Euro Roundup: EU committee publishes pharmaceutical strategy draft
A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms.Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The report stresses the need to cut national approval times and align them with European Medicines Agency (EMA) workflows. ENVI also called on the European Commission to talk to Member States about new pricing criteria such as whether a drug is “Made in Europe.”
Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”
ENVI also urged the Commission to develop appropriate regulatory frameworks for advanced therapy medicinal products and to work with EMA “to consider extending the application of rolling reviews to other emergency medicines.” The rolling review idea is based on the experience of authorizing COVID-19 vaccines.
The report also addresses bolstering the resilience of supply chains. The committee wants the Commission to “facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them.”
ENVI also notes that the Commission should “further facilitate access to global markets for the EU pharmaceutical industry ... through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness.”
Two other European Parliament committees are set to provide opinions on the strategy as the EU builds on last year’s publication of a document detailing plans to create a “future-proof regulatory framework.”
Draft Report
Denmark posts guidance on decentralizing clinical trials
New guidance on decentralized clinical trials from the Danish Medicines Agency (DKMA) is setting the stage for greater use of digital tools that reduce the need for participants to visit study centers.The guidance describes considerations and expectations for implementation of decentralized trials. For example, recruitment and screening methods must be described clearly in the trial protocol. Sponsors should register participants based on pre-screening from social media in a log. By following the guidance and running decentralized trials, DKMA said sponsors can ensure equality in the health service by removing barriers to participation in research.
DKMA called ensuring sufficient safety monitoring “one of the most significant challenges of decentralized clinical trials today.” While trials can use audio and video conferencing to mitigate the reduction in in-person meetings between subjects and investigators, the agency said it has not seen “convincing evidence that the trial participants’ safety can generally be ensured just as effectively in a decentralized setup.”
DKMA permitted some decentralized trial elements through the extraordinary measures it enacted in response to the pandemic. Those measures are due to expire on 1 December. The pandemic rules allow sponsors to deliver investigational medicinal products directly to trial participants. DMKA is looking into the possibility of allowing sponsors to continue such deliveries after the pandemic.
DKMA Guidance
EMA finds Rasi role is a conflict of interest, imposes conditions
EMA’s Administration and Corporate Management Division has ruled former Executive Director Guido Rasi’s role at a clinical trial group is “in conflict with the interest of the service,” placing restrictions on his activities.Rasi, who stepped down as executive director of EMA late last year, told the agency of his plans to take up two positions at the start of 2021. EMA saw no conflict in Rasi’s work as scientific director of medical education provider Sanità Informazione-Consulcesi but raised issues with his appointment as chairman of the Clinical Trials Centre (CTC) at the A.Gemelli polyclinic of Sacro Cuore University.
CTC optimizes “the management of clinical research carried out at the A.Gemelli Polyclinic,” EMA said, as well as giving clinical trial training and acting as an academic contract research organization. To EMA, Rasi’s work with CTC is a conflict of interest, leading it to impose conditions.
The conditions prohibit Rasi from individually liaising with any EMA employee “with regard to any professional activity he may have dealt with in the performance of his responsibilities at the Agency during his last three years of service.” The restriction will apply for two years.
EMA Report
Swissmedic requires importers to check suppliers more rigorously
The Swiss Agency for Therapeutic Products (Swissmedic) has demanded that license holders check suppliers more rigorously when importing finished medicinal products from outside the European Union.The action is a response to 10 cases over the last four years of Swiss wholesalers distributing falsified drugs sourced from Turkey. None of the falsified medicines were sold in Switzerland but rather “made their way into distribution channels within the [European] Union via parallel imports delivered by such suppliers,” according to Swissmedic.
Swissmedic wants wholesalers to ensure their trading partners follow Swiss and EU good distribution practices (GDP), regardless of the partner’s location. Specifically, wholesalers should conduct in-depth audits to verify full compliance with EU GDP requirements. Swissmedic expects wholesalers to be able to “reconstruct the entire supply chain for a finished medicinal product as far as the authorization holder and to verify the legality of the supply chain at each of its steps.”
Swissmedic Notice
MHRA hires chief safety officer in response to criticisms
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has named Alison Cave as its first chief safety officer.MHRA created the role in response to the Cumberlege report, which called for a “substantial revision” of the agency to fix perceived failings in its handling of adverse events and engagement with the public. The chief safety officer will lead the implementation of the recommendations of the review, MHRA said, and “oversee development of a revitalized approach to vigilance.”
The job, which was offered with an annual salary of up to £140,000 ($195,000), has gone to Cave, who will take up the post on 19 July. Cave will rejoin MHRA from UK Research and Innovation, where she serves as director of the Industrial Strategy Challenge Fund.
Cave worked as an expert scientific advisor at MHRA earlier in her career, before later going on to hold the title of principal scientific administrator at EMA.
Press Release