{"id":9500,"date":"2024-09-18T15:38:35","date_gmt":"2024-09-18T14:38:35","guid":{"rendered":"https:\/\/ehma.org\/?p=9500"},"modified":"2024-09-19T09:43:04","modified_gmt":"2024-09-19T08:43:04","slug":"european-parliament-adopts-its-position-on-eu-pharmaceutical-reform-in-plenary","status":"publish","type":"post","link":"https:\/\/ehma.org\/european-parliament-adopts-its-position-on-eu-pharmaceutical-reform-in-plenary\/","title":{"rendered":"European Parliament adopts its position on EU pharmaceutical reform in plenary"},"content":{"rendered":"

On 11 March 2024, the European Parliament\u2019s Committee on Environment, Public Health, and Food Safety (ENVI) adopted two reports on the EU Pharmaceutical Package: the 2023\/0132(COD) Directive on medicinal products for human use<\/a> and the 2023\/0131(COD) Regulation on authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency<\/a>.<\/p>\n

The ENVI Committee suggested raising the EU’s research standing, making it a more attractive market for innovation. It calls for mandatory data protection schemes for at least seven and a half years for new medicines and a period of two years of market protection, during which generic or biosimilar products may not be sold following market authorisation. Extensions would only be granted under certain conditions, such as drug unavailability or during clinical trials. Drugs that meet a ‘high unmet medical need’ or are orphan drugs could gain up to 11 years of market exclusivity, during which competing products cannot enter the market.<\/p>\n

New protocols will be developed to regulate the rational use of antimicrobial drugs, such as prescriptions being issued only for necessary dosages and limited timeframes. Additionally, there is a push for the discovery and development of new drugs, and companies will be required to provide environmental risk assessments for medicinal products that cover their entire life cycle.<\/p>\n

A debate and vote took place in the European Parliament’s April I plenary session. On 10 April 2024, the Parliament fully supported the ENVI position without changes. It adopted its position at first reading with 495 votes in favour, 57 against, and 45 abstentions for the directive, and 488 votes in favour, 67 against, and 34 abstentions for the regulation.<\/p>\n

More specifically, EHMA and the EPACT Alliance succeeded in the following:<\/p>\n

New amendments adopted in plenary:<\/strong><\/p>\n