In new pilot, EC probes uneven oncology product launches

Regulatory NewsRegulatory News
| 05 March 2021 | By Kari Oakes 

A pilot program launched this month by the European Medicines Agency (EMA) and the European Commission (EC) aims to reduce the time to market launch of certain oncology products by providing the regulator with an “early warning system” for sponsors’ impending marketing plans. The pilot also seeks to aid understanding of the reasons behind uneven launch of some products across European Union (EU) countries.
The project, which is planned to run through August 2022, supports the emphasis on equitable and speedy patient access to medicines highlighted in Europe’s Pharmaceutical Strategy, according to an announcement of the initiative. Medicinal products classified as orphan and oncology products with newly submitted centralized applications, or applications under consideration, are eligible to choose to participate in the pilot.
“The pilot is based on a voluntary declaration of market launch intentions and on the engagement of stakeholders from the public and private sector to address the long-standing problem of unequal availability and delayed market launches of medicines,” according to the EC document outlining the initiative.
Different factors contribute to companies deciding against EU--wide market launch, including the fact that some therapies require robust staffing and medical infrastructure that may not be available in some countries. Also, health systems, reimbursement, and pricing structures vary across the member states, and may factor into commercial decisions.
Still, getting to the reasons behind uneven market launches is a valuable exercise that may help inform how the EC carries out its pharmaceutical strategy, said the regulator.
When companies choose to participate in the voluntary procedure, they will provide their planned market launch intentions when they request marketing authorization through the centralized procedure. National competent authorities will be included in the information-sharing exercise, which “will also allow comparing the intended market launch, as provided by the applicant, with the actual marketing situation in the Member States,” according to the pilot document.
The hope is that the EC and EMA will gain insight into how marketing decisions affect both member states and drug sponsors; the pilot will query sponsors in some key areas, including their intended EU market coverage, and the reasoning behind intention to market – or not market – a product in a given country. The template for responses allows free text entries for some queries, with answers being used for qualitative analysis.
The pilot will generate data in other areas of interest as well, including the discrepancy between the intended time to market launch and when products do finally reach intended markets.
The document appends the template for the “Market Launch Intentions” form, but more information will be forthcoming, said EC: “Additional practical guidance on how and to whom to submit the information will be provided to applicants, before the pilot is initiated.”
EMA has also made a Q and A document available outlining the aims of the pilot and sketching out other practicalities.  
Pilot project


© 2022 Regulatory Affairs Professionals Society.

Tags: EMA, EU, oncology

Discover more of what matters to you

No taxonomy
No data found