European Commission consults on roadmap to pharmaceutical reforms

Regulatory NewsRegulatory News
| 02 June 2020 | By Michael Mezher 

The European Commission is looking to revamp parts of the regulatory framework for medicines in the EU to address shortages, access to medicines and innovation, according to a roadmap document released for consultation on Tuesday.
“There is a need to build a holistic, patient-centered, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access,” the Commission writes.
Within the document, the Commission lays out six issues it aims to address with the forthcoming strategy, including medicines access and affordability; shortages of needed medicines such as antibiotics and vaccines; and environmental risks related to the manufacturing, use and disposal of medicines.
The document also raises three distinct issues related to pharmaceutical innovation to be addressed: the alignment of innovation and public health needs, the funding and capitalization of EU-based biotech research and barriers to innovation within the regulatory framework for medicinal products and new technologies.
“Important scientific and technological advances such as gene and personalised therapies, smart health applications, medical technologies, including AI, are transforming the landscape and becoming increasingly integrated as part of overarching therapies. However, the regulatory framework may not be keeping pace with these changes,” the Commission writes.
The Commission says the strategy will explore both legislative and non-legislative actions and areas for EU investment and could include a review of orphan and pediatric medicines regulations, fees collected by the European Medicines Agency (EMA) and “could also include a targeted evaluation and subsequent review of the basic pharmaceutical legislation.”
The proposal also looks at ways the EU can reduce dependence on foreign manufacturing and increase the competitiveness of European companies. The Commission notes that the strategy will be coherent with recent regulations governing clinical trials and medical devices across the EU.
The Commission is requesting feedback on the initiative until 7 July, before moving to a public consultation on the strategy later this year, and says it is aiming to adopt the strategy by the end of 2020.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the roadmap and said in a statement that it “looks forward to working with the EU institutions and Member States to building Europe’s health research ecosystem, increasing our resilience to global health threats and driving our economic recovery.”
EFPIA pushed back on some of the needs for reform, writing that it “believes that much can and should be done already now within the existing framework by recognition and efficient implementation of the lessons learned from the COVID-19 crisis.”


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