Bruxelles (eu24news) – The pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. However, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.
Today members of the Public Health committee (SANT) voted on the decision to open inter-institutional negotiations on the two dossiers of the pharmaceutical package: “Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency” (revision of the regulation) – procedure file, rapporteur Tiemo Wölken (S&D, DE) adopted with 29 in favour (1 against, 2 abstained) and “Medicinal products for human use” (revision of the directive) – procedure file, rapporteur Dolors Montserrat (EPP, ES) adopted with 29 in favour (2 against, 1 abstained). Negotiations can start one the Council adopts its position.
The Directive on “Union code relating to medicinal products for human use” is part of the revision of the EU’s General Pharmaceutical Legislation, which is being revised for the first time for more than 20 years. Together with the proposed Regulation, it replaces a current Directive, Regulation, and special regulation for paediatric and orphan medicines. It introduces a scheme to require new environmental risk assessments (ERAs) for medicines authorized pre-2005 when ERA requirement became applicable.
“With this vote, the EP delegation on the pharmaceutical package, which I have the privilege to lead as rapporteur for the new directive, will be ready to start negotiations with the Council as soon as Member States manage to reach a common position”, said Dolors Montserrat MEP, EPP Group rapporteur for this file. “We continue to deliver on promises – Montserrat emphasised – to ensure a new European pharmaceutical legislation that puts the needs of our patients at the centre, and allows everyone across the Union to have access to the most innovative and effective medicines”.
“We will give our Made in Europe pharmaceutical companies a stable regulatory framework that protects intellectual property and incentivises research and development of the best medicines. Europe must remain a global health model of universal care and competitive industry”, concluded the EPP Group Vice-Chair for Economy and Environment.
The key improvements to the directive are, among other, the revision of the Commission’s proposal aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines. In particular, with reference to the access to medicines, the original proposal for an incentive of two years of data protection for supplying a medicine in each Member State has been replaced by an obligation to file for pricing and reimbursement when a Member State requests. Moreover, the current baseline of data protection has been extended to 7,5 years instead of Commission’s proposal of 6 years.
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