Euro Roundup: EFPIA pushes harder against pharma legislation
How and when a hospital exemption (HE) for advanced therapy medicinal products (ATMPs) can be used under proposed European Union pharmaceutical legislation must be clarified as the legislation moves forward, according to a joint position paper from EFPIA, the Alliance for Regenerative Medicine and EuropaBio.The HE scheme was created through the ATMP Regulation so that member states could allow the provision of unauthorized advanced therapies under certain conditions.
In a joint position paper, the trade groups said the scheme has “an important and legitimate role” but that clearer rules on when and how HE is used are needed considering the “diverse interpretation and use” to date. The organizations voiced support for the European Commission’s plan “to reduce inconsistencies in the interpretation and implementation” and to create an EU repository to improve transparency.
Specifically, the groups want the EU to clarify that HE is only applicable “when there are no authorized treatments nor clinical trials for which the patient is eligible” and specify that the exemption lasts for one year.
“[If] there is an investigational advanced therapy available as part of an ongoing clinical trial, NCAs should only authorize an exemption if the individual patient is not eligible for the program,” the groups wrote. “Clinical trials should always be preferred to the HE, as their review process offers a higher safety standard to patients, and the insights gained during the study can benefit other patients.”
EFPIA also wants the EU to provide clearer definitions to support harmonization. The idea that HE is used on a “non-routine” basis is too vague, according to the groups, and countries have interpreted the term as meaning everything from preparation for a few patients to small-scale use. EFPIA wants the text to clarify that “any standardization of the process or claims of industrialized manufacturing should be understood to deviate from the concept of non-routine.”
Position Paper
European Commission answers new questions on extension of MDR transition period
The European Commission has answered five new questions on practical aspects of the extension of the Medical Device Regulation (MDR) transition period, as well as updated their responses to several existing questions.
In the new questions and answers, the Commission clarifies that legacy devices do not need to comply with unique device identifier (UDI) requirements during the extended transition period. Manufacturers of legacy devices need to put MDR-compliant quality management systems in place by 26 May 2024 but the requirement for verification of UDI assignments only applies to relevant devices.
The Commission also answered two questions about Article 59, a part of MDR that empowers member states to allow the supply of medical devices that lack valid CE marks. One response explains that devices that were provided under Article 59 after 20 March 2023 do not benefit from the extended transitional period because they lack valid certificates.
Another response clarifies that “as long as the removal of the CE marking was a condition for or a consequence of the derogation granted by the national competent authority in accordance with Article 59 MDR, the device can be placed on the market with a CE marking, provided that all other conditions are met.”
Additional new information relates to the conditions that must be met to benefit from the extended MDR transition period. In one response, the Commission states that the transition period stops applying if the manufacturer withdraws its application for conformity assessment, or if the written agreement between notified body and manufacturer is terminated. The exception is if the manufacturer simultaneously enters into a written agreement with another notified body and transfers the application.
In the other response, the Commission discusses the impact of changes related to the manufacturer during the transitional period, explaining that administrative changes such as updates to the address can be made without impacting the transition period. There are exceptions, though, as the Commission says in the updated document.
Commission Q&A
Commission creates guidance on transitioning trials from old directive to new regulation
The European Commission has published guidance on transitioning clinical trials from the old directive to the new regulation. In the guidance, the Commission discusses which trials need transitioning, when the transition needs to happen and the process for moving between the regulatory frameworks.
Officials covered similar topics in a Clinical Trials Regulation question and answer document that includes a chapter on the arrangements for the transitional period. The guidance replaces that chapter.
The Commission used the guidance to explain that clinical trials authorized under the directive that have at least one active site in the EU on 30 January 2025 need to transition. A site is active until the last visit of the last subject or the completion of other “trial-specific interventions with the subject specified in the protocol.”
Sponsors can transition trials until the end of the three-year transitional period on 30 January 2025. The Commission is “strongly” advising sponsors to “submit the application early enough” for it to be processed before the deadline.
Commission Guidance
MedTech Europe voices ‘deep concern’ as Italy leads push to establish payback systems
MedTech Europe has warned that payback systems adopted in Italy and considered in other European countries raise “alarming questions about the consequences for the healthcare industry and access to medical technologies.”
According to the trade group, regional governments in Italy have asked companies that have provided medical technologies to “retroactively repay money,” resulting in “tremendous financial burdens, legal disputes and operational uncertainties.” MedTech Europe cautioned that the “ongoing lack of a definitive resolution is hindering the stability, growth and innovation of the medical device sector in Italy.”
The trade group has received reports that countries including Bulgaria, Cyprus and France are considering adopting similar payback systems. Warning that the systems will “inevitably hamper investment, stifle innovation and erode patient access,” MedTech Europe asked the governments to abstain from adopting the payback model.
Statement
EMA shares advice on remote batch certification, residency rules for qualified persons
EMA has answered additional questions on remote batch certification and where qualified persons can live.
In the updated Q&A, the agency explains that remote batch certification could be allowed if permitted by the national regulator where the authorized site is located. Manufacturers should ensure they comply with local requirements. EMA has also listed points manufacturers should consider, such as the need to give facilities equipment to enable remote certification and discussed the technical requirements.
EMA also used the update to clarify that EU legislation imposes no harmonized requirements on where qualified persons live. However, as EMA notes, local requirements may apply in some member states.
EMA Q&A
Other news:
EMA has adopted the ICH M7 guideline on assessing and controlling DNA reactive impurities. The text will take effect on 30 September. EMA Notice
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