Euro Roundup: Switzerland updates legislation to improve clinical trial framework

Euro Roundup: Switzerland updates legislation to improve regulatory framework for researchers

The Swiss Federal Council has approved legislative amendments intended to strengthen the protection of people participating in research and improve the regulatory framework for researchers.

By changing four ordinances relating to the Human Research Act, the Federal Council is aiming to adapt Swiss law to technological, scientific, and social changes, as well as to international developments. The ordinances cover topics including clinical trials of medicines and medical devices. The Swiss Agency for Therapeutic Products (Swissmedic) highlighted the most important changes for researchers in a notice.

Swissmedic listed five ways in which the changes will promote “a favorable framework for research.” The updated clinical trial ordinances allow researchers to get consent from research subjects electronically and adapt requirements for the anonymization and coding of health-related personal data and biological material. The adapted requirements are intended to “allow a better assessment of the risks.”

The changes are also meant to bring the country’s clinical trial ordinance in line with European Union regulations. Aligning the ordinance with the EU Clinical Trials Regulation affects rules on notifications, reporting, and deadlines for medicinal product clinical trials in Switzerland. Other changes have moved clinical trials from Category C to Category B and clarified questions about the retention of data on human subjects.

Swissmedic also identified ways the changes will improve the protection of people who participate in clinical trials. The updated ordinances create specific requirements about the need to give trial subjects comprehensible information and require researchers to follow aspects of the Federal Act on Human Genetic Testing when performing prenatal or pre-symptomatic genetic tests.

The ordinances establish “specific requirements for the communication of individual results ... [to] strengthen the right to information of participating individuals or the right to waive information” and harmonize the requirements for transparency in clinical trials with international regulations. Researchers must publish summaries of their results.

Officials will start enforcing the transparency requirement on 1 March 2025. Studies completed before that date will not be subject to the requirement. Swissmedic said the transparency deadline will create time for electronic systems to be adapted to the requirements.

The other changes take effect on 1 November 2024, but projects approved before that date will continue to be covered by aspects of the old rules even after the updated ordinances take effect. The current liability, liability coverage, and retention requirements will remain in place and researchers will be able to fulfill notification, reporting, and documentation obligations under the current law until 31 October 2025.

Swissmedic also published a statement on the Federal Council’s approval of a report that identified a need for agencies to address “gender-specific inequalities and a tendency towards male perspectives in research and care delivery.” The Federal Council responded to the report by assigning tasks to various agencies, including Swissmedic.

Officials tasked Swissmedic with examining the need for gender-sensitive research, investigating whether a gender specialist should join its Human Medicines Expert Committee and reviewing its internal guidelines. Swissmedic said its assessment of gender-specific considerations in clinical trials could lead it to “submit a new topic proposal to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to set in motion work on an international standard.”

The Federal Council has asked Swissmedic and other Swiss agencies to implement their tasks by the end of 2029 and report back.

Swissmedic Notice, More

Italian authority inspects Biogen, Novartis over alleged anti-competitive agreement

The Italian Competition Authority (AGCM) has launched an investigation into an alleged anti-competitive agreement involving Biogen, Genentech, Novartis, and Samsung Bioepis.

AGCM alleges the companies may have coordinated commercial strategies to delay entry of a biosimilar copy of the eye disease drug Lucentis (ranibizumab) in Italy. Genentech developed Lucentis, while Novartis markets the product in Italy. Biogen and Samsung Bioepis have developed a biosimilar version of the drug, Byooviz, and Samsung Bioepis won approval for the biosimilar in Europe in 2021.

As part of its investigation, AGCM inspected the premises of Biogen and Novartis’ Italian business units with the assistance of the special antitrust unit of the Italian financial police. In parallel, AGCM’s Dutch counterpart inspected Samsung Bioepis’ premises in the Netherlands.

AGCM carried out the inspections to investigate the alleged existence of commercial practices that could have distorted competitive dynamics, for example by artificially limiting competition. The watchdog said such practices could prevent the health service from realizing savings on drug product purchases and hurt patients and taxpayers by limiting the breadth of supply and propping up medicine prices.

A spokesperson for Novartis told FiercePharma the company has provided the Italian authorities with the requested information and “strongly believes that it has acted appropriately and in accordance with competition law and in the best interests of patients.” Samsung Bioepis and Biogen are also “fully cooperating” with the probe. Genentech said it does not comment on regulatory or legal investigations.

Press Release

EMA answers questions on the tailored scientific advice procedure for biosimilars

The European Medicines Agency (EMA) has answered questions about the tailored scientific advice procedure to support step-by-step development of new biosimilars. EMA introduced the tailored procedure as a pilot project in 2017.

Through the initiative, the agency assesses developers’ existing quality, analytical and functional data to inform recommendations about which studies they should run. The process can show whether the biosimilar pathway is suitable for candidates that have significant differences to their reference drugs and whether a scaled-back clinical development program is viable.

EMA has answered seven questions in its latest update on the program. The agency’s longest answer describes what applicants should include in the briefing package. EMA expects companies to provide an overview of the full development plan and questions related to quality and clinical and non-clinical development. The included analytical and functional data should reflect the applicant’s questions.

“Tailored biosimilar advice requests to pre-assess quality, analytical and functional data without further justification why such request is made will not be accepted,” EMA said. “Questions on quality issues unrelated to the comparability between the biosimilar and reference medicinal product are outside the scope of the tailored biosimilar scientific advice and can only be included on an exceptional basis.”

Q&A

Other News:

EFPIA has published three reports about factors that may contribute to unequal access to medicines in the European Union. The EU is looking to the new pharma legislation to close the gap between how long patients in different countries wait for medicines, but the EFPIA reports highlight barriers to access that are outside of drugmakers’ control, such as the use of external reference pricing. EFPIA Notice

ABPI has published a wishlist for the next UK government ahead of next month’s national election. The UK pharma trade group wants the new government to strengthen the development, regulation and adoption journey for new medicines and vaccines. ABPI praised the manifesto of the ruling Conservative Party, which polls suggest is on course to lose the election to the Labour Party. ABPI Notice, More

EFPIA has shared details of what its members are doing to improve the environmental sustainability of the pharma industry. The statement outlines work toward carbon reduction targets, investments in renewable electricity and steps to minimize the impact of medicines on the environment. The notice follows the targeting of the pharma industry in the Urban Wastewater Treatment directive. EFPIA Notice

Euro Roundup: Switzerland updates legislation to improve clinical trial framework

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