Euro Roundup: EFPIA proposal seek to reverse EU’s shrinking share of R&D pie

Regulatory flexibility and agility, plus a supportive clinical trial environment, are keys to increasing the R&D investment in the EU, according to EFPIA (European Federation of Pharmaceutical Industries and Associations).

After seeing Europe’s share of global biopharma research and development investment fall from 41% to 31% over the past 20 years, EFPIA issued recommendations to address areas of concern. The list includes a comment on the increasing importance of medicines being able to gain conditional approval to reach patients earlier to generate real-world evidence—and the extent to which the EU is adapting to the change.

EFPIA said that it supports the European Commission’s proposed new pharmaceutical legislation including its innovative trial designs and new methods of evidence generation and assessment. However, “the Commission strategy seems not to take into account the link between the early patient access to new medicines and the attractiveness of Europe as a location for companies to locate their research, clinical trials and manufacturing, particularly for new technologies,” the trade group wrote.

The EFPIA statement was issued in conjunction with a report the group commissioned from Charles River Associates. The report looked at the factors affecting the location of biopharmaceutical investments and the implications for European policy priorities. Over the past 20 years, the difference between R&D investment in the US and Europe has grown from €2 billion ($2 billion) to almost €25 billion, according to the report.

Advanced therapy medicinal products such as cell and gene therapies are a particular area of weakness for Europe, according to the report. While the region produces more scientific papers on the products than anywhere else, clinical trial activity is twice as high in the US and almost three times as high in China.

“Supporting generation and use of [real-world evidence] and acceptance of RWE by payers and health technology assessment bodies through appropriate pricing and market access routes” as well as an “innovation-oriented access environment” could help attract investment in ATMP manufacturing, the report said.

EFPIA Statement, CRA Report

EMA shares guidance on anonymization of protected personal data in risk-management plans

The European Medicines Agency (EMA) has shared guidance on how to anonymize protected personal data and delete commercially confidential information when preparing risk-management plans.

Patient-level information is “neither required nor expected” in risk-management plans, EMA noted. If such information is part of case narratives or individual patient entries, companies should assess what to remove on a case-by-case basis, taking factors such as the type of medicinal product, indication and the size of the study into account. In a small study, diagnostic values or genetic characteristics could identify patients.

The guidance features a table of recommendations for managing several types of information. For example, EMA advises companies to delete or reword the subject ID or screening randomisation number. The guidance also recommends deleting or generalizing the date of death, for example by saying 30 days after the first dose rather than providing a specific date.

Most information about company staff should be deleted, with only the name of the qualified person for pharmacovigilance retained. EMA expects applicants to propose deletions of commercially confidential information where applicable. The agency also may request the removal of “certain pieces of information” that are not necessary and may be considered commercially confidential.

EMA Guidance

Swissmedic finds no indication that bubbles in Pfizer’s COVID vaccine pose risks

The Swiss Agency for Therapeutic Products (Swissmedic) has found no indication that bubbles discovered in a Pfizer COVID-19 vaccine pose any risks.

On 2 November, Swissmedic shared details of reports of the formation of bubbles in a batch of the BA.1 bivalent form of Comirnaty, the Pfizer/BioNTech COVID-19 vaccine. At that time, the agency said vials from the batch contained bubbles after being taken out of the refrigerator and asked vaccine centers to check all syringes filled from those vials. Swissmedic advised vaccinators not to administer syringes that contained bubbles.

Two days later, the agency provided an update, revealing that its “analysis did not reveal any specific problem with the vaccine” or find any “indications of risk.” Vaccine centers can continue to use the batch and “there is no risk to persons who have already been vaccinated,” Swissmedic said.

“Physical factors such as differences in pressure or temperature when preparing the doses may have been responsible for the bubbles,” Swissmedic said. “It is essential that doses be prepared in accordance with the manufacturer's instructions.”

Bubbles seem to be more common in syringes prepared several hours in advance, leading Swissmedic to advise doses to be drawn 15 minutes before use.

Swissmedic Notice, More

EMA encourages companies to submit type I variations for 2022 by end of November

EMA is encouraging marketing authorization holders to submit type IA and type IAIN variations for 2022 no later than 30 November. The target is intended to ensure EMA can acknowledge the validity of the submissions before it closes for the year on 23 December.

Typically, the agency aims to review type IA and type IAIN variations and inform the applicant of the outcome in the 30 calendar days after it receives a filing; the holiday period necessitates a tweak to the process.

Companies that want to file type IB variations or groupings of type IBs and type IAs have a little more time. If a submission arrives by 2 December, EMA will start the procedure this year. Applicants that get variation filings to EMA after that date may get procedure start dates in January.

EMA Statement

Swissmedic doubles reporting time for variations without assessment after industry feedback

Swissmedic has doubled the time limit for reporting variations without assessment. The change, which the agency made at the request of marketing authorization holders, increases the limit from 30 days to 60 days.

Companies can report variations that only have minimal consequences for the quality, safety or efficacy of a veterinary medicinal product after they have implemented the changes. Previously, Swissmedic gave the industry 30 days to notify it in writing of the implementation of variations without assessment. Now, manufacturers have up to 60 days.

Swissmedic made the change as part of an update to its guidance on variations that also added “changes to the vaccine antigen master file part of the dossier” to a list of variations.

Swissmedic Guidance

Euro Roundup: EFPIA proposal seek to reverse EU’s shrinking share of R&D pie

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