Asgar Rangoonwala, Managing Director, Emerging Markets, Janssen Pharmaceutical Companies of Johnson & Johnson
Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor)
In recent years, we have seen significant advances in the development of innovative medicines that are changing the way we think about treating many serious, deadly diseases. Drugs based on cell therapy, gene therapy and tissue engineering can be referred to a special group. These revolutionary solutions may give hope to patients for whom there is currently no effective treatment. Because of the specific nature of innovative medicines, many healthcare systems face the question of how to adapt and optimize the regulatory environment for their marketability and accessibility to patients. Russia is also continuously improving its regulatory and legal documents, both within the national legal framework and at the level of interstate cooperation within the EAEU. Given the clinical successes and the demand for new life-saving medicines among patients, there is a need to develop practical solutions that will make innovative high-tech medicines available as soon as possible.
Discussion points: • Key barriers to accessibility of life-saving innovative solutions and opportunities to address them • Areas of harmonization of Russian and EAEU legislation in the field of circulation of high-tech medicines. • Creation of special regimes for circulation of high-tech medicines in Russia — necessity and specifics.