The cancer incidence continues to rise worldwide. There were about 18,000,000 new cases in 2018 and about 9,500,000 deaths. Despite therapeutic advances, cancer has become the leading cause of death since 2004 in France, with 157,000 deaths in 2018. To cope with this challenge, societies need to adapt their approach to cancer prevention and treatment, with changes in the development and use of innovative anti-neoplastic drugs playing an important role. Medical innovation has a major impact on patient survival and longevity. The joint assessment of incidence, mortality and survival shows that real progress has been made in the management of many cancers. Overall, patient survival continues to increase, although there is a wide disparity between countries. Although few studies have addressed the issue because of the many variables and confounding factors, the time required for access to treatment appears to have an impact on survival.

 

In the development of a drug, from the laboratory research phase to the end of clinical trials, it can take more than 10 years to obtain marketing authorization (MA). The MA should guarantee the quality, efficacy and safety of the product. In addition, there are procedures for access to the medicinal products market before the marketing of the medicinal product is possible. Access to cancer drugs, especially new innovative drugs, varies worldwide and depends on the country's economic strength and policy choices based on scientific evidence and cost-effectiveness. In the European Union (EU), access to new cancer drugs involves centralized licensing decisions by regulators and then each country decides on repayment according to its national healthcare systems. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be marketed or not. However, under EU law, EMA has no authority to permit marketing in the different EU countries. The European Commission is the authorizing body for all centrally authorized products, and it takes a legally binding decision based on EMA's recommendation. Once granted by the European Commission, the centralized MA is valid in all EU Member States as well as in the following European Economic Area countries: Iceland, Liechtenstein and Norway.