Health and Food Safety EU Commissioner Stella Kyriakides presented here on Friday the main provisions of the proposed EU pharmaceutical reform which is ‘the embodiment of our vision to build a European Health Union that delivers to our citizens, societies and economies’. Kyriakides delivered on Friday a keynote speech on the pharmaceutical strategy for Europe, in the framework of a conference held at Nicosia University. Noting that the pharmaceutical reform is based on the ‘3 As: Accessibility, Availability and Affordability’ she stressed that it consists the EU’s opportunity to address long-standing challenges and to make sure all patients across Europe have the medicines they need and continue to foster innovation for the EU pharmaceutical industry to remain a world-class innovator. European Commissioner indicated that the pharmaceutical reform includes concrete actions to improve access to medicines in the EU, such as, among others, modulation of the current system of regulatory protection for developers of innovative medicines, so that the incentives better reflect specific public health objectives while safeguarding the competitiveness of the EU and its pharmaceutical sector, a new European alert system with earlier notification of shortages and withdrawals by companies, harmonised reporting criteria and coordinated management of shortages by EMA and measures that facilitate timely market entry of generics and biosimilars once the protection of innovative medicines expires that is expected to increase competition and reduce prices. Commissioner Kyriakides said that at the same time Commission proposes to simplify and modernise the regulatory framework to make it more competitive and innovation friendly. ‘Simplification will result in shorter authorisation times from de facto over 400 days down to 180 days, while maintaining our high standards for the assessment of quality, safety and efficacy,’ she noted ‘We also proposed more digitalisation, better use of data and other future-proofing measures, so we can keep pace with scientific and technological progress and ensure Europe remains an attractive place for investments. ‘We are also putting forward a new toolkit to combat antimicrobial resistance by stimulating enterprise and innovation. This includes the world-pioneering proposal to stimulate the development of game-changing antimicrobials via a transferable exclusivity voucher,’ she added. Kyriakides concluded by expressing confidence that ‘together we can deliver on an ambitious reform that promotes access to medicines for all European patients, while also strengthening our regulatory system so it remains innovation-friendly, competitive, and fit for the future.’
Source: Cyprus News Agency