Every day, academic scientists and the private sector are contributing to numeous scientific discoveries. It takes time – often years or even decades – for scientific progress to bring practical benefits to patients. Constant investment in the research and development of new medicines results in breakthrough innovation with major benefits for patients.
Innovative medicines are products containing a new, original molecule, whose therapeutic effect has been tested and proven in clinical trials and which are protected under the patent. This patent gives the manufacturing company the exclusive right to market the respective drug for a certain period of time (according to the regulations in force), which covers and reflects the initial investment in the research and development of the respective medicine by the pharmaceutical company.
The innovative medicines industry uses scientific and industrial expertise to advance research into the development of new treatments and vaccines.
- The development of a new innovative medicine has an average duration of 10-15 years and an average cost of 2.6 billion dollars.1
- Only 12% of new molecules entering clinical trials ultimately receive approval from the U.S. Food and Drug Administration (FDA), resulting in significant investment in the original drug research and development process. They must demonstrate high standards of quality, safety and efficacy for patients.2
- Currently, there are nearly 800 new medicines in development for chronic diseases, conditions that manifest over long periods of time.3
- Around 260 vaccines are under development at the moment to treat and prevent diseases: 125 for infectious diseases, 108 for cancer prevention, 14 for allergies, 3 for autoimmune diseases, 2 for chronic neurodegenerative diseases.4 Every year, between 3.5 and 5 million lives are saved due to vaccination.5
- More than 7,000 rare diseases have been identified to date, but for only 5% of them there is treatment available. More than 30 million citizens of the European Union (EU) live with a rare disease6, 72% of rare diseases are genetically determined, and 70% of these genetic diseases start from childhood.7
Useful Resources:
- Medicine Development in a Complex, Collaborative Ecosystem
- Forumul Român Pro-Vaccinare
- EFPIA Vaccines Europe Lessons learned from COVID-19
- Platforma europeană privind înregistrarea bolilor rare
- Organizația de Serializare a Medicamentelor din România (OSMR)
- PhRMA data for 2022 and 2023: https://phrma.org/policy-issues/Research-and-Development-Policy-Framework ↩︎
- PhRMA: https://phrma.org/policy-issues/Research-and-Development-Policy-Framework/Clinical-Trials ↩︎
- PhRMA: https://phrma.org/resource-center/Topics/Medicines-in-Development/Medicines-in-Development-for-Chronic-Diseases-2022-Report ↩︎
- PhRMA: https://phrma.org/resource-center/Topics/Science/New-Era-of-Medicine-Vaccines ↩︎
- WHO: https://www.who.int/topics/immunization/en/ ↩︎
- European Commission: https://health.ec.europa.eu/other-pages/basic-page/health-eu-newsletter-231-focus_ro ↩︎
- Rare disease day: https://www.rarediseaseday.org/what-is-a-rare-disease/ ↩︎