Masterstudiengang "Drug Regulatory Affairs"


National Requirements on Direct to Healthcare Professional Communication in the European Economic Area

Jessica Luppus (Abschlußjahr: 2010)

Language: English

The direct to healthcare professional communication (DHPC), sometimes also called "Dear Doctor Letter", is a risk communication tool to disseminate urgent new safety information about a medicinal product to healthcare professionals in a short timeframe.

Basic provisions for pharmacovigilance communication to the public are laid down in Directive 2001/83/EC as amended and in Regulation (EC) No 726/2004 respectively. More precise instructions for the MAH and the competent authority on the DHPC are laid down in Part IV of Volume 9A of the Rules Governing Medicinal Products in the EU as "Guidelines for Marketing Authorisation Holders and Competent Authorities on Pharmacovigilance Communication".

In Volume 9A, different phases of processing a DHPC are described during which the MAH closely interacts with the competent authorities. The relevant main contact points differ depending on the kind of procedure the medicinal product was authorised by, however, for all medicinal products there are times during the processing of the communication where the MAH is required to contact the national competent authorities where the medicinal product is authorised in. Additionally, the guideline encourages the MAH to take national procedures for dissemination and identification of the DHPC into account since they help to identify the communication among the healthcare professionals.

In order to analyse these national requirements on DHPC throughout the different member states of the EEA, the risk communication guidelines in the different member states were scanned and evaluated. In total, national regulations for 16 countries were located. These requirements can be generally divided into national requirements for the processing of a DHPC and requirements on the format of the communication.

Following this categorisation, 12 countries have national requirements on the processing of the DHPC in place, mostly to obtain a prior agreement with the respective national competent authority, but only 6 of these countries published detailed guidelines where the obligations for the MAH are explicitly described. 10 countries have different national requirements on the format of the DHPC in place, either with regard to the design of the letter or to make the information distinguishable to other communication.
These various different guidelines, mainly only published in the national language and sometimes hard to locate at all, make it complicated for the MAH to prepare and set up procedures for the different obligations in the member states in the event of a DHPC distribution.

The current legislative proposals issued by the European Commission to amend the legal framework for pharmacovigilance in the EU involve changes with regard to pharmacovigilance communication to the public. Among others points, it is planned that the EMA coordinates the communication and proposes a timescale for the planned publication in case that multiple Member States are involved. This approach must be considered reasonable, not only because it will hopefully lead to a consistent message throughout the different states, but it will also clarify obligations for the MAH and save the time which would be needed to go through the different national procedures. Additionally, the planned European pharmacovigilance web-portal could be used to publish national requirements, which would give the MAH the opportunity to prepare its own procedures for the varying demands in the different countries.

Pages: 44, Annex: 1, pages : 4