Dialogues about drugs: to fix mistakes, to scale good

The issue of the availability of medicines during a pandemic has become especially acute. The domestic pharmaceutical industry, faced with restrictions caused by the spread of COVID-19, nevertheless continued to provide the population with medicines and even, if necessary, increased the pace of production, maintaining the uninterrupted supply of pharmaceutical products. A number of bills were adopted to improve the availability of medicines and quality medical care. However, not all problems have been solved, not all questions have been answered. On September 24, participants of the IX Partnering “Russian Medicines — to an Interdisciplinary Dialogue” discussed in which direction to move further.

The forum, organized by the Association of Russian Pharmaceutical Manufacturers (ARPM), was held in Kaliningrad with the support of the Ministry of Health of the Kaliningrad Region. Deputy Prime Minister of the Government of the Kaliningrad Region Ilya Barinov, welcoming the participants of the Partnering in the amber capital of Russia, noted that a range of issues has risen in the pharmaceutical industry that require comprehensive discussion on the part of pharmaceutical manufacturers, representatives of the Ministry of Health, the Ministry of Industry and Trade, FAS of Russia, as well as public and patient organizations. Barinov wished everyone fruitful work and expressed confidence that this meeting would help develop constructive solutions that would be implemented at the federal level.

The floor was taken by the Chairman of the Public Council under the Federal Service for Surveillance in Healthcare, General Director of the ARPM Victor Dmitriev, who stressed that, indeed, despite the colossal efforts on the part of the authorities and business, as well as serious financial support, problems in drug supply remain, and it is important to have mechanisms that allow to quickly respond to problem situations and solve them. “And such forums,” he said, “that allow not only to reveal weaknesses, but, most importantly, offer solutions to complex issues to prevent recurrences of mistakes and failures, are extremely important for the system of public control. Today, the provision of prescribed groups of patients with medicines is a priority task for health systems at all levels. It can be solved only through constructive interaction between the state, business and public institutions.»

An effective mechanism for the interregional distribution of drugs is a centralized system of public procurement, says Elena Astapenko, Director of the Department for Regulation of the Circulation of Medicines and Medical Devices of the Ministry of Health of Russia. “Centralized procurement at the federal level is both the stability of financing, and the possibility of creating a carry-over and redistribution of drugs between the subjects, and saving budget funds,” she notes. All this is ensured thanks to the joint work of the Ministry of Health of Russia and Federal Governmental Institution (FGI) «Federal Center for the Regulation and Organization of Medicinal Provision of Citizens». Ms. Astapenko also noted the work of the newly created «Circle of Kindness» fund, noting that the Fund is empowered to purchase medicines unregistered in Russia.

“According to FGI, over the period of its activity, the «Circle of Kindness» Fund purchased medicines worth about 19 billion rubles, and contracts for more than 7 billion rubles (with carry-over) have been signed,” continued Elena Maksimkina, Director of the «Federal Center for regulation and organization of drug provision of citizens» of the Ministry of Health of Russia. She also said that within the framework of its activities, FGI is working to have long-term planning in order to really guarantee the patient the long-term nature of the drug supply. And already in the first year of operation, the center signed 5 long-term contracts, which saved 15 billion rubles in a three-year period. The speaker also drew attention to the problematic moments. For example, a trip of representatives of FGI to Vladimir showed that there is only one point for dispensing drugs for 14 high-cost nosologies (HCN) in the entire Vladimir region. And, for sure, this situation is not only in that region. Approaching the issue of «the second extra», Ms. Maksimkina stressed that, first of all, the Russian Federation should have all the technologies that would allow the production and reproduction of both innovative and biosimilar, generic drugs of appropriate quality. “If we want RND to develop on the territory of the Russian Federation, we need to support preferential programs,” she said.

The pandemic has shown us how important drug safety is. Dmitry Galkin, Director of the Department for Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, noted that in a difficult covid time, in the conditions of extremely unstable interaction both within the country and within the European Union and the whole world, the domestic pharmaceutical industry was able to quickly reorganize, and today 21 drugs out of 29 recommended for the treatment of COVID-19 have production stages in the Russian Federation. Also, Russia has already registered 5 anticovid vaccines. The representative of the Ministry of Industry and Trade expressed the hope that this year the strategy for the development of the pharmaceutical industry «Pharma-2030» will be approved, an updated version of which the authority plans to present in the near future, and it will also take into account the experience gained during the pandemic.

