The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.
The European Medicines Agency (EMA) announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s (UK) impending withdrawal from the European Union (EU) and the EMA’s relocation from its current home in London, UK, to an as yet undetermined city.
As of August 1, 19 cities in EU member states—including Dublin, Amsterdam, Brussels, and Stockholm—have submitted proposals to host the agency upon its departure from London. The European Commission will begin assessing those offers by the end of September 2017, and will vote on a final location for the agency in November.
“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way requires considerable internal resources,” said Noel Wathion, EMA’s deputy executive director. "With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines.”
The plan, which categorizes agency activities into 3 levels of priority, is intended to help the EMA reallocate its resources in order to ensure that its critical activities and functions will be maintained over the coming years.
The agency will suspend the following lowest-priority activities:
The agency also scaled back the number of audits it plans, as well as corporate governance and support activities. Staff will attend fewer external meetings and conferences, and the agency will organize fewer meetings and workshops.
In middle tier of priority, activities including publishing clinical data and undertaking initiatives to promote the availability of medicine will be, the agency said, “maintained as long as possible, workload and staffing situation permitting.”
The highest-priority activities, which the agency deems crucial to the health and wellbeing of Europe’s citizens, include inspections, the assessment and safety monitoring of medicines, and the maintenance of critical information technology systems.
The agency says that it will adjust the business continuity plan as it assesses how many of its 900-person strong staff it may lose in its relocation, as well as how such a loss of personnel may affect its ability to carry out its high-priority tasks. If the EMA loses too many workers too quickly as a result of the move, it warns, “the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.”
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.