Experts discussed ways to improve access to innovative medicines for Russian patients

Progress in the treatment of diseases today is largely determined by the availability of innovative therapies. Without them, it is impossible to achieve the key targets of national programs aimed at increasing life expectancy and combating critical diseases.

Mikhail Tsyferov, President of Petrovax Pharm, took part in the session “Access to Innovations in the Pharmaceutical Industry” at the 5th Right to Health Congress, together with representatives of regulatory authorities, the pharmaceutical industry, and patient organizations. The participants discussed barriers and possible ways to improve the accessibility of innovative medicines in Russia.

According to Alexey Fedorov, an expert of the All-Russian Union of Patients, the pathway from registration to patient access for an innovative drug in Russia currently takes five to seven years:

One of the key issues hindering access to innovative therapies is the absence of a clear regulatory definition of an innovative medicinal product.

Elena Maksimkina, Director of the Federal Center for Planning and Organization of Drug Provision of Citizens of the Ministry of Health of the Russian Federation, believes that to facilitate the inclusion of innovative drugs into the List of Vital and Essential Medicines (Essential Drug List, EDL), it is necessary to create a ‘longlist’. Medicines entering it would then undergo an innovation assessment. She noted that for candidates aiming at inclusion it would be desirable to meet the requirements of technological sovereignty, meaning they should be manufactured in Russia and contribute to the development of the domestic pharmaceutical industry.

In addition, Ms. Maksimkina proposed that when considering drugs for inclusion in the List of Vital and Essential Medicines (Essential Drug List, EDL), the actual status of patients in Russia should be taken into account—an approach proposed by Petrovax Pharm at the August meeting of the EDL Commission.

Mikhail Tsyferov, President of Petrovax Pharm, emphasized that although Russian innovative medicines have been authorized in recent years, their actual access to patients is delayed by 1.5–2 years due to lengthy procedures for inclusion in Clinical Guidelines, Diagnosis-Related Groups (DRGs), and the EDL. This, he noted, reduces the efficiency of investments made by the Russian pharmaceutical industry.

The company president underlined that streamlining and shortening procedures for domestic companies to enter regulatory lists, Clinical Guidelines, and DRGs is essential to improve access to innovations. This would not only help save patients’ lives but also generate significant savings for the national healthcare system.

He added that for the domestic pharmaceutical industry, a long-term planning horizon (5–10 years) is crucial, as they enable significant price reductions. For example, until recently, there were only two molecules available for the treatment of Fabry disease. Petrovax Pharm has localized full-cycle production of a biosimilar of one of these molecules in Russia.

To ensure an objective evaluation of treatment experience in real-world clinical practice, Petrovax Pharm is launching an observational study in collaboration with Sechenov University.

According to him, when including drugs in official lists, it is important to consider clinical efficacy, added therapeutic value, and the impact on the healthcare system. At the same time, the goals of import substitution and support for the domestic pharmaceutical industry must not be overlooked — the industry is already achieving what was unimaginable twenty years ago.

At the conclusion of the discussion, participants have concurred that patients, physicians, and industry share a common goal — to improve public health. Therefore, every possible effort must be made to ensure that innovations become truly accessible.