Euro Roundup: Drugmakers push EU to strengthen confidentiality protections in HTA proposal

EFPIA and some of the large pharmaceutical companies it represents have called for the European Commission to ensure the confidentiality of information shared under the health technology assessment (HTA) process.

In June, the Commission shared a draft implementing regulation on cooperating with the European Medicines Agency (EMA) to exchange information and plan joint clinical assessments (JCA) and joint scientific consultations. The Commission received 53 comments prior to the 24 July deadline.

EFPIA said the type of information covered by the implementing act, which is mainly generated and exchanged prior to the submission of a marketing authorization application, is “highly sensitive for health technology developers (HTDs) competing to launch their products in Europe.

“It is imperative that the EU holds strict measures on commercially confidential information to ensure competitiveness and attractiveness of the region, in full respect of the rights of the HTDs over the information they generate, own and share,” EFPIA said.

EFPIA wants HTDs to remain responsible for sharing information with different authorities, “in response to specific questions and for appropriate and relevant purposes.” The proposal reflects the belief drugmakers should be responsible for sharing information such as the indication and target filing date, which EFPIA said “is of critical competitive nature,” directly with the HTA secretariat.

“This would enable the HTDs to submit the confirmation of eligibility for centralized procedure the same way they share their Letter of Intent to submit, providing the only reliable and timely information for JCA planning. This information should not be published in the Annual Work Plan at such a level that it can be re-engineered to identify the source data,” EFPIA said.

The trade group added that “it should be possible for regulators to share other early product information that HTD made available to them (e.g. portfolio information) as aggregate information once per year or quarterly.” Such sharing would enable the estimation of the volume of upcoming submissions and allow resource forecasting, according to the trade group.

EFPIA also voiced concern regarding the public report on emerging health technologies (EHTs). Use of the data beyond HTA planning leaves “the level of protection and the final distribution and publicity” of the information provided by HTDs “unknown and unclarified,” they said.

“This risks to undermine the trust that constitutes the foundation of this information sharing practice between HTD and the EMA and may negatively jeopardize the willingness of the HTD to share such information with the agency from the get-go. This is why EFPIA highlights that for the purpose of the EHT report, the subgroup should rely on public data sources, inviting HTDs to agree upon and provide data directly and on a voluntary basis,” EFPIA said.

Johnson & Johnson, Novartis and Roche echoed some of the concerns raised by EFPIA. Novartis called for “key guiding principles and safeguards to ensure strong standards of confidentiality,” while Roche said, “any commercially sensitive information must be adequately protected with stronger penalties for those who breach the obligations.”

J&J said its position is aligned with those of EFPIA and, as a medical device company, MedTech Europe. The medtech trade group said, “an appropriate mechanism of confidentiality needs to be implemented” and called for “specific articles to cover medical devices.” Medtronic, a member of the trade group, said the draft regulation fails to clarify the “responsibility of the Commission in ensuring any information and data exchanged during these processes is fit-for-purpose and adequately protected.”

Industry Feedback

EMA clarifies nitrosamine risk assessment expectations in updated Q&A document

EMA has updated a question-and-answer document on nitrosamine impurities in human medicinal products.

The regulator and the Heads of Medicines Agencies updated responses to six questions. EMA revised one answer to update its position on the acceptability of the Ames test and another response to clarify responsibilities related to active substance master files and certification of suitability.

Five answers underwent revisions to “clarify the expectations for risk assessments, confirmatory testing and dossier requirements for products where nitrosamine impurities can be controlled according to ICH Q3A/B limits.” The ICH principles cover the control of nitrosamine impurities.

“For products where nitrosamine impurities can be controlled according to ICH Q3A/B principles ... confirmatory testing is generally not needed if the risk can be sufficiently mitigated based on scientific considerations that demonstrate that the relevant ICH Q3A/B thresholds will not be exceeded,” EMA said.

EMA Q&A

EFPIA calls for ‘workable and future-proof’ implementation of EU health data space

EFPIA has shared recommendations for how authorities can work with industry to realize the potential of the European Health Data Space (EHDS).

A final agreement on EHDS is in place but there are still decisions to make about the implementation of the regulation. EFPIA said “more than 33 delegated and implementing acts, model/template and other guidelines have been introduced in the final text of the EHDS, and, for some of the provisions the implementation is not foreseen before 2030.”

The scope of the secondary legislations “will be very technical and complex in nature and will set the rules for future data sharing from new, continuously emerging data sources,” EFPIA said. As such, the trade group wants the European Commission and national authorities “to regularly consult with industry stakeholders to ensure that implementation measures are workable and future-proof.”

EFPIA has requested meaningful consultations, in which authorities take “the time to carefully consider the input from stakeholders,” throughout the implementation process. The trade group also called for authorities to make the most of the stakeholder forum required under EHDS. EFPIA wants the forum to be “a truly consultative body with the necessary resources to maintain a long-term and granular dialogue with all stakeholders.”

EFPIA Notice

Swissmedic tracks 72% jump in throughput times for new orphan drug applications

Swiss throughput times for orphan drug new applications for new active substances (NA NAS) increased by 72% last year “owing to a high level of text review rounds,” according to a report.

The Swiss Agency for Therapeutic Products (Swissmedic) shared the finding in its benchmarking study for 2023. The study, which Swissmedic has performed annually for 11 years, shows how long the agency takes to authorize human medicines compared to its counterparts in the EU and US. Swissmedic typically takes longer than its counterparts.

Last year, throughput times for NA NAS under the standard procedure increased by 15% in Switzerland. The increase was driven by nine applications for orphan drugs. Median throughput time for the orphan drug NA NAS was 541 calendar days, an increase of 72% over the prior year. Swissmedic’s time limit for standard reviews is 480 calendar days.

Swissmedic Notice

Other news:

The European Pharmacopoeia has released draft monographs on ustekinumab for consultation. Ustekinumab, which J&J sells as Stelara, is used to treat Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. EDQM Notice

Euro Roundup: Drugmakers push EU to strengthen confidentiality protections in HTA proposal

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