It is pointless to continue doing the same and wait for different results

The pharmaceutical industry is at the crossroads of interests between healthcare and patients. Its development is one of the state priorities, therefore it is very important to maintain a balance of interests in providing the population with affordable drugs. Today there are many sensitive topics that need to be considered from different points of view in order to make the right decision. The challenges facing the market were discussed by industry experts at a round table in the amber capital and online on September 25 within the framework of the Partnership "Medicines of Russia — for an interdisciplinary dialogue".

The forum was held with the support of the Ministry of Health of the Kaliningrad Region. The head of the region Anton Alikhanov addressed the participants with a welcoming speech. He noted that the health of Russian citizens is one of the main state tasks, and the volume of expenditures on drug provision is increasing every year. This is also confirmed by analysts.

So the growth driver is still the state segment. Overall, in 2020, sales of pharmaceuticals grew by 15% compared to last year, although the retail market saw a 3% decline in packages. This is due to the fact that the consumer saves and chooses a larger package.

According to Maria Denisova, Chief Operating Officer of IQVIA: “There are two negative factors affecting the market: a pandemic and a further deterioration in the economic situation. The strong dependence of regional budgets on the federal one is present. The patient chooses cheaper drugs, and distributors and pharmacies revise their assortment. Manufacturers have postponed the launch of new planned drugs on the market, with the exception of the anticovid list of drugs. Until the end of the year, the market will grow by 7%, and in the retail segment — no more than 4%. "

According to Cursor-Marketing, in the first half of the year, the number of announced tenders decreased by 5% (183.8 thousand), although in monetary terms an increase of 15% was recorded due to purchases from a single supplier without an auction of goods for prophylaxis, prevention, liquidation of the consequences of the spread of coronavirus infection. If less than 1 billion rubles were spent on the purchase without announcing the tender procedure in 2019, then in 7 months this year it is 20 times more.

 According to statistics, the costs of providing outpatient, inpatient and high-tech care are growing. In world practice, there are mechanisms that significantly reduce costs, for example, purchases based on the “risk-sharing” model, multi-indication pricing, payment “by subscription” and others. “This is an opportunity to expand the criteria for tenders, most of them are result-oriented and contribute to obtaining the best value for money for the customer. But the legislation of the Russian Federation does not allow us to use these approaches, — said Vitaly Omelyanovsky, Director General of the Center for Expertise and Quality Control of Medical Aid of the Ministry of Health of the Russian Federation. — To increase drug availability in the country, drug reimbursement of costs to the population should start working. It is important and effective both for the healthcare system and for the pharmaceutical industry, and even more important, of course, for patients. "

In 2020, the country was supposed to start "pilot projects" on drug reimbursement. Forty seven regions expressed their consent — 23 drugs for the treatment of cardiovascular diseases have been identified. Funding was allocated and the regulatory framework was finalized, but due to the situation with coronavirus infection, the project was suspended.

The regulatory framework in the field of drug circulation is constantly being improved, but problems remain. Importation of unregistered medicinal products into Russia, pricing, use of off-label medicinal products, electronic prescription system, distance selling of medicinal products, registration of medicinal products, clinical and preclinical trials — there are acute unresolved issues in each area.

Drug labeling is one of the main and problematic issues. The system started in a "soft" mode. Companies that did not have time to prepare were allowed to produce drugs without labeling. And those who prepared and began to label their products incur losses, working "for the warehouse", and competitors occupy their niche in the market. Pharmacies and distributors do not want to work with labeled products for various reasons. The Center for the Development of Advanced Technologies (CDAT) — operator assured that after October 6, technical problems will be eliminated. Companies can only wait and hope. State Duma deputy Alexander Petrov calls on companies to sue the operator and demand reimbursement of financial costs.

ARPM General Director Victor Dmitriev said that the Association applied to the FAS of Russia for an assessment of the current competitive environment. “The authority explained to us that according to the Decree of the President of the Russian Federation dated January 21, 2020 No. 21“ On the structure of federal executive bodies ”, the Government of the Russian Federation is not included in the structure of federal executive bodies. In this regard, FAS of Russia does not exercise control over the activities of the Government of the Russian Federation. At the same time, FAS of Russia reports that according to Part 1 of Art. 208 of the Code of Administrative Procedure of the Russian Federation, persons in respect of whom a regulatory legal act has been applied, as well as persons who are subjects of relations regulated by the contested normative legal act, if they believe that their rights were violated or are being violated by this act, or their freedoms and legitimate interests, have the right to apply to the court with an administrative statement of claim declaring the normative legal act invalid in whole or in part. In addition, FAS of Russia informs that the appeal of the Association of Russian Pharmaceutical Manufacturers is sent to the Ministry of Industry and Trade of Russia and the Ministry of Health of Russia, as authorized bodies of power of the Russian Federation for the coordination of activities in the field of drug circulation for consideration by competence ", — quoted the response of the authority to the Association Victor Dmitriev.

In addition, traditionally, within the framework of the Partnership, the law enforcement practice of the current year in the field of state procurement of drugs for medical use has been reviewed and analyzed.

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

For reference:

Partnering "Russian Medicines — Towards Interdisciplinary Dialogue" is an annual meeting of representatives of the legislative and executive authorities, pharmaceutical manufacturers, distributors, retail, scientific and patient communities, a place for discussing the most acute and pressing problems of the pharmaceutical market. The recording of the event is available on the YouTube channel of the Association of Russian Pharmaceutical Manufacturers:


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