(AGENPARL) – BRUXELLES gio 22 giugno 2023 On 26 April 2023, the European Commission launched a revision of the EU’s pharmaceutical legislation, including legislation on medicines for children and for rare diseases. Since the early 2000s, the EU legislative framework has provided a complex set of obligations, incentives and rewards to stimulate the development of medicines for children and for rare disease patients. Over the last 20 years, the EU legislation has led to the development of new medicines for these categories of patients. The legislation has not been flexible enough, however, to integrate scientific and technological advances, nor has it been able to direct research and development towards areas of unmet medical needs. Given the key role of Member States in determining the availability and affordability of medicines, implementation of the legislation cannot be assessed in isolation from the national context. This concerns, notably, key aspects such as pricing and reimbursement of medicines, taxation, and healthcare organisation, but also strategic decisions by pharmaceutical companies.

Fonte : © Unione europea, 2023 – PE

Fonte/Source: https://www.europarl.europa.eu/thinktank/it/document/EPRS_BRI(2023)747440