It is necessary to improve the procurement procedure for medicines, says Valery Alekseev, executive director of the Investigation Bureau of the Public People’s Front (PPF). The Fund is actively working in this direction together with the Ministry of Health of Russia. Noting the danger posed by the decentralization of drug procurement, when the price of the same drugs in neighboring regions may differ 2-3 times, Mr. Alekseev also drew attention to how important it is to give freedom to clinics, especially large ones, which are experiencing a shortage of drugs due to unsuccessful pprocurements or have an unscheduled need, for example, in drugs used in urgent conditions. PPF sees it necessary to consider the possibility of organizing procurement procedures for clinics on the principle of pharmacies, that is, with direct access to information on the availability and volume of drugs in distributors’ warehouses. “People cannot wait in hospitals,” the speaker said. He also stressed the importance and necessity of digitalizing the healthcare system.

Yuri Zhulev, co-chairman of the All-Russian Union of Patients, told how the solution to the problem of drug accessibility is seen from the patients’ point of view. Emphasizing the need to build patient-oriented business models, he assured: «We are ready to engage in dialogue with professional associations to discuss and fill this term and to «push» pharmaceutical manufacturers to implement the principles of patient-focusing.» Mr. Zhulev also pointed out that the role of the domestic pharmaceutical industry has undoubtedly increased in view of the challenges we faced in the context of the pandemic.

“We are hostages of the big Pharma development trend,” says Alexander Khadzhidis, Chairman of the Professional Medical Association of Clinical Pharmacologists of St. Petersburg. He, as a clinical pharmacologist, noted that today evidence-based medicine is largely a marketing tool, since more than 90% of published studies do not allow for better decision making and do not benefit the patient. The social responsibility of the state is, among other things, adequate regulation of the pharmaceutical market and determination of the vector for the development of the pharmaceutical industry.

The dynamics of drug supply in the Kaliningrad region was highlighted by Sergei Reshin, director of the State Budgetary Healthcare Institution «Kaliningrad Regional Pharmaceutical Company». The ratio of the federal and regional budgets in the Kaliningrad region in 2017 was as follows: 280 million rubles were allocated under the federal benefit, 487 million — under the regional. In 2021, the situation changed: 315 million from the federal budget, more than 1 billion rubles — from the regional. Funding has tripled, while the number of beneficiaries has increased by only 14% and the range of nosologies within the framework of preferential drug provision has expanded significantly.

In the country as a whole, according to Cursor-Marketing data, there is a slight 2% decrease in the number of announced tenders in government procurement of medicinal products compared to 2020, and in monetary terms (at the initial maximum price) we have an increase in 6%. A different picture is observed under contracts with a single supplier: a slight increase in quantity and a significant, more than 2 times — in monetary value. This data was shared with the audience by the general director of the agency Ekaterina Zadonskaya.

The trends in legal regulation of state procurements of medicines in 2020-2021 were highlighted in his speech by Konstantin Sharlovsky, Head of the Pharmacy and Healthcare Practice of the Pepeliaev Group Legal Company. The speaker noted 4 main trends: the completion of the global re-registration of prices for VED, a reduction in the possibility of procurements of drugs not from the List, the recognition of the legal practice of concluding a framework agreement by regional pharmacies for the purchase of drugs and medical products under 223-FL, and an ongoing trend — the fight against cartels.

The experts were unanimous that a patient-oriented model for the development of healthcare and the pharmaceutical industry is one of the most promising directions. It allows meeting today’s regulatory and industry challenges while maintaining a focus on the availability of effective, quality and safe medicines for patients.

At the end of the event, Alexander Kravchenko, Minister of Health of the Kaliningrad Region, pointed out that the topics discussed at the Partnering are very relevant and relate to all subjects involved in drug provision. In his opinion, it was especially important to hear from colleagues from the PPF and the Union of Patients, as they give feedback and can indirectly assess the effectiveness of the work of relevant ministries and authorities. “We have not found answers to all the questions and we understand that it is impossible to stop this discussion. And this means that there will be a Partnering!”, The head of the Kaliningrad Ministry of Health concluded the discussion.

As part of the Partnering, a cooperation agreement was signed between the Association of Russian Pharmaceutical Manufacturers and the Pepeliaev Group Law Firm. Victor Dmitriev noted that the association has been cooperating with Pepeliaev Group for a long time, and now, finally, the opportunity presented itself to formalize this cooperation.

Informational support to the forum was provided by «GxP news», «Pharma.RF», «Moscow pharmacies», «Polyclinic», «INFARM».

ARPM expresses gratitude to the organizers and all participants of the meeting. We are waiting for you at the tenth anniversary Partnering » Russian Medicines — to an Interdisciplinary Dialogue», which will be held in Kaliningrad in 2022. The recording of the event is available on the YouTube channel of the Association of Russian Pharmaceutical Manufacturers.

For reference:

Partnering «Russian Medicines – to an Interdisciplinary Dialogue» is an annual meeting of representatives of the legislative and executive authorities, pharmaceutical manufacturers, distributors, retail, scientific and patient communities, a place to discuss the most acute and pressing problems of the pharmaceutical market.

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