Increasing Patient Involvement in Regulatory Procedure

Patients are already involved in regulatory procedures at the European Medicines Agency (EMA) with patient representation on three of the scientific committees but in the decision of public access could patients be more involved in the Health Technology Assessment (HTA) decisions? Perhaps we have reached a point where another good step forward for better involvement would be to have representatives sitting on CHMP. As end users of the medicine, this is another effective way for patients to give their perceived view of benefit/risk of medicines in addition to the regulators or physicians.

A public survey conducted a few years ago by The Medicines and Healthcare products Regulatory Agency (MHRA) highlighted little awareness or interest of the organisation but the public felt it was important that someone was looking out for them and ensuring that medicines were safe. There is a lot more that can be done in communicating to the general public above having patient representative groups.

In the last year the UK has taken two actions with regard to safety restrictions on medicines involving the use of cough medicines in children under 6 and reducing pack sizes for products containing codeine. Although these changes were negotiated with regulators, pharmacists have since revealed that there was an overall lack of understanding from the general public who didn’t appreciate the problem and simply felt deprived of the medicine.

As part of requirements set out in Article 59(3) of Directive 2004/27/EC patients can now be involved in the testing of Patient Information Leaflets (PILs). However, patients can often list a whole host of side effects which can create a negative effect on patient compliance and patient confidence.

This further demonstrates that there is a need for the development of effective communication to the patient population away from patient organisations that could influence the risk/benefit decision both ways. The key is to effectively educate both medical professionals and patients whilst ensuring transparency in the regulation process.

TRAC is a regulatory affairs consultancy created in 2001 by Jonathan and Sarah Trethowan. We help pharmaceutical companies meet the regulatory requirements needed to market and sell their products within Europe. For a medicine to be marketed it needs to meet certain standards of quality, safety and efficacy set by governments and authorised by national regulatory bodies. We work with companies across the pharmaceutical, biotechnology, medical device and healthcare industries. For advice on Patient Information Leaflets visit www.tracservices.co.uk.