Wednesday, 1 October 2014

Regulators go public

The European Medicines Agency (EMA) has a key role in medicines regulation in Europe. Part of its role is to coordinate the EU's safety-monitoring or 'pharmacovigilance' system for medicines. The Agency monitors the safety of medicines through the EU network and can take action if there is a safety concern. Its Pharmacovigilance Risk Assessment Committee (PRAC) provides recommendations on the safety of human medicines. Recently, the EMA launched a public consultation on draft rules of procedures for public hearings held by PRAC. Citizens have been invited to review the proposed draft rules and send their comments to the Agency.

One of the difficulties for outsiders is that it is hard to understand why the EMA arrives at particular decisions and what goes on behind the scenes regarding its processes. Not surprisingly, from time to time the regulators come in for criticism from physicians, industry and the public regarding transparency. In recent years there have been an increasing number of requests from outside parties for access to data that the EMA reviews on products.

The EMA has an ongoing commitment to providing greater clarity and openness in all areas of its operations. It has developed a transparency policy, which aims to promote a proactive approach to transparency in the daily operations of the Agency and submitted this for public consultation. It also held workshops to enable the draft policy to be discussed with stakeholders. The recent launch of a public consultation regarding PRAC is therefore part of a trend by the EMA to show that it is open and welcomes external views. Across the Atlantic, the Food and Drug Administration (FDA) has a more established reputation for holding events open to the public, although this does not prevent external criticism regarding its approach to transparency. One key opportunity for the public to engage with FDA is during the open public hearing (OPH) session of an advisory committee meeting. FDA’s advisory committees serve an important role in providing independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to products. The FDA has issued guidance on how individuals can participate in these public hearings.

Patients are increasingly involved in decisions regarding their health and so regulators will need to show that they are willing to proactively engage with the public regarding their decisions. The EMA has stated that since patients will ultimately be the ones taking the medicines they review, it would be logical to incorporate their knowledge into the regulatory process. However, in the absence of well-publicised mechanisms such as the FDA’s public hearings, European regulators face difficulties in proving that they really are open to external views.

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