The Responsible Officer

The Medical Profession (Responsible Officer) Regulations came into force in Northern Ireland on 1 October 2010 and in England, Scotland and Wales on 1 January 2011. This legislation can be accessed on the UK legislation website.

The Responsible Officer (RO) will play a crucial role in the revalidation process. Every doctor will need to connect to a RO who will make a recommendation to the GMC as to whether a doctor should be revalidated. The RO will also be responsible for ensuring that governance systems and appraisal in their organisation are working and are appropriate for revalidation.

ROs will be responsible for the doctors employed by, or contracted to, the designated body or organisation, or who have some other prescribed link; for example, through membership. Doctors will link to one RO only.

The regulations specify the organisations or bodies which are 'designated bodies' and which must appoint or nominate a RO. ROs must be licensed medical practitioners, such as a Medical Director within a healthcare organisation. The designation of such bodies or organisations and the associated requirement to nominate or appoint a RO will ensure that the vast majority of doctors will link to a RO.

The Faculty of Pharmaceutical Medicine has been named a designated body in the regulations and as such, will be in a position to provide a RO service to its membership. It is anticipated that the next round of legislation will involve the designation of pharmaceutical companies, although details are not yet available.

Designated Bodies for Revalidation

The following statement has been agreed between Faculty of Pharmaceutical Medicine and the Department of Health with regard to the designation of pharmaceutical companies for revalidation.

"Following the enactment of the Medical Profession (Responsible Officer) Regulations 2010 (the Regulations), it was understood that some pharmaceutical organisations were seeking to be designated explicitly in the legislation. Discussions with these companies suggested that they already carried out activities that would make them designated in the Regulations.

The Department of Health has now indicated that there will be no specific designation in the Regulations; individual pharmaceutical companies will have to decide whether or not they meet the criteria set out in the Regulations (i.e. they undertake certain activities and have a connection to one or more doctors) and are therefore a designated body. It is likely that companies will want to seek legal advice to confirm this.

Some designated bodies may have connections with only a small number of doctors; which might cause logistical difficulties and/or issues relating to conflict of interest or perception of bias. These organisations may wish to consider procuring responsible officer services (either the nominated role and/or the RO functions) through a third party. The designated body is responsible for procurement, assuring the quality of the RO service and for covering the cost on behalf of their connected doctors."

The Faculty of Pharmaceutical Medicine recommends that those organisations that decide they meet designated body status should contact the local SHA cluster responsible officer (RO) in the first instance to obtain advice. Thereafter, there is a requirement to complete the Organisational Readiness Self-Assessment (ORSA) document which can be obtained by contacting the NHS Revalidation Support Team.