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New approach focuses on assessing the effectiveness of four key areas related to risk-minimization and pharmacovigilance activities in Europe.
The European Medicines Agency (EMA) has ratified a new approach to measuring the impact of pharmacovigilance activities, covering how to gather data and knowledge on the effectiveness of measures and processes meant to ensure the safe use of medicines for patients in the European Union.
Following the recent incident in Rennes, northwestern France-in which a Phase I trial involving private laboratory Biotrial and Portuguese pharmaceutical company Bial went seriously wrong, reportedly leading to five hospitalizations and the death of one volunteer-this strategy is bound to generate considerable interest.
The new approach adopted by the EMA’s Pharmacovigilance Risk Assessment Committee builds on existing activities in the member states and the agency, and relies on collaboration with stakeholders. It focuses on four areas: measuring the effectiveness of risk-minimization measures on specific products; measuring the effect of specific pharmacovigilance processes (e.g., spontaneous reporting of suspected adverse reactions, signal management); investigating how to ensure engagement of key stakeholders (e.g., patients, healthcare professionals); and further improving methodologies to determine the effect of pharmacovigilance activities on public health.
The strategy includes an overview of activities and deliverables for implementation, along with a summary of the objectives for the next three years and a detailed work plan for 2016.
According to a statement issued by the EMA in January, among the current safety methods used in Europe are proactive planning of risk-minimization measures before a medicine is authorized; the collection and management of suspected adverse reaction reports; the detection and management of potential new safety signals for medicines; and the planning of post-authorization studies to generate data on the use of medicines in the real world.
“As new information emerges from these activities, regulators may take further actions to minimize risks,” the agency stated. “They can, for example, inform and advise patients and doctors on the best use of this medicine or restrict the use of a medicine in case the medicine’s benefits no longer outweigh its risks in a certain population.”
The EMA added that assessing the impact of pharmacovigilance allows regulators to determine which activities are most successful and helps promote best practice.
Board policy: Competing interests
The agency has also published its revised policy on handling competing interests for members of its management board. The policy, which aligns EMA’s management board policy with the agency’s policy on handling declarations of interests for scientific committee members and experts, will become effective on May 1.
“The effective management of competing interests of management board members is critical to ensuring the independence of the decisions of the board,” said Noël Wathion, EMA’s chief policy adviser. “The updated policy brings the rules for board members in line with those for scientific experts, while also taking into account the specific role of the board, without lowering the bar on the independence of its work.”
To ensure its scientific experts, staff, and management board do not have any financial or other interests in the pharmaceutical industry that could affect their impartiality, EMA has continuously reviewed its policies over the past few years. The board takes strategic decisions and supervises the corporate activities of EMA, such as setting the budget and approving its annual work program. It does not give recommendations on marketing authorizations of medicines.
For a EMA board member with a declared interest, the agency will apply a “risk-based” approach to determine the level of involvement in the activities of the management board. The approach will be based on four factors: the nature of the declared interest; the timeframe during which the interest occurred; the type of management board activity; the likely impact of the board’s decision on the pharmaceutical or other industry; and the type of action requested by the management board (e.g., whether a decision such as approval or endorsement has to be taken by the board or not).
The current “breach of trust” procedure on declarations of interests for management board members has also been revised. It was approved in December and went into effect on Jan. 1. The changes are linked with those introduced last year for the breach of trust procedure for scientific committee members and experts. The breach of trust procedure was developed in 2012 to deal with cases of incorrect or incomplete declarations of interests of board members.