Request for a peer evaluation of the supervision function of the Danish

Health and Medicines Authority (DHMA)

The Danish Ministry of Health hereby kindly request EPSO to organise andpreform a peer evaluation of the DHMA’s supervisory function of the healthcare sector and licenced health care personnel that is preformed according tothe Danish legislation named in the Health Act § 212-222 and the Health Per-sonnel Act.According to the Health Act the main purpose of the DHMA´s supervision issurveillance, counseling and supervision.The Ministry is familiar with the peer evaluation that EPSO performed of theNorwegian Board of Health Supervision (Helsetilsynet) in 2011/12.The immediate reason for the request is a number of cases brought forward bythe press, that have introduced doubt whether the health care supervision ofthe DHMA lives up to the common expectation and predictability of a nationalsupervisory organisation.The Ministry therefore kindly request EPSO to coordinate and preform a peerevaluation of DHMA according to the same standards, as the evaluation of theNorwegian Board of Health Supervision.The peer evaluation should be done respecting the formal conditions such aslegislation and budgets, under which the DHMA works.

The aim of the evaluation

The aim of the evaluation is to determine whether the DHMA works in a waythat could be acknowledged as good supervisory practice and point out areasof improvement. Focus should be on the methods, documentation and abilityto react to and address issues of patient safety in the Danish health care sec-tor.The DHMA supervision of the health care sector is preformed by one centraldepartment (Supervision and Patient Safety) and 3 regional departments (TheRegional Medical Health Officers). The peer evaluation shall include all thementioned departments working with supervision and the collaboration be-tween these in the relevant areas.The DHMA supervision works with the following three major groups of focus:

The peer evaluation should give focus to the way concerns about licencedhealth personnel is handled by the DHMA and the reactions to these concernsand the handling of incident cases. The peer evaluation should evaluate if thechanges already made by the DHMA in 2011 are sufficient to manage a rele-vant quick reaction to licenced health personnel that put patient safety at risk.Also the evaluation should look at the risk organisations where supervision ispreformed proactively, such as Nursery Homes, Cosmetic Clinics and PrivateMedical Care and also the incident handling of risk organisations (case Glos-trup and Herlev).The handling of risk areas will often result in letters to the whole health caresector or binding guidelines. This task is only performed by the central de-partment of Supervision and Patient Safety. Concrete cases with issues of pa-tient safety in risk areas should include the handling of the use of misoprostolin birth inducement; the radiology case and the mammography case.The peer evaluation should also include an assessment of how the three riskareas interact and compliment each other considered in an international stan-dard.It should be up to EPSO to choose subjects to explore outside the areasstated in this request and to elect members of the Peer Evaluation Team. TheMinistry assumes that EPSO will handle any conflicts of interest in the connec-tion with the appointment of members of the Peer Evaluation Team.The Ministry will hope that EPSO will appoint a Swedish or Norwegian mem-ber of the Peer Evaluation Team due to translation issues. DHMA will providenecessary translation of documents after further agreement with the PeerEvaluation Team.The process and results of the peer evaluation should be documented by awritten report and we would be grateful if it could be presented for the Ministryat a meeting.

Practical issues

The Ministry hopes that the members of the Peer Evaluation Team can partici-pate as part of their daily work, with permission from their organisations. TheMinistry greatly appreciate this possibility.The Ministry is prepared to cover all direct expenses as costs related to traveland accommodation on field visits in Denmark. As a preliminary budget theMinistry will suggest an upper limit of DKK 300.000,-. Claims for reimburse-ment of expenses shall be sent to The Danish Ministry of Health, Holbergs-gade 6, 1057 Copenhagen K and will be dealt with according to Danish proce-dures.