Answer by the International Society of Drug Bulletins to the consultation on the "Concept paper  on pharmacovigilance implementing measures" (1)

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Brussels, 2 November 2011

Summary

• The "Concept paper on pharmacovigilance implementing measures” released for consultation is a technical document aimed at implementing the pharmacovigilance legislation adopted on 15 December 2010 (Directive 2010/84/EC and the Regulation (EC) 1235/2010).
   
• It reveals the consequences of the implementation of the new pharmacovigilance legislation. In practice, the first and critical step in pharmacovigilance, namely the detection of safety signals, is left to pharmaceutical companies, despite their conflict of interest.
   
• In addition, the proposition to rely on sophisticated technologies to detect signals and monitor data shows a deep misunderstanding on how pharmacovigilance works in practice.
  For example:
  
  • the proposed use of internationally agreed terminology can strip the spontaneous reports from all clinical meaning;
  • the use of statistics and a quantitative approach to detect and assess pharmacovigilance signals is often useless if not counterproductive. Few significant clinical cases very often suffice to make a relevant signal if they are reported to experienced and independent teams.
• As independent scientists and representatives of civil society, we take the opportunity of this consultation to urge the European Agency and National Competent Authorities not to rely too much on technical illusions such as "data mining” and "statistically significant signal detection”. Caution is especially required since pharmaceutical companies are expected to monitor to a large extent their own products.
   
• Transparency of decision making, including in the early "validation” stage of a suspected adverse drug reaction, is key to avoid missing safety assessment opportunities. 
   
• Concrete proposals for improvements include:
  
  • full transparency of the ongoing work on pharmacovigilance among National Competent Authorities  and the European Medicines Agency (minutes of ad hoc working groups and of pharmacovigilance committees made available online);
  • public access to the full content of the Eudravigilance database in order to allow independent teams to work on the data;
  • public access to the periodic safety update reports (PSURs) and to the assessment reports of the PSURs prepared by the Competent Authorities;
  • continuous monitoring of the pharmaceutical companies’ pharmacovigilance system, through inspections by health authorities, and not only "audits” by colleagues from the same pharmaceutical company even if they work in another department;
  • requirement for an annual report of the pharmaceutical company on their pharmacovigilance activities,  to be made publicly available on the Competent authorities’ website;
  • dissuasive penalties in case of non-compliance, withholding of data, or minimisation/misinterpretation of safety data.
• Political willingness to make the doubts benefit the public in the first place will be a decisive factor if pharmacovigilance is to be reinforced in Europe.

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Reference:
1 - European Commission Health and Consumers Directorate General “Implementing measures in order to harmonise the performance of the pharmacovigilance activities provided for in Directive 2001/83/EC and Regulation (EC) N° 726/2004” Brussels, Concept paper submitted for public consultation 08/09/2011
(Deadline for Public Consultation: 7 November 2011; sanco-pharmaceuticals@ec.europa.eu ; PCIM/11/01 - Public Consultation on Implementing measures for pharmacovigilance)