic pharmaceutical industry into the world market while maintaining and increasing the production and financial potential of the industry. ARPM is a member of the Chamber of Commerce and Industry of the Russian Federation, actively cooperates with relevant federal state authorities: the Ministry of Health of the Russian Federation, Federal Service for Surveillance in Healthcare (Roszdravnadzor), the Ministry of Industry and Trade of the Russian Federation, and the State Duma Committee for Health Protection. Representatives of the ARPM are members of the Council for the Development of the Pharmaceutical and Medical Industry under the Government of the Russian Federation.