EU drug agency announces ‘business continuity’ plan amid relocation uncertainty

The EMA in London is closing and transferring operations by end of March 2019. [Shutterstock]

The European Medicines Agency (EMA) presented on Tuesday (1 August) a business continuity plan aimed at tackling the potential challenges poised by its relocation from London to another member state after the Brexit decision.

Noel Wathion, EMA’s deputy executive director and head of the Brexit task force, said that the agency prepared this plan in light of possible staff losses and, therefore, prioritised its tasks.

“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,” he insisted.

Business continuity during a smooth transition is one of the main criteria set by the European Commission and the EU Council.

Pharma firms and consumer groups united over EMA relocation

EU leaders should make a patient-oriented decision on the relocation of the European Medicines Agency (EMA) from London and ensure “minimal disruption”, according to the pharmaceutical industry and consumer groups.

Patient organisations and the pharmaceutical industry have already expressed their concerns related to public health regarding the relocation and have stressed that a patient-driven approach should be adopted.

Member states had until the end of July to submit their bids to host the two agencies, based on particular criteria. The Commission will then review the bids by 30 September.

Dutch health minister Edith Schippers recently told EURACTIV in an interview that the EMA’s relocation is indeed a political decision; however, the assessment of the European Commission should be taken into account.

“Otherwise, why does the Commission make an assessment?” she wondered.

Dutch health minister: EMA relocation is not entertainment, listen to the Commission

The European Medicines Agency (EMA) is not a toy to be played with by politicians, Edith Schippers told The decision on the agency’s relocation should be based on the European Commission’s assessment, she argues in an interview.

Delaying projects

According to the EMA plan, several planned projects will be put on hold, such as the development of the European Medicines Web Portal, a new publicly-available online information source on all medicines marketed in the EU.

Adrian van den Hoven, the director general of Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical industries, told EURACTIV that very important regulatory projects were being frozen.

“And this is not good news for patients and public health,” he noted, adding that the industry wants to make sure that it will be able to keep supplying medicines that it won’t cost too much because there will be some costs.

Particularly for generic medicines, he said that the price they are sold is very low and any additional cost will need to be factored into generic prices.

The plan will also suspend the EMA’s contribution to the e-submission project that “will allow applicants to electronically submit documents linked to authorisation requests for human and veterinary medicines in a secure and efficient way.”

“However, mid-to-long-term, the EMA will need to analyse how long these activities can be put on hold before they start to seriously undermine the quality of the agency’s work and its planning, and the expectations of stakeholders,” the agency said in a statement.

>>Read our Special ReportEuropean Medicines Agency: What’s at stake?

Subscribe to our newsletters