For nearly three decades, GENESIS Pharma has provided a comprehensive array of services to facilitate patients’ seamless access to its innovative medicines in each and every market it serves, ranging from the local regulatory approvals and their reimbursement to the distribution, and ongoing support during the product life cycle.
More specifically, following the marketing authorization by the European Medicines Agency (EMA), we undertake all necessary activities to successfully bring a product in each market, including local regulatory procedures, market access, pharmacovigilance, sales and marketing, medical affairs, as well as storage and logistics. Our international agreements grant us exclusive rights for product sales, marketing, and distribution.
Each innovative drug presents a distinct therapeutic advantage for the patient it addresses, serving as a valuable treatment option for the medical community, and providing substantial benefits to healthcare systems. Representing numerous innovative treatments, predominantly targeting chronic and rare diseases, our foremost priority has always been and still is to ensure swift and unhindered access for patients in the markets we serve.
Simultaneously, as all our medicines are prescription drugs, we prioritize supporting healthcare professionals (doctors, pharmacists, etc.) with a strong emphasis on providing reliable, comprehensive, and scientifically accurate information. This is done in accordance with the European Medicines Agency (EMA) guidelines and local regulatory frameworks, in full compliance with legislative requirements at both European and local levels. Lastly, we ensure the utmost quality of our medicines throughout the stages of import, storage, distribution, and sale, while closely monitoring their safety during use.
Market Access
Market Access activities for the territory covered by GENESIS Pharma, which consists of 14 EU and 6 non-EU countries in the CEE region, are coordinated by our Market Access department. Over the years, this highly experienced team has successfully accomplished the pricing and reimbursement of numerous high-value and orphan medicines under various frameworks in each market including reference-based pricing, HTA localizations, negotiations with local authorities for execution of managed entry agreements, always aiming to optimize the added value of innovation. Part of the market access strategy we employ is also the implementation, in collaboration with our partners and our Medical Affairs department, of Early Access Programs that address the needs of patients earlier.
Medical Affairs
Our Medical Affairs department plays a pivotal role in supporting medical communities in each market. We engage in a wide range of activities during the product lifecycle, including continuous medical education and providing support to healthcare professionals through initiatives such as investigator-initiated study support, medical information management, disease awareness and diagnosis activities, hospital presentations, scientific webinars, and satellite symposia. All activities are conducted in strict compliance with local regulations and procedures. In addition, we foster scientific collaborations with physicians and institutions to generate local real-world data, which is crucial for Health Technology Assessment (HTA) activities and optimizing treatments in routine clinical practice. We also organize expert sessions to facilitate the exchange of clinical management experience among practitioners from different markets.