Tuesday, October 14, 2008

Access to Information or Promotion! Proposed EU Information Laws on Prescription Drugs

A proposed EU law, being considered by the Commission, to facilitate information on prescription-based medicine has been welcomed by the pharmaceutical sector but criticised by pharmacists, civil society and others as proxy advertising.

The EU originally launched a public consultation on its legal proposal on information for patients in February 2008. Responses and outcomes were subsequently analysed as mixed. The industry welcomed the measures, describing the proposal for non-promotional information as integral to achieving a healthier European society. The European Federation of Pharmaceutical Industries and Associations (EFPIA) in particular has supported the proposals as part of an overall policy of "access." But the developments that ultimately led to the publication of the consultation largely originated in strategic discussions for the pharmaceutical sector.

In 2000, the Council of Ministers issued its Conclusions on Medical Products and Public Health, which identified certain issues and factors relevant to the achievement of public health goals - both in terms of the public and in terms of industry advancement and European competitiveness in the pharmaceutical sector. This led to the Commission's establishment of a High Level Group on Innovation and the Provision of Medicines ("G10 Medicines") to examine issues for the pharmaceutical sector.

In May 2002, the G10 Group reported 14 recommendations, which included the recommendation for the creation of a forum dedicated to the pharmaceutical sector. In 2003, the Commission published a communication on a stronger European-based pharmaceutical industry for the benefit of the patient, a call to action in response to the report of the G10 Group. Included in that communication was the key action for the Commission to "explore, with stakeholders, a range of approaches to provide a realistic and practical framework for the provision of information on prescription and non-prescription medicines." And in 2005, the Pharmaceutical Forum was established to progress work according to the three key themes, which are coordinated within special working groups:
  • information to patients on pharmaceuticals

  • pricing policy

  • relative effectiveness.

A European Parliament conference Tuesday heard cautions against the proposed law simply resulting in proxy advertising for the pharmaceutical industry. Secretary General of the Pharmaceutical Group of the European Union (PGEU), John Chave (pictured at right), is not convinced of the need for the legislation: "If, however, the laws are to be changed, it is of fundamental importance that public confidence in the integrity of the information provided is maintained. The pushing of information by the industry should never be a proxy form of promotion or advertising. The sole justification for change can only be to help patients and not to grant more commercial freedom to the pharmaceutical industry." In its submission to the public consultation, the PGEU identified problems with self-regulation in the industry, among other concerns.

Arguably, a reliance upon receiving information from the industry (and indeed the proprietors themselves), where that information still requires intepretation and application by the individual patient in those circumstances, is not conducive to the genuine accessibility of health information. Rather, patient information and autonomy with respect to medicines should issue from contact with health care professionals and access to adequate and effective primary health care, including pharmacists and physicians. The information is therefore available as to alternatives, rather than tied to the product.

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